Summary of Tarsus Pharmaceuticals (TARS) 2025 Conference Call Company Overview - Tarsus Pharmaceuticals is a commercial company based in Orange County, California, focusing on eye care treatments, particularly the launch of their drug Xtampi for blepharitis treatment [3][4]. Key Highlights - **Product Launch Success**: The launch of Xtampi has exceeded expectations, with Q1 revenue recorded at approximately $78.2 million, representing a 20% growth from Q4 [4]. - **Market Potential**: The drug targets a significant patient population, with an estimated 25 million patients in the U.S. suffering from demodex-related conditions, and aims to reach 9 million patients actively visiting doctors [3][4]. - **Sales Force Impact**: The expansion of the sales force has been a major tailwind, contributing to extraordinary growth in Q1, surpassing initial expectations despite typical seasonal challenges [19][20]. Financial Metrics - **Revenue and Dispensed Bottles**: In Q1, Tarsus dispensed 72,000 bottles of Xtampi, with a gross-to-net discount of about 47%, expected to decline to the low 40s in subsequent quarters [4]. - **Patient Coverage**: Over 90% of lives are covered by payers for Xtampi, which is considered remarkable in the current environment [11][12]. Pipeline Developments - **Ocular Rosacea**: Tarsus is initiating a Phase II study for ocular rosacea, targeting 15-18 million patients, with no current FDA-approved treatments available [5][58]. - **Lyme Disease Program**: A prophylactic oral treatment for Lyme disease is also in the pipeline, with plans for a Phase 2b study in 2026 [6]. Competitive Landscape - **Lack of Competition**: Xtampi is positioned as a best-in-class product with no direct competition, as existing treatments do not effectively address the root cause of demodex infestation [10][16]. - **Potential Complementary Products**: Other products in development, such as pimecrilimus, may serve as complementary treatments rather than direct competitors [14][15]. Market Dynamics - **Optometrist Engagement**: The trend of optometrists taking on more medical management roles is increasing, allowing them to bill for comprehensive exams and follow-ups, which enhances patient retention and practice growth [34][37]. - **Direct-to-Consumer (DTC) Marketing**: The DTC program is showing promising early results, with increased website visits and engagement correlating with future prescription growth [29][30]. Future Outlook - **TAM Growth**: The total addressable market (TAM) is expected to grow, with the potential to treat a significant portion of the 9 million targeted patients over time [45][46]. - **Data Generation**: Tarsus plans to conduct multiple Phase IV studies to expand its market presence and validate the efficacy of its products across various patient segments [48]. Regulatory and Market Considerations - **Medicare Part D Impact**: The introduction of Medicare Part D coverage has reduced friction for patient access, positively impacting revenue [50][52]. - **Exploration of International Markets**: Tarsus is considering opportunities in Europe but currently focuses on the U.S. market [56]. Conclusion - Tarsus Pharmaceuticals is positioned for significant growth with its innovative product offerings and strategic market engagement, particularly in the eye care sector. The company is optimistic about its future prospects, driven by a strong sales force, effective marketing strategies, and a robust pipeline of new treatments.

