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ENANTA PHARMACEUTICALS INC (ENTA)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 FY2024 revenue was $14.6M, down 22.7% y/y, driven by lower AbbVie MAVYRET/MAVIRET royalties; GAAP diluted EPS was $(1.36) with a net loss of $(28.8)M .
  • Company did not host a Q4 earnings call; next update was tied to pediatric RSV (RSVPEDs) topline in December 2024 .
  • Strategic momentum: positive EDP-323 Phase 2a RSV challenge topline (highly significant reductions in viral load and symptoms) and subsequent positive pediatric RSV zelicapavir Phase 2 topline (Dec 9) underpin RSV leadership narrative .
  • Cash and marketable securities were $248.2M at 9/30/24; runway expected into fiscal 2027, supported by retained royalties despite the OMERS royalty sale structure .
  • S&P Global consensus estimates for Q4 FY2024 were unavailable via API at the time of analysis; beat/miss vs Street cannot be assessed (S&P Global data unavailable).

What Went Well and What Went Wrong

What Went Well

  • Robust RSV data momentum: “We believe [EDP-323] results are among the strongest ever reported for an antiviral in an RSV challenge study,” with highly statistically significant reductions in viral load and symptoms versus placebo (p<0.0001) .
  • Two leading RSV mechanisms: management highlighted potential optionality with zelicapavir (N-inhibitor) and EDP-323 (L-inhibitor) advancing in parallel, pending pediatric RSVPEDs readout (Dec) and adult high‑risk enrollment progress in RSVHR .
  • Pipeline expansion in immunology: nomination of EPS-1421 (KIT inhibitor) as development candidate and initiation of a STAT6 discovery program aimed at type 2 immune–driven diseases (e.g., atopic dermatitis), broadening beyond virology .

What Went Wrong

  • Top-line pressure from royalties: revenue declined to $14.6M (from $18.9M y/y) due to lower MAVYRET/MAVIRET sales at AbbVie; royalty rate structure tied to OMERS sale also introduces interest expense and partial cash sharing through 2032 .
  • Persistent losses despite opex control: net loss of $(28.8)M (vs $(28.1)M y/y); G&A up for the year on higher legal fees related to Pfizer patent litigation, and royalty-sale interest expense persisted .
  • No Q4 call: reduced real-time visibility/clarifications; management deferred detailed updates to December RSVPEDs results .

Financial Results

Income Statement (last three quarters; GAAP)

Metric ($USD Millions, except per-share)Q2 2024 (Mar 31)Q3 2024 (Jun 30)Q4 2024 (Sep 30)
Revenue$17.05 $17.97 $14.61
Research & Development$35.59 $28.74 $30.78
General & Administrative$14.24 $13.41 $13.68
Total Operating Expenses$49.82 $42.16 $44.46
Loss from Operations$(32.77) $(24.19) $(29.85)
Interest Expense$(2.56) $(2.36) $(2.58)
Interest & Investment Income (net)$3.81 $3.49 $3.25
Net Loss$(31.16) $(22.66) $(28.82)
Diluted EPS$(1.47) $(1.07) $(1.36)

Notes:

  • Q4 y/y revenue decline reflects lower AbbVie MAVYRET/MAVIRET sales; all revenue is royalty-based .
  • OMERS royalty financing: 54.5% of cash royalties paid to OMERS through June 30, 2032 (capped at 1.42x), with associated interest expense recognized .

Liquidity

MetricQ2 2024 (Mar 31)Q3 2024 (Jun 30)Q4 2024 (Sep 30)
Cash, Cash Equivalents and Marketable Securities (period-end)$300.3M $272.6M $248.2M

Additional balance sheet detail (Q4): cash and equivalents $37.23M; short-term marketable securities $210.95M .

Revenue Composition (Q4 FY2024)

  • Total revenue consisted of royalties from AbbVie’s MAVYRET/MAVIRET hepatitis C regimen .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent Guidance (Q4 FY2024)Change
Cash runwayMulti-year“Through the third quarter of fiscal 2027” (reiterated in Q3) “Into fiscal 2027” Maintained (slightly less specific)
R&D expense (FY24)FY2024$125–$145M (set at Q2) No new range update in Q4 releaseMaintained (no update disclosed)
G&A expense (FY24)FY2024$50–$60M (set at Q2) No new range update in Q4 releaseMaintained (no update disclosed)
Financial call cadenceQ4 FY2024N/ANo earnings call; next update tied to RSVPEDs topline in Dec 2024 N/A

No revenue/EPS/dividend guidance was provided in Q4 materials; financial directional commentary centered on cash runway and opex framing .

Earnings Call Themes & Trends

Note: No Q4 earnings call was held . Themes below reflect the evolution of disclosures across Q2, Q3, and the Q4 press release.

