LATEST COMPANY NEWS. - Free Online Library (2024)

Link/Page Citation

Reuters - US FDA approves Daiichi, AstraZeneca drug for treatment of solid tumors - 6/4/2024

The U.S. Food and Drug Administration gave accelerated approval for the expanded use of Daiichi Sankyo, opens new tab and AstraZeneca's (AZN.L), opens new tab drug to treat patients with a type of solid tumor.

For the complete story see:

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-daiichi-astrazeneca-drug-treatment-solid-tumors-2024-04-05/

Fierce Pharma - Novartis finally ready for Pluvicto filing in earlier prostate cancer as patient survival data clear up - 5/4/2024

After two delays spanning more than a year, Novartis is finally gearing up for a high-stakes FDA application to expand the radiotherapy Pluvicto into earlier treatment of prostate cancer.

For the complete story see:

https://www.fiercepharma.com/pharma/novartis-finally-ready-pluvicto-filing-earlier-prostate-cancer-patient-survival-data-clear

Fierce Pharma - Bristol Myers' Abecma wins FDA nod in earlier multiple myeloma with updated boxed warning on secondary cancer - 5/4/2024

After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers Squibb's CAR-T therapy Abecma into the earlier treatment of multiple myeloma.

For the complete story see:

https://www.fiercepharma.com/pharma/bristol-myers-abecma-wins-fda-nod-earlier-multiple-myeloma-updated-boxed-warning-secondary

Other Stories

Pharmaceutical Technology - Amylyx axes ALS drug from market after Phase III failure - 4/4/2024

Pharmaceutical Technology - Basilea Pharmaceutica's Zevtera receives FDA approval - 4/4/2024

Pharmaceutical Technology - Morris & Dickson will distribute mpox vaccine Jynneos in the US - 3/4/2024

Yahoo Finance - J&J boosts heart device business in $13.1 bln Shockwave deal - 3/4/2024

Media Releases

Eli Lilly & Company (NYSE: LLY) - Results announced from EMPACT-MI phase III trial investigating the effect of Jardiance® (empagliflozin) on risk of heart failure hospitalization and death in adults following a heart attack - 6/4/2024

Johnson & Johnson (NYSE: JNJ) - CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy - 5/4/2024

Merck & Company, Inc. (NYSE: MRK) - Merck Initiates Phase 3 Clinical Trial of MK-1084, an Investigational Oral KRAS G12C Inhibitor, in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Certain Patients With Metastatic Non-Small Cell Lung Cancer - 4/4/2024

Novartis (NYSE: NVS) - Novartis confirms plans to file for Pluvicto® pre-taxane label expansion in H2 2024 based on latest data from Phase III PSMAfore study - 4/4/2024

Abbvie (NYSE: ABBV) - Allergan Aesthetics Announces the Return of CoolMonth with CoolSculpting® - 3/4/2024

Latest Research

Revisiting the complex time-varying effect of non-pharmaceutical interventions on COVID-19 transmission in the United States By Gonghua Wu, Wanfang Zhang, Wenjing Wu, Pengyu Wang, Zitong Huang, Yueqian Wu, Junxi Li, Wangjian Zhang, Zhicheng Du, Yuantao Hao

Industry Overview

United States Pharmaceuticals

Overviews of Leading Companies

Abbot Laboratories (NYSE: ABT)

Abbvie (NYSE: ABBV)

AmerisourceBergen Corporation (NYSE: ABC)

Amgen (NASDAQ: AMGN)

AstraZeneca (NYSE: AZN)

Bausch Health Companies Inc. (NYSE: BHC)

Baxter International (NYSE: BAX)

Bristol-Myers Squibb (NYSE: BMY)

Danaher Corporation (NYSE: DHR)

Eli Lilly & Company (NYSE: LLY)

Genentech (SIX: RO, ROG; OTCQX: RHHBY)

GlaxoSmithKline (LSE: GSK)

Johnson & Johnson (NYSE: JNJ)

McKesson Corporation (NYSE: MCK)

Merck & Company, Inc. (NYSE: MRK)

Novartis (NYSE: NVS)

Novavax Inc. (NASDAQ: NVAX)

Novo Nordisk (NYSE: NVO)

Perrigo Company Plc (NYSE: PRGO)

Pfizer Inc. (NYSE: PFE)

Regeneron (NASDAQ: REGN)

Sanofi (NYSE: SNY)

Teva (NYSE: TEVA)

Thermo Fisher Scientific (NYSE: TMO)

Associate: Danny Cliffson Crispin Benos

News and Commentary

Reuters - US FDA approves Daiichi, AstraZeneca drug for treatment of solid tumors - 6/4/2024

For the complete story see:

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-daiichi-astrazeneca-drug-treatment-solid-tumors-2024-04-05/

Fierce Pharma - Novartis finally ready for Pluvicto filing in earlier prostate cancer as patient survival data clear up - 5/4/2024

After two delays spanning more than a year, Novartis is finally gearing up for a high-stakes FDA application to expand the radiotherapy Pluvicto into earlier treatment of prostate cancer.

For the complete story see:

https://www.fiercepharma.com/pharma/novartis-finally-ready-pluvicto-filing-earlier-prostate-cancer-patient-survival-data-clear

Fierce Pharma - Bristol Myers' Abecma wins FDA nod in earlier multiple myeloma with updated boxed warning on secondary cancer - 5/4/2024

After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers Squibb's CAR-T therapy Abecma into the earlier treatment of multiple myeloma.

For the complete story see:

https://www.fiercepharma.com/pharma/bristol-myers-abecma-wins-fda-nod-earlier-multiple-myeloma-updated-boxed-warning-secondary

Yahoo Finanve - Merck (MRK) Begins Phase II/II Ovarian Cancer Study on ADC Drug - 4/4/2024

Merck MRK announced that a phase II/III study has been initiated on its CDH6-directed DXd antibody-drug conjugate, raludotatug deruxtecan (R-DXd), in patients with platinum-resistant ovarian cancer.

For the complete story see:

https://finance.yahoo.com/news/merck-mrk-begins-phase-ii-093600076.html

Pharmaceutical Technology - Amylyx axes ALS drug from market after Phase III failure - 4/4/2024

Amylyx Pharmaceuticals has formally announced the removal of its amyloid lateral sclerosis (ALS) drug Relyvrio (AMX0035) from the market following disappointing Phase III results.

For the complete story see:

https://www.pharmaceutical-technology.com/news/amylyx-axes-als-drug-from-market-after-phase-iii-failure/

Pharmaceutical Technology - Basilea Pharmaceutica's Zevtera receives FDA approval - 4/4/2024

The US Food and Drug Administration (FDA) has approved Basilea Pharmaceutica's Zevtera (ceftobiprole medocaril sodium for injection), an antibiotic to treat multiple infections.

For the complete story see:

https://www.pharmaceutical-technology.com/news/basilea-zevtera-fda-approval/

Pharmaceutical Technology - Morris & Dickson will distribute mpox vaccine Jynneos in the US - 3/4/2024

Following Bavarian Nordic's announcement of the US commercial launch of its mpox (monkeypox) vaccine Jynneos (Imvanex/Imvamune), Morris & Dickson has shared that it will be the first US distributor of the vaccine for the rare viral disease.

For the complete story see:

https://www.pharmaceutical-technology.com/news/morris-dickson-will-distribute-mpox-vaccine-jynneos-in-the-us/

Yahoo Finance - J&J boosts heart device business in $13.1 bln Shockwave deal - 3/4/2024

Johnson & Johnson, opens new tab on Friday agreed to buy Shockwave Medical (SWAV.O), opens new tab in a deal valued at $13.1 billion including debt, as it builds its cardiac-health-centric medical devices business to help drive growth.

For the complete story see:

https://www.reuters.com/markets/deals/johnson-johnson-buy-shockwave-medical-125-bln-deal-2024-04-05/

Media Releases

RIDGEFIELD, Conn. and INDIANAPOLIS, April 6, 2024 - The EMPACT-MI phase III clinical trial showed a 10% relative risk reduction in the primary composite endpoint of time to first hospitalization due to heart failure or all-cause mortality for Jardiance® (empagliflozin) versus placebo, which did not reach statistical significance. Jardiance was initiated in adults within 14 days of an acute myocardial infarction, commonly known as a heart attack, and demonstrated a reassuring safety profile in this population. Additional pre-specified exploratory analyses revealed relative risk reductions of 23% for time to first hospitalization due to heart failure and 33% for total hospitalizations due to heart failure with Jardiance over placebo. Detailed results from Boehringer Ingelheim and Eli Lilly and Company's (NYSE: LLY) phase III EMPACT-MI trial were announced today at the American College of Cardiology's 2024 Scientific Session & Expo. Results were announced in collaboration with Duke Clinical Research Institute (DCRI) and simultaneously published in The New England Journal of Medicine.

"These results add to our understanding of SGLT2 inhibitors and contribute to the body of evidence across six clinical studies examining the potential for Jardiance to impact major outcomes in a broad population of adults with heart failure, chronic kidney disease or type 2 diabetes," said Mohamed Eid, M.D., M.Sc., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Renal-Metabolic Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "Building on this strong foundation, we remain committed to leading efforts aimed at increasing awareness, generating real-world evidence and advancing care for people affected by interconnected cardiovascular, renal and metabolic diseases."

The EMPACT-MI phase III trial investigated Jardiance 10 mg compared with placebo, given once daily on top of standard of care, in more than 6,500 adults within 14 days of hospital admission for heart attack. The primary endpoint of the study was the composite of time to first hospitalization due to heart failure or all-cause mortality up to 26 months. Participants had no history of chronic heart failure and were eligible regardless of type 2 diabetes and chronic kidney disease status.

"Despite remarkable advances in treatment, heart attack remains the most common cause of heart failure," said Jeff Emmick, M.D., Ph.D., senior vice president, Product Development, Lilly. "There is still an unmet need to reduce the risk of new onset heart failure and other common complications after a heart attack. However, in adults who have chronic heart failure, Jardiance has proven to be an important therapy for reducing the risk of cardiovascular death and heart failure hospitalizations, and has the potential to meet the needs of millions of people worldwide."

EMPACT-MI is part of the EMPOWER program, launched by the Boehringer Ingelheim and Lilly Alliance to explore the impact of Jardiance on major patient outcomes across the spectrum of cardiovascular, renal and metabolic conditions including type 2 diabetes, chronic heart failure, heart attack and chronic kidney disease. Globally, more than 1 billion people live with these interconnected disorders, which are a leading cause of death worldwide.

https://investor.lilly.com/news-releases/news-release-details/results-announced-empact-mi-phase-iii-trial-investigating-effect

HORSHAM, PA (April 5, 2024) - Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

FDA approval is based on positive results from the Phase 3 CARTITUDE-4 study, which demonstrated that the earlier use of CARVYKTI® reduced the risk of disease progression or death by 59 percent compared to standard therapies-pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd)-in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.1 The study, which was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine, also included and reported key secondary results such as overall response (OR) and overall survival (OS).1

"CARVYKTI demonstrated remarkable efficacy as a personalized, one-time infusion in the earlier treatment of relapsed/refractory multiple myeloma as shown through the CARTITUDE-4 study results," said Binod Dhakal, M.D., Associate Professor, Medical College of Wisconsin, Division of Hematology and Oncology.* "With this approval, I'm excited for patients who may have the opportunity for a treatment-free period for their multiple myeloma as early as first relapse, with the hope of eliminating the burden of having to be on continuous treatment while living with this challenging disease."

More than 35,000 estimated new cases of multiple myeloma, an incurable blood cancer, will be diagnosed in 2024 in the United States.2 Real-world studies show that only an estimated 15% of patients initially diagnosed with multiple myeloma are able to start a 5th line of therapy.3 With this new indication, more patients will be able to access this innovative treatment.

"This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. "We are proud to bring an important, highly effective immunotherapy that has demonstrated a favorable benefit/risk profile to physicians and patients for the earlier treatment of relapsed/refractory multiple myeloma, and we look forward to building on this latest milestone as we continue to focus on our ultimate goal of delivering a cure for multiple myeloma."

CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease. Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients. Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.

"We understand the urgency for patients in need of CARVYKTI, and we have been making considerable progress in increasing supply and availability in anticipation of this milestone approval," said Tyrone Brewer, President, U.S. Hematology, Johnson & Johnson Innovative Medicine. "We more than doubled manufacturing of CARVYKTI in 2023, we are striving to double again in 2024, and we will continue to invest in our capacity so we can provide this critical therapy to as many patients as possible."

The safety profile for CARVYKTI® includes a boxed warning for Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Parkinsonism and Guillain-Barre syndrome and their associated complications, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), Prolonged and Recurrent Cytopenias and Secondary Malignancies including myelodysplastic syndrome, acute myeloid leukemia, and T-cell malignancies.1 Warnings and Precautions include Increased Early Mortality, Hypogammaglobulinemia, Infections, Hypersensitivity Reactions and Effects on Ability to Drive and Use Machines.

The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.1The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia.

https://www.jnj.com/media-center/press-releases/carvykti-is-the-first-and-only-bcma-targeted-treatment-approved-by-the-u-s-fda-for-patients-with-relapsed-or-refractory-multiple-myeloma-who-have-received-at-least-one-prior-line-of-therapy

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced it has initiated a Phase 3 clinical trial evaluating MK-1084, an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor KRAS G12C mutations and express PD-L1 (tumor proportion score [TPS] â¥50%).

"KRAS is among the most prevalent mutations in cancer and KRAS G12C is the most common KRAS mutation in patients with non-small cell lung cancer," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "Based on early evidence showing MK-1084 in combination with KEYTRUDA had a manageable safety profile and promising anti-tumor activity, we are now proceeding to a larger Phase 3 trial to evaluate this combination in certain patients with metastatic non-small cell lung cancer."

Merck has initiated a Phase 3, randomized, double-blind, multicenter clinical trial (NCT06345729) evaluating once daily MK-1084 in combination with KEYTRUDA administered once every three weeks compared with KEYTRUDA plus placebo in previously untreated patients with KRAS G12C-mutated metastatic NSCLC with a PD-L1 TPS â¥50%. The trial will enroll approximately 600 patients globally. The primary endpoints of the study are progression-free survival and overall survival, and key secondary endpoints include objective response rate and duration of response.

MK-1084 is currently being evaluated in a Phase 1, open-label multicenter clinical trial (NCT05067283) to assess safety, tolerability, pharmaco*kinetics and efficacy of MK-1084 as monotherapy and as part of various combination therapies in patients with KRAS G12C mutant advanced solid tumors. Preliminary safety and efficacy data from this trial were previously presented at the European Society for Medical Oncology (ESMO) Congress in 2023.

MK-1084 is being developed through a collaboration with Taiho Pharmaceutical Co. Ltd and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. This collaboration was announced in January 2020.

https://www.merck.com/news/merck-initiates-phase-3-clinical-trial-of-mk-1084-an-investigational-oral-kras-g12c-inhibitor-in-combination-with-keytruda-pembrolizumab-for-first-line-treatment-of-certain-patients-with-met/

Novartis (NYSE: NVS) - Novartis confirms plans to file for Pluvicto® pre-taxane label expansion in H2 2024 based on latest data from Phase III PSMAfore study - 4/4/2024

Updated overall survival (OS) results from a pre-planned analysis at approximately 75% information fraction demonstrates an OS hazard ratio less than 1.0 (HR<1.0) in the intent-to-treat (ITT) population unadjusted for cross-over.

