SRRK
Scholar Rock Holding Corporation44.32
-0.92-2.03%
Dec 16, 4:00:00 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '25)
FY Q3 '25
Q&A reaffirms 2026 path, financing details
Q&A largely reaffirmed prepared remarks on apitegromab's 2026 U.S. launch path, emphasizing Novo's Bloomington remediation progress and FDA collaboration from the recent Type A meeting, with no contradictions or walk-backs. Analysts grilled on reinspection credibility, resubmission timing, and supply pivots; management countered with confidence in Novo's quality culture, seamless second fill/finish rollout from Q1 2026, and flexible BLA strategies if needed. Financing prioritizes non-dilutive debt expansion over ATMs or equity. Team fielded concerns head-on, no evasions. Outlook stays urgent; investors watch reinspection results.
Key Stats
Market Cap
4.52BP/E (TTM)
-Basic EPS (TTM)
-3.15Dividend Yield
0%Recent Filings
8-K
FDA warning letter to manufacturer
Scholar Rock disclosed that its contract manufacturer Catalent Indiana received an FDA warning letter after a July 2025 Form 483 and 'official action indicated' classification. Catalent works to resolve issues. Company still eyes apitegromab BLA resubmission and SMA launch in 2026. FDA actions pose approval risks.
8-K
FDA meeting advances apitegromab
Scholar Rock completed a constructive Type A FDA meeting on November 12, 2025, with Catalent confirming reinspection readiness by year-end, paving BLA resubmission and 2026 U.S. launch for apitegromab in SMA. Cash stands at $369.6M, funding into 2027 despite Q3 net loss of $102.2M from launch investments. Dosing started in Phase 2 OPAL for infants.
10-Q
Q3 FY2025 results
Scholar Rock posted Q3 operating losses of $103.6M, up 60% y/y from $64.8M (derived), driven by G&A ramp to $53.1M from $16.1M amid launch prep, while R&D edged 4% higher to $50.5M on headcount and OPAL trial startup. YTD net loss hit $287.0M versus $179.8M y/y, with EPS at -$0.90/-$2.54 (113.7M/112.8M diluted shares). Cash burned $224.5M operationally YTD, offset by $155.1M financing including $91.7M ATM equity and $50.0M debt draw; quarter-end liquidity stood at $369.6M ($286.8M cash/$82.9M marketable securities), backing runway into 2027. Debt totals $99.6M under amended Oxford facility (SOFR+5.5%, interest-only to 2029). FDA CRL on apitegromab stemmed from third-party fill-finish OAI status; resubmission awaits reclassification. CRL delays commercialization.
8-K
Expands ATM to $200M
8-K
FDA flags Catalent facility
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