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SpringWorks Therapeutics, Inc. (SWTX)·Q3 2024 Earnings Summary

Executive Summary

  • OGSIVEO net product revenue was $49.3M, up 23% QoQ, with momentum driven by blister pack transition and broader prescriber adoption; cash and marketable securities were $498.1M and management reiterated an expectation to reach profitability in H1 2026 .
  • Mirdametinib NDA received FDA Priority Review with a PDUFA action date of February 28, 2025; EMA MAA validated and under review, positioning the company for a potential second commercial product in early 2025 .
  • Long-term DeFi data for OGSIVEO to be presented at CTOS show deeper responses and sustained symptomatic improvement over ~3 years of treatment, a narrative likely to support longer treatment duration and refills; >800 unique patients filled an OGSIVEO script in September and ~420 centers have ordered since approval .
  • ICD-10 claims data identified ~10,000 unique desmoid tumor patients since October 2023, suggesting the addressable treated population is meaningfully larger than prior estimates, strengthening the multi-year growth case .
  • Wall Street consensus (S&P Global) for Q3 2024 was unavailable due to mapping; beats/misses vs estimates cannot be assessed this quarter (values from S&P Global unavailable).

What Went Well and What Went Wrong

What Went Well

  • OGSIVEO net product revenue rose to $49.3M (+23% QoQ) driven by strong demand and adoption across both centers of excellence and community physicians; August and September were the strongest months since launch .
  • Launch execution and patient experience improved via 150mg/100mg blister packs (flat pricing across doses), enhancing adherence and refill predictability; ~65% of patients transitioned by quarter-end, with completion expected by year-end .
  • Narrative for durable therapy strengthened: CTOS late-breaking long-term DeFi data show further tumor reductions, increased ORR (new PRs/CRs), sustained PRO improvements, and decreasing TEAE incidence over years two to four .
    • CEO: “We have only scratched the surface of OGSIVEO’s opportunity… and are poised for success…” .

What Went Wrong

  • Phase 2 monotherapy data for nirogacestat in ovarian granulosa cell tumors pushed to H1 2025 from prior 2H 2024 timelines, a delay in that readout .
  • SG&A rose to $61.6M (from $46.5M YoY) and R&D to $42.3M (from $37.5M YoY), reflecting launch readiness and pipeline execution; though strategically aligned, these increased expenses weighed on net loss .
  • Short-term operational friction: blister pack transition (new Rx required for some patients) and typical summer seasonality impacted July new starts, albeit offset by strong August/September .

Financial Results

Quarterly P&L and EPS

MetricQ1 2024Q2 2024Q3 2024
Product Revenue, net ($USD Thousands)$21,006 $40,186 $49,301
Other Revenue ($USD Thousands)$— $19,547 $—
Total Revenue ($USD Thousands)$21,006 $59,733 $49,301
Cost of Product Revenue ($USD Thousands)$1,202 $2,453 $3,341
SG&A ($USD Thousands)$60,113 $57,839 $61,601
R&D ($USD Thousands)$53,622 $44,362 $42,296
Total Operating Costs & Expenses ($USD Thousands)$114,937 $104,654 $107,238
Net Loss ($USD Thousands)$(87,385) $(39,919) $(53,530)
Net Loss per Share (Basic/Diluted) ($)$(1.18) $(0.54) $(0.72)

Balance Sheet Snapshots

MetricMar 31, 2024Jun 30, 2024Sep 30, 2024
Cash, Cash Equivalents & Marketable Securities ($USD Thousands)$572,987 $521,933 $498,123
Working Capital ($USD Thousands)$402,881 $376,824 $364,498
Total Assets ($USD Thousands)$656,832 $617,331 $608,878
Total Liabilities ($USD Thousands)$89,392 $60,601 $76,297
Total Stockholders’ Equity ($USD Thousands)$567,440 $556,730 $532,581

YoY Comparison (Q3 2024 vs Q3 2023)

MetricQ3 2023Q3 2024
Total Revenue ($USD Thousands)$— $49,301
SG&A ($USD Thousands)$46,546 $61,601
R&D ($USD Thousands)$37,453 $42,296
Net Loss ($USD Thousands)$(79,437) $(53,530)
Net Loss per Share ($)$(1.27) $(0.72)

Segment/KPI Details

MetricQ1 2024Q2 2024Q3 2024
OGSIVEO Net Product Revenue ($USD Thousands)$21,006 $40,186 $49,301
Other Revenue ($USD Thousands)$— $19,547 (GSK termination recognition) $—
Unique Patients Filling OGSIVEO Script (Monthly)——>800 in September
Treatment Centers Ordering OGSIVEO (Cumulative)——~420
Blister Pack Adoption (% of OGSIVEO Patients)——~65%
Prescribers in Community Setting (% of OGSIVEO prescribers)——57%
Discontinuations (since launch)——<10%

