HEMA Biologics

What HEMA Biologics does

HEMA Biologics is a privately-held, US-based biopharmaceutical company founded in 2016 and headquartered in Louisville, Kentucky. The company is focused exclusively on rare bleeding disorders, with its sole commercial product being SEVENFACT (coagulation factor VIIa (recombinant)-jncw), an injectable recombinant FVIIa bypassing agent that received FDA approval in 2020. SEVENFACT is indicated for the treatment and control of bleeding episodes in adults and adolescents (12 years and older) with Hemophilia A or B who have developed inhibitors to Factor VIII or IX replacement therapy, and was the first new inhibitor bypassing agent approved in over 20 years. The underlying product, known in clinical literature as Eptacog Beta (LR769), demonstrated 84.9%-93.2% sustained clinical response rates in the PERSEPT 1, 2, and 3 clinical trial program.

The company operates as the exclusive US commercial subsidiary of LFB SA, a French state-owned biopharmaceutical company that develops and manufactures SEVENFACT. HEMA Biologics handles US distribution, sales, and commercialization under this partnership arrangement. Its go-to-market approach is sales-led, deploying a National Sales Director and field sales team targeting hematologists and hemophilia treatment centers, supported by a dedicated Market Access team managing payer and specialty pharmacy relationships, and a Medical Affairs function providing scientific engagement to healthcare providers. The company also invests in patient and caregiver education through digital tools (HEMO360 VR experience, Coagulation Intervention Brigade mobile app) and partnerships with major bleeding disorder advocacy organizations including the National Hemophilia Foundation and Hemophilia Federation of America.

HEMA Biologics generates revenue through pharmaceutical product sales of SEVENFACT, with no pricing publicly disclosed. Its customer base comprises hemophilia A/B patients with inhibitors (a small subset of the rare hemophilia population), the healthcare professionals who treat them, and the specialty pharmacy/payer channels that distribute and reimburse the therapy. The company has 11-50 employees and is organized as HEMA Biologics, LLC, incorporated in Delaware. Beyond SEVENFACT, the company references investigational treatments for rare bleeding disorders, suggesting potential pipeline expansion through its LFB SA partnership, though no additional products are commercially approved as of the source data.

Name

HEMA Biologics

Legal name

HEMA Biologics, LLC

Website

https://hemabio.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

HEMA Biologics is a privately-held US biopharmaceutical company that commercializes SEVENFACT, the first new inhibitor bypassing agent approved in over 20 years for hemophilia A/B patients with inhibitors. It operates as the US commercial arm of French biopharmaceutical firm LFB SA.

Ownership category

akta.pro rank

Product category

Specialty Hematology / Rare Bleeding Disorder Therapeutics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Blood Factors & Hemostasis Biologics (recombinant clotting factors, thrombolytics) (HLAAAAAL)

akta.pro secondary industry

Hematology Specialty Pharmaceuticals (Non-malignant) (HLAIACAI)

Keywords

• Rare bleeding disorders
• Hemophilia therapeutics
• Recombinant coagulation factors
• Specialty biopharmaceuticals
• Bypassing agents

Headquarters

HQ city

Louisville

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Sales: HEMA Biologics generates revenue through the sale of SEVENFACT, their FDA-approved coagulation factor VIIa product for treating hemophilia patients with inhibitors. The company commercializes products in the United States through their own distribution and commercialization efforts, partnered with LFB SA as the developer and manufacturer.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

HEMA Biologics commercializes SEVENFACT (coagulation factor VIIa (recombinant)-jncw), an FDA-approved injectable bypassing agent for the treatment and control of bleeding episodes in adults and adolescents 12 years of age and older with Hemophilia A or B with inhibitors. It is the first new inhibitor bypassing agent approved in over 20 years. The product was developed and is manufactured by LFB SA, with HEMA Biologics responsible for US distribution and commercialization.

