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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported): January 19, 2022 (January 18, 2022)

 

DARIOHEALTH CORP.

(Exact name of registrant as specified in its charter)

 

Delaware   001-37704   45-2973162
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

18 W. 18th St, 5th Floor

New York, New York 10011

(Address of Principal Executive Offices)

 

972- 4-770-4055

(Issuer’s telephone number)

 

142 W. 57th St., 8th Floor

New York, New York 10019

(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 to 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 exchange on which 
registered
Common Stock, par value $0.0001 per share   DRIO   The Nasdaq Capital Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in 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 1.01 Entry into a Material Definitive Agreement.

 

On January 18, 2022, DarioHealth Corp., or the Company, entered into a Technology Purchase Agreement, or the Purchase Agreement, by and between Physimax Technologies Ltd., or Physimax, and the Company’s wholly owned subsidiary, Labstyle Innovation Ltd., or the Purchaser. Pursuant to the Purchase Agreement, Physimax agreed to sell transfer and convey all of its right, title and interest in and to certain assets, as defined and under the terms of the Purchase Agreement, or the Physimax Assets. In consideration for Physimax Assets, the Company agreed to issue up to 256,660 shares of the Company’s common stock, $0.0001 par value per share, or the Consideration Shares, representing a purchase price of $5,500,000 in the aggregate, at a price per share equal to $21.35, plus a cash payment of $500,000, as well as assume certain liabilities in an approximate amount of $1,020,000.

 

The Consideration Shares will be subject to the terms of a lock-up agreement, pursuant to which Physimax, or subsequent transferees (subject to certain exceptions), have agreed to restrict their ability to transfer their shares as follows: (i) shares representing 33.3% of the Consideration Shares will be restricted from transfer for a period of one hundred and eighty (180) days from the date of the closing, or the Closing Date, (ii) shares representing 33.3% of the Consideration Shares will be restricted from transfer for a period of two hundred and seventy (270) days from the Closing Date, and (iii) shares representing 33.4% of the Consideration Shares will be restricted from transfer for a period of three hundred and sixty (360) days from the Closing Date. In addition, the Company, Physimax and certain key personnel of Physimax shall enter into specific holdback agreements where no less than 30% of the Consideration Shares, which such key personnel would have received as shareholders of Physimax, had the Consideration Shares been distributed to them, shall be held back by Physimax, and released as follows: (i) 50% of such held back Consideration Shares shall be released at the lapse of the first anniversary as of the Closing; and (ii) the balance 50% of such Consideration Shares shall be released at the lapse of 18 months of the Closing, provided that all such personnel continue to be employed by the Company, the Purchaser or any of its affiliates.

 

The Purchase Agreement contains representations and warranties customary for transactions of this nature negotiated between sophisticated purchasers and sellers acting at arm’s length, certain of which are qualified as to materiality and knowledge and subject to reasonable exceptions. The Closing of the Purchase Agreement is subject to customary closing conditions, including the approval of the Israeli Innovation Authority.

 

Item 2.02 Results of Operations and Financial Condition.

 

On January 18, 2022, the Company issued a press release announcing an investor call on January 19, 2022. In addition, on January 19, 2022, the Company posted to its website a presentation, or the Presentation, that is to be presented on the investor conference call to be held on January 19, 2022. Copies of the press release and the Presentation are furnished with this Current Report on Form 8-K as Exhibits 99.1 and 99.2, respectively. 

 

The information presented in Item 2.02 of this Current Report on Form 8-K and Exhibits 99.1 and 99.2 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or specifically incorporates it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.

 

 

 

In the Presentation, the Company uses information derived from its unaudited, consolidated and financial information that may not be presented in its financial statements or prepared in accordance with generally accepted accounting principles in the United States, or GAAP. Certain of these measures are considered “non-GAAP financial measures” under rules promulgated by the Securities and Exchange Commission. Specifically, the Company has referred to non-GAAP financial measures of revenues, cost of revenues and gross profit, which exclude amortized expenses relating to certain technology acquisitions. These non-GAAP financial measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. The Company uses these non-GAAP financial measures internally in analyzing its financial results and believes they are useful to investors, as a supplement to GAAP measures, in evaluating its ongoing operational performance. The Company believes that the use of these non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial results with peer companies, many of which present similar non-GAAP financial measures to investors.

