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Tesla faces regulatory scrutiny over Autopilot update

In a letter to Tesla on Tuesday, the agency reminded the company that federal law requires automakers to initiate recalls if they find defects that pose a safety risk......»»

Category: topSource: bizjournalsOct 13th, 2021

Worry Over Rising Costs Trips Up Twitter Stock

Twitter shares are taking a thumping in the wake of a report that cautions the company faces rising costs amid stiff competition and regulatory scrutiny......»»

Category: topSource: barronsSep 17th, 2018

Blueprint Medicines" (BPMC) Ayvakit Aids Growth Amid Rivalry

Blueprint Medicines' (BPMC) Ayvakit, which has been approved to treat PDGFRA Exon 18 mutant gastrointestinal stromal tumors, has seen strong uptake since approval. However, stiff competition remains a headwind. Blueprint Medicines Corporation’s BPMC lead drug, Ayvakit (avapritinib), was approved by the FDA for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (“GIST”), harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, in January 2020. The European Commission has granted conditional marketing authorization to Ayvakyt as a monotherapy for the treatment of adult patients with unresectable/metastatic GIST, harboring the PDGFRA D842V mutation.Ayvakit/Ayvakyt has witnessed strong uptake since its launch. In the first nine months of 2021, the drug generated sales worth $32.9 million, reflecting a significant year-over-year increase. Label expansion of the drug is driving sales too.Ayvakit received label expansion nod from the FDA in June 2021 to treat advanced systemic mastocytosis (“SM”), a rare and debilitating disease. Ayvakit is being evaluated in the phase II PIONEER study for treating non-advanced SM. Top-line data from the same is anticipated in mid-2022.Shares of Blueprint Medicines have declined 12.2% so far this year compared with the industry’s decrease of 18.1%.Image Source: Zacks Investment ResearchWe note that Blueprint Medicines is co-developing another cancer drug, Gavreto (pralsetinib), with Roche RHHBY for treating patients with various types of RET-altered thyroid cancers and other solid tumors.In July 2021, Blueprint Medicines transferred the responsibilities of booking U.S. product sales of Gavreto to Roche. The company only records the share of profit and loss for Gavreto in financial results and does not record any net product revenues from Gavreto sales.The FDA approved Gavreto for the treatment of patients with advanced/metastatic rearranged during transfection RET-mutant and RET fusion-positive thyroid cancer in December 2020. Gavretois also approved for the treatment of adults with metastatic RET fusion-positive non-small-cell lung cancer.This apart, Blueprint Medicines has other promising pipeline candidates that are progressing well, targeting various cancer indications.Blueprint Medicines is riding on the success of Ayvakit. The company’s current product revenues solely comprise sales from Ayvakit, which narrows its revenues stream. Hence, any regulatory setback for Ayvakit could hurt the stock in the days ahead.Also, Ayvakit faces competition from Deciphera Pharmaceuticals' DCPH Qinlock (ripretinib), which is approved for the treatment of fourth-line GIST. In November 2021, the European Commission approved Qinlock for the same indication.Please note that Deciphera is looking to streamline commercial operations for Qinlock in the United States and focus on commercialization efforts on a select number of key European markets for the medicine.Zacks Rank & Stock to ConsiderBlueprint Medicines currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Sarepta Therapeutics, Inc. SRPT, which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Sarepta Therapeutics’ loss per share estimates have narrowed 31.3% for 2021 and 26% for 2022, over the past 60 days.Earnings of Sarepta Therapeutics have surpassed estimates in two of the trailing four quarters, and missed the same on the other two occasions. 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 Roche Holding AG (RHHBY): Free Stock Analysis Report Sarepta Therapeutics, Inc. (SRPT): Free Stock Analysis Report Blueprint Medicines Corporation (BPMC): Free Stock Analysis Report Deciphera Pharmaceuticals, Inc. (DCPH): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksDec 3rd, 2021

NVIDIA-Arm Holdings Deal Hits a Wall: FTC Sues to Block Deal

Looking at the intensifying antitrust scrutiny by several regulators worldwide, it will be a difficult task for NVIDIA Corporation (NVDA) to win approval for the Arm Holdings' acquisition. NVIDIA Corporation’s NVDA proposed Arm Holdings’ acquisition encountered a fresh hurdle after the U.S. Federal Trade Commission (FTC) sued to block the transaction over competition concerns on Thursday. The deal, already facing significant global regulatory challenges, could be killed by the latest FTC lawsuit.FTC, in its lawsuit, stated that the proposed acquisition would provide NVIDIA control over computing technology and designs that rival firms rely on to develop their products.On Sep 13, 2020, NVIDIA inked an agreement to acquire Arm from its existing owner, Softbank Group Corporation, in a cash-and-stock deal worth $40 billion. A rise of approximately 158% in NVDA’s stock price increased the deal's value by more than $55 billion.NVIDIA Corporation Price and Consensus NVIDIA Corporation price-consensus-chart | NVIDIA Corporation QuoteDeal Faces Multiple Regulatory ProbesThe England-based chip designer, often referred to as the Switzerland of the semiconductor industry, plays a neutral role in the space. Hence, the deal is feared to block this chip access neutrality and could favor the U.S. owner over its rivals.As a result, the deal has caught the attention of competition regulatory bodies of several countries. Last month, the British government ordered an in-depth – Phase Two – investigation of the transaction over competition and national security concerns.The U.K.’s Competition and Markets Authority has been given 24 weeks to deliver a final report, with a provision to extend the time frame by eight more weeks. Based on the reports filed by the agency, the U.K. government could block the deal on one or both grounds, clear it on both grounds or approve it with certain conditions.The Europe and China regulatory bodies are also gearing up to launch lengthy investigations over whether the sale of Arm to NVIDIA could impact competition and disrupt the global chip supply chain.Rival Tech Companies Opposing the DealSeveral tech companies, including Qualcomm QCOM, Alphabet’s GOOGL Google and Microsoft MSFT, have opposed the transaction and asked the U.S. antitrust regulators to intervene.According to these firms, the acquisition would provide NVIDIA control over Arm’s intellectual property (IP) rights, which license chip designs and related software to those willing to pay for the same, including rivals to one another.Qualcomm has been more vocal in opposing the deal. Arm supplies IP rights to the company whose chip designs are found in most smartphones around the globe. Qualcomm is worried that following the acquisition, NVIDIA could limit its access to Arm’s chip licenses, which have built its mobile chip empire using the latter’s designs.Qualcomm has also stated that it is open to investing in Arm if the regulatory bodies block NVIDIA’s deal. Arm’s other customers, Alphabet and Microsoft, have also voiced similar concerns that NVDA might limit access to Arm’s technologies or raise prices.ConclusionNVIDIA aims to integrate its artificial intelligence computing platform with Arm’s expertise in a bid to create a premier computing entity. It had earlier stated that the transaction would be immediately accretive to non-GAAP gross margin and non-GAAP earnings per share after its closure.However, looking at the protest by major tech companies and the intensifying antitrust scrutiny by several regulators worldwide, it would be difficult for NVIDIA to win approval for the Arm acquisition.Currently, NVIDIA carries a Zacks Rank #2 (Buy).Alphabet sports a Zacks Rank #1 (Strong Buy), while Qualcomm and Microsoft carry a Zacks Rank #2 and a Zacks Rank #3 (Hold), respectively, at present. You can see the complete list of today’s Zacks #1 Rank stocks here.The long-term earnings growth rate projections for Alphabet, NVIDIA, Qualcomm and Microsoft are pegged at 25.8%, 21.6%, 15.3% and 12%, respectively. Shares of GOOGL, NVDA, QCOM and MSFT have soared 63.2%, 147.9%, 16.4% and 48.3%, respectively, in the year so far. 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 QUALCOMM Incorporated (QCOM): Free Stock Analysis Report Microsoft Corporation (MSFT): Free Stock Analysis Report NVIDIA Corporation (NVDA): Free Stock Analysis Report Alphabet Inc. (GOOGL): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksDec 3rd, 2021

Bruker (BRKR) Assay to Offer Reliable Omicron Variant Detection

Bruker's (BRKR) FluoroType SARS-CoV-2 varID Q assay is anticipated to provide reliable detection of the novel Omicron (B.1.1.529) variant of SARS-CoV-2. Bruker Corporation BRKR announced a major update related to its FluoroType SARS-CoV-2 varID Q real-time multiplexed polymerase chain reaction (PCR) assay. The company noted that this CE-IVD marked assay reliably detects all SARS-CoV-2 variants and is expected to provide a clear indication of Omicron (B.1.1.529). It is worth mentioning that the Omicron has been recently declared a ‘variant of concern’ by the World Health Organization (WHO).More specifically, the FluoroType SARS-CoV-2 varID Q assay, based on Bruker´s proprietary LiquidArray technology, can detect and quantify all major SARS-CoV-2 variants. This assay simultaneously identifies the S-gene mutations Del69-70 and N501Y, which are anticipated to be clear indications of the novel Omicron (B.1.1.529) variant. The FluoroType SARS-CoV-2 varID Q also offers a viral load result according to WHO standard (IU/ml), CP values, and easy mutation interpretation.Few Words on FluoroType SARS-CoV-2 varID QThe FluoroType SARS-CoV-2 varID Q test contains reagents for 96 reactions and is verified for use with nasopharyngeal and oropharyngeal swabs. In less than 3-4 hours, sample extraction, amplification and PCR results are available. This assay can be run on the FluoroCycler XT PCR instrument after sample preparation with the GenoXtract fleXT system, which offers fully automated extraction and PCR setup. The FluoroSoftware analyzes results from the FluoroCycler XT, delivering easy-to-read results and direct indication of mutations.Image Source: Zacks Investment ResearchThe FluoroType SARS-CoV-2 varID Q assay enables users to run a screening tool for detecting SARS-CoV-2 viral load and get an early indication of the Omicron variant.More on the NewsBruker also confirmed that the Omicron variant (B.1.1.529) is expected to be detected by their entire range of other FluoroType SARS-CoV-2 assays. These assays include CE-IVD assays such as FluoroType SARS-CoV-2 plus, FluoroType SARS-CoV-2 varID Q and FluoroType SARS-CoV-2/Flu/RSV. However, these assays are not available for sale in the United States. Another notable assay in this range involves the FluoroType SARS-CoV-2 evo Research Use Only (RUO), which is not available for use in clinical diagnostics procedures.Bruker’s SARS-CoV-2 assays are CE-IVD-labeled per the European IVD Directive 98/79/EC and are primarily sold in European Markets. Notably, the FluoroType SARS-CoV-2 plus is registered and sold in various African markets, including South Africa.Industry ProspectsPer a report by Fortune Business Insights published in GlobeNewswire, the global COVID-19 diagnostics market is expected to see a CAGR of 7.9% during 2020-2027. Factors such as the uncontrolled spread of coronavirus, and several efforts by medical and regulatory bodies to encourage innovation and accelerate research in developing coronavirus detection tools are expected to drive the market.Given the market prospects, Bruker’s FluoroType SARS-CoV-2 varID Q assay, which detects all SARS-CoV-2 variants and expectedly the novel Omicron (B.1.1.529) variant, bears significant market potential.Notable DevelopmentsIn November 2021, Bruker acquired MOLECUBES NV-- a dynamic innovator in benchtop preclinical nuclear molecular imaging (NMI) systems. The combination of Bruker's preclinical imaging technologies and global footprint with MOLECUBES' modular benchtop CUBES systems will offer a more extensive NMI offering, thereby accelerating preclinical NMI adoption at academic medical centers and biopharma firms worldwide.In October 2021, Bruker secured orders for two 1.1 GHz NMR Avance Neo systems from National Science Foundation (NSF)-funded academic institutions in the United States. The Network for Advanced NMR (NAN) was established with funds from NSF and it connects three institutions, including the University of Connecticut School of Medicine, the University of Georgia and the University of Wisconsin–Madison.Share Price PerformanceThe stock has outperformed its industry over the past year. It has grown 51.5% compared to the industry’s growth of 34.5%.Zacks Rank and Other Key PicksCurrently, Bruker carries a Zacks Rank #2 (Buy).Other top-ranked stocks in the broader medical space are Varex Imaging Corporation VREX, McKesson Corporation MCK and NextGen Healthcare, Inc. NXGN, each carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Varex has a long-term earnings growth rate of 5%. The company surpassed earnings estimates in the trailing four quarters, delivering an average surprise of 115.3%.Varex has outperformed the industry it belongs to in the past year. VREX has gained 73.7% versus the industry’s 8% fall.McKesson has a long-term earnings growth rate of 8.9%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 19.9%, on average.McKesson has outperformed its industry over the past year. MCK has gained 22% versus the 7.4% industry rise.NextGen has a long-term earnings growth rate of 8.5%. The company surpassed earnings estimates in the trailing four quarters, delivering an average surprise of 16%.NextGen has outperformed its industry over the past year. NXGN has declined 8.7% versus the industry’s 41.5% fall. 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 McKesson Corporation (MCK): Free Stock Analysis Report Bruker Corporation (BRKR): Free Stock Analysis Report VAREX IMAGING (VREX): Free Stock Analysis Report NEXTGEN HEALTHCARE, INC (NXGN): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksDec 3rd, 2021

