TARS on Nasdaq

Tarsus Pharmaceuticals, Inc.

In its 2026 annual report the company says: “We are a commercial stage biopharmaceutical company focused on the development and commercialization of therapeutics, starting with eye care.”3 It is headquartered in Irvine, California.1 Its shares trade on Nasdaq under the symbol TARS.1

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Last updated Oct 21, 2026.

Overview

Compare with Immunocore, ADMA Biologics (United States) or Krystal Biotech, Inc., or pick any stock.

  • TickerTARS on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersIrvine, California1
  • Incorporated inDE2
  • Business address15440 Laguna Canyon Road, Irvine, Ca 926182
  • Filer categoryLarge accelerated filer2

We are a commercial stage biopharmaceutical company focused on the development and commercialization of therapeutics, starting with eye care. We launched XDEMVY ® (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, for the treatment of Demodex blepharitis, in August 2023 after receiving U.S. Food and Drug Administration (“FDA”) approval in July 2023. Demodex blepharitis is caused by the infestation of Demodex mites. Demodex blepharitis (“blephar” is a reference to eyelid and “itis” is a reference to inflammation) is a disease characterized by inflammation of the eyelid margin, redness and ocular irritation, including a specific type of eyelash dandruff called collarettes, which are pathognomonic for Demodex blepharitis. Poorly controlled and progressive Demodex blepharitis can lead to corneal damage over time and, in extreme cases, blindness. There may be as many as approxima…3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-15.7%Operating margin4
-14.7%Net margin4
146.7%Revenue growth, 20254
-19.3%Return on equity4
0.21×Debt to equity4
-$22.3MFree cash flow4

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development13¢$64.3M
  • Selling, general and admin87¢$427.3M
  • Income tax0¢$2.1M

Out of $451.4M in revenue.4 The company lost money this year.

Financial statements

Revenue5674$451.4M in 2025
0$200.0M$400.0M$600.0M2020: $0$020202021: $57.0M$57.0M20212022: $25.8M$25.8M2022−55%2023: $17.4M$17.4M2023−32%2024: $183.0M$183.0M2024+949%2025: $451.4M$451.4M2025+147%
Operating income85674-$71.0M in 2025+1551% since 2019
-$150.0M-$100.0M-$50.0M02019: -$4.3M-$4.3M20192020: -$27.0M-$27.0M2020+528%2021: -$12.2M-$12.2M2021−55%2022: -$62.7M-$62.7M2022+416%2023: -$143.2M-$143.2M2023+128%2024: -$120.6M-$120.6M2024−16%2025: -$71.0M-$71.0M2025−41%
Net income85674-$66.4M in 2025+1322% since 2019
-$150.0M-$100.0M-$50.0M02019: -$4.7M-$4.7M20192020: -$26.8M-$26.8M2020+474%2021: -$13.8M-$13.8M2021−48%2022: -$62.1M-$62.1M2022+349%2023: -$135.9M-$135.9M2023+119%2024: -$115.6M-$115.6M2024−15%2025: -$66.4M-$66.4M2025−43%

Every line of the income statement as filed: the last 3 fiscal years, latest first.4

Period ending2025-12-312024-12-312023-12-31
Total revenues$451.4M$183.0M$17.4M
Research and development$64.3M$53.4M$50.3M
Selling, general and administrative$427.3M$237.3M$108.7M
Total operating expenses$522.3M$303.5M$160.6M
Loss from operations before other income (expense)-$71.0M-$120.6M-$143.2M
Interest income$15.7M$15.0M$10.3M
Interest expense-$8.9M-$7.8M-$3.3M
Loss on debt extinguishment$0-$1.9M$0
Other income (expense), net-$202.0K-$206.0K$274.0K
Total other income, net$6.6M$5.0M$7.3M
Loss before income taxes-$64.4M-$115.6M-$135.9M
Provision for income taxes-$2.1M$0$0
Net loss-$66.4M-$115.6M-$135.9M
Unrealized gain (loss) on marketable securities and cash equivalents$202.0K$181.0K$72.0K
Comprehensive loss-$66.2M-$115.4M-$135.8M
Net loss per share, basic (usd per share)-$1.59-$3.07-$4.62
Net loss per share, diluted (usd per share)-$1.59-$3.07-$4.62
Weighted-average shares outstanding, basic (in shares)41.8M shares37.6M shares29.4M shares
Weighted-average shares outstanding, diluted (in shares)41.8M shares37.6M shares29.4M shares

Compare Tarsus Pharmaceuticals, Inc. with another company

Corporate structure

Tarsus Pharmaceuticals, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Tarsus Pharmaceuticals, Inc.

  • Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on Tarsus Pharmaceuticals, Inc., latest Aug 13, 2026 (2 filings since May 15, 2026)
  • Deep Track Capital, LP Filed SCHEDULE 13G/A on Tarsus Pharmaceuticals, Inc., latest May 15, 2026 (3 filings since Jul 28, 2025)
  • Prudential Financial Filed SCHEDULE 13G/A on Tarsus Pharmaceuticals, Inc., latest May 8, 2026 (2 filings since Nov 14, 2024)
  • JENNISON ASSOCIATES LLC Filed SCHEDULE 13G/A on Tarsus Pharmaceuticals, Inc., latest May 6, 2026 (2 filings since Nov 12, 2024)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Tarsus Pharmaceuticals, Inc., latest Mar 27, 2026 (3 filings since Nov 4, 2024)
  • TANG CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G/A on Tarsus Pharmaceuticals, Inc., latest Feb 17, 2026 (2 filings since May 15, 2025)
  • RTW INVESTMENTS, LP Filed SCHEDULE 13G/A on Tarsus Pharmaceuticals, Inc., latest Aug 14, 2025 (4 filings since Feb 14, 2022)
  • Morgan Stanley Filed SCHEDULE 13G/A on Tarsus Pharmaceuticals, Inc., latest May 7, 2025 (2 filings since Feb 9, 2024)
  • BlackRock Filed SCHEDULE 13G/A on Tarsus Pharmaceuticals, Inc., latest Apr 24, 2025 (6 filings since Feb 8, 2023)
  • Cowen Financial Products LLC Filed SCHEDULE 13G/A on Tarsus Pharmaceuticals, Inc., latest Feb 13, 2025 (3 filings since May 5, 2023)
  • Cormorant Asset Management, LP Filed SC 13G/A on Tarsus Pharmaceuticals, Inc., latest Nov 14, 2024 (4 filings since Feb 14, 2022)
  • Paradigm Biocapital Advisors LP Filed SC 13G/A on Tarsus Pharmaceuticals, Inc., latest Nov 14, 2024 (2 filings since Jan 22, 2024)
  • Tarsus Pharmaceuticals, Inc. Irvine, California

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Tarsus Pharmaceuticals, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$13.8M4 Dec 31, 2025$4.3M4 Dec 31, 2024+220.8%
Accumulated depreciation$2.1M4 Dec 31, 2025$2.0M4 Dec 31, 2024+6.2%
Property and equipment, net$11.7M4 Dec 31, 2025$2.3M4 Dec 31, 2024+404.1%
Operating-lease assets (leased space)$10.1M4 Dec 31, 2025$552.0K4 Dec 31, 2024+1726.1%

Real estate and locations

ItemLatestA year beforeChange
Area of real estate98,807 sq ft4 Dec 31, 202559,626 sq ft7 Dec 31, 2024+65.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$183.6M4 Dec 31, 2025$94.8M4 Dec 31, 2024+93.7%
Marketable securities, current$233.6M4 Dec 31, 2025$196.6M4 Dec 31, 2024+18.9%
Debt securities available for sale$233.6M4 Dec 31, 2025$196.6M4 Dec 31, 2024+18.9%
Long-term investments$3.9M4 Dec 31, 2025$3.0M4 Dec 31, 2024+29.0%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$7.4M4 Dec 31, 2025$8.3M4 Dec 31, 2024−11.5%
Accumulated amortization$1.6M4 Dec 31, 2025$674.0K4 Dec 31, 2024+142.4%
Finite-lived intangibles, net$7.4M4 Dec 31, 2025$8.3M7 Dec 31, 2024−11.5%

