OMER - Decision time 12/26. What do you need to know? Bull case $30. Bear case $2

Cheat Sheets

October 16, 2025

Omeros Corporation - Q3 2025 Earnings Preview: $2.1B Novo Deal Transforms Cash Position, Narsoplimab FDA Decision Dec 26, Stock +1,260% From Lows But Clinical Risk Remains

OMEROS CORPORATION (OMER)

💊🔬 Biopharma Pioneer | Q2 Loss -$0.43/Share Beat Est., $2.1B Novo Deal Oct 15, FDA Decision Dec 26, Stock +1,260% From Lows But No Revenue Yet

Q3 2025 Earnings: ~Nov 7 | Q2 Loss -$0.43/Share (Beat -$0.46 Est.), 210 Employees, Next Test: Can Narsoplimab Get FDA Approval & Launch Successfully?

💰 Market Cap: $696M | 🏢 Employees: 210 | 📊 Cash: $29M Pre-Deal (Now $340M+ Incoming)
👨‍💼 CEO Gregory Demopulos | 🎯 FDA PDUFA: Dec 26 | 🏆 $340M Upfront From Novo
$10.32
📈 +$6.22 (+151.71%) Day | +$9.40 (+1,257%) From $0.92 52w Low
Pre-Market Price (Oct 15, 2025)
Price Target Scenarios

18-Month Price Targets (Stock at $10.32 Today)

$30.00
Bull Case (+191%)
Blockbuster Drug
Multi-Indication
📊 Valuation:
• 2027E Revenue: $300M × P/S: 8x = $2.4B Market Cap ($30/share at 80M shares)
🚀 What Needs To Happen:
FDA approves Dec 26 clean label • Launch Q1 2026 executes perfectly • 40+ centers adopt within 12mo • 60%+ TA-TMA penetration = $250M revenue • EMA approves mid-2026 • IgAN/C3G progress • Novo milestones trigger $500M+ • Multiple pipeline partnerships • Path to 2027 profitability • No safety issues • Favorable reimbursement
$18.00
Base Case (+74%)
Steady Launch
Limited Market
📊 Valuation:
• 2027E Revenue: $150M × P/S: 8x = $1.2B Market Cap ($18/share)
⚖️ What Needs To Happen:
FDA approval Dec 26 with reasonable restrictions • Launch Q1/Q2 2026 at 20-30 centers • Gradual adoption = 30-40% penetration • $100-150M revenue 2 years • EMA mid-2026 adds Europe sales • C5 inhibitor competition persists • Reimbursement secured with hurdles • OMS1029 Phase 2 success • Novo triggers $200M milestones • $340M funds to profitability • Follow-ons enter Phase 2/3 • Losses narrow by 2027 • Manageable AEs
$2.00
Bear Case (-81%)
FDA Rejection
Clinical Failure
📊 Valuation:
• 2027E Revenue: $0 × Net Cash: $300M / 80M shares = $3.75, discounted to $2.00
🔻 What Goes Wrong:
FDA issues CRL Dec 26 = approval denied • Needs new trials = 2-3yr delay • External control rejected • Safety signals emerge • Stock crashes 70%+ • EMA fails too • Novo provides cash but no revenue path • Zaltenibart Phase 3 fails = no milestones • OMS1029 disappoints • OMIDRIA royalties stay tiny ($8M/qtr) • OpEx stays high $100M+/yr • Burns $80M/yr = runway to 2028 • Pipeline stalls • Partnership interest dies • Stock = cash box at discount
TL;DR - What You Need To Know
💊
Complement Therapy Pioneer
Biopharma making complement inhibitors for rare diseases. Lead drug: narsoplimab for TA-TMA (fatal stem cell transplant complication, 90% mortality untreated). FDA decision Dec 26. Just sold zaltenibart to Novo for $2.1B. Current revenue: only $8M/qtr OMIDRIA royalties.
⚠️
Binary FDA Decision Risk
Dec 26 FDA decision is EVERYTHING. Approval = moon to $15-30. Rejection = crash to $2-5. Got rejected in 2021, resubmitted March 2025. PDUFA extended Sept→Dec (concerning). Stock already up 1,260% = approval priced in. Massive downside if rejected again.
📈
Why Bulls Are Buying
Novo deal = $340M upfront validation + no more cash worries. Phase 3 data strong: 61% response, 3x survival vs control. First treatment for TA-TMA = monopoly if approved. $1B peak sales potential. Europe approval coming mid-2026. Pipeline worth billions (IgAN, C3G, cocaine addiction drug). Only $696M market cap = cheap if approved.
⚠️
What Could Wreck This
FDA rejection Dec 26 = game over. Already rejected once in 2021. PDUFA extended = red flag. Zero product revenue. Burns $100M/year even with Novo cash. TA-TMA market tiny (few thousand patients). Commercial execution unproven. Stock up 1,260% = limited upside, massive downside. Pure gamble on binary FDA event.

🔥 BREAKING: Last 90 Days

📈 Oct 15: Stock EXPLODED +152% to $10.32 after $2.1B Novo deal for zaltenibart. $340M upfront = game changer for balance sheet.

⏰ Sept 17: FDA extended PDUFA from Sept 25→Dec 26. 3 months delay = nervous market.

📊 Aug 6: Q2 loss -$0.43/share BEAT -$0.46 est. Cash only $28.7M. Reduced debt $100M+ via note swaps.

💰 July 24: Raised $20.6M from Polar Asset at 14% premium. Needed cash badly pre-Novo deal.

📄 June 27: Submitted Europe MAA for narsoplimab. EU decision mid-2026.

