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Tarsus Pharmaceuticals Inc 2026年季度报告

2026-08-06 美股财报 Daisy.Aldrich
报告封面

FORM 10-Q ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June30, 2026or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____to ____Commission File Number: 001-39614 TARSUS PHARMACEUTICALS, INC.(Exact name of registrant as specified in its charter) Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerginggrowth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of theExchange Act. Accelerated filer☐Smallerreportingcompany☐Emerginggrowthcompany☐ Large accelerated filer☒Non-accelerated filer☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ As of July 30, 2026, the number of outstanding shares of the registrant’s common stock, par value $0.0001 per share, was 43,882,996. SUMMARY OF RISKS ASSOCIATED WITH OUR BUSINESS We face risks and uncertainties associated with our business, many of which are beyond our control. Some of the moresignificant risks associated with our business include the following: •We are a commercial stage biopharmaceutical company with a limited operating history and a single product approved forcommercial sale. Although we have generated revenue from the launch of XDEMVY(lotilaner ophthalmic solution) 0.25%and have recently generated positive cash flows from operations, we have continued to incur losses and historically generatednegative cash flows from operations since our inception. We anticipate that we could continue to incur significant expensesand potential losses in future periods.® •Due to the ongoing commercialization of XDEMVY and our continued development of our pipeline of product candidatesthrough clinical trials and other indications, our capital requirements are difficult to predict and may change. We may need toobtain additional funding to achieve our goals and a failure to obtain this necessary capital when needed on acceptable terms,or at all, could force us to delay, reduce or eliminate our product development programs, commercialization efforts or otheroperations. •We obtained regulatory approval for XDEMVY in the U.S. in July 2023 and commenced the commercial launch ofXDEMVY in August 2023. We have limited experience as a commercial company generating revenue from product sales. Ifthe commercialization of XDEMVY becomes unsuccessful or any future approved product launches are unsuccessful, ourability to become or remain profitable may be unsuccessful. •We are heavily dependent on the continued successful commercialization of XDEMVY and the successful development,regulatory approvals, and commercialization of our current and future product candidates. XDEMVY remains subject toongoing post-marketing review and extensive regulation. •We may not ultimately be successful in educating Eye Care Professionals (“ECPs”), and the market about the need fortreatments specifically forDemodexblepharitis and other diseases or conditions targeted by XDEMVY or our productcandidates. XDEMVY or other product candidates that we may develop may fail to achieve market acceptance by ECPs,other healthcare providers and patients, or adequate formulary coverage, pricing or reimbursement by third-party payers andothers in the medical community, and the market opportunity for these products may be smaller than we estimate. XDEMVYand any product candidates for which we obtain marketing approval may become subject to unfavorable pricing regulations,third-party coverage or reimbursement practices or healthcare reform initiatives, which could harm our business. •The sizes of the market opportunity for our product or product candidates, particularly XDEMVY for the treatment ofDemodexblepharitis, may be