Travere Therapeutics, Inc.

Previous wording

FILSPARI is available only through a risk evaluation and mitigation strategy (REMS) approved by the FDA, regarding mandatory birth control for patients of child-bearing potential regarding risk of embryo-fetal toxicity, as has been required for certain other approved endothelin antagonists, and a REMS for liver monitoring regarding potential risk of hepatotoxicity, as has been required for certain other approved endothelin antagonists. As part of the liver monitoring REMS, monthly monitoring of each patient is required for the first year the patient is on treatment, and quarterly thereafter. The FDA accepted for review our sNDA efficacy supplement requesting modification of the frequency of liver monitoring during the first year that patients are taking FILSPARI, and assigned a PDUFA target action date of August 28, 2025. Additionally, the FDA recently notified us that the REMS for embryo-fetal toxicity is no longer necessary to ensure the benefits of FILSPARI outweigh the risk of embryo-fetal toxicity, and has instructed us to submit a REMS modification to remove the need to monitor the risk of embryo-fetal toxicity. Accordingly, we plan to submit an amendment to the REMS sNDA that is currently under review for potential modification of liver monitoring in order to effect this change. The FDA indicated that this amendment to the REMS sNDA is not expected to impact the review timeline and the Company continues to expect a REMS modification PDUFA target action date of August 28, 2025.

Current wording

FILSPARI is available only through a risk evaluation and mitigation strategy (REMS) approved by the FDA, regarding mandatory birth control for patients of child-bearing potential regarding risk of embryo-fetal toxicity, as has been required for certain other approved endothelin antagonists, and a REMS for liver monitoring regarding potential risk of hepatotoxicity, as has been required for certain other approved endothelin antagonists. As part of the liver monitoring REMS, monthly monitoring of each patient is required for the first year the patient is on treatment, and quarterly thereafter. The FDA accepted for review our sNDA efficacy supplement requesting modification of the frequency of liver monitoring during the first year that patients are taking FILSPARI, and assigned a PDUFA target action date of August 28, 2025. Additionally, the FDA recently notified us that the REMS for embryo-fetal toxicity is no longer necessary to ensure the benefits of FILSPARI outweigh the risk of embryo-fetal toxicity, and has instructed us to submit a REMS modification to remove the need to monitor the risk of embryo-fetal toxicity. Accordingly, we submitted an amendment to the REMS sNDA that is currently under review for potential modification of liver monitoring in order to effect this change. The FDA indicated that this amendment to the REMS sNDA is not expected to impact the review timeline and the Company continues to expect a REMS modification PDUFA target action date of August 28, 2025.

Previous wording

In April 2024, we and our partner CSL Vifor announced that the European Commission had granted conditional marketing authorization (“CMA”) for FILSPARI (sparsentan) for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g), and in April 2025, we and CSL Vifor announced that the European Commission has converted the CMA into a standard marketing authorization (“MA”) for FILSPARI for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). The MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway. As a result of the standard MA approval, we are entitled to receive a regulatory milestone payment of $17.5 million under the terms of the License Agreement, and we are eligible for additional milestone payments upon achievement of market access initiatives in certain countries. FILSPARI became commercially available in Europe under the CMA in August 2024, with an initial launch in Germany and Austria. In October 2024, we and CSL Vifor announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). In April 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK converted its conditional approval of FILSPARI in IgAN to standard approval.

Current wording

In April 2024, we and our partner CSL Vifor announced that the European Commission had granted conditional marketing authorization (“CMA”) for FILSPARI (sparsentan) for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g), and in April 2025, we and CSL Vifor announced that the European Commission has converted the CMA into a standard marketing authorization (“MA”) for FILSPARI for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). The MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway. As a result of the standard MA approval, we received a regulatory milestone payment of $17.5 million in May 2025 under the terms of the License Agreement, and we are eligible for additional milestone payments upon achievement of market access initiatives in certain countries. FILSPARI became commercially available in Europe under the CMA in August 2024, with an initial launch in Germany and Austria. In October 2024, we and CSL Vifor announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). In April 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK converted its conditional approval of FILSPARI in IgAN to standard approval.

