No bad stock

Merck & Co., Inc.
CEO : Mr. Robert M. Davis J.D.

Quarterly earnings growth(YoY,%)

Period	Revenue	Operating Income	EPS	Release Date
2022 Q4	2.3% YoY	-7.0%	-20.1%	2023-02-02

Dr. Dean Li says,

Updates on Oncology Therapies

• KEYTRUDA approved for adjuvant treatment of non-small cell lung cancer
• Positive results from Phase 2 trials for V940/mRNA-4157 in combination with KEYTRUDA for Stage III and IV melanoma
• Positive results from Phase 3 KEYNOTE-966 trial for biliary tract cancer
• Positive topline results from Phase 3 KEYNOTE-859 trial for gastric or gastro-esophageal junction adenocarcinoma
• Acquisition of Imago Biosciences and focus on advancing the clinical development programs

Regulatory Approvals and Collaborations

• Approval of Lynparza in combination with abiraterone and prednisone in the European Union
• Approval of KEYTRUDA in neoadjuvant/adjuvant high-risk, early-stage triple negative breast cancer and hepatocellular carcinoma in China
• FDA acceptance of supplemental biologics license applications for KEYTRUDA with PADCEV for the first-line treatment of certain patients with locally advanced or metastatic urothelial cancer
• Expansion of collaboration with Kelun Biotech for preclinical antibody drug conjugates
• Expansion of collaboration with PeptiDream for the discovery and development of peptide drug conjugates

Updates on Vaccines

• Positive Phase 3 results for a single dose dengue vaccine candidate for registration in Brazil
• Launch of VAXNEUVANCE for the prevention of pneumococcal disease in the pediatric setting
• On track for Phase 3 results from V116 program for the protection of adults
• GARDASIL continues to play a role in preventing certain HPV-related cervical cancers

COVID-19 Treatment

• Conditional marketing authorization granted in China for LAGEVRIO for adult patients with mild to moderate COVID-19 infection and a high risk of progressing to severe cases

Updates on Cardiovascular Therapies

• Upcoming presentation of detailed findings of Phase 3 STELLAR trial evaluating sotatercept in patients with pulmonary arterial hypertension at the American College of Cardiology in conjunction with the World Congress of Cardiology meeting in New Orleans
• Live investor event to answer questions about sotatercept
• Submission of data from the STELLAR trial to the FDA on a rolling basis likely to result in potential approval in early 2024

Rob Davis says,

Merck’s Strong Performance and Growth

• Merck had an exceptional year in 2022, with a sustained track record of fundamental strength from de-risked growth pillars.
• In 2023, Merck is confident in maintaining strong underlying growth, following the significant impact of LAGEVRIO during the pandemic’s height last year.
• The pipeline is advancing with significant progress across several late-stage programs, including Oncology, Cardiovascular, and Vaccines.
• Merck made substantial progress in Cardiovascular research, with candidates across a broad range of diseases, and in Oncology, with expansive research efforts, including moving treatment into earlier stage settings.

Positive Clinical Data

• Merck and Moderna announced highly encouraging Phase 2 results for a personalized mRNA therapeutic cancer vaccine in combination with KEYTRUDA in treating adjuvant melanoma.
• Last week, Merck received FDA approval for KEYTRUDA for treating certain patients with early-stage non-small cell lung cancer.
• Instituto Butantan reported very encouraging topline results for their candidate for the prevention of dengue, which will inform future development of Merck’s dengue vaccine, V181.
• Data from the STELLAR trial evaluating sotatercept in pulmonary arterial hypertension and the Phase 2 trial of MK-0616, Merck’s oral PCSK9 inhibitor, will be presented at the American College of Cardiology conference.

New Programs and Business Development

• Merck brought in four programs through business development efforts, which will have phase three trial starts in 2023 and have the potential to contribute meaningful growth during the latter half of this decade and into the next.
• Merck follows a disciplined approach to business development and acts when scientific opportunity and value align.

Sustainability and Long-Term Outlook

• Merck is building an innovation engine and confident in its ability to deliver sustainable value for patients well into the next decade.
• Merck is following an approach to sustainability closely aligned with its overall business strategy.

Q & A sessions,

Addressable patient population for lung cancer

• Only about 30,000 patients would be the addressable population for KEYTRUDA in the early-stage setting of lung cancer.
• Historically, only about half of those patients have gone on to receive treatment in the form of chemotherapy or IO, which is something they hope to change as they think the outcome will show that if resected, patients should pursue KEYTRUDA in that setting.

KEYTRUDA’s loss of exclusivity (LOE)

• KEYTRUDA and their expectation will lose exclusivity in the United States and China in 2028, in Europe in 2030, and in Japan in 2032.
• The company is confident that they are on a path to sustainable growth into the next decade and are doing a lot to bring incremental value to patients on KEYTRUDA.

Progress on cardiovascular pipeline and business development deals

• They have made a lot of progress in their cardiovascular pipeline and expect those products, that portfolio of opportunity on an unrisk adjusted basis to be in excess of $10 billion as you approach the mid-2030s.
• The company has brought in new assets apart from KEYTRUDA, Lynparza, Lenvima, and WELIREG, that have the potential for $10 billion or more of revenue as you get into the early to mid-2030s.

Importance of improving adherence to established guidelines for lung cancer screening

• Established guidelines currently only have 6% or so of individuals actually who should be screened in the United States.
• Company needs to do a lot to improve adherence to established guidelines to make the treatment broadly available to individuals who should be getting screened.

Future plans for personalized neoantigen therapy and IO-IO strategy with KEYTRUDA

• Currently, the personalized cancer vaccine is being studied in melanoma, but there is potential to move into broader tumors.
• IO-IO strategies may be especially useful in early cancer stages, and the company is interested in pursuing personalized neoantigen therapy as an IO-IO strategy with KEYTRUDA.