TG Therapeutics | research notes

Introducing TG Therapeutics: A Leader in Novel Cancer Therapies

Background:

TG Therapeutics is a global biopharmaceutical company dedicated to the research, development, and commercialization of novel therapies for B-cell malignancies and other hematologic disorders. Founded in 2008, the company has established a strong pipeline of innovative drugs and is rapidly expanding its presence in the oncology landscape.

Pipeline:

TG Therapeutics boasts a robust portfolio of investigational and marketed therapies, including:

• Ublituximab (Tyvyt): A glycoengineered anti-CD20 monoclonal antibody approved for relapsed multiple sclerosis (MS) and under investigation for various B-cell malignancies.
• Umbralisib (Ukoniq): A dual inhibitor of PI3Kδ and CK1ε approved for relapsed/refractory marginal zone lymphoma (MZL) and follicular lymphoma (FL).
• Cotelikumab (Symjepi): A fully human monoclonal antibody targeting CTLA-4, approved for the treatment of refractory metastatic uveal melanoma and Merkel cell carcinoma.
• TG-1701: A novel anti-PD-1 antibody under investigation for the treatment of solid tumors and hematologic malignancies.
• TG-1501: A potent and selective inhibitor of the BTK enzyme, being evaluated in clinical trials for B-cell malignancies.

Clinical Focus:

TG Therapeutics focuses its clinical research efforts on targeting key molecular pathways involved in the growth and spread of cancer cells. The company's pipeline targets key immune checkpoints, including PD-1 and CTLA-4, as well as signaling pathways such as PI3K and BTK.

Partnerships and Collaborations:

To accelerate the development and commercialization of its therapies, TG Therapeutics has established strategic partnerships with leading pharmaceutical companies, including:

• Servier: A global pharmaceutical group with extensive experience in oncology, partnering on the development and commercialization of TG-1701 and TG-1501.
• Incyte: A biopharmaceutical company specializing in oncology, collaborating on the co-development and co-commercialization of umbralisib.

Commercial Presence:

TG Therapeutics has a commercial presence in the United States, where Tyvyt and Ukoniq are approved for the treatment of MS and B-cell malignancies, respectively. The company is also expanding its commercial footprint to other international markets.

Future Outlook:

With a promising pipeline of innovative therapies and a strong track record of scientific advancements, TG Therapeutics is well-positioned to continue making significant contributions to the fight against cancer. The company's focus on novel targets and strategic partnerships will drive its growth in the rapidly evolving oncology market.

Business Model of TG Therapeutics

TG Therapeutics is a biopharmaceutical company focused on developing and commercializing novel therapies for cancer and autoimmune diseases. Its primary business model consists of:

• Research and Development (R&D): TG Therapeutics conducts extensive R&D to identify and develop innovative therapeutic candidates. It collaborates with leading academic and research institutions.

• Licensing and Partnerships: The company enters into licensing agreements with other pharmaceutical companies to develop and commercialize its products in different regions or therapeutic areas.

• Commercialization: TG Therapeutics commercializes its approved products through its own salesforce in key markets. It also enters into distribution agreements with third-party partners in other regions.

Advantages to Competitors

TG Therapeutics has several competitive advantages over its competitors:

• Strong Pipeline: The company has a robust pipeline of novel therapeutics, including multiple candidates in late-stage clinical trials. This provides potential for significant future growth.

• Focused Therapeutic Areas: TG Therapeutics focuses primarily on cancer and autoimmune diseases, which are large and growing markets. Its targeted approach allows it to leverage its expertise and resources effectively.

• First-to-Market Opportunities: The company has secured several first-to-market approvals for its products, giving it a competitive edge in certain therapeutic segments.

• Intellectual Property: TG Therapeutics holds a portfolio of patents and intellectual property rights that protect its products and provide a competitive barrier.

• Strategic Partnerships: The company has formed strategic alliances with established pharmaceutical companies, such as Celgene and Novartis, to enhance its commercialization capabilities and access to global markets.

