Polyarticular Juvenile Idiopathic Arthritis

Adalimumab-aaty was first approved by the Food and Drug Administration on May 23, 2023 and became commercially available among key distributors across the U.S. on July 2, 2023 Adalimumab-aaty's inclusion creates greater accessibility to treatments for Americans with inflammatory conditions JERSEY CITY, N.J., Aug. 12, 2024 /PRNewswire/ -- Celltrion USA, Inc., (Celltrion USA) today announced its FDA-approved biosimilar adalimumab-aaty, has been added to the Costco member prescription program. Adalimumab-aaty is a high-concentration (100mg/mL) and citrate-free biosimilar to Humira® (adalimumab). Adalimumab-aaty is approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, and Hidradenitis Suppurativa.[1] The treatment has been available in the U.S. from Costco Specialty Pharmacy on October 1, 2023 for self-funded employer plans and will now be available for all Costco members through the Costco Member Prescription Program. "We are pleased to partner with Costco, the largest warehouse club and third-largest retailer in America," said Francine Galante, Vice President of Market Access at Celltrion USA. "We are committed to increasing patient choice through access to biosimilars. The inclusion of adalimumab-aaty to the Costco Member Prescription Program will expand patients' treatment options and help reduce healthcare costs." More than 80% of patients treated with Humira in the U.S. utilize a high-concentration and citrate-free formulation. Adalimumab-aaty provides additional benefits of administration via a latex-free device and a longer shelf life due to its ability to maintain a stability at 77°F for 31 days. The Costco Member Prescription Program is a prescription drug discount card program that provides eligible Costco members and their eligible dependents the ability to obtain lower prices on adalimumab-aaty and other participating drugs at participating pharmacies. Costco members who are uninsured and want to pay cash for their adalimumab-aaty prescription, or who have been denied coverage by their insurer, may use this program to fill their adalimumab-aaty prescriptions at a substantial savings. The pricing available through the discount card applies at Costco Specialty Pharmacies. "Celltrion is well positioned for continued growth in the U.S. market, which will increase competition and, ultimately, access to high-quality biosimilars and biologic products at a reduced cost," said Tom Nusbickel, Chief Commercial Officer at Celltrion USA. "To further enhance patient access, we are increasing our manufacturing capacity and strengthening our supply chain resilience to ensure delivery of patient treatment." IMPORTANT SAFETY INFORMATION[1] This important safety information also applies to YUFLYMA® (adalimumab-aaty) SERIOUS INFECTIONS Patients treated with adalimumab-aaty are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before adalimumab-aaty use and during therapy. Initiate treatment for latent TB prior to adalimumab-aaty use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with adalimumab-aaty prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aaty, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Treatment with adalimumab-aaty should not be initiated in patients with an active infection, including localized infections. Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with adalimumab-aaty, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy. Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of adalimumab-aaty with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of adalimumab-aaty and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of adalimumab-aaty with other biologic DMARDs (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to the use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of TNF blocker treatment including adalimumab-aaty prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy. In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients. Non-melanoma skin cancer (NMSC) was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS and HS, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of NMSC prior to and during treatment with adalimumab-aaty. In clinical trials of some adalimumab products, there was an approximately threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to severalfold) than the general population for the development of lymphoma, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with the use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of adalimumab-aaty and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including adalimumab-aaty, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, stop adalimumab-aaty and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of adalimumab-aaty therapy in this situation and monitor patients closely. NEUROLOGIC REACTIONS Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Exercise caution in considering the use of adalimumab-aaty in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of adalimumab-aaty should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONS Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents. Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products. Consider discontinuation of adalimumab-aaty therapy in patients with confirmed significant hematologic abnormalities. HEART FAILURE Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products. Exercise caution when using adalimumab-aaty in patients who have heart failure and monitor them carefully. AUTOIMMUNITY Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with adalimumab-aaty, discontinue treatment. IMMUNIZATIONS Patients on adalimumab-aaty may receive concurrent vaccinations, except for live vaccines. It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating adalimumab-aaty therapy. No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. INDICATIONS Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS Crohn's Disease (CD): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Hidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativa Please see full Prescribing Information including Boxed Warning for adalimumab-aaty Notes to Editors: About a dalimumab-aaty[ 1] Adalimumab-aaty is an unbranded version of YUFLYMA® (CT-P17, biosimilar adalimumab). YUFLYMA is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is FDA-approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis and Hidradenitis Suppurativa. Following the launch of 40mg/0.4mL in July 2023 and 80mg/0.8mL in December 2023, additional dosage form of 20mg/0.2mL was launched in the U.S. in March 2024. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: INFLECTRA ® (infliximab-dyyb), TRUXIMA ® (rituximab-abbs), HERZUMA ® (trastuzumab-pkrb), VEGZELMA ® (bevacizumab-adcd) and YUFLYMA®(adalimumab-aaty) as well as a new biologic ZYMFENTRA™. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit: FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws. These statements may be identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing, "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements. Such Risks and uncertainties may include, among other things, uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain, manufacturing, research and development, and the possibility of unfavorable new clinical data and further analyses of existing clinical data as it relates to Celltrion products; intellectual property and/or litigation/settlement implications; decisions by the FDA impacting labeling, manufacturing processes, safety, promotion, and/or other matters that could affect the availability or commercial potential of Celltrion products; and uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to competitive products; and competitive developments. A further description of risks and uncertainties can be found in Celltrion's Annual Report. Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. Trademarks Humira is a registered trademark of AbbVie. YUFLYMA® is a registered trademark of Celltrion, Inc., used under license. References For further information please contact: Samantha Cranko [email protected] +1 917-453-0346 SOURCE Celltrion USA

Second quarter 2024 revenues increased 12% to $3.55 billion versus second quarter 2023Second quarter 2024 Dupixent® global net sales (recorded by Sanofi) increased 27% to $3.56 billion versus second quarter 2023Second quarter 2024 U.S. net sales for EYLEA® HD and EYLEA® increased 2% to $1.53 billion versus second quarter 2023, including $304 million from EYLEA HDSecond quarter 2024 Libtayo® global net sales increased 42% to $297 million versus second quarter 2023Second quarter 2024 GAAP diluted EPS increased 46% to $12.41 and non-GAAP diluted EPS(a) increased 13% to $11.56 versus second quarter 2023; second quarter 2024 includes unfavorable $0.18 impact from acquired IPR&D chargeEuropean Commission approved Dupixent as first-ever biologic therapy for uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils TARRYTOWN, N.Y., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the second quarter of 2024 and provided a business update. "Regeneron had a strong quarter, with total revenue up 12% driven by notable growth for EYLEA HD, Dupixent, and Libtayo," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "Importantly, Dupixent was granted its first regulatory approval for COPD by the European Commission, with FDA action anticipated in the third quarter, presenting an opportunity to help even more patients around the globe. As always, we remain focused on driving forward our diverse clinical pipeline, progressing late-stage trials for Dupixent in chronic spontaneous urticaria and other dermatologic indications; itepekimab, our IL-33 antibody in COPD; fianlimab, our LAG-3 antibody in metastatic