Xeris Biopharma Holdings, Inc. (XERS): Business Model Canvas [11-2024 Updated]

In the rapidly evolving biopharmaceutical landscape, Xeris Biopharma Holdings, Inc. (XERS) stands out with its innovative approach to addressing critical medical needs. By leveraging its proprietary technologies, XeriSol and XeriJect, Xeris is reshaping the experience of patients and healthcare providers alike. This blog post delves into the company's Business Model Canvas, exploring its key partnerships, activities, resources, and revenue streams that drive its mission to deliver ready-to-use injectable formulations in endocrinology and neurology. Read on to discover how Xeris is positioning itself for success in the market.

Xeris Biopharma Holdings, Inc. (XERS) - Business Model: Key Partnerships

Collaborations with major pharmaceutical companies

Xeris Biopharma has established significant collaborations with major pharmaceutical companies to enhance its product development and market reach. For instance, the collaboration with Taro Pharmaceuticals North America, Inc. focuses on the production of Keveyis, with an amended agreement extending the initial term until March 2027. This partnership includes commitments to annual minimum marketing spend requirements and minimum purchase order quantities, which are based on previous year's purchases.

Partnerships for formulation development using XeriSol and XeriJect

Xeris Biopharma leverages its proprietary formulation technologies, XeriSol and XeriJect, through various partnerships aimed at optimizing drug delivery systems. The company has developed its formulations for products like Gvoke and Recorlev, which are designed to offer improved patient outcomes. This strategy helps Xeris to differentiate its product offerings in the highly competitive pharmaceutical market.

Licensing agreements post successful formulation development

Following successful formulation developments, Xeris has engaged in licensing agreements that allow other pharmaceutical companies to utilize its proprietary technologies. For example, the company has recognized royalty, contract, and other revenues amounting to $3.3 million in the nine months ended September 30, 2024, with significant contributions from collaborative partnerships.

Partnership Type	Partner	Agreement Details	Impact on Revenue
Collaboration	Taro Pharmaceuticals	Supply agreement for Keveyis; extended until March 2027	Minimum purchase order quantities based on previous year’s purchases
Formulation Development	Various Pharmaceutical Companies	Utilization of XeriSol and XeriJect technologies	Enhanced product differentiation and market reach
Licensing Agreements	Multiple partners	Post-development licensing of proprietary technologies	Royalty revenue of $3.3 million in 2024

Xeris Biopharma Holdings, Inc. (XERS) - Business Model: Key Activities

Research and development of new product candidates

Xeris Biopharma is actively engaged in the research and development of innovative product candidates. The company reported research and development expenses of $19.5 million for the nine months ended September 30, 2024, compared to $16.0 million for the same period in 2023. This increase reflects the company's commitment to advancing its pipeline, which includes candidates such as XP-8121, a subcutaneous formulation of levothyroxine, and other formulations targeting endocrine-related diseases.

Clinical trials for product candidates

The company is conducting various clinical trials to validate the efficacy and safety of its product candidates. As of September 30, 2024, Xeris has initiated a Phase 2 study for XP-8121, focusing on a target dose conversion factor from oral levothyroxine. The Phase 1 data for XP-8121 indicated favorable pharmacokinetic profiles, and preparations for a Phase 3 pivotal study are anticipated by year-end 2024, subject to FDA interaction.

Commercial execution of existing products

Xeris is focused on the commercial execution of its existing products, which include Gvoke, Recorlev, and Keveyis. For the nine months ended September 30, 2024, product revenue netted $139.6 million, up from $110.9 million during the same period in 2023. The company continues to face challenges in commercialization but is implementing marketing strategies to enhance product visibility and sales. Additionally, Xeris reported a net loss of $49.7 million for the nine months ended September 30, 2024, reflecting ongoing investments in marketing and product development.

Activity	Details	Financial Impact (2024)
Research and Development	Focus on XP-8121 and other product candidates	$19.5 million in expenses
Clinical Trials	Ongoing Phase 2 studies for XP-8121	Investment in clinical studies
Commercial Execution	Sales of Gvoke, Recorlev, and Keveyis	$139.6 million in product revenue

Xeris Biopharma Holdings, Inc. (XERS) - Business Model: Key Resources

Proprietary formulation technologies (XeriSol and XeriJect)

Xeris Biopharma's proprietary formulation technologies, XeriSol and XeriJect, are integral to its business model. These technologies facilitate the development of stable, ready-to-use injectable formulations for complex biologics, which are pivotal for the company's product offerings. As of September 30, 2024, the company holds 179 patents globally, including those related to these technologies, which expire as late as 2036.

