UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16

OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of August 2020

 

Commission file number: 001-38775

 

 

ITAMAR MEDICAL LTD.

(Name of registrant)

 

 

9 Halamish Street, Caesarea 3088900, Israel

(Address of principal executive office)

_____________________

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F x Form 40-F ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨

 

 

 

 

 

EXPLANATORY NOTE

 

On August 11, 2020, Itamar Medical Ltd. issued a press release entitled "Itamar Medical Reports Second Quarter 2020 Financial Results", which is attached to this Form 6-K as Exhibit 99.1.

 

 

 

 

Exhibits

 

Exhibit Number Description
99.1 Press Release, August 11, 2020: Itamar Medical Reports Second Quarter 2020 Financial Results.

 

 

 

 

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, thereunto duly authorized.

 

 

 

ITAMAR MEDICAL LTD.

 
     
     
  By: /s/ Shy Basson  
 

 

Shy Basson

 
    Chief Financial Officer  
       
Date: August 11, 2020      

 

 

 

Exhibit 99.1 

 

 

 

 

ITAMAR MEDICAL REPORTS SECOND QUARTER 2020 FINANCIAL RESULTS

 

- Second Quarter Revenues Increase 21% to $8.9 Million -

 

- U.S. WatchPATTM Revenues Increase 31% to $6.6 Million -

 

- Company to Host Conference Call Today at 8:00 am ET, 3:00 pm IT -

 

 

CAESAREA, Israel, August 11, 2020-- Itamar Medical Ltd. (Nasdaq and TASE: ITMR), a medical technology company focused on the development and commercialization of non-invasive medical devices and solutions to aid in the diagnosis of respiratory sleep disorders, today reported unaudited financial results for the second quarter of 2020.

 

“Our second quarter results reflect encouraging growth and we have taken several steps to capitalize on this momentum. The recent traction among both new and existing customers in the context of survey results from 300 centers indicating volumes of 70% Home Sleep Apnea Tests versus volumes of 30% in-lab1 is a testament to the advantage of our home-based and digital care pathway sleep solutions and our ability to reach the large undiagnosed patient population suffering from sleep apnea,” said Gilad Glick, President and Chief Executive Officer of Itamar Medical.

 

“While we are pleased with our solid results, there are still many macro factors that remain fluid as the pandemic unfolds, leading to our cautious near-term outlook as we approach the second half of the year. Nonetheless, this does not change our long-term value proposition or market opportunity,” concluded Glick.

 

Second Quarter 2020 Highlights

 

· Revenues in the second quarter of 2020 were $8.9 million, an increase of 21% year-over-year.

 

· U.S WatchPAT revenues in the second quarter of 2020 were $6.6 million, an increase of 31% year-over-year.

 

Recent Business and Production Updates

 

· Doubled WatchPAT ONE production capacity from approximately 3,000 units per week in May to approximately 6,000 units per week in June to meet the overwhelming demand as seen in our backlog from the first quarter, which, as a result, is now normalized.

 

· Active centers using WatchPAT ONE reached a total of 291 after onboarding over 10 new customers per week on average throughout the second quarter.

 

 

 

1 COVID-19 sleep center impact study. EnsoData. 2020. Available at https://www.ensodata.com/landing-pages/covid-19-sleep-center-impact-study.

 

 

 

 

Second Quarter 2020 Financial Results

 

Revenues for the second quarter of 2020 increased 21% to $8.9 million, compared to $7.4 million in the same quarter in 2019. Revenue growth was driven by an increase in WatchPAT sales in the U.S. and Japan, offset by a decrease in WatchPAT sales in Europe and in the rest of the world.

 

WatchPAT revenues for the second quarter of 2020 increased 20% to $7.9 million, compared to $6.5 million in the same quarter in 2019.

 

U.S. WatchPAT revenues for the second quarter of 2020 increased 31% to $6.6 million, compared to $5.0 million in the same quarter in 2019, driven primarily by WatchPAT ONE sales as well as WatchPAT Direct sales. Sales from disposables and renewable products, including WatchPAT ONE, comprised approximately 78% of WatchPAT revenues in the U.S. in the second quarter of 2020, compared to 65% in the same quarter in 2019.

 

Gross profit for the second quarter of 2020 increased to $6.0 million, compared to $5.7 million in the same quarter in 2019. Gross profit margin for the second quarter of 2020 decreased to 68%, compared to 78% in the same quarter in 2019. Non-IFRS gross profit margin for the second quarter of 2020 decreased to 70%, compared to 79% in the same quarter in 2019) See “Use of Non-IFRS Measures” below(. Gross margin decline was manly driven by the increase in WatchPAT ONE sales.

