Omeros Corporation (OMER) Business Model Canvas

Omeros Corporation (OMER): Business Model Canvas [Dec-2025 Updated]

US | Healthcare | Biotechnology | NASDAQ
Omeros Corporation (OMER) Business Model Canvas

Fully Editable: Tailor To Your Needs In Excel Or Sheets

Professional Design: Trusted, Industry-Standard Templates

Investor-Approved Valuation Models

MAC/PC Compatible, Fully Unlocked

No Expertise Is Needed; Easy To Follow

Omeros Corporation (OMER) Bundle

Get Full Bundle:
$9 $7
$9 $7
$9 $7
$9 $7
$25 $15
$9 $7
$9 $7
$9 $7
$9 $7

TOTAL:

You're looking at Omeros Corporation right now, and honestly, the game has completely changed thanks to the recent out-licensing deal. The $240.0 million upfront cash infusion from Novo Nordisk, closing in December 2025, isn't just a nice boost; it's the financial bedrock for their next chapter as they pivot toward product sales. We're moving past the pure R&D story as the company prepares for the critical December 26, 2025 PDUFA date for narsoplimab (YARTEMLEA), which targets a life-threatening condition in transplant patients. This Business Model Canvas distills exactly how Omeros Corporation is structuring its operations, from managing key partnerships to funding its commercial launch, all grounded in that massive strategic capital. Dive in to see the new architecture.

Omeros Corporation (OMER) - Canvas Business Model: Key Partnerships

You're looking at how Omeros Corporation structures its external relationships to drive development and revenue, which is crucial for understanding its financial runway. These partnerships are key to monetizing pipeline assets and funding ongoing operations.

The structure involves major pharmaceutical collaborations for late-stage assets, financial arrangements for existing product royalties, and government funding for specific clinical programs. Here's the quick math on the most significant ones as of late 2025.

Novo Nordisk: Global Rights Deal for Zaltenibart (OMS906)

Omeros Corporation finalized a definitive asset purchase and license agreement with Novo Nordisk for zaltenibart (OMS906). This deal provides Omeros Corporation with significant non-dilutive capital and shifts late-stage development and global commercialization risk to Novo Nordisk. The total potential value is up to $2.1 billion. This structure is designed to maximize value from a Phase 2 asset while allowing Omeros Corporation to focus resources elsewhere. It's a classic biotech move: monetize a high-potential asset to fund the core pipeline.

Payment Component Amount
Maximum Total Payments Up to $2.1 billion
Upfront Cash Payment at Closing $240 million
Upfront and Near-Term Milestone Payments Total $340 million

The agreement also includes further development and commercial milestone-based payments, plus tiered royalties on potential future global net sales. The upfront cash of $240 million alone was intended to fully repay the secured term loan of $67.1 million and repay at maturity the remaining $17.1 million principal balance on 2026 convertible notes, funding over 12 months of post-closing operations.

OMIDRIA Royalties: Rayner Surgical Inc. and DRI Health Acquisition LP

The commercial revenue stream from OMIDRIA is heavily structured through licensing and royalty monetization agreements. Rayner Surgical Inc. acts as the licensee and the direct payer of the underlying royalties based on U.S. net sales. DRI Health Acquisition LP is the recipient of the majority of these cash flows through a specific date. Per the amended 2024 agreements, DRI Health Acquisition LP receives all U.S.-based royalties through 2031.

The royalties Omeros Corporation earns directly have been reported quarterly:

  • Q3 2025 OMIDRIA royalties earned by Omeros Corporation: $9.2 million on Rayner Surgical Inc.'s U.S. net sales of $30.5 million.
  • Q2 2025 OMIDRIA royalties earned by Omeros Corporation: $8.6 million on Rayner Surgical Inc.'s U.S. net sales of $28.6 million.

Omeros Corporation is also eligible to receive milestone payments from DRI Health Acquisition LP, each up to $27.5 million, payable in January 2026 and January 2028, based on OMIDRIA net sales thresholds.