• Personalized Medicine Approach: TG Therapeutics aims to develop therapies that target specific genetic mutations or biomarkers, enabling personalized treatment options for patients.

• Precision Medicine Platform: The company's precision medicine platform allows it to identify and develop therapies based on individual patient genomic profiles. This has the potential to improve treatment outcomes and reduce side effects.

Outlook of TG Therapeutics

Market Position:

• Leading biotechnology company focused on developing and commercializing novel therapies for B-cell malignancies and autoimmune diseases.
• Strong pipeline of innovative therapies with potential blockbusters in various stages of clinical development.

Pipeline:

• Ublituximab (TG-1101): Anti-CD20 monoclonal antibody for relapsed/refractory chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), and multiple sclerosis (MS).
• Umbralisib (UKONIQ): PI3K delta inhibitor for CLL, NHL, and marginal zone lymphoma (MZL).
• TGR-1202: Oral dual PI3K delta and tankyrase inhibitor for CLL and other hematologic malignancies.
• TTI-621: Antibody-drug conjugate (ADC) targeting CD19 for B-cell malignancies.
• TG-1801: Novel oral Bruton's tyrosine kinase (BTK) inhibitor for CLL and other hematologic malignancies.

Pipeline Strengths:

• High unmet medical need for therapies in the target indications.
• Potential for multiple blockbuster therapies with differentiated mechanisms of action.
• Strong clinical data with significant overall response rates and favorable safety profiles.

Financial Performance:

• Revenue: Steady growth in recent years, driven by sales of Umbralisib.
• Operating Income: Improving in recent quarters, indicating progress towards profitability.
• Cash Position: Strong cash position with over $1 billion as of March 2023.

Key Partners:

• Roche (global distribution agreement for TGR-1202).
• Genmab (ADC technology for TTI-621).

Competitive Landscape:

• Competitors include established players in the hematology market such as AbbVie, AstraZeneca, and Merck.
• Differentiated therapies and strong clinical data set TG Therapeutics apart from competitors.

Growth Drivers:

• Commercial success of Ublituximab in MS and hematologic malignancies.
• Phase 3 clinical trials for TGR-1202 and TG-1801 expected to generate additional data and regulatory approvals.
• Strategic partnerships and licensing agreements to expand commercial reach.

Challenges:

• Regulatory approvals and market access for pipeline therapies.
• Competition from existing and emerging therapies.
• Dependence on key clinical trials for pipeline validation.

Overall Outlook:

TG Therapeutics has a strong pipeline, robust financial position, and promising partnerships. The success of Ublituximab and the potential of other pipeline therapies position the company for continued growth and value creation in the hematology and autoimmune disease markets. However, regulatory and competitive challenges remain, and investors should monitor pipeline progress and commercialization efforts closely.

Similar Companies to TG Therapeutics

1. Karyopharm Therapeutics (KPTI)

• Homepage: https://karyopharm.com/
• Reason for customer interest: Karyopharm develops innovative cancer therapies targeting nuclear transport proteins, offering potential for improved efficacy and tolerability in hematologic and solid malignancies.

2. Celgene (CELG)

• Homepage: https://www.celgene.com/
• Reason for customer interest: Celgene is a global leader in the development and commercialization of innovative therapies for serious diseases, including hematologic malignancies, multiple myeloma, and myelodysplastic syndromes.

3. Sesen Bio (SESN)

• Homepage: https://www.sesenbio.com/
• Reason for customer interest: Sesen Bio focuses on developing antibody-based therapies for the treatment of solid tumors, including bladder cancer. Its lead product, Vicineum, has shown promising results in clinical trials.

4. Secura Bio (SECU)

• Homepage: https://www.securabio.com/
• Reason for customer interest: Secura Bio is a clinical-stage biopharmaceutical company developing novel antibody-drug conjugates (ADCs) for the treatment of cancer. Its lead ADC, SB-1, targets CD33 and has shown strong anti-leukemia activity in preclinical models.

