Fourth quarter revenue was $4.0 million, up 2%
sequentially 387 patients added to the pipeline in fourth quarter,
up 75% compared with Q4 2021
Conference call begins at 10:00 a.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 and full year ended December, 31,
2022.
Financial and operational highlights for the fourth quarter of
2022 include the following:
- Product and total revenues were $4.0 million, up 2%
sequentially and similar to the prior year quarter;
- Revenue units were 101, up 16% sequentially and down 6%
compared with the prior year quarter;
- MyoPro® orders and insurance authorizations were received for
98 patients, down 6% compared with the prior year quarter;
- Backlog, which represents insurance authorizations and orders
received but not yet converted to revenue, was 164 units, up 6%
over the prior year quarter;
- 387 new candidates were added to the patient pipeline, up 75%
compared with the fourth quarter of 2021;
- There were 1,153 MyoPro candidates in the patient pipeline as
of December 31, 2022, up 43% compared with December 31, 2021; when
adjusted for re-sizing of the pipeline in 2023 (as described
below), the pipeline was 794 patients as of December 31, 2022, an
increase of 50% compared with December 31, 2021;
- The direct billing channel represented 73% of revenue for the
fourth quarters of both 2022 and 2021;
- Gross margin was 65.0%, down 1,240 basis points from Q4 2021
and down 150 basis points sequentially; and,
- Cost per pipeline add was $2,665, down 45% from the peak in the
prior year quarter.
Management Commentary
“Based on the size of the backlog entering the fourth quarter
and the patient pipeline earlier in 2022, fourth quarter revenue
was in line with our expectations", stated Paul R. Gudonis, Myomo's
chairman and chief executive officer. "Importantly, we achieved our
key objective of significant pipeline growth, moreover with a 45%
reduction in the cost per new candidate entering the patient
pipeline. To accomplish this, we adjusted our marketing strategies
earlier in the year to educate and attract prospective patients
using TV advertising, and then fine-tuned the timing of our
placements in the fourth quarter to minimize competition from
holiday and election advertising. As a result, we had improved
patient acquisition economics, much stronger year over year growth
in the patient pipeline and a record number of candidates in the
process to obtain insurance reimbursement for their MyoPro as we
exited 2022. Entering 2023, we've modified how we determine our
pipeline of candidates to include only those patients with
insurance payers that have a history of reimbursement for the
MyoPro.”
Financial Results
For the Three Months Ended
December 31,
Period- to-Period
Change
For the Year Ended December
31,
Period- to-Period
Change
2022
2021
$
%
2022
2021
$
%
Product revenue
$
4,041,526
$
4,031,634
$
9,892
-
%
$
14,555,229
$
13,856,374
$
698,855
5
%
License revenue
-
-
-
N/M
1,000,000
-
1,000,000
N/M
Total revenue
4,041,526
4,031,634
9,892
0
%
15,555,229
13,856,374
1,698,855
12
%
Cost of revenue
1,413,916
909,175
504,741
56
%
5,302,133
3,544,097
1,758,036
50
%
Gross profit
$
2,627,610
$
3,122,459
$
(494,849
)
(16
)%
$
10,253,096
$
10,312,277
$
(59,181
)
-
%
Gross margin
65.0
%
77.4
%
(12.4
)%
65.9
%
74.4
%
(8.5
)%
Revenue for the fourth quarter of 2022 was $4.0 million, up
slightly compared with the fourth quarter of 2021 and up 2%
sequentially. Growth in revenue was driven by a higher average
selling price (ASP), partially offset by a lower number of revenue
units. Myomo recognized revenue on 101 MyoPro units in the fourth
quarter of 2022, down 6% from the same quarter a year ago. Revenue
for 2022 was $15.6 million, up 12%, compared with 2021. Excluding
the partial joint venture license payment received in the first
quarter of 2022, product revenue for 2022 of $14.6 million was up
5% compared with 2021.
Gross margin for the fourth quarter of 2022 was 65.0%, compared
with 77.4% for the fourth quarter of 2021. The decrease was driven
by higher product costs in the current inflationary environment,
partially offset by a higher ASP. Gross margin for 2022 was 65.9%,
compared with 74.4% for 2021.
Operating expenses for the fourth quarter of 2022 were $4.9
million, a decrease of 17%, compared with the fourth quarter of
2021. The decrease was driven primarily by lower product
development expenses, lower incentive compensation costs and lower
advertising expenses. Advertising costs of $1.0 million decreased
3% compared with the fourth quarter of 2021. Cost per pipeline add
was $2,665, a decrease of 45%, compared with the fourth quarter of
2021. Operating expenses were $20.9 million for 2022, an increase
of 2% over 2021.
