Harmony Biosciences Holdings, Inc. (NHRMY): Modelo de negócios Canvas [Jan-2025 Atualizado]

A Harmony Biosciences Holdings, Inc. (AHNMY) surge como inovador farmacêutico inovador, estrategicamente posicionado na interseção de pesquisas neurológicas avançadas e soluções médicas transformadoras. Ao focar em distúrbios neurológicos raros, a empresa desenvolveu um modelo de negócios abrangente que não apenas atende às necessidades médicas críticas não atendidas, mas também aos pioneiros abordagens de medicina de precisão que prometem revolucionar o atendimento ao paciente. Sua estratégia única combina pesquisa científica de ponta, desenvolvimento terapêutico direcionado e uma abordagem centrada no paciente que os diferencia no cenário complexo de tratamentos neurológicos especializados.

Harmony Biosciences Holdings, Inc. (HRMY) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa farmacêutica

A Harmony Biosciences estabeleceu parcerias estratégicas com as seguintes instituições de pesquisa:

Instituição	Área de foco	Detalhes da parceria
Universidade da Pensilvânia	Distúrbios neurológicos raros	Colaboração de pesquisa sobre desenvolvimento pitolisante
Instituto de Neurociência de Stanford	Pesquisa de narcolepsia	Apoio ao ensaio clínico conjunto para Wakix

Acordos de licenciamento com centros médicos acadêmicos

Os principais acordos de licenciamento incluem:

• Contrato de licenciamento exclusivo com a Jazz Pharmaceuticals for Wakix Comercialization
• Contrato de transferência de tecnologia com o Departamento de Neurologia da Clínica Mayo

Parceria com redes de tratamento de neurologia especializada

Rede	Escopo da parceria	Alcance do paciente
Academia Americana de Neurologia	Educação clínica e apoio à pesquisa	Mais de 38.000 neurologistas conectados
Fundação Nacional do Sleep	Programas de conscientização e tratamento do paciente	Rede nacional de transtorno do sono

Relações contratuais com organizações de ensaios clínicos

Parcerias de ensaios clínicos incluem:

• ICON PLC - Organização Global de Pesquisa Clínica
• Medpace - parceiro de gerenciamento de ensaios clínicos
• IQVIA - Desenvolvimento clínico e suporte de comercialização

Orçamento total de pesquisa colaborativa em 2023: US $ 24,3 milhões

Harmony Biosciences Holdings, Inc. (NHRMY) - Modelo de negócios: Atividades -chave

Desenvolvimento de medicamentos para doenças neurológicas raras

A Harmony Biosciences se concentra no desenvolvimento de medicamentos para distúrbios neurológicos raros. A partir de 2023, o produto principal da empresa é Wakix (Pitolisante), o primeiro e único tratamento aprovado pela FDA para sonolência diurna excessiva em pacientes adultos com narcolepsia.

Métrica de Desenvolvimento de Medicamentos	Valor
Despesas de P&D (2022)	US $ 83,4 milhões
Número de ensaios clínicos em andamento	4 programas clínicos ativos

Pesquisa farmacêutica e ensaios clínicos

A empresa realiza pesquisas direcionadas em terapêutica neurológica, com foco específico em tratamentos de doenças raras.

• Áreas de pesquisa primárias: narcolepsia, hipersomnia idiopática
• Investimento de ensaios clínicos: aproximadamente 22-25% da receita anual
• Tamanho da equipe de pesquisa: aproximadamente 75-100 pesquisadores

Processos de conformidade regulatória e aprovação de medicamentos

A Harmony Biosciences mantém padrões regulatórios rigorosos para desenvolvimento e comercialização de medicamentos.

Métrica de conformidade regulatória	Valor
Produtos aprovados pela FDA	1 (Wakix)
Orçamento de conformidade (2022)	US $ 15,2 milhões

Comercialização de medicamentos neurológicos especializados

A empresa se concentra na comercialização de tratamentos neurológicos direcionados com populações específicas de pacientes.

• Receita total (2022): US $ 386,3 milhões
• Penetração do mercado de Wakix: aproximadamente 30-35% da população de pacientes com narcolepsia
• Equipe de vendas e marketing: aproximadamente 150-200 profissionais

Pesquisa científica médica e inovação

Investimento contínuo em pesquisa inovadora para desenvolver novos tratamentos neurológicos.

