Tarsus Pharmaceuticals, Inc.
For the period ended Jun 30, 2026. Filed Aug 6, 2026.
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.
Jun 30, 2026 · Filed Aug 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-06.
0001819790-26-000038
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001819790-26-000064
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 160 previous paragraphs and 182 current paragraphs.
117 unchanged; 33 reworded; 28 added; 9 removed; 1 previous and 4 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 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 (28)
Current report
•the anticipated timing, terms and benefits of the acquisition of Alkeus Pharmaceuticals, Inc. (“Alkeus”) and, assuming closing of the transaction, our ability to integrate Alkeus and realize the anticipated benefits of the pending acquisition;
Current report
•our ability to integrate iRenix Medical, Inc. (“iRenix”) and realize the anticipated benefits of the acquisition;
Current report
In July 2026, as part of our strategic entry into the retina market, we acquired IRX-101 in connection with the acquisition of iRenix (the “iRenix Acquisition”). IRX-101 is an investigational ocular antiseptic based on a stable aqueous chlorine dioxide solution that is being developed for the potential to reduce post-procedural pain and corneal toxicity in patients receiving intravitreal therapy. Based on data from a Phase 2b/3 trial and in alignment with feedback from the FDA, we plan to initiate a Phase 3 trial (the “COMFORT Trial”) of IRX-101, an investigational ocular antiseptic designed to evaluate the tolerability and safety of IRX-101 compared to povidone-iodine. The COMFORT Trial is expected to begin enrolling in the first half of 2027 with topline results expected in 2028.
Current report
◦The number of eye care professionals (ECPs) prescribing XDEMVY five or more times per week has doubled year-over-year, demonstrating depth of adoption.
Current report
•Direct-to-Consumer (“DTC”) initiatives continued to contribute to prescription growth and awareness, including:
Current report
◦Launched celebrity campaign in partnership with John Cena and an unbranded television campaign featuring “Barry the Cat” increased website engagement by more than 30% since the start of both new initiatives, with high-value actions up 19%.
Current report
◦Unaided awareness of Demodex blepharitis continued to increase and is now approximately 30% vs. 2% of patients surveyed at the beginning of our DTC campaign.
Current report
IRX-101 for the Potential Reduction of Post-Procedural Pain and Corneal Toxicity in Patients Receiving Intravitreal Therapy:
Current report
In July 2026, we acquired iRenix, pursuant to an Agreement and Plan of Merger with iRenix, Dolores Merger Sub, Inc. and Fortis Advisors LLC, as the securityholders’ representative. In connection with the iRenix Acquisition, we acquired IRX-101. We are exploring the potential of IRX-101 as an investigational ocular antiseptic to reduce post-procedural pain and corneal toxicity in patients receiving intravitreal therapy. More than 11 million intravitreal injections are performed in the U.S. each year, the vast majority of which rely on povidone-iodine as a pre-procedural antiseptic. For many patients, povidone-iodine is associated with significant ocular surface toxicity, resulting in corneal damage and pain that can persist for days following treatment. Despite this, and despite being contraindicated in patients with iodine sensitivity, there have been no new FDA-approved ocular antiseptics in more than four decades. We believe IRX-101 has the potential to meaningfully improve that experience while maintaining the antiseptic activity physicians depend on.
Current report
In a Phase 2b/3 RELIEF trial that was completed by iRenix prior to our acquisition of IRX-101, IRX-101 demonstrated statistically significant improvements on two co-primary endpoints versus povidone-iodine:
Current report
•Pain reduction: Approximately 50% relative reduction in post-procedural pain scores (p=0.0003), with half of the patients in the IRX-101 group reporting a pain score of zero.
Current report
•Corneal fluorescein staining: Approximately 25% relative reduction in corneal staining in the IRX-101 group (p=0.0003), reflecting less corneal surface damage.
Current report
Based on this data and in alignment with feedback from the FDA, we plan to initiate the COMFORT Trial. The study is expected to begin enrolling in the first half of 2027 with topline results expected in 2028.
Current report
Other Business Updates:
Current report
Definitive Agreement to Acquire Alkeus: On July 31, 2026, we entered into an Agreement and Plan of Merger (the “Alkeus Merger Agreement”), by and among the Company, Apex 2026 Merger Sub, Inc., Alkeus and Shareholder Representative Services LLC, pursuant to which we have agreed to acquire (the “Alkeus Acquisition”) Alkeus, a privately held ophthalmology-focused biotechnology company developing gildeuretinol (ALK-001), an investigational once-daily oral therapy with a differentiated approach designed to reduce toxic Vitamin A dimer formation in the retina, targeting the underlying biology of Stargardt disease, an inherited retinal disease affecting more than 36,000 diagnosed patients and an estimated 86,000 total patients in the U.S., that can lead to blindness. The Alkeus Acquisition adds a Phase 3 clinical program and is expected to further expand our presence in retina, one of the largest and fastest-growing specialties and is an important advancement in our strategy to become a leading eye care company. The Alkeus Acquisition is expected to close in 2026, subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and the satisfaction of other customary closing conditions. The closing of the Alkeus Acquisition is not conditioned upon the closing of the PIPE Transaction or the receipt of any minimum amount of gross proceeds in the PIPE Transaction. There can be no assurances that the Alkeus Acquisition will be consummated on the terms and in the timing described herein or at all.
