Ivabradine Hydrochloride

Presentations showcase diversity and momentum of Pfizer’s growing portfolio of vaccines and anti-infectives NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) will present data across its infectious disease portfolio at the upcoming IDWeek 2023 held in Boston from October 11-15, 2023. Data from 45 abstracts will highlight the advances Pfizer is making in helping prevent and treat certain infectious diseases, particularly respiratory illnesses. This will include research featured in the IDWeek press program assessing the potential public health impact of ABRYSVO™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent respiratory syncytial virus prefusion F (RSVpreF) vaccine for maternal immunization to protect infants against RSV illness. “The data at this year’s IDWeek highlight Pfizer’s commitment to transforming respiratory health, an area where we are proud to have delivered several innovative vaccine and treatment options over the last three years. We also continue to actively investigate infectious diseases more broadly, with a diverse pipeline of innovative vaccine and anti-infective treatment candidates,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer. “With our unique scientific capabilities and vaccine technology platforms, we are unwavering in the fight against the world’s most pressing disease challenges. We are excited to present our latest clinical results that support our growing infectious disease portfolio for the purpose of improving global health outcomes.” "The burden of respiratory illnesses on global public health is significant. It is particularly relevant as we enter the winter respiratory season in the Northern Hemisphere and once again face the threat of a possible tripledemic with influenza, RSV and COVID-19 co-circulating,” said Luis Jodar, Ph. D., Chief Medical Affairs Officer, Vaccines/Antivirals and Evidence Generation, Pfizer. “At IDWeek, we are pleased to share real-world data that will help educate healthcare professionals about the role Pfizer’s vaccines and treatments can play in helping mitigate the impact of certain respiratory infections during this critical period.” Pfizer's participation at IDWeek 2023 comprises breakthrough research from across the company’s robust infectious disease portfolio, covering RSV, COVID-19, pneumococcal disease, Lyme disease, meningococcal disease, multidrug-resistant gram-negative bacterial infections and more. Eight abstracts have been selected for oral presentation, including data on the successful coadministration of ABRYSVO with an influenza vaccine in older adults and results from the Phase 3 REVISIT study of Pfizer’s investigational antibiotic combination aztreonam-avibactam (ATM-AVI) candidate. Data highlighting the real-world effectiveness of Pfizer’s FDA-approved COVID-19 oral treatment for adults, PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets), will also be featured at the meeting. A complete list of Pfizer-sponsored accepted abstracts is available here. Details for Pfizer-sponsored oral presentations are below: Title/ Abstract Number Presenting Name/Type Date/ Time EDT Location IDWEEK PRESS PROGRAM 1942 - Potential Public Health Impact of Bivalent Respiratory Syncytial Virus Prefusion F (RSVpreF) Maternal Vaccine for Prevention of RSV Among US Infants Amy W. Law, PharmD Oct 13 2:15 - 2:30 PM US ET 104 ABC ORAL PRESENTATIONS 1019 - Respiratory Syncytial Virus (RSV) Diagnoses in Hospitalized Patients Increases when Additional Specimen Types are Added to Nasopharyngeal Swab: Results from the RSV in Adults Multispecimen Study Elizabeth Begier, MD, MPH Oct 12 3:15 - 3:33 PM US ET 104 ABC 1941 - Coadministration of Bivalent Respiratory Syncytial Virus (RSVpreF) Vaccine with Influenza Vaccine in Older Adults James Baber, MBChB, MPH Oct 13 2:00 - 2:15 PM US ET 104 ABC 1944 - Tolerability and Safety of 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Infants and Older Children in Global Studies Kathleen McElwee, MD, MPH Oct 13 2:45 - 3:00 PM US ET 104 ABC 1948 - Rise of Candida auris Infections Worldwide and Trends on the Activity of Fosmanogepix and Comparator Agents Against C. auris Causing Invasive Infections Cecilia G. Carvalhaes, MD, PhD Oct 13 2:30 - 2:45 PM US ET 102 AB 1949 – Activity of Aztreonam-Avibactam Against Enterobacterales Resistant to Recently Approved Beta-Lactamase Inhibitor Combinations Collected Worldwide (ex-US: 2020-2022) Helio S. Sader, MD, PhD, FIDSA Oct 13 2:45 - 3:00 PM US ET 102 AB 2890 - Pharmacokinetics, Safety, and Efficacy of Ceftazidime-Avibactam in Neonates and Young Infants with Bacterial Infections: Results from a Phase 2a, 2-part, Open-label, Non-randomized, Multicenter Trial