Executive Summary

Reported FY 2024 results and unveiled a dual‑path commercialization strategy: target U.S. availability of its proprietary Sildenafil Cream via a 503B outsourcing facility in Q4 2025, with revenue and cash flow expected to begin in Q4 2025 .
Cash and equivalents at year-end were $15.7M; 2024 G&A fell 24% to $9.2M and R&D fell 34% to $14.2M; FY 2024 net loss narrowed to $4.1M, aided by $20.38M in royalty rights sale proceeds .
Ovaprene Phase 3: ~125 women (half target completers) expected to reach ~6 months of use by end Q2 2025 for DSMB safety review; NICHD site recruitment paused due to federal funding uncertainty, but five new sites are enrolling under a Gates grant .
Catalysts: 503B launch partnership disclosure (2Q 2025), Sildenafil Cream Phase 3 protocol/SAP submission (2Q 2025), Ovaprene DSMB review (mid‑2025), and ongoing non‑dilutive funding inflows (ARPA‑H up to $10M, foundation up to ~$10.7M) .

What Went Well and What Went Wrong

What Went Well

Sildenafil Cream acceleration path: management will use FDA‑regulated 503B compounding to make the formulation available in Q4 2025 while continuing toward FDA approval; expected to start recording revenue and cash flow in Q4 2025 . Quote: “We are taking action to make our proprietary Sildenafil Cream formulation available via prescription this year as a compounded drug under Section 503B… We expect to start recording revenue and cash flow in the 4th quarter of this year.”
Cost discipline and capital solutions: FY 2024 G&A down 24% and R&D down 34%; $22M royalty monetization closed, driving FY net loss down to ~$4.05M .
Non‑dilutive funding momentum: selected by ARPA‑H to receive $10M over two years for DARE‑HPV; foundation grant up to ~$10.7M for non‑hormonal contraception/Ovaprene site expansion .

What Went Wrong

Ovaprene enrollment headwinds: NICHD CCTN site recruitment paused due to federal funding uncertainty; timeline visibility reduced, though DSMB timing for safety review remains intact as already‑enrolled participants progress .
Sildenafil Phase 3 timing slipped: prior guidance to submit the Phase 3 protocol/SAP in Q1 2025 shifted to Q2 2025 pending additional FDA recommendations .
Limited operating revenue profile: FY 2024 total revenue was $9,784 (royalties only); quarterly revenue base remains de minimis until future approvals or 503B commercialization .

Financial Results

Note: Year-end release provided annual, not standalone Q4 figures; we show quarterly Q2–Q3 trends and full-year comparisons.

Quarterly trends (selected P&L items)

Metric	Q2 2024	Q3 2024	Q4 2024
Revenue ($)	$22,438	$41,691	N/A (not disclosed)
Net Income (Loss) ($)	$12,910,656 (includes $20.38M royalty sale)	$(4,702,501)	N/A (not disclosed)
Basic EPS ($)	$1.53	$(0.55)	N/A (not disclosed)

Full-year comparison

Metric	FY 2023	FY 2024
Total Revenue ($)	$2,807,885	$9,784
G&A Expense ($)	$12,109,691	$9,156,061
R&D Expense ($)	$21,538,074	$14,205,208
Net Loss ($)	$(30,161,391)	$(4,053,299)
Loss per Share ($)	$(4.15)	$(0.48)
Cash & Equivalents ($)	$10,476,056	$15,698,174
Working Capital ($)	$(2,936,897)	$(3,161,150)
Total Liabilities ($)	$26,329,855	$28,113,220
Stockholders’ Deficit ($)	$(5,047,640)	$(6,012,089)

KPIs and operating metrics

XACIATO commercialization: continued U.S. prescription availability via Organon with positive early adoption signals (qualitative) .
Ovaprene Phase 3 sites/participants: 15 active NICHD sites following participants; 5 additional sites initiated in 2025 funded by the Gates grant; ~125 women to complete ~6 months by end Q2 2025 for DSMB review .
Non‑dilutive funding: ARPA‑H up to $10M (24 months); foundation grant up to ~$10.7M (24 months) .

No segment reporting; revenue currently limited to royalties/transactions .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Sildenafil Cream Phase 3 protocol/SAP submission to FDA	2025	Submit in Q1 2025	Submit in Q2 2025, pending additional FDA recommendations	Lowered (timing delayed)
Sildenafil Cream availability via 503B	Q4 2025	Not previously guided (no 503B plan disclosed in Dec 2024 PR)	Target availability via single 503B partner in Q4 2025	New
Sildenafil Cream revenue/cash flow from 503B	Q4 2025	Not previously guided	Expect to start recording revenue and cash flow in Q4 2025	New
Ovaprene DSMB safety review (≈125 with ~6 months)	By end Q2 2025	≈125 complete ~6 months by end Q2 2025	Reiterated	Maintained
Ovaprene enrollment environment	2025	N/A	NICHD site recruitment paused; five new sites enrolling under grant	New headwind disclosed