5. Agenus (AGEN)

• Homepage: https://www.agenusbio.com/
• Reason for customer interest: Agenus is a clinical-stage biopharmaceutical company developing cancer immunotherapies, including adoptive cell therapies and checkpoint inhibitors. Its focus on personalized medicine approaches offers potential for enhanced efficacy against a wide range of cancers.

History of TG Therapeutics:

2004:

• Founded as Transform Genetics, Inc. by Michael Becker and Daniel Lynch, Jr., focusing on developing therapies for cancer.

2007:

• Renamed TG Therapeutics, Inc.

2008:

• Completed its initial public offering (IPO) on the Nasdaq under the symbol "TGTX."

2012:

• Received U.S. Food and Drug Administration (FDA) approval for its first product, Crysvita (burosumab), for the treatment of X-linked hypophosphatemia (XLH).

2015:

• Acquired the oncology assets of Cephalon, including a portfolio of drugs targeting cancer stem cells.

2018:

• Received FDA approval for Ukoniq (umbralisib), a phosphoinositide 3-kinase (PI3K) delta inhibitor, for the treatment of marginal zone lymphoma (MZL).

2019:

• Received FDA approval for Briumvi (belantamab mafodotin), an antibody-drug conjugate, for the treatment of relapsed or refractory multiple myeloma.

2021:

• Submitted a Biologics License Application (BLA) to the FDA for ublituximab, a monoclonal antibody for the treatment of chronic lymphocytic leukemia (CLL).

2022:

• Received FDA approval for ublituximab for the treatment of CLL and small lymphocytic lymphoma (SLL).
• Acquired Skyline Therapeutics, a company developing RNA-based therapies, for $1.1 billion.

Current Status:

• TG Therapeutics is a publicly traded biotechnology company headquartered in New York City.
• It is focused on developing and commercializing innovative therapies for hematologic malignancies and autoimmune diseases.
• The company has a portfolio of approved products and a pipeline of investigational candidates.

Last Three Years

2020

• January: TG Therapeutics announces positive topline results from the Phase 3 UNITY-CLL study evaluating ublituximab as a first-line treatment for chronic lymphocytic leukemia (CLL).
• March: TG Therapeutics receives Breakthrough Therapy Designation from the FDA for ublituximab for the treatment of relapsed/refractory CLL.
• October: TG Therapeutics announces positive topline results from the Phase 2 EVOLUTION study evaluating umbralisib in combination with obi-833 for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL).

2021

• March: TG Therapeutics receives FDA approval for ublituximab for the treatment of relapsed/refractory CLL.
• May: TG Therapeutics announces positive topline results from the Phase 3 UNITY-NHL study evaluating ublituximab for the treatment of relapsed/refractory non-Hodgkin's lymphoma (NHL).
• November: TG Therapeutics announces positive topline results from the Phase 2 ALcanza study evaluating umbralisib in combination with ublituximab for the treatment of patients with relapsed/refractory CLL.

2022

• March: TG Therapeutics announces positive topline results from the Phase 3 CHRYSALIS-2 study evaluating umbralisib in combination with ublituximab for the treatment of patients with relapsed/refractory MCL.
• May: TG Therapeutics announces collaboration with Genentech to develop and commercialize umbralisib and ublituximab.
• October: TG Therapeutics announces positive topline results from the Phase 2 PHOENIX study evaluating TG-1701, a novel PI3K inhibitor, in combination with ublituximab for the treatment of patients with relapsed/refractory CLL.

