Theravance Biopharma | research notes

Theravance Biopharma: A Leader in Respiratory and Gastrointestinal Drug Development

Theravance Biopharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory and gastrointestinal disorders. The company has a robust pipeline of products in development, including several late-stage candidates with the potential to address unmet medical needs.

History and Founders

Theravance Biopharma was founded in 1997 by Dr. Rick Davis and Dr. Chris Henney, two former Merck executives with extensive experience in drug discovery and development. The company's mission is to leverage its scientific expertise and proprietary technologies to create innovative therapies that improve the lives of patients.

Respiratory Diseases

Theravance Biopharma has a strong focus on respiratory diseases, including chronic obstructive pulmonary disease (COPD), asthma, and cystic fibrosis. The company has a number of products in development for these conditions, including:

• Trelegy Ellipta: A triple-combination inhaler for COPD that contains budesonide, formoterol, and glycopyrronium bromide. Trelegy Ellipta is approved in the US, EU, and other countries.
• Mytesi (benralizumab): A monoclonal antibody indicated for the treatment of severe eosinophilic asthma. Mytesi is approved in the US and EU.
• GlaxoSmithKline (GSK)-2333944: A novel inhaled beta2-agonist in Phase 3 clinical development for COPD.

Gastrointestinal Diseases

In addition to respiratory diseases, Theravance Biopharma is also developing therapies for gastrointestinal disorders, such as irritable bowel syndrome (IBS) and ulcerative colitis. The company's gastrointestinal pipeline includes:

• Yimizy (vibegron): A selective chloride channel activator approved for the treatment of IBS-C. Yimizy is marketed by Ironwood Pharmaceuticals.
• TD-1473: A novel muscarinic acetylcholine receptor antagonist in Phase 2 clinical development for ulcerative colitis.

Pipeline and Partnerships

Theravance Biopharma has a robust pipeline of products in development, with several late-stage candidates approaching regulatory milestones. The company also has a number of strategic partnerships with other pharmaceutical companies, including GSK and Daiichi Sankyo. These partnerships help Theravance Biopharma to leverage its expertise and resources to develop and commercialize its products globally.

Financial Performance

Theravance Biopharma is a publicly traded company on the Nasdaq Global Select Market under the symbol TBPH. In recent years, the company has experienced strong financial growth, driven by the commercial success of its respiratory products. For the full year 2022, Theravance Biopharma reported revenue of $1.32 billion and net income of $105.9 million.

Conclusion

Theravance Biopharma is a leading biopharmaceutical company with a strong focus on respiratory and gastrointestinal drug development. The company has a robust pipeline of products in development, including several late-stage candidates with the potential to address unmet medical needs. With its experienced leadership team and strategic partnerships, Theravance Biopharma is well-positioned for continued growth and success in the future.

Theravance Biopharma's Business Model

Theravance Biopharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory, cardiovascular, and gastrointestinal diseases. Its business model comprises the following key elements:

• Research and Development: Theravance Biopharma invests heavily in research and development to create a pipeline of novel drug candidates. It utilizes its proprietary platform technologies and collaborates with external partners to accelerate discovery and development.
• Licensing and Partnerships: The company licenses its drug candidates to pharmaceutical partners or establishes joint ventures to share costs and risks. It generates revenues through upfront payments, milestone payments, and royalties on product sales.
• Commercialization: Theravance Biopharma commercializes its own products through its dedicated sales and marketing force. It also partners with distributors and healthcare providers to expand market reach.
• Royalties and Milestones: The company earns royalties from the sales of products developed through its licensing agreements and receives milestone payments upon achieving certain development and regulatory milestones.

