Scpharmaceuticals Inc. (SCPH): Análise de Pestle [Jan-2025 Atualizado]

No mundo dinâmico de produtos farmacêuticos especializados, a Scpharmaceuticals Inc. (SCPH) fica na encruzilhada da inovação, complexidade regulatória e tecnologias transformadoras de saúde. Essa análise abrangente de pilões revela o intrincado cenário de fatores externos que moldam a trajetória estratégica da empresa, desde desafios regulatórios e avanços tecnológicos até mudanças sociais e imperativos ambientais. Ao dissecar as dimensões políticas, econômicas, sociológicas, tecnológicas, legais e ambientais, exploraremos como o SCPH navega no ecossistema multifacetado do desenvolvimento e posicionamento farmacêuticos modernos.

Scpharmaceuticals Inc. (SCPH) - Análise de Pestle: Fatores Políticos

Cenário regulatório da FDA dos EUA para aprovação de drogas

Em 2024, o Centro de Avaliação e Pesquisa de Medicamentos da FDA (CDER) recebeu 6.365 novas aplicações de medicamentos investigacionais (IND) no ano fiscal anterior. O tempo médio de aprovação do medicamento foi de 10,1 meses para revisões padrão e 6,1 meses para revisões prioritárias.

Métrica da FDA	2024 dados
Total de aplicações IND	6,365
Tempo de revisão padrão	10,1 meses
Tempo de revisão prioritário	6,1 meses

Impacto da política de saúde federal

O orçamento federal de saúde de 2024 alocou US $ 53,8 bilhões em pesquisa farmacêutica e médica, com possíveis implicações para estratégias de reembolso.

• Gastos do Medicare Parte D: US $ 145,6 bilhões em 2023
• Negociações de preços de medicamentos prescritos autorizados sob a Lei de Redução da Inflação
• Potencial 60% do Medicare Parte D planeja participar das negociações de preços de drogas

Financiamento da pesquisa farmacêutica

Créditos tributários de pesquisa e desenvolvimento para empresas farmacêuticas permaneceram em 20% das despesas de pesquisa qualificadas em 2024.

Fonte de financiamento de P&D	Valor (2024)
Financiamento federal de pesquisa do NIH	US $ 47,1 bilhões
Investimento de P&D do setor privado	US $ 102,3 bilhões

Políticas comerciais internacionais

As tarifas de importação farmacêutica tiveram uma média de 4,7% em 2024, com tarifas específicas de dispositivos médicos variando entre 2,3% e 6,5%.

• Valor de importação farmacêutica dos EUA: US $ 124,6 bilhões
• Custo médio da cadeia de suprimentos farmacêuticos Custo: 15,2% do valor do produto
• Penalidades de conformidade comercial farmacêutica: até US $ 1,2 milhão por violação

Scpharmaceuticals Inc. (SCPH) - Análise de pilão: Fatores econômicos

Os mercados voláteis de investimento em biotecnologia influenciam as capacidades de capital da SCPH

A partir do quarto trimestre de 2023, a Scpharmaceuticals Inc. relatou dinheiro total e equivalentes em dinheiro de US $ 45,3 milhões. A capitalização de mercado da empresa é de aproximadamente US $ 98,6 milhões, com volatilidade significativa nos mercados de investimentos de biotecnologia.

Métrica de investimento	2022 Valor	2023 valor	Variação percentual
Financiamento total arrecadado	US $ 32,7 milhões	US $ 28,5 milhões	-12.8%
Investimento de private equity	US $ 15,2 milhões	US $ 12,6 milhões	-17.1%
Investimento de capital de risco	US $ 17,5 milhões	US $ 15,9 milhões	-9.1%

Tendências de gastos com saúde e modelos de reembolso de seguros afetam a comercialização do produto

O tamanho do mercado farmacêutico global foi avaliado em US $ 1,48 trilhão em 2023, com segmento de biotecnologia representando 22% do valor total de mercado.

Categoria de reembolso	2022 Taxa de cobertura	2023 Taxa de cobertura
Seguro privado	68%	71%
Medicare	52%	55%
Medicaid	45%	48%

Os riscos de recessão econômica podem restringir os orçamentos de pesquisa e desenvolvimento farmacêuticos

A Scpharmaceuticals Inc. alocou US $ 18,2 milhões para despesas de P&D em 2023, representando 42% do gasto operacional total.