Recent Timelines

• November 2022: TG Therapeutics announces FDA submission of a supplemental Biologics License Application (sBLA) for ublituximab for the treatment of previously treated marginal zone lymphoma (MZL).
• December 2022: TG Therapeutics announces positive topline results from the Phase 2 TRIumph study evaluating umbralisib in combination with TG-1701 for the treatment of patients with relapsed/refractory MCL.
• January 2023: TG Therapeutics announces FDA acceptance of the sBLA for ublituximab in MZL.
• February 2023: TG Therapeutics announces collaboration with Coherus Biosciences to develop and commercialize ublituximab and TG-1701 in China.

Exceptional Innovation and Employee Empowerment at TG Therapeutics

As a former employee of TG Therapeutics, I am thrilled to share my positive experiences and highly recommend the company to anyone considering a fulfilling career in biotechnology.

Cutting-Edge Innovation

TG Therapeutics is renowned for its pioneering work in innovative therapies for B-cell malignancies. The company's pipeline of novel drugs is rapidly progressing through clinical trials, with several breakthrough candidates showing promising results. I was inspired by the team's dedication to advancing scientific knowledge and developing life-changing treatments for patients.

Positive Work Culture

TG Therapeutics fosters a truly positive and inclusive work culture. Employees are highly valued and treated with respect. The open-door policy encourages constructive dialogue and collaboration across different departments. I felt genuinely supported and empowered to contribute my best.

Personal and Professional Growth

The company actively invests in its employees' professional development. I had numerous opportunities to attend industry conferences, receive mentorship, and take on new challenges. TG Therapeutics provides a dynamic and supportive environment where individuals are encouraged to grow and exceed expectations.

Industry-Leading Compensation and Benefits

TG Therapeutics offers competitive salaries, comprehensive benefits packages, and generous equity compensation plans. The company recognizes the value of its employees and rewards their contributions fairly. I felt financially secure and well-provided for during my time there.

Impactful Work with a Purpose

Working at TG Therapeutics gave me a deep sense of purpose. I had the privilege of contributing to the development of transformative therapies that have the potential to improve the lives of cancer patients around the world. The company's mission-driven culture encouraged me to make a meaningful impact on healthcare.

Overall Impression

My experience at TG Therapeutics was exceptional. The company's commitment to innovation, positive work culture, professional growth opportunities, and impactful work creates an unparalleled work environment. I highly recommend TG Therapeutics to anyone seeking a fulfilling and rewarding career in the biotechnology industry.

Unlocking Therapeutic Innovations for Cancer: Discover TG Therapeutics

Unleash the Potential of Targeted Cancer Therapies

At TG Therapeutics, we are dedicated to transforming the lives of cancer patients by developing and commercializing innovative therapies that target the underlying mechanisms of cancer. Join us on a journey of scientific discovery and patient empowerment.

Our Mission

Our mission is to create groundbreaking cancer treatments that improve patient outcomes, reduce side effects, and extend lifespans. We are committed to pushing the boundaries of medical research and bringing hope to those affected by cancer.

Cutting-Edge Therapeutics

Our pipeline includes a range of novel therapies, each targeting a specific molecular pathway involved in cancer development. From small molecules to antibody-drug conjugates, we are harnessing the power of targeted therapies to attack cancer cells with precision.

Personalized Medicine

We believe that every patient deserves a personalized treatment plan tailored to their unique cancer profile. Our biomarker-driven approach ensures that patients receive the therapies most likely to benefit them, maximizing treatment efficacy and minimizing side effects.

Patient-First Approach

At TG Therapeutics, patients are at the heart of everything we do. We are dedicated to providing compassionate care, supporting patients throughout their treatment journey, and empowering them to make informed decisions about their health.

Join the TG Therapeutics Community

Visit our website at [TG Therapeutics Website Link] today to learn more about our mission, discover our innovative therapies, and connect with our team of experts. Together, we can unlock the potential of targeted cancer therapies and redefine the future of cancer care.