 

Non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. Investors are encouraged to review the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures provided in the financial statement tables provided at the end of the Presentation.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

99.1 Investor Presentation (furnished herewith pursuant to Item 2.02)
99.2 Press release dated January 18, 2022 (furnished herewith pursuant to Item 2.02)
104 Cover Page Interactive Data File (embedded within the Inline 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.

 

 

Dated: January 19, 2022 DARIOHEALTH CORP.
   
   
  By:  /s/ Zvi Ben David
    Name: Zvi Ben David
Title:   Chief Financial Officer, Treasurer and Secretary

 

 

Exhibit 99.1

1 Dario Health – Investors Day Jan 19 th , 2022

 
 

This presentation and the statements of representatives and partners of DarioHealth Corp . (the “Company”) related thereto contain or may contain forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other U . S . Federal securities laws, as amended . Statements that are not statements of historical fact may be deemed to be forward - looking statements . For example, the Company is using forward - looking statements in this presentation when it discusses preliminary unaudited estimates of revenues cost of revenues and gross margin for the quarter and 12 - month period ended December 31 , 2021 , the Company’s trends, market penetration and growth in 2022 and the timing of release of its 2021 fully audited financial statements . Without limiting the generality of the foregoing, words such as "plan," "project," "potential," "seek," "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward - looking statements . Forward - looking statements are based on management’s current expectations, estimates, projections, and assumptions about future events, and are subject to several factors and uncertainties that could cause actual results to differ materially from those described in the forward - looking statements . These statements are not guarantees of future performance and involve certain risks, uncertainties, and assumptions about the Company, which are difficult to predict, including projections of the Company’s future financial results, its anticipated growth strategies, and anticipated trends in its business and in the market generally . Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward - looking statements that may be made in this news release . Factors that may affect the Company's results include, but are not limited to, regulatory approvals, product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks, and the risks associated with the adequacy of existing cash resources . Additional factors that could cause or contribute to differences between the Company's actual results and forward - looking statements include, but are not limited to, those risks discussed in the Company's filings with the U . S . Securities and Exchange Commission . Readers are cautioned that actual results (including, without limitation, the timing for and results of the Company's commercial and regulatory plans for Dario Œ as described herein) may differ significantly from those set forth in the forward - looking statements . The Company undertakes no obligation to publicly update any forward - looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law . 2

 
 

DarioHealth (NASDAQ: DRIO) Webinar: 3 Navigating Emerging Digital Health Trends for Strategic Growth in 2022

 
 

Sari Kaganoff Sari is the General Manager of Consulting at Rock Health , a digital health focused venture fund and advisory firm, where she advises clients on digital health strategy and innovation. Dr David Kaplan David is a physician and expert on healthcare and the employer market. Dr. Kaplan has led the clinical practices at Towers Perrin and Mercer. At Mercer , he also led the Innovation function and founded Mercer Labs. presently he serves as an advisor to multiple VCs and young companies. 4

 
 

5

 
 

Digital health investment activity 2022

 
 

$3 9 . 9 M $3 0 . 8 M $1 9 . 9 M $2 1 . 6 M $1 5 . 8 M $1 3 . 6 M $1 4 . 7 M $ 1 5.2 M $1 0 . 7 M $1 0 . 8 M $12.3M 7 © ROCK HEALTH 2022 7 Venture funding and deal size increased significantly in 2021 U.S. DIGITAL HEALTH FUNDING AND DEAL SIZE 2011 - 2021 Note: Includes U.S. deals >$2M; data through December 31, 2021 Source: Rock Health Digital Health Venture Funding Database TOTAL VENTURE FUNDING NUMBER OF DEALS AVERAGE DEAL SIZE

 
 

Note: Comp Source: Roc anies can be tagged as multiple value propositions and clinical indications. Rock Health tracks 23 clinical indications. k Health Digital Health Venture Funding Database; includes U.S. deals >$2M; data through December 31, 2021 8 © ROCK HEALTH 2022 8 Top funded therapeutic areas include mental health, diabetes and MSK solutions 2017 2018 2021 Mental Health D iab e t e s 2019 Musculoskeletal O nc o logy 2020 Primary Care Cardiovascular 2021 MENTAL HEALTH, DIABETES & MSK FUNDING 2017 - 2021 $6B $0B $2 B $5. 1 B $4B TOTAL VENTURE FUNDING $1.4B $1.4B (ONC) $1.8B $1.8B (CV) $1.6B (PC)

