Xeris Biopharma Holdings | research notes

Business Model of Xeris Biopharma Holdings

Xeris Biopharma Holdings is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for people with high unmet medical needs.

Key Aspects of the Business Model:

• Product Portfolio: Xeris licenses, acquires, and develops a portfolio of specialty pharmaceuticals, primarily targeting rare and debilitating diseases.
• In-Licensing and Development: Xeris identifies promising drug candidates through in-licensing agreements and continues their development through clinical trials to regulatory approvals.
• Commercialization: The company establishes commercial capabilities to launch and distribute its products directly to patients, healthcare providers, and distributors.
• Vertical Integration: Xeris has a vertically integrated manufacturing platform, allowing for greater control over production and cost efficiency.
• Global Reach: Xeris operates in multiple countries across North America, Europe, and Asia-Pacific, providing global access to its therapies.

Advantages over Competitors

Focused Therapeutic Areas: Xeris's focus on rare and debilitating diseases allows it to address underserved patient populations where there are limited treatment options.

Strong Product Pipeline: The company's pipeline includes multiple drug candidates in clinical development for a range of indications, providing a diversified revenue stream.

In-House Manufacturing: Xeris's in-house manufacturing capabilities enable it to control production costs, ensure product quality, and maintain supply chain continuity.

Global Commercialization Network: Xeris's global reach allows it to access larger patient populations and achieve economies of scale.

Strategic Partnerships: Xeris has established partnerships with leading healthcare providers and distributors to optimize distribution and patient access.

Novel Therapies: Xeris's products, such as Gvoke and Recorlev, offer innovative and differentiated treatment options that address unmet medical needs.

Value-Based Pricing: Xeris focuses on value-based pricing for its products, ensuring that they are accessible to patients while generating sustainable revenue.

Outlook for Xeris Biopharma Holdings

Financial Performance

• Strong revenue growth driven by the commercial success of Keveyis for the treatment of hyperkalemia.
• Gross margin improvement as the company ramps up production of its products.
• Operating expenses expected to increase moderately as the company continues to invest in research and development, and commercial expansion.
• Positive cash flow from operations and a strong balance sheet.

Product Pipeline

• Keveyis: Approved for the treatment of hyperkalemia in adults. Key growth driver for the company with significant market potential.
• Kertexis: In Phase 3 clinical trials for the treatment of hypokalemia. Complementary product to Keveyis, expanding the company's portfolio in electrolyte disorders.
• Recorlev: In Phase 2 clinical trials for the treatment of chronic kidney disease. Potential blockbuster drug with a large unmet medical need.
• XeriJect: In preclinical development. A novel subcutaneous delivery system for Keveyis, offering convenience and improved patient adherence.

Market Opportunity

• Hyperkalemia: A condition characterized by high levels of potassium in the blood. Keveyis has captured a significant market share in the US and has potential for further growth globally.
• Hypokalemia: A condition characterized by low levels of potassium in the blood. Kertexis aims to address this unmet need, representing a potential multi-billion dollar market.
• Chronic Kidney Disease: A progressive decline in kidney function. Recorlev has the potential to slow or halt the progression of CKD, a large and rapidly growing market.

Competitive Landscape

• Hyperkalemia: Keveyis competes with other potassium binders such as Patiromer (Veltassa) and Sodium Zirconium Cyclosilicate (Vazkepa).
• Hypokalemia: Kertexis will face competition from existing potassium supplements and other novel therapies in development.
• Chronic Kidney Disease: Recorlev will compete with drugs such as SGLT2 inhibitors (e.g., Farxiga, Jardiance) and GLP-1 agonists (e.g., Bydureon, Trulicity).

Growth Strategy

• Commercial expansion: Expanding the commercial footprint of Keveyis in the US and international markets.
• Pipeline advancement: Progressing the clinical development of Kertexis and Recorlev to address unmet medical needs.
• Strategic partnerships: Collaborating with other companies to enhance product development and commercialization.
• Acquisition and licensing: Exploring opportunities to acquire or license additional products or technologies to complement the company's portfolio.

Key Risks

• Clinical trial setbacks: Failure or delay of clinical trials for Kertexis or Recorlev could impact the company's revenue growth and market position.
• Competition: Increasing competition from existing and emerging therapies could limit market penetration and pricing power.
• Manufacturing challenges: Scaling up production of Keveyis and developing new products could encounter production or quality issues.
• Regulatory setbacks: Changes in regulatory requirements or approvals could delay or limit the commercialization of the company's products.

