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II

Innoviva, Inc. (INVA)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 delivered solid top-line with total revenue of $91.8M, driven by GSK royalties ($66.0M gross; $62.5M net) and IST net product sales of $28.9M; GAAP net income was $20.3M ($0.32 basic EPS; $0.26 diluted) .
  • IST U.S. net product sales reached $24.9M in Q4 on strong GIAPREZA ($15.9M), XERAVA ($3.1M), and XACDURO ($5.9M); full-year U.S. net product sales rose 47% YoY to $80.9M .
  • Management guided FY 2025 IST U.S. net product sales to exceed $100M and expects ZEVTERA launch mid-2025, with a zoliflodacin NDA submission in early 2025, supported by nearly $400M in cash and receivables .
  • Equity investment fair value changes were a recurring headwind in 2024, tied largely to Armata; the Q4 change was $19.6M unfavorable (equity and LT investments), though smaller than Q2/Q3 . Stock catalysts ahead include ZEVTERA launch and zoliflodacin regulatory milestones .

What Went Well and What Went Wrong

What Went Well

  • IST commercial momentum: “IST’s revenue growth was driven by the successful launch of XACDURO and a renewed commercial strategy unlocking new opportunities for GIAPREZA” .
  • Product recognition: XACDURO named preferred agent in 2024 IDSA guidance; XERAVA recommended by 2024 SIS guidelines, improving market access and visibility .
  • Strengthened portfolio: Exclusive U.S. rights to ZEVTERA, the only FDA-approved MRSA cephalosporin for SAB/endocarditis; targeted mid-2025 launch to leverage IST infrastructure .

What Went Wrong

  • Investment mark-to-market headwinds: Q4 unfavorable change in fair values of equity and LT investments of $19.6M, with Armata depreciation cited; larger headwinds in prior quarters (Q3 $35.2M; Q2 $90.7M) .
  • Royalty revenue softness YoY in Q4: Gross royalties $66.0M vs $69.6M in Q4 2023; net royalty revenue $62.5M vs $66.2M .
  • Limited disclosure on margins and no Q4 earnings call transcript available in the document set, constraining detail on operational cadence and Q&A clarifications [ListDocuments: earnings-call-transcript returned none].

Financial Results

Consolidated P&L vs prior quarters

MetricQ2 2024Q3 2024Q4 2024
Total Revenue ($USD Millions)$99.9 $89.5 $91.8
Net Product Sales ($USD Millions)$21.651 $27.822 $28.935
Royalty Revenue, Net ($USD Millions)$63.742 $57.056 $62.520
License Revenue ($USD Millions)$14.505 $4.630 $0.351
Net Income ($USD Millions)$(34.685) $1.213 $20.332
Basic EPS ($USD)$(0.55) $0.02 $0.32
Diluted EPS ($USD)$(0.55) $0.02 $0.26
Gross GSK Royalties ($USD Millions)$67.198 $60.512 $65.975

Note: Press release rounded Q4 gross royalties to $66.0M; statements show $65.975M .

Segment breakdown – Q4 2024 IST and Royalties

SegmentQ4 2024 ($USD Millions)
GIAPREZA (U.S. net product sales)$15.9
XERAVA (U.S. net product sales)$3.1
XACDURO (U.S. net product sales)$5.9
Ex-U.S. Net Product Sales$4.0
Total Net Product Sales$28.9
GSK Gross Royalties$66.0 (rounded)

Balance sheet KPIs

KPIQ2 2024Q3 2024Q4 2024
Cash & Cash Equivalents ($USD Millions)$217.0 $260.6 $305.0
Royalty & Product Sale Receivables ($USD Millions)$94.0 $91.1 $86.4

Margins vs estimates

MetricQ2 2024Q3 2024Q4 2024Wall St. Consensus
Net Income Margin %N/A (SPGI limit)N/A (SPGI limit)N/A (SPGI limit)N/A (SPGI limit)

Estimates unavailable: We attempted to retrieve S&P Global consensus; request was rate-limited.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
IST U.S. Net Product SalesFY 2025N/A>$100M N/A (new)
ZEVTERA U.S. Launch TimingFY 2025N/AMid-2025 N/A (new)
Zoliflodacin NDA SubmissionEarly 2025N/AEarly 2025 N/A (new)

Earnings Call Themes & Trends

Note: No Q4 earnings call transcript was found in the document set. Themes below reflect disclosures from Q2/Q3/Q4 press releases.

