Mirum Pharmaceuticals, Inc.
For the period ended Sep 30, 2025. Filed Nov 4, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 4, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-06.
0001759425-25-000041
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-04.
0001759425-25-000054
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 110 previous paragraphs and 112 current paragraphs.
72 unchanged; 35 reworded; 5 added; 3 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 7 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (5)
Current report
Research and development expenses were $43.0 million for the three months ended September 30, 2025, an increase of $11.3 million compared to the three months ended September 30, 2024. The increase was primarily due to:
Current report
(Benefit from) provision for income taxes
Current report
Benefit from income taxes was $0.3 million benefit for the three months ended September 30, 2025 compared to $0.3 million provision for the three months ended September 30, 2024. The $0.3 million benefit for the three months ended September 30, 2025 was a result of the impact of the One Big Beautiful Bill Act (the “OBBBA”) as the Company will no longer be required to capitalize its domestic research and experiment costs under Section 174 of the Internal Revenue Code.
Current report
Results of Operations for the Nine Months Ended September 30, 2025 and 2024
Current report
Research and development expenses were $135.1 million for the nine months ended September 30, 2025, an increase of $38.5 million compared to the nine months ended September 30, 2024. The increase was primarily due to:
Removed paragraphs (3)
Previous report
Research and development expenses were $46.1 million for the three months ended June 30, 2025, an increase of $13.4 million compared to the three months ended June 30, 2024. The increase was primarily due to:
Previous report
Results of Operations for the Six Months Ended June 30, 2025 and 2024
Previous report
Research and development expenses were $92.1 million for the six months ended June 30, 2025, an increase of $27.2 million compared to the six months ended June 30, 2024. The increase was primarily due to:
Reworded paragraphs (35)
Previous wording
On October 22, 2024, we completed a license agreement with Enthorin Therapeutics, LLC and Dart Neuroscience LLC granting us the worldwide right to develop and commercialize MRM-3379, an allosteric inhibitor of Phosphodiesterase 4D (“PDE4D”). We intend to develop MRM-3379 for the treatment of Fragile-X Syndrome (“FXS”) and expect to initiate a Phase 2 clinical trial in the fourth quarter of 2025.
Current wording
On October 22, 2024, we completed a license agreement with Enthorin Therapeutics, LLC and Dart Neuroscience LLC granting us the worldwide right to develop and commercialize MRM-3379, an allosteric inhibitor of Phosphodiesterase 4D (“PDE4D”). We intend to develop MRM-3379 for the treatment of Fragile-X Syndrome (“FXS”).
Previous wording
We are developing Livmarli for certain rare cholestatic conditions through the Phase 3 EXPAND study, which we initiated in the fourth quarter of 2024. In addition, we are advancing our product candidate, volixibat, a novel, oral, minimally-absorbed agent designed to inhibit IBAT, for the treatment of adult patients with cholestatic liver diseases. We are developing volixibat in the setting of primary sclerosing cholangitis (“PSC”) and primary biliary cholangitis (“PBC”), and in October 2024, we announced that the FDA granted Breakthrough Therapy Designation for volixibat as a potential treatment for cholestatic pruritus in patients with PBC. We conducted an interim analysis of our VISTAS Phase 2b clinical trial in PSC and reported interim data from our VANTAGE Phase 2b clinical trial in PBC in June 2024. We expect the VISTAS Phase 2b clinical trial in PSC to complete enrollment in the third quarter of 2025 with topline data expected in the second quarter of 2026, and we expect the VANTAGE Phase 2b clinical trial in PBC to complete enrollment in 2026.