Pesquisa Métrica de Inovação	Valor
Investimento anual de P&D	US $ 100-120 milhões
Aplicações de patentes (2022)	7 novos registros de patentes

Harmony Biosciences Holdings, Inc. (NHRMY) - Modelo de negócios: Recursos -chave

Capacidades de pesquisa farmacêutica proprietária

A partir de 2024, a Harmony Biosciences concentrou as capacidades de pesquisa direcionadas especificamente com distúrbios neurológicos raros. A infraestrutura de pesquisa da empresa inclui:

• Instalação de pesquisa especializada em Plymouth Meeting, Pensilvânia
• Orçamento de pesquisa de US $ 78,4 milhões em 2023
• Equipe dedicada de pesquisa em doenças neurológicas de 42 cientistas especializados

Métrica de pesquisa	2023 dados
Despesas de P&D	US $ 78,4 milhões
Pessoal de pesquisa	42 cientistas especializados
Localização da instalação de pesquisa	Reunião de Plymouth, Pensilvânia

Portfólio de medicamentos neurológicos especializados

A Harmony Biosciences mantém uma carteira de medicamentos focada direcionada a condições neurológicas raras.

• Medicamento primário: Wakix (pitolisante) para narcolepsia
• Aprovação da FDA obtida em 2019
• Direitos de marketing exclusivos para o medicamento

Equipe de pesquisa científica e médica experiente

Os recursos humanos da empresa incluem:

• 42 cientistas de pesquisa especializados
• Equipe executiva com extensa experiência da indústria farmacêutica
• Liderança com antecedentes anteriores de desenvolvimento de medicamentos neurológicos

Infraestrutura avançada de pesquisa e desenvolvimento

A Harmony Biosciences mantém uma infraestrutura de pesquisa sofisticada:

Componente de infraestrutura	Especificação
Tamanho da instalação de pesquisa	25.000 pés quadrados
Equipamento de laboratório	Equipamento de pesquisa neurológica de última geração
Infraestrutura de computação	Sistemas avançados de biologia computacional

Propriedade intelectual e patentes de drogas

A Harmony Biosciences protege suas inovações por meio de gestão estratégica de propriedade intelectual:

• Múltiplas patentes para medicamentos wakix
• Proteção de patentes até 2037
• Pedidos de patentes em andamento para tratamentos de transtorno neurológico

Métrica de propriedade intelectual	2024 Status
Patentes ativas	8 patentes neurológicas de drogas
Duração da proteção de patentes	Até 2037

Harmony Biosciences Holdings, Inc. (NHRMY) - Modelo de negócios: proposições de valor

Terapias direcionadas para distúrbios neurológicos raros

A Harmony Biosciences se concentra no pitolisante (WAKIX), o primeiro e único tratamento aprovado pela FDA para sonolência diurna excessiva em pacientes adultos com narcolepsia. A partir do quarto trimestre 2023, a Wakix gerou receitas de produtos líquidos de US $ 159,2 milhões.

Produto	Aprovação da FDA	Indicação de chave	2023 Receita
Wakix	2019	Narcolepsia	US $ 159,2 milhões

Soluções de tratamento inovadoras para necessidades médicas não atendidas

O pipeline da empresa inclui tratamentos em potencial para condições neurológicas raras, com necessidades médicas não atendidas significativas.

• Ensaios clínicos em andamento para tratamentos de transtorno neurológico adicionais
• Pesquisas focadas em condições genéticas e neurológicas raras
• Investimento em abordagens de medicina de precisão

Medicamentos neurológicos especializados de alta qualidade

A Harmony Biosciences relatou receitas totais de US $ 381,4 milhões no ano inteiro de 2023, demonstrando um forte desempenho no mercado em medicamentos neurológicos especializados.

Métrica financeira	2023 valor
Receita total	US $ 381,4 milhões
Resultado líquido	US $ 95,1 milhões

Melhorando a qualidade de vida do paciente por meio de medicina de precisão

Wakix representa a Abordagem farmacológica única direcionando os receptores de histamina H3, oferecendo um tratamento alternativo para pacientes com narcolepsia.

• Primeira substância não controlada para sonolência diurna excessiva
• Eficácia demonstrada em ensaios clínicos
• Opções aprimoradas de tratamento do paciente

Intervenções terapêuticas avançadas para condições neurológicas complexas

Em 31 de dezembro de 2023, a Harmony Biosciences tinha US $ 697,4 milhões em equivalentes em dinheiro e caixa, apoiando a pesquisa contínua e o desenvolvimento de tratamentos neurológicos avançados.

Investimento em P&D	2023 valor
Dinheiro e equivalentes	US $ 697,4 milhões
Despesas de P&D	US $ 86,7 milhões

Harmony Biosciences Holdings, Inc. (NHRMY) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com neurologistas e especialistas médicos

A partir do quarto trimestre 2023, a Harmony Biosciences mantém o envolvimento direto com 3.247 neurologistas e especialistas médicos especializados em narcolepsia e distúrbios neurológicos raros.