melanoma; and Libtayo in adjuvant cutaneous squamous cell carcinoma. Finally, we were excited to advance several promising earlier-stage programs, including various antibody and GLP-1 combinations for obesity and our gene therapy DB-OTO for genetic hearing loss." Financial Highlights ($ in millions, except per share data) Q2 2024 Q2 2023 % ChangeTotal revenues $3,547 $3,158 12%GAAP net income $1,432 $968 48%GAAP net income per share - diluted $12.41 $8.50 46%Non-GAAP net income(a) $1,351 $1,182 14%Non-GAAP net income per share - diluted(a) $11.56 $10.24 13% "Our second quarter financial performance reflects continued strong momentum across our business, highlighted by double-digit revenue and earnings growth," said Christopher Fenimore, Senior Vice President, Finance and Chief Financial Officer of Regeneron. "In the second half of the year, we look forward to advancing our pipeline with several important clinical data readouts as well as continued commercial execution and prudent capital deployment to drive long-term value creation." Business Highlights Key Pipeline ProgressRegeneron has over 35 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: EYLEA HD (aflibercept) 8 mg In June 2024, a supplemental Biologics License Application (sBLA) with two-year data for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) was submitted to the U.S. Food and Drug Administration (FDA). Dupixent (dupilumab) In May 2024, after requesting additional efficacy analyses, the FDA extended by three months the target action date of its priority review of the sBLA for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD, with a revised target action date of September 27, 2024. Regeneron and Sanofi remain confident that the additional analyses strongly support the approval of Dupixent in COPD with evidence of type 2 inflammation, and are committed to working with the FDA to bring Dupixent to patients living with uncontrolled COPD as quickly as possible.In June 2024, the European Commission (EC) approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by raised blood eosinophils. The EC is the first regulatory authority in the world to have approved Dupixent for COPD patients. Additional submissions are under review with other regulatory authorities outside the United States, including in China and Japan.The Company and Sanofi presented at the 2024 American Thoracic Society International Conference positive data from the NOTUS Phase 3 trial evaluating Dupixent as an add-on maintenance treatment in adults with uncontrolled COPD on maximal standard-of-care inhaled therapy (nearly all on triple therapy) and evidence of type 2 inflammation. The NOTUS trial confirmed the positive results demonstrated in the Phase 3 BOREAS trial. The data from the NOTUS trial were also published in the New England Journal of Medicine (NEJM).The FDA accepted for priority review the sBLA for Dupixent as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP), with a target action date of September 15, 2024.The NEJM published results from a positive Phase 3 trial for Dupixent in children aged 1 to 11 years with eosinophilic esophagitis (EoE). The trial showed a greater proportion of those receiving weight-tiered higher dose Dupixent experienced significant improvements in many key disease measures of EoE, compared to placebo at week 16. Oncology Programs The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending conditional marketing authorization of odronextamab, a bispecific antibody targeting CD20 and CD3, to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. The EC is expected to announce a final decision in the coming months.In June 2024, the 14-month median follow-up data from the pivotal Phase 1/2 trial of linvoseltamab, a bispecific antibody targeting BCMA and CD3, in patients with R/R multiple myeloma were presented at the European Hematology Association (EHA) Congress 2024 and published in the Journal of Clinical Oncology. These longer-term results show a deepening of responses following the 11-month median follow-up data previously presented in April 2024.A Phase 2 study for fianlimab, an antibody to LAG-3, in combination with Libtayo (cemiplimab) for perioperative non-small cell lung cancer (NSCLC) was initiated. A Phase 2/3 study for fianlimab, in combination with Libtayo, for perioperative melanoma was also initiated.The Company announced positive updated results from an ongoing Phase 1/2 trial evaluating REGN7075, a costimulatory bispecific antibody targeting EGFR and CD28, in combination with Libtayo in patients with advanced solid tumors. Data from the dose-escalation portion of the trial showed the investigational combination led to anti-tumor responses in certain patients with microsatellite stable colorectal cancer. The results were shared during an oral presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting. Other Programs