TVTX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-11-02

• and immunosuppressant agents are effective in only a subset of patients and use of some of these off-label treatments may be further inhibited by their safety profiles.

• Three Months Ended September 30,Nine Months Ended September 30,

• The increase in total net product sales for the three and nine months ended September 30, 2026 compared to the three and nine months ended September 30, 2025 was primarily due to growth in sales of FILSPARI.

• The decrease in license and collaboration revenue for the three months ended September 30, 2026 compared to the three months ended September 30, 2025 was primarily due to recognition of a $40.0 million market access milestone associated with the CSL Vifor License Agreement and license revenue of $9.…

• Three Months Ended September 30,Nine Months Ended September 30,

Text removed vs the prior filing · source: 10-Q · 2026-08-04

• successful process improvements, the Company restarted enrollment activities in the first quarter of 2026 and dosed the first new patient following study restart in April 2026, with topline data anticipated in the second half of 2027.

• The increase in total net product sales for the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 was primarily due to growth in sales of FILSPARI.

• The decrease in license and collaboration revenue for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was primarily due to recognition of a $17.5 million regulatory milestone associated with the CSL Vifor License Agreement during the three months ended June 30, …

• For the three and six months ended June 30, 2026 compared to 2025, our research and development expenses increased by $10.9 million and $21.1 million, respectively. External service provider costs increased by $5.2 million and $11.0 million, respectively, for the three and six months ended June 30, …

• The change in our total other (expense) income, net for the three and six months ended June 30, 2026 as compared to the three and six months ended June 30, 2025 is primarily due to the $40.0 million inducement expense related to the partial repurchase of the 2.25% Convertible Senior Notes due 2029 (…

Text added vs the prior filing · source: 10-Q · 2026-11-02

• An evaluation was also performed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of any change to our internal control over financial reporting that occurred during the quarter covered by this report and that has …

• Other than the ERP system implementation, there have been no material changes in the Company’s internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934) during the quarter ended September 30, 2026 that have materially affected, …

Text removed vs the prior filing · source: 10-Q · 2026-08-04

• An evaluation was also performed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of any change to our internal control over financial reporting that occurred during the quarter covered by this report and that has …

Text added vs the prior filing · source: 10-Q · 2026-11-02

• The current administration has indicated that it plans to pursue additional policies aimed at lowering prescription drug costs. For example, in May 2025, the administration published an executive order regarding most favored nation (“MFN”) drug pricing, which is sometimes referred to as internationa…

• Based on the complex relationships between the United States and certain foreign countries, there is inherent risk that political, diplomatic and national security influences might lead to trade disputes and impacts and/or disruptions to our third-party manufacturers and product supply. There is cur…

• Moreover, to obtain reimbursement or pricing approval in some countries, medicinal products may be subject to Health Technology Assessments (HTA) at the EU and national levels. This HTA is a multidisciplinary process that summarizes information regarding the medical, patient and social aspects, as w…

• Regulatory authorities in some jurisdictions, including the United States and the EU, may designate drugs for relatively small patient populations as orphan drugs, providing eligibility for orphan drug exclusivity upon regulatory approval if certain jurisdictional-specific conditions are met. For ex…

• for the treatment of HCU, there is no guarantee that our pivotal Phase 3 HARMONY Study will be conducted or completed on the anticipated timeline or be successful, or that pegtibatinase will be approved for HCU in the future.

Text removed vs the prior filing · source: 10-Q · 2026-08-04

• effectively engage or maintain their sales force for sparsentan if approved in the applicable territories, our ability to recognize milestone payments and royalties from the sales in such territories will be adversely affected.

• The current administration has indicated that it plans to pursue additional policies aimed at lowering prescription drug costs. For example, in May 2025, the administration published an executive order regarding most favored nation (“MFN”) drug pricing, which is sometimes referred to as internationa…

• Based on the complex relationships between the United States and certain foreign countries, there is inherent risk that political, diplomatic and national security influences might lead to trade disputes and impacts and/or disruptions to our third-party manufacturers and product supply. There is cur…

• changes with respect to trade policies, treaties, tariffs, taxes, and other limitations on cross-border operations. We currently source products and various materials that are necessary for the manufacturing of our products from countries that are subject to tariffs, and any changes in tariffs, trad…

• Moreover, to obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost effectiveness of our product candidate to other available therapies. This Health Technology Assessment (“HTA”) of medicinal products is becoming an increasin…

Text removed vs the prior filing · source: 10-Q · 2026-08-04

• Chief Legal Officer, General Counsel and Corporate Secretary

• 4Includes shares underlying stock options expiring in May 2028.

• 5Consists of shares underlying stock options expiring in May 2027.

• 6Consists of shares underlying stock options expiring in May 2027 and May 2028.