Executive Summary

Q4 2024 revenue execution remained strong: OGSIVEO U.S. net product revenue reached $61.5M, up sequentially from $49.3M in Q3 and $40.2M in Q2, reflecting continued breadth and depth of adoption in desmoid tumors .
GAAP net loss narrowed year-over-year to $77.3M ($1.04 per share) vs. $94.3M ($1.44) in Q4 2023, with higher operating spend driven by OGSIVEO commercialization and U.S. launch readiness for GOMEKLI (mirdametinib) .
FDA approved GOMEKLI on Feb 11, 2025 for adults and children with symptomatic NF1-PN; management is preparing for U.S. launch and initial EU launches for both OGSIVEO (mid-2025, beginning with Germany) and GOMEKLI in 2025 .
The company ended 2024 with $461.9M in cash and securities; management has previously guided that cash is expected to fund operations through profitability in 1H26 (reaffirmed in January preliminary update) .
Note: The company cancelled the Q4 earnings call; no fresh Q&A or guidance items were provided on Feb 20. Estimates from S&P Global were unavailable via tool access; we cannot assess beat/miss versus consensus at this time .

What Went Well and What Went Wrong

What Went Well

Continued commercial traction: OGSIVEO Q4 U.S. net product revenue of $61.5M capped full-year $172.0M, evidencing durable adoption and patient stacking through 2024 .
Regulatory progress and portfolio expansion: FDA approved GOMEKLI for NF1-PN adults and children, granting a priority review voucher; EU filings for both OGSIVEO and GOMEKLI are under EMA review with 2025 launches expected .
Management conviction and launch readiness: “We are very pleased with the strong execution of OGSIVEO in 2024… With the recent FDA approval of GOMEKLI…we believe we are ready to deliver another strong launch,” CEO Saqib Islam said, underscoring confidence in dual-launch execution and global expansion .

What Went Wrong

Higher operating expenses: Q4 SG&A of $77.1M and R&D of $60.2M increased year-over-year, reflecting commercial activities (OGSIVEO) and launch readiness (GOMEKLI), as well as higher external R&D costs; this pressured quarterly EPS despite revenue growth .
No Q4 call or detailed guidance: The company cancelled the conference call; no quantitative 2025 revenue/expense guidance or non-GAAP frameworks were provided in the release, limiting forward visibility .
Consensus benchmarking gap: S&P Global consensus for Q4 (EPS and revenue) was unavailable through our tool, preventing a formal beat/miss assessment vs. Street expectations (we do not infer) [GetEstimates error – S&P Global mapping unavailable].

Financial Results

Metric	Q4 2023	Q2 2024	Q3 2024	Q4 2024
OGSIVEO Net Product Revenue ($M)	n/a	$40.2	$49.3	$61.5
Total Revenue ($M)	n/a	$59.7 (incl. $19.5 other)	$49.3	n/a
Net Loss ($M)	$94.3	$39.9	$53.5	$77.3
Diluted EPS ($)	$(1.44)	$(0.54)	$(0.72)	$(1.04)
SG&A ($M)	n/a	$57.8	$61.6	$77.1
R&D ($M)	n/a	$44.4	$42.3	$60.2
Cash & Securities (Period-End, $M)	n/a	$521.9 (6/30/24)	$498.1 (9/30/24)	$461.9 (12/31/24)

Notes:

“n/a” indicates the company did not disclose the figure in those documents.
Q2 total revenue includes $19.5M of “Other revenue” recognized upon GSK agreement termination .

KPIs and Commercial Execution (latest disclosed)

Unique desmoid tumor patients filling OGSIVEO Rx in September 2024: >800; ~420 treatment centers have ordered OGSIVEO; ~65% of patients had transitioned to blister packs by end of Q3 (flat pricing for 100/150 mg) .
Discontinuations to date were “limited” (fewer than 10% approximately one year into launch); majority on 150 mg, some on 100 mg; blister packs improve visibility and adherence .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance/Status	Change
Cash runway to profitability	Through 1H 2026	“Expected to fund through profitability, anticipated 1H 2026” (Q3’24 PR)	Reiterated in Jan 13 preliminary update (fund through profitability, anticipated 1H 2026)	Maintained
OGSIVEO EU launch	2025	Anticipated EMA approval 1H 2025; EU launch planning underway (Q3’24)	Launch expected beginning mid-2025, starting with Germany, subject to country reimbursement	Refined timing/details
GOMEKLI (mirdametinib) U.S.	2025	PDUFA Feb 28, 2025 (priority review)	FDA approved Feb 11, 2025; launch preparation active	Achieved approval
GOMEKLI EU	2025	MAA validated/under review (Q3’24)	Under EMA review; initial launch in 2025 expected	Maintained
2025 Revenue/OpEx/Tax guidance	2025	Not provided	Not provided; Q4 call cancelled	n/a

