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SpringWorks Therapeutics, Inc. (SWTX)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 delivered strong commercial momentum: OGSIVEO net product revenue rose to $40.2M, driving total revenue to $59.7M (includes a one-time $19.5M “other revenue” from GSK license termination), and EPS improved to $(0.54) from $(1.18) in Q1 and $(1.25) in Q2 2023 .
  • Mirdametinib NDA submission was completed; subsequent FDA acceptance with Priority Review (PDUFA Feb 28, 2025) and EMA MAA validation were announced later in August, setting up a 2025 second product launch catalyst .
  • Operating discipline continues amid launch buildout: SG&A $57.8M and R&D $44.4M reflect go-to-market for OGSIVEO and commercial readiness for mirdametinib; cash and marketable securities stood at $521.9M, underpinning a “path to profitability” narrative .
  • S&P Global consensus estimates for Q2 2024 EPS and revenue were unavailable, preventing formal beat/miss determination; however, qualitative demand signals and minimal inventory effects suggest underlying demand strength .
  • Key stock catalysts: ongoing OGSIVEO adoption breadth/depth, DeFi long-term follow-up data (2H24), ovarian granulosa cell tumor readout (2H24), and mirdametinib regulatory timeline (Priority Review with Feb 2025 action date) .

What Went Well and What Went Wrong

  • What Went Well

    • Strong OGSIVEO revenue ramp: $40.2M net product revenue in Q2, with positive prescriber feedback and broad reimbursement; CEO: “strong momentum of our U.S. launch” .
    • Coverage progress and physician adoption: “formal coverage policies are in place for over 90% of commercially covered lives”; OGSIVEO “NCCN category 1 preferred treatment” driving front-line use .
    • Pipeline/regulatory execution: mirdametinib NDA submission (Q2) followed by FDA Priority Review and EMA validation in Aug; company “expects path to second medicine in 2025” .
  • What Went Wrong

    • Elevated OpEx to support launches: SG&A $57.8M (+$10.8M YoY) and R&D $44.4M (+$8.5M YoY) pressured losses despite revenue growth .
    • One-time revenue contribution: $19.5M “other revenue” from GSK license termination inflated total revenue; recurring revenue growth needs to be parsed vs non-recurring items .
    • Seasonality risks: management acknowledged potential summer seasonality in Q3, tempering near-term trajectory expectations despite robust demand signals .

Financial Results

  • Income statement snapshot and trajectory
MetricQ4 2023Q1 2024Q2 2024
OGSIVEO Net Product Revenue ($USD Millions)$5.4 $21.0 $40.2
Other Revenue ($USD Millions)N/A$0.0 $19.5
Total Revenue ($USD Millions)N/A$21.0 $59.7
Net Loss ($USD Millions)N/A$(87.4) $(39.9)
Diluted EPS ($USD)N/A$(1.18) $(0.54)
  • YoY comparison
MetricQ2 2023Q2 2024
OGSIVEO Net Product Revenue ($USD Millions)$0.0 $40.2
Other Revenue ($USD Millions)$0.0 $19.5
Total Revenue ($USD Millions)$0.0 $59.7
Diluted EPS ($USD)$(1.25) $(0.54)
  • Margins vs prior quarter (computed from disclosed line items)
MetricQ1 2024Q2 2024
Cost of Product Revenue ($USD Millions)$1.2 $2.5
Product Gross Margin (%)94.3% (computed from $21.0 / $1.2) 93.9% (computed from $40.2 / $2.5)
Net Income (Loss) Margin (%)(416.1%) (computed from $(87.4)/$21.0) (66.8%) (computed from $(39.9)/$59.7)
  • Operating expense and liquidity
MetricQ1 2024Q2 2024
SG&A ($USD Millions)$60.1 $57.8
R&D ($USD Millions)$53.6 $44.4
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$573.0 $521.9
Weighted Avg Shares (Basic & Diluted)73.77M 74.12M
  • Revenue components (segment-like view)
ComponentQ1 2024Q2 2024
OGSIVEO Net Product Revenue ($USD Millions)$21.0 $40.2
Other Revenue ($USD Millions)$0.0 $19.5 (GSK license termination recognition)

Notes: Percent margins are computed from disclosed revenues and costs in company filings; citations reference source figures .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY/Q3 2024Not providedNot providedMaintained (no quantitative guidance)
DeFi Long-term Follow-up Data2H 2024Expected in 2H 2024Still expected in 2H 2024Maintained
Ovarian Granulosa Cell Tumor (OGCT) Phase 2 initial data2H 20242H 20242H 2024Maintained
Mirdametinib NDA status2024–2025Submission completion targeted Q2 2024Completed (Q2); FDA Priority Review; PDUFA 2/28/2025Raised visibility (timeline defined)
EU MAA for mirdametinib2H 2024File in 2H 2024EMA validation announced 8/28/2024Advanced (post-Q2 event)
EMA MAA for nirogacestatOngoingUnder reviewUnder reviewMaintained

