BioCryst Pharmaceuticals, Inc. (BCRX): Business Model Canvas [11-2024 Updated]

In the dynamic world of pharmaceuticals, BioCryst Pharmaceuticals, Inc. (BCRX) stands out with its innovative approach to treating rare diseases. Their business model canvas reveals a robust framework that includes strategic partnerships, a strong focus on research and development, and a commitment to delivering best-in-class therapies. Discover how BioCryst navigates the complexities of the pharmaceutical landscape through effective customer engagement, diverse revenue streams, and a dedicated value proposition aimed at improving patient outcomes.

BioCryst Pharmaceuticals, Inc. (BCRX) - Business Model: Key Partnerships

Collaborations with Torii for ORLADEYO in Japan

BioCryst Pharmaceuticals has established a partnership with Torii Pharmaceutical Co., Ltd. for the commercialization of ORLADEYO (berotralstat) in Japan. This collaboration is crucial for enhancing the market presence of ORLADEYO in the Japanese market, where the drug is indicated for the treatment of hereditary angioedema (HAE).

As of September 30, 2024, the net revenue from ORLADEYO has significantly increased, contributing to the total revenues of $319.2 million for the nine months ended September 30, 2024, compared to $238.0 million in the same period for 2023. This increase includes a direct contribution from the collaboration with Torii, which has been instrumental in driving sales in Japan.

Partnerships with Shionogi and Green Cross for peramivir

BioCryst has engaged in partnerships with Shionogi & Co., Ltd. and Green Cross Corporation for the development and commercialization of peramivir (RAPIVAB) in various markets. These collaborations are pivotal in expanding the reach of peramivir, particularly in treating influenza.

In 2024, BioCryst announced a contract with the U.S. Department of Health and Human Services (HHS) worth up to $69 million for the supply of up to 95,625 doses of RAPIVAB over five years. This contract includes a base ordering period of 12 months, with the first ordering executed for $13.9 million.

Engagements with academic institutions for research

BioCryst Pharmaceuticals actively collaborates with various academic institutions to enhance its research and development efforts. These partnerships facilitate access to cutting-edge research and innovations in drug development, particularly in the fields of rare diseases and infectious diseases.

In the nine months ended September 30, 2024, BioCryst's research and development expenses totaled $125.2 million, with significant allocations towards ongoing clinical trials and new drug applications. These engagements are vital in advancing BioCryst’s pipeline and securing its competitive edge in the pharmaceutical industry.

Partnership	Purpose	Financial Impact
Torii Pharmaceutical Co., Ltd.	Commercialization of ORLADEYO in Japan	Contributed to the increase in ORLADEYO sales, part of $319.2 million total revenue for 2024
Shionogi & Co., Ltd.	Development and commercialization of peramivir	Contract with HHS for up to $69 million over five years
Green Cross Corporation	Development and commercialization of peramivir	Part of the HHS contract revenue stream
Academic Institutions	Research and development collaborations	Supported $125.2 million R&D expenses in 2024

BioCryst Pharmaceuticals, Inc. (BCRX) - Business Model: Key Activities

Clinical trials for product candidates

BioCryst Pharmaceuticals is actively engaged in clinical trials for multiple product candidates. The research and development expenses for the three months ended September 30, 2024, totaled $41.1 million, a decrease from $46.9 million in the same period in 2023. This includes specific allocations such as:

Program	Q3 2024 (in thousands)	Q3 2023 (in thousands)
Berotralstat	$13,151	$10,758
Factor D Program	$4,542	$18,245
Other research, preclinical, and development costs	$23,388	$17,876

The decline in overall R&D expenses is primarily due to reduced costs associated with the Factor D program, following the discontinuation of the BCX10013 program.

Regulatory submissions and approvals

Regulatory activities are crucial for BioCryst as it seeks to obtain necessary approvals for its product candidates. As of September 30, 2024, the company focuses on obtaining regulatory approvals for its lead product, ORLADEYO. The product has already seen strong market performance, with net revenues of $313.3 million for the nine months ended September 30, 2024, compared to $233.9 million in the same period in 2023. This growth is attributed to both increased direct sales and royalties.

Furthermore, BioCryst has received substantial government contracts, such as the $69 million contract from the U.S. Department of Health and Human Services for RAPIVAB, indicating ongoing engagement with regulatory bodies and the government to support product distribution.

