Myomo Reports First Quarter 2023 Financial Results Featuring 20% Year Over Year Increase in Product Revenue
Implementation of virtual waiting room technology enabled a record 438 patients added to the pipeline, up
Advertising efficiencies resulted in cost per pipeline add of
Conference call begins at 4:30 p.m. Eastern time today
Financial and operational highlights for the first quarter of 2023 include the following:
-
Product revenue was
, up$3.4 million 20% compared with the prior year quarter. Total revenue decreased11% due to a partial joint venture license fee payment a year ago; -
Revenue units were 80, up
13% compared with the prior year quarter; -
MyoPro® orders and insurance authorizations were received for 122 patients, up
30% compared with the prior year quarter; -
Backlog, which represents insurance authorizations and orders received but not yet converted to revenue, was 176 units, up
10% over the prior year quarter; -
A record 438 new candidates, consisting entirely of patients with payers that have previously reimbursed for the MyoPro, were added to the patient pipeline, up
54% compared with the prior year quarter; -
There were 855 MyoPro candidates in the patient pipeline as of March 31, 2023, up
28% compared with March 31, 2022; -
The direct billing channel represented
70% of product revenue as the Company achieved record International product revenues; -
Gross margin was
67.0% , up 200 basis points sequentially and up 30 basis points compared with the prior-year quarter, which included the benefit of the partial payment of the technology license fee; and, -
Cost per pipeline add, which reflected only payers that have previously reimbursed for the MyoPro, was
, down$1,579 50% sequentially and53% compared with the prior year quarter.
Management Commentary
“Not only did we deliver revenue at the high end of our guided range, but our execution reflected the positive changes we made to the front end of our patient acquisition process. As a result, we had a record number of pipeline additions, all from previous payers and with a significantly lower cost per pipeline add," stated Paul R. Gudonis, Myomo's chairman and chief executive officer. "We were able to maintain our lead generation while spending
"Additionally, we were paid the remainder of the technology license fee by our Chinese joint venture partner in April, which triggered the process of transferring the technology and know-how to establish MyoPro manufacturing in
Financial Results
|
For the Three Months
|
|
Period-
|
|||||||||
|
2023 |
|
2022 |
|
$ |
|
% |
|||||
Product revenue |
$ |
3,446,708 |
|
$ |
2,867,926 |
|
$ |
578,782 |
|
|
20 |
% |
License revenue |
|
— |
|
|
1,000,000 |
|
|
(1,000,000 |
) |
N/M |
|
|
Total revenue |
|
3,446,708 |
|
|
3,867,926 |
|
|
(421,218 |
) |
|
(11 |
)% |
Cost of revenue |
|
1,139,074 |
|
|
1,290,704 |
|
|
(151,630 |
) |
|
(12 |
)% |
Gross profit |
$ |
2,307,634 |
|
$ |
2,577,222 |
|
$ |
(269,588 |
) |
|
(10 |
)% |
Gross margin % |
|
67.0 |
% |
|
66.6 |
% |
|
|
|
0.4 |
% |
Revenue for the first quarter of 2023 was
Gross margin for the first quarter of 2023 was
Operating expenses for the first quarter of 2023 were
Operating loss for the first quarter of 2023 was
Adjusted EBITDA for the first quarter of 2023 was negative
Operations Update
In 2023 the Company is focusing on working with payers that have previously reimbursed for MyoPro's in the past, rather than expanding the payer base. As a result, the patient pipeline now includes only these previous payers. Reflecting this change, the pipeline was 855 patients as of March 31, 2023, an increase of
CMS Update
"We met the objectives we set for ourselves during the quarter to advance our work to secure reimbursement from the Centers for Medicare and Medicaid Services (CMS). These included the submission of new research for publication that further supports the benefits patients receive from the use of the MyoPro, the submission of our first claims for Medicare Part B beneficiaries and meeting with the medical directors of the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) to present this new research and discuss the path forward to obtain reimbursement from Medicare," continued Mr. Gudonis. “While we cannot predict the outcome regarding payment of our initial claims, I believe we made a compelling case to the DME MACs to make the MyoPro available to Medicare Part B beneficiaries, just as it is for seniors with Medicare Advantage insurance plans, many of which provide reimbursement for the MyoPro."