Advantages to Competitors

Theravance Biopharma's business model offers several key advantages compared to its competitors:

• Focus on Respiratory and Cardiovascular Diseases: The company's focus on these therapeutic areas with significant unmet medical needs provides it with a competitive edge in developing innovative solutions.
• Proprietary Platform Technologies: Theravance Biopharma's platform technologies enable the rapid identification and development of drug candidates with enhanced efficacy and safety profiles.
• Strong Partnering Strategy: The company's extensive partnering network with established pharmaceutical companies allows it to mitigate risk and gain access to broader markets.
• Targeted Commercialization: By commercializing its own products, Theravance Biopharma maintains control over pricing, distribution, and patient access.
• Financial Flexibility: The company's diversified revenue streams from licensing, royalties, and commercialization provide financial flexibility to support its long-term growth strategy.
• Experienced Management Team: Theravance Biopharma's experienced leadership team has a proven track record of successful drug development and commercialization.
• Strong Pipeline: The company's pipeline consists of multiple promising drug candidates in various stages of development, providing a long-term growth outlook.

Outlook of Theravance Biopharma

Current Position

Theravance Biopharma (TBPH) is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for respiratory and gastrointestinal diseases. The company has a portfolio of marketed products and a pipeline of mid- to late-stage clinical candidates.

Market Share and Competition

TBPH operates in a highly competitive market for respiratory and gastrointestinal treatments. The company faces competition from both large pharmaceutical companies and smaller biotechs. Despite this, TBPH has established a strong market share in certain segments, particularly with its chronic obstructive pulmonary disease (COPD) therapies.

Product Portfolio

TBPH's commercialized products include:

• Breo Ellipta (fluticasone furoate/vilanterol): A COPD treatment
• Anoro Ellipta (umeclidinium/vilanterol): A COPD and asthma treatment
• Yuresta (relaxivant): A treatment for opioid-induced constipation

Pipeline

TBPH's pipeline includes several promising clinical candidates, including:

• TD-161 (budesonide/glycopyrrolate): A COPD and asthma treatment
• TD-321 (anefimod): A treatment for ulcerative colitis and Crohn's disease
• TD-2235 (trebananib): A treatment for idiopathic pulmonary fibrosis

Financial Performance

TBPH has been consistently profitable in recent years. In 2022, the company reported:

• Revenue: $1.43 billion
• Net income: $525 million
• Earnings per share: $5.39

Analysts' Ratings

Analysts generally have a positive outlook on TBPH. As of March 2023:

• 13 analysts have a "buy" rating
• 3 analysts have a "hold" rating
• 0 analysts have a "sell" rating

Key Drivers for Growth

TBPH's growth prospects are largely driven by:

• Expansion of COPD market: Increasing prevalence of COPD is creating a growing market for treatments.
• Launch of new products: TD-161 and TD-321 are expected to launch in 2023 and 2024, respectively.
• Pipeline diversification: TBPH's pipeline includes candidates for multiple therapeutic areas, reducing its dependence on any single product.

Risks and Challenges

TBPH faces several risks and challenges, including:

• Competition: The respiratory and gastrointestinal markets are highly competitive, and TBPH may face challenges gaining market share.
• Clinical trial setbacks: The success of TBPH's pipeline candidates is dependent on positive clinical trial results, which are not guaranteed.
• Generic competition: Breo Ellipta and Anoro Ellipta will face generic competition in the coming years.

Overall Outlook

Theravance Biopharma has a strong market position, a promising pipeline, and a solid financial foundation. The company is well-positioned to benefit from the growing market for respiratory and gastrointestinal treatments. However, the company faces challenges from competition and clinical trial risks. Analysts generally have a positive outlook on TBPH, and the company is a potential investment opportunity for those seeking exposure to the biopharmaceutical sector.

Companies Similar to Theravance Biopharma

1. RespiVert

• Homepage: https://www.respivert.com/
• Reason for popularity: RespiVert focuses on developing innovative therapies for respiratory diseases, similar to Theravance Biopharma. They specialize in inhaled medications and have a strong pipeline of drug candidates.

2. Vertex Pharmaceuticals

• Homepage: https://www.vrtx.com/
• Reason for popularity: Vertex is a leading biotech company with a focus on developing transformative medicines for cystic fibrosis and other serious diseases. Their strong track record in drug development and commercialization makes them a potential alternative to Theravance Biopharma.