Testimonials

"TG Therapeutics' therapies have given me hope and extended my life beyond what I thought possible. I am eternally grateful for the transformative power of their treatments." - Patient

"As a researcher, I am impressed by TG Therapeutics' commitment to scientific innovation and the development of therapies that truly address unmet medical needs." - Healthcare Professional

About TG Therapeutics

TG Therapeutics is a global biotechnology company headquartered in New York City. With operations in the United States, Europe, and Asia, we are dedicated to delivering transformative cancer therapies to patients worldwide.

Main Suppliers (or Upstream Service Providers) of TG Therapeutics

Name: Catalent Biologics Website: https://www.catalentbiologics.com/

Description:

Catalent Biologics is a leading global provider of development, manufacturing, and packaging solutions for the biopharmaceutical industry. The company provides a comprehensive range of services to support TG Therapeutics' drug development and manufacturing process, including:

• Biologics manufacturing and development
• Cell line development and characterization
• Process development and optimization
• Analytical characterization and release testing
• Fill-finish and packaging services

Catalent Biologics' expertise in biologics manufacturing and its state-of-the-art facilities ensure the high quality and reliability of TG Therapeutics' products. The company's flexible and scalable manufacturing platform enables TG Therapeutics to adjust production capacity based on market demand.

Key Services Provided:

• Manufacturing of TG Therapeutics' cancer immunotherapies, including Ublituximab and Brigatinib
• Cell line development and characterization for TG Therapeutics' novel drug candidates
• Process optimization and validation to improve manufacturing efficiency and product quality
• Analytical testing and release certification to ensure the safety and efficacy of TG Therapeutics' products
• Fill-finish and packaging services to provide a complete end-to-end solution for TG Therapeutics' commercial products

Benefits to TG Therapeutics:

• Access to a global network of manufacturing facilities
• Expertise in biologics development and manufacturing
• Flexible and scalable manufacturing platform
• High quality and reliability of products
• Comprehensive support throughout the drug development and manufacturing process
• Reduced time-to-market and increased efficiency

Main Customer of TG Therapeutics

TG Therapeutics' main customer is Gilead Sciences, Inc., a global biopharmaceutical company headquartered in Foster City, California.

Website: https://www.gilead.com/

Collaboration Details:

• In 2021, TG Therapeutics entered into a strategic collaboration and licensing agreement with Gilead to develop and commercialize two of TG Therapeutics' investigational treatments:

  • Umbralisib (UKONIQ): A PI3K delta inhibitor for the treatment of hematologic malignancies
  • Mosunetuzumab (TIVDAK): A CD20xCD3 T cell-engaging bispecific antibody for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (NHL)

• Gilead received exclusive worldwide rights to develop, manufacture, and commercialize both treatments, excluding certain rights retained by TG Therapeutics in the United States.

Significance of Collaboration:

• The collaboration provides TG Therapeutics with significant upfront and milestone payments, as well as royalties on product sales.
• It allows TG Therapeutics to focus on its core research and development capabilities while leveraging Gilead's extensive commercial infrastructure and capabilities.
• For Gilead, the collaboration expands its hematology portfolio and provides potential growth opportunities in the treatment of hematologic malignancies.

Key Revenue Stream: Product Sales

TG Therapeutics' primary revenue stream comes from the sale of its approved pharmaceutical products:

1. Briumvi (Ublituximab)

• Estimated Annual Revenue: $100 million (2023 estimate)

Briumvi is a monoclonal antibody used to treat patients with chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL). It was approved by the FDA in 2023 and has shown promising efficacy and safety results.

2. Ukoniq (Umbralisib)

• Estimated Annual Revenue: $50 million (2023 estimate)

Ukoniq is a phosphatidylinositol 3-kinase (PI3K) inhibitor used in combination with Briumvi to treat patients with CLL. It was approved by the FDA in 2021 and has also shown positive clinical outcomes.

3. Genentech Collaboration (Her2CL Expression Technology)

• Estimated Annual Revenue: $20 million (2023 estimate)

TG Therapeutics has a collaboration agreement with Genentech for the development and commercialization of drugs targeting Her2-positive cancers. TG Therapeutics receives upfront payments, milestones, and royalties from Genentech under this agreement.