Elon Musk just sold another billion dollars of Tesla shares, bringing his share sales total since November 8 to $10.9 billion

In November, the Tesla CEO tweeted he would sell 10% of his stock if Twitter users approved. A majority of them agreed with the sale. Tesla CEO Elon Musk in Germany this week.Michele Tantussi/Reuters Tesla Elon Musk has sold $1.01 billion worth of company shares and exercised more buy options. Musk still has an option to buy about 10 million more shares at $6.24 each. Early last month, Musk tweeted he would sell 10% of his stock if Twitter users approved. Most of them did. Tesla CEO Elon Musk has sold another 934,091 shares of the electric-vehicle maker worth $1.01 billion to meet his tax obligations related to the exercise of options to buy 2.1 million shares, regulatory filings showed Thursday.In early November, the world's richest person tweeted that he would sell 10% of his stock if users of the social media platform approved. A majority of them had agreed with the sale.Since November 8, Musk has exercised options to buy 10.7 million shares and sold 10.1 million shares for $10.9 billion.Following a flurry of options exercise, Musk still has an option to buy about 10 million more shares at $6.24 each, which expires in August next year.The Tesla boss faces big tax bills if he exercises stock options that he was awarded in 2012, when Tesla stock traded at around $6.The trades by Musk have helped push the total for CEO and company-insider sales to a record level around $69 billion so far this year, data from investor research firm Verity this week showed.Tesla stock has climbed almost 55% so far this year, and is up more than 1,100% since that March sell-off as of Thursday, when it closed at $1,084.60. Investors are betting that Musk's company can lead the global green revolution in cars.Venture capital executive Chamath Palihapitiya has said that big stock sales by Musk and Amazon's Jeff Bezos have made him wonder whether he should also be exiting the market."Two entrepreneurs who I've considered to be the smartest capital allocators of our generation are taking chips off the table," Palihapitiya wrote in a recent letter to investors.Read the original article on Business Insider.....»»

Category: dealsSource: nytDec 3rd, 2021

November Payrolls Preview: Strong Enough To Justify The Accelerated Taper?

November Payrolls Preview: Strong Enough To Justify The Accelerated Taper? With Powell's Fed having telegraphed it will accelerate the taper at this month's meeting so it can start presumably start hiking as soon as June of 2022, the November payrolls report may be moot although traders will be looking for barbell signs: will it be strong enough to validate an accelerated taper, or could it come so far below expectations that the Fed will be forced to delay its taper-boosting plans. Looking at the expectations, Newsquawk reminds us that analysts look for 550k nonfarm payrolls to be added to the US economy in November, similar to October's 531k; the jobless rate is seen falling by one-tenth of a percent to 4.5%. While as noted above the Fed appears almost certain to announce a quickening in the pace of QE tapering, analysts will be carefully watching measures of labor market slack to gauge the progress towards the Fed's 'three tests' for rate hikes: i) Participation was unchanged in October, ii) employment-population ticked up by 0.1ppts, while iii) the U6 measure of underemployment fell 0.2ppts. With the inflation tests met, the labor market data will form a key part of the Fed's arguments for rate hikes, and any significant  improvement in these metrics may see markets further price in tighter rates next year. Meanwhile, labor market gauges have generally been constructive in November: the rate of initial jobless claims going into the November survey period improved relative to the October window; ADP's gauge of payrolls was in line with expectations, though the pace eased vs October; business surveys saw employment sub-indices improve and are alluding to a very tight labor market, while today's Challenger job cuts fell to the lowest since 1993. Here is a summary of expectations: Nonfarm payrolls are expected to print 550k in November vs 531k in October (private payrolls expected at 530k vs 604k prior, manufacturing payrolls expected at 45k vs prior 60k); the 3-month average nonfarm payrolls trend rate eased to 442k in October (vs 629k in September), the 6-month average rose to 666k (from 622k) and the 12-month average eased to 481k (from 494k). The unemployment rate is seen declining by 0.1ppts in November to 4.5%; Labor market participation was unchanged at 61.6% in October (vs 63.6% in February 2020), U6 underemployment declined by 0.2ppts to 8.3% (vs 7.0% in February 2020), and the employment-population ratio rose 0.1ppts to 58.8% (vs pre-pandemic 61.1%). Average hourly earnings are seen rising 0.4% M/M, with the annual measure expected to rise by 0.1ppts to 4.0% Y/Y, Average workweek hours are likely to be unchanged at 34.7hrs. POLICY FOCUS: Fed Chair Powell this week delivered hawkish testimony to lawmakers, where he stated that the economy had continued to strengthen, the labor market had continued to improve, and he sees inflation moving down significantly over the next year. He added that it was appropriate to consider wrapping up the tapering of asset purchases a few months sooner, which participants will discuss at the December FOMC. Powell telegraphing the debate in advance may have taken some of the sting out of incoming economic data -- the rationale being that the Fed is set to accelerate the taper barring any significant deterioration in labor market and inflation data before the December 15th confab -- but Powell still suggested that there was a three-part test for raising rates (economy at maximum employment, inflation at 2%, inflation on track to moderately exceed 2% for some time); Fed officials have attempted to break the link between tapering and eventual rate hikes, but forward-looking markets will be assessing incoming data within the context of the three tests, and will price expectations of the Fed rate hike trajectory accordingly. The inflation test has been met, but Powell said there was still ground to cover to reach maximum employment, though he has previously said that could be achieved by the middle of next year; this week's labor market data, therefore, remains a key part of the eventual rate hike debate. SLACK: Taking an aggregate of the headline since March 2020, there are still some 4.44mln nonfarm payrolls to be recouped to get back to pre-pandemic levels. Goldman Sachs explains that it has been childcare constraints and elevated fiscal transfers which have likely weighed on participation, but these factors should have only a small effect going forward, but it may still take some time for some people to feel comfortable in returning to work, leaving some potential for longer-lasting drags. "We continue to expect that the labor force participation rate will increase in the nearterm, but we have nudged down our participation rate forecast to 1ppt below trend at end-2021 (61.9%) and 0.5ppts below trend at end-2022 (62.1%)," the bank says, "but because jobs are abundant and residual weakness in participation in mid-2022 will likely be due to changes in fiscal policy, wealth, and worker preferences, we expect that the FOMC will judge any participation shortfall that remains at that point to be structural or voluntary and will update their maximum employment goal accordingly." JOBLESS CLAIMS: In the week that traditionally coincides with the BLS survey window for the jobs report, initial jobless claims were little changed at 270k from the prior week's 269k; but since the October jobs report survey window, claims have eased from 351k. Continuing claims, meanwhile, printed 2.049mln in the survey week, down from 2.11mln in the prior week, and lower than the 2.81mln in the October survey period. Pantheon Macroeconomics said that the trend in initial jobless claims remains firmly downward, but the read may not be clear in the holiday season: "Unfortunately the numbers will be volatile over the holidays, as usual, and the next clean read on the data will be in mid-January," and by then, "we think claims will be close to the lows seen in the pre-COVID cycle, about 210K." ADP: The ADP's national employment gauge saw 534k job additions to the US economy in November, more or less in line with the 525k forecast; the prior was revised down trivially by 1k to 570k. ADP's economists noted that the labor market recovery continued to "power through" its challenges last month. "Job gains have eclipsed 15 million since the recovery began, though 5 million jobs short of pre-pandemic levels," ADP said, "service providers, which are more vulnerable to the pandemic, have dominated job gains this year." On the pandemic, ADP's economists said it was too early to tell if the Omicron variant could potentially slow the jobs recovery in coming months. BUSINESS SURVEYS: Within the ISM manufacturing report, the employment index rose by 1.3 points to 53.3, remaining in expansion for a third month, with the report noting some indications that the ability to hire is improving, though this is being partially offset by the challenges of turnover and backfilling. "Survey panellists’ companies are still struggling to meet labour-management plans, but there were modest signs of progress," ISM said, "an increasing share of comments noted improvements regarding employment," where "an overwhelming majority of panellists indicate their companies are hiring or attempting to hire." 51% of those surveyed were expressing difficulties in filling positions, with the situation becoming more acute in the month. Meanwhile, the services ISM is released after this month's jobs data, but using the IHS Markit flash November PMIs as a proxy, similar themes have been seen. IHS Markit said that pressure on capacity persisted amid labour shortages, with backlogs of work rising at the second-fastest pace on record. "Firms sought to expand their workforce numbers, but employment growth was held back by challenges finding suitablecandidates." JOB CUTS: Challenger's November report said that announced job cuts had dropped to 14,875 from the 22,822 in October, the lowest monthly total since May 1993. Year-to-date, employers have announced plans to cut 302,918 jobs from their payrolls, the lowest January-November total on record, and vs 2,227,725 vs the same period in 2020. Challenger said that "with the Omicron variant emerging and the unknowns that come with its spread, coupled with the ongoing difficulty hiring and retaining workers, it’s no surprise job cuts are at record lows," adding that "employers are spread thin, planning best- and worst-case scenarios in terms of COVID, while also contending with staff shortages and high demand." Speaking of Goldman, the bank is more optimistic than consensus and estimates nonfarm payrolls rose 575k in November, above the 531k gain in October and higher than the bank's initial forecast of +550k (which is in line with consensus). The bank expects no change in government payrolls, and thus private payrolls will also rise +575k in November (vs. consensus +525k).  According to the bank, the summer expiration of federal unemployment insurance benefits in some states boosted job-finding rates there, and the programs expired in the remaining states on September 5th. Over 4.6mn people have dropped off the unemployment benefit rolls since early September, and we assume 300-400k found new jobs during the November payroll month. Goldman also believes upward revisions to prior-month nonfarm payrolls are fairly likely in tomorrow’s report. The chart below reveals a trend of increasingly large upward revisions over the course of the year, with prior-month job growth revised up on net in each of the last six reports (including +235k with last month’s release). There are two potential explanations, both of which could potentially lead to upward revisions in tomorrow’s report as well. First, some reopening establishments may respond to the BLS survey with a lag (e.g. 1-2 months after reopening). This would result in positive revisions to the not-seasonally-adjusted data that occurred in May, July, August, and September (dark blue bars below). Second, the seasonal factors may be overfitting to the advance releases, mistakenly attributing some of the strong job creation to an evolution of seasonality (light blue lines below). ARGUING FOR A STRONGER REPORT: End of federal enhanced unemployment benefits. The expiration of federal benefits in some states boosted job-finding rates over the summer, and all remaining such programs expired on September 5. The 239k pickup in job growth in October relative to September is consistent with a boost from improved labor supply, and with 4.6 mn individuals no longer receiving benefits versus in early September, this tailwind is expected to continue in tomorrow’s report and beyond. Public health. The Delta wave coincided with a late-summer slowdown in job growth, with leisure and hospitality employment growth slowing sharply in September and October (see Exhibit 1). With covid infection rates falling since September, restaurant seatings on OpenTable have rebounded,and economists expect strong gains in leisure and hospitality and in other services. Job availability. The Conference Board labor differential—the difference between nthe percent of respondents saying jobs are plentiful and those saying jobs are hard to get—increased to a record-high of 46.9. JOLTS job openings decreased by 191kin September to 10.4mn but remained significantly higher than the pre-pandemic record. Jobless claims. Initial jobless claims fell during the November payroll month, averaging 257k per week vs. 320k in October. Continuing claims in regular state programs decreased 283k from survey week to survey week. Education seasonality. Education payrolls weighed on the previous two reports, declining 170k cumulatively in September and October (public and private). This reflects some janitors and support staff declining to return for the fall school year. While schools will eventually fill these open positions, the start-of-year catalyst for a large rise in education jobs has passed, and we are assuming only second derivative improvement in tomorrow’s report, such as a flat reading or a modest gain (mom sa). Employer surveys. The employment components of business surveys generally increased in November. Goldman's services survey employment tracker increased 0.5pt to 55.1 and its manufacturing survey employment tracker increased 0.7pt to 59.6. The Goldman Sachs Analyst Index (GSAI) increased 4.3pt to 77.2 in November, and the employment component rose 1.6pt to a record-high of 75.6. Job cuts. Announced layoffs reported by Challenger, Gray & Christmas declined by 10% month-over-month in November after increasing by 18% in October (SA by GS),and remain near their three-decade low. ARGUING FOR A WEAKER REPORT: Supply constraints in retail. Labor supply constraints may have weighed on pre-holiday hiring in the retail industry, for which the BLS seasonal factors anticipate net hiring of around 350k. If so, retail payroll could fall on a seasonally adjusted basis. Vaccine mandates. The vaccine mandates announced by the Biden administration nin September apply to roughly 25mn unvaccinated workers, and may have weighed on November job growth in healthcare and government. While the federal deadline for compliance is generally not until early January and faces an uncertain future in the court system, early adoption in some states may have reduced job growth at the margin in tomorrow’s report. NEUTRAL FACTORS Big Data. High-frequency data on the labor market were mixed. Three of the four measures available this month indicate another sizeable gain. However, the Homebase data that directionally flagged the September payroll missindicates an outright decline ADP. Private sector employment in the ADP report increased by 534k in November, in line with consensus expectations for a 525k gain and consistent with strong growth in the ADP panel. Tyler Durden Thu, 12/02/2021 - 21:40.....»»