National Institute on Drug Abuse (NIDA) Funding for OMS527

The development of OMS527, the phosphodiesterase 7 inhibitor for cocaine use disorder, is substantially supported by non-dilutive funding from the National Institute on Drug Abuse (NIDA). This partnership fully funds the clinical development for this indication. For the upcoming year, covering April 1, 2025 through March 31, 2026, NIDA committed $4.02 million to fund the Phase 1b clinical trial in patients with CUD.

The total grant awarded by NIDA for the development of OMS527 was for $6.24 million over three years. As of the second quarter of 2025 reporting, Omeros Corporation had claimed and received $1.5 million of this total funding. Initial data readout from the Phase 1b trial is expected in the fourth quarter of 2025.

Clinical/Academic Centers

Key collaborators include various Clinical/Academic Centers, which are essential partners for executing the planned clinical trials, such as the NIDA-funded Phase 1b study for OMS527. These centers also support Omeros Corporation's Expanded Access Programs, though specific financial terms for these collaborations are not publicly itemized in the same way as the major deals.

Finance: review the cash flow impact of the $4.02 million NIDA commitment against the Q3 2025 cash burn of $22.0 million (exclusive of financing proceeds).

Omeros Corporation (OMER) - Canvas Business Model: Key Activities

You're looking at the core operational focus for Omeros Corporation as we approach the end of 2025, which is heavily weighted toward a critical regulatory decision and capitalizing on recent strategic financial moves. The key activities are centered on executing near-term milestones while managing the capital structure.

Regulatory Submission and Approval for Narsoplimab (TA-TMA)

The most immediate activity is navigating the final stages of the U.S. Food and Drug Administration (FDA) review for narsoplimab, which will be marketed as YARTEMLEA upon approval. The Prescription Drug User Fee Act (PDUFA) target action date for the Biologics License Application (BLA) in hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is set for December 26, 2025. The BLA resubmission was classified as a Class 2 resubmission. The FDA indicated that, assuming no major deficiencies arise, labeling discussions were planned to commence no later than October 2025. On the European side, the Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA), with an opinion anticipated in mid-2026.

Commercial Launch Preparation for Narsoplimab (YARTEMLEA) in the U.S.

Omeros Corporation has its U.S. commercial organization fully assembled and launch ready, spanning from leadership to field teams and market development liaisons. This preparation includes securing the necessary reimbursement infrastructure ahead of the potential approval. Specifically, the company has established a national ICD-10 diagnostic code for TA-TMA and an associated CPT procedural code specific to YARTEMLEA, positioning it as the only potentially reimbursable TA-TMA treatment. You should note that operating expenses for the fourth quarter of 2025 are expected to be higher than the third quarter, driven primarily by increased marketing costs for this anticipated launch. The third quarter of 2025 saw a GAAP net loss of $30.9 million, or $0.47 per share. Cash burn for that quarter, excluding financing proceeds, was $22.0 million.

Here's the quick math on the balance sheet as of the end of Q3 2025:

Financial Metric Amount as of September 30, 2025
Cash and Short-Term Investments $36.1 million
Net Proceeds from July 2025 Registered Direct Offering $20.3 million
Net Proceeds from ATM Program (Q3 2025) $9.0 million
OMIDRIA Royalties Earned (Q3 2025) $9.2 million

Ongoing R&D for Complement Inhibitors (OMS1029) and Novel Immuno-oncology Programs

While prioritizing narsoplimab, Omeros Corporation continues to advance other pipeline assets. The long-acting MASP-2 inhibitor, OMS1029, has successfully completed its Phase 1 single- and multiple-ascending dose clinical studies. The company's novel oncology platform includes the OncotoX-AML program, which is on track to enter the clinic in the next 18-24 months. Furthermore, the lead phosphodiesterase 7 inhibitor, OMS527, targeting cocaine use disorder, remains in clinical development and is fully funded by the National Institute on Drug Abuse (NIDA).

Managing the Transition and Collaboration for Zaltenibart with Novo Nordisk

A major strategic activity involved finalizing the deal for zaltenibart (formerly OMS906), the MASP-3 inhibitor. The asset purchase and license agreement with Novo Nordisk closed on December 1, 2025. This transaction is structured to provide significant, non-dilutive capital to Omeros Corporation.