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
IST product performanceU.S. net product sales +38% YoY; GIAPREZA $13.1M, XERAVA $6.2M, XACDURO $2.4M U.S. net product sales +68% YoY; GIAPREZA $13.1M, XERAVA $2.3M, XACDURO $4.3M U.S. net product sales $24.9M; GIAPREZA $15.9M, XERAVA $3.1M, XACDURO $5.9M Strengthening growth
Guidelines/clinical recognitionXACDURO preferred in 2024 IDSA; XERAVA recommended by 2024 SIS XACDURO Prix Galien nomination; multiple scientific presentations Continued favorable guidelines placement cited Sustained endorsement
Regulatory pathway (zoliflodacin)Phase 3 positive; NDA planned early 2025 Multiple data presentations; NDA planned early 2025 NDA submission on track for early 2025 Steady progress
Portfolio expansionN/AFocus on capital allocation, value creation Licensed U.S. rights to ZEVTERA; launch mid-2025 Expansion
Regional trendsN/AEx-U.S product sales $8.1M Ex-U.S product sales $4.0M Mixed/variable
Macro/supply chain/tariffsNot discussedNot discussedNot discussedNo material commentary
Investment fair values (Armata)Unfavorable change $90.7M Unfavorable change $35.2M Unfavorable change $19.6M Headwind moderating

Management Commentary

  • “2024 was an exceptional year for Innoviva. Our core royalty portfolio and therapeutics business both delivered strong year-over-year revenue growth…a clear validation of our strategy to build a leading commercial business in critical care and infectious disease.” — Pavel Raifeld, CEO .
  • “Looking ahead, we anticipate another strong year in 2025 highlighted by an NDA submission for zoliflodacin, the launch of ZEVTERA in mid-2025, and continued growth of our marketed products, with U.S. net product sales forecasted to exceed $100 million.” — Pavel Raifeld .
  • “We remain focused on prudent capital allocation… and see multiple opportunities for continued value creation.” — Pavel Raifeld (Q3) .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available in the document set; therefore, Q&A themes and management clarifications cannot be summarized for this quarter [ListDocuments: earnings-call-transcript returned none].

Estimates Context

  • We attempted to retrieve S&P Global consensus for Q4 2024 EPS and revenue; the request was rate-limited and data were unavailable at this time (thus, no vs-estimates comparison can be presented) [GetEstimates error].
  • Implications: Management’s guidance of >$100M U.S. net product sales for FY 2025 may prompt upward IST revenue expectations; near-term estimate changes likely hinge on ZEVTERA launch timing and zoliflodacin NDA submission/acceptance .

Key Takeaways for Investors

  • IST commercial execution is the primary growth driver; Q4 U.S. net product sales rose to $24.9M with balanced contributions across GIAPREZA, XERAVA, and XACDURO .
  • Royalty platform remains resilient, though Q4 gross royalties slightly declined YoY; combined with IST growth, total revenue maintained stability at $91.8M .
  • Portfolio catalysts in 2025: ZEVTERA U.S. launch (mid-year) and zoliflodacin NDA submission (early 2025); both can expand addressable market and revenue base .
  • Balance sheet strength (cash $305.0M; receivables $86.4M) supports continued investment and commercialization initiatives without near-term financing pressure .
  • Equity investment mark-to-market headwinds persisted but moderated vs prior quarters; monitor Armata developments as a swing factor in reported earnings volatility .
  • With no call transcript available, watch for upcoming conference appearances and regulatory updates to gauge management tone and operational cadence .
  • Near-term trading implications: headlines on ZEVTERA launch readiness and zoliflodacin filing progress are likely stock catalysts; medium-term thesis centers on IST scaling and royalty durability .