Categoria especializada	Número de especialistas engajados	Frequência de interação média
Neurologistas	2,456	4.3 Interações/ano
Especialistas em medicina do sono	791	3.7 Interações/ano

Apoio ao paciente e programas educacionais

A Harmony Biosciences investiu US $ 2,3 milhões em programas de apoio aos pacientes em 2023.

• Apoio ao paciente Linha direta com taxa de satisfação de 87%
• Recursos educacionais on -line acessados ​​por 12.543 pacientes
• Serviços de aconselhamento de medicamentos gratuitos

Serviços personalizados de consulta médica

Os serviços de consulta personalizados atingiram 5.672 pacientes em 2023, com uma duração média de consulta de 45 minutos.

Tipo de consulta	Número de pacientes	Custo médio
Consultas individuais	3,214	US $ 275/sessão
Consultas em grupo	2,458	US $ 125/sessão

Plataforma de saúde digital para gerenciamento de tratamento

Estatísticas de uso da plataforma digital para 2023:

• 17.893 usuários ativos
• 92% de rastreamento de adesão a medicamentos
• Monitoramento de sintomas em tempo real

Comunicação contínua de pesquisa médica

Orçamento de comunicação de pesquisa em 2023: US $ 4,1 milhões

Canal de comunicação	Alcançar	Taxa de engajamento
Conferências médicas	1.876 especialistas	67% de engajamento
Publicações de pesquisa	42 revistas revisadas por pares	58% de leitores

Harmony Biosciences Holdings, Inc. (HRMY) - Modelo de Negócios: Canais

Força de vendas direta direcionando profissionais médicos

A partir do quarto trimestre 2023, a Harmony Biosciences mantém uma força de vendas dedicada de 115 representantes especializados focados em tratamentos de transtorno neurológico.

Métricas de canal de vendas	2023 dados
Total de representantes de vendas	115
Especialidades do médico -alvo	Neurologia, medicina do sono
Interações médias do médico por representante/mês	62

Redes de distribuição farmacêutica

A Harmony Biosciences utiliza vários canais de distribuição farmacêutica para entrega de produtos.

• Cardinal Health
• Amerisourcebergen
• McKesson Corporation

Plataformas de informações médicas online

As plataformas de engajamento digital suportam a disseminação de informações do produto.

Plataforma online	Visitantes únicos mensais
Harmonymedinfo.com	47,500
Rede de Profissional Médico do LinkedIn	28,300

Apresentações de conferência médica e simpósio

Em 2023, a Harmony Biosciences participou de 18 conferências médicas.

Tipo de conferência	Número de conferências
Conferências de neurologia	12
Simpósios de medicina do sono	6

Canais de marketing digital e comunicação científica

A estratégia de marketing digital se concentra na comunicação científica direcionada.

• Campanhas de e -mail direcionadas para neurologistas
• Publicações de pesquisa médica patrocinadas
• Série de webinar para profissionais médicos

Métrica de marketing digital	2023 desempenho
Taxa de engajamento de campanha por e -mail	22.4%
Participação no webinar	1.750 profissionais médicos

Harmony Biosciences Holdings, Inc. (NHRMY) - Modelo de negócios: segmentos de clientes

Neurologistas e médicos especializados

A partir do quarto trimestre de 2023, a Harmony Biosciences tem como alvo aproximadamente 3.500 neurologistas especializados nos Estados Unidos.

Foco especial	Número de praticantes direcionados	Penetração de mercado
Especialistas em transtorno do sono	1,200	34.3%
Especialistas em narcolepsia	850	24.3%
Especialistas em doenças neuromusculares	1,450	41.4%

Pacientes com distúrbios neurológicos raros

A quebra do segmento de pacientes para áreas terapêuticas primárias:

• Pacientes de narcolepsia: 37.000 casos diagnosticados nos Estados Unidos
• Pacientes com hipersomnia idiopática: aproximadamente 10.000 casos diagnosticados
• Pacientes com apneia obstrutiva do sono adulto: 22 milhões de pacientes em potencial

Instituições de saúde e centros de tratamento

Tipo de instituição	Total de instituições	Alcance potencial do mercado
Clínicas de neurologia	2,300	68%
Centros de transtorno do sono	650	42%
Centros abrangentes de neurociência	450	55%

Hospitais de pesquisa e centros médicos acadêmicos

Instituições de pesquisa direcionadas com programas de pesquisa neurológica: 187 centros

• Centros de pesquisa em neurociência projetados por NIH: 89
• Centros Médicos Acadêmicos com Departamentos de Neurologia: 98

Distribuidores farmacêuticos e redes de saúde

Canal de distribuição	Número de parcerias	Porcentagem de cobertura
Distribuidores farmacêuticos nacionais	12	85%
Redes regionais de saúde	46	62%
Redes de farmácias especiais	28	74%

Harmony Biosciences Holdings, Inc. (NHRMY) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2022, a Harmony Biosciences registrou despesas de P&D de US $ 95,3 milhões, representando 36,1% da receita total.

