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 May 2019

 

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 May 21, 2019, Itamar Medical Ltd. issued a press release entitled "Itamar Medical Reports First Quarter 2019 Financial Results", which is attached to this Form 6-K as Exhibit 99.1.

 

 

 

 

Exhibits

 

Exhibit
Number
  Description
99.1   Press Release, March 21, 2019: Itamar Medical Reports First Quarter 2019 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: May 21, 2019

 

 

Exhibit 99.1

 

 

  

ITAMAR MEDICAL REPORTS FIRST QUARTER 2019 FINANCIAL RESULTS

 

- WatchPAT™ Revenues Increase 15% to $5.8 Million -

 

-U.S. WatchPAT Revenues Increase 34% to $4.3 Million –

 

- Total Revenues Increase 11% to $6.1 Million -

 

 

CAESAREA, Israel, May 21, 2019 -- Itamar Medical Ltd. (Nasdaq & TASE: ITMR), a company that develops, manufactures and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, today reported unaudited financial results for the first quarter of 2019.

 

“We are pleased that the investment in our U.S. sales and marketing organization is showing initial results with U.S. WatchPAT revenue growing by 34% in the first quarter of this year,” said Gilad Glick, President and Chief Executive Officer of Itamar Medical. “Cardiologists are seeing the benefits that our WatchPAT technology provides in addressing critical clinical needs at a time when sleep apnea is reaching epidemic proportions. We continue to expand our sales force in order to ensure the highest level of customer support and enhance our ability to further penetrate our target markets – especially the U.S. cardiology market - going forward.”

 

First Quarter 2019 Highlights and Recent Events

 

· Total revenues for the first quarter of 2019 increased by 10.7% to $6.1 million, compared with $5.5 million for the same quarter last year

 

· WatchPAT revenues for the first quarter of 2019 increased by 14.8% to $5.8 million, compared with $5.1 million for the same quarter last year

 

· U.S. WatchPAT revenues for the first quarter of 2019 increased by 34.2% to $4.3 million, compared with $3.2 million for the same quarter last year

 

· Itamar Medical ADSs commenced trading on Nasdaq under the ticker symbol "ITMR" in February 2019

 

· Launched WatchPAT300, the latest WatchPAT innovation for home sleep apnea testing in April 2019 which improve both performance and cost structure

 

· Signed a data sharing agreement with ResMed Corp. in May 2019 to add their CPAP compliance data to Philips Respironics data to bring the SleePath™ Dashboard to cover the vast majority of the devices in the market

 

 

First Quarter 2019 Financial Results

 

Revenues for the first quarter of 2019 increased by 10.7% to $6.1 million, compared to $5.5 million in the same quarter in 2018. Revenue growth was mainly due to an increase in U.S. WatchPAT sales and offset due to sales seasonality in Japan.

 

U.S. WatchPAT revenues for the first quarter of 2019 increased by 34.2% to $4.3 million, compared to $3.2 million in the same quarter in 2018. Sales from disposables and renewable products were approximately 65% of WatchPAT revenues in the U.S. in the first quarter of 2019, similar to the first quarter of 2018.

  

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WatchPAT revenues for the first quarter of 2019 increased by 14.8% to $5.8 million, compared to $5.1 million in the same quarter in 2018.

 

Gross profit for the first quarter of 2019 increased to $4.7 million, compared to $4.2 million in the same quarter in 2018. Gross profit margin for both the first quarter of 2019 and 2018 was approximately 77% of total revenues.

 

Operating loss for the first quarter of 2019 was $1.3 million, compared to $0.9 million in the same period in 2018. The increase in operating loss was mainly due to an increase of $0.9 million in selling and marketing expenses as a result of an increase in employee-related costs, primarily related to the expansion of the of the U.S. sale team into new geographical territories, partially offset by the increase in revenues.

 

Non-IFRS operating loss for the first quarter of 2019 was $1.0 million, compared to $0.5 million in the same quarter in 2018. Non-IFRS operating loss excludes approximately $0.3 million in share-based payments; depreciation and amortization of property and equipment and intangible assets; and change in provision for doubtful and bad debt, compared to $0.4 million of similar expenses for the same quarter in 2018 (see “Use of Non-IFRS Measures” below).

 

Net loss for the first quarter of 2019 was $1.2 million, compared to net income of $0.1 million in the same quarter in 2018.

 

Non-IFRS net loss for the first quarter of 2019 was $1.2 million, compared to $0.9 million in the same quarter in 2018. Non-IFRS net loss excludes approximately $0.1 million in share-based payments; depreciation and amortization of property and equipment and intangible assets; change in provision for doubtful and bad debt; and gain from reevaluation of derivatives, compared to $1.0 million of similar expenses for the same quarter in 2018 (see “Use of Non-IFRS Measures” below).

 

As of March 31, 2019, the Company had cash and cash equivalents of $19.9 million. This amount includes the proceeds from the private placement completed in March 2019 of $14.0 million, net of share issuance costs.

 

 

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; and (iv) loss (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 engaged in research, development, sales and marketing of non-invasive medical devices for the diagnosis of respiratory sleep disorders with a focus on the cardiology market. The Company 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 costs. Its flagship PAT-based product, the WatchPAT™ device, is a home-use diagnostic device for sleep breathing disorders. It also offers the EndoPAT™ system, an FDA-approved device to test endothelial dysfunction and to evaluate the risk of heart disease and other cardiovascular diseases. 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

  

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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 our ability to further penetrate our target markets, 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 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

 

Investor Relations Contact (U.S.)

Lazar Partners Ltd.

David Carey

Phone: 212-867-1762

dcarey@lazarpartners.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.