📊 Q2 2025 Results & Q3 Preview: Loss Narrows But No Product Revenue Yet

Q2: Loss -$25.4M (-$0.43/share) BEAT -$0.46 est. Revenue $1.6M (OMIDRIA royalties only). NO product revenue. Cash $28.7M was concerning until Novo deal Oct 15. Now $340M+ incoming. Q3 (~Nov 7) = similar loss. Market ignores earnings - 100% focused on Dec 26 FDA decision for narsoplimab. Binary event: approval = $15-30, rejection = $2-5.

✅
-$0.43
Q2 EPS
Beat -$0.46 Estimate
💰
$1.6M
Q2 Revenue
OMIDRIA Royalties Only
📊
$28.7M
Cash Position
From $109M Dec 2024
🎯
Dec 26
FDA PDUFA Date
Binary Event

📞 Key Q2 2025 Earnings Highlights & Q3 Preview

✅
Loss Improving, Cash Was Issue
Q2 loss -$25.4M improved 55% from -$56M Q2'24. BUT burning $25-30M/qtr with no product revenue. Q2 cash only $28.7M = 3 quarters runway. Oct 15 Novo deal ($340M) changed EVERYTHING. Now fully funded.
💰
Novo Deal Saves Company
$340M upfront + milestones up to $2.1B. Removes existential cash risk. Now $370M+ cash = funded for years. No more dilution. Can focus on launch. Technology validated by Big Pharma. MASSIVE strategic win.
📅
FDA Dec 26 = Everything
Resubmitted March 2025 after 2021 rejection. PDUFA extended Sept→Dec after FDA request. Data strong: 61% response, 3x survival. External control remains controversial. Binary: approval = moon, rejection = crash.
⚠️
Q3 Doesn't Matter
Q3 earnings (~Nov 7) = similar loss, no revenue. Nobody cares. 100% focus on Dec 26 FDA decision. Watch for: FDA updates, launch prep, payer discussions. Pure binary event trade.

📍 CEO Said: "Working with FDA, preparing for anticipated approval and launch of narsoplimab in TA-TMA." Translation: Confident but waiting. Novo deal changed everything - now have capital to execute.

💸 Cash: Q2 ended $28.7M (burning $24M/qtr). July raised $20.6M. Facing crisis by Q1 2026. Post-Novo (Oct 15): $370M+ cash. COMPLETELY transformed. Funded for years.

📉 Risks: Zero product revenue. OMIDRIA only $8-9M/qtr. 2021 CRL history. PDUFA delayed. Small trials. External controls controversial. Tiny TA-TMA market. No commercial team. Soliris entrenched.

🔮 Q3 Watch: ~Nov 7 earnings. -$0.48 EPS est. Watch: FDA updates, launch prep, payer talks, EMA timeline, Novo Phase 3 plans. Dec 26 FDA = ONLY thing that matters. 100% binary trade.

🚀 Why OMER Bulls Are Right
💰
Novo Deal = Total Validation
$2.1B deal with world's 12th largest pharma validates entire platform. $340M upfront for Phase 2 asset = huge vote of confidence. Removes all cash risk. Funds operations for years. Royalty stream incoming. Technology de-risked.
🏆
First-To-Market = Monopoly
NO approved TA-TMA treatment exists. 10,000 US cases/year. 90% mortality untreated. Current off-label options have 6-8x infection risk. Narsoplimab would be FIRST AND ONLY. Breakthrough designation. Orphan status. 7-year exclusivity. $1B+ peak sales.
📊
Clinical Data Strong
61% response rate. 3x survival vs control (P<0.00001). 130+ patients treated successfully in expanded access. Breakthrough therapy designation. 2021 rejection was about control matching, NOT efficacy. Resubmission fixed FDA concerns. High approval odds.
🌍
Pipeline = Multi-Billion Upside
Beyond TA-TMA: IgA nephropathy ($5B+ market), C3G, atypical HUS. OMS1029 Phase 1 done. Zaltenibart with Novo = milestones incoming. OMS527 for cocaine addiction (NIDA-funded). Oncology programs. Platform play worth billions if lead drug succeeds.
🐻 Why OMER Bears Have Valid Concerns
❌
FDA Rejection = Game Over
Dec 26 CRL would DESTROY stock. Already rejected 2021. External control vs randomized trial still controversial. PDUFA delayed 3 months = red flag. Small trials (~60 patients). If rejected, 2-3 year delay minimum. Stock crashes 70%+ on bad news. This is MASSIVE risk.
📉
Already Priced For Perfection
Up 1,260% to $696M market cap with ZERO revenue. Already pricing in approval + launch success. Limited upside ($15-20 range). MASSIVE downside if rejected ($2-5). Risk/reward terrible here. Smart money selling into Novo euphoria. Classic biotech blow-off before binary PDUFA.
🏥
Commercial Execution Unproven
TA-TMA market tiny - only 20-40 key centers US. Diagnosis hard = slow adoption. Off-label drugs entrenched. No commercial team = building from scratch. Reimbursement uncertain. Manufacturing scale-up risk. Even if approved, revenue ramp could disappoint. Peak $200-300M not $1B.
💸
Cash Burn Continues
Burns $100M/year even with Novo cash. No revenue until late 2026 earliest. Launch costs will spike (sales force, marketing). Profitability not until 2028+. Multiple trials burning cash. $340M goes fast. May need more capital 2027-28 = dilution returns.

This analysis is for informational purposes only and should not be considered investment advice. Please consult with a financial advisor before making investment decisions.