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PI

PRECIGEN, INC. (PGEN)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 revenue was $0.95M, down 31% year over year (Q3 2023: $1.38M) and up sequentially from Q2 2024 ($0.72M); net loss was $(23.98)M with $(0.09) EPS, as R&D and commercial readiness spending for PRGN-2012 remained elevated while Exemplar revenues declined .
  • Management achieved full FDA alignment in the pre-BLA meeting and reiterated a rolling BLA submission for PRGN-2012 in Q4 2024 under the accelerated approval pathway; confirmatory trial enrollment is underway and commercial/manufacturing readiness is progressing toward a potential 2025 launch .
  • Operating loss was $(21.26)M and other income (expense) deteriorated due to a $2.9M cumulative translation loss reclassification related to the ActoBio shutdown; SG&A rose on severance and PRGN-2012 readiness while R&D mix shifted toward PRGN-2012 activities .
  • Key near-term catalysts: completion of rolling BLA submission, FDA review dynamics (including potential AdCom), confirmatory trial pace, and financing/partnership updates; management is exploring strategic partnerships and other transactions to support launch .

What Went Well and What Went Wrong

What Went Well

  • Pre-BLA meeting completed with FDA with full alignment on BLA content (including CMC) and path for Q4 2024 rolling submission for PRGN-2012; commercial and manufacturing readiness underway for a potential 2025 launch .
  • Initiated confirmatory clinical trial for PRGN-2012 per FDA guidance; enrollment advancing, supporting accelerated approval framework .
  • Strengthened focus via strategic portfolio reprioritization to accelerate PRGN-2012, with workforce reduction and streamlined spending; raised ~$30.9M net via August offering to fund operations into early 2025 .

What Went Wrong

  • Revenues declined 31% year over year due to reductions in product and service revenues at Exemplar; revenue mix remains subscale and non-core .
  • Other income (expense) fell by $3.8M year over year in Q3 driven by $2.9M translation loss reclassification tied to ActoBio closure and lower interest income; net loss widened year over year .
  • SG&A increased 7% year over year on severance and PRGN-2012 commercial readiness; R&D decreased modestly year over year but remains elevated for PRGN-2012 ahead of BLA submission .

Financial Results

Income Statement Summary (USD Thousands unless noted)

MetricQ3 2023Q1 2024Q2 2024Q3 2024
Total Revenues1,379 1,065 717 953
Cost of Products & Services1,537 1,075 2,089 1,009
Research & Development11,583 14,249 15,693 11,370
SG&A9,196 10,151 10,306 9,836
Operating Loss(20,937) (24,410) (60,841) (21,262)
Other Income (Expense), Net1,136 643 360 (2,704)
Net Loss(19,795) (23,738) (58,792) (23,978)
EPS (Basic & Diluted)$(0.08) $(0.10) $(0.23) $(0.09)
Weighted Avg Shares248,520,724 249,220,335 252,366,533 275,881,170

Revenue Breakdown

Revenue ComponentQ1 2024Q2 2024Q3 2024
Product Revenues138 31 66
Service Revenues919 673 886
Other Revenues8 13 1
Total Revenues1,065 717 953

Liquidity and Balance Sheet

MetricMar 31, 2024Jun 30, 2024Sep 30, 2024
Cash and Cash Equivalents ($000s)17,478 9,345 24,725
Short-term Investments ($000s)27,280 10,191 3,906
Total Assets ($000s)134,847 73,160 83,474
Total Liabilities ($000s)37,828 29,990 28,098
Shareholders’ Equity ($000s)97,019 43,170 55,376

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
PRGN-2012 Rolling BLA Submission TimingQ4 2024H2 2024 rolling BLA Q4 2024 rolling BLA aligned with FDA post pre-BLA Clarified (maintained timing)
Confirmatory Trial (Initiation/Enrollment)2024Initiate prior to BLA submission Initiated and enrolling Executed (progressing)
Commercial & Manufacturing Readiness2024–2025Preparations underway for potential 2025 launch Campaign underway; readiness progressing Maintained (progressing)
Portfolio Reprioritization / OpEx ActionsH2 2024Announced >20% workforce reduction; pause non-priority programs Actions implemented; severance recorded Q2–Q3 Implemented
Financing Runway2024–2025Net offering proceeds ~$31.4M to fund into early 2025 Net proceeds ~$30.9M, exploring strategic partnerships/other transactions Maintained runway; broadened financing options

