Helius Medical Technologies, Inc. Reports Fourth Quarter and Full Year 2018 Financial Results and Introduces Full Year 2019 Outlook

March 14, 2019 Off By BusinessWire

NEWTOWN, Pa.–(BUSINESS WIRE)–Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or
the “Company”), a neurotech company focused on neurological wellness,
today reported financial results for the fourth quarter and full year
ended December 31, 2018.

Full Year 2018 Financial Summary

Revenue of $0.5 million, compared to no revenue in 2017.
Operating loss of $26.7 million, compared to operating loss of $22.9
million in 2017.
Net loss of $28.6 million, compared to net loss of $28.0 million in
2017.
Cash of $25.6 million as of December 31, 2018, compared to $5.6
million as of December 31, 2017.

Fourth Quarter 2018 Financial Summary

Revenue of $0.5 million, compared to no revenue in fourth quarter 2017.
Operating loss of $5.3 million, compared to operating loss of $5.9
million in fourth quarter 2017.
Net loss of $5.1 million, compared to net loss of $3.7 million in
fourth quarter 2017.

Fourth Quarter Highlights

On October 2, 2018, the Company announced it entered into a strategic
alliance agreement with Health Tech Connex, Inc. and Heuro Canada
Inc., to develop and manage neuroplasticity clinics in Canada.
On October 22, 2018, the Company announced it received authorization
from Health Canada to market its PoNS device as a Class II medical
device in Canada. The Health Canada Medical Device License certifies
that the PoNS device meets all Canadian safety, effectiveness, and
quality requirements. The Company may now market its PoNS Treatment as
an adjunct to physical therapy for chronic balance deficit in patients
with mild-to-moderate traumatic brain injury (“mmTBI”).
On October 24, 2018, the Company announced it partnered with Northwell
Health’s Feinstein Institute for Medical Research in Manhasset, New
York. This partnership enabled the Company to implement its second
Clinical Experience Program (“CEP”) for its PoNS Treatment.
In November 2018, the Company completed an underwritten public
offering of 2,439,394 shares of its Class A common stock at a public
offering price of $8.25 per share, raising net proceeds of
approximately $18.3 million. BTIG, LLC and Oppenheimer & Co. Inc.
acted as joint book-running managers for the offering, and Haywood
Securities Inc. acted as a co-manager for the offering.
On December 12, 2018, the Company announced that it submitted an
application for a CE Mark.

Highlights Subsequent to Year-End

On January 3, 2019, the Company announced it partnered with Oregon
Health & Science University (OHSU) in Oregon and with Kessler
Institute for Rehabilitation and Kessler Foundation in New Jersey to
launch its third and fourth CEPs for its PoNS Treatment. Subsequently,
the Company entered its fifth CEP partnership with Baylor Research
Institute in Dallas, Texas.
On January 25, 2019, the Company announced it received a request for
additional information letter from the U.S. Food and Drug
Administration (FDA) related to the Company’s request for de novo
classification and 510(k) clearance of the PoNS device. The Company
submitted its response to the information requested by the FDA, which
the Company expects will enable the FDA to resume its review.
On March 5, 2019, the Company announced the first patients in Canada
have begun PoNS Treatment.

“2018 was an incredibly productive year for Helius,” said Philippe
Deschamps, Chief Executive Officer of Helius. “Among our most important
accomplishments this year, we submitted our PoNS device for regulatory
clearance and marketing authorization in the U.S. and Canada, the two
primary markets where Helius is initially focused, as well as in the
European Union. In Canada, we received a Medical Device License allowing
us to market PoNS Treatment to patients with chronic balance deficit due
to mmTBI. Following this important regulatory milestone, we continued
our rapid pace of progress during the fourth quarter by establishing the
requisite support systems and agreements that enabled us to treat our
first Canadian patients earlier this month, which marked our transition
to a commercial-stage company.”