Core Insights - Tarsus Pharmaceuticals has launched a direct-to-consumer TV campaign for its eyedrop Xdemvy (lotilaner) aimed at treating Demodex blepharitis, marking a significant marketing strategy just over a year after the product's launch [1] Company Summary - Tarsus Pharmaceuticals is actively promoting its product Xdemvy through a direct-to-consumer approach, indicating a shift towards more aggressive marketing tactics to enhance product visibility and sales [1]

Core Insights - Tarsus Pharmaceuticals reported a quarterly loss of $0.64 per share, which is better than the Zacks Consensus Estimate of a loss of $0.69, and an improvement from a loss of $1.01 per share a year ago, indicating a 36.6% year-over-year improvement [1] - The company achieved revenues of $78.34 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 8.06% and showing a significant increase from $27.61 million in the same quarter last year [2] - Tarsus Pharmaceuticals has consistently surpassed consensus EPS estimates over the last four quarters, indicating strong performance relative to market expectations [2] Financial Performance - The company has shown an earnings surprise of 7.25% for the recent quarter and an 11.76% surprise in the previous quarter, reflecting positive momentum in earnings performance [1][2] - The current consensus EPS estimate for the upcoming quarter is -$0.38, with expected revenues of $86.76 million, while the estimate for the current fiscal year is -$1.22 on revenues of $361.17 million [7] Market Position - Tarsus Pharmaceuticals shares have underperformed the market with a decline of about 6.3% since the beginning of the year, compared to a decline of 5.3% for the S&P 500 [3] - The company holds a Zacks Rank 2 (Buy), indicating expectations for the stock to outperform the market in the near future based on favorable estimate revisions [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Tarsus Pharmaceuticals belongs, is currently ranked in the top 32% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - In Q1 2025, Tarsus Pharmaceuticals generated over $78 million in Xtendi sales, representing a year-over-year increase of 217% [5][21] - Approximately 72,000 bottles of Xtendi were dispensed to patients, with a quarter-over-quarter growth of 18% [14][21] - Total operating expenses were approximately $104.6 million, an increase of $14 million compared to Q4 2024, primarily driven by direct-to-consumer advertising and related commercial costs [22] Business Line Data and Key Metrics Changes - Xtendi's sales growth was driven by an expanded sales force, which has led to a significant increase in prescribing frequency among eye care professionals (ECPs) [14][15] - The number of ECPs writing more than one prescription per week increased by approximately 110% compared to the end of Q3 2024 [14] Market Data and Key Metrics Changes - The company reported that over 90% of commercial and Medicare lives are covered, which has significantly reduced barriers to physician adoption [15][16] - The DTC campaign has increased average weekly website visits by 140% in March 2025 compared to December 2024 [16] Company Strategy and Development Direction - Tarsus aims to establish itself as a leader in eye care by creating new categories of treatment, such as ocular rosacea, and expanding the market for Xtendi [7][10] - The company is focused on leveraging its strong financial position to drive growth and advance its pipeline of category-creating medicines [11][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Xtendi, anticipating an increase in bottles dispensed to a range of 85,000 to 90,000 in Q2 2025 [26] - The company expects to see continued growth despite typical seasonal headwinds in the summer [26] Other Important Information - Tarsus recently secured approximately $135 million in equity financing, which strengthens its financial position and supports ongoing growth initiatives [10][25] - The company is on track to initiate a Phase II trial for TPO4 in ocular rosacea later this year [10][59] Q&A Session Summary Question: Have there been any disruptions in meeting with the FDA regarding pipeline products? - Management confirmed there have been no delays in meeting schedules with the FDA [32] Question: What is the current split between Medicare and commercial prescriptions? - The prescribing volume is currently split relatively equally between Medicare and commercial prescriptions, with Medicare coverage acting as a significant growth driver [33][34] Question: What are the key drivers for repeat prescribing? - Key drivers include an expanded sales force and improved coverage, which have led to increased frequency of prescribing among doctors [38][40] Question: How is the feedback from the ORION Registry and MGD data being received? - Doctors are responding positively to the new data, which is prompting them to diagnose and treat more patients across various segments [55][56] Question: What are the potential factors that might affect future guidance? - Factors include the impact of the DTC campaign and macroeconomic events that could influence visibility [64] Question: What is the expected level of stocking in the channel? - The company does not anticipate significant changes in inventory levels, which have remained consistent at around two to two and a half weeks [67]

