Roivant Sciences Q4 Earnings Call Highlights

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Roivant Sciences (NASDAQ:ROIV) executives used the company’s fourth-quarter earnings call to highlight new open-label data for IMVT-1402 in difficult-to-treat rheumatoid arthritis, upcoming pulmonary hypertension data for mosliciguat and continued preparation for a potential brepocitinib launch in dermatomyositis.

Chief Executive Matt Gline called the company’s recent period “a pretty wild 12 months,” citing progress across development programs and the previously announced $2.25 billion settlement with Moderna. Gline said Roivant expects to receive the first $950 million upfront portion of that settlement in July.

IMVT-1402 Shows Open-Label Activity in Refractory RA

The most prominent update centered on preliminary data from the open-label portion of the 1402 study in difficult-to-treat rheumatoid arthritis, or D2T RA. Gline described the results as “surprisingly good,” while cautioning that the data came from an open-label phase of the trial.

The study enrolled heavily refractory patients who had failed steroids and DMARDs as well as at least two advanced lines of therapy. Gline said 65% of patients had failed JAK inhibitors, and that “basically every single one” of those patients had also failed a TNF inhibitor. The study also required autoantibody positivity using ACPA criteria.

In the preliminary period 1 data, Roivant reported that roughly 73% of evaluable patients achieved an ACR20 response. More than half achieved ACR50, and more than one-third achieved ACR70. Gline said the depth of response was especially notable because placebo responses are less common at the ACR50 and ACR70 levels.

“It feels to us like looking at this data, there’s something going on that’s meaningful and interesting with this drug,” Gline said.

Gline said the responses were “basically fully preserved” in the subset of patients who had prior JAK inhibitor exposure, a group he characterized as both JAK- and TNF-experienced. He said the findings support the biological thesis that ACPA positivity may represent a mechanism distinct from other anti-inflammatory approaches.

The randomized withdrawal portion of the study is still ongoing. Gline said more than half of patients remain on study treatment, and the company does not yet have data from period 2. He also noted that period 2 may be harder to interpret because patients with deep ACR50 or ACR70 responses may take time to lose an ACR20 response after withdrawal.

Roivant expects to share additional analysis, including patient-level data and feedback from discussions with the U.S. Food and Drug Administration, in the second half of the year. Gline said the company is preparing to discuss the data with regulators and hopes to outline next steps for the program.

Mosliciguat Data Expected in Second Half

Roivant also provided a detailed preview of mosliciguat, an inhaled soluble guanylate cyclase, or sGC, activator being studied in pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Drew Fromkin, CEO of Pulmovant, said mosliciguat is designed to activate sGC directly in the lungs and potentially address both pulmonary vascular disease and lung parenchymal disease.

Fromkin said Bayer previously studied mosliciguat in 170 participants, including healthy volunteers and pulmonary hypertension patients, before Roivant’s program advanced into PH-ILD. In phase I-B data, he said a single dose produced a mean pulmonary vascular resistance reduction of more than 30% and a mean peak reduction of about 38%. He also said the drug was well-tolerated, with mild to moderate treatment-emergent adverse events and no clinically meaningful systemic blood pressure or heart rate effects.

The ongoing PHocus phase II study enrolled 135 patients, above its target of 120. Fromkin said more than 95% of participants reached and sustained the 4-milligram dose through week 16. The primary endpoint is change from baseline in pulmonary vascular resistance at week 16, with secondary measures including six-minute walk distance and NT-proBNP.

Gline emphasized that the study is not powered to show a statistically significant benefit on six-minute walk distance. He said Roivant is primarily looking for confirmation of dosing, safety and pulmonary vascular resistance effects in the patient population.

Brepocitinib Launch Preparation Continues

Roivant also updated investors on brepocitinib, which Gline said could potentially launch in dermatomyositis by the end of September if the FDA review proceeds as expected. He said the company is engaged in payer discussions, physician outreach, specialty pharmacy partnerships and unbranded patient engagement.

Gline said brepocitinib was awarded breakthrough therapy designation and rare therapy designation for cutaneous sarcoidosis. Roivant expects a phase III study in cutaneous sarcoidosis to begin this year. The company also recently announced lichen planopilaris, or LPP, as a fourth indication for brepocitinib, and Gline said that study is already enrolling.

For dermatomyositis, Gline described a high unmet need, noting that many patients rely on steroids, IVIG or off-label therapies. He said phase III brepocitinib data were published in the New England Journal of Medicine in March, which he called a testament to the importance and quality of the study.

Financial Position and Upcoming Milestones

Gline said Roivant ended March 31 with $4.3 billion in cash and equivalents, before receipt of the Moderna settlement payment, and no debt. He also said the company continued to retire shares during the quarter.

Key milestones discussed on the call include:

• Potential brepocitinib launch in dermatomyositis by the end of September, pending FDA action.
• Phase III top-line data in noninfectious uveitis expected in the second half of the year.
• Mosliciguat phase II-B top-line data in PH-ILD expected in the second half of 2026.
• Additional IMVT-1402 analysis in D2T RA, including FDA feedback, expected in the second half.
• IMVT-1402 data in Graves’ disease and myasthenia gravis expected in 2027.

Gline said Roivant’s portfolio has “as much in the windshield as in the rearview mirror,” pointing to multiple data readouts and potential commercial activities ahead.

About Roivant Sciences (NASDAQ:ROIV)

Roivant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies through a network of subsidiary businesses known as “Vants.” Founded in 2014, Roivant acquires or in-licenses clinical-stage assets that have progressed beyond proof of concept and seeks to advance them efficiently toward regulatory approval. By organizing each program into a dedicated subsidiary, the company aims to streamline decision-making, allocate resources more effectively, and accelerate development timelines.

The core activities of Roivant involve identifying promising drug candidates across a range of therapeutic areas, including neurology, rare diseases, immunology, oncology, and women's health.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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