SCYNEXIS INC (SCYX)·Q4 2023 Earnings Summary

Executive Summary

• SCYNEXIS’s Q4 2023 news flow centered on regulatory remediation and liquidity: the company ended 2023 with $98.0M in cash, cash equivalents and investments and projected a cash runway “more than two years,” while working to lift the FDA clinical hold stemming from the September 2023 BREXAFEMME recall .
• Operationally, management expects to initiate Phase I for second‑generation antifungal SCY‑247 in H2 2024, and aims to deliver final clinical study reports (FURI, CARES, NATURE, SCYNERGIA, VANQUISH) to GSK in H1 2024, which would trigger a $10M development milestone payment .
• The GSK license terms were amended in December 2023, lowering potential regulatory, commercial and sales milestones (regulatory to $49M from $70M; commercial based on first IC sale to $57.5M from $115M; adjusted sales milestones), reflecting the delay from the product recall; royalty rates remain unchanged (mid‑single‑digit to mid‑teens) .
• Key catalysts: lifting the clinical hold and resuming MARIO (Phase III IC), SCY‑247 Phase I start in H2 2024, and the $10M milestone upon delivery of study reports in H1 2024, against the backdrop of an ongoing securities class action filed in November 2023 regarding disclosures around manufacturing controls .

What Went Well and What Went Wrong

What Went Well

• Management progressed SCY‑247 with supportive preclinical efficacy (including mucormycosis) and targeted Phase I initiation in H2 2024: “SCY‑247 continues to demonstrate highly encouraging preclinical results…We look forward to continuing IND‑enabling activities, culminating in the initiation of the first Phase I clinical study later this year” — David Angulo, M.D., CEO .
• Solid liquidity and runway: “SCYNEXIS ended 2023 with cash, cash equivalents and investments of $98.0 million and projects a cash runway of more than two years” .
• Positive data trajectory and near‑term monetization: Top‑line CARES data were “positive,” and delivering clinical study reports in H1 2024 is expected to trigger a $10M development milestone from GSK .

What Went Wrong

• Manufacturing issue drove recall and FDA clinical hold on ibrexafungerp programs, creating timeline uncertainty for milestones and commercialization; management continues working with FDA to resolve and resume trials .
• Financial impact from recall/contamination risk included inventory impairment (~$14.6M) and negative net product revenue in Q3 as recall reserves and GTN adjustments flowed through results .
• GSK license amendment reduced potential milestone payouts given commercialization delays; while royalties were unchanged, aggregate regulatory, commercial, and sales milestones were lowered vs. original deal terms .

Financial Results

Full-Year P&L vs. Prior Year

Notes: FY 2023 revenue was dominated by license recognition ($130.1M at transfer; additional $4.4M from December MOU) with recall impacts flowing through cost of product revenue and GTN .

Quarterly Trend (Q2–Q3 2023) — Total and Mix

Liquidity Snapshot

Revenue Composition (FY)

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “SCYNEXIS had a year of significant progress in 2023, laying the foundation for future success by monetizing our first antifungal, BREXAFEMME®, and progressing the development of SCY‑247, our next generation compound.” — David Angulo, M.D., CEO .
• “We look forward to…initiation of the first Phase I clinical study later this year…We are working diligently toward the resumption of the MARIO Phase III study of ibrexafungerp in invasive candidiasis and, with our strong cash balance, we are well‑positioned to continue advancing SCY‑247.” — David Angulo, M.D. .

Q&A Highlights

• No public Q4 2023 earnings call transcript was available; no Q&A content identified in our document search [ListDocuments result showing 0 transcripts].

Estimates Context

• Wall Street consensus (S&P Global) for Q4 2023 EPS and revenue was unavailable due to data access limits encountered during retrieval. As a result, comparison to estimates cannot be provided in this recap. Values would ordinarily be retrieved from S&P Global.

Key Takeaways for Investors

• Resolution of the FDA clinical hold and resumption of MARIO is the pivotal near‑term catalyst; the H1 2024 delivery of clinical study reports could unlock a $10M milestone from GSK .
• SCY‑247 represents the core medium‑term value driver; Phase I initiation in H2 2024 is a milestone to watch, supported by preclinical efficacy including in mucormycosis .
• Liquidity and runway are robust (>$98M YE cash/investments; >2 years runway), supporting execution through upcoming regulatory and clinical events .
• The amended GSK license reduces near‑term milestone potential but preserves royalty economics and partnership alignment; investors should reset milestone expectations accordingly .
• Recall/hold impacts are evident in product revenue and inventory impairment; risk remains until remediation is complete and regulatory clearance is obtained .
• Legal overhang (securities class action) is present; monitor disclosures and any developments given potential distraction/costs .
• Trading: outcomes tied to (1) clinical hold resolution, (2) study report delivery/milestone receipt, (3) SCY‑247 Phase I start; failure/delay could pressure shares; successful execution could drive rerating given pipeline optionality .

Sources: Company 8‑K and press release (Mar 28, 2024); 10‑Q (Aug 14 & Nov 13, 2023); 10‑K (Mar 28, 2024). All figures and statements cited above reference the following documents: .