Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) Q2 2023 Earnings Conference Call August 3, 2023 8:30 AM ET Company Participants Ryan Crowe - Vice President, Investor Relations Leonard Schleifer - Board Co-Chair, Co-Founder, President and Chief Executive Officer George Yancopoulos - Board Co-Chair, Co-Founder, President and Chief Scientific Officer Marion McCourt - Executive Vice President and Head of Commercial Robert Landry - Executive Vice President and Chief Financial Officer Conference Call Participants Ev ...

Financial Performance - Revenues for Q2 2023 increased to $3,158.1 million, up 10.5% from $2,857.2 million in Q2 2022[104] - Net income for Q2 2023 rose to $968.4 million, a 13.6% increase from $852.1 million in Q2 2022[104] - Diluted net income per share for Q2 2023 was $8.50, up from $7.47 in Q2 2022[104] - Six-month revenues for 2023 reached $6,320.2 million, an 8.6% increase from $5,822.3 million in 2022[104] - Six-month net income for 2023 was $1,786.2 million, slightly down from $1,825.6 million in 2022[104] - Net income for Q2 2023 was $968.4 million, up 13.6% YoY from $852.1 million in Q2 2022[151] - Total revenues for Q2 2023 increased 10.5% YoY to $3,158.1 million, driven by higher collaboration revenue[153] - Net income per diluted share was $8.50 in Q2 2023, up from $7.47 in Q2 2022[151] - Total net product sales increased 1.0% YoY to $1,772.1 million in Q2 2023[153] - Total Roche collaboration revenue for the six months ended June 30, 2023 was $218.4 million, compared to $224.5 million in the same period in 2022[163] - Cash and cash equivalents decreased to $1,937.2 million as of June 30, 2023, from $3,105.9 million as of December 31, 2022[177] - Cash flows from operating activities were $2,390.0 million for the six months ended June 30, 2023, down from $2,666.1 million in the same period in 2022[178] - The company repurchased $1,416.7 million worth of common stock during the six months ended June 30, 2023, compared to $745.5 million in the same period in 2022[184] - As of June 30, 2023, $2.332 billion remained available for share repurchases under the authorized program[183] Product Sales - EYLEA U.S. net product sales for Q2 2023 were $1.5 billion, a decrease of 4% compared to the same period in 2022[113] - Dupixent global net product sales for Q2 2023 were $2.79 billion, a 33% increase compared to Q2 2022[113] - Libtayo global net product sales for Q2 2023 were $210 million, a 49% increase compared to Q2 2022[113] - Praluent global net product sales for Q2 2023 were $140.3 million, a 29% increase compared to Q2 2022[113] - REGEN-COV global net product sales for Q2 2023 were $0, a 100% decrease compared to Q2 2022[113] - Kevzara global net product sales for Q2 2023 were $99.5 million, a 21% increase compared to Q2 2022[113] - EYLEA U.S. net product sales decreased 7.5% YoY to $1,500.1 million in Q2 2023 due to increased competition[153][154] - Libtayo U.S. net product sales grew 43.2% YoY to $130.2 million in Q2 2023[153] - EYLEA net product sales outside the United States for the three months ended June 30, 2023 were $886.3 million, compared to $869.8 million in the same period in 2022[163] - Regeneron's share of profits from EYLEA sales outside the United States was $349.5 million for the three months ended June 30, 2023, representing 39% of net product sales[163] Product Approvals and Developments - EYLEA (aflibercept) Injection is approved for multiple eye diseases including wet AMD, DME, and RVO in the U.S., EU, Japan, and other territories[106] - Dupixent (dupilumab) Injection is approved for atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis across multiple regions[106] - Libtayo (cemiplimab) Injection is approved for NSCLC and cutaneous squamous cell carcinoma in the U.S. and EU[107] - Praluent (alirocumab) Injection is approved for LDL-lowering and cardiovascular risk reduction in the U.S. and EU[107] - Evkeeza (evinacumab) Injection is approved for HoFH in adults and adolescents in the U.S. and EU[107] - Dupixent received EC approval for atopic dermatitis in pediatrics (6 months–5 years of age) in 2023[118] - Dupixent Phase 3 trial in COPD met primary and key secondary endpoints, with results presented at the 2023 American Thoracic Society International Conference[118] - Aflibercept 8 mg BLA resubmitted for wet AMD, DME, and DR after FDA issued a Complete Response Letter due to unresolved observations at a third-party contract manufacturer[118] - Dupixent supplemental BLA filing acceptance and regulatory application submission in the EU for EoE in pediatrics expected in the second half of 2023[118] - Dupixent Phase 3 trial in chronic cold-induced urticaria did not meet efficacy endpoints, leading to discontinuation of further clinical development in allergic fungal rhinosinusitis and chronic rhinosinusitis without nasal polyposis[119] - Kevzara approved by FDA for PMR and submitted sBLA and regulatory application in the EU for pcJIA (second half 2023)[119] - Itepekimab Phase 3 COPD program passed interim