Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Regeneron Pharmaceuticals due to allegations of misleading statements and violations of federal securities laws related to the pricing of its Eylea drug [2][4]. Group 1: Allegations Against Regeneron - The complaint alleges that Regeneron made false and misleading statements regarding credit card fee payments to distributors, which were not disclosed as price concessions [4]. - It is claimed that these undisclosed payments led to inflated reported sales of Eylea and overstated average selling prices (ASP) reported to federal agencies, violating the False Claims Act [4][5]. - The U.S. Department of Justice filed a complaint against Regeneron, alleging that the company failed to report millions in discounts, resulting in inflated Medicare reimbursements [5]. Group 2: Financial Impact - Following the DOJ announcement, Regeneron's stock price fell by $31.50, or 3.36%, closing at $904.70 on April 12, 2024, with unusually heavy trading volume [6]. - On October 31, 2024, Regeneron reported a 3% increase in U.S. net sales for Eylea compared to Q3 2023, with Eylea HD sales of $392 million, missing consensus estimates of $415 million to $425 million [7]. - The stock price dropped by $84.59, or 9.2%, to close at $838.20 on the same day due to weaker-than-expected quarterly sales [7]. Group 3: Legal Proceedings - Investors who suffered losses exceeding $100,000 in Regeneron between November 2, 2023, and October 30, 2024, are encouraged to contact Faruqi & Faruqi to discuss their legal options [1]. - The deadline to seek the role of lead plaintiff in the federal securities class action against Regeneron is March 10, 2025 [2][8]. - Any member of the putative class can move the Court to serve as lead plaintiff or remain an absent class member without affecting their ability to share in any recovery [8].

Company Overview - Regeneron Pharmaceuticals has experienced a bearish trend since August, with shares losing over one third of their value [1] - In Q3 2024, the company reported revenues of $3.72 billion, reflecting an 11% year-over-year growth [1] Key Personnel - Brendan, a co-founder of 1200 Pharma, has a background in organic synthesis with a Ph.D. from Stanford University and has worked for major pharmaceutical companies and biotech startups [1]

Business and Pipeline Updates - Enrollment for a confirmatory study to support resubmission of the BLA for FL to the FDA is underway, targeting the first quarter of 2025 [1] - Two Factor XI antibodies, REGN7508 and REGN9933, will advance to pivotal trials in 2025 based on positive proof-of-concept data [1] - Shares of REGN have declined 33.7% in the past six months, compared to the industry's decline of 12.3% [3] Eylea Franchise Updates - Eylea and Eylea HD recorded $6 billion in sales in 2024 in the United States, with Q4 sales of $1.5 billion [5] - Eylea sales were $1.19 billion in Q4 2024, while Eylea HD's net product sales were $305 million in the same period [5] - Eylea franchise sales in Q4 were favorably impacted by $85 million due to higher wholesaler inventory levels for Eylea, partially offset by lower levels for Eylea HD [6] - Eylea sales have been under pressure due to competition from Roche's Vabysmo [6] - REGN filed an application with the FDA for the use of the Eylea HD pre-filled syringe, with potential approval and launch expected by mid-2025 [7] - Longer-term data for Eylea HD in wet AMD and diabetic macular edema are under FDA review, with a target action date of April 20, 2025 [9] - REGN plans to submit a supplemental BLA for Eylea HD for every four-week dosing and retinal vein occlusion in Q1 2025 [9] - REGN has a collaboration agreement with Bayer for Eylea, with REGN recording net product sales in the United States and Bayer handling sales outside the country [10] Dupixent Updates - REGN's top line includes its share of profits/losses from global sales of Dupixent, with Sanofi recording global net product sales [11] - Dupixent sales have been strong, with encouraging initial uptake for the recently approved indication of COPD [12] - An application for expanding Dupixent's label for chronic spontaneous urticaria is under review in the United States, with a target action date of April 18, 2025 [13] - A supplemental BLA seeking label expansion for bullous pemphigoid was submitted in Q4 2024 [13] Oncology Franchise Updates - REGN's oncology franchise includes Libtayo, which exceeded $1 billion in sales for 2024 [14] - Positive results from the late-stage C-POST study showed that adjuvant treatment with Libtayo improved disease-free survival in high-risk cutaneous squamous cell carcinoma patients [15] - The European Commission approved odronextamab (brand name Ordspono) for treating relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma [17] - REGN's efforts to get odronextamab approved in the United States faced a setback with the issuance of complete response letters for its BLA [19] Pipeline and Collaborations - REGN has a deep pipeline with promising candidates, including itepekimab for COPD, fianlimab for melanoma, and linvoseltamab for multiple myeloma [16] - The BLA for linvoseltamab was resubmitted after resolving third-party manufacturing issues, with a launch anticipated in mid-2025 [16] - REGN is evaluating combinations with GLP-based therapies for obesity, with phase II studies fully enrolled and initial data expected in the second half of 2025 [18] - REGN announced a strategic collaboration with Truveta to advance innovation and data-driven discovery across life sciences and healthcare [20]

