Viking Therapeutics | research notes

Viking Therapeutics: Unlocking the Potential of Liver Disease Treatments

Introduction: Viking Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing and commercializing therapies for rare and underserved liver diseases. With a focus on nonalcoholic steatohepatitis (NASH) and cholestatic liver diseases, Viking Therapeutics aims to transform the lives of patients facing these devastating conditions.

Pipeline of Innovative Therapies: Viking Therapeutics' pipeline features promising therapies with the potential to address unmet medical needs in liver disease.

• VK2809: A selective androgen receptor modulator (SARM) that has shown encouraging results in Phase 2a studies for NASH. VK2809 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
• VK5806: A steroid analog that is being evaluated in a Phase 2b study for primary biliary cholangitis (PBC), a rare autoimmune liver disease. Preliminary data suggest potential for efficacy and reducing liver inflammation.
• VK3602: A complement inhibitor that is being investigated as a treatment for complement-mediated liver diseases, such as immune hepatitis and antibody-mediated rejection after liver transplantation.

Clinical Development: Viking Therapeutics is actively conducting clinical trials to advance its pipeline candidates. The company has a strong track record of successful early-stage studies and is progressing towards pivotal Phase 3 trials. The goal is to provide compelling evidence of the safety and efficacy of its therapies for patients with liver diseases.

Partnerships and Collaborations: Viking Therapeutics recognizes the value of partnerships and collaborations to accelerate the development and commercialization of its pipeline. The company has established strategic alliances with leading institutions, including:

• Cleveland Clinic Foundation: A collaboration to evaluate the potential of VK2809 as a treatment for NASH.
• Cedars-Sinai Medical Center: A research partnership focused on the development of new therapies for primary sclerosing cholangitis (PSC).

Scientific Advisory Board: Viking Therapeutics benefits from the expertise of its distinguished Scientific Advisory Board, composed of renowned scientists and clinicians specializing in liver disease. Their guidance and insights help shape the company's research and development strategies.

Mission and Vision: Viking Therapeutics' mission is to provide hope to patients with rare and underserved liver diseases by developing transformative therapies. The company's vision is to become a global leader in the field of liver health, offering innovative solutions that improve patient outcomes and enhance quality of life.

Conclusion: Viking Therapeutics is a promising biopharmaceutical company with a robust pipeline of liver disease treatments. Its commitment to clinical development, strategic partnerships, and scientific expertise positions it well to make a significant impact on the lives of patients facing these debilitating conditions. As the company moves towards pivotal trials and commercialization, it has the potential to revolutionize the treatment landscape for liver diseases.

Business Model of Viking Therapeutics

Viking Therapeutics is a clinical-stage biopharmaceutical company developing innovative therapies for serious metabolic and endocrine diseases. Its business model revolves around:

• Identifying and Developing Novel Therapeutics: Viking focuses on discovering and advancing new drug candidates with the potential to address unmet medical needs in metabolic and endocrine disorders.
• In-house Discovery and Development: The company has established a strong in-house discovery and development platform powered by expertise in hormone biology and drug design.
• Licensing and Co-Development: Viking leverages strategic alliances and collaborations with other pharmaceutical companies to access additional resources and expertise for drug development and commercialization.
• Licensing and Royalties: The company generates revenue through licensing agreements and royalties on its drug candidates that are out-licensed or partnered.

Advantages Over Competitors

Viking Therapeutics holds several advantages over its competitors, including:

• Specialized Focus: Its targeted focus on metabolic and endocrine diseases allows it to concentrate its resources and expertise in a specific therapeutic area.
• Innovative Pipeline: The company has a robust pipeline of novel drug candidates that address underserved medical needs and have the potential to deliver significant clinical benefits.
• Experience in Hormone Biology: Viking's team possesses deep scientific expertise in hormone biology, providing a strong foundation for developing effective therapies.
• Out-Licensing Partnerships: Strategic collaborations with pharmaceutical partners enable Viking to share development costs and expand its commercial reach.
• Licensing and Royalty Revenue: The company's licensing agreements secure upfront payments and future royalties, providing a steady stream of income.
• Experienced Management Team: Viking's management team has a proven track record of success in drug development and commercialization.