Inventory

ItemLatestA year beforeChange
Inventory, total$4.4M4 Dec 31, 2025$2.6M4 Dec 31, 2024+66.9%
Raw materials$07 Dec 31, 2024$2.5M7 Dec 31, 2023−100.0%
Work in process$1.4M4 Dec 31, 2025$614.0K4 Dec 31, 2024+129.6%
Finished goods$3.0M4 Dec 31, 2025$2.0M4 Dec 31, 2024+47.7%

Properties, in its own words

As of December 31, 2025, the Company had two active leases with combined square footage of 98,807 for office and laboratory suites in Irvine, California. In December 2024, the Company entered into an agreement to terminate its former facility lease agreements and entered into a new lease agreement both with the same landlord, to relocate its corporate headquarters to another location in Irvine, California for a 10-year lease term. In September 2025, the Company gained access to the new facility, and commenced the new lease, however the Company’s headquarters have not yet been relocated. Construction is still in progress on the new facility and the Company plans to move in during 2026. We believe that this space will be sufficient to meet our needs for the foreseeable future and that any additional space we may require will be available on commercially reasonable terms (see Note 9).

Item 2 of the 10-K filed Feb 23, 2026.3

Leadership

Who has led Tarsus Pharmaceuticals, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (19)

Timeline

  1. Oct 13, 20268-K Financial statements and exhibits34
  2. Sep 10, 20268-K Completed an acquisition or sale; Other events35
  3. Aug 6, 20268-K Entered a material agreement; Unregistered sale of shares; Other events36
  4. Aug 6, 20268-K Entered a material agreement; Unregistered sale of shares; Other events37
  5. Aug 6, 20268-K Results of operations38
  6. Jul 13, 20268-K Executive or director change39
  7. Jul 8, 20268-K Entered a material agreement; Unregistered sale of shares; Other events40
  8. Jun 29, 20268-K Shareholder vote41
  9. May 6, 20268-K Results of operations42
  10. Feb 23, 20268-K Results of operations43
  11. Feb 18, 20268-K Executive or director change44
  12. Jan 12, 20268-K Regulation FD disclosure45
  13. Oct 15, 2020New chief executive Bobak R. Azamian becomes CEO12

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.30) a share, on Nov 4, 2025.46

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results38
  2. May 6, 2026Reported quarterly or annual results42
  3. Feb 23, 2026Reported quarterly or annual results43
  4. Nov 4, 2025Reported quarterly or annual results47
  5. Aug 6, 2025Reported quarterly or annual results48
  6. May 1, 2025Reported quarterly or annual results49
  7. Feb 25, 2025Reported quarterly or annual results50
  8. Nov 13, 2024Reported quarterly or annual results51

Drug trials and FDA: coming up

  1. Dec 31, 2026Phase 2 trial readout expected Phase 2 trial of lotilaner and Vehicle in Ocular Rosacea: primary completion expected Dec 31, 2026 (ClinicalTrials.gov NCT07443202).52
  2. Oct 2027Phase 2 trial readout expected Phase 2 trial of TP-05 (lotilaner) Low Dose and TP-05 (lotilaner) High Dose in Lyme Disease: primary completion expected Oct 2027 (ClinicalTrials.gov NCT07562087).53

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

567 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 60 major events, 275 insider forms, 51 large holders, 161 other. The latest 20:

  1. Oct 13, 20268-K/A EDGAR
  2. Oct 13, 2026S-3ASR EDGAR
  3. Oct 13, 2026S-3ASR EDGAR
  4. Sep 17, 20264 EDGAR
  5. Sep 17, 20264 EDGAR
  6. Sep 17, 20264 EDGAR
  7. Sep 15, 2026144 EDGAR
  8. Sep 10, 20268-K EDGAR
  9. Sep 9, 20264 EDGAR
  10. Sep 9, 20264 EDGAR
  11. Sep 9, 20264 EDGAR
  12. Sep 4, 2026144 EDGAR
  13. Sep 4, 2026144 EDGAR
  14. Sep 4, 2026144 EDGAR
  15. Sep 4, 2026144 EDGAR
  16. Sep 3, 20264 EDGAR
  17. Sep 3, 20264 EDGAR
  18. Sep 2, 2026144 EDGAR
  19. Sep 2, 2026144 EDGAR
  20. Sep 2, 2026144 EDGAR

