Keytruda's dominance stems from its broad clinical data across 40 different cancer indications, making it difficult for insurance companies to substitute it with other drugs lacking similar data breadth.
Keytruda's patent expiration in 2028 could lead to significant revenue erosion, potentially closer to the Humira scenario where revenue was sustained post-expiration due to the difficulty in copying biologics like Keytruda.
Merck uses a family of patents including formulation and process patents to extend the life of Keytruda beyond the primary IP expiration, leveraging multiple layers of protection.
Merck's structure is divided into R&D and commercial arms, with a handoff from R&D to commercial once a drug is approved, though Keytruda's continuous clinical trials require parallel activity in both.
Merck's growth drivers include the acquisition of drugs like Sotatercept for pulmonary arterial hypertension, advancements in autoimmune diseases like ulcerative colitis, and new cancer therapies using antibody drug conjugates.
Merck's success is tied to the effective partnership between the CEO and the chief of R&D, exemplified by the relationship between Ken Frazier and Roger Perlmutter, which was crucial for the development and execution of Keytruda.
Other pharma companies can learn the importance of a differentiated offering with broad clinical data, effective R&D execution, and strategic diversification to mitigate risks associated with patent expirations.
Keytruda's list price is $191,000, while the manufacturing cost is approximately $19,000, highlighting the high gross margins in the pharmaceutical industry.
Clinical trial execution is crucial for Merck's success, as seen with Keytruda, where Merck executed its clinical development faster and more effectively than competitors, leading to market dominance.
Merck has increasingly relied on acquisitions to fill its R&D pipeline, with nearly 70-80% of its upcoming drugs being acquired from other companies, reflecting a shift towards external R&D.
This is Zack Fuss. Today we are breaking down Merck, one of the world's largest and oldest pharmaceutical companies. The company has been shaping medicine and fostering innovation for over 130 years. From its humble beginnings as a small family pharmacy in Germany, today's iteration of Merck has transformed into a nearly $300 billion market cap business with particular strength in oncology.
At the heart of Merck's recent success is Keytruda, arguably the world's most important cancer drug. This single medication now generates over $25 billion in annual revenue. But, Merck's story is not only about Keytruda, it's about a company that's consistently pursued innovative science, combined with a handful of bold decisions, which resulted in the development of some of the world's first vaccines and breakthroughs in diabetes treatment.
To break down Merck, I am joined by Ashwin Varma, who is currently a medical student at UT Health San Antonio. We unpack Merck's business model, explore its industry-leading oncology franchise, and examine its pipeline of future drugs, and understand how they have navigated the complex world of pharmaceutical patents and regulation. Please enjoy this Breakdown on Merck.
For the full show notes, transcript, and links to the best content to learn more, check out the episode page here.)
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Business Breakdowns is a property of Colossus, LLC. For more episodes of Business Breakdowns, visit joincolossus.com/episodes).
Editing and post-production work for this episode was provided by The Podcast Consultant (https://thepodcastconsultant.com)).
Show Notes
(00:00:00) Welcome to Business Breakdowns
(00:05:50) History and Evolution of Merck
(00:08:32) Merck's Blockbuster Era and Challenges
(00:10:51) Understanding the Pharma Industry
(00:15:32) Merck's Current Business and Financials
(00:20:48) Patent Protection and R&D Strategies
(00:35:00) Checkpoint Inhibitors: A Breakthrough in Cancer Treatment
(00:35:54) The Rise of Keytruda: From Trials to Triumph
(00:37:56) Keytruda's Expanding Indications and Market Impact
(00:39:56) Understanding Cancer Therapy Lines
(00:42:09) Keytruda's Competitive Landscape and Future Challenges
(00:46:33) Merck's Strategy for Post-Patent Success
(00:57:41) Leadership and Organizational Structure at Merck
(01:04:01) Lessons from breaking down Merck