Executive Summary

Reported net loss of $30.9M and EPS of $-0.47; continuing operations EPS of $-0.32 materially beat Wall Street consensus of $-0.48; OpEx declined 25% YoY as launch prep spending was prioritized. Bold beat on EPS; revenue from continuing ops remains de minimis due to classification of OMIDRIA as discontinued ops .
Cash and short-term investments were $36.1M; cash burn was $22.0M in Q3. Equity financing and ATM proceeds augmented liquidity ahead of expected Novo closing and FDA decision .
Strategic catalysts: Novo Nordisk deal (up to $2.1B) with $240M upfront expected to close in Q4; FDA PDUFA for narsoplimab (YARTEMLEA) on Dec 26, 2025; NTAP application progressing with decision expected to take effect in FY2026 .
Management expects to use Novo upfront to repay term loan ($67.1M) and remaining 2026 converts ($17.1M), funding >12 months of operations and the anticipated U.S. launch; they target potential cash flow positivity in 2027, a key stock narrative shift if approval and closing occur as planned .

What Went Well and What Went Wrong

What Went Well

EPS beat: Continuing EPS of $-0.32 vs consensus ~$-0.48; adjusted net loss narrowed to $22.1M driven by lower OpEx and non-cash remeasurement credit on the OMIDRIA royalty obligation. “Cash burn for the quarter was $22 million,” and “adjusted loss per share was $0.34” .
Strategic deal and regulatory momentum: Novo transaction ($240M upfront, up to $2.1B) and FDA review on track; CEO: “position Omeros for a potentially transformative period ahead… closing before year-end… FDA’s fast-approaching decision” .
Launch readiness: Brand name YARTEMLEA, ICD-10 and CPT codes established; proactive payer and hospital engagement; CCO: formulary approvals will happen over time but are “not critical to actually having narsoplimab ordered” .

What Went Wrong

OMIDRIA royalties trend softer YoY: Earned royalties $9.2M on U.S. net sales $30.5M vs $9.3M on $31.0M YoY; remeasurement led to loss in discontinued ops ($-9.7M) vs income prior year ($+4.9M) .
Interest and other income lower YoY due to reduced investable cash; $0.6M in Q3 vs $2.3M prior year .
Label specifics remain undisclosed; management declined to discuss labeling play-by-play, which can sustain uncertainty until final FDA action .

Financial Results

Metric	Q3 2024	Q2 2025	Q3 2025
Net Loss ($USD Millions)	$32.23	$25.42	$30.92
EPS - Total ($USD)	$-0.56	$-0.43	$-0.47
EPS - Continuing Ops ($USD)	$-0.64	$-0.44	$-0.32
Net Income (Loss) - Discontinued Ops ($USD Millions)	$4.88	$0.47	$-9.67
OMIDRIA Royalties Earned ($USD Millions)	$9.3	$8.6	$9.2
OMIDRIA U.S. Net Sales ($USD Millions)	$31.0	$28.6	$30.5
Total OpEx ($USD Millions)	$35.41	$32.35	$26.39
Research & Development ($USD Millions)	$24.08	$22.01	$15.99
SG&A ($USD Millions)	$11.32	$10.35	$10.40
Interest Expense (Net of Remeasurement) ($USD Millions)	$4.05	$0.02	$-13.36 (credit)
Interest & Other Income ($USD Millions)	$2.35	$1.24	$0.62
Cash & Short-Term Investments ($USD Millions)	—	$28.74	$36.09
Cash Burn ($USD Millions)	—	—	$22.0

Revenue and margins: Omeros reported no material revenue from continuing operations; OMIDRIA royalties are accounted for in discontinued operations and largely pass-through to DRI through 2031 .

Segment breakdown (Q3 2025 vs prior year):

Continuing operations net loss: $21.24M in Q3 2025 vs $37.11M in Q3 2024 .
Discontinued operations: net loss of $9.67M in Q3 2025 vs net income of $4.88M in Q3 2024, largely due to royalty asset remeasurement .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Operating Expenses	Q4 2025	Not disclosed	Higher than Q3 due to increased marketing for anticipated launch	Raised
R&D Expenses	Q4 2025	Not disclosed	Expected consistent with Q3	Maintained
Interest Income	Q4 2025	Not disclosed	Slightly higher vs Q3 on higher average cash	Raised
Other Income	Q4 2025	Not disclosed	Significantly higher (expected gain on Novo transaction after related expenses)	Raised
Interest Expense (ex non-cash adjustments)	Q4 2025	Not disclosed	~$8M (cash basis, excluding non-cash adjustments)	Raised vs Q3
Income from Discontinued Ops	Q4 2025	Not disclosed	$5–$6M, excl. remeasurement	Raised

