Implementation of virtual waiting room
technology enabled a record 438 patients added to the pipeline, up
54% over Q1 2022
Advertising efficiencies resulted in cost per
pipeline add of $1,579, down 50% sequentially
Conference call begins at 4:30 p.m. Eastern
time today
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 financial
results for the three months ended March 31, 2023.
Financial and operational highlights for the first quarter of
2023 include the following:
- Product revenue was $3.4 million, up 20% compared with the
prior year quarter. Total revenue decreased 11% 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 $1,579, down 50%
sequentially and 53% 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 33% less on
advertising in the quarter. In addition, our new virtual waiting
room significantly reduced our cycle time from lead generation to
telehealth screening, enabling more patients to enter the process
to obtain a MyoPro than ever before. We accomplished these results
with 12% fewer employees on our clinical, reimbursement and billing
teams, which is a tremendous achievement. I believe we're
positioned for accelerated year-over-year revenue growth in 2023,"
added Gudonis.
"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 China."
Financial Results
For the Three Months Ended
March 31,
Period- to-Period
Change
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 $3.4 million, down 11%
compared with the first quarter of 2022. Excluding the $1.0 million
partial payment of the technology license fee in the first quarter
of 2022, product revenue increased 20% compared with the same
period a year ago. Growth in product revenue was driven by a higher
number of revenue units and a higher average selling price (ASP).
Myomo recognized revenue on 80 MyoPro units in the first quarter of
2023, up 13% from the same quarter a year ago.
Gross margin for the first quarter of 2023 was 67.0%, compared
with 66.7% for the first quarter of 2022. The increase was driven
primarily by lower warranty reserves combined with a higher average
selling price.
Operating expenses for the first quarter of 2023 were $5.0
million, a decrease of 6% compared with the first quarter of 2022.
The decrease was driven primarily by lower advertising and
compensation expenses. Advertising costs of $0.7 million decreased
33% compared with the first quarter of 2022. Cost per pipeline add
was $1,579, a decrease of 53%, compared with the first quarter of
2022.
Operating loss for the first quarter of 2023 was $2.7 million,
compared with $2.7 million for the first quarter of 2022, which
included the benefit of the license payment. Net loss for the first
quarter of 2023 was $2.6 million, or $0.11 per share, compared with
net loss of $2.8 million, or $0.43 per share, for the first quarter
of 2022.
Adjusted EBITDA for the first quarter of 2023 was negative $2.5
million, compared with negative $2.4 million for the first quarter
of 2022. A reconciliation of GAAP net loss to this non-GAAP
financial measure appears below.
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 28%
compared with 670 patients with previous payers as of March 31,
2022. A record 438 patients were added to the pipeline in the first
quarter of 2023, an increase of 54% compared with 285 patients with
previous payers in the same period a year ago.
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 20% to 30% is attainable in 2023."
Cash Position
Cash and cash equivalents as of March 31, 2023 were $9.3
million. Cash used in operating activities was $1.8 million for the
first quarter of 2023. In January 2023, the Company completed an
offering of common stock and pre-funded warrants that generated net
proceeds of approximately $5.7 million. Including the payment of
the remaining license fee in early April, the Company begins the
second quarter with approximately $11.0 million in cash.
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 (U.S.) or 412-317-9250 (International). A
webcast of the call will also be available at Myomo’s Investor
Relations page at http://ir.myomo.com/.
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 (U.S. toll-free),
855-669-9658 (Canada toll-free) or 412-317-0088 (International),
with passcode 1431578.
Non-GAAP Financial Measures
Myomo is providing 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 the use of this non-GAAP financial measure provides
supplementary information for investors to use in evaluating
operating performance and in comparing Myomo’s financial measures
with other companies in its industry, many of which present similar
non-GAAP financial measures. Adjusted EBITDA is EBITDA adjusted for
stock-based compensation expense and loss on equity investment.
This non-GAAP financial measure 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.
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 Boston,
Massachusetts, with sales and clinical professionals across the
U.S. and representatives internationally. For more information,
please visit www.myomo.com.
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 Ended
March 31,
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
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