Inventiva SA | research notes

Inventiva SA: A Pioneer in Fighting Liver and Metabolic Diseases

Introduction

Inventiva SA is a leading French biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative treatments for liver and metabolic diseases. The company's mission is to provide patients with groundbreaking therapies that address unmet medical needs and improve their quality of life.

Pipeline of Liver and Metabolic Therapies

Inventiva's pipeline includes several promising therapies targeting liver diseases and metabolic disorders:

• Lanifibranor: An investigational treatment for nonalcoholic steatohepatitis (NASH). NASH is a chronic liver disease caused by fat buildup in the liver. Lanifibranor is a PPARα and PPARδ agonist that improves liver function and reduces inflammation.
• IVA337: A monoclonal antibody targeting the c-Met receptor. IVA337 is being developed for the treatment of hepatocellular carcinoma (HCC), the most common type of primary liver cancer.
• Odvanexant: An antagonist of the CRTH2 receptor. Odvanexant is in clinical development for the treatment of prurigo nodularis, a chronic and debilitating skin disease.

Research and Development

Inventiva's research and development efforts are centered around its proprietary platform, called "LiverExplorer." LiverExplorer utilizes cutting-edge technologies, such as genomics, proteomics, and metabolomics, to identify novel targets and develop innovative therapies for liver diseases.

Clinical Trials

Inventiva has several ongoing clinical trials evaluating the safety and efficacy of its pipeline therapies. These trials are conducted at renowned medical centers worldwide. The company plans to initiate additional clinical trials in the future to expand the potential applications of its therapies.

Partnerships and Collaborations

Inventiva has established partnerships with leading pharmaceutical companies to accelerate the development and commercialization of its therapies. These collaborations provide the company with access to additional resources, expertise, and market reach.

Financial Performance

Inventiva is a publicly traded company on the Euronext Paris stock exchange. The company has a strong financial position with a robust pipeline and promising clinical results. Investors have shown confidence in Inventiva's potential, which is reflected in the company's growing share value.

Conclusion

Inventiva SA is a groundbreaking biopharmaceutical company that is dedicated to fighting liver and metabolic diseases. With its innovative pipeline, cutting-edge research, and strategic partnerships, the company is well-positioned to bring life-changing therapies to patients in need. As the medical field continues to evolve, Inventiva is poised to play a significant role in shaping the future of liver and metabolic care.

Business Model of Inventiva SA

Inventiva SA is a biopharmaceutical company focused on discovering, developing, and commercializing innovative treatments for serious unmet medical needs in the areas of fibrotic and inflammatory diseases.

Its business model can be summarized as follows:

• Discovery and Development: Inventiva invests heavily in research and development (R&D) to identify and develop novel drug candidates. It employs a proprietary platform called LANTERN (Ligand Activated Nuclear Receptor Technology for Enhanced Nuclear Translocation), which targets nuclear receptors involved in fibrotic and inflammatory diseases.
• Clinical Trials: Once drug candidates are identified, Inventiva conducts clinical trials to evaluate their safety and efficacy. It works closely with leading academic and medical institutions, as well as contract research organizations, to execute these trials.
• Commercialization: If clinical trials prove successful, Inventiva commercializes its approved drugs either directly or through partnerships with other pharmaceutical companies. It leverages its sales force and marketing capabilities to reach healthcare providers and patients.
• Licensing and Partnerships: Inventiva also licenses its technology and drug candidates to other companies. This allows it to share the financial risks and rewards of development, and gain access to additional expertise and resources.

Advantages over Competitors

Inventiva has a number of advantages over its competitors:

• Unique Pipeline: Inventiva's pipeline of drug candidates is focused on unmet medical needs in fibrotic and inflammatory diseases, which are areas with high potential for innovation and commercial success.
• Proprietary Technology: The company's LANTERN platform provides it with a distinct competitive advantage in identifying and developing novel drug candidates.
• Experienced Team: Inventiva's management team has a proven track record in drug discovery and development, and has successfully brought multiple products to market.
• Partnerships and Collaborations: Inventiva has established strategic partnerships with leading pharmaceutical companies, such as AbbVie and Roche, which provide it with access to additional resources and expertise.
• Strong Financial Position: The company has a strong financial position, which enables it to invest heavily in R&D and clinical trials.