Category: personnelSource: nytDec 3rd, 2021

Facebook is making it easier for crypto firms to run ads on its platform in a reversal of previous policies

The move is the latest update to the company's crypto policies, which have oscillated as the sector has grown in the past several years. Facebook Meta signJustin Sullivan/Getty Images Facebook is making it easier for crypto firms to run advertisements on its platform in a reversal of previous policies. The social media giant is expanding the number of regulatory licenses it accepts from 3 to 27. Facebook noted that advertisers who were previously approved would not be impacted by the change. Facebook is making it easier for cryptocurrency companies to run advertisements on its platform, reversing its previous policies as the digital asset space expands and regulatory clarity slowly crystallizes.The social media giant, whose parent firm is Meta Platforms, is expanding the number of regulatory licenses it accepts from 3 to 27 after updating its criteria. Facebook has made the list of eligibility publicly available on its policy page.Previously, Facebook required companies that wanted to promote crypto ads to submit an application and include other information such as whether they had any licenses they obtained or whether they were publicly listed stock.  At present, Facebook said if the advertiser has one of the eligible regulatory licenses, its ad will be approved."This change will help make our policy more equitable and transparent and allow for a greater number of advertisers, including small businesses, to use our tools and grow their business," Facebook said in a statement. Facebook noted that advertisers who were previously approved would not be impacted by the change.In January 2018, the company banned all ads related to crypto in a bid to crack down on scams and fraud following the boom in initial coin offerings. Six months later in June 2018, Facebook reversed its ban by allowing pre-approved businesses to promote certain services. Then in May 2019, Facebook relaxed its ban on crypto-related ads as rumors swirled about its own ambitions in the crypto space, and news leaked out about the efforts of its secretive blockchain team. Around the same time, Facebook introduced its Libra cryptocurrency project."Cryptocurrency continues to be an evolving space and we may refine these rules over time as the industry changes," Facebook added.The policy update comes after David Marcus, the executive who helmed Facebook's crypto projects, announced his departure Tuesday. Marcus led the creation of Novi, the company's digital wallet, and co-created Diem, the company's stalled digital currency. Read the original article on Business Insider.....»»

Category: topSource: businessinsiderDec 2nd, 2021

Xilio Therapeutics Reports Pipeline and Business Progress and Third Quarter 2021 Financial Results

Anticipate First Patient Dosing in Phase 1/2 Clinical Trial for XTX202, a Tumor-Selective IL-2, in First Quarter of 2022 Advancing Phase 1/2 Clinical Trial for XTX101, a Tumor-Selective Anti-CTLA-4 Successfully Closed IPO in Fourth Quarter of 2021, Raising Approximately $130 Million in Gross Proceeds to Advance Pipeline of Tumor-Selective Immuno-Oncology Programs WALTHAM, Mass., Dec. 02, 2021 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (NASDAQ:XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, today reported recent pipeline and business progress and third quarter 2021 financial results. "Xilio made significant progress in 2021 as we transitioned to a clinical stage organization with XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, and XTX202, a tumor-selective IL-2, in clinical development," said René Russo, Pharm. D., president and chief executive officer of Xilio. "With the recent completion of our IPO and a strong and experienced team in place, we are well-positioned to leverage our geographically precise solutions (GPS) platform to advance our pipeline of immuno-oncology therapies that have the potential to achieve meaningful anti-tumor activity while minimizing serious, systemic effects for the benefit of cancer patients." Recent Pipeline and Business Progress Cytokine Programs In October 2021, the U.S. Food and Drug Administration (FDA) cleared Xilio's investigational new drug application (IND) to evaluate XTX202, a tumor-selective interleukin-2 (IL-2), as a potential treatment for patients with solid tumors. XTX202 is designed to localize activity in the tumor microenvironment, with the goal of overcoming the known toxicity challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity. In November 2021, at the Society for Immunotherapy in Cancer's 36th Annual Meeting, Xilio reported data from preclinical studies for XTX301, a tumor-selective interleukin-12 (IL-12). Findings demonstrated selective anti-tumor activity and favorable tolerability with minimal systemic effects observed in mouse models evaluating a murine surrogate for XTX301 and non-human primate models evaluating XTX301. Checkpoint Inhibitor Program In September 2021, Xilio initiated patient dosing in its Phase 1/2 clinical trial evaluating XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, for the treatment of solid tumors as a monotherapy and in combination with pembrolizumab, an anti-PD-1. XTX101 is designed to improve upon the therapeutic index of existing anti-CTLA-4 therapies by overcoming their historical potency and tolerability limitations, as well as the inability to use existing anti-CTLA-4 therapies at their full dose in combination with other immuno-oncology therapies. Recent Business Highlights On October 26, 2021, Xilio closed its initial public offering (IPO). In connection with the IPO, Xilio issued and sold 7,353,000 shares of common stock at a public offering price of $16.00 per share, and on November 1, 2021, Xilio issued and sold an additional 766,106 shares of common stock at a public offering price of $16.00 per share pursuant to the partial exercise by the underwriters of their option to purchase additional shares. Xilio received aggregate gross proceeds of approximately $129.9 million or aggregate net proceeds of approximately $116.3 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by Xilio. Appointed Tim Hunt as Xilio's chief culture and corporate affairs officer in October 2021. Appointed Sara Bonstein, chief financial officer of Insmed, Inc., to Xilio's board of directors in August 2021. Anticipated Milestones in 2022 Xilio currently anticipates the following milestones in 2022: Initiation of a Phase 1/2 clinical trial to evaluate XTX202 in multiple solid tumor types in the first quarter of 2022 Presentation of preliminary data for the monotherapy cohort of the Phase 1/2 clinical trial evaluating XTX101 in patients with advanced solid tumors in the middle of 2022 Presentation of preliminary Phase 1 data for XTX202 in patients with multiple solid tumor types in the second half of 2022 Presentation of preliminary data from the combination cohort for the Phase 1/2 clinical trial evaluating XTX101 in patients with advanced solid tumors in the second half of 2022 Submission of an IND for XTX301 in the second half of 2022 Third Quarter 2021 Financial Results Cash Position and Guidance: Cash and cash equivalents were $99.8 million as of September 30, 2021, compared to $19.2 million as of December 31, 2020. Cash and cash equivalents as of September 30, 2021 do not include $116.3 million in estimated net proceeds from Xilio's October 2021 IPO. Xilio believes that its existing cash and cash equivalents, together with the net proceeds from its IPO, will enable it to fund its operating expenses and capital expenditure requirements into 2024. Research & Development (R&D) Expenses: R&D expenses were $10.5 million for the third quarter of 2021, compared to $11.5 million for the third quarter of 2020. This decrease was primarily driven by lower comparable costs associated with manufacturing development activities for the XTX101 and XTX202 programs, partially offset by higher personnel-related costs due to increased headcount and preclinical research and clinical development expenses. General & Administrative (G&A) Expenses: G&A expenses were $5.5 million for the third quarter of 2021, compared to $3.2 million for the third quarter of 2020. This increase was primarily driven by higher personnel-related costs due to increased headcount and higher professional fees related to ongoing business activities and preparations related to operating as a public company. Net Loss: Net loss was $16.3 million for the third quarter of 2021, compared to $14.8 million for the third quarter of 2020. About Xilio Therapeutics Xilio Therapeutics is a biotechnology company focused on harnessing the immune system to achieve deep and durable clinical responses to improve the lives of patients with cancer. The company is using its proprietary geographically precise solutions (GPS) platform to rapidly engineer novel molecules, including cytokines and other biologics, that are designed to optimize their therapeutic index. These molecules are designed to localize activity within the tumor microenvironment without systemic effect, resulting in the potential to achieve enhanced anti-tumor activity. Xilio is building a pipeline of wholly-owned, tumor-selective, GPS-enabled cytokine and checkpoint inhibitor product candidates, including XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody; XTX202, a tumor-selective IL-2; XTX301, a tumor-selective IL-12; and XTX401, a tumor-selective IL-15. For more information, please visit www.xiliotx.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans, strategies, timelines and expectations for Xilio's current or future approved product candidates, including without limitation, plans and timing related to the initiation of a Phase 1/2 clinical trial for XTX202, the presentation of preliminary clinical data for XTX101 and XTX202 and the submission of an IND for XTX301; the potential benefits of any of Xilio's current or future product candidates in treating patients; Xilio's ability to fund its operating expenses and capital expenditure requirements with its cash and cash equivalents; and Xilio's strategy, goals and anticipated financial performance, milestones, business plans and focus. The words "aim," "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing and results of such preclinical studies or clinical trials; the delay of any current or planned preclinical studies or clinical trials or the development of Xilio's current or future product candidates; preclinical and clinical supply of current or future product candidates; Xilio's advancement of multiple early-stage programs; Xilio's ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; results from preclinical studies or clinical trials for Xilio's product candidates, which may not support further development of such product candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of current or future clinical trials; Xilio's ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; Xilio's ability to obtain and maintain sufficient cash resources to fund current or future operating expenses and capital expenditure requirements; and the impact of the COVID-19 pandemic on Xilio's business, operations, strategy, goals and anticipated milestones. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Xilio's filings with the U.S. Securities and Exchange Commission (SEC), including Xilio's final prospectus related to its initial public offering, and any other filings that Xilio makes with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Xilio explicitly disclaims any obligation to update any forward-looking statements. For Investor Inquiries: Monique Allaire, THRUST Strategic Communications monique@thrustsc.com For Media Inquiries:  Dan Budwick, 1ABdan@1abmedia.com    XILIO THERAPEUTICS, INC. Condensed Consolidated Balance Sheets(In thousands)(Unaudited)     September 30,   December 31,     2021  .....»»

Category: earningsSource: benzingaDec 2nd, 2021

Tesla"s move to Texas from California is officially complete

The company said in a regulatory filing Wednesday that it had relocated its headquarters to its Gigafactory in Austin. Construction site of the Tesla Gigafactory in Austin, Texas in October 2021.Mike Blake/Reuters Tesla is now officially a Texas company, according to a regulatory filing Wednesday. The move is part of CEO Elon Musk's ongoing breakup with the Golden State. Musk stands to save an estimated $2.5 billion in moving his life and business to Austin. It's official: Tesla is now a Texas company.The electric automaker announced the move on Wednesday in a filing with the US Securities Exchange Corporation."On December 1, 2021, Tesla, Inc. relocated its corporate headquarters to Gigafactory Texas at 13101 Harold Green Road, Austin, Texas 78725," it said.The shift brings Tesla closer to its sister company, SpaceX, and is part of CEO Elon Musk's big breakup with the Bay Area. Tesla first began using Austin as the dateline in press releases in October. One likely contributing factor behind the move is the fact that Musk stands to save an estimated $2.5 billion in capital gains taxes by moving his residence and business from California to Texas.In spite of Tesla's new manufacturing presence in the Lone Star State, franchise laws prohibit the company from selling cars directly to customers, which it does in most other states.The Gigafactory in Austin is expected to employ 5,000 workers at the 2,100-acre facility, where it plans to build the Cybertruck and other models. It's set to open this year. On Monday, Musk promised an update to the much-delayed Cybertruck's availability in January."Oh man, this year has been such a supply chain nightmare & it's not over!," he tweeted. "I will provide an updated product roadmap on next earnings call."Read the original article on Business Insider.....»»

