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A new Medicare pathway, the Medicare GLP-1 Bridge program, makes Lilly's obesity medicines – a daily pill or the number 1 most prescribed injectable – accessible to eligible Medicare Part D patients beginning July 1 INDIANAPOLIS, June 25, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced additional details regarding the Medicare GLP-1 Bridge* program taking effect July 1, 2026. Under the program, Medicare Part D patients may be able to access Foundayo (orforglipron) or Zepbound (tirzepatide) KwikPen for single-patient-use for weight management. The Medicare GLP-1 Bridge program will be the first time eligible Medicare Part D patients will be able to broadly receive coverage for a GLP-1 for overweight or obesity.1 We believe this is a milestone that reflects growing recognition of the impact of obesity, including in older adults. Below is what patients and their healthcare providers need to know, including an overview of the clinical and program eligibility requirements determined by Centers for Medicare & Medicaid Services (CMS). Are Foundayo (orforglipron) and Zepbound (tirzepatide) covered by Medicare through the GLP-1 Bridge program? Medicare Part D patients who meet the Medicare GLP-1 Bridge Clinical Criteria and other CMS eligibility requirements may be able to access Foundayo (orforglipron) or Zepbound (tirzepatide) for weight management under the Medicare GLP-1 Bridge program for $50 per month. Other weight management medications are also covered under the program. Coverage begins July 1, 2026, for new and existing patients and will run through December 31, 2027. Foundayo (orforglipron) and Zepbound (tirzepatide) are indicated for adults with obesity, or some adults with overweight who also have weight-related medical problems, along with a reduced calorie diet and increased physical activity. To learn more, visit . For questions about the Medicare GLP-1 Bridge program, refer to . Why is this a milestone for people on Medicare living with obesity? Until now, weight management medications have not been broadly covered by Medicare even though two in five U.S. adults aged 65 and older are living with obesity.2 Creating a Medicare Part D coverage pathway for eligible patients advances Lilly's long-held view of obesity as a chronic disease. It also unlocks access to Lilly's obesity medicines, offering patients and their doctors options rather than a one-size-fits-all approach. "Lilly estimates that approximately 20 million Medicare patients may meet clinical criteria for obesity medicines, and starting July 1, eligible patients will be able to get Zepbound or Foundayo for $50 per month," said Ilya Yuffa, executive vice president and president of Lilly USA and Global Customer Capabilities. "For many, this will be the first time obesity treatment has been within reach. We're proud to offer Foundayo and Zepbound, giving patients and their doctors a real choice between a daily pill that requires no planning around food or drink and the number 1 most prescribed injectable for weight loss.3 Both are proven to deliver meaningful weight loss when paired with a reduced calorie diet and increased physical activity." How much do Foundayo (orforglipron) and Zepbound (tirzepatide) cost through the program? Medicare Part D patients may be eligible for Foundayo or Zepbound for weight management for $50 a month, with a prior authorization and if they meet the Medicare GLP-1 Bridge Clinical Criteria and other CMS eligibility requirements. To learn more, visit . What are Foundayo (orforglipron) and Zepbound (tirzepatide)? Foundayo (orforglipron) and Zepbound (tirzepatide) are two different Lilly medicines for chronic weight management, giving patients and their healthcare providers a choice of treatment options. Foundayo is a once-daily oral pill that can be taken any time of day, with no planning around food or drink. Zepbound is the most prescribed injectable weight management medication in the U.S. Both are FDA-approved to help adults with obesity, or some adults with overweight who also have weight-related medical problems, lose excess body weight and keep it off, along with a reduced-calorie diet and increased physical activity. How do Foundayo (orforglipron) and Zepbound (tirzepatide) work in adults age 65 and older? In separate analyses of Phase 3 trials, both medicines were associated with meaningful weight loss in adults 65 and older, with safety profiles generally consistent with the overall study population. In a post-hoc analysis of ATTAIN-1, adults 65 and older without type 2 diabetes, experienced an average weight loss of 13% when taking the highest dose of Foundayo. In the ATTAIN program, Foundayo also led to reductions in many markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure in adults of all ages.6 In a separate 72-week Phase 3 study, SURMOUNT-1, 56.7% of adults of all ages without type 2 diabetes taking Zepbound (15 mg) achieved at least 20% body weight reduction.7 In a prespecified subgroup analysis of this study, adults 65 and older without