 
 

© ROCK HEALTH 2022 9 9 COMPANY VALUATION TA(S) $4.8B $4.6B $3.0B $4.2B $2.1B $0.85B $6.2B $2.0B $0.1B $18.5B $0.6B (2019) Mental Health Diabetes M us cu l o s k el et a l VALUATIONS OF MENTAL HEALTH, MSK & DIABETES CARE COMPANIES Source: Pitchbook, NYSE Considering company valuations

 
 

There has been a flurry of Digital Health companies going public NUMBER OF EXITS DIGITAL HEALTH’S PUBLIC EXIT DROUGHT 15 20 10 5 0 10 © ROCK HEALTH 2022 10 Source: Rock Health Digital Health Public Company Index DIGITAL HEALTH PUBLIC EXIT ACTIVITY 2011 - 2021 25

 
 

EXAMPLE ACQUISITIONS 2020 - 2021 QUARTERLY DIGITAL HEALTH M&A ACTIVITY 2020 - 2021 Note: Data through 2021. Digital health M&A activity refers to acquisitions and/or mergers of digital health companies. Source: Rock Health Digital Health M&A Database 0 20 40 60 80 100 M& A DEALS Q 2 Q 3 Q 4 Q 1 Q2 Q 3 Q 1 2020 2021 As well as an increase in M&A activity in 2021 Q 4 © ROCK HEALTH 2022 11

 
 

L E G E N D TOP NON - US HEADQUARTER LOCATIONS 2,3 FDA approvals and clearances from 1997 – 2021 1 OVERALL US VERSUS NON - US BREAKDOWN FDA approvals and clearances from 1997 – 2021 1 31 9 I S R A EL C A N A D A 19 N E T H E RLAND S 14 F R A N CE 14 S WE D EN 13 J A P AN 13 UK 10 C H INA A U ST R A LIA 8 T A I W AN 6 SOUTH KOREA 6 B E L G I U M 6 G E RM A N Y 5 S I N G A P OR E 3 177 166 NUMBER OF APPROVALS OR CLEARANCES Entries from US - based companies Entries from non - US - based companies Note: 1. 2021 includes FDA approvals and clearances for AI - and ML - enabled devices through June 17, 2021; 2. country determination of sponsoring company based upon location of headquarters or primary office according to Pitchbook unless a d 1 iv 2 ision with a different geographic location was specified; 3. entries include companies with headquarters or primary offices in a total of 23 headquarter locations - those with 1 or 2 entries are not captured in the graph at right above Source: FDA list of Artificial Intelligence and Machine Learning (AI/ML) - Enabled Medical Devices as of 09/22/2021 and Pitchbook data Israel is the top ex - US country with FDA approvals for AI/ML enabled devices

 
 

13

 
 

14

 
 

• Getting back into the office/COVID • Retaining and recruiting talent • Addressing equity issues in workplace • Preparing for a resource constrained environment if economic conditions deteriorate 15

 
 

• Ability to bill through their medical budgets • Demonstrable return on investment (ROI) • Programs that simplify their healthcare ecosystems - consolidation of solutions • Programs that focus on rising cost areas • Programs that will delight their employees - consumer centric 16

 
 

17

 
 

apple app store rating Multi Conditions 26 Clinical Studies 38,800 Users per single study with 2 - year sustained results • Best in user - centricity / DNA of the company • Most comprehensive platform • Best Return on investment 18

 
 

19

 
 

• Built to engage based on hyper - personalization. • Proactive flagging and treatment initiation 20

 
 

21

 
 

Expansion of Dario Move Offering with Computer Vision mobile capabilities Significant Capabilities: 1. Objective scoring using evidence - based functional movement AI 2. Automated exercise allocation (reduce human need) 3. Predictive risk of injury assessment Validated by elite NBA & NFL teams as well as WestPoint Academy • Total 257K shares plus $1M debt (long term debt) plus $0.5M cash (used to operate the company) • Asset Deal (*) Definitive agreement signed and pending closing 22