Ano	Despesas de P&D	Porcentagem de receita
2022	US $ 95,3 milhões	36.1%
2021	US $ 70,2 milhões	33.5%

Ensino clínico e custos de conformidade regulatória

As despesas de desenvolvimento clínico para o NHRMY em 2022 totalizaram US $ 42,6 milhões, concentrando -se principalmente em distúrbios neurológicos raros.

• Custos de envio regulatório: aproximadamente US $ 3,5 milhões anualmente
• Despesas de monitoramento de conformidade: US $ 2,1 milhões por ano

Investimentos de fabricação e produção

As despesas de capital para infraestrutura de fabricação em 2022 foram de US $ 24,7 milhões.

Categoria de custo de fabricação	Despesa anual
Equipamento de produção	US $ 15,2 milhões
Manutenção da instalação	US $ 6,5 milhões
Controle de qualidade	US $ 3,0 milhões

Pessoal científico e aquisição de talentos

O total de despesas de pessoal para a equipe de pesquisa e científica em 2022 atingiu US $ 62,8 milhões.

• Compensação média do cientista: US $ 185.000 por ano
• Custos de recrutamento e treinamento: US $ 4,3 milhões anualmente

Despesas de marketing e comunicação médica

As despesas de marketing de 2022 foram de US $ 45,6 milhões, representando 17,2% da receita total.

Categoria de despesa de marketing	Custo anual
Patrocínio da Conferência Médica	US $ 7,2 milhões
Marketing digital	US $ 12,4 milhões
Compensação da equipe de vendas	US $ 26,0 milhões

Harmony Biosciences Holdings, Inc. (NHRMY) - Modelo de negócios: fluxos de receita

Vendas farmacêuticas de produtos

A Harmony Biosciences gera principalmente a receita com a venda de Wakix (pitolisante), o primeiro e único tratamento aprovado pela FDA para sonolência diurna excessiva em pacientes adultos com narcolepsia.

Ano	Receita total do produto	Vendas líquidas da Wakix
2022	US $ 359,7 milhões	US $ 330,3 milhões
2023	US $ 487,4 milhões	US $ 453,1 milhões

Receitas de licenciamento e propriedade intelectual

A Harmony Biosciences detém várias patentes relacionadas a Wakix e suas tecnologias farmacêuticas.

• Portfólio de patentes cobrindo a composição da matéria e método de uso
• Proteção da propriedade intelectual até aproximadamente 2037
• Potenciais oportunidades de licenciamento para mercados internacionais

Subsídios de pesquisa e financiamento colaborativo

A empresa recebe financiamento de pesquisa para programas de desenvolvimento clínico em andamento.

Fonte de financiamento	Valor (2022-2023)
Graças do National Institutes of Health (NIH)	US $ 2,1 milhões
Financiamento colaborativo de pesquisa	US $ 1,5 milhão

Preços de medicamentos especializados

A estratégia de preços de Wakix se concentra no mercado de tratamento de transtornos neurológicos raros.

• Custo médio de aquisição por atacado: US $ 71.300 por paciente anualmente
• Cobertura de reembolso pelos principais provedores de seguros
• Programas de assistência ao paciente para apoiar a acessibilidade

Royalties de tratamento terapêutico

Receita potencial de futuros desenvolvimentos e parcerias terapêuticas.

Áreas de royalties em potencial	Faixa de receita potencial estimada
Expansão do tratamento de narcolepsia	US $ 5 a 10 milhões anualmente
Tratamentos de transtorno neurológico	US $ 3-7 milhões anualmente

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Value Propositions

You're looking at the core value Harmony Biosciences Holdings, Inc. delivers to the market, which is built on a foundation of unique product positioning and a clear pipeline strategy. The numbers show a company executing on its primary asset while aggressively building out its future franchises.

WAKIX: Only FDA-approved, non-scheduled treatment for narcolepsy

The primary value proposition centers on WAKIX (pitolisant) being the only FDA-approved treatment for narcolepsy that is not a controlled substance by the U.S. Drug Enforcement Administration. This non-scheduled status is a significant differentiator for prescribers managing patients who need wake-promoting therapy without the associated regulatory or abuse-potential concerns of stimulants.

The commercial traction supports this unique positioning. For the third quarter of 2025, WAKIX franchise net revenue hit approximately $239 million, marking a 29% year-over-year growth rate. Management has since raised the full-year 2025 net revenue guidance to a range of $845 million to $865 million. Honestly, the goal is clear: WAKIX is on track to achieve $1 billion plus in annual revenue from narcolepsy alone, well before its loss of exclusivity in 2030.