NTAP: Application submitted; CMS town hall in December; decisions expected to take effect for FY2026 .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 2025, Q2 2025)	Current Period (Q3 2025)	Trend
FDA review for narsoplimab (YARTEMLEA)	BLA resubmitted; PDUFA originally 9/25/2025 ; extension to 12/26/2025; labeling discussions planned by October if no major deficiencies	PDUFA 12/26/2025 reaffirmed; government shutdown not expected to affect timeline; optimism for approval	Firming toward decision
Commercial launch readiness	Phased onboarding of hematology-experienced sales; strong stakeholder feedback	U.S. commercial org assembled and launch-ready; brand, ICD-10 and CPT codes set; formulary not critical to ordering	Advancing
NTAP reimbursement	Not detailed earlier	Application submitted; CMS town hall in December; decision expected for FY2026	Progressing
Balance sheet and financing	Converts exchange; equity financing with Polar; reduced near-term debt by >$100M	Novo deal: $240M upfront at closing, up to $2.1B milestones; plan to repay term loan and remaining 2026 notes	Strengthening
MASP-3 (Zaltenibart)	Phase 3 paused to prioritize narsoplimab; strong Phase 2 signals	Definitive agreement with Novo; global phase 3 planned; royalties tiered high-single to high-teens	Externalized acceleration
Safety vs C5 inhibitors	Pediatric study showed 8.5x bacteremia and ~6x infection-related mortality with eculizumab	Reinforced with new publications and messaging; MASP-2 preserves immune protection	Reinforced
Pipeline (OMS1029, PDE7, TCAT, Oncology)	OMS1029 Phase 2-ready; PDE7 funded by NIDA; oncology IND-enabling ongoing	OMS1029 phase 2-ready; PDE7 human study targeted H2 2026; TCAT broad MDRO potential; oncology targeting clinic in 18–24 months/2027	Steady progress

Management Commentary

“Together, [financing, Novo transaction, and FDA decision] could well provide the financial strength and operational flexibility to accelerate significantly the development across our first-in-class pipeline programs” — CEO Gregory Demopulos .
“Upon closing, Omeros will receive $240 million in upfront cash… fully repay our $67.1 million secured term loan… and fund more than 12 months of post-closing operations, including the anticipated U.S. launch of narsoplimab” .
“Our U.S. commercial organization is assembled and launch-ready… we’ve established a national ICD-10 diagnostic code… and an associated CPT procedural code… together, these position Yartemlya… as the only reimbursable TATMA treatment” .
“We would expect to potentially be cash flow positive in 2027” .

Q&A Highlights

Launch pacing and formulary: Management expects to launch quickly post-approval; formulary approvals will occur over time but exceptions and champions in transplant centers enable ordering immediately .
NTAP timeline and confidence: Application submitted; prepared to present at CMS town hall in December; confident decisions go into effect in FY2026 .
Labeling discussion: Declined play-by-play; aim to include adult and pediatric patients; interactions with FDA described as collaborative .
Historical controls concerns: Management views recent CRLs for other products using historical controls as different cases; believes their package is distinct and robust .
2026 OpEx outlook: Expect OpEx to increase with program pushes post deal closing and potential approval; ability to dial up/down based on events .

Estimates Context

Metric	Q1 2025	Q2 2025	Q3 2025
EPS - Continuing Ops (Reported, $USD)	$-0.65	$-0.44	$-0.32
EPS Consensus Mean (S&P Global, $USD)	$-0.60333*	$-0.545*	$-0.4775*
Beat/Miss vs Consensus	Miss	Beat	Beat

Revenue consensus was minimal/unavailable for continuing ops given classification (Q3 2025 consensus $0*); company does not report continuing revenue while OMIDRIA royalties are recognized within discontinued operations and largely pass-through .
Values retrieved from S&P Global.*

Implications:

Consensus EPS likely needs upward revisions if approval/closing proceed and non-cash volatility normalizes; near-term Q4 will include Novo-related gains and higher marketing costs .

Key Takeaways for Investors

Near-term binary catalyst: FDA PDUFA 12/26/2025 for YARTEMLEA; approval plus Novo closing could de-risk liquidity and support launch; stock likely sensitive to FDA outcome and closing timing .
Balance sheet inflection: $240M upfront from Novo earmarked to retire term loan and remaining 2026 notes, leaving 2029 notes outstanding; reduces covenants (incl. $25M minimum liquidity) and interest burden, a positive for equity risk premium .
Commercial readiness and reimbursement: ICD-10/CPT established; NTAP decision expected to support hospital reimbursement in FY2026; early adoption could be aided by formulary exceptions and center champions .
EPS dynamics: Q3 EPS beat driven by lower OpEx and non-cash adjustments; expect Q4 other income uplift from Novo and cash interest around ~$8M; model volatility from derivative marks persists .
OMIDRIA royalties steady but subject to remeasurement swings; they are pass-through to DRI and not core revenue; focus should be on narsoplimab launch trajectory and MASP-2/MASP-3 platform .
Medium-term thesis: If YARTEMLEA approval/launch and Novo deal execution occur, management targets potential cash flow positivity in 2027, shifting the narrative toward a commercially funded pipeline .
Risk watch: Label scope (adult/pediatric), potential regulatory nuances on historical controls, and hospital reimbursement timing (NTAP) are key variables affecting adoption and valuation .

OMEROS CORP (OMER)·Q3 2025 Earnings Summary