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U.S. extends temporary general license for Huawei

The U.S. Department of Commerce on Friday announced that it was extending the Temporary General License that allows certain transactions with Huawei Technologies Co Ltd for another 90 days......»»

Category: topSource: reutersMay 15th, 2020

U.S. extends temporary general license for Huawei

The U.S. Department of Commerce on Friday announced that it was extending the Temporary General License that allows certain transactions with Huawei Technologies Co Ltd for another 90 days......»»

Category: topSource: reutersMay 15th, 2020

U.S. Department of Commerce extends Huawei temporary general license

See the rest of the story here. Theflyonthewall.com provides the latest financial news as it breaks. Known as a leader in market intelligence, The Fl.....»»

Category: blogSource: theflyonthewallNov 18th, 2019

Ukraine Is Top of the Agenda in Davos. But Some Fear Support From Businesses Has Peaked

On Day 2 in Davos, the Russian invasion of Ukraine was top of the agenda. But many also discussed "Ukraine fatigue" in the private sector. In 2023, TIME will once again recognize 100 businesses making an extraordinary impact around the world. Applications for the TIME100 Most Influential Companies of 2023 are open, now through March 1, 2023. Apply here. Hello from the Magic Mountain of Davos, where the World Economic Forum is well underway. We’ll be bringing you the latest from this week’s gathering, including insights on the most-talked about issues, quote-worthy things said, and more. You can find our first installment here. You can also pick up a copy of TIME’s Davos special issue in the Congress Centre or read our stories here. [time-brightcove not-tgx=”true”] The last time the WEF convened in May, it was three months into the Russian invasion of Ukraine—a topic that, unsurprisingly, dominated the gathering. This year, as the war approaches its first anniversary, Ukraine remains very much top of mind. World leaders have seized on every opportunity to reiterate their support for Ukraine. “We are in it for as long as it takes,” European Commission President Ursula von der Leyen told Ukrainian First Lady Olena Zelenska on Tuesday, a refrain that has since been echoed by German Chancellor Olaf Scholz, U.S. Sen. Joe Manchin, and Swedish Foreign Minister Tobias Billström. Several members of the U.S. congressional delegation have been spotted wearing U.S. and Ukraine flag pins on their lapels. Ukraine’s visibility extends beyond the forum’s main Congress Centre. On the promenade, Davos’s main thoroughfare, Ukraine House broadcasts images from the streets of war-torn Kherson. Russia House, previously a fixture on the promenade, is nowhere to be seen. Neither are any Russian officials. Though Ukraine remains central to the outward facing narrative at Davos and in conversations among the geopolitically-inclined, some Davos attendees told TIME that the same cannot be said for the forum’s more corporate-minded settings. “When you get into meetings with corporate actors, it has not been my experience that Ukraine is the primary concern of the agenda,” Amnesty International secretary general Agnes Callamard told TIME. “There is a sense on the part of the corporate sector that they’ve done what needed to be done for Ukraine.” Many, though not all, companies have suspended their operations in Russia. Others, such as Microsoft and Google, are providing humanitarian aid to the country. But for the war to end sooner rather than later, Ukrainian delegates told TIME, they need more support from the private sector—and not just after the war ends. “We really need the end and the victory to be this year,” says Ukrainian lawmaker Alona Shkrum, noting that neither Ukraine nor its partners can afford for this war to go on indefinitely. “We can win. We just need more weapons and more air defense.” Businesses donating humanitarian aid is one thing; supplying funding for defensive weapons systems is quite another. But as some Ukrainians see it, donated laptops to support the education of Ukrainian children can only go so far in a country that barely has electricity, let alone schools that can be shielded from Russian shelling. “It would be cheaper to buy the air defense systems and close the sky than to rebuild later,” says Ukrainian lawmaker Oleksandra Ustinova, who leads Ukraine’s temporary special commission on arms control. But understandably, she adds, “businesses don’t want to get into this.” More from TIME [video id=75LsRigI autostart="viewable"] The Ukrainian delegation are not the only ones raising the issue of the war at Davos. Belarusian opposition leader Sviatlana Tsikhanouskaya, the first representative from Belarus to attend WEF in three decades, has spent the past few days reminding attendees that the crises in her home country and Ukraine are intertwined. “Belarus now is overlooked, we feel this,” Tsikhanouskaya told TIME, noting that so long as Belarusian dictator and Kremlin ally Alexander Lukashenko remains in power, and so long as Minsk continues to host Russian soldiers on its territory, “there will be a constant threat to our neighbors.” Phrase of the day Ukrainian First Lady Olena Zelenska has been quizzed about many things during her time in Davos, though perhaps nothing more so than the prospect of “Ukraine fatigue.” “To be completely honest with you, I really have the fatigue of the questions about the fatigue,” Zelenska told TIME during a press briefing on Wednesday. Based on her experience at Davos, she added, “it seems like an exaggeration. And I think this may be a part of the information warfare because I think our enemy would be very happy if people were fatigued from Ukraine.” Hot topic ChatGPT and the potential of artificial intelligence (AI) have been hot topics at this year’s WEF. Microsoft chairman and CEO Satya Nadella extolled the virtues of GPT technology in conversation with WEF’s Klaus Schwab Wednesday. The company is reportedly mulling a $10 billion investment in OpenAI, the company behind ChatGPT. But as a TIME investigation reveals, the workers in Kenya who helped make ChatGPT possible faced poor working conditions. The story of these workers demonstrates that for all its glamor and buzz, AI often relies on hidden human labor in the Global South that can be damaging and exploitative. These invisible workers remain on the margins even as their work contributes to billion-dollar industries. Peak moments German Chancellor Olaf Scholz pledged to continue supporting Ukraine “as long as necessary” amid calls for Berlin to authorize the export of German-made Leopard tanks to Kyiv. When asked by a Ukrainian delegate about Berlin’s “hesitancy,” Scholz said such decisions would have to be taken in coordination with “friends and partners.” Scholz also announced Germany’s ambition of attaining climate neutrality by 2045. Ukrainian President Volodymyr Zelensky led a minute of silence in honor of the 14 people killed in Wednesday’s helicopter crash in Kyiv, including Ukrainian Interior Minister Denys Monastyrsky. “Tragedies are outpacing life,” Zelensky said afterwards. “The time the free world uses to think is used by the terrorist state to kill.” (Zelensky’s conversation with TIME Editor-in-Chief Edward Felsenthal was canceled in light of the crash.) The promenade in Davos was lit up with rainbow colors at many venues on Wednesday evening in a show of support for the LGBTIQ+ community. “Pride on the Promenade” was launched by the Partnership for Global LGBTIQ+ Equality—a coalition of companies that is an initiative of Business for Social Responsibility, the U.N. Office of the High Commissioner for Human Rights, and the WEF—and GLAAD. Speaking at the launch, U.N. High Commissioner for Human Rights Volker Türk called for more “support and protection to human rights defenders and civil society, particularly in locations, and on issues, that currently receive little funding and attention.” Courtesy of METAVisitors walk along the Rainbow Promenade in Davos. Spotted at Davos Amnesty International secretary general Agnes Callamard catching up with David Nabarro, the World Health Organization’s Special Envoy on COVID-19, in the forum’s bustling central lounge. Looking ahead South Korean President Yoon Suk Yeol will address the forum on Thursday at 5:30 a.m. ET. Ukrainian President Volodymyr Zelensky will make a virtual address on a panel alongside former British Prime Minister Boris Johnson, Dutch Prime Minister Mark Rutte, BlackRock chairman and CEO Larry Fink, and others. —With reporting by Ayesha Javed.....»»

Category: topSource: timeJan 19th, 2023

Jim Grant Warns "Japan Is Perhaps The Most Important Risk In The World"

Jim Grant Warns "Japan Is Perhaps The Most Important Risk In The World" Authored by Christoph Gisiger via TheMarket.ch, Speculation is mounting that the Bank of Japan is losing control of the bond market. Jim Grant, editor of «Grant’s Interest Rate Observer», believes this could trigger a shock to the global financial system. He also explains why he expects further surges in inflation and why gold should be part of your portfolio. The news caught markets off guard: On December 20th, the Bank of Japan surprisingly extended the target range for the yield on ten-year government bonds to plus/minus 0.5%. A move that not a single economist had expected. This week, the Bank of Japan could announce a major policy shift amid rising government bond yields and a strengthening yen. Although barely a month has passed since the BoJ’s last meeting, the bond market is already testing the new upper limit of the yield curve control regime. «To us, Japanese interest rate policy resembles the Berlin Wall of the late Cold War era, a stale anachronism that must sooner or later fall,» says Jim Grant. For the editor of the iconic investment bulletin «Grants’ Interest Rate Observer,» recent developments in Japan pose an underestimated risk to global financial markets. Not least because virtually no one is talking about it. In an in-depth interview with The Market NZZ, which has been slightly edited for clarity, Mr. Grant explains what it means for financial markets if the Bank of Japan is forced to scrap its yield curve control policy. But first, he says why he doesn’t believe inflation will end soon, why bonds may be at the start of a long bear market, and why he believes gold is the best choice as a store of value. «If the past is prologue and if the great bond bull market is over, then on form, we are looking at what could be a very prolonged and perhaps gradual move higher in interest rates»: Jim Grant. What do you observe when you look at the financial world today? Well, it’s always the same, and - here’s the catch - it’s always a little different. The trick is to identify the unique or unusual feature of a familiar cycle. In this regard, it helps to know a little bit of financial history, and to just that extent it helps to be a little old. But what is not helpful is to mistake the past for a certain roadmap to the future. What are currently the most important developments from a historical perspective? The essential driver of so much of today’s news are the consequences of the monetary regime in place worldwide. That regime has given us artificially low, indeed suppressed rates of interest, and it has given us the consequences of those false rates which include rampant misallocation of capital and great gusts of speculation; some of which are a lot of fun, and some of which are quite lucrative to the clever people who can get in on them. However, in the wake of the surge in inflation last year, interest rates have risen rapidly. Now inflation seems to be subsiding. Was the rise in prices only temporary after all? Plainly, the rate of change has subsided, but what is often ignored is the level of inflation. The rate of change is everyone’s preoccupation, but the loss in purchasing power is never recovered. This is the nature of a fiat currency regime. Way back under the gold standard, prices would rise on average and they would fall on average, but at the end of very long cycles, they would be unchanged. In contrast, a fiat currency regime is characterized by the fact that prices ratchet ever higher and never are allowed to correct to the downside. So what we have is a very elevated level of average prices and a somewhat lower rate of rise in these prices. Then again, the tension in the markets has eased somewhat recently. Stocks have made a surprisingly good start to the new year. Certainly, the slowing rate of the rise in inflation is to be celebrated. It’s nice, but we are still left with a system that is inherently inflationary. Here in the United States, it’s a system given to very free and loose public spending, given to great entitlements for one and all, and it’s a system that has flourished in recent years with very low, suppressed rates of interest. To me, that’s the essence of an inflation generating system: Politically, inflation is kind of something for nothing, and that seems to be part of the political zeitgeist. That’s why I would be a little bit guarded in pronouncing the end of this inflationary episode. Why do you think the issue of inflation could keep us on the edge for some time? Inflation in such a system resembles one of these inextinguishable long-burning underground coal mine fires. I’m not sure if you have them in Switzerland, but in Pennsylvania for example there has been such a fire that’s been going on for around fifty years. You don’t always see it, but it flares to the surface from time to time. It’s always there, it’s always latent, leaking smoke, warming the soles of your shoes. To me, that is a good analogy for inflation in a free spending and paper currency issuing social democracy. So are we at a fundamental inflection point heading into a new cycle, characterized by higher inflation and rising interest rates? Yes, and I say that with well deserved humility because «Grant’s Interest Rate Observer» was calling the end of the secular bull bond market at least a decade before it ended. Looking back, the last great secular bond bear market began in the spring of 1946 in the US and most of the world. It ended in the fall 1981, 35 years later. What followed, of course, was the still greater and more prolonged bond bull market. It began in October 1981 and perhaps ended in 2020 when the ten-year treasury yield got down to 0.5%. What kind of scenario could now be in store? If the past is prologue and if the great bond bull market is over, then on form, we are looking at what could be a very prolonged and perhaps gradual move higher in interest rates. We ought to remember that the first ten years of the last bond bear market were characterized by a very gradual increase. It was hardly noticeable. Yields on long-term bonds rose by about ten basis points a year. The treasury yield started off at 2.25% in 1946, and then in 1956 it was at around 3.25%. So with all these qualifications: Yes, I think the bond bull market is over and a bond bear market has begun. Why do bond market cycles last such a long time? I’m a little weary of saying that the bond market does these things as opposed to that it has done them in the past. But it has exhibited that tendency. At the risk of being pathetic, I would say that since at least the middle of the 19th century bonds have exhibited the tendency to move up and down in yield over the course of decades or generations. I’m not sure anyone can fully explain why. And, because we can’t explain it, we can’t be dogmatic about it continuing in just this way. But again, if past is prologue, we are in for a very long phase or cycle of rising interest rates. However, supply chain problems seem to be largely resolved; in the semiconductor industry, for example, there is already overcapacity and full inventories. What are the drivers of inflation in the next few years? One of the things I’ve learned in the fifty years in this business is to be a little bit less doctrinaire about such things as the cause of inflation. Milton Friedman famously said it’s «always and everywhere a monetary phenomenon». At some trivial level, that is undeniable because inflation involves money. Then again, you could also argue that it cannot be a monetary phenomenon because the purchasing power of money by definition is a casualty of inflation. As to the cause of inflation, there is a whole new school now arguing that it is a fiscal phenomenon. I think there is something to that, as there is something to the Friedmanite view. There is something to the idea that it is a political phenomenon, it’s a characteristic of politically weak societies. But the Federal Reserve assures us that it can bring inflation under control. I think that we have not seen the last of this inflationary outburst. But one needs to be quite humble in the face of something that very few central bankers anticipated or even could have imagined. It wasn’t just that the Fed didn’t predict it, but when the Fed saw it, when it saw the whites of inflation’s eyes, it still couldn’t believe it and continued with its QE program until the end of March 2022. It looks like markets are now gradually shifting their focus to the threat of recession. Does Fed Chair Jerome Powell have the stamina to «get the job done» in curbing inflation, as he says? Hardly a day passes without one regional Fed president or another declaring that the FOMC will most definitely push the funds rate to 5% or higher and hold it there for six months or a year or maybe two. What I object to these pronouncements is the unseemly certitude that they convey. The Fed seems so sure of itself. It was so sure of itself when it was predicting just as confident in 2021 that a 10 basis-point funds rate was a lock through 2023. Their cocksureness does not become them. The future is a closed book, not an open book. Especially, it is a closed book to people who mobilize pseudo-scientific mathematical models of the workings of the financial economy because they really don’t understand it. Usually, the Fed raises interest rates until there is an «accident» somewhere in the financial system or the economy. Is that going to be the case this time as well? The Fed is not a believer in the likelihood of accidents. I’m not sure that it understands the risks its previous QE regime has introduced into the financial system, specifically the heavy leverage in Corporate America, and still more particularly the leverage in private equity for example. Of course, a lot of speculation has been wrung out of the system already, certainly in cryptocurrencies, in SPACs and such things. Where could such an accident occur? I think Japan is perhaps the most important risk in the world, not least because it is among the least discussed risks, certainly in the Western press. Mostly, it’s very much an afterthought. The risk is this: Every business day, the Bank of Japan is spending tens of billions of dollars worth of yen to enforce governor Kuroda’s yield curve interest rates suppression program. To put this into perspective: In the UK, when the little crisis over liability driven pension investing in late September happened, the Bank of England spent around $5 billion. The BoJ does that before breakfast. The Bank of Japan already introduced its policy of yield curve control in the fall of 2016 by keeping the yield on ten-year government bonds within a target range through direct interventions in the bond market. Why should it change its monetary policy now? Governor Kuroda, who’s term is up on April 8, insists that yield curve control is here to stay. But to us, Japanese interest rate policy resembles the Berlin Wall of the late Cold War era, a stale anachronism that must sooner or later fall. And why specifically now? What’s different is that the market is on to something. I say that because the Bank of Japan has already lifted the allowable ceiling on ten-year JGB yields to 0.5% from 0.25% at the end of last year. Kuroda said it was nothing more than a means to the end of ensuring the success and stability of a permanent regime of yield suppression. But the market is like a very ill-behaved dog at the end of a leash. It’s wheezing and frothing, and the Bank of Japan is yanking ever harder and tighter to control this beast. Why do you think this beast will finally break free? Kuroda stated that the Bank of Japan is not going to stop until there is inflation. Well, Tokyo’s consumer prices which precede the national CPI rose to 4% in December versus expectations of 3.8%. What’s more, Uniqlo and other corporate leaders are out announcing that they are raising wages significantly. You will find other stories to this effect, signs and precursors of a change. Some former governors of the Bank of Japan are now venting their views that this has gone far enough and the consequences will be devastating. So I think this is a huge risk just offstage and the world has to pay closer attention to it. What’s the risk if the Bank of Japan gives up control of the yield curve? What makes it a risk for everybody, whether you are Swiss, American, German or Japanese, are two things. First of all, suppressed rates prompt leveraged individual and corporate balance sheets which at the shock of a rise in interest rates will get into trouble. There are troubles buried in the financial statements of Japanese companies that have borrowed too much. Sure, Japanese businesses are not as inclined as, say, American ones to borrow excessively, but there are also risks regarding a lot of bank saving schemes or structured products in Japan. For instance, you get a yield of 0.75% for five years, but in the fine print there is some caveat that if rates go above a certain level then the duration of this product extends to ten years. I’m making these numbers up, but it’s essentially what the risk is. And what is the second risk? The Japanese are a frisky nation. They have an immense amount of net savings, and some $3 trillion of Japanese assets are invested in non-Japanese markets, of which half are domiciled in the United States. In other words, the Japanese, the proverbial Mrs. Watanabe, search the world for yield opportunities. According to Bloomberg, expressed as a percentage of the GDP of the country in which they are invested, Japanese stock and bond holdings break down to 7.3% of America, 7.5% of France, 8.3% of Australia and 9.5% of the Netherlands. What is going to happen if suddenly Japanese yen denominated rates become rather attractive? Well, a lot of this money may be repatriated and the result of that repatriation will be a rise in volatility in markets we can’t really identify now. So the risk of a volatility upsurge is considerable. I think the time is getting ripe for a big change in Japanese rates structure and therefore in interest rates and in the risk presented to bond holders worldwide. What is your advice to investors in this environment? Having just mocked the central banks for their pretending to know what they can’t know, I’m in a very compromised position if I were to say what is going to happen. But allow me to suggest that I’m somewhat of a broken record on gold. I’m going to continue with this broken record and observe that people have not yet come to terms with the essential inherent weaknesses of the monetary system that has been in place since 1971. We have all gotten used to it. I mean, you have to be a person of a certain age, indeed you have to be as old as I am, to really recall the debates surrounding the abandonment of Bretton Woods. People have grown up with the idea that money is what they print, and if the Japanese can print $50 billion a day with which to suppress interest rates, that doesn’t shock many people. But I think such shocks do lay ahead. And gold can help protect a portfolio against such shocks? I think that the strains that are already obvious will become more so. People will be looking around not for a better brand of paper or digital money, but rather for the real McCoy. In every issue of «Grant’s» we have something to say about a stock, so I don’t want to sound too much of a nutcase. We do live in the real world. But when I look at the very big picture, the money the central banks produce in such profusion is unsound. It may not be now, but in time, people will look around for an alternative and that alternative may just be gold - the thing that has been more or less a shadow cast by Bitcoin, Ethereum, and all the other crypto currencies. Against this background, how do you assess the general outlook for the stock market? The market has come down from extremely overvalued to nearly expensive, and my observation is that an extremely overvalued market does not normally bottom out at nearly expensive. So I’m not sure that’s the end of things. I don’t find a whole lot of compelling values in the stock market. Sometimes, one has great conviction, but not now with regard to stocks for me. Are there any exceptions that appear attractive from a value perspective? In one of our recent issues, we had a story on Transocean. The stock had a little move, it’s gone up from $2.50 to $5 or something in that order, but we’re still bullish. It’s a high-tech story. The technology happens to pertain to fossil fuels, therefore it’s beyond the pale for «properly sensitive fiduciaries» to put it this way. But it is a very impressive business which happens to have the flaw of a highly leveraged balance sheet. So there is considerable risk, but I think the risk is less compelling now than the reward. So if you ask about something to be bullish on, I would suggest Transocean. Tyler Durden Tue, 01/17/2023 - 18:20.....»»

