8-K
STRATA Skin Sciences, Inc. (SSKN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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): August 25, 2021
STRATA Skin Sciences, Inc.
(Exact Name of Registrant as Specified in Its Charter)
000-51481
(Commission File Number)
| Delaware | 13-3986004 |
|---|---|
| (State or Other Jurisdiction of Incorporation) | (I.R.S. Employer Identification No.) |
5 Walnut Grove Drive, Suite 140
Horsham, Pennsylvania 19044
(Address of principal executive offices, including zip code)
(215) 619-3200
(Registrant’s telephone number, including area code)
NOT APPLICABLE
(Former name or former address, if changed since last report)
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<br><br> <br>Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, $0.001 par value per share | SSKN | 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 Disclosure
On August 25, 2021, Strata Skin Sciences (the “Company”) posted an investor presentation to its website at https://strataskinsciencesinc.gcs-web.com/. A copy of the investor presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached 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 (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed subject to the requirements of amended Item 10 of Regulation S-K, nor shall it be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.
Safe Harbor
This presentation includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to the Company’s plans, objectives, expectations and intentions and may contain words such as “will,” “may,” “seeks,” and “expects,” that suggest future events or trends. These statements, the Company’s ability to migrate customers from the Pharos system to XTRAC and to execute new service agreements to at least portions of the Pharos user base, to generate the growth in its core business, including transitioning capital equipment purchasers into recurring revenue users, to integrate the Pharos service business into the Company’s field service offering, the Company’s ability to develop social media marketing campaigns, and the Company’s ability to build a leading franchise in dermatology, are based on the Company’s current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from the Company’s expectations due to financial, economic, business, competitive, market, regulatory, adverse market conditions or supply chain interruptions resulting from the coronavirus and political factors or conditions affecting the Company and the medical device industry in general, future responses to and effects of COVID-19 pandemic and its variants including the distribution and effectiveness of the COVID-19 vaccines, as well as more specific risks and uncertainties set forth in the Company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all these forward-looking statements may prove to be incorrect or unreliable. The statements in this presentation are made as of the date of this presentation, even if subsequently made available by the Company on its website or otherwise. The Company does not undertake any obligation to update or revise these statements to reflect events or circumstances occurring after the date of this presentation. The Company urges investors to carefully review its SEC disclosures available at www.sec.gov and www.strataskinsciences.com.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
99.1 Strata Skin Sciences Investor Presentation dated August 25, 2021.
SIGNATURE
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.
| STRATA SKIN SCIENCES, INC. | ||
|---|---|---|
| Date: August 25, 2021 | By: | /s/ Matthew C. Hill |
| Matthew C. Hill | ||
| Chief Financial Officer |
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EXHIBIT 99.1
Investor Presentation December 2020 Investor Presentation August 2021 Driving Value to Dermatology Partners Matching Patients with Clinics
Safe Harbor Statement This presentation includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to the Company’s plans, objectives, expectations and intentions and may contain words such as “will,” “may,” “seeks,” and “expects,” that suggest future events or trends. These statements, the Company’s ability to migrate customers from the Pharos system to XTRAC and to execute new service agreements to at least portions of the Pharos user base, to generate the growth in its core business, including transitioning capital equipment purchasers into recurring revenue users, to integrate the Pharos service business into the Company’s field service offering, the Company’s ability to develop social media marketing campaigns, and the Company’s ability to build a leading franchise in dermatology, are based on the Company’s current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from the Company’s expectations due to financial, economic, business, competitive, market, regulatory, adverse market conditions or supply chain interruptions resulting from the coronavirus and political factors or conditions affecting the Company and the medical device industry in general, future responses to and effects of COVID-19 pandemic and its variants including the distribution and effectiveness of the COVID-19 vaccines, as well as more specific risks and uncertainties set forth in the Company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all these forward-looking statements may prove to be incorrect or unreliable. The statements in this presentation are made as of the date of this presentation, even if subsequently made available by the Company on its website or otherwise. The Company does not undertake any obligation to update or revise these statements to reflect events or circumstances occurring after the date of this presentation. The Company urges investors to carefully review its SEC disclosures available at www.sec.gov and www.strataskinsciences.com. 2
Large Market Opportunity 31 Million lives in the U.S.: $6 Billion annual revenue1XTRAC is the market leader in excimer laser therapyReimbursement: 3 unique CPT codes Q3 Acquisition of the U.S. Pharos dermatology business of Ra Medical – Positions Company as predominant provider of excimer laser treatmentsUnique and Proven Business ModelProviding “business in a box” for dermatology practicesGrowing Install base: low hanging fruitDriving domestic + OUS recurring revenue modelA Win-Win-Win CompanyFor patients: safest, most effective treatment, no side effectsFor clinics: stable increased revenue baseFor payers: the least expensive treatment available 3
Acquired the U.S. Pharos Dermatology Business of Ra Medical Systems 4 Provides STRATA with the opportunity to market its full business solution to Ra Medical’s existing customer base of 400 dermatology practices Delivers added long-term recurring revenue growth potential and prospective customer base Positions STRATA as the predominant provider of excimer laser treatments in the U.S.
