Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the
“Company”), a neurotech company focused on delivering a novel
therapeutic neuromodulation approach for balance and gait deficits,
today announced results for the quarter ended March 31, 2023.
First Quarter and Recent Business Updates
- Q1 2023 revenue of $111 thousand,
compared to $190 thousand in Q1 2022, the decrease due to revenue
of $120 thousand recognized in the prior year quarter resulting
from a one-time delivery of Portable Neuromodulation Stimulator
(PoNS®) systems under our previous Canadian distribution agreement,
partially offset by an increase in product sales in the U.S., which
commenced in April 2022
- Operating cash burn of $3.2 million
during the quarter, a decrease of $1.5 million compared to Q1 2022,
reflecting ongoing efforts to extend cash runway into 2024
- Introduced UpScriptHealth
telehealth e-commerce site, allowing Americans with balance and
gait deficits to access online health evaluations, fulfill PoNS
Therapy™ prescriptions through a network of licensed providers, and
order home delivery of PoNS devices
- Received authorization from Health
Canada to market PoNS for the treatment of gait deficit due to mild
and moderate symptoms from stroke
- Signed exclusive
distribution agreement with HealthTech Connex Inc. (“HTC”),
granting HTC the exclusive right to purchase, market, sell, and
distribute PoNS throughout the metropolitan Vancouver and Fraser
Valley regions of British Columbia, Canada
“One year ago, we launched PoNS Therapy in the
United States, and our innovative product continues to resonate in
the marketplace. Neurologists, physical therapists, and those
suffering from MS are seeing how PoNS treatment can improve balance
and gait and we’ve implemented several programs to eliminate
barriers and delays to access, including our ponstherapy.com
e-commerce site and an online training portal for therapists,” said
Dane Andreeff, President and Chief Executive Officer of Helius.
“Although our quarterly revenue came in below
expectations due primarily to a combination of timing differences,
the transition to e-commerce, and cannibalization of sales by our
Therapeutic Experience Program (PoNSTEP) at certain sites, we
remain positive about our momentum both in the U.S. and in Canada,
where the broadened set of authorizations and HTC distribution
agreement have greatly expanded the total addressable market. With
our strong cash position, reduced expenses, and foothold in the
market, we are confident that we can achieve our 2023 goals.”
First Quarter 2023 Financial Results
Total revenue for the first quarter of 2023 was
$111 thousand, a decrease of $79 thousand compared to $190 thousand
in the first quarter of 2022, primarily attributable to lower
Canada product sales, partially offset by increased net product
sales in the United States. Commercial product sales in the United
States commenced in April 2022. Canada product sales for the three
months ended March 31, 2022 included approximately $120 thousand of
revenue recognized in connection with the delivery of PoNS devices
under our prior distribution agreement with HTC.
Cost of revenue was $122 thousand for the three
months ended March 31, 2023, compared to $124 thousand for the
comparable period in 2022, remaining relatively flat due to fixed
overhead costs.
Operating expenses for the first quarter of 2023
decreased to $3.8 million, compared to $4.6 million in the first
quarter of 2022. The decrease was driven primarily by a decrease in
product development expenses and clinical trial activities as we
transitioned our focus in the U.S. from product development and
clinical trials to commercialization activities.
Operating loss for the first quarter of 2023
decreased $0.8 million to a loss of $3.8 million, compared to an
operating loss of $4.6 million in the first quarter of 2022.
Net loss was $2.5 million for the first quarter
of 2023, compared to a net loss of $4.3 million in the
corresponding prior year period. The basic and diluted net loss per
share for the first quarter was $0.09 per share, compared to a net
loss of $1.15 per share for the first quarter of 2022.
Cash and Liquidity
Cash used in operating activities for the three
months ended March 31, 2023, was $3.2 million compared to $4.7
million in the first quarter of 2022, reflecting the results of our
focus on reducing cash burn and extending our cash runway beyond
2023.
As of March 31, 2023, the Company had cash
of $11.3 million, compared to $14.5 million at December 31,
2022.
The Company had no debt outstanding as of
March 31, 2023.
Second Quarter and Near-Term Guidance
The Company currently expects second quarter
2023 revenue to be above the prior year quarter and first quarter
levels, factoring in potential delays for some portion of U.S.
patients to pursue insurance coverage prior to filling their
prescriptions. The Company also expects 2023 revenues to exceed
prior year levels, though we may experience additional quarterly
fluctuations as we make refinements to the U.S. commercial roll-out
of PoNS.