Richard D England, MD Oct 14 2:05 - 2:15 PM US ET 254 AB 2893 - Efficacy and Safety of Aztreonam-Avibactam for the Treatment of Serious Infections Due to Gram-Negative Bacteria, Including Metallo-β-Lactamase-Producing Pathogens: Phase 3 REVISIT Study Yehuda Carmeli, MD MPH Oct 14 2:35 - 2:45 PM US ET 254 AB INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR ABRYSVO U.S. INDICATIONS ABRYSVOTM is a vaccine indicated for: the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age IMPORTANT SAFETY INFORMATION ABRYSVO should not be given to anyone with a history of severe allergic reaction (eg, anaphylaxis) to any of its components For pregnant individuals: to avoid the potential risks of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during fainting Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO Vaccination with ABRYSVO may not protect all people In adults 60 years of age and older, the most common side effects (≥10%) were fatigue, headache, pain at the injection site, and muscle pain In pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, nausea In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo View the full Prescribing Information. INDICATION, AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION FOR PAXLOVID U.S. Indication PAXLOVID is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Limitations of Use PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19. U.S. FDA Emergency Use Authorization Statement The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of PAXLOVID for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with mild to moderate coronavirus disease 2019 (COVID-19) and who are at high risk for progression to severe COVID-19, including hospitalization or death. PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. IMPORTANT SAFETY INFORMATION WARNING: SIGNIFICANT DRUG INTERACTIONS WITH PAXLOVID PAXLOVID includes ritonavir, a strong CYP3A inhibitor, which may lead to greater exposure of certain concomitant medications, resulting in potentially severe, life-threatening, or fatal events Prior to prescribing PAXLOVID: 1) Review all medications taken by the patient to assess potential drug-drug interactions with a strong CYP3A inhibitor like PAXLOVID and 2) Determine if concomitant medications require a dose adjustment, interruption, and/or additional monitoring Consider the benefit of PAXLOVID treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epidermal necrolysis or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care. PAXLOVID is contraindicated with drugs that are primarily metabolized by CYP3A and for which elevated concentrations are associated with serious and/or life-threatening reactions and drugs that are strong CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. There are certain other drugs for which concomitant use with PAXLOVID should be avoided and/or dose adjustment, interruption, or therapeutic monitoring is recommended. Drugs listed here are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID. The healthcare provider should consult other appropriate resources such as the prescribing information for the interacting drug for comprehensive information on dosing or monitoring with concomitant use of a strong CYP3A inhibitor like PAXLOVID. Drugs that are primarily metabolized by CYP3A for which elevated concentrations are associated with serious and/or life-threatening reactions: Alpha 1-adrenoreceptor antagonist: alfuzosin Antianginal: ranolazine Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine Anti-gout: colchicine (in patients with renal and/or hepatic impairment) Antipsychotics: lurasidone, pimozide Benign prostatic hyperplasia agents: silodosin Cardiovascular agents: eplerenone, ivabradine Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine HMG-CoA reductase inhibitors: lovastatin, simvastatin (these drugs can be temporarily discontinued to allow PAXLOVID use) Immunosuppressants: voclosporin Microsomal triglyceride transfer protein inhibitor: lomitapide Migraine medications: eletriptan, ubrogepant Mineralocorticoid receptor antagonists: finerenone Opioid antagonists: naloxegol PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertension Sedative/hypnotics: triazolam, oral midazolam Serotonin receptor 1A agonist/serotonin receptor 2A antagonist: flibanserin Vasopressin receptor antagonists: tolvaptan Drugs that are strong CYP3A inducers: PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer: Anticancer drugs: apalutamide Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin Antimycobacterials: rifampin, rifapentine Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor Herbal Products: St. John’s Wort (hypericum