futility analysis by IDMC, with results expected in 2025[119] - Libtayo approved by EC for first-line NSCLC in combination with chemotherapy[119] - Fianlimab presented positive Phase 1 trial data in advanced melanoma at ASCO 2023, with pivotal Phase 2 studies in melanoma and NSCLC planned for second half 2023[120] - Ubamatamab Phase 1/2 study results in platinum-resistant ovarian cancer expected in second half 2023[120] - Odronextamab Phase 3 studies in FL and DLBCL to initiate in second half 2023, with BLA filing acceptance expected in the same period[121] - Linvoseltamab pivotal study data in multiple myeloma to be presented in Q4 2023, with BLA submission planned for the same quarter[121] - Pozelimab FDA decision on BLA for CHAPLE expected by August 20, 2023[121] - ALN-APP reported positive interim data from Phase 1 trial in early-onset Alzheimer's disease[123] - FDA issued a CRL for aflibercept 8 mg BLA due to unresolved observations at a third-party manufacturing facility, with no issues identified in clinical efficacy, safety, or trial design[127] - 89% of aflibercept 8 mg patients maintained ≥12-week dosing intervals through two years, and 44% met criteria for ≥20-week dosing intervals by week 96[128] - Dupixent demonstrated a 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks in the BOREAS trial[130] - REGN5678 showed antitumor activity but enrollment for combination therapy with full-dose Libtayo was discontinued due to safety concerns[131] - ALN-APP Phase 1 study showed positive interim data in early-onset Alzheimer's disease, with Alnylam eligible for a $100 million milestone payment[133] Collaborations and Partnerships - Regeneron's contingent reimbursement obligation to Sanofi for development expenses was approximately $2.9 billion as of December 31, 2022[134] - Regeneron earned $50 million sales-based milestones from Sanofi in 2022 for antibody sales exceeding $2.0 billion and $2.5 billion outside the U.S.[135] - Regeneron made a $900 million upfront payment and a $100 million regulatory milestone payment to Sanofi for exclusive rights to Libtayo[137] - Regeneron and Bayer share development costs equally for EYLEA and aflibercept 8 mg outside the U.S., with Bayer responsible for commercialization[139] - Regeneron's ability to generate profits depends on the success of EYLEA, Dupixent, and aflibercept 8 mg commercialization, with substantial R&D and commercialization costs expected[146] - Sanofi collaboration revenue increased 39.3% YoY to $943.7 million in Q2 2023, driven by higher Dupixent profits[155][158] - Regeneron's share of Dupixent and Kevzara profits was 26% of net product sales in Q2 2023, up from 23% in Q2 2022[158] - Bayer collaboration revenue increased 5.4% YoY to $376.7 million in Q2 2023[160] - Acquired IPR&D for the six months ended June 30, 2023 included a $45.0 million up-front payment in connection with the collaboration agreement with Sonoma Biotherapeutics, Inc[170] Operating Expenses and Costs - Operating expenses rose 22.6% YoY to $2,141.6 million in Q2 2023[151] - Total research and development expenses for the six months ended June 30, 2023 were $2,186.5 million, an increase of $548.4 million compared to the same period in 2022[164] - Direct research and development expenses for Dupixent (dupilumab) were $99.3 million for the six months ended June 30, 2023, an increase of $27.1 million compared to the same period in 2022[167] - Clinical manufacturing costs for the six months ended June 30, 2023 were $524.1 million, an increase of $56.2 million compared to the same period in 2022[167] - Total operating expenses for the six months ended June 30, 2023 were $4,357.0 million, an increase of $903.1 million compared to the same period in 2022[164] - Selling, general, and administrative expenses increased to $73.3 million for the three months ended June 30, 2023, up from $57.5 million in the same period in 2022, primarily due to higher commercialization-related expenses and headcount costs[171] - Cost of collaboration and contract manufacturing increased for the three and six months ended June 30, 2023, driven by manufacturing costs for Dupixent and Praluent[172] - Capital expenditures for the six months ended June 30, 2023, included $60.0 million in grant proceeds related to facility expansions in New York[179] Other Financial Metrics - Unrealized losses on equity securities were $30.9 million for the three months ended June 30, 2023, compared to $163.7 million in the same period in 2022[174] - Interest income rose to $118.3 million for the three months ended June 30, 2023, up from $28.2 million in the same period in 2022[174] - The company's effective tax rate for the three months ended June 30, 2023, was 10.6%, down from 11.5% in the same period in 2022[175] - Stock-based compensation expense for the six months ended June 30, 2023 was $440.7 million, compared to $326.7 million in the same period in 2022[164] - Regeneron's headcount as of June 30, 2023 was 12,412, an increase of 1,473 compared to June 30, 2022[164]