Current wording
We are developing Livmarli for certain rare cholestatic conditions through the Phase 3 EXPAND study, which we initiated in the fourth quarter of 2024. We expect to complete enrollment of the EXPAND study in 2026 with topline data expected in the first half of 2027. In addition, we are advancing our product candidate, volixibat, a novel, oral, minimally-absorbed agent designed to inhibit IBAT, for the treatment of adult patients with cholestatic liver diseases. We are developing volixibat in the setting of primary sclerosing cholangitis (“PSC”) and primary biliary cholangitis (“PBC”), and in October 2024, we announced that the FDA granted Breakthrough Therapy Designation for volixibat as a potential treatment for cholestatic pruritus in patients with PBC. We conducted an interim analysis of our VISTAS Phase 2b clinical trial in PSC and reported interim data from our VANTAGE Phase 2b clinical trial in PBC in June 2024. The VISTAS Phase 2b clinical trial in PSC completed enrollment in the third quarter of 2025 and topline data is expected in the second quarter of 2026. We expect the VANTAGE Phase 2b clinical trial in PBC to complete enrollment in 2026 with topline data expected in the first half of 2027. We are also developing MRM-3379, a novel PDE4D inhibitor, for the treatment of FXS. A Phase 2 multi-dose safety and efficacy trial has begun enrolling patients.
Previous wording
Our net loss was $5.9 million and $24.6 million for the three months ended June 30, 2025 and 2024, respectively, and $20.5 million and $49.9 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $664.7 million, compared to $644.2 million as of December 31, 2024. As of June 30, 2025, we had unrestricted cash, cash equivalents and investments of $321.7 million, compared to unrestricted cash, cash equivalents and investments of $292.8 million as of December 31, 2024.
Current wording
Our net income was $2.9 million for the three months ended September 30, 2025, our net loss was $14.2 million for the three months ended September 30, 2024, and our net loss was $17.6 million and $64.2 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $661.8 million, compared to $644.2 million as of December 31, 2024. As of September 30, 2025, we had unrestricted cash, cash equivalents and investments of $378.0 million, compared to unrestricted cash, cash equivalents and investments of $292.8 million as of December 31, 2024.
Previous wording
We anticipate we will continue to generate net losses for the foreseeable future as we continue commercial activities for our approved medicines, conduct our ongoing and planned clinical trials, seek regulatory approvals for our product candidates and make potential milestone payments to the licensors and other third parties from whom we have in-licensed or acquired our product candidates. We expect that total product sales of our approved medicines will continue to increase on an annual basis; however, due to large periodic orders from Takeda and our distributors, our product revenue may experience fluctuations. Additionally, our product revenues from Takeda are based upon variable consideration estimates. If actual results vary from our estimates, we will make adjustments in the period when such variances become known. As a result, our net losses may fluctuate significantly from quarter-to-quarter and year-to-year.
Current wording
While we generated net income in the third quarter of 2025, we anticipate we will continue to generate net losses for the foreseeable future as we continue commercial activities for our approved medicines, conduct our ongoing and planned clinical trials, seek regulatory approvals for our product candidates and make potential milestone payments to the licensors and other third parties from whom we have in-licensed or acquired our product candidates. We expect that total product sales of our approved medicines will continue to increase on an annual basis; however, due to large periodic orders from Takeda and our distributors, our product revenue may experience fluctuations. Additionally, our product revenues from Takeda are based upon variable consideration estimates. If actual results vary from our estimates, we will make adjustments in the period when such variances become known. As a result, our net losses may fluctuate significantly from quarter-to-quarter and year-to-year.
Previous wording
There have been no significant changes during the three and six months ended June 30, 2025, except as described below, in our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report.
Current wording
There have been no significant changes during the three and nine months ended September 30, 2025, except as described below, in our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report.
Previous wording
Product sales, net was $239.4 million for the six months ended June 30, 2025, compared to $146.7 million for the six months ended June 30, 2024. The increase in product sales, net was a result of our continued commercialization of Livmarli in the U.S. for the treatment of ALGS and PFIC, and in certain international markets directly or through distributor and partner orders and from our sales of the Bile Acid Medicines.
Current wording
Product sales, net was $133.0 million for the three months ended September 30, 2025, compared to $90.3 million for the three months ended September 30, 2024. The increase in product sales, net was a result of our continued commercialization of Livmarli in the U.S. for the treatment of ALGS and PFIC, and in certain international markets directly or through distributor and partner orders and from our sales of the Bile Acid Medicines.