perforatum) Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PAXLOVID, which contains ritonavir, a strong CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PAXLOVID, may increase plasma concentrations of medications metabolized by CYP3A. Medications that induce CYP3A may decrease concentrations of PAXLOVID. These interactions may lead to: Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications Loss of therapeutic effect of PAXLOVID and possible development of viral resistance Severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with PAXLOVID. The most commonly reported concomitant medications resulting in serious adverse reactions were calcineurin inhibitors (eg, tacrolimus, cyclosporine), followed by calcium channel blockers. Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis. Because nirmatrelvir is coadministered with ritonavir, there may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection. The most common adverse reactions in the PAXLOVID group (≥1%) that occurred at a greater frequency than in the placebo group were dysgeusia (5% and <1%, respectively) and diarrhea (3% and 2%, respectively). The following adverse reactions have been identified during use of PAXLOVID under Emergency Use Authorization: Immune System Disorders: Anaphylaxis, hypersensitivity reactions Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome Nervous System Disorders: Headache Vascular Disorders: Hypertension Gastrointestinal Disorders: Abdominal pain, nausea, vomiting General Disorders and Administration Site Conditions: Malaise PAXLOVID is a strong inhibitor of CYP3A, and an inhibitor of CYP2D6, P-gp, and OATP1B1. Coadministration of PAXLOVID with drugs that are primarily metabolized by CYP3A and CYP2D6 or are transported by P-gp or OATP1B1 may result in increased plasma concentrations of such drugs and increase the risk of adverse events. Coadministration with other CYP3A substrates may require a dose adjustment or additional monitoring. Pregnancy: Available data on the use of nirmatrelvir during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Published studies with ritonavir are insufficient to identify a drug-associated risk of miscarriage. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy. Lactation: There are no available data on the presence of nirmatrelvir in human or animal milk, the effects on the breastfed infant, or the effects on milk production. A transient decrease in body weight was observed in the nursing offspring of rats administered nirmatrelvir. Limited published data report that ritonavir is present in human milk. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PAXLOVID and any potential adverse effects on the breastfed infant from PAXLOVID or from the underlying maternal condition. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception. Pediatrics: The optimal dose of PAXLOVID has not been established in pediatric patients. Systemic exposure of nirmatrelvir increases in renally impaired patients with increase in the severity of renal impairment. No dosage adjustment is recommended in patients with mild renal impairment. Reduce the dose of PAXLOVID in patients with moderate renal impairment (eGFR ≥30 to <60 mL/min). PAXLOVID is not recommended in patients with severe renal impairment (eGFR <30 mL/min) or in patients with end-stage renal disease (eGFR <15 mL/min). PAXLOVID is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Please see Full Prescribing Information, including BOXED WARNING and Patient Information Click for Fact Sheets: For Consumers: EUA Fact sheet for Patients, Parents, and Caregivers For Healthcare Professionals: EUA Fact Sheet for HCPs INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR PREVNAR 20 U.S. INDICATIONS PREVNAR 20® is a vaccine approved for: the prevention of invasive disease caused by 20 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in individuals 6 weeks and older. the prevention of otitis media (middle ear infection) caused by 7 of the 20 strains in individuals 6 weeks through 5 years. IMPORTANT SAFETY INFORMATION PREVNAR 20 should not be given to anyone who has had a severe allergic reaction to any component of PREVNAR 20 or to diphtheria–toxoid-containing vaccine. Individuals with weakened immune systems may have a lower immune response. Safety data are not available for these groups. A temporary pause in breathing after getting the vaccine has been observed in some infants who were born prematurely. For premature infants, talk to your doctor about the infant's medical status when deciding to get vaccinated with PREVNAR 20. In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, decreased appetite and injection site redness, injection site swelling, and fever. In individuals 15 months through 17 years of age vaccinated with a single dose, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, fatigue and muscle pain, decreased appetite, injection site swelling and injection site redness, headache, and fever. Ask your doctor about the risks and benefits of PREVNAR 20. Only a doctor can decide if PREVNAR 20 is right for your child. View the full Prescribing Information. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Disclosure Notice The information contained in this release is as of October 5, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s infectious disease pipeline, in-line products and product candidates, including ABRYSVO (RSVpreF), Pfizer’s aztreonam-avibactam (ATM-AVI) candidate and PAXLOVID, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with pre-clinical and clinical data (including Phase 1/2/3 or Phase 4 or pre-clinical data for ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates, including the data discussed in this release) in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new pre-clinical, clinical or safety data and further analyses of existing pre-clinical, clinical or safety data; risks associated with interim data, including the risk that final results from the Phase 3 trials for RSVpreF could differ from the interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; the ability to produce comparable clinical or other results for ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates, including efficacy, safety and tolerability pro to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of ABRYSVO (RSVpreF) and PAXLOVID to be effective against emerging virus variants; the risk that the use of ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications or submissions to request emergency use or conditional marketing authorizations for any potential indications for ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates may be filed in any jurisdictions and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates (including any requested amendments to the emergency use or conditional marketing authorizations) may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates will be commercially successful; intellectual property and other litigation; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates, including the authorization or approval of products or therapies developed by other companies; the risk that demand for any of our products may be reduced, no longer exist or not meet expectations, which may lead to excess inventory on-hand and/or in the channel, inventory write-offs or reduced revenues; challenges related to and uncertainties regarding the timing of a transition to the commercial market for any of our products; uncertainties related to the public’s adherence to vaccines and boosters; risks related to our ability to achieve our revenue forecasts for any of Pfizer’s infectious disease products or product candidates; the risk that other companies may produce superior or competitive products; risks related to the availability of raw materials to manufacture or test Pfizer’s infectious disease products or product candidates; challenges related to our vaccine’s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines or potential combination respiratory vaccines; whether and when additional supply or purchase agreements will be reached or existing agreements will be completed or renegotiated; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding ABRYSVO (RSVpreF) or any of Pfizer’s other infectious disease products or product candidates and uncertainties regarding the commercial impact of any such recommendations; pricing and access challenges; challenges related to public confidence in, or awareness of ABRYSVO (RSVpreF), Pfizer’s ATM-AVI candidate, PAXLOVID or any of Pfizer’s other infectious disease products or product candidates; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and .

THOUSAND OAKS, Calif. , April 27, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter of 2023. "We delivered 14% volume growth driven by the breadth of our portfolio and strong demand for our products globally," said Robert A. Bradway , chairman and chief executive officer. "We look forward to closing the acquisition of Horizon Therapeutics and joining forces to reach more patients around the world with their innovative medicines." Key results include: References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," "free cash flow" (computed by subtracting capital expenditures from operating cash flow) and "total revenues and product sales adjusted for foreign exchange impact" (computed by converting our current period local currency product sales using the