Delivered quarterly XDEMVY$(R)$ net sales of approximately $119 million, up approximately 147% year-over-year
Weekly multi-patient prescribers grew approximately 30% in the third quarter underscoring strong commercial momentum
Management to host conference call today, November 4, 2025, at 1:30 p.m. PT / 4:30 p.m. ET
IRVINE, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), today announced financial results for the third quarter ended September 30, 2025.
"Our third quarter results, highlighted by nearly $119 million in XDEMVY sales, reflect the strength of our commercial model, the scale of engagement across eye care, and the impact we're having on patients," said Bobak Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus. "We've established a new category in eye care, and XDEMVY is now one of the best-selling prescription eye drops. Simultaneously, we are expanding our pipeline with more category-creating programs like ocular rosacea -- another widespread condition with significant unmet need -- that position Tarsus for sustained, long-term growth. With each new milestone, we are deepening our impact and shaping the future of eye care."
Recent Business and Clinical Highlights
-- XDEMVY is continuing on a strong growth trajectory with Q3 results of:
-- $118.7 million in net product sales.
-- More than 103,000 bottles delivered to patients.
-- Broad, high-quality coverage, with more than 90% of commercial,
Medicare and Medicaid lives covered, leading to a gross-to-net
discount of 44.7%.
-- Two years into launch, Tarsus is fundamentally changing how eye care
professionals (ECPs) diagnose and treat Demodex blepharitis $(DB)$.
-- More than 20,000 ECPs have written multiple prescriptions
reflecting growing confidence and the consistent integration of
XDEMVY into clinical practice.
-- At the end of Q3 2025, the number of ECPs prescribing more than
one bottle per week increased by approximately 30% compared to Q2
2025.
-- Tarsus continues to execute on its category-creation strategy, advancing
a robust pipeline designed to establish new treatment categories, with
plans to initiate:
-- A Phase 2 study of TP-04 (lotilaner ophthalmic gel) for the
potential treatment of ocular rosacea $(OR)$, a highly prevalent and
underserved eye disease with no FDA-approved therapy, in December
2025, with topline data expected by year-end 2026.
-- A Phase 2 study of TP-05 (lotilaner oral tablet) for the potential
prevention of Lyme disease, a novel, on-demand, oral tablet
designed to kill ticks before they can transmit infection, in
2026.
Third Quarter 2025 Financial Results
-- Product sales, net: were $118.7 million compared to $48.1 million for the
same period in 2024, driven by more than 103,000 bottles of XDEMVY
delivered to patients compared to more than 41,400 bottles delivered to
patients in the prior year period.
-- Cost of sales: were $8.3 million compared to $3.2 million for the same
period in 2024, due to manufacturing costs related to XDEMVY, the royalty
Tarsus pays on net product sales, and the amortization of the milestones
paid to Tarsus' licensor, which is being amortized over its remaining
useful life.
-- Research and development (R&D) expenses: were $16.3 million compared to
$12.1 million for the same period in 2024. The increase was primarily due
to $0.8 million of increased TP-04 program expenses, $2.9 million of
increased payroll and personnel-related costs, $0.7 million of increased
early-stage programs, and $0.4 million of increased other indirect
expenses. These increases were partially offset by $0.8 million of
decreased TP-05 program expenses. Total R&D non-cash stock compensation
expense was $3.0 million, compared with $1.7 million in the same period
in 2024.
-- Selling, general and administrative (SG&A) expenses: were $108.6 million
compared to $57.9 million for the same period in 2024. The increase was
due primarily to $7.4 million of increased payroll and personnel-related
costs (including non-cash stock-based compensation), $26.1 million of
increased commercial and marketing costs, including direct-to-consumer
advertising costs, as we continued our commercial launch of XDEMVY, and
$17.2 million of increased variable costs including certain patient
assistance programs, fees related to increased bottles dispensed,
information technology applications, legal, professional, and other
corporate expenses. Total SG&A non-cash stock compensation expense was
$9.1 million, compared with $5.6 million in the same period in 2024.
-- Net loss: was $12.6 million, compared to $23.4 million for the same
period in 2024. Basic and diluted net loss per share for the quarter
ended September 30, 2025 was $(0.30), compared with $(0.61) for the same
period in 2024.
-- Cash position: As of September 30, 2025, cash, cash equivalents and
marketable securities were $401.8 million.
Year-to-Date 2025 Financial Results
-- Product sales: were $299.7 million compared to $113.7 million for the
same period in 2024, driven by approximately 266,000 bottles of XDEMVY
delivered to patients compared to approximately 104,400 bottles delivered
to patients in the prior year period.
-- Cost of sales: were $19.8 million compared to $7.9 million for the same
period in 2024, due to manufacturing costs related to XDEMVY, the royalty
Tarsus pays on net product sales, and the amortization of the milestones
paid to Tarsus' licensor, which is being amortized over its remaining
useful life.
-- Research and development (R&D) expenses: were $46.3 million compared to
$36.5 million for the same period in 2024. The increase was due to $5.1
million of increased compensation and other personnel-related expense
(including non-cash stock-based compensation), $1.0 million of other
indirect expenses, $2.6 million of increased early-stage programs, and
$2.1 million of increased TP-04 program spend. These increases were
partially offset by $0.6 million of decreased TP-05 program spend and
$0.5 million of decreased TP-03 program spend. R&D non-cash stock
compensation expense was $6.4 million, compared with $5.0 million in the
same period in 2024.
-- Selling, general and administrative (SG&A) expenses: were $296.6 million
compared to $168.3 million for the same period in 2024. The increase was
due primarily to $24.0 million of increased payroll and personnel-related
costs (including non-cash stock-based compensation), $81.5 million of
increased commercial and marketing costs, including direct-to-consumer
advertising costs, related to the commercial launch of XDEMVY, and $22.9
million of increased variable costs including certain patient assistance
programs, fees related to increased bottles dispensed, information
technology applications, legal, professional and other corporate
expenses. SG&A non-cash stock compensation expense was $20.5 million,
compared with $14.9 million in the same period in 2024.
-- Net loss: was $58.0 million, compared to $92.4 million for the same
period in 2024. Year-to-date basic and diluted net loss per share was
$(1.40), compared with $(2.48) for the same period in 2024.
Conference Call and Webcast
Tarsus will host a conference call and webcast to discuss its third quarter 2025 financial results and business highlights today, November 4, 2025, at 1:30 p.m. PT / 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
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