Current report
PIPE Transaction: On August 5, 2026, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a syndicate of existing and new healthcare investors for the sale of shares of our common stock and pre-funded warrants to purchase shares of our common stock in a private placement. Pursuant to the terms of the Purchase Agreement, we agreed to issue and sell an aggregate of 2,098,519 shares of our common stock at a purchase price of $56.00 per share and pre-funded warrants to purchase an aggregate of 133,625 shares of our common stock at a purchase price of $55.9999 per pre-funded warrant (the purchase price per share less $0.0001, the exercise price of the pre-funded warrants), which is expected to result in gross proceeds of $125.0 million, before deducting placement agent fees and other offering expenses. The PIPE Transaction is expected to close on August 7, 2026, subject to satisfaction of customary closing conditions.
Current report
Interim Chief Commercial Officer: In July 2026, we appointed Neera Clase, Interim Chief Commercial Officer, as we enter the next phase of growth. Ms. Clase has been instrumental in the development and execution of our successful commercial strategy. Her extensive knowledge of the business and established leadership across the organization position her well to support continued commercial execution.
Current report
Research and development expenses increased by $15.4 million for the three months ended June 30, 2026, as compared to the prior year period. The increase was primarily attributable to (i) an $8.0 million increase in TP-05 program expenses related to our Calliope Trial, which we initiated in March 2026 and has since completed enrollment, (ii) a $3.2 million increase in payroll and personnel-related costs (including increased stock-based compensation expense of $1.1 million) primarily due to employee additions to support our product development initiatives, (iii) a $3.1 million increase in TP-03 program expenses, and (iv) a $0.5 million increase in other early-stage development expenses.
Current report
Comparison of the Six Months Ended
Current report
Product Sales, Net
Current report
Research and Development Expenses
Current report
Selling, General and Administrative Expenses
Current report
Selling, general and administrative expenses increased by $99.1 million for the six months ended June 30, 2026, as compared to the prior year period. The increase was primarily attributable to (i) a $47.0 million increase in commercial and marketing costs, including DTC advertising costs, as we continued to expand our promotional activities for XDEMVY, (ii) a $40.7 million increase in costs associated with patient support functions, information technology, legal, and professional services, and (iii) an $11.1 million increase in payroll and personnel-related costs (including increased stock-based compensation expense of $7.4 million) primarily due to commercial and corporate employee additions to support our continued growth and the expansion of our commercial leadership team. We expect vendor-related expenses to continue to increase during 2026 as we continue to expand our commercial activities for XDEMVY and invest in other corporate initiatives.
Current report
Other Income (Expense), Net
Current report
Other income (expense), net increased by $2.6 million for the six months ended June 30, 2026, as compared to the prior year period and primarily related to a $2.8 million gain on exchange of long-term investments (see Note 12), partially offset by a $0.3 million decrease in interest income earned on our cash, cash equivalents and marketable securities.
Current report
PIPE Transaction
Current report
On August 5, 2026, we entered into the Purchase Agreement for the PIPE Transaction. Pursuant to the terms of the Purchase Agreement, we agreed to issue and sell an aggregate of 2,098,519 shares of our common stock at a purchase price of $56.00 per share, and pre-funded warrants to purchase an aggregate of 133,625 shares of our common stock at a purchase price of $55.9999 per pre-funded warrant (the purchase price per share less $0.0001, the exercise price of the pre-funded warrants), which is expected to result in gross proceeds of $125.0 million, before deducting placement agent fees and other offering expenses. The PIPE Transaction is expected to close on August 7, 2026, subject to satisfaction of customary closing conditions.
Current report
Net Cash Provided by (Used in) Operating Activities
Removed paragraphs (9)
Previous report
•XDEMVY continues to be one of the best-selling prescription eye drops.
Previous report
◦Continued depth of prescribing as eye care professionals (“ECPs”) broaden screening and treatment across a wider range of patients.
Previous report
•Direct-to-Consumer (“DTC”) campaign drove tremendous engagement and generated an increasingly positive and growing return on investment.
Previous report
◦Continued to drive millions of visitors to the XDEMVY website and certain increased high-value actions on the website by approximately 40% quarter-over-quarter reflecting strong patient activation and conversion.
Previous report
•On track to activate approximately 20 new Key Account Leaders by the third quarter of 2026 focusing on driving deeper utilization within high-opportunity eye care practices.
Previous report
•We maintained strong engagement across key ophthalmology and optometry conferences in the first quarter of 2026, presenting numerous data sets that reinforce the clinical importance of diagnosing and treating Demodex blepharitis and expand how ECPs identify and treat the disease.
