Tarsus Reports First Quarter 2025 Financial Results and Recent Business Achievements

Generated $78.3 million in net product sales of XDEMVY$(R)$ , an increase of 217% year over year and 18% over Q4 2024, and dispensed approximately 72,000 bottles to patients

Strengthened financial position with approximately $135 million raised in public equity offering; cash, cash equivalents and marketable securities of approximately $408 million as of March 31, 2025

On-track to initiate a Phase 2 trial of TP-04 (lotilaner ophthalmic gel) for the potential treatment of Ocular Rosacea in H2 2025

Management to host conference call today, May 1, 2025, at 1:30 p.m. P.T. / 4:30 p.m. E.T.

IRVINE, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), today announced financial results for the first quarter ended March 31, 2025.

"Tarsus has entered 2025 with incredible momentum, driven by strong execution of our category-creating strategic blueprint for success and a focused commitment to leadership in eye care. The XDEMVY launch is continuing to exceed our expectations and is on track to potentially become one of the best-selling anterior segment medicines," said Bobak Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus. "Building on a foundation of strong commercial performance and the success of our recent equity offering, we believe we are well positioned to accelerate the growth of XDEMVY, create another new category in Ocular Rosacea and continue to advance our pipeline."

Recent Business and Clinical Highlights

   -- XDEMVY is on track to potentially be one of the fastest growing and 
      best-selling anterior segment medicines. In the first quarter, the 
      Company: 
 
          -- Generated $78.3 million in XDEMVY net product sales, an increase 
             of 217% year over year and 18% over Q4 2024. 
 
          -- Dispensed approximately 72,000 bottles of XDEMVY to patients, an 
             increase of 23% over Q4 2024. 
 
   -- Broad commercial, Medicare and Medicaid reimbursement of XDEMVY now 
      extends to more than 90% of covered lives. 
 
          -- Recognized a gross-to-net discount of approximately 47%. 
 
   -- Substantially increased the depth of prescribing among our target Eye 
      Care Professionals (ECPs). 
 
          -- At the end of Q1 2025, the number of ECPs writing more than one 
             prescription per week increased by nearly 110% compared to Q3 
             2024. 
 
   -- Direct-To-Consumer $(DTC.AU)$ advertising drove a 140% increase in the average 
      weekly website visits in March 2025 compared to December 2024. 
 
          -- Ongoing investment expected to increase alongside leading 
             indicators of utilization. 
 
   -- Presented new data showing the global prevalence and real-world patient 
      burden of Demodex blepharitis $(DB)$. 
 
          -- The Elara study showed the high prevalence and significant impact 
             of DB in Japan, consistent with the U.S. 
 
          -- Results of the Orion registry showed XDEMVY-treated patients 
             experienced meaningful improvements in some of the most impactful 
             symptoms of disease, including fluctuating vision, redness, itchy 
             eyelids, burning or stinging, dryness and crusted eyes. 
 
          -- The combined data from the Ersa and Rhea studies in DB patients 
             with Meibomian Gland Disease (MGD) showed statistically 
             significant and clinically meaningful improvements of the 
             meibomian glands, with at least three times more glands secreting 
             normal or clear liquid in XDEMVY-treated patients compared to 
             vehicle at day 43. 
 
   -- Strengthened financial position with a $134.8 million upsized public 
      equity offering which will continue to fund the launch of XDEMVY and 
      ongoing pipeline investment. 
 
   -- Continued to advance a robust pipeline with multiple catalysts expected 
      in 2025. 
 
          -- On-track to initiate a Phase 2 study of TP-04 (lotilaner 
             ophthalmic gel) for Ocular Rosacea, a highly prevalent and 
             underserved eye disease with no FDA-approved therapy, in H2 2025. 
 
          -- Anticipated to meet with regulatory authorities in Japan in H2 
             2025 to help determine a regulatory path forward for XDEMVY in 
             Japan. 
 
          -- On-track for potential European regulatory approval in 2027 of a 
             preservative-free formulation of XDEMVY. 
 
          -- On-track to initiate a Phase 2 study of TP-05 (an investigational 
             oral tablet) for the potential prevention of Lyme disease in 2026. 

