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Roche Finalizes Merger Agreement to Acquire 89bio

Roche (RHHBY) announced that it has entered into a definitive merger agreement to acquire 89bio (ETNB), a publicly listed clinical-stage biopharmaceutical company pioneering the development of innovative therapies for the treatment of liver and cardiometabolic diseases. 89bio's pegozafermin is a FGF21 analog currently in late-stage development for MASH in moderate and severe fibrotic patients as well as cirrhotic patients. The transaction is expected to close in the fourth quarter of 2025. Current 89bio employees will join the Roche Group as part of Roche's Pharmaceuticals Division. Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all of the outstanding shares of 89bio common stock at a price of $14.50 per share in cash at closing, plus a non-tradeable CVR to receive certain milestone payments of up to an aggregate of $6.00 per share in cash, representing a total equity value of approximately $2.4B at closing and representing a total deal value of up to $3.5B. The price payable at closing represents a premium of approximately 52% to 89bio's 60-day VWAP price on September 17. The merger agreement has been unanimously approved by the boards of Roche and 89bio. 89bio will file a recommendation statement containing the unanimous recommendation of the 89bio board that 89bio's stockholders tender their shares pursuant to the tender offer. Following the completion of the tender offer, Roche will acquire all remaining shares at the same price of $14.50 per share in cash, plus a non-tradeable CVR to receive certain milestone payments of up to an aggregate of $6.00 per share in cash, through a second-step merger. Each non-tradeable CVR will entitle its holders to receive the following contingent cash payments, conditioned upon the achievement of certain commercial milestones, within specified time periods: $2.00 per share in cash, upon the first commercial sale of pegozafermin in F4 MASH cirrhotic patients (by March 31, 2030); $1.50 per share in cash, upon pegozafermin reaching annual net sales globally of at least $3.0B in any calendar year (by December 31, 2033); $2.50 per share in cash, upon pegozafermin reaching annual net sales globally of at least $4.0B in any calendar year (by December 31, 2035). There can be no assurance that any payments will be made with respect to the CVR. Assuming all of the conditions of the CVR are met, this would represent additional cash consideration of up to approximately $1.0B for 89bio's stockholders. The transaction is expected to close in the fourth quarter of 2025. It is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of 89bio's common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. "This acquisition underscores Roche's dedication to advancing innovative therapies in cardiovascular, renal, and metabolic diseases, especially for patients affected by overweight, obesity, and related health challenges such as MASH. Pegozafermin offers a distinct mechanism of action that not only holds the potential for enhanced efficacy and tolerability but also unlocks opportunities for future combination development with incretins, creating synergies with Roche's CVRM portfolio. Acquiring 89bio, therefore, fosters Roche's activities to build a robust and differentiated pipeline that targets additional causes of metabolic disease," the company stated.

89bio reports Q2 EPS (71c), consensus (48c)

As of June 30, 89bio had cash, cash equivalents, and marketable securities of approximately $561.2M. "As we enter the second half of 2025, we remain diligently focused on execution across our three global Phase 3 trials for pegozafermin in MASH and SHTG. In SHTG, we continue to expect topline data from our Phase 3 ENTRUST trial in the first quarter of 2026. In MASH, we expect topline histology data from ENLIGHTEN-Fibrosis in the first half of 2027, and ENLIGHTEN-Cirrhosis in 2028, underpinning our accelerated-approval filings for patients with F2-F3 and F4 MASH, respectively. As our clinical development program in MASH continues to progress, we believe pegozafermin is poised to potentially deliver best-in-class relative risk ratio on histology endpoints, a favorable safety and tolerability profile, and a convenient dosing approach to the large and underserved MASH patient population," said Rohan Palekar, Chief Executive Officer of 89bio.