type 2 diabetes lost an average of 14.1% of their body weight when taking the lowest approved maintenance dose of Zepbound (5 mg), which is only one step up from the starter dose.8 "Obesity is a chronic, complex disease that deserves effective, long-term treatment options at every stage of life," said Rachel Batterham, senior vice president for Global Cardiometabolic Health at Lilly. "Data show Lilly's Foundayo and Zepbound were associated with meaningful weight loss in people aged 65 and older, with safety profiles generally consistent with other age groups, reinforcing that these medicines may be effective and appropriate for older adults." Who is eligible for these medicines through the Medicare GLP-1 Bridge program? To qualify, a person must meet all of the Medicare GLP-1 Bridge Clinical Criteria and other CMS eligibility requirements when treatment is started:9 Be 18 years of age or older Have Medicare Part D drug coverage (not all plan types are covered)† Have a valid prescription, be using, or planning to use, Foundayo or Zepbound for weight management, alongside lifestyle modification consistent with the FDA approved labels Have a Body Mass Index (BMI) of 35 or higher, or a BMI of 27 or higher with certain weight-related medical conditions (or have had one before starting a GLP-1 medicine) Patients currently receiving a GLP-1 through their Part D plan, those with type 2 diabetes, moderate-to-severe obstructive sleep apnea or fatty liver disease are not eligible (a Medicare Part D plan may already cover those conditions). Patients can talk with their healthcare providers about whether they qualify or refer to . How can eligible patients get started? Starting July 1, 2026, eligible patients can begin in five steps: Talk with a healthcare provider about whether Foundayo or Zepbound is right for them. Request that the provider send a prescription to LillyDirect Pharmacy or a retail pharmacy of their choice. Work with the chosen pharmacy. Ensure that the provider completes a prior authorization. Once approved, the patient pays $50 per month for Foundayo or Zepbound. LillyDirect can help to determine eligibility and navigate the pre-authorization process. To learn more about eligibility, and see how to get started, visit . For questions about Foundayo, Zepbound, or LillyDirect Pharmacy, call 1-844-559-3471. About Foundayo (orforglipron) Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day with no planning around food or drink. Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence. About Zepbound (tirzepatide) injection Zepbound (tirzepatide) is the first and only dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity medication. Zepbound tackles an underlying cause of excess weight. It reduces appetite and how much you eat. Zepbound is indicated for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Zepbound should be used with a reduced calorie diet and increased physical activity. Warnings - Foundayo and Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms , such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. About ATTAIN-1 and ATTAIN-2 clinical trial program The ATTAIN Phase 3 global clinical development program for Foundayo (orforglipron) has enrolled more than 4,500 people with obesity or overweight across two global registration trials. ATTAIN-1 (NCT05869903) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Foundayo 5.5 mg, 9 mg and 17.2 mg as a monotherapy to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, who did not have diabetes. The trial is the first Phase 3 study of this patient population in which treatment was evaluated as an adjunct to exercise and a balanced, healthy diet rather than a reduced-calorie diet. The trial randomized 3,127 (195 were 65 and older) participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan in 3:3:3:4 ratio to receive either 5.5 mg, 9 mg or 17.2 mg Foundayo or placebo. The primary objective of the study was to demonstrate that Foundayo (5.5 mg, 9 mg or 17.2 mg) is superior to placebo in body weight reduction from baseline after 72 weeks in people with a BMI ≥30.0 kg/m² or a BMI ≥27.0 kg/m² with at least one weight-related comorbidity and a history of at least one self-reported unsuccessful dietary effort to lose body weight. ATTAIN-2 (NCT05872620) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Foundayo 5.5 mg, 9 mg or 17.2 mg as monotherapy with placebo in adults with obesity or overweight and type 2 diabetes. The trial randomized over 1,613 (418 were 65 and older) participants across the U.S., Argentina, Australia, Brazil, China, Czechia, Germany, Greece, India, South Korea and Puerto Rico in a 1:1:1:2 ratio to receive either 5.5 mg, 9 mg or 17.2 mg Foundayo or placebo. The primary objective of the study was to demonstrate that Foundayo (5.5 mg, 9 mg or 17.2 mg) is superior to placebo in mean body weight change from baseline at 72 weeks in people with a BMI ≥27.0 kg/m² and type 2 diabetes who are on stable treatment with either diet/exercise alone or up to three oral antihyperglycemic medications. In both trials, all participants