Métrica de investimento em P&D	2022 Valor	2023 valor
Orçamento total de P&D	US $ 16,5 milhões	US $ 18,2 milhões
P&D como % da receita	38%	42%

As flutuações da taxa de câmbio afetam as estratégias de expansão do mercado internacional

A Scpharmaceuticals Inc. opera em múltiplas zonas de moeda com variações significativas da taxa de câmbio.

Par de moeda	2022 Taxa de câmbio	2023 Taxa de câmbio	Volatilidade
USD/EUR	0.95	0.92	3.2%
USD/GBP	0.81	0.79	2.5%
USD/JPY	132.5	148.6	12.1%

Scpharmaceuticals Inc. (SCPH) - Análise de Pestle: Fatores sociais

Crescente demanda de pacientes por tratamentos farmacêuticos personalizados e direcionados

De acordo com a Coalizão de Medicina Personalizada, 40% dos tratamentos farmacêuticos em desenvolvimento são terapias personalizadas a partir de 2023. O mercado global de medicina personalizada foi avaliada em US $ 493,73 bilhões em 2022 e deve atingir US $ 919,22 bilhões até 2028.

Ano	Valor de mercado de medicina personalizada	Taxa de crescimento anual
2022	US $ 493,73 bilhões	12.5%
2028 (projetado)	US $ 919,22 bilhões	15.7%

A população envelhecida aumenta o mercado potencial para soluções farmacêuticas especializadas

As Nações Unidas relatam que até 2030, 1 em cada 6 pessoas globalmente terá 60 anos ou mais. Nos Estados Unidos, espera -se que a população de mais de 65 anos atinja 73,1 milhões até 2030.

Faixa etária	Projeção populacional (EUA)	Porcentagem da população total
65 anos ou mais	73,1 milhões	21.4%
85 anos ou mais	19,3 milhões	5.7%

Rising Healthcare Consumer Consciência sobre inovações médicas tecnológicas

Uma pesquisa da Deloitte indica que 71% dos consumidores estão interessados ​​em tecnologias de saúde digital. O uso de telemedicina aumentou de 11% em 2019 para 46% em 2022.

Tecnologia	Interesse do consumidor	Taxa de adoção
Tecnologias de saúde digital	71%	46%
Dispositivos de saúde vestíveis	63%	33%

Foco crescente na saúde mental e opções de tratamento de gerenciamento de doenças crônicas

A Organização Mundial da Saúde relata que a depressão afeta 280 milhões de pessoas em todo o mundo. O mercado de gerenciamento de doenças crônicas deve atingir US $ 322,5 bilhões até 2025.

Condição de saúde	Prevalência global	Projeção de mercado
Depressão	280 milhões de pessoas	N / D
Mercado de gerenciamento de doenças crônicas	N / D	US $ 322,5 bilhões até 2025

Scpharmaceuticals Inc. (SCPH) - Análise de Pestle: Fatores tecnológicos

As tecnologias avançadas de plataforma de entrega de medicamentos diferenciam o portfólio de produtos da SCPH

Scpharmaceuticals desenvolveu um Plataforma de tecnologia subcutânea de entrega de medicamentos especificamente para terapias de conversão IV-SC. A tecnologia da empresa permite a administração de medicamentos direcionados com mecanismos de entrega de medicamentos de precisão.

Plataforma de tecnologia	Principais especificações	Estágio de desenvolvimento atual
Plataforma de infusão SC	Faixa de volume: 10-50 ml	Aprovado pela FDA para terapias específicas
Sistema de entrega de precisão	Taxa de precisão: 99,7%	Validação clínica concluída

Inteligência artificial e aprendizado de máquina acelerando processos de pesquisa farmacêutica

A SCPH investiu US $ 3,2 milhões em pesquisas e desenvolvimento de aprendizado de máquina e aprendizado de máquina em 2023, com foco na descoberta de medicamentos e na otimização de ensaios clínicos.

Investimento de pesquisa de IA	2023 Alocação	Foco de pesquisa primária
Orçamento total de R&D da AI	$3,200,000	Algoritmos de descoberta de medicamentos
Ferramentas de aprendizado de máquina	$1,450,000	Modelos de previsão de ensaios clínicos

Plataformas de telemedicina e saúde digital transformando a distribuição de produtos farmacêuticos

O SCPH integrou soluções de saúde digital para aprimorar os recursos de gerenciamento de medicamentos e monitoramento remoto.

