Name: Ocuphire Pharma, Inc. Q3 2024 Earnings Call
Start: 2024-10-22T00:00:00.000Z

Executive Summary

Q3 2024 revenue was $3.87M, with a net loss of $7.53M and diluted EPS of $(0.29); year-over-year revenue declined from $11.94M due to a one-time $10M FDA approval milestone booked in Q3 2023, while sequential revenue improved as reimbursed R&D ramped; non-dilutive RYZUMVI royalties were $14K
Cash and equivalents were ~$37M as of Sept 30, 2024 (pro forma), extending runway into 2026 following the October 22 all-stock acquisition of Opus Genetics and rebrand; prior Q2 guidance implied “next twelve months” runway .
Strategy pivot: beyond APX3330 (DR) and phentolamine ophthalmic solution 0.75% programs (presbyopia, mesopic DLD), the Opus acquisition adds gene therapy assets (LCA5, BEST1) with multiple 2025 data readouts—framing 2025–26 as a catalyst-heavy period .
No Q3 2024 earnings call transcript was filed; management commentary came via press releases and an 8-K investor update tied to the Opus transaction, limiting live Q&A color but clarifying cash, pipeline, and near-term milestones .

What Went Well and What Went Wrong

What Went Well
- Runway extended into 2026 (~$37M pro forma cash), materially reducing financing overhang into multiple 2025 readouts .
- Strategic expansion: acquisition of Opus Genetics adds late and mid-stage gene therapy programs (LCA5, BEST1) and repositions the company as a diversified ophthalmology platform .
- Presbyopia (VEGA-3) recruiting and DLD (LYNX-2) enrollment momentum persisted, with Phase 3 topline results expected in 2025, funded by the commercial partner .
What Went Wrong
- Year-over-year revenue down sharply (to $3.87M from $11.94M) due to absence of the prior-year $10M FDA approval milestone; highlights volatility of milestone-dependent revenue .
- R&D expenses rose to $9.0M on APX3330 and broader development activity, pressuring operating losses despite partner reimbursements on phentolamine programs .
- Limited revenue diversification: RYZUMVI royalties were only $14K in Q3, underscoring early commercial traction and dependence on partner execution for meaningful royalty flows .

Metric	Q3 2023	Q1 2024	Q2 2024	Q3 2024
License & collaborations revenue ($M)	$11.94	$1.71	$1.11	$3.87
Net income (loss) ($M)	$5.56	$(7.11)	$(7.77)	$(7.53)
Diluted EPS ($)	$0.25	$(0.29)	$(0.30)	$(0.29)

KPIs and Operating Detail

KPI	Q1 2024	Q2 2024	Q3 2024
Cash & equivalents ($M)	$47.16	$41.41	~$37.00 (pro forma)
R&D expense ($M)	$4.75	$6.09	$8.98
G&A expense ($M)	$4.67	$3.35	$2.89
RYZUMVI royalty ($K)	$3	$19	$14

Notes:

Segment breakdown: N/A; the company reports as a single segment .
No non-GAAP adjustments were presented in Q3 materials referenced; results reflect GAAP .

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Corporate liquidity	“Sufficient to fund operations for the next twelve months” (as of 6/30/24)	“Runway into 2026” (~$37M pro forma cash as of 9/30/24)	Raised
Phentolamine 0.75% (Presbyopia, VEGA-3)	Phase 3 topline	Topline expected 2025	Topline expected 2025 (maintained)	Maintained
Phentolamine 0.75% (Mesopic DLD, LYNX-2)	Phase 3 topline	Enrollment strong; SPA in place; 2025 topline expected	2025 topline expected (maintained)	Maintained
2025 Clinical readouts	Corporate outlook	Not specified prior	Four clinical data readouts expected in 2025 (incl. phentolamine and new gene therapy assets)	Introduced

Note: No Q3 2024 earnings call transcript was filed; themes drawn from Q1–Q3 press releases and 8-Ks.

Topic	Previous Mentions (Q1 2024)	Previous Mentions (Q2 2024)	Current Period (Q3 2024)	Trend
APX3330 (DR) regulatory path	SPA submitted; EOP2 alignment on 3-step DRSS worsening endpoint	Ongoing FDA SPA discussions	Continues; seeking partner for late-stage development	Steady, partnering focus
Phentolamine 0.75% (Presbyopia)	VEGA-3 planned	VEGA-3 recruiting; topline 2025	Maintained program timelines	On track
Phentolamine 0.75% (Mesopic DLD)	LYNX-2 under SPA; first subject in April	Strong LYNX-2 enrollment	Maintained enrollment momentum	On track
RYZUMVI royalties	Initial $3K royalty	$19K royalty	$14K royalty	Early, modest
Gene therapy platform	N/A	N/A	Opus Genetics acquired (LCA5, BEST1 added)	Expansion
Cash runway	Into mid-2025	Next 12 months (from 6/30)	Into 2026 (~$37M pro forma)	Improved

“APX3330 has potential to be the first non-invasive, early treatment to delay vision-threatening complications in millions of patients with non-proliferative diabetic retinopathy… We continue to work collaboratively with the FDA on our submitted Special Protocol Assessment” — CEO, Q2 release .
“In October 2024, we acquired Opus Genetics with the goal of creating a leading gene therapy franchise… Our expected cash runway has been extended into 2026, through expected efficacy readouts from four clinical programs in 2025” — CEO, Q3 update .

No Q3 2024 earnings call transcript was available; management disclosures were via press releases and 8-Ks focused on the Opus transaction, liquidity runway, and program timelines .

S&P Global consensus revenue and EPS estimates for OCUP Q3 2024 were not available in our data environment at the time of writing; as such, no beat/miss vs. consensus can be determined. Values retrieved from S&P Global were unavailable due to mapping following the corporate rename (OCUP → IRD) and could not be validated.

Liquidity and runway: Pro forma ~$37M cash extends runway into 2026, bridging multiple 2025 data readouts and reducing near-term financing risk .
Platform expansion: The Opus acquisition transforms the company into a diversified ophthalmic player, adding gene therapy programs (LCA5, BEST1) alongside small-molecule assets, broadening optionality for catalysts and partnerships .
Revenue composition: Q3 revenue ($3.87M) is primarily reimbursed R&D under the Viatris license; year-over-year volatility reflects large, non-recurring milestones in 2023; royalty ramp from RYZUMVI remains modest ($14K) and should be viewed as a long-tail opportunity .
Execution focus: Rising R&D (to $8.98M in Q3) reflects investment in APX3330 and broader development; watch for SPA resolution/partnering on APX3330 and Phase 3 presbyopia/DLD readouts in 2025 as key value inflections .
Trading setup: The expanded pipeline and extended runway create multiple 2025 catalysts; absence of consensus estimates and limited royalty contribution mean stock may trade mostly on clinical/regulatory newsflow rather than quarterly P&L prints in the near term .
Risk checks: Milestone/royalty timing, clinical execution (enrollment, endpoints), and regulatory alignment (SPA for APX3330; adaptive designs for gene therapy) remain core risks given the development-stage profile .

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