Large Unmet Need in Common and Chronic Dermatologic Conditions 5 ATOPIC DERMATITIS PSORIASIS VITILIGO PSORIASIS: Autoimmune disease that causes the skin to regenerate faster than normal; characterized by red, itchy scaly patches (65% Mild; 25% Moderate; 10% Severe)~8 Million patients in the U.S.3 VITILIGO: Autoimmune condition due to a loss of melanocytes, characterized by patches of skin losing its pigment~5 Million patients in the U.S.4 ATOPIC DERMATITIS: Inflammatory condition characterized by red and itchy skin that flares-up periodically~18 Million patients in the U.S.5
Treatment Options Addressing Chronic Dermatologic Conditions6 6 XTRAC NB-UVB* Topical Steroids Non-biologic Systemics Biologics Approximate Costs ($) Cost competitive 1K-3K 3K-9K 1K -7K 1K 32K-68K Clinical Impact Better clinical outcomes (PASI%75) 92% 71% 75% 48% 50-70% Speed of Onset (in weeks) Very fast rate of response 5 10 3 14 12 Days of Actual Care Least days of actual care 18 80 294 52 12-65 Remission Remission without maintenance 2.5 months Continued withmaintenance Continued withmaintenance Continued withmaintenance Continued withmaintenance Adverse Events Least significant side effects MildTemp MildTemp Mild-ModTemp-Lasting Mild-SevereTemp-Lasting Mild-SevereTemp-Lasting *Narrow band UVB Light Therapy Source: "Therapies for Psoriasis: Clinical and Economic Comparisons" in the November 2020 issue of the Journal of Drugs in Dermatology.
XTRAC: A True Partnership – A Complete Business Solution 7 Clinical Support Reimbursement Support Call Center Support Field Service Support Consumables and Parts Laser Upgrades Co-pay Assistance DTC Marketing
Excimer Laser Technology for Dermatology Indications 8 #1 Targeted Laser Therapy Prescribed by Dermatologists FDA approved + established CPT codes150+ Peer-reviewed clinical studies2000+ device installed base, WW20+ million treatments performed WW Best-in-class Excimer TREATMENT
Key Priority: Driving Commercial Execution 9 Increase investment in DTC marketing Re-engage with high-volume accounts Target current, non-revenue partners Increase marketing to drive awareness among derms Historical trends show positive correlation between increased DTC investment and revenue growth High-volume accounts in Q2 ‘21 represented ~22% of total accounts and ~51% of recurring revenues Non-revenue generating partners in Q2 ‘21 represented ~17% of U.S. Installed base Increasing clinical data to support all indications and reinforce safety, efficacy, and cost benefit to patients and clinics
10 After 4 tx After 2 tx Baseline Clinical Protocol – 6.2 treatments to PASI 75 Beam of UVB light applied to the affected area PASI - A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis XTRAC: The treatment for Psoriasis Promotes immunosuppression UVB light induces apoptosis of the keratinocytes and T cells in the dermis Induces alterations in cytokine profile XTRAC: Psoriasis
XTRAC: Vitiligo 11 Beam of UVB light applied to the affected area XTRAC: The solution for Vitiligo Results in re-pigmentation UVB light reduces the immune system’s attack on the melanocytes Simple, safe, effective + long-lastingExcimer laser Baseline After 18 tx After 29 tx
Domestic XTRAC Revenue Funnel 12 REOCCURRENCE DTC ADVERTISING ASSIGNING A DOCTOR PARTNER PATIENTAPPOINTMENT TREATMENT WIN-WIN-WIN DOCTOR + PATIENT + PAYER INTEREST CREATION IN-HOUSE CALL CENTER INSURANCE ADVOCACY VERIFY XTRACTREATMENT VERIFY APPOINTMENTPrescription of Treatment 1. DTC expands Patient Leads 2. Patient Leads turn into Appointments and create a halo effect in clinics3. Appointments drive revenueXTRAC partners and partner clinicsSTRATA
Growing Installed Base Leads to Recurring Revenue Model 13 01/01/18 +92 -99 -7 net Systems 12/31/18 1/01/19 12/31/19 +160 -76 +84 net Systems 12/31/20 01/01/20 +106 -76 +30 net Systems Average Revenue/System $7,055 $7,571 $5,145 Expand Installed Base +Remove Underperforming Systems Utilization Recurring Revenue Q2 2021 Added 18 Systems and averaged $6,133 per system
Domestic Installed Base Growth Drivers 832 1,962 251* XTRAC Partners Group Clinics As of 12/31/20 As of 12/31/19 1,962 clinics owned by 49 roll-up groups at 12/30/2020251 (13%) of which are XTRAC partners at 12/30/2020Signed strategic expansion agreements with major groupsIncreased from 251 at 12/30/2020 to 299 at 6/30/2021 Expansion into group clinic roll ups 300-400 clinics own Excimer lasers Conversion to XTRAC partnership leads to immediate revenue15 Comebacks in 2018 (4 in 2017)19 Comebacks in 201923 Comebacks in 202018 Comebacks YTD 2021 Comebacks 14 * Combination of new XTRAC placements and Clinic acquisitions 820 1,673 221* 746 1,200 86* As of 12/31/18 XTRAC Growth in Groups
