$9.2 million in revenue, raises full-year
revenue guidance 225 MyoPro® authorizations and orders with 316
patients in backlog at quarter end 645 additions to the pipeline
result in 1,263 patients in the pipeline as of September 30,
2024
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 and nine months ended September 30, 2024.
Financial and operating highlights for the third quarter of 2024
include the following (all comparisons are with the third quarter
of 2023 unless otherwise indicated):
- Product and total revenue was a record $9.2 million, up 83% and
81%, respectively;
- Revenue units were a record 161, up 35%;
- Orders and insurance authorizations were received for a record
225 MyoPro units, up 44%;
- Backlog, which represents insurance authorizations and orders
received but not yet converted to revenue, was a record 316 units
as of September 30, 2024, up 71%;
- A record 645 new candidates were added to the patient pipeline,
up 69%;
- There were 1,263 MyoPro candidates in the patient pipeline as
of September 30, 2024, up 21%;
- Gross margin was 75.4%, up 670 basis points, with gross margin
on product revenues up 700 basis points;
- Cost per pipeline add was $1,618, down 25%; and
- The Company launched its orthotics and prosthetics ("O&P")
channel program at the American Orthotic and Prosthetic Association
(AOPA) National Assembly in September, and began training O&P
clinics to provide the MyoPro to their patients.
Management Commentary
“Myomo delivered a second consecutive quarter of record
financial and operating results as we emphasized outreach and
education to the Medicare population regarding the benefits of the
MyoPro, as well as an unwavering commitment to efficiency, quality
and improving patient outcomes across our organization", said Paul
R. Gudonis, Myomo's chairman and chief executive officer. "Our
focus has been on accelerating revenue growth though our direct
provider sales channel and laying the groundwork for growth in the
O&P channel in 2025 and beyond. Demonstrable progress was made
on both of these areas during the third quarter."
Financial Results
For the Three Months Ended
September 30,
Period- to-Period
Change
For the Nine Months Ended
September 30,
Period- to-Period
Change
2024
2023
$
%
2024
2023
$
%
Product revenue
$
9,207,586
$
5,029,523
$
4,178,063
83
%
$
20,482,742
$
12,719,855
$
7,762,887
61
%
License revenue
—
50,000
(50,000
)
(100
)%
—
1,764,920
(1,764,920
)
(100
)%
Total revenue
9,207,586
5,079,523
4,128,063
81
%
20,482,742
14,484,775
5,997,967
41
%
Cost of revenue
2,262,031
1,590,675
671,356
42
%
5,912,632
4,407,270
1,505,362
34
%
Gross profit
$
6,945,555
$
3,488,848
$
3,456,707
99
%
$
14,570,110
$
10,077,505
$
4,492,605
45
%
Gross margin %
75.4
%
68.7
%
6.7
%
71.1
%
69.6
%
1.5
%
Revenue for the third quarter of 2024 was $9.2 million, up 81%
compared with the third quarter of 2023. Product revenue increased
83% compared with the same period a year ago, driven by growth in
revenue units and by a higher average selling price ("ASP"). Myomo
recognized revenue on 161 MyoPro units in the third quarter of
2024, up 35% over the same quarter a year ago. ASP was
approximately $57,200 in the third quarter, up 35%. A portion of
the increase in ASP reflects payments from supplemental insurance
payers on revenue units recognized in a prior period. Excluding
these payments, ASP was approximately $52,700, up 23%. Effective
July 1, 2024, revenue for Medicare Part B patients is being
recognized at the time of product delivery for the amount expected
to be paid for each patient. Revenue from patients with Medicare
Part B represented 55% of revenue in the third quarter.
Year-to-date revenue was $20.5 million, up 41% compared with the
same period a year ago. Year-to-date product revenue was up 61%
compared with the first nine months of 2023.
Gross margin for the third quarter of 2024 was 75.4%, compared
with 68.7% for the third quarter of 2023. The increase was driven
primarily by a higher ASP. Gross margin on product revenues for the
third quarter of 2023 was 68.4%. Year-to-date gross margin was
71.1% compared with 69.6% for the same period a year ago. Gross
margin on product revenue for the first nine months of 2023 was
65.4%.
Operating expenses for the third quarter of 2024 were $7.9
million, an increase of 43% compared with the third quarter of
2023. The increase was driven primarily by higher payroll expense
due to additional headcount to support the Company's engineering
efforts, as well as the addition of field clinical and
reimbursement capacity and incentive compensation accruals.
Advertising costs of $1.0 million were up 23% over the third
quarter of 2023. Cost per pipeline add was $1,618, a decrease of
25% compared with the third quarter of 2023. Year-to-date operating
expenses were $20.5 million, an increase of 29% compared with the
same period a year ago.