Previous report
TP-04 Rosacea for the Potential Treatment of Ocular Rosacea:
Previous report
Cost of Sales
Reworded paragraphs (33)
Previous wording
The words “anticipate,” “believe,” contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements. Factors that may cause actual results to differ from expected results, include, among others:
Current wording
The words “anticipate,” “believe,” contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements. Factors that may cause actual results to differ from expected results, include, among others:
Previous wording
•the timing and progress of our current clinical trials and timing of initiation of our future clinical trials, and the reporting of data from our current and future trials;
Current wording
•the timing and progress of our current clinical trials and timing of enrollment and initiation of our future clinical trials, and the reporting of data from our current and future trials, and our ability to hire and retain personnel to oversee and execute on our current and future trials;
Previous wording
•our anticipated use of our existing resources and the proceeds from our initial public offering (“IPO”), our subsequent follow-on public offerings in May 2022 (the “May 2022 Public Offering”), August 2023 (the “August 2023 Public Offering”), March 2024 (the “March 2024 Public Offering”), and March 2025 (the “March 2025 Public Offering”), collectively the “Follow-On Public Offerings”, as well as proceeds from our sales agreement prospectus (the “2023 ATM Prospectus”), and drawdowns from our loan and security agreement (the “2024 Credit Facility”) with funds associated with Pharmakon Advisors, LP (“Pharmakon”).
Current wording
•our anticipated use of our existing resources and the proceeds from our initial public offering (“IPO”), our subsequent follow-on public offerings in May 2022 (the “May 2022 Public Offering”), August 2023 (the “August 2023 Public Offering”), March 2024 (the “March 2024 Public Offering”), and March 2025 (the “March 2025 Public Offering”), collectively the “Follow-On Public Offerings”, as well as proceeds from our sales agreement prospectus (the “2023 ATM Prospectus”), drawdowns from our loan and security agreement (the “2024 Credit Facility”) with funds associated with Pharmakon Advisors, LP (“Pharmakon”), and a private placement of 2,098,519 shares of our common stock at a purchase price of $56.00 per share and pre-funded warrants to purchase 133,625 shares of our common stock at a purchase price per pre-funded warrant of $55.9999 (the purchase price per share less $0.0001, the exercise price of the pre-funded warrants), which is expected to result in gross proceeds of $125.0 million, before deducting placement agent fees and offering expenses (the “PIPE Transaction”). The PIPE Transaction is expected to close on August 7, 2026, subject to the satisfaction of customary closing conditions.
Previous wording
We intend to further advance our pipeline with, e.g., lotilaner API to address several diseases in human medicine, including eye care, and infectious disease prevention. We are investigating the development of our product candidates to address targeted diseases with high unmet medical needs, which currently include TP-04, an investigational sterile aqueous gel formulation of lotilaner for the potential treatment of ocular rosacea and TP-05, an investigational oral tablet formulation of lotilaner, for potential Lyme disease prophylaxis and community malaria reduction.
Current wording
We intend to further advance our pipeline with, e.g., lotilaner API to address several diseases in human medicine, including eye care, and infectious disease prevention. We are investigating the development of our lotilaner-based product candidates to address targeted diseases with high unmet medical needs, which currently include TP-04, an investigational sterile aqueous gel formulation of lotilaner for the potential treatment of ocular rosacea and TP-05, an investigational oral tablet formulation of lotilaner, for potential Lyme disease prophylaxis and community malaria reduction.
Previous wording
In March 2026, we initiated a Phase 2 clinical trial (the “Calliope Trial”) evaluating TP-05, a novel investigational lotilaner-based oral prophylactic designed to kill ticks before potential disease transmission. Topline results are expected in the first half of 2027, which we believe will have the potential to support a Phase 3-ready package by the end of 2027.
Current wording
In March 2026, we initiated and have since completed enrollment in a Phase 2 clinical trial (the “Calliope Trial”) evaluating TP-05, a novel investigational lotilaner-based oral prophylactic designed to kill ticks before potential disease transmission. Topline results are expected in the first half of 2027, which we believe could support a Phase 3-ready package by the end of 2027.
Previous wording
◦During the first quarter of 2026, recognized $145.4 million in net product sales, a year-over-year increase of more than 85%.
Current wording
•Generated $173.9 million of net product sales in the second quarter of 2026, a year-over-year increase of more than 69%.
Previous wording
We are exploring the therapeutic potential of TP-05 as a novel investigational lotilaner-based oral prophylactic designed to kill ticks. There are approximately 80 million people in the U.S. at risk of Lyme disease exposure with nearly 30 million of which are moderate to high risk. Further, there are approximately 400,000 reported cases of Lyme disease in the U.S. each year, but it is believed that the actual number of cases could be much higher. We believe TP-05 is currently the only on-demand, oral tablet in development that targets ticks, and potentially prevents Lyme disease transmission. It is designed to rapidly and durably provide systemic blood levels of lotilaner potentially sufficient to kill infected ticks attached to the human body before they can transmit the Borrelia bacteria that causes Lyme disease.