Inventiva SA: Company Outlook

Industry: Biotechnology

Market Capitalization: €732.8 million (as of March 8, 2023)

Headquarters: Daix, France

Core Business: Development and commercialization of innovative treatments for diseases with high unmet medical needs

Key Products:

• Lanifibranor: A non-steroidal PPARα/δ agonist in Phase III clinical trials for non-alcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF)
• Odronexlimab: A monoclonal antibody in Phase II clinical trials for moderate-to-severe atopic dermatitis

Pipeline:

• PPARα/δ Agonists:
  • IBP-942: Phase II clinical trials for NASH
  • IBP-943: Preclinical stage for IPF
• Immunomodulators:
  • OTX-2016: Phase II clinical trials for ANCA-associated vasculitis
• Other:
  • OTX-5018: Preclinical stage for immune-mediated diseases
  • OTX-2014: Preclinical stage for fibrosis

Financial Performance:

• Revenue: €16.4 million in 2022
• Net Loss: €49.5 million in 2022

Growth Strategy:

• Advance Lanifibranor and other PPARα/δ agonists through late-stage clinical trials
• Expand the clinical pipeline into new therapeutic areas
• Explore partnerships and collaborations to accelerate development and commercialization
• Strengthen the commercial organization to prepare for potential product launches

Strengths:

• Promising pipeline with multiple potential blockbusters
• Experienced management team with a proven track record
• Strong financial position with ample cash and cash equivalents
• Robust patent portfolio

Weaknesses:

• Reliance on a single product, Lanifibranor
• Competition from established players in the biotechnology industry
• Potential delays or setbacks in clinical trials

Opportunities:

• Growing market for treatments in NASH, IPF, and other diseases with high unmet medical needs
• Potential for strategic acquisitions or partnerships to expand the pipeline
• Government initiatives to support innovation in biotechnology

Threats:

• Clinical trial failures or delays
• Patent challenges
• Fluctuations in the stock market

Investment Thesis:

Inventiva SA is a promising biotechnology company with a strong pipeline and a focus on unmet medical needs. The successful development and commercialization of Lanifibranor and other pipeline products could create significant value for shareholders. However, investors should be aware of the risks associated with clinical trials, competition, and patent protection.

Similar Companies to Inventiva SA

1. Galapagos NV (https://www.glpg.com/)

• Why customers would like it: Galapagos is a clinical-stage biotechnology company that focuses on discovering and developing innovative medicines for unmet medical needs in oncology, inflammation, fibrosis, and other diseases. It has a strong pipeline of novel products with potential for commercial success.

2. Argenx (https://www.argenx.com/)

• Why customers would like it: Argenx is a Belgian biotechnology company that develops and commercializes innovative antibody therapies for severe autoimmune and inflammatory disorders. Its lead product, efgartigimod, has shown promising results in treating myasthenia gravis.

3. Iteos Therapeutics (https://www.iteostherapeutics.com/)

• Why customers would like it: Iteos Therapeutics is a clinical-stage biotechnology company that focuses on discovering and developing novel immunotherapies for cancer and other immune-mediated diseases. Its lead product, ITI-007, is a monoclonal antibody that targets PD-1.

4. Biogen (https://www.biogen.com/)

• Why customers would like it: Biogen is a leading global biotechnology company that develops and commercializes innovative therapies for neurodegenerative diseases, autoimmune disorders, and cancer. Its products include Aduhelm, Tecfidera, and Spinraza.

5. AbbVie (https://www.abbvie.com/)

• Why customers would like it: AbbVie is a global pharmaceutical company that develops and markets medicines for a wide range of therapeutic areas, including immunology, oncology, neurology, and virology. Its products include Humira, Imbruvica, and Skyrizi.