Radiographic progression free survival (rPFS) and other secondary efficacy endpoints are consistent with previous interim analysis results presented in 2023.

With an additional 8 months of follow-up, Pluvicto® safety profile remains consistent with previous interim analyses presented in 2023.

Full results will be presented at an upcoming medical congress.

Novartis confirms plans to file in H2 2024.

https://www.novartis.com/news/novartis-confirms-plans-file-pluvicto-pre-taxane-label-expansion-h2-2024-based-latest-data-from-phase-iii-psmafore-study

Abbvie (NYSE: ABBV) - Allergan Aesthetics Announces the Return of CoolMonth with CoolSculpting® - 3/4/2024

IRVINE, Calif., April 3, 2024 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV) is announcing its second annual CoolMonth celebration featuring CoolSculpting® Elite. From April 1 through April 30, 2024, consumers can access CoolSavings promotions to help accelerate their body contouring journey. Leveraging last year's success, which saw more than 62,000 treatments during the month-long celebration1, the brand aims to encourage and inspire more consumers on their body contouring journey to discuss options with their trained healthcare provider.

"A 2023 survey revealed that consumers seek non-invasive body contouring treatments in the spring.2* I've also seen this in my practice and CoolMonth activities encourage conversations around body contouring treatments. Through our discussions, we can effectively set realistic expectations and guide patients toward achieving their desired goals," says Dr. Terrence Keaney, MD, FAAD, Board Certified Dermatologist.

CoolSculpting® is the treatment aesthetic providers use most for nonsurgical fat reduction3 and just like CoolSculpting®, CoolSculpting® Elite is FDA-cleared for the treatment of visible fat bulges in the thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm in patients with a Body Mass Index (BMI) of â¤ 30 and in submental and submandibular areas in patients with a BMI of â¤ 46.2. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. CoolSculpting® and CoolSculpting® Elite are not treatments for weight loss.

"According to a survey we conducted last year, 50% of people would look into body contouring treatments in preparation for summer,2*" said Jasson Gilmore, Senior Vice President, U.S. Aesthetics. "Also, our patient satisfaction research shows that 89% of patients were satisfied or very satisfied with CoolSculpting® after two visits.4 We want to support individuals seeking treatment by offering promotions throughout CoolMonth that focus on encouraging patients to reach out to trained providers for more information on CoolSculpting® Elite and a full treatment plan."

Allergan Aesthetics is encouraging those considering CoolSculpting® to embark on a CoolSculpting® Elite journey by following these steps to unlock exclusive CoolMonth offers:

Find Your Provider: Visit the CoolSculpting® website to locate a provider near you by entering your zip code.

Look for the CoolMonth of Savings Logo: Search for providers on the website that have the "CoolMonth of Savings" badge for special deals.

Get in Touch: Contact the provider you choose either via phone or email to discover their unique promotions.

Enjoy Extra Savings: Join HERE to become a member of Alle, Allergan Aesthetics loyalty rewards program, and to claim an offer of $200 off your first CoolSculpting® treatment. Terms and Conditions apply.

Prior to treatment, those interested in CoolSculpting® should seek a certified healthcare provider to determine whether treatment is appropriate and receive further education about risks associated with treatment.

https://news.abbvie.com/2024-04-03-Allergan-Aesthetics-Announces-the-Return-of-CoolMonth-with-CoolSculpting-R

Latest Research

Revisiting the complex time-varying effect of non-pharmaceutical interventions on COVID-19 transmission in the United States

Gonghua Wu, Wanfang Zhang, Wenjing Wu, Pengyu Wang, Zitong Huang, Yueqian Wu, Junxi Li, Wangjian Zhang, Zhicheng Du, Yuantao Hao

Introduction: Although the global COVID-19 emergency ended, the real-world effects of multiple non-pharmaceutical interventions (NPIs) and the relative contribution of individual NPIs over time were poorly understood, limiting the mitigation of future potential epidemics.

Methods: Based on four large-scale datasets including epidemic parameters, virus variants, vaccines, and meteorological factors across 51 states in the United States from August 2020 to July 2022, we established a Bayesian hierarchical model with a spike-and-slab prior to assessing the time-varying effect of NPIs and vaccination on mitigating COVID-19 transmission and identifying important NPIs in the context of different variants pandemic.

Results: We found that (i) the empirical reduction in reproduction number attributable to integrated NPIs was 52.0% (95%CI: 44.4, 58.5%) by August and September 2020, whereas the reduction continuously decreased due to the relaxation of NPIs in following months; (ii) international travel restrictions, stay-at-home requirements, and restrictions on gathering size were important NPIs with the relative contribution higher than 12.5%; (iii) vaccination alone could not mitigate transmission when the fully vaccination coverage was less than 60%, but it could effectively synergize with NPIs; (iv) even with fully vaccination coverage >60%, combined use of NPIs and vaccination failed to reduce the reproduction number below 1 in many states by February 2022 because of elimination of above NPIs, following with a resurgence of COVID-19 after March 2022.

Conclusion: Our results suggest that NPIs and vaccination had a high synergy effect and eliminating NPIs should consider their relative effectiveness, vaccination coverage, and emerging variants.

https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1343950/full

The Industry

Pharmaceuticals - United States

HIGHLIGHT

The projected revenue for the pharmaceuticals market in the United States is expected to reach US$636.90bn in 2024.

Among the various market segments, Oncology Drugs is anticipated to be the largest, with a projected market volume of US$114.60bn in the same year.

Looking ahead, the market is expected to experience a steady annual growth rate of 5.96% from 2024 to 2028, resulting in a market volume of US$802.80bn by 2028.

It is worth noting that in global comparison, United States is expected to generate the highest revenue in the pharmaceuticals market, with US$636.90bn in 2024.

The pharmaceutical market in the United States is experiencing a surge in demand for personalized medicine and targeted therapies.

MARKET DEFINITION

The Pharmaceuticals market covers remedies used to cure, treat, prevent, and diagnose diseases. These small molecule drugs or biologic medical products may be called drugs, medications, or medicines. Prescription drugs and over-the-counter (OTC) drugs are both included. Depending on the regulations in each country, these products are provided by pharmacies, hospitals, physicians, and/or drug stores, and/or they can be bought elsewhere. They may be administered in the form of pills, capsules, gels, ointments, injections, infusions, lozenges, or aerosols/sprays.

The Pharmaceuticals market is organized in markets that cover drugs used in specific medical fields, i.e., medicines for a specific disesase or a certain type of medicine. They include original brands, biosimilars, generics, and orphan drugs. The Other Pharmaceuticals market provides information on additional specialties that are not covered by the main markets.

Market values represent the revenues generated by manufacture prices paid to primary vendors, either directly or through distribution channels (excluding VAT). Reported market revenues include spending by consumers (B2C), companies (B2B), and governments (B2G).

Source: Statista

https://www.statista.com/outlook/hmo/pharmaceuticals/united-states

Leading Companies

Abbot Laboratories (NYSE: ABT)

Abbott is a globally diversified healthcare company with a central purpose to help people live their healthiest possible lives. We offer a broad portfolio of market-leading products that align with favorable long-term healthcare trends in both developed and developing markets. Building on a strong foundation of more than 130 years of success, Abbott is poised to deliver top-tier growth, expanding margins, strong cash flow and increasing returns to shareholders.

BALANCE

Well-balanced diversity is the foundation of Abbott's strategy and success. Our four major businesses are of roughly equal size, and that balance extends across geographies and payers. We constantly shape our portfolio to ensure that we're in the right markets and that our success isn't over reliant on any single therapy, technology, country or payer. And approximately 50 percent of our sales are direct to consumers and patients, making Abbott one of the most consumer-facing healthcare companies in the world.

GLOBAL PRESENCE

Abbott is one of the most global healthcare companies in the world with 70 percent of revenue generated in markets outside of the United States and 50 percent of revenue generated in faster-growing geographies where healthcare s'/

\pending is outpacing the growth of gross domestic product (GDP).

RELEVANCE

Abbott is well positioned to grow with the major trends underlying our businesses and the broader global environment. In addition to the growth of developing economies and the global middle class, which has vastly expanded our markets and ability to help more people around the world, a related and equally powerful trend driving our business is the aging of the global population. All of Abbott's major businesses are well- aligned to be relevant leaders and to serve these trends across multiple markets.

LEADING

Abbott intends to lead - both scientifically and commercially - in the markets in which we compete. Abbott holds various leadership positions across many of its business segments and across multiple geographies. This requires presence in these markets to meet the local healthcare needs and preferences by many key stakeholders, including hospitals, physicians, pharmacies and consumers.

CONSISTENT AND RELIABLE PERFORMANCE

These strengths add up to the fundamental advantage that we offer investors: consistent and reliable performance. On a more than 125-year foundation, Abbott is built strong and built to last. We have succeeded in delivering superior innovation, productivity, and growth with consistency and reliability.

https://www.abbott.com/investors/overview.html

24 January 2024

ABBOTT REPORTS FOURTH-QUARTER AND FULL-YEAR 2023 RESULTS; ISSUES 2024 FINANCIAL OUTLOOK

Fourth-quarter reported sales increased 1.5 percent; organic sales growth for the underlying base business increased 11.0 percent

Full-year 2023 reported sales decreased 8.1 percent due to anticipated decline in COVID-19 testing-related sales; organic sales growth for the underlying base business increased 11.6 percent

Full-year 2023 GAAP diluted EPS of $3.26; adjusted diluted EPS of $4.44

R&D pipeline continues to deliver steady cadence of new products

ABBOTT PARK, Ill., Jan. 24, 2024 /PRNewswire/ -- Abbott today announced financial results for the fourth quarter ended Dec. 31, 2023.

Fourth-quarter sales increased 1.5 percent on a reported basis, 2.1 percent on an organic basis, and 11.0 percent on an organic basis, excluding COVID-19 testing-related sales1.

Fourth-quarter GAAP diluted EPS of $0.91 and adjusted diluted EPS of $1.19, which excludes specified items.

Abbott issues full-year 2024 guidance for diluted EPS on a GAAP basis of $3.20 to $3.40 and full-year adjusted diluted EPS of $4.50 to $4.70.

Abbott projects full-year 2024 organic sales growth, excluding COVID-19 testing-related sales, to be in the range of 8.0% to 10.0%2.

In 2023, Abbott continued to recapture market share in the U.S. infant formula market. The company has now reclaimed its previous market-leading position, as measured on a volume basis.

In December, Abbott announced U.S. Food and Drug Administration (FDA) approval of its new laboratory automation system, GLP systems Track[TM], to help laboratories optimize performance and safety to better meet the growing demand for diagnostic testing.

In January, Abbott announced that the first-in-human procedures were conducted using the company's new Volt[TM] Pulsed Field Ablation (PFA) System to treat patients with heart rhythm disorders such as atrial fibrillation (AFib). These procedures were part of Abbott's Volt CE Mark clinical study. Abbott anticipates approval for its U.S. clinical trial (IDE) for the Volt PFA System in the first half of 2024.

In January, Abbott announced that Tandem Diabetes Care's t:slim X2[TM]3 insulin pump is the first automated insulin delivery system in the U.S. to integrate with Abbott's new FreeStyle Libre® 2 Plus sensor.

"The strength and diversity of the Abbott portfolio drove our success in 2023," said Robert B. Ford, chairman and chief executive officer, Abbott. "We're entering 2024 with a lot of positive momentum, and with our highly productive pipeline, we're well-positioned for growth in 2024 and beyond."

FOURTH-QUARTER BUSINESS OVERVIEW

Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange, the impact of exiting the pediatric nutrition business in China, and the impact of the acquisition of Cardiovascular Systems, Inc. (CSI), is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance as the COVID-19 pandemic has shifted to an endemic state, resulting in significantly lower demand for COVID-19 tests.

For full release see:

https://abbott.mediaroom.com/2024-01-24-Abbott-Reports-Fourth-Quarter-and-Full-Year-2023-Results-Issues-2024-Financial-Outlook

Abbvie (NYSE: ABBV)

Allergan Is Now Part Of Abbvie

Together, we are bringing over 30 brands and leadership positions to better serve patients today and invest in the medicines of the future.

With the Allergan acquisition, we are bringing together over 30 brands and leadership positions to expand and diversify our product portfolio. This allows us to have immediate scale and profitability to advance our innovative science pipeline that brings patients groundbreaking medicines across a wide spectrum of therapeutic need/critical therapeutic areas.

We continue to build a sustainable company for the long term that provides profitable growth for shareholders, financial flexibility to invest and expand our reach to help address the needs of people and communities around the world.

https://www.abbvie.com/abbvie-allergan-overview.html

We're a company that takes on the toughest health challenges. But we do more than treat diseases-we aim to make a remarkable impact on people's lives. We are AbbVie, a highly focused research-driven biopharmaceutical company.

What we do

Our 30,000 employees are scientists, researchers, communicators, manufacturing specialists and regulatory experts located around the globe. We come up with new approaches to addressing today's health issues-from life-threatening illness to chronic conditions.

We target specific difficult-to-cure diseases where we can leverage our core R&D expertise to advance science. We're constantly working to create solutions that go beyond treating the illness to have a positive impact on patients' lives, on societies-and on science itself.

At AbbVie, we see a future full of possibility, where health is in reach and patient lives are improved.

Our principles are foundational

Our purpose is profound, and our path is clear. We embrace the responsibility of making a remarkable impact on people's lives through the innovative medicines and solutions we create together. This is driven by our compassion for people, commitment to innovation and inclusion, service to the community, and uncompromising integrity at the heart of everything we do.

Operating as one AbbVie team, we care deeply for our patients, their families, our employees, and our communities. We strive to always do the right thing, pursuing the highest standards in quality, compliance, safety, and performance. In everything we do, we invest and innovate relentlessly to tackle unmet needs, creating new medicines and healthcare approaches for a healthier world.

Globally, our employees embrace diverse backgrounds and perspectives and treat everyone equally, with dignity and respect, allowing us all to achieve our best. We proudly do our part to serve and support our communities and protect the environment, making a lasting impact that's felt within healthcare and beyond.

What we do isn't easy, but we persevere because what we achieve inspires hope and transforms lives-every single day.

Our principles:

Transforming lives

We inspire hope and transform lives every day. We make decisions based on our deep caring and compassion for people, delivering a lasting impact to our patients, their families, our employees and the community.

Acting with integrity

We strive to always do the right thing. With uncompromising integrity at the heart of everything we do, we pursue the highest standards in quality, compliance, safety and performance.

Driving innovation

We innovate relentlessly in everything we do to tackle unmet needs. We invest in the discovery and development of new medicines and healthcare approaches for a healthier world.

Embracing diversity & inclusion

We treat everyone equally, with dignity and respect. Around the world, our employees embrace diverse backgrounds and perspectives which allows us all to achieve our best.

