Lung Biotechnology

What Lung Biotechnology does

Lung Biotechnology PBC is a wholly-owned subsidiary of United Therapeutics Corporation (NASDAQ: UTHR), a Delaware Public Benefit Corporation headquartered in Silver Spring, Maryland. The company operates three core technology platforms: (1) prostacyclin-based pharmaceuticals built around treprostinil — Remodulin (subcutaneous/IV infusion), Tyvaso and Tyvaso DPI (inhaled), Orenitram (oral extended-release) — plus Adcirca (tadalafil, in-licensed from Eli Lilly), spanning all major routes of administration for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD); (2) Unituxin (dinutuximab), a monoclonal antibody for high-risk pediatric neuroblastoma developed in collaboration with the National Cancer Institute; and (3) the manufactured organ platform, comprising ex-vivo lung perfusion (EVLP) services through subsidiary Lung Bioengineering, 3D bioprinted organ scaffolds, the Revivicor xenotransplantation program, plus Miromatrix decellularization-recellularization and IVIVA Medical in-vivo regeneration capabilities acquired in 2023.

The business model combines recurring revenue from five FDA-approved specialty pharmaceuticals dispensed through contracted specialty pharmacies and coordinated via the United Therapeutics Cares patient support hub, with transactional EVLP service revenue (LBE 360° Transplant Support Service) from US lung transplant centers, and licensing/royalty optionality from emerging organ manufacturing programs. Customers are patients with rare, life-threatening diseases (PAH, PH-ILD, high-risk pediatric neuroblastoma) and US transplant centers; prescribers are predominantly pulmonologists, cardiologists, transplant specialists, and pediatric oncologists. Distribution combines field sales and Medical Science Liaison engagement for HCPs, hospital buying channels for infused therapies (Remodulin IV, Unituxin), and specialty pharmacy dispensing for self-administered products (Tyvaso DPI, Orenitram, Adcirca).

United Therapeutics was founded in 1996 by Martine Rothblatt (who remains Founder, Chairperson, and CEO), IPO'd on Nasdaq in 1997 at $12.00 per share, surpassed $1 billion in annual revenue in 2013, and converted to a Public Benefit Corporation in 2021 — the first publicly traded biotech to do so. Recent milestones include the first successful xenothymokidney transplant from a 10-gene-edited pig (April 2024) and the 500th EVLP lung transplant (October 2024). Operations span co-headquarters in Silver Spring, MD and Research Triangle Park, NC, plus facilities in Jacksonville FL (EVLP center with Mayo Clinic), Manchester NH (organ manufacturing), Melbourne FL (patient support), Washington DC, and Bromont Quebec (organ delivery aircraft via Unither Bioelectronics).

Name

Lung Biotechnology

Legal name

United Therapeutics Corporation

Website

https://lungbiotechnology.com

Company type

Public

Founded year

1996

Operating status

Operating

Headcount range

11–50 employees

Short description

Lung Biotechnology, a wholly-owned subsidiary of United Therapeutics Corporation (NASDAQ: UTHR), develops and commercializes specialty pharmaceuticals for pulmonary arterial hypertension and PH-ILD and operates an organ manufacturing platform spanning ex-vivo lung perfusion, 3D bioprinting, and xenotransplantation.

Ownership category

akta.pro rank

Headquarters

HQ city

Silver Spring

HQ country

United States

HQ region

North America

Offices7 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Supply Chain, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Specialty Pharmaceuticals — PAH/PH-ILD: United Therapeutics derives the majority of its revenue from a portfolio of five FDA-approved specialty pharmaceuticals for pulmonary arterial hypertension and PH-ILD: Remodulin (SC/IV treprostinil), Tyvaso (inhaled treprostinil), Tyvaso DPI (dry powder inhaled treprostinil), Orenitram (oral extended-release treprostinil), and Adcirca (tadalafil, licensed from Eli Lilly). Revenue is generated through specialty pharmacy fulfillment, with payers covering the majority of costs for these life-sustaining therapies.
2. Oncology — Unituxin (dinutuximab): Unituxin, an FDA-approved monoclonal antibody for high-risk pediatric neuroblastoma, is distributed through hospital buying channels and specialty pharmacies as a batch-based infusion therapy. Revenue is transactional per patient treatment course.
3. EVLP Organ Restoration Services: Lung Bioengineering provides ex vivo lung perfusion services to transplant centers, functioning as a toll-based service model where donor lungs are assessed and reconditioned for a fee per procedure, with bundled logistical and 24/7/365 support.
4. Organ Manufacturing / Xenotransplantation (Emerging): Emerging revenue streams from manufactured organ programs including xenothymokidney transplants, bioprinted organ scaffolds, and decellularization-recellularization organ platforms are in early clinical stages and not yet revenue-generating.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels8 records

Core offering

Lung Biotechnology PBC develops, manufactures, and commercializes pharmaceutical therapies for pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and high-risk pediatric neuroblastoma, including the Remodulin, Tyvaso, Tyvaso DPI, Orenitram, Adcirca, and Unituxin franchises. The company additionally operates organ manufacturing and transplantation programs, including ex vivo lung perfusion (EVLP), xenotransplantation, and 3D bioprinting, supported by the LBE 360° Transplant Support Service and the Remunity Pump subcutaneous delivery system.