 

Operating loss for the second quarter of 2020 was $3.2 million, compared to $1.7 million in the same quarter in 2019. The increase in operating loss was primarily attributable to an increase in operating expenses, partially offset by the increase in revenues. Selling and marketing expenses increased 31% to $5.9 million, compared to $4.5 million in the same quarter in 2019, due to the planned expansion of the U.S. sales team into new geographical territories and verticals (32 territories and verticals as of June 30, 2020, compared to 27 territories and verticals as of June 30, 2019), as well as additional sales commissions resulting from the increase in revenues. Research and development expenses increased 22% to 1.4 million, compared to $1.1 million in the same quarter in 2019, driven by an increase in personnel to support product development (including the digital health platform).

 

Non-IFRS operating loss for the second quarter of 2020 was $2.4 million, compared to $0.9 million in the same quarter in 2019. Non-IFRS operating loss excludes approximately $0.8 million in share-based payments; depreciation and amortization of property and equipment and intangible assets; change in provision for doubtful and bad debt; and expenses relating to reduction in manpower, compared to $0.8 million of similar expenses for the same quarter in 2019 (see “Use of Non-IFRS Measures” below).

 

Net loss for the second quarter of 2020 was $3.2 million, compared to $2.0 million in the same quarter in 2019.

 

Non-IFRS net loss for the second quarter of 2020 was $2.4 million, compared to $1.2 million in the same quarter in 2019. Non-IFRS net loss excludes approximately $0.8 million in share-based payments; depreciation and amortization of property and equipment and intangible assets; change in provision for doubtful and bad debt; expenses relating to reduction in manpower; and gain from reevaluation of derivatives, compared to $0.7 million of similar expenses and gains for the same quarter in 2019 (see “Use of Non-IFRS Measures” below).

 

As of June 30, 20, the Company had cash, cash equivalents and a short-term bank deposit of $45.2 million.

 

 

 

 

First Half 2020 Financial Results

 

Revenues for the six months ended June 30, 2020 increased 29% to $17.3 million, compared to $13.4 million for the six months ended June 30, 2019. Revenue growth was driven by an increase in WatchPAT sales in the U.S. and Japan, offset by a decrease in WatchPAT sales in the rest of the world.

 

WatchPAT revenues for the six months ended June 30, 2020 increased 30% to $16.1 million, compared to $12.3 million for the six months ended June 30, 2019.

 

U.S. WatchPAT revenues for the six months ended June 30, 2020 increased 36% to $12.7 million, compared to $9.3 million for the six months ended June 30, 2019. U.S. WatchPAT revenues increase was primarily driven by the increase of WatchPAT ONE as well as WatchPAT Direct sales.

 

Gross profit for the six months ended June 30, 2020 increased to $12.3 million, compared to $10.4 million for the six months ended June 30, 2019. Gross profit margin for the for the six months ended June 30, 2020 was 72%, compared to 77% for the six months ended June 30, 2019. Non-IFRS gross profit margin for six months ended June 30, 2020 decreased to 73%, compared to 79% for the six months ended June 30, 2019 (See “Use of Non-IFRS Measures” below(. Gross margin decline was mainly driven by the increase in WatchPAT ONE sales.

 

Operating loss for the six months ended June 30, 2020 was $5.2 million, compared to $3.0 million for the six months ended June 30, 2019. The increase in operating loss was primarily attributable to an increase in operating expenses, partially offset by the increase in revenues. Selling and marketing expenses increased 36% to $11.2 million, compared to $8.3 million in the first half of 2019, due to the planned expansion of the U.S. sales team into new geographical territories and verticals, as well as additional sales commissions resulting from the increase in revenues. Research and development expenses increased 29% to $2.7 million, compared to $2.1 million in the first half of 2019, driven by an increase in personnel to support product development (including the digital health platform).

 

Non-IFRS operating loss for the six months ended June 30, 2020 was $3.8 million, compared to $1.9 million for the six months ended June 30, 2019. Non-IFRS operating loss excludes approximately $1.4 million in share-based payments; depreciation and amortization of property and equipment and intangible asset; change in provision for doubtful and bad debt; and expenses relating to reduction in manpower, compared to $1.1 million of similar expenses for the six months ended June 30, 2019 (see “Use of Non-IFRS Measures” below).