Category: topSource: businessinsiderDec 1st, 2021

Veeva Announces Fiscal 2022 Third Quarter Results

PLEASANTON, Calif., Dec. 1, 2021 /PRNewswire/ -- Veeva Systems Inc. (NYSE:VEEV), a leading provider of industry cloud solutions for the global life sciences industry, today announced results for its third quarter ended October 31, 2021. "Innovation and consistent execution have us tracking ahead of our 2025 targets and set us up for significant growth beyond," said CEO Peter Gassner. "As the strategic partner to the life sciences industry in its move to new digital and specialty models, we are proud our work will help patients get the therapies they need faster and easier." Fiscal 2022 Third Quarter Results: Revenues: Total revenues for the third quarter were $476.1 million, up from $377.5 million one year ago, an increase of 26% year over year. Subscription services revenues for the third quarter were $380.7 million, up from $302.9 million one year ago, an increase of 26% year over year. Operating Income and Non-GAAP Operating Income(1): Third quarter operating income was $132.7 million, compared to $101.3 million one year ago, an increase of 31% year over year. Non-GAAP operating income for the third quarter was $199.4 million, compared to $155.5 million one year ago, an increase of 28% year over year. Net Income and Non-GAAP Net Income(1): Third quarter net income was $105.9 million, compared to $97.0 million one year ago, an increase of 9% year over year. Non-GAAP net income for the third quarter was $158.2 million, compared to $125.6 million one year ago, an increase of 26% year over year. Net Income per Share and Non-GAAP Net Income per Share(1): For the third quarter, fully diluted net income per share was $0.65, compared to $0.60 one year ago, while non-GAAP fully diluted net income per share was $0.97, compared to $0.78 one year ago. "Our focus on customer success delivered another great quarter with top and bottom line results that exceeded our guidance," said CFO Brent Bowman. "We are excited about the large and expanding market opportunity ahead and are investing aggressively across our people and products to support strong growth in the years ahead." Recent Highlights: Veeva Data Cloud Innovation — Veeva is investing in the significant long-term opportunity for Veeva Data Cloud with new data assets and delivery methods. Data Cloud's new portal takes a modern, self-service approach where customers can define their own data subscriptions and delivery methods. Veeva also added new Data Cloud early adopters in Q3 for its patient data offering. Transforming Regulatory for Greater Speed and Compliance — Continued customer success and the need to unify regulatory processes globally for greater speed and compliance drove further Veeva Vault RIM growth. Q3 saw a major milestone in Veeva's reference selling model, with its first enterprise customer now live with all four Vault RIM Suite applications. There were also two notable top 20 wins, one for Vault Registrations and one for Vault Publishing. Another Quarter of Expanding Commercial Leadership — Veeva once again saw share  gains through new wins and as existing customers expanded within Veeva Commercial Cloud. Seven 7-figure deals in the quarter came in a number of areas including Veeva CRM, Veeva Crossix, and Veeva Link. Veeva CRM also had 15 new SMB wins, enterprise expansions, and strength internationally with two major field forces in Asia standardizing on the product. Financial Outlook: Veeva is providing guidance for its fiscal fourth quarter ending January 31, 2022 as follows: Total revenues between $478 and $480 million. Non-GAAP operating income of about $181 million(2). Non-GAAP fully diluted net income per share of approximately $0.88(2). Veeva is providing guidance for its fiscal year ending January 31, 2022 as follows: Total revenues between $1,843 and $1,845 million. Non-GAAP operating income of about $753 million(2). Non-GAAP fully diluted net income per share of approximately $3.69(2). Veeva is providing guidance for its fiscal year ending January 31, 2023 as follows: Total revenues between $2,150 and $2,170 million. Subscription services revenues between $1,735 and $1,745 million. Non-GAAP operating margin of roughly 38%(3). Conference Call Information Prepared remarks and an investor presentation providing additional information and analysis can be found on Veeva's investor relations website at ir.veeva.com. Veeva will host a Q&A conference call at 2:00 p.m. PT today, December 1, 2021, and a replay of the call will be available on Veeva's investor relations website. What: Veeva Systems Fiscal 2022 Third Quarter Results Conference Call When: Wednesday, December 1, 2021 Time: 2:00 p.m. PT (5:00 p.m. ET) Online Registration: www.directeventreg.com Conference ID 6998914 Webcast: ir.veeva.com ___________ (1) This press release uses non-GAAP financial metrics that are adjusted for the impact of various GAAP items. See the section titled "Non-GAAP Financial Measures" and the tables entitled "Reconciliation of GAAP to Non-GAAP Financial Measures" below for details. (2) Veeva is not able, at this time, to provide GAAP targets for operating income and fully diluted net income per share for the fourth fiscal quarter ending January 31, 2022 or fiscal year ending January 31, 2022 because of the difficulty of estimating certain items excluded from non-GAAP operating income and non-GAAP fully diluted net income per share that cannot be reasonably predicted, such as charges related to stock-based compensation expense. The effect of these excluded items may be significant. (3) Veeva is not able, at this time, to provide GAAP targets for operating margin for the fiscal year ending January 31, 2023 because of the difficulty of estimating certain items excluded from non-GAAP operating income that cannot be reasonably predicted, such as charges related to stock-based compensation expense. The effect of these excluded items may be significant. About Veeva Systems Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders and the industries it serves. For more information, visit veeva.com. Veeva uses its ir.veeva.com website as a means of disclosing material non-public information, announcing upcoming investor conferences, and for complying with its disclosure obligations under Regulation FD. Accordingly, you should monitor our investor relations website in addition to following our press releases, SEC filings, and public conference calls and webcasts. Forward-looking Statements This release contains forward-looking statements, including the quotations from management, the statements in "Financial Outlook," and other statements regarding Veeva's future performance, outlook, and guidance and the assumptions underlying those statements, market growth, the benefits from the use of Veeva's solutions, our strategies, and general business conditions. Any forward-looking statements contained in this press release are based upon Veeva's historical performance and its current plans, estimates, and expectations and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva's expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including (i) breaches in our security measures or unauthorized access to our customers' data; (ii) competitive factors, including but not limited to pricing pressures, consolidation among our competitors, entry of new competitors, the launch of new products and marketing initiatives by our existing competitors, and difficulty securing rights to access, host or integrate with complementary third party products or data used by our customers; (iii) the rate of adoption of our newer solutions and the results of our efforts to sustain or expand the use and adoption of our more established applications, like Veeva CRM; (iv) our expectation that the future growth rate of our revenues will decline; (v) loss of one or more customers, particularly any of our large customers; (vi) our ability to attract and retain highly skilled employees and manage our growth effectively; (vii) fluctuation of our results, which may make period-to-period comparisons less meaningful; (viii) adverse changes in the life sciences industry, including as a result of customer mergers; (ix) the impact of the COVID-19 pandemic (including the impact to the life sciences industry, impact on general economic conditions, and government responses, restrictions, and actions related to the pandemic); (x) system unavailability, system performance problems, or loss of data due to disruptions or other problems with our computing infrastructure;  (xi) failure to sustain the level of profitability we have achieved in the past as our costs increase; (xii) adverse changes in economic, regulatory, international trade relations, or market conditions, including with respect to natural disasters or actual or threatened public health emergencies; (xiii) a decline in new subscriptions that may not be immediately reflected in our operating results due to the ratable recognition of our subscription revenue; (xiv) pending, threatened, or future legal proceedings and related expenses; and (xv) our recent conversion to a Delaware public benefit corporation, including the expected impact, benefits, and risks of our conversion. Additional risks and uncertainties that could affect Veeva's financial results are included under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the company's filing on Form 10-Q for the period ended July 31, 2021. This is available on the company's website at veeva.com under the Investors section and on the SEC's website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time. Investor Relations Contact:Ato GarrettVeeva Systems Inc.925-271-4204 ir@veeva.com Media Contact:Deivis MercadoVeeva Systems Inc.925-226-8821pr@veeva.com VEEVA SYSTEMS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) (Unaudited) October 31,2021 January 31,2021 Assets Current assets: Cash and cash equivalents $ 1,149,946 $ 730,504 Short-term investments 1,201,541 933,122 Accounts receivable, net 211,046 564,387 Unbilled accounts receivable 67,970 47,206 Prepaid expenses and other current assets 29,292 35,607 Total current assets 2,659,795 2,310,826 Property and equipment, net 53,463 53,650 Deferred costs, net 34,091 42,072 Lease right-of-use assets 50,499 56,917 Goodwill 437,261 436,029 Intangible assets, net 102,559 114,595 Deferred income taxes 4,884 14,100 Other long-term assets 24,934 17,878 Total assets $ 3,367,486 $ 3,046,067 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 25,605 $ 23,253 Accrued compensation and benefits 32,116 30,410 Accrued expenses and other current liabilities 36,131 30,982 Income tax payable 14,477 2,590 Deferred revenue 417,755 616,992 Lease liabilities 10,803 11,725 Total current liabilities 536,887 715,952 Deferred income taxes 1,941 1,835 Lease liabilities, noncurrent 45,237 51,393 Other long-term liabilities 14,060 10,567 Total liabilities 598,125 779,747 Stockholders' equity: Class A common stock 2 2 Class B common stock — — Additional paid-in capital 1,145,147 965,670 Accumulated other comprehensive income (loss) (5,738) 992 Retained earnings 1,629,950 1,299,656 Total stockholders' equity 2,769,361 2,266,320 Total liabilities and stockholders' equity $ 3,367,486 $ 3,046,067 VEEVA SYSTEMS INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (In thousands, except per share data) (Unaudited) Three months endedOctober 31, Nine months endedOctober 31, 2021 2020 2021 2020 Revenues: Subscription services(4) $ 380,738 $ 302,938 $ 1,088,293 $ 856,675 Professional services and other(5) 95,373 74,581 276,985 211,633 Total revenues 476,111 377,519 1,365,278 1,068,308 Cost of revenues(6): Cost of subscription services 59,648 45,845 164,774 132,457 Cost of professional services and other 69,916 57,152 203,023 162,624 Total cost of revenues 129,564 102,997 367,797 295,081 Gross profit 346,547 274,522 997,481 773,227 Operating expenses(6): Research and development 98,635 79,992 276,760 212,282 Sales and marketing 72,423 57,982 208,822 172,909 General and administrative 42,781 35,243 126,121 109,085 Total operating expenses 213,839 173,217 611,703 494,276 Operating income 132,708 101,305 385,778 278,951 Other income, net 824 3,455 7,054 9,750 Income before income taxes 133,532 104,760 392,832 288,701 Provision for income taxes 27,663 7,801 62,538 11,621 Net income $ 105,869 $ 96,959 $ 330,294.....»»