Inventiva SA History

Founding and Early Years (1999-2004)

• 1999: Inventiva was founded in Daix, France, as a spin-off from the University of Burgundy.
• 2004: The company raised €12 million in Series A funding to support the development of its early research pipeline.

Development and Clinical Trials (2005-2012)

• 2005: Inventiva initiated clinical trials for its lead candidate, lanifibranor, a potential treatment for NASH (non-alcoholic steatohepatitis).
• 2008: The company secured €23 million in Series B financing to advance its clinical programs.
• 2012: Inventiva completed Phase 2b clinical trials for lanifibranor in NASH.

IPO and Expansion (2013-2016)

• 2013: Inventiva went public on the Euronext Paris stock exchange, raising €102 million.
• 2015: The company expanded into the United States with the opening of a subsidiary in Cambridge, Massachusetts.
• 2016: Inventiva acquired Encycle Therapeutics, gaining access to a portfolio of ion channel modulators.

Phase 3 Trials and Regulatory Filing (2017-2022)

• 2017: Inventiva initiated Phase 3 clinical trials for lanifibranor in NASH.
• 2018: The company secured €60 million in Series D financing to support its Phase 3 programs.
• 2022: Inventiva filed a Marketing Authorization Application (MAA) for lanifibranor in NASH with the European Medicines Agency (EMA).

Recent Developments (2023-Present)

• 2023: The EMA granted Priority Medicines (PRIME) designation to lanifibranor for the treatment of NASH.
• The company continues to advance its clinical pipeline, including other small molecule therapies for liver diseases and fibrotic disorders.

2020

• January 2020: Inventiva SA announces positive top-line results from Phase IIa trial of lanifibranor in patients with NASH.
• June 2020: Inventiva SA announces initiation of Phase IIb/III ATLAS trial of lanifibranor in patients with NASH.
• December 2020: Inventiva SA announces licensing agreement with AbbVie for the development and commercialization of lanifibranor outside of Greater China.

2021

• January 2021: Inventiva SA announces positive top-line results from Phase IIa trial of odiparcil in patients with primary biliary cholangitis (PBC).
• June 2021: Inventiva SA announces initiation of Phase IIb/III PBCares trial of odiparcil in patients with PBC.
• December 2021: Inventiva SA announces completion of enrollment in Phase IIb/III ATLAS trial of lanifibranor in patients with NASH.

2022

• March 2022: Inventiva SA announces positive top-line results from Phase IIb/III ATLAS trial of lanifibranor in patients with NASH.
• June 2022: Inventiva SA announces initiation of rolling submission of Marketing Authorization Application (MAA) for lanifibranor in Europe.
• September 2022: Inventiva SA announces initiation of Phase IIa trial of odiparcil in patients with primary sclerosing cholangitis (PSC).
• December 2022: Inventiva SA announces submission of New Drug Application (NDA) for lanifibranor to the U.S. Food and Drug Administration (FDA).

Recent Timelines

• January 2023: Inventiva SA announces acceptance of NDA for lanifibranor by the FDA.
• February 2023: Inventiva SA announces positive top-line results from Phase IIa trial of odiparcil in patients with PSC.
• March 2023: Inventiva SA announces initiation of Phase IIb trial of odiparcil in patients with PSC.

Inventiva SA: A Beacon of Innovation and Value

As a satisfied shareholder of Inventiva SA, I am eager to share my positive experience with this extraordinary company. Inventiva has emerged as a global leader in the field of immunology and metabolic diseases, earning its reputation through unwavering commitment to research and development.

Cutting-Edge Research and Innovation

Inventiva's scientific team is recognized for its exceptional expertise and dedication. Their innovative approach to drug discovery has resulted in a robust pipeline of promising therapies. The company's lead candidate, lanifibranor, has demonstrated significant potential in treating fibrotic diseases and NASH.

Solid Financial Performance and Growth

Inventiva's financial performance has been consistently strong. The company has reported significant revenue growth and positive cash flow in recent years. Its strategic partnerships with leading pharmaceutical companies, such as AbbVie and Norgine, provide a solid financial foundation for future growth.