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) Goldman Sachs 44th Annual Global Healthcare Conference June 14, 2023 11:40 AM ET Company Participants Ryan Crowe - VP, IR Bob Landry - EVP & CFO Marion McCourt - EVP & Head of Commercial Conference Call Participants Salveen Richter - Goldman Sachs Salveen Richter Great. Good morning, everyone. Thanks so much for joining us. I'm Salveen Richter, I cover biotechnology at Goldman Sachs and really pleased to have the team from Regeneron here with us. So we have, at ...

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Jefferies Global Healthcare Conference Call June 7, 2023 8:30 AM ET Company Participants Ryan Crowe - Vice President, Investor Relations Bolanle Akinlade - Senior Vice President, Clinical Development, Immunology & Inflammation Brook Jennings - Vice President, Commercial Dermatology Conference Call Participants Akash Tewari - Jefferies Akash Tewari Good morning, everyone. For those who just got back from ASCO, I feel sorry for you, I am exhausted as well. But thi ...

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) TD Cowen 4th Annual Oncology Innovation Summit May 30, 2023 12:30 PM ET Company Participants Izzy Lowy - SVP, Solid Organ Oncology Development Andres Sirulnik - SVP, Translational & Clinical Sciences, Hematology Ryan Crowe - VP, IR Conference Call Participants Tyler Van Buren - TD Cowen Tyler Van Buren All right. We'll give it a couple of seconds for everyone to join. Okay. So with that, welcome, everyone, again, to the TD Cowen's 4th Annual Oncology Innovation ...

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) 2023 RBC Capital Markets Global Healthcare Conference May 16, 2023 9:30 AM ET Company Participants Aris Baras – Senior Vice President, Regeneron Genetics Center Christos Kyratsous – Senior Vice President-Research Ryan Crowe – Vice President-Investor Relations Conference Call Participants Brian Abrahams – RBC Capital Markets Brian Abrahams Again for being here I'm Brian Abrahams, one of the senior biotech analysts here at RBC Capital Markets. Our next feature com ...

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Bank of America Global Healthcare Conference Call May 9, 2023 4:40 PM ET Company Participants Ryan Crowe - VP, IR Robert Landry - EVP, Finance & CFO Conference Call Participants Geoff Meacham - Bank of America Merrill Lynch Geoff Meacham Welcome to the afternoon of the first day of the BofA Healthcare Conference. So my name is Geoff Meacham. I'm the senior biopharma analyst. And we're excited here to have Regeneron. Bob Landry, CFO is with us, and Ryan's on Stag ...

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) Q1 2023 Results Conference Call May 4, 2023 8:30 AM ET Company Participants Ryan Crowe - Investor Relations Leonard Schleifer - Chief Executive Officer George Yancopoulos - Co-Founder, President and Chief Scientific Officer Marion McCourt - Executive Vice President and Head of Commercial Bob Landry - Chief Financial Officer Conference Call Participants Mohit Bansal - Wells Fargo Robyn Karnauskas - Truist Tyler Van Buren - Cowen Terence Flynn - Morgan Stanley Chri ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 000-19034 REGENERON PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) New York 13- ...

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Barclays Global Healthcare Conference March 15, 2023 9:00 AM ET Company Participants Ryan Crowe - Vice President of Investor Relations Robert Landry - Chief Financial Officer Conference Call Participants Carter Gould - Barclays Carter Gould [Technical difficulty] -- Barclays Global Healthcare Conference. My name is Carter Gould, senior biopharma analyst, here at Barclays. I am pleased to welcome Regeneron Pharmaceuticals to the stage to help us kickoff the day. ...