Business Outlook
“With the revenue from payment of the remaining initial technology license fee and our sequentially higher backlog, we expect record revenue in the second quarter of 2023,” added Mr. Gudonis. “We reiterate our belief that product revenue growth of between
Cash Position
Cash and cash equivalents as of March 31, 2023 were
Conference Call and Webcast Information
Myomo will hold a conference call today at 4:30 p.m. Eastern time to discuss these results and answer questions. Participants are encouraged to pre-register for the call at this link. Callers who pre-register will be given a conference passcode and unique PIN to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time including up to and after the start of the call. Those unable to pre-register may participate by dialing 844-707-6932 (
A replay of the webcast will be available beginning approximately one hour after the completion of the live conference call at http://ir.myomo.com/. A dial-in replay of the call will be available until May 24, 2023 at 877-344-7529 (
Non-GAAP Financial Measures
Myomo is providing financial information that has not been prepared in accordance with generally accepted accounting principles in
About Myomo
Myomo, Inc. is a wearable medical robotics company that offers improved arm and hand function 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 certain 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
Forward-Looking Statements
This press release contains forward-looking statements regarding the Company’s future business expectations, including expectations for second quarter and 2023 revenue, 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:
- We have a history of operating losses and our financial statements for the period ended March 31, 2023 include disclosures regarding there being substantial doubt about our ability to continue as a going concern;
- our ability to achieve reimbursement from third-party payers for our products, including CMS for Medicare Part B patients;
- our ability to continue to serve patients with Medicare Advantage insurance plans CMS does not cover the MyoPro;
- our revenue concentration with a particular insurance payer as a result of focusing our efforts on patients with insurers who have previously reimbursed for the MyoPro;
- our ability to continue normal operations and patient interactions in order to deliver and fit our custom-fabricated device;
- our marketing and commercialization efforts;
- our dependence upon external sources for the financing of our operations, to the extent that we do not achieve or maintain cash flow breakeven;
- our ability to effectively execute our business plan and scale up our operations;
- our expectations as to our product development programs, and;
- general market, economic, environmental and social factors that may affect the evaluation, fitting, delivery and sale of our products to patients.
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 or 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.
(Tables to follow)
MYOMO, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) |
||||||||
|
|
For the Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Revenue |
|
|
|
|
|
|
||
Product revenue |
|
$ |
3,446,708 |
|
|
$ |
2,867,926 |
|
License revenue |
|
|
— |
|
|
|
1,000,000 |
|
|
|
|
3,446,708 |
|
|
|
3,867,926 |
|
|
|
|
|
|
|
|
||
Cost of revenue |
|
|
1,139,074 |
|
|
|
1,290,704 |
|
Gross profit |
|
|
2,307,634 |
|
|
|
2,577,222 |
|
Operating expenses: |
|
|
|
|
|
|
||
Research and development |
|
|
476,991 |
|
|
|
659,536 |
|
Selling, general and administrative |
|
|
4,501,608 |
|
|
|
4,656,417 |
|
|
|
|
4,978,599 |
|
|
|
5,315,953 |
|
|
|
|
|
|
|
|
||
Loss from operations |
|
|
(2,670,965 |
) |
|
|
(2,738,731 |
) |
|
|
|
|
|
|
|
||
Other (income) expense, net |
|
|
|
|
|
|
||
Interest income |
|
|
(86,314 |
) |
|
|
(180 |
) |
Other expense, net |
|
|
31 |
|
|
|
128 |
|
Loss on equity investment |
|
|
17,202 |
|
|
|
— |
|
|
|
|
(69,081 |
) |
|
|
(52 |
) |
Loss before income taxes |
|
|
(2,601,884 |
) |
|
|
(2,738,679 |
) |
Income tax expense |
|
|
42,411 |
|
|
|
76,255 |
|
Net loss |
|
$ |
(2,644,295 |
) |
|
$ |
(2,814,934 |
) |
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Weighted average number of common shares outstanding: |
|
|
|
|
|
|
||
Basic and diluted |
|
|
24,196,732 |
|
|
|
6,885,924 |
|
Net loss per share attributable to common stockholders |
|
|
|
|
|
|
||
Basic and diluted |
|
$ |
(0.11 |
) |
|
$ |
(0.41 |
) |
