Global Pharmaceuticals 6 Mar 24 – INDUSTRY SNAPSHOTS
2023 was a tough year for the biopharma industry, with several companies downsizing and restructuring their workforces to try to stay afloat.
For the complete story, see:
https://www.biospace.com/article/biospace-layoff-tracker-2023-athenex-shutters-facility-cuts-staff/
Pharmaceutical Technology - EMA awards double validation for
Two marketing authorisation applications for
For the complete story, see:
Reuters - GSK CEO
GSK (GSK.L), opens new tab CEO
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Other Stories
Reuters - FDA approves J&J's com -
Reuters - GSK CEO
CNBC - Judge rejects
Pharmaceutical Technology -
Reuters -
Reuters - Eli
Reuters -
Media Releases
Photocatalytic Technologies in the Removal of Pharmaceuticals from Aquatic Systems - By
Industry Overview
Global Pharmaceuticals Industry
Overviews of Leading Companies
Abbvie (NYSE: ABBV)
Roche Products
Sinopharm (
Senior Associate: Theadore Leighton Manjah
News and Commentary
2023 was a tough year for the biopharma industry, with several companies downsizing and restructuring their workforces to try to stay afloat.
For the complete story, see:
https://www.biospace.com/article/biospace-layoff-tracker-2023-athenex-shutters-facility-cuts-staff/
Pharmaceutical Technology - EMA awards double validation for
Two marketing authorisation applications for
For the complete story, see:
Reuters - GSK CEO
GSK (GSK.L), opens new tab CEO
For the complete story, see:
Reuters - FDA approves J&J's com -
The
For the complete story, see:
Reuters - GSK CEO
GSK (GSK.L), opens new tab CEO
For the complete story, see:
Shares of
For the complete story, see:
https://www.scmp.com/print/article/1001851/shanghai-pharma-slides-24pc-after-fraud-probe-report
For the complete story, see:
CNBC - Judge rejects
A federal judge on Friday rejected
For the complete story, see:
Pharmaceutical Technology -
The
For the complete story, see:
https://www.pharmaceutical-technology.com/news/mhra-approves-formulation-xgeva/
Reuters - Bristol Myers CEO says
For the complete story, see:
Reuters - Eli
For the complete story, see:
Reuters -
COVID-19 vaccine maker
For the complete story, see:
Multinational pharmaceutical company
For the complete story, see:
https://www.chinadaily.com.cn/a/202402/28/WS65de87a6a31082fc043b972f.html
AbbVie on Wednesday entered into a strategic partnership with
For the complete story, see:
Media Releases
Parallel applications based on TROPION-Lung01 and TROPION-Breast01 Phase III trial results demonstrating
The
The validations confirm the completion of the applications and commence the scientific review process by the
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by
Additional regulatory submissions for datopotamab deruxtecan in lung cancer and breast cancer are underway in the US and globally.
Approval is based on results from the Phase 3 PAPILLON study, which demonstrated RYBREVANT® plus chemotherapy reduced the risk of disease progression or death by 61 percent versus chemotherapy alone in patients with previously untreated NSCLC with EGFR exon 20 insertion mutations
National Comprehensive Cancer Network ® (NCCN ®) updated its NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) to recommend amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a preferred first-line regimen for patients with NSCLC with EGFR exon 20 insertion mutations
"When aiming for the best possible treatment outcomes, a targeted approach should be used in the first line for patients with EGFR exon 20 insertion mutations, as this is a commonly applied practice for patients with NSCLC harboring other molecular driver alterations," said
Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases.2,3 Alterations in EGFR are the most common actionable driver mutations in NSCLC.4 Clinical data show patients with EGFR exon 20 insertion mutations generally experience limited benefits with currently approved third-generation EGFR tyrosine kinase inhibitors and chemotherapy.5,6 NSCLC driven by EGFR exon 20 insertion mutations carries a worse prognosis and shorter survival rates compared with lung cancer driven by other EGFR driver mutations.7
"For patients with lung cancer and their families, each breakthrough in treatment provides not only a new option, but a potential lifeline. The approval of RYBREVANT plus chemotherapy heralds a promising new first-line treatment option for patients newly diagnosed with non-small cell lung cancer where their driver mutation is an EGFR exon 20 insertion," said
The FDA approval is based on positive results from the randomized, open-label Phase 3 PAPILLON study, which showed RYBREVANT® plus chemotherapy resulted in a 61 percent reduction in the risk of disease progression or death compared to chemotherapy alone.1 Results also showed treatment with RYBREVANT® plus chemotherapy improved objective response rate (ORR) and progression-free survival (PFS).1 Based on PAPILLON data, the National Comprehensive Cancer Network ® (NCCN ®) updated its' NCCN Clinical Practice Guidelines (NCCN Guidelines®) to include a category 1 recommendation for amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a preferred first-line therapy for patients with NSCLC with EGFR exon 20 insertion mutations.8 †‡
"We are redefining care for patients with non-small cell lung cancer by advancing innovative regimens that can be used early, with the goal of extending survival," said
Warnings and Precautions include Infusion Related Reactions (IRR), Interstitial Lung Disease (ILD)/Pneumonitis, Dermatologic Adverse Reactions, Ocular Toxicity and Embryo-fetal Toxicity. The most common adverse reactions (≥20 percent) were rash, nail toxicity, stomatitis, IRR, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea and vomiting. The most common Grade 3 or 4 laboratory abnormalities (≥2 percent) were decreased albumin, increased alanine aminotransferase, increased gamma-glutamyl transferase, decreased sodium, decreased potassium, decreased magnesium, and decreases in white blood cells, hemoglobin, neutrophils, platelets, and lymphocytes.
Regulatory approval for the first fully integrated PFA system with a CARTO-enabled simple and reproducible workflow.
Integrated with the world's leading CARTO™ 3D Cardiac Mapping System for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AF).
CE Mark follows recent approval of the VARIPULSE™ Platform in
The safety and efficacy of the VARIPULSE™ Platform was investigated in the inspIRE trial, which included 186 patients in
"CE mark approval of the VARIPULSE™ Platform represents a significant advance in catheter ablation technology, allowing electrophysiologists to offer patients in
Catheter ablation is a minimally invasive procedure performed by an electrophysiologist to treat heart rhythm disorders, including AF, by interrupting irregular electrical pathways in the heart by delivering either heat (radiofrequency ablation) or cold (cryoablation).3 PFA represents a new approach to treating AF, utilizing a controlled electric field to selectively ablate cardiac tissue that causes the irregular heartbeat through a process called irreversible electroporation (IRE).4 Because the pulsed field energy is minimally thermal, IRE offers the potential to reduce the risk of damage to surrounding tissues including esophageal, pulmonary vein, and phrenic nerve injury.4
"At
AF is the most common type of cardiac arrhythmia, affecting over 11 million people in Europe.5,6,7 If left untreated, patients face a fivefold increased risk of stroke7, while their risk of death doubles7. By 2030, prevalence is projected to increase by up to 70 percent7 presenting an urgent need for innovative treatment solutions that deliver better outcomes for people living with AF while providing healthcare professionals with increased flexibility and efficiency.
Sustained efficacy was confirmed with an annualized relapse rate of 0.098 and 67% of patients were relapse-free at six years
Safety was consistent with prior findings and the established safety profile of Zeposia with nearly 10 years of clinical experience
In a separate DAYBREAK analysis, nearly 97% of followed patients were relapse-free at 90 days post Zeposia discontinuation; patients that did relapse showed no evidence of rebound effect
In the DAYBREAK long-term extension study, treatment with Zeposia demonstrated a low annualized relapse rate of 0.098. Three- and six-month confirmed disability progression was absent in 82.8% and 84.8% of participants in the trial respectively. At Month 60, the adjusted mean number of new/enlarging T2 lesions per scan (range: 0.79-0.93) and the adjusted mean number of gadolinium-enhancing lesions (0.06-0.08) were similar across patient cohorts.
"These DAYBREAK data continue to validate the role of Zeposia in the long-term management of relapsing forms of multiple sclerosis, with two-thirds of patients relapse-free at six years of treatment," said
In the DAYBREAK trial, 2,494 participants were exposed to Zeposia for an average of 60.9 months (12,664.7 person-years); 2,219 participants (89.0%) had any treatment-emergent adverse event (TEAE), 381 (15.3%) had a serious TEAE and 98 (3.9%) discontinued the study due to a TEAE. The most common TEAEs were nasopharyngitis (21.3%), headache (17.1%), COVID-19 infection (16.5%) and upper respiratory tract infection (12.4%). No new safety signals emerged; data from this long-term observational study of patients treated for up to 81.5 months were consistent with the established safety profile of Zeposia.
Additionally, a separate analysis (Poster #P097) was conducted to assess the risk of rebound after Zeposia discontinuation in the DAYBREAK trial. Five hundred forty-four participants (21.8%) discontinued the study early, while 1,950 participants (78.2%) remained on treatment until the end of the trial. Approximately 2.2% were known to have relapsed after permanently discontinuing Zeposia, with 87.3% of relapses occurring between 29 and 90 days (median time to onset: 61 days) after discontinuation. Nearly all patients were not taking any disease modifying therapy for MS at the time of relapse. Most relapses were mild (n=20 [36.4%]) or moderate (n=34 [61.8%]) and most patients made a complete recovery. No post-treatment relapse was associated with rebound effect, characterized by severe exacerbation of disease or severe persistent increase in disability.
"Currently no cure exists for multiple sclerosis, but effective strategies and treatments can help slow disease progression and alleviate symptoms," said
At the
Photocatalytic Technologies in the Removal of Pharmaceuticals from Aquatic Systems
Singh Permender,
ABSTRACT
The need for pharmaceuticals for their use as medicines is rapidly increasing. Consequently, the pharmaceutical industries are springing up quickly to meet the demand. There are many factors that contribute to the production of increasingly inventive pharmaceuticals, including the continual progress of medicinal science, improvements in research and development, and large investments in healthcare. However, the widespread use of pharmaceuticals and their improper release into bodies of water have badly contaminated the water resources and consequently adversely affected the marine life. This is due to the high persistence of several pharmaceuticals and their metabolites, which prevent their breakdown for long time in the aquatic environments. The most common growing pharmaceutical contaminants are analgesics, β-blockers, lipid-lowering pharmaceuticals, antiepileptics, anti-inflammatories, and antibiotics. As a result, the degradation of emerging pharmaceutical pollutants in wastewater is one of the current major global concerns in order to meet the demand for safe water and safeguard aquatic life. Many techniques have been developed recently for pharmaceutical pollutants removal, but at the present time, the photocatalysis approach is the most efficient for eradicating newly emerging pharmaceutical contaminants. It is because the photocatalysis approach has various advantages such as the higher catalytic efficiencies, rapid reaction, no secondary hazardous products, low cost, reusable, complete degradation, and use of sustainable solar energy to trigger catalyst for pharmaceuticals eradication. Various visible light-driven photocatalysts for pharmaceutical pollutants degradation are explored in this chapter along with degradation reaction mechanisms and adverse effects of these pollutants.
The Industry
Building upon the
PhRMA represents the top innovative biopharmaceutical research companies. MAT is the result of an ongoing effort between PhRMA, health care providers, pharmacists, patient advocacy organizations and community groups interested in helping patients access the information they need to be more empowered as they navigate a complex, and sometimes overwhelming, health care system. MAT's focus is to help people
The groups that support MAT include the largest and most influential in health care, ranging from patient groups to consumer groups to health care provider organizations and more.
Source: medicineassistancetools.org
Source: The
The Importance of Strong
A once-in-a-century global pandemic has reinforced the value of the scientific advances America's innovative and indispensable biopharmaceutical industry made possible. The industry has been working around the clock for more than a year to research, develop and deliver safe and effective therapeutics and vaccines to combat COVID-19. To enhance patient access to innovative medicines during this pandemic and beyond, governments should institute and strengthen policies that incentivize the research, development, manufacturing and trade of new medicines for patients.