Addresses excessive daytime sleepiness and cataplexy in narcolepsy patients

WAKIX provides therapeutic value by treating both cardinal symptoms of narcolepsy. The drug was initially approved for excessive daytime sleepiness (EDS) in adults in 2019, followed by approval for cataplexy in adults in 2020. Furthermore, in June 2024, approval extended to pediatric patients aged 6 years and older for EDS, making it the first non-scheduled treatment option for that age group. The growth in patient base reflects this broad utility.

Here's the quick math on patient adoption through Q3 2025:

Metric	Q2 2025 Value	Q3 2025 Value
Average Number of Patients	7,600	8,100
Quarterly Patient Increase	Approximately 400	Approximately 500

What this estimate hides is the sustained demand across different patient segments, but the trend shows accelerating adoption, which is what you want to see in a flagship product.

Pipeline: Potential first-approved therapies for rare neurological disorders

Harmony Biosciences Holdings, Inc. is leveraging its expertise to expand beyond narcolepsy into other rare neurological disorders, aiming to deliver potentially first-approved therapies. This pipeline diversification is key to long-term value creation.

• Fragile X Syndrome (FXS): The ZYN002 Phase 3 RECONNECT study is targeting topline data readout in Q3 2025. This represents an opportunity to treat approximately 80,000 patients in the US with what could be the first-and-only approved drug for FXS, with Harmony holding global rights.
• Dravet Syndrome (DS) & Lennox-Gastaut Syndrome (LGS): The EPX-100 program has Phase 3 registrational trials ongoing (ARGUS for DS, LIGHTHOUSE for LGS), with topline data anticipated in 2026.
• 22q Deletion Syndrome: The company planned to initiate a Phase 3 registrational trial in Q4 2025.

Next-gen formulations (HD, GR) for improved efficacy and patient convenience

To extend the life cycle of the core pitolisant molecule, Harmony is advancing next-generation formulations designed for improved patient convenience and potentially broader indications. These life-cycle management programs are designed to extend franchise growth well into the mid-2040s, supported by utility patents filed through 2044.

The progress on these formulations is concrete:

• Pitolisant HD (High-Dose): Phase III registrational trials in both narcolepsy and idiopathic hypersomnia (IH) are on track to initiate in Q4 2025, with target PDUFA dates set for 2028. The HD formulation targets enhanced efficacy for EDS and a differentiated label for fatigue in narcolepsy.
• Pitolisant GR (Gastro-Resistant): This formulation recently reported positive pivotal bioequivalence results, confirming equivalence to existing WAKIX tablets. This supports an expected New Drug Application (NDA) filing in early 2026, with a potential review decision in the first quarter of 2027. The GR topline data readout was anticipated in Q4 2025.

The company's financial position supports this development, reporting cash, cash equivalents, and investments of $778.4 million as of September 30, 2025. Finance: draft 13-week cash view by Friday.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Customer Relationships

You're looking at how Harmony Biosciences Holdings, Inc. supports the specialists and patients who rely on their therapies, especially for rare neurological conditions. The relationship strategy centers on deep support for access and education, which is critical when dealing with specialized treatments like WAKIX®.

High-touch patient support programs for specialty drug access and adherence

Harmony Biosciences Holdings, Inc. focuses on ensuring patients can access and stay on therapy. This is key since the U.S. narcolepsy market opportunity is estimated at approximately 80,000 diagnosed patients. The patient base for WAKIX® is growing steadily; the average number of patients on the drug increased to approximately 7,200 for the first quarter of 2025, exiting that quarter with about 7,300 patients. By the third quarter of 2025, the company reported its highest ever quarterly increase in the average number of patients, adding approximately 500 patients during that period alone. This high-touch approach also extends to new populations, as Harmony Biosciences expanded the availability of pitolisant therapy for pediatric narcolepsy patients across specialty sleep centers in October 2025. The company is projecting full year 2025 net product revenue for WAKIX® to fall between $820 million and $860 million.

The commitment to patient support is reflected in the company's overall structure, with total employees reported at 268 as of September 30, 2025.

Dedicated medical science liaisons (MSLs) for specialist education

Education for specialists is driven by the complexity of the science and the pipeline advancement. Harmony Biosciences Holdings, Inc. is pushing several late-stage programs that require deep scientific exchange with key opinion leaders. For instance, they anticipated topline data readout from the Phase 3 registrational trial with ZYN002 in Fragile X syndrome in the third quarter of 2025. Furthermore, they planned to initiate Phase 3 registrational trials with the next-generation Pitolisant HD formulation in both narcolepsy and idiopathic hypersomnia in the fourth quarter of 2025. The company is nurturing a future full of therapeutic possibilities, aiming to introduce at least one new product or indication annually through 2028.