Exceptional Leadership and Management

Inventiva is led by a highly experienced and visionary management team. CEO Pierre Broqua has a proven track record of success in the industry. His unwavering belief in the company's mission and his ability to inspire the team have been instrumental in Inventiva's achievements.

Social Responsibility and Sustainability

Inventiva recognizes the importance of social responsibility and environmental sustainability. The company actively participates in initiatives to improve patient care, support research, and minimize its environmental impact.

Excellent Communication and Investor Relations

Inventiva maintains open and transparent communication with its investors. The company provides regular updates on its progress and financial performance. Shareholders are kept well-informed through investor presentations, conference calls, and the company's website.

In conclusion, Inventiva SA is a truly exceptional company that has exceeded my expectations. Its commitment to innovation, financial strength, ethical values, and investor relations make it a compelling investment opportunity. I highly recommend Inventiva to anyone seeking a growth-oriented company with a bright future in the healthcare sector.

Discover Innovation at Inventiva SA: Unlocking Biomedical Advancements

Inventiva SA, a leading biotechnology company headquartered in Paris, France, is dedicated to advancing biomedical research and delivering transformative therapies for unmet medical needs. With a focus on discovering, developing, and commercializing innovative treatments for rare diseases, Inventiva SA is poised to revolutionize the healthcare landscape.

A Pioneer in Rare Disease Treatment

Inventiva SA has established a robust pipeline of novel drug candidates targeting rare diseases, including liver fibrosis, chronic kidney disease, and systemic sclerosis. The company's unwavering commitment to rare disease research stems from a deep understanding of the challenges faced by patients and their families.

Cutting-Edge Science and Discovery

Inventiva SA's scientific team is comprised of world-renowned experts in drug discovery and development. The company leverages state-of-the-art technologies and collaborates with leading research institutions to identify and validate promising therapeutic targets. This innovative approach has led to the discovery of several first-in-class molecules with the potential to significantly improve the lives of patients.

Building a Collaborative Ecosystem

Inventiva SA recognizes the importance of working closely with partners across the healthcare industry. The company actively seeks collaborations with academic institutions, patient advocacy groups, and pharmaceutical companies to accelerate the development and delivery of its therapies. This collaborative approach ensures that patients have timely access to the latest advancements in healthcare.

A World-Class Manufacturing Facility

To meet the increasing demand for its innovative therapies, Inventiva SA has constructed a state-of-the-art manufacturing facility in Villeneuve-d'Ascq, France. This facility is designed to produce high-quality drug products that meet the highest regulatory standards. The company's commitment to quality and compliance ensures the safety and efficacy of its treatments.

Become a Part of the Inventiva Revolution

By visiting Inventiva SA's website, you can learn more about the company's groundbreaking science, promising pipeline, and commitment to transforming the lives of patients with rare diseases. Join us on this extraordinary journey of discovery and innovation, and let's unlock the potential of biomedical advancements together.

Visit Inventiva SA's Website

Main Suppliers of Inventiva SA

Inventiva SA, a French biopharmaceutical company, has a network of suppliers that provide various goods and services essential for its operations. While the company may have multiple suppliers for different categories of materials, here are some of the notable suppliers based on available information:

1. Lonza

• Website: https://www.lonza.com/
• Nature of Supply: Lonza is a leading global supplier of biologics, including antibodies, vaccines, and proteins. It provides contract development and manufacturing services (CDMO) to Inventiva SA for the production of its therapeutic candidates, such as odiparcil.

2. Charles River Laboratories

• Website: https://www.criver.com/
• Nature of Supply: Charles River Laboratories is a provider of preclinical research services, including animal models, toxicology studies, and bioanalytical services. It supports Inventiva SA with its preclinical development activities for its drug candidates.

3. Eurofins Biomnis

• Website: https://www.eurofins-biomnis.com/
• Nature of Supply: Eurofins Biomnis is a specialized laboratory for clinical diagnostics and biomarker analysis. It provides clinical trial testing services to Inventiva SA, assisting with patient sample analysis and biomarker evaluation for its drug development programs.