  • Total potential transaction value is up to $2.1 billion.
  • Omeros is eligible to receive $340.0 million in upfront and near-term milestone payments.
  • The upfront cash payment received at closing was $240.0 million.
  • An additional $100.0 million in achievable near-term milestones is expected.
  • Upon closing, Omeros prepaid its entire outstanding senior secured term loan of $67.1 million.
  • Omeros retains rights to its MASP-3 small-molecule program unrelated to zaltenibart.

Novo Nordisk aims to initiate a global Phase 3 program for zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH) following the close.

Omeros Corporation (OMER) - Canvas Business Model: Key Resources

You're looking at the core assets Omeros Corporation is leaning on as it moves into a potentially transformative period, especially following the recent major transaction. These aren't just abstract concepts; they are tangible, high-value items that underpin the company's near-term strategy.

Intellectual Property: Patented Complement Pathway Inhibitors and Platforms

The foundation of Omeros Corporation's value rests heavily on its proprietary science, particularly around the complement system. The company holds key intellectual property covering its complement pathway inhibitors. While global rights to the late-stage MASP-3 inhibitor, zaltenibart (OMS906), were transferred to Novo Nordisk, Omeros Corporation specifically retained rights to its MASP-3 small-molecule program, which includes the ability to develop and commercialize those small-molecule inhibitors with limited restrictions on indications. The lead asset, narsoplimab, is a proprietary, patented human monoclonal antibody targeting MASP-2, which activates the lectin pathway of complement.

Cash: Financial Position Post-Transaction

The immediate financial strength of Omeros Corporation saw a massive boost with the closing of the asset sale and licensing transaction with Novo Nordisk, which occurred in early December 2025. This deal is structured to provide significant capital to fund operations and the anticipated U.S. launch of narsoplimab. Here's a quick look at the cash situation around that closing:

Financial Metric Amount (USD) Date/Context
Upfront Cash from Novo Nordisk Deal $240.0 million Closing (Dec 2025)
Total Potential Upfront & Near-Term Milestones Up to $340.0 million Total from Novo Nordisk deal
Total Potential Deal Value (Including Milestones/Royalties) Up to $2.1 billion Total potential from Novo Nordisk deal
Cash and Short-Term Investments $36.1 million As of September 30, 2025
Cash Burn (Q3 2025, exclusive of financing) $22.0 million Third Quarter 2025
Repayment of Secured Term Loan $67.1 million Prepaid at closing of Novo Nordisk deal
Repayment of 2026 Convertible Notes Principal $17.1 million Intended repayment at or prior to maturity

The upfront cash of $240.0 million, combined with cash on hand, was expected to fund the repayment of the senior secured term loan ($67.1 million principal plus premium/interest) and the remaining 2026 convertible notes ($17.1 million principal), while also providing capital for more than 12 months of post-closing operations, including the narsoplimab launch.

Clinical Pipeline: Key Development Candidates

Omeros Corporation maintains a pipeline focused on complement-mediated diseases, cancers, and addictive disorders. The status of the key candidates as of late 2025 is critical to future revenue potential:

  • Narsoplimab (MASP-2 inhibitor): Under regulatory review by the U.S. FDA for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA); the PDUFA target action date was extended to December 26, 2025.
  • OMS1029 (Long-acting MASP-2 inhibitor): Has successfully completed Phase 1 clinical trials.
  • OMS527 (Phosphodiesterase 7 inhibitor): In clinical development for cocaine use disorder (CUD), with committed funding from the National Institute on Drug Abuse (NIDA) of $4.02 million for the year commencing April 1, 2025.
  • Oncology Candidates: The OncotoX biologics program, focused on acute myeloid leukemia (AML), has an established Clinical Steering Committee.

Launch-Ready U.S. Commercial Organization

Omeros Corporation has established a launch-ready U.S. commercial organization specifically for specialty drug distribution. This infrastructure is being prepared to support the anticipated U.S. launch of narsoplimab, pending the expected FDA decision in late December 2025.

Omeros Corporation (OMER) - Canvas Business Model: Value Propositions

You're looking at the core value Omeros Corporation (OMER) is offering to the market as of late 2025. It centers on novel mechanisms for severe, often fatal, conditions where current options fall short.