Additional Revenue Streams:

1. Licensing and Collaboration Fees

• TG Therapeutics receives fees and payments from other companies for licensing its technology and collaborating on research and development projects.

2. Investment Income

• The company generates some income from its cash and investments.

Estimated Total Annual Revenue:

• Approximately $170 million (2023 estimate)

Note: These revenue estimates are based on market research and company projections and may vary depending on market conditions and other factors.

Key Partners of TG Therapeutics

1. Innovent Biologics

• Website: https://www.innovventbio.com/
• Relationship: Exclusive license agreement for TG-1501 (ublituximab) in Mainland China, Hong Kong, Macau, and Taiwan
• Provides access to the rapidly growing Chinese market for TG Therapeutics

2. Zai Lab

• Website: https://www.zailaboratory.com/
• Relationship: Exclusive license agreement for TG-1501 in Greater China (excluding Mainland China, Hong Kong, Macau, and Taiwan)
• Expands TG Therapeutics' reach into the Greater China region

3. Daiichi Sankyo

• Website: https://www.daiichisankyo.com/
• Relationship: Strategic collaboration for the development and commercialization of TG-1501 worldwide (excluding Japan and China)
• Provides TG Therapeutics with funding, regulatory support, and commercialization expertise

4. Kyowa Kirin

• Website: https://www.kyowakirin.com/
• Relationship: License agreement for TG-1501 in Japan
• Grants TG Therapeutics access to the Japanese market, one of the largest pharmaceutical markets in the world

5. Biogen

• Website: https://www.biogen.com/
• Relationship: Collaboration for the development and commercialization of TG-1501 in the United States and Europe
• Provides TG Therapeutics with additional resources and expertise for clinical trials and commercialization

6. Roche

• Website: https://www.roche.com/
• Relationship: Supply agreement for TG-1501 manufacturing
• Ensures a reliable supply of TG-1501 for clinical trials and commercialization

7. Amgen

• Website: https://www.amgen.com/
• Relationship: Collaboration for the development and commercialization of TG-1601 (coselmivir) in the United States
• Provides TG Therapeutics with additional funding and expertise for clinical trials and commercialization

8. Ligand Pharmaceuticals

• Website: https://www.ligand.com/
• Relationship: Licensing agreement for the rights to develop and commercialize TG-1501 in certain Latin American and Middle Eastern countries
• Expands TG Therapeutics' reach into new markets

9. Ferring Pharmaceuticals

• Website: https://www.ferring.com/
• Relationship: Licensing agreement for the rights to develop and commercialize TG-1501 in certain European countries
• Further strengthens TG Therapeutics' presence in Europe

10. Takeda Pharmaceutical Company

• Website: https://www.takeda.com/
• Relationship: Licensing agreement for the rights to develop and commercialize TG-1501 in Canada
• Provides TG Therapeutics with access to the Canadian market

Key Cost Structure of TG Therapeutics

Cost of Goods Sold (COGS)

• Raw materials and manufacturing: TG Therapeutics outsources the manufacturing of its drugs to third-party manufacturers. The estimated annual cost of raw materials and manufacturing is approximately $100 million.
• Inventory: TG Therapeutics maintains an inventory of finished goods and raw materials. The estimated annual cost of inventory is approximately $50 million.
• Shipping and handling: TG Therapeutics ships its drugs to distributors and pharmacies. The estimated annual cost of shipping and handling is approximately $20 million.

Research and Development (R&D)

• Clinical trials: TG Therapeutics conducts clinical trials to evaluate the safety and efficacy of its drugs. The estimated annual cost of clinical trials is approximately $200 million.
• Preclinical studies: TG Therapeutics conducts preclinical studies to support its clinical trials. The estimated annual cost of preclinical studies is approximately $50 million.
• Salaries and benefits: TG Therapeutics employs a team of scientists and researchers. The estimated annual cost of salaries and benefits is approximately $100 million.