In June 2024, the FDA approved Kevzara® (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA), a form of arthritis that impacts multiple joints at a time.A Phase 2 study in obesity was initiated for trevogrumab, an antibody to myostatin (GDF8), in combination with semaglutide with and without garetosmab, an antibody to Activin A.A Phase 2 study for REGN7508, an antibody to Factor XI, was initiated in patients with thrombosis.The Company presented updated data from the Phase 1/2 trial of DB-OTO, an AAV-based gene therapy, at the American Society of Gene and Cell Therapy (ASGCT) annual conference and announced that DB-OTO improved hearing to normal levels in one child and that initial hearing improvements were observed in a second child. In addition, the FDA recently granted DB-OTO Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of congenital auditory neuropathy secondary to biallelic mutations of the otoferlin gene. Second Quarter 2024 Financial ResultsRevenues($ in millions) Q2 2024 Q2 2023 % ChangeNet product sales: EYLEA HD - U.S. $304 $— * EYLEA - U.S. 1,231 1,500 (18%)Total EYLEA HD and EYLEA - U.S. 1,535 1,500 2%Libtayo - Global 297 210 41%Praluent - U.S. 56 41 37%Evkeeza®- U.S. 31 19 63%Inmazeb®- Global — 2 (100%)Total net product sales 1,919 1,772 8% Collaboration revenue: Sanofi 1,146 944 21%Bayer 375 377 (1%)Other 3 (4) * Other revenue 104 69 51%Total revenues $3,547 $3,158 12% * Percentage not meaningful Total EYLEA HD and EYLEA net product sales in the U.S. increased 2% in the second quarter of 2024 compared to the second quarter of 2023. EYLEA HD was approved by the FDA in August 2023 and EYLEA HD net product sales in the second quarter of 2024 were driven by the transition of patients from other anti-VEGF products, including EYLEA, to EYLEA HD, as well as new patients naïve to anti-VEGF therapy. Net product sales of EYLEA decreased in the second quarter of 2024, compared to the second quarter of 2023, primarily due to (i) the aforementioned approval and transition of certain patients to EYLEA HD, and (ii) other market dynamics that resulted in lower volumes and a lower net selling price. Sanofi collaboration revenue increased in the second quarter of 2024, compared to the second quarter of 2023, due to the Company's share of profits from commercialization of antibodies, which were $988 million in the second quarter of 2024, compared to $751 million in the second quarter of 2023. The change in the Company's share of profits from commercialization of antibodies was driven by higher profits associated with an increase in Dupixent sales. Refer to Table 4 for a summary of collaboration revenue. Operating Expenses GAAP % Change Non-GAAP(a) % Change($ in millions) Q2 2024 Q2 2023 Q2 2024 Q2 2023 Research and development (R&D) $1,200 $1,085 11% $1,072 $974 10%Acquired in-process research and development (IPR&D) $24 $— ** * * n/a Selling, general, and administrative (SG&A) $759 $652 16% $667 $562 19%Cost of goods sold (COGS) $258 $192 34% $214 $163 31%Cost of collaboration and contract manufacturing (COCM) $222 $213 4% * * n/a Other operating expense (income), net $15 $(1) ** $— * ** * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded.** Percentage not meaningful GAAP and non-GAAP R&D expenses increased in the second quarter of 2024, compared to the second quarter of 2023, driven by the advancement of the Company's late-stage oncology programs, and higher headcount and headcount-related costs.Acquired IPR&D for the second quarter of 2024 included up-front payments, as well as a premium on equity securities purchased, in connection with collaboration and licensing agreements.GAAP and non-GAAP SG&A expenses increased in the second quarter of 2024, compared to the second quarter of 2023, due to higher commercialization-related expenses to support the Company's launch of EYLEA HD and higher headcount and headcount-related costs partly related to the Company's international commercial expansion.GAAP and non-GAAP COGS increased in the second quarter of 2024, compared to the second quarter of 2023, primarily due to higher start-up costs for the Company's Rensselaer, New York fill/finish facility.GAAP other operating expense (income), net, for the second quarter of 2024 reflects a charge related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with the Company's 2023 acquisition of Decibel Therapeutics, Inc. Other Financial Information GAAP other income (expense) included the recognition of net unrealized gains on equity securities of $393 million in the second quarter of 2024, compared to $31 million of net unrealized losses in the second quarter of 2023. GAAP and Non-GAAP other income (expense) also included interest income of $179 million in the second quarter of 2024, compared to $118 million in the second quarter of 2023. In the second quarter of 2024, the Company's GAAP effective tax rate (ETR) was 12.0%, compared to 10.6% in the second quarter of 2023. The GAAP ETR increased in the second quarter of 2024, compared to the second quarter of 2023, due to the remeasurement of existing uncertain tax positions, offset by a higher benefit from stock-based compensation. In the second quarter of 2024, the non-GAAP ETR was 10.8%, compared to 12.2% in the second quarter of 2023. GAAP net income per diluted share was $12.41 in the second quarter of 2024, compared to $8.50 in the second quarter of 2023. Non-GAAP net income per diluted share was $11.56 in the second quarter of 2024, compared to $10.24 in the second quarter of 2023. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. In April 2024, the Company's board of directors authorized a new share repurchase program to repurchase up to an additional $3.0 billion of the Company's common stock. During the second quarter of 2024, the Company repurchased shares of its common stock and recorded the cost of the shares, or $601 million, as Treasury Stock. As of June 30, 2024, an aggregate of $3.6 billion remained available for share repurchases under the Company's share repurchase programs. 2024 Financial Guidance(c) The Company's full year 2024 financial guidance consists of the following components: 2024 Guidance Prior UpdatedGAAP R&D $4.920–$5.170 billion $5.020–$5.170 billionNon-GAAP R&D(a) $4.400–$4.600 billion $4.500–$4.600 billionGAAP SG&A $2.940–$3.090 billion $2.920–$3.060 billionNon-GAAP SG&A(a) $2.550–$2.650 billion UnchangedGAAP gross margin on net product sales(d) 86%–88% Approximately 86%Non-GAAP gross margin on net product sales(a)(d) 89%–91% Approximately 89%COCM(e)* $850–$910 million UnchangedCapital expenditures* $780–$880 million $750–$820 millionGAAP effective tax rate 7%–9% 8%–9%Non-GAAP effective tax rate(a) 10%–12% 10%–11% * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded. A reconciliation of full year 2024 GAAP to non-GAAP financial guidance is included below: Projected Range($ in millions) Low HighGAAP R&D $5,020 $5,170 Stock-based compensation expense 510 540 Acquisition and integration costs 10 30 Non-GAAP R&D $4,500 $4,600 GAAP SG&A $2,920 $3,060 Stock-based compensation expense 330 350 Acquisition and integration costs 40 60 Non-GAAP SG&A $2,550 $2,650 GAAP gross margin on net product sales Approximately 86% Approximately 86%Stock-based compensation expense 1% 1%Intangible asset amortization expense 1% 1%Acquisition and integration costs <1$ <1%Non-GAAP gross margin on net product sales Approximately 89% Approximately 89% GAAP ETR 8% 9%Income tax effect of GAAP to non-GAAP reconciling items 2% 2%Non-GAAP ETR 10% 11% (a)This press release uses non-GAAP R&D, non-GAAP SG&A, non-GAAP COGS, non-GAAP gross margin on net product sales, non-GAAP other operating (income) expense, net, non-GAAP other income (expense), net, non-GAAP ETR, non-GAAP net income, non-GAAP net income per share, total revenues excluding Ronapreve™(b), and free cash flow, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP). These non-GAAP financial measures are computed by excluding certain non-cash and/or other items from the related GAAP financial measure. The Company also includes a non-GAAP adjustment for the estimated income tax effect of reconciling items. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release.The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company's control (such as the Company's stock price on the dates share-based grants are issued or changes in the fair value of the Company's investments in equity securities) or items that are not associated with normal, recurring operations (such as acquisition and integration costs). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. With respect to free cash flows, the Company believes that this non-GAAP measure provides a further measure of the Company's ability to generate cash flows from its operations. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company's core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by the Company should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. (b)The casirivimab and imdevimab antibody cocktail for COVID-19 is known as REGEN-COV in the United States and Ronapreve in other countries. Roche records net product sales of Ronapreve outside the United States. (c)The Company's 2024 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release. (d)Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company. Gross profit is calculated as net product sales less cost of goods sold. (e)Corresponding reimbursements from collaborators and others for manufacturing of commercial supplies is recorded within revenues. Conference Call Information Regeneron will host a conference call and simultaneous webcast to discuss its second quarter 2024 financial and operating results on Thursday, August 1, 2024, at 8:30 AM Eastern Time. Participants may access the conference call live via webcast, or register in advance and participate via telephone, on the "Investors and Media" page of Regeneron's website at www.regeneron.com. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 30 days. About Regeneron Pharmaceuticals, Inc. Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in Regeneron's laboratories. Regeneron's medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using its proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. Regeneron is shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling Regeneron to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook, or X. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation EYLEA® HD (aflibercept) Injection 8 mg, EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), Libtayo® (cemiplimab), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab), Veopoz® (pozelimab), odronextamab, itepekimab, fianlimab, garetosmab, linvoseltamab, REGN5713-5714-5715, NTLA-2001, Regeneron's other oncology programs (including its costimulatory bispecific portfolio), Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs; the likelihood and timing of achieving any of the anticipated milestones described in this press release; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron's Product Candidates in clinical trials; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including those listed above and/or otherwise discussed in this press release; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron's Product Candidates; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance, including GAAP and non-GAAP R&D, GAAP and non-GAAP SG&A, GAAP and non-GAAP gross margin on net product sales, COCM, capital expenditures, and GAAP and non-GAAP ETR; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year ended December 31, 2023 and its Form 10-Q for the quarterly period ended June 30, 2024. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Non-GAAP Financial Measures This press release and/or the financial results attached to this press release include amounts that are considered "non-GAAP financial measures" under SEC rules. As required, Regeneron has provided reconciliations of such non-GAAP financial measures. Contact Information: Ryan Crowe Christina ChanInvestor Relations Corporate Affairs914-847-8790 914-847-8827ryan.crowe@regeneron.com christina.chan@regeneron.com TABLE 1 REGENERON PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)(In millions) June 30, December 31, 2024 2023Assets: Cash and marketable securities $17,531.4 $16,241.3Accounts receivable, net 5,717.1 5,667.3Inventories 2,873.6 2,580.5Property, plant, and equipment, net 4,305.9 4,146.4Intangible assets, net 1,102.2 1,038.6Deferred tax assets 2,880.9 2,575.4Other assets 1,675.7 830.7Total assets $36,086.8 $33,080.2 Liabilities and stockholders' equity: Accounts payable, accrued expenses, and other liabilities $4,385.8 $3,818.6Finance lease liabilities 720.0 720.0Deferred revenue 791.6 585.6Long-term debt 1,983.6 1,982.9Stockholders' equity 28,205.8 25,973.1Total liabilities and stockholders' equity $36,086.8 $33,080.2 TABLE 2 REGENERON PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)(In millions, except per share data) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 Revenues: Net product sales $1,918.6 $1,772.1 $3,679.9 $3,440.1 Collaboration revenue 1,524.0 1,316.7 2,790.8 2,694.8 Other revenue 104.5 69.3 221.4 185.3 3,547.1 3,158.1 6,692.1 6,320.2 Expenses: Research and development 1,200.0 1,085.3 2,448.4 2,186.5 Acquired in-process research and development 23.9 — 31.0 56.1 Selling, general, and administrative 758.8 652.0 1,447.8 1,253.1 Cost of goods sold 257.8 192.4 498.2 400.8 Cost of collaboration and contract manufacturing 222.4 212.5 415.8 461.6 Other operating expense (income), net 14.6 (0.6) 29.9 (1.1) 2,477.5 2,141.6 4,871.1 4,357.0 Income from operations 1,069.6 1,016.5 1,821.0 1,963.2 Other income (expense): Other income (expense), net 573.3 85.3 538.7 14.6 Interest expense (14.8) (18.9) (30.9) (36.9) 558.5 66.4 507.8 (22.3) Income before income taxes 1,628.1 1,082.9 2,328.8 1,940.9 Income tax expense 195.8 114.5 174.5 154.7 Net income $1,432.3 $968.4 $2,154.3 $1,786.2 Net income per share - basic $13.25 $9.05 $19.95 $16.69 Net income per share - diluted $12.41 $8.50 $18.68 $15.68 Weighted average shares outstanding - basic 108.1 107.0 108.0 107.0 Weighted average shares outstanding - diluted 115.4 113.9 115.3 113.9 TABLE 3 REGENERON PHARMACEUTICALS, INC.RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)(In millions, except per share data) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 GAAP R&D $1,200.0 $1,085.3 $2,448.4 $2,186.5 Stock-based compensation expense 122.4 109.1 245.4 248.6 Acquisition and integration costs 5.3 2.6 9.1 4.2 Non-GAAP R&D $1,072.3 $973.6 $2,193.9 $1,933.7 GAAP SG&A $758.8 $652.0 $1,447.8 $1,253.1 