The majority of the world's medical innovation occurs in
Unfortunately, some foreign governments use unfair trade practices to undermine American inventions and disadvantage
Some governments are seeking to waive international commitments to honor intellectual property rights for COVID-19 vaccines under the
Biopharmaceutical innovators depend on strong regulatory systems, robust intellectual property protections and enforcement and fair and transparent access to overseas markets through the operation of competitive markets or other procedures that appropriately recognize the value of innovative medicines.
America's trade policy therefore should:
Enforce existing trade agreements by ensuring that our trading partners value
Eliminate government pricing policies that do not appropriately value
Uphold sound patent law by not allowing trading partners to infringe or misinterpret rules or diminish or modify globally-defined patentability criteria.
Challenge illegal localization barriers by opposing requirements designed to block foreign imports and enrich local competitors.
Reject compulsory licensing, or the elimination of certain patent rights, by preventing foreign governments from expropriating — or threatening to expropriate — American innovations. Too often compulsory licensing is used as a tool to implement industrial policy or as undue leverage in pricing negotiations between governments and right holders
The
Source: The
INDUSTRY OVERVIEW
The Pharmaceutical Industry in
"
5.1% annual revenue growth in the pharmaceutical market (pharmacies and clinics) over a five- year period (CAGR 2014-2019)
12.5% of revenue invested in R&D in 2018 - the highest rate among all major industry sectors in
83 mln population drives domestic demand for health- care products and services
Combining cutting edge innovation, a long tradition as the "world´s pharmacy" and continuously growing demand for healthcare products,
The country is the largest exporter of medicinal products and ranks among the top pharmaceutical producers worldwide. In light of the global need for personalized medicine,
The Pharmaceutical Industry in Numbers
Strong Industry Base
More than 500 pharmaceutical companies are located in
Leading Pharmaceutical Supplier
Following its tradition as the "world's pharmacy,"
R&D Excellence and Innovation
Market Opportunities & Trends
Growing Healthcare Market
With 83 million inhabitants,
Demographic Change
One of the main drivers of the healthcare market is demographic change.
Chronic Diseases
The treatment of the growing number of patients affected by (age-related) chronic and incommunicable diseases constitutes a major concern of the German healthcare system. Together, cardiovascular diseases, psychological disorders and musculoskeletal diseases account for more than one third of overall healthcare spending in
Mandatory health insurance and different sources of financing contribute to solid healthcare provision including access to medicines - in
"Out-of-Pocket" Payments
Increasingly, patients are also paying for medicines "out-of-pocket", mainly for over-the-counter medicines and co-payments for prescribed drugs. This trend is also driven by so-called "switches", meaning that previous prescription-only medicines gain the non-prescription status. This was the case for 25 treatments between 2007 and the beginning of 2020. In the light of growing health- care expenses, self-medication and consultation provided by local pharmacies may also relieve doctors and health insurers.
Over-the-Counter (OTC) Market
Market Trends
Market Segments
The German OTC market comprises two major segments: non-prescription drugs and health products. Non prescription drugs include pharmacy-only drugs as well as OTC drugs that may also be sold outside of pharmacies. Product groups that are not subject to pharmaceutical legislation for example, nutritional supplements, healing earths and seawater nasal sprays belong markets. The average annual growth rate of the German OTC market amounts to four percent for the period 2014 to 2019. In 2019, revenues increased by 3.7 percent to almost
Opportunities
Remedies for the respiratory system and pain treatments account for the highest share of overall OTC sales via pharmacies (including mail order). In 2019, the vitamins and minerals seg- ment demonstrated the highest growth rate (6.8 percent), with revenue exceeding
Biopharmaceuticals
Increasing Market Share
The development of biological drugs has led to substantial shifts in the pharmaceutical industry landscape in recent years. Large companies have moved their focus from small molecule drugs towards the development and production of complex biological compounds that are made with the help of a variety of organisms. Because of their high therapeutic potential, biologics have taken up a considerable share of the pharmaceutical market in
Market penetration has been steadily increasing in recent years, but differs according to therapeutic area. Biopharmaceuticals generate 80 percent of immunology sales, whereas the figure is as low as three percent for cardiovascular indications. Biopharmaceutical sales in oncology grew by 23 percent in 2019, but the highest growth rate was recorded by anti-infective with an increase of 40 percent.
Development Pipeline
The growing importance of biopharmaceuticals is also reflected in the development pipeline. As of 2019, companies active in pharma R&D in
Biosimilars
As innovative biological drug patents expire, more pharma companies have the opportunity to manufacture and commercialize the compound - a key factor in pharma market dynamics in recent years.
Pharma Manufacturing
Major Production Location
Contract Manufacturing Organizations
High Production Standards
Investment and Trade
The investment activity of pharmaceutical companies in
Research Excellence
Research Landscape
Over 30 biotechnology clusters contribute substantially to the advancement of pharmaceutical innovation by bundling scientific expertise as well as connecting academic and industrial players in the field of drug development. In addition to the over 400 universities in
In order to foster the translation of research out- comes into successful products, the Go-BIO pro- gram supports biotechnology start-ups in bringing their inventions to market. Since 2005, 58 newly established biotech companies have received support to grow into sustainable businesses. The Life Science Incubator (LSI) in Bonn and Dresden also helps scientists to bridge the critical gap between a good idea and the proof of concept, making further financing opportunities available. Moreover, the LSI supports academics with out- standing business ideas by providing them with the entrepreneurship expertise required for their value proposition to take off.
Over 15 start-up centers specifically dedicated to fostering emerging biotech/life science companies can be found all over
The pharmaceutical industry is known for its high R&D intensity - and
Clinical Research
Thanks to its high population,
Business Location Germany
Top Investment Location
Sound and Secure Legal Framework
The legal framework for FDI in
Business-friendly Tax Conditions
World-class Infrastructure
With state-of-the-art transportation networks (road, rail, sea, and inland waterways) as well as a dense network of national and international airports,
Competitive Labor Costs
High productivity rates and steady wage levels make
Highly Skilled and Motivated Workforce
Dual Education System
In order to secure the economy's demand for highly qualified personnel and to meet industry needs,
Between 2015 and 2017,
Takeda - Providing a Production Advantage
Takeda is a global biopharmaceutical company headquartered in
"
Heidrun Irschik-Hadjieff
Takeda has invested more than
Source: GTAI
https://www.gtai.de/gtai-en/invest/industries/life-sciences/pharmaceuticals
Recommendations for inclusion in
Despite the 25-year haemorrhaging of research and development activity to the US and
An IP framework that protects investment in medical research can achieved by:
Maintaining and developing
Ensuring that the overall
Identifying and implementing new incentives in areas of unmet medical need. For example, in the fight against AMR. Identifying appropriate incentives to ensure sustainable investment in new scientific developments such as Advanced Therapy Medicinal Products and personalized medicines.
Increasing harmonisation in the area of Supplementary Protection Certification (SPC) and patent systems to increase certainty for all stakeholders.
Implementing a smart trade strategy that promotes this world-class IP system and reward for R&D globally.
A regulatory framework that is stable, fast, effective and globally competitive can achieved by:
Utilising Real World Data (RWD) and Real World Evidence (RWE) in regulatory decision-making.
Embracing innovative clinical trial approaches and the development of the associated IT infrastructure. Creating a dynamic regulatory assessment process allowing for a more flexible EU regulatory pathway.
This would include an iterative process for seeking early advice on data sets intended to be included in the marketing authorisation application, as they are generated and continued evidence review (utilisation of scientific advice/dialogue).
Introducing a clear assessment pathway for drug/device combination products, including a streamlined pathway for a biomarker validation.
Modernising the variation framework (Delegated EU Regulation 1234/2008) to ensure its full alignment with risk-based principles and tools; that it embraces innovation by being adapted to future developments; enables efficiency gains for both regulators and industry by focusing on changes with significant impact; and paves the way to international alignment across variation systems.
Promoting global regulatory convergence through the EU's trade policy and active participation in global forums such as ICH and PIC/S.
Faster, more equitable access to new vaccines and treatments for citizens and patients across
Creating a
Improving understanding and intelligence regarding the root causes and drivers of shortages and implementing appropriate monitoring mechanisms involving all supply chain actors.
Developing and implementing novel pricing and payment approaches to address the needs of patients, health systems and governments. These include combination-based pricing, indication-based pricing, outcomesbased payments, over-time payments and subscription payments.
Evolving HTA to ensure effective harmonisation of clinical data requirements and removal of duplicative assessments.
Promoting disease prevention, including sustainable vaccination programmes that embrace innovation.
A research infrastructure that helps deliver the next generation of vaccines and treatments can achieved by:
Ensuring parity with the US and
Building an operational European Health Data Space with clear rules of engagement for private and public parties.
Developing clinical trials networks and sites, biobanks and data banks of appropriate quality to support the generation of data suitable for regulatory purposes.
Delivering Public Private Collaboration mechanisms to balance health imperatives and scientific advances with translational drive and solid industrial processes which will accelerate bringing health solutions to patients.
An industry integral to
The innovative pharmaceutical industry is an industry of critical strategic importance to
Driving better health in
Deaths from cancer have fallen by 21% since the 1990s. Now two out of three patients diagnosed with cancer live beyond 5 years.
95% of the 15 million Europeans living with Hepatitis C can now be cured with a 12 week course of medicines.
Since the 1990s HIV has been turned from a death sentence to a manageable disease.
Immunization currently prevents between 2,000,000 - 3,000,000 deaths every year. Immunization is one of the most successful and cost-effective public health interventions.
A new generation of gene therapies are transforming the lives of patients living with rare disease, cancer and other diseases
Driving economic growth and trade
As an industry we employ 2.7 million people (directly and indirectly), create a gross value added of €206 billion and consist of both large companies as well as SMEs.
The innovative pharmaceutical industry is also the most R&D intensive industry in the EU with R&D costs constituting 15% of total net sales (and with over €35 billion in investments in the EU). This makes the industry one of the largest drivers for innovation on the European continent.
The pharmaceutical industry's trade surplus amounted to €102 billion for the EU in 2018 (the largest of all industrial sectors), strongly embedded in pharmaceutical global value chains.
Our industry contributes to values that
A digital
The pharmaceutical industry strategic aim in the digital health space is to support the transformation of European healthcare for the benefit of patients and that digital evolution enables a move towards outcomes data-driven healthcare systems, ensuring the continued competitiveness of
EFPIA is involved in several Innovative Medicines Initiative (IMI) projects aimed at harnessing the power of digital health to improve patients' outcomes.
Big Data for Better Outcomes (BD4BO) supports the evolution towards outcomes-focused and sustainable healthcare systems, by exploiting the opportunities offered by big and deep data sources.
The European Health Data & Evidence Network (EHDEN) will harmonise 100 million health records across multiple data sources such as hospitals and primary care networks and develop a 21st century ecosystem for real world health research in
Remote Assessment of Disease and Relapse - Central Nervous System (RADAR-CNS) is a research programme which is developing new ways of monitoring major depressive disorder, epilepsy, and multiple sclerosis using wearable devices and smartphone technology
Policies to preserve the environment
The pharmaceutical industry is committed to making a positive impact on the lives of patients while operating sustainably.
Our industry encourages appropriate use of a risk based approach to environmental challenges and undertakes initiatives to promote greater environmental responsibility by supporting the principles in the
IMI's CHEM21 project dealt with the sustainability of drug manufacturing processes, aiming to reduce the industry's carbon footprint and environmental footprint.
To proactively engage in environmental considerations, together with other industry sectors, EFPIA has developed the Eco-Pharmaco Stewardship Initiative. The initiative strives to protect patient access to medicines while appropriately considering environmental aspects and considers the entire life-cycle of the medicine.
Source:
https://www.efpia.eu/media/413646/eu-industrial-and-pharmaceutical-strategy-an-opportunity-to-drive-europe-s-health-and-growth.pdf
JPMA, celebrating its 50th anniversary in 2018, has been contributing to advancing global healthcare through the development of innovative ethical drugs, facilitating sound development of the pharmaceutical industry through proactively establishing policies and recommendations in response to globalization and enhancing public understanding of pharmaceuticals.
As a member of the IFPMA (
Working collaboratively with PhRMA (
Through mutual information sharing and close collaboration with each member organization, JPMA continues to act globally for the advancement of medical treatments for patients worldwide.