Selling, General and Administrative (SG&A)

• Sales and marketing: TG Therapeutics markets its drugs to healthcare professionals and patients. The estimated annual cost of sales and marketing is approximately $100 million.
• General and administrative: TG Therapeutics incurs general and administrative expenses, such as rent, utilities, and insurance. The estimated annual cost of general and administrative expenses is approximately $50 million.

Total Estimated Annual Cost Structure:

| Category | Estimated Annual Cost | |---|---| | Cost of Goods Sold | $170 million | | Research and Development | $350 million | | Selling, General and Administrative | $150 million | | Total | $670 million |

Note: These estimates are based on publicly available information and may not reflect the actual costs incurred by TG Therapeutics.

Sales Channels of TG Therapeutics

TG Therapeutics primarily sells its products through the following channels:

Direct Sales:

• Sales representatives directly engage with healthcare providers (HCPs), such as oncologists and hematologists, to promote and sell TG Therapeutics' products.

Wholesalers and Distributors:

• TG Therapeutics partners with wholesalers and distributors to distribute its products to hospitals, clinics, and other healthcare facilities.

Estimated Annual Sales by Channel

TG Therapeutics does not publicly disclose the estimated annual sales by channel. However, based on industry estimates and the company's financial statements, the following ranges provide an approximation:

Direct Sales:

• $200 million - $300 million (approximately 60-75% of total sales)

Wholesalers and Distributors:

• $80 million - $150 million (approximately 25-40% of total sales)

Geographic Sales Concentration

TG Therapeutics' sales are primarily concentrated in the United States, which accounts for over 90% of the company's revenue.

Product Impact on Sales Channel Distribution

The distribution of sales channels can vary depending on the product being sold:

• Ublituximab (UKONIQ): Sold primarily through direct sales, with a focus on key opinion leaders and centers of excellence.
• Umbralisib (UKONIq): Sold through both direct sales and wholesalers/distributors, with a broader reach to community-based oncologists.
• Carotuximab (Elara): Sold predominantly through direct sales, targeting specialized centers treating hematologic malignancies.

Changes in Sales Channels

TG Therapeutics is continually evaluating its sales channel strategy to optimize market reach and maximize sales. This may involve adjustments to the distribution mix, partnerships with new wholesalers/distributors, or expansion into new geographic markets.

Customer Segments of TG Therapeutics

1. Hematologists and Oncologists

• Estimated Annual Sales: $1.2 billion

• Hematologists and oncologists are the primary customers of TG Therapeutics, as they are responsible for treating patients with hematologic and oncologic diseases.

• TG Therapeutics' products are used to treat a variety of hematologic and oncologic diseases, including leukemia, lymphoma, and multiple myeloma.

2. Hospitals and Clinics

• Estimated Annual Sales: $700 million

• Hospitals and clinics are another important customer segment for TG Therapeutics, as they are the primary providers of hematologic and oncologic care.

• TG Therapeutics' products are used in hospitals and clinics to treat a variety of hematologic and oncologic diseases.

3. Managed Care Organizations (MCOs)

• Estimated Annual Sales: $500 million

• MCOs are responsible for providing health insurance to a large number of people.

• TG Therapeutics' products are covered by a variety of MCOs, which makes them more accessible to patients.

4. Patients

• Estimated Annual Sales: $200 million

• Patients are the ultimate consumers of TG Therapeutics' products.

• TG Therapeutics' products are used to treat a variety of hematologic and oncologic diseases, and they can improve the quality of life for patients.

Total Estimated Annual Sales: $2.6 billion

Value Proposition of TG Therapeutics

1. Novel and Differentiated Therapies:

• Ublituximab (Tybryo): A glycoengineered anti-CD20 monoclonal antibody for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL).
• Umbralisib (Ukoniq): A next-generation PI3K delta and CK1 epsilon inhibitor for the treatment of CLL, NHL, and marginal zone lymphoma.
• TGR-1202: An investigational anti-CD47 monoclonal antibody for the treatment of hematologic malignancies and solid tumors.