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 & Q3 2024)	Current Period (Q4 2024)	Trend
Dual‑path commercialization (503B + FDA path)	Not discussed as go‑to‑market path	Formal 503B plan for Sildenafil Cream; revenue target Q4 2025; minimal ≤$1M enablement spend	New, positive monetization path
FDA alignment on Sildenafil endpoints	Awaiting additional feedback; two Phase 3s anticipated	Protocol/SAP now planned for Q2 2025, reflecting additional FDA recommendations	Slight delay
Ovaprene Phase 3 execution	20 sites recruiting; ~125 to 6 months by end Q2 2025; adding sites via grant	15 active NICHD sites; NICHD recruitment paused; 5 new sites initiated; DSMB safety review still mid‑2025	Mixed: execution headwind, DSMB timing intact
Funding strategy	$22M royalty monetization; equity line; ARPA‑H + foundation grants	Reiterated up to $20.7M non‑dilutive awards in 2024 and $22M monetization	Maintained
XACIATO commercial progress (Organon)	Positive early adoption, access expansion	Continued satisfaction with 2024 launch progress	Stable

Management Commentary

“We are taking action to make our proprietary Sildenafil Cream formulation available via prescription this year as a compounded drug under Section 503B… We expect to start recording revenue and cash flow in the 4th quarter of this year.” – CEO Sabrina Johnson .
On using real‑world evidence alongside Phase 3: “There is an opportunity to… utilize real world evidence… to support the registration process,” while designing Phase 3 with incentives like open‑label extension for enrollees .
On Ovaprene headwind: “Executive orders and other actions… have negatively impacted the Phase 3 study… recruitment at the CCTN sites has been paused… [but] DSMB timing… will not be affected” .
On cost discipline and capital solutions: G&A down 24%, R&D down 34%; $22M royalty monetization; up to $20.7M new non‑dilutive awards in 2024 .

Q&A Highlights

503B partner and promotion: Partner announcement targeted in Q2 2025; 503B products are cash‑pay (HSA/FSA possible), promotion claims constrained until FDA indication; focus on provider education and evidence, leveraging telehealth for awareness .
Trial enrollment vs commercialization: Phase 3 designed with open‑label extension and pricing strategy to preserve enrollment incentives despite 503B availability .
Market position: Compounded product is not a generic; intent is trusted, consistent, GMP‑made formulation with extensive clinical work specific to this cream .
Ovaprene DSMB: Safety‑focused board; interim at ~6 months primarily for safety; contraceptive effectiveness typically improves over 12 months, informing disclosure approach .

Estimates Context

We queried S&P Global/Capital IQ consensus for Q4 2024 and Q1 2025 EPS and revenue; no estimates were available for DARE at the time of this analysis (Primary EPS Consensus Mean and Revenue Consensus Mean returned no data).*
Implication: Street benchmarks are unavailable; post‑print adjustments likely focus on timeline updates (Sildenafil Phase 3 delay to Q2 2025 submission) and the 503B monetization path (Q4 2025 revenue start).*

*Values retrieved from S&P Global.

Key Takeaways for Investors

503B commercialization is a new, near‑term monetization path: targeted Q4 2025 availability and revenue start for Sildenafil Cream with ≤$1M enablement spend, while preserving the FDA path and potential to leverage real‑world evidence .
Regulatory timing shifted: Sildenafil Phase 3 protocol/SAP moved to Q2 2025; aligns with additional FDA recommendations, adding modest timeline risk .
Ovaprene DSMB mid‑2025 remains on track, but NICHD site recruitment pause is a tangible operational headwind; new grant‑funded sites partially offset .
Cost discipline and non‑dilutive funding help extend runway: lower OpEx in 2024 and multiple grants plus royalty monetization reduced FY loss substantially .
XACIATO provides commercial proof with upside‑sharing via XOMA structure; not a primary cash generator near term but showcases partnering leverage .
Trading setup: Key 2025 catalysts (503B partnership details in Q2 2025, Phase 3 protocol submission, Ovaprene DSMB) are likely to drive narrative inflections; absence of Street estimates limits “beat/miss” framing but increases focus on milestone execution .
Risk checklist: Regulatory feedback pacing, Ovaprene enrollment dynamics, execution of 503B launch and partner performance, and capital market access for Phase 3 spend (each Sildenafil Phase 3 est. ~$15M direct cost) .

Appendix: Other Relevant Q4 2024 Press Releases

Dec 16, 2024: Detailed Sildenafil Cream Phase 3 plan reflecting FDA feedback; initial guidance to submit protocol/SAP in Q1 2025 and target mid‑2025 study start .
Dec 10, 2024: Additional Phase 2b subgroup efficacy analysis publication; no material safety/efficacy detractors identified .
Dec 4, 2024: $2.5M DARE‑LARC1 grant installment; broader drug‑delivery platform potential .
Oct 23, 2024: ARPA‑H Sprint for Women’s Health award (up to $10M over ~24 months) for DARE‑HPV .

Dare Bioscience, Inc. (DARE)·Q4 2024 Earnings Summary