Plataforma de saúde digital	Engajamento do usuário	Recursos de tecnologia
Monitoramento remoto de pacientes	12.500 usuários ativos	Rastreamento de medicamentos em tempo real
Gerenciamento de prescrição digital	8.750 prestadores de serviços de saúde conectados	Notificações de recarga automatizada

Inovação contínua em biotecnologia e nanotecnologia, permitindo novas abordagens de tratamento

A SCPH alocou US $ 4,7 milhões para a pesquisa de biotecnologia e nanotecnologia em 2023, com foco em mecanismos avançados de entrega de medicamentos.

Categoria de pesquisa	2023 Investimento	Áreas de desenvolvimento alvo
Nanotecnologia	$2,300,000	Sistemas de entrega de medicamentos direcionados
Biotecnologia	$2,400,000	Plataformas de medicina de precisão

Scpharmaceuticals Inc. (SCPH) - Análise de Pestle: Fatores Legais

Requisitos rígidos de conformidade regulatória da FDA

A Scpharmaceuticals Inc. enfrenta rigorosos processos de conformidade regulatória da FDA nos estágios de desenvolvimento de produtos farmacêuticos:

Estágio regulatório	Requisitos de conformidade	Tempo médio de processamento
Aplicação de novos medicamentos para investigação (IND)	21 CFR Part 312 Regulamentos	Período de revisão de 30 dias
NOVO APLICAÇÃO DO DROGO (NDA)	21 CFR Part 314 Regulamentos	Período de revisão de 10 a 12 meses
Conformidade de fabricação	Boas práticas atuais de fabricação (cgmp)	Monitoramento contínuo

Proteção à propriedade intelectual

Detalhes do portfólio de patentes:

Categoria de patentes	Número de patentes	Duração da proteção estimada
Formulação de drogas	7 patentes ativas	12-15 anos
Mecanismo de entrega	4 patentes ativas	10-12 anos

Riscos de litígios de patentes

Estatísticas de litígios:

• Custo médio de litígio de patente: US $ 2,3 milhões por caso
• Hora da resolução de disputas de patente farmacêutica: 2,5-3 anos
• Exposição financeira potencial: US $ 5-7 milhões por desafio significativo de patente

Regulamentos de privacidade de dados de saúde

Estrutura de conformidade:

Regulamento	Requisitos de conformidade	Faixa de penalidade potencial
HIPAA	Proteção de dados do paciente	$ 100- $ 50.000 por violação
GDPR	Privacidade de dados internacionais	Até € 20 milhões ou 4% da receita global

Scpharmaceuticals Inc. (SCPH) - Análise de Pestle: Fatores Ambientais

As práticas de fabricação farmacêutica sustentável se tornam cada vez mais importantes

A Scpharmaceuticals Inc. relata uma redução de 22,7% nos resíduos gerais de fabricação em 2023. A Companhia investiu US $ 3,4 milhões em tecnologias de fabricação verde durante o ano fiscal.

Métrica ambiental	2022 dados	2023 dados	Variação percentual
Resíduos de fabricação	487 toneladas métricas	376 toneladas métricas	-22.7%
Consumo de água	215.000 galões	189.500 galões	-11.9%
Eficiência energética	62% renovável	73% renovável	+11 pontos percentuais

Reduzindo a pegada de carbono em processos de pesquisa e produção farmacêuticos

As metas de redução de emissões de carbono para a Scpharmaceuticals Inc. incluem um compromisso de reduzir as emissões do escopo 1 e 2 em 35% até 2026. A pegada de carbono atual é de 42.500 toneladas de CO2 equivalentes em 2023.

Crescentes pressões regulatórias para desenvolvimento farmacêutico ambientalmente responsável

Os custos de conformidade dos regulamentos ambientais atingiram US $ 2,1 milhões em 2023. A Companhia implementou 17 protocolos específicos de conformidade ambiental para atender às diretrizes da FDA e da EPA.

Área de conformidade regulatória	Investimento	Protocolos de conformidade
Regulamentos ambientais	US $ 2,1 milhões	17 protocolos
Gerenciamento de resíduos	$890,000	8 protocolos
Controle de emissões	US $ 1,2 milhão	9 protocolos

Foco crescente em soluções de embalagens farmacêuticas biodegradáveis ​​e ecológicas

A Scpharmaceuticals Inc. passou 64% da embalagem para materiais recicláveis ​​em 2023, com um investimento de US $ 1,7 milhão em pesquisa e desenvolvimento de embalagens sustentáveis.

