Myomo Reports Second Quarter 2019 Results

5 years ago

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Record Quarterly Revenues and 28% Sequential Expansion of Reimbursement Pipeline Myomo, Inc. (NYSE American: MYO) (“Myomo” or the “Company”), a wearable medical robotics company that offers increased functionality for those suffering from neurological disorders and upper limb paralysis, today announced its financial results for the second quarter ended June 30, 2019. Recent Highlights and Accomplishments:
  • Revenues for the second quarter 2019 of approximately $880,000 increased by 39% versus the comparable period of 2018, and Year-to-Date revenues of approximately $1,710,000 increased by 81% over the comparable period in 2018. Gross margin for the quarter was 72%, compared to 68% in the second quarter of 2018.
  • The Company’s reimbursement pipeline contained 453 MyoPro units as of June 30, 2019, up 28% from 354 units at the end of the first quarter 2019 as the Company expanded its direct-to-patient marketing efforts.
  • The Company is now obtaining reimbursements from the largest provider of Medicare Advantage insurance policies in the U.S.
  • The Company expanded its international distribution network and received the first orders from O&P providers in Germany, Denmark, and Chile.
“We continue to see strong demand from patients and successful reimbursements for the MyoPro product line, which have resulted in quarterly revenue growth and an increasing backlog of insurance approvals and orders that will convert into revenue in the coming months. The online marketing, screening days, and broader geographic coverage – in the US and several overseas markets – is also working to build up the pipeline of future orders,” said Paul R. Gudonis, Chairman and CEO of Myomo. “A year ago, we had 92 MyoPro units in the reimbursement process; a year later that number has climbed to 453, a nearly 5-fold increase which we continue to expect will lead to significant revenue growth in 2019.” Financial Results
    For the Three Months Ended June 30,     Period-to-Period Change     For the Six Months Ended June 30,     Period-to-Period Change  
    2019     2018     $     %     2019     2018     $     %  
Revenue   $ 880,349     $ 632,369     $ 247,980       39 %   $ 1,710,415     $ 945,548     $ 764,867       81 %
Cost of revenue     250,676       200,446       50,230       25 %     426,863       308,526       118,337       38 %
Gross margin   $ 629,673     $ 431,923     $ 197,750       46 %   $ 1,283,552     $ 637,022     $ 646,530       101 %
Gross margin%     72 %     68 %             4 %     75 %     67 %             8 %
 
