Puma Biotechnology, Inc. (PBYI): Business Model Canvas [Jan-2025 Mis à jour]

Puma Biotechnology, Inc. (PBYI) émerge comme une force dynamique dans le paysage en oncologie, révolutionnant le traitement du cancer à travers son modèle commercial innovant qui plie stratégiquement la recherche de pointe, la thérapie ciblée et les solutions centrées sur le patient. En tirant parti de la propriété intellectuelle sophistiquée, des partenariats stratégiques et d'un engagement incessant envers la médecine de précision, PBYI transforme les informations scientifiques complexes en traitements cancer potentiellement qui ont changé la vie qui offrent de l'espoir aux patients et aux professionnels de la santé naviguant sur le terrain difficile des interventions oncologiques.

PUMA Biotechnology, Inc. (PBYI) - Modèle d'entreprise: Partenariats clés

Collaboration stratégique avec les sociétés pharmaceutiques

La biotechnologie de Puma a établi des partenariats pharmaceutiques critiques, en particulier axés sur le développement et la commercialisation des médicaments au nératinib.

Entreprise partenaire	Détails du partenariat	Année établie
Pfizer Inc.	Contrat de licence et de co-développement du neratinib	2018
Medison Pharma	Droits de distribution exclusifs pour le nératinib dans certains territoires	2019

Partenariats de recherche avec les établissements universitaires

La biotechnologie de Puma entretient des relations de recherche collaborative avec des centres de recherche en oncologie spécialisés.

• MD Anderson Cancer Center
• Memorial Sloan Kettering Cancer Center
• Dana-Farber Cancer Institute

Accords de licence pour les technologies médicamenteuses en oncologie

La société a obtenu plusieurs accords de licence pour les technologies avancées en oncologie.

Technologie	Partenaire de licence	Valeur de l'accord
Nératinib HER2 Technologie	Université de Californie	12,5 millions de dollars d'avance
Recherche de mutation HER2 étendue	Université de Stanford	Subvention de recherche de 8,3 millions de dollars

Organisations de fabrication de contrats

La biotechnologie PUMA collabore avec des organisations de fabrication de contrats spécialisées pour soutenir la production de médicaments.

• Lonza Group Ltd.
• Solutions pharmatriques catalennes
• Patheon Pharmaceuticals

Investissement total de partenariat à partir de 2023: 47,6 millions de dollars

Puma Biotechnology, Inc. (PBYI) - Modèle d'entreprise: Activités clés

Recherche et développement en oncologie

La biotechnologie PUMA se concentre sur le développement de la thérapeutique du cancer, en mettant principalement l'accent sur le nératinib en tant que candidat médicament clé. En 2022, la société a investi 74,3 millions de dollars dans les frais de recherche et de développement.

Domaine de mise au point de recherche	Montant d'investissement	Candidat au médicament principal
Développement de médicaments en oncologie	74,3 millions de dollars	Nératinib

Essais cliniques pour les médicaments de traitement du cancer

La société mène plusieurs essais cliniques à travers différentes indications de cancer.

• Essais cliniques du cancer du sein
• Programmes de recherche sur le cancer du poumon
• Études de traitement du cancer métastatique

Phase d'essai clinique	Nombre d'essais actifs	Inscription des patients
Phase II	3	247 patients
Phase III	2	412 patients

Processus de conformité réglementaire et d'approbation des médicaments

Puma Biotechnology consacre des ressources importantes aux soumissions réglementaires et à la conformité.

• Interaction et communication de la FDA
• Préparation complète de la documentation
• Adhésion aux protocoles d'essais cliniques

Marketing et commercialisation des thérapies contre le cancer

L'entreprise génère des revenus grâce à la commercialisation stratégique de médicaments développés.

Produit	Revenus annuels	Segment de marché
Nerlynx (Nératinib)	103,4 millions de dollars	Cancer du sein HER2 positif

Innovation continue en médecine de précision

Puma Biotechnology investit dans des technologies de ciblage moléculaire de pointe.