Source:
http://www.jpma.or.jp/english/about_us/about_us.html
Leading Companies
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
GLOBAL PRESENCE
Abbott is one of the most global healthcare companies in the world with 70 percent of revenue generated in markets outside of
\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
ABBOTT REPORTS FIRST-QUARTER 2023 RESULTS; INCREASES OUTLOOK FOR UNDERLYING BASE BUSINESS
Sales of
Reported sales decreased 18.1 percent due to anticipated decline in COVID-19 testing-related sales versus prior year
Organic sales growth for underlying base business of 10.0 percent, led by Medical Devices,
ABBOTT PARK, Ill.,
PRNewswire
/ --
First-quarter GAAP diluted EPS of
Projected full-year 2023 diluted EPS from continuing operations on a GAAP basis of
Projected full-year adjusted EPS from continuing operations of
Abbott now projects full-year 2023 organic sales growth, excluding COVID-19 testing-related sales 1 , of at least high single-digits 2 and COVID-19 testing-related sales of approximately
In January, Abbott announced
In March, data was presented at the
In March, Abbott's market-leading FreeStyle Libre ® continuous glucose monitoring system received
"Our first-quarter results reflect a very strong start to the year," said
FIRST-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange, as well as the impact of exiting the pediatric nutrition business in
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 shifts to an endemic state, resulting in significantly lower expected demand for COVID-19 tests.
Note: In order to compute results excluding the impact of exchange rates, current year
For the full release, see:
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
AbbVie Reports First-Quarter 2023 Financial Results
Reports First-Quarter Diluted EPS of
Delivers First-Quarter Net Revenues of
First-Quarter Global Net Revenues from the Immunology Portfolio Were
First-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were
First-Quarter Global Net Revenues from the Neuroscience Portfolio Were
First-Quarter Global Net Revenues from the Aesthetics Portfolio Were
Raises 2023
AbbVie (NYSE:ABBV) announced financial results for the first quarter ended
"This year is off to an excellent start, with first-quarter revenues and EPS ahead of our expectations, driven by strong commercial execution across all areas of our diversified portfolio," said
First-Quarter Results
Worldwide net revenues were
Global net revenues from the immunology portfolio were
Global Humira net revenues of
Global Skyrizi net revenues were
Global Rinvoq net revenues were
Global net revenues from the hematologic oncology portfolio were
Global Imbruvica net revenues were
Global Venclexta net revenues were
Global net revenues from the neuroscience portfolio were
Global Botox Therapeutic net revenues were
Global Vraylar net revenues were
Global Ubrelvy net revenues were
Global net revenues from the aesthetics portfolio were
Global Botox Cosmetic net revenues were
Global Juvederm net revenues were
On a GAAP basis, the gross margin ratio in the first quarter was 67.4 percent. The adjusted gross margin ratio was 84.2 percent.
On a GAAP basis, selling, general and administrative (SG&A) expense was 24.9 percent of net revenues. The adjusted SG&A expense was 24.4 percent of net revenues.
On a GAAP basis, research and development (R&D) expense was 18.8 percent of net revenues. The adjusted R&D expense was 13.6 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
Acquired IPR&D and milestones expense was 1.2 percent of net revenues.
On a GAAP basis, the operating margin in the first quarter was 22.6 percent. The adjusted operating margin was 45.0 percent.
Net interest expense was
On a GAAP basis, the tax rate in the quarter was 49.3 percent. The adjusted tax rate was 13.7 percent.
Diluted EPS in the first quarter was
Recent Events
AbbVie announced the
AbbVie announced positive top-line results from INSPIRE, a Phase 3 induction study, showing Skyrizi (risankizumab, 1200 mg intravenous (IV), at weeks 0, 4 and 8) met the primary endpoint of clinical remission at week 12, as well as all secondary endpoints in adult patients with moderately to severely active ulcerative colitis (UC). Safety results in this study were consistent with the known safety profile of Skyrizi, with no new safety risks observed. Skyrizi is part of a collaboration between
AbbVie announced positive top-line results from a Phase 2 study of Rinvoq (30 mg, once daily), given alone or as combination therapy (ABBV-599) with a Bruton's Tyrosine Kinase inhibitor (elsubrutinib, 60 mg), in patients with moderately to severely active systemic lupus erythematosus (SLE). The study met the primary endpoint of SLE Responder Index (SRI-4) with a steroid dose of less than or equal to 10 mg per day at week 24 in patients with moderately to severely active SLE. Based on these results, AbbVie intends to advance its clinical program of Rinvoq in SLE to Phase 3.
At the
At the 2023
AbbVie announced that it intends to voluntarily withdraw the
Recent Events (Continued)
AbbVie announced that the FDA approved expanding the indication of Qulipta (atogepant) for the preventive treatment of migraine in adults. The approval makes Qulipta the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. The expanded indication provides an additional treatment option for those with chronic migraine whose frequent disabling attacks negatively impact performance of daily activities. Approval is based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
AbbVie announced it received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). In its letter, the FDA requested additional information about the device (pump) as part of the NDA review. The CRL did not request that AbbVie conduct additional efficacy and safety trials related to the drug. AbbVie plans to resubmit the NDA as soon as possible.
Full-Year 2023 Outlook
AbbVie is raising its adjusted diluted EPS guidance for the full year 2023 from
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at
www.abbvie.com
. Follow
@abbvie
on Twitter,
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or
LinkedIn
.
https://news.abbvie.com/news/press-releases/abbvie-reports-first-quarter-2023-financial-results.htm
Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.
Allergan Fourth Quarter and Full-Year 2019 Financial Results
Q4 2019 GAAP Operating Loss of
Full-Year and Q4 2019 GAAP Net Revenue Driven by Growth in Top Promoted Products Including VRAYLAR®, BOTOX®, JUVÉDERM® Collection, OZURDEX® and Lo LOESTRIN®; Global Facial Aesthetics Rose 9.5% in FY 2019 and 8.2% in Q4 2019 (Excluding Exchange)
Continues to Advance R&D Pipeline on Key Programs Including FDA Approval of UBRELVY™ (Ubrogepant) for Migraine; Bimatoprost SR for Glaucoma NDA and Abicipar for Wet Age-Related Macular Degeneration BLA Under FDA Review
Executive Commentary
"I am proud of Allergan's colleagues
Full-Year 2019 Financial Results
GAAP operating loss in 2019 was
Fourth Quarter 2019 Financial Results
GAAP operating loss in the fourth quarter of 2019 was
Operating Expenses
Total GAAP Selling, General and Administrative (SG&A) Expense was
Amortization, Tax and Capitalization
Amortization expense for the fourth quarter of 2019 was
Operating Charges and Impairments
Allergan recorded a pre-tax charge of
FOURTH QUARTER 2019 BUSINESS SEGMENT RESULTS
Medical Aesthetics
Facial Aesthetics
BOTOX® Cosmetic net revenues in the fourth quarter of 2019 were
JUVÉDERM® Collection (defined as JUVÉDERM®, VOLUMA® and other fillers) net revenues in the fourth quarter of 2019 were
Regenerative Medicine
ALLODERM® net revenues in the fourth quarter of 2019 were
Body Contouring
CoolSculpting® net revenues (including both CoolSculpting® Systems/Applicators and Consumables) in the fourth quarter of 2019 were
CoolTone™ received regulatory clearance in the
Neurosciences & Urology
BOTOX® Therapeutic net revenues in the fourth quarter of 2019 were
RESTASIS® net revenues in the fourth quarter of 2019 were
ALPHAGAN®/COMBIGAN® net revenues in the fourth quarter of 2019 were
OZURDEX® net revenues in the fourth quarter of 2019 were
Central Nervous System
VRAYLAR® net revenues were
VIIBRYD®/FETZIMA® net revenues in the fourth quarter of 2019 were
Gastrointestinal,
LINZESS® net revenues in the fourth quarter of 2019 were
Lo LOESTRIN® net revenues in the fourth quarter of 2019 were
BYSTOLIC®/BYVALSON® net revenues in the fourth quarter of 2019 were
International
International net revenues in the fourth quarter of 2019 were
Facial Aesthetics
BOTOX® Cosmetic net revenues in the fourth quarter of 2019 were
JUVÉDERM® Collection net revenues in the fourth quarter of 2019 were
LUMIGAN®/GANFORT® net revenues in the fourth quarter of 2019 were
OZURDEX® net revenues in the fourth quarter of 2019 were
Botox® Therapeutic
BOTOX® Therapeutic net revenues in the fourth quarter of 2019 were
PIPELINE UPDATE
Allergan R&D continues to advance its pipeline. During the fourth quarter of 2019, the Company's key clinical developments included:
Allergan received approval from the
Allergan announced the FDA has granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation for ATM-AVI (aztreonam and avibactam) for the treatment of antibiotic-resistant gram-negative infections including complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI) and hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP). ATM-AVI is an investigational, fixed-dose, intravenous combination antibiotic being developed jointly with
The FDA approved Allergan's supplemental Biologics License Application (sBLA) to expand the BOTOX® (onabotulinumtoxinA) label for the treatment of pediatric patients ages two years and older with lower limb spasticity, excluding spasticity caused by cerebral palsy. This marks the 14th approved indication for BOTOX® and BOTOX® Cosmetic combined in the
In addition to fourth quarter 2019 pipeline developments listed above, Allergan expects two additional significant launches in the next twelve months:
FDA action is expected in the first half of 2020 on Allergan's NDA for Bimatoprost Sustained-Release, a biodegradable implant for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Launch is expected to follow in the first half of 2020.
The FDA is currently reviewing a Biologics License Application (BLA) for Abicipar pegol, a novel, investigational DARPin® therapy, in patients with neovascular (wet) age-related macular degeneration (nAMD). The FDA is expected to take action on the BLA in mid-2020, with launch expected to follow. The
UPDATE ON PROPOSED ABBVIE TRANSACTION
On
On
The closings of the divestitures of brazikumab and ZENPEP® are contingent upon receipt of
Allergan expects the close of the pending AbbVie transaction around the end of the first quarter 2020, subject to receipt of required regulatory approvals and other closing conditions.
Due to the pending transaction, Allergan is not hosting a conference call to discuss its fourth quarter and full-year 2019 results.
Locations:
https://www.amerisourcebergen.com/abc/about_us/index.jsp
AmerisourceBergen Reports Fiscal 2022 First Quarter Results
Revenues of
First Quarter GAAP Diluted EPS of
Adjusted Diluted EPS Guidance Range Raised to
"
"As we move further into 2022,
First Quarter Fiscal Year 2022 Summary Results
GAAP
Adjusted (Non-GAAP)
Revenue
Gross Profit
Operating Expenses
Operating Income
Interest Expense, Net
Effective Tax Rate
24.6%
21.3%
Net Income Attributable to
Diluted Earnings Per Share
Diluted Shares Outstanding
211.2M
211.2M
Below,
First Quarter GAAP Results
Revenue: In the first quarter of fiscal 2022, revenue was
Gross Profit: Gross profit in the first quarter of fiscal 2022 was
Operating Expenses: In the first quarter of fiscal 2022, operating expenses were
Operating Income: In the fiscal 2022 first quarter, operating income was
Interest Expense, Net: In the fiscal 2022 first quarter, net interest expense of
Effective Tax Rate: The effective tax rate was 24.6 percent for the first quarter of fiscal 2022. This compares to 28.3 percent in the prior year quarter, which was unfavorably impacted by Swiss tax reform.
Diluted Earnings Per Share: Diluted earnings per share was
Diluted Shares Outstanding: Diluted weighted average shares outstanding for the first quarter of fiscal 2022 were 211.2 million, a 2.1 percent increase versus the prior fiscal year first quarter resulting from stock option exercises, restricted stock vesting, and the issuance of 2 million shares of the Company's common stock to
First Quarter Adjusted (non-GAAP) Results
Revenue: No adjustments were made to the GAAP presentation of revenue. In the first quarter of fiscal 2022, revenue was
Adjusted Gross Profit: Adjusted gross profit in the first quarter of fiscal 2022 was
Adjusted Operating Expenses: In the first quarter of fiscal 2022, adjusted operating expenses were
Adjusted Operating Income: In the fiscal 2022 first quarter, adjusted operating income was
Interest Expense, Net: No adjustments were made to the GAAP presentation of net interest expense.In the fiscal 2022 first quarter, net interest expense of
Adjusted Effective Tax Rate: The adjusted effective tax rate was 21.3 percent for the first quarter of fiscal 2022 compared to 22.0 percent in the prior year quarter.