Previous wording

In December 2023, we announced that we had completed a planned Type C meeting with the FDA to discuss results from the Phase 3 DUPLEX Study of sparsentan in FSGS. The FDA acknowledged the high unmet need for approved therapies as well as the challenges in studying FSGS but indicated that the two-year results from the Phase 3 DUPLEX Study alone were not sufficient to support an sNDA submission. The FDA acknowledged the work being done by the larger nephrology community to better understand proteinuria and eGFR as endpoints in clinical trials of FSGS and indicated a willingness to continue to engage with us on a potential path forward for sparsentan in FSGS following our consideration of additional evidence. Subsequently, a collaborative international effort referred to as the PARASOL project was initiated with a goal to define the quantitative relationships between short-term changes in biomarkers (proteinuria and GFR) and long-term outcomes in order to support the use of alternative proteinuria-based endpoints as a basis for accelerated and traditional approval. The PARASOL project is led by several patient advocacy organizations focused on glomerular diseases, with participation from regulators and industry representatives. The principal finding from PARASOL was that in FSGS, reduction in proteinuria over 24 months is strongly associated with a reduction in the risk of kidney failure, and responder definitions based on thresholds of proteinuria are both biologically plausible and strongly supported by epidemiological data. Following the PARASOL public workshop in the fourth quarter of 2024, in which a multi-stakeholder group of rare kidney disease experts aligned around a potential proteinuria-based clinical trial endpoint for FSGS, we scheduled a Type C meeting with the FDA to discuss a potential regulatory pathway for a sparsentan FSGS indication. In February 2025, we announced that we had completed a Type C meeting with the FDA and in March 2025, we announced that we had submitted an sNDA to the FDA seeking priority review for traditional approval of FILSPARI for the treatment of FSGS. The sNDA is supported by results from the Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI. The FDA has 60 days from the receipt of the sNDA to determine whether to accept it for review. We expect to receive notice regarding the acceptance for review of the sNDA submission as well as the timeline for sNDA review from the FDA in the second quarter of 2025. If approved, FILSPARI could become the first and only FDA-approved medicine indicated for FSGS.

Current wording

In December 2023, we announced that we had completed a planned Type C meeting with the FDA to discuss results from the Phase 3 DUPLEX Study of sparsentan in FSGS. The FDA acknowledged the high unmet need for approved therapies as well as the challenges in studying FSGS but indicated that the two-year results from the Phase 3 DUPLEX Study alone were not sufficient to support an sNDA submission. The FDA acknowledged the work being done by the larger nephrology community to better understand proteinuria and eGFR as endpoints in clinical trials of FSGS and indicated a willingness to continue to engage with us on a potential path forward for sparsentan in FSGS following our consideration of additional evidence. Subsequently, a collaborative international effort referred to as the PARASOL project was initiated with a goal to define the quantitative relationships between short-term changes in biomarkers (proteinuria and GFR) and long-term outcomes in order to support the use of alternative proteinuria-based endpoints as a basis for accelerated and traditional approval. The PARASOL project is led by several patient advocacy organizations focused on glomerular diseases, with participation from regulators and industry representatives. The principal finding from PARASOL was that in FSGS, reduction in proteinuria over 24 months is strongly associated with a reduction in the risk of kidney failure, and responder definitions based on thresholds of proteinuria are both biologically plausible and strongly supported by epidemiological data. Following the PARASOL public workshop in the fourth quarter of 2024, in which a multi-stakeholder group of rare kidney disease experts aligned around a potential proteinuria-based clinical trial endpoint for FSGS, we scheduled a Type C meeting with the FDA to discuss a potential regulatory pathway for a sparsentan FSGS indication. In February 2025, we announced that we had completed a Type C meeting with the FDA and in March 2025, we announced that we had submitted an sNDA to the FDA seeking traditional approval of FILSPARI for the treatment of FSGS. In May 2025, we announced that the FDA accepted the sNDA, assigned a Prescription Drug User Fee Act ("PDUFA") target action date of January 13, 2026, and indicated that it is planning to hold an advisory committee meeting to discuss the application. The sNDA submission is supported by results from the Phase 3 DUPLEX Study and the Phase 2 DUET Study. If approved, FILSPARI could become the first and only FDA-approved medicine indicated for FSGS.

Previous wording

Together with CSL Vifor, we continue to evaluate the potential for a regulatory pathway forward for sparsentan in FSGS in Europe.

Current wording

Together with CSL Vifor and Renalys, we continue to evaluate the potential for a regulatory pathway forward for sparsentan in FSGS in Europe and Asia.

