UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (date of earliest event reported): January 8, 2024
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(Exact name of registrant as specified in its charter)
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| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||||||||
(Address of principal executive offices, including Zip Code)
Registrant's telephone number, including area code: (949 ) 409-9820
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
The Nasdaq Stock Market LLC | ||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☒
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 revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 7.01 Regulation FD.
On January 8, 2024, Tarsus Pharmaceuticals, Inc. (the “Company”) published a corporate presentation on the Investor & News section of its website, which is filed as Exhibit 99.1 to this Current Report on Form 8-K (the “Report”).
The information in this Report, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), or otherwise subject to the liabilities of that Section, and shall not be deemed incorporated by reference in any registration statement or other filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly stated in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. | Description | |||||||||||||||||||||||||
99.1 | ||||||||||||||||||||||||||
| 104 | Cover Page Interactive Data File (embedded within XBRL document) | |||||||||||||||||||||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| TARSUS PHARMACEUTICALS, INC. | |||||||||||||||||||||||
| Date: | January 8, 2024 | /s/ Jeffrey S. Farrow | |||||||||||||||||||||
| Jeffrey S. Farrow | |||||||||||||||||||||||
| Chief Financial Officer and Chief Strategy Officer | |||||||||||||||||||||||
| (Principal Financial Officer and Principal Accounting Officer) | |||||||||||||||||||||||
Leading the Way in Category Creation J A N U A R Y 2 0 2 4 Sulma, an XDEMVY® Patient
2 This presentation contains forward-looking statements that involve risks and uncertainties. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current expectations about future events that we believe may affect our financial condition, results of operations, business strategy, and financial needs. All statements other than statements of historical facts contained in this presentation, including any statements regarding our ability to achieve distribution and patient access for our products including XDEMVY® and timing and breadth of payer coverage; our expectations of the potential market size, pricing, gross-to-net yields, fill rates, out-of-pocket costs, payer mix, eye care provider and patient acceptance and demand of XDEMVY, and opportunity and patient populations for our product candidates, including XDEMVY; our sales force size and hiring plans; the commercialization and market acceptance of XDEMVY; revenue expectations and cash runway and financing availability expectations; our ability to obtain marketing approvals of our product candidates and to meet existing or future regulatory standards or comply with post-approval requirements; our expectations regarding intellectual property exclusivity and term; our expectations regarding the potential advantages of our product candidates over existing therapies; our expectations regarding clinical development programs and operations; the market size for TP-03, TP-04, and TP-05, future events and Tarsus’ plans for and the anticipated benefits of its product candidates including TP-03, TP-04 and TP-05 and the timing, objectives and results of the clinical trials including the complete clinical results of the Ersa trial, anticipated regulatory and development milestones, and our research and development programs; our expectations with regard to our ability to develop additional product candidates or product candidates for other indications; our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives; the ability of LianBio to commercialize TP-03 in the Greater China territory; and the implementation of our business model and strategic plans for our business and product candidates are forward-looking statements. The words “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “potential,” “continue” and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Important factors that could cause our actual results to differ materially are detailed from time to time in the reports we file with the Securities and Exchange Commission, copies of which are posted on our website and are available from us 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. Forward-Looking Statements For Investor Purposes Only