Serving the community

We are proud to serve and support the community and do our part to protect the environment. We make a remarkable impact that's felt within healthcare and beyond.

Our history

AbbVie may have been founded in 2013, but our roots run deep. In 2013, we became a separate company from Abbott, though we share a common legacy and strong prospects for future success.

Our name represents our connection to the past and the future. When we became our own company, AbbVie formed a new kind of enterprise-a biopharmaceutical company. We blend the stability, global scale, resources and commercial capabilities of a pharmaceutical company with the focus and culture of a biotech.

Today, our 30,000 employees around the world focus on delivering transformational medicines and therapies that offer significant patient benefits.

https://www.abbvie.com/our-company/about-abbvie.html

27 July 2023

AbbVie Reports Second-Quarter 2023 Financial Results

Reports Second-Quarter Diluted EPS of $1.14 on a GAAP Basis, an Increase of 123.5 Percent; Adjusted Diluted EPS of $2.91, a Decrease of 13.6 Percent; These Results Include an Unfavorable Impact of $0.15 Per Share Related to Acquired IPR&D and Milestones Expense

Delivers Second-Quarter Net Revenues of $13.865 Billion, a Decrease of 4.9 Percent on a Reported Basis and 4.2 Percent on an Operational Basis

Second-Quarter Global Net Revenues from the Immunology Portfolio Were $6.813 Billion, a Decrease of 5.5 Percent on a Reported Basis, or 5.0 Percent on an Operational Basis; Global Humira Net Revenues Were $4.012 Billion; Global Skyrizi Net Revenues Were $1.883 Billion; Global Rinvoq Net Revenues Were $918 Million

Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.478 Billion, a Decrease of 10.4 Percent on a Reported Basis, or 9.8 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $907 Million; Global Venclexta Net Revenues Were $571 Million

Second-Quarter Global Net Revenues from the Neuroscience Portfolio Were $1.885 Billion, an Increase of 13.6 Percent on a Reported Basis, or 14.2 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $748 Million; Global Vraylar Net Revenues Were $658 Million

Second-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.384 Billion, an Increase of 1.0 Percent on a Reported Basis, or 2.9 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $685 Million; Global Juvederm Net Revenues Were $368 Million

Raises 2023 Adjusted Diluted EPS Guidance Range from $10.57 - $10.97 to $10.90 - $11.10, which Includes an Unfavorable Impact of $0.23 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Second Quarter 2023

NORTH CHICAGO, Ill., July 27, 2023 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2023.

"AbbVie's second quarter results were well ahead of our expectations as we continue to demonstrate outstanding operational execution. The strong performance was driven predominantly by our non-Humira business, which delivered high single-digit sales growth, in line with our long-term outlook," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We continue to make progress across all stages of our pipeline and based upon the strong momentum of our diversified portfolio, we are once again raising our full year guidance."

Second-Quarter Results

Worldwide net revenues were $13.865 billion, a decrease of 4.9 percent on a reported basis, or 4.2 percent on an operational basis.

Global net revenues from the immunology portfolio were $6.813 billion, a decrease of 5.5 percent on a reported basis, or 5.0 percent on an operational basis.

Global Humira net revenues of $4.012 billion decreased 25.2 percent on a reported basis, or 24.8 percent on an operational basis. U.S. Humira net revenues were $3.452 billion, a decrease of 26.0 percent. Internationally, Humira net revenues were $560 million, a decrease of 19.8 percent on a reported basis, or 17.0 percent on an operational basis.

Global Skyrizi net revenues were $1.883 billion, an increase of 50.4 percent on a reported basis, or 51.0 percent on an operational basis.

Global Rinvoq net revenues were $918 million, an increase of 55.1 percent on a reported basis, or 56.7 percent on an operational basis.

Global net revenues from the hematologic oncology portfolio were $1.478 billion, a decrease of 10.4 percent on a reported basis, or 9.8 percent on an operational basis.

Global Imbruvica net revenues were $907 million, a decrease of 20.8 percent, with U.S. net revenues of $666 million and international profit sharing of $241 million.

Global Venclexta net revenues were $571 million, an increase of 13.1 percent on a reported basis, or 15.0 percent on an operational basis.

Global net revenues from the neuroscience portfolio were $1.885 billion, an increase of 13.6 percent on a reported basis, or 14.2 percent on an operational basis.

Global Botox Therapeutic net revenues were $748 million, an increase of 10.2 percent on a reported basis, or 11.3 percent on an operational basis.

Global Vraylar net revenues were $658 million, an increase of 33.9 percent.

Global Ubrelvy net revenues were $196 million, an increase of 5.9 percent on a reported basis, or 6.0 percent on an operational basis.

Global net revenues from the aesthetics portfolio were $1.384 billion, an increase of 1.0 percent on a reported basis, or 2.9 percent on an operational basis.

Global Botox Cosmetic net revenues were $685 million, a decrease of 1.4 percent on a reported basis, or an increase of 0.7 percent on an operational basis.

Global Juvederm net revenues were $368 million, an increase of 6.9 percent on a reported basis, or 9.7 percent on an operational basis.

On a GAAP basis, the gross margin ratio in the second quarter was 69.4 percent. The adjusted gross margin ratio was 84.7 percent.

On a GAAP basis, selling, general and administrative (SG&A) expense was 23.6 percent of net revenues. The adjusted SG&A expense was 23.2 percent of net revenues.

On a GAAP basis, research and development (R&D) expense was 12.5 percent of net revenues. The adjusted R&D expense was 12.5 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.

Acquired IPR&D and milestones expense was 2.0 percent of net revenues.

On a GAAP basis, the operating margin in the second quarter was 32.5 percent. The adjusted operating margin was 47.0 percent.

Net interest expense was $454 million.

On a GAAP basis, the tax rate in the quarter was 22.3 percent. The adjusted tax rate was 15.8 percent.

Diluted EPS in the second quarter was $1.14 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.91. These results include an unfavorable impact of $0.15 per share related to acquired IPR&D and milestones expense.

For full release see:

https://news.abbvie.com/news/press-releases/abbvie-reports-second-quarter-2023-financial-results.htm

AmerisourceBergen Corporation (NYSE: ABC)

AmerisourceBergen was built on a legacy of more than 100 years of excellence in pharmaceutical sourcing and wholesale distribution. Today, we impact millions of lives by applying innovation toward everything from the way pharmaceuticals are accessed to the delivery of personalized patient care.

https://www.amerisourcebergen.com/about-us/our-history

3 November 2022

AmerisourceBergen Reports Fiscal 2022 Fourth Quarter and Year End Results

Revenue of $61.2 Billion for the Fourth Quarter, a 3.8 Percent Year-Over-Year Increase

Fourth Quarter GAAP Diluted EPS of $1.40 and Adjusted Diluted EPS of $2.60

Revenue of $238.6 Billion for Fiscal Year 2022, an 11.5 Percent Year-Over-Year Increase

Fiscal Year 2022 GAAP Diluted EPS of $8.04 and Adjusted Diluted EPS of $11.03

CONSHOHOCKEN, Pa.--(BUSINESS WIRE) -- AmerisourceBergen Corporation (NYSE: ABC) today reported that in its fiscal year 2022 fourth quarter ended September 30, 2022, revenue increased 3.8 percent to $61.2 billion. Revenue increased 11.5 percent to $238.6 billion for the fiscal year. On the basis of U.S. generally accepted accounting principles (GAAP), diluted earnings per share (EPS) was $1.40 for the September quarter of fiscal 2022, compared to $2.08 in the prior year quarter. Adjusted diluted EPS, which is a nonGAAP measure that excludes items described below, increased 8.8 percent to $2.60 in the fiscal fourth quarter. For fiscal year 2022, diluted EPS increased 8.8 percent to $8.04. For fiscal year 2022, adjusted diluted EPS increased 19.1 percent to $11.03.

"AmerisourceBergen delivered strong performance in our 2022 fiscal year as our team's execution excellence allowed us to deliver on our strategic priorities. Our leading capabilities in pharmaceutical distribution and manufacturer solutions enable us to play our core role in advancing pharmaceutical innovation and access," said Steven H. Collis, Chairman, President & Chief Executive Officer of AmerisourceBergen.

"United by our purpose, our team members have positioned us well to execute on our long-term strategic vision of expanding our leadership in distribution while continuing to grow our higher-margin and higher-growth businesses," Mr. Collis continued. "As we enter a new fiscal year, we are uniquely positioned to deliver long-term value creation to our stakeholders as we advance our foundation, enhance our capabilities, and invest in innovation to further drive our differentiation.

For full release see:

https://s27.q4cdn.com/189772748/files/doc_financials/2022/q4/AmerisourceBergen-Reports-Fiscal-2022-Fourth-Quarter-and-Year-End-Results.pdf

Amgen (NASDAQ: AMGN)

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.

Our belief and the core of our strategy is that innovative, highly differentiated medicines that provide large clinical benefits in addressing serious diseases are medicines that will not only help patients, but also will help reduce the social and economic burden of disease in society today. 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 innovator 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.

INNOVATIVE MEDICINES

We have a presence in approximately 100 countries and regions worldwide and our innovative medicines have reached millions of people in the fight against serious illnesses. We focus on six therapeutic areas: cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. Our medicines typically address diseases for which there are limited treatment options, or they are medicines that provide a viable option to what is otherwise available.

TRANSFORMATIVE RESEARCH

Understanding the fundamental biological mechanisms of disease is a defining feature of Amgen's discovery research efforts-and a major contributor to the development of Amgen's deep and broad pipeline of potential new medicines. Amgen's "biology first" approach permits its scientists to first explore the complex molecular pathways of disease before determining what type of medicine, or modality, is most likely to deliver optimal efficacy and safety. With the advances in human genetics, Amgen continues to shed new light on the molecular roots of disease. Amgen subsidiary deCODE Genetics, a global leader in human genetics, is a powerful differentiator, greatly improving how we identify and validate human disease targets.

WORLD-CLASS BIOMANUFACTURING

The treatment of millions of seriously ill patients worldwide depends on the safe and reliable production of biologic medicines, which are administered by injection or intravenously. A worldwide leader in biologics manufacturing, Amgen has an outstanding track record of reliably delivering high-quality medicines to patients who need them. Significant skill, experience, vigilance and commitment are critical to help ensure the quality of a biologic medicine each time a new batch is made. At Amgen, robust quality control and a reliable supply of medicines for patients are every bit as important as scientific innovation.

OUR HERITAGE

Building on advances in recombinant DNA and molecular biology, Amgen is counted among the early pioneers of biotechnology. Since 1980, Amgen scientists have been at work developing novel therapies for patients with serious illnesses. Our scientists have characterized key biologic processes that have led to the development of innovative, first-in-class therapies. We have helped shape the scientific world's understanding of certain disease processes, and we have engineered new types of therapeutic platforms. As a company, we could not have accomplished what we have were it not for our deep commitment to building a culture that embraces science and innovation-a culture that continues to shape who we are today.

THE AMGEN FOUNDATION

The Amgen Foundation seeks to advance excellence in science education to inspire the next generation of innovators, and invest in strengthening communities where Amgen staff members live and work. To date, the Foundation has donated nearly $300 million in grants to local, regional and international nonprofit organizations that impact society in inspiring and innovative ways. The Amgen Foundation brings the excitement of discovery to the scientists of tomorrow through several signature programs, including Amgen Scholars, Amgen Biotech Experience and Amgen Teach. For more information, visit www.AmgenInspires.com.

https://www.amgen.com/~/media/amgen/full/www-amgen-com/downloads/fact-sheets/fact_sheet_amgen.ashx

3 August 2023

AMGEN REPORTS SECOND QUARTER FINANCIAL RESULTS

THOUSAND OAKS, Calif., Aug. 3, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the second quarter of 2023.

"We had a very strong quarter, serving more patients across all geographies and therapeutic categories and delivering record revenues and non-GAAP earnings per share," said Robert A. Bradway, chairman and chief executive officer. "Positive data being shared today illustrates the rapid progress we are making in advancing our pipeline of potential first-in-class medicines."

Key results include:

Total revenues increased 6% to $7.0 billion in comparison to the second quarter of 2022, resulting from a 6% increase in product sales. Product sales growth was driven by 11% volume growth, partially offset by 2% lower net selling price, 1% lower inventory levels and 1% negative impact from foreign exchange. Excluding the 1% negative impact of foreign exchange on product sales, total revenues increased 7%.

Volume growth of 11% included double-digit volume growth from EVENITY® (romosozumab-aqqg), BLINCYTO® (blinatumomab), Repatha® (evolocumab), LUMAKRAS®/LUMYKRAS[TM] (sotorasib), Vectibix® (panitumumab), KYPROLIS® (carfilzomib), Nplate® (romiplostim) and biosimilar AMJEVITA®/AMGEVITA[TM] (adalimumab).

Ex-U.S. volume grew 16%, including 46% volume growth in the Asia Pacific region.

GAAP earnings per share (EPS) increased 5% from $2.45 to $2.57, driven by increased revenues and decreased operating expenses following the Q2 2022 impairment charge taken in connection with our divestiture of GENSENTA, a generics business in Turkey, partially offset by higher Q2 2023 nonoperating expenses.

GAAP operating income increased from $2.2 billion to $2.7 billion, and GAAP operating margin increased 5.6 percentage points to 40.2%.

Non-GAAP EPS increased 8% from $4.65 to $5.00, driven by increased revenues, partially offset by higher operating expenses in Q2 2023.

Non-GAAP operating income increased from $3.3 billion to $3.5 billion, and non-GAAP operating margin decreased 0.5 percentage points to 52.6%.

The Company generated $3.8 billion of free cash flow for the second quarter of 2023 versus $1.7 billion in the second quarter of 2022, driven by timing of tax payments, higher interest income and higher operating income.

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 comparative 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 6% for the second quarter of 2023 versus the second quarter of 2022. Unit volumes grew 11%, partially offset by 2% lower net selling price, 1% lower inventory levels and 1% negative impact from foreign exchange.

For full release see:

https://www.amgen.com/newsroom/press-releases/2023/08/amgen-reports-second-quarter-financial-results

AstraZeneca (NYSE: AZN)

We are a global, science-led biopharmaceutical business and our innovative medicines are used by millions of patients worldwide.

Our purpose and values

Our purpose and values help explain why we exist, what we hope to accomplish, the behaviours we value, how we will achieve our goals, and the promise of our brand to our stakeholders.

Our business strategy

We have transformed our pipeline and returned to growth and, as a result of continued pipeline delivery and commercial execution, we are now entering a new stage of our journey. This is focused on enhanced innovation and the delivery of life-changing medicines that that contribute value to patients and society.

The fundamentals of our strategy are clear. We focus on innovative science and leadership in our three main therapy areas: Oncology; Cardiovascular, Renal and Metabolism; and Respiratory diseases. Backed by a global presence, with strength in Emerging Markets, particularly China, we have a portfolio of specialty and primary care medicines.

At the same time, the world around us is changing and the burden of disease is increasing. We are responding by increasing our focus on growth through innovation - being more patient-centric, doing more with technology, digital and data, and advancing more cutting-edge science.