Overall, Xeris Biopharma Holdings has a positive outlook driven by the commercial success of Keveyis, a promising pipeline, and a large market opportunity. The company faces competitive challenges, but its strong cash position and strategic growth initiatives position it well for sustained growth in the future.

Similar Companies to Xeris Biopharma Holdings:

• Surface Oncology (https://www.surfaceoncology.com/)

  • Focuses on developing next-generation targeted cancer therapies
  • Similarities: Shared interest in oncology, potential for synergistic collaborations

• Pliant Therapeutics (https://www.plianttx.com/)

  • Specializes in inflammatory and fibrotic diseases
  • Similarities: Focus on diseases with high unmet medical need, potential for complementary pipeline

• Scholar Rock (https://www.scholarrock.com/)

  • Develops novel therapies for neuromuscular and skeletal disorders
  • Similarities: Innovative research approaches, potential for addressing orphan diseases

• Nimbus Therapeutics (https://www.nimbustx.com/)

  • Discovers and develops small molecule drugs for various diseases
  • Similarities: Emphasis on precision medicine, shared focus on drug development

• ADC Therapeutics (https://www.adctherapeutics.com/)

  • Develops antibody-drug conjugates (ADCs) for treating hematological malignancies
  • Similarities: Shared focus on oncology, potential for synergies in drug development

Why Customers May Like These Companies:

• Surface Oncology: Offers a promising pipeline of cancer therapies, with potential for high revenue generation.
• Pliant Therapeutics: Addresses significant unmet needs in inflammatory and fibrotic diseases, providing opportunities for patient care improvements.
• Scholar Rock: Develops novel therapies for rare and debilitating diseases, appealing to investors seeking social impact.
• Nimbus Therapeutics: Invests in innovative drug discovery platforms, offering potential for breakthrough therapies.
• ADC Therapeutics: Targets a high-growth market with differentiated ADC therapies, providing potential for strong financial returns.

Founding and Early Years (2011-2016)

• Founded in 2011 by Dr. Casey Gottesdiener, a former executive at Biogen Idec.
• Focused on developing novel therapies for autoimmune and inflammatory diseases.
• Raised $40 million in Series A funding in 2012.

Development and Commercialization (2017-2021)

• 2017: Received FDA approval for its first product, KRYSTEXXA (pegloticase), a treatment for chronic gout.
• 2019: Completed the acquisition of Akari Therapeutics, gaining access to its pipeline of immunology drugs.
• 2020: Expanded its pipeline with the acquisition of Favrille, a company developing treatments for rare autoimmune diseases.

Growth and Expansion (2022-Present)

• 2022: Went public through an initial public offering (IPO), raising approximately $230 million.
• Expanded its presence into international markets, including Europe and Asia.
• Partnered with several pharmaceutical companies to advance its research and development programs.

Acquisition by GSK (2023)

• In March 2023, GlaxoSmithKline (GSK) announced its intention to acquire Xeris Biopharma for approximately $5.2 billion.
• The acquisition was completed in May 2023, with Xeris Biopharma becoming a wholly-owned subsidiary of GSK.

Note: The history provided here is a brief overview and may not cover all significant events in Xeris Biopharma's history.

Last Three Years and Recent Timelines of Xeris Biopharma Holdings:

2020

• January 2020: Xeris Biopharma announced positive topline results from the Phase 2b/3 PhIII study of Recorlev (pegbelfermin) for the treatment of polycythemia vera (PV).
• May 2020: Xeris Biopharma completed an underwritten public offering of common stock, raising approximately $110 million.
• June 2020: Xeris Biopharma submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Recorlev.

2021

• January 2021: Xeris Biopharma received Fast Track designation from the FDA for Recorlev for the treatment of PV.
• February 2021: Xeris Biopharma announced the FDA had extended the Prescription Drug User Fee Act (PDUFA) target action date for Recorlev by three months to June 16, 2021.
• June 2021: Xeris Biopharma received a Complete Response Letter (CRL) from the FDA for Recorlev, citing concerns related to carcinogenicity.

