We are a biopharmaceutical company headquartered in San Diego, California, focused on identifying, developing and delivering life-changing therapies to people living with rare kidney, liver, and metabolic diseases.
Uncertainty Related to the COVID-19 Pandemic
Our Pipeline and Approved Products
We have a diversified pipeline designed to address areas of high unmet need in rare kidney, liver, and metabolic diseases. We invest revenues from our commercial portfolio into our pipeline with the goal of delivering new treatments for diseases with no approved therapies.
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* Pegtibatinase (TVT-058) is currently in a Phase 1/2 clinical study. ** CDCA is not indicated for CTX but has received a medical necessity determination in
the US by the FDA for CTX. Travere Therapeutics is conducting a Phase 3 clinical trial
to examine the safety and efficacy of CDCA (Chenodal®) for the treatment of CTX.
Based on these results, the Company is in the process of engaging with regulators to establish next steps for a pivotal development program to ultimately support potential approval of pegtibatinase for the treatment of HCU. In parallel, the Company has initiated one additional cohort in the COMPOSE Study to inform and refine formulation work for future development and commercial purposes and to further evaluate the dose response curve for pegtibatinase.
We acquired pegtibatinase as part of the November 2020 acquisition of Orphan Technologies Limited.
We are a participant in two Cooperative Research and Development Agreements ("CRADAs"), which form a multi-stakeholder approach to pool resources with leading experts, and incorporate the patient perspective early in the therapeutic identification and development process. We have partnered with the National Institutes of Health's National Center for Advancing Translational Sciences ("NCATS") and leading patient advocacy organizations, CDG Care and Alagille Syndrome Alliance, aimed at the identification of potential small molecule therapeutics for NGLY1 deficiency and Alagille syndrome ("ALGS"), respectively. There are no treatment options currently approved for these diseases.
Thiola and Thiola EC (tiopronin)
Results of operations for the three and six months ended June 30, 2022 compared to the three and six months ended June 30, 2021
Selling, general and administrative expenses
Selling, general and administrative expenses include salaries and bonuses, benefits, non-cash share-based compensation, professional fees, rent, depreciation and amortization, travel, insurance, business development, sales and marketing programs, and other operating expenses.
Change in the valuation of contingent consideration
License and Collaboration Agreement with Vifor Pharma
2021 Underwritten Public Offering of Common Stock
Authorized Shares of Common Stock
We have future minimum rental commitments totaling $40.7 million arising from our operating leases. These commitments represent the aggregate base rent through August 2028.
Stock Purchase and Collaboration Agreement with PharmaKrysto
Unamortized debt issuance costs - 2.25% convertible senior notes due 2029
Unamortized debt issuance costs - 2.50% convertible senior notes due 2025
Total convertible senior notes, net of unamortized debt discount and debt issuance costs
•the timing of, and costs involved in, seeking and obtaining marketing approvals for our products, and in maintaining quality systems standards for our products;
•increases or decreases in revenue from our marketed products, including decreases in revenue resulting from the COVID-19 pandemic and generic entrants, if any;
•debt service obligations on the 2025 Notes and 2029 Notes;
•our ability to manufacture sufficient quantities of our products to meet expected demand;
•our ability to enter into collaboration, licensing or distribution arrangements and the terms and timing of these arrangements;
•the potential need to expand our business, resulting in additional payroll and other overhead expenses;
•the potential in-licensing of other products or technologies; and
•the emergence of competing technologies or other adverse market or technological developments.
Future capital requirements will also depend on the extent to which we acquire or invest in additional complementary businesses, products and technologies.
Cash Flows from Operating Activities
Cash Flows from Investing Activities
Cash Flows from Financing Activities
Adoption of New Accounting Standards
See Note 2 to our unaudited Condensed Consolidated Financial Statements in this report for a discussion of adoption of new accounting standards.
See Note 2 to our unaudited Condensed Consolidated Financial Statements in this report for a discussion of recently issued accounting pronouncements.
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