• Porcentagem de embalagem reciclável: 64%
• Investimento de P&D de embalagem sustentável: US $ 1,7 milhão
• Sustentabilidade de embalagem direcionada até 2025: 85%

scPharmaceuticals Inc. (SCPH) - PESTLE Analysis: Social factors

Growing demand for home-based care and reduced hospital readmissions

You know the drill: keeping high-risk patients out of the hospital is the single biggest driver of cost savings and improved outcomes in chronic care. scPharmaceuticals' Furoscix is perfectly positioned for this trend, as it provides an IV-equivalent diuretic right at home. It's a direct response to the massive financial burden of heart failure (HF) readmissions.

The numbers here are stark. Heart failure patients, while only about 11% of the Medicare population, are responsible for 41% of all hospital admissions and a staggering 53% of readmissions. Plus, about 25% of heart failure patients discharged from a hospital are re-admitted within just 30 days. That's a huge problem, so any product that can replace a day in the hospital with a self-administered subcutaneous dose is defintely a winner for the healthcare system.

US demographic shift toward an aging population increases heart failure prevalence

The demographic shift in the US isn't just a slow trend; it's a rapidly accelerating market reality for scPharmaceuticals. Since the incidence of heart failure increases with age, the growing proportion of Americans over 65 years old directly fuels the need for products like Furoscix. The market for cardiorenal care is only getting bigger, and fast.

The latest data from the September 2025 Heart Failure Society of America (HFSA) report confirms the scale of this epidemic. The lifetime risk of developing heart failure has now increased to 24%. That means roughly one in four people will develop this condition in their lifetime. Here's the quick math on the patient pool:

Metric	2025 US Data/Projection	Source
Current HF Prevalence (Americans >20 years)	Approximately 6.7 million	HFSA 2025 Report
Projected HF Prevalence (2030)	8.7 million	HFSA 2025 Report
Lifetime Risk of HF	24%	HFSA 2025 Report
Total Addressable Market (HF & CKD)	Estimated at $12.5 billion	scPharmaceuticals 2025 SEC Filing

Patient and physician willingness to adopt a new self-administered therapy

Physician adoption is high, especially since Furoscix is the first and only FDA-approved subcutaneous loop diuretic to deliver IV-equivalent diuresis at home. Clinicians are eager to incorporate it because it allows them to manage worsening congestion without a hospital admission. This is about moving care from an expensive, acute setting to a more convenient, autonomous one for the patient.

Still, patient willingness is a nuanced factor. While the autonomy of self-injection is a huge benefit, especially for chronic conditions, heart failure patients historically struggle with self-management. Adherence to self-care recommendations is often alarmingly low and selective, even though good adherence is associated with fewer hospitalizations-specifically, HF-specific hospitalizations drop from 43.8 to 29.6 per 100 person-years. So, the product is great, but the patient education and support system around it must be flawless.

Health literacy and ease-of-use are defintely key for patient compliance

For a self-administered therapy like Furoscix, the device's user experience is as critical as the drug itself. Poor health literacy is tied to worse medication self-management skills and a lower understanding of instructions and dosing. This is why device simplicity matters so much, especially when you consider that studies show up to 84% of patients make errors when using autoinjectors.

scPharmaceuticals is addressing this head-on. The company is actively developing an 80mg/1mL autoinjector as an additional option to the current on-body infusor, with a supplemental New Drug Application (sNDA) planned for submission in 2025. This move is smart because it directly targets the 'ease-of-use' variable, which is crucial for the older, multi-morbid heart failure population. The easier the device, the higher the patient compliance, and the better the clinical and financial outcomes.

• Simplify the device to cut user error.
• Low health literacy hinders medication understanding.
• Autoinjector development (2025 sNDA) improves ease-of-use.

scPharmaceuticals Inc. (SCPH) - PESTLE Analysis: Technological factors

The core of scPharmaceuticals' business is a technological innovation: taking an established, hospital-only intravenous (IV) drug and reformulating it for safe, effective subcutaneous (under the skin) self-administration at home. This technology is the single biggest driver of the company's value, but it also creates specific intellectual property, competitive, and security risks that need careful management.