Narsoplimab: First-in-class treatment for life-threatening hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA)

The primary value proposition here is offering the first approved therapy for TA-TMA, a complication occurring in nearly 40% of allogeneic transplants, where one-year survival in high-risk cases was historically well under 20%. The data supporting this value are compelling; the pivotal trial showed a 61% complete response rate and 68% 100-day survival with narsoplimab, which is an approximately three-fold improvement compared to an untreated external control cohort. You have a clear regulatory milestone to watch: the FDA PDUFA date for the Biologics License Application (BLA) resubmission is set for December 26, 2025. Furthermore, the European Medicines Agency (EMA) review for the Marketing Authorization Application (MAA) is expected to yield a decision in mid-2026.

Novel Mechanism: Targeting the lectin pathway of complement (MASP-2 inhibition) for orphan diseases

Omeros Corporation's approach offers a distinct scientific advantage by targeting mannan-binding lectin-associated serine protease 2 (MASP-2), the key activator of the lectin pathway of complement. This mechanism is valued because, unlike inhibiting C3 or C5, MASP-2 inhibition is designed to leave the infection-fighting lytic arm of the classical pathway entirely intact, which helps protect against infection. This positions narsoplimab as a potentially safer option for critically ill patients. The company also has a long-acting second-generation MASP-2 inhibitor, OMS1029, which has successfully completed Phase 1 clinical studies.

Strategic Capital Infusion: The Novo Nordisk deal provides significant non-dilutive funding for operations and launch

The deal Omeros Corporation struck with Novo Nordisk for Zaltenibart (OMS906) fundamentally de-risks the near-term future, directly supporting the planned U.S. launch of narsoplimab. The total potential value of this asset sale and licensing agreement is up to $2.1 billion. Omeros received an upfront cash payment of $240 million at closing, with up to $340 million possible from upfront and near-term milestones. This infusion allowed Omeros to immediately repay its $67.1 million senior secured term loan and the remaining $17.1 million balance on its 2026 Convertible Notes. Honestly, this cash is expected to fund more than 12 months of operations, which is a massive value add given the Q3 2025 net loss was $30.9 million (or an adjusted operating loss of $22.1 million).

Addressing Unmet Needs: Pipeline focused on rare immunologic diseases, cancers, and addictive disorders

The value extends beyond TA-TMA into a diverse portfolio addressing significant unmet needs across several therapeutic areas. You can see the breadth of this focus in the pipeline progression:

  • Narsoplimab (MASP-2 inhibitor) for Immunoglobulin Nephropathy (IgAN) is under review in Europe.
  • Zaltenibart (MASP-3 inhibitor, sold to Novo Nordisk) was in clinical development for Paroxysmal Nocturnal Hemoglobinuria (PNH) and C3 Glomerulopathy.
  • OMS527, a phosphodiesterase 7 inhibitor for cocaine use disorder, is in clinical development and is fully funded by the National Institute on Drug Abuse (NIDA).
  • The company is advancing a portfolio of novel cellular and molecular immuno-oncology programs, with the OncotoX-AML program targeted to enter the clinic in 2027.

Here's a quick look at the balance sheet context as of September 30, 2025, which frames the capital needs this value proposition addresses:

Financial Metric Amount as of September 30, 2025
Cash and Short-Term Investments $36.1 million
Net Loss (Q3 2025) $30.9 million (or $0.47 per share)
Adjusted Net Loss (Q3 2025) $22.1 million (or $0.34 per share)
Net Loss (Nine Months Ended Sept 30, 2025) $89.8 million (or $1.47 per share)

The company is definitely focused on maximizing the value of its complement platform while using external funding to advance its other specialized programs.

Omeros Corporation (OMER) - Canvas Business Model: Customer Relationships

You're preparing to launch a specialized, potentially first-in-class therapy for a critical, life-threatening condition, which means your customer relationships must be intensely focused and expert-driven. For Omeros Corporation, this centers on transplant centers and key opinion leaders (KOLs) managing hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).

High-touch, specialized: Direct engagement with transplant centers and key opinion leaders for TA-TMA.