The 567 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

199 open-market trades by officers, directors and large owners since October 2021: 4 buys and 195 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 15, 2026LINK WILLIAM J PHDDirectorSale12,500$78.38$979.7KForm 4
Sep 4, 2026Lin Elizabeth YeuChief Medical OfficerSale13,953$87.50$1.2MForm 4
Sep 4, 2026Azamian Bobak R.President/CEO and Board ChairSale10,000$90.56$905.6KForm 4
Sep 4, 2026Neervannan SeshadriChief Operating OfficerSale4,564$85.00$387.9KForm 4
Sep 2, 2026Lin Elizabeth YeuChief Medical OfficerSale6,977$80.00$558.2KForm 4
Sep 2, 2026Azamian Bobak R.President/CEO and Board ChairSale10,000$80.06$800.6KForm 4
Sep 1, 2026Lin Elizabeth YeuChief Medical OfficerSale4,601$73.86$339.8KForm 4
Jun 17, 2026Azamian Bobak R.President/CEO and Board ChairSale10,000$61.55$615.5KForm 4
Jun 16, 2026Farrow Jeffrey SSee RemarksSale14,396$60.95$877.4KForm 4
Jun 15, 2026Goodrich KatherineDirectorSale2,954$62.08$183.4KForm 4
Jun 15, 2026LINK WILLIAM J PHDDirectorSale12,500$62.12$776.5KForm 4
Mar 20, 2026Neervannan SeshadriChief Operating OfficerSale2,989$66.75$199.5KForm 4
Mar 19, 2026Lin Elizabeth YeuChief Medical OfficerSale390$67.00$26.1KForm 4
Mar 19, 2026Wahl BryanGeneral CounselSale4,231$67.00$283.5KForm 4
Mar 19, 2026Whitfield Dianne C.Chief Human Resources OfficerSale4,174$67.00$279.7KForm 4
Mar 19, 2026Azamian Bobak R.President/CEO and Board ChairSale11,964$67.00$801.6KForm 4
Mar 19, 2026Neervannan SeshadriChief Operating OfficerSale4,589$67.00$307.5KForm 4
Mar 19, 2026Mottiwala AzizChief Commercial OfficerSale4,440$67.00$297.5KForm 4
Mar 19, 2026Farrow Jeffrey SSee RemarksSale2,186$67.00$146.5KForm 4
Mar 18, 2026Lin Elizabeth YeuChief Medical OfficerSale379$68.71$26.0KForm 4

All 199 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Bobak AzamianM.D., Ph.D.$726.3K$6.6M74
2025Aziz Mottiwala$529.2K$2.8M74
2025Jeffrey Farrow64$541.7K$2.7M74
2025Seshadri NeervannanPh.D.$547.0K$2.6M74
2025Bryan Wahl, M.D., J.D.48$500.8K$2.6M74
2024PresidentChief Executive Officer and Board Chairman$673.4K$7.9M74
2024Chief Financial Officer and Chief Strategy Officer$520.8K$3.2M74
2024Chief Operating Officer$527.3K$3.2M74
2024Chief Commercial Officer$492.6K$3.1M74
2023Chief Financial Officer and Chief Strategy Officer$343.8K$4.0M74
2023PresidentChief Executive Officer and Board Chairman$619.5K$3.1M74
2023Chief Operating Officer$500.0K$1.7M74