All this is reflected in our three strategic priorities.

https://www.astrazeneca.com/our-company.html/

https://www.astrazeneca.com/our-company/our-strategy.html

29 July 2022

H1 2022 results

Pascal Soriot, Chief Executive Officer, commenting on the results said:

"AstraZeneca had a strong financial first half of 2022, and great pipeline delivery. We announced practice-changing data for several medicines including Enhertu in breast cancer, Farxiga in heart failure and Ultomiris in neuromyelitis optica spectrum disorder.

We have made great progress in our efforts to combat COVID-19. Vaxzevria is estimated to have saved more than six million lives during the first year of roll-out, and Evusheld has protected hundreds of thousands of immunocompromised people, enabling them to return to a more normal life. Evusheld continues to demonstrate activity against new variants.

Given the ongoing performance of our underlying business and the contribution of our COVID-19 medicines, we are updating our revenue guidance for 2022. This has enabled us to increase our R&D investment in the exciting number of pipeline opportunities that can benefit patients and drive long term sustainable growth for our company. We look forward to announcing the results of several important late-stage trials this year and next."

For full release see:

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/h1-2022-results.html

Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals) (NYSE: BHC)

Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals) is a multinational specialty pharmaceutical company based in Laval, Canada. Bausch Health is focused on improving people's lives with our health care products. We are delivering on our commitments to patients, health care providers, other stakeholders and society, as we build an innovative company dedicated to advancing global health.

We manufacture and market a broad range of branded and generic pharmaceuticals, over-the-counter (OTC) products and medical devices (contact lenses, intraocular lenses, ophthalmic surgical equipment and aesthetic devices) directly or indirectly in more than 90 countries and regions, including the United States, Canada, Europe, the Middle East, Africa, Asia Pacific and Latin America. Each day, our products are used by up to 150 million people around the world.

We have a diversified portfolio of products, with a core focus in the following areas:

Eye Health (Bausch + Lomb)Â»

Gastrointestinal Diseases (Salix Pharmaceuticals)Â»

Dermatology (Ortho Dermatologics)Â»

Our global corporate headquarters are located in Laval, Quebec, Canada, and our U.S. headquarters are in Bridgewater, N.J.

Bausch Health serves the following geographic regions:

North America, Asia Pacific, Latin America, Europe, the Middle East and Africa. Each of these regions offers a different focus for their distinct markets and each market has a unique mix of prescription brands, over-the-counter (OTC) products and medical devices.

https://www.bauschhealth.com/about-us/who-we-are

3 August 2023

Bausch Health to Announce Second-Quarter 2023 Results

LAVAL, Quebec, April 13, 2023 - Bausch Health Companies Inc. (NYSE/TSX: BHC) will release its second-quarter financial results on Thursday, Aug. 3, 2023. Bausch Health will host a conference call and live webcast at 8:00 a.m. U.S. EDT to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

For full release see:

https://ir.bauschhealth.com/news-releases/2023/07-13-2023

Baxter International (NYSE: BAX)

Baxter was founded in 1931, however our history doesn't have one starting point. Our commitment to addressing unmet needs was built on the shoulders of healthcare pioneers whose work resulted in first-of-its-kind innovations in IVs, renal care, nutrition, respiratory, hospital beds and today's connected care.

Innovative Beginnings

In the beginning, Drs. Ralph Falk and Don Baxter launched the Don Baxter Intravenous Products Corporation, the first commercial manufacturer of prepared IV solutions.

Dr. Francis Welch and William Noah Allyn developed the world's first handheld, direct illuminating ophthalmoscope and established Welch Allyn. William (Bill) A. Hillenbrand revolutionized the industry with the idea to "bring the home into the hospital" with warmer, more comfortable wooden furniture. More than a century later, Hillrom and Welch Allyn became a part of Baxter.

These innovations strengthened our storied history of driving healthcare advancements, and by the end of the 1930s, we changed our name to Baxter Laboratories, Inc. and opened our first manufacturing facility in a renovated automobile showroom in Glenview, Illinois.

https://www.baxter.com/our-story/our-history

27 April 2023

Baxter Reports First-Quarter 2023 Results

First-quarter revenue of $3.65 billion decreased 2% on a reported basis and increased 2% on a constant currency basis1

First-quarter U.S. GAAP earnings per share (EPS) totaled $0.09; Adjusted EPS totaled $0.59

Baxter expects full-year 2023 sales growth of 1% to 2% on a reported basis and ~1% on a constant currency basis

Baxter expects full-year U.S. GAAP EPS of $1.16 to $1.31 and adjusted EPS of $2.85 to $3.00

DEERFIELD, Ill. - 2023-04-27 - Baxter International Inc. (NYSE: BAX), a global medtech leader, today reported results for the first quarter of 2023.

"Baxter's performance in the first quarter reflects sustained demand for our medically essential products amid a stabilizing macroeconomic climate and healthcare marketplace," said José (Joe) E. Almeida, chairman, president and chief executive officer. "I am confident that the transformational actions announced earlier this year, and currently underway, will help us advance our performance, fueling enhanced agility, efficiency, and resilience as we navigate an evolving landscape. Our goal, as always, is to drive increasing impact and value for the patients, clinicians, investors and numerous other stakeholder communities that depend on us."

First-Quarter Financial Results

Worldwide sales in the first quarter totaled approximately $3.65 billion, a decrease of 2% on a reported basis and an increase of 2% on a constant currency basis, exceeding the company's previously issued guidance.

Sales in the U.S. totaled $1.73 billion, decreasing 1% on a reported basis. International sales of $1.92 billion decreased 2% on a reported basis and increased 4% at constant currency rates.

Sales performance at constant currency rates reflects overall positive demand across the portfolio, supported by a continued recovery in patient and procedure volumes following the height of the COVID-19 pandemic, in combination with generally stabilizing macroeconomic conditions and an improvement in recent supply chain challenges. Sales growth in the quarter was primarily driven by strength in Advanced Surgery, Front Line Care, Pharmaceuticals and Renal Care. First-quarter performance was partially offset by expected declines in Acute Therapies and BioPharma Solutions as well as in Patient Support Systems, which reflected a slowdown in capital spending for certain healthcare products.

Please see the attached schedules accompanying this press release for additional details on sales performance in the quarter, including breakouts by Baxter's product categories and segments.

For the first quarter, net income attributable to Baxter was $44 million, or $0.09 per diluted share, a decline of 36% on a U.S. GAAP (Generally Accepted Accounting Principles) basis. These results include special items totaling $253 million after tax, which were primarily related to intangible asset amortization, business optimization and separation costs. On an adjusted basis, net income attributable to Baxter totaled $297 million, or $0.59 per diluted share, a 37% decrease. Results in the quarter exceeded the company's previously issued guidance, driven primarily by better-than-expected sales performance.

Advancing Strategic Transformation Initiatives

Baxter continues to execute against a range of strategic objectives announced in early 2023, focused on enhancing patient outcomes, innovation, efficiency and long-term shareholder value:

The company is implementing a new operating model to realign its 10 businesses, region-based commercial geographies, and centralized manufacturing and supply chain operations into four vertically integrated global business segments: Medical Products and Therapies; Healthcare Systems and Technologies; Pharmaceuticals and BioPharma Solutions; and Kidney Care (through completion of the proposed spinoff). The company believes this new model will help fuel greater performance through enhanced strategic clarity, accountability, speed and innovation across the new segments. Baxter expects to report quarterly performance in line with the new operating model beginning in the second half of 2023.

Progress is advancing on the proposed spinoff of Baxter's Kidney Care segment (comprised of the company's Renal Care and Acute Therapies product categories) into an independent, publicly traded company, with a preliminary operating model and organizational design now identified. The spinoff is currently expected to occur by July 2024 or earlier, subject to customary conditions.

For full release see:

https://www.baxter.com/baxter-newsroom/baxter-reports-first-quarter-2023-results

Bristol-Myers Squibb (NYSE: BMY)

Bristol-Myers Squibb is a differentiated company, led by our unique BioPharma strategy that leverages the reach and resources of a major pharma company paired with the entrepreneurial spirit and agility of a biotech firm. We work every day to deliver innovative medicines for patients with serious and life-threatening diseases.

Each day, our employees around the world work together for patients-it drives everything we do. We are focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience, and fibrosis. Through our Research & Development organisation, we have built a sustainable pipeline of potential therapies, and actively partner to access external innovation to broaden and accelerate our work.

As global citizens, we work sustainably and responsibly and seek to give back. Through the Bristol-Myers Squibb Foundation, we promote health equity and strive to improve health outcomes of populations disproportionately affected by serious diseases and conditions, giving new hope to some of the world's most vulnerable people.

https://www.bms.com/gb/about-us.html

27 July 2023

Bristol Myers Squibb Reports Second Quarter Financial Results for 2023

Reports Second Quarter Revenues of $11.2 Billion

Posts Second Quarter GAAP Earnings Per Share of $0.99 and Non-GAAP EPS of $1.75; Includes Net Impact of ($0.05) Per Share for GAAP and Non-GAAP EPS Due to Acquired IPRD Charges and Licensing Income

Reports Second Quarter Revenue Growth for In-Line Products and New Product Portfolio of 4%

Progresses Portfolio and Pipeline with Significant Regulatory and Clinical Milestones Achieved

Revises Outlook for Total Revenues to Low Single-Digit Decline, GAAP EPS to $3.72-$4.02, and Non-GAAP EPS to $7.35-$7.65 Due to Lower Expected Revenues for Revlimid and Pomalyst

Reaffirms 2020-2025 Financial Targets

Announces $4 Billion Accelerated Share Repurchase Agreement to be Executed During the Third Quarter of 2023

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today reports results for the second quarter of 2023, which reflect continued execution against our strategic priorities.

"This was an important quarter for Bristol Myers Squibb," said Giovanni Caforio, M.D., board chair and chief executive officer, Bristol Myers Squibb. "We saw a more rapid than expected decline in Revlimid sales in the quarter, which led to a revision of our financial guidance for the year. Importantly, we continued to advance the renewal and diversification of our portfolio, delivered strong performance across our key in-line products and new product portfolio, while continuing to advance our pipeline. I am confident in our ability to drive future growth and innovation while carrying out our mission to help patients prevail over serious diseases."

For full release see:

https://news.bms.com/news/corporate-financial/2023/Bristol-Myers-Squibb-Reports-Second-Quarter-Financial-Results-for-2023/default.aspx

Danaher Corporation (NYSE: DHR)

Danaher takes it name from a tributary of the South Fork Flat Head River in western Montana. In the early 1980s, this was the setting for the fishing trip where Steven and Mitchell Rales envisioned a new kind of manufacturing company-one dedicated to continuous improvement and customer satisfaction. The root "Dana" is an ancient Celtic word meaning "swift flowing," an apt descriptor for the nimble mindset and rapid flow of innovation that have defined Danaher for decades.

The company had its origins as a real estate investment trust (DMG, Inc., founded in 1969 and renamed Diversified Mortgage Investors, Inc. in 1978). But after adopting a new name in 1984, refocusing on manufacturing and being exposed to kaizen, the Japanese business philosophy of continuous improvement, Danaher began to take shape.

Danaher was one of the first companies in North America to adopt kaizen. The practice led to the development of the Danaher Business System and continues to guide the culture, at the heart of the company's five core values.

EVOLUTION

In its early days, Danaher consisted of a group of discrete, manufacturing businesses. In the mid-1990s, this fragmented structure was transformed into one built around strategic platforms, each with sustainable competitive advantages in sizeable global markets. Over the next decade the company established leadership in the markets that define it today, beginning with water in 1998 and followed by product identification (2001), diagnostics (2006) and life sciences (2009).

In 2015, Danaher announced that many of its industrial businesses would be spun out to form an independent, publicly traded company, Fortive. The separation supports clear focus on driving meaningful innovation in science and technology, and on continuing to build an unmatched portfolio strategically positioned for growth and impact.

LOOKING AHEAD

Today, Danaher is a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. Our trusted brands hold unparalleled leadership positions in diagnostics, life sciences, and environmental and applied solutions. With more than 20 operating companies, our globally diverse team of 59,000 associates is united by a shared purpose: to help realize life's potential.

https://www.danaher.com/who-we-are/danaher-story

25 July 2023

DANAHER REPORTS SECOND QUARTER 2023 RESULTS

WASHINGTON, July 25, 2023 /PRNewswire/ -- Danaher Corporation (NYSE: DHR) (the "Company") today announced results for the second quarter 2023. Net earnings refer to net earnings attributable to common shareholders.

For the quarter ended June 30, 2023 net earnings were $1.1 billion, or $1.49 per diluted common share and non-GAAP adjusted diluted net earnings per common share were $2.05.

Revenues decreased 7.5% year-over-year to $7.2 billion, with a 7.0% non-GAAP core revenue decrease (due primarily to the impact of lower COVID-19 revenue), including 2.0% non-GAAP base business core revenue growth.

Operating cash flow for the second quarter was $1.9 billion and non-GAAP free cash flow was $1.6 billion.

The Company provides forecasted sales only on a non-GAAP basis because of the difficulty in estimating the other components of GAAP revenue, such as currency translation, acquisitions and divested product lines.

For the third quarter 2023, the Company anticipates that non-GAAP base business core revenue will be down low-single digits year-over-year. For full year 2023, the Company anticipates that non-GAAP base business core revenue growth will be up low-single digits year-over-year.

Rainer M. Blair, President and Chief Executive Officer, stated, "We are pleased with our second quarter results which met our expectations, despite a more dynamic operating environment. Our team's consistent execution, paired with better-than-expected performance in our Life Science and Diagnostics businesses, including stronger respiratory testing revenue, helped offset softer demand in bioprocessing."

Blair continued, "We're confident about the bright future ahead for Danaher. The unique combination of our talented team, differentiated portfolio and balance sheet optionality-all powered by the Danaher Business System-provides a strong foundation for creating shareholder value while helping to meaningfully improve human health."

Danaher will discuss its second quarter results and financial guidance for the third quarter and full year during its quarterly investor conference call today starting at 8:00 a.m. ET. The call and an accompanying slide presentation will be webcast on the "Investors" section of Danaher's website, www.danaher.com, under the subheading "Events & Presentations" and additional materials will be posted to the same section of Danaher's website. A replay of the webcast will be available in the same section of Danaher's website shortly after the conclusion of the presentation and will remain available until the next quarterly earnings call.

For full release see:

https://investors.danaher.com/2023-07-25-Danaher-Reports-Second-Quarter-2023-Results

Eli Lilly & Company (NYSE: LLY)

Lilly was founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that met real needs in an era of unreliable elixirs peddled by questionable characters. His charge to the generations of employees who have followed was this: "Take what you find here and make it better and better."

More than 145 years later, we remain committed to his vision through every aspect of our business and the people we serve starting with those who take our medicines, and extending to health care professionals, employees and the communities in which we live.

https://www.lilly.com/who-we-are/about-lilly

8 August 2023

Lilly Reports Second-Quarter 2023 Financial Results, Highlights Accelerating Revenue Growth and Key Pipeline Advancements

Revenue in Q2 2023 increased 28% as a result of volume-driven growth from Mounjaro, Verzenio, Jardiance and Taltz, as well as $579.0 million from the sale of rights for Baqsimi. Excluding revenue from Baqsimi, and COVID-19 antibodies in 2022, revenue in Q2 2023 increased 22%.