Domestic Market: Installed Base – Sales and Service Engine Overview848 Partner XTRAC Clinics160+ Sold XTRAC4 Regions30 Sales Territories2 National Account Managers15 Field Service TechsIn-House Call Center to Qualify LeadsOnly One Competitor in U.S. 15 Territories color coded
International Market: Installed Base Strategic Growth TargetsCurrent Markets: China, Japan, Saudi Arabia, S. KoreaInsurance covered in most marketsUsage/device higher than domestic market1,300 OUS devices sold and in servicePlacement recurring revenue model agreements:Executed for South Korea (July 2019)Executed for Japan (October 2020)Executed for China (January 2021)41 International partner XTRAC clinics (up from 10 in 2019) 16
Partner Academic Institutions 17
Multicenter Psoriasis Study7 Scalp Study9 124 patients were enrolled and 80 completed the protocol. 72% achieved at least 75% clearing in an average of 6.2 treatments. 84% of patients reached improvement of 75% or better after 10 or fewer treatments. 50% of patients reached improvement of 90% or better after 10 or fewer treatments. Common side effects included erythema, blisters, hyperpigmentation, and erosions, but were well tolerated. All patients improved. 17/35 (49%) of patients cleared >95% (mean: 21 treatments; range: 6-52) and 16/35 (45%) cleared 50-95%. Conclusion - The excimer laser is a successful approach to treatment of psoriasis of the scalp, being a simple treatment that can be performed in a short period of time and which has a high rate of effectiveness. Sample Studies from 150+ Clinical Studies Vitiligo Study8 Out of 221 vitiligo patches treated, 50.6% showed 75% pigmentation or more, 25.5% achieved 100% pigmentation of their patches, and 64.3% showed 50% pigmentation or more. Lesions on the face responded better than lesions elsewhere. Conclusion: The 308-nm xenon chloride excimer laser is an effective and safe modality for the treatment of vitiligo, with good results achieved in a relatively short duration of time. Pediatric Study10 4 children with a mean age of 11.0 years and 12 adults with a mean age of 48.8 years completed the protocol. Both the children and the adult groups yielded a significant decrease in psoriatic severity scores of their respective target lesions. The children’s group had a greater reduction (91.3% reduction) as compared to the adult treatment group (61.6% reduction). 18
Financial Metrics 19 * Total recurring revenue over total installed base** Company estimates not provided Unaudited quarterly results * See press release dated August 16, 2021 for definitions of non-GAAP measures
STRATA Key Investment Takeaways 20 Differentiated Therapy providing a Win-Win-Win for Patients + Clinics + Payers Addressing a Large Unmet Need + Growing Market +Platform for inorganic growth Proven Business Model to Expand + Achieve Sustainable Growth
Investor Presentation December 2020 Thank You
Investor Presentation December 2020 Appendix
Footnotes Company estimatesHistorical phototherapy utilization. Trend in phototherapy utilization among Medicare beneficiaries by billing code across all providers, 2000 to 2015. HCPCS, Healthcare Common Procedure Coding System; PUVA, psoralen plus ultraviolet A; UVB, ultraviolet BNational Eczema AssociationThe Vitiligo FoundationNational Psoriasis Foundation"Therapies for Psoriasis: Clinical and Economic Comparisons" in the November 2020 issue of the Journal of Drugs in Dermatology Multicenter Psoriasis Study - Feldman SR, Mellen BG, Housman TS, Fitzpatrick RE, Geronemus RG, Friedman PM, Vasily DB, Morison WL. Efficacy of the 308-nm excimer laser for treatment of psoriasis: Results of a multicenter study. J Am Acad of Dermatol; vol. 46, no. 6, June 2002, pp. 900-906 Vitiligo Study - Suhail Hadi, Patricia Tinio, Khalid Al-Ghaithi, Haitham Al-Qari, Mohammad Al-Helalat, Mark Lebwohl, and James Spencer. Photomedicine and Laser Surgery. Treatment of Vitiligo Using the 308-nm Excimer Laser. Jun 2006.ahead of printhttp://doi.org/10.1089/pho.2006.24.354Scalp Study - Morison WL, Atkinson DF and Werthman L. Effective treatment of scalp psoriasis using the excimer (308nm) laser. Photodermatol Photoimmunol Photomed 2006; 22: 181-183Pediatric Study - Pahlajani N, Katz BJ, Lonzano AM, Murphy F and Gottlieb A. Comparison of the Efficacy and Safety of the 308nm Excimer laser for the Treatment of Localized Psoriasis in Adults and in Children: A Pilot Study. Pediatric Dermatology Vol. 22 No. 2, March/April 2005, pp. 161-165 23