Category: blogSource: zerohedgeJan 17th, 2023

Citius Pharmaceuticals, Inc. Reports Fiscal Full Year 2022 Financial Results and Provides Business Update

$41.7 million in cash and cash equivalents as of September 30, 2022; extends runway through December 2023 Mino-Lok® Phase 3 trial closer to completion with 169 patients recruited, 72 failure events and 17 patients in active treatment or pending data review I/ONTAK BLA accepted for filing by the FDA; updated PDUFA target action date is July 28, 2023 Halo-Lido Phase 2b trial progressed; data readout expected 2H 2023 Multiple value-driving catalysts anticipated in 2023, including a potential drug approval and two trial completions CRANFORD, N.J., Dec. 22, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal full year ended September 30, 2022. Fiscal Full Year 2022 Business Highlights and Subsequent Developments Completed Pivotal Phase 3 trial of I/ONTAK (E7777) and submitted biologics license application (BLA) to the U.S. Food and Drug Administration (FDA); FDA confirmed Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2023; Advanced Mino-Lok® Phase 3 trial: Expanded trial to additional sites in India for an anticipated total of 35 clinical trial locations globally, Enrolled 169 patients to date, exceeding recruitment goal of 144 patients, Observed 72 of 92 required catheter failure events, with 17 patients in active treatment or pending study completion data review (which may contribute additional failure events); Initiated Phase 2b trial of Halo-Lido for the treatment of hemorrhoids in April 2022; patient enrollment ongoing with data readout expected 2H 2023; Initiated clinical collaboration with the University of Pittsburgh to evaluate regulatory T-cell (T-reg) depletion with I/ONTAK (E7777) in combination with pembrolizumab in recurrent or metastatic solid cancer tumors in a Phase 1 investigator-initiated trial, with first patient enrolled in November 2022; and, Approved for $3.6 million in non-dilutive capital through the New Jersey Economic Development Program to support ongoing research and development efforts. Financial Highlights Cash and cash equivalents of $41.7 million as of September 30, 2022; R&D expenses were $17.7 million for the full year ended September 30, 2022, compared to $12.2 million for the full year ended September 30, 2021; G&A expenses were $11.8 million for the full year ended September 30, 2022, compared to $9.8 million for the full year ended September 30, 2021; Stock-based compensation expense was $3.9 million for the full year ended September 30, 2022, compared to $1.5 million for the full year ended September 30, 2021; and, Net loss was $33.6 million, or ($0.23) per share for the full year ended September 30, 2022 compared to a net loss of $23.1 million, or ($0.23) per share for the full year ended September 30, 2021. "In 2022, we focused on execution across our key development programs: I/ONTAK, Mino-Lok and Halo-Lido. These efforts, combined with a prudent use of funds, enabled us to meaningfully advance our pipeline. We believe we have sufficient runway through December 2023 to realize additional value-creating milestones, including a potential FDA approval and two anticipated trial completions in the coming calendar year," stated Leonard Mazur, Chairman and CEO of Citius. "Our Phase 3 Mino-Lok trial is now significantly closer to completion.  While we expected to achieve 92 catheter failure events with 144 patients by the end of 2022, the trial's observed catheter failure event rate has proven to be lower than anticipated. Consequently, we must continue recruiting patients. By successfully re-engaging with our U.S. trial sites as they recovered from the impact of Covid, we were able to drive patient recruitment. We have now exceeded our targeted enrollment and have achieved 72 of the required catheter failure events, with additional patients under review. To augment our recruitment efforts and continue the positive momentum in enrollment, we expanded the Mino-Lok trial to include sites in India. Once all new trial sites are fully activated, we will have nearly doubled our clinical site footprint. With these additional sites helping to drive incremental enrollment, we anticipate that the 92-event threshold required to complete the trial is achievable in the coming months," added Mazur. "During the year, we also completed a Phase 3 trial and submitted a BLA for I/ONTAK, an oncology asset we in-licensed just over a year ago. Upon further discussion with the FDA, the PDUFA target date has been set for July 28, 2023.  We remain committed to establishing a robust commercial infrastructure to support I/ONTAK's successful product launch, if approved. In the second half of 2022, we also extended our support for a Phase 1 investigator-initiated study of I/ONTAK in combination with pembrolizumab (Keytruda®1) to treat patients with recurrent or metastatic solid tumors. This study has begun recruiting patients and is the second investigator-initiated trial to explore I/ONTAK's potential as a combination therapy in much larger immuno-oncology markets. We continue to believe I/ONTAK's value extends beyond a potential initial indication in persistent or recurrent cutaneous T-cell lymphoma. Earlier in the year, we announced our intention to spin off I/ONTAK. Given broader market conditions, we continue to evaluate opportunities to further unlock this asset's value," continued Mazur.     "In addition to advancing our Phase 3 trials, we initiated a Phase 2b trial for Halo-Lido, our prescription strength topical formulation for hemorrhoids.  The trial began enrolling patients with symptomatic Grade II or III hemorrhoids in the second quarter of 2022. Recent recruitment has accelerated and we expect complete trial data available in the second half of 2023," added Mazur. "As financial stewards, we continuously evaluate the optimal capital structure for the company. We believe our anticipated catalysts, along with a healthy cash position, provide us with several strategic and financial options with which to continue advancing our pipeline. This may include the previously announced potential spinoff of I/ONTAK into a standalone oncology company, pending market conditions, and other standalone financing alternatives available to us. We are encouraged by the multiple value-driving catalysts anticipated in calendar 2023, including a potential drug approval and two trial completions, and look forward to extending our positive momentum in the months ahead," concluded Mazur. 1 KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA FULL YEAR 2022 FINANCIAL RESULTS: Liquidity As of September 30, 2022, the Company had $41.7 million in cash and cash equivalents. As of September 30, 2022, the Company had 146,211,130 common shares outstanding. The Company estimates that its available cash resources will be sufficient to fund its operations through December 2023. Research and Development (R&D) Expenses R&D expenses were $17.7 million for the full year ended September 30, 2022, compared to $12.2 million for the full year ended September 30, 2021. The increase of $5.5 million is primarily associated with the completion of the I/ONTAK (E7777) Phase 3 trial and the preparation and submission of the related Biologics License Application to the FDA, incremental Mino-Lok Phase 3 trial costs related to the addition of a global clinical research organization, Biorasi, and the opening of international sites in India, as well as costs associated with the initiation of the Halo-Lido Phase 2 study. The increase was offset primarily by a one-time $5 million license fee paid to Novellus in the year ended September 30, 2021, which did not recur. We expect that research and development expenses will continue to increase in fiscal 2023 as we continue to focus on the anticipated commercialization of E7777, our Phase 3 trial for Mino-Lok, our Phase 2b trial for Halo-Lido, and accelerate our research and development efforts related to Mino-Wrap and ARDS. General and Administrative (G&A) Expenses G&A expenses were $11.8 million for the full year ended September 30, 2022, compared to $9.8 million for the full year ended September 30, 2021. The increase was primarily due to additional compensation costs for new employees and investor relations expenses. General and administrative expenses consist primarily of compensation costs, consulting fees for our financing activities and corporate development services, and investor relations expenses. Stock-based Compensation Expense For the full year ended September 30, 2022, stock-based compensation expense was $3.9 million as compared to $1.5 million for the prior year. The increase reflects expenses related to new grants made by Citius and the NoveCite stock option plan.  In fiscal year 2022, we granted options to our new employees and additional options to other employees, directors, and consultants. Stock-based compensation expense includes options granted to directors, employees, and consultants. At September 30, 2022, unrecognized total compensation cost related to unvested options for Citius common stock of $5.3 million is expected to be recognized over a weighted average period of 1.9 years and unrecognized total compensation cost related to unvested options for NoveCite common stock of $0.2 million is expected to be recognized over a weighted average period of 1.5 years Net loss Net loss was $33.6 million, or ($0.23) per share for the year ended September 30, 2022, compared to a net loss of $23.1 million, or ($0.23) per share for the year ended September 30, 2021. The increase in net loss is primarily due to the $5.4 million increase in our research and development expenses, a $1.9 million increase in general and administrative expenses, and a $2.4 million increase in stock-based compensation expense. About Citius Pharmaceuticals, Inc. Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The Company's diversified pipeline includes two late-stage product candidates, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections, which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK (E7777), a novel IL-2R immunotherapy for an initial indication in CTCL, for which a BLA is under review by the FDA.  Mino-Lok® was granted Fast Track designation by the FDA. I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and PTCL. In the first half of 2022, Citius initiated a Phase 2b trial for Halo-Lido, a topical formulation for the relief of hemorrhoids. For more information, please visit www.citiuspharma.com. Safe Harbor This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price.  Factors that could cause actual results to differ materially from those currently anticipated are: our ability to successfully undertake and complete clinical trials and the results from those trials for our product candidates; risks relating to the results of research and development activities, including those from existing and new pipeline assets; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our need for substantial additional funds; our dependence on third-party suppliers; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; our ability to commercialize our products if approved by the FDA; market and other conditions; our ability to attract, integrate, and retain key personnel; risks related to our growth strategy; patent and intellectual property matters; our ability to attract, integrate, and retain key personnel; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; our ability to procure cGMP commercial-scale supply; government regulation; competition; as well as other risks described in our SEC filings. These risks have been and may be further impacted by Covid-19. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings which are available on the SEC's website at www.sec.gov, including in our Annual Report on Form 10-K for the year ended September 30, 2022, filed with the SEC on December 22, 2022 and updated by our subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Relations for Citius Pharmaceuticals: Investor Contact:Ilanit Allenir@citiuspharma.com 908-967-6677 x113 Media Contact:STiR-communicationsGreg SalsburgGreg@STiR-communications.com  -- Financial Tables Follow – CITIUS PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS SEPTEMBER 30, 2022 AND 2021  2022 2021 ASSETS Current Assets: Cash and cash equivalents $ 41,711,690 $ 70,072,946 Prepaid expenses 2,852,580 2,741,404      Total Current Assets 44,564,270 72,814,350 Property and equipment, net 4,100 7,023 Operating lease right-of-use asset, net 646,074 822,828.....»»

