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BELLUS Health Inc.


BELLUS Health Inc. is a drug development company focused on rare diseases. Based in Laval, Quebec, the company has a portfolio of rare disease projects including KIACTA for AA amyloidosis (an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death), clinical-stage Shigamab for Shiga toxin-producing Escherichia coli-related hemolytic uremic syndrome, and a research-stage project for AL amyloidosis. Its lead program, KIACTA, is partnered with global private equity firm Auven Therapeutics LLLP and is currently in phase 3 confirmation study.

The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.

Expert Comments:

The Life Sciences Report Interview with Hugh Cleland (9/17/14) "We have a large position in BELLUS Health Inc., with an average cost of around CA$0.50/share, but we still haven't sold any even though we have about a triple, with BELLUS at about CA$1.50 today. The binary events at BELLUS are still almost two years out, so that is our risk point. Its fully diluted market cap is still under CA$100M million (CA$100M), so we think there's still an enormous valuation gap between BELLUS and comparables in the orphan drug space. . .

Comparable orphan drug companies (meaning companies at a similar stage of development, with similar peak sales estimates) trade between $500M and more than $1B. . .there is still plenty of time to fill that gap. If BELLUS fills the valuation gap, as we think it will, it will end up trading somewhere in the $4-8/share range. If the biotech space gets as heated as we think it will, BELLUS could very well trade above $10/share. . ." More >

The Life Sciences Report Interview with Stephen Ireland (9/17/14) "Having looked at the results of BELLUS Health Inc.'s Phase 2/3 trial myself, I think the data were positive. There were clear trends toward improvement in the Kiacta-treated patients. . .in the open-label, follow-up study, there was a significant reduction in time to end-stage renal failure or dialysis. This, to me, is the hard endpoint that you want for a drug like this. If you can treat a patient whose kidney function would otherwise deteriorate to the point where he or she would require a transplant—or would die—and delay the time it takes to get to that event, that's a robust measure of efficacy. . ." More >

Pooya Hemami, Edison Investment Research (6/30/14) "BELLUS Health Inc.'s lead candidate, Kiacta, is in a Phase 3 trial for amyloid A amyloidosis, an orphan drug indication. . .the potential for premium (orphan) pricing for Kiacta and a seven- to 10-year exclusivity period underscore the primary investment case, although with Phase 3 data in 2016, a longer-term view is required."

The Life Sciences Report interview with Brian Bloom (6/12/14) "BELLUS Health Inc. is another of our favorite biotechnology companies. It has a long history in the capital markets, previously as Neurochem Inc. . .the company renamed itself BELLUS Health and has since focused very intelligently on other assets, with a new focus on orphan disease. . .

BELLUS' lead program is Kiacta (NC-503; eprodisate disodium) for the treatment of AA amyloidosis. Kiacta previously was the subject of a Phase 2/3 clinical trial, in which the results were mixed. But there were positive efficacy signals, prompting the FDA to ask the company to conduct a confirmatory Phase 3 trial. This study, with 230 patients, has been slightly redesigned—all to the favor of Kiacta—with refinement of endpoints and patient- or subject-selection criteria. We believe the company has a higher probability of success in its current Phase 3 study than it did in its original Phase 2/3. . ." More >

Jason Napodano, Seeking Alpha (5/20/14) "An in-depth look at Kiacta yields 200% upside on BELLUS Health Inc. . .the company exited Q1/14 with approximately CA$14M, which should enable it to finance its operations beyond the end of the Kiacta Phase 3 trial. We feel confident that the Phase 3 trial for Kiacta will be successful and we are initiating coverage with a Buy rating and $2.50/share price target."

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Pooya Hemami, Edison Investment Research (5/12/14) "BELLUS Health Inc.'s lead candidate, Kiacta, is in a pivotal Phase 3 trial for AA amyloidosis, an orphan drug indication affecting up to 25,000 patients worldwide. We estimate the probability of success at 60%, given positive efficacy trends in a previous Phase 2/3 study and modifications in the ongoing pivotal study to increase its statistical power and target more responsive patients. . .the potential for premium pricing and a 7- to 10-year exclusivity period underscore the investment case. BELLUS is fully funded beyond the Kiacta study results, expected in 2016."

The Life Sciences Report Interview with Hugh Cleland (3/19/14) "BELLUS Health Inc. presented to our advisory board back in May 2013 and came out as one of the favorites. . .one thing that really grabbed me was the enormous valuation disparity that has existed for a variety of very unusual circumstances. With BELLUS, you have a fully funded orphan drug candidate called Kiacta (eprodisate disodium, an orally available small molecule) that is in a phase 3 trial reasonably close to the end of enrollment. The drug is being tested in a lethal disease called AA amyloidosis, which affects 50,000 people in the U.S., Europe and Japan.

The company indicates expected peak sales of around US$500M, but our research suggests we could see peak sales significantly higher than that, perhaps as high as US$1B. Yet somehow, the company is still trading at a fully diluted enterprise value of less than US$35M. I have never seen a fully funded phase 3 asset with such a big market opportunity trade at such a ludicrously low valuation." More >

Pooya Hemami, Edison Investment Research (1/7/14) "BELLUS Health Inc. has announced that it now expects the event-driven phase 3 study for Kiacta in AA amyloidosis to be completed in 2016, earlier than the previously anticipated target of 2017. A reduction in the time to study data, and potentially for Kiacta to reach the market, is a positive development and we raise our risk-adjusted NPV valuation to CA$40M (versus CA$26M), or CA$0.87/share (including cash, fully diluted)."

Pooya Hemami, Edison Investment Research (11/8/13) "BELLUS Health Inc. has divested its Vivimind and BLU8499 noncore assets in order to strengthen its focus on its orphan disease drug candidates, Kiacta and Shigamabs. . .the company is fully funded until the Kiacta study results. . .we continue to estimate a 60% probability of Kiacta's success based on an expected 2018 commercial launch in AA amyloidosis."

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