Previous wording

Under the terms of our exclusive license to CSL Vifor, CSL Vifor is responsible for all commercialization activities in its licensed territories. We remain responsible for the clinical development of sparsentan in the applicable territories. If sparsentan receives marketing authorization in any of the territories covered by the exclusive license to Renalys, Renalys will be responsible for all development, regulatory matters, and commercialization activities in such licensed territories. We will retain all rights to sparsentan in the United States and rest of world outside of the territories licensed to CSL Vifor and Renalys, provided that CSL Vifor has a right of negotiation to expand the licensed territories into Canada, China, Brazil and/or Mexico.

Current wording

Under the terms of our exclusive license to CSL Vifor, CSL Vifor is responsible for all commercialization activities in its licensed territories. We remain responsible for the clinical development of sparsentan in the applicable territories. If sparsentan receives marketing authorization in any of the territories covered by the exclusive license to Renalys, Renalys will be responsible for all development, regulatory matters, and commercialization activities in such licensed territories. We will retain all rights to sparsentan in the United States and rest of world outside of the territories licensed to CSL Vifor and Renalys, provided that CSL Vifor has a right of negotiation to expand the licensed territories into Canada and/or Mexico.

Previous wording

In May 2021, a generic option for the 100mg version of the original formulation of Thiola (tiopronin tablets) became available and in June 2022, a second option for the 100mg version of the original formulation of Thiola (tiopronin tablets) was approved. These generic versions of the original formulation of Thiola have impacted our sales, and these or additional generic versions of either formulation could have a material adverse impact on sales. Several generic options for the 100mg and 300mg versions of Thiola EC have been approved by the FDA and become available. Accordingly, Thiola EC is subject to generic competition.

Current wording

In May 2021, a generic option for the 100mg version of the original formulation of Thiola (tiopronin tablets) became available and in June 2022, a second option for the 100mg version of the original formulation of Thiola (tiopronin tablets) was approved. These generic versions of the original formulation of Thiola have impacted our sales, and these or additional generic versions of either formulation could have a material adverse impact on sales. To date, several generic options for the 100mg and 300mg versions of Thiola EC have been approved by the FDA and become available. Accordingly, Thiola EC is subject to generic competition.

Previous wording

Results of operations for the three months ended March 31, 2025 compared to the three months ended March 31, 2024

Current wording

Results of operations for the three and six months ended June 30, 2025 compared to the three and six months ended June 30, 2024

Previous wording

The increase in total net product sales for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was primarily due to growth in sales of FILSPARI.

Current wording

The increase in total net product sales for the three and six months ended June 30, 2025 compared to the three and six months ended June 30, 2024 was primarily due to growth in sales of FILSPARI.

Previous wording

The increase in license and collaboration revenue for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was primarily due to the $3.8 million sale of active pharmaceutical ingredients to CSL Vifor in March 2025.

Current wording

The increase in license and collaboration revenue for the three months ended June 30, 2025 compared to the three months ended June 30, 2024 was primarily due to a $17.5 million regulatory milestone associated with the CSL Vifor License Agreement. The increase in license and collaboration revenue for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was primarily due to a regulatory milestone associated with the CSL Vifor License agreement and the sale of $3.8 million active pharmaceutical ingredients to CSL Vifor in March of 2025.

Previous wording

Prior to the February 2023 FDA accelerated approval of FILSPARI (sparsentan), we expensed the production of active pharmaceutical ingredients purchased to support the commercial launch of FILSPARI, in research and development expenses. For the three months ended March 31, 2025 and 2024, sales of FILSPARI primarily consisted of zero-cost inventories, and therefore cost of goods sold did not increase proportionally to the increase in product sales. As of March 31, 2025, we had $1.9 million of zero-cost inventory remaining, the majority of which we expect will be consumed in 2025. We began capitalizing inventory costs associated with FILSPARI following the February 2023 accelerated approval.

Current wording

Prior to the February 2023 FDA accelerated approval of FILSPARI (sparsentan), we expensed the production of active pharmaceutical ingredients purchased to support the commercial launch of FILSPARI, in research and development expenses. For the three and six months ended June 30, 2025 and 2024, sales of FILSPARI primarily consisted of zero-cost inventories, and therefore cost of goods sold did not increase proportionally to the increase in product sales. As of June 30, 2025, we had $1.5 million of zero-cost inventory remaining, the majority of which we expect will be consumed in 2025. We began capitalizing inventory costs associated with FILSPARI following the February 2023 accelerated approval.