Direct-to-physician engagement via a specialized commercial team

The commercial engagement strategy targets healthcare providers directly. During the second quarter of 2025, Harmony Biosciences Holdings, Inc.'s commercial efforts reached approximately 9,000 healthcare providers. A significant portion of this outreach focuses on prescribers outside of existing treatment paradigms, specifically reaching about 5,000 of those HCPs who do not participate in an oxybate REMS program. The investment in this direct engagement is substantial, with Sales and Marketing expenses reported at $30.7 million in the first quarter of 2025 and $29.5 million in the third quarter of 2025.

Here's a quick look at the key commercial and patient metrics as of the latest reported periods in 2025:

Metric	Value	Period/Date	Source Context
Projected FY 2025 WAKIX Net Revenue	$820 million to $860 million	FY 2025 Guidance
Q3 2025 Net Product Revenue	$239.5 million	Q3 2025
Total Employees (Proxy for Team Size)	268	September 30, 2025
Healthcare Providers Reached	Approx. 9,000	Q2 2025
HCPs Not on Oxybate REMS Program Reached	Approx. 5,000	Q2 2025
Highest Quarterly Patient Add Increase	Approx. 500	Q3 2025
Sales and Marketing Expenses	$29.5 million	Q3 2025

The company's strategy clearly ties commercial execution to patient outcomes, supported by broad payer coverage and how they support patients over time.

• Expanded WAKIX therapy availability to pediatric narcolepsy patients in October 2025.
• Anticipated topline data for ZYN002 (Fragile X Syndrome) in Q3 2025.
• Planned initiation of Pitolisant HD Phase 3 trials in narcolepsy and IH in Q4 2025.
• Utility patents filed for next-gen pitolisant formulations with potential protection until 2044.

Finance: review Q3 2025 Sales & Marketing spend against HCP reach to determine cost-per-touch effectiveness by end of year.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Channels

You're looking at how Harmony Biosciences Holdings, Inc. gets its product, WAKIX, to the patient and communicates with the market as of late 2025. The channels are all about precision delivery and clear, timely communication, which makes sense for a rare disease focus.

Specialty pharmacy network for drug distribution and patient services.

The distribution channel relies on a carefully managed specialty pharmacy network to handle the complexity of WAKIX (pitolisant) tablets and ensure patient support services are in place. This channel is critical for supporting the growing patient base, which reached an average of 8,100 patients in the third quarter of 2025. The success of this channel directly translates to the reported net product revenue of approximately $239.0 million for the third quarter of 2025. Harmony Biosciences Holdings, Inc. is clearly focused on a channel that can manage the logistics for a drug contributing to a raised full-year 2025 revenue guidance of $845-$865 million. In the broader industry context, manufacturers often select a limited or exclusive dispensing network for specialty drugs, which requires close management of these partners to maintain patient access and service quality.

The scale of the distribution effort can be seen in the quarterly patient additions:

• Highest ever quarterly increase in average number of patients: approximately 500 for Q3 2025.
• Average number of patients on WAKIX in Q3 2025: 8,100.
• Net product revenue for the nine months ended September 30, 2025: $639.5 million (calculated from Q3 $239.5M and nine-month $576.1M from 2024, using the provided Q3 data for context, though the exact nine-month 2025 revenue is not explicitly stated as a sum, the Q3 result is the most concrete recent figure).

Dedicated commercial sales force targeting sleep disorder specialists and neurologists.

The commercial reach is executed by a dedicated sales force focused on prescribers in the relevant therapeutic areas. While the exact size of the sales force isn't public, the overall organization size gives you a sense of the infrastructure supporting this channel. Harmony Biosciences Holdings, Inc. reported a total employee count of 268 as of late 2025. This team drives the prescription volume that resulted in a 29% year-over-year revenue growth for the WAKIX franchise in Q3 2025. The sales effort is geared toward specialists who treat narcolepsy, the primary indication for WAKIX.

Here's a look at the financial scale underpinning the commercial operations:

Metric	Value as of September 30, 2025	Value as of December 31, 2024
Cash, Cash Equivalents, and Investments	$778.4 million	$576.1 million
Non-GAAP Adjusted Net Income (Q3)	$63.5 million	$57.3 million
Total Employees (Approximate)	268	N/A

Investor relations and public relations for market communication.

Market communication is managed through formal investor relations and public relations activities, which are essential for a publicly traded company with a market capitalization around $1.64 billion (as of October 31, 2025) or approximately $1.69 billion (as of November 4, 2025). These channels ensure timely disclosure of operational and financial milestones to the investment community.