Financial Data and Key Metrics Changes - In Q1 2025, Tarsus Pharmaceuticals generated over $78 million in Xtendi sales, a year-over-year increase of 217%, driven by approximately 72,000 bottles dispensed to patients [4][20] - The gross to net discount was approximately 47%, reflecting strong coverage and an adjustment to Medicare accrual estimates [20][21] - Total operating expenses were approximately $104.6 million, an increase of $14 million compared to Q4 2024, primarily due to direct-to-consumer advertising and related marketing costs [21][22] - The company ended the quarter with approximately $407.9 million in cash and cash equivalents, bolstered by a recent equity raise of approximately $135 million [23] Business Line Data and Key Metrics Changes - Xtendi's sales growth was driven by an expanded sales force and increased prescribing frequency among eye care professionals (ECPs), with a 110% increase in ECPs writing more than one prescription per week compared to Q3 2024 [13][14] - The company anticipates dispensing between 85,000 to 90,000 bottles in Q2 2025, with a gross to net discount expected in the range of 45% to 47% [25] Market Data and Key Metrics Changes - The company reported that over 90% of commercial and Medicare lives are covered, significantly reducing barriers to physician adoption [15][20] - The DTC campaign has led to a 140% increase in average weekly website visits in March 2025 compared to December 2024 [15][18] Company Strategy and Development Direction - Tarsus aims to establish itself as a leader in eye care by creating new categories of treatment, with a focus on Xtendi and the upcoming Xembi launch [4][11] - The company is exploring global opportunities for Xtendi, particularly in Japan and Europe, with potential regulatory approval in Europe expected by 2027 [7][8] - Tarsus is also advancing its pipeline with TPO4 for ocular rosacea, targeting a significant and underserved market [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Xtendi, citing strong sales force performance and effective DTC campaigns as key drivers [19][26] - The company anticipates continued revenue growth, despite potential headwinds in Q3 due to seasonal factors, with stronger growth expected in Q4 [25][26] Other Important Information - The company has a proven blueprint for success and is well-positioned for sustained revenue growth in the coming years [11][26] - Management highlighted the importance of patient education and awareness as critical components of their growth strategy [78] Q&A Session Summary Question: Have there been any disruptions in meeting with the FDA regarding pipeline products? - Management confirmed there have been no delays in meeting schedules and they are on track to start trials in the second half of the year [30][31] Question: What is the current split between Medicare and commercial prescriptions? - The script volume is currently split relatively equally between Medicare and commercial prescriptions, with Medicare coverage acting as a significant growth driver [33][34] Question: What are the key drivers for repeat prescribing? - Key drivers include an expanded sales force and improved coverage, which have led to increased frequency of prescribing among doctors [38][40] Question: How is the feedback from the ORION Registry and MGD data being received? - Doctors are responding positively to the new data, which is prompting them to diagnose more patients and consider a broader range of conditions [54] Question: What are the potential factors affecting future guidance? - Factors include the impact of the DTC campaign and macroeconomic events, which may affect visibility for long-range guidance [63] Question: What is the expected level of stocking in the channel? - The company does not anticipate changes in stocking levels, which have remained consistent at around two to two and a half weeks [66]

[Part I - Financial Information](index=6&type=section&id=Part%20I%20-%20Financial%20Information) [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) The company reported **$78.3 million** in Q1 2025 revenues, a reduced net loss, and a strengthened balance sheet with **$407.9 million** in cash and equivalents, bolstered by a **$134.8 million** public offering Condensed Consolidated Statements of Operations (Q1 2025 vs Q1 2024) | Financial Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Product sales, net** | **$78,335** | **$24,720** | | License fees and collaboration revenue | $0 | $2,894 | | **Total revenues** | **$78,335** | **$27,614** | | Cost of sales | $5,211 | $1,654 | | Research and development | $14,409 | $12,066 | | Selling, general and administrative | $84,995 | $51,578 | | **Total operating expenses** | **$104,615** | **$65,298** | | Loss from operations | ($26,280) | ($37,684) | | **Net loss** | **($25,120)** | **($35,731)** | | **Net loss per share, basic and diluted** | **($0.64)** | **($1.01)** | Condensed Consolidated Balance Sheets | Balance Sheet Item | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $175,787 | $94,819 | | Marketable securities | $232,129 | $196,557 | | Accounts receivable, net | $62,426 | $46,760 | | **Total current assets** | **$480,773** | **$356,705** | | **Total assets** | **$500,750** | **$376,991** | | Total current liabilities | $86,308 | $80,612 | | Long-term debt, net | $71,984 | $71,845 | | **Total liabilities** | **$158,292** | **$152,457** | | **Total stockholders' equity** | **$342,458** | **$224,534** | Condensed Consolidated Statements of Cash Flows | Cash Flow Activity | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($20,651) | ($37,789) | | Net cash used in investing activities | ($34,942) | ($102,224) | | Net cash provided by financing activities | $136,562 | $108,771 | | **Net increase (decrease) in cash** | **$80,969** | **($31,242)** | - In March 2025, the company completed a follow-on public offering, selling 2,808,988 shares at $44.50 per share and an additional 421,348 shares via underwriter option exercise, raising approximately **$134.8 million** in net proceeds[27](index=27&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=38&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes Q1 2025 revenue growth to XDEMVY's successful launch, with increased operating expenses for commercial expansion and R&D, while affirming sufficient capital for the next 12 months - XDEMVY net product sales grew to **$78.3 million** in Q1 2025, a **217%** increase year-over-year, with approximately **72,000** bottles dispensed to patients and payer coverage extending to over **90%** of covered lives[192](index=192&type=chunk)[211](index=211&type=chunk) - Selling, General and Administrative (SG&A) expenses increased by **$33.4 million** year-over-year to **$85.0 million**, driven by a **$25.6 million** increase in commercial and marketing costs for XDEMVY, including direct-to-consumer advertising, and a **$9.6 million** increase in personnel-related costs[215](index=215&type=chunk) - Research and Development (R&D) expenses increased by **$2.3 million** to **$14.4 million**, primarily due to increased spending on the TP-04 (Ocular Rosacea) program, early-stage programs, and higher personnel costs[214](index=214&type=chunk) - As of March 31, 2025, the company had **$407.9 million** in cash, cash equivalents, and marketable securities, which management believes are sufficient to support operations for at least the next **12 months**[217](index=217&type=chunk)[226](index=226&type=chunk) - The company plans to initiate a **Phase 2 study** for TP-04 in Ocular Rosacea in the second half of 2025, and for TP-05 in Lyme disease, the FDA has agreed to a **Phase 2b trial** design, with initiation expected in 2026, though the company intends to partner the program[195](index=195&type=chunk)[198](index=198&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=50&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate changes affecting its **$407.9 million** in investments and **$75.0 million** floating-rate debt, though a 100 basis point change is not expected to have a material impact - The company's main market risk is from interest rate changes affecting its cash, cash equivalents, marketable securities (**$407.9 million**), and its floating-rate debt (**$75.0 million**)[247](index=247&type=chunk)[248](index=248&type=chunk) - Due to the short-term and low-risk nature of its investments, management believes a **100 basis point** change in interest rates would not materially affect the fair value of its cash and investments[247](index=247&type=chunk) - The **$75.0 million** debt accrues interest at a floating rate (SOFR + 6.75%) with a 3.75% SOFR floor, and a hypothetical **100 basis point** change in the applicable rate is not expected to have a significant impact on interest expense[248](index=248&type=chunk)[249](index=249&type=chunk) [Controls and Procedures](index=51&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level[252](index=252&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[253](index=253&type=chunk) [Part II - Other Information](index=52&type=section&id=Part%20II%20-%20Other%20Information) [Legal Proceedings](index=52&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though it may face litigation in the ordinary course of business - Tarsus is not currently a party to any material legal proceedings[256](index=256&type=chunk) [Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors) The company faces extensive risks, primarily its dependence on XDEMVY, limited operating history, need for capital, reliance on third parties, intellectual property challenges, and stringent government regulation [Risks Related to Business and Operations](index=52&type=section&id=Risks%20Related%20to%20our%20Business%20and%20Operations) The company faces operational risks due to its early commercial stage, reliance on third parties, cybersecurity threats, and global economic conditions, with a history of significant net losses - The company is an early commercial-stage biopharmaceutical firm with a single approved product, XDEMVY, and a history of significant net losses (**$25.1M** for Q1 2025), with an accumulated deficit of **$385.3M** as of March 31, 2025[258](index=258&type=chunk)[259](index=259&type=chunk) - The company relies heavily on third-party contract organizations (CROs, CMOs) for clinical trials and manufacturing, which exposes it to risks of delays, quality issues, and termination of services[262](index=262&type=chunk)[264](index=264&type=chunk) - Information technology systems are vulnerable to security breaches and disruptions, which could compromise confidential data, delay product development, and result in liability under laws like