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HP

HOOKIPA Pharma Inc. (HOOK)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 revenue surged to $36.6M and GAAP net income reached $14.4M ($0.11 basic/diluted EPS), driven by accelerated recognition of previously deferred upfront/milestone payments tied to the terminated Roche collaboration and the HB‑700 IND milestone; this produced a profitable quarter but reflects non-recurring factors .
  • Management aligned with FDA on a seamless pivotal Phase 2/3 design for HB‑200 + pembrolizumab in first‑line HPV16+ OPSCC (CPS ≥20) and received EMA PRIME designation, with first patient targeted for 4Q 2024—key catalysts for the stock include ASCO data updates and pivotal start .
  • Cash fell to $93.0M at 3/31/24 from $117.5M at year‑end (operating cash usage), while restructuring expenses of $1.3M reflect January strategic refocus to prioritize HB‑200 and Gilead-partnered programs .
  • There was no formal Q1 earnings call transcript; two special calls (Apr 25, Jun 4) provided detailed strategy and updated HB‑200 Phase 2 data (CPS ≥20 ORR 53%, CR 18%, preliminary PFS 16.3 months) and clarity on the pivotal trial, reinforcing the clinical narrative .
  • Wall Street consensus estimates from S&P Global for Q1 were unavailable due to data access limits; comparisons to estimates could not be provided (unavailable).

What Went Well and What Went Wrong

What Went Well

  • FDA Type C alignment and EMA PRIME for HB‑200 + pembrolizumab in first‑line HPV16+ OPSCC (CPS ≥20) de‑risk trial design and accelerate potential approval pathways; CEO: “FDA‑aligned pivotal Phase 2/3 trial design… patient‑centric… high probability of success” .
  • Updated Phase 2 ASCO data in CPS ≥20 subgroup: confirmed ORR 53%, CR 18%, DCR 82%, preliminary PFS 16.3 months and 9‑month OS rate 88%, with favorable tolerability—investigator Dr. Ho highlighted potential durable immune‑based responses .
  • Profitability in Q1 2024 on $36.6M revenue, supported by accelerated recognition under Roche and the HB‑700 IND milestone; net income of $14.4M signaled financial flexibility to execute pivotal plans .

What Went Wrong

  • Revenue quality: Q1 upside largely reflects accelerated recognition due to Roche termination and one‑time HB‑700 milestone (non‑recurring), raising sustainability questions absent ongoing milestones .
  • Cash decreased to $93.0M at quarter‑end versus $117.5M at 12/31/23, reflecting operating cash burn; restructuring expenses were $1.3M in Q1 from severance and consulting costs .
  • No formal Q1 earnings call; reliance on special calls may limit standard quarterly financial commentary and GAAP/non‑GAAP guidance detail typically sought by analysts .

Financial Results

Metric ($USD, thousands except per-share)Q3 2023 (oldest)Q4 2023Q1 2024 (newest)
Revenue from collaboration and licensing$6,867 $7,407 $36,599
Research & Development($24,625) ($21,162) ($20,168)
General & Administrative($4,912) ($4,373) ($4,056)
Restructuring / Impairment$0 ($12,766) ($1,269)
Total Operating Expenses($29,537) ($38,301) ($25,493)
Income (Loss) from Operations($22,670) ($30,894) $11,106
Net Income (Loss)($19,066) ($24,817) $14,383
EPS – Basic($0.17) ($0.22) $0.11
EPS – Diluted($0.17) ($0.22) $0.11

Segment/Revenue Type

Revenue TypeQ3 2023Q4 2023Q1 2024
Collaboration and licensing$6,867 $7,407 $36,599

Balance Sheet / Liquidity KPIs

Metric ($USD, thousands)As of Sep 30, 2023As of Dec 31, 2023As of Mar 31, 2024
Cash, cash equivalents & restricted cash$108,095 $117,521 $92,955
Total Assets$164,010 $161,337 $145,871
Total Liabilities$68,959 $71,480 $41,349
Total Stockholders’ Equity$95,051 $89,857 $104,522

Additional Operating KPIs

Metric ($USD, thousands)Q3 2023Q4 2023Q1 2024
Total interest, other income and taxes, net$3,604 $6,077 $3,277

Narrative notes:

  • Q1 revenue growth vs prior year: $36.6M vs $3.2M (+$33.4M) primarily due to accelerated recognition under the terminated Roche collaboration and the HB‑700 IND milestone achievement .
  • Operating profitability driven by lower operating expenses and the revenue timing effects; management emphasized the strategic refocus on HB‑200 and partnered programs .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
HB‑200 pivotal trial start (first patient)2024“Pivotal study start 2024” (Q4 2023) “Pivotal study start 4Q 2024” (Q1 update) Tightened timing window
HB‑200 pivotal designN/A“Announcement post FDA feedback in 2Q 2024” FDA Type C alignment achieved; protocol aligned Achieved milestone
HB‑200 ASCO update2Q 2024“Additional Phase 2 first-line data in 2Q 2024” ASCO oral abstract with updated Phase 2 data (June 4, 2024) Maintained and delivered
HB‑700 IND (KRAS program)Apr 2024“IND submission April 2024; milestone” FDA IND clearance achieved; IP fully regained 4/25/24 Achieved (post‑submission clearance)
HB‑500 Phase 1 start (HIV, Gilead)2Q 2024“Phase 1 to start in Q2 2024; milestone on first patient” Expect trial initiation in Q2 2024; milestone on first patient Maintained
HB‑400 Phase 1b (HBV, Gilead)Ongoing“Phase 1b actively enrolling; next milestone Phase 2 timing by Gilead” No change—Gilead‑led; timing determined by Gilead Maintained

