DarioHealth Reports First Quarter Financial and Operating Results

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11 May, 2023, 13:30 IDT

Sequential quarterly growth in revenue to $7.07 million
Gross profit margin improving to 44.8% sequentially in the first quarter of 2023, up from 40.1% of revenues in the fourth quarter of 2022
Non-GAAP gross margin was 60.1% of revenues for the first quarter of 2023, up from 58.1% of revenues in the fourth quarter of 2022
Reduced cash used in operating activities in the first quarter to only $4.76 million
Further reduced net loss to $12.8 million in Q1 2023, versus $15.9 million in Q1 2022, and $12.6 million in Q4 2022
Expanded strategic relationships by signing with Amwell and the first account through our relationship with Sanofi, a national pharmacy benefits manager
Announced the presentation of the first Sanofi of Dario data which showed statistically significant reduction in all-cause health care resource utilization, including a 23.5% reduction in hospitalizations.
Cash balance as of the end of Q1 of $38.8 million
Proforma cash balance as of the end of Q1 inclusive of the private placement offering proceeds and the refinanced loan was $61 million
Company to host investor conference call and webcast at 8:30 a.m. ET today

NEW YORK, May 11, 2023 /PRNewswire/ -- DarioHealth Corp. (Nasdaq: DRIO) ("Dario" or the "Company"), a leader in the global digital health market, today reported financial results for the first quarter 2023 and provided a corporate and commercial update.

"During the first quarter, we continued to improve the financial profile of the Company as we capitalized on the growing demand for digital health solutions in the employer and health plan markets," stated Erez Raphael, Chief Executive Officer of Dario. "We generated sequential growth in revenue, improved gross margins and reduced operating expenses as our new business model matures. The strategic shift continues to yield results as we reduced our operating loss and net loss by 21.8% and 21.6% respectively, as compared to the first quarter of 2022, reflecting the higher profitability of the commercial channel.

"Business-to-Business (B2B) revenues continued to increase, representing approximately 70% of our total revenue during the first quarter, up from 56% in the first quarter of 2022. The increase in B2B share of total revenue reflects what we believe are growing trends in the market favoring Dario's single, integrated, multi-condition digital health platform.

"We were very pleased to complete a successful private placement offering of convertible preferred stock along with a concurrent refinancing of our credit facility which together adds significant runway which is expected to extend through late 2025. We believe that our strategy is working, and with our strengthened balance sheet and the significantly reduced cash burn, I believe Dario is well positioned to lead the market for integrated digital health solutions," Mr. Raphael concluded.

"Our partnership strategy continues with the addition of American Well Corporation (Amwell), a leading digital care delivery enablement platform, which will integrate our cardiometabolic solution into its offering," stated Rick Anderson, President of Dario. "Our agreement with Amwell represents a substantial opportunity for Dario with an installed base of approximately 2,000 health plans and hospitals that reach over 90 million lives. Amwell joins a growing list of strategic relationships that includes Sanofi US Services, Inc., CVS Pharmacy Inc., Virgin Pulse, Inc., Solera Health, Inc., and Alliant Insurance Services Inc., that we believe see the value of Dario for their health plan and employer clients. We believe that these relationships will enable us to continue to accelerate market penetration and drive revenue growth this year and beyond.

We are very excited about the first study conducted by Sanofi in one of the largest and most rigorous study designs seen in digital health with the use of the Dario solution. As the digital health industry matures partners, especially health plans, are demanding greater levels of evidence. This study demonstrated statistically significant reductions in health care utilization and a 23.5% reduction in hospitalizations. We believe that these results will be extremely valuable to our sales efforts for customers seeking to reduce cost in this increasingly challenging macro-economic environment.

We exited the first quarter with $67 million of signed contract value, a modest increase over the fourth quarter of 2022 as we have recently started the 2024 sales cycle for employers, and we have yet to reflect any contract value for Amwell. We continue to build a robust B2B business which we believe is strategically aligned with employer and health plan demand and anticipate that we will continue to see strong growth as a result of the foundation we have built," Mr. Anderson concluded.