prior period foreign exchange rates and comparing that to our current period product sales) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion. Product Sales Performance Total product sales increased 2% for the first quarter of 2023 versus the first quarter of 2022. Unit volumes grew 14%, partially offset by 5% lower net selling price, 3% unfavorable changes to estimated sales deductions, 2% lower inventory levels and 2% negative impact from foreign exchange. General Medicine Inflammation Hematology-Oncology Established Products Product Sales Detail by Product and Geographic Region $Millions, except percentages Q1 '23 Q1 '22 YOY Δ US ROW TOTAL TOTAL TOTAL Repatha ® 197 191 388 329 18 % Prolia ® 623 304 927 852 9 % EVENITY ® 164 90 254 170 49 % Aimovig ® 64 5 69 101 (32 %) TEZSPIRE ® 96 — 96 7 * TAVNEOS ® 23 — 23 — NM Otezla ® 294 98 392 451 (13 %) Enbrel ® 564 15 579 862 (33 %) AMJEVITA ® /AMGEVITA ™ 51 113 164 108 52 % BLINCYTO ® 126 68 194 138 41 % Vectibix ® 111 122 233 201 16 % KYPROLIS ® 234 124 358 287 25 % LUMAKRAS ® /LUMYKRAS ™ 48 26 74 62 19 % XGEVA ® 384 152 536 502 7 % Nplate ® 246 116 362 266 36 % MVASI ® 121 81 202 244 (17 %) KANJINTI ® 33 14 47 96 (51 %) EPOGEN ® 60 — 60 120 (50 %) Aranesp ® 115 240 355 358 (1 %) Parsabiv ® 58 33 91 86 6 % Neulasta ® 211 38 249 348 (28 %) Other products** 152 41 193 143 35 % Total product sales $      3,975 $      1,871 $      5,846 $      5,731 2 % *Change in excess of 100% ** Other products include Corlanor ® , AVSOLA ® , NEUPOGEN ® , RIABNI ® , IMLYGIC ® and Sensipar ® /Mimpara ™ , as well as sales by Bergamo and GENSENTA subsidiaries. NM = not meaningful Operating Expense, Operating Margin and Tax Rate Analysis On a GAAP basis: On a non-GAAP basis: $Millions, except percentages GAAP Non-GAAP Q1 '23 Q1 '22 YOY Δ Q1 '23 Q1 '22 YOY Δ Cost of Sales $  1,720 $  1,561 10 % $  1,016 $    951 7 % % of product sales 29.4 % 27.2 % 2.2 pts 17.4 % 16.6 % 0.8 pts Research & Development $  1,058 $    959 10 % $  1,044 $    934 12 % % of product sales 18.1 % 16.7 % 1.4 pts 17.9 % 16.3 % 1.6 pts Selling, General & Administrative $  1,258 $  1,228 2 % $  1,224 $  1,213 1 % % of product sales 21.5 % 21.4 % 0.1 pts 20.9 % 21.2 % (0.3) pts Other $    148 $     (10) * $       — $       — NM Total Operating Expenses $  4,184 $  3,738 12 % $  3,284 $  3,098 6 % Operating Margin operating income as % of product sales 32.9 % 43.6 % (10.7) pts 48.3 % 54.8 % (6.5) pts Tax Rate 17.5 % 11.9 % 5.6 pts 17.8 % 14.1 % 3.7 pts pts: percentage points * change in excess of 100% NM = not meaningful Cash Flow and Balance Sheet $Billions, except shares Q1 '23 Q1 '22 YOY Δ Operating Cash Flow $       1.1 $       2.2 $    (1.1) Capital Expenditures $       0.3 $       0.2 $     0.2 Free Cash Flow $       0.7 $       2.0 $    (1.3) Dividends Paid $       1.1 $       1.1 $     0.1 Share Repurchases $        — $       6.3 $    (6.3) Average Diluted Shares (millions) 538 551 (13) Note: Numbers may not add due to rounding $Billions 3/31/23 12/31/22 YTD Δ Cash and Investments $     31.6 $       9.3 $   22.3 Debt Outstanding $     61.6 $     38.9 $   22.7 Note: Numbers may not add due to rounding 2023 Guidance (Excludes any contribution from the announced acquisition of Horizon Therapeutics plc) The Company expects the announced acquisition of Horizon Therapeutics plc (Horizon) to close in the first half of 2023. For the full year 2023, excluding any contribution from the announced acquisition of Horizon, the Company now expects: First Quarter Product and Pipeline Update The Company provided the following updates on selected product and pipeline programs: General Medicine Olpasiran (AMG 890) AMG 133 AMG 786 Repatha Prolia Aimovig Inflammation TEZSPIRE Rocatinlimab (AMG 451 / KHK4083) Rozibafusp alfa (AMG 570) Efavaleukin alfa (AMG 592) Ordesekimab (AMG 714 / PRV-015) Oncology BLINCYTO Tarlatamab (AMG 757) Bemarituzumab LUMAKRAS/LUMYKRAS Xaluritamig (formerly AMG 509) AMG 340 AMG 193 Biosimilars TEZSPIRE is being developed in collaboration with AstraZeneca. Rocatinlimab, formerly AMG 451 / KHK4083 is being developed in collaboration with Kyowa Kirin. Ordesekimab formerly AMG 714 and also known as PRV-015 is being developed in collaboration with Provention Bio. AMG 509 is being developed in collaboration with Xencor. Humira is a registered trademark of AbbVie, Inc. STELARA is a registered trademark of Janssen Pharmaceutica NV . EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc. SOLIRIS is a registered trademark of Alexion Pharmaceuticals, Inc. Non-GAAP Financial Measures In this news release, management has presented its operating results for the first quarters of 2023 and 2022, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2023 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, divestitures, restructuring and certain other items from the related GAAP financial measures. Beginning January 1, 2022 , following industry guidance from the U.S. Securities and Exchange Commission , the Company no longer excludes adjustments for upfront license fees, development milestones and in-process research and development (IPR&D) expenses of pre-approval programs related to licensing, collaboration and asset acquisition transactions from its non-GAAP financial measures. GAAP financial measures are included in the news release. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the first quarter of 2023 and 2022. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. Management has also presented Total Revenues and Product Sales Adjusted for Foreign Exchange Impact, which is a non-GAAP financial measure, for the first quarter of 2023. Total Revenues and Product Sales Adjusted for Foreign Exchange Impact is computed by converting our current period local currency product sales using the prior period foreign exchange rates and comparing that to our current period product sales. The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's ongoing business activities by facilitating comparisons of results of ongoing business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity. The Company believes Total Revenues and Product Sales Adjusted for Foreign Exchange Impact provides supplementary information on the Company's product sales performance by excluding changes in foreign exchange rates between comparative periods. The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. About Amgen Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2022, Amgen was named one of the "World's Best Employers" by Forbes and one of "America's 100 Most Sustainable Companies" by Barron's. For more information, visit Amgen.com and follow us on Twitter, LinkedIn, Instagram, TikTok and YouTube. Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen . All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd., Kyowa-Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, the Teneobio, Inc. acquisition, the ChemoCentryx, Inc. acquisition, or the proposed acquisition of Horizon Therapeutics plc, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen , including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. CONTACT: Amgen , Thousand Oaks Jessica Akopyan , 805-440-5721 (media) Arvind Sood , 805-447-1060 (investors) Amgen Inc. Consolidated Statements of Income - GAAP (In millions, except per-share data) (Unaudited) Three months ended March 31 , 2023 2022 Revenues: Product sales $    5,846 $    5,731 Other revenues 259 507 Total revenues 6,105 6,238 Operating expenses: Cost of sales 1,720 1,561 Research and development 1,058 959 Selling, general and administrative 1,258 1,228 Other 148 (10) Total operating expenses 4,184 3,738 Operating income 1,921 2,500 Other income (expense): Interest expense, net (543) (295) Other income (expense), net 2,064 (530) Income before income taxes 3,442 1,675 Provision for income taxes 601 199 Net income $    2,841 $    1,476 Earnings per share: Basic $      5.32 $      2.69 Diluted $      5.28 $      2.68 Weighted-average shares used in calculation of earnings per share: Basic 534 548 Diluted 538 551 Amgen Inc. Consolidated Balance Sheets - GAAP (In millions) March 31 , December 31 , 2023 2022 (Unaudited) Assets Current assets: Cash, cash equivalents and marketable securities $              31,561 $                9,305 Trade receivables, net 5,736 5,563 Inventories 5,011 4,930 Other current assets 2,395 2,388 Total current assets 44,703 22,186 Property, plant and equipment, net 5,460 5,427 Intangible assets, net 15,393 16,080 Goodwill 15,531 15,529 Other noncurrent assets 7,633 5,899 Total assets $              88,720 $              65,121 Liabilities and Stockholders' Equity Current liabilities: Accounts payable and accrued liabilities $              13,381 $              14,096 Current portion of long-term debt 834 1,591 Total current liabilities 14,215 15,687 Long-term debt 60,761 37,354 Long-term tax liabilities 5,864 5,757 Other noncurrent liabilities 2,532 2,662 Total stockholders' equity 5,348 3,661 Total liabilities and stockholders' equity $              88,720 $              65,121 Shares outstanding 534 534 Amgen Inc. GAAP to Non-GAAP Reconciliations (Dollars in millions) (Unaudited) Three months ended March 31 , 2023 2022 GAAP cost of sales $       1,720 $       1,561 Adjustments to cost of sales: Acquisition-related expenses (a) (669) (610) Certain net charges pursuant to our restructuring and cost savings initiatives (35) — Total adjustments to