The relationship strategy for narsoplimab (YARTEMLEA, pending FDA decision) is inherently high-touch because TA-TMA is a niche, high-acuity indication. Engagement is driven by the scientific data supporting the drug's mechanism-inhibiting MASP-2 while preserving the classical complement pathway. This requires deep, one-on-one scientific exchange with transplant physicians.

  • Engagement built on peer-reviewed data published in journals like the American Journal of Hematology.
  • Collaboration involved an international panel of pediatric and adult transplant experts in manuscript authorship.
  • The Biologics License Application (BLA) resubmission to the FDA was developed with input from the agency, suggesting a close working relationship with regulatory bodies that impacts physician trust.

Dedicated Commercial Team: Building a focused sales and medical affairs team for narsoplimab.

Omeros Corporation has been building out its commercial infrastructure specifically to support the anticipated U.S. launch of narsoplimab. This team is small but highly specialized, focusing only on the centers that perform HSCT. Honestly, you can see the financial commitment ramping up as they prepare for market entry.

The company expected operating expenses in the fourth quarter of 2025 to increase specifically due to marketing costs associated with the YARTEMLEA launch. The commercial team was described as 'well-prepared to execute a successful market launch' following the March 2025 BLA resubmission.

Expanded Access Program (EAP): Providing pre-approval access to narsoplimab for critical patients.

The EAP served as a critical relationship-building tool, providing access to narsoplimab for patients with life-threatening TA-TMA before formal approval. This demonstrated commitment to patients facing no other options. The data generated from this program is now a core part of the regulatory package.

The survival data from the EAP was robust, especially for patients who had failed prior treatments like C5 inhibitors. For EAP allogeneic transplant patients who failed one or more regimens, the 1-year survival was 41% for adults and 47% for pediatrics. This is over 2-fold higher than the historical 1-year survival rate of less-than-20-percent for patients failing targeted TA-TMA therapy. The submission to the European Medicines Agency (EMA) included outcomes from over 130 TA-TMA patients treated under this program.

Strategic Partner Management: Long-term collaboration with Novo Nordisk on zaltenibart development.

The relationship with Novo Nordisk for zaltenibart (OMS906) is a major strategic pillar, shifting the development and commercialization burden for that asset to a global leader. This partnership structure provides Omeros Corporation with significant, non-dilutive capital to support its ongoing operations and the narsoplimab launch.

Here's the quick math on the deal structure, which defines the ongoing relationship terms:

Payment Component Amount (USD)
Upfront + Near-term Milestones $340,000,000
Total Potential Development & Commercial Milestones Up to $2,100,000,000
Additional Consideration Tiered royalties on net sales
Expected Closing Period Q4 2025

This agreement grants Novo Nordisk exclusive global rights for zaltenibart in all indications, and the transaction was expected to close in the fourth quarter of 2025. Omeros Corporation is eligible to receive $340 million in upfront and near-term milestone payments.

The financial structure of the zaltenibart agreement directly impacts Omeros Corporation's ability to manage its customer relationships for narsoplimab, as the proceeds support operations. As of September 30, 2025, Omeros Corporation held $36.1 million in cash and short-term investments, and the cash burn for Q3 2025 was $22.0 million (exclusive of financing proceeds). The upfront payment from Novo Nordisk was reported as $240 million in one source, providing capital for the anticipated narsoplimab U.S. launch.

Omeros Corporation (OMER) - Canvas Business Model: Channels

You're looking at how Omeros Corporation moves its value proposition-its investigational drugs-to the customer, which is highly dependent on regulatory milestones and specialized distribution for complex biologics. The channels strategy for late 2025 is clearly bifurcated between the anticipated launch of narsoplimab and the recent out-licensing of zaltenibart.

Specialty Pharmacy/Distribution

For a high-cost, complex biologic therapy like narsoplimab (marketed as Yartemlya for hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA), the channel relies heavily on a specialty pharmacy network. This is necessary because these therapies require specific handling, administration, and patient support services beyond what a standard retail pharmacy can provide. Omeros Corporation is actively preparing for this, as evidenced by the expected increase in operating expenses for marketing related to the anticipated Yartemlya launch in the fourth quarter of 2025.