in the Foundayo treatment arms started the study at a dose of Foundayo 0.8 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 5.5 mg (via steps at 0.8 mg and 2.5 mg), 9 mg (via steps at 0.8 mg, 2.5 mg and 5.5 mg) or 17.2 mg (via steps at 0.8 mg, 2.5 mg, 5.5 mg, 9 mg and 14.5 mg). These trials were conducted using an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets. The post-hoc analysis included in this press release examined efficacy and safety outcomes in subgroups of participants aged <65 and ≥65 years. Efficacy outcomes were analyzed separately for each study; safety data were pooled. The primary endpoint was percent change in body weight from baseline in Week 72. Limitations This is a post-hoc, exploratory analysis of data from the ATTAIN-1 and ATTAIN-2 trials. Results are not pre-specified and should be considered hypothesis-generating. The subgroups analyzed (<65 year and ≥65 and) reflect the distribution of participants enrolled in the trials; the number of participants ≥65 is smaller than the <65 subgroup, and formal comparisons between age groups were not pre-specified. These findings will need to be confirmed in dedicated prospective analyses. About SURMOUNT-1 Throughout the 72-week clinical trial, people who took Zepbound (tirzepatide) sustained weight loss—whether taking the 5 mg, 10 mg or 15 mg dose along with diet and exercise. In a 72-week study of adults without diabetes, average weight loss was 15.0% (34 lbs) for 5 mg, 19.5% (44 lbs) for 10 mg, 20.9% (48 lbs) for 15 mg, and 3.1% (7 lbs) for placebo. Average starting weights were 226.8 lbs for 5 mg, 233.3 lbs for 10 mg, 232.8 lbs for 15 mg, and 231.0 lbs for placebo. Limitations of the SURMOUNT-1 prespecified subgroup analysis: This was a prespecified sub‑group analysis among the secondary endpoints of the SURMOUNT‑1 study. This analysis was not adjusted for type I error. Endnotes and References *Terms apply. Eligibility based on Medicare GLP-1 Bridge Clinical Criteria. Prescription required. Talk to your doctor to learn more. †Ineligible plan types: Private fee-for-service (PFFS) plans Section 1876 cost contract plans Section 1833 health care prepayment plans (HCPPs) PACE organizations Fallback plans Religious fraternal benefit (RFB) plans Centers for Medicare & Medicaid Services. Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly. Federal Register. December 10, 2024. Available at: Federal Interagency Forum on Aging-Related Statistics. Older Americans: key indicators of well-being. Published May 2024. Accessed February 4, 2026. Based on IQVIA® National Prescription Audit (NPA) Data for both new and refill prescriptions (total) in the U.S. as of 01/10/2025. Data accessed 01/14/2026, representing 94% of prescription data in US. Total prescription volumes and shares for obesity management therapies include Zepbound®, Wegovy®, Saxenda®, Belviq®, Contrave®, Qsymia®, Xenical® and other obesity management medicines. Other product/company names mentioned are the trademarks of their respective owners. Foundayo. Prescribing Information. Lilly USA, LLC. Zepbound. Prescribing Information. Lilly USA, LLC. Horn DB, et al. Orforglipron for Obesity Treatment in Older Patients ≥65 Years With or Without Type 2 Diabetes. Presented at: European Congress on Obesity (ECO); May 12–15, 2026; Istanbul, Turkey. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3)(Incl suppl mat):205-216. doi:10.1056/NEJMoa2206038 Data on File. DOF-ZP-US-0060. Lilly USA, LLC. Medicare GLP-1 Bridge. CMS.gov, Centers for Medicare & Medicaid Services, . Accessed 24 June 2026. INDICATION AND SAFETY SUMMARY WITH WARNINGS Foundayo (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. Foundayo should not be used with other GLP-1 receptor agonist medicines. It is not known if Foundayo is safe and effective for use in children. Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo. Foundayo may cause serious side effects, including: Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back. Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery. Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo. Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before taking Foundayo Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works. Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. Review these questions with your healthcare provider: ❏ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? ❏ Do you have a history of diabetic retinopathy? ❏ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)? ❏ Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby. ❏ Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo. ❏ Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements? How to take Take Foundayo exactly as your healthcare provider tells you to. Use Foundayo with a reduced-calorie diet and increased physical activity. Take Foundayo by mouth 1 time each day, with or without food. Swallow tablets whole. Do not break, crush, or chew the tablet. If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day. Do not take more than 1 tablet per day. If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment. If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Learn more Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com. This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you. OG CON BS APR2026 INDICATIONS AND SAFETY SUMMARY WITH WARNINGS Zepbound® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with: obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA. Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children. Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound. KwikPen® : Do not share your KwikPen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them. Zepbound may cause serious side effects, including: Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel pain from your abdomen to your back. Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effects that bothers you or don't go away. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before using Zepbound Your healthcare provider should show you how to use Zepbound before you use it for the first time. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound. Review these questions with your healthcare provider: ❏ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? ❏ Do you take diabetes medicines, such as insulin or sulfonylureas? ❏ Do you have a history of diabetic retinopathy? ❏ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)? ❏ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements? ❏ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound. Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979). How to take Read the Instructions for Use that come with Zepbound. Use Zepbound exactly as your healthcare provider says. Use Zepbound with a reduced-calorie diet and increased physical activity. Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously). Use Zepbound 1 time each week, at any time of the day. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection. Learn more Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to . This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you. ZP CON BS 25FEB2026 About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995), including statements about the supply and access of Zepbound (tirzepatide) and Foundayo (orforglipron) as a treatment for adults with obesity or overweight and Foundayo as a treatment for adults with obesity or some adults with overweight who also have weight-related medical problems and reflects Lilly's current belief and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, access, and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that Zepbound or Foundayo will receive additional regulatory approvals, or that Lilly will execute its access and other strategies as planned. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. CMAT-23048 6/2026 ©Lilly USA, LLC 2026. All rights reserved. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced earnings of $239.5M for Q3 2025, representing 29% year-over-year revenue growth for WAKIX®. These results were driven by the highest ever increase in average number of patients of approximately 500 for the quarter, accelerating the trajectory toward blockbuster status for WAKIX in narcolepsy. The company continues to build on four consecutive years of revenue growth and profitability. With over $778 million in cash and investments at quarter end, Harmony has further strengthened its financial position, solidifying its unique profile as a profitable, self-funding biotech company with a robust, late-stage pipeline and strong long-term growth potential. “Our exceptional performance this quarter highlights the continued strength of WAKIX and significant market opportunity that remains ahead. I am incredibly proud of our team’s focus and executional excellence, as we delivered very strong results today, which positions Harmony for future growth,” said Jeffrey M. Dayno, M.D., President and CEO of Harmony Biosciences. “I continue to have firm conviction in our late-stage pipeline to deliver multiple catalysts over the next several years and, given our strong cash position, we intend to strategically pursue value-enhancing assets to add to our pipeline and build a broader product portfolio of innovative treatments that can help even more patients living with unmet medical needs.” Franchise Highlights Sleep/Wake Franchise WAKIX in Narcolepsy Net Revenue was $239.5 million for Q3 2025 Recently raised 2025 Net Revenue guidance from $820-$860 million to $845-$865 million Record increase in average number of patients of approximately 500 to achieve approximately 8,100 average patients in Q3 2025 Pitolisant HD (high dose) IND submitted to the FDA Phase 3 registrational trials in both narcolepsy and IH to initiate in Q4 2025 with target PDUFA dates in 2028 Higher dose and optimized pharmacokinetic profile designed for greater efficacy without compromising safety and tolerability profile Phase 3 registrational trial in narcolepsy designed for greater efficacy in excessive daytime sleepiness and cataplexy; includes endpoint on narcolepsy-related fatigue in pursuit of a differentiated label Phase 3 