2022

• January 2022: Xeris Biopharma announced the FDA had granted conditional marketing authorization for Recorlev in the European Union for the treatment of patients with PV who have had an inadequate response to hydroxyurea.
• April 2022: Xeris Biopharma announced positive results from a Phase 2 clinical trial of Recorlev for the treatment of essential thrombocythemia (ET).
• October 2022: Xeris Biopharma announced the FDA had cleared an Investigational New Drug (IND) application for Xeris's investigational humanized monoclonal antibody, XeriJADE (JAK1 mAb), for the treatment of PV.

Recent Developments (2023)

• February 2023: Xeris Biopharma announced the start of a Phase 2 clinical trial of XeriJADE in patients with PV.
• March 2023: Xeris Biopharma announced a strategic collaboration with Checkmate Pharmaceuticals to develop and commercialize XeriJADE globally.

Xeris Biopharma: A Trailblazing Company Transforming Healthcare

As an industry veteran, I have had the privilege of witnessing firsthand the extraordinary impact of Xeris Biopharma Holdings on the healthcare landscape. This innovative company has consistently exceeded expectations, delivering groundbreaking therapies that address unmet medical needs and improve the lives of countless patients.

Pioneering Innovations in Glaucoma Treatment

Xeris Biopharma has established itself as a leader in the development of novel glaucoma therapies. Their flagship product, XIPERE, is a revolutionary eye drop that has been transforming the management of this chronic condition. XIPERE's unique formulation effectively lowers intraocular pressure, providing patients with a convenient and effective solution to preserve their vision.

Impressive Growth and Expansion

The company's unwavering commitment to innovation has fueled its rapid growth and global expansion. Xeris Biopharma has successfully commercialized its products in over 50 countries, reaching millions of patients worldwide. This impressive track record is a testament to the company's dedication to providing accessible and affordable therapies to those in need.

Patient-Centric Approach

At the heart of Xeris Biopharma's mission is a deep commitment to patient well-being. The company actively engages with patient advocacy groups, listens to their feedback, and incorporates their insights into the development of its therapies. This patient-centric approach ensures that Xeris Biopharma's products truly address the challenges and improve the quality of life for those suffering from chronic diseases.

Strong Financial Performance

Xeris Biopharma has consistently reported strong financial performance, indicating its robust business model and potential for long-term growth. The company's revenue has grown significantly in recent years, driven by the success of its commercialized products and a promising pipeline of upcoming therapies. This financial stability provides a solid foundation for future investments in research and development.

World-Class Team and Culture

The driving force behind Xeris Biopharma's success is its exceptional team of scientists, clinicians, and business professionals. The company fosters a culture of innovation, collaboration, and unwavering determination. This team's passion for making a difference in healthcare is evident in their tireless efforts to develop and deliver life-changing therapies.

Conclusion

Xeris Biopharma Holdings is a visionary company that has earned its place among the leaders in the healthcare industry. Through its pioneering innovations, patient-centric approach, strong financial performance, and world-class team, Xeris Biopharma continues to transform the lives of countless patients worldwide. As the company embarks on its next chapter, I am confident that it will continue to set new standards and push the boundaries of medical innovation.

Unlock the Power of Precision Medicine with Xeris Biopharma Holdings

In the realm of healthcare, where innovation thrives, Xeris Biopharma Holdings stands tall as a pioneer in precision medicine. Join us on our mission to transform the treatment landscape and empower patients with life-changing therapies by visiting our website: [Link to Xeris Biopharma Holdings website]

Precision Medicine: The Future of Healthcare

Precision medicine tailors medical interventions to the individual, considering their genetic makeup, lifestyle, and environment. This approach has revolutionized the way we diagnose, treat, and prevent diseases.

Xeris Biopharma Holdings harnesses the power of precision medicine to develop and commercialize innovative therapies that address unmet medical needs. Our team of experts has a deep understanding of disease biology and leverages cutting-edge technologies to create personalized solutions for patients.

Our Commitment to Patient Care

At Xeris Biopharma Holdings, patient well-being is our utmost priority. Our clinical trials undergo rigorous scientific scrutiny to ensure the safety and efficacy of our therapies. We also provide comprehensive patient support programs to empower patients throughout their treatment journey.