Adjusted Diluted Earnings Per Share: Adjusted diluted earnings per share was up 18.3 percent to
Diluted Shares Outstanding: No adjustments were made to the GAAP presentation of diluted shares outstanding. Diluted weighted average shares outstanding for the first quarter of fiscal 2022 were 211.2 million, a 2.1 percent increase versus the prior fiscal year first quarter resulting from stock option exercises, restricted stock vesting, and the issuance of 2 million shares of the Company's common stock to WBA for the
Segment Discussion
The Company is organized geographically based upon the products and services it provides to its customers. The Company has re-aligned its reporting structure under two reportable segments:
International Healthcare Solutions
Revenue in International Healthcare Solutions was
Recent Company Highlights & Milestones
Fiscal Year 2022 Expectations
The Company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available or cannot be reasonably estimated. Please refer to the Supplemental Information Regarding Non-GAAP Financial Measures following the tables for additional information.
Fiscal Year 2022 Expectations on an Adjusted (non-GAAP) Basis
Adjusted Diluted Earnings Per Share to be in the range of
Additional expectations now include:
Adjusted operating income growth to be in the high-teens percent range, up from growth in the mid- to high-teens percent range;
Interest expense to be in the range of
All other previously communicated aspects of the Company's fiscal year 2022 financial guidance and assumptions remain the same.
Dividend Declaration
The Company's Board of Directors declared a quarterly cash dividend of
Opioid Litigation
On
Conference Call & Slide Presentation
The Company will host a conference call to discuss the results at
investor.amerisourcebergen.com
. Participating in the conference call will be:
The dial-in number for the live call will be (844) 200-6205. From outside
investor.amerisourcebergen.com
. Users are encouraged to log on to the webcast approximately 10 minutes in advance of the scheduled start time of the call.
Replays of the call will be made available via telephone and webcast. A replay of the webcast will be posted on
investor.amerisourcebergen.com
approximately one hour after the completion of the call and will remain available for one year. The telephone replay will also be available approximately one hour after the completion of the call and will remain available for seven days. To access the telephone replay from within the
Upcoming Investor Events
About
investor.amerisourcebergen.com
.
For full release see:
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.
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
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,
OUR HERITAGE
Building on advances in recombinant DNA and molecular biology,
THE
https://www.amgen.com/~/media/amgen/full/www-amgen-com/downloads/fact-sheets/fact_sheet_amgen.ashx
"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
Key results include:
Total revenues increased 6% to
Volume growth of 11% included double-digit volume growth from EVENITY® (romosozumab-aqqg), BLINCYTO® (blinatumomab), Repatha® (evolocumab), LUMAKRAS®/LUMYKRAS™ (sotorasib), Vectibix® (panitumumab), KYPROLIS® (carfilzomib), Nplate® (romiplostim) and biosimilar AMJEVITA®/AMGEVITA™ (adalimumab).
Ex-
GAAP earnings per share (EPS) increased 5% from
GAAP operating income increased from
Non-GAAP EPS increased 8% from
Non-GAAP operating income increased from
The Company generated
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
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
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
Q1 2023 results
Strong start to the year with stable Total Revenue and 15% growth excluding COVID-19 medicines1
Financial performance (Q1 2023 figures unless otherwise stated, growth numbers at CER)
Total Revenue stable at
Excluding COVID-19 medicines, Total Revenue increased 15% and Product Sales increased 16%
Total Revenue from Oncology medicines increased 19%, CVRM7 22%, R&I8 8%, and Rare Disease 14%
Core Gross margin of 83%, up four percentage points, reflecting the decline in sales of lower margin COVID-19 medicines, the cost of production in prior periods, and a mix shift to more speciality medicines
Core Operating margin of 36%, up one percentage point, reflecting a
Core EPS increased 6% to
"
Our pipeline momentum continued with positive Phase III results for a Lynparza-plus-Imfinzi combination in ovarian cancer, Imfinzi in lung cancer, and promising new data for Enhertu across a range of cancer types. Additionally, in the year to date we have started six new Phase III trials and are on track to initiate 30 over the course of 2023.
Finally, I would like to thank
Key milestones achieved since the prior results
Key read outs: positive results for Lynparza and Imfinzi in ovarian cancer (DUO-O), Imfinzi in NSCLC9 (AEGEAN) and Enhertu in multiple tumour types (DESTINY-PanTumor02). Tagrisso showed a statistically significant improvement in overall survival in NSCLC (ADAURA)
Key regulatory approvals: EU approvals for Imfinzi and Imjudo in HCC10 (HIMALAYA) and NSCLC (POSEIDON), Calquence maleate tablet formulation, and positive CHMP recommendation for Ultomiris in NMOSD11.
As announced on
Guidance
The Company reiterates guidance for FY 2023 at CER, based on the average exchange rates through 2022.
Total Revenue is expected to increase by a low-to-mid single-digit percentage
Excluding COVID-19 medicines, Total Revenue is expected to increase by a low double-digit percentage
Core EPS is expected to increase by a high single-digit to low double-digit percentage
While challenging to forecast, Total Revenue from COVID-19 medicines (Vaxzevria14 and COVID-19 mAbs15) is expected to decline significantly in FY 2023, with minimal revenue from Vaxzevria
Total Revenue from
Alliance Revenue and Collaboration Revenue are both expected to increase16, driven by continued growth of our partnered medicines and success-based milestones
Other operating income is expected to increase
Core Operating expenses are expected to increase by a low-to-mid single-digit percentage, driven by investment in recent launches and the ungating of new trials following pipeline success
The Core Tax Rate is expected to be between 18-22%
The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement.
Currency impact
If foreign exchange rates for April to
For the full release, see:
https://www.astrazeneca.com/content/dam/az/PDF/2023/q1/Q1-2023-results-announcement.pdf
The parent company of the global
Bayer is a Life Science company with a more than 150-year history and core competencies in the areas of health care and agriculture. With our innovative products, we are contributing to finding solutions to some of the major challenges of our time.
The Pharmaceuticals division focuses on prescription products, especially for cardiology and women's healthcare, and on specialty therapeutics in the areas of oncology, hematology and ophthalmology. The division also comprises the radiology business, which markets diagnostic imaging equipment together with the necessary contrast agents.
The Crop Science division is a world-leading agriculture enterprise with businesses in seeds, crop protection and nonagricultural pest control. The Crop Protection / Seeds operating unit markets a broad portfolio of high-value seeds and innovative pest management solutions, while at the same time providing extensive customer service for sustainable agriculture. The Environmental Science operating unit provides products and services for professional nonagricultural applications, such as vector and pest control and forestry.
https://www.bayer.com/en/profile-and-organization.aspx
Quarterly Statement First Quarter of 2023
Slow start to the year as expected
Group sales stable at €14.4 billion (Fx & p adj. - 1.1%)
Accelerated normalization in glyphosate business - good price dynamics in other Crop Science units
EBITDA before special items: €4.5 billion (- 14.9%)
Glyphosate and inflation weigh on earnings
Pharmaceuticals maintains high R&D investment
Core earnings per share at €2.95 (- 16.4%)
Net income at €2.2 billion
Free cash flow at minus €4.1 billion // Group outlook confirmed; target attainment at lower end of guidance
Earnings Performance of the
First quarter of 2023
Group sales
Group sales decreased by 1.1% (Fx & portfolio adj.) to €14,389 million in the first quarter of 2023 (Q1 2022: €14,639 million; reported: -1.7%). There was a positive currency effect of €102 million (Q1 2022: €529 million). Sales in
Crop Science sales were down slightly. The division recorded a significant decline in sales of glyphosatebased products that was almost fully offset by the other parts of its business. Pharmaceuticals posted a decrease in sales. Xarelto™ sales were down, especially in
EBITDA before special items Group
EBITDA before special items declined by 14.9% to €4,471 million. This figure included a negative currency effect of €4 million (Q1 2022: positive currency effect of €67 million). Crop Science registered a decline in EBITDA before special items, mainly due to the fall in sales of our glyphosate-based products. Earnings were also diminished by an increase in costs, particularly in the cost of goods sold, which was mainly due to high inflation. At Pharmaceuticals, EBITDA before special items decreased significantly due to the drop in sales, inflation-related cost increases and higher R&D investments. The moderate decline in EBITDA before special items at
EBIT and special items
EBIT of the
Net income
After a financial result of minus €367 million (Q1 2022: minus €490 million), income before income taxes amounted to €2,606 million (Q1 2022: €3,722 million). The improvement in the financial result was largely due to higher interest income from investments in money market funds and to positive changes in the fair value of financial investments. After income tax expense of €424 million (Q1 2022: €428 million) and accounting for noncontrolling interest, net income amounted to €2,178 million (Q1 2022: €3,291 million).
Core earnings per share
Core earnings per share decreased by 16.4% to €2.95 (Q1 2022: €3.53), mainly due to the decline in earnings at the Crop Science and Pharmaceuticals divisions. By contrast, the improvement in the financial result before special items had a positive impact.
Earnings per share (total) came in at €2.22 (Q1 2022: €3.35). The difference between this figure and the one for core earnings per share is mainly due to depreciation and amortization.
Business Development by Division
Crop Science
First quarter of 2023
Sales
Sales at Crop Science declined by 1.1% (Fx & portfolio adj.) to €8,351 million in the first quarter of 2023. We recorded double-digit percentage gains in the
Sales at Corn Seed & Traits rose substantially, primarily driven by higher prices in the
Our Herbicides business saw a significant decline in sales due to lower volumes and prices for our glyphosate-based products. However, our other herbicide products registered higher sales due to increased prices.
Sales at Fungicides came in at the prior-year level, with higher prices in all regions offsetting lower volumes in Latin and
Our Soybean Seed & Traits business posted a slight increase in sales against the prior-year period, predominantly due to higher volumes in
Insecticides registered significant price and volume increases in
Sales at Cotton Seed came in slightly below the prior-year level, mainly due to lower volumes in
Business at Vegetable Seeds expanded mainly in
Sales in the reporting unit "Other" were up slightly, with our SeedGrowth business mainly benefitting from higher volumes. Our remaining Environmental Science business, which encompasses Industrial Turf & Ornamental (IT&O) and Lawn & Garden, saw sales decline due to lower volumes and prices at the IT&O unit.
Earnings
EBITDA before special items at Crop Science decreased by 11.0% to €3,267 million in the first quarter of 2023 (Q1 2022: €3,669 million), mainly due to the fall in sales in Latin and
EBIT came in at €2,319 million (Q1 2022: €3,028 million) after special charges of €296 million (Q1 2022: special gains of €45 million). The special charges primarily comprised an impairment loss within the cashgenerating unit glyphosate that was mainly due to significantly reduced market price expectations for glyphosate.