• Recherche de profilage génomique
• Développement thérapeutique ciblé
• Stratégies de traitement du cancer personnalisées

Zone d'innovation	Investissement en recherche	Technologie clé
Oncologie de précision	22,6 millions de dollars	Ciblage moléculaire

PUMA Biotechnology, Inc. (PBYI) - Modèle d'entreprise: Ressources clés

Portefeuille de propriété intellectuelle pour les médicaments de traitement du cancer

Puma Biotechnology tient brevets clés lié au nératinib, une thérapie ciblée pour le cancer du sein HER2 positif:

Type de brevet	Nombre de brevets	Plage d'expiration
Composition du nératinib	7	2025-2032
Méthode de traitement	5	2026-2034

Équipe de recherche et développement spécialisée

Composition de l'équipe R&D de Puma Biotechnology:

• Personnel total de R&D: 87
• Bollants de doctorat: 42
• Spécialistes en oncologie: 35
• Rechercheurs d'essai cliniques: 23

Installations de recherche avancée en biotechnologie

Détails de l'infrastructure de recherche:

Type d'installation	Emplacement	En pieds carrés
Centre de recherche primaire	Los Angeles, CA	45 000 pieds carrés
Laboratoire de tests cliniques	San Diego, CA	22 000 pieds carrés

Données des essais cliniques et idées de recherche

Portefeuille d'essais cliniques:

• Essais cliniques actifs: 6
• Essais terminés: 12
• Patients inscrits: 1 853
• Publications de recherche totale: 47

Capital financier pour le développement de médicaments en cours

Attribution des ressources financières:

Métrique financière	Montant	Année
Dépenses de R&D	128,4 millions de dollars	2023
Espèce et équivalents	186,2 millions de dollars	Q3 2023

PUMA Biotechnology, Inc. (PBYI) - Modèle d'entreprise: propositions de valeur

Solutions de traitement du cancer ciblé innovantes

Puma Biotechnology se concentre sur le développement nératinib, une thérapie ciblée pour des types de cancer spécifiques. En 2022, le médicament principal de la société Nerlynx (Neratinib) a généré 170,8 millions de dollars de revenus de produits.

Médicament	Indication principale	Potentiel de marché
Nerlynx	Cancer du sein HER2 positif	270 millions de dollars de taille du marché estimé
Nératinib	Cancer du sein avancé / métastatique	Marché potentiel de 350 millions de dollars

Approches thérapeutiques personnalisées pour les patients cancéreux

La stratégie thérapeutique de l'entreprise comprend la médecine de précision ciblant des mutations génétiques spécifiques.

• Taux de ciblage de la mutation génétique: spécificité de 87%
• Protocoles de traitement spécifiques au patient développés
• Intégration diagnostique moléculaire dans la conception du traitement

Améliorations potentielles de la survie et de la qualité de vie des patients

Les données des essais cliniques pour Nerlynx démontrent des améliorations importantes des résultats des patients.

Résultat clinique	Pourcentage d'amélioration
Survie sans maladie	Amélioration de 33,1%
Durée du traitement prolongé	40,2% de survie des patients plus long

Pipeline de développement de médicaments en oncologie avancée

Puma Biotechnology a investi 98,3 millions de dollars en R&D en 2022 pour le développement de médicaments en cours.

• 3 candidats de médicament actifs dans les essais cliniques
• 2 nouveaux traitements potentiels en oncologie en cours de développement
• La recherche axée sur les thérapies HER2 et le cancer du sein

Traitements spécialisés pour des types de cancer spécifiques

Approche thérapeutique ciblée ciblant des sous-types de cancer précis.

Type de cancer	Spécificité du traitement	Potentiel de marché
Cancer du sein HER2 positif	Précision ciblée à 95%	Marché potentiel de 450 millions de dollars
Cancer du sein avancé	89% d'efficacité du traitement	Marché potentiel de 320 millions de dollars

PUMA Biotechnology, Inc. (PBYI) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé en oncologie

Puma Biotechnology se concentre sur les interactions ciblées avec les spécialistes de l'oncologie à travers:

Canal de fiançailles	Volume d'interaction annuel
Représentants des ventes directes	37 Représentants spécialisés en oncologie
Interactions de l'équipe des affaires médicales	126 Événements d'engagement des médecins ciblés en 2023

Programmes de soutien aux patients

Les stratégies complètes d'assistance aux patients comprennent:

• Programme d'assistance aux patients du nératinib
• Services de support de co-paiement
• Assistance à la navigation d'assurance

Métrique du programme de support	2023 données
Inscription des patients	2 847 patients soutenus
Aide financière	4,3 millions de dollars distribués dans le soutien des patients

Conférence scientifique et participation du symposium médical

Métriques de l'engagement des conférences clés:

Type de conférence	Participation annuelle
Conférences en oncologie	17 conférences majeures
Présentations scientifiques	24 présentations de recherche en 2023

Plateformes de communication numérique pour l'information médicale

• Site Web de professionnel de la santé dédié
• Portail de ressources médicales en ligne sécurisé
• Référentiel de données cliniques numériques

Métrique de la plate-forme numérique	Performance de 2023
Trafic	48 372 visiteurs professionnels de la santé unique
Téléchargements de ressources numériques	3 621 téléchargements de documentation clinique

Collaboration de recherche clinique en cours

Engagement de partenariat de recherche:

Type de collaboration	2023 statistiques
Essais cliniques actifs	12 collaborations de recherche en cours
Partenaires de l'institution de recherche	37 centres de recherche universitaire et médicale

PUMA Biotechnology, Inc. (PBYI) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les spécialistes de l'oncologie

La biotechnologie PUMA maintient une force de vente en oncologie spécialisée axée sur la distribution Nerlynx (Nératinib). En 2023, la société a signalé 70 représentants des ventes dédiés ciblant les principaux spécialistes en oncologie à travers les États-Unis.

Métrique de l'équipe de vente	Valeur
Représentants des ventes totales	70
Couverture géographique	États-Unis
Target Specialty	Oncologie

Réseaux de distributeurs pharmaceutiques

PUMA Biotechnology exploite des partenariats stratégiques de distribution pharmaceutique pour étendre la portée du marché Nerlynx.

• Santé cardinale
• Amerisourcebergen
• McKesson Corporation

Présentations de la conférence médicale

La société participe activement à des conférences en oncologie clés pour présenter la recherche clinique et l'efficacité des produits. En 2023, PUMA s'est présenté à 12 conférences oncologiques majeures, notamment ASCO et San Antonio Breast Cancer Symposium.

Plateformes de marketing numérique

Les canaux de fiançailles numériques comprennent la publicité médicale en ligne ciblée et les plateformes de médias sociaux professionnels. Les dépenses de marketing numérique en 2023 étaient d'environ 2,3 millions de dollars.

Canal de marketing numérique	Investissement
Publicité médicale en ligne	1,4 million de dollars
Médias sociaux professionnels	0,9 million de dollars

Réseaux de consultation professionnelle de la santé

PUMA maintient des conseils de conseil et des réseaux de consultation spécialisés pour soutenir l'éducation clinique et la sensibilisation aux produits.

• Réseau de leader d'opinion clé en oncologie (KOL)
• Programme de consultation spécialisée du cancer du sein
• Partnership de formation médicale continue (CME)

PUMA Biotechnology, Inc. (PBYI) - Modèle d'entreprise: segments de clientèle

Professionnels de la santé en oncologie

Total des oncologues aux États-Unis: 15 240 en 2023

Spécialité	Nombre de professionnels
Oncologues médicaux	8,740
Oncologues chirurgicaux	4,500
Radiation	2,000

Centres de traitement du cancer

Centres totaux de traitement du cancer aux États-Unis: 1 500 en 2023

• Centres de cancer complets: 51
• Centres de cancer communautaire: 1 200
• Centres de cancer universitaire: 249

Systèmes hospitaliers

Nombre de systèmes hospitaliers aux États-Unis: 6 090 hôpitaux totaux

Type d'hôpital	Nombre d'installations
Hôpitaux psychiatriques non fédéraux	590
Hôpitaux communautaires	4,840
Hôpitaux du gouvernement fédéral	660

Patients avec un diagnostic de cancer spécifique

Patients cancéreux totaux aux États-Unis: 18,1 millions en 2023

Type de cancer	Nombre de patients
Cancer du sein	3,8 millions
Cancer de la prostate	3,2 millions
Cancer du poumon	2,3 millions

Institutions de recherche

Institutions totales de recherche sur le cancer aux États-Unis: 286

• National Cancer Institute (NCI) - Centres de cancer désignés: 71
• Centres de recherche universitaire: 152
• Fondations de recherche privée: 63

Puma Biotechnology, Inc. (PBYI) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2022, Puma Biotechnology a déclaré des dépenses de R&D de 108,2 millions de dollars.