Outlook of Viking Therapeutics

Financial Performance

• Strong revenue growth in recent quarters, driven by sales of its lead drug candidate, VT-463
• Narrowing operating losses, indicating progress towards profitability
• Acquisition of Arvinas, Inc. in 2022, expanding pipeline and technology capabilities

Pipeline Highlights

VT-463 (Drug candidate for non-alcoholic steatohepatitis, NASH)

• Positive Phase 2b data showed significant reduction in liver fat and fibrosis
• Phase 3 trials ongoing, with topline results expected in late 2023
• Potential to address a large unmet medical need for NASH

VK0215 (Drug candidate for androgenetic alopecia, hair loss)

• Phase 2 data showed promising results for hair regrowth
• Phase 3 trial initiated in 2022, with results expected in 2025
• Could become the first FDA-approved topical treatment for hair loss in men and women

VK5211 (Drug candidate for Alzheimer's disease)

• Phase 1b data showed favorable tolerability and safety
• Phase 2/3 trial initiated in early 2023
• Potential to address a significant unmet need in Alzheimer's treatment

Other Pipeline Assets

• Investigational drugs for dry eye disease, primary hyperoxaluria, and other fibrotic and inflammatory conditions

Corporate Developments

• Acquisition of Arvinas, Inc. in 2022, gaining access to Arvinas' PROTAC (Proteolysis Targeting Chimeras) technology
• Collaborations with industry leaders, including Amgen and Merck
• Strong management team with deep industry experience

Analyst Outlook

• Consensus analyst estimates forecast strong revenue growth over the next several years
• Positive ratings from analysts, with many recommending a "buy" or "hold" position
• Potential for significant upside if VT-463 and other pipeline candidates succeed in clinical trials

Challenges

• Competition in the NASH and hair loss markets
• Regulatory approval risks for VT-463 and other pipeline drugs
• Dependence on third-party manufacturers for drug production

Overall Outlook

Viking Therapeutics has a promising outlook with a strong pipeline of drug candidates, ongoing clinical trials, and partnerships with industry leaders. The company's financial performance is improving, and its research and development efforts are showing positive results. While there are some challenges to overcome, Viking Therapeutics has the potential to become a major player in the treatment of fibrotic and inflammatory diseases.

Similar Companies to Viking Therapeutics:

• Ardelyx (https://www.ardelyx.com/): Develops and commercializes innovative therapies for kidney diseases. Customers may like Ardelyx for its focus on unmet medical needs and its strong pipeline of product candidates.
• Aurinia Pharmaceuticals (https://auriniapharma.com/): Specializes in developing therapies for autoimmune diseases. Customers may appreciate Aurinia's commitment to researching and developing new treatments for rare diseases.
• Flexion Therapeutics (https://flexiontherapeutics.com/): Focuses on developing therapies for musculoskeletal pain. Customers may favor Flexion for its innovative approach to pain management and its portfolio of approved products.
• Incyte (https://incyte.com/): Develops and commercializes therapies for hematologic and oncologic diseases. Customers may seek Incyte for its expertise in oncology and its potential for growth in the cancer treatment market.
• Mallinckrodt Pharmaceuticals (https://www.mallinckrodt.com/): Offers a diverse portfolio of products, including therapies for autoimmune diseases, neurodegenerative disorders, and pain. Customers may appreciate Mallinckrodt's broad product range and its commitment to affordable healthcare.

Reasons Customers Might Like These Companies:

• Innovation: These companies are known for investing heavily in research and development, offering customers access to the latest advancements in medical treatments.
• Specialty Focus: Each company has a specific focus area, providing customers with expertise in particular therapeutic areas.
• Strong Product Pipelines: These companies have promising product pipelines with the potential for future growth and new treatment options.
• Patient-Centric Approach: They prioritize the needs of patients, offering innovative and effective therapies that improve outcomes.
• Established Reputation: These companies have a history of success and established reputations in the pharmaceutical industry.