Note: No quantitative revenue/EPS guidance was provided for Q3 2024 .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2024)Previous Mentions (Q2 2024)Current Period (Q3 2024)Trend
PRGN-2012 Regulatory Path (BLA)On track for rolling BLA in H2 2024 On track to submit BLA by year-end 2024 Pre-BLA completed; full FDA alignment; rolling BLA in Q4 2024 Advancing per plan
Confirmatory TrialPlan to initiate prior to BLA Enrollment initiated Enrollment continuing Executing
Commercial ReadinessUnderway for potential 2025 launch CCO hired; footprint planning Campaign underway; manufacturing readiness progressing Building capabilities
Financing / RunwayEvaluating financing options ~$31.4M raised; runway into early 2025 Exploring strategic partnerships/transactions Diversifying options
UltraCAR-T PortfolioMultiple programs active 3006 Phase 1b completed enrollment; others ongoing Paused 3005/3007; advancing 3006 regulatory next steps Focused spend; partner-driven
Manufacturing ReadinessFacility build-out; cGMP progress Facility operational; confidence in supply Readiness ongoing for potential 2025 launch Strengthening
Ex-U.S. StrategyEU orphan designation; global outlook Global ambition under evaluation Continued readiness for global supply Developing

Management Commentary

  • “We are excited about our imminent submission of a BLA for PRGN-2012 in RRP as we have finalized our pre-BLA meetings and are aligned with the FDA on the content for all modules and plan for submission in the fourth quarter. Our commercial and manufacturing readiness campaigns for PRGN-2012 are well underway to support a potential 2025 launch.” — CEO Helen Sabzevari .
  • “We remain focused on fiscal management while appropriately investing in activities necessary for the potential launch of PRGN-2012. We are making good progress on a number of potential financing options, including strategic partnerships and other transactions.” — CFO Harry Thomasian Jr. .
  • “Following our reprioritization and public equity offering announced in August, we remain focused on fiscal management… We will update our investors on this progress in the coming months.” — CFO Harry Thomasian Jr. .

Q&A Highlights

No Q3 2024 earnings call transcript was available. Representative Q2 2024 Q&A themes:

  • BLA timing and gating factors: Management reiterated submission by year-end 2024 and emphasized PRGN-2012’s differentiated profile (subcutaneous dosing, safety, efficacy) .
  • Potential AdCom: Management noted AdCom is at FDA discretion; highlighted consistency across Phase 1 (50% CR) and Phase 2 (52% CR) results and robust endpoints presented at ASCO .
  • UltraCAR-T prioritization and partnerships: 3006 Phase 1b completed; planning end-of-Phase 1b FDA meeting; pausing other programs to prioritize PRGN-2012 while pursuing partnerships .
  • Confirmatory trial design and enrollment: Single-arm design consistent with pivotal studies; not required to be complete for approval; patient interest strong .
  • Commercial build-out: Rare disease footprint sized to “tens” in sales with integrated medical affairs to support launch .

Estimates Context

  • Wall Street consensus (S&P Global) for Q3 2024 EPS and revenue was unavailable at the time of this analysis due to S&P Global access limits. As a result, we cannot assess beats/misses versus consensus for this quarter. Investors should anchor expectations on company-reported outcomes and regulatory milestones rather than near-term financial estimates [GetEstimates error].

Key Takeaways for Investors

  • Regulatory execution remains on track: full FDA alignment post pre-BLA and Q4 rolling BLA submission for PRGN-2012; confirmatory trial enrollment underway, supporting accelerated approval mechanics .
  • Commercial readiness and manufacturing prep are advancing for a potential 2025 launch, with newly hired CCO driving go-to-market planning in a rare-disease footprint; watch for distribution/access updates .
  • Financial profile remains pre-commercial: minimal revenue and continued operating losses; Q3 other expense impacted by ActoBio translation loss reclassification; liquidity strengthened by August equity raise and reduced non-priority spend .
  • Strategic focus on PRGN-2012: portfolio reprioritization and workforce reduction to concentrate resources; expect reduced spend on paused programs and potential non-dilutive partnerships to fund launch .
  • Clinical differentiation: PRGN-2012 pivotal data demonstrate 51% Complete Response and 86% surgery reduction with favorable safety; a compelling profile for first/best-in-class therapy in RRP if approved .
  • Near-term catalysts likely to drive stock reactions: rolling BLA completion, any FDA review updates (including AdCom decision), confirmatory trial enrollment cadence, and partnership/financing announcements .
  • Risk-monitoring points: absence of consensus estimates, timing/complexity of FDA process, and funding pathway to commercial launch; management indicates active pursuit of strategic transactions and partnerships [GetEstimates error] .

Appendix: Additional Notes

  • Q3 revenue decline was driven by reduced Exemplar product/service revenues; SG&A increased year over year on severance and PRGN-2012 readiness; R&D mix reflects heightened PRGN-2012 activity for BLA preparation .
  • No financial guidance ranges (revenue, margins, OpEx) were provided; guidance centered on regulatory, clinical, and commercial milestones .