Scott Gottlieb 3.0 13 ideas

"I think Lilly has a best in class drug with respect to Tirzepatide... Lilly has another drug behind Tirzepatide, Retatrutide... which may be even more effective." LLY is innovating faster than competitors. The upcoming "Triple G" agonist targets three receptors (GLP, GIP, Glucagon) and early data suggests it is superior to current options. This technological moat will allow LLY to capture dominant market share in the obesity space. LONG. Potential side effects from the triple-agonist mechanism; failure in Phase 3 trials.

"I would be surprised to see tariffs put back on the table with respect to the drugmakers, because a lot of the deals... specifically excluded tariffs being imposed on those companies." The market may be pricing in "Trump Trade" tariff risks across the board, but Big Pharma (like Pfizer, where Gottlieb is a board member) has regulatory immunity due to prior pricing agreements. This makes them a defensive play against trade war volatility. LONG. The administration reneges on verbal/written agreements regarding tariff exclusions.

"It certainly looks better in terms of overall efficacy than the Novo compounds." (Referring to LLY's portfolio). Novo Nordisk is losing its "best in class" status. As LLY releases data on Retatrutide (Triple G) and oral formulations, NVO's comparative efficacy disadvantage will pressure its valuation and market share. AVOID. LLY's new drugs fail safety trials, allowing NVO to retain duopoly status without superior competition.

Gottlieb cites a Wall Street Journal editorial noting FDA leader Vinay Prasad rejected Moderna's (MRNA) mRNA vaccine without a cursory review. This "arbitrary" regulatory behavior increases the cost of capital and unpredictability for the entire sector. Gottlieb notes investment in vaccines and cell/gene therapies is drying up in the US and shifting to China (where half of the global mRNA pipeline now sits). The regulatory environment in the US has become hostile to innovation, making the sector uninvestable in the medium term until leadership changes. A change in FDA administration or successful appeals by pharma companies could reverse sentiment.

Hims & Hers (HIMS) paused sales of its copycat weight-loss pill after the FDA and Novo Nordisk (NVO) threatened action. The stock dropped ~15.8%. Novo has filed a lawsuit seeking damages and a permanent ban. Gottlieb explains that HIMS claimed to use a "liposomal" delivery system to mimic Novo's patented oral absorption technology. If true, this technically makes it an "unapproved new drug," not just a compounded copy. The FDA referred the case directly to the DOJ, which is highly unusual; typically, the FDA sends a warning letter first. A DOJ referral implies the regulator is seeking an immediate injunction or seizure of products. Novo Nordisk spent ~$1.8B acquiring the specific technology to make oral semaglutide absorbable. HIMS attempted to bypass this with a novel formulation without going through the drug approval process. HIMS could theoretically settle, though Gottlieb views them as a "bad actor" unlikely to secure partnerships with big pharma.

Hims & Hers attempted to launch a compounded oral GLP-1 using a "liposomal" delivery system to bypass Novo Nordisk's patents. The FDA immediately referred the case to the DOJ, and Hims withdrew the product. Gottlieb argues this wasn't just compounding; by creating a new delivery mechanism to survive stomach acid, Hims effectively created an "unapproved new drug" which requires years of trials. The immediate referral to the DOJ (rather than a standard FDA warning letter) suggests regulators were preparing for a seizure or injunction. The Department of Health and Human Services (HHS) General Counsel made a rare, direct referral to the DOJ before the FDA even took enforcement action. Hims could pivot to standard compounding, though Gottlieb believes their reputation is damaged.

Novo Nordisk (NVO) and Eli Lilly (LLY) retain tight control over the GLP-1 market. Novo specifically spent ~$1.8B to acquire the "SNAC" technology that allows their oral drug to survive stomach acid. The regulatory crackdown on Hims validates the "moat" around Big Pharma's IP. While compounding exists, the incumbents will only partner with "compliant" telehealth platforms (like Ro) that respect regulatory boundaries, freezing out aggressive actors like Hims. Novo's patent on the absorption technology prevents generic oral versions from working effectively without infringing IP or triggering FDA "new drug" rules. Continued compounding of the *injectable* versions (which is legally distinct from the oral pill issue).

Investment capital is fleeing the vaccine research sector. Gottlieb notes that research into vaccines for Epstein-Barr Virus (EBV), MS, and cancer prevention is being pulled back. The political and regulatory environment has become hostile. It is increasingly difficult to get vaccines through the FDA due to policy changes, and even if approved, the CDC is showing reluctance to recommend them due to anti-vaccine sentiment. Gottlieb states that as a Venture Capital partner, he sees it is "very hard to get a new vaccine program funded" right now. A shift in political sentiment or a new public health crisis forcing a regulatory pivot.