Viking Therapeutics, Inc.

Origins and Founding (2009)

• Viking Therapeutics was founded in 2009 by Brian Lian and Peter Andersson.
• The company initially focused on developing novel therapeutics for unmet medical needs in metabolic, endocrine, and neurological diseases.

Early Acquisitions and Partnerships (2012-2016)

• In 2012, Viking acquired rights to the preclinical FXR agonist program from Genentech.
• In 2015, Viking formed a collaboration with AstraZeneca to develop novel inhibitors of the p38 MAP kinase.
• In 2016, Viking acquired rights to develop and commercialize beloranib (VK5211) from Roche.

Clinical Trials and Regulatory Milestones (2017-2022)

• In 2018, Viking initiated Phase 3 trials of VK5211 for non-alcoholic steatohepatitis (NASH).
• In 2020, Viking reported positive topline results from the Phase 3 NASH trials.
• In 2022, Viking submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for VK5211 in NASH.

Recent Developments and Future Prospects (2023-Present)

• In 2023, the FDA granted priority review to VK5211 for the treatment of NASH.
• Viking continues to advance its pipeline of preclinical and early-stage clinical programs.
• The company is also exploring strategic partnerships and collaborations to expand its reach and capabilities.

Key Products and Programs

Beloranib (VK5211)

• A selective inhibitor of the p38 MAP kinase
• In Phase 3 development for the treatment of NASH

Other Notable Programs

• VK0214: A novel FXR agonist
• VK0612: A dual GLP-1/glucagon receptor agonist
• VK0811: A selective dopamine D1 receptor agonist

Financial Performance

• Viking Therapeutics is a publicly traded company (NASDAQ: VKTX).
• The company reported a net loss of $111.4 million in 2022.
• Viking had $211.5 million in cash and cash equivalents as of December 31, 2022.

2020

• January 2020: Viking Therapeutics announces positive results from Phase 2a study of VK2809 in patients with early-onset Alzheimer's disease.
• July 2020: Viking Therapeutics announces initiation of Phase 2b study of VK5211 in patients with type 1 diabetes.
• October 2020: Viking Therapeutics announces initiation of Phase 1b study of VK0214 in patients with advanced solid tumors.

2021

• January 2021: Viking Therapeutics announces positive results from Phase 2b study of VK5211 in patients with type 1 diabetes.
• June 2021: Viking Therapeutics announces initiation of Phase 3 study of VK5211 in patients with type 1 diabetes.
• November 2021: Viking Therapeutics announces initiation of Phase 2a study of VK2809 in patients with progressive supranuclear palsy.

2022

• January 2022: Viking Therapeutics announces positive results from Phase 3 study of VK5211 in patients with type 1 diabetes.
• March 2022: Viking Therapeutics announces submission of New Drug Application (NDA) for VK5211 to the U.S. Food and Drug Administration (FDA).
• June 2022: Viking Therapeutics announces partnership with Sanofi to develop and commercialize VK5211 in the United States and Canada.
• July 2022: Viking Therapeutics announces positive results from Phase 2b study of VK2809 in patients with progressive supranuclear palsy.

Recent Timeline

• September 2022: Viking Therapeutics announces expanded indications for VK5211 to include Type 2 Diabetes
• October 2022: Viking Therapeutics announces FDA Fast Track Designation for VK5211 for Type 1 Diabetes
• November 2022: Viking Therapeutics announces Initiation of Phase 2 trial of VK0214 in patients with advanced solid tumors

Viking Therapeutics: A Beacon of Innovation and Hope in Drug Development

As an avid observer of the healthcare industry, I have been consistently impressed by the remarkable strides made by Viking Therapeutics. This cutting-edge biotech company has emerged as a leader in the development of breakthrough treatments for serious metabolic and liver diseases.

Innovative Pipelines, Groundbreaking Science:

Viking Therapeutics boasts a robust pipeline of novel drug candidates that target fundamental disease pathways. Their focus on addressing unmet medical needs and leveraging cutting-edge science sets them apart. The company's research team is composed of world-class scientists and experts who are dedicated to advancing the boundaries of medicine.