cost of sales (704) (610) Non-GAAP cost of sales $       1,016 $          951 GAAP cost of sales as a percentage of product sales 29.4 % 27.2 % Acquisition-related expenses (a) (11.4) (10.6) Certain net charges pursuant to our restructuring and cost savings initiatives (0.6) 0.0 Non-GAAP cost of sales as a percentage of product sales 17.4 % 16.6 % GAAP research and development expenses $       1,058 $          959 Adjustments to research and development expenses: Acquisition-related expenses (a) (14) (25) Non-GAAP research and development expenses $       1,044 $          934 GAAP research and development expenses as a percentage of product sales 18.1 % 16.7 % Acquisition-related expenses (a) (0.2) (0.4) Non-GAAP research and development expenses as a percentage of product sales 17.9 % 16.3 % GAAP selling, general and administrative expenses $       1,258 $       1,228 Adjustments to selling, general and administrative expenses: Acquisition-related expenses (a) (34) (15) Non-GAAP selling, general and administrative expenses $       1,224 $       1,213 GAAP selling, general and administrative expenses as a percentage of product sales 21.5 % 21.4 % Acquisition-related expenses (a) (0.6) (0.2) Non-GAAP selling, general and administrative expenses as a percentage of product sales 20.9 % 21.2 % GAAP operating expenses $       4,184 $       3,738 Adjustments to operating expenses: Adjustments to cost of sales (704) (610) Adjustments to research and development expenses (14) (25) Adjustments to selling, general and administrative expenses (34) (15) Certain net charges pursuant to our restructuring and cost savings initiatives (b) (141) (2) Certain other expenses (c) (7) 12 Total adjustments to operating expenses (900) (640) Non-GAAP operating expenses $       3,284 $       3,098 Three months ended March 31 , 2023 2022 GAAP operating income $       1,921 $       2,500 Adjustments to operating expenses 900 640 Non-GAAP operating income $       2,821 $       3,140 GAAP operating income as a percentage of product sales 32.9 % 43.6 % Adjustments to cost of sales 12.0 10.6 Adjustments to research and development expenses 0.2 0.4 Adjustments to selling, general and administrative expenses 0.6 0.2 Certain net charges pursuant to our restructuring and cost savings initiatives (b) 2.5 0.1 Certain other expenses (c) 0.1 (0.1) Non-GAAP operating income as a percentage of product sales 48.3 % 54.8 % GAAP interest expense, net $        (543) $        (295) Adjustments to interest expense, net: Interest expense on acquisition-related debt (d) 123 — Non-GAAP interest expense, net $        (420) $        (295) GAAP other income (expense), net $       2,064 $        (530) Adjustments to other income (expense), net: Interest income and other expenses on acquisition-related debt (d) (6) — Equity method investment basis difference amortization — 47 Net (gains)/losses from equity investments (e) (1,853) 365 Total adjustments to other income (expense), net (1,859) 412 Non-GAAP other income (expense), net $          205 $        (118) GAAP income before income taxes $       3,442 $       1,675 Adjustments to income before income taxes: Adjustments to operating expenses 900 640 Adjustments to interest expense, net 123 — Adjustments to other income (expense), net (1,859) 412 Total adjustments to income before income taxes (836) 1,052 Non-GAAP income before income taxes $       2,606 $       2,727 GAAP provision for income taxes $          601 $          199 Adjustments to provision for income taxes: Income tax effect of the above adjustments (f) (117) 189 Other income tax adjustments (g) (19) (4) Total adjustments to provision for income taxes (136) 185 Non-GAAP provision for income taxes $          465 $          384 GAAP tax as a percentage of income before taxes 17.5 % 11.9 % Adjustments to provision for income taxes: Income tax effect of the above adjustments (f) 1.0 2.3 Other income tax adjustments (g) (0.7) (0.1) Total adjustments to provision for income taxes 0.3 2.2 Non-GAAP tax as a percentage of income before taxes 17.8 % 14.1 % GAAP net income $       2,841 $       1,476 Adjustments to net income: Adjustments to income before income taxes, net of the income tax effect (719) 863 Other income tax adjustments (g) 19 4 Total adjustments to net income (700) 867 Non-GAAP net income $       2,141 $       2,343 Note: Numbers may not add due to rounding Amgen Inc. GAAP to Non-GAAP Reconciliations (In millions, except per-share data) (Unaudited) The following table presents the computations for GAAP and non-GAAP diluted earnings per share: Three months ended March 31, 2023 Three months ended March 31, 2022 GAAP Non-GAAP GAAP Non-GAAP Net income $        2,841 $        2,141 $        1,476 $        2,343 Weighted-average shares for diluted EPS 538 538 551 551 Diluted EPS $          5.28 $          3.98 $          2.68 $          4.25 (a) The adjustments related primarily to noncash amortization of intangible assets from business acquisitions. (b) For the three months ended March 31, 2023 , the adjustments related primarily to severance expenses associated with our restructuring plan initiated in early 2023. (c) For the three months ended March 31, 2023 , the adjustments related to the change in fair values of contingent consideration liabilities. For the three months ended March 31, 2022 , the adjustments related primarily to an in-process research and development asset adjustment. (d) For the three months ended March 31, 2023 , the adjustments included (i) interest expense and income on senior notes issued in March 2023 and (ii) debt issuance costs and other fees related to our bridge credit and term loan credit agreements, incurred prior to the closing of our proposed acquisition of Horizon Therapeutics plc. (e) For the three months ended March 31, 2023 , the adjustments related primarily to our BeiGene, Ltd. equity fair value adjustment. (f) The tax effect of the adjustments between our GAAP and non-GAAP results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). Generally, this results in a tax impact at the U.S. marginal tax rate for certain adjustments, including the majority of amortization of intangible assets, whereas the tax impact of other adjustments, including expenses related to restructuring and cost savings initiatives, depends on whether the amounts are deductible in the respective tax jurisdictions and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax rate for the adjustments to our GAAP income before income taxes for the three months ended March 31, 2023 , was 14.0% compared to 18.0% for the corresponding period of the prior year. (g) The adjustments related to certain acquisition items, prior period and other items excluded from GAAP earnings. Amgen Inc. Reconciliations of Cash Flows (In millions) (Unaudited) Three months ended March 31 , 2023 2022 Net cash provided by operating activities $     1,064 $     2,164 Net cash provided by (used in) investing activities 1,358 (111) Net cash provided by (used in) financing activities 21,509 (3,514) Increase (decrease) in cash and cash equivalents 23,931 (1,461) Cash and cash equivalents at beginning of period 7,629 7,989 Cash and cash equivalents at end of period $   31,560 $     6,528 Three months ended March 31 , 2023 2022 Net cash provided by operating activities $     1,064 $     2,164 Capital expenditures (344) (190) Free cash flow $       720 $     1,974 Amgen Inc. Reconciliation of Total Revenues and Product Sales Adjusted for Foreign Exchange (FX) Impact (Dollars in millions) (Unaudited) Three months ended March 31 , 2023 2022 Change FX impact $ (a) Three months ended March 31, 2023 excluding FX FX impact % (a) Change excluding FX Product Sales $       5,846 $       5,731 2 % $         (103) $        5,949 (2 %) 4 % Total Revenues $       6,105 $       6,238 (2 %) $         (103) $        6,208 (2 %) — % (a) Foreign exchange impact was calculated by converting our current period local currency Product sales using the prior period foreign exchange rates and comparing that to our current period Product sales. Amgen Inc Reconciliation of GAAP EPS Guidance to Non-GAAP EPS Guidance for the Year Ending December 31, 2023 (Unaudited) GAAP diluted EPS guidance $  15.38 — $ 16.59 Known adjustments to arrive at non-GAAP*: Acquisition-related expenses (a) 4.31 — 4.36 Net charges related to restructuring and cost savings initiatives 0.47 — 0.53 Net (gains)/losses from equity investments (2.70) Other 0.03 Non-GAAP diluted EPS guidance $  17.60 — $ 18.70 * The known adjustments are presented net of their related tax impact, which amount to approximately $0.48 - $0.50 per share. (a) The adjustments relate primarily to noncash amortization of intangible assets acquired in business acquisitions. Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, including any impact of the proposed Horizon acquisition, divestitures, asset impairments, litigation, changes in fair value of our contingent consideration obligations and changes in fair value of our equity investments. Reconciliation of GAAP Tax Rate Guidance to Non-GAAP Tax Rate Guidance for the Year Ending December 31, 2023 (Unaudited) GAAP tax rate guidance 17.0 % — 18.5 % Tax rate of known adjustments discussed above 0.5 % — 1.0 % Non-GAAP tax rate guidance 18.0 % — 19.0 % View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-reports-first-quarter-financial-results-301810090.html SOURCE Amgen