Executive Summary

Biohaven’s Q3 2025 narrowed losses sequentially on lower R&D spend and delivered a modest non-GAAP EPS beat versus Street, while initiating a major cost-optimization to focus on three late-stage programs; the FDA’s Complete Response Letter (CRL) for VYGLXIA (troriluzole) in SCA was the dominant negative development .
Management is “right-sizing” innovation, targeting ~60% reduction in annual direct R&D (ex personnel/SBC) and prioritizing opakalim (Kv7) in epilepsy/depression, MoDE/TRAP degraders (BHV-1300/1400), and taldefgrobep alfa (obesity/SMA) .
Liquidity: $263.8M cash, equivalents, marketable securities, and restricted cash at 9/30/25; subsequently priced and closed an equity offering for ~$175M (priced) and ~$200M gross (upsized with greenshoe exercised), extending runway post-quarter .
Near-term catalysts: Phase 2 MDD topline (4Q25), two Phase 2/3 focal epilepsy studies with initial topline in 1H26, path forward discussions on SCA, and potential pivots to pivotal studies for BHV-1300/1400 in Graves’/IgAN .

What Went Well and What Went Wrong

What Went Well
- Cost discipline and strategic focus: Company launched portfolio restructuring with an expected ~60% reduction in annual direct R&D to concentrate resources on late-stage, value-driving programs .
- Clear near-term readouts: Management reiterated 4Q25 Phase 2 MDD topline for opakalim and maintained initial top-line from two Phase 2/3 focal epilepsy studies in 1H26, providing tangible upcoming clinical catalysts .
- CEO tone on focus and execution: “Our redirected approach to ‘right-sizing’ innovation is an important step…to ultimately drive growth and resources to the most critical areas of our business.” – Vlad Coric, M.D., CEO .
What Went Wrong
- Regulatory setback: FDA issued a CRL for VYGLXIA (troriluzole) in SCA, citing concerns typical of externally controlled RWE designs; Biohaven plans to meet FDA to discuss next steps, but the setback pushes out SCA commercialization and elevates regulatory risk .
- Lower other income: Q3 “Other (expense) income, net” swung to ($3.8M) from $13.8M in Q2 and $17.8M in Q3’24, driven by non-cash fair value changes on notes payable and derivatives and reduced investment income .
- Dilution to extend runway: Post-quarter, the company raised equity ($175M priced, ~$200M gross with shoe), necessary for runway but dilutive to shareholders in the near term .

Financial Results

Metric	Q1 2025	Q2 2025	Q3 2025
R&D Expense ($M)	$187.6	$184.4	$141.2
G&A Expense ($M)	$34.0	$27.3	$28.2
Total Operating Expenses ($M)	$221.6	$211.7	$169.4
Other Income (Expense), Net ($M)	$0.5	$13.8	($3.8)
Net Loss ($M)	$221.7	$198.1	$173.4
GAAP EPS	($2.17)	($1.94)	($1.64)
Adjusted Net Loss ($M)	$166.8	$166.4	$155.9
Adjusted EPS (Non-GAAP)	($1.64)	($1.63)	($1.47)

Notes: The Q3 2025 release presented operating expenses first; no revenue line was reported in the statement of operations .

KPIs and Balance Sheet Snapshot

KPI	Q1 2025	Q2 2025	Q3 2025
Cash, Equivalents, Mkt Sec, Restricted ($M)	$327.0 (as of 3/31/25)	$408.2 (as of 6/30/25)	$263.8 (as of 9/30/25)
Cash & Equivalents ($M)	$98.4	$165.8	$184.8
Marketable Securities ($M)	$224.3	$239.2	$75.4
Notes Payable ($M)	—	$257.1	$268.3
Forward/Derivative Liability ($M)	$88.3	$26.0	$22.0
Common Shares O/S (period-end)	102.10M	105.78M	105.80M
Post-quarter Equity Raise	—	—	$175.0M priced; ~$200.0M gross closed

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Direct R&D spend (annual, ex personnel/SBC)	Forward	N/A	Target ~60% reduction	New cost-optimization program
Opakalim (Kv7) – MDD topline	4Q 2025	“2H 2025” (Q1/Q2)	4Q 2025	Clarified timing within 2H25
Opakalim – focal epilepsy topline	1H 2026	1H 2026	1H 2026	Maintained
Taldefgrobep – obesity Phase 2 start	4Q 2025	1H 2025 → 2H 2025 (slipped in Q2)	4Q 2025	Delayed vs original, now 4Q25
VYGLXIA (troriluzole) – SCA	2025	Priority Review; PDUFA timeline extended to 4Q25	CRL received; appeal Type A meeting planned	Negative revision; approval timing uncertain
BHV-1400 (IgAN) – pivotal	2026	Potentially registrational study in 2026	Advance to pivotal studies (2026)	Maintained trajectory
BHV-1300 (Graves’) – pivotal	2025/26	Phase 1b in 2H25; potentially registrational in 2H25	Advance to pivotal studies	Maintained intent

Earnings Call Themes & Trends

Note: Q3 2025 earnings call transcript was not available in the document corpus at the time of this analysis (no transcript returned) – commentary below reflects company press materials.