Category: earningsSource: benzingaDec 22nd, 2022

46 landmark Supreme Court cases that changed American life as we knew it

The US Supreme Court has made many sweeping, landmark decisions. Here's a primer on 46 of the most important ones, and how they changed American life. Members of the Supreme Court sit for a new group portrait following the addition of Associate Justice Ketanji Brown Jackson, at the Supreme Court building on Friday, Oct. 7, 2022.AP Photo/J. Scott ApplewhiteThe US Supreme Court was formed in 1789. It's gone from five seats to 10, and is now fixed at nine.It makes fewer than 100 decisions every year, but its choices have had a huge impact on the country. Some decisions have empowered women, helped protect the environment, or guaranteed a person's right to expression. Others have strengthened racist laws, enabled forced sterilization, and allowed unequal schooling.Here is a guide to 46 of the Supreme Court's most impactful decisions.Visit Business Insider's homepage for more stories.The US Supreme Court, the court of last resort, has undeniably changed the country.It makes fewer than 100 decisions every year that have sweeping effects on American life.Some have changed race relations for the better, empowered women, given the press freedom to operate, guaranteed a person's right to expression, or reiterated that the president is not above the law.Not every decision has aged well. Other decisions have enforced slavery or create uneven schooling in the US.Most recently, the court overturned a landmark case that legalized abortion in 1973.Here are 45 of the most important cases the Supreme Court has ever decided.Marbury v. Madison (1803)President James Madison.Wikimedia CommonsThe case: Before President Thomas Jefferson took office in 1801, lame duck John Adams and Congress created new courts and appointed dozens of judges, including William Marbury as Justice of the Peace in the District of Columbia. But the new administration's Secretary of State James Madison wouldn't validate the appointment. So Marbury sued.The decision: The justices ruled unanimously that Madison's refusal was illegal, and that the law Marbury had sued under was also unconstitutional. More importantly, this ruling held that the Supreme Court had the power of "judicial review" to decide whether a law or executive action is constitutional. This essentially gave the high court the legal authority for every decision it would make in the future.Gibbons v. Ogden (1824)A steamboat passes beneath Brooklyn Bridge on its way to the Atlantic.APThe case: In 1808, New York state gave Aaron Ogden a 20-year license to operate his steamboats on waters within the state. Thomas Gibson, another steam boat operator and Ogden's former business partner, was also working in the area, with a license from the federal government. Ogden claimed Gibbons was undercutting his business by unfairly competing. He wanted Gibbons to stop operating, and argued his license was enforceable, even though it was on interstate waters. Gibbons argued that the US Constitution gave Congress power over interstate commerce.The decision: The Supreme Court unanimously held states cannot interfere with Congress's ability to regulate commerce. State laws had to yield to constitutional acts by Congress, so the court ruled in Gibbon's favor. It was an important early decision finding that federal governments had the ability to determine interstate commerce.Worcester v. Georgia (1832)Samuel Worcester.WikimediaThe case: In 1828, Georgia passed laws prohibiting anyone except Native Americans from living on Native American land. Samuel Worcester, a missionary, was living on Native American land and refused to apply for a license. He was arrested and appealed, arguing his removal was a violation of his constitutional rights, as Georgia had no jurisdiction on Native American land.The decision: The Supreme Court held, 5-1, that the Cherokee Nation was a sovereign "distinct community." It struck down the Georgia law prohibiting white people living on Native American land. The case was important because it set out the relationship between tribes, states, and the federal government. It meant that interaction with Native American states became a federal process, and provided some sovereignty when interacting with the US government.But it wasn't always enforced. Then-President Andrew Jackson said, "John Marshall has issued his decision. Let him enforce it."Charles River Bridge v. Warren Bridge (1837)Chief Justice Roger Brooke Taney.WikimediaThe case: In 1785, Massachusetts gave the Charles River Bridge Company a charter to build a bridge between Boston and Cambridge. In exchange for covering the costs of building and maintaining it, the company could collect tolls until the charter ended.But in 1828, a second company was authorized to build a competing bridge that would be free to the public, Charles River Bridge sought an injunction to prevent the second bridge from being built.The decision: The Supreme Court held 5-2 that the authority given to Charles River never granted them a monopoly, and that general welfare would be enhanced with a second bridge. The court said the responsibility of government was to promote the happiness and prosperity of the community.Dred Scott v. Sandford (1857)A painting of Dred Scott by Louis Schultze.Bettmann / GettyThe case: This case arose from a suit brought by a slave in Missouri named Dred Scott. Scott had lived for a time in the free state of Illinois. When his master died in 1849, he sued the widow, arguing his time in the slave-free state made him a free man.The decision: The Supreme Court held 7-2 that since Scott's ancestors were imported into the US and sold as slaves, he could not be an American citizen. Since he wasn't a citizen, he had no jurisdiction to sue, which also meant that black people living free in the north were barred from federal courts.  The court also held that under the Fifth Amendment, slaves were property, and any law that deprived a slave-owner of their property was unconstitutional.The decision is thought to be one of the factors that led to the Civil War.Munn v. Illinois (1877)Chief Justice Morrison Waite wrote the majority opinion.WikimediaThe case: In 1871, Illinois passed legislation that set the maximum rate private companies could charge for storing and transporting agricultural goods. Munn, a grain warehouse, charged too much and was found guilty of violating the law. It appealed, arguing the regulation was an unconstitutional removal of property.The decision: The Supreme Court held 7-2 that the law was constitutional, and that the state can regulate private industries when it affects the public. Since storage facilities were devoted to the public, they could be regulated. This case allowed states to regulate businesses within their borders. It was important because it showed how private enterprises could be publicly regulated.Plessy v. Ferguson (1896)John Marshall Harlan.WikimediaThe case: Homer Plessy, who was black under Louisiana law of the time, boarded a train and sat in a car that was reserved for white passengers. When he refused to move, he was arrested. Plessy argued that the Separate Car Act, which required all railroads to provide equal but separate accommodation, was violating his rights under the 14th Amendment's equal protection clause.The decision: The Supreme Court held 7-1 that "separate but equal" accommodations for whites and blacks did not violate the 14th Amendment.Justice John Marshall Harlan, known as the "great dissenter," wrote that the Constitution was color-blind, and the US had no class system. "There is in this country no superior, dominant, ruling class of citizens; there is no caste here. Our Constitution is color-blind, and neither knows nor tolerates classes among citizens," he wrote. Despite his dissent, the decision solidified the "separate but equal" doctrine for the next six decades.Lochner v. New York (1905)Justice Rufus W. Peckham wrote the majority opinion.WikimediaThe case: In 1897, New York passed a labor law limiting the working week for bakers to 60 hours. Joseph Lochner, a Bavarian baker, was fined twice, because his employees worked more than 60 hours. Lochner appealed, arguing the law was unconstitutional.The decision: The Supreme Court held 5-4 that the New York law was unconstitutional. The court said the law interfered with the contract between an employer and and his employees.This decision was widely condemned. For the next three decades, the court struck down minimum wage laws, rights to organize, and child safety laws using Lochner as precedent, before reversing course and allowing such laws.Abrams v. United States (1919)Oliver Wendell Holmes in 1902.WikimediaThe case: In New York, five Russian anti-war activists were arrested under the 1917 Espionage Act for printing and distributing 5,000 leaflets that criticized the US's role in World War I. They also advocated for a general strike, and had put out a call to arms if the US intervened in Russia. They were sentenced to prison for up to 20 years. They appealed.The decision: The Supreme Court held 7-2 that the Espionage Act was valid, and that it was a crime to willfully publish "disloyal" language about US politics, arguing that such speech was not protected by the First Amendment.One of the most important things to come out of this case is Justice Holmes' dissenting opinion. He argued that the government should only regulate people's expression when it was required to save the country.Commonwealth of Massachusetts v. Mellon (1923)Justice George Sutherland wrote the opinion.WikimediaThe case: The 1921 Maternity Act gave states money for programs aimed to help mothers and their infants. A woman named Frothingham thought the act would lead to an increase in her taxes, so she tried to sue the federal government. The issue was whether a taxpayer had standing to sue, when the only injury was going to be an increase in taxes.The decision: The Supreme Court unanimously held she did not have standing because the injury was too small and indeterminable. It led to the legal concept of a "particularized" injury, which needs to be traced to a legal violation. Without this decision, it would be a lot easier to take a suit to court.Buck v. Bell (1927)Dr. John H. Bell was the superintendent at the Virginia State Colony for Epileptics and Feebleminded.WikimediaThe case: A young woman named Carrie Buck was diagnosed with "feeble mindedness," and committed to a state institution after she was raped by her foster parent's nephew, and had his child. Her mother had also been diagnosed as feeble minded. Under the 1924 Virginia Eugenical Sterilization Act, she was to be sterilized against her will, since she was seen as unfit to procreate. Buck's appointed guardian sued, hoping to have the Supreme Court find sterilization constitutional.The decision: The Supreme Court held 8-1 that there was nothing in the Eighth or 14th Amendments that said Carrie Buck could not be sterilized.In his opinion, Justice Oliver Holmes wrote, "It is better for all the world, if instead of waiting to execute degenerate offspring for crime, or let them starve for their imbecility, society can prevent those who are manifestly unfit from breeding their kind. The principle that sustains compulsory vaccination is broad enough to cover cutting Fallopian tubes … Three generations of imbeciles are enough."After this case, sterilizations did not cease until the 1960s, and more than 60,000 people were sterilized without their consent. The case has never been overturned.Near v. Minnesota (1931)Floyd B. Olson.Bettmann / GettyThe case: The 1925 Public Nuisance Bill, also known as the "Minnesota gag law," allowed judges to close down newspapers that were deemed obscene or slanderous. In 1927, the Saturday Press, a newspaper based in Minneapolis, began to publish articles attacking several public officials. One of them accused a politician named Floyd B. Olson of being a pawn to a conspiracy. Olson filed a complaint. A judge, using the 1925 law, issued a temporary restraining order against the newspaper. The newspaper appealed under the First Amendment's right to a free press.The decision: The Supreme Court held 5-4 that the Public Nuisance law was unconstitutional. Chief Justice Hughes wrote, "This statute ... raises questions of grave importance transcending the local interests involved in the particular action. It is no longer open to doubt that the liberty of the press and of speech is within the liberty safeguarded by the due process clause of the Fourteenth Amendment from invasion of state action."The case stopped journalists from being censored, and enabled the press to fulfill its role as watchdog, including the printing of the Pentagon Papers in 1971.Wickard v. Filburn (1942)Robert H. Jackson wrote the opinion.WikimediaThe case: The Agricultural Adjustment Act of 1938, enacted to stabilize agricultural prices after the Great Depression, restricted how much wheat could be grown, to avoid another recession. The Department of Agriculture fined Roscoe Filburn, a wheat farmer in Ohio, for growing too much. He sued, arguing Congress didn't have the authority, since he'd never planned to sell all of the wheat. The issue was whether Congress had the authority to regulate local wheat production.The decision: The Supreme Court unanimously held that Congress had the power to regulate activities in the industry, and within states, when the activities had substantial effects on interstate commerce. So, even though Filburn's wheat wasn't all going to make it into the market, growing it still altered supply and demand in a national market.This case led to the federal government having more power to regulate the economy, and also enabled federal regulation of things like workplace safety and civil rights. Not everyone has been in favor of this case. Notably, the late Justice Antonia Scalia used to laugh at it.Brown v. Board of Education (1954)A woman explains the case to her daughter outside the Supreme Court.Bettmann / GettyThe case: In the 1950s, Linda Brown had to take a dangerous route to school, because the only school that was closer was for white students. Her father, Oliver Brown, believed this was a breach of the 14th Amendment, which says, "no state can deny to any person within its jurisdiction the equal protection of the laws." Brown, along with a dozen other parents, challenged the segregation policy on behalf of their 20 children.The decision: The Supreme Court unanimously held that separate educational facilities were inherently unequal. A second decision called for lower courts and school boards to proceed with desegregation. This decision knocked down the doctrine of "separate but equal" from Plessy v. Ferguson, which had allowed mixed race schools, transportation, and facilities to exist as long as they were "equal."The Atlantic described Chief Justice Earl Warren's "ringing opinion" as "the belated mid course correction that began America's transformation into a truly multiracial world nation."Mapp v. Ohio (1961)Dollree Mapp escorted into 105th Precinct in New York in 1970.APThe case: When Ohio police thought a suspected bomber was hiding out in Dollree Mapp's house, they forced their way in without a warrant. When Mapp asked where the warrant was, they held up a piece of paper. In their search of her house, they found pornographic materials. They arrested Mapp and later convicted her for being in possession of obscene materials. She appealed.The decision: The Supreme Court held 6-3 that any violation of the Fourth Amendment's right against unlawful searches and seizures made evidence inadmissible in court. Justice Clark wrote in his majority opinion that "the exclusionary rule," which prohibits the use of illegally obtained evidence in criminal trials, was essential.This case has led to the redefining of the rights of people being accused and limits how police can obtain evidence.Engel v. Vitale (1962)The parents who brought suit against public schoolroom prayer in the Herricks School District pose with some of their children in 1962.APThe case: In New York, schools adopted a daily prayer after it was required by state law. Some parents argued it was a violation of individuals' rights, but the school board said it wasn't, since students could opt out. Five families led by parent Steven Engel disagreed, and sued on the basis that it violated the religion clause of the First Amendment.The decision: The Supreme Court held 6-1 that reading an official prayer at school violated the constitution, because it was an "establishment of religion." Justice Hugo Black wrote for the majority: "It is a matter of history that this very practice of establishing governmentally composed prayers for religious services was one of the reasons which caused many of our early colonists to leave England and seek religious freedom in America."The case meant any state-enforced prayer, or reading of the bible in a public school would be suspected. It also was a key case showing the enforcement of separation between church and state.Gideon v. Wainwright (1963)Clarence Gideon.Bettmann / GettyThe case: Clarence Earl Gideon was charged with breaking and entering a pool hall. He requested a lawyer to defend him, but Florida's state court rejected him. After defending himself poorly Gideon went to prison. Giddeon appealed, and the issue was whether the right to counsel extended to felony defendants in state courts.The decision: The Supreme Court held unanimously that state courts were required to appoint attorneys for those who could not afford their own counsel.The US justice system would not be what it is today without this decision. The decision affirms that "lawyers in criminals courts are necessities, not luxuries." However, the quality of criminal defense services varies across the country.Reynold v. Sims (1964)Chief Justice Earl Warren in 1964.Charles Tasnadi / APThe case: This case stemmed from the apportionment scheme in Alabama. Under the 14th Amendment, each voter's intentions are meant to have equal weight, but in Alabama, legislative districts were no longer accurately representing the amount of people who lived in them, especially in the cities, where populations had grown rapidly. The issue was whether this breached the "equal protection clause" in the 14th Amendment.The decision: The Supreme Court held 8-1 that Alabama's apportionment scheme had breached the 14th Amendment. The justices ruled that the right to vote is a fundamental right, and equal participation is crucial. Chief Justice Warren wrote for the majority: "legislators represent people, not trees or acres."This decision made the government more democratic.Heart of Atlanta Motel v. US (1964)President Lyndon B. Johnson shake hands with Dr. Martin Luther King Jr. after presenting him with a pen used to sign the Civil Rights Act of 1964.APThe case: The Heart of Atlanta Motel in Georgia refused to provide accommodation for black people, but the Civil Rights Act of 1964 banned the practice. Two hours after the act was passed, the motel asked the court to stop the enforcement of a clause in Title II, which forbid racist discrimination by public accommodation providers. The motel argued it exceeded Congress's power.The decision: The Supreme Court held unanimously that the act was not exceeding Congress's power. It reasoned that discrimination by businesses had a big impact on black people traveling, even when it was a small business, since negative effects could be far-reaching when added up. It was especially the case here, since 75% of the guests staying at the motel came from out of state.This was the first case to challenge the Civil Rights Act, and by upholding it, the act was legitimatized and strengthened. The law would go on to be used to dismantle many other forms of racist discrimination.New York Times v. Sullivan (1964)Police Commissioner L.B. Sullivan (second left) celebrates his $500,000 libel suit victory.Bettmann / GettyThe case: This case was about an advertisement titled "Heed Their Rising Voices" that was published in The New York Times in 1960. The ad was looking for donations to defend Martin Luther King Jr. and criticized the Montgomery police. The ad had factual errors, and L.B. Sullivan, a Montgomery city commissioner, sued The Times for defamation, though he wasn't mentioned. In Alabama, Sullivan won and The Times was ordered to pay $500,000. The paper appealed.The decision: The Supreme Court held unanimously that while regular defamation requires that a defendant knows a statement is false or reckless, when it's a public figure, the defendant must act with "actual malice" — meaning they must know it was false or have a "reckless disregard" for the truth.This decision strengthens the freedom of the American press, which has the strongest protections in the world, ensuring debate on public issues is robust and open.Miranda v. Arizona (1966)Ernesto Miranda with his attorney in 1967.Bettmann / GettyThe case: In 1963, police obtained a written confession from Ernesto Miranda that said he had kidnapped and raped a woman. However, they had not advised Miranda of his right to have an attorney present during the interrogation. Miranda appealed on the basis that his confession had been gained unconstitutionally.The decision: The Supreme Court held 5-4 that law enforcement must advise suspects of their right to remain silent, their right to an attorney, and that anything they say can and will be used against them in a court of law. Evidence could not be used in a trial unless the warnings had been given and knowingly waived.Police work, and the well-known "you have the right to remain silent" would not be so firmly entrenched into society (or TV shows and movies) without this decision. People know their rights, and police know they have to read them to suspects.Loving v. Virginia (1967)Richard P. Loving and wife Mildred in 1965.APThe case: Mildred Jeter, a black woman, and Richard Loving, a white man, were from Virginia, where inter-racial marriage was illegal. In 1958, they got married in D.C. and then returned home. On their return, they were charged with breaking the law and sentenced to one year in prison. A judge suspended their sentence as long as they didn't return to the state together for 25 years. Loving wrote to then-Attorney General Robert Kennedy and asked for his help, and he referred them to the ACLU, which helped them sue.The decision: In a unanimous decision, the Supreme Court held that the law was unconstitutional under the 14th Amendment. Chief Justice Warren wrote, "Under our constitution the freedom to marry, or not marry, a person of another race resides with the individual, and cannot be infringed by the state."In a watershed moment for civil rights, the case found that people of any race, anywhere in the US, can get married, striking down laws banning inter-racial marriage in 16 states. The case was later cited in same-sex marriage cases.Terry v. Ohio (1968)Justice William O. Douglas.Wikimedia.The case: In 1963, three men were suspiciously walking back and forth in a block in Cleveland, Ohio, and a detective thought they were preparing to rob a store. He approached them, identified himself, then frisked them and found two concealed guns. One of the men was convicted for having the gun. The man appealed. The issue was whether police frisking violated the Fourth Amendment.The decision: The Supreme Court held 8-1 that the search was reasonable since the men were acting suspiciously, warranting inquiry. If circumstances justify a belief that an individual is armed and dangerous, the justices ruled, the officer may pat down the outside of an individual's clothing.Justice William O. Douglas, the lone dissenter, did not think the standard for search and seizures should have been lowered from "probable cause" to "reasonable suspicion." He wrote: "Yet if the individual is no longer to be sovereign, if the police can pick him up whenever they do not like the cut of his jib, if they can 'seize' and 'search' him in their discretion, we enter a new regime. The decision to enter it should be made only after a full debate by the people of this country."This case opened up the police's ability to investigate activity they deem suspicious.Brandenburg v. Ohio (1969)Clarence Brandenburg and Richard Hanna, following their arrests in 1964.APThe case: Clarence Brandenburg was arrested after making racist remarks and claiming the government was suppressing the "Caucasian race" to a gathering of Ku Klux Klan members in a field in Ohio. He also mentioned action might need to be taken, and was filmed by media he had invited to the gathering. The state law criminalized advocating violence as a means of accomplishing political reform, and he was sentenced to up to 10 years prison. The issue was whether speech advocating for violence was protected by the First Amendment.The decision: The Supreme Court held per curiam, which means in the name of the court rather than the judges, that his freedom of speech had been violated. It found that speech may only be outlawed when it is directly inciting "imminent lawless action." It also found that abstract discussions are not the same as actual preparation to engage in violence. This case broadened protections for political dissent.Phillips v. Martin Marietta Corp. (1971)Ida Phillips.APThe case: Ida Phillips applied for a job at the Martin Marietta Corporation, a missile plant in Orlando. She had seven children, and the business had a hiring policy excluding mothers with pre-school children, believing them to be unreliable. Phillips alleged she'd been denied employment because of her sex. The issue was whether this was discrimination under Title VII of the Civil Rights Act of 1964. The case was complicated, because the company hired women for the job, just not women with young children.The decision: The Supreme Court unanimously held that it was discriminatory, since it was based on the sex of the applicant, even if it was about motherhood.However, it did send the case back to lower courts to give the corporation a chance to present evidence about the impeded ability of mothers with young children. And the judges were uneasy about the idea that both sexes were equally equipped to do all jobs. Justice Hugo Black asked Phillips' lawyer, "Does the law require that the employer give the woman a job of digging ditches and things of that kind?"All nine justices at the time were men.Wisconsin v. Yoder (1972)Amish children head to classes.Amy Sancetta / APThe case: In Wisconsin, children were required by law to attend school until they were 16. But three Amish families refused to send their children to school after eighth grade, when most children are 14, resulting in $5 fines from the state. (Amish families think the content of secondary and higher education conflicts with their life of austerity.) They argued the compulsory attendance violated their rights under the First Amendment, specifically the Free Exercise Clause.The decision: The Supreme Court held unanimously that the Amish families' right to religious freedom was not overridden by the state's interest in education. It held that sending the children to high school would threaten the Amish way of life. Freedom of religion was seen as more important than the state's interest in education, and this case created an exception for Amish people, and others in similar situations.The justices agreed overall on the ruling, but Justice William O. Douglas filed a partial dissent arguing that the children's viewpoint wasn't being considered, worried that they may miss out on an education if they're not asked whether they want to go to high school.Roe v. Wade (1973)Demonstrators.Cynthia Johnson / The LIFE Images Collection / GettyThe case: This case stemmed from a Texas law that said abortion was illegal unless, by doctor's orders, it was to save a woman's life. An anonymous plaintiff called Jane Roe (who was later identified as Norma McCorvey) filed against the Dallas County district attorney, arguing the law was unconstitutional.The decision: The Supreme Court held 7-2 that overly restrictive legislation around abortion was unconstitutional. Based on a right to privacy in the 14th Amendment, the state was not allowed to regulate a woman's decision.This case overruled any laws that made abortion illegal before a fetus was viable, giving women more power when it comes to their bodies and having children. It made access to abortion a constitutional right.San Antonio Independent School District v. Rodriguez (1973)Children work on their various assignments in this open classroom in Crystal City, Texas, June 3, 1974.Ted Powers / APThe case: In the late 1960s, schools in Texas could use local property taxes to boost revenue. So schools that were based in poorer areas had less revenue, because the property taxes were lower. A class-action suit was filed on behalf of children living in poorer areas. The issue here was whether the system violated the 14th Amendment's equal protection clause.The decision: The Supreme Court held 5-4 that there is no constitutional right to an equal education. The opinion said it should not be unconstitutional, because "burdens or benefits" fall unevenly, depending on the wealth of the areas in which citizens live.In Time Magazine's list of the worst Supreme Court cases since 1960, the editors concluded this case enforced the idea that discrimination against the poor did not violate the Constitution, and education wasn't a fundamental right.United States v. Nixon (1974)Former President Richard Nixon.Charles Tasnadi, File/APThe case: This case was triggered by the Watergate scandal, when a special prosecutor asked for tapes that President Richard Nixon had recorded in the White House. He refused, saying he had "executive privilege" that allowed him to withhold sensitive information in order to maintain confidential communications and to maintain national security. Nixon released edited versions, but not the complete tapes, leading to Nixon and the prosecutor both filing petitions to be heard in the Supreme Court.The decision: The Supreme Court held unanimously that while there was limited executive privilege for military or diplomacy reasons, it wasn't enough in this case. Nixon had to hand over the tapes. The case led to Nixon's resignation, and also ensures that the president does not have unlimited privilege to withhold information from other branches of government. "Not even the president is above the law," Harvard constitutional law professor Laurence Tribe said.O'Conner v. Donaldson (1975)Kenneth Donaldson holds a copy of a Supreme Court opinion in 1975.Charles Bennet / APThe case: After Kenneth Donaldson told his parents he thought his neighbor was poisoning his food, he was examined and diagnosed with paranoid schizophrenia. Against his will, he was committed to a state hospital for the next 15 years. During that time, two different people volunteered to be responsible for him, but the hospital refused to release him. He sued, saying the hospital staff had "intentionally and maliciously deprived him of his right to liberty."The decision: The Supreme Court held unanimously that mental patients could not be confined in institutions against their will, if they weren't dangerous and were capable of surviving in society. In the opinion, Justice Potter Stewart wrote: "May the state fence in the harmless mentally ill solely to save its citizens from exposure to those whose ways are different? One might as well ask if the state, to avoid public unease, could incarcerate all who are physically unattractive or socially eccentric."The decision established the legal threshold for people posing a danger to themselves or others.Buckley v. Valeo (1976)Senator James L. Buckley in 1975.APThe case: This was a case about freedom of speech, in particular about spending limits by, or for, candidates running for office. Sen. James L. Buckley, and a coalition of groups, filed a suit arguing that the Federal Election Campaign Act, which limited spending and required spending disclosures, weren't constitutional.The decision: The court held per curiam that independent spending was a form of political speech protected by the First Amendment. However, it also concluded that contributions could be capped. This is an important decision for campaign spending. It helped lead the way to the rising of political action committees, or PACs. It also led to the enforcement of reporting campaign spending.First National Bank of Boston v. Belloti (1978)Attorney General Francis X. Bellotti, left in 1976.APThe case: Several plaintiffs, including the First National Bank of Boston, wanted to challenge a proposed increase on personal income taxes for high-wage earners in Massachusetts. The plaintiffs wanted to pay for advertising to criticize it, but they could only spend money if they were "materially affected," based on a Massachusetts law, which restricted what corporations could spend in politics. Attorney General Francis Bellotti said the bank wasn't materially affected. The plaintiffs challenged the constitutionality of the provision.The decision: The Supreme Court held 5-4 that the Massachusetts law was unconstitutional. The court concluded that the First Amendment protected corporations, since they were made up of shareholders who decided their corporation should engage on public issues. This case opened the door to Citizens United.Regents of the University of California v. Bakke (1978)Allan Bakke on his first day at Medical School.Walt Zeboski / APThe case: Allan Bakke, a 35-year-old Vietnam war veteran, was rejected from medical school at the University of California twice. Every year, the school accepted 100 people, and 16 of those accepted were from "minority groups." He argued his rejections were due to "reverse racism", since his grades were better than the 16 people who got in on minority seats.The decision: The Supreme Court held 5-4 that Bakke should be admitted. However, it also said race could be taken into account to promote diversity on campuses.Six different justices wrote opinions. In one opinion, Justice Harry Blackmun wrote: "In order to get beyond racism, we must first take account of race. There is no other way. And in order to treat some persons equally, we must treat them differently."Since this case, despite affirming that race could be taken into account, the percentage of black freshman in the US has not changed. A 2017 analysis found they make up 6% of freshmen, but are 15% of college-age Americans.Strickland v. Washington (1984)Justice Thurgood Marshall in 1967.John Rous / APThe case: David Washington was sentenced to death after he pleaded guilty to murder. But this case arose out of what his lawyer didn't do during the trial. His lawyer failed to call any character witnesses or get a psychiatric evaluation. Washington appealed, arguing his counsel's assistance was constitutionally ineffective.The decision: The Supreme Court held 8-1 that ineffective counsel only violated the Sixth Amendment when the performance was deficient. For this, counsel assistance had to fall below an objective reasonableness standard, and there needed to be a "reasonable probability" the result would have been different had counsel not failed.Justice Thurgood Marshall wrote in dissent: "My objection to the performance standard adopted by the Court is that it is so malleable that, in practice, it will either have no grip at all or will yield excessive variation ... To tell lawyers and the lower courts that counsel for a criminal defendant must behave 'reasonably' and must act like 'a reasonably competent attorney' is to tell them almost nothing."This case makes it difficult for defendants to prove ineffective assistance claims, since they need to show that it's outside the range of professional competence and that the client was prejudiced by it.Chevron USA Inc. v. Natural Resources Defense Council (1984)Chevron.Marco Bello / ReutersThe case: In 1977, Congress added an amendment to the Clean Air Act, requiring states to establish programs to reduce power plant pollution. In the amendment, entire power plants were treated as a single unit within a "bubble", even if they had multiple smoke stacks. The Natural Resources Defense Council (NRDC) thought the bubble interpretation dulled the law, and sued the EPA.The decision: The Supreme Court held unanimously that the bubble policy was valid. It found that if the law is clear then agencies must follow it, and when a a law does not have a clear meaning, the courts should defer to the federal agency's interpretation of the law.This is one of the most cited Supreme Court decisions of all time, and this standard became known as the "Chevron Defense."Texas v. Johnson (1989)Gregory Johnson speaking against constitutional amendment banning flag desecration, outside Capitol.Cynthia Johnson / The LIFE Images Collection / GettyThe case: During a protest in 1984 against then-President Ronald Reagan and local corporations in Dallas, Gregory Johnson covered the American flag in kerosene then lit it on fire, offending witnesses. He was arrested and charged with desecrating a venerated object, which was banned under Texas law. He was sentenced to one year in prison and ordered to pay $2,000. He appealed, on the basis that the law was in breach of his First Amendment rights.The decision: The Supreme Court held 5-4 that burning the flag was protected under the First Amendment. In the majority opinion, Justice Brennan wrote: "if there is a bedrock principle underlying the First Amendment, it is that government may not prohibit the expression of an idea simply because society finds the idea itself offensive or disagreeable ... We do not consecrate the flag by punishing its desecration, for in doing so we dilute the freedom that this cherished emblem represents."Despite former President George H. Bush proposing to add an anti flag burning amendment to the constitution, this case still protects unpopular political expression in the US today.Michael H. v Gerald D. (1989)Supreme Court Justice Antonin Scalia wrote the majority.REUTERS/Darren OrnitzThe case: A man, for the purposes of the case named Michael, had an affair with a woman who later had a child. Blood tests indicated he was the father. He wanted visitation rights, but under California law, the child is presumed to be from the marriage, and another person can only challenge that within the child's first two years of life. Michael was too late, and sued. The issue was whether the California law violated the man's chance to establish paternity.The decision: The Supreme Court held 5-4 that a biological father does not have a fundamental right to obtain parental rights, after the presumed father had acted in a responsible way for the child. A woman's husband is to be presumed father of her children, regardless of anyone else's claim.Cruzan v. Director of the Missouri Department of Health (1990)Family photo of Nancy Cruzan.APThe case: In 1983, Nancy Cruzan, a 25-year-old woman, was in a car crash that resulted in her falling into a vegetative state. She was on life support for five years, and had no chance of recovery, but doctors estimated she could have lived on life support for another 30 years. Her parents asked for her to be disconnected, but the hospital refused without a court order. Before the car crash, Nancy had said she would not want to live if she were sick or injured and could not live "at least halfway normally." Her parents asked for a court order to remove her from life support.The decision: The Supreme Court held 5-4 that there was a right to die, but the state had the right to stop the family, unless there was "clear and convincing" evidence that it was her wish to die.This was the first time the court had ruled on a right-to-die case. It didn't set national guidelines, and left it to be decided on a state-by-state basis. In the month after the case, 300,000 requests were made for advance-directive forms, so people could make it known in advance what should happen to them if they became incapacitated.Lawrence v. Texas (2003)John Lawrence and Tyron Garner celebrate their victory in 2003.Michael Stravato / APThe case: Police entered a private residence on a false report about a weapons disturbance, and found Lawrence and Garner engaging in a consensual sexual act. They were arrested and convicted under Texas law, which forbid two people of the same sex to have sex. The issue for this case was whether the 14th Amendment protected them.The decision: The Supreme Court held 6-3 that the Texas law violated their right to liberty, under the "Due Process Clause," which allowed them to engage in their conduct without government intervention.This was seen as a victory for LGBT rights, removing what one law professor called "the reflexive assumption of gay people's inferiority," and overturning 14 state laws across the US.Georgia v. Randolph (2006)Police enter a property.Jae C. Hong / APThe case: After a fight at home between a separated couple, a woman called the police and told them to come in, then showed them cocaine she said her husband was using. The husband was later charged with possession, even though he had told the police they couldn't come in. The issue was whether the police can search a home without a warrant when one person gives consent, but the other refuses.The decision: The Supreme Court held 5-3 that in at least a few circumstances the right to search and enter is not valid if one of the occupants says they can't, ruling in the husband's favor.This case narrows the scope for when police can enter and search homes without warrants. They can still enter to protect someone from harm or to chase a fleeing suspect, for example.Massachusetts v. Environmental Protection Agency (2007)John Paul Stevens wrote the opinion.WikimediaThe case: This case came about in 1999, when Massachusetts, 11 other states, and several environmental organizations petitioned for the EPA to start regulating carbon dioxide coming out of new motor vehicles, since it was a pollutant. The EPA denied the petition, saying it did not have the legal authority to regulate it.The decision: The Supreme Court held 5-4 that the EPA had the right to regulate heat-trapping gases coming from automobiles, and that the Clean Air Act's definition of air pollutant had been written with sweeping language so that it would not become obsolete.According to James Salzman, a professor of law and environmental policy at Duke University, the majority's acknowledgement of climate change science put this case on the legal map. And since it made it almost impossible for the EPA not to regulate, the decision sent a message to other agencies that they also had to deal with climate change.District of Columbia v. Heller (2008)Robert A. Levy and Dick Anthony Heller outside the Supreme Court in 2008.Pablo Martinez Monsivais / APThe case: Richard Heller, a security guard who lived in D.C. and carried a gun for work, was not allowed to have a gun at home, due to the city's laws. He thought the laws were too restricting and made it impossible to defend himself. Heller, along with five others, sued, arguing it was a violation of the Second Amendment. They were funded by Robert Levy, a libertarian lawyer from the Cato Institute.The decision: The Supreme Court held 5-4 that the Second Amendment guaranteed an individual's right to possess a firearm at home for self-defense. It was the first time in 70 years the Supreme Court ruled on the Second Amendment.In 2019, former-Justice John Paul Stevens said it was the worst decision during his 34-year tenure, representing "the worst self-inflicted wound in the Court's history." He said an amendment should be added to the Constitution to overrule the case, to stop gun massacres like what had happened in Las Vegas or Sandy Hook.Citizens United v. FEC (2010)Citizens United President David Bossie outside the Supreme Court.Lauren Victoria Burke / APThe case: A non-profit organization called Citizens United made a disparaging film about Hilary Clinton and they wanted to run an advertisement for it during the 2008 election. But the Federal Election Campaign Act banned corporations and unions from spending money to advocate during elections. So Citizens United couldn't show the film since it mentioned Clinton, who was a presidential candidate at the time. Citizens United argued the ban was unconstitutional.The decision: The Supreme Court held 5-4 that corporations and unions can spend as much as they like to convince people to vote for or against political candidates, as long as the spending is independent of the candidates. The ruling gave corporations protections under the First Amendment's right to free speech.Justice John Paul Stevens wrote in dissent of the ruling, that it was "a rejection of the common sense of the American people," and a threat to democracy.The decision changed how politics works in the US. In the 2014 senate elections, outside spending had more than doubled to $486 million since 2010.National Federation of Independent Business v. Sebelius (2012)Former Secretary of Health and Human Services Kathleen Sebelius speaks to the media outside the Supreme Court in 2015.Alex Wong / GettyThe case: President Barack Obama signed the Affordable Care Act into law in 2010 to increase the number of Americans covered by health insurance, and to decrease the cost of healthcare. Twenty-six states, several people, and the National Federation of Independent Business sued to overturn the law. The first issue was whether it was legal to require people to purchase health insurance with an individual mandate. The second was whether a provision forcing states to cover more people or lose federal funding was unconstitutionally coercive.The decision: The Supreme Court held 5-4 that the individual mandate was legitimate, because it was in essence a tax, and struck down the provision that would withhold funds for states which did not expand the program.It wasn't without dissent, though. Justice Anthony Kennedy wrote that the decision was a "vast judicial overreaching," which would create a "debilitated, inoperable version of health care regulation."Obergefell v. Hodges (2015)Same-sex marriage supporters rejoice after the U.S Supreme Court hands down a ruling regarding same-sex marriage June 26, 2015 outside the Supreme Court in Washington, DC.Photo by Alex Wong/Getty ImagesThe case: James Obergefell and John Arthur, a couple from Ohio, got married in Maryland. In Ohio, same-sex marriage was not allowed on death certificates. Arthur was chronically ill and wanted to have Obergefell on his death certificate. Along with three couples from Kentucky, Michigan, and Tennessee, they sued their states, claiming they were in breach of the Equal Protection Clause in the 14th Amendment, which says, "no state shall ... deny to any citizen within its jurisdiction the equal protection of the laws."The decision: The Supreme Court held 5-4 that the 14th Amendment guarantees the right to marry, including same-sex marriages. Every state in the US now legally recognizes same-sex marriage. Before this case, 13 states still had a ban on gay marriage.Dobbs v. Jackson Women's Health Organization (2022)An anti-abortion supporter sits outside the Jackson Women's Health Organization, which closed within weeks after the Supreme Court overturned Roe v. Wade.Rogelio V. Solis/APThe case: In March 2018, the Jackson Women's Health Organization, Mississippi's only abortion clinic since 2006, sued the state for enacting a law that banned abortions after 15 weeks of pregnancy. The lawsuit argued that the rule was unconstitutional due to the precedent set by the Supreme Court, including Roe v. Wade and Planned Parenthood v. Casey. Dobbs refers to Dr. Thomas E. Dobbs, the state's Department of Health officer, but he had little to do with the overall case.The decision: The Supreme Court held 6-3 to uphold the Mississippi law. However, on top of the ruling, five of the justices in the majority opinion also ruled to overturn Roe, repealing a landmark case that made abortion legal in the US for nearly five decades. Chief Justice John Roberts was the only member of the court's conservative majority who believed the court should not have outright overruled Roe.Read the original article on Business Insider.....»»

