Leonard Schleifer | $1B+
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Leonard S. Schleifer, M.D., Ph.D. is an American physician, neuroscientist, and biotechnology executive who co-founded Regeneron Pharmaceuticals, Inc. in 1988 and has served continuously as its president and chief executive officer.[1][2]
A licensed neurologist certified by the American Board of Psychiatry and Neurology, Schleifer earned a B.A. from Cornell University and both an M.D. and a Ph.D. in pharmacology from the University of Virginia before transitioning from academic neurology at Weill Cornell Medical College to entrepreneurship.[1][2] Under his leadership, Regeneron advanced genetic engineering and monoclonal antibody technologies to yield multiple FDA-approved therapies, including the vascular endothelial growth factor inhibitor Eylea for wet age-related macular degeneration and the interleukin-4 receptor antagonist Dupixent for severe atopic dermatitis and asthma, both achieving blockbuster status with annual sales exceeding $1 billion.[1][3]
Schleifer's strategic recruitment of co-founder George D. Yancopoulos, M.D., Ph.D., as chief scientific officer catalyzed Regeneron's focus on translating basic neuroscience into therapeutics, culminating in pioneering antibody cocktails like REGEN-COV for COVID-19 and treatments for Ebola.[1][4] The company's pipeline now encompasses over a dozen investigational candidates targeting oncology, immunology, and rare diseases, reflecting Schleifer's emphasis on rigorous scientific validation over short-term market pressures.[1] He also holds a clinical professorship in neurology and neuroscience at Weill Cornell and received the Biotechnology Heritage Award in 2025 for advancing biopharmaceutical innovation.[1][1]
Early life and education
Childhood and family background
Leonard Schleifer was born in 1953 in Queens, New York, to Florence and Charles Baker Schleifer.[5] His father, a sweater manufacturer who had attended Cornell University on a scholarship during the Depression era, aspired for his son to pursue a medical career.[3] The family was middle-class and Jewish, providing a stable environment in the borough's urban setting.[6] [5]
From a young age, Schleifer's parents and teachers nurtured his interests in science and entrepreneurship, fostering a foundation for his later pursuits.[1] During his youth, he took on part-time jobs such as shoveling snow, delivering prescription drugs, and bagging groceries, experiences that reflected the working-class aspects of his upbringing despite the family's relative stability.[7] These early influences shaped his practical approach to problem-solving and ambition in the sciences.[8]
Academic achievements and training
Schleifer earned a Bachelor of Science degree in biological sciences, with a concentration in neurobiology and behavior, from Cornell University in 1973, graduating summa cum laude and as a member of Phi Beta Kappa.[9][10] He attended Cornell on scholarship, reflecting early academic promise in the sciences.[8]
He then pursued combined MD-PhD training at the University of Virginia School of Medicine, earning both degrees with a PhD focused on pharmacology around 1980.[11][1] During this period, Schleifer trained under pharmacologist Alfred Gilman, who later received the Nobel Prize in Physiology or Medicine for work on G proteins and cellular signaling.[3]
Following his graduate training, Schleifer completed a residency in neurology at New York Hospital-Cornell Medical Center, where he became a licensed physician board-certified in neurology.[1] This clinical experience complemented his molecular biology interests, shaping his later focus on applying genetic and pharmacological insights to disease mechanisms.[1] Prior to college, Schleifer participated in the Westinghouse Science Talent Search as a high school student, an early indicator of his scientific aptitude.[6]
Founding and leadership of Regeneron Pharmaceuticals
Establishment and initial vision
Leonard Schleifer founded Regeneron Pharmaceuticals in 1988 after leaving his position as an assistant professor of neurology at Cornell University Medical College.[12] As a physician-scientist with training in pharmacology and an MD-PhD from the University of Virginia, Schleifer established the company in his New York City apartment, drawing on his academic background to pursue biotechnology ventures.[11] He co-founded the firm with George Yancopoulos, recruiting him for expertise in molecular biology to complement his own vision for translating scientific discovery into therapeutics.[1]
The initial vision centered on building a science-driven enterprise where rigorous research would accelerate the development of novel medicines, positioning scientists as central figures in operations rather than ancillary to business priorities.[6] Schleifer conceptualized Regeneron as akin to "Genentech for the nervous system," emphasizing regeneration of nerve cells and broader applications of innovative technologies to address unmet medical needs through empirical, first-principles approaches to drug discovery.[13] This foundation rejected conventional biotech models reliant on incremental tweaks, instead prioritizing proprietary platforms like genetic engineering to generate therapeutic antibodies and proteins systematically.[14]
