Tarsus Reports First Quarter 2025 Financial Results and Recent Business Achievements

Rhea-AI Summary

Tarsus Pharmaceuticals (TARS) reported strong Q1 2025 financial results, with XDEMVY net product sales reaching $78.3 million, up 217% year-over-year and 18% from Q4 2024. The company dispensed approximately 72,000 bottles to patients, a 23% increase from Q4 2024. Tarsus strengthened its financial position through a $134.8 million public equity offering, ending Q1 with $407.9 million in cash and equivalents. The company reported a net loss of $25.1 million ($0.64 per share), improved from $35.7 million ($1.01 per share) in Q1 2024. XDEMVY now has broad reimbursement coverage for over 90% of covered lives. The company plans to initiate a Phase 2 trial of TP-04 for Ocular Rosacea in H2 2025 and is pursuing European regulatory approval for a preservative-free XDEMVY formulation by 2027.

Positive

• XDEMVY sales grew 217% YoY to $78.3 million with 72,000 bottles dispensed
• Broad insurance coverage achieved with >90% of covered lives
• Successfully raised $134.8 million through public equity offering
• 110% increase in Eye Care Professionals writing multiple prescriptions per week
• Strong cash position of $407.9 million as of Q1 2025
• Net loss per share improved from ($1.01) to ($0.64) YoY

Negative

• Significant gross-to-net discount of 47% on XDEMVY sales
• Increased SG&A expenses by $33.4 million to $85.0 million
• Continued net loss of $25.1 million in Q1 2025

Insights

Pharmaceutical Financial Analyst

Tarsus reports impressive 217% YoY XDEMVY sales growth with improving financials and strong cash position to fund continued expansion.

The XDEMVY launch is demonstrating exceptional commercial traction with Q1 2025 sales of $78.3 million, representing a 217% year-over-year increase and 18% sequential growth from Q4 2024. Patient adoption continues to strengthen with approximately 72,000 bottles dispensed, a 23% increase over the previous quarter.

Despite impressive revenue growth, Tarsus reported a net loss of $25.1 million ($0.64 per share), though this represents a substantial improvement from the $35.7 million loss ($1.01 per share) in Q1 2024. The company is investing heavily in commercial infrastructure, with SG&A expenses increasing to $85.0 million from $51.6 million in the prior year period, primarily driven by marketing initiatives including direct-to-consumer advertising.

This commercial investment is yielding results beyond just revenue, with the number of Eye Care Professionals writing more than one prescription weekly increasing by 110% since Q3 2024, and website visits up 140% since December 2024. The company has secured broad reimbursement coverage spanning 90% of covered lives, though operating with a 47% gross-to-net discount.

Tarsus has solidified its financial position through a $134.8 million upsized equity offering, bringing total cash and equivalents to $407.9 million. This strengthened balance sheet provides substantial runway to fund continued XDEMVY commercialization and pipeline advancement, including the upcoming Phase 2 trial for Ocular Rosacea.

Ophthalmology Expert

XDEMVY shows remarkable commercial growth and clinical impact for Demodex blepharitis, with promising pipeline expansion into additional eye conditions.

XDEMVY is rapidly establishing itself as a category-creating treatment for Demodex blepharitis, with compelling commercial momentum suggesting strong clinical adoption. The 110% increase in high-frequency prescribers indicates growing recognition of both the condition's prevalence and XDEMVY's efficacy among eye care specialists.

New clinical evidence further supports XDEMVY's value proposition. The Elara study confirmed high prevalence and significant disease burden in Japan, consistent with US findings, validating the global market opportunity. The Orion registry demonstrated meaningful real-world improvements in the most impactful symptoms, including fluctuating vision, redness, itching, and dryness.

Particularly significant are the combined Ersa and Rhea studies in patients with concurrent Meibomian Gland Disease (MGD), showing treated patients had three times more normally functioning meibomian glands compared to vehicle at day 43. This suggests potential utility beyond the primary indication, possibly addressing root causes of dry eye symptoms in certain patients.

The planned Phase 2 trial of TP-04 for Ocular Rosacea represents a strategic pipeline expansion targeting another highly prevalent, underserved anterior segment condition with no FDA-approved therapy. This progression, alongside plans for Japanese market entry and a preservative-free European formulation, demonstrates a focused eye care strategy leveraging the company's expertise in parasitic and inflammatory ocular conditions.

Generated $78.3 million in net product sales of XDEMVY^®, 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) 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^®
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® 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
TP-05 is an investigational oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-Cl channels. 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.

About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. XDEMVY (lotilaner ophthalmic solution) 0.25% is FDA approved in the United States for the treatment of Demodex blepharitis. Tarsus is also developing TP-04 for the potential treatment of Ocular Rosacea and TP-05 as an oral tablet for the prevention of Lyme disease, all of which are in Phase 2.