Current wording
We are exploring the therapeutic potential of TP-05 as a novel investigational lotilaner-based oral prophylactic designed to kill ticks. There are approximately 80 million people in the U.S. at risk of Lyme disease exposure with more than 30 million at high or moderate risk. Further, there are approximately 400,000 reported cases of Lyme disease in the U.S. each year, but it is believed that the actual number of cases could be much higher. We believe TP-05 is currently the only on-demand, oral tablet in development that targets ticks, and potentially prevents Lyme disease transmission. It is designed to rapidly and durably provide systemic blood levels of lotilaner potentially sufficient to kill infected ticks attached to the human body before they can transmit the Borrelia bacteria that causes Lyme disease.
Previous wording
In March 2026, we initiated the Calliope Trial evaluating TP-05, a novel investigational lotilaner-based oral prophylactic designed to kill ticks before potential disease transmission. Topline results are expected in the first half of 2027, which we believe will have the potential to support a Phase 3-ready package by the end of 2027.
Current wording
In March 2026, we initiated and have since completed enrollment in the Calliope Trial evaluating TP-05, a novel investigational lotilaner-based oral prophylactic designed to kill ticks before potential disease transmission. Topline results are expected in the first half of 2027, which we believe could support a Phase 3-ready package by the end of 2027.
Previous wording
In Europe, we believe we are on track to complete stability work of a preservative-free formulation in 2026 and continue to evaluate the path to approval of TP-03 for the potential treatment of Demodex blepharitis.
Current wording
In Europe, we have completed stability work of a preservative-free formulation in 2026 and continue to evaluate the path to possible approval of TP-03 for the potential treatment of Demodex blepharitis.
Previous wording
Ongoing discussions continue with regulatory authorities in Japan on a potential path to approval of TP-03 for Demodex blepharitis. The Elara prevalence trial showed high prevalence and significant impact of Demodex blepharitis in Japan, consistent with U.S. findings.
Current wording
In Japan, we continue to evaluate a potential path to approval of TP-03 for Demodex blepharitis.
Previous wording
To date, we have financed our operations through private placements of preferred stock, convertible promissory notes, net proceeds from issuance of common stock in our IPO, our subsequent Follow-On Public Offerings and our 2023 ATM Prospectus, as well as proceeds from net product sales, our China Out-License, and drawdowns from the 2024 Credit Facility and the previous loan and security agreement with Hercules Capital, Inc. and Silicon Valley Bank, a division of First Citizens Bank & Trust Company (the “2022 Credit Facility”, and collectively the “Credit Facilities”).
Current wording
To date, we have financed our operations through private placements of preferred stock, convertible promissory notes, net proceeds from issuance of common stock in our IPO, our subsequent Follow-On Public Offerings and our 2023 ATM Prospectus, as well as proceeds from net product sales, our China Out-License, and drawdowns from the 2024 Credit Facility and the previous loan and security agreement with Hercules Capital, Inc. and Silicon Valley Bank, a division of First Citizens Bank & Trust Company (the “2022 Credit Facility”, and collectively the “Credit Facilities”). On August 5, 2026, we entered into the Purchase Agreement for the PIPE Transaction, which is expected to close on August 7, 2026, subject to satisfaction of customary closing conditions.
Previous wording
We have incurred significant net operating losses (“NOLs”) in every year since our inception and expect to continue to incur significant operating expenses as we continue to commercialize XDEMVY for Demodex blepharitis and as we advance our other product candidates through clinical trials, regulatory submissions, and potential commercialization. Our net losses were $7.0 million and $25.1 million for the three months ended March 31, 2026 and 2025, respectively. Our net losses may fluctuate significantly from quarter to quarter and year to year and could be substantial. We anticipate that our operating expenses will increase significantly as we:
Current wording
We have incurred significant net operating losses (“NOLs”) in every year since our inception and expect to continue to incur significant operating expenses as we continue to commercialize XDEMVY for Demodex blepharitis and as we advance our other product candidates through clinical trials, regulatory submissions, and potential commercialization. Our net losses were $18.6 million and $20.3 million for the three months ended June 30, 2026 and 2025, respectively, and $25.5 million and $45.5 million for the six months ended June 30, 2026 and 2025, respectively. Our net losses may fluctuate significantly from quarter to quarter and year to year and could be substantial. We anticipate that our operating expenses will increase significantly as we:
Previous wording
We expect to finance our operations through existing capital balances, revenue from product sales, public equity or debt financings, or collaborations, strategic alliances, or licensing arrangements with third parties. Adequate funding may not be available to us when needed on acceptable terms, or at all. If we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional capital or enter into such agreements as and when needed, we could be forced to significantly delay, scale back, or discontinue our product development and/or commercialization plans, which would negatively and adversely affect our financial condition.