Product overview

Lung Biotechnology, a subsidiary of United Therapeutics Corporation, operates as a public benefit corporation focused on rare diseases and end-stage lung disease. The product portfolio includes five FDA-approved pharmaceutical products for pulmonary arterial hypertension (PAH Group 1) and PH-ILD (Group 3): Remodulin (injectable prostacyclin), Tyvaso and Tyvaso DPI (inhaled treprostinil formulations), Orenitram (oral treprostinil), and Adcirca (PDE-5 inhibitor). The company also offers Unituxin for high-risk neuroblastoma in pediatric oncology. Complementing its pharmaceutical portfolio is the LBE 360° Transplant Support Service, providing ex vivo lung perfusion procedures to expand transplantable organ availability, alongside the Remunity Pump delivery device for Remodulin administration. The company is also advancing organ manufacturing programs through subsidiaries including Lung Bioengineering, Miromatrix, and IVIVA Medical.

Differentiator

Problem solved

Functional benefit

Brands

• LBE 360° Transplant Support Service: A centralized ex vivo lung perfusion (EVLP) service model dedicated to making more donor organs available for transplant, offered through subsidiary Lung Bioengineering Inc.
• United Therapeutics Cares
• PAH Initiative
• Jenesis Awards Program

Products and services

• Remodulin (treprostinil) Injection Remodulin (treprostinil) Injection is a prostacyclin analog administered via continuous subcutaneous or intravenous infusion for adults with pulmonary arterial hypertension (WHO Group 1) to diminish symptoms associated with exercise and reduce the rate of clinical worsening. It is the foundational parenteral prostacyclin therapy in the company's PAH franchise.
• Tyvaso (treprostinil) Inhalation Solution Tyvaso (treprostinil) Inhalation Solution is an inhaled prostacyclin therapy for adults with pulmonary arterial hypertension (WHO Group 1) and for adults with pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3), used to improve exercise ability. It is administered via a Tyvaso Inhalation System with a nebulizer.
• Tyvaso DPI (treprostinil) Inhalation Powder Tyvaso DPI (treprostinil) Inhalation Powder is a dry-powder inhaled prostacyclin therapy for adults with PAH and PH-ILD, designed to improve exercise capacity with a portable, single-dose, breath-actuated inhaler that eliminates the need for a nebulizer.
• Orenitram (treprostinil) Extended-Release Tablets Orenitram (treprostinil) Extended-Release Tablets is an oral prostacyclin therapy indicated for adults with pulmonary arterial hypertension (WHO Group 1) to delay disease progression and improve exercise capacity, providing a non-parenteral and non-inhaled option within the company's treprostinil franchise.
• Adcirca (tadalafil) Tablets Adcirca (tadalafil) Tablets is a once-daily PDE5 inhibitor indicated for adults with pulmonary arterial hypertension (WHO Group 1) to improve exercise ability, complementing the prostacyclin franchise with a distinct mechanism of action.
• Unituxin (dinutuximab) Injection Unituxin (dinutuximab) Injection is a GD2-binding monoclonal antibody indicated, in combination with GM-CSF, isotretinoin, and IL-2, for pediatric patients with high-risk neuroblastoma who have at least partially responded to prior first-line multimodality therapy. It is administered in specialized pediatric oncology centers.
• LBE 360° Transplant Support Service The LBE 360° Transplant Support Service is a patient and provider support program for people being evaluated for or who have received a lung transplant, offering insurance navigation, reimbursement support, copay assistance, and logistics coordination to improve access to transplantation.
• Remunity Pump for Remodulin The Remunity Pump is a proprietary compact, disposable subcutaneous infusion pump system developed with DEKA to deliver Remodulin (treprostinil), available through certified specialty pharmacies, designed to be smaller and simpler to use than prior subcutaneous pumps for parenteral treprostinil therapy.

Quantifiable outcome

• 500th lung transplant using UT's EVLP service
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Nine partnerships are on record, tiered core and minor.