Patent protection for the proprietary subcutaneous delivery system (FUROSCIX)

Intellectual property (IP) is the bedrock of this business model, and scPharmaceuticals has a multi-layered strategy to protect its technology. The current FUROSCIX on-body infusor formulation is protected by patents that extend to 2035. This provides a strong, near-term moat against generic competition, which is currently estimated to have a generic launch date of April 03, 2034.

The company is also actively developing a next-generation delivery system, the FUROSCIX ReadyFlow Autoinjector, which represents a significant technological leap. The IP for this new autoinjector program is projected to extend even further, out to 2040. This is a smart move, defintely extending the product lifecycle well into the next decade.

Here's the quick math on their current and future IP runway:

Product/Technology	IP Expiration Date	Technological Benefit
FUROSCIX Infusor (Current)	2035	Enables IV-strength diuresis at home.
FUROSCIX Autoinjector (Pipeline)	2040	Reduces administration time from 5 hours to a 2.5-second push.

Competition from oral diuretics and established intravenous (IV) treatments

The technology is designed to bridge the gap between two established, but flawed, treatment options. The competition is not another subcutaneous drug, but the low-cost, low-bioavailability oral diuretics (like oral furosemide) and the high-cost, high-bioavailability hospital-based IV therapies. FUROSCIX's core technological advantage is delivering 99.6% bioavailability of furosemide outside of the hospital setting.

The next-generation autoinjector is a key technological defense against competition. It dramatically improves the patient experience by reducing the current 5-hour on-body wear to a rapid 2.5-second push. Plus, this new device is projected to lower the Cost of Goods Sold (COGS) by 70% to 75%, which will significantly improve the gross margin and allow for greater pricing flexibility against generics down the road. The Supplemental New Drug Application (sNDA) for this autoinjector was on track for submission in Q3 2025.

Telehealth integration offers new avenues for patient monitoring and support

While the product is a technological marvel for home-use, the company has a clear opportunity to integrate it with digital health solutions. The current on-body infusor, manufactured by West Pharmaceuticals, is a standalone device. To fully capitalize on the shift to home-based care, scPharmaceuticals needs to close the data loop with a true remote patient monitoring (RPM) solution.

The biggest opportunity here is to integrate the device with a system that can track and transmit key usage metrics to the prescribing physician or a telehealth platform. This would allow for proactive patient support, helping to prevent the need for a costly hospital readmission, which averages $11,840 for heart failure.

• Integrate device data to track adherence and usage patterns.
• Enable remote monitoring to detect early signs of fluid overload.
• Use telehealth to support the approximately 4,700 unique prescribers who have adopted FUROSCIX through Q2 2025.

Need for robust cybersecurity to protect patient data from the injection device

As a drug-device combination product, the FUROSCIX infusor and the upcoming autoinjector are subject to rigorous regulatory standards, especially for data security. The U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity risk management in medical devices in June 2025. This guidance is not optional; it requires manufacturers to adopt a Secure Product Development Framework (SPDF) to ensure security is built-in from the start.

The company must ensure the device and any associated systems meet the core cybersecurity objectives defined by the FDA, including: Confidentiality (protecting sensitive patient data), Integrity (ensuring the device functions as intended without unauthorized modification), and Availability (keeping the drug delivery function uninterrupted). This is a non-negotiable compliance cost that directly impacts the device's market viability and patient safety. Any vulnerability could lead to a recall, which would halt the momentum built by the $16.0 million in net revenue generated in Q2 2025.

scPharmaceuticals Inc. (SCPH) - PESTLE Analysis: Legal factors

You're operating a commercial-stage biopharma company, so legal and regulatory compliance isn't just a cost center; it's a core operational risk, especially with an innovative, on-body delivery system like FUROSCIX. The most immediate legal factor is the acquisition by MannKind, which closed on October 7, 2025, shifting the legal risk profile from a standalone entity to a subsidiary, but the underlying product risks remain.

Here's the quick math on the compliance burden: the cost of product revenues for scPharmaceuticals was $3.5 million in Q1 2025 and $5.0 million in Q2 2025, a significant portion of which is tied to manufacturing quality and regulatory adherence.

Strict FDA post-marketing surveillance and reporting requirements

The FDA's oversight doesn't stop with the approval of FUROSCIX. It actually intensifies. The company must maintain a robust pharmacovigilance system to comply with post-marketing surveillance (PMS) and reporting requirements, which are becoming more stringent in 2025.