Pharmaceuticals
First quarter of 2023
Sales
Sales at Pharmaceuticals fell by 3.1% (Fx & portfolio adj.) to €4,407 million in the first quarter of 2023. The decline was primarily due to tender procedures in
Sales of our oral anticoagulant Xarelto™ decreased notably, largely due to tender procedures and pandemic-related developments in
Despite declining prices, business with our ophthalmology drug Eylea™ expanded, driven by higher volumes in nearly all regions, particularly in
Sales of our cancer drug Nubeqa™ more than doubled, with gains in all regions. The product therefore continued its growth momentum, especially in
We also generated significant gains with Kerendia™, our product for the treatment of patients with chronic kidney disease associated with type 2 diabetes, particularly due to the successful market launch in
Sales of our YAZ™/Yasmin™/Yasminelle™ line of oral contraceptives declined markedly, due primarily to lower volumes in
Our Radiology business, and especially the CT Fluid Delivery, Gadovist™ and Ultravist™ product lines, posted considerable growth driven by higher volumes and prices in
For the full release, see:
https://www.bayer.com/sites/default/files/2023-05/bayer-quarterly-statement-q1-2023.pdf
The parent company of the global
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885,
As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma,
We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.
https://www.boehringer-ingelheim.com/
https://www.boehringer-ingelheim.com/corporate-profile/our-company
Strong R&D commitment to developing therapeutics against SARS-CoV-2 virus
Overall R&D investment up 7% to
Outlook 2021: slight year-on-year increase in net sales on a comparable basis
Ingelheim,
"We started our R&D for potential COVID-19 therapies early in the first quarter of 2020, recognizing the urgent need," said
Building on its vast knowledge in various therapeutic areas, such as respiratory diseases and virology,
Solid performance despite COVID-19 pandemic
2020 was a good year for
Emphasis on profitable growth and protecting liquidity
Operating income at Group level rose to
"We are pleased with the results we achieved in 2020, considering the challenging conditions we faced," said
Continued high investments in tangible assets
The company invested
Targeted M&A activities round off the portfolio
Human Pharma - Strong growth across all regions
At
Medicines for the treatment of cardiovascular and metabolic diseases, as well as respiratory diseases, remain the most important contributors to net sales. JARDIANCE ® , a medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, remains the biggest revenue contributor in Human Pharma, generating net sales of
High R&D investment in Human Pharma
R&D investments in the Human Pharma business amounted to
Biopharmaceutical Contract Manufacturing - One of the leading providers in the industry
Outlook 2021:
The ongoing COVID-19 pandemic and a more challenging industry environment with increasing price pressure in several key markets is expected to have an impact on
The 2020 Annual Report can be found here:
https://annualreport.boehringer-ingelheim.com/
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
https://www.bms.com/gb/about-us.html
Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2022
Reports Fourth Quarter Revenues of
Fourth Quarter Revenues from In-Line Products and New Product Portfolio were
Full-Year Revenues from In-Line Products and New Product Portfolio were
Posts Fourth Quarter GAAP EPS of
Reports Full-Year GAAP EPS of
Provides GAAP and Non-GAAP Financial Guidance for 2023 Reflecting Continued Revenue and Earnings Growth
"2022 was a successful year for our company, one of significant clinical and regulatory achievements that broadened our product portfolio and advanced our pipeline," said
Fourth Quarter
$ amounts in millions, except per share amounts
2022
2021
Change
Change
Excl. F/X**
Total Revenues
(5)%
(1)%
Earnings Per Share - GAAP*
0.95
1.07
(11)%
N/A
Earnings Per Share - Non-GAAP*
1.82
1.84
(1)%
N/A
GAAP and non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income of (
Full Year
$ amounts in millions, except per share amounts
2022
2021
Change
Change
Excl. F/X**
Total Revenues
—
3 %
Earnings Per Share - GAAP*
2.95
3.12
(5)%
N/A
Earnings Per Share - Non-GAAP*
7.70
7.16
8 %
N/A
GAAP and non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income of (
FOURTH QUARTER FINANCIAL RESULTS
All comparisons are made versus the same period in 2021 unless otherwise stated.
Gross margin decreased from 80.3% to 77.3% and decreased from 80.3% to 77.9% on a non-GAAP basis primarily due to product mix and higher manufacturing costs.
On a GAAP and non-GAAP basis, marketing, selling and administrative expenses decreased 4% to
On a GAAP and non-GAAP basis, research and development expenses remained constant at
Acquired IPRD expenses decreased from
Amortization of acquired intangible assets decreased 3% to
Income tax benefit was
The company reported net earnings attributable to
The company reported non-GAAP net earnings attributable to
In addition to the items discussed above, the earnings per share results in 2022 include the impact of lower weighted-average common shares outstanding
For full release see:
Danaher takes it name from a tributary of the
The company had its origins as a real estate investment trust (
Danaher was one of the first companies in
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,
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
DANAHER REPORTS FOURTH QUARTER AND FULL YEAR 2022 RESULTS
For the quarter ended
Revenues increased 2.5% year-over-year in the fourth quarter of 2022 to
For the full year 2022, net earnings were
Revenues for the full year 2022 increased 7.0% to
Operating cash flow for the full year 2022 was
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.
Starting with the first quarter 2023, the Company will revise its definition of base business core growth to exclude revenues related to COVID-19 testing, vaccines and therapeutics, in addition to the exclusion of currency translation, acquisitions and divested product lines.
For the first quarter 2023, the Company anticipates that non-GAAP base business core revenue growth will be up mid-single digits. For the full year 2023, the Company anticipates non-GAAP base business core revenue to be up high-single digits.
Blair continued, "Looking ahead, we believe the combination of our leading portfolio, the power of the Danaher Business System and the strength of our balance sheet position Danaher to continue generating sustainable, long-term shareholder value for many years to come."
Danaher will discuss its results during its quarterly investor conference call today starting at
The conference call can be accessed by dialing 800-245-3047 within the
ABOUT DANAHER
Danaher is a global science and technology innovator committed to helping its customers solve complex challenges and improving quality of life around the world. Its family of world class brands has leadership positions in the demanding and attractive health care, environmental and applied end-markets. With more than 20 operating companies, Danaher's globally diverse team of approximately 81,000 associates is united by a common culture and operating system, the Danaher Business System, and its Shared Purpose, Helping Realize Life's Potential. For more information, please visit www.danaher.com.
NON-GAAP MEASURES
In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings release also contains non-GAAP financial measures. Calculations of these measures, the reasons why we believe these measures provide useful information to investors, a reconciliation of these measures to the most directly comparable GAAP measures, as applicable, and other information relating to these non-GAAP measures are included in the supplemental reconciliation schedule attached.
FORWARD-LOOKING STATEMENTS
Statements in this release that are not strictly historical, including the statements regarding the Company's expected financial performance for the first quarter and full year 2023, Danaher's prospects, future shareholder value generation and any other statements regarding events or developments that we believe or anticipate will or may occur in the future are "forward-looking" statements within the meaning of the federal securities laws. There are a number of important factors that could cause actual results, developments and business decisions to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include, among other things, the highly uncertain and unpredictable severity, magnitude and duration of the COVID-19 pandemic (and the related governmental, business and community responses thereto) on our business, results of operations and financial condition, the impact of our debt obligations on our operations and liquidity, deterioration of or instability in the economy, the markets we serve and the financial markets (including as a result of the COVID-19 pandemic), uncertainties relating to
https://investors.danaher.com/2023-01-24-Danaher-Reports-Fourth-Quarter-and-Full-Year-2022-Results
Lilly was founded in 1876 by Colonel Eli
More than 140 years later, we remain committed to his vision through every aspect of our business and the people we serve starting with those
Three long established core values guide Lilly in all that we do:
Integrity: We conduct our business consistent with all applicable laws and are honest in our dealings with customers, employees, shareholders, partners, suppliers, competitors and the community.
Excellence: We pursue pharmaceutical innovation, provide high quality products and strive to deliver superior business results.
Respect for People: We maintain an environment built on mutual respect, openness and individual integrity. Respect for people includes our concern for all people
Key Facts
Lilly at a Glance
A heritage more than 140 years strong: company founded on
Headquarters located in
Approximately 33,000 employees worldwide
More than 7,800 employees engaged in research and development
Clinical research conducted in more than 55 countries
Research and development facilities located in 8 countries
Manufacturing plants located in 8 countries
Products marketed in 120 countries
Employees
(as of
Outside
Worldwide total: 33,816
2018 Financials
(dollars in millions, except per-share data)
Net sales:
Net income as reported:
Net income non-GAAP:
Earnings per share as reported:
Earnings per share non-GAAP:
Dividends paid per share:
Research & Development
2018 Expenditures
R&D as a percentage of sales: 21.6%
Employees engaged in R&D activities: 7,836
Percentage of total workforce: 23%
Cost of Pharmaceuticals
Average cost to discover and develop a new drug:
Average length of time from discovery to patient: 10 years
https://www.lilly.com/who-we-are /
https://www.lilly.com/key-facts
Revenue in Q4 2022 decreased 9%. Excluding COVID-19 antibodies, revenue in Q4 2022 increased 5%, or 10% on a constant currency basis, driven by volume growth of key growth products, partially offset by lower Alimta revenue. Excluding COVID-19 antibodies, total worldwide volume in Q4 2022 increased 13%.
\Pipeline advancements included FDA approval of Jaypirca for mantle cell lymphoma under the accelerated approval pathway and FDA and EMA acceptance of regulatory submissions for Jardiance for adults with chronic kidney disease. Additionally, the company initiated a rolling submission in the
Key growth products - consisting of Verzenio, Mounjaro, Jardiance, Taltz, Trulicity, Retevmo, Emgality, Cyramza, Tyvyt and Olumiant - grew 21% and represented 70% of revenue in Q4 2022.
Q4 2022 EPS increased 13% to
2023 EPS guidance updated to be in the range of
"2023 is an inflection point for Lilly - a chance to expand our impact on patients and growth potential as an R&D-driven biopharma company," said
Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:
The
FDA issuance of a complete response letter for the accelerated approval submission of donanemab for early Alzheimer's disease;
FDA and
The initiation of a rolling submission in the
The announcement that Jardiance is the first SGLT2 inhibitor to show statistically significant reduction in blood sugar levels in children and adolescents with type 2 diabetes;
Positive donanemab data from the first Phase 3 active comparator study in early Alzheimer's disease, TRAILBLAZER-ALZ 4;
Plans to invest an additional
The acquisition of
The fifth consecutive 15% annual increase in Lilly's quarterly dividend, doubling since 2018;
A collaboration with EVA Pharma to establish local manufacturing capabilities to supply low-cost insulin to at least 1 million people by 2030, mostly in
An initiative with Direct Relief to expand cold chain capacity in
For additional information on these and other important public announcements, visit the news section of Lilly's website.
For full release see:
See
http://investors.gilead.com/
Gilead Sciences Announces First Quarter 2023 Financial Results
Product Sales Excluding Veklury Increased 15% Year-Over-Year to
Biktarvy Sales Increased 24% Year-Over-Year to
Oncology Sales Increased 59% Year-Over-Year to
"Gilead's track record of strong commercial and clinical execution continued through the first quarter of 2023. A 15% year-over-year revenue increase reflects growth in each of our core areas," said
First Quarter 2023 Financial Results
Total first quarter 2023 revenue decreased 4% to
Diluted Earnings Per Share ("EPS") increased to
Non-GAAP diluted EPS decreased to
As of
During the first quarter of 2023, Gilead generated
During the first quarter of 2023, Gilead paid dividends of
Product Sales Performance
Total first quarter 2023 product sales decreased 3% to
HIV product sales increased 13% to
Biktarvy ® (bictegravir 50mg/emtricitabine 200mg ("FTC")/tenofovir alafenamide 25mg ("TAF")) sales increased 24% year-over-year in the first quarter of 2023, reflecting higher demand, as well as favorable pricing and inventory dynamics.
Descovy ® (
The Liver Disease portfolio sales, which includes chronic hepatitis C virus ("HCV"), chronic hepatitis B virus ("HBV") and chronic hepatitis delta virus ("HDV"), increased 6% to
Yescarta ® (axicabtagene ciloleucel) sales increased 70% to
Tecartus ® (brexucabtagene autoleucel) sales increased 40% to
Trodelvy sales increased by 52% to
Veklury sales decreased by 63% to
First Quarter 2023 Product Gross Margin, Operating Expenses and Effective Tax Rate
Product gross margin was 77.8% for the first quarter of 2023 compared to 78.2% for the same period in 2022. Non-GAAP product gross margin was 86.2% for the first quarter of 2023 compared to 87.4% in the same period in 2022.
