What Relay Therapeutics, Inc. told the SEC could break it.

The third parties supplying Relay's active pharmaceutical ingredients (API), drug product, and starting materials for its product candidates are sole/single-source suppliers; loss of any could significantly harm the business.

“The third parties upon whom we rely for the supply of the active pharmaceutical ingredients, drug product and starting materials used in our product candidates are our sole source of supply, and the loss of any of these suppliers could significantly harm our business. The active pharmaceutical ingredients, or API, drug product and starting materials used in our product candidates are supplied to us primarily from single-source suppliers.”

Proposed CMS most-favored-nation drug-pricing models — GLOBE for Medicare Part B and GUARD for Part D — would mandate manufacturer rebates against international reference prices (GLOBE performance period beginning Oct 1, 2026; GUARD in 2027), potentially constraining pricing for Relay's future approved products.

“The second proposal, the Guarding U.S. Medicare Against Rising Drug Costs, or GUARD, model for Medicare Part D, would similarly mandate manufacturer rebates for qualifying sole source drugs where the Medicare net price exceeds an MFN benchmark derived from international reference pricing methodologies. As proposed, GLOBE would begin a five year performance period on October 1, 2026 and GUARD would begin its performance period in 2027.”