Early efforts focused on mammalian cell-based production systems and trap proteins to inhibit disease pathways, reflecting Schleifer's commitment to causal mechanisms over symptomatic treatments.[12] By 1991, the company had secured initial funding and gone public, validating the vision amid a nascent biotech sector, though commercial success remained years away as research pipelines matured.[8] This patient, evidence-based strategy distinguished Regeneron from competitors chasing short-term gains, establishing a framework for long-term breakthroughs in immunology and oncology.[10]
Key strategic decisions and partnerships
One of Schleifer's earliest and most consequential strategic decisions was forging a global collaboration with Sanofi-aventis in November 2007 to discover, develop, and commercialize fully human therapeutic antibodies using Regeneron's VelocImmune technology. This agreement provided Regeneron with $85 million upfront, up to $475 million in research funding over five years (with an option for three more), and Sanofi's purchase of 12 million Regeneron shares, bolstering the company's finances during a period of high R&D burn. Profits were to be shared equally in the U.S. and 65-35% outside (favoring Sanofi), with Sanofi leading global commercialization; this partnership enabled Regeneron to scale its antibody platform without diluting internal control over core technologies.[15]
The Sanofi alliance expanded in November 2009, committing to advance four to five antibodies annually into clinical development and providing additional funding tied to milestones, further validating Schleifer's approach of licensing proprietary tools like VelocSuite for collaborative discovery while retaining manufacturing and certain rights. This model yielded key products like Dupixent (dupilumab), approved in 2017 for atopic dermatitis, with shared development costs and co-promotion. Complementing this, Regeneron partnered with Bayer HealthCare on aflibercept (EYLEA), a VEGF trap for retinal diseases, collaborating on global development since the early 2000s; Regeneron retained U.S. rights and co-promotion, while Bayer handled ex-U.S. markets, sharing costs and profits 50-50, which facilitated EYLEA's 2011 FDA approval and sustained revenue growth.[16][17]
Schleifer has pursued targeted expansions and adjustments to these partnerships to align with evolving priorities, such as the 2015 immuno-oncology agreement with Sanofi to develop combination therapies involving PD-1 inhibitors like cemiplimab (Libtayo). In a notable pivot toward independence, Regeneron acquired Sanofi's stake in Libtayo in June 2022 for a $900 million upfront payment plus royalties and milestones, securing full global rights to the asset after Phase 3 successes in skin and lung cancers. These decisions underscore Schleifer's emphasis on science-led R&D, using partnerships for risk-sharing and market access but repatriating control for high-value programs to maximize long-term value.[18][19]
Scientific and business achievements
Development of major therapeutics
Regeneron Pharmaceuticals, founded and led by Leonard Schleifer, achieved its first major therapeutic breakthrough with EYLEA (aflibercept), a recombinant fusion protein that inhibits vascular endothelial growth factor (VEGF) to treat neovascular age-related macular degeneration (wet AMD). Developed through a 2006 collaboration with Bayer HealthCare for global co-development and commercialization outside the U.S., EYLEA received FDA approval on November 18, 2011, based on Phase 3 trials demonstrating superior vision improvement compared to monthly ranibizumab injections.[20][21] Subsequent label expansions included diabetic macular edema in 2014 and macular edema following retinal vein occlusion in 2015, with U.S. net product sales reaching $5.6 billion in 2023, underscoring its role as a cornerstone of Regeneron's revenue.[22]
In partnership with Sanofi, Regeneron advanced Dupixent (dupilumab), a fully human monoclonal antibody generated via Schleifer's championed VelocImmune technology platform, which targets the IL-4 and IL-13 pathways in type 2 inflammation. The FDA approved Dupixent on March 28, 2017, for moderate-to-severe atopic dermatitis in adults whose condition was inadequately controlled by topical therapies, following pivotal Phase 3 SOLO trials showing significant skin clearance and itch reduction.[23] Expansions followed for asthma in 2018, chronic rhinosinusitis with nasal polyps in 2019, eosinophilic esophagitis in 2022, and prurigo nodularis in 2022, with global collaboration sales hitting $11.7 billion in 2023, driven by broad efficacy across allergic and inflammatory diseases.[24][25]
Praluent (alirocumab), another Sanofi-Regeneron collaboration leveraging VelocImmune to produce a PCSK9 inhibitor monoclonal antibody, gained FDA approval on July 24, 2015, as an adjunct to diet and statins for adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease requiring further LDL cholesterol reduction.[26] Phase 3 ODYSSEY trials supported approval by showing 50-60% LDL reductions, and a 2019 label update incorporated ODYSSEY OUTCOMES data demonstrating a 20% relative risk reduction in major adverse cardiovascular events.[27] Pediatric approval for homozygous familial hypercholesterolemia followed in 2021.