 

Net loss for the six months ended June 30, 2020 was $5.2 million, compared to $3.1 million for the six months ended June 30, 2019.

 

Non-IFRS net loss for the for the six months ended June 30, 2020 was $3.9 million, compared to $2.4 million for the six months ended June 30, 2019. Non-IFRS net loss excludes approximately $1.3 million in share-based payments; depreciation and amortization of property and equipment and intangible assets; change in provision for doubtful and bad debt; expenses relating to reduction in manpower; and gain from reevaluation of derivatives, compared to $0.7 million of similar expenses and gains for the six months ended June 30, 2019 (see “Use of Non-IFRS Measures” below).

 

 

 

 

Conference Call and Webcast Information

 

The Company will host a conference call today at 8:00 a.m. Eastern Time, 3:00 p.m. Israel Time to review financial results and provide a corporate update.

 

To listen live via webcast, please visit https://www.itamar-medical.com/, or by clicking here.

 

To participate via phone, please use the dial in information:

U.S. toll-free: 833-519-1272
International: 914-800-3844
Israel toll-free: 1-809-315-362

Conference ID: 8798951

 

Please log in approximately 10 minutes prior to the scheduled start time. An archived webcast also will be provided in the Events and Presentations section of the Company’s website.

 

Use of Non-IFRS Measures

 

In addition to disclosing financial results prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board (IASB), this press release contains Non-IFRS financial measures for operating loss and net loss, which are adjusted from results based on IFRS to exclude: (i) share-based payments; (ii) depreciation and amortization of property and equipment and intangible assets; (iii) change in provision for doubtful and bad debt; (iv) expenses relating to reduction in manpower; and (v) gain from reevaluation of derivatives. Management believes that the Non-IFRS financial measures provided in this press release are useful to investors’ understanding and assessment of the Company’s performance. Management uses both IFRS and Non-IFRS measures when operating and evaluating the Company’s business internally and therefore decided to make these Non-IFRS adjustments available to investors. The presentation of this Non-IFRS financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with IFRS. For further details, see a reconciliation of operating loss and net loss on an IFRS basis to a Non-IFRS basis that is provided in the table that accompanies this press release.

 

About Itamar Medical Ltd.

 

Itamar Medical is a medical technology company focused on the development and commercialization of non-invasive medical devices and solutions to aid in the diagnosis of respiratory sleep disorders. Itamar Medical commercializes a digital healthcare platform to facilitate the continuum of care for effective sleep apnea management with a focus on the core sleep, cardiology and direct to consumer markets. Itamar Medical offers a Total Sleep Solution to help physicians provide comprehensive sleep apnea management in a variety of clinical environments to optimize patient care and reduce healthcare system costs. The Company’s key product, WatchPAT, is commercially available within major markets including the U.S., Japan and Europe. Itamar Medical is a public company traded on the Nasdaq and on the Tel Aviv Stock Exchanges, and is based in Caesarea, Israel with U.S. headquarters based in Atlanta, GA. For additional information visit www.itamar-medical.com.

 

 

 

 

Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Statements preceded by, followed by, or that otherwise include the words "believes", "expects", "anticipates", "intends", "estimates", "plans", and similar expressions or future or conditional verbs such as "will", "should", "would", "may" and "could" are generally forward-looking in nature and not historical facts. For example, when we discuss the momentum gained by our business we are using forward-looking statements. Because such statements deal with future events, they are subject to various risks, uncertainties and assumptions, including events and circumstances out of Itamar Medical's control and actual results, expressed or implied by such forward-looking statements, could differ materially from Itamar Medical's current expectations. Factors that could cause or contribute to such differences include, but are not limited to, risks, uncertainties and assumptions discussed from time to time by Itamar Medical in reports filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC) and the Israel Securities Authority (ISA), including the Company’s latest Annual Report on Form 20-F, which is on file with the SEC (accessible at www.sec.gov) and the ISA. Except as otherwise required by law, Itamar Medical undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

 

 

Company Contact

Itamar Medical Ltd.

Shy Basson

Chief Financial Officer

Phone: +972-4-617-7700

bshy@itamar-medical.com

 

Itamar Medical Investor Relations Contact (U.S.)

Leigh Salvo or Caroline Paul

Gilmartin Group

Phone: +1-415-937-5412

investors@itamar-medical.com

 

 

 

* The contents of any website or hyperlinks mentioned in this press release are for informational purposes and the contents thereof are not part of this press release.