3 Expert Leadership Team With Decades of Eye Care, Product Launch and Market Building Experience Bobby Azamian, M.D., Ph.D. CEO & Chairman Former CEO/CMO Metavention with extensive investment/entrepreneurial experience with Versant & Third Rock Ventures Aziz Mottiwala Chief Commercial Officer Jeff Farrow Chief Financial and Strategy Officer Dianne Whitfield Chief Human Resources Officer 20+ years of product launch experience and former VP Marketing, Allergan Eye Care (Restasis®, Lumigan®) 25+ years of finance and operational experience; former CFO at Global Blood Therapeutics 20+ years HR leadership including multiple roles at Allergan Elizabeth Yeu, M.D. Chief Medical Advisor and Director Sesha Neervannan, Ph.D. Chief Operating Officer Jose Trevejo, M.D., Ph.D. Chief Medical Officer Board Member and President American Society of Cataract and Refractive Surgeons (ASCRS) 25+ years drug development experience, deep expertise in ophthalmic and dermatology products 20+ years experience leading drug development, clinical trials and research Bryan Wahl. M.D., J.D. General Counsel ~20 years broad legal experience including IP and strategic transactions; former partner at Knobbe For Investor Purposes Only
4 The first and only FDA-approved therapy for Demodex blepharitis A category-creating medicine with a clear value proposition Compelling patient outcomes driving: • Rapid uptake • Ongoing waves of eye care provider (ECP) adoption • Strong traction with payers and high-value net price “Pipeline in a product” filled with multiple category-creating product candidates Near-term potential for partnership Three major 2024 catalysts • Meibomian Gland Disease (TP-03) – FDA meeting to determine path forward planned 1H 24 • Rosacea (TP-04) – Phase 2a topline data expected 1Q 24 • Lyme Disease Prevention (TP-05) – Phase 2a topline data expected 1Q 24 A Category-Creating Approach to Delivering Blockbuster Medicines and Serving Millions of Patients For Investor Purposes Only *as of 9/30/2023
5 Beginning With a Large, Durable Eye Care Market $21$15 by 2028 Source: EvaluatePharma ophthalmic revenues Posterior E X P E C T E D OPHTHALMIC MARKET Anterior Category creation has led to eye care blockbusters • Dry Eye Disease, Thyroid Eye Disease, Anti-VEGF in Wet AMD*, Prostaglandins in Glaucoma • Significant untapped opportunities remain to help patients Eyelid diseases represent one of the largest untapped opportunities • Demodex blepharitis (DB) impacts 25M in the U.S.1,2 • Meibomian Gland Disease (MGD) impacts 30-40M patients in the U.S.3,4 Eye care market is rich with opportunity • Vision is our most valued sense • Double digit growth expected from anterior segment (existing categories) 1. Wilson J Ophthalmology 2015, 435606, 2014; 2. Titan collarette prevalence study; 3. Milner, MS, et al. Curr Opin Ophthalmol 2017 Jan; 28 Suppl 1, 3–47; 4. Foulks GN, Bran AJ. Ocul Surf. 2003;1:107-126. For Investor Purposes Only *Age-related macular degeneration
6 • Caused by an infestation of Demodex mites • Patients can suffer eyelid inflammation, redness, irritation and a negative impact on daily activities • Quickly diagnosed during a routine eye exam through the identification of collarettes • Potential for serious clinical implications if left untreated Demodex Blepharitis A Pervasive and Damaging Eyelid Disease ~25M Americans Impacted1,2 Collarettes are the pathognomonic sign of DB: Waxy, cylindrical plaque composed of dead mites, mite eggs & waste Singular eyelash with multiple mites 1. Wilson J Ophthalmology 2015, 435606, 2014; 2. Titan collarette prevalence study For Investor Purposes Only
7 Easily Diagnosed Through the Presence of Collarettes have Demodex blepharitis1 of patients with collarettes WATCH VIDEO 1. Gao YY, Di Pascuale MA, Li W, et al. Invest Ophthalmol Vis Sci. 2005;46(9):3089-3094. For Investor Purposes Only
8 Demodex Blepharitis is a Potential $1B+ Opportunity G O A L 1. Wilson J Ophthalmology 2015, 435606, 2014; 2. Symphony claims data; 3. Titan collarette prevalence study; 4.Market Scope 2020 Dry Eye Products Report: A Global Market Analysis for 2019 to 2025; 5. White et al., Clin Ophthalmology 2019: 13 2285-2292 6. AAO/ASCRS Statement on Cataract Surgery, July 2021; 7. Refractive Surgery Council August 2021 2.2M1.2M 2.3M >7M Dry Eye Rx patients with DB1,3,4,5 Cataract patients with DB1,3,6 Contact lens patients with DB1,3,7 Proactively seeking treatment for complementary eye conditions / diseases 1.5M $1B+ peak net sales potential in initial addressable segment alone $1,850 WAC/Rx ~50% GTN Yield ~1.5M Patients Patients with Demodex blepharitis (DB) Already diagnosed & seeking treatment1,2 For Investor Purposes Only
►An innovative, category-creating therapeutic ►A strong value proposition for patients, ECPs and payers ►A high-touch, market-building commercial plan ►Patent protection expected through 2038 The First and Only FDA-Approved Medicine for Demodex Blepharitis XDEMVY: An eye care p roduc t UNLIKE ANY OTHER 9 For Investor Purposes Only
10 XDEMVY: Delivering for Patients B E F O R E A F T E R For Investor Purposes Only B E F O R E A F T E R B E F O R E A F T E R Patient outcomes and experiences may vary.