Q1 2023 and Recent Highlights

Continued to improve the financial profile of the Company, driven by the continued growth of scalable, high margin B2B customers.
Announced a strategic partnership with Amwell, a leader in digital healthcare enablement, to deliver its cardiometabolic solution to Amwell's customers.
Entered into an agreement with Dexcom, the global leader in real-time continuous glucose monitoring (CGM) technology, to integrate its market-leading CGMs into Dario's multi-chronic condition platform.
Announced a new contract with a leading national Pharmacy Benefits Manager (PBM) to provide its employer clients with Dario's digital therapeutics solutions, beginning with its diabetes solution, beginning in the second quarter of 2023.
Announced hiring of digital health product leader Eitan Shay as Chief Product Officer and appointment of digital veteran Arnaud Robert as Strategic Advisor to the Chief Executive Officer.
Announced the publication of new research in Pain Reports investigating the personalized efficacy of digital therapeutics for pain management, linking the reduction of back pain for users in a digital posture training program with the personalization of user journeys adapting machine learning models.
Presented two new clinical studies at the 16th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) 2023, which was held February 22-25 in Berlin. One of the studies demonstrated improved clinical outcomes in users with Type 2 diabetes and provided further analysis to understand the mediating effects of live human coaching and digital interventions across the Dario user journey, and the second study demonstrated Dario's ability to reduce hypoglycemic events in older adults with a digital chronic condition management solution.
Continue to demonstrate the strength of Dario's multi-condition suite, with more than 50% of pipeline opportunities for multi-condition contracts.

First Quarter 2023 Results Summary

Revenues for the first quarter ended March 31, 2023 were $7.07 million, a 12.3% decrease from $8.06 million for the first quarter ended March 31, 2022, and an increase of 3.8% from $6.8 million for the fourth quarter of 2022. The decrease in revenues for the quarter ended March 31, 2023 as compared to the quarter ended March 31, 2022 resulted mainly from lower revenues from the Company's Business-to-Consumer (B2C) Channel.

Gross profit for the first quarter of 2023 was $3.2 million, a decrease of $0.8 million, compared to gross profit of $4 million for the first quarter of 2022, and an increase of 16% from $2.7 million for the fourth quarter of 2022. Gross profit as a percentage of revenues decreased to 44.8% in the first quarter of 2023, from 49.4% in the first quarter of 2022, and increased from 40.1% in the fourth quarter of 2022.

Pro-forma gross profit, excluding $1.1 million of amortization expenses related to the acquisition of technology, was $4.2 million, or 60.1% of revenues, for the three months ended March 31, 2023, compared to a pro-forma gross profit of $4.9 million, or 61% of revenues, for the three months ended March 31, 2022, and pro-forma-gross profit of $4 million, or 58.1% of revenues, for the three months ended December 31, 2022. A reconciliation of GAAP to non-GAAP measures has been provided in the financial statement tables included in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Total operating expenses for the first quarter of 2023 were $15.6 million, compared with $19.9 million for the first quarter of 2022, and $11.7 million for the fourth quarter of 2022, a decrease of $4.3 million, or 21.6%, compared to the first quarter of 2022, and an increase of $3.8 million, or 32.6%, compared to the fourth quarter of 2022. The decrease compared to the first quarter of 2022 resulted mainly from the decrease in our digital marketing expenses. The increase compared to the fourth quarter of 2022 resulted mainly from lower operating expenses in the fourth quarter of 2022 due to year-end adjustments in stock-based compensation expenses and headcount related items. Total operating expenses excluding stock-based compensation, acquisition expenses, earn-out measurement, and depreciation for the first quarter of 2023 were $10.6 million, compared to $14.8 million for the first quarter of 2022, and $10 million for the fourth quarter of 2022.

Operating loss for the first quarter of 2023 was $12.4 million, a decrease of $3.5 million, or 21.8%, compared to $15.9 million for the first quarter of 2022, and an increase of $3.4 million, or 37.7%, compared to $9.0 million for the fourth quarter of 2022. The decrease compared to the first quarter of 2022 and the increase compared to the fourth quarter of 2022, were mainly due to the decrease and increase respectively in our operating expenses.

Operating loss excluding stock-based compensation, acquisition expenses and depreciation for the first quarter of 2023 were $6.3 million compared to $9.9 million for the first quarter of 2022, and $6.0 million for the fourth quarter of 2022.