Libtayo (cemiplimab), Regeneron's internally developed PD-1 inhibitor antibody from the VelocImmune platform, received accelerated FDA approval on September 28, 2018, for metastatic or locally advanced cutaneous squamous cell carcinoma in patients ineligible for curative surgery or radiation, based on Phase 2 EMPOWER-CSCC-1 trial response rates exceeding 50%.[28] Further approvals included basal cell carcinoma in 2021 and non-small cell lung cancer in combination with chemotherapy in 2022, with ongoing adjuvant use approval in October 2025 for high-risk cutaneous squamous cell carcinoma following resection.[29]
Kevzara (sarilumab), co-developed with Sanofi as an IL-6 receptor antagonist monoclonal antibody, was approved by the FDA on May 22, 2017, for moderately to severely active rheumatoid arthritis in adults with inadequate response to one or more disease-modifying antirheumatic drugs, supported by Phase 3 MOBILITY and TARGET trials showing improved disease activity scores.[30] Emergency use authorization in 2021 for COVID-19 cytokine release syndrome was later withdrawn after trials showed limited benefit in hospitalized patients.[31]
Technological innovations and R&D breakthroughs
Under Schleifer's leadership, Regeneron developed the VelociSuite® of proprietary technologies, which revolutionized monoclonal antibody discovery by enabling rapid genetic engineering of mice and high-throughput screening.[32] This suite includes VelocImmune®, a platform using humanized mice to produce fully human antibodies, derived from foundational work on inserting human immunoglobulin genes into mouse genomes to bypass immunogenicity issues in traditional hybridoma methods.[32] VelociMouse® and VelociGene® further support this by allowing precise, large-scale DNA modifications in embryonic stem cells for accurate disease modeling, reducing development timelines from years to months and facilitating evaluation of hundreds of gene targets annually.[32] These tools, integrated into collaborations such as the 2007 partnership with sanofi-aventis, accelerated the pipeline for antibody-based therapeutics by addressing key bottlenecks in target validation and production scalability.