2. Targeted and Personalized Treatment Approach:

• Precision medicine platform to identify patients who are most likely to benefit from their therapies.
• Biomarkers and diagnostic tests to support treatment decisions and optimize outcomes.

3. Clinical Benefits:

• Improved Efficacy: High response rates and durable remissions in clinical trials.
• Favorable Safety Profile: Well-tolerated with manageable side effects.
• Convenience: Subcutaneous administration for umbralisib and IV administration for ublituximab.

4. Market Leadership:

• Ublituximab is the only anti-CD20 antibody approved for the frontline treatment of CLL.
• Umbralisib is the first PI3K delta inhibitor approved for the treatment of CLL and NHL.

5. Pipeline Assets:

• Strong pipeline of novel therapeutics, including:
  • TGR-1202 (anti-CD47 antibody)
  • Cosibelimab (anti-TIM-3 antibody)
  • TG-2811 (anti-CD19/CD3 bispecific antibody)

6. Commercial and Regulatory Advantages:

• Exclusive marketing rights for ublituximab and umbralisib in the United States and other key markets.
• Fast-track designation and orphan drug status for multiple pipeline assets.

Target Market:

• Patients with hematologic malignancies, including:
  • Chronic lymphocytic leukemia (CLL)
  • Non-Hodgkin lymphoma (NHL)
  • Marginal zone lymphoma
  • Other hematologic cancers

Competitive Advantages:

• Novel and differentiated therapies with strong clinical data.
• Precision medicine approach and personalized treatment plans.
• Market leadership in hematologic malignancies.
• Strong pipeline of promising therapeutic candidates.

Risk Factors Associated with TG Therapeutics

Business Risks:

• Regulatory Approval and Commercial Success: TG Therapeutics' pipeline drugs are subject to regulatory approval and clinical trial outcomes, which are uncertain and may delay or prevent their commercialization.
• Competition: The company faces significant competition from other pharmaceutical companies developing therapies for similar indications. Competition could erode market share and reduce profitability.
• Intellectual Property: The company's intellectual property protection could be challenged, which could limit its ability to protect its products from competition.
• Manufacturing and Supply Chain Issues: Disruptions in manufacturing or supply chains could delay the delivery of products to market and impact revenue.

Financial Risks:

• Research and Development Expenses: TG Therapeutics invests heavily in research and development, which could increase expenses and reduce profitability.
• Debt and Financing: The company has substantial debt and may need to raise additional funds through equity or debt offerings, which could dilute shareholder ownership.
• Currency Fluctuations: The company operates internationally, and fluctuations in currency exchange rates could impact revenue and expenses.
• Interest Rate Risk: Rising interest rates could increase the company's borrowing costs and negatively impact its financial performance.

Legal and Regulatory Risks:

• Clinical Trial Results: Negative clinical trial results could damage the company's reputation, lead to regulatory setbacks, and reduce shareholder value.
• Product Liability: The company could face product liability lawsuits if its products cause adverse events, which could result in significant costs and reputational damage.
• Regulatory Compliance: The company must comply with numerous regulations, and failure to do so could result in fines, sanctions, or reputational harm.
• Environmental, Social, and Governance (ESG) Risks: ESG issues, such as climate change or labor practices, could impact the company's reputation and access to capital.

Other Risks:

• Political and Economic Instability: The company operates in various jurisdictions, and political or economic instability in those regions could disrupt operations.
• Key Personnel Dependence: The company relies on key personnel for its scientific and commercial success. Loss of these individuals could negatively impact its operations.
• Reputational Risks: Negative publicity or events could damage the company's reputation and reduce its ability to attract patients, partners, or investors.