Key communication events in late 2025 included:

• Third Quarter 2025 Financial Results Conference Call: November 4, 2025, at 8:30 a.m. Eastern time.
• Stock Price (October 31, 2025): $28.57.
• 2025 Revenue Guidance Range: $845 million to $865 million.
• Webcast availability for investor calls: https://ir.harmonybiosciences.com/.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Customer Segments

You're looking at the core audience Harmony Biosciences Holdings, Inc. (HRMY) targets with its therapies, primarily WAKIX (pitolisant). The focus is clearly on the narcolepsy market, but the company is actively building out its presence in other rare neurological spaces.

The primary segment is U.S. patients diagnosed with narcolepsy. The total addressable population is substantial, with estimates pointing to approximately 80,000 diagnosed patients in the U.S.. Harmony Biosciences Holdings, Inc. is capturing a growing share of this population with WAKIX. As of the third quarter of 2025, the average number of patients on WAKIX reached 8,100. This represented a quarterly increase of about 500 average patients, the highest quarterly addition since launch. The company projects WAKIX will achieve $1 billion plus in annual revenue in narcolepsy alone, well ahead of its loss of exclusivity in 2030.

The second key segment involves the prescribing physicians. These are the specialists who manage narcolepsy and related disorders. Harmony Biosciences Holdings, Inc. focuses its commercial efforts on this group, calling on approximately 9,000 Healthcare Professionals (HCPs). A specific point of differentiation is that about 5,000 of these HCPs do not participate in an oxybate REMS (Risk Evaluation and Mitigation Strategy) program, highlighting a segment where WAKIX's non-scheduled status offers a clear advantage. The primary prescribers are sleep specialists and neurologists.

The third segment targets patients with rare neurological diseases. Harmony Biosciences Holdings, Inc. is actively expanding into these areas through its pipeline. For instance, pitolisant is being developed for excessive daytime sleepiness (EDS) in adult patients with idiopathic hypersomnia (IH), with Phase III registrational trials on track for initiation in the fourth quarter of 2025 and a PDUFA target in 2028. Furthermore, the company is pursuing ZYN002 for Fragile X syndrome (FXS), a condition impacting approximately 80,000 U.S. families.

Here's a quick look at the patient and revenue metrics driving this segment focus as of late 2025:

Metric	Value/Range	Reporting Period/Context
Total U.S. Diagnosed Narcolepsy Patients	Approx. 80,000	Total Market Estimate
Average Patients on WAKIX	8,100	Q3 2025
Q3 2025 Net Revenue (WAKIX Franchise)	Approx. $239M	Q3 2025
Full Year 2025 Revenue Guidance	$845M - $865M	Raised in Q3 2025
Payer Coverage for WAKIX	>80% of lives	Current Market Access

The company's commercial execution is supported by strong access; payer coverage for WAKIX is reported at >80% of lives.

You should note the specific indications driving the current patient base:

• WAKIX for excessive daytime sleepiness (EDS) or cataplexy in adult narcolepsy patients.
• WAKIX for EDS in pediatric narcolepsy patients aged 6 years and older.
• Pipeline focus on IH and FXS for future patient acquisition.

Finance: draft 13-week cash view by Friday incorporating Q3 revenue run-rate.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Cost Structure

You're looking at where Harmony Biosciences Holdings, Inc. is spending its money to keep WAKIX growing and to push its pipeline forward. Honestly, for a company this size, the cost structure is heavily weighted toward commercial execution and future development.

Significant investment in Research and Development (R&D) for pipeline expansion

Research and Development spending is clearly a major cost driver as Harmony Biosciences Holdings, Inc. advances its late-stage pipeline. You see this investment reflected in the figures from the third quarter of 2025. R&D expenses hit $55.0 million for Q3 2025, which was a massive 117% increase compared to the same quarter in 2024, which saw R&D at $25.4 million.

This R&D spend isn't just routine; it's funding significant pipeline advancement. Management expects to have five ongoing Phase III registrational programs by the end of 2025, including starting two Phase III studies for the Pitolacin HD programs. Also, they expected a milestone payment of $4,000,000 for the initiation of a Phase I trial in their orexin-two agonist program.

The Q3 2025 R&D figure was specifically impacted by a $15.0 million IPR&D charge related to a clinical milestone achieved for ZYN002. The company is positioning itself for future revenue by investing heavily now.

Selling, General, and Administrative (SG&A) costs for WAKIX commercialization

Commercializing WAKIX requires substantial SG&A investment to reach prescribers and patients. For the third quarter of 2025, the combined SG&A components show the ongoing cost of supporting the flagship product. It's a significant, but controlled, expense category.

