Helius Medical Applied sciences, Inc. Stories Fourth Quarter and Full Yr 2020 Monetary Outcomes
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NEWTOWN, Pa., March 10, 2021 (GLOBE NEWSWIRE) — Helius Medical Applied sciences, Inc. (Nasdaq: HSDT) (TSX:HSM) (“Helius” or the “Firm”), a neurotech firm centered on neurological wellness, as we speak reported monetary outcomes for the quarter and full yr ended December 31, 2020.
Fourth Quarter and Latest Enterprise Updates
- The Firm closed a personal placement for complete internet proceeds of roughly $3.2 million and an underwritten public providing of items for internet proceeds of roughly $9.6 million.
• Helius expects its current capital, together with internet proceeds from the general public providing that closed and internet proceeds raised by way of the train of warrants within the first quarter of 2021, might be enough to fund the Firm’s operations into the primary quarter of 2022.
- The Firm introduced on January 11, 2021 that it submitted its formal response to the U.S. Meals and Drug Administration’s (the “FDA”) request for added data, associated to Helius’ request for de novo classification and clearance of the PoNS system.
- The Firm acquired written discover from The Nasdaq Inventory Market LLC on January 19, 2021 that Helius is in compliance with all relevant itemizing requirements.
- The Facilities for Medicare & Medicaid Providers (“CMS”) introduced that it’s finalizing a brand new protection pathway, Medicare Protection of Revolutionary Expertise, or “MCIT,” for FDA-designated breakthrough medical units cleared by FDA.
• The MCIT rule will present nationwide Medicare protection as early as the identical day as FDA market authorization for breakthrough units and protection would final for 4 years.
Fourth Quarter 2020 Monetary Abstract
- Income of $191 thousand, in comparison with income of $152 thousand in fourth quarter of 2019.
- Working lack of $3.0 million, in comparison with working lack of $5.6 million in fourth quarter of 2019.
- Web lack of $2.5 million, in comparison with internet lack of $5.3 million in fourth quarter of 2019.
Full Yr 2020 Monetary Abstract
- Income of $0.7 million, in comparison with income of $1.5 million in 2019.
- Working lack of $14.4 million, in contrast working lack of $24.0 million in 2019.
- Web lack of $14.1 million, in comparison with internet lack of $9.8 million in 2019.
- As of December 31, 2020, the Firm had money of $3.3 million, in comparison with $5.5 million at December 31, 2019. The Firm had no debt excellent at December 31, 2020.
“In the course of the fourth quarter, we had been happy with our tempo of progress and the dedication our staff have proven in view of the continued headwinds created by the COVID-19 pandemic,” mentioned Dane Andreeff, Interim President and Chief Govt Officer of Helius. “Our regulatory workforce centered on getting ready a radical response to FDA’s request for added data associated to our request for U.S. de novo classification and clearance in MS. Because of their efforts, we had been happy to announce the submission of our response on January eleventh, and we hope to obtain de novo classification and clearance throughout the first half of 2021. In Canada, whereas we continued to see the impacts of COVID on the clinics we serve and their sufferers, our industrial workforce efficiently expanded our community of licensed PoNS clinics from 7 to 31 areas by year-end, exceeding our objective. Subsequent to quarter-end, we additionally secured roughly $11 million to strengthen our steadiness sheet and help our operations going ahead.”
“As we enter 2021, Helius is targeted on securing regulatory clearance and protection for our breakthrough PoNS system within the U.S. whereas supporting our lately expanded community of Canadian clinics. With our U.S. de novo submission in MS beneath evaluation, a community of 31 clinics in Canada and an enhanced steadiness sheet, we consider we’re well-positioned to climate the continued results of the pandemic and broaden the provision of our PoNS Remedy going ahead. We stay dedicated to executing on our regulatory and industrial methods as successfully and effectively with the last word objective of bringing our revolutionary PoNS Remedy to assistance from as many sufferers as potential.”
Fourth Quarter 2020 Monetary Outcomes
Whole income for the fourth quarter of 2020 was $191 thousand, in comparison with $152 thousand within the fourth quarter of 2019. Product gross sales represented roughly 96% of complete income within the fourth quarter of 2020 in comparison with 100% of complete income within the fourth quarter of 2019. Product gross sales in each intervals had been generated by way of gross sales of the PoNS system pursuant to provide agreements with PoNS Approved clinic areas in Canada. License and payment income represented 4% of gross sales within the fourth quarter of 2020, in comparison with 0% of gross sales within the fourth quarter of 2019.
Gross loss for the fourth quarter of 2020 was $10 thousand, in comparison with gross lack of $156 thousand within the fourth quarter of 2019. Working bills for the fourth quarter of 2020 decreased $2.5 million, or 45% year-over-year, to $3 million, in comparison with $5.5 million within the fourth quarter of 2019.
Working loss for the fourth quarter of 2020 decreased $2.6 million, or 47% year-over-year, to $3.0 million, in comparison with $5.6 million within the fourth quarter of 2019.
Whole different earnings for the fourth quarter of 2020 was $468 thousand, in comparison with $294 thousand within the fourth quarter of 2019.