Sales and marketing efforts for commercialization

Sales and marketing are key activities for BioCryst as they commercialize their products. Selling, general, and administrative expenses for the three months ended September 30, 2024, were $65.1 million, up from $50.6 million in the same period in 2023. This increase reflects the company's efforts to expand its marketing and commercial operations.

The commercial success of ORLADEYO is evident, with U.S. sales reaching $278.9 million for the nine months ended September 30, 2024, compared to $208.9 million for the same period in 2023. This growth is supported by targeted marketing strategies and the establishment of partnerships to enhance distribution channels.

BioCryst Pharmaceuticals, Inc. (BCRX) - Business Model: Key Resources

Intellectual property portfolio, including patents

BioCryst Pharmaceuticals holds a robust intellectual property portfolio critical to its competitive advantage. As of 2024, the company has over 100 issued patents and pending patent applications across various jurisdictions, primarily focusing on treatments for rare diseases, including hereditary angioedema (HAE). Notably, BioCryst's lead product, ORLADEYO (berotralstat), is protected by multiple patents, contributing to its market position.

Research and development personnel and facilities

BioCryst employs approximately 200 skilled personnel dedicated to research and development (R&D). The company has invested significantly in its R&D facilities, including a state-of-the-art Discovery Center located in Alabama. For the three months ended September 30, 2024, BioCryst's R&D expenses totaled $41.1 million, with major investments directed towards the berotralstat program and other investigational drugs .

R&D Expenses by Program (in thousands)	Q3 2024	Q3 2023
Berotralstat	$13,151	$10,758
Factor D Program	$4,542	$18,245
Other research, preclinical, and development costs	$23,388	$17,876
Total R&D Expenses	$41,081	$46,879

Financial resources from capital markets and collaborations

As of September 30, 2024, BioCryst had approximately $96.8 million in cash and cash equivalents and $252.6 million in available-for-sale investments. The company's financial strategy includes leveraging capital markets through public offerings and collaborations. In April 2023, BioCryst secured a $450 million loan agreement with BioPharma Credit Investments, which includes a $300 million initial term loan. Additionally, revenues from ORLADEYO sales in the third quarter of 2024 reached $116.3 million, showing significant growth compared to previous periods.

Financial Overview (in thousands)	Q3 2024	Q3 2023
Total Revenues	$117,085	$86,742
Net Loss	$(14,033)	$(36,149)
Cash and Cash Equivalents	$96,841	$110,643
Total Assets	$491,254	$516,960

BioCryst Pharmaceuticals, Inc. (BCRX) - Business Model: Value Propositions

Best-in-class therapies for rare diseases

BioCryst Pharmaceuticals focuses on developing therapies specifically for rare diseases, leveraging its expertise in structure-guided drug design. The company aims to deliver first-in-class or best-in-class oral small-molecule and protein therapeutics.

Unique treatment options like ORLADEYO

One of BioCryst's flagship products, ORLADEYO (berotralstat), is designed for the prophylactic treatment of hereditary angioedema (HAE). In the third quarter of 2024, ORLADEYO generated revenues of $116.3 million, a significant increase from $85.7 million in the same quarter of 2023. For the nine months ending September 30, 2024, total revenues reached $313.5 million, compared to $235.1 million in 2023.

Period	ORLADEYO Revenue (in millions)
Q3 2024	$116.3
Q3 2023	$85.7
9M 2024	$313.5
9M 2023	$235.1

Commitment to patient assistance programs

BioCryst is dedicated to supporting patients through various assistance programs. Their initiatives include providing financial support and resources to ensure access to ORLADEYO. This commitment is reflected in the $62.1 million net loss reported for the nine months ending September 30, 2024, indicating ongoing investments in patient outreach and support.

Furthermore, BioCryst's operating expenses totaled $317.2 million for the nine months ended September 30, 2024, with a significant portion allocated to research and development, underscoring their focus on innovation and patient-centric solutions.

Financial Metric	Amount (in millions)
Net Loss (9M 2024)	$62.1
Total Operating Expenses (9M 2024)	$317.2

BioCryst Pharmaceuticals, Inc. (BCRX) - Business Model: Customer Relationships

Direct engagement with healthcare providers

BioCryst Pharmaceuticals focuses on direct engagement with healthcare providers to promote its products, particularly ORLADEYO (berotralstat). For the nine months ended September 30, 2024, the total revenues reached $319.2 million, reflecting a substantial increase from $238.0 million in the same period in 2023. The growth was primarily driven by a $78.4 million increase in ORLADEYO net revenue, attributed to enhanced direct sales efforts.