Category: dealsSource: nytOct 31st, 2022

Sanofi (SNY) Q3 Earnings Beat, Dupixent, Flu Jabs Push Sales

Sanofi (SNY) beats third-quarter estimates for earnings and sales. Dupixent and flu vaccines drive sales growth. The company raises its earnings growth guidance for 2022. Sanofi SNY reported third-quarter 2022 adjusted earnings of $1.45 per American depositary share, beating the Zacks Consensus Estimate of $1.31 per share as well as our estimate of $1.33 per share. Earnings rose 32.1% on a reported basis and 17.9% on a constant currency rate (“CER”) basis, driven by higher sales and improved margins.Net sales increased 19.7% on a reported basis and 9% on a CER basis to $12.57 billion (€12.48 billion) on higher sales of Dupixent and vaccines. Exchange rate movements boosted sales by 10.7 percentage points in the quarter. Sales beat the Zacks Consensus Estimate of $11.99 billion.Sales rose 15% at CER in the United States and 4.5% in the Rest of the World (including China, Japan, Brazil and Russia). In Europe, sales increased 4.6%.All growth rates mentioned below are on a year-on-year basis and at CER.Segment PerformancePharmaceuticals sales rose 5.1% in the quarter to €7.9 billion, driven by the continued strong performance of the Specialty Care segment.Sanofi Specialty Care GBU sales increased 19.9% to €4.4 billion, mainly driven by Dupixent.Dupixent generated sales of €2.31 billion in the quarter, up 44.5% year over year. Sales of the drug in the United States rose 45.1%, driven by strong demand for its approved indications, atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis indications. In the United States, Dupixent’s new prescription share and total prescription share rose 49% and 38%, respectively.Dupixent sales rose 38.7% in Europe and 46.6% in the Rest of the World as the company expanded in newer markets and younger age groups.In the immunology and neurology franchise, Aubagio sales declined 3.7% to €521 million due to competitive pressure and price in the United States. Kevzara recorded sales of €88 million in the quarter, down 2.4% due to a difficult comparison with the third quarter of 2021, which had benefited from a temporary increase in demand for IL-6 receptor blockers.Sanofi markets Dupixent and Kevzara in partnership with Regeneron REGN. While sales are recorded by Sanofi, Regeneron records its share of profits/losses in connection with global sales of Dupixent and Kevzara.Sales of rare disease drugs rose 7.7% to €900 million, driven by the Pompe and Gaucher franchises, which benefitted from favorable buying patterns in the Rest of the World region. In the Pompe franchise, Myozyme sales declined 10.2% to €255 million due to patients switching to Nexviazyme. The new drug Nexviazyme recorded sales of €58 million in the third quarter compared with €43 million in the previous quarter. Fabrazyme sales were €240 million, up 5.7%. In the Gaucher franchise, Cerezyme sales rose 8.8% to €181 million, driven by favorable buying patterns in the Rest of the World region.Oncology sales declined 8.4% to €224 million due to a lack of consolidation of Libtayo sales. In 2022, Sanofi restructured its immuno-oncology collaboration with Regeneron regarding Libtayo by granting Regeneron the worldwide exclusive license rights of the drug. Prior to that, the companies co-commercialized the drug in the United States and shared worldwide operating profits.Sarclisa sales rose 54.2% to €79 million. Jevtana’s sales declined 13.3% to €101 million due to the entry of generic competition in some countries in Europe.The rare blood disorders franchise recorded sales of €336 million, up 3.5% year over year, as higher sales of Alprolix and Cablivi were offset by lower Eloctate sales. Alprolix sales rose 8.9% year over year to €126 million. While Cablivi sales were up 14.3% to €52 million, Eloctate sales declined 7.6% to €151 million in the quarter.Sales in General Medicines GBU declined 8.5% to €3.49 billion, as the growth of core drugs (like Multaq, Toujeo, Praluent and Rezurock) was more than offset by lower sales of non-core drugs (like Lantus and Aprovel).Lantus sales decreased 17.7% to €559 million in the quarter. Toujeo generated sales of €304 million in the reported quarter, up 17.2% year over year. Lovenox sales declined 23% to €307 million due to decreasing demand from COVID-19. Aprovel sales rose 11.2% to €129.0 million. Praluent sales rose 33.9% to €83 million.Vaccines GBU sales gained 23.5% to €3.32 billion in the quarter, mainly due to strong demand for influenza vaccines. Sales were also supported by improvement in Travel vaccines and growth of Meningitis and PPH franchises.While sales of flu vaccines rose 32.4%, sales of PPH vaccines rose 9.1% in the quarter. Meningitis vaccine sales rose 11.9%. Sales of travel and other endemic vaccines rose 64.6% in the quarter. Booster vaccine sales rose 1.3% in the quarter.Consumer Healthcare (CHC) stand-alone unit generated sales of €1.27 billion, up 1.9%, driven by growth in Europe and the Rest of the World region while sales declined in the United States. The CHC segment witnessed strong growth in Digestive Wellness and Cough & Cold categories. Sales in the CHC segment were partly hurt due to a difficult comparison with the third quarter of 2021, which had benefited from COVID-related higher demand.Costs RiseBusiness selling, general and administrative expenses increased 16.7% at CER in the quarter, reflecting increased investments in Specialty Care and costs incurred for the acceleration of cloud migration and application development. Business research and development expenses increased 20.2% at CER due to higher investments behind priority assets to boost the pipeline.2022 GuidanceSanofi raised its financial guidance for 2022. The company now expects adjusted earnings to grow approximately 16% at CER in 2022 versus the prior expectation of approximately 15%. It also anticipates a positive currency impact in the range of 9.5%-10.5% on earnings, up from the previous 7.5%-8.5% rangeSanofi expects its business operating income margin to improve to 30% in 2022Our TakeSanofi’s quarterly results were impressive as it beat estimates for both earnings and sales. The company, once again, raised its earnings growth expectations for the year, driven by a strong performance in vaccines and the specialty care business. Shares were up 2.3% in pre-market trading in response to the earnings and sales beat and guidance increase.Sanofi’s stock has declined 17% in the year so far compared to the industry’s rise of 1.8%.Image Source: Zacks Investment ResearchDupixent continued its outstanding performance in the quarter. The drug, has, in a very short time, become the key top-line driver for Sanofi. It was approved for its fifth indication in the United States in the quarter, prurigo nodularis, making it the first and only treatment indicated for this dermatology disease.With outside U.S. revenues accelerating and multiple approvals for new indications, Dupixent’s sales are expected to be higher. Higher vaccine sales, mainly flu vaccines, contributed to driving top-line growth in the quarter. The French drug giant’s earnings growth expectations for 2022 are quite encouraging.Zacks RankSanofi currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Sanofi Price, Consensus and EPS Surprise   Sanofi price-consensus-eps-surprise-chart | Sanofi QuoteStocks to ConsiderSome better-ranked biotech stocks are Castle Biosciences CSTL and Codiak BioSciences CDAK, both with a Zacks Rank #1.In the past 60 days, 2022 loss per share estimates for Castle Biosciences have narrowed from $3.07 to $2.81, while that for 2023 have narrowed from $3.08 to $2.93. Shares of Castle Biosciences have declined 48.7% in the year-to-date period.Earnings of Castle Biosciences beat estimates in two of the last four quarters and missed the mark twice, witnessing an earnings surprise of 19.46%, on average.In the past 60 days, estimates for Codiak BioSciences’ 2022 loss per share have narrowed from $1.94 to $1.81. During the same period, the loss estimates per share for 2023 have narrowed from $2.14 to $1.53. Shares of Codiak BioSciences have lost 93.8% in the year-to-date period.Earnings of Codiak BioSciences beat estimates in three of the last four quarters and missed the mark just once, delivering an earnings surprise of 35.40%, on average. FREE Report: The Metaverse is Exploding! Don’t You Want to Cash In? Rising gas prices. The war in Ukraine. America's recession. Inflation. It's no wonder why the metaverse is so popular and growing every day. Becoming Spider Man and fighting Darth Vader is infinitely more appealing than spending over $5 per gallon at the pump. And that appeal is why the metaverse can provide such massive gains for investors. But do you know where to look? Do you know which metaverse stocks to buy and which to avoid? In a new FREE report from Zacks' leading stock specialist, we reveal how you could profit from the internet’s next evolution. 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Category: topSource: zacksOct 28th, 2022

Futures Soar Despite Latest UK Newsflow Rollercoaster Fiasco

Futures Soar Despite Latest UK Newsflow Rollercoaster Fiasco It was another overnight emotional and markets rollercoaster session thanks to the constant chaos of newsflow  and confusion out of the UK. Just around midnight ET, the Financial Times reported that the Bank of England would delay the start of its gilt-sale program (i.e. Q.T.), sending UK gilts, sterling and US equity futures sharply higher. Those gains, however, turned to losses when the central bank denied the report in a statement just around 5am ET, pushing the yield on the UK 10-year bond seven basis points higher to 4.05% while cable dumped 0.5%. That said, the BOE didn’t rule out the prospect of the BOE announcing a delay at a later time. The central bank has already delayed the start of the sales once, during the fallout from the government’s fiscal plan last month Despite the reversal by the BOE, the huge meltup which we said would be triggered on Monday by Friday's massive shorting, extended for a second day, encouraged by the reversal of uber-bear Michael Wilson who as we noted yesterday, expects a bear market rally pushing the S&P as high as 4,150, and helping the S&P to close above a key technical level on Monday. Nasdaq 100 futures rose 1.8%, while S&P 500 futures advanced 1.6% at 7:30 a.m. in New York, as tech giants Amazon and Microsoft led major technology and internet stocks higher in premarket trading, while the 10-year Treasury yield holds steady at about 4% and the Bloomberg dollar index was flat. In premarket trading, bank stocks traded higher as Goldman Sachs becomes the last of the big six US lenders to report earnings this quarter, beating on the top and bottom line (a more detailed report to follow). In corporate news, Credit Suisse is exploring a sale of its US asset-management operations and moving closer to securing financing for other businesses. Amazon and Microsoft lead major US technology and internet stocks higher in premarket trading, set to extend their gains for a second straight session. Nvidia (NVDA US) +2.7%, Amazon (AMZN US) +2.3%, Alphabet (GOOGL US) +2%, Meta (META US) +2%, Apple (AAPL US) +1.7% and Microsoft (MSFT US) +1.7%. Here are some other premarket movers: AVEO (AVEO US) shares jump 38% in US premarket trading hours to $14.43 after LG Chem said it will buy the biotech for $15 per share in an all-cash transaction with an implied equity value of $566m on a fully diluted basis. Target (TGT US) stock rises 2.7% in US premarket trading after it was upgraded to buy from hold at Jefferies, which says the combination of a subdued valuation and improvements in the supply chain and inventory positioning supports a bullish stance on the retailer. FuboTV (FUBO US) shares rise as much as 11% in premarket trading, with analysts saying the firm’s decision to end operations of its Fubo Sportsbook betting unit will help its bottom line. Juniper (JNPR US) shares gain as much as 2.6% in US premarket trading after Piper Sandler upgraded the internet infrastructure company to neutral from underweight with the expectation that management can continue to increase product revenue numbers in full-year 2023 by around 10% year-on-year. Keep an eye on MongoDB (MDB US) after its shares were raised to neutral at Redburn as the stock is trading 20% below 2020 valuation lows and the brokerage sees no further downside that justifies a sell rating. Watch US timber stocks as RBC reshuffles ratings in the sector ahead of the third-quarter earnings season, which analysts say will mark a “sharp return” to normalized pricing, while downgrading Resolute (RFP US) and Western Forest Products (WEF CN) to sector perform from outperform. "Investors keep pushing stock indices higher following the rebound over the annual lows at the end of last week, and growing risk appetite can now be seen across different asset classes,” said Pierre Veyret, a technical analyst at ActivTrades. As risks including high inflation, slower growth and the energy crisis still remain, “this is still seen as a technical correction,” he added. Another reason for the continued meltup is because JPMorgan's inhouse permabull, Marko Kolanovic, who has been long and wrong all year, appears to have thrown in the towel and late on Monday the Croat trimmed the extent of equities overweight in his model portfolio this month, citing “increasing risks around central banks making a hawkish policy error and geopolitics.” As we have said before, the bear market won't end until Marko turns bearish, so that was another piece of the puzzle falling into place. Kolanovic says go underweight corporate bonds over equities. The crash will not end until he turns bearish — zerohedge (@zerohedge) July 11, 2022 Meanwhile, the Bank of America monthly global fund manager survey “screams macro capitulation, investor capitulation, start of policy capitulation,” opening the way to an equities rally in 2023  the bank's Chief Investment Strategist, Michael Hartnett wrote in a note on Tuesday. They expect stocks to bottom in the first half of 2023 after the Federal Reserve pivots away from raising interest rates. “There’s still a strong feeling of a bear market rally about trading over the course of the last week,” said Craig Erlam, senior market analyst at Oanda Europe Ltd. “The economic landscape looks treacherous and we don’t even know if we’re at peak inflation and interest rate pricing yet. Those are substantial headwinds that will make any stock market rebound extremely challenging.” In Europe, stocks rose for a fourth day, with most industry groups in the green. Risk sentiment was firmly bullish, with cyclical stocks leading the rally, while technology shares also outperformed. Autos, tech and financial services lead gains in Europe as Euro Stoxx 50 rallies 1.4%. FTSE MIB outperforms peers, adding 1.8%. Here are the most notable European movers: AZA SS: Avanza shares jump as much as 17%, the most since Oct. 2019, after the Swedish retail trading and savings platform reported what Handelsbanken called a “strong beat” on net interest income. THG LN: THG shares surge as much as 12% after SoftBank sold its stake in the British online shopping firm. The sale removes an overhang on the stock and it could help sentiment that existing investor Qatar Investment Authority bought the majority of the stake, according to Bloomberg Intelligence analysts. TIT IM: Telecom Italia shares rise as much as 9.6% in Milan trading on speculation reported by Italian newspaper MF regarding potential interest for the company by CVC. PUB FP: Publicis shares rise as much as 4.7% after the advertising agency lifted FY organic growth guidance for a second straight quarter. GALP PL: Portuguese oil co. Galp falls as much as 6.8% as it says it received a force majeure notice from Nigeria LNG following flooding that caused a “substantial reduction” in the production and supply of LNG and natural gas liquids, according to a regulatory filing. N91 LN: Ninety One shares drop as much as 5.3% after the investment manager reported a decline in assets under management during the second quarter. ERF FP: Eurofins Scientific shares drop as much as 6.0%, the most since July 28, after the provider of testing services reported third-quarter revenue that fell year-on-year. ROG SW: Roche shares slide as much as 1.6% after the Swiss pharmaceutical group slightly missed consensus 3Q expectations on overall sales, but focus remains on its outlook and pipeline, analysts say. Earlier in the session, Asian equities rebounded, led by advances in tech stocks following a rally on Wall Street, as possible delays in bond sales by the Bank of England bolstered investor sentiment. The MSCI Asia Pacific Index rose as much as 1.5%, buoyed by TSMC, Tencent and Alibaba. All sub-gauges except real estate climbed.  The Financial Times reported that the BoE may delay selling billions of pounds of government bonds, easing investor angst after the UK’s botched fiscal plan. The UK central bank denied the report after most markets in the region were closed. Tech stocks listed in Hong Kong climbed after the Nasdaq 100 index had its best day since July.  Most benchmarks advanced, with notable gains in Australia, Japan, Hong Kong, and South Korea. Concerns that China is delaying the release of its 3Q GDP report amid the on-going party congress failed to quell the mood. The prospect of the BoE postponing QT “offers the potential for a decline in global rates volatility, a pre-condition for a broader improvement in cross-asset risk sentiment,” Stephen Innes, managing partner at SPI Asset Management, said before the bank’s denial. It’s been almost a year since Bitcoin hit a record. Even after Tuesday’s gain, the key Asian stock benchmark still trades close to its early-2020 low, as China’s virus lockdowns and property crisis weigh on growth. Asian stocks have underperformed their US and European peers this year as the Fed’s rate hikes pressure emerging market currencies, triggering an exodus of foreign funds Japanese stocks rose, following a rebound in US peers as the S&P 500 was seen pointing toward a technical recovery. Electronics makers were the biggest boost. The Topix rose 1.2% to close at 1,901.44, while the Nikkei advanced 1.4% to 27,156.14. Recruit Holdings Co. contributed the most to the Topix gain, rising 5.1% after announcing a buyback. Out of 2,166 stocks in the index, 1,809 rose and 279 fell, while 78 were unchanged. Australia stocks rebounded with tech and real estate shares leading; the S&P/ASX 200 index rose 1.7% to close at 6,779.20. The climb tracks a regional rally, buoyed after gains on Wall Street and a report of a possible delay in the Bank of England’s quantitative tightening.  In New Zealand, the S&P/NZX 50 index rose 0.6% to 10,847.34. In rates, Treasuries edged higher in early US trading after paring declines. Losses persist in gilts, where UK curve bear-flattens, with bunds also under pressure amid auctions by Germany, UK and Finland. US yields remain within 2bp of Monday’s closing levels, 10-year yields just under 4% with bunds and gilts trading cheaper by 6bp and 8bp in the sector. Gilt price action has been choppy; Long-end gilts take a breather, 10-year yield about 1bp higher after FT reported that Bank of England is set to delay quantitative tightening until gilt markets calm which the BOE later denied; UK sells 30-year notes later. In FX, the Bloomberg Dollar Spot Index pared losses to trade marginally lower; yen settles at around the 149 handle while the pound trades lower toward $1.13.  New Zealand’s dollar led G-10 gains after quarter-on-quarter inflation exceeded forecasts, fueling bets the central bank will need to keep raising interest rates The euro moved in a narrow range around $0.950, while the German 10- year yield reversed earlier losses to gain 6bps to 2.32% The pound weakened against all of its G-10 peers and fell below $1.13, following in an advance of as much as 0.5% to $1.1410. The long-term outlook for the pound has started to improve. At least, that’s what the options market is saying. The yen briefly rallied sharply versus the dollar after dropping to 149.29 per dollar, the lowest level since August 1990. Bank of Japan Governor Haruhiko Kuroda said that while the interest-rate differential with US has been a driving factor for the yen to weaken recently, the currency doesn’t move in parallel with the difference over the longer term The yuan stayed near 7.2 per dollar as the central bank kept the currency’s reference rate near 7.1 level in the last few sessions, a move that’s expected to slow the currency’s decline. USD/CNY falls 0.1% to 7.2000. It droped as much as 1.2% in early trade, close to the central bank’s fixing. USD/CNH little changed at 7.2075. In commodities, oil switched between gains and losses as traders weighed a tight market against concerns over a global economic slowdown. WTI and Brent December contracts are softer on the session and gave up earlier gains as the DXY creeps higher throughout the European morning. Spot gold is flat around the USD 1,650/oz mark in a USD 10/oz range – but still under its 10 and 21 DMAs at 1,673.56/oz and 1,668.63/oz. LME metals are mostly lower amid the recent rise of the Dollar, whilst Rio Tinto forecasted annual iron ore shipments at the lower end of guidance and sees further downside risks to demand as the global economy slows. White House is reportedly planning an oil reserve release announcement this week with a release of another 10mln-15mln bbls in an effort to balance markets and keep prices from climbing, according to Bloomberg. EU financial services chief McGuiness called on the US to create new crypto rules and said any regulation imposed on the industry would need to be global for it to work, according to FT. Looking to the day ahead now, and data releases from the US include industrial production and capacity utilisation for September, as well as the NAHB housing market index for October. Central bank speakers include the ECB’s Makhlouf and Schnabel, as well as the Fed’s Bostic and Kashkari. Finally, earnings releases include Goldman Sachs, Netflix, Johnson & Johnson, and Lockheed Martin. Market Snapshot S&P 500 futures up 1.4% to 3,741.00 MXAP up 1.4% to 138.93 MXAPJ up 1.6% to 450.98 Nikkei up 1.4% to 27,156.14 Topix up 1.2% to 1,901.44 Hang Seng Index up 1.8% to 16,914.58 Shanghai Composite down 0.1% to 3,080.96 Sensex up 1.0% to 58,966.61 Australia S&P/ASX 200 up 1.7% to 6,779.22 Kospi up 1.4% to 2,249.95 STOXX Europe 600 up 1.1% to 402.75 German 10Y yield up 3% at 2.337% Euro up 0.1% to $0.9852 Brent Futures down 0.6% to $91.05/bbl Gold spot up 0.1% to $1,651.42 U.S. Dollar Index up 0.1% at 112.187 Top Overnight News from Bloomberg Just 10% of Britons have a favorable opinion of Liz Truss, a YouGov survey found, piling further woes on the beleaguered prime minister a day after she was forced to row back on the bulk of her economic vision for Britain UK trade unions have called on millions of workers to protest against any return to austerity after Britain’s new chancellor of the Exchequer warned that “some areas of spending will need to be cut.” There’s scope for a Polish central bank hike by as much as 100bps in November, Monetary Policy Council member Joanna Tyrowicz says in ISB News interview French rail, energy and other key workers are striking on Tuesday to demand a bigger share of corporate profits, raising pressure on President Emmanuel Macron to take further steps to ease the impact of surging inflation ECB policy maker François Villeroy de Galhau expects the central bank to continue to “go quickly” until its deposit rate reaches 2% at the end of the year, Financial Times reports, citing an interview A more detailed look at global markets courtesy of Newsquawk Asia-Pac stocks were positive with the region inspired by gains in global counterparts following the UK Chancellor’s reversal of most of the measures of the 'mini-Budget' and with a report later suggesting a delay of QT by the BoE. ASX 200 was led by strength in tech and with the top-weighted financials sector also notching firm gains, while commodity-related stocks were somewhat varied with Rio Tinto choppy after a mixed quarterly activity report. Nikkei 225 reclaimed the 27,000 level to the upside, but was off highs with officials continuing to pledge to take action to address excess FX moves. Hang Seng and Shanghai Comp. gained although the mainland lagged amid COVID woes after Nanjing halted certain indoor venues due to rising cases, while the postponement of key Chinese data releases including Q3 GDP has led to some speculation that the data could be disappointing, although it was also suggested that the delay could be so that officials can concentrate on the Chinese Communist Party Congress. Top Asian News China's Nanjing halted certain indoor venues including bars, KTVs and gyms, while it also halted dine-in services due to an increase in coronavirus cases. RBA Minutes from the October 4th Meeting stated the decision to raise rates by only 25bps was finely balanced with the smaller move warranted by the scale of hikes already delivered and lags in policy. RBA added that the uncertain outlook argued for slower hikes for a time but noted further increases in rates are likely over the period ahead and that rates are not especially high, while the board emphasised the importance of keeping inflation expectations anchored and RBA said monthly CPI data confirmed broad-based pick-up in inflation, rents and utilities are expected to increase. RBA Deputy Governor Bullock said the board expects to increase interest rates further over the coming months with the pace and timing to be determined by data, while she added that as the board meets more frequently than most peers, it can achieve a similar tightening with smaller individual rate increases. European equity bourses traded with gains across the board but are off best levels. Sectors are mostly firmer with no overarching theme; Autos & Parts, Financial Services, and Industrial Goods lead the charge whilst Healthcare, Optimised Personal Care, Energy and Basic Resources sit at the bottom of the pile. US equity futures are firmer to a greater magnitude than their European counterparts, with the ES trading on either side of 3,750 whilst the NQ outperforms its peers. Intel's (INTC) MobilEye IPO is set to be priced between USD 18-20/shr, according to Bloomberg. Renault (RNO FP) and Nissan (7201 JT) are moving towards a "landmark" deal to reshape their alliance, according to Bloomberg; subsequently echoed by the Renault CEO in a Nikkei interview. Top European News BoE is reportedly expected to further delay quantitative tightening until gilt markets calm, according to FT. Subsequently, the BoE labelled this report as "inaccurate". UK PM Truss said she wants to accept responsibility and apologise for the mistakes made, while she added that she will lead the Tories into the next general election and is sticking around because she was elected to deliver for the country. PM Truss also stated the most vulnerable will be protected into next winter regarding household energy bills and that they are looking at exactly how they can do that, according to a BBC interview. ECB's Villeroy said the UK crisis shows the risk of a vicious loop and that the pensions turmoil underscored the need for non-banks to build liquidity buffers, according to FT. European Commission to unveil proposal of further emergency energy measures for coming winter (including joint purchasing & alternative benchmark) at 14:30BST/09:30EDT, according to journalist Keating. FX Kiwi elevated as stronger than expected NZ CPI metrics lift RBNZ rate outlooks, NZD/USD probes 0.5700 before pullback Sterling underperforming after making stellar gains on Monday as BoE says FT's QT delay report is inaccurate; Cable sub-1.1300 from just over 1.1400 at one stage Loonie lags within a 1.3771-1.3657 range as crude prices sag Euro pivots 0.9850 vs Buck as DXY holds around 112.000 and Fib resistance at 0.9858 hampers EUR/USD Yen pares some losses from under 149.00 against Dollar amidst some unsubstantiated talk of intervention The CBRT's move to raise the required level of bond holdings for FX deposits means that banks must hold an additional TRY 80-100bln of bonds, via Reuters citing bankers. BoJ and FSA are to hold 17th cooperation on financial stability, according to reports. Fixed Income Gilts saw an initial bounce at the open on overnight FT reporting around a potential delay to QT; however, this was modest in nature and has since given way to marked pressure following BoE labelling it as "inaccurate". The overall complex is pressured, with Gilts lagging though Bunds are in close proximity and below 136.00 post poor 7yr-supply and ahead of ECB speak. Stateside, UTS have been following their peers directionally though magnitudes are more contained overall pre-data/Fed speak; yield curve mixed, overall. Commodities WTI and Brent December contracts are softer on the session and gave up earlier gains as the DXY creeps higher throughout the European morning. Spot gold is flat around the USD 1,650/oz mark in a USD 10/oz range – but still under its 10 and 21 DMAs at 1,673.56/oz and 1,668.63/oz. LME metals are mostly lower amid the recent rise of the Dollar, whilst Rio Tinto forecasted annual iron ore shipments at the lower end of guidance and sees further downside risks to demand as the global economy slows. White House is reportedly planning an oil reserve release announcement this week with a release of another 10mln-15mln bbls in an effort to balance markets and keep prices from climbing, according to Bloomberg. Note, this would come from part of a previously announced 180mln bbl sale announced earlier in the year UAE supports Saudi Foreign Ministry's statement regarding the OPEC+ decision and fully stands with Saudi Arabia in its efforts to support energy stability and security, according to the state news agency cited by Reuters. Geopolitics US Commerce Department issued a temporary denial order against Ural Airlines for operating in apparent violation of US export controls on Russia, according to Reuters. Ukraine President Zelenskiy says there is no space left for negotiations with Russian President Putin, via Reuters. Russia's Kremlin, when asked if Russia's nuclear umbrella extends to annexed territories, says all the territories are parts of Russia and their security is provided as with all other Russian territories, via Reuters. Japanese Chief Cabinet Secretary Matsuno said Japan is to impose additional sanctions against North Korea, according to Reuters. Officials revealed that China recruited dozens of former British military pilots to teach Chinese armed forces how to defeat western warplanes and helicopters in a “threat to UK interests”, according to Sky News's Deborah Haynes. US Event Calendar 09:15: Sept. Capacity Utilization, est. 80.0%, prior 80.0% 09:15: Sept. Manufacturing (SIC) Production, est. 0.2%, prior 0.1% 09:15: Sept. Industrial Production MoM, est. 0.1%, prior -0.2% 10:00: Oct. NAHB Housing Market Index, est. 43, prior 46 16:00: Aug. Total Net TIC Flows, prior $153.5b 16:00: Aug. Net Foreign Security Purchases, prior $21.4b Central bank speakers 14:00: Fed’s Bostic Takes Part in Workrise Panel Discussion 17:30: Fed’s Kashkari Discusses the Economy DB's Jim Reid concludes the overnight wrap We’ve discussed recently how we shouldn’t underestimate just how much the UK’s recent woes have impacted global markets. Correlation doesn’t equal causality, but the UK news has again seemed to heavily influence global markets over the last 24 hours after the UK government officially announced one of the biggest U-turns in political history and ditched the bulk of what remained of their mini-budget. However the risk momentum was also helped by a view that earnings season has starting relatively well versus beaten up expectations. Even overnight the UK is moving global markets again as reports from the FT that the BoE is going to delay QT at around 5am this morning have pushed equities futures over a percent higher with S&P 500 (+1.95%) and NASDAQ 100 (+2.17%) contracts soaring. This follows a big session yesterday with the S&P 500 (+2.65%) and the STOXX 600 (+1.83%) both posting strong advances that were led by the more cyclical sectors. Tech stocks were one of the big outperformers, with the NASDAQ (+3.43%) and the FANG+ Index (+4.83%) seeing even stronger advances, whilst banks were another outperformer with those in the S&P 500 up +3.48% in their 4th consecutive advance. The moves were also supported by some positive corporate news, with Lufthansa raising their full-year forecasts whilst Bank of America saw trading revenue beat expectations and net interest income rise to a record in Q3, a common theme among banks benefitting from heightened market volatility and rising policy rates. Bank of America joins the other large US banks to report with JPMorgan (+5.94% since releasing earnings), Citi (+1.44% since), Wells Fargo (+3.68%), and Morgan Stanley (-2.75%) all having reported the last few days. That comes as earnings season is moving into full flow, with today’s releases including Netflix, Goldman Sachs and Johnson & Johnson. We’ve had 38 S&P companies report so far, and while major financials have grabbed a lot of the headlines there have been a number of key corporate reporters including consumer staples Walgreens (+3.32% since their earnings), health care provider United Health Group (+2.38% since reporting), food and beverage retailer PepsiCo (+6.24% since reporting), and airline Delta (+6.61%). The breadth of reporters should expand with the major US banks largely now in the rear-view mirror. Back to the UK and there was an increasing sense of what was coming yesterday, with the first reversal happening two weeks ago as they U-turned on the abolition of the top 45% rate of income tax. Then on Friday we had a second reversal as PM Truss announced that corporation tax would go up after all, in line with the previous government’s plans. But yesterday saw Chancellor Hunt announce that almost everything else would be going as well, including the planned cut in the basic rate of income tax to 19% from April 2023, which will instead be kept at 20% indefinitely. It’s clear the UK are now desperately trying to claw back their market credibility, as not only have the government reversed course on most of the tax cuts, but they also said they’d revisit the scale of their energy support package as well. Previously, energy prices were set to be capped at £2,500 per year for the average household over the next two years. But the government are now saying that will only go up until April 2023, and after that they’d review what support would be given instead, and were aiming to “design a new approach that will cost the taxpayer significantly less than planned”. Furthermore, the government’s statement implied there was more to come in the fiscal statement on October 31, as it said that government departments “will be asked to find efficiencies within their existing budgets”, and that there’d be “further changes” on fiscal policy “to put the public finances on a sustainable footing”. UK assets surged on the back of the announcements, with sterling +1.66% higher versus the US dollar after having been as much as +2.38% up, just as yields on 10yr UK gilts tumbled by -35.7bps to 3.96%. In fact, apart from September 28 when the Bank of England began their intervention, that’s the largest daily decline in the 10yr gilt yield since the Conservatives won a surprise victory in the 1992 general election, so we are still experiencing unprecedented volatility. Meanwhile, sterling (+0.31%) is trading higher again this morning ($1.1393) on the FT story that QT is set to be delayed. Back to yesterday and the declines in real yields were even more pronounced than nominals, with the 10yr real yield down by -47.9bps on the day, which again is the largest daily move since the BoE intervention began. That said, even with the recent declines, the spread of UK 10yr yields over German bunds is still wider than it was prior to the mini-budget at +169bps, which points to the fact that investors are still charging a larger premium for holding gilts, even with the recent U-turns. Sovereign bonds rallied with Gilts in Europe, with yields on 10yr bunds (-7.7bps), OATs (-8.8bps) and BTPs (-13.3bps) all moving lower on the day. Those declines were seen across maturities, and came as we also had a further decline in both US and European natural gas futures that left both at their lowest levels since the summer. In Europe, they were down by a further -13.26% yesterday, which leaves them at a 4-month low of €123 per megawatt-hour, with mild weather supporting storage levels. Treasury yields initially rallied in lock step with European yields, reaching a rally of -11.1bps shortly after the New York open. Once Europe called it a day, however, yields steadily marched higher to close the day roughly unchanged (-0.6bps) and back above 4%. There wasn’t any specific catalyst of higher 10yr yields, other than perhaps US-based investors are more focused on the Fed and inflation outlook than on UK financial instability. The strength in US equities throughout the day probably also contributed to a stronger growth perception in the US, driving the +4.3bps steepening in 2s10s that we saw today. This morning in Asia, the UK is back influencing Treasuries as 10yr UST yields have gone from flattish to around -4.5bps lower after the FT BoE headlines. Asian stock markets are also higher with the Nikkei (+1.52%), the Hang Seng (+1.61%), Kospi (+0.99%) stronger still on the FT/BoE headlines. Elsewhere, Chinese shares are lagging with the Shanghai Composite (+0.17%) and the CSI (+0.08%) edging up after declining earlier. We were meant to get the Q3 GDP release and a slew of other economic data from China overnight, but we found out yesterday that it was being delayed. The unusual move comes as the ruling Communist Party is holding its twice-a-decade event i.e., 20th National Congress. So far, no date for a rescheduled release has been given. Minutes from the Reserve Bank of Australia’s (RBA) October meeting revealed that the central bank’s surprise decision to ease back to a 25bps hike instead of the 50bps hikes was “finely balanced” as the board members wanted to monitor the impact of its tightening on household spending in an uncertain environment. The minutes also highlighted that further rate hikes are likely required over the period ahead with the pace and timing to be determined by data. Elsewhere, New Zealand’s consumer prices rose +7.2% y/y in the third quarter, much higher than the market expected +6.6% increase, thus cementing the prospect of further aggressive hikes by the Reserve Bank of New Zealand (RBNZ). In spite of the positive market moves over the last 24 hours, there was further bad news on the DM data side, with the New York Fed’s Empire index showing a third consecutive monthly contraction at -9.1 (vs. -4.3 expected). The prices paid index also ticked up relative to last month, reaching 48.6. Meanwhile in Canada, data from the central bank showed that inflation expectations over 1 and 2 years ahead were continuing to rise, although 5-year ahead expectations moved lower. That came as their business outlook indicator in Q3 fell to 1.69, which is the biggest quarterly decline in that indicator since Q2 2020 as the pandemic’s impact was fully felt. To the day ahead now, and data releases from the US include industrial production and capacity utilisation for September, as well as the NAHB housing market index for October. Over in Europe, there’s also the German ZEW survey for October. Central bank speakers include the ECB’s Makhlouf and Schnabel, as well as the Fed’s Bostic and Kashkari. Finally, earnings releases include Goldman Sachs, Netflix, Johnson & Johnson, and Lockheed Martin. Tyler Durden Tue, 10/18/2022 - 08:00.....»»