Forward-Looking Statements
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.” These statements include statements regarding the potential commercial success and growth of XDEMVY in Demodex blepharitis, including market size, acceptance, demand, prescription fill rate and adoption rate for XDEMVY; our ability to successfully implement and continue our new direct-to-consumer campaign; our ability to achieve and maintain distribution and patient access for XDEMVY and timing and breadth of payer coverage; our ability to continue to educate the market about Demodex blepharitis; our ability to initiate planned clinical studies; anticipated regulatory and development milestones including potential Europe and Japan regulatory pathways and approval for XDEMVY; the results of our clinical studies; the test results of our pipeline formulations; our ability to continue investing in our business, and the quotations of Tarsus’ management. The words, without limitation, “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, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: Tarsus is heavily dependent on the successful commercialization of its lead product, XDEMVY for the treatment of Demodex blepharitis and the development and regulatory approval and commercialization of its current and future product candidates; Tarsus’ ability to obtain and maintain regulatory approval for and successfully commercialize its products, including XDEMVY for the treatment of Demodex blepharitis, and its product candidates to meet existing and future regulatory standards; Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it will continue to incur significant expenses and losses for the foreseeable future; Tarsus’ capital requirements are difficult to predict and may change; Tarsus may need to obtain additional funding to achieve its goals and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force Tarsus to delay, reduce, or eliminate its product development programs, commercialization efforts or other operations; Tarsus may not be successful in educating healthcare professionals and the market about the need for treatments specifically for Demodex blepharitis and other diseases targeted by XDEMVY or our product candidates; the development and commercialization of Tarsus products is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus expects to expand its development, regulatory, operational, sales, and marketing capabilities and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for XDEMVY and Tarsus’ product candidates, particularly TP-04 for the treatment of Ocular Rosacea, as well as TP-05 for the prevention of Lyme disease, have not been established with precision and may be smaller than estimated; the results of Tarsus’ earlier studies and trials may not be predictive of future results; any termination or suspension of, or delays in the commencement or completion of, Tarsus’ planned clinical trials could result in increased costs, delay or limit its ability to generate revenue and adversely affect its commercial prospects; if Tarsus is unable to obtain and maintain sufficient intellectual property protection for its product candidates, or if the scope of the intellectual property protection is not sufficiently broad, Tarsus’ competitors could develop and commercialize products similar or identical to Tarsus’ products; and if Tarsus is unable to access capital (including but not limited to cash, cash equivalents, and credit facilities) and/or loses capital, as a result of potential failure of any financial institutions that Tarsus does business with directly or indirectly. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statements and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus’ Form 10-K for the year ended December 31, 2024 filed on February 25, 2025 and the most recent Form 10-Q quarterly filing filed with the SEC on May 1, 2025, which Tarsus incorporates by reference into this press release, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this earnings release are based on the current expectations of Tarsus’ management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Contact:
Adrienne Kemp
Sr. Director, Corporate Communications
(949) 922-0801
akemp@tarsusrx.com
Investor Contact:
David Nakasone
Head of Investor Relations
(949) 620-3223
DNakasone@tarsusrx.com

TARSUS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
(unaudited)
	Three Months Ended March 31,
	2025				2024
Revenues:
Product sales, net	$	78,335			$	24,720
License fees and collaboration revenue		—				2,894
Total revenues		78,335				27,614
Operating expenses:
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 before other income (expense)		(26,280	)			(37,684	)
Other income (expense):
Interest income		3,454				3,117
Interest expense		(2,213	)			(983	)
Other income (expense), net		(81	)			(181	)
Total other income (expense), net		1,160				1,953
Net loss	$	(25,120	)		$	(35,731	)
Unrealized gain (loss) on marketable securities and cash equivalents		(94	)			(61	)
Comprehensive loss	$	(25,214	)		$	(35,792	)
Net loss per share, basic and diluted	$	(0.64	)		$	(1.01	)
Weighted-average shares outstanding, basic and diluted		39,345,359				35,300,655

TARSUS PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(In thousands, except share and par value amounts)
	March 31, 2025				December 31, 2024
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	175,787			$	94,819
Marketable securities		232,129				196,557
Accounts receivable, net		62,426				46,760
Inventory		2,705				2,620
Other receivables		1,727				1,299
Prepaid expenses		5,999				14,650
Total current assets		480,773				356,705
Restricted cash, non-current		2,563				2,562
Inventory, non-current		2,532				2,533
Property and equipment, net		2,787				2,314
Intangible assets, net		8,086				8,326
Operating lease right-of-use assets		393				552
Long-term investments		3,000				3,000
Other assets		616				999
Total assets	$	500,750			$	376,991
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and other accrued liabilities	$	76,375			$	64,789
Accrued payroll and benefits		9,933				15,823
Total current liabilities		86,308				80,612
Long-term debt, net		71,984				71,845
Total liabilities		158,292				152,457
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.0001 par value; 10,000,000 authorized; no shares issued and outstanding		—				—
Common stock, $0.0001 par value; 200,000,000 shares authorized; 41,995,537 shares issued and outstanding at March 31, 2025 (unaudited); 38,349,826 shares issued and outstanding at December 31, 2024		6				6
Additional paid-in capital		727,697				584,559
Accumulated other comprehensive income (loss)		85				179
Accumulated deficit		(385,330	)			(360,210	)
Total stockholders’ equity		342,458				224,534
Total liabilities and stockholders’ equity	$	500,750			$	376,991

FAQ

What were Tarsus Pharmaceuticals (TARS) Q1 2025 XDEMVY sales?

Tarsus reported XDEMVY net product sales of $78.3 million in Q1 2025, representing a 217% increase year-over-year and 18% growth from Q4 2024.

How many XDEMVY bottles did Tarsus (TARS) dispense in Q1 2025?

Tarsus dispensed approximately 72,000 bottles of XDEMVY to patients in Q1 2025, representing a 23% increase compared to Q4 2024.

What is Tarsus (TARS) cash position after their recent equity offering?

As of March 31, 2025, Tarsus had $407.9 million in cash, cash equivalents and marketable securities, bolstered by a $134.8 million public equity offering.

What was Tarsus Pharmaceuticals (TARS) net loss per share in Q1 2025?

Tarsus reported a net loss of $0.64 per share in Q1 2025, improved from a net loss of $1.01 per share in Q1 2024.

What are Tarsus Pharmaceuticals' (TARS) pipeline developments for 2025?

Tarsus plans to initiate a Phase 2 trial of TP-04 for Ocular Rosacea in H2 2025, pursue regulatory meetings in Japan for XDEMVY, and is on track for potential European approval of a preservative-free XDEMVY formulation by 2027.