Specialty pharmacy partnerships for distribution

BioCryst has established partnerships with specialty pharmacies for the distribution of ORLADEYO. In the U.S., the company ships ORLADEYO directly to patients through a single specialty pharmacy, which is essential for managing patient access and ensuring adherence to therapy. The sales of ORLADEYO in the U.S. for the nine months ended September 30, 2024, amounted to $278.9 million.

Revenue Source	Q3 2024 Revenue (in thousands)	Q3 2023 Revenue (in thousands)	Change (in thousands)
U.S. ORLADEYO Sales	$103,112	$75,268	$27,844
International ORLADEYO Sales	$13,207	$10,416	$2,791
Total ORLADEYO Revenue	$116,319	$85,684	$30,635

Patient support programs for access to medications

BioCryst Pharmaceuticals implements patient support programs designed to enhance access to medications. These programs include financial assistance and educational resources for patients prescribed ORLADEYO. The company's commitment to patient support is reflected in its research and development expenditures, which totaled $125.2 million for the nine months ended September 30, 2024, down from $146.5 million in the same period in 2023.

Through these initiatives, BioCryst aims to build long-term relationships with patients and healthcare providers, ensuring that patients receive the necessary support for their treatment regimens.

BioCryst Pharmaceuticals, Inc. (BCRX) - Business Model: Channels

Direct sales through specialty pharmacies

BioCryst Pharmaceuticals primarily sells its product ORLADEYO directly to patients through a single specialty pharmacy in the United States. For the three months ended September 30, 2024, the net revenue from ORLADEYO was $116.3 million, an increase from $85.7 million in the same period of 2023. The U.S. sales accounted for $103.1 million of this revenue.

Distribution agreements with specialty distributors

In international markets, BioCryst utilizes distribution agreements with specialty distributors, hospitals, and pharmacies. For the nine months ended September 30, 2024, the total revenue from ORLADEYO outside the U.S. was $34.5 million. The company has established a network of partnerships to ensure effective distribution and market penetration globally.

Online platforms for information and support

BioCryst Pharmaceuticals also leverages online platforms to provide information and support regarding its products. The company’s website offers resources for both healthcare professionals and patients, facilitating access to product information and support services. This approach is designed to enhance customer engagement and streamline the information-sharing process for patients and providers alike.

Channel Type	Details	Revenue Impact (Q3 2024)
Direct Sales	Specialty pharmacy in the U.S.	$103.1 million
International Sales	Specialty distributors, hospitals, pharmacies	$34.5 million
Online Support	Website resources for healthcare professionals and patients	N/A

BioCryst Pharmaceuticals, Inc. (BCRX) - Business Model: Customer Segments

Patients with hereditary angioedema

BioCryst Pharmaceuticals primarily serves patients diagnosed with hereditary angioedema (HAE). HAE is a rare genetic condition characterized by recurrent episodes of severe swelling. BioCryst’s lead product, ORLADEYO (berotralstat), is designed to provide a treatment option for these patients. In the nine months ended September 30, 2024, total revenues from ORLADEYO were $313.3 million, reflecting a significant increase from $233.9 million in the same period of 2023.

Healthcare providers and specialists

Healthcare providers, including specialists such as allergists and immunologists, are critical customer segments for BioCryst. These professionals prescribe ORLADEYO and other products to manage HAE in patients. The company has established relationships with healthcare providers through education and marketing efforts. The sales strategy includes direct sales to specialty pharmacies that distribute ORLADEYO, thereby ensuring availability for healthcare professionals to prescribe.

Government and private payers

Government and private payers are essential stakeholders in the BioCryst business model. The company engages with these payers to secure reimbursement for their products. For instance, the U.S. Department of Health and Human Services awarded BioCryst a contract worth up to $69 million for RAPIVAB, highlighting the importance of government contracts in their revenue streams. As of September 30, 2024, the company had significant revenues from government contracts and private insurance reimbursements for ORLADEYO and other products.

Customer Segment	Description	Revenue Impact (2024)
Patients with HAE	Individuals diagnosed with hereditary angioedema using ORLADEYO for treatment.	$313.3 million from ORLADEYO sales.
Healthcare Providers	Specialists who prescribe BioCryst products to manage HAE.	Significant sales through specialty pharmacies.
Government and Private Payers	Entities that reimburse for BioCryst products.	$69 million contract for RAPIVAB; other reimbursements for ORLADEYO.