Operating loss for the third quarter of 2024 was $1.0 million,
compared with $2.0 million for the third quarter of 2023. Net loss
for the third quarter of 2024 was $1.0 million, or $0.03 per share,
compared with a net loss of $2.0 million, or $0.06 per share, for
the third quarter of 2023. Year-to-date operating loss was $6.0
million, compared with an operating loss of $5.8 million for the
same period a year ago. Year-to-date net loss was $5.9 million, or
$0.16 per share, compared with a net loss of $5.7 million, or $0.21
per share, for the same period a year ago.
Adjusted EBITDA for the third quarter of 2024 was $(0.6)
million, compared with $(1.7) million for the third quarter of
2023. Year-to-date Adjusted EBITDA was $(5.3) million, compared
with $(4.9) million for the same period a year ago. A
reconciliation of GAAP net loss to this non-GAAP financial measure
appears below.
Operations Update
The patient pipeline was 1,263 patients as of September 30,
2024, compared with 1,046 as of September 30, 2023, an increase of
21%. A record 645 patients were added to the pipeline during the
third quarter of 2024, an increase of 69% compared with the same
period a year ago. The Company generated a record 225
authorizations and orders in the third quarter of 2024, an increase
of 44% compared with the same period a year ago. As a result,
backlog was a record 316 patients as of September 30, 2024, an
increase of 71% compared with September 30, 2023.
Cash Position
Cash, cash equivalents and restricted cash as of September 30,
2024 were $7.0 million. Cash used in operating activities was $1.5
million for the third quarter of 2024, compared with $1.7 million
for the third quarter of 2023. Cash used in operating activities in
the third quarter of 2024 was impacted by a payment delay during
the last two to three weeks of the quarter from the Centers for
Medicare & Medicaid Services ("CMS") due to a transition from
check payments to electronic funds transfer, which is expected to
speed up payments going forward. The delayed payments were
subsequently received in October.
Business Outlook
“We are positioned to deliver sequential revenue growth in the
fourth quarter due to the strength of our backlog," added Mr.
Gudonis. "As a result, we expect fourth quarter revenue to be in
the range of $9.5 million to $10.5 million, resulting in full year
revenue of $30 million to $31 million, up from our previous
guidance of $28 million to $30 million."
"We believe our objective of reaching operating cash flow
breakeven in the fourth quarter is achievable. We also expect to
approach Adjusted EBITDA breakeven in the fourth quarter. We expect
a moderation in cash used to fund growth in working capital, as we
collected in the fourth quarter the Medicare payments that were
delayed from the third quarter," said David Henry, Myomo's chief
financial officer. "Moderation in the growth of working capital in
the fourth quarter is predicated on minimizing growth in days sales
outstanding and receipt of a contractual reimbursement from the
landlord for initial costs associated with the lease on our new
facility."
Conference Call and Webcast
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 receive 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 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 November 20, 2024 at 877-344-7529 (U.S. toll-free),
855-669-9658 (Canada toll-free) or 412-317-0088 (International),
with passcode 3377340.
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 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 full year 2024 revenue, as well as
expectations regarding achieving operating cash flow breakeven and
approaching Adjusted EBITDA breakeven in the fourth quarter of
2024, 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 ability to obtain sufficient reimbursement from third-party
payers for our products;
- our ability to navigate factors both within and outside our
control to grow revenues sufficiently to achieve operating cash
flow breakeven on a quarterly basis;
- our revenue concentration with Medicare and 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 without supply chain disruption in order to deliver
and fit our custom-fabricated devices;
- 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 obtain and maintain our strategic collaborations
and to realize the intended results of such collaborations;
- our ability to effectively execute our business plan and scale
up our operations;
- our expectations as to our product development programs,
including improving our existing products and developing new
products;
- our ability to maintain and grow our reputation and to achieve
and maintain the market acceptance of our products;
- our expectations as to our clinical research program and
clinical results;
- our ability to maintain adequate protection of our intellectual
property and to avoid violation of the intellectual property rights
of others;
- our ability to gain and maintain regulatory approvals;
- our ability to compete and succeed in a highly competitive and
