Latest news with #LeonardS.Schleifer
Yahoo
15-05-2025
- Business
- Yahoo
Regeneron Prevails over Amgen in Antitrust PCSK9 Lawsuit Protecting Biotech Innovation and Patient Access to Life-Saving Treatments
Federal court jury found Amgen liable for violating antitrust and tort laws by using cross-therapeutic bundled rebates to prevent Praluent® (alirocumab) from competing in the market Jury awarded Regeneron $135.6 million dollars of compensatory damages and $271.2 million dollars in punitive damages TARRYTOWN, N.Y., May 15, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) applauds the jury verdict in the U.S. District Court for the District of Delaware that found that Amgen Inc. violated antitrust and tort laws by creating a bundling scheme that illegally leveraged its blockbuster anti-inflammatory drugs Enbrel® (etanercept) and Otezla® (apremilast) to convince pharmacy benefit managers (PBMs) to select Repatha® (evolocumab) as the exclusive PCSK9 category product over Praluent® (alirocumab). The jury found that Amgen violated the Clayton Act, the Sherman Act, the New York State Donnelly Act, the California Cartwright Act and Delaware tort law. Enbrel and Otezla are therapeutically different medicines that do not treat the heart conditions that Praluent or Repatha address. Amgen threatened to withhold rebates unless PBMs preferred Repatha and excluded Praluent. Amgen prevented Regeneron from competing on a level playing field and unfairly denied patients access to Praluent. This anticompetitive practice shut out an innovative therapy from the PCSK9 marketplace, not based on clinical merit or price. Because of Amgen's size and unrelated product portfolio, their anticompetitive actions ultimately hurt competition and patients. The jury awarded Regeneron $135.6 million dollars of compensatory damages. The jury also awarded Regeneron $271.2 million dollars in punitive damages. Punitive damages may be awarded to punish a party for outrageous conduct and deter a party, and others like it, from engaging in similar conduct in the future. "Patients rely on the biotech industry to find solutions for their most urgent medical conditions. At Regeneron, we take this responsibility very seriously and are committed to delivering breakthrough therapies that improve patient lives. To achieve this, companies must be able to compete fairly based on the clinical and economic value of their products. Larger companies should not be allowed to use anticompetitive tactics to push competitors out of the market," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. 'Fair competition is critical as it expands patient access to life-changing therapies and drives innovation forward so we can continue to address the medical challenges of tomorrow.' 'Since the FDA approved Praluent in 2015, Amgen has tried to remove and exclude Praluent from the market. After a failed patent litigation campaign, they pivoted toward an anticompetitive bundling scheme that created a dangerous precedent that virtually eliminated all competition,' said Joseph J. LaRosa, Executive Vice President, General Counsel and Secretary of Regeneron. 'Today's verdict validates Regeneron's efforts to help protect patient access to our innovations and provides a clear sign that anticompetitive efforts will not remain unchecked.' Regeneron thanks the jury for their time and thoughtful consideration of the facts of this case. Regeneron's lead counsel was Jonathan D. Polkes of White & Case LLP. About PraluentPraluent inhibits the binding of PCSK9 to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells to clear LDL, which lowers LDL-C levels in the blood. Praluent was developed by Regeneron and Sanofi under a global collaboration agreement and invented by Regeneron using the company's proprietary VelocImmune® technology that yields optimized fully-human monoclonal antibodies. In addition to the U.S., Praluent is approved in 60 countries, including the European Union, Japan, Canada, Switzerland and Brazil. About Regeneron's TechnologyRegeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopouloswas a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV®(casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. Indications and Important Safety Information PRALUENT is an injectable prescription medicine used: in adults with cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of chest pain conditions (unstable angina) requiring hospitalization. along with diet, alone or together with other cholesterol-lowering medicines in adults with high blood cholesterol levels called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia [HeFH]), to reduce low-density lipoprotein cholesterol (LDL-C) or bad cholesterol. along with other LDL-lowering treatments in adults with a type of high cholesterol called homozygous familial hypercholesterolemia, who need additional lowering