Current wording
We expect to finance our operations through existing capital balances, revenue from product sales, equity or debt financings, or collaborations, strategic alliances, or licensing arrangements with third parties. Adequate funding may not be available to us when needed on acceptable terms, or at all. If we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional capital or enter into such agreements as and when needed, we could be forced to significantly delay, scale back, or discontinue our product development and/or commercialization plans, which would negatively and adversely affect our financial condition.
Previous wording
As of March 31, 2026, our aggregate cash, cash equivalents and marketable securities was $388.7 million – see the section below titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources.”
Current wording
As of June 30, 2026, our aggregate cash, cash equivalents and marketable securities was $449.7 million – see the section below titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources.”
Previous wording
During the three months ended March 31, 2026 and 2025, we recognized revenue of $145.4 million and $78.3 million, respectively, from product sales, net of rebates, chargebacks, discounts, and other adjustments. This increase in revenue was driven by higher volume and improvement in the gross-to-net discounts.
Current wording
During the three months ended June 30, 2026 and 2025, we recognized revenue of $173.9 million and $102.7 million, respectively, from product sales, net of rebates, chargebacks, discounts, and other adjustments, an increase of 69% compared to the prior year period. This increase in revenue was driven by higher volume and improvement in the gross-to-net discounts.
Previous wording
For the three months ended March 31, 2026 and 2025, we recognized $9.4 million and $5.2 million, respectively, in cost of sales for XDEMVY, and gross margins remained consistent at 94% and 93% for the respective periods. Cost of sales consists of direct and indirect costs related to the manufacturing and distribution of XDEMVY, including raw materials, third- party manufacturing costs, packaging services, freight-in, third-party royalties payable on our product sales, net, and amortization of capitalized intangible assets associated with XDEMVY.
Current wording
For the three months ended June 30, 2026 and 2025, we recognized $12.1 million and $6.2 million, respectively, in cost of sales for XDEMVY, and gross margins remained consistent at 93% and 94% for the respective periods. Cost of sales consists of direct and indirect costs related to the manufacturing and distribution of XDEMVY, including raw materials, third-party manufacturing costs, packaging services, freight-in, third-party royalties payable on our product sales, net, and amortization of capitalized intangible assets associated with XDEMVY.
Previous wording
Selling, general and administrative expenses increased by $51.4 million for the three months ended March 31, 2026, as compared to the prior year period. The increase was due to (i) $25.7 million of increased commercial and marketing costs, including DTC advertising costs, as we continue to expand our promotional efforts for XDEMVY’s commercial launch, (ii) $21.2 million of increased patient support functions, information technology, legal, and professional expenses, and (iii) $4.5 million of increased payroll and personnel-related costs (including increased stock-based compensation expense of $3.5 million) for commercial and corporate employee additions to support our business growth and commercial leadership hires for XDEMVY. We expect increased vendor expenses in 2026 due to further growth and expansion of our commercial activities for XDEMVY and other corporate initiatives.
Current wording
Selling, general and administrative expenses increased by $47.7 million for the three months ended June 30, 2026, as compared to the prior year period. The increase was primarily attributable to (i) a $21.2 million increase in commercial and marketing costs, including DTC advertising costs, as we continued to expand our promotional activities for XDEMVY, (ii) a $19.5 million increase in expenses associated with patient support functions, information technology, legal, and professional services, and (iii) a $6.7 million increase in payroll and personnel-related costs (including increased stock-based compensation expense of $3.9 million) primarily due to commercial and corporate employee additions to support our continued growth and expansion of our commercial leadership team. We expect vendor-related expenses to increase during 2026 as we continue to expand our commercial activities for XDEMVY and invest in other corporate initiatives.
Previous wording
Other income (expense), net for the three months ended March 31, 2026 increased by $0.3 million primarily due to increased interest income earned on our cash, cash equivalents and marketable securities.
Current wording
Other income (expense), net increased by $2.2 million for the three months ended June 30, 2026, as compared to the prior year period and primarily related to a $2.8 million gain on exchange of long-term investments (see Note 12), partially offset by a $0.5 million decrease in interest income earned on our cash, cash equivalents and marketable securities.
Previous wording
For three months ended March 31, 2026, we recognized $16.7 million in license fees and collaboration revenue related to (i) a $15.0 million regulatory milestone achievement under the China Out-License (see Note 9) and (ii) $1.7 million of required China withholding tax payable by GrandPharma on the associated milestone (see Note 11). The milestone payment was recorded on a gross basis, which increased license fees and collaboration revenue by $1.7 million, with an equal offsetting amount recorded as foreign tax expense within provision for income taxes. During the three months ended March 31, 2025, we did not recognize any license fees and collaboration revenue.
Current wording
For the six months ended June 30, 2026, we recognized $16.7 million in license fees and collaboration revenue related to (i) a $15.0 million regulatory milestone achievement under the China Out-License (see Note 9) and (ii) $1.7 million of required China withholding tax payable by GrandPharma on the associated milestone (see Note 11). The milestone payment was recorded on a gross basis, which increased license fees and collaboration revenue by $1.7 million, with an equal offsetting amount recorded as foreign tax expense within provision for income taxes. During the six months ended June 30, 2025, we did not recognize any license fees and collaboration revenue.