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Profitability TimingCompany“Clear path to profitability” (no date) Expected H1 2026 Introduced timeline (specified)
OGSIVEO Blister Pack Transition2024Introduced mid-May; transition over ~3 months Full transition by year-end; flat pricing 100mg/150mg Maintained, expanded detail
Nirogacestat (Granulosa Cell Tumors) Phase 2 DataReadoutInitial data in 2H 2024 Initial data in H1 2025 Delayed
Mirdametinib (NF1-PN) U.S.RegulatoryNDA submission completed; PDUFA to be announced FDA Priority Review; PDUFA Feb 28, 2025 Firmed timing
Mirdametinib (NF1-PN) EURegulatoryMAA planned/under review in 2H 2024 MAA validated; under EMA review Maintained/progressed
OGSIVEO EU Approval TimingEUUnder EMA review; potential 2025 Anticipate approval in H1 2025 Narrowed window
Japan OGSIVEORegulatory—Bridging study expected next year New item

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
OGSIVEO Adoption & Standard of CareRapid uptake; category 1 NCCN; most prescribed systemic therapy; strong prescriber satisfaction 23% QoQ revenue growth; strongest months in Aug/Sep; broadened community adoption Strengthening
Blister Pack TransitionFDA-approved blister packs introduced mid-May to enhance convenience/adherence ~65% transitioned; flat pricing; improved refill predictability; short-term July delays Positive, operationally maturing
Market Size/ICD-10 InsightsActively managed pool 5,500–7,000; ICD-10 adoption improving identification ~10,000 unique patients identified via ICD-10 since Oct 2023; larger addressable base Upward revision of TAM
EU ExpansionEMA MAA for OGSIVEO under review; mirdametinib EU filing planned EU approvals anticipated 2025; European HQ established; launch sequencing starting with Germany Advancing execution
Mirdametinib DifferentiationReNeu data: deep responses; QoL improvements; manageable tolerability Priority Review; PDUFA set; additional SNO presentations; adult first-in-class, pediatric best-in-class positioning De-risking/regulatory progress
Long-term OGSIVEO DataASCO subgroup data; ovarian toxicity resolution; plans for long-term follow-up CTOS late-breaking long-term DeFi: increased ORR, deeper responses, sustained PROs, decreasing TEAE severity over time Reinforcing durability

Management Commentary

  • CEO: “We have only scratched the surface of OGSIVEO’s opportunity to benefit patients with desmoid tumors and are poised for success…” .
  • CCO: “In September, over 800 unique patients filled a prescription… ~65% are on blister packs… we expect to complete the transition by year-end” .
  • CFO: “We believe our balance sheet will be sufficient to fully fund our operations through profitability… in the first half of 2026” .
  • CMO (on DeFi long-term): “Longer-term treatment… associated with further reductions in tumor size… increased PRs and CRs… sustained improvements… and a consistent safety profile” .

Q&A Highlights

  • Blister pack transition caused ~two-week Rx delays for many patients, mostly in July; trend reversed with record August and September; benefits include reduced pill burden, improved adherence, and flat pricing between 100mg/150mg .
  • ICD-10 desmoid-specific codes indicate underestimation of treated population; ~10,000 unique patients identified in <1 year, with continued adoption expected .
  • Momentum into Q4: management sees “acceleration” with patient stacking and improved refills; no signs of abatement in trends going into October/November .
  • Patient mix: newly diagnosed, watch-and-wait transitioning to active therapy, and switches from TKIs/chemo/surgery; no specific skew identified .
  • Discontinuations remain low (<10%); dose reductions to be better quantified post full blister adoption; DeFi protocol saw ~40% dose reductions, providing a reference .

Estimates Context

  • S&P Global consensus estimates for Q3 2024 revenue/EPS were unavailable due to a CIQ mapping issue for SWTX; as a result, we cannot assess beats/misses vs consensus this quarter (values from S&P Global unavailable).
  • Management provided no quantitative revenue/EPS guidance; operational/milestone guidance focused on regulatory timelines and profitability timing .

Key Takeaways for Investors

  • OGSIVEO growth is compounding: +23% QoQ revenue with operational tailwinds from blister packs, broader community adoption, and expanding identifiable patient pool via ICD-10; momentum should carry into Q4 .
  • Long-duration therapy case is strengthening: CTOS data indicate deeper responses and sustained PROs over ~3 years, supporting longer treatment durations and refills—a structural driver for revenue durability .
  • 2025 is a dual-launch year potential: mirdametinib Priority Review (Feb 28, 2025 PDUFA) plus OGSIVEO EU approval targeted H1 2025; commercial infrastructure build-out in Europe underway .
  • Capital runway and profitability timeline provide de-risking: $498.1M cash/marketable securities and path to profitability in H1 2026 enable sustained investment in launches and pipeline .
  • Near-term catalysts: CTOS long-term DeFi presentation (Nov), SNO mirdametinib data (Nov), ongoing EU regulatory reviews, and continued U.S. OGSIVEO adoption—all potential stock reaction drivers .
  • Watch execution on delayed granulosa cell tumor readout (shifted to H1 2025); any further delays could modestly temper pipeline contribution assumptions .
  • Tactical trading implication: strength into Q4 as blister transition completes and refill predictability increases; attention on Feb 28, 2025 PDUFA as a binary catalyst and EU approval windows in H1 2025 .