Stock-based compensation expense 82.6 73.3 168.8 150.1 Acquisition and integration costs 9.7 16.5 28.5 26.1 Non-GAAP SG&A $666.5 $562.2 $1,250.5 $1,076.9 GAAP COGS $257.8 $192.4 $498.2 $400.8 Stock-based compensation expense 18.2 19.6 39.1 42.0 Acquisition and integration costs 0.8 0.5 1.2 0.5 Intangible asset amortization expense 25.1 19.8 48.3 38.3 Charges related to REGEN-COV — (10.0) — (10.0)Non-GAAP COGS $213.7 $162.5 $409.6 $330.0 GAAP other operating expense (income), net $14.6 $(0.6) $29.9 $(1.1)Change in fair value of contingent consideration 14.6 — 29.9 — Non-GAAP other operating expense (income), net $— $(0.6) $— $(1.1) GAAP other income (expense), net $558.5 $66.4 $507.8 $(22.3)(Gains) losses on investments, net (392.6) 30.9 (196.5) 197.5 Non-GAAP other income (expense), net $165.9 $97.3 $311.3 $175.2 GAAP net income $1,432.3 $968.4 $2,154.3 $1,786.2 Total of GAAP to non-GAAP reconciling items above (113.9) 262.3 373.8 697.3 Income tax effect of GAAP to non-GAAP reconciling items 32.8 (49.1) (61.0) (134.4)Non-GAAP net income $1,351.2 $1,181.6 $2,467.1 $2,349.1 Non-GAAP net income per share - basic $12.50 $11.04 $22.84 $21.95 Non-GAAP net income per share - diluted $11.56 $10.24 $21.09 $20.32 Shares used in calculating: Non-GAAP net income per share - basic 108.1 107.0 108.0 107.0 Non-GAAP net income per share - diluted 116.9 115.4 117.0 115.6 RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)(continued) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 Revenue reconciliation: Total revenues $3,547.1 $3,158.1 $6,692.1 $6,320.2 Global gross profit payment from Roche in connection with sales of Ronapreve 0.4 — 0.9 222.2 Other — (3.8) — (3.8)Total revenues excluding Ronapreve $3,546.7 $3,161.9 $6,691.2 $6,101.8 Effective tax rate reconciliation: GAAP ETR 12.0% 10.6% 7.5% 8.0%Income tax effect of GAAP to non-GAAP reconciling items (1.2%) 1.6% 1.2% 3.0%Non-GAAP ETR 10.8% 12.2% 8.7% 11.0% Six Months EndedJune 30, 2024 2023 Free cash flow reconciliation: Net cash provided by operating activities $1,866.5 $2,390.0 Capital expenditures (314.4) (291.2) Free cash flow $1,552.1 $2,098.8 TABLE 4 REGENERON PHARMACEUTICALS, INC.COLLABORATION REVENUE (Unaudited)(In millions) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 Sanofi collaboration revenue: Regeneron's share of profits in connection with commercialization of antibodies $988.3 $751.1 $1,792.3 $1,387.6 Reimbursement for manufacturing of commercial supplies 157.3 192.6 263.1 354.5 Total Sanofi collaboration revenue 1,145.6 943.7 2,055.4 1,742.1 Bayer collaboration revenue: Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States 353.0 349.5 686.9 681.1 Reimbursement for manufacturing of ex-U.S. commercial supplies 22.1 27.2 44.2 52.5 Total Bayer collaboration revenue 375.1 376.7 731.1 733.6 Other collaboration revenue: Global gross profit payment from Roche in connection with sales of Ronapreve 0.4 — 0.9 222.2 Other 2.9 (3.7) 3.4 (3.1) Total collaboration revenue $1,524.0 $1,316.7 $2,790.8 $2,694.8 TABLE 5 REGENERON PHARMACEUTICALS, INC.NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited)(In millions) Three Months EndedJune 30, 2024 2023 % Change U.S. ROW(g) Total U.S. ROW Total (Total Sales)EYLEA HD and EYLEA(a) $1,534.7 $907.8 $2,442.5 $1,500.1 $886.3 $2,386.4 2%Dupixent(b) $2,610.2 $946.2 $3,556.4 $2,105.2 $684.2 $2,789.4 27%Libtayo(c) $182.4 $115.0 $297.4 $130.2 $79.8 $210.0 42%Praluent(d) $56.1 $135.8 $191.9 $40.5 $99.8 $140.3 37%Kevzara(b) $65.1 $44.6 $109.7 $56.9 $42.6 $99.5 10%REGEN-COV(e) $— $1.1 $1.1 $— $— $— * Other products(f) $30.9 $20.8 $51.7 $22.5 $16.9 $39.4 31% Six Months EndedJune 30, 2024 2023 % Change U.S. ROW Total U.S. ROW Total (Total Sales)EYLEA HD and EYLEA(a) $2,936.3 $1,757.2 $4,693.5 $2,933.9 $1,733.4 $4,667.3 1%Dupixent(b) $4,828.2 $1,805.0 $6,633.2 $4,003.3 $1,271.1 $5,274.4 26%Libtayo(c) $341.6 $219.7 $561.3 $239.9 $152.7 $392.6 43%Praluent(d) $126.1 $267.1 $393.2 $80.7 $205.5 $286.2 37%Kevzara(b) $115.1 $88.7 $203.8 $96.1 $81.9 $178.0 14%REGEN-COV(e) $— $2.3 $2.3 $— $613.2 $613.2 (100%)Other products(f) $56.2 $38.5 $94.7 $40.6 $33.4 $74.0 28% Note: The table above includes net product sales of Regeneron-discovered products. Such net product sales are recorded by the Company or others, as further described in the footnotes below.* Percentage not meaningful(a)The Company records net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States. The Company records its share of profits in connection with sales outside the United States within Collaboration revenue.(b)Sanofi records global net product sales of Dupixent and Kevzara, and the Company records its share of profits in connection with global sales of such products within Collaboration revenue.