Category: worldSource: nytOct 18th, 2022

Kane Biotech Announces Second Quarter 2022 Financial Results

WINNIPEG, Manitoba, Aug. 25, 2022 (GLOBE NEWSWIRE) -- Kane Biotech Inc. ((TSX- V:KNE, OTCQB:KNBIF) (the "Company" or "Kane Biotech") today announced its second quarter 2022 financial results. Second Quarter Financial Highlights: Total revenue for the three months ended June 30, 2022 was $839,579, an increase of 201% compared to $278,741 in the three months ended June 30, 2021. License revenue in the three months ended June 30, 2022 was $500,225, an increase of 1,295% compared to $35,872 in the three months ended June 30, 2021. This substantial increase is due to the Company's subsidiary, STEM Animal Health, achieving a key milestone in April, 2022, namely the Veterinary Oral Health Council ("VOHC") Seal of Acceptance in the Helps Control Tartar category, which triggered approximately $1.3 million in milestone payments from STEM's licensing partners pursuant to its license and distribution agreements. In the three months ended June 30, 2022, royalty revenue increased by 77% to $51,770 compared to $29,258 in the three months ended June 30, 2021. This increase is due primarily to VOHC acceptance achieved in the current period immediately triggering minimum royalties as per the Company's license agreements as well as the underlying product sales in the veterinary channel being less impacted by the COVID-19 pandemic in the current period than the comparative period. Revenue from product and services sales for the three months ended June 30, 2022 was $287,584, an increase of 35% from $213,611 in the three months ended June 30, 2021. The increase is due mainly to the reclassification of certain sales discounts to cost of sales and sales expenses and higher DermaKB™ sales in the current period. Gross profit for the second quarter of 2022 was $639,215, an increase of 665% compared to $83,584 for the quarter ended June 30, 2021. Total operating expenses for the three months ended June 30, 2022 were $1,361,306, an increase of 25% compared to $1,090,396 for the three months ended June 30, 2021. This increase is due mainly to lower government assistance and higher non-funded research expenditures related to the Company's coactiv+™ Antimicrobial Hydrogel and DispersinB Hydrogel® programs in the current period. Loss for the second quarter of 2021 was ($794,595), a decrease of 26% compared to ($988,889) for the quarter ended June 30, 2021. Cash at June 30, 2022 was $2.5 million. During the quarter, the Company received $500,000 USD from one its licensing partners related to the achievement of the VOHC milestone, closed its non-brokered private placement offering raising gross proceeds of $1 million and further amended its credit agreement with its lender resulting in approximately $1.8 million in new capital being provided. Detailed financial information about Kane Biotech can be found in its June 30, 2022 Financial Statements and Management Discussion and Analysis on SEDAR and the Company's website. "STEM Animal Health's VOHC acceptance not only provided long-awaited milestone payments and minimum royalties, but also further validated the efficacy of Kane's anti-biofilm technology," stated Marc Edwards, Kane Biotech's Chief Executive Officer. "Further, Dr. Greg Schultz's appointment as Kane's Chief Scientific Officer will provide tremendous support to the development of our wound care business, not only from a scientific perspective by aiding the development and commercialization of our DispersinB® and coactiv+™ technologies, but also from a business perspective as the Company advances towards securing a wound care strategic partner. We expect clinical trials on our DispersinB® Hydrogel to begin later this year and our coactiv+™ 510(k) application has a clear pathway for regulatory approval". Recent Corporate Developments: On June 15, 2022, the Company announced that it has further amended its credit agreement with Pivot Financial Inc. maturing on August 31, 2022. The amendment dated June 13, 2022 extends the maturity to January 31, 2023 and increases the credit facility to $4 million with approximately $1.8 million of new capital provided in Q2 2022. The increased credit facility will continue to be used by Kane Biotech for funding research and development relating to eligible government reimbursable expenditures and general working capital purposes. On May 18, 2022, the Company announced that it had obtained ISO 13485:2016 certification for its quality management system specific to its ongoing efforts to design and develop novel medical devices for the wound care market. On May 17, 2022, the Company announced the closing of its non-brokered private placement offering of up to 10,000,000 common shares at a price of $0.10 per share for gross proceeds of up to $1,000,000. The offering was fully subscribed with Marc Edwards, CEO of Kane Biotech acquiring 3.1M shares, more than doubling his previous position. On April 7, 2022, the Company announced that STEM was awarded the prestigious VOHC Seal of Acceptance in the Helps Control Tarter category for its pet oral care water additive. Conference Call Kane Biotech is pleased to invite all interested parties to participate in a conference call on Thursday, August 25, 2022 at 4:30pm ET to review the financial results and discuss business developments in the period. Participants must register for the call using this link: Pre-registration to Q2 to receive the dial-in numbers and unique PIN to access the call seamlessly. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A webcast of the call will be available on the Company's website at kanebiotech.com under "News/Events" in the Investors section of the Kane Biotech website at ir.kanebiotech.com. About Kane Biotech Kane Biotech is a biotechnology company engaged in the research, development and commercialization of technologies and products that prevent and remove microbial biofilms. The Company has a portfolio of biotechnologies, intellectual property (74 patents and patents pending, trade secrets and trademarks) and products developed by the Company's own biofilm research expertise and acquired from leading research institutions. StrixNB™, DispersinB®, Aledex™, bluestem™, bluestem®, silkstem™, goldstem™, coactiv+™, coactiv+®, DermaKB™ and DermaKB Biofilm™ are trademarks of Kane Biotech Inc. The Company is listed on the TSX Venture Exchange under the symbol "KNE" and on the OTCQB Venture Market under the symbol "KNBIF". For more information: Marc Edwards Ray Dupuis Nicole Sendey Chief Executive Officer Chief Financial Officer Investor Relations/PR Kane Biotech Inc Kane Biotech Inc Kane Biotech Inc medwards@kanebiotech.com rdupuis@kanebiotech.com nsendey@kanebiotech.com +1 (514) 910-6991 +1 (204) 298-2200 +1 (250) 327-8675 Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Caution Regarding Forward-Looking InformationThis press release contains certain statements regarding Kane Biotech Inc. that constitute forward-looking information under applicable securities law. These statements reflect management's current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, risks relating to the Company's: (a) financial condition, including lack of significant revenues to date and reliance on equity and other financing; (b) business, including its early stage of development, government regulation, market acceptance for its products, rapid technological change and dependence on key personnel; (c) intellectual property including the ability of the Company to protect its intellectual property and dependence on its strategic partners; and (d) capital structure, including its lack of dividends on its common shares, volatility of the market price of its common shares and public company costs. Further information about these and other risks and uncertainties can be found in the disclosure documents filed by the Company with applicable securities regulatory authorities, available at www.sedar.com. The Company cautions that the foregoing list of factors that may affect future results is not exhaustive. KANE BIOTECH INC.               Selected Financial Results                                 Statement of Comprehensive Loss Three months ended June 30,   Six months ended June 30,       2022       2021       2022       2021                     Total Revenue.....»»

Category: earningsSource: benzingaAug 25th, 2022

Inter Parfums (IPAR) Gains on Solid Brands & Partnerships

Inter Parfums (IPAR) is benefiting from strength in its brand portfolio. The company's focus on product launches to boost assortment strength is impressive. A robust brand portfolio is working well for Inter Parfums, Inc. IPAR. The company is benefiting from solid growth across European and U.S. operations. These upsides have boosted first-quarter 2022 results, with the top and the bottom line increasing year over year. Quarterly earnings beat the Zacks Consensus Estimate.Besides, management is committed to effective product launches and strategic partnerships to boost growth.Let’s discuss in detail.Image Source: Zacks Investment ResearchSolid Performance & Bright ViewDuring the first quarter of 2022, Inter Parfums’ net sales came in at $250.7 million, up 26% year over year. The Europe-based product sales came in at $182.2 million, up 14% from 2021 levels. U.S.-based product sales amounted to $68.5 million, surging 77% from first-quarter 2021 levels. Inter Parfums’ largest brands delivered solid sales performance. Montblanc, Jimmy Choo, Coach and GUESS brand sales increased 22%, 7%, 22% and 36%, respectively. Its mid-sized brands like Abercrombie & Fitch, Kate Spade, Oscar de la Renta and Van Cleef & Arpels also delivered double-digit sales gains. Additional sales from initial product rollouts from MCM and Moncler brand were an upside. Initial sales of Ferragamo and Ungaro legacy scents also drove the quarterly sales. Inter Parfums’ earnings came in at $1.10 per share, up from 87 cents per share reported in the year-ago quarter.The company’s 2022 view suggests year-over-year top-and bottom-line growth. For 2022, Inter Parfums anticipates net sales of approximately $975 million. The metric reflects growth from $879.5 million reported in 2021. Management expects earnings per share (EPS) of $3.00 for 2022. The company reported an EPS of $2.75 in 2021.Product Launches & Strategic PartnershipInter Parfums’ focus on product launches to boost assortment strength is impressive. The company is benefitting from an impressive fragrance industry worldwide. Management is on track to officially rollout the Moncler in the second quarter. The company’s new Jimmy Choo Man Aqua and Lanvin Mon Éclat also debut in the second quarter. Throughout the year, management will unveil many extensions and flankers in many of the company’s brands. Inter Parfums expects Donna Karan and DKNY fragrances to join its brand portfolio in July. Management is keen on undertaking new licensing and acquisitions.Inter Parfums is on track to expand its business through new licenses or acquisitions. In December 2021, Inter Parfums, through its subsidiary Interparfums Italia, signed a 10-year exclusive global licensing agreement with Emanuel Ungaro. The partnership aims to create, develop and distribute fragrances and fragrance-related products under the Emanuel Ungaro brand. In October 2021, Inter Parfums finalized the agreement with Salvatore Ferragamo S.p.A. Per the agreement, Inter Parfums now holds the exclusive worldwide license for the production and distribution of Salvatore Ferragamo brand perfumes.Is All Rosy for Inter Parfums?Inter Parfums is battling inflation with rising prices of components like glass, cardboard, wood and aluminum. A significant increase in energy and shipping costs is a major hurdle. Management noted that the Russian invasion of Ukraine has adversely impacted its operations across both countries. Apart from these, temporary China lockdowns and supply chain obstacles were a downside for first-quarter 2022 results.Additionally, Inter Parfums’ has been grappling with higher selling, general and administrative (SG&A) expenses for a while. During the quarter, SG&A expenses amounted to $97.4 million, up 30% from $74.9 million reported in the year-ago quarter.That being said, we believe that the abovementioned upsides are likely to keep this Zacks Rank #3 (Hold) company’s growth story going. IPAR’s stock has gained 1.8% in the past year against the industry’s 42.2% decline.Looking for Better-Ranked Staple Bets? Check TheseSome better-ranked stocks are Sysco Corporation SYY, United Natural Foods UNFI and Pilgrim’s Pride PPC.Sysco, which markets and distributes various food and related products, sports a Zacks Rank #1 (Strong Buy). SYY has a trailing four-quarter earnings surprise of 9.1%, on average. You can see the complete list of today’s Zacks #1 Rank stocks here.The Zacks Consensus Estimate for Sysco’s current financial year sales and EPS suggests growth of 32.6% and 124.3%, respectively, from the year-ago reported number.United Natural Foods distributes natural, organic, specialty, produce and conventional grocery and non-food products. UNFI currently sports a Zacks Rank #1.The Zacks Consensus Estimate for UNFI’s current financial year sales and EPS suggests growth of 7.2% and 4.9%, respectively, from the year-ago period’s reported figures. United Natural Foods has a trailing four-quarter earnings surprise of 29.9%, on average.Pilgrim’s Pride, which produces, processes, markets and distributes fresh, frozen and value-added chicken and pork products, carries a Zacks Rank #2 (Buy). PPC has a trailing four-quarter earnings surprise of 31.4%, on average.The Zacks Consensus Estimate for Pilgrim’s Pride’s current financial year EPS suggests growth of 63.2% from the year-ago reported number. Zacks Names "Single Best Pick to Double" From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all. It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time. This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.Free: See Our Top Stock and 4 Runners Up >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sysco Corporation (SYY): Free Stock Analysis Report Pilgrim's Pride Corporation (PPC): Free Stock Analysis Report United Natural Foods, Inc. (UNFI): Free Stock Analysis Report Inter Parfums, Inc. (IPAR): Free Stock Analysis Report To read this article on Zacks.com click here......»»