The company did not issue quantitative revenue/EPS/OpEx guidance for Q3/Q4; management reiterated pipeline and regulatory milestones .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2023, Q1 2024)Current Period (Q2 2024)Trend
Product performance (OGSIVEO)Launch ramp: $5.4M in Q4; $21.0M in Q1; strong prescriber breadth/depth $40.2M net product revenue; minimal inventory effects; deeper patient pool than initially estimated Accelerating adoption; demand-driven growth
Payer access & coverageReimbursement aligned with label; rapid commercial/Medicare/Medicaid access >90% of commercially covered lives with formal coverage policies; NCCN Cat-1 preferred Durable, broadening access
Seasonality/macroNot discussed meaningfullyExpect some summer seasonality in Q3 Cautious near-term cadence
Regulatory/legal (mirdametinib)Rolling NDA initiated; plan to complete Q2 NDA completed; later FDA Priority Review and EMA validation Milestones achieved; timeline clarity
R&D execution (DeFi, OGCT, MM combos)DeFi data at ASCO; OGCT Phase 2 2H24; MM combo validation DeFi subgroup/ovarian toxicity updates; long-term follow-up data expected 2H24; OGCT data 2H24; MM combos ongoing Steady progress; near-term data catalysts
Emerging pipeline (SW-682, brimarafenib)SW-682 IND cleared; brimarafenib expansion planned SW-682 Phase 1a initiated; brimarafenib dose expansion data 1H25 Advancing early pipeline

Management Commentary

  • “We are very pleased with the continued strong momentum of our U.S. launch of OGSIVEO… completed the submission of our NDA for mirdametinib… potentially have our second medicine available for patients in 2025.” — CEO Saqib Islam .
  • “OGSIVEO is already the most prescribed systemic therapies for adults with desmoid tumors... $40.2 million in net product revenue.” — CCO Bhavesh Ashar .
  • “We have a strong balance sheet supporting our clear path to profitability with $522 million in cash… as of the end of the second quarter.” — CFO Francis Perier .
  • “Inventory impact in the second quarter was minimal… inventory was not a key driver of performance.” — CCO Bhavesh Ashar .
  • “We expect to see some seasonality in the summer months.” — CEO Saqib Islam .

Q&A Highlights

  • Demand composition and prescriber behavior: Increasing mix from existing patient refills with continued new patient starts; opportunity to move “wait-and-watch” patients to treatment as guidelines favor systemic therapy .
  • Community adoption and targeting: Minimal inventory impact; improved clinic targeting using desmoid tumor ICD-10 codes to be “in the right place at the right time” for community centers .
  • Seasonality and discontinuations: Some summer seasonality expected; discontinuations tracking to DeFi expectations; feedback highlights rapid pain relief and persistence on therapy .
  • Mirdametinib launch dynamics: Significant “white space” in adults (3/4 of market) with no approved therapy; pediatric market minimally penetrated—expect initial adoption across untreated segments .
  • Guidance clarity: PDUFA date timing expected about 60 days from filing (subsequently confirmed late August); no guidance on accelerated review beyond Priority Review .

Estimates Context

  • S&P Global consensus estimates for Q2 2024 EPS and revenue were unavailable due to mapping constraints; as a result, formal beat/miss assessment versus S&P consensus cannot be determined. Attempted retrieval of “Primary EPS Consensus Mean,” “Revenue Consensus Mean,” and “# of Estimates” for Q2 2024 returned unavailable; therefore, we note estimates were not accessible for this period.
  • Implication: Investors should focus on qualitative indicators (prescriber breadth/depth, minimal inventory effects, broad payer coverage, and ongoing milestones) for near-term trajectory until consensus access is restored .

Key Takeaways for Investors

  • OGSIVEO growth remains demand-led with minimal inventory effects; broad coverage and NCCN Cat-1 preferred status underpin continued adoption depth in COEs and breadth in community settings .
  • Expect some Q3 seasonality; however, growing patient pool visibility (ICD-10) and strong real-world symptom relief feedback support sustained trajectory into 2H24 .
  • One-time $19.5M “other revenue” boosted Q2 total revenue—model recurring OGSIVEO performance separately from non-recurring items .
  • Near-term catalysts: DeFi long-term follow-up data (extended treatment duration signal), OGCT Phase 2 initial data, continuous MM combination readouts .
  • Medium-term thesis: Mirdametinib Priority Review (PDUFA Feb 28, 2025) with adult first-in-class potential and pediatric best-in-class profile creates a second, sizable commercial opportunity; EMA validation broadens geographic scope .
  • Balance sheet ($521.9M cash and marketable securities) supports commercialization and pipeline execution toward profitability—monitor OpEx discipline as launch and readiness activities scale .
  • Without accessible S&P consensus, treat Q2 as a clean demand read; once consensus mapping is available, reassess beat/miss and update trading stance accordingly.