Operating loss for the fourth quarter of 2022 was $2.2 million,
compared with $2.7 million for the fourth quarter of 2021. Net loss
attributable to common stockholders for the fourth quarter of 2022
was $2.2 million, or $0.29 per share, compared with net loss
attributable to common stockholders of $3.4 million, or $0.52 per
share, for the fourth quarter of 2021. Operating loss for 2022 was
$10.7 million, compared with $10.3 million for 2021. Net loss
attributable to common stockholders for 2022 was $10.7 million, or
$1.52 per share, compared with net loss attributable to common
stockholders of $11.0 million, or $1.89 per share, for 2021. Net
loss attributable to common stockholders for the 2021 fourth
quarter and full year includes a deemed dividend of $0.6 million on
the discounting and repricing of certain warrants.
Adjusted EBITDA for the fourth quarter of 2022 was negative $1.9
million, compared with negative $2.4 million for the fourth quarter
of 2021. Adjusted EBITDA was negative $9.3 million for 2022,
compared with negative $9.0 million for 2021. 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 reimbursed for MyoPro's in the past, rather than expanding the
payer base. The Company's analysis revealed that new payers
generated less than 2% of the Company's 2022 revenues, yet consumed
significant resources. As a result, the Company reduced its
workforce by 12% in January 2023. This and other planned actions
are expected to save approximately $2.0 million in 2023.
Further, the patient pipeline was re-focused in January on
patients with insurance by payers that have reimbursed for the
MyoPro in the past. Reflecting this change, the adjusted pipeline
was 794 patients as of December 31, 2022, an increase of 50%,
compared with 528 patients as of December 31, 2021. The Company
expects these actions to have a minimal impact on 2023 revenues and
to result in a higher authorization rate on a go-forward basis.
CMS Update
"We are preparing for a meeting with the DME MAC medical
directors to discuss payment of the MyoPro for Medicare Part B
patients and expect to submit our initial Medicare Part B claims as
a direct provider before the end of the first quarter." continued
Mr. Gudonis. "As we anticipated, CMS issued a public notice in
January regarding its intention to propose a new rule that defines
the scope of the Medicare Part B benefit for leg, arm, back and
neck braces, as well as for newer technology devices. We expect
that this new rule will address the request we made in June 2022 to
change our benefit category from DME rental to a brace, or
orthotic. We don't have any information regarding the timing for
the publication of this proposed rule."
Business Outlook
“We expect first quarter 2023 product revenue to increase
between 15% and 20% compared with the first quarter of 2022,” added
Mr. Gudonis. “Given the strength of the patient pipeline entering
2023 - now only with reliable payers- we believe full-year product
revenue growth of between 20% to 30% is attainable."
Cash Position and Silicon Valley Bank Update
Cash and cash equivalents as of December 31, 2022 were $5.3
million. Cash used in operating activities was $2.4 million for the
fourth quarter of 2022 and $10.2 million for the full year 2022. In
January 2023, the Company completed an offering of common stock and
pre-funded warrants that generated net proceeds of approximately
$5.7 million. The Company plans to reduce its cash burn in 2023
through a combination of revenue growth and the impact of the
aforementioned actions.
On March 10, 2023, Silicon Valley Bank ("SVB") was placed under
receivership with the Federal Deposit Insurance Corporation (the
“FDIC”). The Company conducted its commercial banking through SVB.
According to the FDIC, all depositors of SVB will have full access
to their deposits on Monday morning, March 13, 2023.
Conference Call and Webcast Information
Myomo will hold a conference call today at 10:00 a.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 March 27, 2023 at 877-344-7529 (U.S. toll-free),
855-669-9658 (Canada toll-free) or 412-317-0088 (International),
with passcode 9026221.
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 fourth quarter and 2023 revenue, savings from cost reduction
actions in 2023, the timing of filing initial Medicare Part B
claims and expectations for a lower cash burn in 2023, 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 December 31, 2022 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;
- the direct and indirect impact of the novel coronavirus
(COVID-19) on our business and operations, including fabrication
and delivery, sales, patient consultations, supply chain,
manufacturing, insurance reimbursements and employees;
- 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.
MYOMO, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
Three Months Ended
Year Ended
December 31,
December 31,
2022
2021
2022
2021
(unaudited)
Revenue
Product revenue
$
4,041,526
$
4,031,634
$
14,555,229
$
13,856,374
License revenue
—
—
1,000,000
—
4,041,526
4,031,634
15,555,229
13,856,374
Cost of revenue
1,413,916
909,175
5,302,133
3,544,097
Gross profit
2,627,610
3,122,459
10,253,096
10,312,277
Operating expenses:
Research and development
499,674
787,627
2,482,489
2,557,367
Selling, general and administrative
4,357,287
5,040,562
18,442,811
18,022,975
4,856,961
5,828,189
20,925,300
20,580,342
Loss from operations
(2,229,351
)
(2,705,730
)
(10,672,204
)
(10,268,065
)
Other (income) expense
Interest income
(40,748
)
(191
)
(88,731
)
(1,612
)
Other (income) expense, net
(14,540
)
5,335
1,101
16,948
Loss on equity investment
16,652
-
66,511
-
(38,636
)
5,144
(21,119
)
15,336
Loss before income taxes
(2,190,715
)
(2,710,874
)
(10,651,085
)
(10,283,401
)
Income tax expense (benefit)
(23,265
)
22,324
69,937
88,928
Net loss
$
(2,167,450
)
$
(2,733,198
)
$
(10,721,022
)
$
(10,372,329
)
Deemed dividend on discounting and
repricing of warrants
—
(639,953
)
—
(639,953
)
Net loss attributable to common
stockholders
$
(2,167,450
)
$
(3,373,151
)
$
(10,721,022
)
$
(11,012,282
)
Weighted average number of common
shares outstanding:
Basic and diluted
7,349,122
6,547,707
7,051,447
5,830,353
Net loss per share attributable to
common stockholders
Basic and diluted
$
(0.29
)
$
(0.52
)
$
(1.52
)
$
(1.89
)
MYOMO, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
December 31,
2022
2021
ASSETS
Current Assets:
Cash and cash equivalents
$
5,345,967
$
15,524,378
Accounts receivable, net
1,896,163
1,960,037
Inventories, net
1,399,865
808,308
Prepaid expenses and other current
assets
573,462
799,164
Total Current Assets
9,215,457
19,091,887
Operating lease assets with right of
use
508,743
632,906
Equipment, net
194,283
275,289
Investment in Jiangxi Myomo Medical
Assistive Appliance Co. Ltd.