Net loss was $12.8 million in the first quarter of 2023, a decrease of $3.1 million, or 19.4%, compared to a net loss of $15.9 million in the first quarter of 2022, and an increase of $0.2 million, or 1.7%, compared to $12.6 million for the fourth quarter of 2022. Net loss excluding stock-based compensation, acquisition related expenses and depreciation for the first quarter of 2023 was $6.8 million compared to $9.9 million for the first quarter of 2022 and $9.6 million in the fourth quarter of 2022.

Non-GAAP billings for the three months ended March 31, 2023, were $6.7 million, a 16% decrease from $8.0 million for the three months ended March 31, 2022. The decrease is a result of lower sales generated in the B2C channel, in the three months ended March 31, 2023, compared to the three months ended March 31, 2022.

A reconciliation of GAAP to non-GAAP measures has been provided in the financial statement tables included in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Conference Call Details: Thursday, May 11, 8:30am ET

Dial-in: 1-833-816-1389 (domestic) or 1-412-317-0482 (international)

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Passcode: 9873766

Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. This link will be made active 15 minutes prior to scheduled start time.

Conference title: DarioHealth Corp. – First Quarter 2023 Results Call

Webcast link: https://viavid.webcasts.com/starthere.jsp?ei=1610598&tp_key=6f49dba576

Participants are asked to dial-in approximately 10 minutes prior to the start of the event. A replay of the call will be available approximately two hours after completion through Sunday, June 11, 2023. To listen to the replay, dial 1-844-512-2921 (domestic) or 1-412-317-6671 (international) and use replay passcode 10178111.

About DarioHealth Corp.

DarioHealth Corp. (Nasdaq: DRIO) is a leading digital health company revolutionizing how people with chronic conditions manage their health through a user-centric, multi-chronic condition digital therapeutics platform. Our platform and suite of solutions deliver personalized and dynamic interventions driven by data analytics and one-on-one coaching for diabetes, hypertension, weight management, musculoskeletal pain and behavioral health.

Our user-centric platform offers people continuous and customized care for their health, disrupting the traditional episodic approach to healthcare. This approach empowers people to holistically adapt their lifestyles for sustainable behavior change, driving exceptional user satisfaction, retention and results and making the right thing to do the easy thing to do.

Dario provides its highly user-rated solutions globally to health plans and other payers, self-insured employers, providers of care and consumers. 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 the Company 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. 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. For example, when it discusses that its increase in B2B share of total revenue reflects growing trends in the market favoring its single, integrated, multi-condition digital health platform, its expected runway, the belief that with its strengthened balance sheet and the significantly reduced cash burn, it is well positioned to lead the market for integrated digital health solutions, that its agreement with Amwell represents a substantial opportunity, that its growing list of strategic relationships reflects the value of its platform for health plan and employer clients, that such relationships will enable it to continue to accelerate market penetration and drive revenue growth this year and beyond, the expected timing of its product launches, that the study results will be valuable to its sales efforts for customers seeking to reduce cost and that its B2B is strategically aligned with employer and health plan demand and that it anticipate that it will continue to see strong growth. 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.

Non-GAAP Financial Measures

We have provided in this release financial information that has not been prepared in accordance with Generally Accepted Accounting Principles (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. We use these non-GAAP financial measures internally in analyzing our financial results and believe they are useful to investors, as a supplement to GAAP measures, in evaluating our ongoing operational performance. We believe 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 our 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.

Billings (non-GAAP). We define billings as revenue recognized in accordance with GAAP plus the change in deferred revenue from the beginning to the end of the period and adjustment to the deferred revenue balance due to adoption of the new revenue recognition standard less any deferred revenue balances acquired from business combination(s) during the period. We consider billings to be a useful metric for management and investors because billings drive future revenue, which is an important indicator of the health and viability of our business. There are a number of limitations related to the use of billings instead of GAAP revenue. First, billings include amounts that have not yet been recognized as revenue and are impacted by the term of security and support agreements. Second, we may calculate billings in a manner that is different from peer companies that report similar financial measures. Management accounts for these limitations by providing specific information regarding GAAP revenue and evaluating billings together with GAAP revenue.