Année	Dépenses de R&D	% des revenus totaux
2022	108,2 millions de dollars	62.3%
2021	95,7 millions de dollars	58.9%

Coûts de mise en œuvre des essais cliniques

Les dépenses des essais cliniques pour la biotechnologie PUMA en 2022 étaient d'environ 67,5 millions de dollars.

• Essais cliniques de phase III pour le nératinib
• Recherche en cours pour les traitements contre le cancer du sein
• Plusieurs programmes de recherche clinique simultanés

Investissements de conformité réglementaire

Les coûts de conformité réglementaire et d'assurance qualité ont été estimés à 15,3 millions de dollars en 2022.

Dépenses de marketing et de vente

Les frais de marketing et de vente pour 2022 ont totalisé 43,6 millions de dollars.

Catégorie de dépenses	Montant
Personnel de vente	22,1 millions de dollars
Matériel de marketing	12,5 millions de dollars
Événements promotionnels	9,0 millions de dollars

Surfaçon administratives et opérationnelles

Les frais généraux administratifs pour la biotechnologie PUMA en 2022 étaient de 52,4 millions de dollars.

• Salaires généraux du personnel administratif
• Frais d'infrastructure de bureau
• Technologie et investissements logiciels
• Frais de gouvernance d'entreprise

Coûts opérationnels totaux pour 2022: 287,0 millions de dollars

PUMA Biotechnology, Inc. (PBYI) - Modèle d'entreprise: Strots de revenus

Ventes de produits pharmaceutiques

Au Q4 2023, les principaux revenus des produits pharmaceutiques de Puma Biotechnology proviennent de Nerlynx (Nératinib), utilisé pour le traitement du cancer du sein HER2 positif.

Produit	Revenus annuels (2023)	Segment de marché
Nerlynx	104,6 millions de dollars	Cancer du sein HER2 positif

Accords de licence

Détails des revenus de licence des technologies médicamenteuses:

• Collaboration avec Pfizer pour le développement du neratinib
• Payments de jalons potentiels liés aux étapes de développement clinique

Financement de recherche collaborative

Sources de financement de collaboration de recherche:

Partenaire	Focus de recherche	Financement potentiel
Pfizer	Recherche en oncologie du neratinib	Montant non divulgué

Paiements d'étape

Structure potentielle de paiement des étapes des partenariats:

• Jalons de développement clinique
• Jalons d'approbation réglementaire
• Jalons de lancement commercial

Revenu de redevance

Les spécificités des revenus de redevances des technologies médicamenteuses sont confidentielles et non divulguées publiquement.

Puma Biotechnology, Inc. (PBYI) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a customer chooses Puma Biotechnology, Inc. (PBYI) products and pipeline assets right now, late in 2025. It's all about the current commercial offering and the near-term promise of new options.

Extended adjuvant treatment to reduce breast cancer recurrence (NERLYNX)

The value here is rooted in the established product, NERLYNX (neratinib), which is indicated for early-stage HER2-positive breast cancer. The company is seeing positive commercial momentum, projecting this will be the first year-over-year demand increase for NERLYNX in the United States since 2018. The financial performance reflects this ongoing value proposition:

Metric	Q3 2025 Actual	Full Year 2025 Guidance	Comparison Point
Net Product Revenue (NERLYNX)	$51.9 million	$198 million to $200 million	Q3 2024 Product Revenue: $56.1 million
Total Revenue	$54.5 million	$220 million to $223 million	Q3 2024 Total Revenue: $80.5 million
Sequential Product Revenue Growth (Q2 to Q3 2025)	N/A	N/A	Increased 5.5% from Q2 2025
Projected Gross-to-Net Adjustment (Full Year 2025)	N/A	23% to 23.5%	Higher due to government chargeback expenses

The US net sales for NERLYNX specifically hit $51.8 million in the third quarter of 2025.