Earnings Call Themes & Trends

Topic	Q2 2024 (Q-2)	Q3 2024 (Q-1)	Q4 2024 (Current)	Trend
OGSIVEO launch momentum	$40.2M; broadening adoption; blister pack introduced	$49.3M; 23% q/q growth; >800 monthly unique patients; 420 centers; 65% blister pack	$61.5M product revenue; continued strong execution	Up
Market size (ICD-10)	n/a	~10,000 unique patients identified via new code through Aug 2024; suggests larger TAM	Not updated in Q4 PR (no call)	Up (Q3 data)
Blister pack transition	Introduced blister packs	Transition caused July delays; stronger Aug/Sep; flat pricing 100/150 mg	Not updated in Q4 PR (no call)	Completed/beneficial
EU expansion (OGSIVEO)	MAA under EMA review	Approval anticipated 1H 2025	Launch after reimbursement by country, starting Germany mid-2025	Progressing
GOMEKLI (NF1-PN)	NDA submitted; ASCO ReNeu data	PDUFA 2/28/25; EMA MAA validated	FDA approved 2/11/25; U.S. launch readiness	Achieved approval
Long-term DeFi data (OGSIVEO)	ASCO subgroup updates	CTOS late-breaking long-term efficacy/safety planned	Long-term DeFi highlighted in Q4 materials (publication planned 2025)	Reinforcing durability
Cash runway	$521.9M (6/30)	$498.1M (9/30); runway to 1H26 profitability	$461.9M (12/31); Jan prelim reaffirmed 1H26 profitability target	Adequate

Management Commentary

“We are very pleased with the strong execution of OGSIVEO in 2024… With the recent FDA approval of GOMEKLI…we believe we are ready to deliver another strong launch…” — Saqib Islam, CEO .
On portfolio and global expansion: EU MAA reviews are underway for both OGSIVEO and GOMEKLI; OGSIVEO EU launch expected mid-2025 beginning in Germany; GOMEKLI initial EU launch expected in 2025 .
On financial drivers: Q4 SG&A ($77.1M) rose due to commercial readiness for GOMEKLI and OGSIVEO activities; R&D ($60.2M) increased on licensing, manufacturing, clinical and professional services .

Q&A Highlights

Note: The Q4 2024 conference call was cancelled; highlights below reflect Q3 2024 Q&A.

Blister packs: Transition created ~2-week refill delays for many patients in July; strongest months ever in Aug/Sep; expected to improve adherence and refill predictability with flat pricing across doses .
Market sizing: New ICD-10 code identified ~10,000 unique desmoid tumor patients within ~11 months, indicating prior TAM estimates were conservative and adoption of the code still maturing .
Discontinuations and dosing: Fewer than 10% of OGSIVEO patients discontinued roughly one year into launch; majority remained on 150 mg; visibility improving with blister pack conversion .
Demand trajectory: Management indicated poised for acceleration beyond Q3 with month-over-month strength and durable patient stacking .

Estimates Context

S&P Global consensus (revenue, EPS) for Q4 2024 was not retrievable via our tool due to a Capital IQ mapping gap for SWTX; we cannot determine beat/miss against Street at this time. We will reassess when S&P Global mapping is available. Values would be retrieved from S&P Global if available.

Key Takeaways for Investors

Demand-driven revenue ramp: OGSIVEO sequential growth to $61.5M in Q4 (from $49.3M in Q3 and $40.2M in Q2) indicates durable stacking and expanding prescriber base; near-term trend favors continued U.S. growth .
Dual-launch setup: FDA approval of GOMEKLI provides a second commercial pillar in 2025; EMA reviews and EU launch plans for both assets add ex-U.S. optionality (OGSIVEO Germany mid-2025) .
Operating spend elevated but strategic: SG&A and R&D increases are tied to commercialization and pipeline execution; absent formal guidance, investors should monitor OpEx cadence versus launch uptake .
Cash runway: $461.9M year-end cash supports execution through the anticipated profitability timeline in 1H26, reducing near-term financing risk absent unexpected setbacks .
Data catalysts: Long-term DeFi results (publication planned 2025), initial nirogacestat monotherapy data in ovarian granulosa cell tumors (1H25), and continuing real-world OGSIVEO metrics are potential narrative drivers .
EU reimbursement pacing: Timing and breadth of ex-U.S. launches (country-by-country) are key to FY25 trajectory; Germany mid-2025 is the first step .
Process note: With Q4 call cancellation and no guidance provided, buyside should triangulate near-term trends using prescription/specialty data where available and revisit Street models post-initial GOMEKLI launch updates .

Supporting Detail: Other Relevant Q4 2024 Press Releases

Long-term OGSIVEO DeFi data to be presented at CTOS 2024 showed deepening responses and sustained PRO benefits with median ~3 years’ therapy; safety consistent and TEAE severity decreased after year one .

Appendix: Source Documents

Q4/FY 2024 8-K (Item 2.02) and EX-99.1 press release (Feb 20, 2025): Revenues, expenses, net loss, cash, regulatory updates .
Preliminary Q4/FY update (Jan 13, 2025): Early revenue and cash update; profitability timing reiterated .
Q3 2024 PR and call: Launch metrics, ICD-10 market sizing, financials, runway .
Q2 2024 PR: Early OGSIVEO ramp, financials including “Other revenue” from GSK termination .

S&P Global estimates: Unavailable via our tool for SWTX this quarter due to mapping; will update when accessible.

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