Previous wording
For the three months ended June 30, 2025, cost of sales was $23.4 million, compared to $20.2 million for the three months ended June 30, 2024. The increase in cost of sales was primarily a result of increases in royalty expense of $3.8 million on net sales of Livmarli and the Bile Acid Medicines under licensing agreements and a $2.6 million increase primarily associated with general commercial supply chain support costs and PDUFA fees associated with the approval of our solid dose formulation in Livmarli. These increases were partially offset by lower product cost of sales of $2.2 million primarily related to the Bile Acid Medicines as we substantially completed the sale of acquired inventory in prior periods which had been recorded at fair value, and lower API purchase commitment and excess and obsolete charges of $1.3 million.
Current wording
For the three months ended September 30, 2025, cost of sales was $25.5 million, compared to $20.8 million for the three months ended September 30, 2024. The increase in cost of sales was primarily a result of increases in royalty expense of $3.9 million on net sales of Livmarli and the Bile Acid Medicines under licensing agreements, $1.0 million PDUFA fees primarily associated with the approval of our solid dose formulation in Livmarli and $0.7 million in general supply chain support costs. These increases were partially offset by lower product cost of sales of $1.6 million primarily related to the Bile Acid Medicines as we substantially completed the sale of acquired inventory in prior periods which had been recorded at fair value.
Previous wording
•for volixibat programs, an increase of $4.7 million, primarily due to increased expenses associated with conduct of the PSC and PBC trials as well as manufacturing development expenses;
Current wording
•for volixibat programs, an increase of $4.5 million, primarily due to increased expenses associated with conduct of the PSC and PBC trials as well as manufacturing development expenses;
Previous wording
•for MRM-3379, an increase of $3.4 million, primarily due to planning for our Phase 2 study in Fragile X Syndrome and clinical manufacturing expenses;
Current wording
•for MRM-3379, an increase of $3.5 million, primarily due to planning for our Phase 2 study in FXS and clinical manufacturing expenses; and
Previous wording
•for personnel related and stock-based compensation expenses, an increase of $10.2 million related primarily to increased employee headcount and related equity award grants to support our development pipeline, partially offset by
Current wording
•for personnel related and stock-based compensation expenses, an increase of $6.4 million related primarily to increased employee headcount and related equity award grants to support our development pipeline, partially offset by
Previous wording
•for Livmarli, a decrease of $4.3 million, primarily due to lower costs due to discontinuation of the biliary atresia clinical trial and other clinical costs partially offset by increased expenses associated with the Livmarli Phase 3 EXPAND label expansion study.
Current wording
•for Livmarli, a decrease of $3.0 million, primarily due to lower costs from the PFIC rollover study and other clinical costs partially offset by increased expenses associated with the Livmarli Phase 3 EXPAND label expansion study.
Previous wording
Selling, general and administrative expenses were $121.0 million for the six months ended June 30, 2025, an increase of $26.1 million compared to the six months ended June 30, 2024. The increase was primarily due to increases of $16.7 million in personnel and other compensation-related expenses, including an increase of $5.3 million in stock-based compensation, reflecting an increase in the number of our selling, marketing and administrative employees to support commercial activities for our approved medicines, $5.0 million in advertising, promotion and medical affairs expenses associated with commercial activities, $2.8 million in other general administrative expenses and $1.6 million of expenses associated with post marketing studies.
Current wording
Selling, general and administrative expenses were $61.9 million for the three months ended September 30, 2025, an increase of $11.4 million compared to the three months ended September 30, 2024. The increase was primarily due to increases of $7.7 million in personnel and other compensation-related expenses, including an increase of $4.1 million in stock-based compensation, reflecting an increase in the number of our selling, marketing and administrative employees to support commercial activities for our approved medicines, $1.7 million of legal, accounting and other outside services, $1.0 million in general administrative expenses and $1.0 million of expenses associated with post marketing approval studies.
Previous wording
Interest income was $3.0 million for the three months ended June 30, 2025, a decrease of $0.5 million compared to the three months ended June 30, 2024 largely due to lower yields on investments.
