ROIV
Roivant Sciences Ltd.22.94
+1.04+4.75%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q1 '26)
No earnings call transcript available yet
Last Quarter (Q4 '25)
FY Q3 '25
Q&A reinforces CS data, Phase III hints
Q&A largely reaffirmed prepared remarks on brepocitinib's stellar Phase II cutaneous sarcoidosis data, explaining baseline imbalances that made the 45mg arm's 100% response rate even more impressive. Management hinted at Phase III mirroring DM trial size with 45mg dose, eyeing a 40,000-patient market smaller than dermatomyositis. Pricing bookends: IVIG to Vyvgart levels. Pfizer's 25% JV hits below net income line. Brepo expansion and BD stay priorities amid internal R&D focus. Analysts grilled Phase III risks, competition—answers direct, confident. Q&A adds color, no walk-backs. Investors eye 2026 pivots.
Key Stats
Market Cap
15.95BP/E (TTM)
-Basic EPS (TTM)
-0.99Dividend Yield
0%Recent Filings
8-K
Moderna settles for $2.25B
Roivant's Genevant and Arbutus settled global LNP patent litigation with Moderna on March 3, 2026, securing $950 million upfront by July 8 plus $1.3 billion contingent on favorable §1498 appeal outcome. This ends disputes over Moderna's Spikevax use of their tech, granting Moderna a non-exclusive license. Board boosted share repurchases to $1 billion total. Cash bolsters Roivant's position amid ongoing Pfizer suit.
8-K
FDA Priority Review for brepocitinib
Roivant subsidiary Priovant scored FDA acceptance and Priority Review of brepocitinib's NDA for dermatomyositis on March 3, 2026, backed by positive Phase 3 VALOR results—the first 52-week placebo-controlled win in the disease. PDUFA target lands in Q3 2026, with U.S. launch eyed end-September. Serious infections rose on drug versus placebo. First targeted therapy on deck, if approved.
8-K
Brepocitinib Phase 2 success
Roivant unveiled positive Phase 2 BEACON results for brepocitinib in cutaneous sarcoidosis, with 45 mg delivering a 22.3-point CSAMI-A improvement at week 16 versus 0.7 for placebo (Δ21.6, p<0.0001); 100% hit key endpoints. Priovant advances to Phase 3 in 2026 post-FDA talks, third pivotal for the drug. Cash at $4.5B funds runway into profitability. Pipeline heats up.
10-Q
Q3 FY2026 results
Roivant posted Q3 FY2026 revenue of $2.0M, down sharply y/y from $9.0M yet in line with tiny scale, while operating loss widened to $339.2M from $274.4M on surging R&D ($165.4M, +16.7% y/y) and G&A ($175.1M, +23.7% y/y), fueled by $105M share-based comp. EPS loss from continuing ops hit $(0.38) on 697M diluted shares, consistent with no anti-dilution. Cash and marketable securities stood at $4.5B end-Q3, with operating cash burn of $587M YTD; no debt disclosed. Earn-out shares vested, reclassed $57.7M to equity. Clinical trials remain uncertain.
8-K
Pipeline timelines accelerated
Roivant accelerated timelines across four key programs at its 2025 Investor Day on December 11: brepocitinib NDA in dermatomyositis now early 2026 with launch early 2027, NIU Phase 3 topline 2H 2026, CS proof-of-concept 1H 2026, and IMVT-1402 D2T RA topline 2026. Roivant-led $550 million Immunovant financing extends cash to IMVT-1402 Graves' launch. Timelines accelerated. Pipeline sets up catalyst-rich 2026.
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