Previous wording

For the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, our cost of goods sold - license and collaboration increased by $3.4 million, primarily due to the sale of active pharmaceutical ingredients to CSL Vifor in March of 2025.

Current wording

For the six months ended June 30, 2025 compared to the six months ended June 30, 2024, our cost of goods sold - license and collaboration increased by $3.3 million, primarily due to the sale of active pharmaceutical ingredients to CSL Vifor in March 2025.

Previous wording

For the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, our research and development expenses decreased by $2.5 million. External service provider costs decreased by $2.9 million, which was largely driven by a decrease in costs associated with the development of sparsentan as our Phase 3 programs advance towards completion.

Current wording

2025 compared to the six months ended June 30, 2024 was driven by a decrease in costs associated with the development of sparsentan as our Phase 3 programs advance towards completion and a decrease in costs associated with the development of pegtibatinase.

Previous wording

For the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, our selling, general and administrative expenses increased by $8.6 million, primarily as a result of an increase in spend in connection with the full approval of FILSPARI granted by the FDA in September 2024 and an increase in intangible asset amortization from capitalized FILSPARI royalties.

Current wording

For the three and six months ended June 30, 2025 compared to the three and six months ended June 30, 2024, our selling, general and administrative expenses increased by $11.4 million and $20.1 million, respectively, primarily as a result of an increase in intangible asset amortization from capitalized FILSPARI royalties, an increase in commercial investment to support FILSPARI following full approval by the FDA in September 2024 and commercial spend in preparation for the potential launch of FSGS, if approved.

Previous wording

We did not recognize any in-process research and development (IPR&D) expense during the three months ended March 31, 2025. In March 2024, we recognized $65.2 million in IPR&D expense upon the achievement of a development milestone associated with our treatment candidate pegtibatinase, which we acquired as part of the November 2020 acquisition of Orphan Technologies Limited.

Current wording

We did not recognize any in-process research and development (IPR&D) expense during the three and six months ended June 30, 2025. In March 2024, we recognized $65.2 million in IPR&D expense upon the achievement of a development milestone associated with our treatment candidate pegtibatinase, which we acquired as part of the November 2020 acquisition of Orphan Technologies Limited.

Previous wording

The following table provides information regarding other income (expenses), net (in thousands):

Current wording

The following table provides information regarding other (expense) income, net (in thousands):

Previous wording

The change in our total other income, net for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, is partly attributable to changes in interest income, driven by a decrease in the overall balance of interest-bearing security investments held along with fluctuations in short-term interest rates on those investments.

Current wording

The change in our total other (expense) income, net for the three and six months ended June 30, 2025 as compared to the three and six months ended June 30, 2024 is partially attributable to changes in interest income, driven by a decrease in the overall balance of interest-bearing security investments held along with fluctuations in short-term interest rates on those investments. For the three and six months ended June 30, 2024, we recognized $3.4 million in other expense in connection with our equity investment in Renalys, for the difference in basis between the carrying value and fair value of our proportionate share of the investee's net assets.

Previous wording

We have financed our operations through a combination of borrowings, sales of our equity securities, and revenues generated from our commercialized products, along with proceeds from license and collaboration agreements and the divestiture of our bile acid business. We experienced significant growth in recent years in the number of our employees and the scope of our operations. We also expanded our sales and marketing, compliance and legal functions in addition to expansion of all functions to support a commercial organization, including by adding additional members to our sales force in connection with the commercial launch of FILSPARI in the United States for IgAN.

Current wording

We have financed our operations through a combination of borrowings, sales of our equity securities, and revenues generated from our commercialized products, along with proceeds from license and collaboration agreements and the divestiture of our bile acid business. We experienced significant growth in recent years in the number of our employees and the scope of our operations. We also expanded our sales and marketing, compliance and legal functions in addition to expansion of all functions to support a commercial organization, including by adding additional members to our sales force in connection with the commercial launch of FILSPARI in the United States for IgAN and for the potential commercial launch of FILSPARI in the United States for FSGS, if approved.