Research and development ("R&D") expenses and non-GAAP R&D expenses for the first quarter of 2023 were
Acquired IPR&D expenses for the first quarter of 2023 were
Selling, general and administrative ("SG&A") expenses and non-GAAP SG&A expenses for the first quarter of 2023 were
The effective tax rate ("ETR") for the first quarter of 2023 was 24.3% compared to 107.9% for the same period in 2022. The decrease in ETR was primarily due to a
Guidance and Outlook
For the full-year, Gilead expects:
Total product sales between
Total product sales, excluding Veklury, between
Total Veklury sales of approximately
Diluted earnings per share between
Non-GAAP diluted earnings per share between
Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2023 guidance is provided in the accompanying tables. Also see the Forward-Looking Statements described below. The financial guidance is subject to a number of risks and uncertainties, including uncertainty around the duration and magnitude of the COVID-19 pandemic.
Key Updates Since Our Last Quarterly Release
Virology
Presented positive Phase 1b proof-of-concept data for an investigational combination regimen of lenacapavir with broadly neutralizing antibodies teropavimab and zinlirvimab as a potential long-acting treatment regimen for HIV with twice-yearly dosing at the Conference on Retroviruses and Opportunistic Infections ("CROI") 2023. In addition, announced results from multiple collaborative studies evaluating novel investigational combinations and strategies as part of the HIV cure research program.
Announced new real-world study data at CROI demonstrating Veklury use in hospitalized patients with COVID-19 was associated with a statistically significant reduction in mortality in the overall patient population, including immunocompromised patients. Real-world data analyses of Veklury from other sources are ongoing and may vary in their results or conclusions. Separate in vitro analyses were also presented that showed Veklury retains potent antiviral activity against recent Omicron subvariants.
Presented new COVID-19 data at the
Oncology
Received FDA approval of Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer
Presented positive results from a three-year follow-up analysis of Tecartus in the Phase 2 ZUMA-3 study of patients with R/R ALL at the European CAR T-cell Meeting.
Presented positive data from the Phase 2 TROPHY-U-01 study of Trodelvy for the treatment of metastatic urothelial cancer at the
Completed the acquisition of Tmunity, a clinical stage private biotech company, which provides preclinical and clinical programs, including an investigational "armored" CAR T technology platform that has the potential to be applied to a variety of CAR Ts to enhance anti-tumor activity, as well as rapid manufacturing processes.
Announced primary overall survival results from the Phase 3 ZUMA-7 study for initial treatment of adult patients with R/R LBCL, which showed a statistically significant improvement for Yescarta in overall survival versus historical treatment.
Inflammation
Exercised option to license investigational targeted protein degrader molecule NX‑0479 ("GS-6791") from Nurix. GS-6791 is a potent, selective, oral IRAK4 degrader with potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases.
Corporate
The company's Board of Directors declared a quarterly dividend of
Certain amounts and percentages in this press release may not sum or recalculate due to rounding.
Conference Call
At
http://investors.gilead.com
and will be archived on
www.gilead.com
for one year.
Non-GAAP Financial Information
The information presented in this document has been prepared in accordance with
About
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies.
Our strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people.
Our values and expectations are at the heart of everything we do and form an important part of our culture:
Our values are Patient focus, Transparency, Respect, Integrity
Our expectations are Courage, Accountability, Development, Teamwork
https://uk.gsk.com/en-gb/about-us/
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;
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
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,
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
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
"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:
At
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 Reports Q4 and Full-Year 2022 Results
2022 Fourth-Quarter reported sales decline of 4.4% to
2022 Fourth-Quarter earnings per share (EPS) of
2022 Full-Year reported sales growth of 1.3% to
2022 Full-Year earnings per share (EPS) of
Company guides 2023 adjusted operational sales growth excluding COVID-19 Vaccine of 4.0%* and adjusted operational EPS of
FULL YEAR 2022 SEGMENT COMMENTARY:
Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.
Pharmaceutical
Pharmaceutical worldwide adjusted operational sales grew 6.8%*, driven by DARZALEX (daratumumab), a biologic for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, and INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults. This growth was partially offset by declines in sales of REMICADE (infliximab), a biologic approved for the treatment of several immune-mediated inflammatory diseases, IMBRUVICA (ibrutinib), an oral, once daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, and ZYTIGA (abiratone acetate), an oral, once daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer.
NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with
www.sec.gov
,
www.jnj.com
or on request from
news releases
, as
wellas
www.factsabouttalc.com
,
www.factsaboutourprescriptionopioids.com
, and
www.LTLManagementInformation.com
.
FULL-YEAR 2023 GUIDANCE:
($ in Billions, except EPS)
Adjusted Operational Sales 1,2,5
Change vs. Prior Year / Mid-point
3.5% - 4.5% / 4.0%
Operational Sales 2,5 / Mid-point 2,5
Change vs. Prior Year / Mid-point
4.5% - 5.5% / 5.0%
Estimated Reported Sales 3,5 / Mid-point 3,5
Change vs. Prior Year / Mid-point
4.5% - 5.5% / 5.0%
Adjusted Operational EPS (Diluted) 2,4 / Mid-point 2,4
Change vs. Prior Year / Mid-point
2.5% - 4.5% / 3.5%
Adjusted EPS (Diluted) 3,4 / Mid-point 3,4
Change vs. Prior Year / Mid-point
3.0% - 5.0% / 4.0%
For the full release, see:
https://www.jnj.com/johnson-johnson-reports-q4-and-full-year-2022-results
The company is known as
Description
Our core product categories include diabetes, cancer, vaccines and hospital acute care. We continue to focus our research on conditions that represent some of today's most significant health challenges - like cancer, HIV, HPV, hepatitis C, cardio-metabolic disease, antibiotic-resistant infection and Alzheimer's disease, and we are on the front lines in the fight against emerging global pandemics, such as Ebola.
We also devote extensive time and energy to increasing access to medicines and vaccines through far-reaching programs that donate and deliver our products to the people
At
Employees
Approximately 71,000 (as of
Headquarters
Businesses
Pharmaceuticals Vaccines Animal Health
2019 Revenue
2019 Revenues
(by geographic area, including pharmaceutical and animal
health revenue)
latin America
Other
2019 R&D Expenses
Products
Pipeline
Senior Leadership
https://www.merck.com/about/our-history/facts/home.html
https://www.merck.com/index.html
Third-Quarter Results Reflect Sustained Strong Business Momentum Across Key Growth Drivers as Well as Investment and Progress in the Pipeline
Third-Quarter 2022 Worldwide Sales Were
KEYTRUDA Sales Grew 20% to
GARDASIL/GARDASIL 9 Sales Grew 15% to
Third-Quarter 2022 GAAP EPS From Continuing Operations Was
Announced Positive Top-line Results From Pivotal Phase 3 STELLAR Trial Evaluating the Safety and Efficacy of Sotatercept
2022 Continuing Operations Financial Outlook:
Company Raises and Narrows Expected Full-Year 2022 Worldwide Sales To Be Between
Company Lowers Expected Full-Year 2022 GAAP EPS To Be Between
Company Raises and Narrows Expected Full-Year 2022 Non-GAAP EPS To Be Between
"We continue to execute on our strategy, invest in leading-edge science and drive innovation as our colleagues deliver meaningful value for patients - which in turn provides value for our shareholders," said
Cardiovascular pipeline highlights
announced
positive results from its pivotal Phase 3 STELLAR trial evaluating sotatercept, the company's investigational activin receptor type IIA-Fc fusion protein, as an add-on to stable background therapy for the treatment of adults with pulmonary arterial hypertension. The trial met its primary efficacy outcome measure, demonstrating a statistically significant and clinically meaningful improvement in six-minute walk distance (6MWD) from baseline at 24 weeks, and eight out of nine secondary efficacy outcome measures, including the outcome measure of proportion of participants achieving multicomponent improvement [defined as improvement in 6MWD, improvement in N-terminal pro-B-type natriuretic peptide level, and either improvement in
received
a Fast Track designation from the
Oncology program highlights
Five-year overall survival (OS)
data
from the pivotal Phase 3 KEYNOTE-189 trial (KEYTRUDA plus pemetrexed and either cisplatin or carboplatin) in patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) and the Phase 3 KEYNOTE-407 trial (KEYTRUDA plus carboplatin-paclitaxel or nab-paclitaxel) in patients with metastatic squamous NSCLC.
In collaboration with
data
from Cohort K of the Phase 1b/2 EV-103/KEYNOTE-869 trial evaluating Padcev (enfortumab vedotin-ejfv) in combination with KEYTRUDA as first-line treatment for patients with cisplatin-ineligible unresectable locally advanced or metastatic urothelial cancer.
Seven-year OS
data
from the Phase 3 SOLO-1 trial evaluating Lynparza as maintenance treatment in patients with advanced BRCA-mutated ovarian cancer, following first-line platinum-based chemotherapy, and final OS results from the Phase 3 PAOLA-1 trial evaluating Lynparza in combination with bevacizumab as maintenance treatment in patients with advanced ovarian cancer
announced
that KEYTRUDA received four new approvals in
Priority review
granted
by the FDA for a supplemental New Drug Application for Lynparza in combination with abiraterone and prednisone or prednisolone for patients with metastatic castration-resistant prostate cancer (mCRPC), based on results from the Phase 3 PROpel trial. The Prescription Drug User Fee Act (PDUFA) date is in the fourth quarter of 2022.
Approved in the
and
as adjuvant treatment for patients with germline BRCA-mutated, HER2-negative high-risk early breast cancer, based on results from the Phase 3 OlympiA trial.
Approved
in
KEYNOTE-412
,
KEYNOTE-921
and
LEAP-002
.
Vaccines program highlights
announced
Infectious diseases pipeline highlights
initiate
a new Phase 3 clinical program with islatravir for the treatment of people with HIV-1 infection. These new Phase 3 studies will evaluate a once-daily oral combination of doravirine 100 mg and islatravir (DOR/ISL) 0.25 mg.
resume
the Phase 2 clinical trial evaluating an investigational oral once-weekly combination treatment regimen of islatravir and Gilead's lenacapavir in adults with HIV-1 infection
provided
an update on a preliminary analysis of the
Business development highlights
announced
that
announced
a collaboration agreement to discover, develop and commercialize multiple programs, including vaccines and therapeutics in the areas of infectious diseases and oncology. This collaboration will combine
formed
a global development and commercialization agreement for Orion's investigational candidate ODM-208/MK-5684 and other drugs targeting cytochrome P450 11A1 (CYP11A1), an enzyme important in steroid production. ODM-208/MK-5684 is an oral, non-steroidal inhibitor of CYP11A1 currently being evaluated in a Phase 2 clinical trial for the treatment of patients with mCRPC.
acquired
Vence, an innovator in virtual fencing for rotational grazing and livestock management, which complements
Environmental, Social and Governance (ESG) highlights
issued
its 2021/2022 ESG Progress Report, highlighting the company's performance and progress in ESG efforts across four main focus areas: Access to Health, Employees, Environmental Sustainability and Ethics & Values. These efforts come as part of a long-standing commitment to operating responsibly and creating value for patients and shareholders.
launched
the
recognized
on Fortune's 2022 Change the World list for its work to make HPV vaccines broadly available in underserved countries through partnerships and manufacturing investments.
Pharmaceutical revenue
Third-quarter pharmaceutical sales increased 13% to
Growth in oncology was largely driven by higher sales of KEYTRUDA, which rose 20% to
Growth in vaccines was primarily driven by higher combined sales of GARDASIL (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant) and GARDASIL 9 vaccines to prevent certain cancers and other diseases caused by HPV. Third-quarter GARDASIL/GARDASIL 9 sales grew 15% to
Growth in hospital acute care reflects higher demand globally for BRIDION (sugammadex) injection 100 mg/mL, a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults and pediatric patients ages 2 years and older undergoing surgery. Sales increased 15% to $423 million, primarily due to an increase in its share among neuromuscular blockade reversal agents and an increase in surgical procedures. Growth in hospital acute care also reflects higher sales of ZERBAXA (ceftolozane and tazobactam), a combination cephalosporin antibacterial and beta-lactamase inhibitor for the treatment of adults with certain bacterial infections. Sales of $43 million resulted from the phased resupply initiated in the fourth quarter of 2021, which has been completed in 2022.