registrational trial in IH to include endpoint on sleep inertia in pursuit of a differentiated label Utility patents filed for pitolisant HD with potential exclusivity to 2044 Pitolisant GR (gastro-resistant) Designed to minimize the potential for treatment-related GI side effects as patients with narcolepsy commonly experience GI symptoms related to their underlying disease (up to 90%) Topline data readout from pivotal bioequivalence study on track for Q4 2025 Provides patients with the ability to start at therapeutic dose range without the need for titration Topline data from dosing optimization study showed 100% (46/46) of patients were able to initiate pitolisant GR at the therapeutic dose of 17.8mg Topline data from dosing optimization study showed 100% (46/46) of patients were able to initiate pitolisant GR at the therapeutic dose of 17.8mg Utility patents filed for pitolisant GR with potential exclusivity to 2044 Orexin-2 receptor agonist (BP1.15205) First-in-human study to commence in Q4 2025 with clinical data anticipated in 2026 Comprehensive and compelling preclinical safety and efficacy data presented at SLEEP and World Sleep Congress Potential to be best-in-class orexin-2 receptor agonist based on a novel chemical scaffold, preclinical potency, selectivity, safety and efficacy data, as well as its potential for once-a-day dosing Rare Epilepsy Franchise EPX-100 (clemizole hydrochloride) One of the most advanced development programs in the 5HT2 (serotonin) agonist class Enrollment ongoing for Phase 3 registrational trial in Dravet syndrome (ARGUS Study) with topline data anticipated in 2026 Enrollment ongoing for Phase 3 registrational trial in patients with Lennox-Gastaut syndrome (LIGHTHOUSE Study) with topline data anticipated in 2026 Presenting data from the ARGUS open label extension study at the American Epilepsy Society Meeting in December 2025 EPX-200 (lorcaserin hydrochloride) Proven mechanism of action in developmental and epileptic encephalopathies (DEEs) confirmed via non-clinical and clinical data Currently in the IND-enabling stage Neurobehavioral Franchise ZYN002 The ZYN002 phase 3 RECONNECT study in Fragile X syndrome did not meet the primary endpoint of improvement in social avoidance primarily due to a higher-than-expected placebo response rate; a review of the full data set is ongoing The ZYN002 development program in 22q11.2 deletion syndrome (22q) has been paused pending the full review of the RECONNECT data Third Quarter 2025 Financial Results Harmony Biosciences reported net product revenue of $239.5 million for the quarter ended September 30, 2025, compared to $186 million for the same period in 2024, representing 29% year-over-year growth. This performance reflects both continued demand for WAKIX within the large narcolepsy market opportunity (approximately 80,000 diagnosed patients in the U.S.) and the product's broad clinical utility. Our continued success has been driven by strong execution across the organization from sales effectiveness to marketing and promotion and supported by broad payer coverage and how we support patients over time. On a GAAP basis, net income for the quarter was $50.9 million, or $0.87 per diluted share, compared to $46.1 million, or $0.79 per diluted share, in Q3 2024. Non-GAAP adjusted net income, which we believe better reflects our core business performance, was $63.5 million ($1.08 per diluted share) for the third quarter of 2025 versus $57.3 million ($0.99 per diluted share) for the comparable 2024 period. Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release. Harmony’s operating expenses include the following: Research and Development expenses were $55.0 million in the third quarter of 2025, as compared to $25.4 million for the same quarter in 2024, representing a 117% increase; primarily driven by a $15.0 million IPR&D charge related to a clinical milestone achieved for ZYN002; Sales and Marketing expenses were $29.5 million in the third quarter of 2025, as compared to $27.6 million for the same quarter in 2024, representing a 7% increase; General and Administrative expenses were $29.8 million in the third quarter of 2025, as compared to $28.6 million for the same quarter in 2024, representing a 4% increase; and Total Operating Expenses were $114.3 million in the third quarter of 2025, as compared to $81.6 million for the same quarter in 2024, representing a 40% increase. As of September 30, 2025, Harmony had cash, cash equivalents and investments of $778.4 million, compared to $576.1 million as of December 31, 2024. 