11 XDEMVY: A High-Value, Market-Building Launch Setting a New Standard for Blockbuster-Potential Eye Care Launches • Action-oriented, visually focused physician and patient education campaigns • Peer-to-peer scientific exchange conducted by all-ECP medical field force • Deep eye care, biotech and product launch expertise • 85 territory leaders targeting 15K ECPs covering >80% of prescriptions • Best-in-class field team establishing behavioral change for an entirely new category • Strong traction with payers • Unique distribution model leveraging high touch retail and digital pharmacies (18K+ pharmacies in network) • Robust patient co-pay and bridging assistance program Industry-Leading Team Clear Value PropositionHigh-Impact Disease Education For Investor Purposes Only
12 XDEMVY: Delivering on Expectations To date • >50% repeat prescribers • Positive trend in new writers – moving from “interest” to “action” In the first month following product launch • Unique online/retail distribution model provides convenient access to >18K pharmacies • Patient out-of-pocket costs ≤ $100 (in majority of cases) In Q3 2023 • Ongoing payer conversations indicate on-track for broad commercial/Medicare coverage *As of Jan. 4, 2024 Five weeks post launch (Sept. 30, 2023) For Investor Purposes Only
13 U T I L I Z AT I O N A C R O S S S E G M E N T S ONGOING PRESCRIBING AFTER 5-10 TRx† In less than 5 months XDEMVY Prescribers *As of Jan. 4, 2024 Early Adopters (Diagnosing and treating patients on Day 1) Eager Treaters (Ready for an FDA-approved solution; ramping TRx alongside patient successes) New to DB (Beginning to diagnose, recognizing prevalence and acting) Ongoing Waves of ECP Adoption writing multiple times For Investor Purposes Only †TRx = Total prescriptions
14 A Clear Path to Blockbuster Potential Strong Early Launch Trajectory ► Patients eager to share positive benefits of treatment ► Success stories created a positive prescribing feedback loop for ECPs ► Payers recognizing high-value benefit of XDEMVY Accelerated Impact ► Broad commercial coverage secured with major payers ► A new standard set for “year one” eyecare launch revenues and GTN ► Breadth and depth of prescribing Sustainable Growth ► Medicare D coverage secured ► Bridge program phasing out ► Steady-state net revenues and GTN discount ~50% 2023 2024 2025+ $1B+ Peak Net Sales Potential For Investor Purposes Only Anticipated 2024+ milestones listed above
PIPELINE Abby, an XDEMVY Patient For Investor Purposes Only
16 Tarsus Product Portfolio Product Candidate Indication Formulation Preclinical Phase 1 Phase 2 Phase 3 Marketed Upcoming Catalyst XDEMVY Demodex blepharitis (US) Eye drop TP-03 Demodex blepharitis (EU) Eye drop Preservative-free formulation to be evaluated after FDA approval TP-03 Meibomian Gland Disease (US) Eye drop Existing and Potential Partnership Opportunities TP-03 Demodex blepharitis and Meibomian Gland Disease (Greater China) Eye drop TP-03 Demodex blepharitis and Meibomian Gland Disease (OUS) Eye drop Active partnering discussions TP-04 Papulopustular Rosacea (WW) Topical TP-05 Lyme disease prevention (WW) Oral Tablet Determining U.S. Regulatory Path Data Expected 1Q 2024 LianBio Determining Regulatory Path In China Ersa Phase 2a Libra Phase 3 Galatea Phase 2a Carpo Phase 2a A Category-Creating Pipeline With Near-Term Catalysts For Investor Purposes Only Data Expected 1Q 2024