Operating expenses (non-GAAP). Our presentation of non-GAAP operating expenses excludes stock-based compensation expenses. Due to varying available valuation methodologies, subjective assumptions, and the variety of equity instruments that can impact a company's non-cash operating expenses, we believe that providing non-GAAP financial measures that exclude non-cash expense provides us with an important tool for financial and operational decision making and for evaluating our own core business operating results over different periods of time.

Net loss (non-GAAP). Our presentation of adjusted net loss excludes the effect of certain items that are non-GAAP financial measures. Adjusted net loss represents net loss determined under GAAP without regard to stock-based compensation expenses, deferred inventory, depreciation of fixed assets, earn-out remeasurement and acquisition related expenses and amortization. We believe these measures provide useful information to management and investors for analysis of our operating results.

DARIOHEALTH CORP. AND ITS SUBSIDIARIES
INTERIM CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands

	March 31,		December 31,
	2023		2022
	Unaudited
ASSETS

CURRENT ASSETS:
Cash and cash equivalents	$	38,789	$	49,357
Short-term investments		4,304		-
Short-term restricted bank deposits		225		165
Trade receivables		2,797		6,416
Inventories		6,877		7,956
Other accounts receivable and prepaid expenses		2,484		1,630

Total current assets		55,476		65,524

NON-CURRENT ASSETS:
Deposits		6		6
Operating lease right of use assets		1,170		1,206
Long-term assets		149		111
Property and equipment, net		765		788
Intangible assets, net		8,803		9,916
Goodwill		41,640		41,640

Total non-current assets		52,533		53,667

Total assets	$	108,009	$	119,191

DARIOHEALTH CORP. AND ITS SUBSIDIARIES
INTERIM CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except stock and stock data)


	March 31,		December 31,
	2023		2022
	Unaudited
LIABILITIES AND STOCKHOLDERS' EQUITY

CURRENT LIABILITIES:
Trade payables	$	1,883	$	2,322
Deferred revenues		925		1,320
Operating lease liabilities		291		293
Other accounts payable and accrued expenses		5,935		6,592
Loan, current		8,583		8,823

Total current liabilities		17,617		19,350

NON-CURRENT LIABILITIES
Operating lease liabilities		751		827
Long-term loan		16,745		18,105
Warrant liability		830		910
Other long-term liabilities		36		—

Total non-current liabilities		18,362		19,842

STOCKHOLDERS' EQUITY
Common stock of $0.0001 par value - Authorized: 160,000,000 shares; Issued and Outstanding: 25,875,295 and 25,724,470 shares at March 31, 2023 and December 31, 2022, respectively		3		3
Preferred stock of $0.0001 par value - Authorized: 5,000,000 shares; Issued and Outstanding: 3,557 and 3,567 shares at March 31, 2023 and December 31, 2022, respectively		*) -		*) -
Additional paid-in capital		370,702		365,846
Accumulated deficit		(298,675)		(285,850)

Total stockholders' equity		72,030		79,999

Total liabilities and stockholders' equity	$	108,009	$	119,191

DARIOHEALTH CORP. AND ITS SUBSIDIARIES
INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S. dollars in thousands (except stock and stock data)

	Three months ended
	March 31,
	2023		2022
	Unaudited
Revenues:
Services	$	5,257	$	4,984
Consumer hardware		1,809		3,075
Total revenues		7,066		8,059

Cost of revenues:
Services		1,477		452
Consumer hardware		1,340		2,689
Amortization of acquired intangible assets		1,081		932
Total cost of revenues		3,898		4,074

Gross profit		3,168		3,985

Operating expenses:
Research and development	$	5,165	$	5,927
Sales and marketing		6,340		9,535
General and administrative		4,071		4,395

Total operating expenses		15,576		19,857

Operating loss		12,408		15,872

Total financial expenses, net		417		44

Net loss	$	12,825	$	15,916

Other comprehensive loss:
Deemed dividend	$	-	$	451

Net loss attributable to shareholders	$	12,825	$	16,367

Net loss per share:

Basic and diluted loss per share of common stock	$	0.45	$	0.74
Weighted average number of common stock used in computing basic and diluted net loss per share		27,570,013		19,624,079