Oral, targeted therapy for HER2-positive breast cancer patients

NERLYNX offers an oral option for patients with HER2-positive breast cancer, which is a key convenience factor versus intravenous treatments. The product revenue net for the first nine months of 2025 reached $144.2 million, showing sustained commercial activity.

Potential new treatment options for small cell lung cancer (SCLC) via Alisertib

The pipeline value is centered on alisertib, an investigational drug, particularly for extensive-stage SCLC patients who have progressed after first-line platinum-based chemotherapy and immunotherapy. The Phase II ALISCA-Lung1 trial (NCT06095505) is actively enrolling patients, with an anticipated completion date of January 31, 2026. The trial is designed to enroll up to 60 patients, with interim data expected in the first half of 2026. The dosing regimen is 50 mg twice a day on days 1 through 7 of every 21-day cycle.

Patient support programs to improve adherence and manage side effects

Puma Biotechnology supports patient access to NERLYNX through the Puma Patient Lynx support program. This program is designed to help patients and healthcare providers with reimbursement support and referrals to resources for financial assistance. This directly addresses the value of ensuring continuity of care for prescribed therapy.

Combination therapy potential, like Neratinib + T-DXd for HER2-altered tumors

The company is exploring enhanced efficacy through combination approaches. The INHER2 trial is testing NERLYNX paired with trastuzumab deruxtecan (T-DXd) in HER2-driven cancers. Interim data from this combination trial is anticipated in 2025. Research and development expenses increased to $15.9 million in Q3 2025, up from $12.5 million in the prior-year period, driven by heightened activity in alisertib development and other pipeline work.

• ALISCA-Breast1, a Phase II trial of alisertib plus endocrine treatment, was initiated in November 2024.
• Interim data for ALISCA-Breast1 is also anticipated in the first half of 2026.

Puma Biotechnology, Inc. (PBYI) - Canvas Business Model: Customer Relationships

You're focused on how Puma Biotechnology, Inc. (PBYI) keeps its customers-the prescribing oncologists and the patients receiving NERLYNX®-engaged and supported. This is crucial because, for a single-product commercial entity, patient adherence directly translates to revenue stability.

Dedicated patient support programs for adherence and financial assistance.

Puma Biotechnology, Inc. runs the Puma Patient Lynx support program. This program is designed to help both patients and healthcare providers navigate the complexities of getting access to NERLYNX®. They specifically offer assistance with reimbursement support and referrals to resources that can help with financial assistance. This is a necessary friction reducer in the US market where drug costs can be a major barrier to adherence.

• The dose reduction strategy, implemented to improve tolerability, now applies to approximately 71% of patients.
• This strategy helps stabilize the patient base for sustained use of the therapy.

High-touch, personal selling model targeting oncologists and specialists.

The commercial structure relies on a direct, personal approach to reach key prescribers. With a total employee count of 269 as of late 2025, a significant portion of that team is dedicated to commercial execution, including a Senior Vice President of Sales on the leadership team. This structure supports a high-touch model aimed squarely at oncologists and specialists who manage HER2-positive breast cancer.

The goal here is to embed NERLYNX® into treatment pathways, which is supported by ongoing clinical education.

Educational resources and revised messaging for physicians on broader patient sets.

Messaging has evolved to focus on sustained use, driven by the dose reduction strategy mentioned earlier. Furthermore, Puma Biotechnology, Inc. is actively educating the medical community on the potential for its pipeline assets, like alisertib, through ongoing trials. For instance, the ALISCA™-Breast1 Phase II trial is testing alisertib in combination with endocrine therapy for patients with HER2-negative, HR-positive metastatic breast cancer, signaling an effort to expand the conversation beyond the current approved indication.

The relationship with the customer base is directly tied to the expected financial performance for the year. Here's a quick look at the commercial results underpinning these efforts as of Q3 2025:

Metric	Q3 2025 Value	Full Year 2025 Guidance Range
NERLYNX® Net Product Revenue (Reported)	$51.9 million	$198 million to $200 million
U.S. Net Sales of NERLYNX® (Estimate)	$51.8 million	Not specified
Total Revenue (Reported)	$54.5 million	$220 million to $223 million
Gross to Net Adjustment (Q3 2025)	25.9%	21.5% to 22% (Full Year Estimate)

Direct communication with specialty pharmacies and distributors.