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.3,856,137$242.7M0.0%+303,525
Deep Track Capital, LP3,666,768$230.8M3.4%+66,768
Rtw Investments, LP3,357,059$211.3M1.8%+11,034
Jupiter Topco LLC2,808,796$176.8M0.1%New
Paradigm Biocapital Advisors LP2,775,649$174.7M3.3%+213,495
Assenagon Asset Management S.A.1,894,990$119.3M0.1%+614,796
Morgan Stanley1,827,082$115.0M0.0%−117,190
Vanguard Capital Management LLC1,793,064$112.9M0.0%+32,523
Jennison Associates LLC1,663,655$104.7M0.1%−48,469
Tang Capital Management LLC1,568,266$98.7M4.5%+379,642
Millennium Management LLC1,427,124$89.8M0.1%+862,545
Bank Of America Corp /de/1,193,182$75.1M0.0%−1,195
Geode Capital Management, LLC1,105,689$69.6M0.0%−15,402
State Street Corp1,072,951$67.5M0.0%+94,739
Vestal Point Capital, LP1,050,000$66.1M1.5%+850,000
Invesco Ltd.785,808$49.5M0.0%+43,311
Goldman Sachs Group Inc742,693$46.7M0.0%+303,067
Frazier Life Sciences Management, L.P.728,644$45.9M1.0%No change
D. E. Shaw & Co., Inc.710,559$44.7M0.0%−80,587
Fmr LLC672,949$42.4M0.0%−60,385
Nomura Asset Management International Inc.607,272$38.2M0.1%+107,419
Clearbridge Investments, LLC549,387$34.6M0.0%+4,036
Toronto Dominion Bank510,253$32.1M0.1%No change
Massachusetts Financial Services Co /ma/427,008$26.9M0.0%New
Northern Trust Corp386,611$24.3M0.0%+33,654

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Tarsus Pharmaceuticals, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARTarsus Pharmaceuticals, Inc.1
  • CIK0001819790
  • Employer ID (EIN)81-47178613
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address15440 Laguna Canyon Road, Irvine, CA 926181
  • Phone(949) 409-98201
  • Shares outstanding43,882,996 as of Jul 30, 202610
  • Public float$1.7B as of Jun 30, 20253
  • AuditorErnst & Young LLP, Irvine, California PCAOB ID 42; it also attests to the company’s internal control over financial reporting3
  • On EDGAR sinceAug 7, 20201
  • Filings671 in all: 4 (303), 144 (118), 8-K (70), SC 13G/A (28), 3 (24), SC 13G (19), 10-Q (18), SCHEDULE 13G/A (12)1
    All 35 form types

    424B5 (8), CORRESP (8), S-8 (7), UPLOAD (7), 10-K (6), DEF 14A (6), DEFA14A (6), ARS (4), EFFECT (3), S-3ASR (3), DRS/A (2), S-3 (2), SCHEDULE 13G (2), SEC STAFF LETTER (2), 144/A (1), 3/A (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), DRS (1), DRSLTR (1), FWP (1), S-1 (1), S-1/A (1), S-1MEF (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Feb 23, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Sep 10, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareTARSNasdaq Global Select Market

From the cover page of the 10-K filed Feb 23, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Tarsus Pharmaceuticals, Inc. names in Item 1A of its 10-K filed Feb 23, 2026: 73 risks under these headings, as written.3