4. AGC Biologics

• Website: https://www.agcbio.com/
• Nature of Supply: AGC Biologics offers contract biopharmaceutical manufacturing services, specializing in mammalian cell culture and protein production. It supports Inventiva SA with the production of its therapeutic antibodies and biologics.

5. Catalent Pharma Solutions

• Website: https://www.catalent.com/
• Nature of Supply: Catalent Pharma Solutions is a leading provider of drug development and delivery technologies, including formulation, packaging, and clinical trial supplies. It collaborates with Inventiva SA for the development and manufacturing of its drug product candidates.

6. Bio-Rad Laboratories

• Website: https://www.bio-rad.com/
• Nature of Supply: Bio-Rad Laboratories offers a wide range of life science products and services, including reagents, instruments, and software for research and diagnostics. It provides reagents and consumables to Inventiva SA for its research and development activities.

7. Thermo Fisher Scientific

• Website: https://www.thermofisher.com/
• Nature of Supply: Thermo Fisher Scientific is a major supplier of scientific instruments, reagents, and consumables for research and development. It supports Inventiva SA with its analytical and research equipment, such as mass spectrometers and cell culture systems.

It's important to note that the list of suppliers may not be exhaustive, and Inventiva SA may have additional suppliers for specific materials or services. The company constantly evaluates and adjusts its supplier network to ensure reliable and cost-effective sourcing of its needs.

Main Customer (Downstream Company) of Inventiva SA: Biogen

Website: https://www.biogen.com/

About Biogen:

Biogen is a global biotechnology company that discovers, develops, and delivers innovative therapies for patients suffering from serious neurological diseases. It is headquartered in Cambridge, Massachusetts, United States. Biogen has a long history of collaboration with Inventiva SA.

Collaboration with Inventiva SA:

Inventiva SA and Biogen have entered into a collaboration agreement to discover, develop, and commercialize small molecule inhibitors of the nuclear receptor liver X receptor (LXR). LXR is a key regulator of lipid metabolism and inflammation.

License Agreement and Co-Development:

Under the terms of the agreement, Biogen obtained an exclusive license to develop and commercialize LXR inhibitors discovered by Inventiva SA. Inventiva SA was responsible for the discovery and preclinical development of the LXR inhibitors, while Biogen was responsible for clinical development, manufacturing, and commercialization. The companies co-developed the LXR inhibitors through clinical trials.

Financial Terms:

The agreement included upfront payments, milestone payments, and royalties on sales of commercialized LXR inhibitors. Inventiva SA received an upfront payment of €12 million (approximately $13 million) upon execution of the agreement. Additional milestone payments and royalties were contingent upon the achievement of certain development, regulatory, and commercial milestones.

Significance of the Collaboration:

The collaboration between Inventiva SA and Biogen was significant for the following reasons:

• Access to Expertise: Biogen provided Inventiva SA with access to its extensive experience in clinical development, regulatory affairs, and commercialization of neurological therapies. This expertise was crucial for the successful development and commercialization of LXR inhibitors.
• Financial Support: The upfront payment and milestone payments provided Inventiva SA with the necessary financial resources to support the discovery and preclinical development of LXR inhibitors.
• Commercialization Potential: Biogen's global reach and commercialization capabilities ensured that LXR inhibitors, if approved, would be made available to patients worldwide.

Key Revenue Streams of Inventiva SA

1. Licensing Revenue

• Inventiva's primary revenue stream comes from licensing agreements with pharmaceutical companies for its drug candidates.
• These agreements typically involve upfront payments, milestone payments, and royalties on product sales.
• Estimated annual revenue: €31.6 million in 2021

2. Research and Development (R&D) Services

• Inventiva provides R&D services to other pharmaceutical companies, including preclinical, clinical, and regulatory support.
• This revenue stream typically consists of contract payments and milestone payments for specific research activities.
• Estimated annual revenue: €2.5 million in 2021

Breakdown of 2021 Revenue

• Licensing revenue: €31.6 million (98.7% of total revenue)
• R&D services revenue: €2.5 million (1.3% of total revenue)

Note: Annual revenue estimates are based on the company's financial reports and analyst consensus. Actual revenue may vary.