of LDL-C. along with diet and other LDL-C lowering treatments in children aged 8 years and older with HeFH to reduce LDL-C. It is not known if PRALUENT is safe and effective in children who are younger than 8 years of age or in children with other types of high cholesterol (hyperlipidemias). Important Safety InformationDo not use PRALUENT if you are allergic to alirocumab or to any of the ingredients in PRALUENT. Before you start using PRALUENT, tell your healthcare provider about all of your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed. Tell your healthcare provider or pharmacist about any medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. PRALUENT can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Stop using PRALUENT and call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, hives, severe itching, trouble breathing, or swelling of the face, lips, throat, or tongue. The common side effects of PRALUENT include: redness, itching, swelling, or pain/tenderness at the injection site; flu or flu-like symptoms; diarrhea; muscle pain; muscle spasms; and bruising. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Talk to your doctor about the right way to prepare and give yourself a PRALUENT injection and follow the 'Instructions For Use' that comes with PRALUENT. In children aged 12 to 17 years, it is recommended that PRALUENT be given by or under the supervision of an adult. In children aged 8 to 11 years, PRALUENT should be given by a caregiver. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please click here for full Prescribing Information. About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn, Instagram, Facebook or X. Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ('Regeneron' or the 'Company'), and actual events or results may differ materially from these forward-looking statements. Words such as 'anticipate,' 'expect,' 'intend,' 'plan,' 'believe,' 'seek,' 'estimate,' variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation the antitrust litigation discussed in this press release), risks associated with intellectual property of other parties and pending or future litigation relating thereto, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition; the outcome of any post-trial motions or other appeals relating to the jury verdict discussed in this press release; the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Products') and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Product Candidates') and research and clinical programs now underway or planned, including without limitation Praluent® (alirocumab); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on any of the foregoing; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron's Products (such as Praluent) and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; and the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024 and its Form 10-Q for the quarterly period ended March 31, 2025. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( and its LinkedIn page ( Contacts: Media RelationsMary HeatherTel: +1 Investor RelationsMark HudsonTel: +1
Yahoo
29-04-2025
- Business
- Yahoo
Regeneron (NASDAQ:REGN) Misses Q1 Sales Targets
Biotech company Regeneron (NASDAQ:REGN) missed Wall Street's revenue expectations in Q1 CY2025, with sales falling 3.7% year on year to $3.03 billion. Its non-GAAP profit of $8.22 per share was 3% below analysts' consensus estimates. Is now the time to buy Regeneron? Find out in our full research report. Revenue: $3.03 billion vs analyst estimates of $3.24 billion (3.7% year-on-year decline, 6.6% miss) Adjusted EPS: $8.22 vs analyst expectations of $8.48 (3% miss) Operating Margin: 19.5%, down from 23.9% in the same quarter last year Free Cash Flow Margin: 26.9%, down from 43.8% in the same quarter last year Market Capitalization: $65.38 billion "Regeneron has one of the most exciting pipelines in the industry, with unmatched diversity, scientific distinction, and potential to help millions of patients," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. Founded by scientists who wanted to build a company where science could thrive, Regeneron Pharmaceuticals (NASDAQ:REGN) develops and commercializes medicines for serious diseases, with key products treating eye conditions, allergic diseases, cancer, and other disorders. Reviewing a company's long-term sales performance reveals insights into its quality. Even a bad business can shine for one or two quarters, but a top-tier one grows for years. Thankfully, Regeneron's 15% annualized revenue growth over the last five years was solid. Its growth beat the average healthcare company and shows its offerings resonate with customers. Long-term growth is the most important, but within healthcare, a half-decade historical view may miss new innovations or demand cycles. Regeneron's recent performance shows its demand