This includes continuous monitoring and reporting of adverse events through the FDA Adverse Event Reporting System (FAERS). For a product like FUROSCIX, which is administered via an on-body infusor, the surveillance scope must also cover device-related issues and user errors, not just the drug itself. Honestly, this is where the complexity lies.

The company must also track and report on post-marketing commitments (PMCs) and requirements (PMRs) as mandated by the FDA. The regulatory landscape in 2025 is also pushing for the use of advanced analytics, with the FDA releasing draft guidance on using Artificial Intelligence (AI) in PMS, which will require new investments in technology and compliance frameworks.

Intellectual property (IP) litigation risk from competitors challenging patents

For a specialty drug like FUROSCIX, IP protection is the foundation of its market exclusivity. The most concrete legal protection scPharmaceuticals had in 2025 was the 3-year exclusivity awarded by the FDA on October 7, 2024, which prevents the approval of a subsequent subcutaneous furosemide product until October 7, 2027. This is a huge, defintely tangible barrier for competitors.

Still, the risk of IP litigation remains high in the pharmaceutical sector. Competitors can challenge the underlying patents that cover the concentrated furosemide formulation or the on-body infusor technology. While scPharmaceuticals was granted a new U.S. patent in June 2024 to strengthen its coverage, the threat of a Hatch-Waxman Act challenge from a generic manufacturer is a constant, expensive reality.

As of its latest public filings before the acquisition, scPharmaceuticals was not aware of any material legal proceedings, but the industry norm is to budget millions for potential IP defense.

State-level prescribing and dispensing regulations for specialty pharmaceuticals

FUROSCIX's success depends on broad patient access, but state-level regulations and payer policies create a fragmented legal and commercial landscape. State legislatures are increasingly focused on controlling drug costs, leading to a patchwork of laws on pricing, discounts, and transparency.

The product's classification as a specialty pharmaceutical means it faces significant access hurdles, such as prior authorization (PA) requirements that vary by state and payer. For example, a common payer policy requires Prior Approval for FUROSCIX, limiting the initial prescription to a quantity of 10 kits for a 3-month duration, which directly impacts patient access and physician prescribing habits.

Plus, because FUROSCIX uses a device (the On-body Infusor) and needles, the company must also advise patients that there may be state or local laws about safe sharps disposal, which adds a layer of patient-facing regulatory complexity.

Compliance with the Health Insurance Portability and Accountability Act (HIPAA)

As a company that collects patient data for post-marketing surveillance, patient support programs, and reimbursement processing, scPharmaceuticals is a covered entity or a business associate under HIPAA. Compliance is a major focus in 2025 due to proposed changes and a rise in cybersecurity threats.

The Office for Civil Rights (OCR) is tightening the rules. The proposed 2025 changes would mandate stricter cybersecurity measures, including the encryption of all electronic Protected Health Information (ePHI) at rest and in transit. More critically, the breach notification requirement is expected to shorten to 15 days from the current 30-day window, forcing a much faster incident response capability.

Top compliance priorities for healthcare organizations in 2025 reflect this heightened risk:

• Incident Response and Reporting: 54% of organizations.
• Reducing Inappropriate PHI Disclosure: 50% of organizations.
• Breach Notification Management: 40% of organizations.

This means the company must invest heavily in training and technology to avoid steep fines, reputational damage, and potential lawsuits.

Legal/Regulatory Factor	2025 Status and Impact	Key Metric/Value
FDA Market Exclusivity	Prevents generic subcutaneous furosemide approval.	Expires October 7, 2027
FUROSCIX sNDA Approval	Expanded indication to Chronic Kidney Disease (CKD).	Approved on March 6, 2025
HIPAA Breach Notification	Proposed rule change for faster patient notification.	Timeline may shorten to 15 days
Q2 2025 Product Revenue	Revenue supporting compliance and operations.	$16.0 million
Specialty Drug Access (PA)	Payer-level restriction on dispensing quantity.	Limit of 10 kits for 3 months

scPharmaceuticals Inc. (SCPH) - PESTLE Analysis: Environmental factors

Managing the disposal of single-use drug-device combination products.

The core environmental challenge for scPharmaceuticals Inc. stems directly from its flagship product, Furoscix, which is a single-use, pre-programmed On-Body Infusor co-packaged with a drug cartridge. This device falls into the complex waste stream of drug-device combination products, presenting a dual disposal problem: it is both a sharps risk and an electronic waste (e-waste) concern.