the CCPA[270](index=270&type=chunk)[273](index=273&type=chunk) - Unfavorable global economic conditions, including inflation and geopolitical conflicts, could reduce demand for products, increase operating costs, and disrupt the supply chain[278](index=278&type=chunk)[280](index=280&type=chunk) [Risks Related to Development and Commercialization](index=61&type=section&id=Risks%20Related%20to%20Development%20and%20Commercialization) The company's success depends on XDEMVY's commercialization and pipeline development, facing risks in market acceptance, competition, clinical development uncertainties, and compliance with government pricing programs - The company is heavily dependent on the successful commercialization of its single approved product, XDEMVY, and the development of its pipeline candidates (TP-04, TP-05)[293](index=293&type=chunk) - Market acceptance of XDEMVY is a risk, as the company must educate eye care providers (ECPs) and patients about Demodex blepharitis and compete with existing over-the-counter and off-label treatments[295](index=295&type=chunk)[296](index=296&type=chunk)[297](index=297&type=chunk) - Clinical drug development is identified as a lengthy, expensive, and risky process with uncertain outcomes, and results from earlier trials may not predict future success[335](index=335&type=chunk) - The company is subject to government pricing programs like the Medicaid Drug Rebate Program and the 340B program, and failure to comply with complex pricing and rebate calculations could lead to significant penalties and fines[318](index=318&type=chunk)[320](index=320&type=chunk) [Risks Related to Financial Position and Need for Additional Capital](index=79&type=section&id=Risks%20Related%20to%20our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company faces significant capital requirements for commercialization and pipeline development, risking dilution or restrictive debt covenants if additional funding is not secured, and may have limitations on NOL carryforwards - The company will require substantial additional capital to fund the commercialization of XDEMVY and develop its pipeline, and failure to obtain this capital could force delays or elimination of programs[368](index=368&type=chunk)[371](index=371&type=chunk) - Raising additional capital could lead to stockholder dilution through equity offerings or restrictive covenants from debt financing, which could limit operational flexibility[374](index=374&type=chunk) - The existing 2024 Credit Facility with Pharmakon contains negative covenants that restrict the company's ability to dispose of assets, incur more debt, make investments, or pay dividends, among other actions[383](index=383&type=chunk) - The company's ability to use its net operating loss (NOL) carryforwards may be limited under Section 382 of the Internal Revenue Code if an "ownership change" occurs[387](index=387&type=chunk) [Risks Related to Reliance on Third Parties](index=86&type=section&id=Risks%20Related%20to%20Reliance%20on%20Third%20Parties) The company's high dependence on third-party CROs and CMOs for clinical trials and manufacturing, including single-source API suppliers, poses significant risks to development and commercialization efforts - The company relies on third parties like CROs to conduct clinical trials, which reduces control over these activities and may lead to delays or data integrity issues if these parties fail to perform[390](index=390&type=chunk)[391](index=391&type=chunk) - The company contracts with third parties for all manufacturing and relies on single-source suppliers for certain materials, including the API (lotilaner) for XDEMVY from Elanco, creating a high risk of supply chain disruption[395](index=395&type=chunk)[396](index=396&type=chunk) - All manufacturing partners must comply with cGMP regulations, and any failure to do so could lead to an inability to meet commercial demand, product recalls, or delays in regulatory approvals[397](index=397&type=chunk)[400](index=400&type=chunk) - The company may be unable to successfully scale-up manufacturing in sufficient quality and quantity, which could delay or prevent the commercialization and development of its products[402](index=402&type=chunk) [Risks Related to Intellectual Property](index=90&type=section&id=Risks%20Related%20to%20Intellectual%20Property) The company's success is highly dependent on its intellectual property, facing risks from reliance on Elanco licenses, patent enforceability uncertainties, potential infringement claims, and inadequate patent terms - The development and commercialization of the company's entire pipeline, including XDEMVY, TP-04, and TP-05, is dependent on intellectual property licensed from Elanco, and a breach or termination of these license agreements could cause the company to lose its rights to these products[409](index=409&type=chunk)[410](index=410&type=chunk) - The company's ability to obtain and maintain sufficient patent protection is uncertain, as pending applications may not issue, and issued patents may be challenged, invalidated, or circumvented by competitors[411](index=411&type=chunk)[416](index=416&type=chunk) - The company may be sued for infringing third-party intellectual property rights, which could be costly, time-consuming, and could force it to cease commercializing its products or