Complementing antibody platforms, Regeneron's Genetics Center (RGC) established a massive-scale exome sequencing effort, generating a database of nearly 3 million human exomes paired with deidentified health data to identify causal genetic variants driving disease.[33] This initiative yielded breakthroughs like the rare GPR75 variant associated with lower body mass index and reduced obesity risk in over 650,000 sequenced individuals, informing precision medicine targets.[34] Similarly, mutations in CIDEB were linked to a 53% reduced risk of non-alcoholic steatohepatitis (NASH), while HSD17B13 variants protect against chronic liver disease, spurring clinical programs such as ALN-HSD RNAi therapies.[34][35] By leveraging machine learning and proprietary analytics on this dataset, RGC validates therapeutic hypotheses from first principles, prioritizing variants with high causal confidence over correlative associations and enhancing R&D efficiency across modalities like antibodies and gene editing.[33]
These innovations collectively disrupted conventional R&D by integrating genetics-driven target selection with accelerated engineering platforms, enabling Regeneron to advance over a dozen approved biologics and maintain a robust investigational pipeline as of 2025.[36] The VelociSuite's bispecific extensions, such as Veloci-Bi®, further expanded capabilities for multifunctional antibodies with optimized pharmacokinetics, while genetic insights from RGC have de-risked programs in oncology, cardiometabolic, and rare diseases.[32] This approach, rooted in empirical variant-to-phenotype mapping and scalable mouse models, underscores a commitment to causal mechanisms over empirical screening alone.[37]
Company growth and financial milestones
Regeneron Pharmaceuticals, founded by Leonard Schleifer in 1988, initially focused on biotechnology research with limited commercial revenue, relying on venture funding and grants for early operations. The company achieved a key financial milestone with its initial public offering on April 2, 1991, raising $91.6 million on NASDAQ, which provided capital for expanded research and development infrastructure.[12][38] Strategic partnerships accelerated growth, notably the 2007 antibody discovery collaboration with Sanofi, expanded in 2009 amid hiring the 1,000th employee, enabling scalable platform technologies that underpinned later commercial successes.[12]
The 2011 U.S. approval and launch of Eylea (aflibercept) for wet age-related macular degeneration represented a pivotal revenue driver, transforming Regeneron from a research-focused entity to a commercial powerhouse, with Eylea generating over $6 billion in combined U.S. net sales alongside Eylea HD by 2024. Subsequent collaborations, including the 2015 immuno-oncology alliance with Sanofi, facilitated the development of Dupixent (dupilumab), whose global net sales—recorded by Sanofi—rose 22% to approximately $3.5 billion in the first half of 2025 alone, bolstering Regeneron's profit-sharing revenues. These therapeutics propelled annual revenues from under $1 billion pre-2011 to $14.20 billion in 2024, an 8% year-over-year increase driven primarily by collaboration and net product sales.[39]
To support expanding production demands, Regeneron invested heavily in manufacturing capacity, announcing a $1.8 billion expansion in Westchester County, New York, in 2021 to add research, preclinical manufacturing, and support facilities, creating 1,000 jobs with groundbreaking in June 2022. By April 2025, cumulative investments in New York and North Carolina infrastructure exceeded $7 billion, including a $3 billion capacity deal with FUJIFILM Diosynth Biotechnologies to enhance biologics output. These efforts coincided with robust financial metrics, including a market capitalization of approximately $61 billion as of October 2025 and initiation of a $0.88 quarterly dividend in 2024 alongside expanded share repurchases totaling $4.5 billion in capacity.[40][41][12][25][42]
Controversies and public debates
Drug pricing and industry critiques
Leonard Schleifer has critiqued arbitrary price increases in the pharmaceutical industry, labeling many such hikes as "ridiculous" during a December 2016 healthcare conference where he argued with executives from companies like Pfizer, asserting that pricing should reflect genuine value rather than unlinked annual adjustments.[43][44] He has emphasized value-based pricing models, pushing for reimbursements tied to patient outcomes, as seen in Regeneron's 2016 agreement with Cigna for its PCSK9 inhibitor Praluent, which linked payments to cholesterol reductions.[45] In response to a 2016 analysis by the Institute for Clinical and Economic Review deeming Praluent overpriced at its $14,600 annual list price, Schleifer dismissed the assessment as "unscientific," defending the drug's innovation in reducing cardiovascular risks despite high costs.[46]