First Quarter 2025 Financial Results

   -- Product sales, net: were $78.3 million compared to $24.7 million for the 
      same period in 2024, driven by approximately 72,000 bottles of XDEMVY 
      delivered to patients compared to approximately 26,000 bottles delivered 
      in the prior year period. 
 
   -- Cost of sales: were $5.2 million compared to $1.7 million for the same 
      period in 2024, due to manufacturing costs incurred after the approval of 
      XDEMVY, the royalty we pay on net product sales, and the amortization of 
      the milestones paid to our licensor, which is being amortized over its 
      remaining useful life of 8.4 years. 
 
   -- Research and development (R&D) expenses: were $14.4 million compared to 
      $12.1 million for the same period in 2024. The increase was primarily due 
      to $0.5 million of increased TP-04 program expenses, $0.9 million of 
      increased payroll and personnel-related costs, $0.9 million of increased 
      early-stage programs, and $0.3 million of increased other indirect 
      expenses. These increases were partially offset by $0.4 million of 
      decreased TP-03 program expenses. Total R&D non-cash stock compensation 
      expense was $1.5 million, which was consistent with $1.5 million in the 
      same period in 2024. 
 
   -- Selling, general and administrative (SG&A) expenses: were $85.0 million 
      compared to $51.6 million for the same period in 2024. The increase was 
      due primarily to $9.6 million of increased payroll and personnel-related 
      costs (including non-cash stock-based compensation), and $25.6 million of 
      increased commercial and marketing costs, including direct-to-consumer 
      advertising costs, as we continued our commercial expansion of XDEMVY. 
      These increases were partially offset by $1.9 million of decreased 
      information technology applications, legal, professional and other 
      corporate expenses. Total SG&A non-cash stock compensation expense was 
      $5.3 million, compared with $3.9 million in the same period in 2024. 
 
   -- Net loss: was $25.1 million, compared to $35.7 million for the same 
      period in 2024. Basic and diluted net loss per share for the quarter 
      ended March 31, 2025 was $(0.64), compared with $(1.01) for the same 
      period in 2024. 
 
   -- Cash position: As of March 31, 2025, cash, cash equivalents and 
      marketable securities were $407.9 million. 

Conference Call and Webcast

Tarsus will host a conference call and webcast to discuss its first quarter 2025 financial results and business highlights today, May 1, 2025, at 1:30 p.m. P.T. / 4:30 p.m. ET. A live webcast will be available on the events section of the Tarsus website. A recorded version of the call will be available on the website shortly after the completion of the call and will be archived there for at least 90 days.

About XDEMVY(R)

XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop designed to treat Demodex blepharitis by targeting and eradicating the root cause of the disease -- Demodex mite infestation. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found the XDEMVY eye drop to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis.

XDEMVY Indication and Important Safety Information

INDICATIONS AND USAGE

XDEMVY is indicated for the treatment of Demodex blepharitis.

Most common side effects: The most common side effect in clinical trials was stinging and burning in 10% of patients. Other side effects in less than 2% of patients were chalazion/hordeolum and punctate keratitis.

For additional information, please see full prescribing information available at: https://xdemvy.com/.

About TP-03

TP-03 (lotilaner ophthalmic solution) 0.25% is a novel therapeutic designed to treat Demodex blepharitis by targeting and eradicating the root cause of disease -- Demodex mite infestation. It was approved by the FDA in 2023 under the brand name XDEMVY(R) for the treatment of Demodex blepharitis. Lotilaner is a well-characterized anti-parasitic agent that paralyzes and eradicates Demodex mites by selectively inhibiting parasite-specific gamma-aminobutyric acid-gated chloride (GABA-Cl) channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eye lash follicles where the mites reside.

About TP-04

TP-04 is an investigational aqueous gel formulation of lotilaner, a well-characterized anti-parasitic agent that paralyzes and kills mites by selectively inhibiting parasite-specific GABA-Cl channels. Tarsus is studying TP-04 for the treatment of Ocular Rosacea $(OR)$.

About TP-05

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