 
 

23

 
 

24

 
 

25 national health plan significant partnerships of deals signed in last 6 months * Estimates revenues (unaudited) for 2021 between $20.3M to $20.5M ** Adjusted NON - GAAP gross profit for the nine months ended Sep. 30, 2021, excluding amortization of expenses related to acquisitions of technologies 46.5% GAAP unaudited gross profit for the nine months ended Sep. 30, 2021 – 23.6% The Company is providing revenue, cost of revenue and gross profit estimates in this presentation, rather than specific amounts , primarily because the financial closing process and review are not yet complete and, as a result, the Company’s final results upon completion of its closing process and review may vary from these preliminary estimates. A reconciliation of GAAP to non - GAAP measures has been provided in the financial statement tables included at the end of this presentation The Company expects to release the fully audited 2021 financial statements on or before March 31, 2022.

 
 

2016 2017 2018 2019 2020 2021 Growth of integrated platform creates demand from stakeholders who desire healthier outcomes for their constituents 26

 
 

Validation of platform from multiple market segments 2 nd health plan announced this morning. 3 additional accounts announced since year start 27

 
 

28 1.67 1.79 2.04 2.08 3.6 5.3 5.6 5.9 Q 1 Q 2 Q 3 Q4 Q 1 Q 2 Q 3 Q4 2020 2021 • • The Company is providing revenue, cost of revenue and gross profit estimates in this presentation, rather than specific amounts , primarily because the financial closing process and review are not yet complete and, as a result, the Company’s final results upon completion of its closing process and review may vary from these preliminary estimates. The Company expects to release the fully audited 2021 financial statements on or before March 31, 2022. 7.6 20.4 0 5 10 15 20 25 2020 2021

 
 

29

 
 

Eligible Population Enrollment Rate • Paid per employee with access to the platform • Paid for eligible members that are enrolled to the platform • Recurring billing for retained members 30

 
 

8% Eligible 40 % Eligible $60 PEMPM on similar sales effort $89 PEMPM More Members per account on the platform Higher ARPU (average revenue per user) Eligible Population Enrollment Rate 31

 
 

32 140 120 100 80 60 40 20 0 • 2021 sales activity positioned us to double account base in 2022 • 70% of the signed accounts have been signed in the last 6 month * Represents the Company’s potential signed account growth in 2022

 
 

33 • Potential annual recurring revenues (ARR) upon full implementation of clients. #54 #100 - #120 #5 • Clients potential ARR includes B2B only and does not includes the Direct - to - consumer revenues. • Full potential implementation is expected within 4 - 6 quarters. * Includes potential expansion of ARR from existing clients. • Expect average ARR per account to increase in the future (multi condition)

 
 

34

 
 

Healthcare is transforming to be digital, consumer centric driven and value based “Non - Digital” Health Care giants recognize the transformation and will take bigger role in being part of the newly created space Dario Health is positioned to lead the newly created category Strong tech, high margins model, “Digital Therapeutic Platform - as - a - Service” 2022 accelerate momentum with potential key value creation events 35

 
 

Gross profit as reported Amortization of expenses related to acq. of technology Gross profit Non - GAAP Revenues $14,485 $14,485 Cost of revenues $11,070 - $3,324 $7,746 Gross Profit $3,415 $3,324 $6,739 GP % 23.6% 46.5% 36 The Company is providing revenue, cost of revenue and gross profit estimates in this presentation, rather than specific amounts, primarily because the financial closing process and review are not yet complete and, as a result, the Company’s final results upon completion of its closing process and review may vary from these preliminary estimates . The Company expects to release the fully audited 2021 financial statements on or before March 31 , 2022 . Non - GAAP Financial Measures The Company has provided in this presentation, financial information that has not been prepared in accordance with GAAP. These non - GAAP financial measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. The Company is using these non - GAAP financial measures internally in analyzing its financial results and believe they are useful to investors, as a supplement to GAAP measures, in evaluating its ongoing operational performance. The Company believes that the use of these non - GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company's financial results with peer companies, many of which present similar non - GAAP financial measures to investors. Non - GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. Investors are encouraged to review the reconciliation of these non - GAAP financial measures to their most directly comparable GAAP financial measures provided in the financial statement tables below

 
 

37 Thank You

 

 

 

Exhibit 99.2

 

DarioHealth to Host Investor Webinar on Navigating Emerging Digital Health Trends for Strategic Growth in 2022

 

Webinar to be held Wednesday, January 19th at 8am ET

 

NEW YORK, January 18, 2022 – DarioHealth Corp. (Nasdaq: DRIO) a leader in the global digital therapeutics (DTx) market, today announced that it will host an investor webinar on navigating the emerging digital health trends in 2022 on Wednesday, January 19th at 8am ET.