Lawsuit Overview - Levi & Korsinsky, LLP has notified investors of a class action securities lawsuit against Regeneron Pharmaceuticals, Inc (NASDAQ: REGN) [1] - The lawsuit aims to recover losses for Regeneron investors affected by alleged securities fraud between November 2, 2023 and October 30, 2024 [1] Allegations - Regeneron allegedly paid credit card fees to distributors on the condition that they did not charge Eylea customers more for using credit cards [2] - These payments subsidized the prices customers paid when using credit cards to purchase Eylea [2] - As a result, Regeneron offered price concessions that lowered Eylea's selling price [2] - The price concessions provided a competitive advantage due to retina practices' sensitivity to higher prices when purchasing anti-VEGF medications with credit cards [2] - Regeneron allegedly boosted reported Eylea sales misleadingly [2] - The company failed to report its payment of credit card fees as price concessions, thereby overstating the ASP reported to federal agencies and violating the False Claims Act [2] - Defendants' positive statements about the company's business, operations, and prospects were allegedly materially misleading and/or lacked a reasonable basis [2] Next Steps - Investors who suffered losses in Regeneron during the relevant time frame have until March 10, 2025 to request the Court appoint them as lead plaintiff [4] - Class members may be entitled to compensation without payment of any out-of-pocket costs or fees [4] Levi & Korsinsky's Track Record - Over the past 20 years, Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders [5] - The firm has a track record of winning high-stakes cases and extensive expertise in representing investors in complex securities litigation [5] - Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States for seven consecutive years [5]

Key Points Company and Industry Information 1. **Company Presentation**: The presentation is being made by Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) at the 43rd Annual J.P. Morgan Healthcare Conference 2025 on January 13, 2025 [3]. 2. **Industry**: The company operates in the biotechnology industry [2]. 3. **Management Team**: Leonard Schleifer is the Board Co-Chair, Co-Founder, President, and CEO, while George Yancopoulos is the Co-Founder, Board Co-Chair, President, and CSO [3]. Core Views and Arguments 1. **Longevity in Industry**: Leonard Schleifer highlights his long-standing experience in the biotechnology industry, emphasizing his role as the longest-serving CEO and part of the longest-serving management team in the industry [2]. 2. **Investor Focus**: Schleifer emphasizes that investors are always interested in knowing what unique aspects of the company make it a worthy investment [2]. Other Important Content 1. **Introduction**: The conference call is introduced by Chris Schott from J.P. Morgan, who expresses his pleasure in introducing Regeneron and looks forward to the presentation [3]. 2. **Backward-Looking Statements**: Leonard Schleifer mentions making backward-looking statements during the presentation, suggesting a focus on past achievements and experiences [4].

J.P. Morgan Healthcare Conference JANUARY 13, 2025 This non-promotional presentation contains investigational data as well as forward-looking statements; actual results may vary materially. J.P. Morgan Healthcare Conference 2025 Strategy & Business Update Leonard S. Schleifer, MD, PhD Co-Founder, Board Co-Chair, President & Chief Executive Officer 2 Note regarding forward-looking statements This presentation includes forward-looking statements that involve risks and uncertainties relating to future events a ...

Financial Performance - Regeneron's Q3 2024 sales increased by only 3% year-over-year, with Eylea sales at $392 million, missing consensus estimates of $415 million to $425 million [1] - Eylea sales were adversely impacted by a lower net selling price compared to Q3 2023 [1] - Regeneron's stock price fell $84.59, or 9%, to close at $838.20 per share on October 31, 2024 [1] Legal and Regulatory Issues - The DOJ alleges that Regeneron inflated the average sales price of Eylea, inappropriately increasing Medicare reimbursements [2] - Regeneron's stock price declined by $31.50, more than 3%, over two trading days following the DOJ announcement, closing at $904.70 per share on April 12, 2024 [2] - A securities class action lawsuit has been filed against Regeneron on behalf of purchasers of its securities between November 2, 2023, and October 30, 2024 [3] - The DOJ filed a complaint against Regeneron under the False Claims Act for failing to report millions of dollars in discounts provided to drug distributors in the form of reimbursed credit card fees [4] Legal Representation and Investor Participation - Investors who purchased Regeneron securities during the Class Period may seek to be appointed as a lead plaintiff representative by March 10, 2025 [4] - Berger Montague, a pioneer in securities class action litigation, is representing investors in this case [6]

