RocheRoche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has entered into a definitive merger agreement to acquire 89bio, Inc. (Nasdaq: 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 (F2 and F3 stages) as well as cirrhotic patients (F4 stage). The transaction is expected to close in the fourth quarter of 2025.

This acquisition underscores Roche’s dedication to advancing innovative therapies in cardiovascular, renal, and metabolic diseases (CVRM), 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.

"This acquisition further strengthens our portfolio in cardiovascular, renal, and metabolic diseases and offers opportunities to explore combinations with existing programmes in our pipeline," said Thomas Schinecker, Roche Group CEO. "We are highly encouraged by pegozafermin’s potential to become a transformative treatment option in MASH, one of the most prevalent comorbidities of obesity, and to meet diverse patient needs associated with this complex disease. With its combined anti-fibrotic and anti-inflammatory mechanism, pegozafermin could potentially offer best-in-disease efficacy for all moderate to severe MASH patients."

89bio’s pegozafermin is a glycoPEGylated analog of fibroblast growth factor 21 (FGF21) specifically designed to address critical unmet needs in MASH. With its anti-fibrotic and anti-inflammatory mechanism of action combined with a favourable safety profile, pegozafermin is positioned to potentially deliver best-in-disease efficacy for patients suffering from moderate to severe liver fibrosis (F2/F3 stages) and cirrhotic MASH (F4 stage).

Current 89bio employees will join the Roche Group as part of Roche’s Pharmaceuticals Division.

Terms of the Agreement

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 US$14.50 per share in cash at closing, plus a non-tradeable CVR to receive certain milestone payments of up to an aggregate of US$6.00 per share in cash, representing a total equity value of approximately US$2.4 billion at closing and representing a total deal value of up to US$3.5 billion. The price payable at closing represents a premium of approximately 52% to 89bio’s 60-day VWAP price on 17 September 2025. 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 US$14.50 per share in cash, plus a non-tradeable CVR to receive certain milestone payments of up to an aggregate of US$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:

1. US$2.00 per share in cash, upon the first commercial sale of pegozafermin in F4 MASH cirrhotic patients (by March 31, 2030)
2. US$1.50 per share in cash, upon pegozafermin reaching annual net sales globally of at least US$3.0 billion in any calendar year (by December 31, 2033)
3. US$2.50 per share in cash, upon pegozafermin reaching annual net sales globally of at least US$4.0 billion 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 US$1.0 billion 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.

Citi is acting as exclusive financial advisor to Roche and Sidley Austin LLP is acting as legal counsel to Roche. Moelis & Company LLC and Centerview Partners LLC are serving as financial advisors to 89bio and Gibson, Dunn & Crutcher LLP is serving as legal counsel.

About Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Metabolic Dysfunction-Associated Steatohepatitis (MASH), a serious and increasingly prevalent form of fatty liver disease, is strongly associated with the global rise in obesity and type 2 diabetes.(1) It is estimated that 5 - 7% of the world’s adult population is affected by MASH1, and more than 75% of those living with the condition experience comorbidities such as overweight, obesity, and type 2 diabetes.(2) MASH is progressive and, when left untreated, can progress to cirrhosis, liver decompensation, and even to hepatocellular carcinoma.

About 89bio

89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The Company is in Phase 3 trials for its lead candidate, 89bio’s pegozafermin, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis, including patients with compensated cirrhosis, and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco.

About Roche

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

1. Diabetes Care 2025;48(7):1057-1082
2. Front Cell Dev Biol. 2024 Jul 16;12:1433857. Doi: 10.3389/fcell.2024.1433857