NEW YORK, Jan. 16, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN).Shareholders who purchased shares of REGN during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/regeneron-pharmaceuticals-inc-loss-submission-form/?id=123059&from=4CLASS ...

Core Viewpoint - Regeneron Pharmaceuticals, Inc. is facing a securities fraud class action following a significant drop in its share price, which resulted in a loss of approximately $9 billion in market value due to alleged misleading statements regarding its EYLEA product [1][5]. Group 1: Legal Issues and Investigations - Hagens Berman has initiated an investigation into Regeneron for potentially misleading investors about its marketing and reimbursement practices related to EYLEA, urging affected investors to report their losses [2][6]. - The class action lawsuit focuses on Regeneron's compliance with regulations concerning Medicare reimbursement claims, particularly for EYLEA [3]. - The complaint alleges that Regeneron made false statements and failed to disclose various practices that misrepresented the pricing and sales of EYLEA, including undisclosed credit card fees that effectively lowered the selling price [4]. Group 2: Financial Impact and Company Performance - On October 31, 2024, Regeneron reported disappointing Q3 2024 financial results, with U.S. net sales for EYLEA and EYLEA HD products increasing only 3% year-over-year, attributed to lower net selling prices and pricing pressure in the anti-VEGF category [5]. - The announcement of these results led to a more than 9% decline in Regeneron's share price on the same day [5].

Core Viewpoint - A class action lawsuit has been filed against Regeneron Pharmaceuticals, Inc. for alleged misleading statements and failure to disclose critical information regarding its product Eylea during the Class Period from November 2, 2023, to October 30, 2024 [1][5]. Group 1: Lawsuit Details - The lawsuit claims that Regeneron made false statements and failed to disclose that it paid credit card fees to distributors to prevent them from charging Eylea customers more for credit card purchases [5]. - These undisclosed payments allegedly subsidized customer prices, leading to a price concession that lowered Eylea's selling price, which misled investors about the actual sales performance of Eylea [5]. - The lawsuit also alleges that Regeneron overstated the Average Sales Price (ASP) reported to federal agencies, violating the False Claims Act, and that positive statements about the company's business were materially misleading [5]. Group 2: Participation Information - Investors who purchased Regeneron securities during the Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - Interested parties can join the class action by visiting the provided link or contacting the law firm directly for more information [3][6].

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]