  • Risks Related to our Business and Operations
  • We are a commercial stage biopharmaceutical company with a limited operating history and a single product approved for commercial sale. While we have generated revenue from the launch of XDEMVY® (lotilaner ophthalmic solution) 0.25%, we have continued to incur losses and negative cash flows from operations since our inception and anticipate that we could continue to incur significant expenses and potential losses in the future.
  • We expect to expand our development, regulatory, operational, sales, marketing, and distribution capabilities and, as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our future success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel.
  • Our information technology systems, or those of our third-party contract research organizations (“CROs”) or other contractors or consultants, may fail or suffer security breaches, loss or leakage of data, and other disruptions, which could result in a material disruption of XDEMVY and our product candidates’ development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
  • Product liability lawsuits against us could cause us to incur substantial liabilities, could divert our resources and could limit or delay our commercialization of XDEMVY or any product candidates that we may develop.
  • Our employees, independent contractors, including our CROs and CMOs, commercial partners, consultants, suppliers, service providers, and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
  • Unfavorable global and geopolitical economic conditions could adversely affect our business, financial condition or results of operations.
  • Health epidemics may affect our ability to initiate and complete preclinical studies and clinical trials, disrupt regulatory activities, disrupt our manufacturing and supply chain or have other adverse effects on our business and operations. In addition, health epidemics could cause substantial disruption in the financial markets and may adversely impact economies worldwide, both of which could result in adverse effects on our business and operations.
  • We or the third parties upon whom we depend on may be adversely affected by earthquakes, fires or other natural disasters, or geopolitical events and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Risks Related to Development and Commercialization
  • We obtained regulatory approval for XDEMVY in the U.S. in July 2023 and commenced the commercial launch of XDEMVY in August 2023. We have limited experience as a commercial company and generating revenue from product sales. If the commercialization of XDEMVY becomes unsuccessful or any future approved product launches are unsuccessful, our ability to become or remain profitable may be unsuccessful.
The other 63 risks
  • 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.
  • We may not ultimately be successful in educating ECPs and the market about the need for treatments specifically for Demodex blepharitis and other diseases or conditions targeted by XDEMVY or our product candidates. 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 and others in the medical community, and the market opportunity for these products may be smaller than we estimate.
  • The sales, marketing, and distribution of XDEMVY or any future approved products may be unsuccessful or less successful than anticipated. If we are unable to establish sales and marketing capabilities for any of our future approved products or enter into agreements with third parties to sell and market XDEMVY or any future approved products on acceptable terms, we may be unable to continue to successfully commercialize XDEMVY or successfully commercialize any future approved products.
  • The sizes of the market opportunities for our product or product candidates, particularly XDEMVY for the treatment of Demodex blepharitis, may be smaller than we estimate, possibly materially. If we overestimate the size of these markets, our sales growth may be adversely affected. We may also not be able to grow the markets for our product candidates as intended or at all.
  • We may face significant potential competition in the future, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted. XDEMVY and our product candidates, if approved, will also compete with existing branded, generic and off-label products.
  • Although we obtained FDA approval of XDEMVY, and even if we obtain FDA approval of any of our product candidates, we may never obtain approval or authorization for such product candidates, including XDEMVY, in any other jurisdiction or commercialize such product candidates in the U.S. or in any other jurisdiction, which would limit our ability to realize their full market potential.
  • Our future product candidates may cause significant adverse events, toxicities or other undesirable side effects which may delay or prevent marketing approval or cause us to abandon or limit further clinical development or commercialization of those product candidates. In addition, significant adverse events, toxicities or other undesirable side effects may be identified during post-marketing surveillance for XDEMVY, or future approved products, which could result in regulatory action or negatively affect our ability to market the product.
  • As we participate in the Medicaid Drug Rebate Program and other governmental pricing programs, failure to comply with obligations under these programs could result in additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • We may expend our limited resources on the commercialization of XDEMVY for the treatment of Demodex blepharitis and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • The terms of approvals and ongoing regulation of XDEMVY and any other current product candidates or product candidates we develop could require substantial expenditure of resources and may limit how we manufacture and market our products, which could materially impair our ability to generate revenue from product sales.
  • If XDEMVY or any of our product candidates that are approved for marketing are found to have been improperly promoted for off-label uses by us, or if ECPs misuse our products or use our products off-label, we may become subject to prohibitions
  • on the sale or marketing of our products, product liability claims and significant fines, penalties and sanctions, and our brand and reputation could be harmed.
  • Clinical drug development is a lengthy, expensive and risky process with uncertain timelines and uncertain outcomes, and results of earlier studies and trials may not be predictive of future results. If clinical trials of our product candidates do not meet safety or efficacy endpoints or are prolonged or delayed, we may be unable to obtain required regulatory approvals, and therefore be unable to commercialize our product candidates on a timely basis or at all.
  • Our product candidates still require significant testing. We only recently began clinical trials to test TP-04 and TP-05 in humans and, as a company, we have limited experience in this area.
  • We have and may continue to encounter difficulties or delays enrolling patients in our clinical trials, which could cause delays in or adverse effects of our clinical development activities.
  • Any termination or suspension of, or delays in the commencement or completion of, our planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue from product sales and adversely affect our commercial prospects.
  • Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • We have conducted a number of our completed clinical trials and may conduct ongoing clinical trials for our product candidates at sites outside the U.S., and the FDA may not accept data from trials conducted in such locations.
  • Managing our obligations under our in-license and out-license agreements and other strategic agreements may divert management time and attention, causing delays or disruptions to our business.
  • Our operating activities may be restricted by certain covenants in our license and other strategic agreements, which could limit our development and commercial opportunities.
  • Interim top-line and preliminary results from our clinical trials that we announce or publish from time to time may change as more participant data become available and are subject to audit and verification procedures, which could result in material changes in the final data.
  • Risks Related to our Financial Position and Need for Additional Capital
  • Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • Due to the ongoing commercialization of XDEMVY and our continued development of our pipeline of product candidates through clinical trials and other indications, our capital requirements are difficult to predict and may change. We may need to obtain 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 other operations.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our business and our financial condition and results of operations.
  • Our existing indebtedness may limit our flexibility in financing and operating our business and adversely affect our business, financial condition and results of operations.
  • We may engage in acquisitions or strategic partnerships that could disrupt our business, cause dilution to our stockholders, reduce our financial resources, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition.
  • Risks Related to Reliance on Third Parties
  • We rely on third parties to conduct our clinical trials and perform some of our research and preclinical studies. If these third parties do not satisfactorily carry out their contractual duties or fail to meet expected deadlines, our development programs may be delayed or subject to increased costs, each of which may have an adverse effect on our business and prospects.
  • We, or our third-party manufacturers, may be unable to successfully scale-up manufacturing of XDEMVY or our product candidates in sufficient quality and quantity, which would delay or prevent us from commercializing, conducting clinical trials and developing our product candidates.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Risks Related to Intellectual Property
  • Changes in patent law in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect XDEMVY or our product candidates.
  • The development and commercialization of our product, or our product candidates, including XDEMVY for the treatment of Demodex blepharitis, TP-04 for the potential treatment of ocular rosacea, and TP-05 for potential Lyme disease prophylaxis and community malaria reduction, is dependent on intellectual property we license from Elanco. If we breach our agreements with Elanco or the agreements are terminated, we could lose license rights that are important to our business.
  • If we are unable to obtain and maintain sufficient intellectual property protection for XDEMVY or our product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be adversely affected.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop and market our products.
  • We may wish to acquire rights to future assets through in-licensing or may attempt to form collaborations in the future with respect to XDEMVY or our product candidates, but may not be able to do so, which may cause us to alter or delay our commercialization or development plans.
  • In the future, we may need to obtain additional licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms or we may fail to comply with our obligations under such agreements and our business could be harmed.
  • We cannot ensure that patent rights relating to inventions described and claimed in our pending patent applications will issue or that our patents or patents based on our patent applications will not be challenged and rendered invalid and/or unenforceable.
  • If we are sued for infringing, misappropriating or otherwise violating intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates.
  • If we do not obtain patent term extension for any product candidates we may develop, our business may be materially harmed.
  • We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We may rely on trade secret and proprietary know how which can be difficult to trace and enforce, and if we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Patent terms may be inadequate to protect our competitive position on our product candidates and preclinical programs for an adequate amount of time.
  • Risks Related to Government Regulation
  • Our industry is highly regulated by the FDA and comparable foreign regulatory authorities. We must comply with extensive, strictly enforced regulatory requirements to develop, obtain, and maintain marketing approval for XDEMVY or any of our product candidates, if approved.
  • Changes in healthcare law and implementing regulations, as well as changes in healthcare policy, may impact our business in ways that we cannot currently predict, and may have a significant adverse effect on our business and results of operations.
  • Our direct-to-consumer marketing and telehealth pilot program may be subject to increased regulatory scrutiny.
  • Our employees, independent contractors, clinical trial investigators, CROs, consultants, vendors and any potential commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • We may be subject to federal, state and foreign healthcare and abuse laws and false claims laws, as well as information privacy and security laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could
  • face substantial penalties, criminal sanctions, contractual damages, reputational harm, and diminished profits and future earnings.
  • Inadequate funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations.
  • For XDEMVY, or if we receive marketing approval for another product candidate, we are and will continue being subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to restrictions, withdrawal from the market, or penalties if we fail to comply with applicable regulatory requirements or if we experience unanticipated problems with our product candidates, when and if approved.
  • Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), significant fines, private litigation, and/or adverse publicity and could negatively affect our financial condition, operating results and business.
  • Risks Related to Ownership of our Common Stock
  • The stock price of our common stock may be volatile or may decline regardless of our operating performance and you could lose all or part of your investment.
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
  • Sales of a substantial number of shares of our common stock in the public market could cause the price of our common stock to fall.

Legal proceedings

We are not currently a party to any material legal proceedings. From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors.

The opening of Item 3, Legal Proceedings.3

Sources

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