• Miromatrix Medical Inc.coreStrategic or Co-development Partner · 13 December 2023United Therapeutics completed the tender offer and merger for Miromatrix Medical Inc. in December 2023. Miromatrix brings proprietary technology for decellularizing and recellularizing organs to create bioengineered organs for transplant, complementing United Therapeutics' broader organ manufacturing mission.
• IVIVA Medical Inc.coreStrategic or Co-development Partner · 1 January 2023United Therapeutics acquired IVIVA Medical Inc. in 2023. IVIVA is developing an in-vivo organ regeneration platform, adding to United Therapeutics' suite of organ availability technologies alongside EVLP and Miromatrix.
• MannKind CorporationcoreStrategic or Co-development Partner · 1 January 2018In 2018, United Therapeutics launched a collaboration with MannKind for Tyvaso DPI (treprostinil inhalation powder), utilizing MannKind's dry powder inhaler technology to deliver treprostinil for PAH and PH-ILD.
• 3D SystemsminorStrategic or Co-development Partner · 1 January 2017In 2017, United Therapeutics' subsidiary Lung Biotechnology PBC launched an organ bioprinting program in collaboration with 3D Systems, leveraging 3D printing technology to fabricate organ scaffolds for transplantable organs.
• Mayo Clinic (Jacksonville)coreStrategic or Co-development Partner · 1 January 2015United Therapeutics entered into a collaboration with Mayo Clinic Jacksonville in 2015 to build and operate an ex-vivo lung perfusion center in Jacksonville, FL. The collaboration also established Mayo's Innovation Exchange, a life sciences incubator co-located with the EVLP facility.
• DEKA Research & Development Corp.coreTechnology or Integration · 1 January 2014United Therapeutics and DEKA entered into an agreement in 2014 to develop a next-generation subcutaneous pump for Remodulin, which ultimately resulted in the commercial Remunity Pump for Remodulin (launched commercially in 2021; FDA clearance of pharmacy fill in 2020).
• Revivicor (Xenotransplantation Program)coreStrategic or Co-development Partner · 1 January 2011United Therapeutics acquired the Revivicor xenotransplantation program in 2011. Revivicor provided the proprietary porcine platform that enabled United Therapeutics' historic xenothymokidney transplant achievements, including the 2024 first successful transplant from a pig with ten gene edits.
• National Cancer InstitutecoreStrategic or Co-development Partner · 1 January 2010United Therapeutics launched a collaboration with the National Cancer Institute in 2010 to develop the monoclonal antibody for high-risk neuroblastoma, which became Unituxin (dinutuximab), approved by the FDA in 2015.
• Thymmune TherapeuticsminorStrategic or Co-development PartnerThymmune Therapeutics is listed as a subsidiary under United Therapeutics' corporate umbrella, focused on thymus cell therapy or immune engineering applications related to organ transplantation.

Scale indicators5 records

Recent moves9 records

Expansion highlights7 records

Direct peers

• Janssen Pharmaceuticals (Actelion): Janssen's Actelion franchise markets Opsumit (macitentan), Uptravi (selexipag), and Tracleer (bosentan) — the most direct competing portfolio of branded PAH therapies targeting the same pulmonologists and prescribers as United Therapeutics' prostacyclin franchise. Closest direct competitor in PAH commercial dynamics.
• Bayer: Bayer markets Adempas (riociguat), the only FDA-approved sGC stimulator for PAH and chronic thromboembolic pulmonary hypertension. Adempas competes head-to-head with United Therapeutics' PAH portfolio in WHO Group 1 and 4 patients via a different mechanism of action.
• Gilead Sciences: Gilead markets Letairis (ambrisentan), an endothelin receptor antagonist for PAH that directly competes for the same WHO Group 1 patient population targeted by United Therapeutics' prostacyclin and PDE-5 inhibitor products. Comparable specialty-pharma distribution and physician targeting model.
• Pfizer: Pfizer markets Revatio (sildenafil) for PAH, a PDE-5 inhibitor competing with United Therapeutics' Adcirca (tadalafil). Both target the same vasodilatory pathway and prescriber base in PAH.
• OrganOx: OrganOx develops the metra normothermic machine perfusion device for liver and now kidney preservation, a direct competitor to United Therapeutics' Lung Bioengineering EVLP service. Both target the same unmet need of expanding transplantable organ supply via ex-vivo perfusion technology.
• TransMedics: TransMedics markets the Organ Care System for lung, liver, and heart preservation and runs the National OCS Program. Directly comparable to United Therapeutics' Lung Bioengineering in offering commercial organ-preservation services to U.S. transplant centers, with a national logistics network.
• XVIVO Perfusion: XVIVO offers XPS and STEEN solution-based EVLP technologies for lung preservation used globally in transplant centers. A direct technology and service competitor to United Therapeutics' Lung Bioengineering EVLP platform.

Emerging players

• eGenesis: eGenesis is developing gene-edited porcine organs for xenotransplantation, including kidneys and hearts, with active clinical programs. Directly comparable to United Therapeutics' Revivicor-derived xenothymokidney program and competing in the same regulatory and clinical pathway for manufactured transplant organs.
• Humacyte: Humacyte is developing bioengineered human tissues and vessels using regenerative medicine techniques analogous to United Therapeutics' Miromatrix decellularization-recellularization platform. Both target the broader regenerative-medicine and manufactured-organ opportunity.
• Y-mAbs Therapeutics: Y-mAbs develops GD2-targeting antibodies (Danyelza) for high-risk pediatric neuroblastoma, directly competing with United Therapeutics' Unituxin (dinutuximab) in the same rare pediatric oncology indication. Both rely on specialty distribution to a limited number of pediatric oncology centers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/UnitedTherapeutics
• LinkedInlinkedin.com/company/lung-biotechnology-pbc

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries7 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments4 records

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Lung Biotechnology