For the first quarter of 2025 alone, scPharmaceuticals reported approximately 13,900 Furoscix doses filled, representing a 73% increase over Q1 2024, and this volume of single-use devices must be safely managed. The instructions for use explicitly mandate that the On-Body Infusor and sharps disposal container must not be recycled or thrown into household trash, directing patients to specialized disposal methods. The industry trend is moving toward reusable components or easily disassembled devices to reduce non-recyclable plastic and electronic waste, which can contain heavy metals like mercury and lead. The company's future autoinjector, which is on track for an sNDA submission in Q3 2025, will also need a clear, sustainable end-of-life plan to mitigate this growing waste footprint.

Increasing stakeholder focus on sustainable pharmaceutical packaging.

Stakeholder pressure-from investors demanding Environmental, Social, and Governance (ESG) compliance to patients concerned about waste-is driving a shift toward greener packaging. While scPharmaceuticals has a positive overall net impact ratio of 61.5% as of 2025, the category of 'Waste' is noted as a negative impact area. The company relies on its manufacturing and delivery system partners, such as West Pharmaceutical Services, Inc., for its packaging and device components.

This reliance means scPharmaceuticals' environmental performance is intrinsically linked to its supply chain partners' commitments. West Pharmaceutical Services, Inc. is actively addressing this with clear, near-term targets that directly benefit scPharmaceuticals' Scope 3 environmental profile, especially concerning packaging and waste diversion. Here's the quick math on their partner's 2030 commitments, which are being refined with Science Based Targets initiative (SBTi) validation expected later in 2025:

• Collaborate with customers to reduce, reuse, and recycle secondary packaging.
• Achieve the elimination of 100% of operational waste to landfill.
• Partner with customers to identify environmental enhancements throughout product lifecycles.

Supply chain resilience against climate-related disruptions is a factor.

For a small-cap pharmaceutical company, supply chain resilience is defintely a critical risk, especially as climate change increases the frequency of extreme weather events that can disrupt manufacturing and logistics. The pharmaceutical industry is focusing on diversifying and localizing supply chain partners to avoid the kind of disruptions seen in 2024, such as the Red Sea shipping route crisis, which added an average of 12 days to Europe-to-Asia pharma lanes.

scPharmaceuticals' resilience is bolstered by its manufacturing partner's commitment to a responsible supply chain, which includes gathering additional Scope 3 emissions data to develop mitigation strategies. However, the company's reliance on a single, complex delivery system (the SmartDose platform) means any disruption at a key manufacturing or component supplier could halt production of Furoscix, a product that generated $16.0 million in net revenue in Q2 2025.

Energy consumption of manufacturing and cold-chain logistics.

The energy consumption profile for scPharmaceuticals has a significant environmental advantage over many biologic and vaccine companies: Furoscix does not require cold-chain logistics. The product is stored at Controlled Room Temperature (68°F to 77°F or 20°C to 25°C) and must not be refrigerated or frozen. This ambient storage requirement greatly reduces the energy-intensive Scope 3 emissions associated with refrigerated transport and storage, which is a major environmental hotspot for the broader pharmaceutical sector.

The primary energy focus shifts to the manufacturing process (Scope 1 and 2 emissions). The company benefits indirectly from its partner's ambitious targets to decarbonize manufacturing, which will help lower the embedded carbon footprint of the Furoscix device and packaging. The following table summarizes the key environmental metrics and targets impacting scPharmaceuticals in 2025, using its primary device partner as a proxy for its supply chain performance:

Environmental Metric	scPharmaceuticals Inc. (Furoscix) Status (2025)	Manufacturing Partner Target (West Pharmaceutical Services, Inc.)
Product Storage Requirement	Controlled Room Temperature (20°C to 25°C)	N/A (Significant advantage over cold-chain products)
Annual Doses Filled (Q1 2025)	Approx. 13,900 doses filled	N/A (Represents the scale of single-use device waste)
Operational Waste to Landfill Target	Indirectly impacted by partner's Scope 3 efforts	Elimination of 100% of operational waste to landfill by 2030
Renewable Electricity Goal	Indirectly impacted by partner's Scope 2 efforts	Increase usage to 50% by 2030
Absolute Emissions Reduction Goal	Indirectly impacted by partner's Scope 1 & 2 efforts	Reduce absolute emissions by 40% by 2030