17 Meibomian Gland Disease: A Large, Underserved Eye Care Category No FDA-Approved Pharmacologic Treatment ~30-40M Americans impacted by MGD1,2 1. Milner, MS, et al. Curr Opin Ophthalmol 2017 Jan; 28 Suppl 1, 3–47; 2. Foulks GN, Bran AJ. Ocul Surf. 2003;1:107-12; 3. Titan collarette prevalence study; 4. Siong, R, et al. Philip. J. Ophthalmol. (2011): 15-22; 5. Bhandari, V, et al. Middle East African J. Ophthalmol 21.4 (2014): 317. MGD Occurs when the glands do not produce enough lipids or lipids are of poor quality TP-03 • Targets and kills Demodex mites that contribute to MGD • Left untreated, MGD can lead to gland loss and threaten vision • Positive Phase 2a data reported in Dec. 2023 Determining U.S. Regulatory Path Forward For Investor Purposes Only Reprinted with permission from Vincent de Luise, MD >50% of patients with MGD have Demodex infestation1,3,4,5
18 Ersa Phase 2a Trial for the Treatment of MGD with Demodex Mites 21.8 28.1 32.7 22.1 27.6 33.8 0 5 10 15 20 25 30 35 40 Baseline (N=21/18) Day 43 (N=20/18) Day 85 (N=20/18) Mean (± SE) MGSS Score Range 0-45 BID TID p<0.001 p<0.001 M ea n # of g la nd s 0.6 2.9 5.5 0.9 3 6.3 0 1 2 3 4 5 6 7 8 Baseline (N=21/18) Day 43 (N=20/18) Day 85 (N=20/18) Mean (± SE) Number of Glands with Clear Meibum (Score = 3) BID TID p<0.001 p<0.001 TP-03 Significantly Improves Gland Function and Number of Glands Secreting Clear Liquid For Investor Purposes Only No discontinuations due to treatment-related adverse events
19 Rosacea – An Inflammatory Skin Condition Current Treatment Options Offer Limited Efficacy 1. Buddenkotte J. Steinhoff M. Recent advances in understanding and managing rosacea. F1000Res.2018.7. 2. Source on file ~16M Americans impacted by rosacea1 ~3-5M Experience papulopustular rosacea (PPR)2 Rosacea Chronic skin disease characterized by facial redness, inflammatory lesions, burning and stinging For Investor Purposes Only
20 Topline data expected in 1Q 2024 Demodex Mites: Highly prevalent in the skin of patients with PPR and may contribute to the inflammatory response associated with the disease Patient Impact: Redness, swelling and/or pus-filled bumps TP-04: The lotilaner API has demonstrated potent ability across several studies to eradicate Demodex mites TP-04: Potential to be the First Topical to Address Root Cause of Disease TP-04 O N G O I N G Galatea Phase 2a Study • BID for 12 weeks • 30 patients with moderate to severe PPR For Investor Purposes Only
21 Lyme Disease – A Growing Public Health Crisis No FDA-Approved Prophylaxis ~27M Americans at high-to- moderate infection risk $1.3B Impact to U.S. healthcare system Lyme Disease A tick-borne infection caused by the transmission of Borrelia burgdorferi For Investor Purposes Only
22 Topline data expected in 1Q 2024 Prevention is key: Strong patient/physician interest in an oral, on-demand, non-vaccine option that targets the tick – preventing exposure to the bacteria that causes Lyme Disease Patient Impact: Difficult to manage; long-term sequelae can progress to severe joint, CNS and cardiac complications TP-05: Fast- and long-acting,* with the potential to provide protection throughout the entire tick season TP-05: Potential to Be the First and Only Durable, On-Demand Oral Prophylaxis for Lyme Disease TP-05 O N G O I N G Carpo Phase 2a Study To inform: • Safety • Pharmacokinetics • Tick-kill efficacy For Investor Purposes Only
23 The first and only FDA-approved therapy for Demodex blepharitis A category-creating medicine with a clear value proposition Compelling patient outcomes driving: • Rapid uptake • Ongoing waves of eye care provider (ECP) adoption • Strong traction with payers and high-value net price “Pipeline in a product” filled with multiple category-creating product candidates Near-term potential for partnership Three major 2024 catalysts • Meibomian Gland Disease (TP-03) – FDA meeting to determine path forward planned 1H 24 • Rosacea (TP-04) – Phase 2a topline data expected 1Q 24 • Lyme Disease Prevention (TP-05) – Phase 2a topline data expected 1Q 24 A Category-Creating Approach to Delivering Blockbuster Medicines and Serving Millions of Patients For Investor Purposes Only *as of 9/30/2023