PRECIGEN, INC. (PGEN)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 revenue of $1.341M increased 26% YoY, driven by higher Exemplar product/service volumes; revenue materially beat S&P Global consensus of $0.50M. Bold: Revenue beat (+$0.84M vs consensus) *.
• Diluted EPS of $(0.18) missed S&P Global consensus of $(0.08), primarily due to a non-cash $32.5M increase in warrant liabilities tied to stock price appreciation and paid-in-kind dividend warrants. Bold: EPS miss ($(0.10) vs consensus); non-cash driver *.
• PRGN-2012 BLA remains under FDA priority review with an August 27, 2025 PDUFA date; FDA currently does not plan to hold an advisory committee meeting, and commercialization readiness continues (EVERSANA selected; first field teams deploying) .
• Liquidity: Cash, cash equivalents, and investments were $81.0M at March 31, 2025; management reiterates runway into 2026, supporting pre-launch commercialization and confirmatory trial execution .

What Went Well and What Went Wrong

What Went Well

• Strong regulatory momentum: “We remain laser-focused on advancing the program toward the rapidly approaching PDUFA target action date in August” (CEO) .
• Commercial readiness on track: EVERSANA selected to support launch and U.S. commercialization; first wave of field teams deploying .
• Revenue quality: YoY revenue growth driven by Exemplar volumes; underscores underlying services/product demand despite small base .

What Went Wrong

• EPS pressure from non-cash warrant liability remeasurement ($32.5M); flipped “other income (expense)” to a $31.6M expense vs $0.6M income prior-year, widening net loss .
• SG&A up 22% YoY due to PRGN-2012 commercial readiness investments, partially offset by lower insurance and IP fees .
• Continued operating losses as R&D spending remains focused on PRGN-2012 and confirmatory activities, though R&D down 27% YoY with ActoBio shutdown and CRO reductions .

Financial Results

Values marked with * retrieved from S&P Global.

Results vs estimates (S&P Global consensus):

Values marked with * retrieved from S&P Global.

Revenue breakdown:

KPIs:

Margin metrics (limited usefulness given small revenue base):

Values marked with * retrieved from S&P Global. N/M = not meaningful.

Guidance Changes

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was found; nearest detailed Q&A is from the FY/Q4 2024 call (Mar 19, 2025).

Management Commentary

• CEO: “We remain laser-focused on advancing [PRGN-2012] toward the rapidly approaching PDUFA target action date in August. If approved, PRGN-2012 has the potential to be the first and only FDA-approved therapeutic for the treatment of RRP.” .
• CEO on efficacy: pivotal study achieved 51% complete response with durability beyond 12 months, and some patients surgery-free for three years as of March 20, 2025 data cutoff .
• CFO: “We ended the quarter with cash, cash equivalents, and investments of $81 million, and we reiterate that our cash runway is expected to take us into 2026...” .
• Commercial: EVERSANA selected to support PRGN-2012 U.S. launch; targeted go-to-market strategy with initial field deployment in preparation for potential approval .

Q&A Highlights

From FY/Q4 2024 call:

• Field force and targeting: Plan for ~15–20 reps; focus on ~500 fellowship-trained otolaryngologists concentrated in academic centers and IDNs .
• Patient identification and demand: Expect a bolus at launch given lack of approved therapies; visibility from frequent surgeries and awareness efforts (RRP Awareness Day) .
• Payer dynamics: Expect prior authorization aligned to label; exploring value-based approaches though operationally complex; building strong economic and clinical value propositions .
• Manufacturing: In-house GMP for drug substance with CDMO for drug product; process validation completed; confident in supply at launch .

Estimates Context

• Q1 2025 vs S&P Global consensus: Revenue $1.341M vs $0.50M (beat); EPS $(0.18) vs $(0.08) (miss). The EPS miss was driven by non-cash warrant liability remeasurement ($32.5M), not core operating performance *.
• Estimate dispersion low (# of estimates: 2 for revenue and EPS), suggesting limited sell-side coverage; revisions likely to focus on non-operating items and upcoming regulatory catalysts*.

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

• Regulatory catalyst intact: Priority review with 8/27/25 PDUFA and no planned AdCom—near-term stock driver; commercial readiness and field deployment ramping .
• Quality of beat/miss: Revenue beat was operational (Exemplar volumes); EPS miss was largely non-cash (warrant liabilities tied to stock price and PIK features), reducing read-through to ongoing operating loss trajectory .
• Liquidity adequate: $81.0M cash/investments and reiterated runway into 2026 support commercialization, confirmatory trial enrollment, and launch activities without immediate financing .
• Launch execution risk: Payer PA criteria and site operational readiness appear manageable; EVERSANA partnership mitigates execution risk, but pricing/access remains a monitored variable .
• Narrative focus: Durable efficacy (51% CR; 86% surgery reduction), safety, and simple subcutaneous administration underpin potential adoption; expect early pent-up demand .
• Monitoring items: Pre-approval inspections, payer access specifics, label details, and timing/scale of confirmatory trial enrollment/readouts; warrant liability volatility may continue to impact GAAP EPS .
• Medium-term: If approved, initial PRGN-2012 revenue in 2H 2025 could shift the profile from clinical to commercial stage; broader platform optionality (PRGN-2009, UltraCAR-T) provides longer-term upside .