8-K: Merck Reports Strong Second Quarter 2024 Results Driven by Keytruda and Vaccine Growth
Summary
- Merck's total worldwide sales for the second quarter of 2024 were $16.1 billion, a 7% increase compared to the same period in 2023, or 11% excluding foreign exchange impacts.
- Keytruda sales grew by 16% to $7.3 billion, or 21% excluding foreign exchange impacts, driven by increased global uptake in earlier-stage indications.
- GAAP earnings per share (EPS) was $2.14, while non-GAAP EPS was $2.28.
- The company successfully launched WINREVAIR in the U.S. and received a positive EU CHMP opinion for adults with PAH.
- Merck achieved key milestones in vaccine programs, including FDA approval and CDC recommendation for CAPVAXIVE.
- The company completed the acquisitions of EyeBio and Elanco's aqua business in July 2024.
- Merck has raised and narrowed its full-year 2024 worldwide sales outlook to between $63.4 billion and $64.4 billion.
- The company now expects non-GAAP EPS to be between $7.94 and $8.04, reflecting a negative impact from a one-time charge of approximately $1.3 billion for the acquisition of EyeBio.
Sentiment
Score: 6
Explanation: The sentiment is moderately positive due to strong sales growth and pipeline progress, but tempered by the reduced EPS outlook and negative impacts from foreign exchange and some product declines.
Positives
- Strong sales growth driven by Keytruda and vaccines.
- Successful launch of WINREVAIR in the U.S.
- Positive regulatory milestones for CAPVAXIVE and WINREVAIR.
- Completion of strategic acquisitions of EyeBio and Elanco's aqua business.
- Raised and narrowed full-year sales outlook.
- Positive results from Phase 2b/3 trial of clesrovimab, an investigational RSV preventative monoclonal antibody for infants.
Negatives
- The full-year non-GAAP EPS outlook was lowered due to a one-time charge of approximately $1.3 billion, or $0.51 per share, for the acquisition of EyeBio.
- The company experienced a negative impact from foreign exchange, particularly due to the devaluation of the Argentine peso.
- Sales of JANUVIA/JANUMET declined by 27% due to lower pricing and demand.
- LAGEVRIO sales declined by 46% due to lower demand and pricing in certain markets.
- Non-GAAP EPS outlook includes a negative impact of foreign exchange of more than $0.30 per share.
Risks
- The company faces risks related to currency exchange rate fluctuations, particularly the devaluation of the Argentine peso.
- There are risks associated with the development and regulatory approval of pipeline candidates.
- The company is exposed to competition from other pharmaceutical companies.
- The company is subject to the impact of pharmaceutical industry regulation and healthcare legislation.
- There are risks related to manufacturing difficulties or delays.
Future Outlook
Merck has raised and narrowed its full-year 2024 sales outlook and now expects non-GAAP EPS to be between $7.94 and $8.04, reflecting the impact of recent acquisitions and foreign exchange.
Management Comments
- Our business is demonstrating strong momentum as we exit the first half of the year, said Robert M. Davis, chairman and chief executive officer, Merck.
- Through excellent scientific, commercial and operational execution, were achieving significant milestones for our company and for patients, including the launch of WINREVAIR.
- I am proud of our dedicated teams around the world that are working tirelessly to advance our deep pipeline as we continue delivering innovation that solves unmet medical needs.
Industry Context
The results reflect the ongoing demand for oncology and vaccine products, and the company's strategic focus on acquisitions to expand its pipeline and market presence. The launch of WINREVAIR and the progress in vaccine programs highlight the company's commitment to innovation in key therapeutic areas.
Comparison to Industry Standards
- Merck's 16% growth in Keytruda sales is strong compared to other major oncology players, such as Bristol Myers Squibb and Roche, who have also reported growth in their oncology portfolios, but not at the same rate for a single product.
- The successful launch of WINREVAIR positions Merck as a leader in the treatment of pulmonary arterial hypertension, a space where competitors like United Therapeutics also operate, but with different mechanisms of action.
- The FDA approval and CDC recommendation for CAPVAXIVE places Merck ahead of competitors like Pfizer and GSK in the pneumococcal vaccine market, as it is the first vaccine specifically designed to address the serotypes responsible for approximately 85% of invasive pneumococcal disease cases in adults age 65 and older.
- Merck's overall revenue growth of 7% is in line with the average growth of large pharmaceutical companies, but the 11% growth excluding foreign exchange is above average.
- The company's non-GAAP EPS of $2.28 is competitive, but the reduction in the full-year outlook due to the EyeBio acquisition highlights the impact of strategic acquisitions on short-term profitability.
Stakeholder Impact
- Shareholders may experience short-term volatility due to the reduced EPS outlook, but long-term growth prospects remain positive.
- Employees may benefit from the company's continued growth and strategic acquisitions.
- Patients will have access to new treatment options with the launch of WINREVAIR and the development of new vaccines.
- Suppliers and partners may see increased business opportunities due to the company's expansion.
