Scholar Rock Holding Corp (SRRK)·Q2 2025 Earnings Summary

Executive Summary

• Scholar Rock reported Q2 2025 with no revenue and a larger net loss of $110.0M ($0.98 per share) as operating expenses ramped for launch readiness; cash and marketable securities were $295.0M, expected (with available cash and planned revenues) to fund operations into 2027 .
• FDA BLA for apitegromab remains under priority review with a September 22, 2025 PDUFA; management noted constructive late-cycle meeting and active resolution of CDMO inspection observations, indicating the FDA is working toward the PDUFA date .
• Positive Phase 2 EMBRAZE topline showed 54.9% preservation of lean mass (4.2 lbs) versus tirzepatide alone (p=0.001), reinforcing the platform and partnership optionality beyond SMA .
• Versus S&P Global consensus, Q2 EPS missed (Actual: -$0.98 vs Est: -$0.666), while revenue aligned at $0; elevate focus on regulatory clarity and launch execution as near-term stock catalysts. Values retrieved from S&P Global.*

What Went Well and What Went Wrong

What Went Well

• “Constructive” FDA engagement: “We are encouraged by the dialogue with the agency at the late cycle meeting where the FDA indicated that they are working towards completing the review of our BLA by our September 22 PDUFA date” .
• EMBRAZE POC success: apitegromab + tirzepatide preserved an additional 4.2 lbs (1.9 kg) of lean mass, a 54.9% reduction in lean mass loss vs tirzepatide alone (p=0.001), and was generally well tolerated .
• Commercial readiness: U.S. customer-facing teams hired, trained, and deployed; payer discussions “going positive,” with prior dual-therapy precedents and durability of response resonating with payers .

What Went Wrong

• Operating expense surge: R&D rose to $62.4M (+$20.0M YoY) and G&A to $49.7M (+$32.6M YoY) on manufacturing, launch readiness, and one-time leadership transition costs, driving a wider net loss .
• EPS miss vs Street: actual -$0.98 vs S&P Global consensus -$0.666; revenue remained $0 as expected. Values retrieved from S&P Global.*
• CDMO inspection observations at two sites introduced regulatory risk; management emphasized robust responses and noted supply is manufactured and “ready to go,” but inspections add uncertainty into the review process .

Financial Results

Actuals vs prior periods

• Cash, cash equivalents and marketable securities: $364.4M at 3/31/25 and $295.0M at 6/30/25; runway into 2027 (with available cash and planned revenues) .
• YoY: Net loss widened ($110.0M vs $58.5M) on higher R&D and G&A supporting manufacturing and launch; QoQ: step-up from Q1 primarily G&A (commercial build) and R&D (drug supply manufacturing) .

Actuals vs estimates (S&P Global)

Values retrieved from S&P Global.*

No segments to report; pre-commercial stage, no revenue segmentation disclosed .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We are encouraged by the dialogue with the agency at the late cycle meeting where the FDA indicated that they are working towards completing the review of our BLA by our September 22 PDUFA date.” — CEO David Hallal .
• “Apitegromab increased lean mass preservation by greater than 54% compared to tirzepatide alone with a p value equal to 0.001… the highly selective anti-myostatin approach continues to deliver.” — CEO David Hallal .
• “Our U.S. customer-facing team is fully onboard, trained, and now deployed in the field… meetings have been going positive as we’ve been going through the apitegromab data… durability of response payers have found quite impressive.” — COO Keith Woods .
• “We would request that 10 mg/kg is the approved dose… both [10 and 20 mg/kg] have almost identical pharmacodynamic effect.” — President R&D Akshay Vaishnaw .

Q&A Highlights

• CDMO inspections: Observations at two sites (including a general site inspection at Catalent Indiana); Novo Nordisk submitted responses; SRRK preparing comprehensive responses; FDA late-cycle post-inspection was constructive and targeting PDUFA timing .
• Label/dose: Combined-dose efficacy supports lowest efficacious dose (10 mg/kg); seeking broad label for ≥2 years; consistency across 2–21 years emphasized .
• Payer dynamics: Existing precedent for dual SMN therapy reimbursement; payers receptive to dual-modality SMA treatment; durability valued .
• Launch cadence: Multiple centers of excellence with formulary timelines; planning immediate launch post-approval; J-code expected ~6+ months post-launch .
• Financing levers: Additional $50M available under debt facility in 2025, ~$16M from warrant exercises by YE, further $50M post-approval, and potential PRV monetization .

Estimates Context

• Q2 2025: EPS missed Street (Actual -$0.98 vs -$0.666), revenue in line at $0; SRRK remains pre-commercial with expenses stepping up for launch preparations. Values retrieved from S&P Global.*
• Target price consensus remained ~$47.3 in Q2-Q3 2025 windows; consensus coverage 10–12 EPS estimates quarter-to-quarter. Values retrieved from S&P Global.*

Key Takeaways for Investors

• Near-term catalyst: FDA decision by 9/22/25 remains on track per “constructive” late-cycle feedback; inspection observations are a watch item but management actions and timelines suggest resolution within the review cycle .
• Launch execution in focus: U.S. field force deployed; payer conversations positive with dual-therapy precedents; initial uptake likely paced by formulary cycles/J-code timing .
• Expense inflection pre-approval: G&A and R&D elevated by commercial build and drug supply manufacturing; expect spend to remain focused on launch and core clinical programs .
• Funding runway intact: $295M cash at 6/30/25 and multiple non-dilutive/structured levers (debt tranches, warrants, PRV) support runway into 2027 (with available cash and planned revenues) .
• Platform momentum: EMBRAZE success strengthens myostatin biology leadership, creates partnering optionality in cardiometabolic, while neuromuscular expansion (OPAL, additional indications) underpins medium-term growth .
• Label and dose clarity: Expectation for 10 mg/kg dose and pursuit of broad label (≥2 yrs) could expand treated population and simplify commercial logistics if approved .
• Risk monitor: Any FDA-required reinspections or remediation delays at CDMOs could push timelines; management is engaged with CDMOs and FDA, with launch supply “manufactured… ready to go” .

KPIs and Operating Milestones

Sources: Press release furnished via 8-K and company PRs ; Q2 2025 call transcript -; Q1 2025 materials -; FY2024 materials -.
Values retrieved from S&P Global.*