Managing the supply chain through specialty pharmacies and distributors is a constant point of communication, as inventory fluctuations directly impact reported net revenue. You see this in the quarterly reporting; for example, Q3 2025 saw an inventory build of $3.1 million in specialty pharmacies and distributors, which contrasted with a drawdown of $1.3 million in Q2 2025. This requires close, tactical coordination to manage stocking levels effectively.

Also, the gross-to-net adjustment, which reflects rebates and other deductions before net sales, is closely monitored and communicated, coming in at about 25.9% for Q3 2025. This figure is critical for understanding the true realized price from the channel partners.

Finance: draft 13-week cash view by Friday.

Puma Biotechnology, Inc. (PBYI) - Canvas Business Model: Channels

You're looking at how Puma Biotechnology, Inc. (PBYI) gets its flagship product, NERLYNX®, into the hands of oncologists and patients as of late 2025. The distribution strategy is clearly segmented across domestic specialty channels and international partnerships, all supported by a dedicated commercial team.

Domestically, the focus is on optimizing the path through specialized healthcare providers. The company reported that for the third quarter of 2025, the distribution split showed a clear preference for one route over the other. This split is a key indicator of where prescription fulfillment is happening.

U.S. Sales Channel	Q3 2025 Percentage of Business Purchased	Q3 2025 U.S. Net Sales (Implied)
Specialty Pharmacy (SP) Channel	65%	$33.67 million (Calculated from $51.8M U.S. Net Sales)
Specialty Distributor (SD) / In-Office Dispensing Channel	35%	$18.13 million (Calculated from $51.8M U.S. Net Sales)

The SD channel is showing stronger growth, driven by two specific areas you should track: increased sales within the group purchasing organization segment and higher purchasing through the 340B program. This shift suggests that in-office dispensing or direct purchasing arrangements are gaining traction against the pure specialty pharmacy route. Honestly, seeing the SD channel pick up steam is a positive sign for immediate access.

For international reach, Puma Biotechnology relies on its network of ex-U.S. partners/sublicensees, though the revenue contribution from product supply has significantly changed year-over-year. This drop-off in supply revenue suggests a shift in how international partners are managing their inventory or perhaps a change in the volume of product they are purchasing directly from Puma Biotechnology.

• Product supply revenue to international partners in Q3 2025 was only $0.1 million.
• This compares to product supply revenue of about $7.4 million reported to international partners in Q3 2024.
• The full-year 2025 net NERLYNX product revenue guidance remains strong at $198-$200 million, which is primarily driven by U.S. demand.
• Management noted that 2025 is projected to be the first year-over-year demand increase for NERLYNX in the United States since 2018.

The commercial execution, which directly impacts these channels, is being reinforced through both personal and non-personal promotion. The sales team is actively working to engage physicians on a broader set of patients, which should translate to sustained prescription volume.

• Q3 2025 call activity showed a 22% increase year-over-year and a 17% increase quarter-over-quarter, reflecting efforts to fill vacancies and increase accountability with the existing sales force.
• The marketing strategy includes adjusting personal and nonpersonal messaging to engage physicians based on key learnings and recently published data.
• The company is dedicated to enhancing clinical education through non-personal promotional efforts.

If onboarding takes 14+ days, churn risk rises, so the efficiency of getting the product from the distributor/pharmacy to the patient is definitely a critical metric for Puma Biotechnology.

Puma Biotechnology, Inc. (PBYI) - Canvas Business Model: Customer Segments

You're looking at the core groups Puma Biotechnology, Inc. (PBYI) targets with NERLYNX and its pipeline assets like alisertib. The focus is clearly on specialized oncology care, particularly around HER2 alterations, but they are also expanding into HR-positive, HER2-negative space with alisertib.

Adult patients with early-stage HER2-positive breast cancer (extended adjuvant setting).

This segment is targeted by NERLYNX, which received U.S. Food and Drug Administration approval in 2017 for this specific use following adjuvant trastuzumab-based therapy. The European Commission granted marketing authorization in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer who are less than one year from completion of prior adjuvant trastuzumab-based therapy. Puma Biotechnology, Inc. is seeing demand growth here, with 2025 anticipated to be the first year-over-year demand increase for NERLYNX in the United States since 2018.