Previous wording

As of March 31, 2025, we had cash and cash equivalents of $61.9 million and available-for-sale marketable debt securities of $260.3 million. Substantial sources of funds over the past year, as summarized further below, include net proceeds of $134.7 million from an underwritten public offering of our common stock in November 2024.

Current wording

As of June 30, 2025, we had cash and cash equivalents of $75.2 million and available-for-sale marketable debt securities of $244.4 million. Substantial sources of funds over the past year, as summarized further below, include net proceeds of $134.7 million from an underwritten public offering of our common stock in November 2024.

Previous wording

Over the next 12 months, our expected financial obligations include, but are not limited to, funding our operations, operating lease payments, interest payments on our outstanding debt, anticipated milestone payments, royalties on sales of our existing commercialized products, research and development expenses pertaining to clinical and preclinical development activities across our pipeline, expenses associated with the ongoing launch of FILSPARI and the anticipated repayment of the outstanding principal of approximately $68.9 million on the 2025 Notes, which mature on September 15, 2025. Sources of cash over this period include net revenues from sales of our products, the sale or maturity of investments in our portfolio of marketable debt securities, FILSPARI royalties and certain earned and potential milestone payments. We anticipate achieving milestones with FILSPARI that will result in us receiving payments of approximately $17.5 million during the next 12 months, with the potential for additional milestone payments depending on timing and outcomes that are currently uncertain.

Current wording

Over the next 12 months, our expected financial obligations include, but are not limited to, funding our operations, operating lease payments, interest payments on our outstanding debt, anticipated milestone payments, royalties on sales of our existing commercialized products, research and development expenses pertaining to clinical and preclinical development activities across our pipeline, expenses associated with the ongoing launch of FILSPARI, expenses associated with the preparations for a potential commercial launch of FILSPARI in FSGS, and the anticipated repayment of the outstanding principal of approximately $68.9 million on the 2025 Notes, which mature on September 15, 2025. Sources of cash over this period include net revenues from sales of our products, the sale or maturity of investments in our portfolio of marketable debt securities, FILSPARI royalties and certain earned and potential milestone payments. We anticipate achieving milestones with FILSPARI with the potential for additional payments depending on timing and outcomes of events over the next 12 months.

Previous wording

In September 2021, we entered into a license agreement with CSL Vifor, pursuant to which we granted an exclusive license to CSL Vifor for the commercialization of FILSPARI in the licensed territories. Under the terms of the license agreement, we will be eligible for up to $135.0 million in aggregate regulatory and market access related milestone payments and up to $655.0 million in aggregate sales-based milestone payments for a total potential value of up to $845.0 million. We are also entitled to receive tiered double-digit royalties of up to 40 percent of annual net sales of sparsentan in the licensed territories.

Current wording

In September 2021, we entered into a license agreement with CSL Vifor, pursuant to which we granted an exclusive license to CSL Vifor for the commercialization of FILSPARI in the licensed territories. Under the terms of the license agreement, we will be eligible for up to $135.0 million in aggregate regulatory and market access related milestone payments and up to $655.0 million in aggregate sales-based milestone payments for a total potential value of up to $845.0 million. Through June 30, 2025, we have received upfront and milestone payments totaling $72.5 million associated with the license agreement. We are also entitled to receive tiered double-digit royalties of up to 40 percent of annual net sales of sparsentan in the licensed territories.

Previous wording

As of March 31, 2025, we have future minimum rental commitments totaling $23.5 million arising from our operating lease and sublease income totaling $4.5 million. These commitments represent the aggregate base rent through August 2028.

Current wording

As of June 30, 2025, we have future minimum rental commitments totaling $21.8 million arising from our operating lease and sublease income totaling $4.2 million. These commitments represent the aggregate base rent through August 2028.

Previous wording

In 2012, we entered into an agreement with Ligand Pharmaceuticals, Inc. ("Ligand") for a worldwide sublicense to develop, manufacture and commercialize FILSPARI (the “Ligand License Agreement”). As consideration for the license, we are required to make substantial payments upon the achievement of certain milestones, totaling up to $114.1 million. Through March 31, 2025, we have capitalized $47.2 million for contractual milestones achieved under the Ligand License Agreement. Pursuant to the terms of the Ligand License Agreement, we are obligated to pay to Ligand an escalating royalty between 15% and 17% of net sales of FILSPARI and any other products containing FILSPARI or related compounds, with payments due quarterly. We began incurring costs associated with such royalties following the February 2023 approval of FILSPARI. For the three months ended March 31, 2025, we capitalized $8.9 million to intangible assets for royalties owed on net sales of FILSPARI.