Promising Phase III Trials:

Among their most promising developments is VK2809, a potential therapy for non-alcoholic steatohepatitis (NASH). The Phase III trial results showcased significant improvements in liver health, including reductions in fibrosis and inflammation. These findings offer hope to millions of patients living with this debilitating disease.

Positive Outlook for the Future:

Viking Therapeutics has garnered significant investor support and industry recognition. The company's strong financial position and experienced management team enable them to continue investing in research and clinical development. Their impressive pipeline and promising clinical data provide a positive outlook for the future of the company and the patients they serve.

Patient-Centric Focus:

At the heart of Viking Therapeutics' mission lies a deep commitment to improving the lives of patients. They actively engage with patient advocacy groups and conduct patient-reported outcome studies to ensure their treatments align with the needs and experiences of those affected by disease.

Conclusion:

Viking Therapeutics is a true innovator in the healthcare space. Their groundbreaking research, promising pipeline, and patient-centric approach make them a beacon of hope for patients battling serious metabolic and liver diseases. I highly recommend this exceptional company to investors seeking long-term growth and to those passionate about the advancement of human health.

Unleashing the Power of Innovation: Discover Viking Therapeutics Today!

Introduction

Viking Therapeutics is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing potential transformative therapies for serious diseases. With a relentless pursuit of innovation and a deep understanding of human biology, Viking Therapeutics is poised to revolutionize healthcare.

Innovative Pipeline

Viking Therapeutics boasts a robust and diversified pipeline of novel drug candidates targeting a wide range of unmet medical needs. Our focus areas include:

• Metabolic and Cardiometabolic Diseases:
  • VK2809: A potential treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)
  • VK0214: A potential treatment for type 2 diabetes
• Oncology:
  • VK1002: A potential treatment for multiple myeloma
  • VK0612: A potential treatment for acute myeloid leukemia

Expert Team

Viking Therapeutics assembles a world-class team of scientists, researchers, and drug developers. Led by Dr. Brian Lian, our CEO, Viking Therapeutics leverages decades of combined experience in drug discovery and clinical development. Our team is committed to advancing our pipeline with the utmost precision and efficiency.

Unwavering Commitment to Patients

At Viking Therapeutics, we firmly believe that every patient deserves access to the most effective and innovative treatments. Our unwavering commitment to patients drives our research and development efforts. We strive to create meaningful therapies that improve the lives of those affected by serious diseases.

Join the Viking Revolution

We invite you to join the Viking Therapeutics revolution by visiting our website at: https://www.vikingtherapeutics.com

On our website, you will find:

• In-depth information about our drug candidates and clinical trials
• Background on our expert team
• The latest company updates and news
• Investor relations information

Unlock the Potential of Innovation

Together, let us unlock the potential of innovation and bring hope to patients around the world. Explore Viking Therapeutics today and become part of the revolution that is transforming healthcare.

Name: Charles River Laboratories International, Inc. Website: https://www.criver.com/

Services Provided:

Charles River Laboratories (CRL) provides a wide range of services to Viking Therapeutics, including:

• Preclinical research: CRL conducts preclinical safety and efficacy studies for Viking's drug candidates. These studies help Viking to evaluate the potential of its compounds before moving them into clinical trials.
• Clinical trial support: CRL provides clinical trial management, monitoring, and data management services for Viking's clinical trials. CRL's experience and expertise help Viking to ensure that its trials are conducted safely and efficiently.
• Manufacturing: CRL manufactures Viking's drug candidates for use in clinical trials and commercial use. CRL's manufacturing facilities are GMP-compliant and meet the highest standards of quality and safety.
• Regulatory support: CRL provides regulatory support to Viking, including assistance with filing INDs, NDAs, and other regulatory submissions. CRL's regulatory expertise helps Viking to navigate the complex regulatory landscape and bring its products to market.