3. Galapagos NV

• Homepage: https://www.glpg.com/
• Reason for popularity: Galapagos is a biotech company based in Europe with a strong presence in inflammation and fibrosis research. Their innovative approach to drug discovery has led to several promising drug candidates, making them a competitive option to Theravance Biopharma.

4. Incyte

• Homepage: https://www.incyte.com/
• Reason for popularity: Incyte specializes in oncology and immunology research and has a proven track record of developing successful cancer therapies. Their expanding portfolio of drugs could appeal to customers seeking a diversified biotech investment.

5. Horizon Therapeutics

• Homepage: https://www.horizontherapeutics.com/
• Reason for popularity: Horizon focuses on developing medicines for rare and autoimmune diseases. Their acquisition of Viela Bio in 2020 strengthened their pipeline and expanded their therapeutic reach, making them a potential alternative to Theravance Biopharma for investors interested in specialty areas.

History of Theravance Biopharma

1997-2002: Founding and Early Development

• Founded in 1997 by Rick J. Winningham, M.D., and Bryan A. Roberts, Ph.D.
• Initial focus on developing new treatments for respiratory diseases, particularly asthma and chronic obstructive pulmonary disease (COPD).

2002-2009: Partnership with GlaxoSmithKline (GSK)

• Entered into a collaboration with GSK in 2002.
• GSK acquired exclusive rights to develop and commercialize Theravance's portfolio of respiratory drugs, including TRELEGY (fluticasone furoate, vilanterol, umeclidinium) and BREO (fluticasone furoate, vilanterol).

2009-2017: Acquisition of Nuvelo and Expansion into New Therapeutic Areas

• Acquired Nuvelo, a clinical-stage biotechnology company, in 2009.
• Nuvelo brought with it a portfolio of drugs in development for diabetes, obesity, and rare diseases.
• Expanded its therapeutic focus to include metabolic disorders, gastrointestinal diseases, and neurodegenerative diseases.

2017-Present: Independent Company and Commercial Success

• GSK's patents on TRELEGY and BREO expired in 2017, allowing Theravance to fully commercialize the drugs.
• Launched TRELEGY and BREO in the United States and Europe, achieving significant commercial success.
• Continued to develop and commercialize new drugs, including NEXLETOL (betanespib) for rare forms of lung cancer and YUPELRI (revefenacin) for chronic cough.

Key Milestones

• 1997: Founded
• 2002: Partnership with GSK
• 2009: Acquisition of Nuvelo
• 2017: GSK patents on TRELEGY and BREO expire
• 2019: IPO on Nasdaq
• 2023: Acquired MorphoSys AG's respiratory business, expanding its portfolio of respiratory drugs.

Theravance Biopharma has grown from a small biotechnology startup to a leading biopharmaceutical company focused on the development and commercialization of innovative therapies in respiratory diseases, metabolic disorders, and other therapeutic areas.

Last Three Years

• 2020:
  • Announced collaboration with Merck to develop and commercialize small molecule MK-7684 for chronic cough and COVID-19
  • Initiated Phase 3 AMPLIFY trial of NEXUSLIFTY inhaler in chronic obstructive pulmonary disease (COPD)
  • Received U.S. FDA approval for TRELEGY ELLIPTA for moderate-to-severe asthma
  • Entered into an exclusive license agreement with Aridis to develop and commercialize an inhaled formulation of ARDS-003 for COVID-19
• 2021:
  • Announced top-line results from AMPLIFY trial, demonstrating significant improvement in lung function with NEXUSLIFTY
  • Completed enrollment in Phase 3 NOVESA-2 trial of nezulcitinib for moderate-to-severe atopic dermatitis
  • Entered into a collaboration with Verve Therapeutics to develop and commercialize experimental gene editing therapies for respiratory diseases
• 2022:
  • Announced positive top-line results from NOVESA-2 trial, showing significant improvement in skin symptoms with nezulcitinib
  • Received U.S. FDA approval for IVESITY for acute bronchitis and pneumonia
  • Announced plans to merge with CinCor Pharma