has slowed as its annualized revenue growth of 6.7% over the last two years was below its five-year trend. Regeneron also breaks out the revenue for its most important segments, Collaboration and Product & Pipeline, which are 50.6% and 46.7% of revenue. Over the last two years, Regeneron's Collaboration revenue averaged 13.8% year-on-year growth while its Product & Pipeline revenue averaged 2.6% growth. This quarter, Regeneron missed Wall Street's estimates and reported a rather uninspiring 3.7% year-on-year revenue decline, generating $3.03 billion of revenue. Looking ahead, sell-side analysts expect revenue to remain flat over the next 12 months, a deceleration versus the last two years. This projection doesn't excite us and implies its products and services will see some demand headwinds. Today's young investors likely haven't read the timeless lessons in Gorilla Game: Picking Winners In High Technology because it was written more than 20 years ago when Microsoft and Apple were first establishing their supremacy. But if we apply the same principles, then enterprise software stocks leveraging their own generative AI capabilities may well be the Gorillas of the future. So, in that spirit, we are excited to present our Special Free Report on a profitable, fast-growing enterprise software stock that is already riding the automation wave and looking to catch the generative AI next. Regeneron has been a well-oiled machine over the last five years. It demonstrated elite profitability for a healthcare business, boasting an average operating margin of 38.6%. Analyzing the trend in its profitability, Regeneron's operating margin decreased by 16.2 percentage points over the last five years. The company's two-year trajectory also shows it failed to get its profitability back to the peak as its margin fell by 8.6 percentage points. This performance was poor no matter how you look at it - it shows its expenses were rising and it couldn't pass those costs onto its customers. This quarter, Regeneron generated an operating profit margin of 19.5%, down 4.4 percentage points year on year. This contraction shows it was less efficient because its expenses increased relative to its revenue. Revenue trends explain a company's historical growth, but the long-term change in earnings per share (EPS) points to the profitability of that growth – for example, a company could inflate its sales through excessive spending on advertising and promotions. Regeneron's EPS grew at a remarkable 10.6% compounded annual growth rate over the last five years. However, this performance was lower than its 15% annualized revenue growth, telling us the company became less profitable on a per-share basis as it expanded due to non-fundamental factors such as interest expenses and taxes. We can take a deeper look into Regeneron's earnings to better understand the drivers of its performance. As we mentioned earlier, Regeneron's operating margin declined by 16.2 percentage points over the last five years. This was the most relevant factor (aside from the revenue impact) behind its lower earnings; taxes and interest expenses can also affect EPS but don't tell us as much about a company's fundamentals. In Q1, Regeneron reported EPS at $8.22, down from $9.55 in the same quarter last year. This print missed analysts' estimates, but we care more about long-term EPS growth than short-term movements. Over the next 12 months, Wall Street expects Regeneron's full-year EPS of $44.31 to shrink by 10.9%. We struggled to find many positives in these results. Its revenue missed significantly and its EPS fell short of Wall Street's estimates. Overall, this quarter could have been better. The stock traded down 1.7% to $600 immediately following the results. Regeneron may have had a tough quarter, but does that actually create an opportunity to invest right now? The latest quarter does matter, but not nearly as much as longer-term fundamentals and valuation, when deciding if the stock is a buy. We cover that in our actionable full research report which you can read here, it's free. Sign in to access your portfolio
Yahoo
14-04-2025
- Business
- Yahoo
Reflecting On Immuno-Oncology Stocks' Q4 Earnings: Regeneron (NASDAQ:REGN)