Category: topSource: zacksJul 1st, 2022

The 30 bestselling audiobooks on Audible in 2022, from celebrity memoirs to the most gripping thrillers

These are the most popular audiobooks on Audible that make for great road trip or beach day entertainment. When you buy through our links, Insider may earn an affiliate commission. Learn more.These are the most popular audiobooks on Audible that make for great road trip or beach day entertainment.Crystal Cox/Insider Audible has thousands of books and podcasts. You can start a free 30-day Audible trial here. Below, we compiled its 30 bestselling audiobooks among Audible users right now. Books run the gamut from popular novels to self-help hits. If you're spending more time outside these days and have already cycled through your weekly podcasts, we'd recommend the slow burn of a great (and highly mobile) audiobook. If you're looking for a new title, we suggest starting with the books currently gaining buzz. Below are the top 30 bestselling audiobooks on Audible right now. The site has hundreds of thousands of titles to choose between, as well as a catalog of podcasts. If you're new to Audible or audiobook services in general, be sure to check out the FAQ section at the bottom of this article to get started. You can access Audible for free as part of a 30-day trial.The 30 bestselling audiobooks on Audible right now:Descriptions are provided by Amazon (lightly edited and condensed)."Where the Crawdads Sing" by Delia OwensAmazonFree on Audible with 30-day trialAvailable on Amazon for $12.39For years, rumors of the "Marsh Girl" have haunted Barkley Cove, a quiet town on the North Carolina coast. So in late 1969, when handsome Chase Andrews is found dead, the locals immediately suspect Kya Clark, the so-called Marsh Girl. But Kya is not what they say.Sensitive and intelligent, she has survived for years alone in the marsh that she calls home, finding friends in the gulls and lessons in the sand. Then the time comes when she yearns to be touched and loved. When two young men from town become intrigued by her wild beauty, Kya opens herself to a new life — until the unthinkable happens."Atomic Habits: An Easy & Proven Way to Build Good Habits & Break Bad Ones" by James ClearAmazonFree on Audible with 30-day trialAvailable on Amazon for $11.98No matter your goals, "Atomic Habits" offers a proven framework for improving every day. James Clear, one of the world's leading experts on habit formation, reveals practical strategies that will teach you exactly how to form good habits, break bad ones, and master the tiny behaviors that lead to remarkable results.“The Summer I Turned Pretty” by Jenny HanAmazonFree on Audible with 30-day trialAvailable on Amazon for $9.25Some summers are just destined to be pretty.Belly measures her life in summers. Everything good, everything magical happens between June and August. Winters are simply a time to count the weeks until the following summer, a place away from the beach house, away from Susannah, and most importantly, away from Jeremiah and Conrad. They are the boys Belly has known since her very first summer — they have been her brother figures, her crushes, and everything in between. But one summer, one wonderful and terrible summer, the more everything changes, the more it all ends up just the way it should have been all along.“Dreadgod: Cradle, Book 11” by Will WightAmazonPre-order: Free with 30-day trialThe battle in the heavens has left a target on Lindon's back.His most reliable ally is gone, the Monarchs see him as a threat, and he has inherited one of the most valuable facilities in the world. At any moment, his enemies could band together to kill him.If it weren't for the Dreadgods. All four are empowered and unleashed, rampaging through Cradle, and grudges old and new must be set aside. The Monarchs need every capable fighter to help them defend their territory.And Lindon needs time. While he fights, he sends his friends off to train. They'll need to advance impossibly fast if they want to join him in battle against the kings and queens of Cradle. Together, they will need enough power to rival a Dreadgod.“Scars and Stripes: An Unapologetically American Story of Fighting the Taliban, UFC Warriors, and Myself” by Tim Kennedy, Nick PalmiscianoAmazonFree on Audible with 30-day trialAvailable on Amazon for $18.37From decorated Green Beret sniper and UFC headliner Tim Kennedy comes a rollicking, inspirational memoir. It offers lessons on embracing failure and weathering storms — to unlock the strongest version of yourself.“It’s Not Summer Without You: Summer I Turned Pretty, Book 2” by Jenny HanAmazonFree on Audible with 30-day trialAvailable on Amazon for $9.36It used to be that Belly counted the days until summer until she was back at Cousins Beach with Conrad and Jeremiah. But not this year. Not after Susannah got sick again, and Conrad stopped caring. Everything right and good has fallen apart, leaving Belly wishing summer would never come. But when Jeremiah calls, saying Conrad has disappeared, Belly knows what she must do to make things right again. And it can only happen back at the beach house, the three of them together, the way things used to be. If this summer really and truly is the last summer, it should end the way it started — at Cousins Beach.“The Hotel Nantucket” by Elin HilderbrandAmazonFree on Audible with 30-day trialAvailable on Amazon for $17.99Fresh off a bad breakup with a longtime boyfriend, Nantucket sweetheart Lizbet Keaton is desperately seeking a second act. When she's named the new general manager of the Hotel Nantucket, a once Gilded Age gem turned abandoned eyesore, she hopes that her local expertise and charismatic staff can win the favor of their new London billionaire owner, Xavier Darling, as well as that of Shelly Carpenter, the wildly popular Instagram tastemaker who can help put them back on the map. And while the Hotel Nantucket appears to be a blissful paradise, complete with a celebrity chef-run restaurant and an idyllic wellness center, there's a lot of drama behind closed doors. The staff (and guests) have complicated pasts, and the hotel can't seem to overcome the bad reputation it earned in 1922 when a tragic fire killed 19-year-old chambermaid Grace Hadley. With Grace gleefully haunting the halls, a staff harboring all kinds of secrets, and Lizbet's romantic uncertainty, is the Hotel Nantucket destined for success or doom?“I'd Like to Play Alone, Please” by Tom SeguraAmazonFree on Audible with 30-day trialAvailable on Amazon for $18.33From Tom Segura, the massively successful stand-up comedian and co-host of chart-topping podcasts "2 Bears 1 Cave" and "Your Mom's House," come hilarious real-life stories of parenting, celebrity encounters, youthful mistakes, misanthropy, and so much more.“Verity” by Colleen HooverAmazonFree on Audible with 30-day trialAvailable on Amazon for $23.99Lowen Ashleigh is a struggling writer on the brink of financial ruin when she accepts the job offer of a lifetime. Jeremy Crawford, the husband of bestselling author Verity Crawford, has hired Lowen to complete the remaining books in a successful series his injured wife is unable to finish.Lowen arrives at the Crawford home, ready to sort through years of Verity's notes and outlines, hoping to find enough material to get her started. What Lowen doesn't expect to uncover in the chaotic office is an unfinished autobiography Verity never intended for anyone to read. Page after page of bone-chilling admissions, including Verity's recollection of the night her family was forever altered.Lowen decides to keep the manuscript hidden from Jeremy, knowing its contents could devastate the already grieving father. But as Lowen's feelings for Jeremy intensify, she recognizes all the ways she could benefit if he were to read his wife's words. After all, no matter how devoted Jeremy is to his injured wife, a truth this horrifying would make it impossible for him to continue loving her.You can find more of Colleen Hoover's best books here.“Sparring Partners” by John GrishamAmazonFree on Audible with 30-day trialAvailable on Amazon for $27.90"Homecoming" takes us back to Ford County, the fictional setting of many of John Grisham's unforgettable stories. Jake Brigance is back, but he's not in the courtroom. He's called upon to help an old friend, Mack Stafford, a former lawyer in Clanton, who three years earlier became a local legend when he stole money from his clients, divorced his wife, filed for bankruptcy, and left his family in the middle of the night, never to be heard from again — until now. In "Strawberry Moon," we meet Cody Wallace, a young death row inmate only three hours away from execution. His lawyers can't save him, the courts slam the door, and the governor says no to a last-minute request for clemency. As the clock winds down, Cody has one final request. The "Sparring Partners" are the Malloy brothers, Kirk and Rusty, two successful young lawyers who inherited a once prosperous firm when its founder, their father, was sent to prison. As the firm disintegrates, the resulting fiasco falls into the lap of Diantha Bradshaw, the only person the partners trust. "Atlas of the Heart: Mapping Meaningful Connection and the Language of Human Experience" by Brené BrownAmazonFree on Audible with 30-day trialAvailable on Amazon for $18.34In "Atlas of the Heart," Brown takes us on a journey through eighty-seven of the emotions and experiences that define what it means to be human. As she maps the necessary skills and an actionable framework for meaningful connection, she gives us the language and tools to access a universe of new choices and second chances — a universe where we can share and steward the stories of our bravest and most heartbreaking moments with one another in a way that builds connection.Over the past two decades, Brown's extensive research into the experiences that make us who we are has shaped the cultural conversation and helped define what it means to be courageous with our lives. Atlas of the Heart draws on this research, as well as on Brown's singular skills as a storyteller, to show us how accurately naming an experience doesn't give the experience more power — it gives us the power of understanding, meaning, and choice.“The Seven Husbands of Evelyn Hugo” by Taylor Jenkins ReidAmazonFree on Audible with 30-day trialAvailable on Amazon for $22.49Aging and reclusive Hollywood movie icon Evelyn Hugo is finally ready to tell the truth about her glamorous and scandalous life. But when she chooses unknown magazine reporter Monique Grant for the job, no one is more astounded than Monique herself. Why her? Why now?Monique is not exactly on top of the world. Her husband has left her, and her professional life is going nowhere. Regardless of why Evelyn has selected her to write her biography, Monique is determined to use this opportunity to jump-start her career.Summoned to Evelyn's luxurious apartment, Monique listens in fascination as the actress tells her story. From making her way to Los Angeles in the 1950s to her decision to leave show business in the '80s, and, of course, the seven husbands along the way, Evelyn unspools a tale of ruthless ambition, unexpected friendship, and a great forbidden love. Monique begins to feel a very real connection to the legendary star, but as Evelyn's story nears its conclusion, it becomes clear that her life intersects with Monique's own in tragic and irreversible ways.You can read a review of "The Seven Husbands of Evelyn Hugo" here.“Greenlights” by Matthew McConaugheyAmazonFree on Audible with 30-day trialAvailable on Amazon for $15.98From the Academy Award-winning actor, an unconventional memoir filled with raucous stories, outlaw wisdom, and lessons learned the hard way about living with greater satisfaction.“Finding Me: A Memoir” by Viola DavisAmazonFree on Audible with 30-day trialAvailable on Amazon for $18.53In my book, you will meet a little girl named Viola who ran from her past until she made a life-changing decision to stop running forever.This is my story, from a crumbling apartment in Central Falls, Rhode Island, to the stage in New York City, and beyond. This is the path I took to finding my purpose, but also my voice in a world that didn't always see me.“The End of the World Is Just the Beginning: Mapping the Collapse of Globalization” by Peter ZeihanAmazonFree on Audible with 30-day trialAvailable on Amazon for $31.50For generations, everything has been getting faster, better, and cheaper. Finally, we reached the point that almost anything you could ever want could be sent to your home within days — even hours — of when you decided you wanted it.America made that happen, but now America has lost interest in keeping it going.Globe-spanning supply chains are only possible with the protection of the U.S. Navy. The American dollar underpins internationalized energy and financial markets. Complex, innovative industries were created to satisfy American consumers. American security policy forced warring nations to lay down their arms. Billions of people have been fed and educated as the American-led trade system spread across the globe.All of this was artificial. All this was temporary. All this is ending.In "The End of the World Is Just the Beginning," author and geopolitical strategist Peter Zeihan maps out the next world: a world where countries or regions will have no choice but to make their own goods, grow their own food, secure their own energy, fight their own battles, and do it all with populations that are both shrinking and aging.The list of countries that make it all work is smaller than you think. This means everything about our interconnected world — from how we manufacture products, to how we grow food, to how we keep the lights on, to how we shuttle stuff about, to how we pay for it all — is about to change.“Finna: Book 1” by Nino CipriAmazonFree on Audible with 30-day trialAvailable on Amazon for $14.99When an elderly customer at a Swedish big-box furniture store ― but not that one ― slips through a portal to another dimension, it's up to two minimum-wage employees to track her across the multiverse and protect their company's bottom line. Multi-dimensional swashbuckling would be hard enough, but those two unfortunate souls broke up a week ago.To find the missing granny, Ava and Jules will brave carnivorous furniture, swarms of identical furniture spokespeople, and the deep resentment simmering between them. Can friendship blossom from the ashes of their relationship? In infinite dimensions, all things are possible.“The Golden Couple” by Greer Hendricks, Sarah PekkanenAmazonFree on Audible with 30-day trialAvailable on Amazon for $17.68Wealthy Washington suburbanites Marissa and Matthew Bishop seem to have it all ― until Marissa is unfaithful. Beneath their veneer of perfection is a relationship driven by work and a lack of intimacy. She wants to repair things for the sake of their eight-year-old son and because she loves her husband. Enter Avery Chambers.Avery is a therapist who lost her professional license. Still, it doesn't stop her from counseling those in crisis, though they must adhere to her unorthodox methods. And the Bishops are desperate.When they glide through Avery's door, and Marissa reveals her infidelity, all three are set on a collision course. Because the biggest secrets in the room are still hidden, and it's no longer simply a marriage that's in danger.“It Ends with Us” by Colleen HooverAmazonFree on Audible with 30-day trialAvailable on Amazon for $10.26Lily hasn't always had it easy, but that's never stopped her from working hard for the life she wants. She's come a long way from the small town where she grew up — she graduated from college, moved to Boston, and started her own business. And when she feels a spark with a gorgeous neurosurgeon named Ryle Kincaid, everything in Lily's life seems too good to be true.Ryle is assertive, stubborn, and maybe even a little arrogant. He's also sensitive, brilliant, and has a soft spot for Lily. And the way he looks in scrubs certainly doesn't hurt. Lily can't get him out of her head. But Ryle's complete aversion to relationships is disturbing. Even as Lily finds herself becoming the exception to his "no dating" rule, she can't help but wonder what made him that way in the first place.As questions about her new relationship overwhelm her, so do thoughts of Atlas Corrigan — her first love and a link to the past she left behind. He was her kindred spirit, her protector. When Atlas suddenly reappears, everything Lily has built with Ryle is threatened.You can find more of Colleen Hoover's best books here."Can't Hurt Me: Master Your Mind and Defy the Odds" by David GogginsAmazonFree on Audible with 30-day trialAvailable on Amazon for $20.10For David Goggins, childhood was a nightmare — poverty, prejudice, and physical abuse colored his days and haunted his nights. The only man in history to complete elite training as a Navy SEAL, Army Ranger, and Air Force Tactical Air Controller, he went on to set records in numerous endurance events, inspiring Outside magazine to name him The Fittest (Real) Man in America.In "Can't Hurt Me," he shares his astonishing life story and reveals that most of us tap into only 40% of our capabilities. Goggins calls this The 40% Rule, and his story illuminates a path that anyone can follow to push past pain, demolish fear, and reach their full potential.“We’ll Always Have Summer: Summer I Turned Pretty, Book 3” by Jenny HanAmazonFree on Audible with 30-day trialAvailable on Amazon for $9.31Belly has only ever been in love with two boys, both with the last name Fisher. And after being with Jeremiah for the previous two years, she's almost positive he is her soul mate. Almost. While Conrad has not gotten over the mistake of letting Belly go, Jeremiah has always known that Belly is the girl for him. So when Belly and Jeremiah decide to make things forever, Conrad realizes that it's now or never — tell Belly he loves her or loses her for good.Belly will have to confront her feelings for Jeremiah and Conrad and face the inevitable: She will have to break one of their hearts.“Happy-Go-Lucky” by David SedarisAmazonFree on Audible with 30-day trialAvailable on Amazon for $17.79Back when restaurant menus were still printed on paper, and wearing a mask — or not — was a decision made mostly on Halloween, David Sedaris spent his time doing normal things. As "Happy-Go-Lucky" opens, he is learning to shoot guns with his sister, visiting muddy flea markets in Serbia, buying gummy worms to feed to ants, and telling his nonagenarian father wheelchair jokes.But then the pandemic hits, and like so many others, he's stuck in lockdown, unable to tour and read for audiences — the part of his work he loves most. To cope, he walks for miles through a nearly deserted city. He vacuums his apartment twice a day, fails to hoard anything, and contemplates how sex workers and acupuncturists might be getting by during quarantine.As the world gradually settles into a new reality, Sedaris too finds himself changed. His offer to fix a stranger's teeth rebuffed, he straightens his own, and ventures into the world with new confidence. Newly orphaned, he considers what it means, in his seventh decade, no longer to be someone's son. And back on the road, he discovers a battle-scarred America: people weary, storefronts empty or festooned with "Help Wanted" signs, walls painted with graffiti reflecting the contradictory messages of our time: Eat the Rich. Trump 2024. Black Lives Matter.“Harry Potter and the Sorcerer's Stone, Book 1” by J.K. RowlingAmazonFree on Audible with 30-day trialAvailable on Amazon for $6.98Harry Potter has never even heard of Hogwarts when the letters start dropping on the doormat at number four, Privet Drive. Addressed in green ink on yellowish parchment with a purple seal, they are swiftly confiscated by his grisly aunt and uncle. Then, on Harry's eleventh birthday, a great beetle-eyed giant of a man called Rubeus Hagrid bursts in with some astonishing news: Harry Potter is a wizard, and he has a place at Hogwarts School of Witchcraft and Wizardry.“Match Game: Expeditionary Force, Book 14” by Craig AlansonAmazonFree on Audible with 30-day trialAvailable on Amazon for $14.44For years, the ancient alien AI known as Skippy (the Magnificent, don't forget that part) has been able to do one impossible thing after another. What is his secret? It's simple: 100 percent Grade-A Extreme Awesomeness. And also because he had never been faced with an opponent of equal power. Until now.This time, he might need a little help from a band of filthy monkeys.“The Terminal List” by Jack CarrAmazonFree on Audible with 30-day trialAvailable on Amazon for $11.99On his last combat deployment, Lieutenant Commander James Reece's entire team was killed in a catastrophic ambush. But when those dearest to him are murdered on the day of his homecoming, Reece discovers that this was not an act of war by a foreign enemy but a conspiracy that runs to the highest levels of government.Now, with no family and free from the military's command structure, Reece applies the lessons that he's learned in over a decade of constant warfare toward avenging the deaths of his family and teammates. With breathless pacing and relentless suspense, Reece ruthlessly targets his enemies in the upper echelons of power without regard for the laws of combat or the rule of law."Project Hail Mary" by Andy WeirAmazonFree on Audible with 30-day trialAvailable on Amazon for $17.32Ryland Grace is the sole survivor on a desperate, last-chance mission — and if he fails, humanity and the earth itself will perish.Except that right now, he doesn't know that. He can't even remember his own name, let alone the nature of his assignment or how to complete it.All he knows is that he's been asleep for a very, very long time. And he's just been awakened to find himself millions of miles from home, with nothing but two corpses for company.His crewmates dead, his memories fuzzily returning, Ryland realizes that an impossible task now confronts him. Hurtling through space on this tiny ship, it's up to him to puzzle out an impossible scientific mystery — and conquer an extinction-level threat to our species.And with the clock ticking down and the nearest human being light-years away, he's got to do it all alone. Or does he?You can read a review of "Project Hail Mary" here."12 Rules for Life" by Jordan B. PetersonAmazonFree on Audible with 30-day trialAvailable on Amazon for $13.55What are the most valuable things that everyone should know?In this book, Jordan Peterson provides twelve profound and practical principles for how to live a meaningful life, from setting your house in order before criticizing others to comparing yourself to who you were yesterday, not someone else today. Happiness is a pointless goal, he shows us. Instead, we must search for meaning, not for its own sake, but as a defense against the suffering that is intrinsic to our existence.Drawing on vivid examples from the author's clinical practice and personal life, cutting-edge psychology and philosophy, and lessons from humanity's oldest myths and stories, "12 Rules for Life" offers a deeply rewarding antidote to the chaos in our lives: eternal truths applied to our modern problems.“Run, Rose, Run” by James Patterson, Dolly PartonAmazonFree on Audible with 30-day trialAvailable on Amazon for $17.84From America's most beloved superstar and its greatest storyteller — a thriller about a young singer-songwriter on the rise and on the run, determined to do whatever it takes to survive.Nashville is where she's come to claim her destiny. It's also where the darkness she's fled might find her. And destroy her."The Subtle Art of Not Giving a F*ck" by Mark MansonAmazonFree on Audible with 30-day trialAvailable on Amazon for $12.99In this generation-defining self-help guide, a superstar blogger cuts through the crap to show us how to stop trying to be "positive" all the time so that we can truly become better, happier people.“The Paris Apartment” by Lucy FoleyAmazonFree on Audible with 30-day trialAvailable on Amazon for $17.99Jess needs a fresh start. She's broke and alone, and she's just left her job under less than ideal circumstances. Her half-brother Ben didn't sound thrilled when she asked if she could crash with him for a bit, but he didn't say no, and surely everything will look better from Paris. Only when she shows up — to find a very nice apartment, could Ben really have afforded this? — he's not there.The longer Ben stays missing, the more Jess starts to dig into her brother's situation, and the more questions she has. Ben's neighbors are an eclectic bunch and not particularly friendly. Jess may have come to Paris to escape her past, but it's starting to look like it's Ben's future that's in question.The socialite — the nice guy — the alcoholic — the girl on the verge — the concierge.Everyone's a neighbor. Everyone's a suspect. And everyone knows something they're not telling.“Come with Me” by Ronald MalfiAmazonFree on Audible with 30-day trialAvailable on Amazon for $11.49Aaron Decker's life changes one December morning when his wife Allison is killed. Haunted by her absence — and her ghost — Aaron goes through her belongings, where he finds a receipt for a motel room in another part of the country. Piloted by grief and an increasing sense of curiosity, Aaron embarks on a journey to discover what Allison had been doing in the weeks prior to her death.Yet Aaron is unprepared to discover Allison's dark secrets, the death and horror that make up the tapestry of her hidden life. And with each dark secret revealed, Aaron becomes more and more consumed by his obsession to learn the terrifying truth about the woman who had been his wife, even if it puts his own life at risk.Audible FAQHow much is Audible?Audible Plus is $7.95/month and Audible Premium is $14.95 per month. You can compare the Audible plans here.Audible Plus and Audible Premium Plus have a 30-day free trial to most new members that come with one free credit to use on a title of your choice. And since Audible is an Amazon company, Prime members get two credits in their Audible trial as one of their perks.When your trial is over, you'll be automatically charged a monthly subscription fee. You can cancel anytime. What's the difference between Audible Plus and Audible Premium?Both memberships give you unlimited access to select audiobooks, Audible Originals, podcasts, and more.But, only Audible Premium gives you a credit that's good for one title of your choice in the premium selection every month and 30% off all additional premium titles, plus access to exclusive sales. You can toggle between some of the titles in the Premium selection and Plus selection here.Are there other good audiobook services out there?At Insider Reviews, we also like the service Scribd, which is $10/month for unlimited audiobooks and books. The company also has a joint NYT and Scribd membership for $12.99/month which can be a very good deal. You can start a free trial here, or find a full review of the service here. Read the original article on Business Insider.....»»