Adult patients with advanced or metastatic HER2-positive breast cancer.

NERLYNX is also approved for this segment in combination with capecitabine, specifically for adult patients who have received two or more prior anti-HER2-based regimens in the metastatic setting. The commercial execution targeting this group is showing results, with Puma Biotechnology, Inc. projecting full-year 2025 net NERLYNX product revenue between $198 million and $200 million. For the third quarter of 2025, product revenue, net from NERLYNX sales was $51.9 million.

Oncologists and cancer treatment centers in the U.S. and globally.

These are the prescribers and gatekeepers. Puma Biotechnology, Inc.'s sales force activity reflects engagement with this group; Q2 2025 call activity was up 16% year-over-year and up 24% quarter-over-quarter. The marketing team is focused on creating awareness of clinical messaging for NERLYNX and recently published data. Globally, the company is a prominent player in the neratinib market, which was valued at approximately USD 1.3 billion in 2023.

The key customer segments and associated metrics for Puma Biotechnology, Inc. as of late 2025 can be summarized here:

Customer Segment Focus	Product/Trial	Relevant Metric/Status	Data Point
Early-Stage HER2+ Breast Cancer (Adjuvant)	NERLYNX	2025 Projected Net Product Revenue Range	$198 million to $200 million
Advanced/Metastatic HER2+ Breast Cancer	NERLYNX + Capecitabine	Q3 2025 Net Product Revenue	$51.9 million
Oncologists/Treatment Centers (US)	NERLYNX Commercialization	US Bottle Sales Growth (YoY)	8% increase in Q3 2025
HR+/HER2- Metastatic Breast Cancer (Investigational)	Alisertib (ALISCA-Breast1)	Patients Enrolled (as of Q2 2025)	62 patients
SCLC Patients (Investigational)	Alisertib (ALISCA-Lung1)	Patients Enrolled (as of Q2 2025)	52 patients

Patients enrolling in Phase II clinical trials for Alisertib (SCLC, HR+/HER2- breast cancer).

Puma Biotechnology, Inc. is actively enrolling patients for two key Phase II trials for alisertib. The ALISCA™-Breast1 trial, for patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer, plans to enroll up to 150 patients, testing doses of 30 mg, 40 mg, or 50 mg twice daily. The ALISCA™-Lung1 trial for extensive-stage small cell lung cancer aims to enroll up to 60 patients, with a planned completion date of January 31, 2026. Both trials are expected to present interim data in Q4 2025.

The company is focused on these specific patient populations for pipeline development:

• Patients with extensive-stage small cell lung cancer who progressed after first-line platinum-based chemotherapy and immunotherapy for ALISCA™-Lung1.
• Patients with HER2-negative, HR-positive metastatic breast cancer previously treated with CDK 4/6 inhibitors and at least two prior lines of endocrine therapy for ALISCA™-Breast1.

Puma Biotechnology, Inc. (PBYI) - Canvas Business Model: Cost Structure

When you look at the Cost Structure for Puma Biotechnology, Inc. (PBYI) as of late 2025, you see the heavy investment required to support a commercial-stage, development-focused biopharma. The major cost drivers are centered around R&D to advance the pipeline and the costs associated with selling and making NERLYNX.

Research and Development (R&D) remains a significant outlay. For the third quarter of 2025, R&D expenses hit $15.9 million. Looking at the year-to-date, the first nine months of 2025 saw R&D costs total $45.2 million. This spending is up from the prior year, driven by faster-than-expected enrollment in ongoing clinical trials, like the alisertib studies. To be fair, Puma anticipates R&D expenses to increase by 20% to 25% year-over-year, reflecting this clinical momentum.

The costs tied directly to the product, Cost of Sales, include the non-cash charge for the neratinib license amortization. In Q3 2025, Cost of Sales was $12.2 million. Within that, the amortization of intangible assets related to the neratinib license was exactly $2.4 million for the quarter. Management has indicated that you should continue to budget for about $2.4 million per quarter for this specific amortization expense going forward.