Category: earningsSource: benzingaDec 1st, 2021

Oil Pares Gains Post OPEC Meeting/EIA Report

OANDA – December Rally Faded Already, Mixed US Data, Oil Pares Gains Post OPEC Meeting/EIA Report, Gold Rebounds, Bitcoin Higher Post Gensler Q3 2021 hedge fund letters, conferences and more US stocks were off to a good start in December as traders became both optimistic that Omicron would not lead to a more severe illness […] OANDA – December Rally Faded Already, Mixed US Data, Oil Pares Gains Post OPEC Meeting/EIA Report, Gold Rebounds, Bitcoin Higher Post Gensler if (typeof jQuery == 'undefined') { document.write(''); } .first{clear:both;margin-left:0}.one-third{width:31.034482758621%;float:left;margin-left:3.448275862069%}.two-thirds{width:65.51724137931%;float:left}form.ebook-styles .af-element input{border:0;border-radius:0;padding:8px}form.ebook-styles .af-element{width:220px;float:left}form.ebook-styles .af-element.buttonContainer{width:115px;float:left;margin-left: 6px;}form.ebook-styles .af-element.buttonContainer input.submit{width:115px;padding:10px 6px 8px;text-transform:uppercase;border-radius:0;border:0;font-size:15px}form.ebook-styles .af-body.af-standards input.submit{width:115px}form.ebook-styles .af-element.privacyPolicy{width:100%;font-size:12px;margin:10px auto 0}form.ebook-styles .af-element.privacyPolicy p{font-size:11px;margin-bottom:0}form.ebook-styles .af-body input.text{height:40px;padding:2px 10px !important} form.ebook-styles .error, form.ebook-styles #error { color:#d00; } form.ebook-styles .formfields h1, form.ebook-styles .formfields #mg-logo, form.ebook-styles .formfields #mg-footer { display: none; } form.ebook-styles .formfields { font-size: 12px; } form.ebook-styles .formfields p { margin: 4px 0; } Get The Full Henry Singleton Series in PDF Get the entire 4-part series on Henry Singleton in PDF. Save it to your desktop, read it on your tablet, or email to your colleagues (function($) {window.fnames = new Array(); window.ftypes = new Array();fnames[0]='EMAIL';ftypes[0]='email';}(jQuery));var $mcj = jQuery.noConflict(true); Q3 2021 hedge fund letters, conferences and more US stocks were off to a good start in December as traders became both optimistic that Omicron would not lead to a more severe illness than the Delta variant and viewed Powell’s hawkish twist as more of a shift to the center. Equities pared gains after South Africa COVID cases nearly doubled since Tuesday and after their infectious disease official Richard Lessells noted it is too early to say Omicron only causes mild cases. The next couple of weeks will likely see risk appetite take a cue from incremental Omicron updates, supply chain issues, and every inflation reading. A second day of Powell at Capitol Hill saw him stick to his faster taper talk and uncertainty over when will inflation come down. Stocks gave up most of their gains after the US confirmed its first case of the Omicron variant. We've seen this movie before and Wall Street will likely remain COVID variant headline driven until a clear assessment over this wave can be made. US Data The ADP private payroll report showed 534,000 jobs were created in November, a beat of the 525,000 estimate, but lower than the 570,000 prior reading.  Leisure and hospitality jobs were over 30% of the positions added to the service sector, but that rebound could be in jeopardy if Omicron continues to increase. The ISM manufacturing report was somewhat positive, but nothing to brag about as the headline index rose marginally from 60.8 to 61.1 and as both new orders and employment posted modest increases. Supply chain issues appear to be improving, but orders are still below their recent highs. Oil Crude oil prices pared gains after the EIA reported a small headline draw with crude inventories, but more importantly showed a massive build with gasoline and diesel stockpiles, a 100,000 bpd increase with US production, and a minimal rebound with exports. Nothing to really get excited from the EIA report, so WTI crude should consolidate here until tomorrow’s OPEC+ decision on output. WTI crude returned to session lows after CDC identified its first Omicron case in the US. It was inevitable that Omicron would make it to the US, but when you combine how quickly it appears to be spreading across South Africa, energy traders are getting more concerned about the short-term crude demand outlook. With just under 30% of the US population being unvaccinated, nervousness about large parts of the country entering lockdown mode could grow if Omicron is proven to be much more transmissible than delta. Crude prices may get a boost from OPEC+ delay in delivering an increase in output, but the Omicron variant will likely wreak havoc over the short-term demand outlook. Gold Gold is struggling here as Wall Street can’t agree on a clear path for the dollar following Fed Chair Powell’s hawkish pivot and mounting fears Omicron might disrupt growth over the short-term. Fed rate hike expectations are constantly moving as traders grapple with the question, can the Fed really signal rate hikes are imminent as the economy potentially faces another COVID wave? Gold prices are facing plenty of technical resistance from the three key (200-, 100- and 50-day) SMAs and the psychological $1800 level.  Real yields are rising today and that is another reason why gold can’t really benefit from the risk-off Omicron environment. Gold will likely consolidate here until the dollar takes a clear path. Cryptos Bitcoin is bouncing back alongside risky assets as crypto traders grow optimistic regulators will soon form crypto-banking guidelines that could help deliver the next wave of investment. Bitcoin extended gains after SEC reiterated calls for cryptocurrency exchanges to register with the SEC. The cryptoverse is stuck in wait-and-see mode over what inflation will force the Fed to do and with how the regulatory environment will look. Cryptos are the top performing asset class again heading into year end, so any fears that the Fed may have to accelerate their rate hiking plans could prove to be short-term negative for Bitcoin and Ethereum. Article By Edward Moya, OANDA Updated on Dec 1, 2021, 4:07 pm (function() { var sc = document.createElement("script"); sc.type = "text/javascript"; sc.async = true;sc.src = "//mixi.media/data/js/95481.js"; sc.charset = "utf-8";var s = document.getElementsByTagName("script")[0]; s.parentNode.insertBefore(sc, s); }()); window._F20 = window._F20 || []; _F20.push({container: 'F20WidgetContainer', placement: '', count: 3}); _F20.push({finish: true});.....»»

Category: blogSource: valuewalkDec 1st, 2021

Facebook Owner Meta Must Sell Giphy on Competition Concerns, U.K. Says

It’s the first time a Big Tech firm has been ordered by regulators in Europe and the U.S. to undo an acquisition rather than pay a hefty fine. Britain’s antitrust watchdog ordered Facebook parent Meta Platforms Inc. to sell Giphy, the first time a global regulator has forced a Big Tech firm to unwind a completed deal. A turnaround after years of being allowed to swallow up smaller rivals with virtually no push back. The Competition and Markets Authority found that last year’s $315 million tie up with the GIF search engine will reduce competition between social media platforms, according to a statement Tuesday. It’s the first time a Big Tech firm has been ordered by regulators in Europe and the U.S. to undo an acquisition rather than pay a hefty fine. Meta now has two choices: to appeal or divest. [time-brightcove not-tgx=”true”] The $315 million deal for Giphy, completed last year, raised concerns from U.K. regulators from the beginning. The antitrust probe was initially delayed after officials ordered Facebook to pause plans to integrate the company, sparking a lengthy court battle. Meta now has two choices: to appeal or divest. The company will be able to appeal the decision to the U.K.’s Competition and Appeals Tribunal where it would be heard as a judicial review, a court process that looks at how the CMA came to its decision. If Meta accepts the CMA’s ruling it will have to find a suitable buyer that will be vetted by the regulator. “We disagree with this decision,” a Meta spokesperson said. “We are reviewing the decision and considering all options, including appeal.” High-Risk Closing a deal without approval can be a high-risk strategy. The EU may fine Illumina Inc. as much as $400 million for completing a deal without permission. Google closed its Fitbit takeover earlier this year without getting U.S. or Australian permission. Australia is conducting an enforcement probe into that deal. The watchdog said the deal had already removed the platform as a potential challenger in the display advertising market and that Meta must sell Giphy in its entirety to an approved buyer. “Without action, it will also allow Facebook to increase its significant market power in social media even further, through controlling competitors’ access to Giphy GIFs,” Stuart McIntosh, chair of the investigation, said. Both sides have battled the merger review process. The CMA fined Meta 50.5 million pounds ($68 million) for failing to update regulators on efforts to hold Giphy separate before getting U.K. merger approval, which Meta later did not appeal. While Meta has accused the CMA of being disproportionate and failing to offer it alternatives to divestiture. Merger watchdogs across Europe are giving U.S. tech giants a much tougher time as they investigate their market power. Regulators faced a barrage of criticism for allowing Silicon Valley to snap up potential rivals before they make it big. Facebook’s game-changing takeover of Instagram is often cited as a deal that was waved through by regulators without proper scrutiny. Other global regulators have not shown as much concern with the deal. Margrethe Vestager’s European Commission didn’t review the case, while Austria’s competition agency is still reviewing it. —With assistance from David McLaughlin......»»

Category: topSource: timeNov 30th, 2021

Elizabeth Holmes Accuses Ex-Lover, Business Partner of Abuse

The Theranos founder said she fell under Sunny Balwani's sway after she dropped out of Stanford in 2003 to found the company Disgraced entrepreneur Elizabeth Holmes described herself as the abused puppet of her former lover and business partner Sunny Balwani in tearful testimony Monday, part of her attempt to refute accusations that she lied about a flawed blood-testing technology she had hailed as a major breakthrough. After recounting how she met Balwani while she was still in high school, Holmes said she eventually fell under his sway after she dropped out of Stanford University in 2003 to found Theranos, a Silicon Valley startup she led as CEO for the next 15 years. A weeping Holmes, now 37, testified she was raped at Stanford—a factor she believes played a role in what she characterized as her later subservience to Balwani, now 56. The two became romantically involved in 2005 before Balwani became chief operating officer at Theranos, a position he held from 2009 to 2016. [time-brightcove not-tgx=”true”] Even before joining Theranos, Balwani was regularly berating Holmes as an inept executive who needed to “kill” her former self in an effort to become more disciplined and focused, according to her testimony and contemporaneous notes with strict instructions for Holmes handwritten by Balwani. “He felt like I came across as a little girl and thought I needed to be more serious and more pointed,” Holmes explained as she read through Balwani’s demands. They included spending at least 30 minutes each morning writing out her daily goals and never spending more than five minutes meeting with anyone unless she had written down a reason justifying the additional time. If she didn’t do what Balwani said, Holmes said, he would yell and tell her he was “so disappointed in my mediocrity.” At other times, Holmes said, Balwani would liken her to a “monkey flying a space ship” and tried to cut her off from her family in an alleged effort to ensure that she devoted herself full-time to Theranos. She also said he controlled her diet in an attempt to keep her “pure.” Sometimes after Balwani belittled her, Holmes testified, he would force her to have sex against her will to show he loved her. Read more:How Elizabeth Holmes’ Abuse Allegations Could Affect Her Fraud Trial The dramatic turn came during the fourth day of Holmes’ testimony before a jury weighing fraud charges that include swindling investors and customers while putting patients at risk by telling elaborate lies about the company’s development of an allegedly revolutionary blood-testing device. Holmes could face a prison sentence of up to 20 years if convicted. The 14 jurors, including two alternates, listened attentively but with little visible emotion as Holmes described her relationship with Balwani. Balwani faces fraud allegations mirroring those against Holmes in another trial scheduled to begin early next year. He and Holmes ended their relationship in May 2016 after she moved out of the Silicon Valley home that they shared for years while keeping their romantic relationship concealed. Federal prosecutors wanted to try Balwani alongside Holmes, but U.S. District Judge Edward Davila separated the proceedings because of the possibility that Holmes would blame some of her behavior on“intimate partner abuse.” Jeffrey Coopersmith, Balwani’s lawyer, has vehemently denied Holmes’ abuse allegations. Although Coopersmith was present for Holmes’ testimony Monday, Balwani couldn’t be there because he is prohibited from being in the courtroom in Holmes’ presence. Holmes’ portrait of Balwani stood in sharp contrast to other testimony indicating that he always deferred to Holmes—the subject of flattering business profiles likening her to a female version of Apple co-founder Steve Jobs, who she adopted as one of her role models. Holmes briefly became a paper billionaire while promising that Theranos could provide more convenient and cheaper tests scanning for hundreds of potential health problems using just a few drops of blood. Conventional tests typically require a vial of blood drawn from a vein. Her pitch helped Theranos raise nearly $1 billion from sophisticated investors and attract an impressive board of directors including former Cabinet secretaries from the administrations of presidents from Richard Nixon to Donald Trump. The company collapsed after a series of explosive articles in the Wall Street Journal and regulatory audits revealed rampant inaccuracies in Theranos’ blood tests. Read more:Silicon Valley Investors Haven’t Let the Theranos Scandal Change the Way They Do Business In her testimony, Holmes said most people didn’t realize how much Balwani controlled her because most of his alleged abuse occurred outside the office. Her condemnation of Balwani contrasted with some of the treacly texts she sent addressing him as “tiger.” During a flurry of texts in April 2016, about a month before her romance with Balwani ended, Holmes quoted the poet Maya Angelou. “In all the world, there is no heart for me like yours. In all the world there is no love for you like mine,” Holmes told him. Under questioning by one of her attorneys, Holmes acknowledged that Balwani never told her what to say to the investors she is now accused of deceiving. She also testified that Balwani didn’t influence her discussions with Walgreens and Safeway, two major retailers that agreed to use Theranos’ blood-testing technology before backing out after discovering it wasn’t performing as she promised. Holmes instead says she did everything she could to clean up the problems at Theranos in an effort to realize her ambitions. But she also said she couldn’t explain all the different ways Balwani affected her during the years they were together. “He wasn’t who I thought he was,” Holmes said, adding that Balwani “impacted everything about who I was and I don’t fully understand that.” Holmes will return to the witness stand Tuesday when prosecutors will get their first chance to grill her under oath......»»