Total revenue in the second quarter 2019 was approximately $880,000, an increase of 39%, versus the comparable period of 2018. Total revenue for the six months ended June 30, 2019 was approximately $1,710,000, an increase of 81%, versus the comparable period of 2018. Our results for the three and six months ended June 30, 2019, included higher unit volumes, offset by lower average selling prices due in part to higher sales to distributors. Gross margin was 72% and 68% for the quarter ended June 30, 2019 and 2018. Gross margin was 75% and 67% for the six months ended June 30, 2019 and 2018. Operating expenses were approximately $3,336,000, an increase of $222,000, or 7%, during the three months ended June 30, 2019, versus the comparable period of 2018. Operating expenses were approximately $6,673,000, an increase of $951,000, or 17%, during the six months ended June 30, 2019. The increases in our operating expenses primarily reflect higher compensation costs associated with the addition of personnel, marketing and product development efforts, and increased spending to secure reimbursement. The Company’s net loss for the quarter ended June 30, 2019 was approximately $2,565,000, or ($0.15) per share, compared with a net loss of approximately $2,630,000, or ($0.21) per share for the corresponding period of 2018. Net loss for the six months ended June 30, 2019 was approximately $5,163,000, or ($0.32) per share, compared with a net loss of approximately $4,975,000 or ($0.41) per share for the corresponding period of 2018. Adjusted EBITDA1 for the quarter ended June 30, 2019 was a loss of approximately $2,486,000, compared with a loss of approximately $2,512,000 for the corresponding period in 2018. Adjusted EBITDA for the six months ended June 30, 2019 was a loss of approximately $4,751,000, compared with a loss of approximately $4,564,000 for the corresponding period of 2018. A reconciliation of GAAP net loss to this non-GAAP financial measure has been provided in the financial statement tables included in this press release. An explanation of this measure is also included below under the heading “Non-GAAP Financial Measures.” Liquidity Cash on hand at June 30, 2019 was approximately $6,669,000. Cash burn in the second quarter slowed to $2.6 million, compared to $3.0 million in the first quarter of 2019. Conference Call and Webcast Information Myomo will hold a conference call today, August 8, 2019 at 4:30 p.m. EDT. To access the conference call, please dial 1-877-270-2148 from the U.S. or 1-412-902-6510 internationally. Our webcast can also be accessed through Myomo’s Investor Relations page. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. A replay of the conference call will be available approximately one hour after completion of the live conference call at the Investor Relations page. A dial-in replay of the call will be available until August 22, 2019; please dial 1-877-344-7529 from the U.S. or 1-412-317-0088 internationally and provide the passcode of 10133890. About Myomo Myomo, Inc. is a wearable medical robotics company that offers expanded mobility for those suffering from neurological disorders and upper limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper limb orthosis designed to support the arm and restore function to the weakened or paralyzed arms of patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS or other neuromuscular disease or injury. It is currently the only marketed device that, sensing a patient’s own EMG signals through non-invasive sensors on the arm, can restore an individual’s ability to perform activities of daily living, including feeding themselves, carrying objects and doing household tasks. Many are able to return to work, live independently and reduce their cost of care. Myomo is headquartered in Cambridge, Massachusetts, with sales and clinical professionals across the U.S. For more information, please visit www.myomo.com. _____________ Adjusted EBITDA is earnings before interest, taxes, depreciation and amortization adjusted for stock based-compensation and the impact of the fair value revaluation of our derivative liabilities. Forward Looking Statements This press release contains forward-looking statements regarding the Company’s future business expectations, including the receipt of revenues from units being processed for insurance reimbursement, the scale-up and expansion of commercial operations, our expectations for revenues and our results of operations, and the potential benefits to users of our products, our financial position and cash runway, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors. These factors include, among other things:
  • our sales and commercialization efforts;
  • our ability to achieve reimbursement from third-party payers for our products;
  • our dependence upon external sources for the financing of our operations;
  • our ability to effectively execute our business plan; and
  • our expectations as to our clinical research program and clinical results.
More information about these and other factors that potentially could affect our financial results is included in Myomo’s filings with the Securities and Exchange Commission, including those contained in the risk factors section of the Company’s annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. Although the forward-looking statements in this release of financial information are based on our beliefs, assumptions and expectations, taking into account all information currently available to us, we cannot guarantee future transactions, results, performance, achievements or outcomes. No assurance can be made to any investor by anyone that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be material and adverse. The Company disclaims any obligation subsequently to revise any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events. Non-GAAP Financial Measures Myomo has provided in this release of financial information that has not been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. This information includes Adjusted EBITDA. This non-GAAP financial measure is not in accordance with, or an alternative for, GAAP and may be different from similar non-GAAP financial measures used by other companies. Myomo believes that the use of this non-GAAP financial measures provides supplementary information for investors to use in evaluating operating performance and in comparing its financial measures with other companies in Myomo’s industry, many of which present similar non-GAAP financial measures. Adjusted EBITDA is EBITDA adjusted for stock based-compensation and the impact of the fair value revaluation of our derivative liabilities. Non-GAAP financial measures that Myomo uses may differ from measures that other companies may use. This non-GAAP financial measure disclosed by Myomo is not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP, and should be viewed in conjunction with, GAAP financial measures. Investors are encouraged to review the reconciliation of this non-GAAP measure to its most directly comparable GAAP financial measure. A reconciliation of GAAP to the non-GAAP financial measures has been provided in the tables included as part of this press release.
 
MYOMO, INC. CONDENSED STATEMENTS OF OPERATIONS (unaudited)
 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2019     2018     2019     2018  
Revenue   $ 880,349     $ 632,369     $ 1,710,415     $ 945,548  
Cost of revenue     250,676       200,446       426,863       308,526  
Gross margin     629,673       431,923       1,283,552       637,022  
Operating expenses:                                
Research and development     535,898       486,982       1,071,152       859,341  
Selling, general and administrative     2,800,119       2,627,005       5,601,540       4,862,642  
      3,336,017       3,113,987       6,672,692       5,721,983  
                                 
Loss from operations     (2,706,344 )     (2,682,064 )     (5,389,140 )     (5,084,961 )
                                 
Other expense (income)                                
Change in fair value of derivative liabilities     (99,449 )     (2,661 )     (141,420 )     (17,968 )
Interest income and other expense, net     (41,568 )     (49,842 )     (84,333 )     (92,030 )
      (141,017 )     (52,503 )     (225,753 )     (109,998 )
                                 