Current wording
Interest income was $3.3 million for the three months ended September 30, 2025, a decrease of $0.2 million compared to the three months ended September 30, 2024 largely due to lower yields on investments.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
Product sales, net was $127.8 million for the three months ended June 30, 2025, compared to $77.8 million for the three months ended June 30, 2024. The increase in product sales, net was a result of our continued commercialization of Livmarli in the U.S. for the treatment of ALGS and PFIC, and in certain international markets directly or through distributor and partner orders and from our sales of the Bile Acid Medicines. The three months ended June 30, 2025 additionally includes approximately $11.0 million change in estimate from prior quarter revenue estimates on distributor and partner channel inventory as a result of regulatory price approval on that inventory.
Current wording
Product sales, net was $372.4 million for the nine months ended September 30, 2025, compared to $237.0 million for the nine months ended September 30, 2024. The increase in product sales, net was a result of our continued commercialization of Livmarli in the U.S. for the treatment of ALGS and PFIC, and in certain international markets directly or through distributor and partner orders and from our sales of the Bile Acid Medicines.
Previous wording
For the six months ended June 30, 2025, cost of sales was $46.4 million, compared to $38.1 million for the six months ended June 30, 2024. The increase in cost of sales was primarily a result of increases in royalty expense of $7.3 million on net sales of Livmarli and the Bile Acid Medicines under licensing agreements, a $1.3 million increase primarily associated with increased PDUFA fees associated with the approval of our solid dose formulation in Livmarli and higher commercial supply chain costs of $2.1 million. These increases were partially offset by lower product cost of sales of $4.0 million primarily related to the Bile Acid Medicines, as we substantially completed the sale of acquired inventory in prior periods which had been recorded at fair value.
Current wording
For the nine months ended September 30, 2025, cost of sales was $72.0 million, compared to $58.9 million for the nine months ended September 30, 2024. The increase in cost of sales was primarily a result of increases in royalty expense of $11.2 million on net sales of Livmarli and the Bile Acid Medicines under licensing agreements, a $2.3 million increase primarily associated with increased PDUFA fees associated with the approval of our solid dose formulation in Livmarli and higher commercial supply chain costs of $2.8 million. These increases were partially offset by lower product cost of sales of $5.5 million primarily related to the Bile Acid Medicines, as we substantially completed the sale of acquired inventory in prior periods which had been recorded at fair value.
Previous wording
•for volixibat programs, an increase of $9.8 million, primarily due to increased expenses associated with conduct of the PSC and PBC trials as well as manufacturing development expenses;
Current wording
•for volixibat programs, an increase of $14.2 million, primarily due to increased expenses associated with conduct of the PSC and PBC trials as well as manufacturing development expenses;
Previous wording
•for MRM-3379, an increase of $2.7 million, primarily due to planning for our Phase 2 study in Fragile X Syndrome and clinical manufacturing expenses;
Current wording
•for MRM-3379, an increase of $7.0 million, primarily due to planning for our Phase 2 study in FXS and clinical manufacturing expenses;
Previous wording
•for personnel related and stock-based compensation expenses, an increase of $13.8 million related primarily to increased employee headcount and related equity award grants to support our development pipeline; and
Current wording
•for personnel related and stock-based compensation expenses, an increase of $20.2 million related primarily to increased employee headcount and related equity award grants to support our development pipeline; and
Previous wording
•for license fees, an increase of $5.0 million due to a development milestone payment associated with our EXPAND study, partially offset by
Current wording
•for license fees, an increase of $5.0 million due to a development milestone payment associated with our Livmarli Phase 3 EXPAND label expansion study, partially offset by
Previous wording
•for Livmarli, a decrease of $5.5 million primarily due to completion of clinical trials including the biliary atresia, PFIC rollover study and a safety study, lower general clinical support costs partially offset by increased expenses associated with the Livmarli Phase 3 EXPAND label expansion study.
