Regeneron(US:REGN)2023-08-02 16:00Financial 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]