 

 

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ITAMAR MEDICAL LTD.

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(Unaudited)

 

 

   

March 31,

2019

   

December 31,

2018

 
    U.S. dollars in thousands  
Assets                
Current assets                
Cash and cash equivalents   $ 19,887     $ 6 ,471  
Trade receivables     6,366       6,549  
Other receivables     877       1,018  
Inventories     2,426       2,235  
Total current assets     29,556       16,273  
                 
Non-current assets                
Long-term restricted deposits and prepaid expenses     385       365  
Long-term trade receivables     247       243  
Property and equipment     1,243       1,213  
Right-of-use assets     1,732       -  
Intangible assets     338       298  
Total non-current assets     3,945       2,119  
Total assets   $ 33,501     $ 18,392  
                 
Liabilities                
Current liabilities                
Trade payables   $ 1,869     $ 1,517  
Short-term employee benefits     302       222  
Current maturities of lease liabilities     765       -  
Short-term bank loan     5,000       5,000  
Provisions     219       215  
Accrued expenses     1,258       1,034  
Other accounts payable     2,075       2,063  
Total current liabilities     11,488       10,051  
                 
Non-current liabilities                
Lease liabilities     1,016       -  
Derivative instruments     78       442  
Long-term employee benefits     169       159  
Other long-term liabilities     1,071       1,052  
Total non-current liabilities     2,334       1,653  
Total liabilities     13,822       11,704  
                 
Commitments                
                 
Equity                
Ordinary share capital     874       748  
Additional paid-in capital     125,338       111,486  
Accumulated deficit     (106,533 )     (105,546 )
Total equity     19,679       6,688  
Total liabilities and equity   $ 33,501     $ 18,392  

  

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ITAMAR MEDICAL LTD.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

   

Three Months Ended

March 31,

 
    2019     2018  
   

U.S. dollars in thousands (except

per share data)

 
             
Revenues   $ 6,056     $ 5,470  
Cost of revenues     1,402       1,249  
Gross profit     4,654       4,221  
                 
Selling and marketing expenses     3,722       2,809  
Research and development expenses     940       983  
General and administrative expenses     1,287       1,313  
Total operating expenses     5,949       5,105  
Operating loss     (1,295 )     (884 )
                 
Financial income from cash and investments     92       210  
Financial expenses from leases, notes and loans     (298 )     (578 )
Gain from derivatives instruments, net     364       1,400  
Financial income, net     158       1,032  
Income (loss) before taxes on income     (1,137 )     148  
Taxes on income     (27 )     (36 )
Net income (loss)   $ (1,164 )   $ 112  
                 
Earnings (loss) per share (in U.S. dollars):                
Basic   $ (0.00 )   $ 0.00  
Diluted   $ (0.00 )   $ 0.00  

  

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ITAMAR MEDICAL LTD.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   

Three Months Ended

March 31,

 
    2019     2018  
    U.S. dollars in thousands  
Cash flows from operating activities                
Net income (loss)   $ (1,164 )   $ 112  
Adjustments for:                
Depreciation and amortization     331       115  
Share-based payment     176       240  
Change in provision for doubtful and bad debt     (13 )     2  
Net financial cost     24       389  
Gain from reevaluation of derivatives     (364 )     (1,400 )
Decrease (increase) in trade receivables     192       (410 )
Decrease in other accounts receivable     128       30  
Increase in inventories     (273 )     (387 )
Increase in trade payables     378       269  
Increase (decrease) in other accounts payable and accrued expenses     236       (227 )
Increase in employee benefits     90       79  
Increase in provisions     4       2  
Income tax expenses     27       36  
Taxes paid during the period     (27 )     (4 )
Net interest paid during the period     (8 )     (473 )
Net cash used in operating activities     (263 )     (1,627 )
                 

Cash flows from investing activities

               
Sale of marketable securities     -       3,109  
Purchase of property and equipment, intangible assets and capitalization of development expenditure     (146 )     (27 )
Net cash provided by (used in) investing activities     (146 )     3,082  
                 
Cash flow from financing activities                
Proceeds from issuance of shares, net of share issuance costs     13,968       -  
Short-term bank credit     -       5,000  
Principle element of lease payments     (224 )     -  
Repayment of convertible notes     -       (9,939 )
Issuance of shares due to the exercise of stock options     11       25  
Net cash provided by (used in) financing activities     13,755       (4,914 )
Increase (decrease) in cash and cash equivalents     13,346       (3,459 )
Cash and cash equivalents at beginning of period     6,471       7,643  
Effect of exchange rate fluctuations on balances of cash and cash equivalents     70       80  
Cash and cash equivalent balance at end of period   $ 19,887     $ 4,264  
Non-cash financing activity- conversion of notes to a loan from related parties   $ -     $ 1,076  

   

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ITAMAR MEDICAL LTD.

RECONCILIATIONS OF IFRS TO NON-IFRS FINANCIAL MEASURES

(Unaudited)

  

    Three Months Ended
March 31,
 
    2019     2018  
    U.S. dollars in thousands  
             
IFRS operating loss   $ (1,295 )   $ (884 )
Share-based payment     170       240  
Depreciation and amortization of property and equipment and intangible assets     132       115  
Change in provision for doubtful and bad debt     (13 )     2  
Non-IFRS operating loss   $ (1,006 )   $ (527 )
                 
IFRS net income (loss)   $ (1,164 )   $ 112  
Share-based payment     176       240  
Depreciation and amortization of property and equipment and intangible assets     132       115  
Change in provision for doubtful and bad debt     (13 )     2  
Gain from reevaluation of derivatives     (364 )     (1,400 )
Non-IFRS net loss   $ (1,233 )   $ (931 )

  

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