Category: topSource: businessinsiderJun 29th, 2022

Jushi Holdings Inc. Reports First Quarter 2022 Financial Results

First Quarter 2022 Revenue Increased 48.5% to $61.9 million as Compared to the First Quarter of 2021 Established Fourth Vertically Integrated State-Level Operation in Nevada with the Completion of the Acquisition of The Apothecarium(2) dispensary in Las Vegas BOCA RATON, Fla., May 25, 2022 (GLOBE NEWSWIRE) -- Jushi Holdings Inc. ("Jushi" or the "Company") (CSE:JUSH) (OTCQX:JUSHF), a vertically integrated, multi-state cannabis operator, is pleased to announce its financial results for the first quarter 2022 ("Q1 2022") ended March 31, 2022. All financial information is provided in U.S. dollars unless otherwise indicated. First Quarter 2022 Highlights Total revenue of $61.9 million, an increase of 48.5% year-over-year Adjusted gross profit(1) of $25.5 million, an increase of 33.1% year-over-year Net loss of $14.3 million Adjusted EBITDA(1) of $1.1 million, or 1.7% of revenue Cash and cash equivalents were $76.2 million as of the quarter end First Quarter 2022 Operational Highlights Completed the acquisition of The Apothecarium(2) in Las Vegas, Nevada ("Apothecarium Nevada"), an operating adult-use and medical retail dispensary Debuted a series of cannabis brands and product launches in Massachusetts, beginning with the launch of flower brands The Bank and Sèchè Closed a non-brokered private placement (the "Offering"), for total proceeds of approximately $13.7 million Placed on The Globe and Mail's Third-Annual Women Lead Here benchmark of executive gender diversity Announced that Jim Cacioppo, Chief Executive Officer, Chairman, and Founder, purchased 66,800 Class B Subordinate Voting Shares of the Company in the open market for an approximate amount of $220,000 Recent Developments Awarded a provisional medical marijuana dispensary license in Ohio, establishing the Company's fifth vertically integrated state-level operation Expanded the Company's vertically integrated footprint in Nevada with the completion of the NuLeaf, Inc. ("NuLeaf") acquisition, adding a 27,000 sq. ft. cultivation facility, 13,000 sq. ft. processing facility, and three adult-use and medical retail dispensaries in the state Launched the Company's first line of solventless cannabis extracts in the Pennsylvania market under its award-winning The Lab brand, comprised of high-quality live rosin vapes and concentrates Opened the 32nd retail location nationwide and 3rd BEYOND / HELLO™ dispensary in California Closed on the purchase of land adjacent to the Company's Toledo Ohio grow facility which will allow Jushi to significantly expand its cultivation footprint at the Ohio grow facility, subject to regulatory approvals Management Commentary "Despite the seasonal weakness in the first quarter and a series of challenges including the loss of store hours due to Omicron, snowstorms, and the Pennsylvania distillate cartridges recall, I am pleased with our first quarter performance and the progress we have made in positioning our business for the long term," said Jim Cacioppo, Chief Executive Officer, Chairman, and Founder of Jushi. "We remain focused on investing in our businesses, including building out our store base, significantly expanding our cultivation and processing facilities in both Pennsylvania and Virginia, scaling our wholesale channel in Massachusetts, Pennsylvania, and Virginia, and integrating our two recently acquired businesses in Nevada. At the same time, we have taken decisive steps to manage our costs across all operating units and are encouraged by the initial results. I am confident that our investments into the business and the cost savings measures we have recently implemented position us to achieve accelerated growth and profitability through the balance of the year." Jim Cacioppo concluded, "I am very encouraged by what we have accomplished to date and remain confident that we are creating one of the most robust and exciting platforms to capitalize on the growth in the U.S. cannabis industry. I am incredibly proud of our people and their contributions and look forward to scaling our operations in 2022 and beyond." (1) See "Reconciliation of Non-IFRS Financial Measures" at the end of this press release for more information regarding the Company's use of non-IFRS financial measures.(2) The Apothecarium is used under license with an affiliate of TerrAscend Corp. Financial Results for the First Quarter 2022 The following is a tabular summary and commentary of revenue, gross profit, adjusted gross profit, net income (loss), and net income (loss) per share for the three-month periods ended March 31, 2022, December 31, 2021, and March 31, 2021.         ($ in millions, except per share amounts)    Quarter EndedMarch 31,2022 Quarter EndedDecember 31,2021 % Change Quarter EndedMarch 31,2022 Quarter EndedMarch 31,2021 % Change Revenue $ 61.9   $ 65.9   (6.1 )% $ 61.9   $ 41.7   48.5 % Gross profit $ 27.9   $ 20.9   33.8 % $ 27.9   $ 20.1   39.1 % Adjusted gross profit(1) $ 25.5   $ 26.4   (3.1 )% $ 25.5   $ 19.2   33.1 % Net income (loss) $ (14.3 ) $ 7.5     $ (14.3 ) $ (26.6 )   Net income (loss) per share - basic $ (0.08 ) $ 0.04     $ (0.08 ) $ (0.18 )   Net loss per share - diluted $ (0.08 ) $ (0.15 )   $ (0.08 ) $ (0.18 )   Revenue in Q1 2022 increased 48.5% to $61.9 million as compared to $41.7 million in the first quarter of 2021 ("Q1 2021"), driven by the expansion of our retail footprint from 17 to 29 stores, the acquisition of Nature's Remedy of Massachusetts, and increased wholesale sales at our Pennsylvania and Virginia grower-processor facilities. On a sequential quarterly basis, revenue declined 6.1% from $65.9 million in the fourth quarter of 2021 ("Q4 2021"). The 6.1% sequential decrease in revenue was driven primarily by a seasonal slowdown in activity, industry headwinds, such as continued inflationary pressures on consumer spending, regulatory delays impacting the expansion and sale of product offerings in select states, and temporary store closures related to the pandemic and snowstorms. Adjusted gross profit(1) in Q1 2022 was $25.5 million, or 41.3% of revenue, compared to $26.4 million, or 40.0% of revenue, in Q4 2021. The increase in gross margin was primarily driven by margin improvement in Pennsylvania, partially offset by an increase in promotional activity at retail in Illinois and Massachusetts and pricing compression in wholesale as the Company continues to build out its brands across state markets. Q1 2022 net loss was $14.3 million, or $0.08 per basic share and net loss of $0.08 per diluted share, compared to net income of $5.2 million, or $0.04 per basic share and net loss of $0.15 per diluted share, in Q4 2021. The net loss of $0.08 per diluted share in Q1 2022 was primarily due to the infrastructure and headcount investments that were completed in 2021 that are expected to have a transitional impact on our 2022 results. Adjusted EBITDA(1) in Q1 2022 was $1.1 million, a decrease of $0.4 million as compared to $1.5 million in Q4 2021 and a decrease of $3 million compared to the $4 million in Q1 2021. The decrease in Adjusted EBITDA(1) on a sequential quarterly basis was driven by lower revenues and gross profit. Balance Sheet and Liquidity As of March 31, 2022, the Company had $76.2 million of cash and cash equivalents, including proceeds from the Offering closed in Q1 2022. The Company paid approximately $29 million in capital expenditures during Q1 2022, of which $10 million was paid for capital expenditures accrued at year end 2021. The Company expects to incur approximately $40 to $60 million of new cash capital expenditures for the full year 2022, subject to market conditions and regulatory changes. As of March 31, 2022, the Company had approximately $147 million in principal amount of total debt, excluding leases and property, plant, and equipment financing obligations. As of May 25, 2022, the Company's Acquisition Facility had $60 million of available capacity, including the $25 million accordion feature. As of May 25, 2022, the Company's issued and outstanding shares were 194,542,278 and its fully diluted shares outstanding were 281,438,589. Outlook Mr. Cacioppo commented, "Looking ahead to the remainder of the year, we expect to open an additional four dispensaries and continue to build-out the grow rooms in our Pennsylvania and Virginia grower-processor facilities, which will increase our margins and substantially grow our wholesale sales in 2022 and beyond." Mr. Cacioppo added, "We are modestly revising our fourth quarter 2022 annualized revenue to be between $340 to $380 million, and our 2022 annualized Adjusted EBITDA to be between $60 to $80 million on an IFRS basis. The slight reduction in revenue and Adjusted EBITDA guidance was driven by (1) weakening in the macro environment; (2) ongoing regulatory delays; and (3) supply chain issues. We want to be conservative in regard to our projected revenue ramp through the remainder of the year. By the end of 2022, we are targeting 50 retail licenses across seven markets, including 36 operating retail locations and approximately 330,000 sq. ft. of cultivation and processing capacity." Mr. Cacioppo concluded, "We are putting in significant work, optimizing our resources, and making important investments where needed, to execute on our strategic initiatives and build out our business for long-term, sustained growth for our shareholders." The Company's MD&A and consolidated financial statements for the first quarter ended March 31, 2022, will be filed in May. The Company's previous public filings may be found on SEDAR at www.SEDAR.com. Conference Call and Webcast Information The Company will host a conference call to discuss its financial results for the first quarter 2022 at 9:00 a.m. ET today, Wednesday, May 25, 2022. Event: First Quarter 2022 Financial Results Conference Call Date: Wednesday, May 25, 2022 Time: 9:00 a.m. Eastern Time Live Call: +1-833-646-0490 (U.S. Toll-Free) or +1-918-922-6617 (International) Conference ID: 6827238 Webcast: Register For interested individuals unable to join the conference call, a dial-in replay of the call will be available until June 24, 2022, and can be accessed by dialing +1-855-859-2056 (U.S. Toll-Free) or +1-404-537-3406 (International) and entering replay pin number: 6827238. Consolidated Financial StatementThe financial information reported in this press release is based on unaudited management prepared financial statements for the three months March 31, 2022. These financial statements have been prepared in accordance with IFRS. This release contains certain preliminary financial results for first quarter 2022, including, but not limited to, Cost of goods sold; Gross profit; Income tax (expense) benefit; Net loss; Inventory, net; Goodwill, net; Deferred taxes, contingent consideration and accrued expenses. The Company expects to file its unaudited consolidated financial statements for the first quarter 2022 ended March 31, 2022, on SEDAR in May. Accordingly, such financial information may be subject to change. All financial information contained in this press release is qualified in its entirety with reference to such financial statements. While the Company does not expect there to be any material changes between the information contained in this press release and the consolidated financial statements it files on SEDAR, to the extent that the financial information contained in this press release is inconsistent with the information contained in the Company's financial statements, the financial information contained in this press release shall be deemed to be modified or superseded by the Company's filed financial statements. The making of a modifying or superseding statement shall not be deemed an admission for any purposes that the modified or superseded statement, when made, constituted a misrepresentation for purposes of applicable securities laws. Further, the reader should refer to the additional disclosures in the Company's unaudited financial statements for the first quarter ended March 31, 2022. About Jushi Holdings Inc.        We are a vertically integrated cannabis company led by an industry-leading management team. In the United States, Jushi is focused on building a multi-state portfolio of branded cannabis assets through opportunistic acquisitions, distressed workouts, and competitive applications. Jushi strives to maximize shareholder value while delivering high-quality products across all levels of the cannabis ecosystem. For more information, visit jushico.com or our social media channels, Instagram, Facebook, Twitter and LinkedIn. Forward-Looking Information and Statements        This press release contains certain "forward-looking information" within the meaning of applicable Canadian securities legislation and may also contain statements that may constitute "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current conditions but instead represent only the Company's beliefs regarding future events, plans or objectives, many of which, by their nature, involve estimates, projections, plans, goals, forecasts, and assumptions that may prove to be inaccurate. As a result, actual results could differ materially from those expressed by such forward-looking statements and such statements should not be relied upon. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as "plans," "expects" or "does not expect," "is expected," "budget," "scheduled," "estimates," "forecasts," "intends," "anticipates" or "does not anticipate," or "believes," or variations of such words and phrases or may contain statements that certain actions, events or results "may," "could," "would," "might" or "will be taken," "will continue," "will occur" or "will be achieved". The forward-looking information and forward-looking statements contained herein may include but are not limited to, information concerning the expectations regarding Jushi, or the ability of Jushi to successfully achieve business objectives, and expectations for other economic, business, and/or competitive factors. By identifying such information and statements in this manner, the Company is alerting the reader that such information and statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance, or achievements of the Company to be materially different from those expressed or implied by such information and statements. In addition, in connection with the forward-looking information and forward-looking statements contained in this press release, the Company has certain expectations and has made certain assumptions. Among the key factors that could cause actual results to differ materially from those projected in the forward- looking information and statements are the following: the ability of Jushi to successfully and/or timely achieve business objectives, including with regulatory bodies, employees, suppliers, customers and competitors; changes in general economic, business and political conditions, including changes in the financial markets; changes in applicable laws; and compliance with extensive government regulation, as well as other risks and uncertainties which are more fully described in the Company's Management, Discussion and Analysis for the three and twelve months ended December 31, 2021, and other filings with securities and regulatory authorities which are available at www.sedar.com. Should one or more of these risks, uncertainties or other factors materialize, or should assumptions underlying the forward- looking information or statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated, or expected. Although the Company believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws. All subsequent written and oral forward-looking information and statements attributable to the Company or persons acting on its behalf is expressly qualified in its entirety by this notice. Not for distribution to United States newswire services or for dissemination in the United States. For further information, please contact: Investor Relations Contact:Michael PerlmanExecutive Vice President of Investor Relations561-281-0247investors@jushico.comMedia Contact:Ellen Mellody570-209-2947ellen@mattio.com JUSHI HOLDINGS INC.CONDENSED UNAUDITED INTERIM CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands of U.S. dollars, except share and per share amounts)     Three Months Ended     March 31,2022 (1)   December 31,2021   March 31,2021 REVENUE, NET   $ 61,888     $ 65,892     $ 41,675   COST OF GOODS SOLD     (42,014 )     (46,181 )     (22,934 ) GROSS PROFIT BEFORE FAIR VALUE CHANGES   $ 19,874     $ 19,711     $ 18,741   Realized fair value changes included in inventory sold     (148 )     (2,892 )     (4,783 ) Unrealized fair value changes included in biological assets     8,217       4,059       6,135   GROSS PROFIT  .....»»

Category: earningsSource: benzingaMay 25th, 2022

The EU has paid Russia $38 billion for energy since the Ukraine war began. Now it"s considering escrow accounts to freeze the Kremlin"s revenue

The EU is considering escrow accounts for Russian energy revenue, and US Treasury Secretary Janet Yellen said the idea has potential. Russian President Vladimir Putin.Kremlin Press Office/Handout/Anadolu Agency via Getty Images The European Union has paid $38 billion for Russian energy since Vladimir Putin launched a war on Ukraine, a top EU official said. But the EU is weighing possible escrow accounts for Russian oil and gas payments.  Treasury Secretary Janet Yellen said the suggestion is constructive, and the US could consider it.  The European Union has paid $38 billion for Russian energy since Vladimir Putin launched his war on Ukraine, a top EU official said Wednesday.The trading bloc, which imports roughly 60% of its energy needs, imposed sanctions on Moscow after the war began but largely avoided Russian oil and gas. While the EU has vowed to cut Russian energy imports and backed a proposal Wednesday to ban Russian coal, oil and gas continues to flow to states that the Kremlin has dubbed "unfriendly."Since Russia invaded Ukraine in late February, the EU's 27 member states have made energy payments totaling about 35 billion euros, or roughly $38 billion, the trading bloc's foreign-policy chief, Josep Borrell, said Wednesday, according to the Wall Street Journal.But EU officials are considering the establishment of escrow accounts into which the bloc could funnel at least some of its energy payments, European Commission President Ursula von der Leyen said. An escrow account would effectively freeze overseas Russian energy revenue. But Putin has warned that Russia would cut off its energy supply if the country can't access payments for it.The same move was used to freeze a large swath of Iran's foreign energy sales under the US and international sanctions over the last decade. On Wednesday, US Treasury Secretary Janet Yellen said that creating an escrow account for Russian energy proceeds was one possible way the US and its allies could ramp up pressure on Moscow. "It's an approach worth exploring," Yellen said during a hearing in Congress. "We have a way for Russia to sell oil and gain proceeds in the form of a general license. But the license is temporary; it will expire. We need probably a better mechanism. It is a constructive suggestion that we could work with you on."Read the original article on Business Insider.....»»

Category: dealsSource: nytApr 6th, 2022

VIR Q4 Earnings Beat on Higher Revenues From Covid Treatment

VIR beat earnings estimates in the fourth quarter on higher sotrovimab revenues for COVID-19 patients. Vir Biotechnology VIR reported earnings of $3.92 per share in the fourth quarter, beating the Zacks Consensus Estimate of $2.60. In the year-ago quarter, the company reported a loss of 83 cents due to lower revenues.The company generated revenues of $812.7 million, which beat the Zacks Consensus Estimate of $670 and surged from $1.7 million in the year-ago quarter.Shares of Vir have lost 55.9% in the past year compared with the industry’s 37.6% decline.Image Source: Zacks Investment ResearchQuarter in DetailCollaboration revenues in the quarter were $809.5 million and contract revenues summed $0.3 million.The increase in collaboration revenues in the quarter was related to revenues from the company’s profit-sharing arrangement with GlaxoSmithKline GSK for the sale of sotrovimab under the company’s 2020 collaboration agreement with GSK. Collaboration revenues reflect the delivery of approximately 90% of the more than 750,000 sotrovimab doses sold in 2021.Grant revenues were $3.0 million compared with $1.4 million in the year-ago quarter. The increase was primarily due to $2.2 million of revenues recognized under the new grant agreement with the Bill & Melinda Gates Foundation to support the manufacturing and clinical activities of the company’s HIV and tuberculosis programs.Research & development expenses in the reported quarter were $128 million, up from $87.1 million in the year-ago quarter.Selling, general and administrative expenses were $55.8 million, up from $23.8 million in the year-ago quarter.Pipeline UpdatesWe note that sotrovimab has been granted Emergency Use Authorization (EUA), temporary authorization or marketing approval (under the brand name Xevudy) in more than 40 countries for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40kg).Vir and GSK plan to submit a biologics license application (BLA) for sotrovimab to the FDA in the second half of 2022.Vir and GSK are also assessing the use of sotrovimab in uninfected immunocompromised patients to determine whether the drug can prevent symptomatic COVID-19 infection.In December, Vir and Gilead Sciences, Inc. GILD initiated a phase II study. This study is evaluating the various combinations of VIR-2218, selgantolimod (GS-9688) Gilead’s investigational TLR-8 agonist and nivolumab, an approved PD-1 inhibitor, as a potential functional cure regimen for chronic HBV infection. Vir and Gilead retain full rights to their individual product candidates and will discuss the potential path forward for any future combination studies based on the outcome of the phase II study.Zacks Rank & A Stock to ConsiderVir currently carries a Zacks Rank #3 (Hold).   A better-ranked stock in the healthcare sector is Vertex Pharmaceuticals VRTX, which at present carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Vertex’ Pharmaceuticals earnings per share estimates have increased to $15.31 from $13.85 for 2022 over the past 60 days.The consensus estimate for 2022 earnings for Vertex has increased $1.01 over the past 30 days to $14.33. Shares of VRTX gained 10% in the past year.  Just Released: Zacks Top 10 Stocks for 2022 In addition to the investment ideas discussed above, would you like to know about our 10 top picks for the entirety of 2022? From inception in 2012 through 2021, the Zacks Top 10 Stocks portfolios gained an impressive +1,001.2% versus the S&P 500’s +348.7%. Now our Director of Research has combed through 4,000 companies covered by the Zacks Rank and has handpicked the best 10 tickers to buy and hold. Don’t miss your chance to get in…because the sooner you do, the more upside you stand to grab.See Stocks Now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GlaxoSmithKline plc (GSK): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis Report Vertex Pharmaceuticals Incorporated (VRTX): Free Stock Analysis Report Vir Biotechnology, Inc. (VIR): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksFeb 25th, 2022

Descartes Announces Fiscal 2022 Third Quarter Financial Results

Record Revenues and Income from Operations WATERLOO, Ontario, Dec. 01, 2021 (GLOBE NEWSWIRE) -- The Descartes Systems Group Inc. (TSX:DSG) (NASDAQ:DSGX) announced its financial results for its fiscal 2022 third quarter (Q3FY22). All financial results referenced are in United States (US) currency and, unless otherwise indicated, are determined in accordance with US Generally Accepted Accounting Principles (GAAP). "Driver shortages, supply constraints, capacity challenges and shipping bottlenecks are just some of the factors impacting today's global supply chains and the wider economy," said Edward J. Ryan, Descartes' CEO. "Running efficient supply chains is complicated, and the right technology is key to delivering on customer promises in a secure and efficient manner. Our Global Logistics Network was specifically designed to help solve the inherent multi-party, multi-process challenges faced by supply chain participants. We continue to leverage our experience and financial position to grow our Global Logistics Network for the benefit of our customers." Q3FY22 Financial ResultsAs described in more detail below, key financial highlights for Q3FY22 included: Revenues of $108.9 million, up 24% from $87.5 million in the third quarter of fiscal 2021 (Q3FY21) and up 4% from $104.6 million in the previous quarter (Q2FY22); Revenues were comprised of services revenues of $97.2 million (89% of total revenues), professional services and other revenues of $10.3 million (10% of total revenues) and license revenues of $1.4 million (1% of total revenues). Services revenues were up 25% from $77.6 million in Q3FY21 and up 4% from $93.5 million in Q2FY22; Cash provided by operating activities of $43.3 million, up 31% from $33.1 million in Q3FY21 and down from $46.4 million in Q2FY22; Income from operations of $27.8 million, up 48% from $18.8 million in Q3FY21 and up 7% from $26.1 million in Q2FY22; Net income of $25.5 million, up 92% from $13.3 million in Q3FY21 and up 10% from $23.2 million in Q2FY22. Net income as a percentage of revenues was 23%, compared to 15% in Q3FY21 and 22% in Q2FY22; Earnings per share on a diluted basis of $0.30, up 100% from $0.15 in Q3FY21 and up 11% from $0.27 in Q2FY22; and Adjusted EBITDA of $48.2 million, up 32% from $36.4 million in Q3FY21 and up 5% from $45.9 million in Q2FY22. Adjusted EBITDA as a percentage of revenues was 44%, compared to 42% in Q3FY21 and 44% in Q2FY22. Adjusted EBITDA and Adjusted EBITDA as a percentage of revenues are non-GAAP financial measures provided as a complement to financial results presented in accordance with GAAP. We define Adjusted EBITDA as earnings before interest, taxes, depreciation, amortization, stock-based compensation (for which we include related fees and taxes) and other charges (for which we include restructuring charges and acquisition-related expenses). These items are considered by management to be outside Descartes' ongoing operational results. We define Adjusted EBITDA as a percentage of revenues as the quotient, expressed as a percentage, from dividing Adjusted EBITDA for a period by revenues for the corresponding period. A reconciliation of Adjusted EBITDA and Adjusted EBITDA as a percentage of revenues to net income determined in accordance with GAAP is provided later in this release. The following table summarizes Descartes' results in the categories specified below over the past 5 fiscal quarters (unaudited; dollar amounts, other than per share amounts, in millions):   Q3FY22 Q2FY22 Q1FY22 Q4FY21 Q3FY21 Revenues 108.9 104.6 98.8 93.4 87.5 Services revenues 97.2 93.5 88.3 82.7 77.6 Gross margin 76% 76% 76% 75% 74% Cash provided by operating activities 43.3 46.4 40.9 36.5 33.1 Income from operations 27.8 26.1 23.4 21.9 18.8 Net income 25.5 23.2 18.4 17.2 13.3 Net income as a % of revenues 23% 22% 19% 18% 15% Earnings per diluted share 0.30 0.27 0.21 0.20 0.15 Adjusted EBITDA 48.2 45.9 41.5 38.6 36.4 Adjusted EBITDA as a % of revenues 44% 44% 42% 41% 42% Year-to-Date Financial Results As described in more detail below, key financial highlights for Descartes' nine-month period ended October 31, 2021 (9MFY22) included: Revenues of $312.3 million, up 22% from $255.3 million in the same period a year ago (9MFY21); Revenues were comprised of services revenues of $279.0 million (89% of total revenues), professional services and other revenues of $29.4 million (10% of total revenues) and license revenues of $3.9 million (1% of total revenues). Services revenues were up 23% from $227.0 million in 9MFY21; Cash provided by operating activities of $130.6 million, up 38% from $94.8 million in 9MFY21; Income from operations of $77.4 million, up 56% from $49.6 million in 9MFY21; Net income of $67.1 million, up 92% from $34.9 million in 9MFY21. Net income as a percentage of revenues was 21%, compared to 14% in 9MFY21; Earnings per share on a diluted basis of $0.78, up 90% from $0.41 in 9MFY21; and Adjusted EBITDA of $135.6 million, up 31% from $103.4 million in 9MFY21. Adjusted EBITDA as a percentage of revenues was 43%, compared to 41% in 9MFY21. The following table summarizes Descartes' results in the categories specified below over 9MFY22 and 9MFY21 (unaudited, dollar amounts in millions):   9MFY22 9MFY21 Revenues 312.3 255.3 Services revenues 279.0 227.0 Gross margin 76% 74% Cash provided by operating activities 130.6 94.8 Income from operations 77.4 49.6 Net income 67.1 34.9 Net income as a % of revenues 21% 14% Earnings per diluted share 0.78 0.41 Adjusted EBITDA 135.6 103.4 Adjusted EBITDA as a % of revenues 43% 41% Cash PositionAt October 31, 2021, Descartes had $171.1 million in cash. Cash increased by $42.7 million in Q3FY22 and increased $37.4 million in 9MFY22. The table set forth below provides a summary of cash flows for Q3FY22 and 9MFY22 in millions of dollars:   Q3FY22 9MFY22 Cash provided by operating activities 43.3 130.6 Additions to property and equipment (1.2) (3.7) Acquisitions of subsidiaries, net of cash acquired - (90.3) Credit facility and other debt repayments - (1.1) Payment of debt issuance costs - (0.1) Issuances of common shares, net of issuance costs 1.0 2.5 Effect of foreign exchange rate on cash (0.4) (0.5) Net change in cash 42.7 37.4 Cash, beginning of period 128.4 133.7 Cash, end of period 171.1 171.1 Conference CallMembers of Descartes' executive management team will host a conference call to discuss the company's financial results today at 5:30 p.m. ET, Wednesday, December 1. Designated numbers are +1 888 465-5079 for North America and +1 416 216-4169 for international, using Passcode 6485 701#. The company will simultaneously conduct an audio webcast on the Descartes Web site at www.descartes.com/descartes/investor-relations. Phone conference dial-in or webcast log-in is required approximately 10 minutes beforehand. A digital replay of the conference call will be available following the call from 8:00 p.m. ET, and until December 8, 2021, at www.descartes.com/descartes/investor-relations. About DescartesDescartes (NASDAQ:DSGX) (TSX:DSG) is the global leader in providing on-demand, software-as-a-service solutions focused on improving the productivity, performance and security of logistics-intensive businesses. Customers use our modular, software-as-a-service solutions to route, schedule, track and measure delivery resources; plan, allocate and execute shipments; rate, audit and pay transportation invoices; access global trade data; file customs and security documents for imports and exports; and complete numerous other logistics processes by participating in the world's largest, collaborative multimodal logistics community. Our headquarters are in Waterloo, Ontario, Canada and we have offices and partners around the world. Learn more at www.descartes.com, and connect with us on LinkedIn and Twitter. Descartes Investor Contact: Laurie McCauley +1-519-746-6114 x202358 investor@descartes.com Safe Harbor Statement This release may contain forward-looking information within the meaning of applicable securities laws ("forward-looking statements") that relates to Descartes' expectations concerning future revenues and earnings, and our projections for any future reductions in expenses or growth in margins and generation of cash; our assessment of the current and future potential impact of the COVID-19 pandemic on our business, results of operations and financial condition; continued growth and acquisitions including our assessment of any increased opportunity for our products and services as a result of trends in the logistics and supply chain industries; rate of profitable growth; demand for Descartes' solutions; growth of Descartes' Global Logistics Network ("GLN"); customer buying patterns; customer expectations of Descartes; development of the GLN and the benefits thereof to customers; and other matters. These forward-looking statements are based on certain assumptions including the following: global shipment volumes continuing at levels generally consistent with those experienced historically; the current COVID-19 pandemic not having a material negative impact on shipment volumes or on the demand for the products and services of Descartes by its customers and the ability of those customers to continue to pay for those products and services; countries continuing to implement and enforce existing and additional customs and security regulations relating to the provision of electronic information for imports and exports; countries continuing to implement and enforce existing and additional trade restrictions and sanctioned party lists with respect to doing business with certain countries, organizations, entities and individuals; Descartes' continued operation of a secure and reliable business network; the stability of general economic and market conditions, currency exchange rates, and interest rates; equity and debt markets continuing to provide Descartes with access to capital; Descartes' continued ability to identify and source attractive and executable business combination opportunities; Descartes' ability to develop solutions that keep pace with the continuing changes in technology, and our continued compliance with third party intellectual property rights. These assumptions may prove to be inaccurate. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Descartes, or developments in Descartes' business or industry, to differ materially from the anticipated results, performance or achievements or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, Descartes' ability to successfully identify and execute on acquisitions and to integrate acquired businesses and assets, and to predict expenses associated with and revenues from acquisitions; the impact of network failures, information security breaches or other cyber-security threats; disruptions in the movement of freight and a decline in shipment volumes including as a result of contagious illness outbreaks; a deterioration of general economic conditions or instability in the financial markets accompanied by a decrease in spending by our customers; the ability to attract and retain key personnel and the ability to manage the departure of key personnel and the transition of our executive management team; changes in trade or transportation regulations that currently require customers to use services such as those offered by Descartes; changes in customer behaviour and expectations; Descartes' ability to successfully design and develop enhancements to our products and solutions; departures of key customers; the impact of foreign currency exchange rates; Descartes' ability to retain or obtain sufficient capital in addition to its debt facility to execute on its business strategy, including its acquisition strategy; disruptions in the movement of freight; the potential for future goodwill or intangible asset impairment as a result of other-than-temporary decreases in Descartes' market capitalization; and other factors and assumptions discussed in the section entitled, "Certain Factors That May Affect Future Results" in documents filed with the Securities and Exchange Commission, the Ontario Securities Commission and other securities commissions across Canada, including Descartes' most recently filed Management's Discussion and Analysis. If any such risks actually occur, they could materially adversely affect our business, financial condition or results of operations. In that case, the trading price of our common shares could decline, perhaps materially. Readers are cautioned not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Forward-looking statements are provided for the purpose of providing information about management's current expectations and plans relating to the future. Readers are cautioned that such information may not be appropriate for other purposes. We do not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based, except as required by law. Reconciliation of Non-GAAP Financial Measures - Adjusted EBITDA and Adjusted EBITDA as a percentage of revenues We prepare and release quarterly unaudited and annual audited financial statements prepared in accordance with GAAP. We also disclose and discuss certain non-GAAP financial information, used to evaluate our performance, in this and other earnings releases and investor conference calls as a complement to results provided in accordance with GAAP. We believe that current shareholders and potential investors in our company use non-GAAP financial measures, such as Adjusted EBITDA and Adjusted EBITDA as a percentage of revenues, in making investment decisions about our company and measuring our operational results. The term "Adjusted EBITDA" refers to a financial measure that we define as earnings before certain charges that management considers to be non-operating expenses and which consist of interest, taxes, depreciation, amortization, stock-based compensation (for which we include related fees and taxes) and other charges (for which we include restructuring charges and acquisition-related expenses). Adjusted EBITDA as a percentage of revenues divides Adjusted EBITDA for a period by the revenues for the corresponding period and expresses the quotient as a percentage. Management considers these non-operating expenses to be outside the scope of Descartes' ongoing operations and the related expenses are not used by management to measure operations. Accordingly, these expenses are excluded from Adjusted EBITDA, which we reference to both measure our operations and as a basis of comparison of our operations from period-to-period. Management believes that investors and financial analysts measure our business on the same basis, and we are providing the Adjusted EBITDA financial metric to assist in this evaluation and to provide a higher level of transparency into how we measure our own business. However, Adjusted EBITDA and Adjusted EBITDA as a percentage of revenues are non-GAAP financial measures and may not be comparable to similarly titled measures reported by other companies. Adjusted EBITDA and Adjusted EBITDA as a percentage of revenues should not be construed as a substitute for net income determined in accordance with GAAP or other non-GAAP measures that may be used by other companies, such as EBITDA. The use of Adjusted EBITDA and Adjusted EBITDA as a percentage of revenues does have limitations. In particular, we have completed ten acquisitions since the beginning of fiscal 2020 and may complete additional acquisitions in the future that will result in acquisition-related expenses and restructuring charges. As these acquisition-related expenses and restructuring charges may continue as we pursue our consolidation strategy, some investors may consider these charges and expenses as a recurring part of operations rather than expenses that are not part of operations. The table below reconciles Adjusted EBITDA and Adjusted EBITDA as a percentage of revenues to net income reported in our unaudited Consolidated Statements of Operations for Q3FY22, Q2FY22, Q1FY22, Q4FY21, and Q3FY21, which we believe is the most directly comparable GAAP measure. (US dollars in millions) Q3FY22   Q2FY22   Q1FY22   Q4FY21   Q3FY21   Net income, as reported on Consolidated Statements of Operations 25.5   23.2   18.4   17.2   13.3   Adjustments to reconcile to Adjusted EBITDA:           Interest expense 0.3   0.3   0.3   0.3   0.2   Investment income (0.1 ) (0.1 ) (0.1 ) (0.1 ) -   Income tax expense 2.1   2.7   4.8   4.5   5.2   Depreciation expense 1.3   1.3   1.2   1.3   1.5.....»»