Pharmaceutical sales growth was partially offset by lower combined sales of JANUVIA (sitagliptin) and JANUMET (sitagliptin and metformin HCI), which declined 15% to $1.1 billion, primarily reflecting lower demand and pricing in certain international markets as a result of generic competition, particularly in
Animal Health revenue
Animal Health sales totaled $1.4 billion for the third quarter of 2022, a decline of 3% compared with the third quarter of 2021. Excluding the unfavorable effect from foreign exchange, Animal Health sales grew 4% primarily reflecting higher pricing. Sales of livestock products also reflect higher demand for poultry products. Sales of companion animal products also reflect higher demand for the BRAVECTO (fluralaner) parasiticide line of products, partially offset by supply constraints for certain vaccines.
For the full release, see:
https://www.merck.com/news/
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
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
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
19 July 2022
Ad hoc announcement pursuant to Art. 53 LR
Q2 sales grew +5% cc1 (-1% USD)
Innovative Medicines (IM) sales grew +5% cc (-1% USD); strong performance of key growth brands including Entresto (+33% cc), Kesimpta (+270% cc), Cosentyx (+12% cc), Kisqali (+43% cc) and Zolgensma (+26% cc)
Q2 core1 operating income grew +5% cc (-2% USD) , mainly driven by higher sales
Q2 operating income declined -30% cc (-36% USD) , mainly due to prior year divestment gains, higher impairments and higher restructuring costs. Net income declined -34% cc (-41% USD), or -29% (cc) excluding the impact of
Q2 core EPS USD 1.56 +1% cc (-6% USD) ; excluding
Strong H1 performance with sales growing +5% cc (0% USD) and core operating income growing +7% cc (+1% USD):
Innovative Medicines sales grew +5% cc (0% USD) and core operating income +6% cc (-1% USD)
Previously announced up to USD 15 billion share buyback ongoing; USD 9.4 billion still to be executed
Progressing our new organizational model with a focus on 5 core therapeutic areas; now expect to deliver approximately USD 1.5 billion in SG&A savings by 2024
Q2 key innovation milestones:
Cosentyx approved in the EU for childhood arthritic conditions
Kymriah approved in the US and EU for adults with relapsed or refractory follicular lymphoma
Scemblix received positive CHMP opinion for adults with Ph+ chronic myeloid leukemia
2022 Group guidance confirmed.
Strategy Update
In April, we announced a streamlined organizational model, designed to support innovation, growth and productivity, the implementation of which is progressing well. With the changes,
The strategic review of
Financials
Second quarter
Net sales were USD 12.8 billion (-1%, +5% cc) in the second quarter, driven by volume growth of 12 percentage points, price erosion of 4 percentage points and the negative impact from generic competition of 3 percentage points.
Operating income was USD 2.2 billion (-36%, -30% cc), mainly due to lower product divestment gains (USD 0.4 billion), higher impairments (USD 0.4 billion) and higher restructuring costs (USD 0.3 billion) primarily related to the implementation of the new organizational model.
Net income was USD 1.7 billion (-41%, -34% cc), mainly due to lower operating income. Excluding the impact of
Core operating income was USD 4.3 billion (-2%, +5% cc), mainly driven by higher sales, partly offset by higher R&D and M&S investments and lower gross margin. Core operating income margin was 33.4% of net sales, decreasing by 0.1 percentage points (+0.1 percentage points cc).
Core net income was USD 3.4 billion (-8%, -1% cc), as growth in core operating income was more than offset by the loss of
Free cash flow amounted to USD 3.3 billion (-22% USD), compared to USD 4.2 billion in the prior year quarter, mainly due to lower divestment proceeds and unfavorable changes in working capital.
Innovative Medicines net sales were USD 10.5 billion (-1%, +5% cc) with volume contributing 13 percentage points to growth. Sales growth was mainly driven by continued strong performance from Entresto, Kesimpta, Cosentyx, Kisqali and Zolgensma. Generic competition had a negative impact of 4 percentage points, mainly due to Afinitor/Votubia, Gilenya (ex-US), Gleevec/Glivec, Exjade, and Sandostatin. Pricing had a negative impact of 4 percentage points. Sales in the US were USD 3.9 billion (+6%) and in the rest of the world USD 6.5 billion (-5%, +5% cc).
First half
Net sales were USD 25.3 billion (+0%, +5% cc) in the first half, driven by volume growth of 12 percentage points, price erosion of 4 percentage points and the negative impact from generic competition of 3 percentage points.
Operating income was USD 5.1 billion (-14%, -7% cc), mainly due to lower product divestment gains (USD 0.4 billion), unfavorable fair value adjustments on financial assets (USD 0.2 billion) and higher restructuring costs (USD 0.2 billion) primarily related to the implementation of the new organizational model.
Net income was USD 3.9 billion (-21%, -14% cc), mainly due to lower operating income. Excluding the impact of
Core operating income was USD 8.4 billion (+1%, +7% cc), mainly driven by higher sales, partly offset by higher R&D and M&S investments. Core operating income margin was 33.0% of net sales, increasing by 0.3 percentage points (+0.6 percentage points cc).
Core net income was USD 6.7 billion (-6%, +0% cc), as growth in core operating income was offset by the loss of
Free cash flow amounted to USD 4.2 billion (-28% USD), compared to USD 5.8 billion in the prior year period, mainly due to lower divestment proceeds, unfavorable changes in working capital, and the loss of
Innovative Medicines net sales were USD 20.6 billion (0%, +5% cc) with volume contributing 12 percentage points to growth. Sales growth was mainly driven by continued strong performance from Entresto, Kesimpta, Cosentyx, Kisqali and Zolgensma. Generic competition had a negative impact of 3 percentage points, mainly due to Afinitor/Votubia, Gleevec/Glivec, Exjade, Gilenya (ex-US) and Exforge. Pricing had a negative impact of 4 percentage points. Sales in the US were USD 7.6 billion (+4%) and in the rest of the world USD 13.1 billion (-3%, +5% cc).
For the full release, see:
https://www.novartis.com/news/media-releases/
Our strategy is rooted in four strategic imperatives that have remained constant since we began to transform
OUR STRATEGIC IMPERATIVES
INNOVATE & LEAD
Improve
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
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
The second-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to
www.pfizer.com
.
EXECUTIVE COMMENTARY
Dr.
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,
Finally, we continue to make progress toward our proposed acquisition of
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."
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
For the full release, see:
https://s28.q4cdn.com/781576035/files/doc_financials/2023/q2/Q2-2023-PFE-Earnings-Release.pdf
Roche Products
Founded in 1896,
Twenty-nine medicines developed by
We have had a presence in the
Our pharmaceutical business in the
We lead the
We provide diabetes management solutions and services to improve the lives of people living with diabetes.
https://www.roche.co.uk/en/roche-in-the-uk.html
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
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,
Core earnings per share are targeted to develop broadly in line with sales decline (at constant exchange rates).
Key figures
CHF millions
% change
January-December 2022
2022
2021
At CER 1
In CHF
Group sales
63,281
62,801
2
1
Pharmaceuticals Division
45,551
45,041
2
1
Diagnostics Division
17,730
17,760
3
0
Core operating profit
22,173
21,897
3
1
Core EPS - diluted (CHF)
20.30
19.81
5
2
IFRS net income
13,531
14,935
-6
-9
Group results
In 2022,
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
For full release see:
https://www.roche.com/media/releases/med-cor-2023-02-02
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
Strong sales performance and double digit EPS growth marking the achievement of the 2022 profitability milestone
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® (€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 nonconsolidated Vaxelis® sales
General Medicines core assets up 8.0% while GBU sales were lower (-3.7%) mainly due to Lantus® and spin-off of
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 €42,997 million driven by Dupixent® (€8,293 million, +43.8%), adding €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 €2.5 billion achieved
Business EPS(1) of €8.26 up 25.9% on a reported basis and 17.1% at CER
IFRS EPS of €5.37 (up 8.0%)
Board held on February 2, proposes annual dividend of €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
Beyfortus® (nirsevimab) approved in
VidPrevtyn® Beta approved in
Enjaymo® approved in
Full-year 2023 business EPS guidance
"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."
2022 fourth-quarter and full-year
Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER1
In the fourth quarter of 2022,
In 2022,
Fourth-quarter 2022 operating income
Fourth-quarter business operating income (BOI) increased 20.7% to €2,724 million. At CER, BOI increased 15.0%. The ratio of BOI to net sales increased 2.8 percentage point to 25.4% (25.3% at CER). In 2022, BOI increased 21.7% to €13,040 million. At CER, BOI increased 13.3%. The ratio of business operating income to net sales increased 1.9 percentage point to 30.3% (30.0% at CER).
Pharmaceuticals Fourth-quarter
Pharmaceutical sales increased 7.3% to €7,793 million, mainly driven by the Specialty Care portfolio (up 18.1%) with continued strong performance of Dupixent® while sales in General Medicines decreased 3.7%. In 2022, Pharmaceuticals sales increased 6.9% to €30,688 million reflecting the strong performance of Specialty Care and General Medicines core assets.
For the full release, see:
https://www.sanofi.com/dam/jcr:0e9df19c-7a67-47de-83ad-19e63173b0cb/2023_02_03_Q4_FY_2022_SANOFI_Press_Release_EN.pdf
Sinopharm (China National Pharmaceuticals Group Co Ltd) (HKSE: 01099)
About Us.
China National Pharmaceutical Group Co., Ltd. (Sinopharm) is a large healthcare group directly under the State-owned Assets Supervision and Administration Commission (SASAC) of the State Council, with 128,000 employees and a full chain in the industry covering R&D, manufacturing, logistics and distribution, retail chains, healthcare, engineering services, exhibitions and conferences, international business and financial services.
Sinopharm owns over 1,100 subsidiaries and 6 listed companies which are
The past years witnessed Sinopharm's steady and sound development. From 2009to 2018, the CAGR of revenue and total assets reached 24.24% and 30.54% respectively. Sinopharm ranked 169th in Fortune Global 500 and the revenue of 2018 amounted to nearly 400 billion yuan..
Sinopharm has built a nationwide logistic and distributing network for drugs and medical devices and equipment, including 5logistic hubs, more than 40 provincial-level centers and over 240 municipal-level logistic sites. By establishing the smart medical service system, Sinopharmdelivers quality servicesto more than 230,000 corporate clients.
Sinopharm has an applied pharmaceutical research institute and an engineering design institute, both taking a leading position in
Sinopharm has built up manufacturing and medicinal materials sites for biological drugs, narcotic and psychotropic drugs, anti-infectious drugs, oncology drugs, cardio-vascular drugs and respiratory drugs. Some of the production lines have been approved by the
As world's 6th largest vaccine manufacturer, Sinopharm is able to produce all the vaccines in the National Vaccination Program and is the supplier of over 80% vaccines used in the Expanded Program on Immunization in
Sinopharm leads in TCM sector by establishing an integrated TCM industry chain that covers planting, R&D, pieces for decoction, formulated instant granules, and preparations. It is able to produce over 900 medicines,owns 15 China Time-honored Brands and 4 National Intangible Cultural Heritage medicines.
Sinopharmhas fostered 30 highly recognized events represented by CMEF (China International Medical Equipment Fair), serving the entire chain and many subdivisions concerning healthcare. These exhibitions and conferences have become a platform for exchange and cooperation that advances the whole industry.
Sinopharm explored a new model of drugstores with extensive healthcare services. There are over 5,100 chain drugstores under the brands of Guoda, Jinxiang, Dadesheng and Tianyitang, providing convenientaccess for customers. Sinopharm forms a healthcare network consisting of regional healthcare groups in provinces of
Sinopharm broadens its international cooperation by founding 26 joint ventures with world-renowned pharmaceutical companies andtrading with more than 120 countries and regions, including60 Belt and Road countries.
The JE vaccine of which Sinopharm owns complete independent intellectual property right has been listed into the procurement catalog by the UN organizations to benefit the whole world.Sinopharm'sproduction sites in
As healthcare-centered financial services develop, an industry-and-finance model with Sinopharm features takes shape.