 

 

 

 

ITAMAR MEDICAL LTD.

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(Unaudited)

 

   

June 30,

2020

   

December 31,

2019

 
    U.S. dollars in thousands  
Assets                
Current assets                
Cash and cash equivalents   $ 37,666     $ 15,115  
Short-term bank deposit     7,500       -  
Trade receivables     7,662       8,384  
Other receivables     2,015       1,404  
Inventories     4,727       3,363  
Total current assets     59,570       28,266  
                 
Non-current assets                
Long-term restricted deposits and prepaid expenses     519       476  
Long-term trade receivables     263       156  
Property and equipment     1,924       1,472  
Intangible assets     687       395  
Right-of-use assets     1,961       2,442  
Total non-current assets     5,354       4,941  
Total assets   $ 64,924     $ 33,207  
                 
Liabilities                
Current liabilities                
Short-term bank loan   $ 5,000     $ 5,000  
Current maturities of lease liabilities     883       890  
Trade payables     2,646       2,028  
Other accounts payable     3,248       3,455  
Accrued expenses     1,119       1,317  
Provisions     334       273  
Short-term employee benefits     593       352  
Total current liabilities     13,823       13,315  
                 
Non-current liabilities                
Lease liabilities, net of current maturities     1,253       1,708  
Recognized liability for defined benefit plan, net     203       260  
Other long-term liabilities     1,262       1,260  
Total non-current liabilities     2,718       3,228  
Total liabilities     16,541       16,543  
                 
Equity                
Ordinary share capital     1,133       878  
Additional paid-in capital     161,407       125,435  
Accumulated deficit     (114,157 )     (109,649 )
Total equity     48,383       16,664  
Total liabilities and equity   $ 64,924     $ 33,207  

 

 

 

 

 

ITAMAR MEDICAL LTD.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

   

Three Months Ended

June 30,

   

Six Months Ended

June 30,

 
    2020     2019     2020     2019  
    U.S. dollars in thousands (except per share and ADS data)  
                         
Revenues   $ 8,885     $ 7,353     $ 17,263     $ 13,409  
Cost of revenues     2,869       1,627       4,919       3,029  
Gross profit     6,016       5,726       12,344       10,380  
Selling and marketing expenses     5,943       4,546       11,206       8,268  
Research and development expenses     1,377       1,130       2,679       2,070  
General and administrative expenses     1,914       1,793       3,634       3,080  
Total operating expenses     9,234       7,469       17,519       13,418  
Operating loss     (3,218 )     (1,743 )     (5,175 )     (3,038 )
Financial income (expenses):                                
Financial income     152       101       387       193  
Financial expenses     (166 )     (298 )     (400 )     (596 )
Gain from derivatives instruments, net     -       78       -       442  
Financial income (expenses), net     (14 )     (119 )     (13 )     39  
Loss before taxes on income     (3,232 )     (1,862 )     (5,188 )     (2,999 )
Taxes on income     (10 )     (96 )     (52 )     (123 )
Net loss   $ (3,242 )   $ (1,958 )   $ (5,240 )   $ (3,122 )
                                 
Loss per share – basic and diluted (in U.S. dollars)   $ (0.01 )   $ (0.01 )   $ (0.01 )   $ (0.01 )
                                 
Weighted average number of shares used in computation of loss per shares (in thousands):                                
Basic     423,137       333,951       406,624       331,087  
Diluted     423,137       335,149       406,624       331,087  
                                 
Loss per ADS – basic and diluted (in U.S. dollars)   $ (0.23 )   $ (0.18 )   $ (0.39 )   $ (0.28 )
                                 
Weighted average number of ADSs used in computation of loss per ADS (in thousands):                                
Basic     14,105       11,132       13,554       11,036  
Diluted     14,105       11,172       13,554       11,036  

 

 

 

 

ITAMAR MEDICAL LTD.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   

Three Months Ended

June 30,

   