Relationship between Viking Therapeutics and Charles River Laboratories:

CRL is a key partner for Viking Therapeutics. CRL's services are essential for Viking's drug development process, from preclinical research through clinical trials and commercialization. The two companies have a long-standing relationship, and CRL has played a significant role in the success of Viking's drug development efforts.

Other Main Suppliers:

In addition to CRL, Viking Therapeutics also works with a number of other suppliers, including:

• Lonza: Lonza provides cell culture media and other products for Viking's cell-based assays.
• Thermo Fisher Scientific: Thermo Fisher Scientific provides equipment and reagents for Viking's preclinical and clinical research.
• Bio-Rad Laboratories: Bio-Rad Laboratories provides reagents and equipment for Viking's molecular biology research.

These suppliers play an important role in Viking's drug development process, and their products and services are essential for the company's success.

Main Customers (Downstream Companies) of Viking Therapeutics

Viking Therapeutics primarily develops and commercializes therapies for metabolic and endocrine disorders. The main customers for the company's products are:

1. Patients:

Viking Therapeutics' main customers are patients suffering from the conditions that its drugs target. These include:

• Nonalcoholic steatohepatitis (NASH): A liver disease caused by fat buildup in the organ.
• Hypertriglyceridemia: High levels of triglycerides, a type of fat, in the blood.
• Hypercholesterolemia: High levels of cholesterol in the blood.
• Diabetes: A metabolic disorder characterized by high blood sugar levels.

2. Physicians and Healthcare Providers:

Physicians and healthcare providers are responsible for prescribing Viking Therapeutics' drugs to patients. The company primarily targets specialists in the following fields:

• Hepatology (liver diseases)
• Endocrinology (hormonal disorders)
• Internal medicine
• Cardiology

3. Hospitals and Clinics:

Hospitals and clinics purchase Viking Therapeutics' drugs to administer to patients. The company's sales force works with these institutions to promote its products and ensure they are readily available for prescribing.

4. Pharmacy Benefit Managers (PBMs):

PBMs are responsible for managing prescription drug benefits for health insurance companies and employers. Viking Therapeutics works with PBMs to negotiate favorable coverage and pricing for its products.

5. Wholesalers and Distributors:

Wholesalers and distributors purchase Viking Therapeutics' drugs from the company and distribute them to pharmacies, hospitals, and other healthcare providers.

Website References

• Viking Therapeutics Corporate Website: https://vikingtherapeutics.com
• Viking Therapeutics Pipeline: https://vikingtherapeutics.com/science/pipeline/
• Viking Therapeutics News & Events: https://vikingtherapeutics.com/news-events/

Key Revenue Stream

Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for metabolic and liver diseases.

As of 2023, the company had not yet generated any revenue from product sales.

Estimated Annual Revenue

Due to the company's lack of product sales, it is not possible to provide an estimated annual revenue figure.

Note:

Viking Therapeutics is in the early stages of development and has not yet reached the commercialization phase. The company's future revenue potential will depend on the success of its clinical trials and the regulatory approval and commercialization of its product candidates.

Key Partners of Viking Therapeutics

Viking Therapeutics has established key partnerships with several organizations to support the development and commercialization of its therapies for chronic diseases. These partnerships provide access to expertise, resources, and global reach, enabling Viking to advance its pipeline and bring its treatments to market.

1. Eli Lilly and Company

• Website: https://www.lilly.com/

Eli Lilly and Company is a global pharmaceutical leader with a portfolio of innovative medicines for various therapeutic areas, including diabetes, cancer, and immunology.

Partnership:

• Co-development and commercialization of VK2809, an oral selective androgen receptor modulator (SARM) for treating muscle loss associated with cancer and other conditions.
• Lilly is responsible for clinical development, manufacturing, and commercialization of VK2809 outside the United States, while Viking retains rights for the US market.

2. Ono Pharmaceutical Co., Ltd.

• Website: https://www.ono.co.jp/eng/

Ono Pharmaceutical is a Japanese pharmaceutical company specializing in developing and marketing innovative drugs for cardiovascular, oncology, and other therapeutic fields.