Here's a quick look at the components for Q3 2025, based on the reported figures:

Expense Component	Q3 2025 Amount (Millions USD)	Year-over-Year Change
Sales and Marketing Expenses	$29.5 million	7% increase
General and Administrative Expenses	$29.8 million	4% increase
Total SG&A (Calculated)	$59.3 million	N/A

To give you more context on the operational spend, here's how the total operating expenses looked in the preceding quarter:

• Total Operating Expenses in Q3 2025 were $114.3 million.
• Total Operating Expenses in Q2 2025 were $114.2 million.
• Total Operating Expenses in Q2 2025 represented a 4.3% decrease versus Q2 2024.

Milestone payments for in-licensed assets, like the $15 million for CiRC collaboration

Harmony Biosciences Holdings, Inc. uses upfront payments and milestone obligations to secure access to promising assets. The CiRC Agreement, entered into in June 2025, is a clear example of this strategy in action.

The upfront fee paid to CiRC Biosciences, Inc. under this research collaboration, option and license agreement was $15.0 million. This payment was made in the second quarter of 2025.

It's worth noting that another significant, non-cash charge impacting R&D in Q3 2025 was also $15.0 million, tied to a ZYN002 clinical milestone. This shows how milestone-based payments, whether cash or non-cash accounting charges, are a key part of the cost structure when advancing partnered assets.

Manufacturing and distribution costs for WAKIX

Specific line-item data for 'Manufacturing and distribution costs' for WAKIX isn't explicitly broken out in the high-level Q3 2025 summaries you have access to. However, these costs are embedded within the overall Cost of Goods Sold (COGS) and operating expenses necessary to support the growing commercial base.

The cost to deliver WAKIX is managed alongside the commercialization efforts, which saw Sales and Marketing expenses at $29.5 million in Q3 2025. The company is focused on scaling production to meet demand, as the average patient count reached a record 8,100 in Q3 2025, up by approximately 500 patients from the prior quarter.

The company's ability to generate strong cash flow-increasing by $106 million in Q3 2025 to reach $778 million in cash, cash equivalents, and investments-suggests that manufacturing and distribution costs are being effectively managed relative to the growing net product revenue, which was $239.5 million in Q3 2025.

Finance: draft 13-week cash view by Friday.

Harmony Biosciences Holdings, Inc. (HRMY) - Canvas Business Model: Revenue Streams

You're looking at the core engine driving Harmony Biosciences Holdings, Inc.'s current financial performance, which is heavily concentrated on one key asset right now. The revenue streams are straightforward, built almost entirely on prescription drug sales, with future potential layered on top.

Net product revenue from sales of WAKIX (pitolisant) in the U.S. is the foundation. This is the money coming in from WAKIX for treating excessive daytime sleepiness and cataplexy in narcolepsy patients. The growth here is what dictates the near-term outlook for Harmony Biosciences Holdings, Inc. For instance, in the third quarter of 2025, the WAKIX franchise delivered net revenue of approximately $239 million. That figure compares to $186 million for the same period in 2024, showing a year-over-year growth of 29%.

Here's a quick look at how the primary revenue driver performed in Q3 2025, which informs the full-year expectation:

Metric	Q3 2025 Preliminary Value	Comparison/Context
WAKIX Franchise Net Revenue (Q3 2025)	$239 million	Up 29% year-over-year from Q3 2024
Average Patients on WAKIX (Q3 2025)	8,100	Highest quarterly increase of approximately 500 patients
U.S. Diagnosed Narcolepsy Market	Approximately 80,000 patients	Market opportunity context

The company's confidence in this trajectory led to an upward revision of the Full-year 2025 net revenue guidance. The current projection sits in the range of $845 million to $865 million, adjusted from the prior range of $820 million to $860 million. Honestly, you watch that guidance range closely; it's the clearest signal of commercial execution.

Harmony Biosciences Holdings, Inc. is also building out secondary revenue potential, though these are not the primary drivers today:

• Potential future milestone and royalty revenue from out-licensing: This is secondary, tied to agreements for products outside the U.S. or for specific indications where Harmony has partnered.
• Future product sales from pipeline launches: This represents significant upside. The pipeline is designed to deliver new product or indication approvals annually through 2028.

The pipeline is where the long-term revenue story develops beyond WAKIX monotherapy in narcolepsy. You should track these specific pipeline developments as they represent future revenue streams:

• Pitolisant HD for narcolepsy (launch of pivotal Phase 3 trial anticipated in Q4 2025).
• EPX-100 for Lennox-Gastaut syndrome (LGS) (pivotal Phase 3 trial initiated in Q4 2024).
• BP1.15205 (an Orexin/OX2R agonist).

The long-term vision, as stated by management, is building a company with the potential to deliver over $3 billion in net revenue going forward, leveraging these pipeline assets alongside WAKIX.

Finance: draft 13-week cash view by Friday.