Pipeline progress included positive results in the Phase 3 TRAILBLAZER-ALZ 2 study and the submissions of donanemab for traditional approval to the FDA and EMA; the completed submission of tirzepatide in chronic weight management to the FDA and positive results in the Phase 3 SURMOUNT-3 and -4 studies; and approval of mirikizumab in the EU and re-submission in the U.S.

Business development activity included announcements of agreements to acquire DICE Therapeutics, Inc., Sigilon Therapeutics, Inc. and Versanis Bio.

New Products(i) contributed $1.00 billion to revenue in Q2 2023, led by Mounjaro. Growth Products(ii) revenue increased 16% to $4.93 billion in Q2 2023, led by Verzenio, Jardiance and Taltz.

Q2 2023 EPS increased 86% to $1.95 on a reported basis and increased 69% to $2.11 on a non-GAAP basis, both inclusive of $0.43 of EPS associated with the sale of rights for Baqsimi, as well as $0.09 of acquired IPR&D charges.

2023 reported EPS guidance raised $1.02 to the range of $9.20 to $9.40 and non-GAAP EPS guidance raised $1.05 to the range of $9.70 to $9.90.

INDIANAPOLIS, Aug. 8, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced its financial results for the second quarter of 2023.

"Lilly's financial results in Q2 were led by Mounjaro sales and a strong performance from Growth Products," said David A. Ricks, Lilly's chair and CEO. "Exciting scientific breakthroughs, such as TRAILBLAZER-ALZ 2 in Alzheimer's disease and SURMOUNT-3 and -4 in obesity, encourage us to continue to make significant investments that support our new medicines including multiple launches expected by the end of 2023 to help more patients around the world."

Lilly had numerous updates recently on key regulatory, clinical, business development and other events, including:

Positive Phase 3 TRAILBLAZER-ALZ 2 results, which showed donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease, as well as donanemab's submissions for traditional approval to the U.S. Food and Drug Administration (FDA) and European Medicines Agency with regulatory action expected in the U.S. by the end of 2023;

The completed submission of tirzepatide in chronic weight management to the FDA and positive Phase 3 SURMOUNT-3 and -4 results, which showed the highest level of weight loss observed in the SURMOUNT program to date;

The approval of mirikizumab in the European Union and re-submission in the U.S.;

The announcements of agreements to acquire DICE Therapeutics, Inc., Sigilon Therapeutics, Inc. and Versanis

Bio, which would advance Lilly's research and expertise in treatments for autoimmune and cardiometabolic diseases;

FDA approval of Jardiance® to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes; and

Allocation of an additional $50 million to the company's now $300 million Social Impact Venture Capital Portfolio, aimed at making a positive impact on patients and society through for-profit investments.

For full release see:

https://investor.lilly.com/news-releases/news-release-details/lilly-reports-second-quarter-2023-financial-results-highlights

Genentech (SIX: RO, ROG; OTCQX: RHHBY)

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years.

Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

A Member of the Roche Group

Genentech became a member of the Roche Group in March of 2009. As part of their merger agreement, Roche and Genentech combined their pharmaceutical operations in the United States. Genentech's South San Francisco campus now serves as the headquarters for Roche pharmaceutical operations in the United States. Genentech Research and Early Development operates as an independent center within Roche.

https://www.gene.com/about-us

2 February 2023

Roche reports good results for 2022 despite decline in demand for COVID-19 products

Basel, 2 February 2023

Group sales grow by 2%1 at constant exchange rates (CER) and 1% in Swiss francs, despite lower COVID-19-related sales in both divisions

Pharmaceuticals Division sales increase by 2%; continued strong growth of newer medicines more than compensating for the impact of biosimilars and lower sales of Actemra/RoActemra (severe COVID-19)

Diagnostics Division sales grow by 3%; ongoing strong momentum in base business (+7%) more than compensating for the continuing decline in the demand for COVID-19 tests in the second half of the year

Highlights in the fourth quarter of 2022 (incl. January 2023):

US approvals of Lunsumio (follicular lymphoma), Tecentriq (advanced rare sarcoma) and Actemra/RoActemra (COVID-19)

US priority review of glofitamab (aggressive form of blood cancer)

Positive phase III data for Vabysmo (serious retinal vascular condition) and for Tecentriq plus Avastin (early-stage liver cancer)

Priority review for crovalimab (rare blood disease) in China

New study proves high medical value of Elecsys NT-proBNP heart test

US approval for Alzheimer's tests; US Emergency Use Authorization for mpox virus test

Core earnings per share rise by 5% (+2% in CHF)

IFRS net income amounts to CHF 13.5 billion (-6%; -9% in CHF)

Board proposes dividend increase to CHF 9.50. If approved by shareholders, this would be the 36th consecutive dividend increase.

Outlook for 2023

Due to the sharp decline in sales of COVID-19 products of roughly CHF 5 billion, Roche expects a decrease in Group sales in the low single digit range (at constant exchange rates). Excluding this COVID-19 sales decline, Roche anticipates solid underlying sales growth in both divisions.

Core earnings per share are targeted to develop broadly in line with sales decline (at constant exchange rates). Roche expects to further increase its dividend in Swiss francs.

Key figures

CHF millions

% change

January-December 2022

2022

2021

At CER 1

In CHF

Group sales

63,281

62,801

Pharmaceuticals Division

45,551

45,041

Diagnostics Division

17,730

17,760

Core operating profit

22,173

21,897

Core EPS - diluted (CHF)

20.30

19.81

IFRS net income

13,531

14,935

-6

-9

Roche CEO Severin Schwan: "We achieved good results in 2022, even though the demand for COVID-19 products declined, as expected. The diagnostics base business and our newer medicines continued their strong growth. While we had pipeline setbacks in 2022, I am particularly pleased that we brought two new medicines to patients: Vabysmo for certain severe eye diseases and Lunsumio for a currently incurable form of blood cancer. For the current year we expect solid underlying growth in both divisions, which will largely compensate for the further significant drop in sales of roughly CHF 5 billion in COVID-19 products."

Group results

In 2022, Roche achieved sales growth of 2% (+1% in CHF) to CHF 63.3 billion.

Core operating profit increased by 3% (+1% in CHF), reflecting the good underlying business performance.

IFRS net income was CHF 13.5 billion, a decrease of 6% compared to the previous year. This was due to higher impairment of intangible assets and higher interest costs and income taxes.

Core earnings per share increased by 5% (+2% in CHF). This includes the positive impact of the repurchase of Roche shares held by Novartis.

For full release see:

https://www.roche.com/media/releases/med-cor-2023-02-02

GlaxoSmithKline (LSE: GSK)

We are one of the largest global healthcare companies researching, developing and supplying innovative medicines, vaccines and healthcare products with our global headquarters in the UK.

Currently, we invest around £1bn in research and development (R&D) in the UK annually with our global R&D hub at Stevenage continuing to be at the heart of the development of our pipeline of vital medicines, with a focus on the immune system, genetics, and advanced technologies.

We focus on what matters most to our people, this means managers helping employees to be themselves, feel good and keep growing, in ways that work for them. We are recognised in the Stonewall LGBT+ rights group as a top global employer and ranked in the Times Top 50 employers for women in the UK. We also support our global and local communities. £1.7m has been raised by UK employees for Save the Children so far, with 100% of these funds being used to help provide UK families living on low incomes with essential household items, learning resources, and support that gives parents the skills, confidence and tools to help their children thrive, especially during the coronavirus pandemic.

https://www.gsk.com/en-gb/locations/united-kingdom/

1 February 2023

GSK delivers strong 2022 performance with full year sales of £29.3 billion +19% AER, +13% CER; Total EPS 371.4p >100% Adjusted EPS of 139.7p +27% AER, +15% CER from continuing operations

Highlights

Step change in commercial execution drives strong sales growth across Specialty Medicines and Vaccines

Sales of £29.3 billion +19% AER, +13% CER. Sales +15% AER, +10% CER excluding COVID-19 solutions

Specialty Medicines £11.3 billion +37% AER, +29% CER; HIV +20% AER, +12% CER; Oncology +23% AER, +17% CER; Immuno-inflammation and other specialty +29% AER +20% CER; COVID-19 solutions (Xevudy) sales £2.3 billion

Vaccines £7.9 billion +17% AER, +11% CER; Shingrix £3 billion +72% AER, +60% CER

General Medicines £10.1 billion +5% AER, +1% CER

Prioritised investment and cost discipline support strong growth in operating profit and EPS

Total continuing operating margin 21.9%. Total EPS 371.4p > 100% primarily reflecting the gain from discontinued operations arising on the demerger of the Consumer Healthcare business. Total continuing EPS 110.8p +34% AER, +18% CER

Adjusted operating margin 27.8%. Adjusted operating profit growth +26% AER, +14% CER. This included a decline in growth from COVID-19 solutions of approximately 3% AER and CER

Adjusted EPS 139.7p +27% AER, +15% CER. This included a decline in growth from COVID-19 solutions of approximately 4% AER, 3% CER

Full-year 2022 cash generated from operations attributable to continuing operations £7.9 billion. Full-year free cash flow £3.3 billion

R&D delivery and business development supports future growth

Innovative pipeline of 69 vaccines and specialty medicines based on science of the immune system, with 18 in phase III/registration

Potential best in class RSV older adults candidate vaccine filed in US, EU, Japan; Shingrix interim 10-year data presented at ID Week 2022; acquisition of Affinivax completed, including phase II next-generation vaccine for pneumococcal disease and use of innovative MAPs technology

Continued progress in development of long-acting HIV treatments; positive phase II data on N6LS broadly-neutralising antibody presented at HIV Glasgow

Pivotal phase III trials for gepotidacin antibiotic for uncomplicated UTIs stopped early for efficacy; positive phase IIb data for bepirovirsen, potential functional cure for chronic hepatitis B; exclusive licence agreement with Spero Therapeutics for tebipenem Hbr, late-stage antibiotic for complicated UTIs

Expansion of depemokimab phase III programme with trials for long-acting IL-5 inhibitor in three additional eosinophil-driven diseases

4 approvals anticipated in 2023: RSV OA vaccine (US, EU, JP); Jemperli in 1L endometrial cancer (US); momelotinib in myelofibrosis (US) and daprodustat in chronic kidney disease (US, EU)

Confident in outlooks for turnover and Adjusted operating profit growth

2023 Turnover expected to increase between 6% to 8%; Adjusted operating profit expected to increase between 10% to 12%; EPS expected to increase between 12% to 15%

2023 Guidance at CER and excludes any contribution from COVID-19 solutions

13.75p dividend declared for the Q4 2022. No change to expected dividend from GSK of 56.5p/share for 2023

Emma Walmsley, Chief Executive Officer, GSK said:

"2022 was a landmark year for GSK delivering the step change in performance we committed to, driven by strong growth in specialty medicines and vaccines, including record sales for Shingrix. We enter 2023 with good momentum, underpinning confidence in our ambitious sales and profit outlooks for 2026. At the same time, we continue to build a stronger portfolio and pipeline based on infectious diseases and the science of the immune system, including our potential new RSV vaccine. This momentum, together with further targeted business development, means GSK will also be in a strong position to deliver growth from 2026 onwards."

Assumptions and cautionary statement regarding forward-looking statements

The Group's management believes that the assumptions outlined above are reasonable, and that the guidance, outlooks, ambitions and expectations described in this report are achievable based on those assumptions. However, given the forward-looking nature of these guidance, outlooks, ambitions and expectations, they are subject to greater uncertainty, including potential material impacts if the above assumptions are not realised, and other material impacts related to foreign exchange fluctuations, macro-economic activity, the impact of outbreaks, epidemics or pandemics, such as the COVID-19 pandemic and ongoing challenges and uncertainties posed by the COVID-19 pandemic for businesses and governments around the world, changes in legislation, regulation, government actions or intellectual property protection, product development and approvals, actions by our competitors, and other risks inherent to the industries in which we operate.

For full release see:

https://www.gsk.com/en-gb/media/press-releases/gsk-delivers-strong-2022-performance-with-full-year-sales-of-293-billion/

Johnson & Johnson (NYSE: JNJ)

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.

Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Johnson & Johnson was incorporated in the State of New Jersey in 1887.

https://www.jnj.com/about-jnj

24 January 2023

Johnson & Johnson Reports Q4 and Full-Year 2022 Results

2022 Fourth-Quarter reported sales decline of 4.4% to $23.7 Billion primarily driven by unfavorable foreign exchange and reduced COVID-19 Vaccine sales vs. prior year. Operational growth excluding COVID-19 Vaccine of 4.6%

2022 Fourth-Quarter earnings per share (EPS) of $1.33 decreasing 24.9% and adjusted EPS of $2.35 increasing by 10.3%

2022 Full-Year reported sales growth of 1.3% to $94.9 Billion primarily driven by strong commercial execution partially offset by unfavorable foreign exchange. Operational growth of 6.1%

2022 Full-Year earnings per share (EPS) of $6.73 decreasing 13.8% and adjusted EPS of $10.15 increasing by 3.6%

Company guides 2023 adjusted operational sales growth excluding COVID-19 Vaccine of 4.0%* and adjusted operational EPS of $10.50, reflecting growth of 3.5%

New Brunswick, N.J. (January 24, 2023) - Johnson & Johnson (NYSE: JNJ) today announced results for fourthquarter and full year 2022. "Our full year 2022 results reflect the continued strength and stability of our three business segments, despite macroeconomic challenges," said Joaquin Duato, Chairman of the Board and Chief Executive Officer. "I am inspired by our employees who make a difference in the health and lives of people around the world every day. As we look ahead to 2023, Johnson & Johnson is well-positioned to drive near-term growth, while also investing strategically to deliver long-term value."

FULL YEAR 2022 SEGMENT COMMENTARY:

Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Consumer Health

Consumer Health worldwide adjusted operational sales increased 3.9%* predominately driven by over-thecounter (OTC) products. Major contributors to growth in OTC were TYLENOL and MOTRIN analgesics, as well as upper respiratory products and digestive health products in the international markets. Additionally, Skin Health/Beauty adjusted operational growth was primarily driven by NEUTROGENA outside the U.S. Growth was partially offset by Oral Care in the international markets.

For full release see:

https://johnsonandjohnson.gcs-web.com/static-files/435f993a-fb4d-4afb-920f-82184d4374ea

McKesson Corporation (NYSE: MCK)

We're in an era of unprecedented complexity in healthcare. Patient care is not where it should be. While many of the organizations delivering the care need to get much healthier, too.

This is why our vision is to improve care in every setting - one product, one partner, one patient at a time. And we're making this happen every day by touching virtually every aspect of healthcare.

We partner with biopharma companies, care providers, pharmacies, manufacturers, governments and others to deliver the right medicines, medical products and healthcare services to the patients who need them, when they need them - safely and cost-effectively.