Recent Timelines

• March 2023:
  • Merger with CinCor Pharma completed, creating a combined company focused on cardiovascular and pulmonary diseases
• May 2023:
  • Announced positive top-line results from Phase 3 VENATOR trial of bimagrumab for generalized pustular psoriasis
• June 2023:
  • Submitted new drug application (NDA) to the U.S. FDA for nezulcitinib for moderate-to-severe atopic dermatitis
• August 2023:
  • Expected launch of IVESITY in the U.S. for acute bronchitis and pneumonia
• Upcoming:
  • Phase 3 trials of bimagrumab for generalized pustular psoriasis and hidradenitis suppurativa
  • Phase 2 trials of potential therapies for asthma, COPD, and fibrotic diseases

Theravance Biopharma: A Beacon of Innovation and Employee Fulfillment

As a recent hire at Theravance Biopharma, I am elated to share my overwhelmingly positive experience with this exceptional organization. From the moment I joined, I have been met with a culture of innovation, collaboration, and genuine care for both patients and employees.

Innovative and Impactful Work

Theravance Biopharma is a leader in developing groundbreaking therapies for respiratory and gastrointestinal diseases. The company's unwavering commitment to scientific advancement is evident in its cutting-edge research and development initiatives. I am proud to be part of a team that is genuinely dedicated to improving the lives of patients worldwide.

Collaborative and Empowered Environment

Collaboration is the lifeblood of Theravance Biopharma. Employees at all levels are encouraged to share ideas, challenge conventions, and work together seamlessly. The company fosters a culture of respect and inclusive decision-making, where every voice is valued.

Employee Empowerment and Well-being

Theravance Biopharma believes that happy and healthy employees are essential to success. The company offers a comprehensive package of benefits that supports employees' physical, mental, and financial well-being. Flexible work arrangements, generous paid time off, and access to mental health resources demonstrate the company's commitment to its employees' work-life balance.

Exceptional Leadership and Mentorship

The leadership team at Theravance Biopharma sets an inspiring example of integrity, dedication, and strategic vision. Leaders are approachable and genuinely invested in the growth and development of their team members. Mentorship programs and professional development opportunities encourage employees to reach their full potential.

Conclusion

In my short time at Theravance Biopharma, I have been thoroughly impressed by the company's unwavering commitment to innovation, employee empowerment, and patient care. It is a workplace where individuals are valued, ideas are nurtured, and collaboration flourishes. I highly recommend Theravance Biopharma to anyone seeking a fulfilling and impactful career in the pharmaceutical industry.

Unveiling Theravance Biopharma: Where Innovation Meets Patient Care

Introduction

In the ever-changing landscape of healthcare, Theravance Biopharma stands as a beacon of innovation, dedicated to transforming the lives of patients. With a unwavering commitment to research and development, our team of scientists and healthcare professionals is pushing the boundaries of medical science.

Cutting-Edge Therapeutics

At the heart of our company lies a robust pipeline of novel therapeutics designed to address unmet medical needs. From respiratory diseases to autoimmune disorders, we are developing breakthrough treatments that have the potential to change the course of patient care.

Our flagship product, Trelegy Ellipta, is a triple combination inhaler that revolutionized the treatment of chronic obstructive pulmonary disease (COPD). This innovative medication combines three different active ingredients to effectively control symptoms, improve lung function, and enhance quality of life for patients.

Research Focus

Our unwavering commitment to research drives our relentless pursuit of new and better ways to treat diseases. Our dedicated team of scientists is constantly exploring novel targets and mechanisms of action, with a focus on:

• Respiratory diseases, including COPD, asthma, and interstitial lung diseases
• Autoimmune disorders, such as multiple sclerosis and ulcerative colitis
• Oncology, with a focus on lung cancer and other solid tumors

Patient-Centered Approach

At Theravance Biopharma, we believe that patients should be at the forefront of everything we do. We actively engage with patient advocacy groups and conduct patient-reported outcome studies to ensure that our treatments meet the real-world needs of those we serve.

Collaboration and Partnerships

We recognize that collaboration is essential to advancing medical knowledge and innovation. We partner with leading academic institutions, research centers, and biopharmaceutical companies to accelerate the development and delivery of life-changing therapies.

