10-Q: Merck & Co. Reports Strong Q1 2024 Results Driven by Oncology and Vaccine Sales

• Merck & Co. reported a 9% increase in worldwide sales to $15.8 billion for the first quarter of 2024, or 12% excluding the unfavorable impact of foreign exchange.
• The growth was primarily driven by the oncology franchise, particularly Keytruda, and the vaccines franchise, with Gardasil/Gardasil 9 and Vaxneuvance contributing significantly.
• Net income attributable to Merck & Co., Inc. was $4.76 billion, or $1.88 per share basic and $1.87 per share diluted, compared to $2.82 billion, or $1.11 per share basic and diluted, in the same period last year.
• The company incurred a $656 million charge related to the acquisition of Harpoon Therapeutics, impacting research and development expenses.
• A new restructuring program was approved in January 2024, expected to cost approximately $4.0 billion and yield annual net cost savings of approximately $750 million by the end of 2031.
• The effective income tax rate for the quarter was 15.9%, reflecting an unfavorable impact from the Harpoon acquisition charge.

Score: 8

Explanation: The document presents a positive outlook with strong sales growth and increased profitability, although there are some challenges related to pricing pressures and generic competition. The strategic acquisitions and restructuring efforts indicate a proactive approach to future growth.

• Strong sales growth in the oncology and vaccine franchises.
• Significant increase in Keytruda sales, driven by new indications and continued uptake.
• Strong performance of Gardasil/Gardasil 9, particularly in China.
• Successful launch and uptake of Vaxneuvance in the pediatric market.
• Improved gross margin due to favorable product mix and lower royalty rates.
• Increased net income and earnings per share compared to the same period last year.

• Lower sales in the diabetes franchise due to competitive pressures and pricing.
• Decline in Lagevrio sales due to lower demand in certain markets.
• Decreased sales of Bridion due to generic competition in the EU.
• Lower sales of RotaTeq due to inventory stocking in the prior year and public sector buying patterns.
• Pneumovax 23 sales declined due to market shift towards newer vaccines.
• Animal Health segment profits declined due to higher production costs and increased administrative and promotional costs.
• The company incurred a $656 million charge to research and development expenses related to the acquisition of Harpoon Therapeutics.

• Global efforts toward healthcare cost containment continue to exert pressure on product pricing and market access.
• The Inflation Reduction Act (IRA) will impact drug pricing and coverage under Medicare, including government price-setting for certain drugs.
• The company faces generic competition for several products, including Bridion and Januvia/Janumet.
• The company is involved in various legal proceedings, including product liability and intellectual property lawsuits.
• The company is subject to ongoing inquiries from governmental agencies in China and other markets.
• The company is exposed to foreign exchange rate fluctuations, which can impact sales and profits.

The company anticipates that global efforts toward healthcare cost containment and the Inflation Reduction Act will negatively affect sales and profits. The company expects to record charges of approximately $800 million in 2024 related to the 2024 Restructuring Program and anticipates the actions under the 2024 Restructuring Program will result in cumulative annual net cost savings of approximately $750 million by the end of 2031. The company anticipates pricing and volume declines for Januvia and Janumet in the U.S. for the remainder of 2024.

• Management believes non-GAAP measures enhance investors understanding of the Companys results.
• Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics.
• Senior management receives a monthly analysis of operating results that includes a non-GAAP EPS metric.
• Annual employee compensation, including senior managements compensation, is derived in part using a non-GAAP pretax income metric.

The pharmaceutical industry is facing increasing pressure on drug pricing and market access due to global healthcare cost containment efforts and government regulations. The Inflation Reduction Act in the U.S. is a significant development that will impact how drugs are covered and paid for under Medicare. The industry is also seeing increased competition from generic manufacturers, which is impacting sales of branded drugs. Merck's focus on oncology and vaccines aligns with areas of high growth potential in the pharmaceutical market.