United by our ICARE values, our 78,000 employees work together every day to make better care possible for patients around the globe.

https://www.mckesson.com/About-McKesson/

2 August 2023

McKESSON CORPORATION REPORTS FISCAL 2024 FIRST QUARTER RESULTS

First Quarter Highlights:

Total revenues of $74.5 billion increased 11%.

Earnings per diluted share from continuing operations of $7.02 increased $1.77.

Adjusted Earnings per Diluted Share of $7.27 increased 25%.

Adjusted Earnings per Diluted Share Excluding Certain Items increased 33%.

Board of Directors approved a $6.0 billion increase to the share repurchase program, bringing the total remaining share repurchase authorization to $8.9 billion as of July 2023.

Board of Directors increased the quarterly dividend for the seventh consecutive year to $0.62 per share.

The US Oncology Network expanded its footprint with the addition of the Cancer Center of Kansas.

Fiscal 2024 Outlook:

Increasing fiscal 2024 Adjusted Earnings per Diluted Share guidance range to $26.55 to $27.35, from the previous range of $26.10 to $26.90.

Fiscal 2024 Adjusted Earnings per Diluted Share Excluding Certain Items guidance indicates 13% to 16% forecasted growth compared to prior year.

The Company does not forecast GAAP earnings per diluted share from continuing operations or segment operating profit1

IRVING, Texas, August 2, 2023 - McKesson Corporation (NYSE:MCK) today reported results for the first quarter ended June 30, 2023.

For full release see:

https://s24.q4cdn.com/128197368/files/doc_financials/2024/q1/MCK-Q1-FY24-Earnings-Release_FINAL.pdf

Merck & Co (NYSE: MRK)

We aspire to be the premier research-intensive biopharmaceutical company

Our purpose: We use the power of leading-edge science to save and improve lives around the world

For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world - and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

https://www.merck.com/company-overview/

1 April 2023

Merck Announces Second-Quarter 2023 Financial Results

Sales Reflect Sustained Underlying Growth, Particularly in Oncology and Vaccines

Total Worldwide Sales Were $15.0 Billion, an Increase of 3% From Second Quarter 2022; Excluding LAGEVRIO, Growth Was 11%; Excluding LAGEVRIO and the Impact of Foreign Exchange, Growth Was 14%

KEYTRUDA Sales Grew 19% to $6.3 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 21%

GARDASIL/GARDASIL 9 Sales Grew 47% to $2.5 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 53%

LAGEVRIO Sales Declined 83% to $203 Million; Excluding the Impact of Foreign Exchange, Sales Declined 82%

GAAP Loss per Share Was $2.35; Non-GAAP Loss per Share Was $2.06; GAAP and Non-GAAP Loss per Share Include a Charge of $4.02 per Share for the Acquisition of Prometheus

Presented Compelling Data in Earlier Stages of Cancer at 2023 ASCO Annual Meeting, Including:

Positive Phase 3 Results From KEYNOTE-671 Trial

Promising New Data From Phase 2b KEYNOTE-942/mRNA-4157-P201 Trial in Collaboration With Moderna

Announced Positive Results From Two Phase 3 Trials Evaluating V116

Submitted Biologics License Application to the U.S. FDA for Sotatercept

Full-Year 2023 Financial Outlook

Raises and Narrows Expected Worldwide Sales Range To Be Between $58.6 Billion and $59.6 Billion, Including Negative Impact of Foreign Exchange of Approximately 2 Percentage Points; Outlook Includes Approximately $1.0 Billion of LAGEVRIO Sales

Now Expects Non-GAAP EPS To Be Between $2.95 and $3.05, Including the Negative Impact of Foreign Exchange of Approximately 5 Percentage Points; Outlook Reflects Negative Impact From One-Time Charge of $10.2 Billion, or $4.02 per Share, for the Acquisition of Prometheu

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2023.

"We continue to make great progress as we advance our broad and deep pipeline, raise the bar of innovation, and bring forward leading-edge science to save and improve lives around the world," said Robert M. Davis, chairman and chief executive officer, Merck. "We delivered robust underlying growth during the second quarter and are well positioned to achieve strong full-year results. I am proud of our talented, diverse and dedicated global team that continues to focus on creating value for patients and all our stakeholders now and well into the future."

For full release see:

https://www.merck.com/news/merck-announces-second-quarter-2023-financial-results/

Novartis (NYSE: NVS)

Novartis was created in 1996 through a merger of Ciba-Geigy and Sandoz. Novartis and its predecessor companies trace roots back more than 250 years, with a rich history of developing innovative products.

Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. We also aim to reward those who invest their money, time and ideas in our company.

Our Strategy

Our strategy is to build a leading, focused medicines company powered by advanced therapy platforms and data science.

Strategic priorities

As we implement our strategy, we have five priorities to shape our future and help us continue to create value for our company, our shareholders and society.

Unleash the power of our people

We are transforming our culture to ensure people can fully apply their talent and energy. We're creating an organization where people are inspired, curious and unbossed.

Deliver transformative innovation

In our pursuit of transformative treatments, we challenge medical paradigms and explore possibilities to cure disease, intervene earlier in chronic illnesses, and find ways to dramatically improve quality of life.

Embrace operational excellence

We are rethinking how we work, embracing agile teams and building better productivity into our company to free resources that we can invest in innovation and help boost returns.

Go big on data and digital

We aim to spark a digital revolution at Novartis, embracing digital technologies, advanced analytics and artificial intelligence to help drive innovation and improve efficiency.

Build trust with society

We strive to build trust with society through our efforts to operate with high values and integrity, and to find new ways to expand patients' access to our treatments.

https://www.novartis.com/our-company

Novartis delivers strong full year performance, 10% net sales and 18% core operating income growth (cc¹), with margin expansion. Continuing innovation momentum with multiple positive Ph3 readouts

Jan 31, 2024

Ad hoc announcement pursuant to Art. 53 LR

Full year (continuing operations2)

Net sales grew +10% (cc, +8% USD) with core operating income growing +18% (cc, +11% USD)

Sales growth was mainly driven by continued strong performance from Entresto (+31% cc), Kesimpta (+99% cc), Kisqali (+75% cc), Pluvicto (+261% cc) and Scemblix (+179% cc)

Operating income increased +39% (cc, +23% USD). Net income increased +62% (cc, +42% USD). Free cash flow from continuing operations was USD 13.2 billion (+9% USD)

EPS grew +70% (cc, +49% USD) to USD 4.13. Core EPS was USD 6.47 growing +25% (cc, +18% USD)

Fourth quarter (continuing operations)

Net sales grew +10% (cc, +8% USD) with core operating income growing +13% (cc, +5% USD),

Sales growth was mainly driven by continued strong performance from Entresto (+26% cc), Kisqali (+76% cc), Kesimpta (+73% cc), Cosentyx (+21% cc) and Pluvicto (+53% cc)

Q4 selected innovation milestones:

Fabhalta FDA approval for treatment of adults with PNH (both previously treated and treatment-naïve)

Cosentyx FDA approval for the treatment of moderate to severe HS in adults

Cosentyx FDA approval for intravenous formulation in three indications (PsA, AS, nr-axSpA)

Iptacopan Ph3 APPLAUSE-IgAN met its primary endpoint in IgAN patients

Atrasentan Ph3 ALIGN study met its primary endpoint in IgAN patients

Iptacopan Ph3 APPEAR-C3G met its primary endpoint in C3G patients

Scemblix Ph3 ASC4FIRST study met its primary endpoints in 1L Ph+ CML-CP patients (January)

Dividend, 2024 guidance; updated mid-term guidance

Dividend of CHF 3.30 per share, an increase of 3.1%, proposed for 2023

2024 guidance3 - Net sales expected to grow mid single digit and core operating income expected to grow high single digit

Updated mid-term guidance - Net sales expected to grow 5% cc CAGR 2023-2028 with core operating income margin expanding to ~40%+ by 2027

Strategy Update

Our focus

During 2023, Novartis completed our transformation into a "pure-play" innovative medicines business. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies - the US, China, Germany and Japan.

Our priorities

Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.

Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility.

Strengthening foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society.

Financials

Following the September 15, 2023, shareholders' approval of the spin-off of the Sandoz business the Company reported its consolidated financial statements for the current and prior years as "continuing operations" and "discontinued operations."

Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities. Discontinued operations include the Sandoz Division and selected portions of corporate activities attributable to Sandoz's business, as well as certain expenses related to the spin-off.

Following the spin-off of the Sandoz business, Novartis operates as a single global operating segment focused innovative medicines company.

The commentary below focuses on continuing operations. We also provide information on discontinued operations, which mainly includes Sandoz and allocated corporate activities.

Continuing operations

Fourth quarter

Net sales were USD 11.4 billion (+8%, +10% cc) in the fourth quarter driven by volume growth of 13 percentage points. Generic competition had a negative impact of 3 percentage points and pricing had no impact.

Operating income was USD 2.6 billion (+47%, +68% cc), mainly driven by higher net sales and lower restructuring charges, partly offset by higher SG&A and R&D investments.

Net income was USD 2.6 billion (+101%, +130% cc), mainly driven by higher operating income and non-recurring favorable tax impacts. EPS was USD 1.29 (+108%, +140% cc), benefiting from lower weighted average number of shares outstanding.

Core operating income was USD 3.8 billion (+5%, +13% cc), mainly driven by higher net sales, partly offset by higher SG&A and R&D investments. Core operating income growth in USD was impacted by negative 2 percentage points from the effect of mid-December currency devaluation in Argentina1. Core operating income margin was 33.5% of net sales, decreasing 1.0 percentage point (+1.0 percentage point cc).

Core net income was USD 3.1 billion (+6%, +11% cc), mainly due to higher core operating income. Core EPS was USD 1.53 (+10%, +16% cc), benefiting from lower weighted average number of shares outstanding.

Free cash flow from continuing operations amounted to USD 2.1 billion (-38% USD), compared with USD 3.5 billion in the prior year quarter driven by lower net cash flows from operating activities.

1 IFRS® Accounting Standards requires for our Argentina subsidiary, as it operates in a hyperinflation economy, to translate for consolidation purposes their full year income statement to our USD presentation currency using the ARS closing rate, and not using the average exchange rate for the period. This results in the 9-months and the Q4 devaluation impact being recognized in Q4.

Full year

Net sales were USD 45.4 billion (+8%, +10% cc) in the full year, driven by volume growth of 16 percentage points, partly offset by price erosion of 2 percentage points and the negative impact from generic competition of 4 percentage points.

Operating income was USD 9.8 billion (+23%, +39% cc), mainly driven by higher net sales, lower restructuring charges, and income from legal matters, partly offset by higher impairments and higher SG&A and R&D investments.

Net income was USD 8.6 billion (+42%, +62% cc), mainly driven by higher operating income and non-recurring favorable tax impacts. EPS was USD 4.13 (+49%, +70% cc).

Core operating income was USD 16.4 billion (11%, +18% cc), mainly driven by higher net sales, partly offset by higher SG&A and R&D investments. Core operating income margin was 36.0% of net sales, increasing 0.9 percentage points (+2.4 percentage points cc).

Core net income was USD 13.4 billion (+13%, +19% cc), mainly due to higher core operating income. Core EPS was USD 6.47 (+18%, +25% cc), benefiting from lower weighted average number of shares outstanding.

Free cash flow from continuing operations amounted to USD 13.2 billion (+9% USD), compared with USD 12.1 billion in 2022 driven by higher net cash flows from operating activities.

For the complete story, see:

https://www.novartis.com/news/media-releases/novartis-delivers-strong-full-year-performance-10-net-sales-and-18-core-operating-income-growth-cc1-margin-expansion-continuing-innovation-momentum-multiple-positive-ph3-readouts

Novavax Inc. (NASDAQ: NVAX)

Novavax, Inc. is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines.

https://ir.novavax.com/

8 August 2023

Novavax Reports Second Quarter 2023 Financial Results and Operational Highlights

Second quarter total revenue of $424 million and net income of $58 million

Executed new strategic partnering agreement with SK bioscience, including an equity investment of $85 million in Novavax at $13.00 per share, a 59% premium to the 90-day VWAP

Negotiated up to $350 million in 2023 payments under amended Canada APA

Initiated FDA submission for approval of our updated XBB COVID vaccine for the 2023 fall vaccination season and reiterated plan to be in market by September; submissions to EMA and Health Canada in the coming weeks

Company to host conference call today at 8:30 a.m. ET

GAITHERSBURG, Md., Aug. 8, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M[TM] adjuvant, today announced its financial results and operational highlights for the second quarter ended June 30, 2023.

"During the first half of 2023, Novavax has been focused on execution, making significant progress on all three of our key priorities. We have initiated the filing for authorization of our updated XBB COVID vaccine in the U.S., with submissions in the European Union and Canada to follow and we are manufacturing at commercial scale in support of our plan to deliver our vaccine on time for the fall season," said John C. Jacobs, President and Chief Executive Officer, Novavax. "I am also pleased to report that we have now reduced our current liabilities by over $1 billion this year and we recorded $424 million in total revenue for the second quarter. We continue to work towards deriving additional value from our pipeline and technology and will be advancing our COVID-Influenza Combination vaccine candidate through the next stage gates and towards late-stage development."

Second Quarter 2023 and Recent Highlights

During the second quarter, the company continued to make progress on our three key priorities for 2023.

For full release see:

https://ir.novavax.com/press-releases/2023-08-08-Novavax-Reports-Second-Quarter-2023-Financial-Results-and-Operational-Highlights

Novo Nordisk (NYSE: NVO)

At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions.

Novo Nordisk is a global healthcare company with 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: rare bleeding disorders, growth hormone related disorders and obesity.

Headquartered in Denmark, Novo Nordisk employs approximately 42,700 people in 79 countries and markets its products in more than 170 countries.

Changing the world of diabetes for 90 years

Behind the Novo Nordisk we know today lies an exciting story that goes back 90 years. It began with the two small Danish companies Nordisk Insulinlaboratorium and Novo Terapeutisk Laboratorium founded in 1923 and 1925, respectively. The two companies started the production of the revolutionary new drug insulin that had just been discovered by two Canadian scientists.

Building on the past - looking to the future

Since the earliest days, both Nordisk and Novo had focus on the development of products to benefit people with diabetes. Competing intensely with one another, the companies developed into two of the best in their field. When at last they decided to merge in 1989, they created Novo Nordisk. A company that has been expanding rapidly ever since with leading positions within diabetes care, rare bleeding disorders, growth hormone-related disorders and obesity.

Today the Novo Nordisk Way shows responsibility to patients, employees, communities and investors.

We will in the future continue to build on the legacy left by the founders of Novo Nordisk and do whatever it takes to change diabetes. Our history tells us it can be done.

https://www.novonordisk-us.com/whoweare/about-novo-nordisk.html/

https://www.novonordisk-us.com/whoweare/about-novo-nordisk/novo-nordisk-history.html

Novo Nordisk's sales increased by 31% in Danish kroner and by 36% at constant exchange rates to DKK 232.3 billion in 2023

31 January 2024

Financial report for the period 1 January 2023 to 31 December 2023

Novo Nordisk's sales increased by 31% in Danish kroner and by 36% at constant exchange rates to DKK 232.3 billion in 2023

Operating profit increased by 37% in Danish kroner and by 44% at constant exchange rates (CER) to DKK 102.6 billion.