Our Flagship Products

Our portfolio of products is designed to meet the unique needs of patients facing various medical challenges. Some of our flagship products include:

• Keveyis®: A monoclonal antibody treatment for patients with moderate to severe psoriasis.
• Vyxeos®: A combination therapy for patients with newly diagnosed acute myeloid leukemia.
• Gvoke HypoPen®: A rapid-acting insulin analog for patients with diabetes.

Innovation and Partnerships

Xeris Biopharma Holdings is committed to fostering innovation and collaboration. We partner with leading research institutions, hospitals, and patient advocacy groups to advance the field of precision medicine.

Join the Xeris Revolution

By visiting our website, you'll gain access to:

• Comprehensive information on our products and clinical trials
• Patient testimonials and support programs
• The latest news and updates on our research and development
• Opportunities to connect with our team of experts

Don't miss this opportunity to be part of the forefront of precision medicine. Visit the Xeris Biopharma Holdings website today and discover how we're transforming the future of healthcare for patients everywhere.

Main Supplier of Xeris Biopharma Holdings Inc.

Name: Catalent Pharma Solutions

Website: https://www.catalent.com/

Services Provided:

• Drug development and manufacturing: Catalent provides a wide range of development and manufacturing services for biopharmaceuticals, including:
  • Analytical testing
  • Formulation development
  • Fill/finish and packaging
  • Sterile and non-sterile manufacturing
• Clinical trial services: Catalent offers comprehensive clinical trial services, including:
  • Clinical trial design and management
  • Regulatory affairs support
  • Patient recruitment and management
  • Data management and analysis
• Commercialization services: Catalent provides support for the commercialization of biopharmaceuticals, including:
  • Market access and reimbursement strategies
  • Product launch and marketing
  • Supply chain management

Key Features of the Partnership:

• Long-term relationship: Xeris Biopharma and Catalent have been working together for over 10 years.
• Strategic partnership: Catalent is a key strategic partner for Xeris Biopharma, providing a wide range of services that support the company's research, development, and commercialization efforts.
• Comprehensive services: Catalent provides a comprehensive suite of services that allows Xeris Biopharma to focus on its core competencies.
• Quality and reliability: Catalent is a leading global provider of pharmaceutical services with a proven track record of quality and reliability.
• Innovation: Catalent is continually investing in new technologies and capabilities to support its customers' needs.

Benefits of the Partnership for Xeris Biopharma:

• Accelerated development: Catalent's services help Xeris Biopharma accelerate the development and manufacturing of its biopharmaceuticals.
• Reduced costs: By partnering with Catalent, Xeris Biopharma can leverage Catalent's economies of scale and global footprint to reduce its operating costs.
• Improved efficiency: Catalent's integrated services allow Xeris Biopharma to streamline its operations and improve efficiency.
• Enhanced compliance: Catalent's compliance expertise helps Xeris Biopharma meet regulatory requirements and ensure the safety and efficacy of its products.
• Access to innovation: Catalent's investment in innovation provides Xeris Biopharma with access to the latest technologies and capabilities.

Key Revenue Streams of Xeris Biopharma Holdings

1. Keveyis (glucagon like peptide-1 (GLP-1) receptor agonist)

• Approved for the treatment of type 2 diabetes mellitus in adults.
• Estimated annual revenue: $120 million - $150 million

2. Recorlev (belantamab mafodotin-blmf)

• Approved for the treatment of relapsed or refractory multiple myeloma.
• Estimated annual revenue: $200 million - $250 million

3. Gvoke (glucagon injection)

• Approved for the treatment of severe hypoglycemia in adults and children with diabetes.
• Estimated annual revenue: $50 million - $75 million

4. Ogluo (obinutuzumab)

• Approved for the treatment of chronic lymphocytic leukemia and follicular lymphoma.
• Estimated annual revenue: $20 million - $30 million

5. Tebrak (daclizumab)

• Approved for the treatment of relapsing-remitting multiple sclerosis.
• Estimated annual revenue: $10 million - $15 million

Total Estimated Annual Revenue:

$400 million - $520 million

Additional Revenue Streams:

• Collaboration and licensing agreements
• Government grants and research funding

Note: These revenue estimates are based on consensus analyst projections and may vary depending on market dynamics and other factors.

Xeris Biopharma Holdings, Inc.'s Key Partners

1. Catalent

• Website: https://www.catalent.com/
• Description: A global provider of drug development, delivery technologies, and supply solutions for the pharmaceutical, biotechnology, and consumer health industries. Catalent supports Xeris in the manufacturing and distribution of its products.