Conference Call
As previously announced, management will host a
conference call as follows:
Date: |
Thursday, May
11, 2023 |
|
|
Time: |
4:30 PM ET |
|
|
Register* (Audio Only): |
Click here |
|
|
Webcast: |
Click here |
The webcast will be archived under the Newsroom section of the
Company’s investor relations website.
About Helius Medical Technologies,
Inc.
Helius Medical Technologies is a leading
neurotech company in the medical device field focused on neurologic
deficits using non-implantable platform technologies that amplify
the brain’s ability to compensate and promotes neuroplasticity,
aiming to improve the lives of people dealing with neurologic
diseases. The Company’s first commercial product is the Portable
Neuromodulation Stimulator (PoNS). For more information, visit
www.heliusmedical.com.
About the PoNS Device and PoNS
Therapy
The Portable Neuromodulation Stimulator (PoNS)
is an innovative non-surgical medical device, inclusive of a
controller and mouthpiece, which delivers electrical stimulation to
the surface of the tongue to improve balance and gait. The PoNS
device is indicated for use in the United States as a short-term
treatment of gait deficit due to mild-to-moderate symptoms from
multiple sclerosis (“MS”) and is to be used as an adjunct to a
supervised therapeutic exercise program in patients 22 years of age
and over by prescription only.
PoNS is also authorized for sale in Canada for
three indications: (i) for use as a short-term treatment (14 weeks)
of chronic balance deficit due to mild-to-moderate traumatic brain
injury (“mmTBI”) and is to be used in conjunction with physical
therapy; and (ii) for use as a short-term treatment (14 weeks) of
gait deficit due to mild and moderate symptoms from MS and is to be
used in conjunction with physical therapy; and (iii) for use as a
short-term treatment (14 weeks) of gait deficit due to mild and
moderate symptoms from stroke, to be used in conjunction with
physical therapy. PoNS is also authorized for sale in Australia for
short term use by healthcare professionals as an adjunct to a
therapeutic exercise program to improve balance and gait. For more
information visit www.ponstherapy.com.
Cautionary Disclaimer
Statement
Certain statements in this news release are not
based on historical facts and constitute forward-looking statements
or forward-looking information within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995 and Canadian
securities laws. All statements other than statements of historical
fact included in this news release are forward-looking statements
that involve risks and uncertainties. Forward-looking statements
are often identified by terms such as “believe,” “expect,”
“continue,” “will,” “goal,” “aim” and similar expressions. Such
forward-looking statements include, among others, statements
regarding the Company’s expected results for the Company’s business
and financial performance in 2023, the success of the Company’s
PoNS device and related treatment, and the Company’s strategic
operating plans.
There can be no assurance that such statements
will prove to be accurate and actual results and future events
could differ materially from those expressed or implied by such
statements. Important factors that could cause actual results to
differ materially from the Company’s expectations include
uncertainties associated with the Company’s capital requirements to
achieve its business objectives, disruptions in the banking system
and financial markets, lingering impacts of the COVID-19 pandemic,
the effect of macroeconomic conditions and the Company’s ability to
access capital markets, the Company’s ability to train physical
therapists in the supervision of the use of the PoNS Treatment, the
Company’s ability to secure contracts with rehabilitation clinics,
the Company’s ability to obtain national Medicare coverage and to
obtain a reimbursement code so that the PoNS device is covered by
Medicare and Medicaid, the Company’s ability to build internal
commercial infrastructure, secure state distribution licenses,
build a commercial team and build relationships with Key Opinion
Leaders, neurology experts and neurorehabilitation centers, market
awareness of the PoNS device, availability of funds, manufacturing,
labor shortage and supply chain risks, our ability to maintain and
enforce our intellectual property rights, clinical trials and the
clinical development process, the product development process, the
regulatory submission review and approval process, our operating
costs and use of cash, and our ability to achieve significant
revenues, ongoing government regulation, and other risks detailed
from time to time in the “Risk Factors” section of the Company’s
Annual Report on Form 10-K for the year ended December 31, 2022,
and its other filings with the United States Securities and
Exchange Commission and the Canadian securities regulators, which
can be obtained from either at www.sec.gov or www.sedar.com.
The reader is cautioned not to place undue
reliance on any forward-looking statement. The forward-looking
statements contained in this news release are made as of the date
of this news release and the Company assumes no obligation to
update any forward-looking statement or to update the reasons why
actual results could differ from such statements except to the
extent required by law.
