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UT

UNITED THERAPEUTICS Corp (UTHR)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 delivered strong growth: total revenues rose 20% year-over-year to $735.9M, net income increased 39% to $301.3M, and diluted EPS was $6.19 versus $4.36 in Q4 2023 . Sequentially, revenue declined from Q3’s $748.9M due to higher gross-to-net deductions tied to Tyvaso contracting, despite record gross revenues and record product shipments, positioning a higher base for future growth .
  • Tyvaso franchise remained the primary driver: total Tyvaso revenue reached $415.9M (+19% YoY), with DPI at $273.2M (+28% YoY) and nebulized at $142.7M (+4% YoY), supported by PH-ILD prescriber breadth/depth and Part D dynamics .
  • Strategic pipeline catalysts: FDA cleared the IND for the UKidney xenotransplantation clinical trial (first transplant expected mid-2025), and TETON IPF program achieved full enrollment in TETON 1 with top-line data timelines (TETON 2 H2’25; TETON 1 H1’26) .
  • Management reiterated confidence in double-digit growth for the foundational business and reinforced payer contracting strategy to defend parity ahead of potential competition; no formal 2025 sales guidance provided .
  • Wall Street consensus estimates from S&P Global were unavailable at the time of this analysis due to API limits; beat/miss assessment could not be performed (see Estimates Context).

What Went Well and What Went Wrong

What Went Well

  • Tyvaso execution: Q4 Tyvaso revenue grew 19% YoY to $415.9M, driven by record patient shipments and near-record referrals/starts; management highlighted strengthened ILD prescriber penetration and continued growth in both PH-ILD and PAH indications .
  • Broad product strength: Orenitram (+28% YoY to $107.8M), Remodulin (+17% YoY to $134.5M), and Unituxin (+25% YoY to $67.5M) all posted solid Q4 growth, with Unituxin’s U.S. revenue at $62M on price and volume .
  • Pipeline momentum: UKidney IND clearance (phaseless study up to 50 patients); TETON 1 fully enrolled (598 patients), TETON 2 top-line expected H2’25, supporting IPF label expansion efforts and potential DPI bridging thereafter .

Quotes:

  • “Congratulations…another record revenue year…third year in a row of record-setting revenue…we have now begun our 3-year cascade of clinical and regulatory events, starting with…IND clearance for our UKidney clinical trial.” – Martine Rothblatt .
  • “Our fourth quarter total net revenue was down slightly sequentially…due in part to our recent contracting efforts for Tyvaso…creating a new base from which Tyvaso can continue to grow.” – Michael Benkowitz .
  • “Completing enrollment in [TETON 1] brings us one step closer to potentially delivering a transformative…treatment option for…IPF.” – Peter Smith .

What Went Wrong

  • Sequential revenue softness: Q4 net revenue declined versus Q3 due to higher gross-to-net deductions from Tyvaso contracting, even as underlying gross revenues were record-setting .
  • SG&A step-up: Selling, general, and administrative expense increased 27% YoY in Q4 to $168.5M, with a $6.0M litigation accrual (Sandoz), and share-based compensation nearly doubling YoY, pressuring opex .
  • Adcirca headwind: Q4 Adcirca revenue fell 31% YoY to $4.7M, continuing to be a small drag within the portfolio .

Financial Results

Consolidated Performance vs Prior Year and Prior Quarter

MetricQ4 2023Q3 2024Q4 2024
Total Revenues ($USD Millions)$614.7 $748.9 $735.9
Operating Income ($USD Millions)$260.1 $343.1 $357.7
Net Income ($USD Millions)$217.1 $309.1 $301.3
Diluted EPS ($USD)$4.36 $6.39 $6.19

Note: Sequential decline in Q4 2024 revenues vs Q3 largely due to gross-to-net impacts tied to Tyvaso contracting .

Segment Breakdown (Net Product Sales)

Segment ($USD Millions)Q4 2023Q3 2024Q4 2024
Tyvaso DPI$213.7 $274.6 $273.2
Nebulized Tyvaso$136.9 $159.2 $142.7
Total Tyvaso$350.6 $433.8 $415.9
Remodulin$115.1 $128.3 $134.5
Orenitram$84.1 $113.2 $107.8
Unituxin$54.2 $61.1 $67.5
Adcirca$6.8 $7.0 $4.7
Other$3.9 $5.5 $5.5
Total Revenues$614.7 $748.9 $735.9

Geographic Revenue Split

Geography ($USD Millions)Q4 2023Q3 2024Q4 2024
U.S. Total Revenues$585.9 $717.3 $705.7
ROW Total Revenues$28.8 $31.6 $30.2
Total$614.7 $748.9 $735.9

Margins (Computed from reported figures)

Margin (%)Q4 2023Q3 2024Q4 2024
EBIT Margin %42.3% (260.1/614.7) 45.8% (343.1/748.9) 48.6% (357.7/735.9)
Net Income Margin %35.3% (217.1/614.7) 41.3% (309.1/748.9) 40.9% (301.3/735.9)
Gross Profit Margin %88.4% ((614.7-71.0)/614.7) 88.9% ((748.9-83.1)/748.9) 89.7% ((735.9-75.9)/735.9)

Note: Gross margin computed using total cost of sales; EBIT margin uses operating income; margins are derived from company-reported financials with cited inputs.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Company Sales GuidanceFY 2025Not providedNot providedMaintained (no formal guidance)
Foundational business growth commentary2025–2026Double-digit growth expectationContinues to expect double-digit growthMaintained (management commentary)
Tax Rate (effective ETR)FY 2024 actual~23% in 2023~22% in 2024 actualDecrease vs prior year (actuals, not guidance)

Management did not issue formal revenue, margin, or EPS guidance; commentary reiterated confidence in double-digit growth for the foundational portfolio.

