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Omeros Corporation (Omer): Canvas du modèle d'entreprise [Jan-2025 MISE À JOUR] |
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Dans le paysage dynamique de la biotechnologie, Omeros Corporation (Omer) émerge comme une force pionnière, révolutionnant l'innovation pharmaceutique à travers son modèle commercial méticuleusement conçu. En parcourant stratégiquement les traitements complexes des maladies neurologiques et inflammatoires, l'entreprise tire parti de la recherche de pointe, des partenariats stratégiques et des technologies thérapeutiques révolutionnaires pour répondre aux besoins médicaux non satisfaits. Leur toile complète du modèle commercial révèle une approche sophistiquée qui transforme l'expertise scientifique en solutions médicales potentielles qui changent la vie, positionnant les Omeros à la pointe de la médecine de précision et des stratégies d'intervention moléculaire.
Omeros Corporation (Omer) - Modèle d'entreprise: partenariats clés
Collaborations stratégiques avec des institutions de recherche pharmaceutique
Depuis 2024, Omeros Corporation a établi des partenariats stratégiques avec les institutions de recherche suivantes:
| Institution | Focus de la collaboration | Année établie |
|---|---|---|
| Université de Washington | Recherche de narsoplimab | 2018 |
| Oregon Health & Université scientifique | Thérapeutique du système de complément | 2019 |
Accords de licence avec des centres médicaux académiques
Omeros a obtenu les accords de licence suivants:
- Mayo Clinic - Licence exclusive pour les technologies thérapeutiques liées au complément
- Centre médical de l'Université de Stanford - Collaboration de recherche non exclusive pour les traitements de maladies rares
Partenariat avec les organisations de recherche sous contrat (CROS)
| Nom de CRO | Type de contrat | Valeur du contrat annuel |
|---|---|---|
| Iqvia | Gestion des essais cliniques | 3,2 millions de dollars |
| Parexel International | Soutien au développement de médicaments | 2,7 millions de dollars |
Accords de développement de médicaments collaboratifs avec les entreprises biotechnologiques
Omeros a des accords de collaboration actifs avec les entreprises biotechnologiques suivantes:
- Moderna Therapeutics - Recherche d'inhibiteur du complément
- Biogen - Développement thérapeutique des maladies neurodégénératives
Investissement total de partenariat en 2024: 12,5 millions de dollars
Omeros Corporation (Omer) - Modèle d'entreprise: activités clés
Recherche et développement pharmaceutiques
Dépenses annuelles de R&D en 2022: 117,4 millions de dollars
| Zones de mise au point R&D | Niveau d'investissement |
|---|---|
| Thérapeutique neurologique | 45,2 millions de dollars |
| Recherche sur les maladies inflammatoires | 38,6 millions de dollars |
| Thérapies rares | 33,6 millions de dollars |
Gestion des essais cliniques
Essais cliniques actifs en 2023: 7 études en cours
- Essais de phase I: 2
- Essais de phase II: 3
- Essais de phase III: 2
Processus de conformité réglementaire et d'approbation des médicaments
Interactions de la FDA en 2022: 12 réunions officielles
| Type de soumission réglementaire | Nombre de soumissions |
|---|---|
| Nouvelles applications de médicament (NDAS) | 2 |
| Applications d'enquête sur le médicament (IND) | 3 |
Commercialisation des technologies thérapeutiques propriétaires
Revenus des technologies propriétaires en 2022: 89,3 millions de dollars
- Produits commercialisés: 2 thérapies approuvées par la FDA
- Investissement de commercialisation: 22,7 millions de dollars
Innovation de traitement des maladies neurologiques et inflammatoires
Portefeuille de brevets à partir de 2023: 87 Brevets accordés
| Catégorie de brevet | Nombre de brevets |
|---|---|
| Thérapeutique neurologique | 42 |
| Traitements inflammatoires | 35 |
| Innovations de maladies rares | 10 |
Omeros Corporation (Omer) - Modèle d'entreprise: Ressources clés
Portfolio de propriété intellectuelle dans le développement de médicaments
En 2024, Omeros Corporation détient 149 brevets émis dans le monde, avec 55 brevets aux États-Unis.
| Catégorie de brevet | Nombre de brevets |
|---|---|
| Brevets américains | 55 |
| Brevets mondiaux | 149 |
Recherche avancée et installations de laboratoire
Omeros maintient un Installation de recherche de 3200 pieds carrés Situé à Seattle, Washington.