The financial underpinning for this launch channel is now secured, post-Novo Nordisk deal. The company expects the proceeds from that transaction to fund more than 12 months of post-closing operations, which explicitly includes the anticipated U.S. launch of narsoplimab for TA-TMA.

Direct Sales Force

Omeros Corporation's channel strategy for its lead product involves building out a dedicated U.S. commercial organization to target specialized medical centers where TA-TMA patients are treated. This is a classic biopharma channel approach for a niche indication. The plan was to hire this field sales force contingent upon FDA approval.

As of November 2025, Omeros Corporation is described as having a launch-ready U.S. commercial organization in preparation for the anticipated launch of Yartemlya. The company's total employee count, which supports this and other functions, stood at 233 as of September 30, 2025.

Here's a quick look at the financial context supporting the operational readiness:

Metric Value as of September 30, 2025 Context
Q3 2025 Net Loss $30.9 million Improvement from Q3 2024 loss
Q3 2025 Cash Burn (ex-financing) $22.0 million Conservation effort prior to deal close
Cash & Short-Term Investments (End Q3) $36.1 million Pre-Novo Nordisk closing

Regulatory Agencies

Regulatory agencies are a critical, non-negotiable channel for market access. For narsoplimab, Omeros Corporation has been engaged in an intensive review process with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

  • FDA PDUFA date for narsoplimab BLA resubmission: Extended to December 26, 2025.
  • FDA labeling discussions planned: No later than October 2025.
  • EMA Marketing Authorization Application (MAA) submission date: June 2025.
  • Expected EMA Committee opinion on MAA: mid-2026.

The success of these regulatory interactions directly dictates when the commercial channels can activate. The BLA resubmission in March 2025 was classified as a Class 2 resubmission.

Licensing/Partnering

The out-licensing of zaltenibart (OMS906) to Novo Nordisk represents a major channel strategy shift, moving global commercialization rights for that asset to a partner with established rare disease infrastructure. This transaction closed on December 1, 2025.

The financial structure of this channel partnership is substantial:

Payment Component Amount Status/Type
Upfront Cash Received at Closing $240.0 million Received December 2025
Total Upfront & Near-Term Milestones Up to $340.0 million Total potential near-term cash
Total Potential Payments (Including Dev/Commercial) Up to $2.1 billion Total deal value
Royalties Tiered royalties on net sales Post-commercialization revenue stream

This deal immediately provided Omeros Corporation with capital to pay off debt; specifically, the company prepaid its entire $67.1 million principal amount outstanding under its senior secured term loan at closing. Omeros retains rights to its MASP-3 small-molecule program, which will use a different, likely partnership-based, channel strategy for development.

Finance: draft 13-week cash view by Friday.

Omeros Corporation (OMER) - Canvas Business Model: Customer Segments

You're looking at the customer segments for Omeros Corporation (OMER) as they gear up for the potential late-2025 FDA decision on narsoplimab for transplant-associated thrombotic microangiopathy (TA-TMA). The focus here is on the specific groups that drive adoption, partnership value, and revenue realization.

Patients with TA-TMA: Critically ill patients in Hematopoietic Stem Cell Transplant (HSCT) centers.

This segment represents the direct beneficiaries of Omeros Corporation's lead product candidate, narsoplimab, for TA-TMA. The clinical data used for the Biologics License Application (BLA) submission provides a clear picture of the patient population Omeros is targeting.

The pivotal trial data compared 28 TA-TMA patients treated with narsoplimab against an external control registry of more than 100 TA-TMA patients who did not receive the drug. Furthermore, the Expanded Access Program (EAP) included a total of 136 TA-TMA patients.

Patient Group Metric Data Point
Pivotal Trial Treated Patients 28
External Control Registry Patients Over 100
EAP Total Patients 136
EAP High-Risk Patients (per consensus criteria) 102
PDUFA Target Action Date for Approval December 26, 2025

The survival superiority demonstrated in the pivotal trial showed narsoplimab-treated patients had a hazard ratio of 0.32 compared to the external control. That translates to a 68% lower risk of death in the treated group based on one analysis.

Hematologists and Oncologists: Key prescribers at major transplant and cancer centers.