obtain expensive licenses[438](index=438&type=chunk)[441](index=441&type=chunk) - Patent terms are of limited duration and may expire before or shortly after products are commercialized, and the company may not be able to obtain patent term extensions, which would shorten its period of market exclusivity[443](index=443&type=chunk)[458](index=458&type=chunk) [Risks Related to Government Regulation](index=103&type=section&id=Risks%20Related%20to%20Government%20Regulation) The company faces significant risks from extensive government regulation, including uncertain regulatory approvals, impacts of healthcare reform on pricing, compliance with fraud and abuse laws, and complex data privacy requirements - The company's products and activities are subject to extensive and strict regulation by the FDA and comparable foreign authorities, and securing and maintaining marketing approval is a long, costly, and uncertain process[459](index=459&type=chunk) - Changes in healthcare laws, such as the ACA and the Inflation Reduction Act (IRA), could significantly impact pricing, reimbursement, and profitability through mechanisms like drug price negotiation and inflation rebates[462](index=462&type=chunk)[463](index=463&type=chunk)[468](index=468&type=chunk) - The company is subject to federal and state healthcare fraud and abuse laws, and arrangements with physicians and payers could be scrutinized, potentially leading to significant penalties if found to be in violation[482](index=482&type=chunk)[483](index=483&type=chunk) - Compliance with complex and evolving U.S. (e.g., CCPA) and international (e.g., GDPR) data privacy and security laws is required, and failure to comply could result in government enforcement, significant fines, and private litigation[496](index=496&type=chunk)[499](index=499&type=chunk)[501](index=501&type=chunk) [Risks Related to Ownership of our Common Stock](index=114&type=section&id=Risks%20Related%20to%20Ownership%20of%20our%20Common%20Stock) Ownership of common stock involves risks including price volatility, concentrated ownership, increased compliance costs as a non-emerging growth company, potential stock price depression from future sales, and anti-takeover provisions - The market price of the company's common stock is subject to significant volatility due to factors such as clinical trial outcomes, regulatory developments, and overall market performance[507](index=507&type=chunk) - A significant concentration of stock ownership among officers, directors, and **5%+** holders limits the ability of other stockholders to influence corporate matters[515](index=515&type=chunk) - As of December 31, 2024, the company no longer qualifies as an emerging growth company or a smaller reporting company, which will increase operating and compliance costs[510](index=510&type=chunk)[511](index=511&type=chunk) - The company's amended and restated certificate of incorporation includes anti-takeover provisions and designates the Court of Chancery of the State of Delaware as the exclusive forum for most stockholder disputes, which could limit stockholder actions[527](index=527&type=chunk)[530](index=530&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=121&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[535](index=535&type=chunk) [Other Information](index=121&type=section&id=Item%205.%20Other%20Information) The company disclosed the adoption of Rule 10b5-1 trading plans by CEO Bobak Azamian and CCO Aziz Mottiwala, with some shares already sold by the CEO in Q1 2025 - CEO Bobak Azamian adopted a Rule 10b5-1 trading plan in December 2024 for the sale of up to **24,000 shares**; **6,000 shares** were sold under this plan in Q1 2025[538](index=538&type=chunk) - Chief Commercial Officer Aziz Mottiwala adopted a Rule 10b5-1 trading plan in March 2025 for the sale of up to **17,500 shares**, with sales eligible to begin in June 2025[539](index=539&type=chunk) [Exhibits](index=122&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including CEO and CFO certifications pursuant to Sarbanes-Oxley Act Sections 302 and 906, and the Inline XBRL documents - The exhibits filed with this report include certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act, as well as XBRL data files[541](index=541&type=chunk)

Financial Performance - Generated $78.3 million in net product sales of XDEMVY, an increase of 217% year over year and 18% over Q4 2024, with approximately 72,000 bottles dispensed to patients[1][4] - Total revenues for Q1 2025 reached $78.335 million, a significant increase from $27.614 million in Q1 2024, representing a growth of 184%[21] - Product sales accounted for $78.335 million in Q1 2025, compared to $24.720 million in Q1 2024, indicating a growth of 216%[21] - The net loss for Q1 2025 was $25.120 million, an improvement from a net loss of $35.731 million in Q1 2024, showing a reduction of 30%[21] - The company reported a net loss per share of $0.64 in Q1 2025, an improvement from $1.01 in Q1 2024[21] Expenses - Research and development (R&D) expenses were $14.4 million, an increase from $12.1 million in the same period in 2024, primarily due to increased program expenses and personnel-related costs[6] - Selling, general and administrative (SG&A) expenses rose to $85.0 million from $51.6 million in Q1 2024, driven by increased payroll and commercial