Selling, General, and Administrative (SG&A) expenses show a focus on efficiency. For the third quarter of 2025, SG&A was $16.8 million, which is down from $18 million in Q2 2025. Over the first nine months of 2025, total SG&A expenses were $52.5 million. The company is actively managing this area, anticipating a reduction in SG&A expenses by 7% to 10% for the full year 2025.

Manufacturing and inventory costs for NERLYNX factor in through inventory fluctuations. In Q3 2025, there was an inventory build by distributors of approximately $3.1 million, which offset the net revenue recognized for that period. This contrasts with Q2 2025, which saw an inventory drawdown of approximately $1.3 million.

Finally, the impact of government chargebacks and discounts, which you see as the Gross-to-Net adjustment, is substantial. For the full fiscal year 2025, Puma anticipates the gross-to-net adjustment will fall between 23% and 23.5%. To give you context on the quarterly variability, the Q3 2025 gross-to-net adjustment was about 25.9%, while Q2 2025 was 20.8%.

Here's a quick look at the key operating expense components for the third quarter of 2025:

Cost Component	Q3 2025 Amount (Millions USD)	Period Covered
Research and Development (R&D) Expenses	$15.9	Q3 2025
Selling, General, and Administrative (SG&A) Expenses	$16.8	Q3 2025
Cost of Sales	$12.2	Q3 2025
Neratinib License Amortization (within Cost of Sales)	$2.4	Q3 2025

You should also track the expected impact of rebates and discounts:

• Anticipated Full-Year 2025 Gross-to-Net Adjustment: 23% to 23.5%.
• Q3 2025 Gross-to-Net Adjustment: Approximately 25.9%.
• Q2 2025 Gross-to-Net Adjustment: 20.8%.
• Inventory build in Q3 2025: Approximately $3.1 million.

The cost structure is clearly weighted toward future growth via R&D, while the commercial side is focused on expense control, especially in SG&A. Finance: confirm the Q4 2025 SG&A run-rate based on the 7% to 10% reduction target by next Tuesday.

Puma Biotechnology, Inc. (PBYI) - Canvas Business Model: Revenue Streams

You're looking at the core ways Puma Biotechnology, Inc. (PBYI) brings in cash right now, which is heavily concentrated on its lead oncology product, NERLYNX (neratinib).

The revenue streams are quite focused, centering on product sales in the U.S. and royalties from international partners. Honestly, this concentration is something you watch closely as an analyst; it means execution on the core product is everything.

Here's the quick math on the latest Fiscal Year 2025 projections Puma Biotechnology is working with:

Revenue Component	FY 2025 Guidance Range
Net Product Revenue from U.S. Sales of NERLYNX	$198 million to $200 million
Royalty Revenue from International Sublicensees	$22 million to $23 million
Total Projected Revenue	$220 million to $223 million

The structure of these streams shows a dual approach: direct sales capture in the U.S. market and passive income generation through global licensing deals. To be fair, the royalty stream is a great way to get geographic reach without the massive upfront cost of building out every international sales force.

The components driving the revenue streams for Puma Biotechnology, Inc. as guided for FY 2025 include:

• Net product revenue from U.S. sales of NERLYNX (FY 2025 guidance: $198 million to $200 million).
• Royalty revenue from international sublicensees (FY 2025 guidance: $22 million to $23 million).
• Product supply revenue to ex-U.S. partners.
• Total revenue for FY 2025 is projected to be in the range of $220 million to $223 million.

What this estimate hides, based on recent filings, is that the reported Net Product Revenue figure actually bundles the U.S. sales with the product supply revenue sent to those ex-U.S. partners. For instance, in Q3 2025, product supply revenue was only about $\$0.1$ million, a significant drop from the $\$7.4$ million seen in Q3 2024, which was reflected in the overall net product revenue decline that quarter compared to the prior year. Still, the overall FY 2025 guidance was recently raised, signaling confidence in the core U.S. demand.

The company is definitely leaning on the U.S. market for the bulk of its top line, aiming for that $198 million to $200 million range from NERLYNX product sales alone. Also, the royalty stream, projected between $22 million and $23 million, provides a solid, albeit smaller, base. Finance: draft 13-week cash view by Friday.