These are the specialists who will ultimately write the prescriptions for narsoplimab upon approval. Omeros Corporation is positioning itself to engage this group directly for the anticipated launch.

The company is actively preparing its commercial strategy to target a specific number of sites where these prescribers practice.

  • Target for narsoplimab launch: 175 transplant centers nationwide.
  • The company is preparing for commercial launch following the expected FDA decision by December 26, 2025.

Biopharmaceutical Companies: Partners seeking to acquire or license novel complement and immunology assets.

This segment is validated by Omeros Corporation's recent major transaction, which provides significant non-dilutive capital and external validation of their science, particularly the MASP-3 program.

The agreement with Novo Nordisk for zaltenibart (OMS906) involved substantial financial components, which defines the value Omeros places on its preclinical and clinical assets outside of narsoplimab.

Deal Component Financial Amount
Upfront Cash Payment (Novo Nordisk Deal) $240 million
Near-Term Milestone Payments (Novo Nordisk Deal) $100 million (additional)
Total Potential Transaction Value (Excluding Royalties) Up to $2.1 billion
Cash on Hand (as of September 30, 2025) $36.1 million
Net Proceeds from July 2025 Registered Direct Offering $20.3 million

The upfront cash alone was intended to cover the full repayment of the $67.1 million senior secured term loan and the remaining $17.1 million principal balance on the 2026 Convertible Notes.

Government and Private Payers: Entities responsible for reimbursement of high-cost orphan drugs.

Securing favorable reimbursement is critical for a high-cost orphan drug like narsoplimab. Omeros Corporation has taken concrete steps to address this segment ahead of the anticipated launch.

The company has focused on establishing the necessary coding and payment mechanisms to ensure patient access and appropriate revenue capture.

  • The NTAP (New Technology Add-on Payment) application was timely filed, with an expected benefit effective in 2026.
  • Omeros Corporation is scheduled to present at the CMS town hall in December to discuss reimbursement.
  • For orphan drugs, Omeros Corporation qualifies for a tax credit of up to 25% of expenditures on qualified clinical testing.
  • The Q3 2025 net loss was reported at $30.9 million, but the adjusted operating loss, which better reflects core performance, was $22.1 million.

Omeros Corporation (OMER) - Canvas Business Model: Cost Structure

You're hiring before product-market fit, so understanding where Omeros Corporation is spending its capital is key to assessing runway and execution risk.

The Cost Structure for Omeros Corporation is dominated by the necessary, high-stakes spending required to bring a novel therapeutic, narsoplimab, to market, alongside the ongoing costs of maintaining a pipeline of other assets.

The company's operating expenses reflect this focus, though specific breakdowns for the nine months ended September 30, 2025, are not fully itemized in the public disclosures provided, outside of the net loss figure. For example, total operating expenses for the first quarter of 2025 were $35.0 million.

Here's a look at the major cost components based on late 2025 data:

  • Research and Development (R&D): The largest expense, covering clinical trials and preclinical research.
  • Commercial Launch Costs: Significant investment in sales, marketing, and distribution for narsoplimab. The company noted reduced expenditures on various programs in Q3 2025 in an ongoing effort to conserve capital ahead of the expected commercial launch of narsoplimab in TA-TMA.
  • General and Administrative (G&A): Corporate overhead and legal/regulatory compliance.

The financial structure was significantly altered by a major transaction in late 2025, which directly impacted debt-related costs.

Interest Expense/Debt Repayment:

  • Prepayment of the $67.1 million secured term loan was completed using proceeds from the Novo Nordisk deal.
  • The total cost to retire the senior secured term loan was $72.6 million, which included the principal, a $3.4 million mandatory prepayment premium, and approximately $2.1 million in accrued interest and transaction expenses.
  • The company expects remaining proceeds to cover the repayment of the $17.1 million balance on its 2026 Convertible Notes.

Net Loss:

For the nine months ended September 30, 2025, the reported net loss was $89.8 million, or $1.47 per share. This compares favorably to the net loss of $125.5 million in the corresponding prior year period. The Non-GAAP adjusted net loss for the nine months ended September 30, 2025, was $89.1 million, or $1.46 per share.