Mr. Deschamps continued: “In 2019, we will continue to advance through
the initial stages of our commercialization in Canada, with the ultimate
goal of addressing the substantial opportunity that exists in this
market of more than 350,000 Canadians suffering from chronic balance
deficit due to mmTBI. I’m also pleased to announce that we have
submitted our response to the additional information requested by the
FDA. We will continue to work closely with the FDA to facilitate its
review of our submission for de novo classification and 510(k) clearance
of the PoNS device. We look forward to a year of continued progress and
exciting new developments as we bring our PoNS Treatment to the aid of
patients whose lives have been impacted by the effects of traumatic
brain injury.”

Fourth Quarter 2018 Financial Results

Revenue for the fourth quarter of 2018 was $0.5 million, which
represents the Company’s first revenue since its inception. In the
fourth quarter of 2018, Company recognized license fee revenue of $0.5
million in connection with the satisfaction of its performance
obligation related to the strategic alliance agreement with Health Tech
Connex, Inc. and Heuro Canada, Inc.

Operating expenses for the fourth quarter of 2018 decreased 2%
year-over-year, to $5.7 million, compared to $5.9 million in the fourth
quarter of 2017. The year-over-year decrease in operating expenses in
the fourth quarter was driven by a decrease of $1.1 million, or 34%
year-over-year, in research and development expenses, which was due to
reduced product development costs. The year-over-year decrease in
research and development expenses was offset almost entirely by an
increase of $1.0 million, or 38% year-over-year, in general and
administrative expenses, primarily due to increased expenses related to
the buildout of the Company’s commercial operations infrastructure.

Operating loss for the fourth quarter of 2018 decreased approximately
$0.6 million, or 10% year-over-year, to $5.3 million, compared to $5.9
million in the fourth quarter of 2017.

Total other expense for the fourth quarter of 2018 decreased $2.0
million, or 93% year-over-year, to $0.1 million, compared to $2.1
million in the fourth quarter of 2017. The year-over-year decrease in
total other expense was driven primarily by the change in fair value of
derivative financial instruments, which was a loss of $0.2 million for
the fourth quarter of 2018, compared to a gain of $2.0 million in the
fourth quarter of 2017. The change in fair value of the Company’s
derivative financial instruments was primarily attributable to the
change in the Company’s stock price, volatility and the number of
derivative financial instruments being measured during the period.

Net loss for the fourth quarter of 2018 increased $1.4 million, or 37%
year-over-year, to $5.1 million, or $0.21 per basic common share,
compared to net loss of $3.7 million, or $0.19 per basic common share,
in the fourth quarter of 2017. Diluted loss per common share was $0.22
and $0.26 for the quarters ended December 31, 2018 and 2017,
respectively. Weighted average shares used to compute basic net loss per
common share were 24.5 million and 19.4 million for the fourth quarters
of 2018 and 2017, respectively. Weighted average shares used to compute
diluted net loss per common share were 24.8 million and 19.9 million for
the fourth quarters of 2018 and 2017, respectively.

Full Year 2018 Financial Results

Revenue for the full year ended December 31, 2018 was $0.5 million,
which represents the Company’s first revenue since its inception. In
2018, the Company recognized license fee revenue of $0.5 million in
connection with the satisfaction of its performance obligation related
to the strategic alliance with Health Tech Connex, Inc. and Heuro
Canada, Inc.

Operating expenses for the full year ended December 31, 2018 increased
$4.3 million, or 19% year-over-year, to $27.2 million, compared to $22.9
million for the full year ended December 31, 2017. The increase in
operating expenses in the period was driven primarily by an increase of
$8.7 million, or 103% year-over-year, in general and administrative
expenses. The increase in general and administrative expenses was
largely due to higher stock-based compensation expense, which was
primarily the result of the change in the Company’s functional currency.
The increase in general and administrative expenses was also driven, in
part, by increased expenses related to the buildout of the Company’s
commercial operations infrastructure and higher headcount compared to
the prior year period. The year-over-year increase in operating expenses
was offset partially by a decrease of $4.4 million, or 31%
year-over-year, in research and development expenses, primarily due to
reduced clinical trial and product development expenses.

Operating loss for the full year ended December 31, 2018 increased $3.8
million, or 17% year-over-year, to $26.7 million, compared to operating
loss of $22.9 million in the prior year period.