BioCryst Pharmaceuticals, Inc. (BCRX) - Business Model: Cost Structure

Research and Development Expenses

For the nine months ended September 30, 2024, BioCryst Pharmaceuticals reported total research and development expenses of $125.2 million, down from $146.5 million in the same period in 2023. The breakdown of these expenses is as follows:

Program	2024 (in thousands)	2023 (in thousands)
Berotralstat	$38,255	$29,931
Factor D Program	$20,579	$70,064
Other Research, Preclinical and Development Costs	$66,363	$46,519
Total R&D Expenses	$125,197	$146,514

The decrease in overall R&D expenses was primarily due to reduced spending on the Factor D program, attributed to the discontinuation of the BCX9930 program. Conversely, increased investments were noted for the Berotralstat and other research initiatives, including clinical trials and new drug application activities.

Marketing and Sales Costs

For the nine months ended September 30, 2024, selling, general and administrative expenses incurred by BioCryst Pharmaceuticals amounted to $185.7 million, an increase from $149.5 million in the same period in 2023. This increase can be attributed to:

• Heightened commercial expenses associated with the launch of new regions.
• Expanded international operations.
• Increased headcount and consulting expenses aimed at supporting accounting functions.
• Boost in information technology and human resources costs due to commercial growth.
• Increased stock-based compensation expenses due to the Retirement Policy adopted in July 2024.

The sales and marketing strategies have focused on bolstering the visibility and distribution of ORLADEYO, leading to a significant rise in associated costs.

Regulatory Compliance and Legal Fees

Regulatory compliance and legal fees are integral to maintaining BioCryst's operations, particularly in navigating the complex pharmaceutical landscape. For the nine months ended September 30, 2024, these costs are incorporated within the total operating expenses. The company has incurred:

• Interest Expense: $74.1 million for the nine months ended September 30, 2024, compared to $83.7 million in 2023.
• Income Tax Expense: $1.1 million for the nine months ended September 30, 2024, down from $1.7 million in 2023.

These expenses reflect the ongoing commitment to compliance with regulatory requirements that govern drug development and commercial operations, which are critical for sustaining market access and maintaining product integrity.

BioCryst Pharmaceuticals, Inc. (BCRX) - Business Model: Revenue Streams

Product sales from ORLADEYO and peramivir

For the nine months ended September 30, 2024, BioCryst Pharmaceuticals reported total revenues of $319.2 million, an increase from $238.0 million in the same period of 2023. This growth was primarily driven by a $78.4 million increase in net revenue from ORLADEYO, which totaled $313.5 million for the same period.

Revenue Source	Q3 2024 Revenue	Q3 2023 Revenue	9M 2024 Revenue	9M 2023 Revenue
ORLADEYO (U.S.)	$103.1 million	$75.3 million	$279.0 million	$208.9 million
ORLADEYO (Outside U.S.)	$13.2 million	$10.4 million	$34.5 million	$26.2 million
Other Revenues (peramivir)	$0.8 million	$1.1 million	$5.7 million	$2.9 million
Total Revenue	$117.1 million	$86.7 million	$319.2 million	$238.0 million

Milestone payments from partnerships

BioCryst Pharmaceuticals engages in strategic partnerships that yield milestone payments. For instance, the company has entered into collaborations that could generate significant milestone revenue upon the achievement of certain developmental and regulatory milestones. Specific financial details of these agreements vary, but they are an essential component of BioCryst's total revenue strategy.

Royalties from licensing agreements

In addition to direct product sales, BioCryst earns royalties from licensing agreements related to its product portfolio, including peramivir. For the nine months ended September 30, 2024, royalty revenues amounted to $0.18 million. This reflects the company's strategy of leveraging intellectual property rights to generate passive income streams.

Royalty Source	Q3 2024 Royalties	Q3 2023 Royalties	9M 2024 Royalties	9M 2023 Royalties
Royalties from Licensing Agreements	$0.02 million	$0.04 million	$0.18 million	$0.10 million

Updated on 16 Nov 2024

Resources:

1. BioCryst Pharmaceuticals, Inc. (BCRX) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of BioCryst Pharmaceuticals, Inc. (BCRX)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View BioCryst Pharmaceuticals, Inc. (BCRX)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.