• Merck's 9% sales growth is strong compared to the industry average, which is facing pricing pressures and generic competition.
• The 20% growth in Keytruda sales is a standout performance, indicating the drug's continued dominance in the oncology market.
• The company's investment in research and development, despite a decrease in expenses this quarter, is consistent with industry trends of focusing on innovation.
• The restructuring program is a common strategy among large pharmaceutical companies to optimize operations and reduce costs.
• The acquisition of Harpoon Therapeutics is a strategic move to expand Merck's pipeline in the immunotherapy space, which is a key area of growth in the industry.
• The company's collaboration agreements with other pharmaceutical companies are also a common practice in the industry to share development costs and risks.

• Shareholders will benefit from the increased profitability and strong sales growth.
• Employees may be affected by the restructuring program, which includes headcount reductions.
• Customers will benefit from the continued availability of innovative medicines and vaccines.
• Suppliers may be impacted by changes in the company's manufacturing network.
• Creditors will be impacted by the company's debt management and cash flow.

• Continue to monitor the impact of the Inflation Reduction Act on drug pricing and coverage.
• Focus on the launch of new indications for Keytruda and other key products.
• Implement the new restructuring program to optimize operations and reduce costs.
• Integrate the acquired aqua business of Elanco Animal Health.
• Continue to defend intellectual property rights against generic competition.
• Advance the clinical development pipeline, including regulatory submissions for key candidates.

• Merck is a defendant in product liability lawsuits related to Dr. Scholls foot powder and Gardasil/Gardasil 9.
• The company is involved in ongoing antitrust litigation related to Zetia.
• The company is defending its patents against generic manufacturers for products like Bridion, Januvia, and Lynparza.
• Merck is in a legal dispute with The Johns Hopkins University regarding patents related to Keytruda.

• Merck has various collaborative arrangements with companies such as AstraZeneca, Eisai, Bayer, Ridgeback Biotherapeutics, Daiichi Sankyo, Moderna, and Bristol-Myers Squibb, which involve shared development costs, profit sharing, and royalty payments.
• Merck has manufacturing and supply agreements with Organon & Co. related to the spin-off of Organon.

• January 1, 2024: The statutory cap on rebates drug manufacturers pay to Medicaid was eliminated.
• January 2024: Merck approved a new restructuring program.
• January 2024: Merck's Board of Directors declared a quarterly dividend of $0.77 per share for the first quarter of 2024.
• February 2024: Merck entered into a definitive agreement to acquire the aqua business of Elanco Animal Health Incorporated.
• March 2024: Merck acquired Harpoon Therapeutics, Inc.
• March 2024: Merck's $750 million, 2.90% notes matured and were repaid.
• April 2024: Merck's Board of Directors declared a quarterly dividend of $0.77 per share for the second quarter of 2024.
• April 2024: Merck notified Kelun-Biotech it was terminating an additional candidate under their agreement.
• May 1, 2024: Date of the company's research pipeline update.
• May 3, 2024: Date of the filing of the 10-Q report.
• June 17, 2024: FDA PDUFA date for V116.
• June 21, 2024: FDA PDUFA date for Keytruda supplemental BLA for endometrial carcinoma.
• June 26, 2024: FDA PDUFA date for MK-1022 (patritumab deruxtecan).
• October 1, 2024: Merck's marketing rights for Simponi and Remicade revert to Johnson & Johnson Innovative Medicine.
• October 2024: Continuation payment of $750 million related to patritumab deruxtecan due from Merck to Daiichi Sankyo.
• October 2025: Continuation payment of $750 million related to raludotatug deruxtecan due from Merck to Daiichi Sankyo.
• May 2026: Expected loss of market exclusivity for Januvia and Janumet in the U.S.
• July 2026: Expected loss of market exclusivity for Janumet XR in the U.S.
• January 1, 2026: Government price-setting for certain Medicare Part D drugs becomes effective.
• January 2026: Generic companies can bring their generic versions of Bridion to the market.
• January 27, 2026: Merck's U.S. patent protection for Bridion through at least this date.
• January 2028: Government price-setting for certain Medicare Part B drugs becomes effective.
• December 2028: Merck's royalty payment on sales of Gardasil/Gardasil 9 in the U.S. to one third party expires.
• End of 2031: The actions contemplated under the 2024 Restructuring Program are expected to be substantially completed.