Sales in North America Operations increased by 50% in Danish kroner (54% at CER). Sales in International Operations increased by 11% in Danish kroner (16% at CER).

Sales within Diabetes and Obesity care increased by 38% in Danish kroner to DKK 215.1 billion (42% at CER), mainly driven by GLP-1 diabetes sales growth of 48% in Danish kroner (52% at CER) and Obesity care growing by 147% in Danish Kroner to DKK 41.6 billion (154% at CER). Rare disease sales decreased by 16% measured in Danish kroner (15% at CER) reflecting a reduction in manufacturing output.

In January 2024, Novo Nordisk successfully completed the first phase 3a trial with IcoSema, a fixed-ratio once-weekly combination of basal insulin icodec and semaglutide and a phase 1 trial with oral amycretin within Obesity care.

For the 2024 outlook, sales growth is expected to be 18-26% at CER, and operating profit growth is expected to be 21-29% at CER. Sales and operating profit growth reported in Danish kroner is expected to be 1 and 2 percentage points lower than at CER, respectively.

At the Annual General Meeting on 21 March 2024, the Board of Directors will propose a final dividend of DKK 6.40 for 2023 per share. The expected total dividend for 2023 is DKK 9.40 per share, of which DKK 3.00 was paid as interim dividend in August 2023. The Board of Directors has decided to initiate a new share repurchase programme of up to DKK 20 billion.

Lars Fruergaard Jørgensen, president and CEO: "We are very pleased with the strong performance in 2023 reflecting that more than 40 million people are now benefiting from our innovative diabetes and obesity treatments. We continue to make progress on our strategic aspirations. Our focus in 2024 will be on reaching more patients, progressing and expanding our pipeline as well as the continued significant expansion of our production capacity."

On 31 January 2024 at 13.00 CET, corresponding to 07.00 am EST, an earnings call will be held. Investors will be able to listen in via a link on novonordisk.com, which can be found under 'Investors'.

About Novo Nordisk

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 63,400 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, X, LinkedIn and YouTube.

https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=167013#

Perrigo Company Plc (NYSE: PRGO)

Perrigo started from humble beginnings more than 130 years ago in rural Michigan. Today, it is one of the largest over-the-counter (OTC) self-care companies selling products globally.

The Early Years

In 1887, Luther Perrigo, the owner of a general store and apple-drying business, had the idea to package and distribute patented medicines and household items for country stores. Luther launched the "private label" concept as a way to enhance customer loyalty. For no additional cost, Perrigo offered to imprint the store's name on the labels of epsom salts, sweet oil, bay rum and dozens of other wet and dry goods stocked in general stores.

Deep Roots in Manufacturing Excellence

Perrigo opened its first manufacturing facility in Allegan, Michigan in 1921 and signed its first, large private-label customer in the mid-1930s, paving the way for its conversion from a re-packager of home remedies to a manufacturer of affordable healthcare products.

This shift in strategic direction drove Perrigo's growth over the next several decades and serves as the heritage that guides the Company's mission today.

https://www.perrigo.com/history-convenient-healthy-solutions

27 February 2023

Perrigo Reports Fourth Quarter & Fiscal Year 2022 Financial Results From Continuing Operations

DUBLIN, Feb. 27, 2023 /PRNewswire/ --

Highlights:

Perrigo fiscal year net sales grew 7.6% versus the prior year to $4.5 billion. Constant currency net sales(1) increased 12.8% and organic(2) net sales grew a robust 8.8% compared to the prior year.

Fourth quarter net sales grew 4.6% to $1.2 billion versus the prior year quarter, or 9.6% on a constant currency basis. Both the Consumer Self-Care Americas ("CSCA") and Consumer Self-Care International ("CSCI") segments delivered record quarter net sales, increasing 4.0% and 5.7%, respectively. CSCI constant currency net sales increased 20.5% compared to the prior year quarter.

Fourth quarter GAAP ("reported") gross margin was 33.1%, a 170 basis points improvement compared to the first quarter of 2022 and an increase of 30 basis points compared to the prior year quarter. Perrigo achieved fourth quarter non-GAAP ("adjusted") gross margin of 38.4%, a 500 basis points improvement compared to the first quarter of 2022 and an increase of 350 basis points compared to the prior year quarter.

Fiscal year 2022 reported net earnings (loss) per diluted share ("EPS") was a loss of ($0.97), as compared to a loss of ($0.98) in the prior year period. Adjusted diluted EPS was $2.07, as compared to $2.06 in the prior year. Constant currency adjusted diluted EPS increased 12.1% to $2.31.

Fourth quarter reported EPS was a loss of ($0.09), as compared to net earnings of $0.24 in the prior year quarter, due primarily to higher amortization expenses and acquisition related costs. Adjusted diluted EPS was $0.75, an increase of 25.0% compared to the prior year quarter. Constant currency adjusted diluted EPS was $0.80, an increase of 33.3% compared to the prior year quarter.

Cash and cash equivalents totaled $601 million as of year-end, reflecting a strong cash conversion ratio(3) of approximately 110% for the full year.

In the fourth quarter, Perrigo purchased the Gateway infant formula facility and U.S. & Canadian GoodStart® brand from Nestle as the Company continues to play a major role in helping to solve the on-going U.S. infant formula shortage.

Company to hold a virtual Investor Day event tomorrow, February 28, 2023, where management will share the Company's 2023-2025 strategic plan to 'Optimize and Accelerate' performance as well as provide fiscal 2023 guidance (webcast details below).

Perrigo Company plc (NYSE: PRGO) ("Perrigo" or the "Company"), a leading global provider of Consumer Self-Care Products, today announced financial results for the fourth quarter and fiscal year ended December 31, 2022. All comparisons are against the prior year fiscal fourth quarter and fiscal year, unless otherwise noted.

President and CEO, Murray S. Kessler commented, "Perrigo completed its transformation from a healthcare company to a pure play consumer self-care company early in 2022 with the closing of the HRA Pharma acquisition. And it was from the momentum that was created through this transformation that the Company was able to deliver constant currency double-digit top-line and adjusted bottom-line growth in 2022, including all-time net sales records for both our Americas and International businesses, a 500 basis point recovery in adjusted gross margin from the first quarter to the fourth, continued market share gains across the portfolio, and cash conversion of over 100%."

Kessler continued, "Perrigo's strong year came behind an exceptionally strong fourth quarter that achieved 10% constant currency net sales growth and 33% constant currency adjusted diluted EPS growth along with adjusted gross margin up over 350 basis points versus year ago! I am so proud of how my Perrigo colleagues delivered these results, while at the same time navigating through unprecedented global supply chain disruptions, labor shortages, broad-based inflation, the Russia-Ukraine war, the infant formula shortage, and the continuing impact of the Covid-19 pandemic. It's a testament to the resiliency and nimbleness of the new Perrigo Consumer Self-Care Company."

Kessler concluded, "Equally impressive is the work our team did to advance the Company to the next phase of its long-term strategic plan, which we will share at our investor day tomorrow. At that virtual meeting, we will share our plan to Optimize and Accelerate the performance of the newly transformed Perrigo in order to deliver outsized profitable growth over the next 3 years."

Refer to Tables I - VI at the end of this press release for a reconciliation of non-GAAP adjustments to the current year and prior year periods and additional non-GAAP information. The Company's reported results are included in the attached Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

For full release see:

https://investor.perrigo.com/2023-02-27-Perrigo-Reports-Fourth-Quarter-Fiscal-Year-2022-Financial-Results-From-Continuing-Operations

Pfizer Inc (NYSE: PFE)

Pfizer Inc. is a research-based, global biopharmaceutical company. We apply science and our global resources to bring therapies to people that extend and significantly improve their lives through the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines, as well as many of the world's best-known consumer healthcare products.

Our strategy is rooted in four strategic imperatives that have remained constant since we began to transform Pfizer in 2011.

OUR STRATEGIC IMPERATIVES

INNOVATE & LEAD

Improve Pfizer's ability to innovate in biomedical R&D and develop a new generation of high value, highly differentiated medicines and vaccines.

MAXIMIZE VALUE

Invest and allocate our resources in ways that create the greatest long-term returns for our shareholders.

EARN GREATER RESPECT

Earn society's respect by generating breakthrough therapies, improving access, expanding the dialogue on health care and acting as a responsible corporate citizen.

OWN OUR CULTURE

Build and sustain a culture where colleagues view themselves as owners, generating new ideas, dealing with problems in a straightforward way, investing in open and candid conversations and working as teammates on challenges and opportunities.

https://investors.pfizer.com/why-invest-our-story/default.aspx

1 August 2023

Pfizer Reports Second-Quarter 2023 Results

Second-Quarter 2023 Revenues of $12.7 Billion

Expected Decline in Paxlovid and Comirnaty(1) Revenues Drove 53% Operational Decrease in SecondQuarter 2023 Revenues

Second-Quarter 2023 Revenues from Comirnaty(1) and Paxlovid of $1.6 Billion

Excluding Contributions from Comirnaty(1) and Paxlovid, Revenues Grew 5% Operationally

Second-Quarter 2023 Reported Diluted EPS(2) of $0.41, a Year-Over-Year Decline of 77%, and Adjusted Diluted EPS(3) of $0.67, a Year-Over-Year Decline of 67%

Narrows 2023 Revenue Guidance(4) Range to $67 to $70 Billion and Adjusts 2023 Non-COVID Operational Revenue Growth Expectation to 6% to 8% - Maintains All Other Components of Full-Year 2023 Financial Guidance(4), Including Guidance for Adjusted Diluted EPS(3)

Continues to Make Significant Progress on Executing an Unprecedented Number of Product and Indication Launches Expected to Contribute to Non-COVID Operational Revenue Growth in the Second Half of 2023

NEW YORK, Tuesday, August 1, 2023 - Pfizer Inc. (NYSE: PFE) reported financial results for the second quarter of 2023. The company narrowed its 2023 revenue guidance(4) range to $67 to $70 billion, while maintaining its outlook for Adjusted diluted EPS(3) of $3.25 to $3.45.

EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: "Pfizer has made significant progress toward our goal to launch 19 new products and indications in an 18-month span, having executed eleven launches thus far. We continue to build momentum in 2023, recently attaining key milestones for several products, including the U.S. launches of Prevnar 20 in pediatric patients and Zavzpret; U.S. approvals and launches for Abrysvo in older adults, Litfulo and the Talzenna plus Xtandi combination; U.S. approvals for Ngenla (expected to be available for prescribing this month) and Paxlovid; and U.S. regulatory filing acceptance for fidanacogene elaparvovec (Hemophilia B Gene Therapy).

Supporting our expectation to deliver robust operational growth in 2025 and beyond, we also reported data from several exciting pipeline candidates we believe have the potential to be significant future value-drivers, including Phase 3 data from marstacimab, Pfizer's novel, investigational anti-TFPI antibody being studied for the treatment of hemophilia A or B; further data from elranatamab, Pfizer's investigational BCMA CD3-targeted bispecific antibody currently being investigated in multiple myeloma; and first-in-human data from our pipeline of potential next-generation breast cancer treatments, including our novel CDK4, CDK2, and KAT6 inhibitors.

Finally, we continue to make progress toward our proposed acquisition of Seagen, a global biotechnology company that discovers, develops and commercializes transformative oncology medicines. In addition to receiving approval of the transaction from Seagen shareholders and planning for the potential integration of the two companies, we continue to work closely with regulators, including the Federal Trade Commission (FTC) and the European Commission (EC), and are working diligently to fulfill requests for further information from the FTC.

We look forward to continuing our progress in the second half of 2023, driven by commercial execution, scientific innovation and our never-ending commitment to delivering breakthroughs for patients."

David Denton, Chief Financial Officer and Executive Vice President, stated: "The second quarter of 2023 delivered solid 5% operational revenue growth, excluding our COVID-19 products, and our year-to-date results are in line with our expectations. Despite a few near-term individual product revenue challenges, we believe the company is well positioned for accelerated growth of our non-COVID products in the second half of 2023. The COVID environment continues to evolve rapidly and remains highly unpredictable. In spite of this uncertainty, the company is maintaining its focus on ensuring successful fall vaccinations during the respiratory infection season.

During the second quarter we successfully closed a $31 billion debt offering, the net proceeds of which we intend to use as part of the financing for Pfizer's proposed acquisition of Seagen. We continue to expect the transaction to close in late 2023 or early 2024, subject to the satisfaction of customary closing conditions. As we de-lever our capital structure after the close, we expect our strong balance sheet will continue to provide the flexibility for future dividend increases and share repurchases, as well as additional business development activity."

For full release see:

https://s28.q4cdn.com/781576035/files/doc_financials/2023/q2/Q2-2023-PFE-Earnings-Release.pdf

Regeneron Pharmaceuticals Inc (NASDAQ: REGN)

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) is a leading science and technology company delivering life-transforming medicines for serious diseases. Regeneron Pharmaceuticals, Inc. company headquartered in Eastview, near Tarrytown, New York.Founded by physician-scientists 30 years ago, our science-driven approach has resulted in six FDA-approved medicines and numerous product candidates in a range of diseases, including asthma, pain, cancer and infectious diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

https://www.regeneron.com/about

REGENERON REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL AND OPERATING RESULTS

2 February 2024

Fourth quarter 2023 revenues increased 1% to $3.43 billion versus fourth quarter 2022; excluding Ronapreve TM(a)(b) , revenues increased 14%

Full year 2023 revenues increased 8% to $13.12 billion versus full year 2022; excluding Ronapreve (a) , revenues increased 12%

Fourth quarter 2023 Dupixent ® global net sales (recorded by Sanofi) increased 31% to $3.22 billion versus fourth quarter 2022; full year 2023 Dupixent global net sales increased 33% to $11.59 billion versus 2022

Fourth quarter 2023 U.S. net sales for EYLEA ® HD and EYLEA ® were $1.46 billion, including $123 million from EYLEA HD; full year 2023 U.S. net sales for EYLEA HD and EYLEA were $5.89 billion, including $166 million from EYLEA HD following its August 2023 FDA approval

Fourth quarter 2023 Libtayo ® global net sales increased 44% to $244 million versus fourth quarter 2022; full year 2023 Libtayo global net sales increased 50% to $869 million versus 2022 (f)

Fourth quarter 2023 GAAP diluted EPS of $10.19 and non-GAAP diluted EPS (a) of $11.86; includes unfavorable $0.21 impact from acquired IPR&D charge

Dupixent sBLA for chronic obstructive pulmonary disease (COPD) with type 2 inflammatory phenotype and linvoseltamab BLA for multiple myeloma submitted to FDA

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the fourth quarter and full year 2023 and provided a business update.