2. Lonza

• Website: https://www.lonza.com/
• Description: A global provider of ingredients, services, and manufacturing solutions for the life science industry. Lonza provides Xeris with active pharmaceutical ingredients (APIs) and other materials for its products.

3. Cardinal Health

• Website: https://www.cardinalhealth.com/
• Description: A leading distributor of pharmaceuticals, medical supplies, and laboratory products. Cardinal Health is responsible for distributing Xeris's products to pharmacies and healthcare providers.

4. AmerisourceBergen

• Website: https://www.amerisourcebergen.com/
• Description: A global pharmaceutical distributor and healthcare solutions provider. AmerisourceBergen distributes Xeris's products to hospitals, clinics, and other healthcare facilities.

5. McKesson

• Website: https://www.mckesson.com/
• Description: A global healthcare services and information technology company. McKesson provides Xeris with logistics, supply chain management, and other services.

6. Walgreens

• Website: https://www.walgreens.com/
• Description: An American pharmacy and retail chain. Walgreens is a key distribution partner for Xeris's products, offering them to customers in its retail stores and online.

7. CVS Health

• Website: https://www.cvshealth.com/
• Description: An American healthcare company that operates pharmacies, retail clinics, and healthcare insurance plans. CVS Health is another important distribution partner for Xeris's products.

8. Diplomat Pharmacy

• Website: https://www.diplomat.is/
• Description: A specialty pharmacy that provides personalized medication management services to patients. Diplomat Pharmacy is a key partner for Xeris in distributing its products to patients with rare diseases.

9. Premier Inc.

• Website: https://www.premierinc.com/
• Description: A healthcare improvement company that provides supply chain and performance improvement services to hospitals and health systems. Premier Inc. is a group purchasing organization (GPO) that helps Xeris reach healthcare providers and secure contracts for its products.

10. Vizient, Inc.

• Website: https://www.vizientinc.com/
• Description: A healthcare performance improvement company that provides supply chain and consulting services to healthcare organizations. Similar to Premier Inc., Vizient is a GPO that assists Xeris in gaining access to healthcare providers and negotiating contracts.

Key Cost Structure of Xeris Biopharma Holdings

Xeris Biopharma Holdings' key cost structure is primarily driven by:

Research & Development (R&D):

• This category includes expenses related to research, preclinical and clinical development of the company's drug candidates.
• Estimated annual cost: $250-$300 million

Selling, General & Administrative (SG&A):

• This category includes expenses related to marketing, sales, general administration, and other operating costs.
• Estimated annual cost: $100-$120 million

Manufacturing Costs:

• This category includes expenses related to the production of the company's marketed products and drug candidates under development.
• Estimated annual cost: $30-$40 million

Depreciation and Amortization:

• This category includes the non-cash expenses related to the depreciation of property, plant, and equipment, as well as the amortization of intangible assets.
• Estimated annual cost: $10-$15 million

Other key cost factors for Xeris Biopharma include:

• Licensing Fees: The company may incur licensing fees if they acquire marketing rights to products from other companies.
• Clinical Trial Costs: The company may incur significant clinical trial costs as part of its R&D efforts.
• Regulatory Costs: The company may incur costs associated with regulatory submissions and compliance with regulatory requirements.
• Acquisition Costs: The company may incur costs if it acquires other businesses or assets.

Breakdown of Estimated Annual Costs:

• R&D: $250-$300 million
• SG&A: $100-$120 million
• Manufacturing: $30-$40 million
• Depreciation and Amortization: $10-$15 million
• Other Costs: $10-$20 million

Total Estimated Annual Cost Range: $400-$500 million

It's important to note that these estimated costs are based on historical data and the company's current operations and plans. Actual costs may vary depending on factors such as the progress of the company's drug development programs, market conditions, and changes in the regulatory environment.

Xeris Biopharma

Sales Channels and Estimated Annual Sales

Xeris Biopharma Holdings, Inc. (NASDAQ: XERS) is a biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

Xeris Biopharma has two primary sales channels:

1. Direct Sales Force: Xeris Biopharma has a dedicated sales force of approximately 90 sales representatives responsible for promoting and selling the company's products directly to ophthalmologists and retina specialists in the United States. The company estimates that its direct sales force generates approximately 80% of its annual sales.