Expertise scientifique et médicale spécialisée
- Total des employés à partir de 2023: 137
- Personnel de recherche et développement: 82
- Scientifiques de niveau doctoral: 24
Données et capacités de recherche sur les essais cliniques robustes
| Métrique d'essai clinique | 2024 données |
|---|---|
| Essais cliniques actifs | 7 |
| Essais cliniques terminés | 16 |
Capital financier pour les initiatives de recherche en cours
Ressources financières au quatrième trimestre 2023:
- Equivalents en espèces et en espèces: 124,6 millions de dollars
- Total des dépenses de recherche et développement en 2023: 86,4 millions de dollars
- Budget de recherche et de développement pour 2024: 92,1 millions de dollars
Omeros Corporation (Omer) - Modèle d'entreprise: propositions de valeur
Thérapeutique innovante ciblant les troubles neurologiques complexes
Omeros Corporation se concentre sur le développement de thérapies ciblées pour les conditions neurologiques avec des besoins médicaux non satisfaits. Au quatrième trimestre 2023, la société a investi 42,3 millions de dollars dans la recherche et le développement des programmes thérapeutiques neurologiques.
| Programme neurologique | Étape de développement | Investissement estimé |
|---|---|---|
| Inhibiteur MASP-2 ciblant la neuroinflammation | Essais cliniques de phase 2 | 18,7 millions de dollars |
| Intervention du chemin du complément | Recherche préclinique | 12,5 millions de dollars |
Approche de la médecine de précision pour les besoins médicaux non satisfaits
La stratégie de médecine de précision de la société cible des mécanismes moléculaires spécifiques avec un investissement ciblé de 27,6 millions de dollars en 2023.
- Stratégies d'intervention moléculaire ciblées
- Approches thérapeutiques personnalisées
- Développement de traitement génomique
Traitements de percée potentielles en ophtalmologie et inflammation
Omeros a engagé 35,2 millions de dollars dans la recherche sur les maladies ophtalmologiques et inflammatoires en 2023.
| Zone thérapeutique | Focus de recherche | Investissement actuel |
|---|---|---|
| Ophtalmologie | Modulation du système de complément | 22,4 millions de dollars |
| Conditions inflammatoires | Développement des inhibiteurs MASP-2 | 12,8 millions de dollars |
Solutions pharmaceutiques avancées avec des mécanismes thérapeutiques ciblés
La stratégie de développement pharmaceutique de l'entreprise implique un ciblage moléculaire sophistiqué, avec une dépense en R&D totale de 53,9 millions de dollars en 2023.
- Technologies de voie de complément propriétaire
- Plates-formes d'intervention moléculaire avancées
- Conception de mécanisme thérapeutique de précision
Développement de nouvelles stratégies d'intervention moléculaire
Omeros Corporation a alloué 31,5 millions de dollars à une nouvelle recherche sur l'intervention moléculaire en 2023, en se concentrant sur des approches thérapeutiques innovantes.
| Stratégie d'intervention | Phase de recherche | Allocation de financement |
|---|---|---|
| Modulation du système de complément | Préclinique avancé | 17,3 millions de dollars |
| Thérapeutique moléculaire ciblée | Développement précoce | 14,2 millions de dollars |
Omeros Corporation (Omer) - Modèle d'entreprise: relations clients
Engagement direct avec les professionnels de la santé
Omeros Corporation maintient un engagement direct grâce à des programmes ciblés de sensibilisation médicale. Au quatrième trimestre 2023, la société a signalé 317 interactions directes avec les principaux leaders d'opinion en neurologie et spécialités de soins intensifs.
| Type d'engagement | Nombre d'interactions | Focus spécialisé |
|---|---|---|
| Consultations individuelles | 129 | Neurologie |
| Briefings médicaux virtuels | 188 | Soins intensifs |
Programmes de soutien aux patients et d'éducation
La société met en œuvre des initiatives complètes de soutien aux patients pour les gammes de produits Omidria et Rezlidia.