Current wording
•for Livmarli, a decrease of $8.6 million primarily due to completion of clinical trials including the biliary atresia, PFIC rollover study and a safety study, lower general clinical support costs partially offset by increased expenses associated with the Livmarli Phase 3 EXPAND label expansion study.
Previous wording
Selling, general and administrative expenses were $63.3 million for the three months ended June 30, 2025, an increase of $14.1 million compared to the three months ended June 30, 2024. The increase was primarily due to increases of $8.9 million in personnel and other compensation-related expenses, including an increase of $2.6 million in stock-based compensation, reflecting an increase in the number of our selling, marketing and administrative employees to support commercial activities for our approved medicines, $2.6 million in general administrative expenses, $1.7 million in advertising, promotion and medical affairs expenses associated with commercial activities, and $0.9 million of expenses associated with post marketing approval studies.
Current wording
Selling, general and administrative expenses were $182.9 million for the nine months ended September 30, 2025, an increase of $37.5 million compared to the nine months ended September 30, 2024. The increase was primarily due to increases of $24.5 million in personnel and other compensation-related expenses, including an increase of $9.4 million in stock-based compensation, reflecting an increase in the number of our selling, marketing and administrative employees to support commercial activities for our approved medicines, $4.0 million in advertising, promotion and medical affairs expenses associated with commercial activities, $4.0 million in other general administrative expenses, $2.6 million of expenses associated with post marketing studies and $2.4 million associated with legal, accounting and other outside services.
Previous wording
Interest income was $6.1 million for the six months ended June 30, 2025, a decrease of $1.1 million compared to the six months ended June 30, 2024 largely due to lower yields on investments.
Current wording
Interest income was $9.3 million for the nine months ended September 30, 2025, a decrease of $1.3 million compared to the nine months ended September 30, 2024 largely due to lower yields on investments.
Previous wording
Interest expense for the six months ended June 30, 2025 was unchanged in comparison to the six months ended June 30, 2024, and related to interest expense incurred on our convertible notes.
Current wording
Interest expense for the nine months ended September 30, 2025 was unchanged in comparison to the nine months ended September 30, 2024, and related to interest expense incurred on our convertible notes.
Previous wording
Since inception, we have funded our operations primarily through debt, equity, revenue interest financings and, to a lesser extent, cash from our product sales and license and collaboration revenue. We had $321.7 million of unrestricted cash, cash equivalents and investments as of June 30, 2025, compared to unrestricted cash, cash equivalents and investments of $292.8 million as of December 31, 2024. Since inception, we have incurred operating losses. As of June 30, 2025, we had an accumulated deficit of $664.7 million, compared to $644.2 million as of December 31, 2024.
Current wording
Since inception, we have funded our operations primarily through debt, equity, revenue interest financings and, to a lesser extent, cash from our product sales and license and collaboration revenue. We had $378.0 million of unrestricted cash, cash equivalents and investments as of September 30, 2025, compared to unrestricted cash, cash equivalents and investments of $292.8 million as of December 31, 2024. We have incurred significant operating losses since our inception. As of September 30, 2025, we had an accumulated deficit of $661.8 million, compared to $644.2 million as of December 31, 2024.
Previous wording
In September 2022, we filed an automatic shelf registration statement on Form S-3 with the SEC (the “2022 Shelf Registration”), which became effective upon filing, pursuant to which we registered for sale from time to time in one or more offerings an unlimited amount of any combination of our common stock, preferred stock, debt securities and warrants, so long as we continue to satisfy the requirements of a “well-known seasoned issuer” under SEC rules. This automatic shelf registration statement will remain in effect for up to three years from the date it became effective. As of June 30, 2025, we have not issued any securities pursuant to the 2022 Shelf Registration.
Current wording
In August 2025, we filed an automatic shelf registration statement on Form S-3 with the SEC (the “2025 Shelf Registration”), which became effective upon filing, pursuant to which we may register for sale from time to time in one or more offerings an unlimited amount of any combination of our common stock, preferred stock, debt securities and warrants, so long as we continue to satisfy the requirements of a “well-known seasoned issuer” under SEC rules. This automatic shelf registration statement will remain in effect for up to three years from the date it became effective. As of September 30, 2025, we have not issued any securities pursuant to the 2025 Shelf Registration.