 

Join DarioHealth’s management and two renowned industry experts from Rock Health and Mercer to better understand how strong tailwinds from the evolving digital health landscape are powering the Company’s strategic approach for 2022.

 

Sari Kaganoff, General Manager of Consulting at Rock Health, brings deep experience advising companies on digital health strategy and innovation, sharing emerging trends shaping the digital health landscape in 2022 and beyond.

 

David Kaplan, former head of Mercer’s healthcare practice, is a highly regarded healthcare innovator specializing in the commercialization of digital health solutions, offering key insights on industry trends shaping opportunities in the employer, provider, and payer markets.

 

Finally, Erez Raphael, DarioHealth’s Chief Executive Officer, and Rick Anderson, DarioHealth’s President and General Manager for North America, will provide a deep dive into the company’s digital therapeutics platform, including a demonstration of the seamless user experience at the heart of user adoption across its polychronic platform. They will summarize the company’s 2021 major accomplishments and preview the strategic roadmap propelling the company to category leadership and sales activity in 2022.

 

DarioHealth is transforming healthcare through its cloud-based Digital Therapeutics platform that delivers personalized care when and where patients need it for a range of health conditions. Our single platform connects services, devices and people at scale ensuring clinical and financial outcomes that positively impact tens of millions of lives and save billions of dollars.

 

To register for the event, please click here.

 

About DarioHealth Corp.

 

DarioHealth Corp. (Nasdaq: DRIO) is a leading global digital therapeutics company revolutionizing how people with chronic conditions manage their health. DarioHealth offers one of the most comprehensive digital therapeutics solutions on the market - covering multiple chronic conditions including diabetes, hypertension, weight management, musculoskeletal and behavioral health within one integrated technology platform.

 

Dario's next-generation, AI-powered, digital therapeutic platform supports more than just an individual's disease. Dario provides adaptive, personalized experiences that drive behavior change through evidence-based interventions, intuitive, clinically proven digital tools, high-quality software, and coaching to help individuals improve health and sustain meaningful outcomes.

 

Dario's unique user-centric approach to product design and engagement creates an unparalleled experience that is highly rated by users and delivers sustainable results.

 

 

 

The company's cross-functional team operates at the intersection of life sciences, behavioral science, and software technology and utilizes a performance-based approach to improve its users' health.

 

On the path to better health, Dario makes the right thing to do the easy thing to do. To learn more about DarioHealth and its digital health solutions, or for more information, visit http://dariohealth.com.

 

Cautionary Note Regarding Forward-Looking Statements

 

This news release and the statements of representatives and partners of DarioHealth Corp. related thereto contain or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not statements of historical fact may be deemed to be forward-looking statements. For example, the Company is using forward-looking statements in this press release when it discusses the expected timing of the new clients providing the Dario platform and solution to its users, that the agreements will contribute to 2022 revenue and the belief that employers are finding value in its integrated multi-condition suite in comparison to individual point solutions and that it looks forward to expanding its clients across the full suite this year. Without limiting the generality of the foregoing, words such as "plan," "project," "potential," "seek," "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect the Company's results include, but are not limited to, regulatory approvals, product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks, and the risks associated with the adequacy of existing cash resources. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include, but are not limited to, those risks discussed in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned that actual results (including, without limitation, the timing for and results of the Company's commercial and regulatory plans for Dario™ as described herein) may differ significantly from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

 

 

DarioHealth Corporate Contact

Suzanne Bedell

VP Marketing

suzanne@dariohealth.com

+1-347-767-4220

 

Media Contact:

Josephine Galatioto

Josephine.Galatioto@russopartnersllc.com

+1-212-845-4262