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Merck & Co., Inc. reports news across a global pharmaceutical business known as MSD outside the United States and Canada. Company updates center on human health products for areas such as oncology, cardiometabolic disease and infections; vaccines including Gardasil; and Merck Animal Health medicines, devices and customer-support systems.
Recurring developments include FDA approvals, clinical and regulatory disclosures, research publications, pipeline additions, business development transactions, material agreements, capital-structure updates, governance matters, and operating and financial results. Recent themes include the approved HIV-1 regimen IDVYNSO, investigational programs such as enlicitide decanoate and TERN-701, technology partnerships for research, manufacturing and commercial functions, and animal health digital engagement initiatives.
Merck (MRK) and Eisai announced that the FDA has accepted priority review for two new applications regarding the combination of KEYTRUDA and LENVIMA. These applications target the first-line treatment of advanced renal cell carcinoma and patients with advanced endometrial carcinoma who are not candidates for curative surgery. The applications are based on pivotal Phase 3 studies demonstrating statistically significant improvements in progression-free survival, overall survival, and objective response rates. Target action dates are set for August 25, 26, and September 3, 2021.
Merck announced that the FDA has approved KEYTRUDA in combination with trastuzumab and chemotherapy for first-line treatment of HER2-positive gastric or gastroesophageal junction adenocarcinoma. The approval, based on the Phase 3 KEYNOTE-811 trial, demonstrated a significant objective response rate (ORR) of 74% for the KEYTRUDA regimen compared to 52% for standard treatment.
However, this approval is under accelerated terms, hinging on further verification of clinical benefits.
Merck (NYSE: MRK) is hosting a meeting to discuss its spinoff of Organon, aiming to enhance growth and shareholder value. Rob Davis, Merck's president, emphasized that this separation will create a more agile company. Organon's launch on June 3 will feature over 60 products focused on women's health, biosimilars, and established brands. The new company expects low to mid-single organic revenue growth, with significant opportunities in the women's health market projected at over $60 billion by 2026. The event will outline Organon's growth strategy and commercial roadmap.
Merck (NYSE: MRK) reported its Q1 2021 financial results, showing total sales of $12.08 billion, a marginal increase from $12.057 billion in Q1 2020. GAAP net income fell by 1% to $3.179 billion, with GAAP EPS at $1.25. Non-GAAP EPS declined 7% to $1.40. Oncology sales were strong, led by KEYTRUDA, which grew 19% to $3.9 billion. However, the pandemic negatively impacted vaccine sales, particularly for GARDASIL, by approximately $230 million. Merck anticipates 2021 revenue growth of 8%-12%, with a GAAP EPS outlook of $5.05-$5.25.
Merck (NYSE: MRK) announced an upcoming virtual investor event on May 3 at 10:00 am EDT, where Organon management will unveil the business strategy and financial outlook for the spinoff company focused on women's healthcare. With over 60 established medicines, Organon aims to leverage a robust cash flow and commercial capabilities to foster growth and partnerships in international markets. Interested participants can pre-register for the event and access additional resources online.
Merck (NYSE: MRK) has entered into non-exclusive licensing agreements for molnupiravir with five Indian generics manufacturers to enhance its availability in India and over 100 low- and middle-income countries. This investigational oral antiviral agent is currently in a Phase 3 trial for non-hospitalized COVID-19 patients. The generics include Cipla, Dr. Reddy’s, Emcure, Hetero, and Sun Pharma. Additionally, Merck will donate over $5 million in aid to support relief efforts in India, highlighting its commitment to alleviating suffering amid the pandemic.
Merck (NYSE: MRK) aims to achieve carbon neutrality across its operations by 2025 and cut 30% of value chain emissions by 2030. These goals align with global climate efforts and the Paris Agreement. Merck plans to enhance efficiency, reduce fossil fuel use, and offset remaining emissions with high-quality carbon credits.
The company has signed new virtual power purchase agreements in Texas and Spain, aiming to address 35% of its Scope 2 emissions. Merck is committed to sustainability and engaging suppliers to achieve these ambitious environmental goals.
Merck (NYSE: MRK) has announced the discontinuation of MK-7110's development for COVID-19 treatment. Acquired through OncoImmune in December 2020, the drug required more data than previously expected, which would delay its availability until 2022. Consequently, Merck will redirect resources towards enhancing molnupiravir, an oral outpatient medicine, and increasing production of Johnson & Johnson's COVID-19 vaccine. This decision aligns with Merck's commitment to prioritize impactful efforts during the pandemic, as stated by Dr. Roy Baynes, senior vice president at Merck Research Laboratories.
Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced updates on molnupiravir, an investigational COVID-19 antiviral. Following positive interim data from the Phase 2 dose-finding trials, Merck will advance molnupiravir to the Phase 3 stage in outpatients with COVID-19, focusing on an 800 mg dosage. However, the drug's Phase 2 MOVe-IN trial for hospitalized patients was halted due to insufficient evidence of clinical benefit. Final data from the MOVe-OUT Phase 3 trial is expected by September/October 2021, with potential Emergency Use Authorization anticipated later in the year.
Merck (NYSE: MRK) announced its 20th community-based grant under the Safer Childbirth Cities initiative, focusing on improving maternal health outcomes for Black women in Austin, TX. The funding supports the Maternal Health Equity Collaborative (MHEC) to address racial inequities and enhance access to quality healthcare. The initiative aligns with Black Maternal Health Week (April 11-17, 2021), spotlighting systemic racism's impact on maternal mortality rates. Merck for Mothers pledges $500 million to combat these disparities, emphasizing local solutions.