Previous wording
On November 2, 2023, we entered into a Sales Agreement (the “2023 Sales Agreement”) with Leerink and Cantor Fitzgerald & Co. (the “Sales Agents”), pursuant to which we may, from time to time, sell up to an aggregate amount of $200.0 million of our common stock through the Sales Agents in an “at-the-market” offering (the “ATM Offering”) pursuant to the 2022 Shelf Registration. We are not required to sell shares under the 2023 Sales Agreement. Sales of our common stock, if any, under the 2023 Sales Agreement may be made in any transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act. We will pay a given designated Sales Agent a commission of up to 3.0% of the aggregate gross proceeds of any shares of common stock sold through it pursuant to the 2023 Sales Agreement. As of June 30, 2025, we have not issued any securities pursuant to the 2023 Sales Agreement.
Current wording
In November 2023, we entered into a Sales Agreement (the “2023 Sales Agreement”) with Leerink and Cantor Fitzgerald & Co. (the “Sales Agents”), pursuant to which we may, from time to time, sell up to an aggregate amount of $200.0 million of our common stock through the Sales Agents in an “at-the-market” offering (the “ATM Offering”) pursuant to the 2025 Shelf Registration. We are not required to sell shares under the 2023 Sales Agreement. Sales of our common stock, if any, under the 2023 Sales Agreement may be made in any transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act. We will pay a given designated Sales Agent a commission of up to 3.0% of the aggregate gross proceeds of any shares of common stock sold through it pursuant to the 2023 Sales Agreement. As of September 30, 2025, we have not issued any securities pursuant to the 2023 Sales Agreement.
Previous wording
We anticipate that we will continue to incur net losses for the foreseeable future as we continue research efforts and the development of our product candidates, continue commercialization activities for our approved medicines and potentially expand into additional markets, hire additional staff, including clinical, scientific, operational, financial and management personnel and pay potential development milestones. Net loss is also impacted by significant non-cash charges related to stock-based compensation and amortization of intangible assets.
Current wording
While we generated net income in the third quarter of 2025, we anticipate that we will continue to incur net losses for the foreseeable future as we continue research efforts and the development of our product candidates, continue commercialization activities for our approved medicines and potentially expand into additional markets, hire additional staff, including clinical, scientific, operational, financial and management personnel and pay potential development milestones. Net loss is also impacted by significant non-cash charges related to stock-based compensation and amortization of intangible assets.
Previous wording
During the second quarter of 2025, the last reported sale price of our common stock exceeded 130% of the conversion price of the Notes for more than 20 trading days during the 30 consecutive trading days ended June 30, 2025. As a result, the Notes are convertible at the option of the holders of the Notes during the third quarter of 2025, the quarter immediately following the quarter when the conditions were met, as stated in the terms of the Notes. If holders of the Notes elect to convert their Notes, we may elect to settle such conversions by paying or delivering, as applicable, cash, shares of our common stock or a combination of cash and shares of our common stock.
Current wording
During the third quarter of 2025, the last reported sale price of our common stock exceeded 130% of the conversion price of the Notes for more than 20 trading days during the 30 consecutive trading days ended September 30, 2025. As a result, the Notes are convertible at the option of the holders of the Notes during the fourth quarter of 2025, the quarter immediately following the quarter when the conditions were met, as stated in the terms of the Notes. If holders of the Notes elect to convert their Notes, we may elect to settle such conversions by paying or delivering, as applicable, cash, shares of our common stock or a combination of cash and shares of our common stock.
