DRIO

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0001533998

2023-07-24 2023-07-24

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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): July 24, 2023

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)

(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 2.02 Results of Operations and Financial Condition.

On July 24, 2023, DarioHealth Corp. (the Company") issued a press release which provided certain preliminary unaudited results of operations for the second quarter ended June 30, 2023, based on currently available information. The preliminary unaudited results presented reflect the Company’s estimates based solely upon information available, and the Company’s final results could differ from these estimates due to the completion of the Company’s financial closing procedures, final adjustments and other developments that may arise between now and the time such unaudited consolidated financial statements for the quarter ended June 30, 2023 are issued. The Company expects to announce its full results for the three and six months ended June 30, 2023 on or before August 14, 2023.

A copy of the press release issued by the Company announcing the preliminary unaudited financial information for its fiscal quarter ended June 30, 2023, is furnished as Exhibit 99.1 hereto.

Item 8.01. Other Events.

On July 24, 2023, the Company announced preliminary unaudited revenue results for the three months ended June 30, 2023 of between $6.0 million and $6.15 million, driven by growth in its Business-to-Business (B2B) sales channel. Revenue from strategic partnerships was less than expected in the second quarter due to fewer milestone deliveries than anticipated. The Company also announced preliminary unaudited revenues for the six months ended June 30, 2023 were between $13 million and $13.15 million, resulting from the expected reduction in direct sales to consumers that took place during the same period. The Company also announced that it had preliminary unaudited cash and cash equivalents of $52.6 million as of June 30, 2023.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein that do not describe historical facts, including, but not limited to statements related to the Company’s preliminary unaudited revenue results for the three and six months ended June 30, 2023 as well as its estimated cash and cash equivalents as of June 30, 2023. These statements involve risks and uncertainties, including the Company’s ability to satisfy certain conditions to closing on a timely basis or at all, as well as other risks detailed from time to time in the Company’s filings with the SEC, the documents incorporated by reference and therein, and subsequent filings with the SEC. Any of these risks and uncertainties could materially and adversely affect the Company’s results of operations, which would, in turn, have a significant and adverse impact on the Company’s stock price. The Company cautions you not to place undue reliance on any forward-lo

0001533998 false

0001533998

2023-01-31 2023-01-31

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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 31, 2023

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 10019

(Address of Principal Executive Offices)

972- 4-770-4055

(Issuer’s telephone number)

(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 2.02 Results of Operation and Financial Condition.

On February 6, 2023, DarioHealth Corp. (the “Company”) issued a press released which provided certain preliminary results of operations for the quarter and fiscal year ended December 31, 2022 based on currently available information. The preliminary results presented reflect the Company’s estimates based solely upon information available, and the Company’s final results could differ from these estimates due to the completion of the Company’s financial closing procedures, final adjustments and other developments that may arise between now and the time such audited consolidated financial statements for the year ended December 31, 2022 are issued. The Company expects to announce its full results for the twelve months ended December 31, 2022 on or before March 31, 2023.

A copy of the press release issued by the Company announcing the preliminary unaudited financial information for its fiscal quarter ended December 31, 2022 is filed as Exhibit 99.1 hereto.

Item 2.04 Triggering Events That Accelerate or Increase a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement.

The Company, as borrower, previously entered into its Credit Agreement (the “Credit Agreement”) with OrbiMed Royalty and Credit Opportunities III, LP, as the lender (the “Lender”). The Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $50 million (the “Loan Facility”), of which $25 million was made available on June 9, 2022 and up to $25 million will be made available on or prior to June 30, 2023, subject to certain revenue requirements.

Pursuant to the terms of the Credit Agreement, and the preliminary results of operations for the fiscal year ended December 31, 2022 as described above in Item 2.02, the Company started repayment of the outstanding principal amount of the initial tranche of $25 million issued as part of the Loan Facility, together with a repayment premium and other fees in monthly installments of up to $518,500 beginning as of January 31, 2023, and continuing through the maturity date, or June 9, 2027.

Item 7.01. Regulation FD Disclosure.

The information set forth in Item 2.02 is incorporated by reference into this Item 7.01.

In addition, on February 6, 2023, the Company posted to its website an investor presentation, a copy of which is attached hereto as Exhibit 99.2.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

99.1 Press release dated February 6, 2023.

99.2 Investor Presentation dated February 6, 2023 (furnished herewith).

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

0001533998 false

0001533998

2022-08-15 2022-08-15

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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): August 15, 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)

(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 2.02 Results of Operations and Financial Condition.

On August 15, 2022, DarioHealth Corp. (the “Company”) issued a press release providing selected financial information for the three and six months ended June 30, 2022. On August 15, 2022, the Company posted to its website a presentation (the “Presentation”) containing its financial results for the quarter ended June 30, 2022. Copies of the press release and Presentation are furnished with this Report on Form 8-K as Exhibits 99.1 and 99.2, respectively.

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 operating expenses and operating loss which exclude inventory step-up amortization, amortization of acquired technology, stock-based compensation, depreciation, amortization of acquired brand and earn out revaluation. 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.

Exhibit

Number

Description

99.1

Press Release of DarioHealth Corp., dated August 15, 2022

99.2

Presentation of DarioHealth Corp., dated August 15, 2022

104

Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101).

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: August 15, 2022

DARIOHEALTH CORP.

By: /s/ Zvi Ben David

N