Net loss   $ (2,565,327 )   $ (2,629,561 )   $ (5,163,387 )   $ (4,974,963 )
Weighted average number of common shares outstanding:                                
Basic and diluted     17,105,527       12,407,758       16,033,584       12,155,600  
Net loss per share                                
Basic and diluted   $ (0.15 )   $ (0.21 )   $ (0.32 )   $ (0.41 )
 
MYOMO, INC. CONDENSED BALANCE SHEETS
 
    June 30,     December 31,  
    2019     2018  
    (unaudited)          
ASSETS                
Current Assets:                
Cash and cash equivalents   $ 6,668,871     $ 6,540,794  
Accounts receivable, net     331,013       382,258  
Inventories, net     349,196       256,149  
Prepaid expenses and other     817,478       695,276  
Total Current Assets     8,166,558       7,874,477  
Restricted cash     75,000       75,000  
Deferred offering costs     108,402       144,582  
Equipment, net     192,574       187,513  
Total Assets   $ 8,542,534     $ 8,281,572  
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:                
Accounts payable and other accrued expenses   $ 1,376,878     $ 1,743,427  
Derivative liabilities     58,477       3,661  
Deferred revenue     570       1,990  
Customer advance payments     40       106,609  
Total Current Liabilities     1,435,965       1,855,687  
Non-Current Liabilities            
Total Liabilities     1,435,965       1,855,687  
Commitments and Contingencies                
Stockholders’ Equity:                
Common stock     1,713       1,245  
Additional paid-in capital     57,687,680       51,720,630  
Accumulated deficit     (50,576,360 )     (45,289,526 )
Treasury stock, at cost     (6,464 )     (6,464 )
Total Stockholders’ Equity     7,106,569       6,425,885  
Total Liabilities and Stockholders’ Equity   $ 8,542,534     $ 8,281,572  
 
MYOMO, INC. CONDENSED STATEMENTS OF CASH FLOWS (unaudited)
 
For the six months ended June 30,   2019   2018
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $   (5,163,387 ) $   (4,974,963 )
Adjustments to reconcile net loss to net cash used in operations:
Depreciation   45,076     28,900  
Stock-based compensation 593,353   492,080  
Excess and obsolete inventory reserve 28,887  
Change in fair value of derivative liabilities (141,420 ) (17,968 )
Loss on disposal of asset 2,481  
Other non-cash charges 12,606  
Changes in operating assets and liabilities:    
Accounts receivable 51,245   (87,912 )
Inventories   (195,397 )   (109,498 )
Prepaid expenses and other (161,014 ) (74,507 )
Other assets 23,574  
Accounts payable and other accrued expenses   (366,549 )   122,099  
Deferred revenue   (1,420 )   (17,466 )
Other current liabilities (106,569 )
NET CASH USED IN OPERATING ACTIVITIES   (5,407,421 )   (4,610,348 )
NET CASH USED IN INVESTING ACTIVITIES (34,903 ) (81,457 )
NET CASH PROVIDED BY FINANCING ACTIVITIES   5,570,401     3,439,161  
 
Net (decrease) increase in cash, cash equivalents and restricted cash   128,077     (1,252,644 )
 
Cash, cash equivalents and restricted cash, beginning of period   6,615,794     13,011,373  
   
Cash, cash equivalents and restricted cash, end of period $   6,743,871   $   11,758,729  
 
MYOMO, INC. RECONCILIATION OF GAAP NET LOSS TO ADJUSTED EBITDA (unaudited)
 
 
    Three months ended   Six months ended
    June 30,   June 30,
      2019         2018       2019         2018  
GAAP net loss   $   (2,565,327 )     $   (2,629,561 )   $   (5,163,387 )     $   (4,974,963 )
Adjustments to reconcile to Adjusted EBITDA:                            
Interest (income) expense     (41,568 )       (49,842 )     (84,333 )       (92,030 )
Depreciation expense     23,449         14,301       45,076         28,900  
Stock-based compensation     197,028         155,724       593,353         492,080  
Change in fair value of derivative liabilities     (99,449 )       (2,661 )     (141,420 )       (17,968 )
Adjusted EBITDA   $   (2,485,867 )     $   (2,512,039 )   $   (4,750,711 )     $   (4,563,981 )
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