Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced that the U.S. government will purchase an additional 1.4 million courses of molnupiravir, bringing the total commitment to approximately 3.1 million courses for around $2.2 billion. This procurement is contingent on Emergency Use Authorization (EUA) or FDA approval for molnupiravir, an oral antiviral treatment for COVID-19. Merck has been producing the drug at risk, expecting to deliver 10 million courses by year-end 2021, with capabilities to produce at least 20 million in 2022.

Merck has received antitrust clearance for its acquisition of Acceleron Pharma Inc. from competition authorities in Germany and Austria. The acquisition involves a cash tender offer of $180 per share, as announced on October 12, 2021. This step fulfills one of the necessary conditions for the tender offer's completion. The tender offer is set to expire on November 18, 2021, unless extended. The acquisition is anticipated to close in Q4 2021, pending other conditions detailed in the SEC filings.

Acceleron Pharma reported Q3 2021 revenue of $34.2 million, including $32.0 million in royalty revenue from REBLOZYL, up from $25.6 million last quarter. Merck agreed to acquire Acceleron for $180 per share, valuing the deal at approximately $11.5 billion, expected to close in Q4. The company has several ongoing Phase 3 trials for its therapies, including sotatercept for pulmonary hypertension and ACE-1334 for systemic sclerosis-associated lung disease. Cash reserves stand at $652.5 million.

The U.K. Medicines and Healthcare Products Regulatory Agency has authorized molnupiravir, an oral antiviral, for treating mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 test and risk factors for severe illness. This marks a significant step as it is the first oral antiviral to receive such authorization. Merck (NYSE: MRK) is working to gain additional approvals globally, with applications submitted to the FDA and the European Medicines Agency. The authorization is based on positive results from the Phase 3 MOVe-OUT trial, indicating a 50% reduction in hospitalization or death risk.

Merck announced significant findings for KEYTRUDA at the SMR 2021 Congress, showcasing its effectiveness in treating melanoma. The exploratory 7-year follow-up data from KEYNOTE-006 showed a median overall survival of 32.7 months for KEYTRUDA versus 15.9 months for ipilimumab. The 7-year survival rates were 37.8% vs. 25.3%, respectively. In the KEYNOTE-716 trial, KEYTRUDA demonstrated a 39% reduction in the risk of disease recurrence compared to placebo in patients with resected stage IIB/IIC melanoma. Safety profiles were consistent across studies, with no new safety signals identified.

Merck (NYSE: MRK) has withdrawn its Premerger Notification under the HSR Act concerning its acquisition of Acceleron Pharma Inc. (NASDAQ: XLRN), initially filed on October 14, 2021. This decision allows more time for FTC review, with a refiling expected around November 1, 2021. The tender offer for Acceleron shares at $180 per share is extended until November 18, 2021. As of October 28, 2021, approximately 8.4 million shares have been tendered, representing 13.7% of Acceleron's outstanding shares. The acquisition is anticipated to close in Q4 2021, pending regulatory approvals.

Avoro Capital Advisors, holding approximately 7% of Acceleron Pharma, opposes Merck's proposed acquisition of Acceleron at $180 per share, deeming it undervalued. Avoro believes Acceleron has significant potential as a standalone entity, especially with upcoming Phase 3 STELLAR trial results expected by end of 2022 that could enhance share price. The letter emphasizes monetizing existing royalties from Reblozyl and exploring better strategic alternatives to maximize shareholder value, criticizing the Board's decision-making process and urging fellow shareholders to reject the tender offer.

Organon (NYSE: OGN) will release its third quarter 2021 financial results on November 11, 2021, before a webcast and conference call at 8:30 a.m. ET. Interested parties can access the live call via the Organon website, with a replay available two hours post-event. Institutional investors must register in advance to participate. Formed from a spin-off of Merck (NYSE: MRK), Organon focuses on women's health with over 60 medicines and products, pursuing collaboration with biopharmaceutical innovators.

Merck (MRK) reported strong third-quarter 2021 sales of $13.2 billion, a 20% increase year-over-year. Key drivers included KEYTRUDA sales, up 22% to $4.5 billion, and GARDASIL, with sales surging 68% to $2 billion. The company achieved a GAAP EPS of $1.80 and non-GAAP EPS of $1.75. Merck raised its 2021 revenue outlook to $47.4-$47.9 billion, reflecting a 14-15% growth. The acquisition of Acceleron Pharma aims to enhance Merck's cardiovascular pipeline. Multiple regulatory approvals for cancer treatments and COVID-19 antiviral molnupiravir highlight ongoing innovation.