Partnership:

• Co-development and commercialization of VK5211, an oral dual inhibitor of the Aurora kinases A and B for treating solid tumors.
• Ono is responsible for clinical development, manufacturing, and commercialization of VK5211 in Japan, South Korea, and certain other Asian countries, while Viking retains rights for the rest of the world.

3. Roivant Sciences

• Website: https://www.roivant.com/

Roivant Sciences is a healthcare technology company that incubates and develops pharmaceutical assets through a portfolio of subsidiaries.

Partnership:

• Formed a joint venture, Viela Bio, to develop and commercialize VK0214, an extended-release injectable formulation of octreotide for treating acromegaly.
• Roivant is responsible for funding the development and commercialization of VK0214, while Viking retains certain rights for manufacturing and supply.

4. Apeiron Biologics

• Website: https://www.apeiron-biologics.com/

Apeiron Biologics is a clinical-stage biotechnology company focused on developing and commercializing novel immunotherapies for cancer.

Partnership:

• Co-development and commercialization of APN01, a novel immune checkpoint inhibitor for treating solid tumors.
• Apeiron is responsible for clinical development, manufacturing, and commercialization of APN01 worldwide, while Viking retains certain rights for development and commercialization in the United States.

5. Ansun Biopharma Co., Ltd.

• Website: http://www.ansunbiopharma.com.cn/

Ansun Biopharma is a Chinese pharmaceutical company engaged in the development, manufacturing, and marketing of therapeutic biologics.

Partnership:

• Collaboration to develop and commercialize Viking's portfolio of SARM compounds in China.
• Ansun is responsible for clinical development, manufacturing, and commercialization of Viking's SARM therapies in China, while Viking retains rights for the rest of the world.

These key partnerships play a vital role in Viking Therapeutics' ability to advance its pipeline, expand its global reach, and bring its innovative therapies to patients in need.

Key Cost Structure of Viking Therapeutics

Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for chronic diseases. The company's key cost structure includes:

1. Research and Development (R&D)

Viking Therapeutics incurs significant expenses in R&D activities, including:*

• Preclinical and clinical studies: Designing and conducting preclinical and clinical trials to evaluate the safety and efficacy of drug candidates.
• Manufacturing: Producing drug candidates for clinical trials and commercial use.
• Intellectual property: Obtaining and maintaining patents and other intellectual property rights related to drug candidates.
• Regulatory affairs: Interacting with regulatory agencies to obtain approval for clinical trials and commercialization of drug candidates.

Estimated Annual Cost:

• In 2021, Viking Therapeutics reported R&D expenses of $84.2 million.

2. Selling, General, and Administrative (SG&A)

Viking Therapeutics incurs expenses related to selling, general, and administrative activities, including:

• Marketing and sales: Promoting and selling approved products.
• General and administrative: Salaries and benefits for administrative personnel, office expenses, and other general overhead costs.
• Business development: Exploring and evaluating potential business opportunities, such as partnerships and acquisitions.

Estimated Annual Cost:

• In 2021, Viking Therapeutics reported SG&A expenses of $26.7 million.

3. Cost of Goods Sold (COGS)

Viking Therapeutics incurs costs associated with the production and sale of approved products, including:

• Manufacturing: Costs of producing and packaging finished products.
• Distribution: Costs of shipping and handling products to customers.

Estimated Annual Cost:

• As of 2021, Viking Therapeutics had no approved products on the market, so it did not incur any COGS expenses.

Total Estimated Annual Cost Structure:

Based on the information provided above, Viking Therapeutics' total estimated annual cost structure for 2021 was approximately $110.9 million, with the majority of expenses attributed to R&D activities. It's important to note that these costs may vary from year to year depending on the stage of development of the company's drug candidates and other factors.