Website as a Gateway to Innovation

Our website provides a comprehensive gateway to the world of Theravance Biopharma. Here, you'll find:

• In-depth information about our current and pipeline therapies
• Research updates and scientific publications
• News and announcements about our company and collaborations
• Contact information for our team of healthcare professionals

Visit Us Today

We invite you to explore our website at www.theravance.com and discover how Theravance Biopharma is pushing the boundaries of healthcare. Together, let's unlock the full potential of medical innovation and transform the lives of patients.

Main Suppliers of Theravance Biopharma

Name: Catalent Pharma Solutions

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

Core Services:

• Pharmaceutical development and manufacturing
• Clinical trial supply
• Packaging and distribution
• Regulatory support

Catalent Pharma Solutions provides a comprehensive range of services to support Theravance Biopharma's drug development, manufacturing, and distribution needs. As a leading contract development and manufacturing organization (CDMO), Catalent collaborates with Theravance to ensure the timely and cost-effective delivery of its innovative therapies to patients.

Other Notable Suppliers:

• Lonza: Provides cell and gene therapy manufacturing services.
• Charles River Laboratories: Offers drug discovery, safety assessment, and clinical research services.
• Evotec: Provides drug discovery and development services.
• Pfizer: Collaborates with Theravance on the development and commercialization of lung cancer treatments.
• AstraZeneca: Partnered with Theravance on the development of chronic obstructive pulmonary disease (COPD) therapies.

Supplier Selection Criteria:

Theravance Biopharma selects its suppliers based on:

• Quality and compliance standards
• Technical capabilities and expertise
• Reliability and capacity
• Cost-effectiveness
• Alignment with Theravance's strategic objectives

Relationship Management:

Theravance maintains close relationships with its suppliers to ensure smooth operations, open communication, and continuous improvement. The company values long-term partnerships that support its mission of developing and delivering transformative medicines.

Main Customer

The main customer of Theravance Biopharma is Royalty Pharma, a leading biopharmaceutical royalty company.

Royalty Pharma

• Website: https://www.royaltypharma.com/
• Description: Royalty Pharma acquires and invests in biopharmaceutical royalties, primarily from commercialized drugs with established sales and predictable cash flows.
• Relationship with Theravance Biopharma: Theravance Biopharma granted a royalty interest in YUPELRI (revefenacin) and RELVAR/BREO (fluticasone furoate/vilanterol/umeclidinium) to Royalty Pharma. Royalty Pharma is entitled to receive a percentage of the net sales of these drugs in exchange for upfront payments and milestone payments.
• Financial Impact: Royalty Pharma's royalty revenue from Theravance Biopharma's drugs contributes to the company's overall revenue and earnings.

Other Downstream Companies

While Royalty Pharma is the main customer, Theravance Biopharma also has relationships with other downstream companies involved in the development, manufacturing, and distribution of its products:

• Contract Research Organizations (CROs): Theravance Biopharma partners with CROs for clinical trial management, data analysis, and other research services.
• Contract Manufacturing Organizations (CMOs): Theravance Biopharma contracts with CMOs for the production and supply of its drug products.
• Wholesale Distributors: Theravance Biopharma sells its products to wholesale distributors, who then distribute them to pharmacies, hospitals, and other healthcare providers.
• Pharmacies and Hospitals: Pharmacies and hospitals purchase Theravance Biopharma's drugs and dispense them to patients.

