Tarsus Pharmaceuticals(TARS) - 2025 Q2 - Quarterly Results

Executive Summary & Business Highlights Tarsus Pharmaceuticals achieved record Q2 2025 net product sales for XDEMVY, driven by a successful DTC campaign, while advancing its clinical pipeline and global expansion efforts Q2 2025 Performance Overview Tarsus Pharmaceuticals achieved record quarterly net product sales of $102.7 million for XDEMVY in Q2 2025, marking a 152% year-over-year increase within two years of its launch - Record quarterly net product sales of $102.7 million achieved within two years of XDEMVY launch, an increase of 152% year over year[1] - XDEMVY has been established as the standard of care for Demodex blepharitis[2] - The peak potential of XDEMVY is now believed to be even greater than initially expected at launch[2] Recent Business and Clinical Achievements The company's direct-to-consumer (DTC) campaign significantly boosted prescription growth for XDEMVY, leading to increased patient activation and prescriber engagement, while clinical development and global expansion progress XDEMVY Commercial Performance XDEMVY demonstrated strong commercial growth in Q2 2025, with $102.7 million in net product sales and approximately 91,000 bottles distributed, driven by a successful DTC campaign XDEMVY Q2 2025 Commercial Metrics | Metric | Q2 2025 | | :----- | :------ | | Net Product Sales ($) | $102.7 million | | Bottles Distributed | ~91,000 | | Commercial, Medicare, Medicaid Coverage (%) | >90% | | Gross-to-Net Discount (%) | ~45% | - The Company's action-oriented direct-to-consumer (DTC) advertising campaign meaningfully contributed to prescription growth[3] DTC Campaign Impact | DTC Metric | Change since early 2025 | | :--------- | :---------------------- | | XDEMVY.com Active Consumer Engagement | Up nearly 400% | | Consumer Unaided Awareness | More than tripled | | ECPs Prescribing XDEMVY | >20,000 (30%+ increase) | Clinical Pipeline Advancements Tarsus' robust pipeline remains on track, with Phase 2 studies for TP-04 (ocular rosacea) planned for H2 2025 and TP-05 (Lyme disease prevention) for 2026 - The Company's robust pipeline remains on track[3] - A Phase 2 study of TP-04 for the potential treatment of ocular rosacea is planned to initiate in H2 2025[3] - A Phase 2 study of TP-05 for the potential prevention of Lyme disease is planned to initiate in 2026[6] Global Expansion Efforts Global expansion efforts are progressing, with regulatory meetings in Japan on track for H2 2025 and potential European approval for a preservative-free XDEMVY formulation expected in 2027 - Meetings with regulatory authorities in Japan remain on track for H2 2025[6] - Potential European regulatory approval for a preservative-free formulation of XDEMVY is expected in 2027[6] Financial Results Tarsus Pharmaceuticals demonstrated strong financial performance in Q2 and YTD 2025, driven by significant product sales growth, leading to a reduced net loss and improved balance sheet Second Quarter 2025 Financial Performance Tarsus reported significant growth in Q2 2025, with net product sales reaching $102.7 million, a 152% increase year-over-year, and a reduced net loss of $20.3 million Q2 2025 vs Q2 2024 Financial Performance | Metric | Q2 2025 | Q2 2024 | YoY Change | | :----- | :------ | :------ | :--------- | | Product sales, net ($) | $102.7 million | $40.8 million | +152% | | Bottles of XDEMVY delivered | ~91,000 | ~37,000 | +146% | | Cost of sales ($) | $6.2 million | $3.0 million | +107% | | R&D expenses ($) | $15.6 million | $12.3 million | +27% | | SG&A expenses ($) | $103.0 million | $58.8 million | +75% | | Net loss ($) | $(20.3) million | $(33.3) million | -39% | | Basic & Diluted Net Loss per Share ($) | $(0.48) | $(0.88) | -45% | - Cash, cash equivalents and marketable securities were $381.1 million as of June 30, 2025[6] Year-to-Date 2025 Financial Performance For the six months ended June 30, 2025, net product sales grew to $181.0 million, up 176% from the prior year, with a significantly narrowed net loss of $45.5 million YTD 2025 vs YTD 2024 Financial Performance | Metric | YTD 2025 | YTD 2024 | YoY Change | | :----- | :------- | :------- | :--------- | | Product sales, net ($) | $181.0 million | $65.5 million | +176% | | Bottles of XDEMVY delivered | ~163,000 | ~63,000 | +159% | | Cost of sales ($) | $11.4 million | $4.7 million | +143% | | R&D expenses ($) | $30.0 million | $24.4 million | +23% | | SG&A expenses ($) | $188.0 million | $110.4 million | +70% | | Net loss ($) | $(45.5) million | $(69.0) million | -34% | | Basic & Diluted Net Loss per Share ($) | $(1.11) | $(1.89) | -41% | Condensed Statements of Operations and Comprehensive Loss The condensed statements of operations show significant increases in product sales and operating expenses for both the three and six months ended June 30, 2025, with a decreased net loss due to substantial revenue growth Condensed Statements of Operations and Comprehensive Loss | (In thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Product sales, net (in thousands) | $102,660 | $40,813 | $180,995 | $65,533 | | Total revenues (in thousands) | $102,660 | $40,813 | $180,995 | $68,427 | | Cost of sales (in thousands) | $6,237 | $3,004 | $11,448 | $4,658 | | Research and development (in thousands) | $15,594 | $12,319 | $30,003 | $24,385 | | Selling, general and administrative (in thousands) | $103,013 | $58,792 | $188,008 | $110,370 | | Total operating expenses (in thousands) | $124,844 | $74,115 | $229,459 | $139,413 | | Loss from operations (in thousands) | $(22,184) | $(33,302) | $(48,464) | $(70,986) | | Net loss (in thousands) | $(20,340) | $(33,290) | $(45,460) | $(69,021) | | Net loss per share, basic and diluted ($) | $(0.48) | $(0.88) | $(1.11) | $(1.89) | | Weighted-average shares outstanding | 42,360,452 | 37,823,233 | 40,869,364 | 36,530,756 | Condensed Balance Sheets As of June 30, 2025, Tarsus' total assets increased to $494.99 million from $376.99 million at December 31, 2024, driven by growth in marketable securities and receivables, alongside increased liabilities and stockholders' equity Condensed Balance Sheets | (In thousands) | June 30, 2025 | December 31, 2024 | | :------------- | :------------ | :---------------- | | ASSETS | | | | Cash and cash equivalents (in thousands) | $96,648 | $94,819 | | Marketable securities (in thousands) | $284,495 | $196,557 | | Accounts receivable, net (in thousands) | $58,334 | $46,760 | | Total current assets (in thousands) | $474,429 | $356,705 | | Total assets (in thousands) | $494,994 | $376,991 | | LIABILITIES | | | | Total current liabilities (in thousands) | $90,253 | $80,612 | | Long-term debt, net (in thousands) | $72,129 | $71,845 | | Total liabilities (in thousands) | $162,382 | $152,457 | | STOCKHOLDERS' EQUITY | | | | Total stockholders' equity (in thousands) | $332,612 | $224,534 | Product and Pipeline Information This section details XDEMVY, an FDA-approved treatment for Demodex blepharitis, and the investigational pipeline including TP-04 for ocular rosacea and TP-05 for Lyme disease prevention XDEMVY (Lotilaner Ophthalmic Solution) XDEMVY (lotilaner ophthalmic solution) 0.25% is an FDA-approved prescription eye drop for Demodex blepharitis, demonstrating statistical significance in clinical trials with common side effects of instillation site stinging and burning - XDEMVY is indicated for the treatment of Demodex blepharitis[10] - Evaluated in two pivotal trials collectively involving more than 800 patients, both trials met the primary endpoint and all secondary endpoints with statistical significance[9] - The most common ocular adverse reactions observed in studies were instillation site stinging and burning, reported in 10% of patients[9][10] Investigational Pipeline Tarsus is advancing its pipeline with two investigational products: TP-04 for ocular rosacea and TP-05 for Lyme disease prevention, both currently in Phase 2 development TP-04 (Ocular Rosacea) TP-04 is an investigational sterile aqueous gel formulation of lotilaner being studied for the potential treatment of ocular rosacea, a prevalent and underserved eye disease without FDA-approved therapy, with a Phase 2 study planned for H2 2025 - TP-04 is an investigational sterile aqueous gel formulation of lotilaner[13] - Tarsus is studying TP-04 for the potential treatment of ocular rosacea, a highly prevalent and underserved eye disease with no FDA-approved therapy[3][13] - A Phase 2 study of TP-04 is planned to initiate in H2 2025[3] TP-05 (Lyme Disease Prevention) TP-05 is an investigational oral systemic formulation of lotilaner, believed to be the only non-vaccine, drug-based preventative therapeutic in development for Lyme disease prevention, with a Phase 2 study planned for 2026 - TP-05 is an investigational oral systemic formulation of lotilaner[15] - TP-05 is believed to be the only non-vaccine, drug-based, preventative therapeutic in development designed to kill ticks to potentially prevent Lyme disease transmission[15] - A Phase 2 study of TP-05 for the potential prevention of Lyme disease is planned to initiate in 2026[6] Corporate Information This section provides details on the Q2 2025 conference call, an overview of Tarsus Pharmaceuticals, forward-looking statement disclaimers, and contact information Conference Call and Webcast Tarsus hosted a conference call and webcast on August 6, 2025, to discuss its second quarter 2025 financial results and business highlights, with a recorded version available online - Tarsus hosted a conference call and webcast on August 6, 2025, at 1:30 p.m. PT / 4:30 p.m. ET to discuss Q2 2025 financial results and business highlights[1][8] - A recorded version of the call will be available on the Tarsus website shortly after completion and archived for at least 90 days[8] About Tarsus Pharmaceuticals, Inc. Tarsus Pharmaceuticals focuses on revolutionizing patient treatment, starting with eye care, by applying proven science and new technology, advancing a pipeline across eye care, dermatology, and infectious disease prevention - Tarsus Pharmaceuticals applies proven science and new technology to revolutionize treatment for patients, starting with eye care[16] - The company is advancing its pipeline to address several diseases with high unmet need across eye care, dermatology, and infectious disease prevention[16] - XDEMVY is FDA approved for Demodex blepharitis, and TP-04 (ocular rosacea) and TP-05 (Lyme disease prevention) are in Phase 2 development[16] Forward-Looking Statements The report contains forward-looking statements regarding future expectations, plans, and prospects, which are subject to various important factors and risks detailed in SEC filings that could cause actual results to differ materially - Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute 'forward-looking statements'[17] - Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors and risks detailed in SEC filings[17][18] - Readers are cautioned not to place undue reliance on these forward-looking statements, which are based on current expectations and speak only as of the date of the release[18] Media and Investor Contacts Contact information for media inquiries (Adrienne Kemp) and investor relations (David Nakasone) is provided - Media Contact: Adrienne Kemp, Sr. Director, Corporate Communications, (949) 922-0801, akemp@tarsusrx.com[19] - Investor Contact: David Nakasone, Head of Investor Relations, (949) 620-3223, DNakasone@tarsusrx.com[19]