evolving industry; 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 (unaudited)
For the Three Months
ended
For the Nine Months
Ended
September 30,
September 30,
2024
2023
2024
2023
Revenue
Product revenue
$
9,207,586
$
5,029,523
$
20,482,742
$
12,719,855
License revenue
—
50,000
—
1,764,920
9,207,586
5,079,523
20,482,742
14,484,775
Cost of revenue
2,262,031
1,590,675
5,912,632
4,407,270
Gross profit
6,945,555
3,488,848
14,570,110
10,077,505
Operating expenses:
Research and development
1,248,870
717,256
3,212,309
1,758,480
Selling, clinical and marketing
3,401,182
2,387,090
8,540,161
6,689,578
General and administrative
3,253,056
2,408,871
8,779,024
7,427,818
7,903,108
5,513,217
20,531,494
15,875,876
Loss from operations
(957,553
)
(2,024,369
)
(5,961,384
)
(5,798,371
)
Other (income) expense, net
Interest income, net
(76,020
)
(112,300
)
(318,555
)
(302,053
)
Other expense, net
—
467
—
6,098
Loss on equity investment
—
70,124
—
99,840
(76,020
)
(41,709
)
(318,555
)
(196,115
)
Loss before income taxes
(881,533
)
(1,982,660
)
(5,642,829
)
(5,602,256
)
Income tax expense
84,876
46,356
280,819
85,204
Net loss
$
(966,409
)
$
(2,029,016
)
$
(5,923,648
)
$
(5,687,461
)
Weighted average number of common
shares outstanding:
Basic and diluted
37,950,515
35,266,361
37,359,366
27,537,357
Net loss per share attributable to
common stockholders
Basic and diluted
$
(0.03
)
$
(0.06
)
$
(0.16
)
$
(0.21
)
MYOMO, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
September 30,
December 31,
2024
2023
(unaudited)
ASSETS
Current Assets:
Cash and cash equivalents
$
6,622,675
$
6,871,306
Short-term investments
—
1,994,662
Accounts receivable, net
3,729,387
2,382,658
Inventories, net
3,383,513
1,803,507
Prepaid expenses and other current
assets
968,569
598,850
Total Current Assets
14,704,144
13,650,983
Restricted cash
375,000
—
Operating lease assets with right of
use
466,962
663,554
Equipment, net
561,325
175,794
Other assets
205,440
91,237
Total Assets
$
16,312,871
$
14,581,568
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current Liabilities:
Accounts payable and accrued expenses
6,448,076
4,885,944
Current operating lease liability
205,464
486,143
Income taxes payable
305,861
96,461
Deferred revenue
31,971
8,510
Total Current Liabilities
6,991,372
5,477,058
Non-current operating lease liability
29,165
115,160
Total Liabilities
7,020,537
5,592,218
Commitments and Contingencies
—
—
Stockholders’ Equity:
Preferred stock
—
—
Common stock
3,026
2,715
Additional paid-in capital
111,754,495
105,840,239
Accumulated other comprehensive income
395,734
83,669
Accumulated deficit
(102,854,457
)
(96,930,809
)
Treasury stock, at cost
(6,464
)
(6,464
)
Total Stockholders’ Equity
9,292,334
8,989,350
Total Liabilities and Stockholders’
Equity
$
16,312,871
$
14,581,568
MYOMO, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS (unaudited)
For the Nine Months Ended
September 30,
2024
2023
CASH FLOWS FROM OPERATING
ACTIVITIES
Net loss
$
(5,923,648
)
$
(5,687,461
)
Adjustments to reconcile net loss to net
cash used in operations:
Depreciation
114,346
136,416
Stock-based compensation
552,580
781,513
Accretion of discount on short-term
investments
(108,999
)
—
Credit losses
5,257
12,626
Loss on equity investment
—
99,840
Amortization of right-of-use assets
196,592
301,053
Other non-cash charges
84,180
(49,271
)
Changes in operating assets and
liabilities:
Accounts receivable
(1,116,352
)
(625,596
)
Inventories
(1,573,193
)
(90,100
)
Prepaid expenses and other current
assets
(614,951
)
(439,584
)
Other assets
(16,640
)
19,797
Accounts payable and accrued expenses
1,895,795
2,141,978
Income taxes payable
202,137
(74,944
)
Operating lease liabilities
(366,675
)
(352,820
)
Deferred revenue
23,460
9,533
Net cash used in operating activities
(6,655,632
)
(3,817,020
)
CASH USED IN INVESTING
ACTIVITIES
1,613,180
(4,324,017
)
CASH PROVIDED BY FINANCING
ACTIVITIES
5,162,409
9,713,426
Effect of foreign exchange rate changes on
cash
6,412
(6,610
)
'Net (decrease) increase in cash and cash
equivalents and restricted cash
126,369
1,565,780
Cash, cash equivalents and restricted
cash, beginning of period
6,871,306
5,345,967
Cash, cash equivalents and restricted
cash, end of period
$
6,997,675
$
6,911,747
MYOMO, INC.
RECONCILIATION OF GAAP NET
LOSS TO ADJUSTED EBITDA
(unaudited)
For the Three Months Ended
September 30,
For the Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP net loss
$
(966,409
)
$
(2,029,016
)
$
(5,923,648
)
$
(5,687,461
)
Adjustments to reconcile to Adjusted
EBITDA:
Interest income
(76,020
)
(112,300
)
(318,555
)
(302,053
)
Depreciation expense
48,682
35,794
114,346
136,416
Stock-based compensation
324,185
330,394
552,580
781,513
Loss on investment in minority
interest
—
70,124
—
99,840
Income tax expense
84,876
46,356
280,819
85,204
Adjusted EBITDA
$
(584,686
)
$
(1,658,648
)
$
(5,294,458
)
$
(4,886,541
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241106431006/en/
For Myomo: ir@myomo.com Investor Relations: Kim Sutton Golodetz
Alliance Advisors IR kgolodetz@allianceadvisors.com
212-838-3777
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