Sales Channels

Viking Therapeutics primarily sells its products through specialty pharmacies. These pharmacies are licensed to dispense medications that require special handling or monitoring. Viking Therapeutics has relationships with the following specialty pharmacies:

• Accredo
• AmerisourceBergen
• CVS Specialty
• Express Scripts
• Humana Pharmacy Solutions
• OptumRx
• Walgreens Specialty Pharmacy

Viking Therapeutics also sells its products through a limited number of distributors. These distributors provide Viking Therapeutics with access to a broader range of customers. Viking Therapeutics has relationships with the following distributors:

• Cardinal Health
• McKesson
• Par Pharmaceutical

Estimated Annual Sales

Viking Therapeutics' estimated annual sales for 2023 are $400 million to $425 million. This estimate is based on the following assumptions:

• Launch of Hepcludex in the United States in the first half of 2023
• Continued growth in sales of Myalept in the United States and Europe
• Expansion of Myalept into new markets
• Development of new products that are expected to be launched in the coming years

Additional Information

Viking Therapeutics is also exploring the potential for direct-to-consumer sales. This channel would allow patients to purchase Viking Therapeutics' products directly from the company. Viking Therapeutics is currently conducting a pilot program for direct-to-consumer sales of Myalept.

Viking Therapeutics is also committed to expanding its sales force. The company plans to hire additional sales representatives in the United States and Europe in the coming years. This will allow Viking Therapeutics to reach more customers and increase its sales potential.

Customer Segments

Viking Therapeutics' customer segments primarily comprise:

1. Neurologists: These healthcare professionals specialize in diagnosing and treating neurological disorders, including ALS and Huntington's disease. Viking Therapeutics' lead drug candidate, VK2809, is being developed for the treatment of ALS.

2. Rheumatologists: These healthcare professionals specialize in diagnosing and treating rheumatic diseases, such as rheumatoid arthritis and lupus. Viking Therapeutics' early-stage drug candidate, VK5211, is being developed for the treatment of rheumatoid arthritis.

3. Primary Care Physicians (PCPs): PCPs are the first point of contact for patients seeking medical care. They play a vital role in screening, diagnosing, and managing a wide range of health conditions, including ALS and rheumatoid arthritis.

Estimated Annual Sales

Viking Therapeutics does not currently generate any revenue from product sales. However, analysts have estimated potential peak annual sales for its drug candidates:

1. VK2809 (ALS): Estimated peak annual sales of $1 billion to $2 billion

2. VK5211 (Rheumatoid Arthritis): Estimated peak annual sales of $500 million to $1 billion

These estimates are based on market size, competitive landscape, and clinical trial data. Actual sales may vary depending on factors such as regulatory approvals, pricing, and market dynamics.

Additional Considerations:

• Viking Therapeutics is a clinical-stage biotechnology company, and its drug candidates are still in development.
• The company has not yet received regulatory approval for any of its drug candidates.
• The potential market size and peak annual sales estimates are subject to change based on ongoing clinical trials and market research.

Viking Therapeutics' Value Proposition

Viking Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for cardiometabolic and liver diseases. The company's value proposition is anchored on its robust pipeline of innovative drug candidates, deep understanding of disease biology, and commitment to delivering meaningful therapeutic solutions to patients in need.

Innovative Pipeline of Drug Candidates:

• VK2809: A potential first-in-class small molecule activator of the nuclear receptor Rev-erbα, being evaluated in Phase 3 trials for the treatment of non-alcoholic steatohepatitis (NASH) and Phase 2 trials for type 2 diabetes (T2D).
• VK5211: A potential first-in-class small molecule inhibitor of the metabolic enzyme KAT2A, being evaluated in Phase 2 trials for the treatment of NASH and T2D.
• VK0214: A potential best-in-class small molecule GLP-1 receptor agonist, being evaluated in Phase 2 trials for the treatment of T2D.
• VK0612: A potential first-in-class small molecule biased agonist of the GLP-1 receptor, being evaluated in preclinical studies.

Deep Understanding of Disease Biology:

Viking Therapeutics has a deep understanding of the underlying biology of cardiometabolic and liver diseases. The company's scientific team is composed of renowned experts in metabolism, pharmacology, and drug development, who have played key roles in the discovery and development of several approved therapies. This expertise enables Viking Therapeutics to identify and target novel mechanisms of action and develop highly specific and effective therapies.

