Pegozafermin

iStock, nndanko Regulatory documents show how 89bio’s board pushed Roche hard for a deal valued at $20 per share in upfront and milestone payments. The success of Akero Therapeutics’ liver disease drug brought Roche to 89bio’s yard looking to make a deal. While Roche and 89bio had been in communication for several years, it was the success of Akero’s efruxifermin in a Phase IIb trial for metabolic dysfunction-associated steatohepatitis (MASH) that kicked Roche’s interest in an acquisition into high gear. This detail, along with a timeline of how the purchase played out, was revealed in regulatory documents released October 1 regarding Roche’s $3.5 billion acquisition of 89bio . There were as many as six companies closely watching 89bio’s progress over the years, with an eye to a potential transaction someday. Efruxifermin reduced liver fibrosis by 24% compared to placebo in the mid-stage SYMMETRY trial, Akero reported in January. According to the regulatory documents, this development “heightened industry focus on the FGF21 class of therapeutics.” Roche then went to 89bio suggesting that the results had readthrough to the rest of the class of therapies—such as 89bio’s other FGF21 analog pegozafermin for MASH. Over the months that followed, Roche conducted due diligence, including manufacturing site visits. At the same time, three other companies were seeking more information on 89bio’s programs, too. In March, Roche suggested to 89bio a licensing deal for pegozafermin and offered to pause the ongoing diligence efforts to begin focusing on a manufacturing strategy for pegozafermin . The companies agreed and discussions on a manufacturing deal began. In June, 89bio suggested via a financial advisor that a buyout would be preferred to a collaboration agreement. CEO Rohan Palekar reiterated this in person to Roche’s Head of M&A Marc Buser at an unnamed conference in Europe later in the month. The suggestion worked, and in early July, Roche offered to buy the biotech for $13 per share in cash. At the time, 89bio’s share price was $10.22. Palekar rejected the first offer and expressed his confidence in 89bio’s ability to go it alone on developing pegozafermin. Roche was still set to conduct some manufacturing site visits later that month, which Palekar hoped might spur a higher bid. Meanwhile, advisors for 89bio reached out to five other potential companies to see if they might want to make a deal. None were interested. Palekar then suggested to Roche that a per share price “in the twenties may be more amenable,” according to the documents. Roche countered on July 30 with an offer of $14 per share plus a contingent value right of $2 per share after the first sale of pegozafermin for stage 4 MASH as long as that occurs by December 31, 2029. 89bio’s share price was sitting at $9.53 at this time. Palekar’s suggested price was reiterated to Roche’s Buser, but advisors for Roche said there was “minimal further room on the upfront portion of the offer.” But 89bio’s board wanted more. They voted to reject the proposal and push for a larger upfront payment and an even greater prospect in the CVR value. Again, the board suggested that the deal would need to have a value of about $20 per share altogether. In late August, Roche revised the proposal to $14.50 per share upfront, followed by three CVR triggering regulatory and clinical milestones that totaled $5, bringing the deal just shy of the $20 goal. Roche indicated that the upfront was as high as they would go, but expressed openness to discussing the CVR package. 89bio’s board rejected the offer, still seeking more upfront and at least 50 cents more for each CVR. Roche presented its “best and final” offer on August 29: $14.50 per share in cash upfront, plus CVRs of $2 upon the first sale of pegozafermin by March 31, 2030; $1.50 upon the achievement of $3 billion in annual global sales by December 31, 2033; and $2.50 at $4 billion in sales by December 31, 2035. At the time, 89bio was trading at $9.03. This brought the total consideration to $20.50 per share. After much legal back and forth, the deal was announced on September 18. 89bio’s shares closed at $14.96 that day.