Topic	Q1 2025 (prior)	Q2 2025 (prior)	Q3 2025 (current)	Trend
Regulatory (VYGLXIA SCA)	Priority Review; PDUFA 3Q25; mid-cycle complete	PDUFA extended; timing 4Q25	CRL issued; appeal meeting planned	Deteriorated
Cost structure	No restructuring disclosed	No restructuring disclosed	New portfolio optimization; ~60% direct R&D reduction	Focus on efficiency
Kv7 (opakalim)	MDD topline 2H25; epilepsy 1H26	Reiterated MDD 2H25; epilepsy 1H26	MDD 4Q25; epilepsy 1H26	On track/clarified
MoDE/TRAP (BHV-1300/1400)	Phase 1 completions 1H25	Deep IgG and Gd-IgA1 reductions; expansion to patients	Advance to pivotal in Graves’/IgAN	Advancing
Taldefgrobep (myostatin)	Obesity Phase 2 start 1H25; SMA path discussions	Obesity Phase 2 start 2H25	Obesity Phase 2 start 4Q25; SMA path ongoing	Slipped timeline
Capital & liquidity	$600M Oberland NPA; $518M cash incl. April tranche	$408.2M cash etc.; notes payable on balance sheet	$263.8M cash etc.; follow-on equity $175M priced/$200M gross closed	Runway bolstered post-Q3

Management Commentary

“Our redirected approach to ‘right-sizing’ innovation is an important step we have undertaken to ultimately drive growth and resources to the most critical areas of our business.” – Vlad Coric, M.D., Chairman & CEO .
“We are particularly excited about…MoDE and TRAP…BHV-1300 and BHV-1400…opakalim…for epilepsy and depression; and taldefgrobep alfa…for obesity and SMA.” – Vlad Coric, M.D. .
On CRL: “We are extremely disappointed on behalf of patients…Real-world evidence is an important research approach…[but] front-line review divisions are not yet embracing FDA policy for the use of real-world evidence or the application of regulatory flexibility for rare disease.” – Vlad Coric, M.D. .
“Restructuring of business priorities…to achieve an approximately 60% reduction in annual direct R&D spend…will result in delay of non-priority programs.” .

Q&A Highlights

No Q3 2025 earnings call transcript was available in the document corpus (no returns found for earnings-call-transcript). We will update Q&A highlights if a transcript becomes available [ListDocuments returned 0 for transcripts].

Estimates Context

Q3 2025 results versus S&P Global consensus:
- Non-GAAP (Normalized) EPS: Actual ($1.47) vs consensus ($1.54) → beat by $0.07* .
- Primary (GAAP) EPS: Tool indicates consensus ($1.93) loss vs an “actual” field of ($1.47); company-reported GAAP EPS was ($1.64); most analysts focus on normalized EPS for BHVN* .
- Revenue: Company did not report revenue in Q3 financials; consensus was ~$0.38M, implying no material revenue contribution this quarter* .

Metric	Q3 2025 Consensus	Q3 2025 Actual
EPS Normalized (Non-GAAP)	($1.54)*	($1.47)
Primary EPS (GAAP)	($1.93)*	($1.64)
Revenue ($M)	$0.38*	Not reported

*Values retrieved from S&P Global.

Drivers of variance: The EPS beat on a normalized basis reflected lower R&D QoQ ($141.2M vs $184.4M in Q2) and lower total operating expenses ($169.4M vs $211.7M in Q2), partially offset by unfavorable other expense in Q3 vs strong other income in Q2 .

Key Takeaways for Investors

The CRL for VYGLXIA resets the rare-disease regulatory path; near-term stock narrative likely shifts to opakalim MDD topline (4Q25) and degrader pivot plans (BHV-1300/1400) as primary catalysts .
Material cost-optimization (~60% cut in direct R&D) should extend runway and improve operating leverage as BHVN concentrates on three late-stage pillars .
Liquidity improved post-quarter via ~$200M gross equity raise; along with $263.8M cash/etc at 9/30/25, this supports execution through key 4Q25–1H26 readouts .
Sequential decline in R&D ($184.4M → $141.2M) and total opex drove adjusted EPS beat; monitor sustainability of opex reductions and potential impact on non-priority programs .
Watch for FDA Type A meeting outcome on SCA and any alternate regulatory paths (e.g., additional study design, use of RWE) that could reintroduce optionality to the SCA asset .
For 1H26, epilepsy readouts from two Phase 2/3 studies could be a larger value inflection if efficacy and tolerability replicate opakalim’s profile; degrader programs entering pivotal phase would further de-risk the I&I platform .
Risk balance: regulatory uncertainty (SCA), clinical execution risk (multiple platforms), and financing needs versus robust pipeline optionality, tightened focus, and near-term catalysts .

Citations: Q3 2025 8-K and press release ; CRL press release ; Q2 2025 press release ; Q1 2025 8-K ; Equity offering press releases .

Biohaven Ltd. (BHVN)·Q3 2025 Earnings Summary