Scpharmaceuticals Inc. (SCPH): Analyse Pestle [Jan-2025 MISE À JOUR]

Dans le monde dynamique des produits pharmaceutiques spécialisés, Scpharmaceuticals Inc. (SCPH) se dresse au carrefour de l'innovation, de la complexité réglementaire et des technologies de santé transformatrices. Cette analyse complète du pilon dévoile le paysage complexe de facteurs externes façonnant la trajectoire stratégique de l'entreprise, des défis réglementaires et des percées technologiques aux changements sociétaux et aux impératifs environnementaux. En disséquant les dimensions politiques, économiques, sociologiques, technologiques, juridiques et environnementales, nous explorerons comment SCPH navigue dans l'écosystème multiforme du développement pharmaceutique moderne et du positionnement.

Scpharmaceuticals Inc. (SCPH) - Analyse du pilon: facteurs politiques

Paysage réglementaire de la FDA américaine pour l'approbation des médicaments

En 2024, le Centre d'évaluation et de recherche sur les médicaments et la recherche de la FDA (CDER) a reçu 6 365 demandes de médicaments d'enquête (IND) au cours de l'exercice précédent. Le temps moyen d'approbation du médicament était de 10,1 mois pour les examens standard et 6,1 mois pour les examens prioritaires.

Métrique de la FDA	2024 données
Applications totales IND	6,365
Temps d'examen standard	10,1 mois
Temps de révision prioritaire	6,1 mois

Impact de la politique fédérale sur les soins de santé

Le budget fédéral de la santé 2024 a alloué 53,8 milliards de dollars pour la recherche pharmaceutique et médicale, avec des implications potentielles pour les stratégies de remboursement.

• Dépenses Medicare Part D: 145,6 milliards de dollars en 2023
• Négociations sur les prix des médicaments sur ordonnance autorisés en vertu de la loi sur la réduction de l'inflation
• Potentiel 60% de Medicare Part D prévoit de participer aux négociations de prix des médicaments

Financement de la recherche pharmaceutique

Les crédits d'impôt à la recherche et au développement pour les sociétés pharmaceutiques sont restés 20% des frais de recherche qualifiés en 2024.

Source de financement R&D	Montant (2024)
Financement fédéral de recherche NIH	47,1 milliards de dollars
Investissement de R&D du secteur privé	102,3 milliards de dollars

Politiques commerciales internationales

Les tarifs d'importation pharmaceutique étaient en moyenne de 4,7% en 2024, avec des tarifs spécifiques des dispositifs médicaux variant entre 2,3% et 6,5%.

• Valeur d'importation pharmaceutique américaine: 124,6 milliards de dollars
• Coût logistique de la chaîne d'approvisionnement pharmaceutique moyenne: 15,2% de la valeur du produit
• Pénalités de conformité au commerce pharmaceutique: jusqu'à 1,2 million de dollars par violation

Scpharmaceuticals Inc. (SCPH) - Analyse du pilon: facteurs économiques

Les marchés d'investissement de biotechnologie volatile influencent les capacités de levée de capitaux de SCPH

Au quatrième trimestre 2023, Scpharmaceuticals Inc. a déclaré des équivalents totaux en espèces et en espèces de 45,3 millions de dollars. La capitalisation boursière de la société s'élève à environ 98,6 millions de dollars, avec une volatilité importante sur les marchés des investissements en biotechnologie.

Métrique d'investissement	Valeur 2022	Valeur 2023	Pourcentage de variation
Financement total collecté	32,7 millions de dollars	28,5 millions de dollars	-12.8%
Investissement de capital-investissement	15,2 millions de dollars	12,6 millions de dollars	-17.1%
Investissement en capital-risque	17,5 millions de dollars	15,9 millions de dollars	-9.1%

Les tendances des dépenses de santé et les modèles de remboursement d'assurance affectent la commercialisation des produits

La taille mondiale du marché pharmaceutique était évaluée à 1,48 billion de dollars en 2023, avec un segment de biotechnologie représentant 22% de la valeur marchande totale.

Catégorie de remboursement	2022 Taux de couverture	Taux de couverture 2023
Assurance privée	68%	71%
Médicament	52%	55%
Medicaid	45%	48%

Les risques de récession économique pourraient limiter les budgets de recherche et de développement pharmaceutique

Scpharmaceuticals Inc. a alloué 18,2 millions de dollars aux dépenses de R&D en 2023, ce qui représente 42% du total des dépenses opérationnelles.