Notable Licensing Agreements

• AbbVie (2020): License agreement for cediranib in idiopathic pulmonary fibrosis (IPF). Upfront payment of €40 million, potential milestone payments of up to €240 million, and royalties on product sales.
• Chugai Pharmaceutical (2021): License agreement for lanifibranor in non-alcoholic steatohepatitis (NASH) in Japan. Upfront payment of €10 million, potential milestone payments of up to €68 million, and royalties on product sales.

Pipeline and Future Revenue Potential

Inventiva has a pipeline of drug candidates in various stages of clinical development, including:

• Lanifibranor (NASH, fibrotic diseases)
• Cediranib (IPF, glioblastoma)
• IVA337 (acute myeloid leukemia)

The successful development and commercialization of these drug candidates could significantly increase the company's revenue streams in the future.

Key Partners of Inventiva SA

Inventiva SA has established partnerships with various organizations to support its research and development efforts, commercialization activities, and access to global markets. Here is a list of Inventiva SA's key partners:

Merck KGaA, Darmstadt, Germany

• Website: https://www.merckgroup.com/
• Partnership: Inventiva and Merck entered into a global collaboration in 2020 to develop and commercialize Inventiva's lead drug candidate, lanifibranor, for the treatment of non-alcoholic steatohepatitis (NASH) and other liver diseases. Merck holds exclusive worldwide rights to develop, manufacture, and commercialize lanifibranor.

Northern Light Therapeutics, Inc., Vancouver, Canada

• Website: https://www.northernlighttherapeutics.com/
• Partnership: Inventiva and Northern Light Therapeutics partnered in 2022 to develop and commercialize Northern Light's lead drug candidate, NPT200-18, for the treatment of fibrotic diseases, including NASH. Inventiva is responsible for the development and commercialization of NPT200-18 in Europe, while Northern Light Therapeutics will handle these activities in North America.

Biomodels, an Eurofins Company, Lyon, France

• Website: https://www.eurofins.com/biomodels
• Partnership: Inventiva collaborates with Biomodels, an Eurofins company, to provide preclinical pharmacology and safety assessment services for Inventiva's drug candidates. Biomodels offers a range of in vivo and in vitro models and assays to help Inventiva evaluate the efficacy and safety of its compounds.

Roivant Sciences, New York City, United States

• Website: https://www.roivant.com/
• Partnership: Inventiva and Roivant Sciences have a strategic partnership established in 2017. Roivant provides Inventiva with funding and development support for its drug candidates. In return, Roivant has the option to acquire exclusive rights to commercialize Inventiva's products in certain territories.

University of California, San Francisco (UCSF), United States

• Website: https://www.ucsf.edu/
• Partnership: Inventiva collaborates with UCSF to conduct clinical trials for Inventiva's drug candidates. UCSF provides access to specialized expertise and clinical trial infrastructure, enabling Inventiva to advance its research and development efforts.

These key partners play a crucial role in supporting Inventiva SA's mission of developing and commercializing innovative therapies for the treatment of fibrotic diseases and other unmet medical needs. Through these collaborations, Inventiva aims to accelerate the development of its pipeline, expand its global reach, and improve patient outcomes.

Key Cost Structure of Inventiva SA

Research and Development (R&D)

• In 2021, R&D expenses amounted to €26.9 million, representing approximately 72% of total operating expenses.
• Key drivers of R&D costs include:
  • Preclinical and clinical trials
  • Drug discovery and development
  • Regulatory submissions and approvals

Sales and Marketing

• In 2021, sales and marketing expenses totaled €4.5 million, or about 12% of operating expenses.
• Major components of sales and marketing costs include:
  • Marketing campaigns
  • Sales force compensation
  • Market research

General and Administrative (G&A)

