Roivant Sciences (Nasdaq: ROIV) on Friday reported its financial results for the fiscal third quarter ended December 31, 2025, revealing a widened net loss as the company aggressively scales its clinical development programs. Despite the increased spending, the company maintained a substantial capital reserve of $4.5 billion, positioning it to navigate a high-density calendar of clinical catalysts through 2026.
Clinical Breakthrough in Cutaneous Sarcoidosis
Parallel to its financial update, Roivant announced positive topline results from the Phase 2 BEACON study of brepocitinib, a dual JAK1/TYK2 inhibitor, for the treatment of cutaneous sarcoidosis. The trial met its primary efficacy goals, with the 45 mg dose achieving a placebo-adjusted improvement of 21.6 points on the Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI-A).
Notably, 100% of participants in the high-dose arm achieved at least a 10-point reduction in disease activity, compared to just 14% for the placebo group. Management indicated that based on these “breakthrough” results, the company intends to initiate a Phase 3 program for this orphan indication by the end of calendar year 2026.
Fiscal Third Quarter Financial Performance
For the three months ended December 31, 2025, Roivant reported a net loss from continuing operations of $313.7 million, or $0.38 per share, compared to a net loss of $208.9 million for the same period in the prior year. On an adjusted (non-GAAP) basis, the net loss from continuing operations was $167.0 million.
Operating expenses were driven by significant investments in research and development (R&D) and general administrative costs:
Research and Development: Expenses rose to $165.4 million, up from $141.6 million in the prior-year quarter. Adjusted R&D expenses, which exclude non-cash share-based compensation, stood at $146.7 million.
General and Administrative: GAAP expenses increased to $175.1 million from $141.5 million. This figure included an $86.9 million charge for share-based compensation and a $17.1 million impairment loss related to the relocation of the company’s U.S. headquarters.
Liquidity: The company ended the quarter with $4.5 billion in cash, cash equivalents, and marketable securities, with no debt on the balance sheet.
Strategic Outlook and Execution
The company’s strategy remains focused on its “Vant” model of decentralized development, aiming to deliver multiple pivotal readouts over the next 36 months. Management highlighted that the current cash position provides a sufficient runway to reach multiple commercial launches.
In addition to the brepocitinib data, Roivant confirmed that several other key programs have reached major milestones:
IMVT-1402: The Phase 3 study in difficult-to-treat rheumatoid arthritis is now fully enrolled, with topline data expected in the second half of 2026.
Mosliciguat: The Phase 2 study for pulmonary hypertension associated with interstitial lung disease (PH-ILD) has completed enrollment, with a data readout also anticipated in late 2026.
Dermatomyositis: A New Drug Application (NDA) for brepocitinib in dermatomyositis has already been submitted to the FDA.
Industry Context and Intellectual Property
Beyond clinical data, Roivant continues to progress through high-stakes litigation. A jury trial regarding lipid nanoparticle (LNP) technology in the U.S. Moderna case is scheduled for March 2026. A recent summary judgment affirmed the company’s view that a significant majority of potential liability resides with Moderna rather than the U.S. government, a development that investors are monitoring closely as a potential non-dilutive capital catalyst.
While the widened quarterly loss reflects the cost of managing a broad late-stage pipeline, the company’s massive cash reserves and high trial success rate—highlighted by the recent sarcoidosis data—suggest a period of intensive value creation. Investors will likely focus on the second half of 2026, which is slated to be a “catalyst-rich” period with five separate topline readouts across major indications.
Reasons to Pass on ROIV
- Widening losses: Net loss increased year over year as spending on clinical programs accelerated, with no near-term path to profitability.
- Rising cost structure: R&D and G&A expenses continued to climb, including sizable share-based compensation and one-time charges.
- Delayed revenue visibility: Key clinical readouts and potential commercial launches are largely back-end loaded into late 2026.
- High execution risk: Advancing multiple late-stage programs in parallel increases operational and development complexity.
- Regulatory uncertainty: Positive mid-stage data does not eliminate approval risk for brepocitinib and other pipeline assets.
- Event-driven valuation: The stock remains highly sensitive to upcoming clinical milestones, increasing downside risk if trials disappoint.
- Litigation overhang: Ongoing IP litigation adds uncertainty around potential financial outcomes.
- Sustained cash burn: Strong liquidity offsets risk in the near term, but continued high spending could pressure capital over time.