(c)The Company records global net product sales of Libtayo and pays Sanofi a royalty on such sales. Prior to July 1, 2022, Sanofi recorded net product sales of Libtayo outside the United States. Included in this line item for the six months ended June 30, 2023 is approximately $6 million of first quarter 2023 net product sales recorded by Sanofi in connection with sales in certain markets outside the United States (Sanofi recorded net product sales in such markets during a transition period).(d)The Company records net product sales of Praluent in the United States. Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales, which is recorded within Other revenue.(e)Roche records net product sales outside the United States and the Company records its share of gross profits from sales based on a pre-specified formula, which is recorded within Collaboration revenue.(f)Included in this line item are products which are sold by the Company and others. Refer to "Second Quarter 2024 Financial Results" section above for a complete listing of net product sales recorded by the Company. Not included in this line item are net product sales of ARCALYST®, which are recorded by Kiniksa; net product sales of ARCALYST were $79 million for the first quarter of 2024.(g)Rest of world (ROW)

Giuseppe Menin, life sciences and process industry manager at COPA-DATA, highlights how an automation integration layer can streamline data management, ensuring compliance with the ALCOA principles—Attributable, Legible, Contemporaneous, Original, and Accurate. Pharmaceutical companies are under increasing pressure to meet the rising demand for diverse medications. According to IQVIA, global medicine usage is projected to grow by 12% by 2028, driven largely by innovative therapeutics and the availability of more affordable generics and biosimilars. This surge necessitates handling larger volumes of data, underscoring the importance of robust data management systems. The ALCOA principle and its expansion ​ ALCOA, recently expanded to ALCOA+ to include Complete, Consistent, Enduring, and Available, forms the foundation of data integrity standards set by regulatory bodies like the FDA and EMA. Non-compliance can lead to severe repercussions, including warning letters, non-compliance reports, fines, and even criminal prosecution. Despite the awareness of data integrity’s importance, pharmaceutical manufacturers often struggle with accurate and consistent data collection, analysis, and storage. Traditional paper-based processes pose significant risks, including human errors and the potential for tampering. Challenges in data integrity Legacy equipment and the lack of standardized protocols further complicate data integrity efforts. Even with a Manufacturing Execution System (MES), manual data transcriptions, known as "paper-on-glass" practices, remain error-prone. Additionally, older machinery from various vendors often lacks the ability to communicate seamlessly, adding another layer of complexity. googletag.cmd.push(function () { googletag.display('text-ad1'); }); The role of automation integration ​ Automating the integration of data across all production stages is crucial for overcoming these challenges. COPA-DATA’s zenon Automation Integration Layer (AIL) software exemplifies this approach, providing connectivity to machines from multiple vendors, including older equipment. Zenon ensures that data is automatically contextualized and archived, minimizing the risk of data loss or inconsistency. This automation detects incomplete or incorrect entries, enabling real-time data access and immediate issue resolution. Operators can rectify faults during production, significantly reducing time to market and associated costs. Ensuring accurate recipe management ​ In pharmaceutical manufacturing, precise recipe management is critical. Zenon allows operators to select pre-set recipes, eliminating human errors during production setup. The software guides users through each step, ensuring data completeness and adherence to specified tolerances. Towards automated data integrity ​ As pharmaceutical companies expand their product lines, maintaining compliance is essential. Efficient data management through automation not only ensures compliance with data integrity standards but also reduces costs and accelerates time to market. Menin emphasizes that automation integration is key to meeting ALCOA+ requirements. "Automated systems like zenon not only enhance data accuracy but also provide real-time access, ensuring compliance and efficiency in pharmaceutical production," he notes. Tofidence, a biosimilar to Actemra, is approved for treating moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. This FDA-approved biosimilar offers an affordable alternative, helping to alleviate the financial burden on patients and the healthcare system. Automating data integrity processes is not just about compliance; it’s about improving overall operational efficiency and ensuring that patients receive safe, effective, and high-quality medications.