2025 Net Product Revenue Guidance Recently raised full year 2025 net product revenue range from $820-$860 million to $845-$865 million. Conference Call Today at 8:30 a.m. ET We are hosting our third quarter 2025 financial results conference call and webcast today, beginning at 8:30 a.m. Eastern time. The live and replay webcast of the call will be available on the investor relations page of our website https://ir.harmonybiosciences.com/. To participate in the live call by phone, dial 800-274-8461 (domestic) or 203-518-9814 (international), and reference passcode HRMYQ325. Non-GAAP Financial Measures In addition to our GAAP results, we present certain Non-GAAP measures including Non-GAAP adjusted net income and Non-GAAP adjusted net income per share, which we believe provides important supplemental information to management and investors regarding our performance. These measurements are not a substitute for GAAP measurements, and the manner in which we calculate Non-GAAP adjusted net income and Non-GAAP adjusted net income per share may not be identical to the manner in which other companies calculate adjusted net income and adjusted net income per share. We use these Non-GAAP measurements as an aid in monitoring our financial performance from quarter-to-quarter and year-to-year and benchmarking against comparable companies. Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our Non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our Non-GAAP financial measures. About WAKIX® (pitolisant) Tablets WAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States. Indications and Usage WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy. Important Safety Information Contraindications WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported. WAKIX is also contraindicated in patients with severe hepatic impairment. Warnings and Precautions WAKIX prolongs the QT interval; avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant; monitor these patients for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is contraindicated in patients with severe hepatic impairment and not recommended in patients with end-stage renal disease (ESRD). Adverse Reactions In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and at least twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory tract infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash. In the placebo-controlled phase of the clinical trial conducted in pediatric patients 6 years and older with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and greater than placebo) for WAKIX were headache (19%) and insomnia (7%). The overall adverse reaction profile of WAKIX in the pediatric clinical trial was similar to that seen in the adult clinical trial program. Drug Interactions Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. Reduce the dose of WAKIX by half. Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%. Dosage adjustments may be required. H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX. Patients should avoid centrally acting H1 receptor antagonists. WAKIX is a borderline/weak inducer of CYP3A4. WAKIX may reduce the effectiveness of sensitive CYP3A4 substrates, including hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuing treatment. Use in Specific Populations There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460. The safety and effectiveness of WAKIX have not been established for treatment of excessive daytime sleepiness in pediatric patients less than 6 years of age with narcolepsy. The safety and effectiveness of WAKIX have not been established for treatment of cataplexy in pediatric patients with narcolepsy. WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is required in patients with moderate hepatic impairment. WAKIX is not recommended in patients with end-stage renal disease. Dosage adjustment of WAKIX is recommended in patients with eGFR <60 mL/minute/1.73 m2. Dosage reduction is recommended in patients known to be poor CYP2D6 metabolizers; these patients have higher concentrations of WAKIX than normal CYP2D6 metabolizers. Please see the Full Prescribing Information for WAKIX for more information. To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About Narcolepsy Narcolepsy is a rare, chronic, debilitating neurological disease of sleep-wake state instability that impacts approximately 170,000 Americans and is primarily characterized by excessive daytime sleepiness (EDS) and cataplexy – its two cardinal symptoms – along with other manifestations of REM sleep dysregulation (hallucinations and sleep paralysis), which intrude into wakefulness. EDS is the inability to stay awake and alert during the day and is the symptom that is present in all people living with narcolepsy. In most patients, narcolepsy is caused by the loss of hypocretin/orexin, a neuropeptide in the brain that supports sleep-wake state stability. This disease affects men and women equally, with typical symptom onset in adolescence or young adulthood; however, it can take up to a decade to be properly diagnosed. About Idiopathic Hypersomnia Idiopathic Hypersomnia (IH) is a rare and chronic neurological disease that is characterized by excessive daytime sleepiness (EDS) despite sufficient or even long sleep time. EDS in IH cannot be alleviated by naps, longer sleep or more efficient sleep. People living with IH experience significant EDS along with the symptoms of sleep inertia (prolonged difficulty waking up from sleep) and 'brain fog' (impaired cognition, attention, and alertness). The cause of IH is unknown, but it is likely due to alterations in areas of the