Guided by the core value of "all for health, health for all", Sinopharm shoulders the social responsibility of national medical and pharmaceutical reserve on a long-term basis with pride. In times of epidemics and disasters, it provides medicines, bio-products, traditional Chinese medicines, and medical devices promptly to the stricken areas not only at home, but also abroad as in
Sinopharm acts as the president enterprise in many influential associations such as China Pharmaceutical Industry Association, China National Narcotic Drugs Association, China Association of Pharmaceutical Commerce, etc., and plays its role in preventing diseases, safeguarding people's health, and advancing the whole industry.
http://www.sinopharm.com/en/1398.html
TOKYO:4502/NYSE:TAK
) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in
https://www.takeda.com
Reinforces Long-term Growth Through Pipeline Advancement and Two Targeted Acquisitions Delivers Another Strong Quarter in FY2022 Q3
1/2/2023
Announced Agreement With Nimbus Therapeutics in December to Acquire a Potential Best-in-Class TYK2 Inhibitor, and with
Continued Momentum With Q3 Year-to-Date Reported Revenue Growth of +13.9% and Core Revenue Growth of +4.5% at Constant Exchange Rate; Reported EPS Growth of +19.6%
Approval for Dengue Vaccine, QDENGA ® in EU;
Net Debt / Adjusted EBITDA Improves to 2.5x as of Q3 End Even After Full-year Dividend Payment
Robust Cash Flow and Improved Debt Profile Enabling Investment for Growth While Maintaining Focus on Shareholder Returns
Takeda chief financial officer,
"Our third-quarter performance demonstrates sustained momentum as our Growth and Launch Products and solid commercial execution again drove strong revenue and core profit growth. We continue to advance our organic pipeline, including notable approvals in the EU and
FINANCIAL HIGHLIGHTS
Results for FY2022 Q3 Ended December 31, 2022
(Billion yen, except percentages and per share amounts)
REPORTED
CORE (c) (Non-IFRS) (a)
FY2022 Q3 YTD
vs. PRIOR YEAR (Actual % change)
FY2022 Q3 YTD
vs. PRIOR YEAR (Actual % change)
vs. PRIOR YEAR (CER % change (d) )
Revenue
3,071.3
+13.9%
3,071.3
+19.8%
+4.5%
Operating Profit
401.9
-13.1%
954.7
+26.0%
+9.7%
Margin
13.1%
-4.1pp
31.1%
+1.5pp
Net Profit
285.9
+18.4%
707.2
+35.6%
+15.9%
EPS (yen)
184
+19.6%
456
+37.0%
+17.1%
Operating Cash Flow
683.5
-8.6%
Free Cash Flow (Non-IFRS) (a)(b)
585.2
-12.8%
(a) Further information regarding certain of Takeda's Non-IFRS measures is posted on Takeda's investor relations website at https://www.takeda.com/investors/financial-results/.
(b) We define Free Cash Flow as cash flows from operating activities, subtracting acquisition of property, plant and equipment ("PP&E"), intangible assets and investments as well as removing any other cash that is not available to Takeda's immediate or general business use, and adding proceeds from sales of PP&E, as well as from sales of investments and businesses, net of cash and cash equivalents divested.
(c) Core results adjust our reported results calculated and presented pursuant to IFRS to exclude the effect of items unrelated to Takeda's core operations, such as, to the extent applicable for each line item, non-recurring items, purchase accounting effects and transaction related costs, as well as amortization and impairment of intangible assets and other operating income and expenses.
(d) CER (Constant Exchange Rate) change eliminates the effect of foreign exchange rates from year-over-year comparisons by translating Reported or Core results for the current period using corresponding exchange rates in the same period of the previous fiscal year.
COMMERCIAL UPDATES ACROSS FIVE KEY BUSINESS AREAS
Growth in our key business areas in FY2022 Q3 YTD was driven largely by Growth & Launch Products 1 , which delivered reported revenue of 1,199.6 billion yen, marking a +20% increase on a CER basis.
Gastroenterology (GI), with 857.5 billion yen in reported revenue, grew +11% on a CER basis, driven by ENTYVIO ® (for ulcerative colitis and Crohn's disease; +17% on a CER basis) and by TAKECAB ® /VOCINTI (for acid-related diseases), whose strong uptake in
Rare Diseases, with 553.6 billion yen in reported revenue, grew +5% on a CER basis. Sales of TAKHZYRO ® (for hereditary angioedema) grew +25% on a CER basis due to expansion of the prophylactic market, continued geographic expansion and strong patient uptake. LIVTENCITY™ (for post-transplant cytomegalovirus) continues to generate high interest and strong uptake since its launch in the
Plasma-Derived Therapies (PDT) Immunology, with 502.4 billion yen in reported revenue, delivered outstanding growth of +18% on a CER basis. Growth was driven by higher sales of immunoglobulin products (for primary immunodeficiency and multifocal motor neuropathy), with +19% growth on a CER basis, particularly in the
Oncology, with 345.0 billion yen in reported revenue, declined -13% on a CER basis as a result of the expected entry of VELCADE ® generics (for multiple myeloma) that began in the
Neuroscience, with 477.1 billion yen in reported revenue, grew +10% on a CER basis, driven by an expanding ADHD adult market in the
PIPELINE UPDATE
Takeda has continued to deliver on its ability to bring new therapies to patients and capitalize on momentum within its innovative pipeline. Updates since the FY2022 H1 announcement include:
Takeda announced that it has entered into an exclusive licensing agreement with
Additional information related to this announcement is available
here
.
Takeda announced that it will acquire NDI-034858, an oral selective allosteric TYK2 inhibitor being evaluated for the potential treatment of multiple autoimmune diseases, from Nimbus Therapeutics. With Phase 3 studies in psoriasis expected to begin this year, NDI-034858 has the potential to demonstrate best-in-class efficacy and safety and convenience in psoriasis as well as other immune-mediated diseases including psoriatic arthritis, inflammatory bowel disease and systemic lupus erythematosus. The acquisition is expected to strengthen Takeda's growing late-stage pipeline in alignment with the company's therapeutic area strategy and expertise in immune-mediated diseases. Takeda will pay Nimbus USD 4 billion upfront in addition to two milestone payments of USD 1 billion each upon achieving annual net sales of USD 4 billion and USD 5 billion for products developed from the NDI-034858 program. The upfront payment will be primarily funded by cash on hand. The transaction is expected to be finalized before the end of FY2022.
Additional information related to this announcement is available
here
.
QDENGA, Takeda's dengue vaccine, was approved by the
Additional information related to the EC and
here
and
here
.
Additional information related to this announcement is available
here
.
LIVTENCITY ™ (maribavir) was approved by the
Additional information related to this announcement is available
here
.
Takeda announced favorable safety and efficacy results of TAK-755 from the first and only Phase 3 trial in congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare disease with limited treatment options. Based on this data, Takeda aims to seek marketing authorization for TAK-755 as the first recombinant ADAMTS13 replacement therapy for cTTP, a disorder with considerable unmet patient need.
Additional information related to this announcement is available
here
.
Takeda and
Additional information related to this announcement is available
here
.
Results from Takeda's Phase 3 AURORA trial provided evidence of maribavir's clinically meaningful and durable effect in cytomegalovirus infection in hematopoietic stem cell transplant patients despite missing the primary endpoint. Full data results will be submitted for publication in a peer-reviewed journal and are being shared with relevant regulatory agencies.
Additional information related to this announcement is available
here
.
Takeda's Phase 3 PhALLCON trial met its primary endpoint, demonstrating that adult patients with newly diagnosed
Additional information related to this announcement is available
here
.
TAK-861, Takeda's oral orexin agonist for narcolepsy, met pre-specified criteria set to advance the program into two Phase 2b studies in narcolepsy type 1 and narcolepsy type 2. Both Phase 2b trials are currently enrolling patients.
FY2022 Outlook
On track towards full-year FY2022 Management Guidance
(Billion yen)
FY2022
FORECAST (Upgraded October 2022)
FY2022 MANAGEMENT GUIDANCE Core Growth at CER (Non-IFRS) (Unchanged from May 2022)
Revenue
3,930.0
Core Revenue
3,930.0
Low-single-digit growth
Reported Operating Profit
530.0
Core Operating Profit
1,180.0
High-single-digit growth
Reported Net Profit
307.0
Reported EPS (Yen)
198
Core EPS (Yen)
525
High-single-digit growth
Free Cash Flow
650.0 - 750.0
Annual Dividend per Share (Yen)
180
Free Cash Flow forecast does not include the impact of the upfront cash payment for the acquisition of NDI-034858 from
For more details on Takeda's FY2022 Q3 results and other financial information including key assumptions in FY2022 forecast and management guidance, please visit:
https://www.takeda.com/investors/financial-results/
.
About Takeda
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in
https://www.takeda.com
.
https://www.takeda.com/newsroom/newsreleases/2023/takeda-reinforces-long-term-growth-through-pipeline-advancement-and-two-targeted-acquisitions-delivers-another-strong-quarter-in-fy2022-q3/
https://corporate.thermofisher.com/en/about-us.html
Thermo
October 25, 2023
Third Quarter 2023 Highlights
Third quarter revenue was $10.57 billion, 1% lower versus the same quarter last year. Core organic revenue growth was 1%.
Third quarter GAAP diluted earnings per share (EPS) was $4.42, 17% higher versus the same quarter last year, driven by 160 basis points of operating margin expansion.
Third quarter adjusted EPS was $5.69, 12% higher versus the same quarter last year, driven by 200 basis points of adjusted operating margin expansion.
The impact of the macroeconomic conditions that the industry has experienced through the year increased in the third quarter. Our PPI Business System and strong execution by our global team enabled the company to deliver strong financial performance for the quarter.
Advanced our proven growth strategy, launching a range of high-impact, innovative new products, including the groundbreaking EXENT® Solution in
Shortly after the quarter ended, announced an agreement to acquire
Building on our environmental, social and governance (ESG) priorities, we are collaborating with the National Minority Quality Forum (NMQF) to make clinical research more accessible to historically underserved communities. The collaboration supports biopharmaceutical and biotech customers' desire to increase diversity in clinical trials by enrolling and retaining patients
"While market conditions further weakened during the third quarter, I'm very pleased with our team's execution which enabled our company to deliver both excellent margin expansion and adjusted EPS growth," said
Casper added, "We are incredibly focused on delivering differentiated short-term performance while enhancing our long-term competitive position."
Third Quarter 2023
Revenue for the quarter declined 1% to $10.57 billion in 2023, versus $10.68 billion in 2022. Organic revenue was 3% lower, Core organic revenue growth was 1%, and COVID-19 testing revenue was $0.05 billion.
GAAP Earnings Results
GAAP diluted EPS in the third quarter of 2023 was $4.42, versus $3.79 in the same quarter last year. GAAP operating income for the third quarter of 2023 was $1.86 billion, compared with $1.71 billion in the year-ago quarter. GAAP operating margin was 17.6%, compared with 16.0% in the third quarter of 2022.
Non-GAAP Earnings Results
Adjusted EPS in the third quarter of 2023 was $5.69, versus $5.08 in the third quarter of 2022. Adjusted operating income for the third quarter of 2023 was $2.56 billion, compared with $2.37 billion in the year-ago quarter. Adjusted operating margin was 24.2%, compared with 22.2% in the third quarter of 2022.
Annual Guidance for 2023
Given the current macroeconomic environment,
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.
Conference Call
During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (833) 470-1428 within the
About
Safe Harbor Statement
The following constitutes a "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements that involve a number of risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include risks and uncertainties relating to: the COVID-19 pandemic; the need to develop new products and adapt to significant technological change; implementation of strategies for improving growth; general economic conditions and related uncertainties; dependence on customers' capital spending policies and government funding policies; the effect of economic and political conditions and exchange rate fluctuations on international operations; use and protection of intellectual property; the effect of changes in governmental regulations; any natural disaster, public health crisis or other catastrophic event; and the effect of laws and regulations governing government contracts, as well as the possibility that expected benefits related to recent or pending acquisitions, including our pending acquisition of
Additional Information and Where to Find It
The tender offer for all of the outstanding
https://ir.thermofisher.com/investors/news-events/news/news-details/2023/Thermo-
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