TopicPrevious Mentions (Q2 and Q3 FY2024)Current Period (Q4 FY2024)Trend
RSV program executionQ2: RSVPEDs near completion; adult RSVHR enrolling; EDP-323 challenge data expected in Q3 . Q3: RSVPEDs enrollment complete; EDP-323 data on track late Q3 .EDP-323 positive topline (p<0.0001) in Sept challenge study; RSVPEDs pediatric data expected Dec; RSVHR adult high-risk enrollment targeted to complete in current NH season .Positive momentum; multiple clinically meaningful data catalysts delivered/expected.
Immunology expansion (KIT/STAT6)Q2: KIT program candidate selection targeted Q4 2024; second immunology program planned in 2024 . Q3: KIT preclinical optimization ongoing; second program to be introduced in Q4 .EPS-1421 (KIT) nominated; STAT6 inhibitor discovery program introduced, targeting type 2 immune–driven diseases .Scope broadened beyond virology; concrete progress in 4Q.
Royalty/OMERS financing dynamicsQ2/Q3 explained OMERS structure and interest expense impacts .Continued recognition of full royalties as revenue and OMERS interest expense; 54.5% of cash royalties paid to OMERS until cap/2032 .Structural factor persists; interest expense moderating vs 2023.
Legal/regulatoryQ2/Q3: Higher G&A from Pfizer patent litigation; no call at Q3 .Full-year G&A up on legal fees; Dec 24 post‑quarter: company to appeal adverse patent ruling .Ongoing legal overhang; appeal underway post-quarter.
Capital runwayQ2: runway through Q3 FY2027 ; Q3 reiterated .Runway “into fiscal 2027” .Maintained capacity to fund key programs.

Management Commentary

  • “We believe these [EDP-323] results are among the strongest ever reported for an antiviral in an RSV challenge study, and significantly unlock further promise of our RSV program…” — Jay R. Luly, Ph.D., President & CEO .
  • “We could potentially have two of the leading clinical candidates for the treatment of RSV with different mechanisms of action, providing us with important optionality.” — Jay R. Luly, Ph.D. .
  • “We also made notable progress in advancing and expanding our immunology portfolio with the nomination of EPS-1421… [and] introduce our second discovery stage program to develop oral STAT6 inhibitors…” — Jay R. Luly, Ph.D. .
  • “There is a substantial need for safe and effective oral treatments for RSV… these important antiviral data [in pediatrics]… support further clinical evaluation of zelicapavir.” — Scott T. Rottinghaus, M.D., CMO (Dec 9 pediatric topline) .
  • Corporate cadence: “Enanta will not be holding a conference call with today’s fiscal fourth quarter and year-end update.” .

Q&A Highlights

  • No Q4 earnings call or Q&A session was held; management deferred updates to the December RSVPEDs topline release .

Estimates Context

  • S&P Global consensus for Q4 FY2024 revenue/EPS was unavailable via API at the time of analysis; therefore, we cannot assess beat/miss vs Street or quantify the magnitude of any variance (S&P Global data unavailable).
  • Reported figures: revenue $14.6M; diluted EPS $(1.36); net loss $(28.8)M .

Key Takeaways for Investors

  • RSV remains the core value driver: Highly significant EDP-323 challenge data and positive pediatric zelicapavir topline de-risk two distinct RSV mechanisms, broadening potential patient coverage and combination optionality .
  • Near-term catalyst density: Pediatric RSVPEDs (Dec) and ongoing RSVHR enrollment progress are pivotal to shaping Phase 3 design/partnership paths and can move the stock around data readouts .
  • Funding runway intact: $248.2M cash and marketable securities at FY-end; runway into fiscal 2027 provides time to prosecute RSV and immunology milestones despite royalty-sharing headwind .
  • Expense mix evolving: R&D down vs prior year on reduced COVID spend; immunology investment rising; G&A historically elevated due to Pfizer litigation (appeal announced Dec 24) .
  • Royalty structural nuance: 100% of MAVYRET/MAVIRET royalties recognized as revenue, but 54.5% of cash paid to OMERS through 2032 with interest expense; investors should model cash vs GAAP nuance carefully .
  • No Q4 call: Less clarity on quarter-specific drivers; focus shifts to upcoming data and potential business development around RSV assets .
  • Medium-term thesis: If adult high‑risk and pediatric RSV signals translate into Phase 3-enabling outcomes, ENTA could occupy a first‑in‑disease RSV antiviral position; immunology (KIT/STAT6) adds optional upside and pipeline diversification .

Appendix: Additional Relevant Q4 Press Releases

  • EDP-323 RSV challenge positive topline (Sept 26, 2024): 85–87% viral load AUC reduction by qRT-PCR; 97–98% infectious viral load reduction; 66–78% symptom AUC reduction; favorable safety .
  • Pediatric zelicapavir Phase 2 positive topline (Dec 9, 2024): antiviral effect on virology endpoints; 1.4 log decline vs placebo at Day 5 (Part 2); prespecified ≤3‑day subset 1.2 log decline; well‑tolerated .
  • Legal: Company to appeal ruling on ’953 patent litigation vs Pfizer (Dec 24, 2024) .