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].

Business Performance & Key Products - Dupixent's global net sales reached $3.8 billion in Q3 2024, representing a 23% year-over-year increase, annualizing to over $15 billion[8] - EYLEA HD and EYLEA U S net sales totaled approximately $6 billion in 2024, a 1% increase compared to the previous year[14] - EYLEA HD U S net sales in 2024 were $12 billion, comprising 20% of the total EYLEA and EYLEA HD net sales[17] - LIBTAYO's worldwide net sales reached $850 million through the first nine months of 2024, a 36% increase year-over-year[23] Pipeline & Clinical Development - Itepekimab Phase 2 trial data showed a 42% reduction in exacerbations in former smokers with COPD compared to placebo[38] - Fianlimab combined with LIBTAYO in first-line metastatic melanoma showed a 57% overall response rate (ORR) and a 25% complete response (CR) rate in pooled proof-of-concept cohorts[55] - In a Phase 3 trial for adjuvant CSCC, LIBTAYO demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo (HR: 032, p < 00001)[52] - In relapsed/refractory multiple myeloma, linvoseltamab showed a 71% overall response rate (ORR) and a 50% complete response (CR) rate[68] Strategic Outlook - Regeneron anticipates the therapeutic categories it is addressing to exceed an aggregate of $220 billion in 2030[4] - The company plans to resubmit the BLA for odronextamab in relapsed/refractory follicular lymphoma in Q1 2025[67] - FDA approval for linvoseltamab in relapsed/refractory multiple myeloma is anticipated by mid-2025[68]

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]

Clinical Trial Results - Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death in high-risk CSCC patients compared to placebo, meeting the primary endpoint of DFS at the first prespecified interim analysis [1][2] - The Phase 3 C-POST trial enrolled 415 patients with high-risk CSCC, randomized to receive Libtayo or placebo for up to 48 weeks, with a median follow-up duration of 24 months [2] - Libtayo is the first and only immunotherapy to show a statistically significant and clinically meaningful benefit in high-risk CSCC in the adjuvant setting, following a recent Phase 3 trial with Keytruda that failed in the same setting [1] Safety Profile - Adverse events of any grade occurred in 91% of patients in the Libtayo arm and 89% in the placebo arm, with Grade ≥3 AEs occurring in 24% and 14% of patients, respectively [3] - Treatment discontinuations due to adverse reactions occurred in 10% of patients in the Libtayo arm and 1.5% in the placebo arm, with two patients experiencing an AE leading to death in each arm [3] Regulatory and Market Impact - Libtayo is already the standard of care for certain patients with advanced CSCC and has been approved in more than 30 countries for various indications, including advanced BCC, CSCC, NSCLC, and cervical cancer [5][25] - The company plans to submit the trial results to the U.S. FDA in the first half of 2025, with detailed results to be presented at an upcoming medical meeting [20] Company Background and Technology - Regeneron's VelocImmune technology, which utilizes a genetically engineered mouse platform, was instrumental in developing Libtayo and other FDA-approved fully human monoclonal antibodies [26] - The company's oncology strategy includes a robust pipeline with nearly half of its assets in clinical development, focusing on checkpoint inhibitors, bispecific antibodies, and costimulatory bispecific antibodies [16] Trial Design and Methodology - The C-POST trial is a randomized, placebo-controlled, double-blind, multicenter Phase 3 study investigating Libtayo as adjuvant treatment for high-risk CSCC patients who have completed surgery and post-operative radiation therapy [22] - The trial design includes a primary endpoint of DFS and secondary endpoints such as freedom from locoregional recurrence, freedom from distant recurrence, overall survival, and cumulative incidence of second primary CSCC tumors [24]