Mr. Roberto Bellini reports

GSK REACHES AGREEMENT TO ACQUIRE LATE-STAGE BIOPHARMACEUTICAL COMPANY BELLUS HEALTH

GSK PLC and Bellus Health Inc. have entered into an agreement under which GSK will acquire Bellus for $14.75 (U.S.) per share of common stock in cash, representing an approximate total equity value of $2-billion (U.S.) (1.6 billion pounds sterling). The acquisition provides GSK access to camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in phase III development for the first-line treatment of adult patients with refractory chronic cough (RCC).

It is estimated that 28 million patients suffer from chronic cough, with 10 million patients globally and six million in the United States and European Union suffering from RCC for over a year. RCC is defined as a persistent cough for more than eight weeks that does not respond to treatment for an underlying condition or is otherwise unexplained. RCC significantly impacts quality of life, with patients suffering from depression (53 per cent), urinary incontinence (approximately 50 per cent), pain, rib fractures, social withdrawal and loss of sleep. There are no approved medicines for RCC in the U.S. and EU.

P2X3 is a validated biological target implicated in cough reflex hypersensitization, and camlipixant is a highly selective P2X3 antagonist. Current clinical data show that by selectively inhibiting P2X3 receptors, camlipixant may reduce cough frequency for patients suffering from RCC with a relatively low incidence of dysgeusia, the taste disturbance adverse event associated with other medicines that broadly target the P2X2/3 receptor. These taste disturbances frequently lead to patients discontinuing treatment. Notably, low rates of taste-related adverse events were reported at all doses in the phase IIb trial.

Luke Miels, chief commercial officer, GSK, said: "Patients suffering from severe forms of refractory chronic cough can experience over 900 coughs daily, resulting in quality of life issues. Camlipixant, a novel, highly selective P2X3 antagonist, has the potential to be a best-in-class treatment with significant sales potential. This proposed acquisition complements our portfolio of specialty medicines and builds on our expertise in respiratory therapies."

The acquisition of Bellus is highly synergistic with GSK's expertise in respiratory medicines and is further supported by GSK's leading research and development, manufacturing, and commercialization capabilities.

Following the anticipated regulatory approval and launch of camlipixant in 2026, the acquisition is expected to be accretive to adjusted earnings per share from 2027 and has the potential to deliver significant sales through 2031 and beyond.

In December, 2021, Bellus announced positive data from the Soothe phase IIb trial, indicating that it met its primary end point for the 50-milligram and 200-milligram twice-daily doses. Based on these data, Bellus initiated the Calm phase III development program consisting of the CALM-1 and CALM-2 trials, with data anticipated in H2 2024 and 2025, respectively. Bellus is also evaluating a QD (once-daily) formulation for camlipixant, which is currently in phase I.

Roberto Bellini, chief executive officer of Bellus, said: "This acquisition recognizes the value of our highly selective P2X3 antagonist camlipixant and validates the hard work and dedication of all the Bellus employees in advancing camlipixant to date. As a leader in respiratory research for over five decades, GSK shares our commitment to bettering the lives of individuals suffering from a persistent cough and is the ideal company to rapidly bring camlipixant to the millions suffering from refractory chronic cough around the world."

The transaction remains subject to regulatory approvals.

Financial considerations

Under the terms of the agreement, the acquisition will be effected through a plan of arrangement pursuant to the Canada Business Corporations Act in which the shares of Bellus outstanding will be acquired by the company in consideration of $14.75 (U.S.) per share in cash. Subject to customary conditions, including court approval, the approval of the acquisition by at least 66.67 per cent of the votes cast at a meeting of Bellus's shareholders and a majority of the votes cast by non-interested shareholders at such meeting, and approval by the appropriate regulatory agencies, the transaction is expected to close in the third quarter of 2023 or earlier.

The per-share price represents a premium of approximately 103 per cent to Bellus's closing stock price on April 17, 2023, and a premium of approximately 101 per cent to Bellus's volume-weighted average price (VWAP) over the past 30 trading days. Bellus's board of directors has unanimously recommended that Bellus's shareholders vote in favour of the approval of the acquisition.

GSK will account for the transaction as a business combination and expects it to be accretive to adjusted EPS in 2027, the expected first full year of camlipixant's sales.

There is no change to GSK's full-year 2023 guidance or the medium-term outlook for 2021 to 2026 of more than 5 per cent sales and 10 per cent adjusted operating profit compound annual growth rate at constant exchange rate.

Advisers

PJT Partners is acting as the exclusive financial adviser to GSK. Paul, Weiss, Rifkind, Wharton & Garrison LLP, and Stikeman Elliott LLP serve as legal counsel to GSK in connection with the transaction. Centerview Partners is acting as the exclusive financial adviser, and Skadden, Arps, Slate, Meagher & Flom LLP, and Davies Ward Phillips & Vineberg LLP serve as legal counsel to Bellus.

About Bellus Health Inc.

Bellus is a late-stage biopharmaceutical company working to better the lives of patients suffering from persistent cough.

We seek Safe Harbor.