Note: No formal financial guidance (revenue, margins, OpEx, tax rate) was provided in Q1 2024 materials .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2023, Q4 2023)Current Period (Q1 2024)Trend
HB‑200 efficacy in first‑line HPV16+ HNSCCPreliminary Phase 2 ORR ~42% (19 evaluable), positioning for randomized trial; Fast Track noted CPS ≥20 subgroup: ORR 53%, CR 18%, DCR 82%; preliminary PFS 16.3 months; ORR primary endpoint for Phase 2 of pivotal Strengthening efficacy narrative; durability highlighted
Regulatory alignmentPlan for randomized pivotal trial in 2024 FDA Type C alignment on seamless Phase 2/3 pivotal; EMA PRIME designation De‑risked path; acceleration potential
Safety/tolerabilityHB‑200 generally well‑tolerated in Phase 1/2 HB‑200 + pembrolizumab generally well‑tolerated; Grade ≥3 TRAEs in 15%, no treatment‑related deaths Stable favorable profile
Portfolio prioritizationFocus on HB‑200 and partnered HBV/HIV; pause HB‑300; regain KRAS IP from Roche effective 4/25/24 Reiterated focus; HB‑700 IND cleared; HB‑500 Phase 1 expected in Q2; HB‑400 Gilead‑led Consolidation and execution
Financing/OpEx disciplineYE23 cash $117.5M; 2023 capital raises and milestones Q1 cash $93.0M; restructuring $1.3M tied to January plan Cash burn visible; refocus costs recognized

Management Commentary

  • CEO on strategic focus: “We are embarking on a pivotal trial for HB‑200… FDA‑aligned pivotal Phase 2/3 trial design… patient‑centric… high probability of success” .
  • CEO on competitive positioning: “HB‑200 plus pembrolizumab has shown to be a potentially powerful combination… a best‑in‑class asset… alignment on clinical development strategy with the U.S. FDA… path to potential accelerated approval” .
  • CDO on pivotal design: “Seamless and adaptive double‑blinded randomized Phase II/III… 250 patients randomized 1:1… ORR primary endpoint for Phase II with anticipated analysis in 2026; OS primary endpoint for Phase III with anticipated analysis in 2028” .
  • Investigator Dr. Ho: “The updated data… showed a 53% confirmed ORR, 18% CR rate, and 82% DCR [CPS ≥20]… well‑tolerated… likely increase immunogenic tumor cell death, leading to improved response rates and potential durability” .

Q&A Highlights

  • Estimates/efficacy confirmation: Unconfirmed responses in ASCO abstract converting to confirmed over time; additional PRs emerging as follow‑up matures .
  • Control arm and CPS selection: FDA agreed pembrolizumab monotherapy is the clear control for CPS ≥20 oropharyngeal SCC; CPS ≥20 chosen to optimize probability of success and time to market .
  • Durability/OS: As of cutoff, 16 of 19 CPS ≥20 patients alive; only 5 deaths across 46 treated; subsequent therapies standard second‑line chemo/chemo+pembro .
  • Enrollment and feasibility: Global pivotal enrollment with rollover sites; Phase II readout targeted 2026; feasibility supports timelines .
  • Trial cost and funding: Estimated ~$100M to complete Phase II/III to registration; company prepared to go alone but open to partnering on attractive terms .

Estimates Context

  • Wall Street consensus (S&P Global) for Q1 2024 EPS and revenue was unavailable due to data access limits; as a result, we cannot provide an estimates comparison for this quarter (unavailable).
  • Given the non‑recurring nature of Q1 revenue drivers (accelerated recognition under Roche termination and HB‑700 IND milestone), consensus models may need to focus on milestone timing and collaboration accounting dynamics rather than recurring revenue run‑rate .

Key Takeaways for Investors

  • Q1 profitability was driven by one‑time accounting/milestone effects; expect revenue normalization absent new milestones—focus on cash runway and trial execution pacing .
  • Regulatory momentum (FDA alignment, EMA PRIME) materially de‑risks HB‑200’s pivotal pathway; ORR‑based accelerated approval is a realistic near‑term objective with Phase II analysis targeted in 2026 .
  • Clinical signal is compelling in CPS ≥20 (ORR 53%, CR 18%, PFS 16.3 months prelim.), with tolerability supportive of combination use; durability and OS maturation are key watch items into 2025 .
  • Cash of $93.0M provides capacity to initiate pivotal in 4Q 2024; restructuring costs recognized, but disciplined OpEx remains essential through pivotal milestones .
  • Near‑term catalysts: HB‑200 ASCO updates (delivered), Phase 1 HB‑500 initiation/milestone, HB‑700 early development plans post IND clearance, and pivotal site activation—each capable of moving sentiment .
  • Absence of formal financial guidance and unavailable consensus estimates heighten focus on execution updates and clinical data flow to drive valuation.
  • Medium‑term thesis centers on HB‑200’s first‑to‑market opportunity in HPV16+ OPSCC (CPS ≥20) and platform expansion potential (neoadjuvant/adjuvant HNSCC, broader HPV+ tumors), with partnered HBV/HIV as strategic optionality .