Total other expense for the full year ended December 31, 2018 decreased
$3.2 million, or 62% year-over-year, to $1.9 million, compared to $5.2
million in the prior year period. The year-over-year decrease in total
other expense was driven primarily by the change in foreign exchange
gain (loss), which resulted in a gain of $1.6 million for the full year
ended December 31, 2018, compared to a loss of $1.7 million in the prior
year period.

Net loss for the full year ended December 31, 2018 increased
approximately $0.6 million, or 2% year-over-year, to $28.6 million, or
$1.26 per basic and diluted common share, compared to net loss of $28.0
million, or $1.50 per basic and diluted common share, in the prior year
period. Weighted average shares used to compute net loss per basic and
diluted common share were 22.8 million and 18.6 million for the full
years ended December 31, 2018 and 2017, respectively.

As of December 31, 2018, the Company had cash of approximately $25.6
million, compared to $5.6 million at December 31, 2017. The Company had
no outstanding debt at December 31, 2018 and 2017.

Full Year 2019 Outlook

For the twelve months ending December 31, 2019, the Company expects
total revenue in a range of $1.6 million to $2.0 million.

Conference Call

Management will host a conference call at 4:30 p.m. Eastern Time on
March 14, 2019 to discuss the results of the quarter and the full year.
Those who would like to participate may dial 866-393-4306 (734-385-2616
for international callers) and provide access code 8929969. A live
webcast of the call will also be provided on the Events section of the
Company’s investor relations website at https://heliusmedical.com/index.php/investor-relations/events/upcoming-events.

For those unable to participate, a replay of the call will be available
for two weeks at 855-859-2056 (404-537-3406 for international callers);
access code 8929969. The webcast will be archived on the Events section
of the Company’s investor relations website.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on
neurological wellness. The Company’s purpose is to develop, license and
acquire unique and non-invasive platform technologies that amplify the
brain’s ability to heal itself. The Company’s first product in
development is the Portable Neuromodulation Stimulator (PoNS^TM).
For more information, visit www.heliusmedical.com.

About the PoNS Device and PoNS Treatment

The Portable Neuromodulation Stimulator (PoNS) is a licensed class II,
noninvasive, medical device in Canada indicated for the treatment of
chronic balance deficit due to mild-to-moderate traumatic brain injury
when used in conjunction with physical therapy. The PoNS is an
investigational medical device in the United States and the European
Union (“EU”), and it is currently under review for clearance by the FDA
and EU Notified Body. PoNS Treatment is currently not commercially
available in the United States or the European Union.

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,” “continue,” “look forward,” “will” and similar expressions.
Such forward-looking statements include, among others, statements
regarding projected financial results, the success of the Company’s
commercial launch in Canada, expected future development timelines,
regulatory approvals, business and commercialization initiatives and
objectives and the potential receipt of regulatory clearance of the PoNS
device.

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 the uncertainties associated with the commercial
launch of a new therapeutic treatment, the FDA regulatory submission and
approval process, including the Company’s capital requirements to
achieve its business objectives and other risks detailed from time to
time in the filings made by the Company with securities regulators, and
including the risks and uncertainties about the Company’s business
described in the “Risk Factors” sections of the Company’s Annual Report
on Form 10-K for the year ended December 31, 2018 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.

The Toronto Stock Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of the content of this news
release.


Helius Medical Technologies, Inc.
Consolidated Balance Sheets
(Except for share data, amounts in thousands)