marketing costs[7] - Operating expenses increased to $104.615 million in Q1 2025 from $65.298 million in Q1 2024, reflecting a rise of 60%[21] - Research and development expenses were $14.409 million in Q1 2025, compared to $12.066 million in Q1 2024, an increase of 19%[21] Financial Position - Strengthened financial position with approximately $135 million raised in public equity offering; cash, cash equivalents, and marketable securities totaled approximately $408 million as of March 31, 2025[1][4] - Cash and cash equivalents increased to $175.787 million as of March 31, 2025, up from $94.819 million at the end of 2024, a growth of 85%[23] - Total assets rose to $500.750 million as of March 31, 2025, compared to $376.991 million at the end of 2024, marking an increase of 33%[23] - Stockholders' equity increased to $342.458 million as of March 31, 2025, up from $224.534 million at the end of 2024, representing a growth of 53%[23] Market and Product Development - Direct-to-Consumer (DTC) advertising led to a 140% increase in average weekly website visits in March 2025 compared to December 2024[6] - Gross-to-net discount recognized was approximately 47%, with broad commercial, Medicare, and Medicaid reimbursement of XDEMVY extending to over 90% of covered lives[4] - On track to initiate a Phase 2 trial of TP-04 for the potential treatment of Ocular Rosacea in H2 2025, with multiple catalysts expected in 2025[4][6] - Anticipated regulatory meetings in Japan and potential European regulatory approval for a preservative-free formulation of XDEMVY in 2027[6] - The number of Eye Care Professionals writing more than one prescription per week increased by nearly 110% compared to Q3 2024[4]

Core Insights - Tarsus Pharmaceuticals reported a significant increase in net product sales of XDEMVY, reaching $78.3 million, which represents a 217% year-over-year growth and an 18% increase over Q4 2024 [4][10] - The company has strengthened its financial position by raising approximately $135 million through a public equity offering, resulting in cash, cash equivalents, and marketable securities totaling approximately $408 million as of March 31, 2025 [4][10] - Tarsus is on track to initiate a Phase 2 trial of TP-04 (lotilaner ophthalmic gel) for the treatment of Ocular Rosacea in the second half of 2025 [4][10] Financial Performance - The first quarter of 2025 saw net product sales of XDEMVY at $78.3 million compared to $24.7 million in the same period of 2024, driven by approximately 72,000 bottles delivered to patients, up from 26,000 bottles year-over-year [10][19] - Cost of sales increased to $5.2 million from $1.7 million in the prior year, attributed to manufacturing costs and royalties [10][19] - Research and development expenses rose to $14.4 million from $12.1 million, while selling, general, and administrative expenses increased to $85.0 million from $51.6 million, primarily due to higher payroll and marketing costs [10][19] - The net loss for the quarter was $25.1 million, an improvement from a net loss of $35.7 million in the same quarter of 2024, with a basic and diluted net loss per share of $(0.64) compared to $(1.01) [10][19] Business Highlights - XDEMVY is positioned to be one of the fastest-growing anterior segment medicines, with broad commercial reimbursement coverage extending to over 90% of covered lives [4][10] - The company reported a gross-to-net discount of approximately 47% and a 23% increase in the number of bottles dispensed compared to Q4 2024 [4][10] - Direct-to-consumer advertising led to a 140% increase in average weekly website visits in March 2025 compared to December 2024 [4][10] - Tarsus is advancing its pipeline with multiple catalysts expected in 2025, including a meeting with regulatory authorities in Japan to discuss the regulatory path for XDEMVY [4][10] Pipeline Developments - Tarsus is on track to initiate a Phase 2 study of TP-04 for Ocular Rosacea, a condition with no FDA-approved therapy, in H2 2025 [4][10] - The company is also developing TP-05, an investigational oral tablet for the potential prevention of Lyme disease, expected to begin trials in 2026 [5][10]

Tarsus Pharmaceuticals, Inc. (TARS) closed the last trading session at $50.90, gaining 4.1% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $67.13 indicates a 31.9% upside potential.The mean estimate comprises eight short-term price targets with a standard deviation of $13.74. While the lowest estimate of $41 indicates a 19.5% decline from the current price level, the most optimist ...

Company Overview - Tarsus Pharmaceuticals, Inc. focuses on revolutionizing treatment for patients, particularly in eye care, by applying proven science and new technology [2] - The company is advancing its pipeline to address diseases with high unmet needs across various therapeutic categories, including eye care and infectious disease prevention [2] Product Development - Tarsus has FDA approval for XDEMVY® (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis [2] - The company is developing TP-04 for the potential treatment of Ocular Rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease [2] Upcoming Events - Tarsus Pharmaceuticals will host a live webcast on May 1, 2025, at 1:30 p.m. PT / 4:30 p.m. ET to report its first quarter 2025 financial results and provide a corporate update [1]