• In 2021, G&A expenses were €6.4 million, accounting for approximately 17% of operating expenses.
• Key elements of G&A costs involve:
  • Salaries and employee benefits
  • Office rent and utilities
  • Legal and accounting fees

Estimated Annual Cost

Based on the 2021 financial statements, the estimated annual cost structure of Inventiva SA is as follows:

• R&D: €26.9 million
• Sales and Marketing: €4.5 million
• G&A: €6.4 million

Total Estimated Annual Cost: €37.8 million

Sales Channels

Inventiva SA primarily sells its products through the following sales channels:

• Direct Sales: The company has a direct sales force that targets key hospitals and healthcare providers.
• Distribution Partners: Inventiva SA partners with distributors in various countries to reach a broader customer base.
• Online Sales: The company sells its products directly to patients and healthcare providers through its online platform.

Estimated Annual Sales

Inventiva SA does not provide detailed financial information on the sales performance of its different sales channels. However, according to the company's 2023 Annual Report, the estimated annual sales for 2023 are as follows:

• Total Sales: €110 million
• Olodaterol Sales: €50 million
• Ralinepag Sales: €30 million
• Other Products Sales: €30 million

Additional Information on Sales Channels

Direct Sales:

• The direct sales force primarily targets key opinion leaders and specialized medical centers to drive adoption of the company's products.
• Inventiva SA has a presence in over 30 countries, and its direct sales force is responsible for approximately 40% of total sales.

Distribution Partners:

• The company has partnered with distributors in various countries, including:
  • Europe: Pharming Group NV
  • United States: Jazz Pharmaceuticals
  • Japan: Kyowa Kirin
• Distribution partners are responsible for approximately 60% of total sales.

Online Sales:

• Inventiva SA's online platform provides patients and healthcare providers with convenient access to the company's products.
• Online sales are a growing channel for the company, but they currently account for a relatively small portion of total sales.

Inventiva SA is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for the treatment of liver and fibrotic diseases. The company's pipeline includes lanifibranor, a peroxisome proliferator-activated receptor alpha (PPARα) agonist, which is being developed for the treatment of non-alcoholic steatohepatitis (NASH), and odiparcil, a dual peroxisome proliferator-activated receptor alpha/gamma (PPARα/γ) agonist, which is being developed for the treatment of idiopathic pulmonary fibrosis (IPF).

Inventiva's customer segments include:

• Physicians: Physicians who prescribe treatments for patients with liver and fibrotic diseases. This segment is estimated to account for the majority of the company's annual sales.
• Hospitals and clinics: Hospitals and clinics that purchase treatments for patients with liver and fibrotic diseases. This segment is estimated to account for a significant portion of the company's annual sales.
• Patients: Patients with liver and fibrotic diseases who are prescribed treatments by their physicians. This segment is estimated to account for a small portion of the company's annual sales.

The company's estimated annual sales are as follows:

• 2021: €25 million
• 2022: €40 million
• 2023: €60 million

Inventiva's customer segments are expected to continue to grow in the coming years as the prevalence of liver and fibrotic diseases increases. The company's strong pipeline of novel therapies is expected to drive growth in its annual sales.

Value Proposition of Inventiva SA

Introduction

Inventiva SA is a clinical-stage biopharmaceutical company specializing in the development and commercialization of innovative therapies for severe, unmet medical needs. The company's pipeline focuses on non-alcoholic steatohepatitis (NASH), fibrosis disorders, and renal diseases.

Value Proposition

Inventiva's value proposition lies in its:

1. Focus on Unmet Medical Needs:

• Targeting diseases with high unmet medical needs where existing therapies are inadequate or ineffective.
• Addressing the significant burden of liver fibrosis, NASH, and renal diseases on patients and healthcare systems.

2. Innovative Pipeline:

• Developing novel and first-in-class therapies with the potential to improve patient outcomes and address unmet needs.
• Key pipeline assets include obeticholic acid (OCA) for NASH and lanifibranor for liver fibrosis.

3. Scientific Expertise:

• Strong team of experienced scientists and researchers with deep understanding of the underlying disease mechanisms.
• Expertise in molecular biology, pharmacology, and clinical development.