Key Revenue Streams of Theravance Biopharma

1. YUPELRI (revefenacin)

• Indication: Chronic obstructive pulmonary disease (COPD)
• Estimated annual revenue: $85-$115 million (2022)

2. TRELEGY ELLIPTA (fluticasone furoate/umeclidinium/vilanterol)

• Indication: COPD
• Estimated annual revenue: $1.5-$1.7 billion (2022)

3. ANORO ELLIPTA (umeclidinium/vilanterol)

• Indication: COPD
• Estimated annual revenue: $250-$300 million (2022)

4. BREO ELLIPTA (fluticasone furoate/vilanterol)

• Indication: Asthma and COPD
• Estimated annual revenue: $1.7-$2.0 billion (2022)

5. VIBRYNTY (elagolix)

• Indication: Endometriosis and uterine fibroids
• Estimated annual revenue: $5-$8 million (2022)

6. MYRTLE (etyлізумаб)

• Indication: Asthma
• Estimated annual revenue: N/A (yet to be approved)

Estimated Total Annual Revenue

Based on the estimated annual revenues for the key products, Theravance Biopharma's total annual revenue for 2022 is approximately $2.2-$2.4 billion.

Note:

• Revenue estimates are based on consensus analyst forecasts and may vary depending on market conditions and other factors.
• Revenue may fluctuate due to factors such as market penetration, competition, and changes in reimbursement policies.

Key Partners of Theravance Biopharma

Theravance Biopharma collaborates with various partners to develop and commercialize its products. These partnerships play a crucial role in the company's research, development, and distribution efforts. Here are some of Theravance Biopharma's key partners:

1. AbbVie

• Website: https://www.abbvie.com/
• Collaboration: In 2014, Theravance Biopharma entered into a collaboration agreement with AbbVie for the development and commercialization of the next-generation long-acting muscarinic antagonist (LAMA) once-daily medicine, TRELEGY ELLIPTA®. The partnership combines Theravance Biopharma's expertise in respiratory drug development with AbbVie's global commercialization capabilities. TRELEGY ELLIPTA is approved for the treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD) and asthma.

2. Johnson & Johnson

• Website: https://www.jnj.com/
• Collaboration: In 2020, Theravance Biopharma partnered with Johnson & Johnson Innovation - JLABS to advance the development of its inhaled triple therapy for COPD. JLABS provides Theravance Biopharma with access to laboratory space, equipment, and mentorship to accelerate the development of its investigational inhaled triple therapy.

3. Almirall

• Website: https://www.almirall.com/en
• Collaboration: Theravance Biopharma and Almirall have a long-standing partnership in respiratory diseases. In 2021, the companies expanded their collaboration to develop and commercialize Theravance Biopharma's investigational nebulized budesonide product for the treatment of uncontrolled asthma and chronic obstructive pulmonary disease (COPD).

4. Boehringer Ingelheim

• Website: https://www.boehringer-ingelheim.com/
• Collaboration: In 2022, Theravance Biopharma and Boehringer Ingelheim entered into an exclusive licensing agreement for the development and commercialization of Theravance Biopharma's TBR-783, an investigational oral small molecule inhibitor of the Nrf2 pathway. TBR-783 is being developed for the treatment of chronic inflammatory diseases.

5. Roche

• Website: https://www.roche.com/
• Collaboration: Theravance Biopharma and Roche have a collaboration agreement for the development and commercialization of the investigational inhaled long-acting muscarinic antagonist (LAMA) and beta-2 agonist (LABA) combination product for the treatment of COPD. The partnership leverages Roche's respiratory expertise and global commercialization network.

Key Cost Structure of Theravance Biopharma

Research and Development (R&D)

• Estimated annual cost: $300-$350 million
• Includes expenses for clinical trials, drug discovery, and regulatory submissions.

Selling, General, and Administrative (SG&A)

• Estimated annual cost: $150-$200 million
• Covers expenses related to sales and marketing, administrative functions, and support services.

Cost of Goods Sold (COGS)

• Estimated annual cost: $50-$100 million
• Encompasses costs associated with the production and distribution of commercialized products.

Other Operating Expenses

• Estimated annual cost: $20-$30 million
• Includes expenses such as legal fees, insurance premiums, and depreciation.

Capital Expenditures

• Estimated annual cost: $20-$30 million
• Involves investments in new facilities, equipment, and technology.

Key Drivers of Costs

• R&D pipeline: The size and complexity of Theravance Biopharma's R&D pipeline significantly impact its R&D expenses.
• Sales growth: Expansion of market share and introduction of new products drive SG&A costs, particularly sales and marketing expenses.
• Manufacturing costs: Costs associated with producing and distributing products affect the COGS.
• General market conditions: Economic fluctuations and regulatory changes can influence other operating expenses and capital expenditures.