Experienced leadership and development team

Xeris is led by a team with extensive experience in pharmaceutical development and commercialization. The leadership includes professionals with significant backgrounds in drug development and commercialization across various therapeutic areas. This expertise is critical to navigating the complexities of regulatory approvals and market launch strategies. For example, in 2024, the company reported a net loss of $49.7 million, reflecting ongoing investments in leadership and R&D.

Established commercial products: Gvoke, Recorlev, Keveyis

Xeris has successfully commercialized several products, including Gvoke, Recorlev, and Keveyis. For the three months ended September 30, 2024, the net revenue from Gvoke was $22.8 million, reflecting a 29.4% increase year-over-year, driven by higher prescription growth. Recorlev's revenue surged by 118.9% to $17.7 million during the same period. However, Keveyis saw a decrease in revenue of 23.1% to $12.3 million, attributed to lower volumes.

Product	Net Revenue (3 months ended September 30, 2024)	Year-over-Year Change	Key Factors
Gvoke	$22.8 million	+29.4%	Higher prescription growth
Recorlev	$17.7 million	+118.9%	Higher volume and pricing
Keveyis	$12.3 million	-23.1%	Lower volume

The company's accumulated deficit stood at $666.7 million as of September 30, 2024, indicating substantial ongoing investments in product development and commercialization.

Xeris Biopharma Holdings, Inc. (XERS) - Business Model: Value Propositions

Innovative, ready-to-use injectable formulations

Xeris Biopharma Holdings, Inc. specializes in developing innovative injectable formulations, notably their glucagon product Gvoke. For the three months ended September 30, 2024, Gvoke generated net revenue of $22.8 million, reflecting a 29.4% increase year-over-year, driven by a volume increase of 21.5%. This product is designed for rapid administration, addressing the need for effective treatment of severe hypoglycemia in diabetic patients.

Addressing unmet medical needs in endocrinology and neurology

Xeris focuses on addressing significant unmet medical needs in the fields of endocrinology and neurology. Their product Recorlev, used for the treatment of Cushing’s syndrome, saw an impressive revenue increase of 118.9% for the three months ended September 30, 2024, totaling $17.7 million. This growth is attributed to a higher volume of prescriptions and favorable pricing strategies. Xeris has also developed XP-8121, a subcutaneous formulation of levothyroxine, aiming to improve patient outcomes in hypothyroidism.

Improving patient and caregiver experience with stable formulations

Xeris emphasizes enhancing the patient and caregiver experience through stable formulations that simplify administration. Their products, such as Keveyis for the treatment of hyperkalemia, have been shown to provide a more stable and manageable treatment option. The company's strategy includes investing in research and development, with R&D expenses increasing by 22% year-over-year to $19.5 million for the nine months ended September 30, 2024. This commitment underlines Xeris's focus on innovation to improve treatment protocols and outcomes for patients and caregivers alike.

Value Proposition	Product	Revenue (3Q 2024)	Year-over-Year Growth
Ready-to-use injectable formulations	Gvoke	$22.8 million	29.4%
Addressing unmet medical needs	Recorlev	$17.7 million	118.9%
Stable formulations for better experience	Keveyis	Not specified	Not specified

Xeris Biopharma Holdings, Inc. (XERS) - Business Model: Customer Relationships

Direct engagement with healthcare providers

Xeris Biopharma actively engages healthcare providers to enhance product awareness and utilization. In the third quarter of 2024, the net revenue from their key products was as follows:

Product	Net Revenue (3Q 2024)	Net Revenue (3Q 2023)	Year-over-Year Change (%)
Gvoke	$52.9 million	$41.7 million	26.8%
Recorlev	$17.5 million	$8.0 million	118.8%
Keveyis	$3.9 million	$5.8 million	-32.8%

The increase in Gvoke's revenue was attributed to higher prescription volume and effective outreach to healthcare practitioners, facilitating better patient outcomes and adherence.

Support programs for patients using commercial products

Xeris implements various support programs aimed at improving patient access to its products. This includes copay assistance and educational resources. The company reported the following financial metrics regarding their support programs:

Metric	Value (9M 2024)
Total Patient Support Expenditure	$8.2 million
Copay Assistance Provided	$4.1 million
Patient Education Programs Cost	$3.1 million

These programs are essential in retaining patients and ensuring they remain on therapy, which is reflected in the growth of prescription numbers observed in their revenue reports.