Previous wording
Research and development expenses increased by $7.9 million for the three months ended March 31, 2026, as compared to the prior year period. The increase was primarily due to (i) $3.7 million of increased payroll and personnel-related costs (including increased stock-based compensation expense of $1.5 million) related to employee additions to drive our product development initiatives, (ii) $2.0 million related to an upfront payment upon execution of a new in-license agreement (see Note 8), and (iii) $1.4 million of increased TP-05 program expenses related to our Calliope Trial that was initiated in March 2026. These increases were partially offset by a decrease of $0.3 million of TP-04 program expenses.
Current wording
Research and development expenses increased by $23.4 million for the six months ended June 30, 2026, as compared to the prior year period. The increase was primarily attributable to (i) a $9.4 million increase in TP-05 program expenses related to our Calliope Trial, which we initiated in March 2026 and has since completed enrollment, (ii) a $6.9 million increase in payroll and personnel-related costs (including increased stock-based compensation expense of $2.6 million) primarily due to employee additions to support our product development initiatives, (iii) a $4.0 million increase in TP-03 program expenses, (iv) a $2.0 million upfront payment made upon execution of the February 2026 In-License Agreements (see Note 8), and (v) a $0.5 million increase in other indirect expenses.
Previous wording
In July 2025, the OBBB Act was enacted in the U.S., which contains a broad range of tax reform provisions affecting businesses, including permitting the immediate expensing of domestic research and development expenditures. Provision for income taxes was $2.4 million for the three months ended March 31, 2026, primarily due to (i) $0.7 million of state income tax expense resulting from states that do not conform to the OBBB Act and therefore continue to require the capitalization and amortization of domestic research and development expenditures and (ii) $1.7 million of foreign withholding tax expense in connection with our China Out-License and a milestone that was achieved during the three months ended March 31, 2026. There was no provision for income taxes recorded during the three months ended March 31, 2025.
Current wording
In July 2025, the OBBB Act was enacted in the U.S., which contains a broad range of tax reform provisions affecting businesses, including permitting the immediate expensing of domestic research and development expenditures. Provision for income taxes was $5.1 million for the six months ended June 30, 2026, primarily due to (i) $3.1 million of state income tax expense resulting from states that do not conform to the OBBB Act and therefore continue to require the capitalization and amortization of domestic research and development expenditures and (ii) $1.7 million of foreign withholding tax expense in connection with our China Out-License and a milestone that was achieved during the six months ended June 30, 2026. There was no provision for income taxes recorded during the six months ended June 30, 2025.
Previous wording
Since our inception, we have financed our operations substantially through private placements of preferred stock, convertible promissory notes, net proceeds from the issuance of common stock through our IPO, Follow-on Public Offerings, and the 2023 ATM Prospectus, as well as proceeds from net product sales, the China Out-License, and drawdowns from our Credit Facilities. As of March 31, 2026, we had cash, cash equivalents and marketable securities of $388.7 million.
Current wording
Since our inception, we have financed our operations substantially through private placements of preferred stock, convertible promissory notes, net proceeds from the issuance of common stock through our IPO, Follow-on Public Offerings, and the 2023 ATM Prospectus, as well as proceeds from net product sales, the China Out-License, and drawdowns from our Credit Facilities. As of June 30, 2026, we had cash, cash equivalents and marketable securities of $449.7 million. On August 5, 2026, we entered into the Purchase Agreement for the PIPE Transaction, which is expected to result in gross proceeds of $125.0 million, before deducting placement agent fees and other offering expenses. The PIPE Transaction is expected to close on August 7, 2026, subject to satisfaction of customary closing conditions.
Previous wording
As of the date of this filing, we have received $86.1 million of total proceeds in connection with our China Out-License comprised of (i) $15.0 million of initial consideration, (ii) $67.5 million for the achievement of specified milestones, and (iii) $3.6 million related to the transition of the China Out-License from LianBio to GrandPharma.
Current wording
As of the date of this filing, we have received $101.1 million of total proceeds in connection with our China Out-License comprised of (i) $15.0 million of initial consideration, (ii) $82.5 million for the achievement of specified milestones, and (iii) $3.6 million related to the transition of the China Out-License from LianBio to GrandPharma.
Previous wording
As of the date of this filing, we are eligible to receive further consideration from GrandPharma upon the achievement of additional TP-03 events, including: (i) additional regulatory approval and/or patent issuance milestones and one-time payments of up to an aggregate of $20.0 million (of which $15.0 million was achieved in March 2026 and the Company is awaiting the corresponding cash receipt); (ii) China-based TP-03 sales threshold milestones of up to an aggregate of $100.0 million; and (iii) tiered low to high-teen royalties for China Territory TP-03 product sales.