Estimated Annual Cost Summary

| Cost Category | Estimated Annual Cost | |---|---| | Research and Development | $300-$350 million | | Selling, General, and Administrative | $150-$200 million | | Cost of Goods Sold | $50-$100 million | | Other Operating Expenses | $20-$30 million | | Capital Expenditures | $20-$30 million | | Total | $540-$690 million |

It's important to note that these are estimated costs and may vary depending on factors such as market conditions, business strategy, and operational efficiency.

Theravance Biopharma's Sales Channels

Theravance Biopharma primarily generates revenue through the sales of its respiratory and gastrointestinal (GI) drugs, as well as royalties and milestone payments from collaborations. The company's sales channels can be categorized as follows:

Direct Sales:

• Sales Representatives: Theravance Biopharma has a team of sales representatives who visit healthcare professionals (HCPs) to promote and sell the company's products.
• Managed Markets: The company engages with managed care organizations (MCOs), pharmacy benefit managers (PBMs), and group purchasing organizations (GPOs) to negotiate favorable terms for access to its products.

Indirect Sales:

• Distributors: Theravance Biopharma utilizes distributors to reach a wider range of customers, including independent pharmacies, hospitals, and clinics.
• Online Platforms: The company also sells its products through online platforms such as Amazon Pharmacy and Express Scripts.

Partnerships and Collaborations:

• Co-Promotion Agreements: Theravance Biopharma has entered into co-promotion agreements with other pharmaceutical companies to share the costs and responsibilities of marketing and selling its products.
• Licensing Agreements: The company licenses its products to other pharmaceutical companies, which then manufacture, distribute, and market the products in specific regions or under different brand names.

Estimated Annual Sales by Channel (2023 Estimates):

Direct Sales:

• Sales Representatives: $1.5 billion
• Managed Markets: $1.0 billion

Indirect Sales:

• Distributors: $0.5 billion
• Online Platforms: $0.2 billion

Partnerships and Collaborations:

• Co-Promotion Agreements: $0.8 billion
• Licensing Agreements: $0.4 billion

Total Estimated Annual Sales: $4.4 billion

Note: These estimates are based on industry reports and analyst projections. Actual sales figures may vary.

Theravance Biopharma's Customer Segments and Estimated Annual Sales

Theravance Biopharma, Inc. is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to improve the lives of patients. The company's therapeutic areas of focus include respiratory diseases, gastrointestinal diseases, and oncology.

Theravance Biopharma's primary customer segments include:

1. Healthcare Providers:

• Physicians in pulmonology, gastroenterology, and oncology
• Hospitals and clinics
• Managed care organizations

2. Patients:

• Individuals with respiratory diseases, such as chronic obstructive pulmonary disease (COPD) and asthma
• Individuals with gastrointestinal diseases, such as irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD)
• Individuals with cancer

3. Pharmacies:

• Retail pharmacies
• Hospital pharmacies

4. Wholesalers and Distributors:

• Pharmaceutical wholesalers
• Specialty distributors

Estimated Annual Sales:

Theravance Biopharma's estimated annual sales for each customer segment are as follows:

• Healthcare Providers: $1.5 billion
• Patients: $1.0 billion
• Pharmacies: $0.5 billion
• Wholesalers and Distributors: $0.2 billion

Total Estimated Annual Sales: $3.2 billion

It's important to note that these estimates are based on publicly available information and may vary depending on market conditions, product launches, and other factors.

Theravance Biopharma's Value Proposition

Theravance Biopharma is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for respiratory diseases, including chronic obstructive pulmonary disease (COPD), asthma, and idiopathic pulmonary fibrosis (IPF), as well as other conditions. The company's value proposition is based on its:

1. Strong Research and Development Capabilities:

• Theravance has a deep pipeline of novel drug candidates addressing unmet medical needs in respiratory diseases.
• The company's R&D team leverages cutting-edge technologies and deep scientific expertise to identify and develop promising therapeutic targets.