Building trust through education and product efficacy

Education initiatives are pivotal in establishing trust with both healthcare providers and patients. Xeris has invested significantly in educational campaigns, with expenditures amounting to:

Type of Educational Initiative	Expenditure (2024)
Webinars and Workshops	$1.5 million
Printed Educational Materials	$0.8 million
Online Resources and Tools	$1.2 million

Through these initiatives, Xeris aims to demonstrate the efficacy of its products, particularly Gvoke and Recorlev, thereby increasing patient and prescriber confidence.

Xeris Biopharma Holdings, Inc. (XERS) - Business Model: Channels

Direct sales force targeting healthcare professionals

Xeris Biopharma employs a dedicated sales force that focuses on engaging healthcare professionals, particularly in the endocrinology sector. The company aims to establish strong relationships with endocrinologists to promote its products, including Gvoke and Recorlev. The sales force is pivotal in driving product awareness and education, which is crucial for a company with specialized biopharmaceuticals.

Distribution through pharmacies and hospitals

Xeris distributes its products through a network of pharmacies and hospitals. The company partners with wholesalers and specialty pharmacies to ensure that its products are readily available to patients. As of September 30, 2024, Xeris reported product revenue of $52.9 million, reflecting a 27% increase from $41.7 million in the same quarter of the previous year. This growth indicates the effectiveness of its distribution channels in reaching healthcare facilities and patients.

Channel Type	Key Metrics	Comments
Wholesalers	Major distributors include McKesson, Cardinal Health	Focus on efficiency and breadth of distribution to pharmacies
Specialty Pharmacies	Partnerships with specialty pharmacies for targeted distribution	Critical for managing complex medications and patient education
Hospitals	Direct contracts with hospitals	Ensures availability in emergency and inpatient settings

Digital marketing and educational platforms

Xeris leverages digital marketing strategies and educational platforms to reach healthcare professionals and patients. The company invests in online campaigns to increase product visibility and educate potential users about its offerings. In 2024, Xeris allocated approximately $44.9 million to selling, general, and administrative expenses, which includes marketing efforts. This investment reflects the company's commitment to enhancing its online presence and providing resources that support healthcare providers and patients.

Marketing Strategy	Budget Allocation (2024)	Objective
Online Advertising	$15 million	Increase brand awareness and product adoption
Educational Webinars	$5 million	Provide training and updates for healthcare professionals
Social Media Campaigns	$2 million	Engage with patients and healthcare communities

Xeris Biopharma Holdings, Inc. (XERS) - Business Model: Customer Segments

Patients with diabetes requiring glucagon

Xeris Biopharma focuses on patients with diabetes who require glucagon for emergency situations, particularly in cases of severe hypoglycemia. The primary product catering to this segment is Gvoke, a ready-to-use glucagon formulation. In the third quarter of 2024, Gvoke generated a net revenue of approximately $52.9 million, reflecting a year-over-year increase of 29.4% compared to the same period in 2023.

Adults with Cushing's syndrome or periodic paralysis

The company also targets adults suffering from Cushing's syndrome and periodic paralysis with its product, Recorlev. This medication is vital for the management of endogenous Cushing's syndrome. In the same quarter, Recorlev reported a net revenue increase of 118.9%, reaching $9.6 million, driven by higher prescription volume. The total addressable market for Cushing's syndrome is estimated to be around 100,000 patients in the United States, highlighting a significant opportunity for Xeris.

Healthcare providers in endocrinology and neurology

Xeris Biopharma also serves healthcare providers specializing in endocrinology and neurology. This customer segment is crucial for the prescription and administration of their products, particularly Gvoke and Recorlev. The company has established partnerships with various healthcare providers to enhance product accessibility. As of September 2024, Xeris is focused on expanding its reach within this demographic by increasing its marketing efforts and educational initiatives.

Customer Segment	Key Product	Market Size (Estimate)	Q3 2024 Revenue	Year-over-Year Growth
Patients with diabetes	Gvoke	Approx. 1.6 million severe hypoglycemic events annually	$52.9 million	29.4%
Adults with Cushing's syndrome	Recorlev	Approx. 100,000 patients	$9.6 million	118.9%
Healthcare providers	Gvoke, Recorlev	Multiple specialties, significant growth potential	N/A	N/A

Xeris Biopharma Holdings, Inc. (XERS) - Business Model: Cost Structure

Significant R&D expenses for product development

For the nine months ended September 30, 2024, Xeris Biopharma Holdings reported research and development expenses of $19.5 million, an increase of $3.5 million or 22.0% compared to the same period in 2023. The breakdown of R&D expenses for the three and nine months ended September 30, 2024 and 2023 is as follows:

Expense Type	Three Months Ended September 30, 2024 ($)	Three Months Ended September 30, 2023 ($)	Change ($)	Change (%)	Nine Months Ended September 30, 2024 ($)	Nine Months Ended September 30, 2023 ($)	Change ($)	Change (%)
Pipeline	1,539	951	588	61.8	5,610	3,734	1,876	50.2
Technology Development	235	500	(265)	(53.0)	1,074	1,508	(434)	(28.8)
Personnel Related Expenses	3,280	2,829	451	15.9	10,288	8,755	1,533	17.5
Lab Supplies and Equipment	442	481	(39)	(8.1)	1,206	1,094	112	10.2
Other	392	273	119	43.6	1,290	868	422	48.6
Total	5,888	5,034	854	17.0	19,468	15,959	3,509	22.0

Manufacturing and supply chain costs

The cost of goods sold (COGS) for Xeris Biopharma increased significantly, reaching $27.4 million for the nine months ended September 30, 2024, compared to $21.1 million in the same period of 2023. This represents an increase of $6.3 million or 29.8%. The COGS for the three months ended September 30, 2024 was reported at $13.6 million, a 65.7% increase from $8.2 million in the same quarter of the previous year. The COGS as a percentage of total product revenue also increased to 25.7% for the three months ended September 30, 2024, compared to 19.7% in the same period of 2023, primarily due to write-offs related to manufacturing process changes.

Marketing and sales expenses

Selling, general and administrative expenses for the nine months ended September 30, 2024 amounted to $123.3 million, an increase of $14.8 million or 13.7% from $108.5 million in the same period of 2023. For the three months ended September 30, 2024, these expenses totaled $45.0 million, reflecting a rise of $7.7 million or 20.6% compared to the previous year's quarter. Major contributors to this increase included costs associated with the CEO succession plan and restructuring efforts, as well as higher expenses related to the expansion of Recorlev.

Expense Type	Three Months Ended September 30, 2024 ($)	Three Months Ended September 30, 2023 ($)	Change ($)	Change (%)	Nine Months Ended September 30, 2024 ($)	Nine Months Ended September 30, 2023 ($)	Change ($)	Change (%)
Selling, General and Administrative	44,969	37,287	7,682	20.6	123,342	108,527	14,815	13.7

Xeris Biopharma Holdings, Inc. (XERS) - Business Model: Revenue Streams

Product sales from Gvoke, Recorlev, and Keveyis

For the three months ended September 30, 2024, Xeris Biopharma reported the following product revenues:

Product	Revenue (Q3 2024)	Revenue (Q3 2023)	Change (%)
Gvoke	$22,942,000	$17,735,000	29.4%
Recorlev	$17,726,000	$8,097,000	118.9%
Keveyis	$12,193,000	$15,865,000	(23.1%)
Total Product Revenue	$52,861,000	$41,697,000	26.8%

For the nine months ended September 30, 2024, product revenue was:

Product	Revenue (9M 2024)	Revenue (9M 2023)	Change (%)
Gvoke	$59,567,000	$48,406,000	23.1%
Recorlev	$41,663,000	$19,741,000	111.0%
Keveyis	$38,406,000	$42,708,000	(10.1%)
Total Product Revenue	$139,636,000	$110,855,000	26.0%

Royalty and contract revenue from partnerships

For the three months ended September 30, 2024, royalty and contract revenue decreased significantly:

Period	Royalty and Contract Revenue	Change (%)
Q3 2024	$1,407,000	(78.8%)
Q3 2023	$6,623,000	N/A

For the nine months ended September 30, 2024:

Period	Royalty and Contract Revenue	Change (%)
9M 2024	$3,335,000	(61.5%)
9M 2023	$8,669,000	N/A

Potential future licensing fees from developed products

Xeris Biopharma has ongoing discussions regarding potential future licensing agreements for their developed products. The financial impact of these agreements is not yet fully realized. However, the company has expressed intentions to pursue additional partnerships that may yield licensing fees. This is expected to be a critical component of their revenue strategy moving forward.

Updated on 16 Nov 2024

Resources:

1. Xeris Biopharma Holdings, Inc. (XERS) Financial Statements – Access the full quarterly financial statements for Q1 2025 to get an in-depth view of Xeris Biopharma Holdings, Inc. (XERS)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View Xeris Biopharma Holdings, Inc. (XERS)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.