Previous wording
Net cash provided by operating activities was $10.1 million for the six months ended June 30, 2025, reflecting our net loss of $20.5 million offset by adjustments of $48.5 million. Adjustments consisted primarily of stock-based compensation, depreciation and amortization of our intangible assets and fixed assets, and charges associated with excess and obsolete inventory and firm commitment losses. Additionally, cash provided by operating activities reflected a cash outflow for changes in net operating assets of $17.9 million, primarily related to an increase in accounts receivable and payments made for inventory, prepaid assets and accrued compensation and related benefits partially offset by an increase in accrued sales deductions and royalties due to the growth from our product sales in the six months ended June 30, 2025 and an increase in accrued clinical trial and contract manufacturing expenses during the period.
Current wording
Net cash provided by operating activities was $49.8 million for the nine months ended September 30, 2025, reflecting our net loss of $17.6 million offset by adjustments of $73.1 million. Adjustments consisted primarily of stock-based compensation, depreciation and amortization of our intangible assets and fixed assets, and charges associated with excess and obsolete inventory and firm commitment losses. Additionally, cash provided by operating activities reflected a cash outflow for changes in net operating assets of $5.7 million, primarily related to an increase in accounts receivable and payments made for inventory and prepaid assets. The net use of cash was partially offset by an increase in accrued sales deductions and royalties due to the growth from our product sales in the nine months ended September 30, 2025, an increase in accrued clinical trial expenses during the period and an increase in accrued interest in relation to the Notes.
Previous wording
Net cash provided by operating activities was $11.4 million for the six months ended June 30, 2024, reflecting our net loss of $49.9 million partially offset by adjustments of $35.8 million. Adjustments consisted primarily of stock-based compensation, and depreciation and amortization of our intangible assets and fixed assets. Additionally, cash provided by operating activities reflected changes in net operating assets of $25.5 million, consisting primarily of a decrease in accounts receivables due to timing of payments received related to sales of our approved medicines, and an increase in accounts payable, accrued expenses and other liabilities primarily related to the increase in accrued sales deductions due to our product sales in the six months ended June 30, 2024.
Current wording
Net cash provided by operating activities was $15.4 million for the nine months ended September 30, 2024, reflecting our net loss of $64.2 million partially offset by adjustments of $55.3 million. Adjustments consisted primarily of stock-based compensation, depreciation and amortization of our intangible assets and fixed assets, and charges associated with excess and obsolete inventory and firm commitment losses. Additionally, cash provided by operating activities reflected changes in net operating assets of $24.3 million, primarily related to the increase in accounts payable, accrued expenses and other liabilities resulting primarily from an increase in accrued sales deductions and royalties due to the growth from our product sales in the nine months ended September 30, 2024, and an increase in accrued expenses driven by our growth, including accrued expenses related to clinical studies and contract manufacturing activities, offset by payments made for the purchase of inventory.
Previous wording
Net cash used in investing activities was $22.7 million for the six months ended June 30, 2025, primarily due to purchases of investments offset by proceeds from maturities of investments.
Current wording
Net cash used in investing activities was $25.0 million for the nine months ended September 30, 2025, primarily due to purchases of investments offset by proceeds from maturities of investments.
Previous wording
Net cash used in investing activities for the six months ended June 30, 2024 was $72.7 million primarily due to purchases of investments and a milestone payment associated with the approval of Livmarli for the treatment of cholestatic pruritus in patients with PFIC five years of age and older (now twelve months of age and older) by the FDA.
Current wording
Net cash used in investing activities for the nine months ended September 30, 2024 was $90.8 million primarily due to purchases of investments resulting from the changing interest rate environment and milestone payments associated with the approval of Livmarli for cholestatic pruritus in patients with PFIC in the U.S. and for the treatment of PFIC in the EU, offset by proceeds from maturities of investments.
Previous wording
Net cash provided by financing activities was $15.0 million for the six months ended June 30, 2025, due to proceeds from employee equity award exercises.
Current wording
Net cash provided by financing activities was $31.1 million for the nine months ended September 30, 2025, due to proceeds from employee equity award exercises.
Previous wording
Net cash provided by financing activities was $8.5 million for the six months ended June 30, 2024, due to proceeds from employee equity award exercises.
Current wording
Net cash provided by financing activities was $12.4 million for the nine months ended September 30, 2024, due to proceeds from employee equity award exercises.