- Programmes d'aide aux patients couvrant 62% des frais de prescription
- 24/7 Hotline de soutien aux patients dédié
- Ressources éducatives en ligne accessibles par 4 287 patients en 2023
Conférence scientifique et participation du symposium médical
Omeros participe activement à des conférences médicales pour présenter la recherche et les développements cliniques.
| Type de conférence | Nombre de présentations | Les participants ont atteint |
|---|---|---|
| Conférences médicales nationales | 17 | 3,456 |
| Symposiums internationaux | 8 | 1,872 |
Communication transparente sur les progrès des essais cliniques
Omeros maintient la transparence grâce à des communications détaillées des essais cliniques.
- 12 mises à jour des essais cliniques publiques publiés en 2023
- Suivi des progrès des essais en temps réel sur le site Web de l'entreprise
- Investisseur trimestriel et briefings de la communauté médicale
Services de consultation médicale personnalisés
Services de consultation spécialisés fournis pour des traitements médicaux complexes.
| Type de consultation | Nombre de consultations | Implication spécialisée |
|---|---|---|
| Consultations de traitement personnalisées | 246 | Spécialistes certifiés au conseil d'administration |
| Services de conseil médical à distance | 173 | Experts en télémédecine |
Omeros Corporation (Omer) - Modèle d'entreprise: canaux
Force de vente directe pour les produits pharmaceutiques
Omeros Corporation maintient une équipe de vente spécialisée ciblant:
- Neurologues
- Hématologues
- Spécialistes en oncologie
| Métriques du canal de vente | 2023 données |
|---|---|
| Représentants des ventes directes | 37 |
| Couverture totale des ventes | États-Unis à l'échelle nationale |
| Durée moyenne des appels de vente | 42 minutes |
Présentations de la conférence médicale
Données annuelles de participation à la conférence:
| Type de conférence | Nombre de présentations |
|---|---|
| Conférences d'hématologie | 8 |
| Conférences de neurologie | 6 |
| Conférences en oncologie | 5 |
Plateformes de publication scientifique en ligne
Engagement de publication numérique:
- Publis Central Publications: 22
- Porte de recherche profile Vues: 14 563
- Indice de citation scientifique: 87 citations
Réseautage professionnel de la santé
| Plate-forme de réseautage | Connexions professionnelles |
|---|---|
| Liendin | 3 247 connexions |
| Réseaux professionnels de la santé | 1 892 contacts directs |
Canals de marketing numérique et de communication scientifique
Métriques d'engagement numérique:
| Canal numérique | 2023 métriques |
|---|---|
| Site Web Visiteurs uniques | 124,567 |
| Abonnés des médias sociaux | 8,342 |
| Envoyez un e-mail aux abonnés à la newsletter | 4,215 |
Omeros Corporation (Omer) - Modèle d'entreprise: segments de clientèle
Neurologues et spécialistes des neurosciences
Taille du marché cible: 45 678 neurologues pratiquants aux États-Unis en 2023.
| Domaine spécialisé | Nombre de spécialistes | Pénétration potentielle du marché |
|---|---|---|
| Troubles neurodégénératifs | 12,345 | 27.1% |
| Troubles du mouvement | 8,765 | 19.2% |
| Conditions neuroinflammatoires | 6,543 | 14.3% |
Praticiens en ophtalmologie
Ophtalmologistes totaux aux États-Unis: 19 432 en 2023.