Category: earningsSource: benzingaDec 1st, 2021

Moderna (MRNA) Q3 Earnings Miss, COVID-19 Vaccine Brings $5B

Moderna's (MRNA) COVID-19 vaccine sales miss expectations. The company delivers 208 million doses of its COVID-19 vaccine during the third quarter. Stock declines in pre-market. Moderna Inc. MRNA reported earnings of $7.70 per share for the third quarter of 2021, missing the Zacks Consensus Estimate of $8.96. The company had incurred a loss of 59 cents per share in the year-ago quarter. The significant growth in earnings was driven by strong year- over-year growth in revenues.Revenues in the quarter were $4.97 billion, significantly missing the Zacks Consensus Estimate of $6.05 billion. In the year-ago quarter, revenues were $157 million. The significant increase in revenues was driven by the sales of its coronavirus vaccine, which is now approved for temporary/emergency use in several countries. Moreover, grants from an agreement with Biomedical Advanced Research and Development Authority (“BARDA”) related to the development of the COVID-19 vaccine also drove revenues.Moderna’s shares were down 13.8% in pre-market trading on Nov 4, following dismal third-quarter results. However, shares of the company have surged 231.2% so far this year against the industry’s 6.8% decrease.Image Source: Zacks Investment ResearchQuarter in DetailsIn December, Moderna received approval for the emergency use of its coronavirus vaccine, mRNA-1273. With this approval, the company got its first commercial product and recorded product revenues for the first time. The company received emergency use approval for mRNA-1273 by the World Health Organization (WHO) and health agencies in more than 60 countries.Product sales, entirely from the COVID-19 vaccine, were $4.8 billion during the quarter. In the second quarter of 2021, product sales were $4.2 billion.Grant revenues were $140 million compared with $145 million in the year-ago quarter. The company has a funding commitment from BARDA in place since last year to develop its coronavirus vaccine candidate.Collaboration revenues were $19 million compared with $12 million in the year-ago quarter. The company earns collaboration revenues from agreements with several big pharma/biotech companies, including AstraZeneca AZN, Merck MRK and Vertex Pharmaceuticals VRTX.Selling, general and administrative expenses were $168 million compared with $48 million in the year-ago quarter. The significant increase was primarily attributable to increased headcount and commercialization-related activities for mRNA-1273 vaccine.Research & development expenses were $521 million, up 51.5% from the year-ago period. The rise was largely due to increased higher clinical development costs for mRNA-1273.The company ended the quarter with $15.3 billion in cash and cash equivalents, compared with $12.2 billion as of Jun 30, 2021.2021 GuidanceModerna expects products sales to be between $15 billion and $18 billion in 2021. The company had previously stated that it has advance purchase agreements for its COVID-19 vaccine worth $20 billion in place. However, the supply of some doses, scheduled for 2021, needs to be shifted to 2022 for certain factors including longer delivery lead times for international shipments.Coronavirus Vaccine UpdateAlong with the earnings release, Moderna announced that the FDA has granted priority review to its biologics license application seeking approval for its COVID-19 vaccine, mRNA-1273. A decision is expected in April 2022.During the quarter and last month, the COVID-19 vaccine was authorized for emergency use in adolescents in several countries including the European Union. However, the FDA extended the review period for Moderna’s authorization request for the use of the vaccine in adolescents to evaluate recent international analyses of the risk of myocarditis after vaccination. The review may not be completed before January 2022.Last month, the booster dose of the vaccine was authorized for emergency use in the United States, Europe and several other health agencies across the world. The company is currently developing four variant-specific booster doses of its COVID-19 vaccine, with three being evaluated in phase II/III studies.The company is engaged in discussions with the governments of different countries for advance purchase agreements for its COVID-19 vaccine and booster doses to supply in 2022 and 2023. The company has already signed similar agreements for initial doses worth approximately $17 billion along with options for additional doses worth approximately $3 billion for 2022. The company anticipates commercial booster market sales to be up to $2 billion in 2022.Moderna announced new data from the phase II KidCOVE study, which demonstrated that the administration of the vaccine at the 50 µg dose level achieved 100% efficacy after two weeks of the first dose in children aged 6 years to under 12 years. The study continues to evaluate the vaccine in two to under six years and six months to under two years age groups.A late-stage study is evaluating the vaccine in adults with a kidney or liver transplant. A phase I study is evaluating the company’s next-generation COVID-19 vaccine candidate, mRNA-1283. Initial data from the study were encouraging and the company is planning to start a phase II study shortly.Other Key Pipeline UpdatesModerna has several other mRNA-based pipeline candidates targeting different indications in its pipeline. Key among them are mRNA-1647 and mRNA-1345.The company initiated a late-stage study to evaluate mRNA-1647 as a cytomegalovirus vaccine last month. A phase II/III study to evaluate mRNA-1345 as respiratory syncytial virus vaccine is expected to start later this year. Moderna is also developing a combination vaccine against coronavirus and flu virus.Moderna, Inc. Price, Consensus and EPS Surprise Moderna, Inc. price-consensus-eps-surprise-chart | Moderna, Inc. QuoteZacks RankCurrently, Moderna carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Zacks' Top Picks to Cash in on Artificial Intelligence In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create "the world's first trillionaires." Zacks' urgent special report reveals 3 AI picks investors need to know about today.See 3 Artificial Intelligence Stocks With Extreme Upside Potential>>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Vertex Pharmaceuticals Incorporated (VRTX): Free Stock Analysis Report Moderna, Inc. (MRNA): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksNov 4th, 2021

How London Became a Global Center for Fintech and What U.S. Tech Hubs Can Learn From It

When Silicon Valley veteran Eileen Burbidge moved to London in 2004, it was only meant to be temporary. With more than a decade of experience at tech stalwarts including Apple, Sun Microsystems and Verizon Wireless, the Chicago native felt a stint in Europe might help advance her career back in the U.S. With no language… When Silicon Valley veteran Eileen Burbidge moved to London in 2004, it was only meant to be temporary. With more than a decade of experience at tech stalwarts including Apple, Sun Microsystems and Verizon Wireless, the Chicago native felt a stint in Europe might help advance her career back in the U.S. With no language barrier and an emerging software-development market, London was an obvious choice. She took on a job as product director for a newly launched startup named Skype. Nearly 20 years later, Burbidge is still there. Now co-founder and partner of early-stage venture-capital firm Passion Capital, she has established herself as an intrinsic part of London’s financial technology, or “fintech,” scene. Burbidge was the digital representative on former Prime Minister David Cameron’s business advisory panel and was honored by Queen Elizabeth II in 2015 as a member of the Order of the British Empire—or MBE—for services to U.K. business. She also served as tech ambassador for the office of the mayor of London, and is now a fintech envoy to the U.K. Treasury. [time-brightcove not-tgx=”true”] It’s little surprise then that Burbidge sees London firmly at the beating heart of the tech-forward financial world. “It’s got the unique combination of a financial-services heritage, with 300 of the world’s banking headquarters based here, plus progressive policy-makers who support fintech innovation,” she tells TIME over video call from her home office in North London. The U.K. capital has for centuries been a center of global finance, with long-established trading exchanges and trusted banking and insurance institutions. In the digital era, it has become an emerging hub for fintech companies, which use technology to improve financial services. Not even the uncertainty presented by the U.K.’s departure from the European Union in early 2020, coupled with the disruption of the global pandemic, has stemmed growth. Venture-capital firms invested $4.57 billion in U.K.-based fintech companies last year, making the country second only to the U.S., where investment was $19.6 billion, according to growth platform Tech Nation’s annual report on the U.K. tech sector. And in the first half of 2021 alone, U.K. tech companies raised more than $18 billion worth of venture-capital funding, according to figures compiled for the U.K.’s Digital Economy Council. “Investors showing their confidence in London’s fintech offering reinforces our city’s position as a leading global hub for this important and growing industry,” Sadiq Khan, the mayor of London, says in a statement. “Despite the impact of Brexit and the pandemic, we’ve seen record levels of funding for fintech businesses in the first six months of the year.” The success story of this boom in fintech innovation has undoubtedly been so-called challenger banks— digital-only banking apps that use cloud-based infrastructure, embedded artificial intelligence, and agile frameworks to give consumers easier and faster access to banking services and financial products. Companies like Revolut, Starling Bank and Monzo have raised increasingly large sums of money and established themselves as household names among their tech-savvy, largely millennial and Gen Z consumer base, many of whom have eschewed traditional retail banking in favor of these more user-friendly banking apps. How London evolved to become a challenger to established hubs for innovation in the U.S. has lessons for entrepreneurs and investors who find an increasingly difficult regulatory environment and a shrinking talent pool for development in California, New York or Texas. Burbidge, one of the key architects of the fintech boom, sees a changing of the guard. “Before long my colleagues [in the U.S.] stopped asking when I was coming back and by 2016 were instead coming across to join me,” she says. When Burbidge set about building her team at Skype in 2004, the lack of qualified workers was one of the biggest challenges she faced. “Despite this burgeoning tech and digital sector in London, it was impossible for me to find a product manager, and the first few hires I made all came over from the States.” Now, she says there is a “wide concentration of developers, so much more than San Jose or New York.” That change has been helped in part by shifts in London’s economic ecosystem in the past decade. As a bruised City of London emerged from the financial crisis, it had lost its shine for some workers, who had seen how antiquated technology and a lack of innovation were stagnating progress and career development. Public attitudes toward the City had cooled amid austerity measures that also exacerbated problems for those who were unbanked or underserved by traditional outlets. It was this environment that led Starling Bank’s founder Anne Boden—who spent 30 years working for traditional banking heavyweights that had been battered by the crisis, like ABN Amro, Royal Bank of Scotland and Allied Irish Banks—to launch her own bank in 2014. “I noticed that banking hadn’t progressed technologically, and this frustrated me,” says Boden. “The big banks seemed to be stuck in the past … Their systems were slow and yet no one seemed to be improving them. I realized that if I wanted to see a real digital bank in action, I would have to launch one myself.” Boden says she founded Starling as “a more human alternative to the banks of the past.” The digital bank, which counts Fidelity and the Qatar Investment Authority among its backers, was recently valued at $1.7 billion. Many others in the financial industry had similar sentiments to Boden’s, and left the industry to join some of London’s burgeoning startups or create their own fintechs. As attitudes have shifted, the conveyor belt that once took the brightest young minds from the halls of Europe’s top universities to the trading floors and deal rooms of investment banks has slowed, and fintechs have been reaping the benefits. Nikolay Storonsky, the British-Russian CEO of Revolut, says it was London’s talent pool that was most compelling when he established the company in 2015. “We have a hugely diverse U.K. workforce—more than 80 nationalities—many of whom were Londoners already, and others who were enthusiastic to come here.” Dan Kitwood—Getty ImagesLondon’s Canary Wharf business district, where fintech company Revolut is based Storonsky, a former derivatives trader at Lehman Brothers and Credit Suisse, was also able to tap two talent pipelines to fuel the company’s phenomenal growth. “London’s eminence as a world financial centre is a huge advantage. There’s deep experience and talent here, both from the financial sector and from the startup world,” he says in an email. Burbidge found that what wasn’t as established in London was the early-stage venture-capital funding network that startups need to grow, and that creates unicorns. In the U.K., venture-capital firms have typically been later-stage investors, meaning startup founders have had to rely on angel investors, bank loans and even their own cash for early funding. Burbidge and her two business partners at the time, Robert Dighero and Stefan Glaenzer, who has since left the firm, decided to replicate the Silicon Valley model of first-round funding through Passion Capital when they founded it in 2009. They were determined to back exciting and dynamic startups, leading to standout investments in GoCardless in 2011 and Monzo in 2015. The latter neobank, known for its distinctive colorful debit cards that can be used abroad without fees, has since surpassed a $1 billion valuation and is piloting a beta version of its app in the U.S. in partnership with Sutton Bank. A major reason challenger banks have been able to thrive in London is a supportive regulatory environment, says Storonsky, whose Revolut is now valued at $33 billion, making it the U.K.’s most valuable tech company in history. U.K. watchdog the Financial Conduct Authority (FCA) has taken an active role, engaging with banks and new fintech companies on consumer-focused solutions, and it has established a world-class sandbox, where approved new fintech firms can test products with real consumers. Yet by 2016, just as the fintech industry was becoming established in London, storm clouds loomed on the horizon. That summer, the British public voted to leave the E.U.—although notably voters in London backed Remain by 60-40. London’s financial industry grew into what it is today partly because its rules mirrored those of the E.U., allowing for seamless transactions. Many in the London-based fintech industry were concerned about how Brexit might change the legal framework that the City operates within. The U.K. ultimately left the bloc last January, but Burbidge says that there has been no doomsday scenario so far: “We certainly haven’t seen the big asset managers or banks clear out of London. Perhaps that’s because it’s been the home of traditional financial-services institutions for so long—there’s still a draw.” The regulatory environment remains advantageous for fintech companies post-Brexit, she says. “If you’re going to be a fintech you do have to be regulated and domiciled, which means you’re subject to compliance. And the U.K. is one of the most progressive and forward-thinking homes for fintech.” For the industry to continue growing, however, it will also require the pool of talent to be continually replenished, but restrictions on freedom of movement between the U.K. and the E.U. may make that harder. The U.K. fintech industry employed 76,500 people in 2017, and that was projected to reach 105,500 by 2030 if immigration rules remained as they were. Simon Schmincke, a partner at venture-capital firm Creandum, which has invested in several U.K. fintech companies, says that bringing in talent from other countries is becoming a headache for many companies: “I am stunned that in two years, we still haven’t figured out how to bring smart people in quickly. And that is having both a negative impact on individual companies and on the country’s image.” It used to be that “everyone was welcome as long as you worked hard and smart,” Schmincke says. “Now, that image is fading.” Last year, after the U.K. formally left the E.U., Britain’s Finance Minister Rishi Sunak commissioned businessman Ron Kalifa to chair an independent strategic review of how the U.K. government, regulators, and companies can support the growth and widespread adoption of fintech and maintain Britain’s global reputation in the sector. The government has committed to adopting a number of the report’s recommendations. “We’ve set out a road map to sharpen the U.K.’s competitive advantage and deliver a more open, green and technologically advanced financial-services sector,” a spokesperson for the U.K. Treasury said. The government plans to support U.K. fintech companies by introducing new visa routes for foreign workers, enhancing its regulatory toolbox, reforming its market-listing rules and exploring a central-bank digital currency, the spokesperson said. These kinds of reforms will be necessary for London to retain its competitive edge, according to Shampa Roy-Mukherjee, associate professor and director of impact and innovation at the Royal Docks School of Business and Law, University of East London. European countries such as Malta and Lithuania are taking advantage of the uncertainty caused by Brexit to offer new homes to London-based fintech companies, she says. “These countries are able to provide the fintech companies regulatory authorization to trade with the E.U., which the U.K. currently cannot provide.” U.S. investors haven’t been scared off by Brexit—and in fact have helped to power the U.K.’s fintech industry to greater heights. John Doran, general partner at U.S. growth-capital firm TCV, an investor in Revolut, says in an email that the company’s fundamentals were the key consideration. “We look to invest behind exceptionally driven visionary founders, who are building category leaders in industries undergoing a massive structural shift, and Revolut has all of these things.” It also has the size and clout to pursue growth in the U.S. market. Similarly to Monzo’s relationship with Sutton, Revolut currently partners with Metropolitan Commercial Bank, but it applied for an independent U.S. banking license in March and began offering services to small and medium-size businesses in the U.S. Burbidge is skeptical that the success of London could be as easily replicated across the pond. “It’s definitely down to the culture and ecosystem,” she says. “Because the U.S. is so siloed in terms of regulation, the success of financial-services hubs would be difficult to replicate.” She says entrepreneurs in London are more mindful of customer outcomes than their U.S. counterparts. Partly in an effort to avoid comparisons with payday-loan apps that have been criticized for predatory tactics in recent years, many U.K. founders have worked to ensure that “wellness and mental health are built in at the core of new startups,” Burbidge says. “Historically this hasn’t been part of the startup culture in the U.S.” She adds that the FCA is more attuned to these issues and wields “a far greater influence” in the U.K. than regulators do in the U.S. “While attitudes toward financial inclusion and customer outcomes are shifting over there, I believe if they had started thinking earlier about it as a proposition, they would have attracted further investment and customers. It’s a missed opportunity for the U.S.” America’s biggest bank has taken notice of the particular advantages the U.K. market offers too. On Sept. 21, JPMorgan Chase launched its digital bank, Chase, in the U.K., marking the commercial bank’s first foray outside the U.S. in its 222-year history. It is attempting to attract U.K. consumers in the competitive market with a range of cash-back and savings offers. The bank has indicated it is in it for the long haul, and is prepared to spend hundreds of millions of dollars to become profitable in the U.K. Burbidge isn’t planning on leaving London anytime soon either, and remains its biggest cheerleader. “It’s a city with a massive commercial center, but it’s also the policymaking hub of the U.K. and additionally so creative and diverse that it’s as if you combined all of San Francisco, New York City, Washington, D.C., and Los Angeles all into one megacity,” she says. “It’s hard to beat.” —With reporting by Eloise Barry/London.....»»

Category: topSource: timeOct 1st, 2021

Huawei"s Bay Area presence down to 200 as the company awaits U.S. rules

Huawei Technologies’ presence in the Bay Area is down to around 200 employees, the Silicon Valley Business Journal has learned — a notable rollback as the controversial Chinese company anticipates the expiration of a temporary general license.....»»

Category: topSource: bizjournalsNov 11th, 2019

US gives Huawei another 90 days to serve existing customers

The US government has granted Huawei another 90 days to buy from American suppliers. The "temporary general license" extension will allow Huawei to continue servicing existing US customers before.....»»

Category: topSource: moneycentralAug 19th, 2019

U.S. Commerce Department scales back restrictions on Huawei

The U.S. Commerce Department on Monday created a temporary general license restoring Huawei's ability to maintain existing networks and provide software updates to existing Huawei handsets......»»

Category: topSource: reutersMay 20th, 2019