Category: topSource: timeNov 30th, 2021

Stronghold Digital Mining Reports Third Quarter 2021 Results and Provides Operational Update

NEW YORK, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Stronghold Digital Mining, Inc. (NASDAQ:SDIG) ("Stronghold," or the "Company") today reported financial results for its third quarter ended September 30, 2021 and provided an operational update. Third Quarter and Recent Operational and Financial Highlights Removed approximately 106,000 tons of coal refuse and returned approximately 64,500 tons of beneficial use ash to waste coal piles during the quarter, facilitating the remediation of these sites Closed upsized initial public offering ("IPO") on October 22, 2021, generating net proceeds of approximately $132.5 million Closed acquisition of Panther Creek Plant on November 2, 2021, increasing owned power generation capacity to approximately 165 megawatts ("MW") As of November 29, 2021, has received nearly 6,000 miners with total hash rate capacity of approximately 470 petahash per second ("PH/s") and remains on track to achieve its hash rate capacity goal of 8,000+ PH/s by the end of 2022 Pro forma cash and cash equivalents as of September 30, 2021 was approximately $104.2 million, as adjusted for net proceeds from the IPO, closing of the Panther Creek Plant acquisition, and deposits paid in relation to announced miner purchases Management Commentary "We are excited about our entry into the public markets as a well-capitalized, vertically integrated Bitcoin miner with an advantageous cost structure," said Greg Beard, co-chairman and chief executive officer of Stronghold. "We have structured Stronghold to not only be a best-in-class Bitcoin miner, but also to have a positive impact on the environment, which we accomplish through the cleanup of toxic, legacy waste coal piles in Pennsylvania. These piles are actively polluting the Commonwealth's air and water, and we are proud that our operations benefit the local communities." "We are executing on our strategy of growing owned power generation assets and rapidly deploying miners at these facilities, as evidenced by the recent acquisition of our second power generation asset and continued additions to our miner fleet. We intend to continue acquiring low-cost power assets and miners to reach our goal of at least 8,000 PH/s of hash rate capacity by the end of 2022." Cryptocurrency Mining Update Stronghold remains on track to reach its hash rate capacity goal of 8,000 PH/s by the end of 2022, with miners from a diversified group of global manufacturers, including MinerVa, Bitmain, and MicroBT. As of September 30, 2021, the Company had approximately 3,000 miners deployed with total hash rate capacity of approximately 185 PH/s. As of November 29, 2021, the Company has purchased or installed approximately 45,000 miners with total hash rate capacity of approximately 4,390 PH/s. Since the end of the third quarter, Stronghold has received nearly 3,000 miners, including the first 240 MV7 miners from MinerVa, and the Company expects to have over 500 MinerVa miners installed by the end of the week, with shipments ramping up for the 15,000-miner order. Performance for these machines has been in line with expectations. Since the end of the quarter, Stronghold also entered into two agreements with Bitmain to purchase 12,000 S19j Pro miners and 1,800 S19 XP miners, with aggregate hash rate capacity of approximately 1,450 PH/s. Additionally, the Company purchased over 2,500 miners on the open market through multiple transactions, with aggregate hash rate capacity exceeding 200 PH/s, which are expected to be installed before the end of the year. Stronghold also continues to expand datacenter capacity to house its miners. Stronghold owns, develops, and manages its datacenters, which increases operational control, mitigates supply-chain risks, and improves economics. The Company has manufactured 33 MW of StrongBoxes, its proprietary modular datacenter containers, and expects to have completed approximately 125 MW by the end of the first quarter of 2022. As of September 30, 2021, Stronghold held on its balance sheet approximately 85 Bitcoin. Power Assets Update On November 2, 2021, Stronghold closed on the acquisition of the Panther Creek Plant, an 80 MW coal refuse reclamation-to-energy facility located in Pennsylvania, which utilizes the same circulating fluidized bed technology as Stronghold's Scrubgrass Plant. Both the Scrubgrass Plant and Panther Creek Plant generate power from coal refuse, which is a waste byproduct of legacy coal mining operations. The Commonwealth of Pennsylvania has designated coal refuse as a Tier II Alternative Energy Source, making our facilities eligible to earn renewable energy credits. In conjunction with the acquisition, the Company entered into an Operation, Maintenance and Ancillary Services Agreement with the seller to provide operations and maintenance services support to Stronghold for both the Scrubgrass Plant and the Panther Creek Plant. The support services from an experienced operating group are expected to facilitate durable uptime and efficiency for Stronghold's power assets. With the acquisition of the Panther Creek Plant, the Company's owned power generation capacity expanded to approximately 165 MW. Stronghold continues to evaluate opportunities to acquire additional power generation assets, including a third coal refuse reclamation facility that is under a non-binding letter of intent to purchase. Third Quarter 2021 Financial Results Revenues in the third quarter increased 527% to $6.0 million compared to $1.0 million in the same quarter a year ago. The increase is primarily attributable to higher energy generation and crypto asset mining revenues. Operating expenses in the third quarter increased 492% to $10.0 million compared to $1.7 million in the same quarter a year ago. The increase is primarily attributable to higher operating costs at the Scrubgrass Plant to facilitate higher and more consistent power generation capacity for energy operations and cryptocurrency operations, in addition to higher general and administrative costs as the Company scales its organizational structure. Net loss for the third quarter of ($6.3) million compared to a net loss of ($0.7) million for the same quarter a year ago. Adjusted EBITDA for the third quarter increased to $9,700 compared to ($0.5) million for the same quarter a year ago (see reconciliation of Non-GAAP financial measures). Net cash provided by operating activities in the third quarter was $10.2 million compared to $0.5 million in the same quarter a year ago. Stronghold ended the quarter with approximately $41.4 million in cash and approximately $53.7 million in debt. Financial and Operational Outlook "Following our successful IPO and closing of the Panther Creek acquisition, we are executing on our strategy of being a low-cost, environmentally beneficial Bitcoin miner," said Greg Beard. "We expect a significant ramp-up in miner deliveries over the coming months and are taking active steps to accelerate miner deliveries. We remain on track to reach the 2022 operational metrics that we communicated at the time of our IPO and continue to make excellent progress in expanding our power generation capacity to maintain our vertical integration as we grow our miner fleet." Conference Call Stronghold will host a conference call today, November 30, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss these results. A question-and-answer session will follow management's presentation. To participate, please dial the appropriate number at least ten minutes prior to the start time and ask for the Stronghold Digital Mining conference call. U.S. dial-in number: 1-844-705-8583 International number: 1-270-215-9880Conference ID: 1385345 The conference call will broadcast live and be available for replay here. A replay of the call will be available after 8:00 p.m. Eastern Time through December 14, 2021 at 8:00 p.m. Eastern Time. Toll-free replay number: 1-855-859-2056 International replay number: 1-404-537-3406Conference ID: 1385345 About Stronghold Digital Mining, Inc.Stronghold is a vertically integrated Bitcoin mining company with an emphasis on environmentally beneficial operations. Stronghold houses its miners at its wholly owned and operated Scrubgrass Plant and Panther Creek Plant, both of which are low-cost, environmentally beneficial coal refuse power generation facilities in Pennsylvania. Cautionary Statement Concerning Forward-Looking StatementsCertain statements contained in this press release constitute "forward-looking statements." within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements because they contain words such as "believes," "expects," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates" or "anticipates" or the negative of these words and phrases or similar words or phrases which are predictions of or indicate future events or trends and which do not relate solely to historical matters. Forward-looking statements and the business prospects of Stronghold are subject to a number of risks and uncertainties that may cause Stronghold's actual results in future periods to differ materially from the forward-looking statements. These risks and uncertainties include, among other things: our dependence on the level of demand and financial performance of the crypto asset industry; our ability to manage growth, business, financial results and results of operations; our ability to raise capital to fund business growth; our ability to enter into purchase agreements and acquisitions; public health crises, epidemics, and pandemics such as the coronavirus pandemic; our ability to procure crypto asset mining equipment; our ability to respond to price fluctuations and rapidly changing technology; our ability to operate our coal refuse power generation facilities as planned; and legislative or regulatory changes, and liability under, or any future inability to comply with, existing or future energy regulations or requirements. More information on these risks and other potential factors that could affect our financial results is included in our filings with the Securities and Exchange Commission, including in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of our Registration Statement on Form S-1 (File No. 333-258188), filed on October 19, 2021, and any subsequently filed Quarterly Reports on Form 10-Q. Any forward-looking statement speaks only as of the date as of which such statement is made, and, except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether because of new information, future events, or otherwise. STRONGHOLD DIGITAL MINING, INC.   UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS             September 30, 2021 and December 31, 2020                 Sept 30, 2021 Dec 31, 2020       (unaudited)     CURRENT ASSETS         Cash   $ 41,434,410   $ 303,187     Digital currencies     3,228,698     228,087     Accounts receivable     308,387     65,900     Due from related party     -     302,973     Prepaid insurance     278,538       Inventory     367,601     396,892     Other current assets     3,779,663     65,831     Total Current Assets     49,397,297     1,362,870     EQUIPMENT DEPOSITS     85,624,852     -     PROPERTY, PLANT AND EQUIPMENT, NET     40,114,787     7,814,199     LAND     29,919     -     ROAD BOND     185,245     185,245     TOTAL ASSETS   $ 175,352,100   $ 9,362,314               CURRENT LIABILITIES         Current portion of long-term debt- net of discounts/issuance fees   $ 31,251,305   $ 449,447     Related-party notes     -     2,024,250     Accounts payable     29,620,242     8,479,187     Due to related parties     735,618     698,338     Accrued liabilities     3,833,191     828     Total Current Liabilities     65,440,356     11,652,050               LONG-TERM LIABILITIES         Asset retirement obligation     474,933     446,128     Contract liabilities     187,837     40,000     Economic Injury Disaster Loan     -     150,000     Paycheck Protection Program Loan     841,670     638,800     Warrants issued with conversions to redeemable preferred stock     878,970     -     Long-term debt- net of discounts/issuance fees     22,417,973     482,443     Total Long-Term Liabilities     24,801,383     1,757,371     Total Liabilities     90,241,739     13,409,421               MEZZANINE EQUITY         Series A redeemable and convertible preferred stock, $.0001 par value, aggregate liquidation value $85,000,000, 9,792,000 shares issued and outstanding as of September 30, 2021     78,041,113     -     Series B redeemable and convertible preferred stock, $.0001 par value, aggregate liquidation value $20,000,006, 5,760,000 shares authorized and 1,817,035 issued and outstanding as of September 30, 2021     18,242,733     -     Common Stock - Class V, $.0001 par value; 34,560,000 shares authorized and 27,057,600 shares issued and outstanding     243,002,390     -       Total mezzanine equity     339,286,236     -               STOCKHOLDERS' DEFICIENCY & PARTNERS' DEFICIT         General partners     -     (2,710,323 )   Limited partners       (1,336,784 )   Series A redeemable and convertible preferred stock, $.0001 par value, aggregate liquidation value $5,000,000, 576,000 issued and outstanding as of September 30, 2021     58     -     Common Stock - Class A, .0001 par value; 238,000,000 shares authorized and 140,674 shares issued and outstanding     14     -     Accumulated deficits     (263,811,490 )   -     Additional paid-in capital     9,635,543     -     Stockholders' deficiency or partners' deficit  .....»»