DARIOHEALTH CORP. AND ITS SUBSIDIARIES
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
	Three months ended
	March 31,
	2023		2022
	Unaudited
Cash flows from operating activities:
Net loss	$	(12,825)	$	(15,916)
Adjustments required to reconcile net loss to net cash used in operating activities:
Stock-based compensation, common stock, and payment in stock to directors, employees, consultants, and service providers		4,856		5,343
Depreciation		97		70
Change in operating lease right of use assets		36		7
Amortization of acquired intangible assets		1,113		963
Decrease (increase) in trade receivables		3,619		(3,264)
Increase in other accounts receivable, prepaid expense and long-term assets		(892)		(1,550)
Decrease (increase) in inventories		1,079		(1,555)
Decrease in trade payables		(439)		(890)
Decrease in other accounts payable and accrued expenses		(621)		(721)
Decrease in deferred revenues		(395)		(102)
Change in operating lease liabilities		(78)		(27)
Remeasurement of earn-out		-		(452)
Non-Cash financial income		(307)		-

Net cash used in operating activities		(4,757)		(18,094)

Cash flows from investing activities:
Purchase of property and equipment		(74)		(66)
Purchase of short-term investments		(4,996)		-
Proceeds from redemption of short-term investments		708		-
Cash paid as part of Upright Technologies Ltd. acquisition		-		(115)

Net cash used in investing activities		(4,362)		(181)

Cash flows from financing activities:
Proceeds from issuance of common stock and prefunded warrants (net of issuance costs)		-		38,023
Principal payments on long-term loan		(1,389)		-

Net cash provided by financing activities		(1,389)		38,023

Increase in cash, cash equivalents and restricted cash and cash equivalents		(10,508)		19,748
Cash, cash equivalents and restricted cash and cash equivalents at beginning of period		49,470		35,948
Cash, cash equivalents and restricted cash and cash equivalents at end of period	$	38,962	$	55,696
Supplemental disclosure of cash flow information:
Cash paid during the period for interest on long-term loan	$	1,072	$	-
Non-cash activities:
Right-of-use assets obtained in exchange for lease liabilities	$	28	$	58

Reconciliation of Revenue to Billing (Non-GAAP)
U.S. dollars in thousands

	Three Months Ended March 31,
	2023	2022

GAAP Revenue	7,066	8,059
Add:
Change in deferred revenue	(395)	(102)

Billing (Non-GAAP)	6,671	7,957

Reconciliation of Operating Loss, Net Loss and Operating Expenses to Adjusted
Operating Loss, Net Loss and Operating Expenses (Non-GAAP)
U.S. dollars in thousands

Three months ended March 31, 2023

	GAAP		Stock-Based Compensation Expenses		Amortization of acquisition related expenses and depreciation of fixed assets		Non-GAAP
Cost of Revenues	$	3,898		(27)		(1,112)		2,759
Gross Profit		3,168		27		1,112		4,307

Research and development		5,165		(1,185)		(19)		3,961
Sales and Marketing		6,340		(1,847)		(44)		4,449
General and Administrative		4,071		(1,797)		(35)		2,239
Total Operating Expenses		15,576		(4,829)		(98)		10,649
Operating Loss	$	(12,408)		4,856		1,210		(6,342)
Financing expenses		417		-		-		417
Income Tax		-						-
Net Loss	$	(12,825)		4,856		1,210		(6,759)

Three months ended March 31, 2022

	GAAP		Stock-Based Compensation Expenses		Earn-out remeasurement, amortization of acquisition related expenses and depreciation of fixed assets		Non-GAAP
Cost of Revenues	$	4,074		(23)		(954)		3,097
Gross Profit		3,985		23		954		4,962

Research and development		5,927		(1,488)		(11)		4,428
Sales and Marketing		9,535		(1,651)		(41)		7,843
General and Administrative		4,395		(2,181)		338		2,552
Total Operating Expenses		19,857		(5,320)		286		14,823
Operating Loss	$	(15,872)		5,343		668		(9,861)
Financing income		44		-				44
Income Tax		-
Net Loss	$	(15,916)		5,343		668		(9,905)