MYOMO, INC. CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2023 |
|
|
2022 |
|
||
|
|
(unaudited) |
|
|
|
|
||
ASSETS |
|
|
|
|
|
|
||
Current Assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
9,263,560 |
|
|
$ |
5,345,967 |
|
Accounts receivable, net |
|
|
1,547,801 |
|
|
|
1,896,163 |
|
Inventories, net |
|
|
1,565,268 |
|
|
|
1,399,865 |
|
Prepaid expenses and other current assets |
|
|
535,558 |
|
|
|
573,462 |
|
Total Current Assets |
|
|
12,912,187 |
|
|
|
9,215,457 |
|
Operating lease assets with right of use |
|
|
406,915 |
|
|
|
508,743 |
|
Equipment, net |
|
|
190,736 |
|
|
|
194,283 |
|
Investment in Jiangxi Myomo Medical Assistive Appliance Co. Ltd. |
|
|
115,287 |
|
|
|
132,489 |
|
Other assets |
|
|
111,034 |
|
|
|
111,034 |
|
Total Assets |
|
$ |
13,736,159 |
|
|
$ |
10,162,006 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
||
Current Liabilities: |
|
|
|
|
|
|
||
Accounts payable and accrued expenses |
|
|
3,475,543 |
|
|
|
3,086,932 |
|
Current operating lease liability |
|
|
275,028 |
|
|
|
353,701 |
|
Income taxes payable |
|
|
182,768 |
|
|
|
140,650 |
|
Deferred revenue |
|
|
747 |
|
|
|
20,653 |
|
Total Current Liabilities |
|
|
3,934,086 |
|
|
|
3,601,936 |
|
Non-current operating lease liability |
|
|
169,770 |
|
|
|
200,207 |
|
Deferred revenue |
|
|
312 |
|
|
|
498 |
|
Total Liabilities |
|
|
4,104,168 |
|
|
|
3,802,641 |
|
Commitments and Contingencies |
|
|
— |
|
|
|
— |
|
Stockholders’ Equity: |
|
|
|
|
|
|
||
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
2,092 |
|
|
|
775 |
|
Additional paid-in capital |
|
|
100,954,887 |
|
|
|
95,105,071 |
|
Accumulated other comprehensive income |
|
|
109,015 |
|
|
|
43,227 |
|
Accumulated deficit |
|
|
(91,427,539 |
) |
|
|
(88,783,244 |
) |
Treasury stock, at cost |
|
|
(6,464 |
) |
|
|
(6,464 |
) |
Total Stockholders’ Equity |
|
|
9,631,991 |
|
|
|
6,359,365 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
13,736,159 |
|
|
$ |
10,162,006 |
|
MYOMO, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) |
||||||||
For the Three Months Ended March 31, |
|
2023 |
|
|
2022 |
|
||
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
||
Net loss |
|
$ |
(2,644,295 |
) |
|
$ |
(2,814,934 |
) |
Adjustments to reconcile net loss to net cash used in operations: |
|
|
|
|
|
|
||
Depreciation |
|
|
48,632 |
|
|
|
45,630 |
|
Stock-based compensation |
|
|
171,027 |
|
|
|
266,270 |
|
Bad debt expense |
|
|
13,000 |
|
|
|
26,075 |
|
Loss on equity investment |
|
|
17,202 |
|
|
|
— |
|
Amortization of right-of-use assets |
|
|
101,829 |
|
|
|
76,654 |
|
Other non-cash charges |
|
|
49,012 |
|
|
|
(6,364 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Accounts receivable |
|
|
340,533 |
|
|
|
272,748 |
|
Inventories |
|
|
(157,148 |
) |
|
|
(229,740 |
) |
Prepaid expenses and other current assets |
|
|
(53,577 |
) |
|
|
(142,240 |
) |
Other assets |
|
|
— |
|
|
|
(16,079 |
) |
Accounts payable and accrued expenses |
|
|
386,880 |
|
|
|
294,828 |
|
Operating lease liabilities |
|
|
(109,109 |
) |
|
|
(97,098 |
) |
Deferred revenue |
|
|
(20,093 |
) |
|
|
1,650 |
|
Net cash used in operating activities |
|
|
(1,816,690 |
) |
|
|
(2,322,600 |
) |
CASH USED IN INVESTING ACTIVITIES |
|
|
(45,085 |
) |
|
|
(248,879 |
) |
CASH PROVIDED BY FINANCING ACTIVITIES |
|
|
5,772,057 |
|
|
|
- |
|
Effect of foreign exchange rate changes on cash |
|
|
7,311 |
|
|
|
(10,392 |
) |
|
|
|
|
|
|
|
||
Net increase (decrease) in cash and cash equivalents |
|
|
3,917,593 |
|
|
|
(2,581,871 |
) |
|
|
|
|
|
|
|
||
Cash and cash equivalents, beginning of period |
|
|
5,345,967 |
|
|
|
15,524,378 |
|
|
|
|
|
|
|
|
||
Cash and cash equivalents, end of period |
|
$ |
9,263,560 |
|
|
$ |
12,942,507 |
|
MYOMO, INC. RECONCILIATION OF GAAP NET LOSS TO ADJUSTED EBITDA (unaudited) |
||||||||
|
|
For the Three Months
|
|
|||||
|
|
2023 |
|
|
2022 |
|
||
GAAP net loss |
|
$ |
(2,644,295 |
) |
|
$ |
(2,814,934 |
) |
Adjustments to reconcile to Adjusted EBITDA: |
|
|
|
|
|
|
||
Interest income |
|
|
(86,314 |
) |
|
|
(180 |
) |
Depreciation expense |
|
|
48,632 |
|
|
|
45,630 |
|
Stock-based compensation |
|
|
171,027 |
|
|
|
266,270 |
|
Loss on investment in minority interest |
|
|
17,202 |
|
|
|
— |
|
Income tax expense |
|
|
42,411 |
|
|
|
76,255 |
|
Adjusted EBITDA |
|
$ |
(2,451,337 |
) |
|
$ |
(2,426,959 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230510005706/en/
For Myomo:
ir@myomo.com
Investor Relations:
Kim Sutton Golodetz
LHA Investor Relations
kgolodetz@lhai.com
212-838-3777
Source: Myomo, Inc.