– 89bio stockholders to receive up to $20.50 per share in cash, comprised of $14.50 per share in cash at closing and a non-tradeable contingent value right (CVR) to receive up to an aggregate of $6.00 per share in cash; transaction represents total equity value of up to approximately $3.5 billion – – Transaction reflects pegozafermin’s potential best-in-disease profile for the treatment of moderate to severe metabolic dysfunction-associated steatohepatitis (MASH) – – 89bio to join the Roche Group as part of Roche’s Pharmaceuticals Division – Sept. 17, 2025 -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that it has entered into a merger agreement to be acquired by Roche at a price of $14.50 per share in cash at closing, representing a premium of approximately 79% to 89bio’s closing stock price on September 17, 2025, the last trading day before the announcement of the transaction, and a premium of 52% to 89bio’s 60-day volume-weighted average price (VWAP). In addition, 89bio stockholders will receive a non-tradeable CVR to receive certain contingent payments of up to an aggregate of $6.00 per share in cash upon achievement of specified milestones, for a total transaction equity value of up to approximately $3.5 billion on a fully diluted basis. The merger agreement has been unanimously approved by 89bio’s Board of Directors, and 89bio’s Board of Directors unanimously recommends that 89bio stockholders tender their shares in the tender offer. “Our mission at 89bio has always been to develop innovative therapies to help patients with serious liver and cardiometabolic diseases, a commitment demonstrated by the strategic design and successful execution of the development program for pegozafermin over the years,” said Rohan Palekar, Chief Executive Officer of 89bio. “We are thrilled to be joining with Roche to combine the promise of pegozafermin with Roche’s established global development, manufacturing, and commercialization capabilities, to accelerate and maximize potential benefit for patients in need and unlock significant shareholder value. I am tremendously proud of the entire team at 89bio and would like to express my deepest thanks and gratitude to them, our Board, investigators, clinical trial participants, numerous vendors, and MASH and SHTG communities for helping us reach this pivotal moment.” “We are excited about this agreement and to further develop this promising therapy, which we hope will provide people with moderate to severe MASH a new treatment option,” said Boris L. Zaïtra, Head of Roche Corporate Business Development. “By adding pegozafermin to our cardiovascular, renal, and metabolism portfolio and with our Diagnostics expertise in cardiovascular and metabolic diseases, we are aiming to transform the standard of care and positively impact patients' lives.” Under the terms of the merger agreement, an affiliate of Roche will commence a tender offer to acquire all of 89bio’s outstanding shares for a price of $14.50 per share in cash at closing, representing an aggregate payment of $2.4 billion. In addition, 89bio's stockholders will receive a non-tradeable CVR to receive up to an aggregate of $6.00 per share in cash, for a total transaction equity value of up to approximately $3.5 billion on a fully diluted basis. Each non-tradeable CVR will entitle its holders to receive the following contingent cash payments, conditioned upon the achievement of certain 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 US $3.0 billion in any calendar year (by December 31, 2033) $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) The closing of the transaction is subject to customary closing conditions, including the tender of shares representing at least a majority of 89bio’s outstanding shares (other than shares held by 89bio, Roche or any of their respective subsidiaries, and any dissenting shares), the completion of regulatory review and other customary closing conditions. Upon the successful completion of the tender offer, Roche will acquire all remaining 89bio shares that are not tendered into the tender offer through a second-step merger at the same price of $14.50 per share in cash at closing, plus a non-tradeable CVR to receive up to an aggregate of $6.00 per share in cash, payable upon achievement of the specified milestones. The closing of the transaction is currently expected to take place in the fourth quarter of 2025, subject to satisfaction of the closing conditions described above. Until that time, 89bio will continue to operate as a separate and independent company. Moelis & Company LLC and Centerview Partners LLC are serving as financial advisors to 89bio and Gibson, Dunn & Crutcher LLP is serving as legal counsel to 89bio. Citi is acting as financial advisor to Roche and Sidley Austin LLP is acting as legal counsel to Roche. 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, 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. The tender offer described in this communication has not yet commenced. This communication is for information purposes only and is neither an offer to buy nor a solicitation of an offer to sell any securities of 89bio, Inc. (“89bio”), nor is it a substitute for the tender offer materials that Roche Holdings, Inc. (“Roche”) and its wholly owned acquisition subsidiary, Bluefin Merger Subsidiary, Inc. (“Merger Sub”), will file with the Securities and Exchange Commission (the “SEC”). The solicitation and the offer to buy shares of 89bio’s common stock will only be made pursuant to a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials that Roche and Merger Sub intend to file with the SEC. In addition, 89bio will file with the SEC a Solicitation/ Recommendation Statement on Schedule 14D-9 with respect to the tender offer. The content above comes from the network. if any infringement, please contact us to modify.