132,489
-
Other assets
111,034
95,330
Total Assets
$
10,162,006
$
20,095,412
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current Liabilities:
Accounts payable and accrued expenses
3,179,362
3,910,639
Current operating lease liability
353,701
333,380
Income taxes payable
48,220
39,145
Deferred revenue
20,653
249
Total Current Liabilities
3,601,936
4,283,413
Deferred revenue, net of current
portion
498
1,246
Non-current operating lease liability
200,207
401,622
Total Liabilities
3,802,641
4,686,281
Commitments and Contingencies
—
—
Stockholders’ Equity:
Preferred stock
—
—
Common stock
775
687
Additional paid-in capital
95,105,071
93,537,807
Accumulated other comprehensive loss
43,227
(60,677
)
Accumulated deficit
(88,783,244
)
(78,062,222
)
Treasury stock, at cost
(6,464
)
(6,464
)
Total Stockholders’ Equity
6,359,365
15,409,131
Total Liabilities and Stockholders’
Equity
$
10,162,006
$
20,095,412
MYOMO, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
For the Year Ended December 31,
2022
2021
CASH FLOWS FROM OPERATING
ACTIVITIES
Net loss
$
(10,721,022
)
$
(10,372,329
)
Adjustments to reconcile net loss to net
cash used in operations:
Depreciation
192,799
145,995
Stock-based compensation
1,190,494
1,096,408
Bad debt expense
26,075
—
Loss on disposal of asset
—
202
Amortization of right-of-use assets
349,828
189,968
Loss on equity investment
66,511
—
Other non-cash charges
111,755
(19,929
)
Changes in operating assets and
liabilities:
—
—
Accounts receivable
47,445
(1,046,282
)
Inventories
(607,400
)
(118,222
)
Prepaid expenses and other current
assets
224,677
(323,644
)
Other assets
(15,704
)
—
Accounts payable and accrued expenses
(711,898
)
1,113,235
Operating Lease Liabilities
(406,759
)
(92,525
)
Deferred revenue
19,657
(2,512
)
Other liabilities
—
(118,060
)
Net cash used in operating activities
(10,233,542
)
(9,547,695
)
CASH USED IN INVESTING
ACTIVITIES
(310,793
)
(326,462
)
CASH PROVIDED BY FINANCING
ACTIVITIES
376,858
13,167,666
Effect of foreign exchange rate changes on
cash
(10,934
)
(10,392
)
Net (decrease) increase in cash, cash
equivalents and restricted cash
(10,178,411
)
3,283,117
Cash, cash equivalents and restricted
cash, beginning of period
15,524,378
12,241,261
Cash, cash equivalents and restricted
cash, end of period
$
5,345,967
$
15,524,378
MYOMO, INC.
RECONCILIATION OF GAAP NET
LOSS TO ADJUSTED EBITDA
(unaudited)
For the Three Months Ended
December 31,
For the Year Ended December
31,
2022
2021
2022
2021
GAAP net loss
$
(2,167,450
)
$
(2,733,198
)
$
(10,721,022
)
$
(10,372,329
)
Adjustments to reconcile to Adjusted
EBITDA:
Interest income
(40,748
)
(191
)
(88,731
)
(1,612
)
Depreciation expense
49,057
51,049
192,799
145,995
Stock-based compensation
273,369
265,362
1,190,494
1,096,408
Loss on investment in minority
interest
16,652
—
66,511
—
Income tax expense (benefit)
(23,265
)
22,324
69,937
88,928
Adjusted EBITDA
$
(1,892,385
)
$
(2,394,654
)
$
(9,290,012
)
$
(9,042,610
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230313005411/en/
For Myomo: ir@myomo.com Investor Relations: Kim Sutton Golodetz
LHA Investor Relations kgolodetz@lhai.com 212-838-3777
Myomo (AMEX:MYO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Myomo (AMEX:MYO)
Historical Stock Chart
From Sep 2023 to Sep 2024