Métrique d'investissement de R&D	Valeur 2022	Valeur 2023
Budget total de R&D	16,5 millions de dollars	18,2 millions de dollars
R&D en% des revenus	38%	42%

Les fluctuations des taux de change ont un impact sur les stratégies d'expansion du marché international

Scpharmaceuticals Inc. fonctionne dans plusieurs zones de devise avec des variations de taux de change significatives.

Paire de devises	2022 Taux de change	Taux de change 2023	Volatilité
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) - Analyse du pilon: facteurs sociaux

Demande croissante des patients de traitements pharmaceutiques personnalisés et ciblés

Selon la Personalized Medicine Coalition, 40% des traitements pharmaceutiques en développement sont des thérapies personnalisées en 2023. Le marché mondial de la médecine personnalisée était évalué à 493,73 milliards de dollars en 2022 et devrait atteindre 919,22 milliards de dollars d'ici 2028.

Année	Valeur marchande de la médecine personnalisée	Taux de croissance annuel
2022	493,73 milliards de dollars	12.5%
2028 (projeté)	919,22 milliards de dollars	15.7%

La population vieillissante augmente le marché potentiel des solutions pharmaceutiques spécialisées

Les Nations Unies rapportent que d'ici 2030, 1 personnes sur 6 dans le monde seront âgées de 60 ans ou plus. Aux États-Unis, la population de 65+ devrait atteindre 73,1 millions d'ici 2030.

Groupe d'âge	Projection de la population (États-Unis)	Pourcentage de la population totale
65 ans et plus	73,1 millions	21.4%
85 ans et plus	19,3 millions	5.7%

Sensibilisation des consommateurs à la hausse des soins de santé aux innovations médicales technologiques

Une enquête Deloitte indique que 71% des consommateurs s'intéressent aux technologies de santé numérique. L'utilisation de la télémédecine est passée de 11% en 2019 à 46% en 2022.

Technologie	Intérêt des consommateurs	Taux d'adoption
Technologies de santé numérique	71%	46%
Dispositifs de santé portables	63%	33%

Accent croissant sur les options de traitement de la santé mentale et de la gestion des maladies chroniques

L'Organisation mondiale de la santé rapporte que la dépression affecte 280 millions de personnes dans le monde. Le marché chronique de la gestion des maladies devrait atteindre 322,5 milliards de dollars d'ici 2025.

Condition de santé	Prévalence mondiale	Projection de marché
Dépression	280 millions de personnes	N / A
Marché de la gestion des maladies chroniques	N / A	322,5 milliards de dollars d'ici 2025

Scpharmaceuticals Inc. (SCPH) - Analyse du pilon: facteurs technologiques

Advanced Drug Delivery Plateforme Technologies différencié le portefeuille de produits de SCPH

Scpharmaceuticals a développé un Plateforme de technologie de livraison de médicaments sous-cutanés Plus précisément pour les thérapies de conversion IV-SC. La technologie de l'entreprise permet une administration ciblée de médicaments avec des mécanismes de précision de l'administration de médicaments.

Plate-forme technologique	Spécifications clés	Étape de développement actuelle
Plate-forme de perfusion SC	Plage de volume: 10-50 ml	Approuvé par la FDA pour des thérapies spécifiques
Système de livraison de précision	Taux de précision: 99,7%	Validation clinique terminée

Intelligence artificielle et apprentissage automatique Accélération des processus de recherche pharmaceutique

SCPH a investi 3,2 millions de dollars dans l'IA et la recherche et le développement de l'apprentissage automatique en 2023, en se concentrant sur la découverte de médicaments et l'optimisation des essais cliniques.

Investissement de recherche sur l'IA	2023 allocation	Focus de recherche primaire
Budget total de R&D AI	$3,200,000	Algorithmes de découverte de médicaments
Outils d'apprentissage automatique	$1,450,000	Modèles de prédiction des essais cliniques

Plate-forme de télémédecine et de santé numérique transformant la distribution de produits pharmaceutiques

SCPH a intégré des solutions de santé numérique pour améliorer la gestion des médicaments des patients et les capacités de surveillance à distance.