Six Months Ended

June 30,

 
    2020     2019     2020     2019  
    U.S. dollars in thousands  
Cash flows from operating activities                        
Net loss   $ (3,242 )   $ (1,958 )   $ (5,240 )   $ (3,122 )
Adjustments for:                                
Depreciation and amortization     479       343       889       674  
Share-based payment     309       355       671       531  
Change in provision for doubtful and bad debt     126       207       158       194  
Net financial cost (income)     (102 )     148       (199 )     172  
Gain from reevaluation of derivatives     -       (78 )     -       (442 )
Decrease (increase) in trade receivables     (728 )     (251 )     456       (59 )
Increase in other accounts receivable     (832 )     (318 )     (604 )     (190 )
Increase in inventories     (1,054 )     (247 )     (1,815 )     (520 )
Increase in trade payables     151       147       580       525  
Increase (decrease) in other accounts payable and accrued expenses     866       78       (426 )     314  
Increase in employee benefits     166       39       245       129  
Increase in provisions     10       3       61       7  
Income tax expenses     10       96       52       123  
Taxes paid during the period     (29 )     (17 )     (30 )     (44 )
Net interest received (paid) during the period     127       (166 )     53       (174 )
Net cash used in operating activities     (3,743 )     (1,619 )     (5,149 )     (1,882 )
Cash flows from investing activities                                
Investment in short-term bank deposits     (7,500 )     (9,000 )     (7,500 )     (9,000 )
Investment in restricted long-term deposits     (50 )     -       (50 )     -  
Purchase of property and equipment, intangible assets and capitalization of development expenditure     (478 )     (116 )     (709 )     (262 )
Net cash used in investing activities     (8,028 )     (9,116 )     (8,259 )     (9,262 )
Cash flows from financing activities                                
Proceeds from issuance of shares, net of share issuance costs (share issuance costs)     (876 )     -       36,185       13,968  
Repayment of principal of lease liabilities     (220 )     (215 )     (445 )     (439 )
Issuance of shares due to the exercise of stock options     81       14       81       25  
Net cash provided by (used in) financing activities     (1,015 )     (201 )     35,821       13,554  
Increase (decrease) in cash and cash equivalents     (12,786 )     (10,936 )     22,413       2,410  
Cash and cash equivalents at beginning of period     50,442       19,887       15,115       6,471  
Effect of exchange rate fluctuations on balances of cash and cash equivalents     10       65       138       135  
Cash and cash equivalent balance at end of period   $ 37,666     $ 9,016     $ 37,666     $ 9,016  
Non-cash financing activity- share issuance costs   $ 38     $ -     $ 38     $ -  
                                 

 

 

 

 

ITAMAR MEDICAL LTD.

RECONCILIATIONS OF IFRS TO NON-IFRS FINANCIAL MEASURES

(Unaudited)

 

   

Three Months Ended

June 30,

   

Six Months Ended

June 30,

 
    2020     2019     2020     2019  
    U.S. dollars in thousands (except per share and ADS data)  
                         
IFRS operating loss   $ (3,218 )   $ (1,743 )   $ (5,175 )   $ (3,038 )
IFRS net loss   $ (3,242 )   $ (1,958 )   $ (5,240 )   $ (3,122 )
                                 
Cost of revenues:                                
Share-based payment     5       2       7       4  
Depreciation and amortization of property and equipment and intangible assets     162       90       264       169  
Expenses relating to reduction of manpower     27       -       27       -  
      194       92       298       173  
Operating expenses:                                
Selling and marketing:                                
Share-based payment     80       169       199       168  
Depreciation and amortization of property and equipment and intangible assets     37       30       68       59  
Expenses relating to reduction of manpower     63       -       63       -  
      180       199       330       227  
Research and development:                                
Share-based payment     71       25       142       54  
Depreciation and amortization of property and equipment and intangible assets     31       16       50       28  
Expenses relating to reduction of manpower     18       115       18       115  
      120       156       210       197  
General and administrative:                                
Share-based payment     147       153       310       293  
Depreciation and amortization of property and equipment and intangible assets     18       14       34       26  
Change in provision for doubtful and bad debt     126       207       158       194  
Expenses relating to reduction of manpower     9       -       9       -  
      300       374       511       513  
Financial income (expenses), net:                                
Share-based payment     6       6       13       12  
Gain from reevaluation of derivatives     -       (78 )     -       (442 )
      6       (72 )     13       (430 )
                                 
Non-IFRS operating loss   $ (2,424 )   $ (922 )   $ (3,826 )   $ (1,928 )
Non-IFRS net loss   $ (2,442 )   $ (1,209 )   $ (3,878 )   $ (2,442 )
                                 
IFRS loss per ADS – basic and diluted (in U.S. dollars)   $ (0.23 )   $ (0.18 )   $ (0.39 )   $ (0.28 )
Non-IFRS loss per ADS – basic and diluted (in U.S. dollars)   $ (0.17 )   $ (0.11 )   $ (0.29 )   $ (0.22 )