Investor Relations Contact
Lisa M. Wilson, In-Site Communications, Inc.T:
212-452-2793E: lwilson@insitecony.com
Helius Medical Technologies, Inc. |
Unaudited Condensed Consolidated Statement of
Operations |
(in thousands, except shares and per share data) |
|
|
|
|
|
|
|
Three Months Ended |
|
March 31, |
|
2023 |
|
|
2022 |
|
Revenue |
|
|
|
|
|
Product sales, net |
$ |
106 |
|
|
$ |
183 |
|
Other revenue |
|
5 |
|
|
|
7 |
|
Total revenue |
|
111 |
|
|
|
190 |
|
Cost of revenue |
|
122 |
|
|
|
124 |
|
Gross profit (loss) |
|
(11 |
) |
|
|
66 |
|
Operating
expenses |
|
|
|
|
|
Selling, general and administrative |
|
2,874 |
|
|
|
2,819 |
|
Research and development |
|
886 |
|
|
|
1,764 |
|
Amortization expense |
|
39 |
|
|
|
47 |
|
Total operating expenses |
|
3,799 |
|
|
|
4,630 |
|
Loss from operations |
|
(3,810 |
) |
|
|
(4,564 |
) |
Nonoperating income
(expense) |
|
|
|
|
|
Interest income (expense), net |
|
100 |
|
|
|
— |
|
Change in fair value of derivative liability |
|
1,221 |
|
|
|
— |
|
Foreign exchange (loss) gain |
|
(5 |
) |
|
|
217 |
|
Other income (expense), net |
|
— |
|
|
|
1 |
|
Nonoperating income (expense), net |
|
1,316 |
|
|
|
218 |
|
Loss before provision for
income taxes |
|
(2,494 |
) |
|
|
(4,346 |
) |
Provision for income
taxes |
|
— |
|
|
|
— |
|
Net loss |
$ |
(2,494 |
) |
|
$ |
(4,346 |
) |
Net loss per
share |
|
|
|
|
|
Basic |
$ |
(0.09 |
) |
|
$ |
(1.15 |
) |
Diluted |
$ |
(0.09 |
) |
|
$ |
(1.15 |
) |
Weighted average
number of common shares outstanding |
|
|
|
|
|
Basic |
|
28,209,346 |
|
|
|
3,787,871 |
|
Diluted |
|
28,209,346 |
|
|
|
3,787,871 |
|
|
|
|
|
|
|
Helius Medical Technologies, Inc. |
Unaudited Condensed Consolidated Balance
Sheets |
(in thousands, except shares and per share data) |
|
|
|
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
ASSETS |
|
|
|
|
|
Current
assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
11,340 |
|
|
$ |
14,549 |
|
Accounts receivable, net |
|
11 |
|
|
|
71 |
|
Other receivables |
|
156 |
|
|
|
272 |
|
Inventory, net |
|
617 |
|
|
|
589 |
|
Prepaid expenses and other current assets |
|
1,085 |
|
|
|
1,216 |
|
Total current assets |
|
13,209 |
|
|
|
16,697 |
|
Property and equipment,
net |
|
354 |
|
|
|
347 |
|
Intangible assets, net |
|
101 |
|
|
|
140 |
|
Operating lease right-of-use
asset, net |
|
91 |
|
|
|
103 |
|
Total assets |
$ |
13,755 |
|
|
$ |
17,287 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Accounts payable |
$ |
840 |
|
|
$ |
627 |
|
Accrued liabilities |
|
856 |
|
|
|
1,280 |
|
Operating lease liabilities |
|
51 |
|
|
|
54 |
|
Deferred revenue |
|
42 |
|
|
|
27 |
|
Total current liabilities |
|
1,789 |
|
|
|
1,988 |
|
Operating lease
liabilities |
|
46 |
|
|
|
56 |
|
Deferred revenue |
|
157 |
|
|
|
175 |
|
Derivative liability |
|
5,696 |
|
|
|
6,917 |
|
Total liabilities |
|
7,688 |
|
|
|
9,136 |
|
STOCKHOLDERS’
EQUITY |
|
|
|
|
|
Class A common stock, $0.001 par value; 150,000,000 shares
authorized; 28,213,378 and 28,207,330 shares issued and outstanding
as of March 31, 2023 and December 31, 2022,
respectively |
|
28 |
|
|
|
28 |
|
Additional paid-in capital |
|
160,023 |
|
|
|
159,618 |
|
Accumulated deficit |
|
(153,601 |
) |
|
|
(151,107 |
) |
Accumulated other comprehensive loss |
|
(383 |
) |
|
|
(388 |
) |
Total stockholders' equity |
|
6,067 |
|
|
|
8,151 |
|
Total liabilities and stockholders' equity |
$ |
13,755 |
|
|
$ |
17,287 |
|
|
|
|
|
|
|
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