Plate-forme de santé numérique	Engagement des utilisateurs	Caractéristiques technologiques
Surveillance à distance des patients	12 500 utilisateurs actifs	Suivi des médicaments en temps réel
Gestion de prescription numérique	8 750 fournisseurs de soins de santé connectés	Notifications de recharge automatisées

Innovation continue en biotechnologie et en nanotechnologie permettant de nouvelles approches de traitement

Le SCPH a alloué 4,7 millions de dollars à la recherche de biotechnologie et de nanotechnologie en 2023, en se concentrant sur les mécanismes avancés de l'administration de médicaments.

Catégorie de recherche	2023 Investissement	Zones de développement cibles
Nanotechnologie	$2,300,000	Systèmes de livraison de médicaments ciblés
Biotechnologie	$2,400,000	Plateformes de médecine de précision

Scpharmaceuticals Inc. (SCPH) - Analyse du pilon: facteurs juridiques

Exigences strictes de conformité réglementaire de la FDA

Scpharmaceuticals Inc. fait face à des processus rigoureux de conformité réglementaire de la FDA à travers les étapes de développement de produits pharmaceutiques:

Étape réglementaire	Exigences de conformité	Temps de traitement moyen
Application de médicament enquête (IND)	21 Règlement sur la partie 312 CFR	Période d'examen de 30 jours
Nouvelle demande de médicament (NDA)	21 Règlement sur la partie 314 CFR	Période d'examen de 10 à 12 mois
Conformité de la fabrication	Bonnes pratiques de fabrication actuelles (CGMP)	Surveillance continue

Protection de la propriété intellectuelle

Détails du portefeuille de brevets:

Catégorie de brevet	Nombre de brevets	Durée de protection estimée
Formulation de médicament	7 brevets actifs	12-15 ans
Mécanisme de livraison	4 brevets actifs	10-12 ans

Risques des litiges en matière de brevet

Statistiques des litiges:

• Coût moyen des litiges de brevet: 2,3 millions de dollars par cas
• Temps de résolution des différends des brevets pharmaceutiques: 2,5-3 ans
• Exposition financière potentielle: 5 à 7 millions de dollars par défi de brevet important

Règlement sur la confidentialité des données sur les soins de santé

Cadre de conformité:

Règlement	Exigences de conformité	Range de pénalité potentielle
Hipaa	Protection des données des patients	100 $ - 50 000 $ par violation
RGPD	Confidentialité internationale des données	Jusqu'à 20 millions d'euros ou 4% des revenus mondiaux

Scpharmaceuticals Inc. (SCPH) - Analyse du pilon: facteurs environnementaux

Les pratiques de fabrication pharmaceutique durables deviennent de plus en plus importantes

Scpharmaceuticals Inc. rapporte une réduction de 22,7% des déchets de fabrication globaux en 2023. La société a investi 3,4 millions de dollars dans les technologies de fabrication vertes au cours de l'exercice.

Métrique environnementale	2022 données	2023 données	Pourcentage de variation
Déchets de fabrication	487 tonnes métriques	376 tonnes métriques	-22.7%
Consommation d'eau	215 000 gallons	189 500 gallons	-11.9%
Efficacité énergétique	62% renouvelable	73% renouvelable	+11 points de pourcentage

Réduire l'empreinte carbone dans les processus de recherche et de production pharmaceutique

Les cibles de réduction des émissions de carbone pour Scpharmaceuticals Inc. incluent un engagement à réduire les émissions des étendus 1 et 2 de 35% d'ici 2026. L'empreinte carbone actuelle s'élève à 42 500 tonnes métriques CO2 équivalent en 2023.

Pressions réglementaires croissantes pour le développement pharmaceutique responsable de l'environnement

Les frais de conformité pour les réglementations environnementales ont atteint 2,1 millions de dollars en 2023. La société a mis en œuvre 17 protocoles de conformité environnementaux spécifiques pour répondre aux directives de la FDA et de l'EPA.

Zone de conformité réglementaire	Investissement	Protocoles de conformité
Règlements environnementaux	2,1 millions de dollars	17 protocoles
Gestion des déchets	$890,000	8 protocoles
Contrôle des émissions	1,2 million de dollars	9 protocoles

Accent croissant sur les solutions d'emballage pharmaceutique biodégradables et écologiques

Scpharmaceuticals Inc. a transféré 64% de l'emballage à des matériaux recyclables en 2023, avec un investissement de 1,7 million de dollars dans la recherche et le développement de l'emballage durable.

• Pourcentage d'emballage recyclable: 64%
• Investissement en R&D d'emballage durable: 1,7 million de dollars
• Sustainabilité des emballages ciblés d'ici 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