	As of December 31,
	2018			2017
ASSETS
Current assets
Cash	$	25,583		$	5,562
Receivables		275			704
Inventory		392			—
Prepaid expenses		447			352
Other current assets		264			—
Total current assets		26,961			6,618
Property and equipment, net		554			173
Other assets
Non-current receivables		294			—
Other non-currents assets		18			18
Total other assets		312			18
TOTAL ASSETS	$	27,827		$	6,809
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities
Accounts payable	$	2,392		$	3,479
Accrued liabilities		1,812			1,242
Derivative financial instruments		13,769			9,578
Total current liabilities		17,973			14,299
TOTAL LIABILITIES		17,973			14,299
Commitments and contingencies (Note 7)
STOCKHOLDERS’ EQUITY (DEFICIT)
Preferred stock, $0.001 par value; 10,000,000 shares authorized, 0 shares issued and outstanding as of December 31, 2018; no preferred stock authorized as of December 31, 2017		—			—
Class A common stock, $0.001 par value; 150,000,000 shares authorized; 25,827,860 shares issued and outstanding as of December 31, 2018		26			—
Common stock (Unlimited Class A common shares authorized); 20,178,226 shares issued and outstanding as of December 31, 2017		—			52,230
Additional paid-in capital		105,411			6,602
Accumulated other comprehensive income (loss)		(591	)		47
Accumulated deficit		(94,992	)		(66,369	)
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT)		9,854			(7,490	)
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)	$	27,827		$	6,809


Helius Medical Technologies, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(Amounts in thousands except share and per share data)

	Three Months Ended						Year Ended
	December 31,						December 31,
	2018			2017			2018			2017
		Unaudited						Audited
Revenue:
License revenue	$	478		$	–		$	478		$	–
Operating expenses:
Research and development		2,159			3,266			9,939			14,387
General and administrative		3,582			2,604			17,214			8,466
Total operating expenses		5,741			5,870			27,153			22,853
Operating loss		(5,263	)		(5,870	)		(26,675	)		(22,853	)
Other income (expense):
Other income		—			—			63			—
Change in fair value of derivative financial instruments		(221)			2,009			(3,577	)		(3,443	)
Foreign exchange gain (loss)		368			132			1,566			(1,728	)
Total other income (expense)		147			2,141			(1,948	)		(5,171	)
Net loss		(5,116	)		(3,729	)		(28,623	)		(28,024	)
Other comprehensive (loss) gain:
Foreign currency translation adjustments		292			(141	)		(638	)		1,775
Comprehensive loss	$	(4,824	)	$	(3,870	)	$	(29,261	)	$	(26,249	)
Net loss per share
Basic	$	(0.21	)	$	(0.19	)	$	(1.26	)	$	(1.50	)
Diluted	$	(0.22	)	$	(0.26	)	$	(1.26	)	$	(1.50	)
Weighted average shares outstanding
Basic		24,461,357			19,416,708			22,786,192			18,632,740
Diluted		24,826,566			19,948,971			22,786,192			18,632,740


Helius Medical Technologies, Inc.
Condensed Consolidated Statements of Cash Flows
(Amounts in thousands)

	Year Ended December 31,
	2018			2017

Cash flows from operating activities
Net loss	$	(28,623	)	$	(28,024	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense		59			17
Change in fair value of derivative financial instruments		3,577			3,443
Stock-based compensation expense		8,095			1,818
Unrealized foreign exchange (gain) loss		(1,711	)		1,585
Changes in operating assets and liabilities:
Receivables		135			(479	)
Prepaid expenses		(95	)		186
Inventory		(392	)		—
Other assets		(264	)		—
Account payable		(1,087	)		1,318
Accrued liabilities		685			811
Net cash used in operating activities		(19,621	)		(19,325	)
Cash flows from investing activities
Purchase of property and equipment		(440	)		(190	)
Net cash used in investing activities		(440	)		(190	)
Cash flows from financing activities
Proceeds from the issuances of common stock and warrants		38,526			20,878
Share issuance costs		(3,161	)		(1,248	)
Proceeds from the exercise of stock options and warrants		4,663			2,588
Net cash provided by financing activities		40,028			22,218
Effect of foreign exchange rate changes on cash		54			190
Net increase in cash		20,021			2,893
Cash at beginning of year		5,562			2,669
Cash at end of year	$	25,583		$	5,562
Supplemental disclosure of non-cash cash activities
Cash paid for interest	$	—		$	—
Cash paid for income taxes		—			—
Supplemental schedule of non-cash investing and financing activities
Share issuance costs included in accounts payable and accrued liabilities	$	52		$	73