Under Schleifer's leadership, Regeneron has faced allegations of manipulative pricing practices for Eylea (aflibercept), its top-selling drug for retinal diseases with U.S. sales exceeding $5.8 billion in 2023.[47] In April 2024, the U.S. Department of Justice filed a False Claims Act complaint accusing Regeneron of knowingly excluding over $400 million in credit card processing fee concessions from average sales price (ASP) reports to Medicare between 2010 and 2021, inflating reimbursements by an estimated $300 million to $500 million as physicians used company-subsidized cards to purchase doses.[48][49] Regeneron countered that its ASP calculations followed Centers for Medicare & Medicaid Services guidance, which did not require including such fees as price concessions, and denied any intent to defraud.[47]
Similar claims emerged in state-level actions; in August 2024, attorneys general from Washington, Michigan, and others sued Regeneron for allegedly inflating Medicaid reimbursement rates for Eylea by omitting the same credit card fee rebates, potentially overcharging state programs by tens of millions.[50][51] These cases highlight broader industry tensions over opaque rebate structures and ASP reporting, which critics argue distort public payer costs for high-volume biologics like Eylea, priced at approximately $1,850 per intravitreal injection.[52]
Despite his criticisms of systemic pricing flaws—such as high co-pays burdening patients—Schleifer has maintained that Regeneron's approach prioritizes innovation funding over cost-cutting, as articulated in a 2018 analysis of U.S. pricing dynamics where he called for "responsible pricing" without endorsing broad price controls.[53][54]
Regulatory and legal challenges
In August 2025, the U.S. Food and Drug Administration (FDA) issued a second Complete Response Letter (CRL) for Regeneron's bispecific antibody odronextamab, intended for treating certain blood cancers, citing unresolved chemistry, manufacturing, and controls (CMC) deficiencies at a third-party manufacturing facility operated by Novo Nordisk in Indiana.[55][56] This followed an initial CRL in 2024 for similar issues, highlighting ongoing reliance on external manufacturers prone to inspection failures. The FDA's October 2025 classification of the Novo facility as "Official Action Indicated" (OAI)—its most severe compliance rating—stemmed from Form 483 observations of contamination risks, pest infestations, and equipment breakdowns during a July 2025 inspection, further complicating Regeneron's supply chain for biologics.[57][58]
Separate regulatory delays affected Eylea HD (aflibercept injection 8 mg), Regeneron's leading ophthalmology product. In August 2025, the FDA extended review timelines for two supplemental Biologics License Applications seeking expanded dosing intervals, invoking its discretion after a third-party inspection revealed major amendments needed post-inspection of the same Novo site.[59][60] These setbacks underscore vulnerabilities in Regeneron's outsourced manufacturing strategy, despite internal expansions aimed at mitigation.[61]
On the legal front, Regeneron faced a significant U.S. Department of Justice (DOJ) enforcement action under the False Claims Act (FCA), alleging violations of the Anti-Kickback Statute (AKS) through copay assistance programs for Eylea. Filed in 2020 and intervening in a whistleblower suit, the government claimed Regeneron funneled millions via charitable foundations from 2014 to 2017 to subsidize patient copays, inducing prescriptions and generating false Medicare claims; a separate April 2024 complaint accused fraudulent average sales price reporting to inflate reimbursements.[62][63] In February 2025, the First Circuit Court of Appeals ruled that FCA liability requires proving AKS violations were the "but-for" cause of submitted claims, adopting a stricter causation standard that bolstered Regeneron's defense and deepened a circuit split potentially headed to the Supreme Court.[64][65]
A securities class action lawsuit, consolidated in July 2025 as Radtke v. Regeneron Pharmaceuticals, Inc., accused the company of misleading investors on Eylea demand, price concessions, and credit card fee impacts from 2023 to 2024, with disclosures in October 2024 revealing weaker sales growth.[66][67] The suit, covering purchases through Q3 2024 results, seeks lead plaintiff status with a March 2025 deadline and remains ongoing in the U.S. District Court for the Southern District of New York.[68]
Earlier, in January 2017, a federal judge in Delaware ruled against Regeneron and partner Sanofi in a patent infringement suit brought by Amgen over PCSK9 inhibitor Praluent, finding willful infringement on two antibodies and permanently enjoining U.S. sales within 30 days—a decision that dropped Regeneron's stock 5% and reduced founder Leonard Schleifer's net worth by hundreds of millions overnight.[69][70] The Federal Circuit granted a stay pending appeal, allowing continued sales, and subsequent litigation shifted to antitrust claims where Regeneron prevailed in 2025, securing $407 million in damages against Amgen's bundling tactics.[71][72]