You can see the key financial metrics related to the cost base here:

Cost/Loss Component Amount (USD) Period/Context
Net Loss $89.8 million Nine Months Ended September 30, 2025
Non-GAAP Adjusted Net Loss $89.1 million Nine Months Ended September 30, 2025
Senior Secured Term Loan Principal Repaid $67.1 million October 2025 Transaction
Total Senior Secured Term Loan Retirement Cost $72.6 million October 2025 Transaction
2026 Convertible Notes Balance Expected to be Repaid $17.1 million Post-Transaction Expectation
Total Operating Expenses $35.0 million First Quarter of 2025

Finance: draft 13-week cash view by Friday.

Omeros Corporation (OMER) - Canvas Business Model: Revenue Streams

You're looking at the hard numbers driving Omeros Corporation's revenue engine as we head into 2026. It's a mix of recent, significant upfront cash, ongoing legacy product royalties, and the massive potential of a near-term launch. Here's the quick math on where the money is coming from.

The most immediate and transformative revenue event was the closing of the asset sale and licensing transaction with Novo Nordisk for zaltenibart in December 2025. This deal immediately provided a substantial cash infusion.

Revenue Component Specific Amount/Value Context/Timing
Zaltenibart Upfront Payment (Novo Nordisk) $240.0 million Received at closing, December 2025
Total Upfront & Near-Term Milestones (Zaltenibart) Up to $340.0 million Includes the upfront payment
Total Potential Deal Value (Zaltenibart) Up to $2.1 billion Includes development/commercial milestones plus royalties
OMIDRIA Royalties Earned (Q3 2025) $9.2 million For the quarter ended September 30, 2025
OMIDRIA U.S. Net Sales (Q3 2025) $30.5 million Generated the Q3 2025 royalty amount

The OMIDRIA stream, while important, has a unique structure. All U.S.-based royalties through 2031 are remitted to DRI Health Acquisition LP, so while Omeros earns the royalty, it doesn't flow directly to the bottom line as revenue in the same way. Still, it's a measure of the product's ongoing commercial success.

The future revenue streams are heavily weighted toward Narsoplimab (YARTEMLEA) and the long-term potential from the Novo Nordisk partnership. You'll want to watch the regulatory dates closely; if onboarding takes 14+ days, the launch timeline could shift.

  • Narsoplimab (YARTEMLEA) FDA PDUFA date: December 26, 2025.
  • Analyst projected peak sales for Narsoplimab: $500M-$750M.
  • Total Addressable Market estimate for Narsoplimab in TA-TMA: Exceeds $2 billion annually.
  • EMA decision for Yartemlia expected: Mid-2026.
  • EU exclusivity for Narsoplimab could add ~$150M/year in revenue.
  • Potential OMIDRIA milestone payments due to DRI: $27.5 million in January 2026 and January 2028.

The Zaltenibart agreement also locks in future income via tiered royalties on global net sales, which will be a key driver of long-term, post-2025 revenue, separate from the upfront and near-term milestones. Omeros defintely retains rights to its MASP-3 small-molecule program, which is separate from the zaltenibart deal.

Finance: draft 13-week cash view by Friday.


Disclaimer

All information, articles, and product details provided on this website are for general informational and educational purposes only. We do not claim any ownership over, nor do we intend to infringe upon, any trademarks, copyrights, logos, brand names, or other intellectual property mentioned or depicted on this site. Such intellectual property remains the property of its respective owners, and any references here are made solely for identification or informational purposes, without implying any affiliation, endorsement, or partnership.

We make no representations or warranties, express or implied, regarding the accuracy, completeness, or suitability of any content or products presented. Nothing on this website should be construed as legal, tax, investment, financial, medical, or other professional advice. In addition, no part of this site—including articles or product references—constitutes a solicitation, recommendation, endorsement, advertisement, or offer to buy or sell any securities, franchises, or other financial instruments, particularly in jurisdictions where such activity would be unlawful.

All content is of a general nature and may not address the specific circumstances of any individual or entity. It is not a substitute for professional advice or services. Any actions you take based on the information provided here are strictly at your own risk. You accept full responsibility for any decisions or outcomes arising from your use of this website and agree to release us from any liability in connection with your use of, or reliance upon, the content or products found herein.