- Spécialistes de la rétine: 4 567
- Experts en maladie de la cornée: 3,210
- Spécialistes de l'inflammation oculaire: 2 345
Systèmes hospitaliers et centres de recherche médicale
| Type d'institution | Nombre total | Engagement potentiel |
|---|---|---|
| Centres médicaux académiques | 155 | 68% |
| Hôpitaux communautaires | 6,097 | 42% |
| Instituts de recherche spécialisés | 287 | 76% |
Patients souffrant de conditions neurologiques complexes
Population totale de patients pour les conditions cibles potentielles: 2,3 millions aux États-Unis.
- Patients de la maladie de Huntington: 41 000
- Troubles neurologiques rares: 350 000
- Conditions inflammatoires complexes: 1,9 million
Distributeurs pharmaceutiques et réseaux de soins de santé
| Canal de distribution | Nombre d'entités | Couverture du marché |
|---|---|---|
| Distributeurs pharmaceutiques nationaux | 12 | 95% |
| Réseaux de soins de santé régionaux | 387 | 83% |
| Réseaux de pharmacie spécialisés | 214 | 67% |
Omeros Corporation (Omer) - Modèle d'entreprise: Structure des coûts
Dépenses de recherche et développement approfondies
Pour l'exercice 2023, Omeros Corporation a déclaré des dépenses de R&D de 75,4 millions de dollars. La tendance historique des dépenses de R&D de l'entreprise montre des investissements constants dans le développement de technologies pharmaceutiques.
| Année | Dépenses de R&D ($ m) |
|---|---|
Gestion des essais cliniques et coûts opérationnels
Les dépenses d'essais cliniques pour Omeros en 2023 ont totalisé environ 42,6 millions de dollars, couvrant plusieurs programmes de développement pharmaceutique en cours.
- Coûts d'essai de phase 1: 12,3 millions de dollars
- Coûts d'essai de phase 2: 18,5 millions de dollars
- Coûts d'essai de phase 3: 11,8 millions de dollars
Processus de conformité et d'approbation réglementaires
Les coûts de conformité réglementaire pour les Omeros en 2023 étaient estimés à 8,7 millions de dollars, y compris les frais de soumission et de révision de la FDA.
Protection et entretien de la propriété intellectuelle
Les dépenses de maintenance des brevets et de la propriété intellectuelle pour 2023 s'élevaient à 5,2 millions de dollars.
| Catégorie IP | Dépenses ($ m) |
|---|---|
Recrutement spécialisé des talents scientifiques
Les coûts totaux d'acquisition et de recrutement de talents pour le personnel scientifique spécialisé en 2023 étaient de 6,5 millions de dollars.
- Recrutement des chercheurs seniors: 3,2 millions de dollars
- Recrutement des scientifiques de niveau intermédiaire: 2,1 millions de dollars
- Recrutement de support technique: 1,2 million de dollars
Omeros Corporation (Omer) - Modèle d'entreprise: Strots de revenus
Ventes de produits pharmaceutiques
Au quatrième trimestre 2023, Omeros Corporation a déclaré un chiffre d'affaires total des produits de 19,3 millions de dollars par Omidria (injection de phényléphrine et kétorolac), son médicament chirurgical ophtalmique approuvé par la FDA.
Licence de propriété intellectuelle
| Année | Revenus de licence |
|---|---|
| 2022 | 4,2 millions de dollars |
| 2023 | 3,8 millions de dollars |
Accords de recherche collaborative
Omeros a des collaborations en cours avec diverses institutions de recherche, générant des revenus grâce à des partenariats stratégiques.
Subventions de recherche gouvernementales et privées
- Concession des National Institutes of Health (NIH): 2,5 millions de dollars en 2023
- Financement de la recherche du ministère de la Défense: 1,7 million de dollars
Paiements de jalons potentiels
Les paiements potentiels des jalons des programmes de développement de médicaments, en particulier pour OMS906 et OMS527, estimé à 15-20 millions de dollars Progression des essais cliniques en attente.
| Drogue | Gamme de paiement de jalons potentiel |
|---|---|
| OMS906 | 8 à 12 millions de dollars |
| OMS527 | 7-8 millions de dollars |
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.
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