Next Steps
- Continue the global launch of WINREVAIR.
- Advance the development of clesrovimab for RSV prevention in infants.
- Pursue regulatory approvals for KEYTRUDA in new indications.
- Integrate the acquired businesses of EyeBio and Elanco's aqua business.
- Monitor and manage the impact of foreign exchange fluctuations.
Key Dates
- 2024-07-30: Date of the earnings report and 8-K filing.
Keywords
Filings with Classifications
Quarterly Report
- The company has experienced manufacturing delays related to ProQuad and Varivax, and anticipates that some international markets will experience supply constraints during 2025.
Quarterly Report
- Worldwide sales were down 2% year over year.
- Gardasil/Gardasil 9 sales declined significantly by 41% due to lower demand in China.
- Lagevrio sales decreased by 71% due to lower demand in the Asia Pacific region.
Quarterly Report
- Total worldwide sales decreased by 2% compared to the first quarter of 2024.
- The full-year 2025 non-GAAP EPS outlook was revised to reflect a negative impact from an anticipated one-time charge of approximately $0.06 per share related to the license agreement with Hengrui Pharma.
Annual Results
- The company expects a significant decline in Gardasil/Gardasil 9 sales in China for 2025.
- The company expects U.S. sales of Keytruda to decline beginning in January 2028 due to government pricing under the IRA.
Annual Results
- The company is currently experiencing manufacturing delays related to Varivax and ProQuad which will result in supply constraints in 2025.
Earnings Release
- The company's full year sales of $64.2 billion were better than the $60.115 billion in the prior year.
- The company's full year GAAP EPS of $6.74 was better than the $0.14 in the prior year.
- The company's full year Non-GAAP EPS of $7.65 was better than the $1.51 in the prior year.
SEC Form 4
- The performance shares were paid out at 169 percent of target awards, indicating that the company exceeded its performance goals during the three-year period.
SEC Form 4 Filing
- The performance shares were paid out at 169 percent of target awards, indicating that the company exceeded its performance goals.
SEC Form 4
- The performance shares were paid out at 169 percent of target awards, indicating better than expected performance.
SEC Form 4 Filing
- The performance shares were paid out at 169 percent of target awards, indicating better than expected performance.
SEC Form 4 Filing
- The performance shares were paid out at 169 percent of target awards, indicating better than expected performance.
SEC Form 4 Filing
- The performance shares were paid out at 169 percent of target awards, indicating better than expected performance.
SEC Form 4 Filing
- The performance shares were paid out at 169 percent of target awards, indicating better than expected performance.
SEC Form 4 Filing
- The performance shares were paid out at 169 percent of target awards, indicating better than expected performance.
SEC Form 4 Filing
- The performance shares were paid out at 169 percent of target awards, indicating better than expected performance.
Quarterly Report
- Merck is currently working to incorporate guidance from regulatory authorities into the company's clinical trial design for its two prospective Gardasil 9 single-dose trials, consequently, the trials will not be started in 2024.
Quarterly Report
- Net income attributable to Merck decreased in Q3 2024 compared to Q3 2023 due to significant acquisition charges and restructuring costs.
Quarterly Report
- The company's GAAP and non-GAAP EPS were lower than the previous year due to significant charges related to business development transactions.
Quarterly Report
- The company received a complete response letter from the FDA for patritumab deruxtecan due to manufacturing facility issues.
Quarterly Report
- The company's net income improved significantly compared to the same period last year, which had a net loss.
- The company's sales growth exceeded expectations, driven by strong performance in oncology and vaccines.
- The company's research and development expenses decreased due to lower charges for business development transactions.
Quarterly Report
- The full-year non-GAAP EPS outlook was lowered due to a one-time charge of approximately $1.3 billion, or $0.51 per share, for the acquisition of EyeBio.
Debt Issuance Announcement
- MSD Netherlands Capital B.V. raised $3.4 billion through the issuance of senior notes.
- The proceeds from the offering will be used for general corporate purposes.
Quarterly Report
- The company's sales and net income exceeded expectations due to strong performance in oncology and vaccines.
- Keytruda sales growth was higher than anticipated, driven by new indications and continued uptake.
- The company's gross margin improved due to favorable product mix and lower royalty rates.
Quarterly Report
- Merck's first quarter sales and earnings exceeded expectations, driven by strong growth in key products.
- The company raised and narrowed its full-year outlook, indicating increased confidence in future performance.
Annual Results
- The company experienced a significant decrease in net income from continuing operations, with GAAP net income at $365 million and non-GAAP net income at $3.837 billion, which is worse than the previous year.
- The company experienced a substantial decline in Lagevrio sales, which is worse than the previous year.
Quarterly Report
- The company reported a GAAP loss per share for the fourth quarter and a significantly lower EPS for the full year compared to the previous year, primarily due to charges related to collaborations and business development transactions.
- Non-GAAP EPS also declined significantly compared to the previous year, indicating a weaker financial performance despite excluding certain items.
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