brain that stabilize states of sleep and wakefulness. IH is one of the central disorders of hypersomnolence and, like narcolepsy, is a debilitating sleep disorder that can result in significant disruption in daily functioning. About ZYN002 ZYN002 is the first-and-only pharmaceutically manufactured synthetic cannabidiol devoid of THC and formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. The product is manufactured through a synthetic process in a cGMP facility and is not extracted from the cannabis plant. ZYN002 does not contain THC, the compound that causes the euphoric effect of cannabis, and has the potential to be a nonscheduled product if approved. Cannabidiol, the active ingredient in ZYN002, has been granted orphan drug designation by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of FXS and for the treatment of 22q. Additionally, ZYN002 has received FDA Fast Track designation for the treatment of behavioral symptoms in patients with FXS. About Fragile X Syndrome Fragile X syndrome (FXS) is a rare genetic disorder that is the leading known cause of both inherited intellectual disability and autism spectrum disorder. The disorder negatively affects synaptic function, plasticity and neuronal connections, and results in a spectrum of intellectual disabilities and behavioral symptoms, such as social avoidance and irritability. While the exact prevalence is unknown, upwards of 80,000 patients in the U.S. and 121,000 patients in the European Union and the UK are believed to have FXS, based on FXS prevalence estimates of approximately 1 in 4,000 to 7,000 in males and approximately 1 in 8,000 to 11,000 in females. There is a significant unmet medical need in patients living with FXS as there are currently no FDA-approved treatments for this disorder. FXS is caused by a mutation in FMR1, a gene which modulates a number of systems, including the endocannabinoid system, and most critically, codes for a protein called FMRP. The FMR1 mutation manifests as multiple repeats of a DNA segment, known as the CGG triplet repeat, resulting in deficiency or lack of FMRP. FMRP helps regulate the production of other proteins and plays a role in the development of synapses, which are critical for relaying nerve impulses, and in regulating synaptic plasticity. In people with full mutation of the FMR1 gene, the CGG segment is repeated more than 200 times, and in most cases causes the gene to not function. Methylation of the FMR1 gene also plays a role in determining functionality of the gene. In approximately 60% of patients with FXS, who have complete methylation of the FMR1 gene, no FMRP is produced, resulting in dysregulation of the systems modulated by FMRP. About Clemizole Hydrochloride (EPX-100) EPX-100, clemizole hydrochloride, is under development for the treatment of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). EPX-100 acts by targeting central 5-hydroxytryptamine receptors to modulate serotonin signaling. The drug candidate is administered orally twice a day in a liquid formulation and has been developed based on a proprietary phenotype-based zebrafish drug screening platform. DS is caused by a loss of function mutation in the SCN1A gene, and scn1 mutant zebrafish replicate the genetic etiology and phenotype observed in the majority of DS patients. The scn1Lab mutant zebrafish model that expresses voltage gated sodium channels has been used for high-throughput screening of compounds that modulate Nav1.1 in the central nervous system. About Dravet Syndrome Dravet syndrome (DS) is a severe and progressive epileptic encephalopathy that begins in infancy and causes significant impact on patient functioning. DS begins in the first year of life and is characterized by high seizure frequency and severity, intellectual disability, and a risk of sudden unexpected death in epilepsy. Approximately 85% of Dravet syndrome cases are caused by de novo loss-of-function (LOF) mutations in a voltage-gated sodium channel gene, SCN1A1. DS has an estimated incidence rate of 1:15,700. About Lennox-Gastaut Syndrome Lennox-Gastaut syndrome (LGS) is a rare and drug-resistant epileptic encephalopathy characterized by onset in children between 3-5 years of age. The underlying cause of LGS is unknown and can be related to a wide range of factors including genetic differences and structural differences in the brain. As a result, patients experience multiple seizure types, including atonic seizures, and developmental, cognitive, and behavioral issues. LGS affects approximately 48,000 patients in the U.S. About Harmony Biosciences Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2025 net product revenue, expectations for the growth and value of WAKIX, plans to submit an sNDA for pitolisant in idiopathic hypersomnia; our future results of operations and financial position, business strategy, products, prospective products, product approvals, the plans and objectives of management for future operations and future results of anticipated products. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved, including ZYN002 and EPX-100; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche (“Bioprojet”); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony's common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe; and macroeconomic effects and changes in market conditions, including the impact of tariffs, inflation and the risk of recession. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 25, 2025, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (In thousands, except share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Net product revenue $ 239,455 $ 186,038 $ 624,677 $ 513,467 Cost of product sold 59,650 42,778 129,797 102,406 Gross profit 179,805 143,260 494,880 411,061 Operating expenses: Research and development 54,962 25,387 139,661 111,159 Sales and marketing 29,549 27,576 90,333 83,316 General and administrative 29,807 28,587 94,974 81,487 Total operating expenses 114,318 81,550 324,968 275,962 Operating income 65,487 61,710 169,912 135,099 Other expense, net (106) (124) (575) (228) Interest expense (3,621) (4,348) (11,103) (13,287) Interest income 5,730 4,932 16,070 14,065 Income before income taxes 67,490 62,170 174,304 135,649 Income tax expense (16,625) (16,077) (38,103) (39,631) Net income $ 50,865 $ 46,093 $ 136,201 $ 96,018 Unrealized income on investments 118 733 291 497 Comprehensive income $ 50,983 $ 46,826 $ 136,492 $ 96,515 EARNINGS PER SHARE: Basic $ 0.88 $ 0.81 $ 2.36 $ 1.69 Diluted $ 0.87 $ 0.79 $ 2.32 $ 1.66 Weighted average number of shares of common stock - basic 57,550,902 56,870,234 57,655,272 56,815,167 Weighted average number of shares of common stock - diluted 58,717,910 58,103,963 58,738,361 57,754,016 HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data) September 30, December 31, 2025 2024 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 646,999 $ 453,001 Investments, short-term 25,582 14,185 Trade receivables, net 100,651 83,033 Inventory, net 6,882 7,198 Prepaid expenses 23,308 13,714 Other current assets 35,378 8,121 Total current assets 838,800 579,252 NONCURRENT ASSETS: Property and equipment, net 1,440 1,257 Investments, long-term 105,831 108,874 Intangible assets, net 95,380 113,263 Deferred tax asset 157,075 190,398 Other noncurrent assets 9,692 6,156 Total noncurrent assets 369,418 419,948 TOTAL ASSETS $ 1,208,218 $ 999,200 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Trade payables $ 26,341 $ 13,744 Accrued compensation 14,935 18,776 Accrued expenses 161,302 120,640 Current portion of long-term debt 20,000 16,250 Other current liabilities 825 5,672 Total current liabilities 223,403 175,082 NONCURRENT LIABILITIES: Long-term debt, net 148,506 163,016 Other noncurrent liabilities 1,186 1,947 Total noncurrent liabilities 149,692 164,963 TOTAL LIABILITIES 373,095 340,045 COMMITMENTS AND CONTINGENCIES (Note 13) STOCKHOLDERS’ EQUITY: Common stock—$0.00001 par value; 500,000,000 shares authorized at September 30, 2025 and December 31, 2024, respectively; 57,596,358 and 57,144,887 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively 1 1 Additional paid in capital 696,348 656,872 Accumulated other comprehensive income 357 66 Retained earnings 138,417 2,216 TOTAL STOCKHOLDERS’ EQUITY 835,123 659,155 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 1,208,218 $ 999,200 HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS (In thousands except share and per share data) Three Months Ended Nine Months Ended September 30, September 30, September 30, September 30, 2025 2024 2025 2024 GAAP net income (1) $ 50,865 $ 46,093 $ 136,201 $ 96,018 Non-GAAP Adjustments: Non-cash interest expense (2) 161 175 490 531 Depreciation 7 7 20 261 Amortization (3) 5,961 5,961 17,883 17,883 Stock-based compensation expense 10,824 11,448 34,668 32,845 Income tax effect related to non-GAAP adjustments (4) (4,338) (6,412) (11,599) (15,044) Non-GAAP adjusted net income (1) $ 63,480 $ 57,272 $ 177,663 $ 132,494 GAAP reported net income per diluted share $ 0.87 $ 0.79 $ 2.32 $ 1.66 Non-GAAP adjusted net income per diluted share $ 1.08 $ 0.99 $ 3.02 $ 2.29 Weighted average number of shares of common stock used in non-GAAP diluted per share 58,717,910 58,103,963 58,738,361 57,754,016 (1) Includes a $15,000 IPR&D charge related to a clinical milestone achieved for ZYN002 during the three and nine months ended September 30, 2025. Includes a $15,000 IPR&D charge related to an upfront fee incurred upon closing the CiRC research collaboration agreement for the nine months ended September 30, 2025. Includes a $1,000 IPR&D charge related to a preclinical milestone achieved for HBS-102 during the three and nine months ended September 30, 2024. Includes a $25,500 charge related to an upfront license fee incurred upon closing the 2024 Bioprojet Sublicense Agreement and a $17,095 IPR&D charge related to the acquisition of Epygenix for the nine months ended September 30, 2024. (2) Includes amortization of deferred finance charges. (3) Includes amortization of intangible asset related to WAKIX. (4) Calculated using the reported effective tax rate for the periods presented less impact of discrete items.