CEO Matt Gline is juggling Roivant Sciences’ first solo drug launch and several maturing programs as the hub-and-spoke company sets its sights on a massive turning point into commercial viability.
Roivant Sciences has always been a little different from traditional drugmakers with its hub-and-spoke subsidiary model and an overarching hedge fund mentality. And now that the company has embarked on a new drug launch solo, CEO Matt Gline plans to further differentiate the company with a commercial portfolio.
“Very few companies in biopharma have graduated from being a biotech company to being a proper commercial portfolio of drugs that matter, and I think we have been given as good a shot as anybody,” Gline told BioSpace.
And with the August approval of oral TYK2/JAK inhibitor Lisraya for dermatomyositis handed out to subsidiary Priovant, Roivant is on the cusp of that transition. "[It’s] the busiest time in company history,” Gline said.
Priovant’s first-in-class launch will test whether the company can turn a promising clinical pipeline into market success, the CEO continued. Following behind Lisraya is a clinical pipeline with several catalysts on the horizon.
Gline describes the business as a three-legged stool, with Lisraya serving as one leg. The other two legs are Pulmovant’s pulmonary hypertension candidate mosliciguat, which exceeded expectations in a Phase 2 trial last month and is now in a late-stage study, and Immunovant’s IMVT-1402, in mid- to late-stage development for multiple inflammatory indications.
Leerink Partners analyst David Risinger confirmed that those three products are the most critical to parent Roivant, describing them as “three multi-billion-dollar pipeline candidates, each of which is a pipeline within a product.”
The firm estimates Lisraya could bring in $7.9 billion by 2035, and following the recent mid-stage readout for mosliciguat, Leerink raised total 2035 unadjusted sales expectations for that asset to $9.8 billion. “We think the stock is undervalued based on the three lead assets alone,” Risinger said.
But the true test will be in the market, he told BioSpace. “They have to execute well on the commercial launches ahead, starting with [Lisraya] in dermatomyositis, and they need to prove to the investment community that they can execute commercial launches very well.”
Diamonds in the rough
Roivant was founded in 2014 by entrepreneur and 2024 U.S. presidential candidate Vivek Ramaswamy. The company made a name for itself picking up promising yet underutilized drug candidates from the wider pharma landscape and ushering them through development via individual “vant” entities focused on different therapeutic areas.
The model has served as a way for Roivant to build a sizable bankroll through divestment, including the sales of Telavant in 2023 to pharma giant Roche for more than $7 billion, and subsequently Dermavant to women’s health specialist Organon for up to $1.2 billion in 2024.
“The ‘vant’ model has proven to be very successful because Roivant is able to recruit exceptional talent to lead individual ‘vants,’ and offers very compelling pay-for-performance opportunities for executives at each of them,” Risinger said. “Roivant has been most successful at bringing forward diamonds in the rough, and we’re hoping they can continue to do that.”
But Roivant wasn’t built to be a commercial company. Before the Dermavant acquisition, Roivant secured its first approved medication, Vtama, for plaque psoriasis in 2022. Over the course of less than two years, however, the company suffered from a lackluster launch with slow uptake and missed expectations, giving the company “a difficult time” before selling Dermavant to Organon, Risinger said.
Gline insisted that Roivant has grown up. “At some level, we are unrecognizable to our former selves. We’ve gone from a motley crew of outsiders with no obvious evidence that we had any clue what we were doing to, at this point, a place among real businesses in biopharma.” And he feels confidence Roivant is ready to shift to commercial company status, beginning with Lisraya, which was licensed from Pfizer through the joint spinoff of Priovant in 2022.
Gline acknowledges the uphill battle ahead but points to the company’s readiness as well as the shape of the industry today that allows for commercial success outside of the Big Pharma machine.
“Six or seven years ago we would have had a hard time convincing the world that we were going to be able to do this, but from an industry perspective over that time, others have all demonstrated an ability to launch products.” He specifically highlighted Horizon Therapeutics, Argenx, Alnylam Pharmaceuticals and others. “In some cases, they’ve launched those products better than any Big Pharma company would have, and that gives everybody including investors and ourselves confidence that we too should be able to do this.”
On the flip side, Gline sees difficult lessons from failed launches as a roadmap for Lisraya.
“Biotech is a woodchipper built to take you in and destroy your soul, and in that sense we are all built out of the wreckage and fires of our failures,” Gline said. “We continue to build skepticism and resilience, and a healthy reverence for the environment that we’re in, so that we don’t get cocky and make dumb mistakes.”
Biotech is a woodchipper built to take you in and destroy your soul, and in that sense we are all built out of the wreckage and fires of our failures.
Key to the Lisraya launch, according to Leerink Partners’ Risinger, will be appropriately educating a broad range of physicians beyond just the key opinion leaders with whom Roivant has worked for clinical trial execution in the past and demonstrating that the drug offers a new kind of treatment.
“The company needs to lean into the dual mechanism and educate physicians, payers and patients that this is not just a JAK inhibitor—it’s a dual TYK2/JAK, which offers a differentiated profile,” Risinger said.
Establishing the drug on the market will then set up future expansions. Lisraya is being studied in three other registrational programs, the first of which—in the eye disease non-infectious uveitis—will read out by the end of the year. This will give Lisraya “another brick to build a big wall,” Gline said.
Beyond Lisraya
Next on Roivant’s commercial horizon is mosliciguat, which Roivant acquired from Bayer in 2024 through subsidiary Pulmovant, committing $14 million upfront and up to $280 million in milestones. A Phase 3 trial in pulmonary hypertension is underway with a primary completion date in early 2029.
“When Bayer decided to get out of the respiratory business for their own reasons, we saw an opportunity to take the baton and press forward in an indication that was a little newer, and one in which someone had already bushwhacked a path for us,” Gline said, referring to United Therapeutics’ Tyvaso.
Importantly, Risinger noted, Pulmovant’s asset has an advantage. “What makes mosliciguat so special is it is a simple, easy-to-use dry powder inhaler that is differentiated from [Tyvaso], which is associated with increasing patients’ cough,” he said.
The latest clinical data from mosliciguat’s mid-stage trial in patients with pulmonary hypertension associated with interstitial lung disease showed a reduction in pulmonary vascular resistance of more than 56%—a result that analysts called a “blowout.”
As for IMVT-1402, licensed to the subsidiary Immunovant from South Korea’s HanAll Biopharma, Risinger said company leadership has downplayed the drug’s performance in rheumatoid arthritis, adding that “they don’t expect statistically significant results given the design.” But in Graves’ disease, an autoimmune disorder with few treatment options, Phase 3 results expected in 2027 could be “highly compelling,” he said.
Similarly, while Gline touted “exciting response rates” for IMVT-1402 in rheumatoid arthritis, he expects the asset’s performance in Graves’ disease” to be transformative for the field.”
Risinger attributes much of Roivant’s success to Gline and his fellow executives making the difficult calls.
“For the leadership team led by Matt Gline and Chief Investment Officer Mayukh Sukhatme, it comes down to exceptional experience, intellect and judgment that allows them to dramatically outperform,” Risinger said. “Their leadership stands apart from many other large biopharmaceutical companies.”
Gline, who has served as CEO since 2021 following more than four years as CFO, takes pride in that track record and promises that even as Roivant enters its commercial era, the company will continue to do what it does best.
“We’re inveterate drug hunters,” he said, “and we’ll always be looking.”
