After 'transformative' year, Roivant aims to challenge bigger rivals in inflammation and immunology

By Eleanor Laise

Roivant shares gain more than 10% after narrower-than-expected quarterly loss

After surviving some turbulent market conditions in its first years as a public company, Roivant Sciences Ltd. (ROIV) is taking on industry behemoths as it develops new treatments for ulcerative colitis, Crohn's disease and other conditions.

Over the past year or so, Roivant has introduced key programs focused on experimental treatments for autoimmune diseases and inflammatory bowel disease and celebrated the launch of its first in-house commercial product, a treatment for plaque psoriasis.

Those advances mark a sharp turnaround from the spring of last year, Roivant CEO Matt Gline told MarketWatch in an interview Wednesday. "We were in a relatively tough spot as a business in March of 2022," Gline said. "The sector was pretty beaten up at that point, and we were doing what a lot of people were doing -- we were rationalizing our portfolio. We were thinking about how to survive a storm."

Late last year, the company laid off about 12% of its staff. While the company had to make some "hard decisions" over the course of the year, Gline said, that allowed Roivant to focus on its late-stage portfolio in inflammation and immunology. "It's been a completely transformative year," he said.

The ups and downs added up to a narrower-than-expected loss for Roivant in its fiscal fourth quarter, the company reported Wednesday. For the quarter ending March 31, Roivant reported a net loss of $33.6 million, or 5 cents a share, compared with a loss of $270.1 million, or 39 cents a share, in the year-earlier period. Revenue came to $27.4 million, up from $9.2 million a year ago. The FactSet consensus was for a loss of 36 cents and revenue of $18.2 million.

Roivant shares were up more than 10% in intraday trading on Wednesday.

The quarterly results come on the heels of new data Roivant released last week showing promising longer-term results for RVT-3101, its monoclonal antibody that targets the inflammation-causing TL1A protein in adults with ulcerative colitis. The treatment resulted in an improved clinical remission rate of 36% at week 56, versus 29% at week 14, the company said. Based on the data, Gline said, "I'm increasingly confident that anti-TL1A antibodies as a whole will represent a major step forward for patients with ulcerative colitis -- and I hope also for Crohn's disease."

Roivant late last year formed a new company with Pfizer (PFE) to develop and commercialize RVT-3101. Although there's competition -- including from Merck & Co. (MRK) and Teva Pharmaceutical Industries Ltd. (TEVA.TV) -- Gline sees a key advantage for Roivant in the size and scope of Pfizer's comprehensive Phase 2 study of the treatment.

Interest in anti-TL1A antibodies has spawned some deal making lately. Merck in April announced a deal to acquire Prometheus Biosciences, which is also developing a treatment in the category, for about $10.8 billion. As for the prospects for Roivant to be involved in any deals, Gline noted that a number of other pharmaceutical companies were interested in Prometheus, indicating that acquirers generally have an appetite for such assets. "Anything's possible," he said, "and we're going to be economic and thoughtful when faced with the options that we have."

Roivant is also taking on some bigger competition as it develops an autoimmune-disease treatment -- an anti-neonatal Fc receptor (FcRn) antibody. Argenx (ARGX.BT) is the "800-pound gorilla" in the space, Gline said, with a product already on the market, and Roivant ran into a snag with its first-generation investigational treatment in the category, which had the undesirable side effect of raising LDL cholesterol. Roivant is hoping to demonstrate that its second-generation attempt, IMVT-1402, does not raise LDL cholesterol and has "best-in-class" efficacy, Gline said.

Analysts, meanwhile, saw a brighter outlook for Roivant in prescriptions written for its psoriasis treatment Vtama in the fourth quarter. As of June, over 170,000 Vtama prescriptions have been written by about 11,000 unique prescribers, up from about 8,600 prescribers at the end of last year. The update "indicates that both breadth and depth are continuing to drive Vtama demand," Goldman Sachs analysts wrote in a research note Wednesday.

Roivant shares have gained 25% in the year to date, while the S&P 500 is up nearly 14%.

-Eleanor Laise

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06-28-23 1550ET

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