Earnings Call Themes & Trends

TopicQ2 2024 (Prior)Q3 2024 (Prior)Q4 2024 (Current)Trend
Part D redesign (IRA) impactConversion from PAP to commercial payers; supports Tyvaso DPI and Orenitram utilization Continued benefits; payer contracting begins to phase in Impact largely played out in 2024; baseline ~90% commercial / ~10% PAP Stabilizing
Payer contracting / rebatesPreparing for parity; entering contracts to defend access Contracts phased in (July/Oct/Jan), higher gross-to-net in Q3 Gross-to-net weighed on Q4 sequential; “new base” for growth Completed ramp; base reset
PH-ILD prescriber expansionSales force expansion; growing breadth/depth ILD prescribers + breadth; DPI/nebulizer steady-state Majority of growth from ILD treating community; strong breadth/depth Strengthening
Merck’s product (“Wind River”/sotatercept)Combination use with prostacyclins observed; base business solid Contracting preemptively for competition Impact expected immaterial; PAH remains progressive; prostacyclins essential Neutral
Xenotransplantation (UKidney)Pre-IND feedback; design discussions Pre-IND, planning; xeno momentum IND cleared; first transplant mid-2025; cohort design & endpoints detailed Advancing
IPF program (TETON)Enrollment progress; FDA interactions; bridging strategy foreseen Marketing/manufacturing readiness for DPI in IPF TETON 1 fully enrolled; TETON 2 topline H2’25; IPF label plan incl. bridging Advancing
Capital allocationASR in process; prioritization across R&D/CD/ASR $1B ASR completed; capacity for DPI expansion Reaffirmed capital philosophy; $1B returned via ASR Balanced

Management Commentary

  • Strategic positioning: “Record performance…innovative and revolutionary development programs…disciplined financial management and capital allocation…we’ve never been in a better position” – Martine Rothblatt .
  • Contracting rationale: “Lock in payers with additional rebates…keep us at parity…payers less likely to disadvantage us as rebate dollars are flowing” – Michael Benkowitz .
  • Foundational growth outlook: “Expect to continue to grow double digits out into the mid-decade…no change in perspective despite contracting” – Michael Benkowitz .
  • UKidney study design: “Six-participant cohort, 12-week review…endpoints include graft survival, patient survival, kidney function, and safety including zoonotic infections” – Leigh Peterson .

Q&A Highlights

  • Growth trajectory without formal guidance: Management expects continued double-digit revenue growth for the foundational business in 2025–2026, even after contracting impacts; no formal sales guidance provided .
  • Xenotransplantation program: Cohort-based “phaseless” clinical design; privacy protocols in formal study; progression contingent on DSMB review at 12 weeks between first and second transplant .
  • Competitive dynamics (sotatercept): Management views impact as immaterial over long term; PAH’s progressive nature implies eventual prostacyclin use; combination therapy already observed .
  • Tyvaso PH-ILD prescriber strategy: Sales force expansion led to meaningful breadth/depth gains in ILD treating community; Tyvaso growing in both PH-ILD (~35–40% in 2024) and PAH (mid-teen growth) .
  • Contracting and IPF launch prep: Preemptive payer contracts establish rebate flows and parity; clinicians to decide best product, with UT believing it’s well positioned .

Estimates Context

  • S&P Global Wall Street consensus estimates for Q4 2024 EPS and revenue were unavailable at the time of analysis due to API request limits; beat/miss analysis versus consensus could not be performed. Users should expect potential updates once S&P Global data access is restored.

Key Takeaways for Investors

  • Sequential softness in Q4 was driven by intentional Tyvaso contracting (gross-to-net) rather than demand; underlying KPIs (shipments, referrals, starts) remained robust, suggesting a reset to a higher base for 2025 growth .
  • Tyvaso remains the core near-term growth engine across PH-ILD and PAH; ILD prescriber breadth/depth is improving, reinforcing runway ahead of IPF readouts .
  • High-impact pipeline catalysts: UKidney first transplant mid-2025 and TETON timelines (TETON 2 H2’25; TETON 1 H1’26) represent material optionality for IPF label expansion and broader organ innovation narrative .
  • Portfolio breadth supports resilience: Orenitram, Remodulin, and Unituxin all delivered double-digit YoY growth; Remunity Pro pump clearance may further support Remodulin uptake .
  • Margin quality remains strong with expanding EBIT margin versus prior periods; opex elevated due to SG&A and litigation accrual, but operating leverage evident on higher revenue base .
  • Payer strategy reduces competitive risk: Preemptive contracting creates parity and ongoing rebate flows, positioning UT favorably if new entrants arrive; expect gross-to-net normalization from Q4 levels .
  • Trading lens: Near-term stock catalysts include UKidney milestones and TETON 2 topline in H2’25; watch for incremental updates on payer dynamics, PH-ILD prescriber expansion, and any signals on ralinepag timelines .