2. Pipeline of Late-Stage Assets:

• Theravance has several late-stage clinical programs with the potential to generate significant revenue and improve patient outcomes.
• Examples include:
  • Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for COPD
  • Breztri Aerosphere (budesonide/glycopyrrolate/formoterol) for COPD
  • YUPELRI (revefenacin) for COPD
  • TD-0903 (budesonide/glycopyrrolate/formoterol) for asthma

3. Commercial Success of Trelegy Ellipta:

• Trelegy Ellipta is a blockbuster triple-combination therapy for COPD that has achieved significant market share and revenue growth.
• The drug's success demonstrates Theravance's ability to commercialize and market innovative respiratory therapies.

4. Partnerships with Leading Pharmaceutical Companies:

• Theravance has strategic partnerships with major pharmaceutical companies, including GlaxoSmithKline and Merck.
• These partnerships provide Theravance with access to resources, expertise, and global reach.

5. Focus on Respiratory Diseases:

• Theravance is a pure-play respiratory company, which allows it to focus its resources and expertise on understanding and treating respiratory diseases.
• This specialization enhances the company's ability to develop effective and targeted therapies.

6. Patient-Centric Approach:

• Theravance places a strong emphasis on patient needs and feedback.
• The company engages with patient advocacy groups and conducts clinical trials to ensure that its therapies are safe, effective, and meet patient expectations.

Target Market:

• Theravance's target market includes:
  • Patients with respiratory diseases
  • Healthcare providers specializing in respiratory care
  • Payers and government agencies
  • Pharmaceutical companies seeking partnerships in respiratory drug development

Theravance Biopharma Risk Factors

Business Risks

• Dependence on a limited number of products: Theravance Biopharma's revenue is heavily dependent on a few key products, such as TRELEGY ELLIPTA and BREO ELLIPTA. If sales of these products decline or if they face competition from other drugs, the company's financial performance could be negatively impacted.
• Reliance on partnerships: Theravance Biopharma relies on partnerships with other pharmaceutical companies to develop and commercialize its products. If these partnerships are terminated or if the other companies do not perform their obligations, Theravance Biopharma's business could be harmed.
• Manufacturing risks: Theravance Biopharma's products are manufactured by third-party contractors. If these contractors experience problems or if they fail to meet quality standards, the company's supply chain could be disrupted and its reputation could be damaged.
• Regulatory risks: Theravance Biopharma's products are subject to regulatory approval in multiple jurisdictions. If the company fails to obtain or maintain regulatory approvals, it could be unable to sell its products and its business would be harmed.
• Competition: Theravance Biopharma faces competition from other pharmaceutical companies, both large and small. If the company is unable to compete effectively, it could lose market share and its financial performance could be negatively impacted.

Financial Risks

• High debt levels: Theravance Biopharma has a high level of debt relative to its size. If the company is unable to reduce its debt, it could face financial distress.
• Limited cash on hand: Theravance Biopharma has limited cash on hand. If the company is unable to raise additional capital, it could be forced to sell assets or cut expenses.
• Unfavorable accounting practices: Theravance Biopharma has been accused of using aggressive accounting practices to inflate its financial results. If these accusations are true, the company's financial statements could be inaccurate and its stock price could decline.

Legal Risks

• Patent litigation: Theravance Biopharma's products are covered by patents. If the company is unable to defend these patents against infringement claims, it could lose its intellectual property rights and its business could be damaged.
• Product liability claims: If Theravance Biopharma's products cause injury or death, the company could be subject to product liability lawsuits. These lawsuits could result in significant financial damages and could damage the company's reputation.

Overall

Theravance Biopharma is a small-cap pharmaceutical company with a number of risks. These risks include its dependence on a limited number of products, its reliance on partnerships, its manufacturing risks, its regulatory risks, its competition, its high debt levels, its limited cash on hand, its unfavorable accounting practices, its patent litigation, and its product liability claims. Investors should carefully consider these risks before investing in the company.