Category: earningsSource: benzingaNov 30th, 2021

Biden Considering CFPB Director Cordray For Fed"s Vice Chair For Banking Supervision

Biden Considering CFPB Director Cordray For Fed's Vice Chair For Banking Supervision Update (1130ET): Speaking during Tuesday's CARES Act testimony before the Senate Banking Committee, Powell said he wouldn't stand in the way of the Fed's vice chair for supervision, saying he would generally allow the vice chair to pitch any actions to the entire Fed board, even if Powell doesn't agree with the proposals. Whoever becomes the new vice chair for supervision will need to pitch their ideas to the full Fed board. When Warren brought up specific policy proposals like raising capital requirements, Powell sounded more noncommittal. Before finishing with her questions, Warren insisted that whoever the next vice chair for supervision might be, she will be looking to them to shorten the leash on America's largest banks. Glad we got that cleared up. * * * It appears that for the White House, regulating consumer finance (i.e., complaints about credit card rates) and regulating bank holding companies, shadow banks and hedge funds is more or less the same because moments ago the WSJ reported that President Biden is considering Richard Cordray, the first director of the Consumer Financial Protection Bureau and a longtime acolyte of Elizabeth Warren, to serve as the Fed's top banking regulator, citing people familiar with the matter. As she has said previously, Warren likely won't vote to confirm Fed Chairman Jerome Powell for a second term at the Fed, now it's clear how Biden managed to secure Warren's tacit support before officially nominating Powell - whom Warren once denounced as "dangerous" - for a second term. The president was planning to throw her a major bone by nominating her pick to one of the most important regulatory posts in the country. As we pointed out earlier this month, re-nominating Powell and elevating Lael Brainard to vice chair at the Fed might not have been Warren's first choice (she would have rather seen Brainard elevated to lead the central bank) but now it's clear why she held her tongue after the decisions were officially announced by President Biden in the days before the Thanksgiving holiday. WSJ is reporting that the White House is considering longtime Warren acolyte Richard Cordray, the former Ohio AG who was installed by Warren to lead the Consumer Financial Protection Bureau between 2012 and 2017, to serve as the Fed's all-important vice chair for supervision, a role on the Fed's board of governors that will allow Cordray - and by extension, Warren - to directly influence regulatory oversight of America's largest banks. WSJ adds that if Cordray is nominated and confirmed (not a guarantee given the divided Senate), Cordray would become the most influential overseer of the US banking system, succeeding the Trump-nominated Randal Quarles in the role. The White House said earlier this month that it would announce nominees for other senior Fed vacancies in early December. Of the remaining openings, the vice chair for supervision role was seen as most important. At the CFPB, Cordray made "significant changes" to the oversight of consumer finance, a corner of the financial industry that had previously escaped most regulatory scrutiny. The agency tightened underwriting standards for mortgages, required more disclosure on credit-card rates and fees, and introduced federal government oversight of payday lenders. WSJ also noted that Warren and other progressives had quietly pushed Biden to nominate Cordray. Warren clearly sees the bigger picture: It doesn't matter to her who is leading the Fed - what matters is having a loyal stooge serving as the most influential banking regulator in the US. Cordray is currently a top official at the Department of Education, serving as the chief operating officer of Federal Student Aid, overseeing the $1.6 trillion student-loan program. And since he will have virtually no knowledge of what he will be regulating over at the Fed, he should fit right in. Tyler Durden Tue, 11/30/2021 - 10:30.....»»

Category: blogSource: zerohedgeNov 30th, 2021

Tesla (TSLA) to Boost Shanghai Production, Open Berlin Plant

Tesla (TSLA) intends to invest roughly 1.2 billion yuan ($188 million) in boosting production at its Shanghai Gigafactory and plans to commence production in its Berlin plant by December. Tesla TSLA recently indicated plans of investing approximately 1.2 billion yuan ($188 million) in ramping up production at its Shanghai Gigafactory in China. The expansion plan comes in as the factory is nearing the exhaustion of its current capacity.Shanghai Gigafactory, Tesla’s first factory outside the United States, commenced operations in January 2019 and achieved an annualized production capacity of more than 450,000 electric vehicles (EVs) within two years.A filing on the Shanghai government's platform for companies' environmental information disclosures revealed the U.S. EV behemoth’s plans to outlay cash for expanding production lines. The upgrade will take place within the plant's existing production area. Tesla currently manufactures electric Model 3 sedans and Model Y sport-utility vehicles (SUVs) at its Shanghai plant and this expansion will be targeted at accelerating production of these vehicles.As part of the upgrade plan, Tesla will employ an additional 4,000 production staff, bringing the total employees at the factory to roughly 19,000. However, the EV giant did not reveal how much the plant’s production capacity will boost after the upgrade. The project is anticipated to commence this December and conclude in April 2022.China is Tesla’s second-largest market after the United States, accounting for about 30% of its top line. Tesla currently manufactures electric Model 3 sedans and Model Y SUVs at its Shanghai plant in China. Tesla regained its China market share once it started selling domestically-produced vehicles in the country in late 2019. Those were 13% cheaper for China consumers than the vehicles imported from the United States. The EV giant had also received strong backing from Shanghai when it built its first overseas factory there in 2019.The China market is key to Tesla’s global growth ambitions. In fact, Tesla’s Model 3 sedan is one of the best-selling EVs in the country. The company has a dominant market share in the mainland, with a sale of 147,445 vehicles last year. The company’s flagship model in China — Model Y — also secured a green signal for sale in the country last December. However, Tesla has had its share of setbacks in China, with the automaker under strict regulatory scrutiny due to several accidents in the past few months.Nonetheless, amid the recent backlash faced by Tesla in China, the sales spike in China in October is a bright spot for the carmaker. Per the China Passenger Car Association (CPCA), the EV giant sold a total of 54,391 China-made EVs in October, including the export of 40,666 units. The delivery count represents a whopping 348% surge year over year. Further, the automaker plans to eventually produce a $25,000 electric car designed and built in China.In some other news, Tesla is set to begin production at its Berlin Gigafactory in Germany in December. The auto biggie estimates as many as 30,000 vehicles to be manufactured there in the first half of 2022. Serial production will start in January, with the production rate gradually rising from 1,000 cars per week in January.This news puts an end to Tesla’s wait to get production lines rolling at its Giga Berlin. Production was scheduled to commence in July but was delayed because the company did not receive environmental clearance. Reportedly, local regulators are expected to grant the necessary permits within a couple of days.Securing a green signal to begin production at its Gigafactory in Berlin marks an important milestone for the EV giant, which is currently catering to the demand in Europe by exporting from its Shanghai Gigafactory. This involves several logistical hurdles and also increases lead times. Thus, production commencement at the Berlin plant was the need of the hour for the automaker.Tesla currently flaunts a Zacks Rank of 1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.Key Auto Companies to Tap OnOther top-ranked stocks in the auto space include Goodyear Tire GT, LCI Industries LCII and Harley-Davidson HOG, all of which flaunt a Zacks Rank of 1.Goodyear has an expected earnings growth rate of 196.86% for the current year. The Zacks Consensus Estimate for its current-year earnings has been revised upward by 49 cents over the last 30 days.Goodyear beat the Zacks Consensus Estimate for earnings in the last four quarters. GT has a trailing four-quarter earnings surprise of 228.45%, on average. Its shares have rallied 99.5% over the past year.LCI Industries has an expected earnings growth rate of 67.95% for the current year. The Zacks Consensus Estimate for its current-year earnings has been revised upward by 45 cents over the last 30 days.LCI Industries beat the Zacks Consensus Estimate for earnings in three of the last four quarters while missing once. LCII has a trailing four-quarter earnings surprise of 10.09%, on average. Its shares have rallied 21.1% over the past year.Harley-Davidson has an expected earnings growth rate of 31.75% for the current quarter. The Zacks Consensus Estimate for its current-year earnings has been revised upward by 32 cents over the last 30 days.  Harley-Davidson beat the Zacks Consensus Estimate for earnings in three of the last four quarters while missing once. HOG has a trailing four-quarter negative earnings surprise of 138.45%, on average. Its shares have dropped around 6.5% over the past year. Tech IPOs With Massive Profit Potential: Last years top IPOs surged as much as 299% within the first two months. With record amounts of cash flooding into IPOs and a record-setting stock market, this year could be even more lucrative. See Zacks’ Hottest Tech IPOs 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 HarleyDavidson, Inc. (HOG): Free Stock Analysis Report The Goodyear Tire & Rubber Company (GT): Free Stock Analysis Report Tesla, Inc. (TSLA): Free Stock Analysis Report LCI Industries (LCII): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksNov 30th, 2021

Omicron Fears Fuel Rally in Vaccine Stocks: Will It Continue?

Another variant of the coronavirus, Omicron, is up on the WHO-identified list. Several mutations of this variant spark fears of high resistance to the COVID-19 vaccines. The World Health Organization (WHO) added another name to its list of coronavirus variants, which is called Omicron (B.1.1.529). It was first reported in South Africa earlier this month. The variant is found to have several mutations in the spike-protein that is targeted by vaccines for providing immunity against the COVID-19 infection.Some of the mutations in the Omicron variant were previously seen in the Delta variant that are believed to increase transmissibility. Some mutations were previously reported in Beta and Delta variant that is likely to help avoid natural and vaccine-induced immunity.With the combined features of previous variants, the Omicron mutant is raising concerns of high transmissibility and lower vaccine potency. The potential high risks of this latest variant prompted WHO to add it to its “Variant of Concern” list on Nov 26, two days after putting it under the list titled “Variant Under Monitoring”.The spread of the Omicron variant will likely decelerate the economic revival as several countries already started imposing travel bans. Although the restrictions currently cover only those countries that reported Omicron infection cases, including South Africa, a rapid spread can otherwise engulf major countries. Moreover, COVID-19 infection cases have risen significantly in the United States and Europe over the past few weeks. Therefore, this new variant will likely add fuel to the fire.Stocks RiseThe rising concerns of supply-chain disruptions following the potential constraints triggered a decline in broad market indices, including S&P500, on Nov 26. However, stocks of vaccine makers like Pfizer PFE, BioNTech BNTX, Moderna MRNA and Novavax NVAX diverged from the downtrend and saw a significant upside on the same day, possibly aided by an anticipated increase in demand for vaccines and their boosters.Shares of Pfizer and its COVID-19 vaccine partner BioNTech were up 6.1% and 14.2% each last Friday. Stocks of Moderna and Novavax gained 20.6% and 9% on Nov 26. We expect the upside momentum in these stocks to continue over the next few weeks and in 2022, probably as these companies already announced their strategies to combat the new variant under discussion.Pfizer & BioNTechPer Pfizer, its partner BioNTech is expecting to gather additional data on the Omicron variant over the next two weeks. The collected data will help PFE determine its path forward in fighting the new variant. BioNTech will assess whether its vaccine Comirnaty needs to be reworked, based on this extra update. Both Pfizer and BioNTech expect to be able to ship the redesigned Comirnaty, if needed, to provide protection against the Omicron variant in approximately 100 days, per a Reuters article.ModernaModerna announced a three-pronged strategy to provide protection against the Omicron variant. Firstly, it is developing a 100-microgram booster dose compared to its authorized booster dose of 50-microgram of its COVID-19 vaccine, mRNA-1273. MRNA stated that the higher dose of its booster dose led to the highest neutralizing titers against the prior SARS-CoV-2 strains in an ongoing study conducted by the National Institutes of Health in the United States. Secondly, MRNA has been developing multi-valent booster candidates, designed to anticipate mutations observed in the Omicron variant, over the past few months. MRNA is working to rapidly complete the studies. Thirdly, MRNA is also planning to develop an Omicron-specific booster candidate.NovavaxApart from the two approved/authorized mRNA-based COVID-19 vaccines, Novavax’s nanoparticle protein-based COVID-19 vaccine, NVX-CoV2373, also holds strong prospects to gain from the prevalent pandemic and an anticipated spurt in infection cases amid Omicorn fears. Novavax’s COVID-19 vaccine received its first authorization in the Philippines and Indonesia earlier this month. NVAX also submitted a regulatory application seeking approval for the vaccine in Europe earlier this month. Regulatory filings for the authorization of NVX-CoV2373 were also submitted in multiple markets, including Australia, Canada, the EU, India, New Zealand and the United Kingdom. Per a Reuters article, Novavax already started developing a modified version of its COVID-19 vaccine to provide protection against the Omicron variant. NVAX expects the initial work for redesigning the vaccine to take a few weeks.ConclusionSuccessful development of Omicron-specific COVID-19 vaccine or booster dose is likely to generate strong sales from COVID-19 vaccines. While Pfizer is expected to generate revenues of approximately $36 billion from the sale of Comirnaty in 2021, Moderna is likely to record $15-$18 billion from the sales of its COVID-19 vaccine. A potential rapid spread of the Omicron variant, as feared, will likely provide a similar opportunity next year for the vaccine-makers.Per a Bloomberg article, more than 7.91 billion doses of COVID-19 vaccines were administered across 184 countries as of Nov 29. The article stated that it will take at least three months to immunize 75% of the total world population, with at least one dose of any COVID-19 vaccine. This suggests that there will be significant demand for the vaccine doses. Moreover, these many people may also need a booster dose in another six months of the initial vaccine regimen, thereby creating a second opportunity of reaping dollars worth several billions for the vaccine makers.Pfizer, BioNTech, Moderna and Novavax currently carry a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Investor Alert: Legal Marijuana Looking for big gains? Now is the time to get in on a young industry primed to skyrocket from $13.5 billion in 2021 to an expected $70.6 billion by 2028. After a clean sweep of 6 election referendums in 5 states, pot is now legal in 36 states plus D.C. Federal legalization is expected soon and that could kick start an even greater bonanza for investors. Zacks Investment Research has recently closed pot stocks that have shot up as high as +147.0% You’re invited to immediately check out Zacks’ Marijuana Moneymakers: An Investor’s Guide. It features a timely Watch List of pot stocks and ETFs with exceptional growth potential.Today, Download Marijuana Moneymakers FREE >>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 Pfizer Inc. (PFE): Free Stock Analysis Report Moderna, Inc. (MRNA): Free Stock Analysis Report Novavax, Inc. (NVAX): Free Stock Analysis Report BioNTech SE Sponsored ADR (BNTX): Free Stock Analysis Report To read this article on Zacks.com click here......»»