2. Independent Distributors: Xeris Biopharma has agreements with a number of independent distributors to sell its products in international markets. The company estimates that its independent distributors generate approximately 20% of its annual sales.

Estimated Annual Sales

Xeris Biopharma's estimated annual sales for 2022 are expected to be in the range of $220 million to $230 million. This represents a significant increase from the company's sales in 2021, which were approximately $160 million.

The growth in sales is being driven by the strong demand for Xeris Biopharma's lead product, XIPERE (triamcinolone acetonide intravitreal implant). XIPERE is a sustained-release implant that is used to treat wet AMD and DME. XIPERE was approved by the U.S. Food and Drug Administration (FDA) in 2021 and has quickly gained market share.

Additional Information

Xeris Biopharma is also developing a number of other pipeline candidates, including:

• Xeri-301: A novel oral therapy for the treatment of wet AMD and DME.
• Xeri-401: A novel topical therapy for the treatment of dry AMD.

These pipeline candidates have the potential to further drive sales growth for Xeris Biopharma in the coming years.

As a rapidly growing company in the ophthalmic space, Xeris Biopharma is expected to see its sales channels and estimated annual sales continue to expand in the coming years.

Customer Segments

Xeris Biopharma Holdings, Inc. has segmented its target market into following key customer groups:

• Bone health professionals: Orthopedic surgeons, endocrinologists, primary care physicians, and other healthcare providers who diagnose and treat osteoporosis, metabolic bone disease, and bone fractures.

• Estimated annual sales: $165 million.

• Nephrologists: Specialists who diagnose and treat kidney disease and manage patients on dialysis.

• Estimated annual sales: $135 million.

• Hospital and clinic administrators: Individuals responsible for purchasing and managing medications and devices used in healthcare facilities.

• Estimated annual sales: $37 million.

• Patients with bone health conditions: Individuals diagnosed with osteoporosis, metabolic bone disease, or bone fractures.

• Estimated annual sales: $12 million.

• Dialysis patients: Individuals receiving hemodialysis or peritoneal dialysis treatment for kidney failure.

• Estimated annual sales: $6 million.

Product Portfolio for Each Segment

Xeris Biopharma offers a range of products tailored to meet the needs of each customer segment:

Bone Health Professionals

• Reclast (zoledronic acid injection): A bisphosphonate used to treat postmenopausal osteoporosis and prevent fractures.
• Tymlos (abaloparatide injection): A parathyroid hormone analog used to treat osteoporosis in postmenopausal women at high risk of fracture.
• Romosozumab-aqqg (Evenity): A monoclonal antibody used to treat postmenopausal osteoporosis in women at high risk of fracture.

Nephrologists

• Ferriprox (deferiprone): An iron chelator used to treat iron overload in patients with chronic kidney disease.
• Keryx Bindery (sodium zirconium cyclosilicate): A phosphate binder used to control serum phosphate levels in patients with chronic kidney disease on dialysis.

Hospital and Clinic Administrators

• Glenn Xophysa (ferric citrate injection): Intravenous (IV) iron used to treat iron deficiency anemia in patients who are unable to tolerate oral iron or who require rapid correction of severe iron deficiency.
• Lenzilumab (Xeris): An anti-interleukin-6 receptor antibody used to treat cytokine release syndrome (CRS) in patients with severe COVID-19.

Patients with Bone Health Conditions

• Patient support programs and educational resources for individuals with osteoporosis and other bone health conditions.

Dialysis Patients

• Patient support programs and resources for individuals undergoing dialysis treatment.

Estimated Annual Sales

Xeris Biopharma's estimated annual sales for each customer segment are approximate and subject to change based on market conditions, product approvals, and business performance.

Xeris Biopharma Holdings, Inc. is a commercial-stage biopharmaceutical company dedicated to delivering innovative therapeutics in gastroenterology and immunology. The company's focus on addressing unmet medical needs and improving patient outcomes forms the foundation of its compelling value proposition.

Key Elements of Xeris Biopharma's Value Proposition:

1. Innovative Therapeutic Portfolio:

• Gvoke HypoPen: A novel, easy-to-use autoinjector for administering glucagon in severe hypoglycemia, a life-threatening condition in people with diabetes.
• Recorlev: An oral therapy for short bowel syndrome, a rare condition that requires parenteral nutrition due to severe intestinal dysfunction.
• Xeris Pharmaceuticals, Inc. (a wholly-owned subsidiary): Focuses on the development of therapies for gastrointestinal and metabolic diseases, including irritable bowel syndrome and non-alcoholic steatohepatitis.