Current wording
As of the date of this filing, we are eligible to receive further consideration from GrandPharma upon the achievement of additional TP-03 events, including: (i) an additional regulatory approval milestone and one-time payment of $5.0 million; (ii) China-based TP-03 sales threshold milestones of up to an aggregate of $100.0 million; and (iii) tiered low to high-teen royalties for China Territory TP-03 product sales.
Previous wording
Our operating expenditures currently consist of cost of sales, research and development costs (including activities within our preclinical, clinical, regulatory, and drug manufacturing initiatives) and selling, general and administrative costs. Our use of cash is impacted by the timing and extent of payments for each of these activities and other business requirements. We have incurred significant losses and negative cash flows from operations since our inception and had an accumulated deficit of $433.6 million and $426.6 million as of March 31, 2026 and December 31, 2025, respectively.
Current wording
Our operating expenditures currently consist of cost of sales, research and development costs (including activities within our preclinical, clinical, regulatory, and drug manufacturing initiatives) and selling, general and administrative costs. Our use of cash is impacted by the timing and extent of payments for each of these activities and other business requirements. Although we have recently generated positive cash flows from operations, we have historically incurred significant losses and generated negative cash flows from operations since our inception. As of June 30, 2026 and December 31, 2025, we had accumulated deficits of $452.1 million and $426.6 million, respectively.
Previous wording
We believe our cash, cash equivalents and marketable securities of $388.7 million as of March 31, 2026, is sufficient to fund our current and planned operations for at least the next twelve months from the date of filing this Quarterly Report on Form 10-Q. Our cash runway estimate is predicated on current assumptions for future revenue, operating expenses, and debt availability and may require future adjustments. Accordingly, we may be required to raise additional capital earlier than we currently expect based on our cash requirements and market dynamics.
Current wording
As of the date of this filing, we have paid $37.5 million of cash consideration (the “iRenix Upfront Payment”) in connection with the iRenix Acquisition and have agreed to pay, subject to the consummation of the Alkeus Acquisition, $270.0 million of cash consideration in connection with the Alkeus Acquisition (see Note 13) (the “Alkeus Upfront Payment”). Further, we expect to receive an additional $125.0 million in gross proceeds upon the closing of the PIPE Transaction, which is expected to occur on August 7, 2026, subject to satisfaction of customary closing conditions. After giving effect to the iRenix Upfront Payment and assuming that we will pay the Alkeus Upfront Payment upon the consummation of the Alkeus Acquisition and will receive the gross proceeds upon the closing of the PIPE Transaction, we believe that our remaining cash, cash equivalents and marketable securities will be sufficient to fund our current and planned operations for at least the next twelve months following the filing date of this Quarterly Report on Form 10-Q. Our cash runway estimate is predicated on current assumptions regarding future revenue, operating expenses, and the availability of debt and equity financing, and may require future adjustments. Accordingly, we may be required to raise additional capital earlier than we currently expect based on our cash requirements and market dynamics.
Previous wording
In November 2023, we filed a shelf registration statement on Form S-3 that was declared effective by the SEC on November 21, 2023, (the “2023 Shelf Registration Statement”), and as part of the 2023 Shelf Registration Statement, we concurrently filed the 2023 ATM Prospectus with Jefferies. The 2023 ATM Prospectus covers the sale of up to $100.0 million of our common stock pursuant to an Open Market Sales Agreement TM we entered into with Jefferies in 2021 (the “ATM Sales Agreement”). Under the terms of the 2023 ATM Prospectus and ATM Sales Agreement, Jefferies will act as the Company’s sales agent and is entitled to compensation for its services equal to 3% of the gross proceeds of any shares of common stock sold.
Current wording
In November 2023, we filed a shelf registration statement on Form S-3 that was declared effective by the SEC on November 21, 2023, (the “2023 Shelf Registration Statement”), and as part of the 2023 Shelf Registration Statement, we concurrently filed the 2023 ATM Prospectus with Jefferies. The 2023 ATM Prospectus covers the sale of up to $100.0 million of our common stock pursuant to an Open Market Sale Agreement TM we entered into with Jefferies in 2021 (the “ATM Sales Agreement”). Under the terms of the 2023 ATM Prospectus and ATM Sales Agreement, Jefferies will act as the Company’s sales agent and is entitled to compensation for its services equal to 3% of the gross proceeds of any shares of common stock sold.
Previous wording
Net cash used in operating activities was $20.7 million for the three months ended March 31, 2025, which primarily consisted of a net loss of $25.1 million and a net decrease in operating assets and liabilities of $1.9 million, partially offset by non-cash charges of $6.4 million. Our cash outflows primarily related to: (i) $108.4 million of vendor payments, (ii) $30.7 million of personnel-related costs, and (iii) $3.3 million of royalty payments. These cash outflows were partially offset by cash receipts of $122.8 million related to XDEMVY net product sales.