Product overview

HEMA Biologics is a privately held biopharmaceutical company focused on rare bleeding disorders. The company's sole product is SEVENFACT (coagulation factor VIIa (recombinant)-jncw), an injectable bypassing agent for hemophilia A or B patients with inhibitors. The company operates as a commercial distribution and commercialization entity for products developed and manufactured by its parent company LFB SA, a French state-owned biopharmaceutical company.

Differentiator

Problem solved

Functional benefit

Brands

• SEVENFACT: Coagulation factor VIIa (recombinant)-jncw, an injectable medicine for the treatment and control of bleeding episodes in adults and adolescents with Hemophilia A or B with inhibitors.
• Coagulation Intervention Brigade (CIB)

Products and services

• SEVENFACT (coagulation factor VIIa (recombinant)-jncw) FDA-approved injectable bypassing agent (recombinant coagulation factor VIIa) for the treatment and control of bleeding episodes in adults and adolescents 12 years of age and older with Hemophilia A or B with inhibitors. Indicated for treatment/control of bleeding episodes, routine prophylaxis to reduce bleeding frequency, and surgical bleeding prevention.

Quantifiable outcome

• 84.9% sustained clinical response at 12 hours with 75 μg/kg initial dose regimen in mild/moderate bleeding episodes
• +1 more outcomes

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

One partnership is on record.

• LFB SAcoreOEM/ Whitelabel/ Licensing PartnerLFB SA is a French state-owned biopharmaceutical company dedicated to the development, manufacture, and safety of therapeutic proteins. Through this partnership, HEMA Biologics is responsible for distribution and commercialization of LFB SA's product (SEVENFACT) in the United States market. The heritage of LFB SA provides the foundation for HEMA Biologics' product portfolio, with the company taking pride in this European roots while making a difference in the US.

Scale indicators1 record

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Grifols: Vertically integrated plasma fractionator with hemophilia products and a major US specialty distribution channel for blood/plasma-derived therapies, providing direct comparability on commercial distribution of coagulation products.
• CSL Behring: Global leader in plasma-derived and recombinant coagulation therapies (including Idelvion, Afstyla, Humate-P) competing in hemophilia and serving the same HTC and hematologist channel as HEMA Biologics.
• Novo Nordisk: Global biopharma whose NovoSeven (recombinant Factor VIIa) is the long-established leader in hemophilia inhibitor bypassing therapy and directly competes with SEVENFACT in the same patient population.
• Octapharma: Family-owned plasma therapeutics company marketing Nuwiq, Octanate and other recombinant/plasma-derived hemophilia products across the same hospital and specialty pharmacy channels as SEVENFACT.
• Genentech / Roche: Markets Hemlibra (emicizumab), a bispecific antibody approved for hemophilia A with/without inhibitors that has reshaped the inhibitor treatment landscape and competes for the same HCP/patient channel HEMA serves.
• Takeda (Shire): Markets FEIBA (activated prothrombin complex concentrate), a competing inhibitor bypassing agent, and through the legacy Shire franchise is a major player across hemophilia and rare bleeding disorders with broad HCP relationships overlapping HEMA's.
• Sanofi (Bioverativ): Through the Bioverativ acquisition, Sanofi markets Eloctate and Alprolix (recombinant Factor VIII/IX) and is a major rare blood disorder commercial franchise competitor with overlapping hemophilia treatment center relationships.

Others

• LFB SA: French state-owned biopharmaceutical company that developed and manufactures SEVENFACT (eptacog beta) and is HEMA's strategic parent; included as the upstream R&D and manufacturing peer and supply partner.

Emerging players

• Aptevo Therapeutics: Small-cap biotech developing hematology-focused biologics (e.g., IXINITY for hemophilia B) with a similar scale and commercial focus on niche coagulation indications, comparable in size and strategic profile to HEMA.
• Catalyst Biosciences: Clinical-stage biotech developing next-generation coagulation biologics for hemophilia and other rare bleeding disorders, addressing the same patient population and physician channel as HEMA.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights6 records

Customer concentration

• Xx.com/HEMABiologics
• Facebookfacebook.com/HEMABiologics
• LinkedInlinkedin.com/company/hema-biologics

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about HEMA Biologics