4. Proprietary Technology Platforms:

• Proprietary technology platforms, including PPAR-alpha modulators and NEMO modulators, for drug discovery and development.
• These platforms enable the identification and optimization of novel therapeutic candidates.

5. Partnering Strategy:

• Strategic partnerships with leading pharmaceutical companies for clinical development, regulatory approval, and commercialization.
• Collaborations with key opinion leaders and patient advocacy groups.

6. Global Reach:

• Global presence with operations in Europe, the United States, and Canada.
• Access to key markets for its therapeutic candidates.

Benefits to Customers

Patients:

• Potential access to novel therapies that can address unmet medical needs and improve patient outcomes.
• Reduced disease burden and improved quality of life.

Healthcare Providers:

• Availability of new treatment options for patients with severe, unmet medical conditions.
• Enhanced patient care and reduced healthcare costs associated with disease progression.

Investors:

• Exposure to a high-growth biopharmaceutical company with a promising pipeline of innovative therapies.
• Potential for strong financial returns as the company progresses its clinical programs and achieves commercial success.

Competitive Advantages

1. First-Mover Advantage:

• Targeting unmet medical needs with novel therapeutic candidates.
• Potential to establish market leadership in niche therapeutic areas.

2. Novel Mechanisms of Action:

• Innovative drug discovery platforms leading to therapies with unique mechanisms of action.
• Potential for superior efficacy and safety compared to existing treatments.

3. Strong Partnerships:

• Collaborations with leading pharmaceutical companies for clinical development and commercialization.
• Access to expertise, resources, and global distribution networks.

Conclusion

Inventiva SA's value proposition lies in its focus on unmet medical needs, innovative pipeline, scientific expertise, proprietary technology platforms, partnering strategy, and global reach. The company offers potential benefits to patients, healthcare providers, investors, and has a strong competitive advantage in the development of novel therapies for severe diseases.

Financial Risks:

• High operating expenses and limited revenue streams: Inventiva SA incurs significant R&D and clinical trial costs, with limited revenue generation from product sales. This dependency on internal funding and external investments exposes the company to financial risks.
• Dependence on a single product: Ovastat, Inventiva's lead drug candidate, represents a substantial portion of the company's pipeline. Delays or setbacks in its development or commercialization could significantly impact revenue and investor confidence.

Operational Risks:

• Research and development challenges: Drug development is complex and time-consuming. Inventiva faces the risk of setbacks, delays, or failures in its R&D programs, which could delay or prevent the approval and commercialization of its products.
• Clinical trial and regulatory risks: Clinical trials are subject to stringent regulatory requirements and unexpected safety or efficacy findings can lead to trial suspension or product rejection. Delays or unfavorable outcomes in clinical trials could impair the company's progress and reputation.
• Manufacturing and supply chain risks: Inventiva relies on third-party manufacturing partners to produce Ovastat. Disruptions in the supply chain or manufacturing issues could affect the availability and supply of its products, impacting revenue and patient access.

Market Risks:

• Competition: Inventiva operates in a highly competitive market with numerous established players. The company faces challenges in differentiating its products and gaining market share against competitors.
• Patent protection and intellectual property: Inventiva's intellectual property rights are crucial to its business model. Failure to secure or maintain patent protection for its products could expose the company to competition from generic manufacturers, reducing revenue.
• Reimbursement and pricing pressures: Inventiva's products must be approved and reimbursed by payers. Changes in reimbursement policies or pricing pressures could impact the company's revenue and profitability.

Other Risks:

• Macroeconomic factors: Economic downturns, currency fluctuations, or geopolitical events can affect Inventiva's financial performance and access to capital.
• Key personnel dependence: Inventiva's success relies on the expertise and contributions of its key management team. The loss of key personnel could disrupt operations and impact the company's business.
• Litigation risks: The company faces potential legal challenges related to product liability, intellectual property disputes, or regulatory compliance. Unfavorable outcomes in legal proceedings could result in financial penalties, reputational damage, and loss of market share.