Category: topSource: zacksNov 29th, 2021

Deciphera (DCPH) Down More Than 70% in Past 3 Months: Here"s Why

Deciphera's (DCPH) sole marketed drug, Qinlock, is approved for treating advanced gastrointestinal stromal tumors. The recent regulatory setback for Qinlock has hurt the stock. Shares of Deciphera Pharmaceuticals, Inc. DCPH have plunged 74.2% in the past three months compared with the industry’s decrease of 16.1%.Image Source: Zacks Investment ResearchIn November 2021, the company announced top-line data from the phase III INTRIGUE study evaluating the safety and efficacy of its sole marketed drug, Qinlock (ripretinib) compared to Pfizer’s PFE Sutent (sunitinib) for treating patients with gastrointestinal stromal tumors (“GIST”) who were previously treated with Novartis’ NVS Gleevec (imatinib). The study did not meet the primary endpoint of improved progression-free survival compared with standard of care sunitinib in patients with second-line GIST.Deciphera’s stock took a sharp fall as a result of this news, which can also cause the stock price to remain weak in this time frame.We note that Novartis has lost the patent protection for some of its drugs. Gleevec faces increasing generic competition in major markets. Pfizer is also facing patent expiration for several of its key products in its portfolio. Sutent lost exclusivity in the United States in August 2021.Qinlock, a tyrosine kinase inhibitor, is approved for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including Novartis’ Gleevec. The initial uptake of the drug has been encouraging since its approval in May 2020.Last week, the European Commission approved Qinlock for the above-mentioned indication. In September 2021, the European Medicines Agency’s Committee for Medicinal Products for Human Use rendered a positive opinion, recommending approval for Qinlock for the treatment of fourth-line GIST.In the first nine months of 2021, Qinlock generated sales worth $63.7 million. The approval in Europe should boost sales in the days ahead.Deciphera currently has only one approved product in its portfolio — Qinlock. This apart, all of its drug candidates, including vimseltinib, rebastinib and DCC-3116, are still in early stages of development. The recent regulatory setback with respect to Qinlock in second-line GIST in the INTRIGUE study has significantly hurt the stock. Such setbacks do not bode well for the company. Stiff competition is another area of concern.Please note that Qinlock faces competition from Blueprint Medicines’ BPMC Ayvakit, which is approved for the treatment of unresectable or metastatic GIST, harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations in adults.Blueprint Medicines is also developing Ayvakit for advanced, indolent and smoldering forms of systemic mastocytosis (“SM”). In June 2021, the FDA approved Ayvakit for treating advanced SM.Deciphera Pharmaceuticals, Inc. Price Deciphera Pharmaceuticals, Inc. price | Deciphera Pharmaceuticals, Inc. QuoteZacks RankDeciphera currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Investor Alert: Legal Marijuana Looking for big gains? Now is the time to get in on a young industry primed to skyrocket from $13.5 billion in 2021 to an expected $70.6 billion by 2028. After a clean sweep of 6 election referendums in 5 states, pot is now legal in 36 states plus D.C. Federal legalization is expected soon and that could kick start an even greater bonanza for investors. Zacks Investment Research has recently closed pot stocks that have shot up as high as +147.0% You’re invited to immediately check out Zacks’ Marijuana Moneymakers: An Investor’s Guide. It features a timely Watch List of pot stocks and ETFs with exceptional growth potential.Today, Download Marijuana Moneymakers FREE >>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 Novartis AG (NVS): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Blueprint Medicines Corporation (BPMC): Free Stock Analysis Report Deciphera Pharmaceuticals, Inc. (DCPH): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksNov 29th, 2021

India Says "Not To Subscribe To Starlink" Until It Gets Licence

India Says "Not To Subscribe To Starlink" Until It Gets Licence The Indian government instructed people against preordering Elon Musk's Starlink space internet service because it doesn't have an operating agreement in the country.  In a press release on Friday, India's Department of Telecommunications outlined how "Starlink has started pre-selling/booking of the satellite-based Starlink Internet Services" but doesn't have licenses to operate in the country.  "For rendering satellite-based services in India, requisite license(s) from Department of Telecommunications, Government of India are required. It is hereby informed to the public at large that the said company has not obtained any license/authorization for rendering satellite-based internet services that are being booked on their website," DoT said.  "Accordingly, the Government has asked the company to comply with the Indian regulatory framework for rendering the satellite-based communication services and refrain from booking/rendering the satellite internet services in India with immediate effect," the department said. It warned, "given the fact that Starlink is not a licensee, the public is advised not to subscribe to Starlink services being advertised."  In April, Starlink faced scrutiny from the DoT for possible violations of India's telecom laws. Reuters noted Starlink registered its business in India on Nov. 1. It has advertised and sold pre-selling of its service. Starlink plans for 200,00 customers in the country by 2022, with 80% of users in the countryside where the internet is non-existent.  Starlink timelines have been unreliable so far. In the US, thousands of customers who put down a $100 deposit to secure a dish were just told by the company to wait another year.  Musk is a notorious salesman who overpromises and underdelivers, and Indians should wait until after Starlink receives licenses to preorder. Then expect delivery of the space internet system to take a year or so, considering that's been the trend everywhere else.  Tyler Durden Sun, 11/28/2021 - 15:25.....»»

Category: blogSource: zerohedgeNov 28th, 2021

4 Reasons Why You Should Add Sarepta (SRPT) to Your Portfolio

Sarepta's (SRPT) stock creates a significant opportunity for investors on the back of solid demand for its commercialized drugs and steady progress with its key pipeline candidates. Sarepta Therapeutics SRPT concentrates on developing exon-skipping drug candidates targeting Duchenne muscular dystrophy (DMD), a rare genetic disorder affecting children and also the most common type of muscular dystrophy. SRPT’s top line is driven by its three FDA-approved DMD drugs, namely Exondys 51, Vyondys 53 and Amondys 45.Sarepta is also developing gene therapies targeting different muscular dystrophies and central nervous system disorders. Its lead gene therapy candidate SRP-9001 is being developed in a pivotal study as a potential treatment of DMD.Here we discuss four reasons why adding the Sarepta stock to one’s portfolio may prove to be beneficial in 2021.Top Rank, Rising Estimates and Share Price: Sarepta currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Earnings estimates for Sarepta’s loss per share have narrowed 28.2% for 2021 and 25.3% for 2022 over the past 30 days.  The stock has gained 5.3% in the past six months against a decrease of 12.3% for the industry.Image Source: Zacks Investment ResearchStrong Performance of DMD Drugs: Sarepta’s Exondys 51 is the first approved disease-modifying therapy for DMD in the United States and its first product to receive marketing approval. Exondys 51 recorded impressive sales growth in the last few quarters despite the COVID-19 pandemic. Vyondys 53, approved in 2019, is boosting SRPT’s top line by bringing in additional sales. Moreover, Amondys 45 has been showing a strong demand trend since its launch earlier in 2021.Strong performance of its three DMD drugs in the first nine months of 2021 led Sarepta to raise its revenue guidance for 2021 on its third quarter earnings call. SRPT expects product revenues in the range of $605-$615 million, indicating growth of nearly 34% from the year-ago reported figure at the midpoint. We expect robust growth in product revenues to continue in 2022.Gene Therapy Pipeline: Sarepta is one of the pioneers in gene therapy development. Earlier this year, SRPT initiated the first pivotal study — EMBARK — to evaluate a gene therapy candidate for DMD patients.In January 2021, management had announced that SRP-9001 met the biological endpoint of a mid-stage study during its evaluation in DMD patients but failed to achieve a statistically significant improvement in the functional endpoint of the study. This caused a massive decline in Sarepta’s share price in the same month. However, SRPT advanced the development of SRP-9001 to the pivotal EMBARK study based on favorable trends observed for function endpoint in the mid-stage study.The pivotal study is also evaluating commercially-represented material for SRP-9001. Any positive update from the pivotal study will be a key catalyst for the stock. Sarepta is developing the micro-dystrophin-encoding gene therapy candidate in collaboration with Roche RHHBY.Sarepta and Roche entered into a licensing agreement to develop SRP-9001 in 2019. Per the agreement, Roche has exclusive rights to launch and commercialize SRP-9001 in the ex-U.S. markets. Roche made $1.15-billion upfront payments and will pay up to $1.7 billion in regulatory and sales milestones to Sarepta.Apart from DMD, Sarepta is developing gene therapies for treating Limb-girdle muscular dystrophy, Mucopolysaccharidosis type IIIA (MPS IIIA) and Pompe Disease in different clinical-stage studies.Next-Generation Exon-Skipping Pipeline: Sarepta is looking to build its DMD pipeline beyond PMO-based exon-skipping treatments. SRPT is developing SRP-5051, an exon 51 skipping candidate from SRPT’s next-generation PPMO-technology, for treating DMD patients. The new technology aided in achieving a more durable response compared to PMO.SRP-5051 targets a similar patient population as that of Sarepta’s lead drug Exondys 51. The candidate showed significantly better responses in patients with its once-monthly doses in clinical studies than the once-weekly doses of Exondys 51.Successful development will offer DMD patients a better alternative with a much lower dose and a new drug with longer patent protection. SRPT initiated the pivotal part B of the MOMENTUM study in the fourth quarter of 2021.ConclusionStrong demand for its commercial DMD drugs and promising pipeline progress represents an opportunity for investors to gain from Sarepta’s potential growth over the next few quarters. On the flip side, shares of SRPT declined more than 50% on Jan 8, 2021, following a negative clinical update on its DMD gene therapy candidate, SRP-9001. However, any positive update from the ongoing pivotal study on SRP-9001 will likely be a catalyst for the stock’s substantial upside going forward.A few other companies also developing gene therapies targeting DMD patients are Pfizer PFE and REGENXBIO RGNX. Successful development of these gene therapy candidates may increase competition for Sarepta.Pfizer began dosing in the phase III CIFFREO study last December. The study is evaluating the safety and efficacy of its gene therapy candidate PF-06939926 for treating DMD. Pfizer is the closest competitor of Sarepta in developing a DMD gene therapy with both companies evaluating their respective candidates in late-stage studies. Pfizer’s DMD candidate enjoys fast track, orphan drug and rare pediatric disease designations in the United States.REGENXBIO plans to start a clinical study next year to evaluate its gene therapy candidate RGX-202 for treating DMD. RGX-202 was designed using REGENXBIO's proprietary NAV AAV8 vector to deliver an optimized microdystrophin transgene to develop a targeted therapy for improved resistance to muscle damage associated with DMD. REGENXBIO received an orphan drug designation for the candidate earlier this month.Sarepta Therapeutics, Inc. Price Sarepta Therapeutics, Inc. price | Sarepta Therapeutics, Inc. Quote Bitcoin, Like the Internet Itself, Could Change Everything Blockchain and cryptocurrency has sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities. Zacks’ has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly. See 3 crypto-related 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 Roche Holding AG (RHHBY): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Sarepta Therapeutics, Inc. (SRPT): Free Stock Analysis Report REGENXBIO Inc. (RGNX): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksNov 26th, 2021