Looking back on immuno-oncology stocks' Q4 earnings, we examine this quarter's best and worst performers, including Regeneron (NASDAQ:REGN) and its peers. Over the next few years, immuno-oncology companies, which harness the immune system to fight illnesses such as cancer, faces strong tailwinds from advancements in precision medicine (including the use of AI to improve hit rates) and growing demand for treatments targeting rare diseases. However, headwinds such as rising scrutiny over drug pricing, regulatory unknowns, and competition from larger, more resourced pharmaceutical companies could weigh on growth. The 4 immuno-oncology stocks we track reported a strong Q4. As a group, revenues beat analysts' consensus estimates by 3.5%. Amidst this news, share prices of the companies have had a rough stretch. On average, they are down 15% since the latest earnings results. Founded by scientists who wanted to build a company where science could thrive, Regeneron Pharmaceuticals (NASDAQ:REGN) develops and commercializes medicines for serious diseases, with key products treating eye conditions, allergic diseases, cancer, and other disorders. Regeneron reported revenues of $3.79 billion, up 10.3% year on year. This print exceeded analysts' expectations by 1%. Overall, it was a strong quarter for the company with a decent beat of analysts' EPS estimates. "Regeneron's financial and commercial strength allows for continued investment in our industry-leading R&D pipeline, while simultaneously returning capital to our shareholders through our newly initiated dividend program and increased share repurchase capacity," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. Regeneron delivered the weakest performance against analyst estimates of the whole group. The stock is down 16.3% since reporting and currently trades at $557.21. Is now the time to buy Regeneron? Access our full analysis of the earnings results here, it's free. Founded in 2003 as Gene Security Network before rebranding in 2012, Natera (NASDAQ:NTRA) develops and commercializes genetic tests for prenatal screening, cancer detection, and organ transplant monitoring using its proprietary cell-free DNA technology. Natera reported revenues of $476.1 million, up 53% year on year, outperforming analysts' expectations by 8.6%. The business had a stunning quarter with an impressive beat of analysts' EPS estimates and full-year revenue guidance exceeding analysts' expectations. Natera delivered the biggest analyst estimates beat, fastest revenue growth, and highest full-year guidance raise among its peers. Although it had a fine quarter compared its peers, the market seems unhappy with the results as the stock is down 4.6% since reporting. It currently trades at $149.50. Is now the time to buy Natera? Access our full analysis of the earnings results here, it's free. Founded in 1991 and evolving from a genomics research firm to a commercial-stage drug developer, Incyte (NASDAQ:INCY) is a biopharmaceutical company that discovers, develops, and commercializes proprietary therapeutics for cancer and inflammatory diseases. Incyte reported revenues of $1.18 billion, up 16.3% year on year, exceeding analysts' expectations by 3%. Still, it was a slower quarter as it posted a significant miss of analysts' EPS estimates. As expected, the stock is down 24.5% since the results and currently trades at $56.01. Read our full analysis of Incyte's results here. With a mission to detect cancer earlier when it's more treatable, Exact Sciences (NASDAQ:EXAS) develops and markets cancer screening and diagnostic tests, including its flagship Cologuard stool-based colorectal cancer screening test. Exact Sciences reported revenues of $713.4 million, up 10.3% year on year. This print topped analysts' expectations by 1.6%. Overall, it was a strong quarter as it also logged a solid beat of analysts' constant currency revenue estimates and an impressive beat of analysts' EPS estimates. Exact Sciences had the slowest revenue growth and weakest full-year guidance update among its peers. The stock is down 14.6% since reporting and currently trades at $43.11. Read our full, actionable report on Exact Sciences here, it's free. As a result of the Fed's rate hikes in 2022 and 2023, inflation has come down from frothy levels post-pandemic. The general rise in the price of goods and services is trending towards the Fed's 2% goal as of late, which is good news. The higher rates that fought inflation also didn't slow economic activity enough to catalyze a recession. So far, soft landing. This, combined with recent rate cuts (half a percent in September 2024 and a quarter percent in November 2024) have led to strong stock market performance in 2024. The icing on the cake for 2024 returns was Donald Trump's victory in the U.S. Presidential Election in early November, sending major indices to all-time highs in the week following the election. Still, debates around the health of the economy and the impact of potential tariffs and corporate tax cuts remain, leaving much uncertainty around 2025. Want to invest in winners with rock-solid fundamentals? Check out our Top 5 Quality Compounder Stocks and add them to your watchlist. These companies are poised for growth regardless of the political or macroeconomic climate. Join Paid Stock Investor Research Help us make StockStory more helpful to investors like yourself. Join our paid user research session and receive a $50 Amazon gift card for your opinions. Sign up here. Sign in to access your portfolio