Political affiliations and donations
Leonard Schleifer has made substantial political donations predominantly to Democratic candidates and committees, with no recorded contributions to Republicans in available federal election records.[73][74]
In the 2016 election cycle, he contributed $2,700 to Hillary Clinton's presidential campaign.[73]
During the 2018 midterm elections, Schleifer donated between $120,000 and $126,500 exclusively to Democratic recipients, bucking the trend among many pharmaceutical CEOs who favored Republicans that cycle.[75][74]
This pattern aligned with a broader 2020 shift in biopharma executive giving toward Democrats, including support for Joe Biden's presidential bid amid industry contributions totaling millions to Democratic causes, though Schleifer's specific 2020 amounts remain less detailed in public disclosures.[76][77]
As recently as October 29, 2024, he gave $8,700 to the Democratic Senatorial Campaign Committee.[78]
Schleifer holds membership in Trump National Golf Club Westchester but has not publicly endorsed Republican figures or policies, with his giving reflecting consistent Democratic support despite Regeneron's interactions with the Trump administration, such as providing experimental COVID-19 treatment to President Trump in October 2020.[79][80]
Personal life and legacy
Family and residences
Schleifer has been married to Harriet Schleifer (née Partel), whom he first met in junior high school, since December 24, 1974.[81][82] The couple has two sons, Adam and David; their younger son David was diagnosed with a rare genetic disorder known as transketolase (TKT) deficiency, which prompted the family to fund research and awareness initiatives, including a program at Yale University focused on the condition, which appears disproportionately common among Ashkenazi Jews.[83][5]
Schleifer primarily resides in Tarrytown, New York, near the headquarters of Regeneron Pharmaceuticals in Westchester County.[8] The family has supported community programs in the area, such as residential services for individuals with developmental disabilities through the Chapel Haven Schleifer Center.[84]
Wealth accumulation and philanthropy
Schleifer's wealth primarily derives from his equity stake in Regeneron Pharmaceuticals, which he co-founded in 1988 with an initial investment of $1 million and took public via an initial public offering in 1991.[8][85] As of October 2025, he owns approximately 2% of the company's common stock, with his net worth estimated at $2.2 billion, largely driven by the commercial success of Regeneron's therapeutics such as Eylea, an anti-VEGF treatment for macular degeneration approved in 2011.[8][8] Regeneron's market capitalization has grown substantially, from modest early funding rounds to over $100 billion by 2025, reflecting breakthroughs in monoclonal antibodies and genetic engineering that boosted stock value and Schleifer's holdings.[1] He receives annual compensation as CEO, totaling $6.8 million for fiscal year 2024, including salary, bonus, and stock awards, though this forms a minor portion of his fortune compared to unrealized equity gains.[86]
Schleifer has periodically sold Regeneron shares to realize gains, such as over $798,000 from transactions in June 2024, reducing his direct holdings while maintaining significant indirect ownership through trusts.[87] These sales, reported via SEC Form 4 filings, align with standard executive liquidity practices amid the company's volatility tied to drug approvals and patent expirations, yet his stake has appreciated amid Regeneron's revenue exceeding $13 billion in 2024 from products like Dupixent collaborations.[88] His fortune has fluctuated with market conditions, dipping from peaks above $3.5 billion in prior years due to competitive pressures in biologics.[5]
In philanthropy, Schleifer established the Schleifer Family Foundation, a private entity with assets of about $13.7 million focused on arts, education, and human services primarily in New York.[89] The foundation granted over $1.2 million to Cornell University in 2024 for general charitable purposes, reflecting his undergraduate alma mater ties, alongside cash donations and support for local initiatives.[89] In 2025, Schleifer and co-founder George Yancopoulos backed Regeneron's $200 million donation-matching program for the Good Days Retinal Fund, aimed at aiding patients with retinal diseases in affording medications like Eylea, though this initiative operates through corporate channels rather than personal outlays.[90] His giving remains selective and lower-profile relative to his wealth, emphasizing science-adjacent causes without large-scale public endowments documented to date.
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