Current wording
Net cash provided by operating activities was $36.6 million for the six months ended June 30, 2026, which primarily consisted of a net loss of $25.5 million, offset by a net increase in operating assets and liabilities of $39.2 million and non-cash charges of $22.9 million. Our cash inflows primarily related to $530.0 million of cash receipts from XDEMVY net product sales, and $15.0 million from GrandPharma for a regulatory milestone achievement under the China Out-License. These cash inflows were partially offset by (i) $430.7 million of vendor payments, (ii) $58.9 million of personnel-related costs, and (iii) $16.4 million of royalty payments.
Previous wording
Net cash used in operating activities was $24.7 million for the three months ended March 31, 2026, which primarily consisted of a net loss of $7.0 million and a net decrease in operating assets and liabilities of $29.5 million, partially offset by non-cash charges of $11.8 million. Our cash outflows primarily related to: (i) $214.5 million of vendor payments, (ii) $36.4 million of personnel-related costs, and (iii) $9.1 million of royalty payments. These cash outflows were partially offset by cash receipts of $234.8 million related to XDEMVY net product sales.
Current wording
Net cash used in operating activities was $50.0 million for the six months ended June 30, 2025, which primarily consisted of a net loss of $45.5 million and a net decrease in operating assets and liabilities of $18.3 million, partially offset by non-cash charges of $13.7 million. Our cash outflows primarily related to: (i) $292.5 million of vendor payments, (ii) $51.9 million of personnel-related costs, and (iii) $7.2 million of royalty payments. These cash outflows were partially offset by cash receipts of $303.6 million related to XDEMVY net product sales.
Previous wording
Net cash used in investing activities was $58.6 million for the three months ended March 31, 2026, and related to $126.8 million of purchased marketable securities and $5.8 million of purchased property and equipment, partially offset by $74.1 million of proceeds from maturities of marketable securities.
Current wording
Net cash used in investing activities was $20.7 million for the six months ended June 30, 2026, and related to $129.2 million of purchased marketable securities and $9.9 million of purchased property and equipment, partially offset by $118.4 million of proceeds from maturities of marketable securities.
Previous wording
Net cash used in investing activities was $34.9 million for the three months ended March 31, 2025, and related to $125.6 million of purchased marketable securities and $0.6 million of purchased property and equipment, partially offset by $91.2 million of proceeds from maturities of marketable securities.
Current wording
Net cash used in investing activities was $86.6 million for the six months ended June 30, 2025, and related to $255.3 million of purchased marketable securities and $1.6 million of purchased property and equipment, partially offset by $170.2 million of proceeds from maturities of marketable securities.
Previous wording
Net cash provided by financing activities was $1.2 million for the three months ended March 31, 2026, and related to proceeds from employee stock option exercises.
Current wording
Net cash provided by financing activities was $4.5 million for the six months ended June 30, 2026, and related to $3.1 million of proceeds from employee stock option exercises and $1.4 million of proceeds from the issuance of common stock pursuant to our employee stock purchase plan (“ESPP”).
Previous wording
Net cash provided by financing activities was $136.6 million for the three months ended March 31, 2025, and related to $135.1 million of net proceeds from the issuance of common stock in the March 2025 Public Offering and $1.4 million of proceeds from employee stock option exercises.
Current wording
Net cash provided by financing activities was $138.5 million for the six months ended June 30, 2025, and related to $134.8 million of net proceeds from the issuance of common stock in the March 2025 Public Offering, $2.6 million of proceeds from employee stock option exercises, and $1.1 million of proceeds from the issuance of common stock pursuant to our ESPP.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
TP-04 for the Potential Treatment of Ocular Rosacea:
Current report — wording carried from elsewhere
In July 2025, the OBBB Act was enacted in the U.S., which contains a broad range of tax reform provisions affecting businesses, including permitting the immediate expensing of domestic research and development expenditures. Provision for income taxes was $2.7 million for the three months ended June 30, 2026, primarily due to $2.4 million of state income tax expense resulting from states that do not conform to the OBBB Act and therefore continue to require the capitalization and amortization of domestic research and development expenditures. There was no provision for income taxes recorded during the three months ended June 30, 2025.
Current report — wording carried from elsewhere
During the six months ended June 30, 2026 and 2025, we recognized revenue of $319.3 million and $181.0 million, respectively, from product sales, net of rebates, chargebacks, discounts, and other adjustments, a year-over-year increase of more than 76%. This increase in revenue was driven by higher volume and improvement in the gross-to-net discounts.
Current report — wording carried from elsewhere
For the six months ended June 30, 2026 and 2025, we recognized $21.5 million and $11.4 million, respectively, in cost of sales for XDEMVY, and gross margins remained consistent at 93% and 94% for the respective periods. Cost of sales consists of direct and indirect costs related to the manufacturing and distribution of XDEMVY, including raw materials, third-party manufacturing costs, packaging services, freight-in, third-party royalties payable on our product sales, net, and amortization of capitalized intangible assets associated with XDEMVY.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Net Cash Used in Operating Activities