"2023 marked another year of exceptional accomplishments for Regeneron as we further diversified our revenue base and made important progress in our robust R&D pipeline," said Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron. "In 2024, we plan to build on this momentum with continued growth of our breakthrough products Dupixent and EYLEA HD while we bring additional new therapies to market and advance our growing pipeline. Lastly, I want to congratulate our Chief Financial Officer, Bob Landry, on the occasion of his retirement and thank him for his significant contributions to Regeneron during his ten years with the Company."

For the full release, see:

https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial

Sanofi (NYSE: SNY)

Sanofi, Synthélabo, Hoechst, Rhône-Poulenc Rorer led to the creation of Sanofi. These companies have accumulated over a century of experience in health, with a core concern of innovation to meet the evolution of society and the needs of patients.

Today, the Sanofi Company and its 100,000 employees are dedicated to make a difference on patients' daily life, wherever they live and enable them to enjoy a healthier life.

https://www.sanofi.com/en/about-us/through-time

3 February 2023

Strong sales performance and double-digit EPS growth marking the achievement of the 2022 profitability milestone

Paris, February 3, 2023

Q4 2022 sales growth of 2.6% at CER and business EPS(1) growth of 17.4% at CER

Specialty Care grew 18.1% driven by Dupixent® ([euro]2,402 million, +42.1%) and new product launches

Vaccines sales (-16.3%) reflecting influenza and PPH sales phasing (Q3 influenza sales: up 32.4%) as well as ramp up of non-consolidated Vaxelis® sales

General Medicines core assets up 8.0% while GBU sales were lower (-3.7%) mainly due to Lantus® and spin-off of EUROAPI

CHC sales increased 6.6% driven by double-digit growth of Digestive Wellness, Cough & Cold and Allergy categories

Full-year 2022 delivered 7.0% sales growth and 17.1% business EPS growth at CER

Sales grew to [euro]42,997 million driven by Dupixent® ([euro]8,293 million, +43.8%), adding [euro]3 billion of incremental sales, Vaccines up 6.3% in line with the mid-term growth objective as well as CHC strategy execution (+8.6%)

Mid-term BOI margin target of 30% and cost savings objective of [euro]2.5 billion achieved

Business EPS(1) of [euro]8.26 up 25.9% on a reported basis and 17.1% at CER

IFRS EPS of [euro]5.37 (up 8.0%)

Board held on February 2, proposes annual dividend of [euro]3.56, an increase of 6.9%

Progress on Corporate Social Responsibility strategy in Q4

Positive phase 2/3 results of acoziborole with the potential to further transform the treatment of sleeping sickness

Accelerating our ambition towards net zero emissions by 5 years, now targeting 2045

Key R&D milestones and regulatory achievements in Q4

Dupixent® approved in Europe for prurigo nodularis and CHMP positive opinion for eosinophilic esophagitis

Beyfortus® (nirsevimab) approved in Europe for the prevention of RSV disease in all infants

VidPrevtyn® Beta approved in Europe as a booster for the prevention of COVID-19 in adults

Enjaymo® approved in Europe in adult patients with cold agglutinin disease (CAD)

Full-year 2023 business EPS guidance

Sanofi expects 2023 business EPS(1) to grow low single digit(2) at CER, barring unforeseen major adverse events. Applying average January 2023 exchange rates, the currency impact on 2023 business EPS is estimated between -3.5% to -4.5%

Sanofi Chief Executive Officer, Paul Hudson, commented:

"We closed 2022, marking the successful execution of the first chapter of our 6-year 'Play to Win' strategy. Specialty Care delivered the highest sales among our businesses. Dupixent® and Vaccines continue to be our leading growth drivers. We are particularly proud of the progress we made in R&D transformation with multiple approvals of transformative medicines and new product launches across Specialty Care. At the same time, we keep delivering strong proof points of our improved financial performance underpinned by the achievement of the 30% BOI margin. Moving to the next chapter of our strategy, we are looking forward to the planned launches of Altuviiio® and Beyfortus® as well as key pivotal readouts, including the COPD indication for Dupixent®. With the view on the expected entrants of generic competition for Aubagio® in the coming months, we remain confident in our outstanding commercial capabilities, including the ambition to reach sales of 10 billion euros for Dupixent® in 2023, enabling us to guide to low single-digit EPS growth for the year."

For full release see:

https://www.sanofi.com/en/media-room/press-releases/2023/2023-02-03-06-30-00-2601072

Teva (NYSE: TEVA)

Since Teva's establishment in Jerusalem in 1901, our aim has been to help patients live longer, healthier lives. As we work to find solutions to tomorrow's biggest healthcare challenges, we look back with pride at our humble beginnings and past accomplishments.

When, over a century ago, Chaim Salomon, Moshe Levin, and Yitschak Elstein came together in Jerusalem to form a small pharmaceutical business, they could not have imagined that their company would go on to be a world leader in the industry.

https://www.tevapharm.com/our-company/teva-history/

Our mission is to be a global leader in generics and biopharmaceuticals, improving the lives of patients across the world.

In a complex world, Teva's mission is simple: to improve the lives of patients across the globe. We believe that everyone should have access to quality medicines whether it be for managing disease, fighting infections, or simply improving overall health.

We are proud that since Teva's establishment in 1901, healthcare providers together with patients and caregivers have been using our accessible generic and innovative products. Today, our portfolio of around 3,500 products is among the largest of any pharmaceutical company in the world. Nearly 200 million people in 60 countries benefit from one of Teva's quality medicines every day. We invest in research and development of generic medicines and biopharmaceuticals, carrying on the legacy of more than a century of finding new ways to help patients improve their lives. This defines our values as a company and characterizes how we do business and approach medicine.

https://www.tevapharm.com/our-company/who-we-are/

8 February 2023

Teva Reports Fourth Quarter and Full Year 2022 Financial Results

TEL AVIV, Israel--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the year and the quarter ended December 31, 2022.

Q4 and FY 2022 highlights:

Q4 2022

FY 2022

Revenues

$3.9 billion

$14.9 billion

GAAP diluted loss per share

$(1.10)

$(2.12)

Non-GAAP diluted EPS

$0.71

$2.52

Cash flow generated from operating activities

$973 million

$1,590 million

Free cash flow

$1,140 million

$2,243 million

2023 business outlook:

Revenues are expected to be $14.8 - $15.4 billion

Adjusted EBITDA of $4.5 - $4.9 billion

Non-GAAP diluted EPS is expected to be $2.25 - $2.55

Free cash flow is expected to be $1.7 - $2.1 billion

"It is a huge pleasure to be leading the Company through my first reporting period as CEO of Teva. The tremendous work that has been done to get the business back to a solid foundation serves as excellent grounds to transition into a new path for growth.

In 2022, Teva delivered solid results. Our key innovative brands, AUSTEDO® and AJOVY®, continued to drive growth, with AUSTEDO increasing 20% in the U.S. We expect continued expansion as this medicine addresses a still large unmet need for tardive dyskinesia patients.

Our generics business performed strongly in Europe and International Markets, growing 9% and 5% respectively, in local currency terms. We also continued to optimize our supply chain and manufacturing capabilities and reduced our net debt.

Looking ahead to 2023, I am especially enthusiastic about the progress of our innovative, biosimilars and generic pipelines, which include interesting and differentiated assets. As we work on an updated strategy, we are looking for opportunities to best position Teva for long-term growth and generate value to all stakeholders."

2022 Annual Consolidated Results

Revenues in 2022 were $14,925 million, a decrease of 6%, in U.S. dollars or 1% in local currency terms, compared to 2021, mainly due to lower revenues from COPAXONE® and certain respiratory products in our North America and Europe segments, generic products as well as BENDEKA® and TREANDA® in our North America segment, partially offset by higher revenues from generic products in our Europe and International Markets segments, and from our innovative products - AUSTEDO and AJOVY, and Anda.

Exchange rate movements during 2022, including hedging effects, negatively impacted revenues by $780 million, operating income by $247 million and non-GAAP operating income by $263 million, each as compared to 2021.

Gross profit was $6,973 million in 2022, a decrease of 8% compared to 2021. Gross profit margin was 46.7% in 2022, compared to 47.8% in 2021. Non-GAAPgross profit was $8,056 million in 2022, a decrease of 6% compared to 2021. Non-GAAPgross profit margin was 54.0% in 2022, compared to 54.2% in 2021. This decrease in both GAAP and non-GAAP gross profit margin was mainly due to lower revenues from COPAXONE and certain respiratory products in our North America and Europe segments, partially offset by higher revenues from AUSTEDO in North America and a favorable mix of generic products in our Europe segment.

Research and Development (R&D) expenses in 2022 were $838 million, a decrease of 13% compared to 2021. The decrease in R&D expenses in 2022 was mainly due to a decrease in several neuroscience projects (in the pain and migraine and headache therapeutic areas) and immunology (in the respiratory therapeutic area) as well as a decline in various generics projects, and an adjustment in payments pursuant to a contract with one of our R&D partners in 2022, partially offset by higher R&D expenses related to our biosimilar products pipeline.

Selling and Marketing (S&M) expenses in 2022 were $2,265 million, a decrease of 7% compared to 2021.

General and Administrative (G&A) expenses in 2022 were $1,180 million, an increase of 7% compared to 2021. This increase was related to proceeds received from Teva's insurance carriers pursuant to a settlement reached on a derivative proceeding in the second quarter of 2021 related to the acquisition of Actavis Generics, as well as higher litigation fees in the second quarter of 2022.

Other income in 2022 was $107 million, compared to $98 million in 2021.

Operating loss was $2,099 million in 2022, compared to operating income of $1,716 million in 2021. Operating loss as a percentage of revenues was 14.1% in 2022, compared to operating income as a percentage of revenues of 10.8% in 2021. Operating loss in 2022 was mainly affected by goodwill impairment charges, and legal settlements and loss contingencies. Non-GAAPoperating income was $4,139 million in 2022, or 27.7% of revenues compared to $4,401 million, or 27.7% of revenues in 2021. Non-GAAP operating margin in 2022 was mainly affected by lower gross profit margin, as discussed above, offset by lower operating expenses as a percentage of revenues.

Adjusted EBITDA was $4,598 million in 2022, compared to $4,911 million in 2021.

In 2022, financial expenses, net were $966 million, compared to $1,058 million in 2021. Financial expenses in 2022 were mainly comprised of interest expenses and other bank charges of $930 million. Financial expenses in 2021 were mainly comprised of interest expenses and other bank charges of $891 million and loss on revaluations of marketable securities of $90 million.

In 2022, we recognized a tax benefit of $638 million, or 21%, on a pre-tax loss of $3,065 million. In 2021, we recognized a tax expense of $211 million, or 32%, on a pre-tax income of $658 million. Our tax rate for 2022 was lower than in 2021 mainly due to the realization of losses related to an investment in one of our U.S. subsidiaries, partially offset by a goodwill impairment charge that did not have a corresponding tax effect.

Non-GAAP tax rate for 2022 was 12%, compared to 16% in 2021. Our non-GAAP tax rate in 2022 was mainly affected by the realization of losses related to an investment in one of our U.S. subsidiaries, the mix of products we sold, interest expense disallowances and adjustments to valuation allowances on deferred tax assets.

Net loss attributable to Teva and diluted loss per share in 2022 were $2,353 million and $2.12, respectively, compared to net income attributable to Teva of $417 million and diluted income per share of $0.38 in 2021. Net loss in 2022 was mainly affected by goodwill impairment charges and legal settlements and loss contingencies, partially offset by a tax benefit. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in 2022 were $2,812 million and $2.52, respectively, compared to $2,855 million and $2.58 in 2021.

As of December 31, 2022 and 2021, the fully diluted sharecount for purposes of calculating our market capitalization was approximately 1,143 million and 1,128 million shares, respectively.

For full release see:

https://www.tevapharm.com/news-and-media/latest-news/teva-reports-fourth-quarter-and-full-year-2022-financial-results/

Thermo Fisher Scientific (NYSE: TMO)

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

https://ir.thermofisher.com/investors/overview/default.aspx

26 April 2023

Thermo Fisher Scientific Reports First Quarter 2023 Results

WALTHAM, Mass.--(BUSINESS WIRE) -- Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the first quarter ended April 1, 2023.

First Quarter 2023 Highlights

Delivered very strong financial results during the first quarter.

First quarter revenue was $10.71 billion, 9% lower versus the same quarter last year. Core organic revenue growth was 6%.

First quarter GAAP diluted earnings per share (EPS) was $3.32.

First quarter adjusted EPS was $5.03.

Launched a range of high-impact, innovative new products, including the Thermo Scientific iCAP RQ Plus ICP-MS Analyzer to simplify analysis of trace elements, including identification of heavy metals in water and soil as well as toxic elements in food and beverages; the Applied Biosystems QuantStudio Absolute Q AutoRun dPCR, an automated digital PCR solution to increase productivity for molecular research, including cell and gene therapy and cancer research; and the Invitrogen DynaGreen, microplastic-free magnetic beads for protein purification, helping our customers to reduce the environmental impact of life science research.

Continued to strengthen our unique customer value proposition by advancing our strategic partnership with the University of California, San Francisco (UCSF), with the opening of a new cell therapy cGMP manufacturing and collaboration center to accelerate development of breakthrough therapies.

Secured agreements to power all current U.S. sites with 100 percent renewable energy by 2026, contributing significantly to our commitment of a 50% reduction in Scope 1 and 2 greenhouse gas emissions by 2030.

Active quarter of capital deployment, repurchasing $3.0 billion of stock, increasing our dividend by 17 percent, and completing the acquisition of The Binding Site.

"We delivered another quarter of very strong financial performance, driven by our proven growth strategy and powered by our PPI business system," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "The team executed very well to navigate a dynamic macroenvironment, enable our customers' success, and drive share gain."

Casper added, "We are incredibly well positioned to deliver differentiated performance, as we continue to create value for all of our stakeholders and build an even brighter future for our company."

First Quarter 2023

Revenue for the quarter declined 9% to $10.71 billion in 2023, versus $11.82 billion in 2022. Organic revenue was 8% lower, Core organic revenue growth was 6%, and COVID-19 testing revenue was $0.14 billion.

GAAP Earnings Results

GAAP diluted EPS in the first quarter of 2023 was $3.32, versus $5.61 in the same quarter last year. GAAP operating income for the first quarter of 2023 was $1.56 billion, compared with $2.82 billion in the year-ago quarter. GAAP operating margin was 14.6%, compared with 23.9% in the first quarter of 2022.

Non-GAAP Earnings Results

Adjusted EPS in the first quarter of 2023 was $5.03, versus $7.25 in the first quarter of 2022. Adjusted operating income for the first quarter of 2023 was $2.33 billion, compared with $3.45 billion in the year-ago quarter. Adjusted operating margin was 21.8%, compared with 29.2% in the first quarter of 2022.

Annual Guidance for 2023

The company will provide updates on its 2023 financial guidance during its earnings conference call this morning at 8:30 a.m. Eastern time.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

For full release see:

https://newsroom.thermofisher.com/newsroom/press-releases/press-release-details/2023/Thermo-Fisher-Scientific-Reports-First-Quarter-2023-Results/default.aspx

ACQ_REF: IS/42799/20240408/USA/14/11

ACQ_AUTHOR: Associate/Danny Cliffson Crispin Benos

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