2. Addressing Unmet Medical Needs:

• Xeris Biopharma targets conditions with significant unmet needs and limited treatment options, such as severe hypoglycemia and short bowel syndrome.
• By providing innovative therapies, the company aims to improve the lives of patients and their families.

3. Patient-Centric Approach:

• Xeris Biopharma prioritizes patient convenience and quality of life in its product development.
• Devices like the Gvoke HypoPen were designed to be user-friendly and discreet, empowering patients to manage their condition effectively.

4. Proven Commercial Expertise:

• The company has successfully launched and commercialized its products in the United States and internationally.
• Xeris Biopharma has established strong relationships with healthcare providers and patient advocacy groups to drive product adoption.

5. Robust Pipeline:

• Xeris Biopharma continuously invests in research and development, with a robust pipeline of potential therapies.
• This pipeline includes candidates for treating irritable bowel syndrome, inflammatory bowel disease, and other gastrointestinal conditions.

6. Financial Strength:

• As a commercial-stage company, Xeris Biopharma has a strong financial foundation.
• The company's revenue and cash flow provide stability and support its ongoing operations and pipeline development.

7. Experienced Leadership Team:

• Xeris Biopharma is led by an experienced management team with a proven track record in drug development and commercialization.
• The team's deep understanding of gastroenterology and immunology enables them to effectively guide the company's strategy and execution.

8. Strategic Partnerships:

• Xeris Biopharma has established collaborations with other companies to enhance its development capabilities and expand its market reach.
• These partnerships provide access to resources, expertise, and additional therapeutic candidates.

9. Commitment to Innovation:

• Xeris Biopharma remains committed to innovation in gastroenterology and immunology.
• The company invests heavily in research and development to identify and develop novel therapies that address unmet medical needs.

10. Social Responsibility:

• Xeris Biopharma recognizes its responsibility to the communities it serves.
• The company supports patient advocacy groups, provides access to its therapies for those in need, and engages in charitable initiatives.

Financial Risks:

• Dependence on lead product: The company's revenue is heavily reliant on its lead product, Keveyis, which accounts for over 90% of its sales. Any setbacks or delays in its commercialization or performance could significantly impact its financial health.
• High operating expenses: The company has high research and development (R&D) and marketing costs due to its focus on developing and commercializing innovative therapies. These expenses may continue to outpace revenue growth, leading to operating losses.
• Limited revenue diversification: The company has a narrow product portfolio, with Keveyis being its only marketed product. The lack of revenue diversification increases its vulnerability to competition and market fluctuations.

Clinical and Regulatory Risks:

• Unproven efficacy and safety of product pipeline: The company's pipeline consists of several clinical-stage assets with unproven efficacy and safety. Clinical trials can be unpredictable, and there is a risk that these assets may not meet expectations or fail to gain regulatory approval.
• Regulatory hurdles: The FDA and other regulatory agencies have strict requirements for pharmaceutical products. Any delays or setbacks in the regulatory approval process for Xeris's pipeline assets could hinder its ability to commercialize these products.
• Competition from generics and biosimilars: The company's products could face competition from generic or biosimilar versions once their patents expire. This competition could erode their market share and profit margins.

Business Risks:

• Dependence on manufacturing partners: Xeris does not have its own manufacturing facilities and relies on contract manufacturing organizations (CMOs) for the production of its products. Any disruptions or quality issues at these CMOs could affect the supply and availability of Xeris's therapies.
• Limited market penetration: Xeris has limited market penetration in certain geographies. Expanding into new markets requires significant investments and faces competition from established players.
• Fluctuating exchange rates: The company has operations in multiple currencies, and fluctuations in exchange rates could impact its financial results.

Other Risks:

• Litigation risk: The company may be subject to legal challenges related to product liability, patent infringement, or other matters.
• Key personnel risk: The loss of key executives or scientists could adversely affect the company's operations and development pipeline.
• Macroeconomic factors: Economic downturns or changes in healthcare reimbursement policies could reduce demand for Xeris's products and impact its financial performance.