Lawsuit Overview - A class action securities lawsuit has been filed against Regeneron Pharmaceuticals Inc (NASDAQ: REGN) on behalf of investors who suffered losses between November 2 2023 and October 30 2024 due to alleged securities fraud [3] - The lawsuit seeks to recover losses for investors adversely affected by the alleged misconduct during the specified period [3] Allegations - Regeneron allegedly paid credit card fees to distributors on the condition that they did not charge Eylea customers more for using credit cards [4] - These payments subsidized the prices customers paid when using credit cards to purchase Eylea resulting in price concessions that lowered Eylea's selling price [4] - The price concessions provided a competitive advantage as retina practices were sensitive to higher prices when purchasing anti-VEGF medications with credit cards [4] - Regeneron allegedly boosted reported Eylea sales misleadingly by failing to report the payment of credit card fees as price concessions [4] - The company overstated the Average Selling Price (ASP) reported to federal agencies violating the False Claims Act [4] - Defendants' positive statements about the company's business operations and prospects were allegedly materially misleading and/or lacked a reasonable basis [4] Legal Representation - Levi & Korsinsky LLP a law firm with over 20 years of experience in securities litigation is representing the aggrieved shareholders [5] - The firm has secured hundreds of millions of dollars for shareholders and has a track record of winning high-stakes cases [5] - Levi & Korsinsky has been ranked in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the top securities litigation firms in the United States [5] Investor Participation - Investors who suffered losses in Regeneron during the relevant period have until March 10 2025 to request the Court to appoint them as lead plaintiff [1] - Participation in the lawsuit does not require serving as a lead plaintiff and there is no cost or obligation for class members to participate [1]

Eylea Sales and Competition - Eylea sales have been declining due to competition from Roche's Vabysmo, which has seen phenomenal uptake [3][12] - Regeneron developed Eylea HD to counter the decline, but it will take time to offset the rapid erosion in Eylea sales [2] - Biosimilar competition for Eylea is a significant concern, with Amgen's Pavblu being the fifth biosimilar approved for Eylea [18] Oncology Franchise - Regeneron is focusing on strengthening its oncology franchise, which includes Libtayo for various advanced cancers [5] - The European Commission approved odronextamab (Ordspono) for treating relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma [6] - However, the company faced setbacks with odronextamab and linvoseltamab in the US, receiving complete response letters from the FDA [7][8] - Phase II and II/III studies for fianlimab in combination with Libtayo for non-small cell lung cancer and melanoma are ongoing [9] Dupixent Performance - Dupixent has been a strong contributor to Regeneron's top line, with solid sales and consistent label expansion [13][14] - The FDA approved Dupixent for chronic obstructive pulmonary disease, and the European Commission expanded its label to treat eosinophilic esophagitis in children [14] Financial Performance and Valuation - Regeneron's shares have dropped 35.6% in the past six months, underperforming the industry and the S&P 500 Index [11] - The company's forward price/earnings ratio is 17.64, higher than the large-cap pharma industry's 15.90 [10] - The Zacks Consensus Estimate for 2024 earnings per share has risen 39 cents to $45.25 over the past 60 days [15] Market Sentiment and Future Prospects - Regeneron is bearing the brunt of investor sentiment due to Eylea's rapid sales decline and pipeline setbacks [18][19] - Despite near-term challenges, the company has solid long-term growth prospects, particularly with its oncology franchise and Dupixent [19]

Dupixent Updates - Dupixent is now used to treat over a million patients globally, with continued growth in multiple indications for diseases involving type 2 inflammation [1][3] - The recent approval and launch in chronic obstructive pulmonary disease (COPD) has secured coverage from top commercial and Medicare payers, addressing approximately 300,000 patients in the US [3] - Continued growth potential exists in additional indications, including chronic spontaneous urticaria (CSU) with an FDA decision expected by April 18, 2025, and bullous pemphigoid, for which a supplemental Biologics License Application (sBLA) was submitted in Q4 2024 [3] EYLEA and EYLEA HD Updates - EYLEA HD and EYLEA remained the US anti-VEGF category leader in 2024, with aggregate US net product sales of $6 billion, up 1% year-over-year [1][40] - Combined US net product sales for Q4 2024 were $1.5 billion, with EYLEA HD contributing $305 million and EYLEA contributing $1.19 billion [40][45] - The company filed an application with the FDA for the EYLEA HD pre-filled syringe (PFS), with approval and launch expected by mid-2025 [1][12] Libtayo Updates - Libtayo exceeded $1 billion in annual net sales for 2024, becoming the first and only immunotherapy to show a statistically significant clinical benefit as adjuvant therapy in high-risk cutaneous squamous cell carcinoma (CSCC) [1][12] - A Phase 3 study demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo in high-risk CSCC patients [12] Pipeline and R&D Highlights - The company has approximately 40 investigational candidates in its pipeline, covering dozens of disease states with expansive market potential [1] - The total addressable commercial market for advanced pipeline programs is expected to exceed $220 billion by 2030 [12] - Key pipeline candidates include itepekimab (IL-33) for COPD, fianlimab (LAG3) for melanoma, linvoseltamab (BCMAxCD3) for multiple myeloma, and odronextamab (CD20xCD3) for lymphoma [12] Genetics and Data-Driven Innovation - The Regeneron Genetics Center has sequenced nearly three million people with de-identified linked healthcare records [6] - A strategic collaboration with Truveta, Inc is expected to expand the DNA-linked healthcare database to include sequencing and linked Electronic Health Records for up to 10 million additional individuals [6] - The company was selected by UK BioBank consortium members to complete proteomic assay data generation for the UK Biobank Pharma Proteomics Project [6]