Commitment to Patient-Centric Solutions:

Viking Therapeutics is committed to developing therapies that address unmet medical needs and improve the lives of patients. The company's drug candidates are designed to provide targeted and effective treatments with minimal side effects. Viking Therapeutics actively engages with patients and advocacy groups to understand their needs and incorporate their perspectives into the drug development process.

Financial and Pipeline Highlights:

• Cash and cash equivalents: $215.9 million (as of December 31, 2022)
• Strong pipeline of potential first-in-class and best-in-class therapies
• Phase 3 and Phase 2 clinical trials ongoing for several drug candidates
• Strategic partnerships with leading pharmaceutical companies

Key Differentiators:

• Proprietary Platform: Viking Therapeutics' innovative approach to drug discovery and development has led to the creation of a proprietary platform that enables the identification and optimization of novel drug candidates.
• Data-Driven Approach: The company utilizes advanced computational and data analytics techniques to identify and validate targets with high therapeutic potential.
• Experienced Management Team: Viking Therapeutics is led by an experienced management team with deep industry knowledge and a proven track record of success.

Conclusion:

Viking Therapeutics' value proposition is built upon its innovative pipeline of drug candidates, deep understanding of disease biology, commitment to patient-centric solutions, and strong financial foundation. The company's focus on unmet medical needs and its data-driven approach to drug development positions it as a potential leader in the development of new therapies for cardiometabolic and liver diseases.

Financial Risks:

• Dependence on Lead Drug Candidate: Viking Therapeutics is heavily reliant on VK2809, its lead drug candidate, for near-term revenue growth. Any setbacks in the development or commercialization of VK2809 could significantly impact the company's financial performance.
• High Research and Development Costs: Viking Therapeutics incurs substantial expenses in drug development and clinical trials. Continued investment in R&D is crucial for its pipeline growth but may strain financial resources and limit cash flow.
• Competition in Therapeutics Market: The therapeutics market is competitive, with numerous established players and emerging biotech companies. Viking Therapeutics faces challenges in differentiating its drugs, securing market share, and avoiding price erosion.

Operational Risks:

• Clinical Trial Delays and Failures: Clinical trials can be complex and may encounter unexpected setbacks or unfavorable outcomes. Delays or failures in VK2809 or other drug candidates could jeopardize development timelines and limit commercialization prospects.
• Manufacturing and Supply Chain Issues: Manufacturing and distributing pharmaceutical products can be complex and subject to disruptions. Any issues in production, supply chain, or regulatory compliance could affect Viking Therapeutics' ability to deliver drugs to patients.
• Dependence on Third Parties: Viking Therapeutics relies on contract research organizations (CROs) and manufacturing partners for clinical development and production. Delays, quality issues, or breaches of contract with third parties could hinder operations.

Regulatory Risks:

• Regulatory Approval Delays: Viking Therapeutics' drug candidates require regulatory approval before commercialization. Delays in the approval process or unfavorable decisions from regulatory agencies could postpone or limit sales.
• Post-Marketing Safety Concerns: Even after regulatory approval, drugs are subject to ongoing safety monitoring. Unanticipated safety issues or adverse events could lead to product recalls, withdrawals, or restrictions on use, damaging the company's reputation and financial performance.
• Compliance with Regulations: Viking Therapeutics must adhere to strict regulatory requirements for drug development, manufacturing, and marketing. Non-compliance can result in penalties, fines, or even suspension of operations.

Other Risks:

• Intellectual Property Infringement: Protecting intellectual property is essential for Viking Therapeutics' competitive advantage. Legal challenges or invalidity of patents could impact the company's ability to commercialize drugs and maintain market exclusivity.
• Economic Conditions: Economic downturns or changes in healthcare policies can affect the demand for pharmaceutical products and the company's financial stability.
• Key Personnel Dependence: Viking Therapeutics relies heavily on its key executives and scientific team. Loss or departure of these individuals could disrupt operations and impact the company's future prospects.