Roivant Sciences Q1 Earnings Call Highlights

Key Points

• Roivant expects a busy second half of 2026, highlighted by a potential FDA approval and launch of brepocitinib for dermatomyositis by the end of September, plus clinical readouts in noninfectious uveitis, PH-ILD and cutaneous lupus.
• Brepocitinib development is expanding, with Phase III trials underway in cutaneous sarcoidosis and lichen planopilaris. Roivant also plans further updates on Immunovant’s IMVT-1402 programs in rheumatoid arthritis and Graves’ disease.
• Roivant reported nearly $4 billion in cash before receiving about $772 million from its Moderna settlement, repurchased roughly $200 million of stock during the quarter and said it will continue buybacks while funding its pipeline.

Roivant Sciences NASDAQ: ROIV said it expects a busy second half of 2026, with a potential launch of brepocitinib in dermatomyositis, several clinical readouts and additional regulatory discussions across its pipeline.

Chief Executive Officer Matt Gline characterized the quarter as relatively quiet but said the company has advanced several priorities outlined at its investor day. Those include the anticipated brepocitinib launch, development work at Immunovant, progress in litigation-related matters and continued capital returns.

“The next 6-12 months are in many ways busier than the prior 6-12 months for us,” Gline said on the company’s first-quarter earnings call.

Brepocitinib Launch and Pipeline Progress

Roivant said brepocitinib, which is under priority FDA review for dermatomyositis, is expected to launch by the end of September if it receives approval. Gline said the commercial and patient-support teams at Priovant have been built, trained and are ready for a potential launch.

Management reiterated that it intends to pursue a “slow and steady” launch rather than focus on near-term sales metrics. Gline said the company is seeking to establish access, patient-support, institutional and physician-engagement infrastructure that can support brepocitinib across multiple potential indications beyond dermatomyositis.

Gline said physicians and patients have expressed enthusiasm for new treatment options in dermatomyositis, a condition in which patients often use multiple therapies and remain dissatisfied with available treatments. He also said Roivant expects brepocitinib’s label to include the boxed warnings associated with other JAK inhibitors, but management believes physicians will weigh those considerations against the severity of dermatomyositis and risks associated with treatments such as high-dose steroids and immunosuppressants.

The company also began enrolling patients in a Phase III trial of brepocitinib for cutaneous sarcoidosis. The 140-patient study will compare 45 milligrams of brepocitinib with placebo over 16 weeks and uses a primary endpoint of at least a 50% response on the Cutaneous Sarcoidosis Activity and Morphology Instrument, or CSAMI. Participants will undergo a mandatory steroid taper from week two through week eight.

Roivant expects top-line data from that study in 2028. Gline said the company estimates there are approximately 40,000 U.S. patients with cutaneous sarcoidosis and pointed to potential overlap with ocular and pulmonary manifestations of sarcoidosis.

Roivant also said its registrational study of brepocitinib in lichen planopilaris is enrolling “extremely well,” according to Gline. The company added lichen planopilaris as a fourth brepocitinib indication earlier this year.

Second-Half Readouts

Roivant expects several important data events during the second half of 2026. These include top-line data from a Phase III study of brepocitinib in noninfectious uveitis, which Gline said could represent an opportunity comparable in size to dermatomyositis.

The company also expects top-line data from the Phase II FOCUS study of mosliciguat in pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Management said it is looking for a clear signal in pulmonary vascular resistance, or PVR, while noting that the trial is not powered to provide a definitive assessment of six-minute walk distance.

Gline said Roivant believes inhaled vasodilation could benefit PH-ILD patients, though the Phase II study is intended to assess whether results seen in pulmonary arterial hypertension translate to the PH-ILD population. He said the company designed the study with limits on emphysema to support broad enrollment while seeking to maximize the therapy’s potential benefit.

For mosliciguat, Roivant said monotherapy data will be released before data from an open-label combination study, which began later and remains in enrollment. Management said the combination trial is intended to add safety experience and provide information that may help inform Phase III trial design.

Roivant also expects a proof-of-concept readout in cutaneous lupus erythematosus, or CLE, during the second half. The first disclosure will include 12-week data comparing a 600-milligram dose with placebo. Gline described the trial as a small fact-finding study intended to help the company assess treatment benefit and determine whether to advance the program.

Immunovant Programs and Litigation

Roivant plans to provide a fuller update later this year on Immunovant’s IMVT-1402 program in difficult-to-treat rheumatoid arthritis. That update could include results from the randomized-withdrawal portion of the study, feedback from an anticipated FDA discussion and potential next steps for registrational development.

The company is also advancing IMVT-1402 in Graves’ disease. Gline said Roivant views the condition as a market with substantial unmet need, rather than one defined primarily by competition among emerging mechanisms. He said the company expects to be the first to bring an advanced therapy to the market if its program succeeds.

Separately, Roivant received the initial payment from its settlement with Moderna. Gline said the $950 million payment included approximately $770 million for Genevant and the remainder for Arbutus. He said litigation under Section 1498 remains under review at the Federal Circuit and could result in an additional $1.3 billion with a favorable outcome. Roivant also filed international lawsuits against Pfizer and BioNTech, including actions in Canada and the Unified Patent Court, during July.

Financial Position and Capital Returns

Roivant reported approximately $200 million in research-and-development expense for the quarter. Non-GAAP adjusted general and administrative expense was just under $100 million, while GAAP general and administrative expense was $166 million.

The company reported cash of just under $4 billion before receipt of approximately $772 million associated with the Moderna settlement payment. Roivant repurchased about $200 million of stock during the quarter, with additional repurchases in March, after accelerating its buyback activity following the Moderna settlement announcement.

Gline said the company will continue repurchasing shares under its existing authorizations while preparing for a catalyst-rich period that could include multiple clinical readouts, regulatory filings and commercial launches through the end of 2028.

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.

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