Current wording

In 2012, we entered into an agreement with Ligand Pharmaceuticals, Inc. ("Ligand") for a worldwide sublicense to develop, manufacture and commercialize FILSPARI (the “Ligand License Agreement”). As consideration for the license, we are required to make substantial payments upon the achievement of certain milestones, totaling up to $114.1 million. Through June 30, 2025, we have paid $47.2 million for contractual milestones achieved under the Ligand License Agreement. Pursuant to the terms of the Ligand License Agreement, we are obligated to pay to Ligand an escalating royalty between 15% and 17% of net sales of FILSPARI and any other products containing FILSPARI or related compounds, with payments due quarterly. We began incurring costs associated with such royalties following the February 2023 approval of FILSPARI.

Previous wording

In November 2020, we completed the acquisition of Orphan Technologies Limited (“Orphan”), including Orphan’s rare metabolic disorder drug pegtibatinase. We acquired Orphan by purchasing all of its outstanding shares. Under the Stock Purchase Agreement (the "Agreement"), we agreed to make contingent cash payments up to an aggregate of $427.0 million based on the achievement of certain development, regulatory and commercialization events as set forth in the Agreement, as well as additional tiered mid-single digit royalty payments based upon future net sales of any pegtibatinase products in the U.S. and Europe, subject to certain reductions as set forth in the Agreement, and a contingent payment in the event a pediatric rare disease voucher for any pegtibatinase product is granted.

Current wording

In November 2020, we completed the acquisition of Orphan Technologies Limited (“Orphan”), including Orphan’s rare metabolic disorder drug pegtibatinase. We acquired Orphan by purchasing all of its outstanding shares. Under the Stock Purchase Agreement (the "Agreement"), we agreed to make contingent cash payments up to an aggregate of $427.0 million based on the achievement of certain development, regulatory and commercialization events as set forth in the Agreement, as well as additional tiered mid-single digit royalty payments based upon future net sales of any pegtibatinase products in the U.S. and Europe, subject to certain reductions as set forth in the Agreement, and a contingent payment in the event a pediatric rare disease voucher for any pegtibatinase product is granted. We made a $65.0 million payment in the second quarter of 2024 following the achievement of a development milestone.

Previous wording

Cash used in operating activities from continuing operations for the three months ended March 31, 2025 was $42.2 million compared to cash used of $118.9 million for the three months ended March 31, 2024. The change was due to a $35.9 million increase in total net product sales and the timing of payments from normal operations.

Current wording

Cash used in operating activities from continuing operations for the six months ended June 30, 2025 was $37.2 million compared to $158.8 million for the six months ended June 30, 2024. The change was due to a $78.5 million increase in total net product sales, a regulatory milestone of $17.5 million and the timing of payments from normal operations.

Previous wording

Cash provided by investing activities from continuing operations for the three months ended March 31, 2025 was $41.3 million compared to cash provided by $104.9 million for the three months ended March 31, 2024. The fluctuation in net cash used in investing activities resulted primarily from the timing differences in investment purchases, sales and maturities, and the fluctuation of our portfolio mix between cash equivalents and short-term investment holdings and an increase in intangible asset purchases.

Current wording

Cash provided by investing activities for the six months ended June 30, 2025 was $46.1 million compared to $133.5 million for the six months ended June 30, 2024. The fluctuation in net cash used in investing activities resulted primarily from the timing differences in investment purchases, sales and maturities, and the fluctuation of our portfolio mix between cash equivalents and short-term investment holdings, an increase in intangible asset purchases, and a $65.0 million payment in the second quarter of 2024 following the achievement of a development milestone.

Previous wording

Cash provided by financing activities from continuing operations for the three months ended March 31, 2025 was $3.7 million compared to cash used of $0.5 million for the three months ended March 31, 2024. The change was primarily due to proceeds from the exercise of stock options during the three months ended March 31, 2025.

Current wording

Cash provided by financing activities from continuing operations for the six months ended June 30, 2025 was $5.2 million compared to $0.3 million for the six months ended June 30, 2024. The change was primarily due to proceeds from the exercise of stock options during the six months ended June 30, 2025.