Web loss for the fourth quarter of 2020 was $2.5 million, or $(1.77) per primary and diluted widespread share, in comparison with a internet lack of $5.3 million, or $(6.71) per primary and diluted widespread share, within the fourth quarter of 2019. Weighted common shares used to compute primary and diluted internet loss per widespread share had been 1.4 million and 0.8 million for the fourth quarter of 2020 and 2019, respectively.
Full Yr 2020 Monetary Outcomes
Whole income for the complete yr 2020 was $0.7 million, in comparison with $1.5 million for full yr 2019. Product gross sales represented 95% of complete income for full yr 2020, in comparison with 97% of complete for full yr 2019. Product gross sales in each intervals had been generated by way of gross sales of the PoNS system pursuant to provide agreements with PoNS Approved clinic areas in Canada. License and payment income represented 5% of complete income for full yr 2020, in comparison with 3% of complete income for the complete yr 2019.
Gross revenue for full yr 2020 was $0.3 million, in comparison with gross revenue of $0.7 million for full yr 2019. Working bills for full yr 2020 decreased $9.9 million, or 41% year-over-year, to $14.7 million, in comparison with $24.6 million for full yr 2019.
Working loss full yr 2020 decreased $9.6 million, or 40% year-over-year, to $14.4 million, in comparison with working lack of $24.0 million for full yr 2019.
Whole different earnings for full yr 2020 was $0.3 million, in comparison with $14.2 million of different earnings for full yr 2019. The year-over-year change is pushed primarily by the change in truthful worth of spinoff devices which is primarily attributable to the change in our inventory value, volatility and the variety of spinoff monetary devices being measured throughout the interval.
Web loss for full yr 2020 was $14.1 million, or $(11.80) per primary and diluted widespread share, in comparison with internet lack of $9.8 million, or $(12.99) per primary and diluted widespread share, for full yr 2019. Weighted common shares used to compute primary and diluted internet loss per share had been 1.2 million and 0.8 million for full yr 2020 and full yr 2019, respectively.
Web money offered by financing actions throughout the twelve months ended December 31, 2020 was $9.6 million.
As of December 31, 2020, the Firm had money of $3.3 million, in comparison with $5.5 million at December 31, 2019. The Firm had no debt excellent at December 31, 2020.
Full Yr 2021 Outlook
The Firm isn’t offering a proper monetary outlook for the complete yr 2021 at the moment, given the continued uncertainty on the period and impression of the COVID-19 pandemic on its monetary and working outcomes.
Administration will host a convention name at 5:00 p.m. Japanese Time on March 10, 2021 to debate the outcomes of the quarter and enterprise outlook. Those that wish to take part could dial 877-407-2988 (201-389-0923 for worldwide callers) and supply entry code 13715793. A dwell webcast of the decision may even be offered on the Occasions part of the Firm’s investor relations web site at:
For these unable to take part, a replay of the decision might be out there for 2 weeks at 877-660-6853 (201-612-7415 for worldwide callers); entry code 13715793. The webcast might be archived on the Occasions part of the Firm’s investor relations web site.
About Helius Medical Applied sciences, Inc.
Helius Medical Applied sciences is a neurotech firm centered on neurological wellness. The Firm’s function is to develop, license and purchase distinctive and non-invasive platform applied sciences that amplify the mind’s skill to heal itself. The Firm’s first industrial product is the Transportable Neuromodulation Stimulator (PoNS™). For extra data, go to www.heliusmedical.com.
In regards to the PoNS Machine and PoNS Remedy
The Transportable Neuromodulation Stimulator (PoNS™) is a licensed class II, non-implantable, medical system in Canada supposed to be used as a brief time period therapy (14 weeks) of gait deficit as a result of gentle and average signs from a number of sclerosis (MS), and continual steadiness deficit as a result of mild-to-moderate traumatic mind damage (mmTBI) and is for use together with bodily remedy. The PoNS™ is an investigational medical system in america, the European Union (“EU”), and Australia (“AUS”). The system is at present beneath evaluation for de novo classification and clearance by the FDA. It is usually beneath premarket evaluation by the AUS Therapeutic Items Administration. PoNS™ is at present not commercially out there in america, the European Union or Australia.
Cautionary Disclaimer Assertion:
Sure statements on this information launch aren’t primarily based on historic information and represent forward-looking statements or forward-looking data throughout the which means of the U.S. Personal Securities Litigation Reform Act of 1995 and Canadian securities legal guidelines. All statements apart from statements of historic truth included on this information launch are forward-looking statements that contain dangers and uncertainties. Ahead-looking statements are sometimes recognized by phrases equivalent to “consider,” “proceed,” “count on,” “look ahead,” “will” and related expressions. Such forward-looking statements embody, amongst others, statements relating to the COVID-19 pandemic, together with its impression on the Firm, the Firm’s future progress and operational progress, together with scientific and regulatory growth plans for the PoNS system, the Firm’s expectations relating to the sufficiency of funds for anticipated future operations, potential receipt of regulatory clearance of the PoNS system in america, the success of the Firm’s deliberate research, enterprise and commercialization initiatives and targets, and expectations for full yr 2021.
There could be no assurance that such statements will show to be correct and precise outcomes and future occasions may differ materially from these expressed or implied by such statements. Vital elements that might trigger precise outcomes to vary materially from the Firm’s expectations embody uncertainties related to the scientific growth course of and FDA regulatory submission and approval course of, together with that the Firm’s request for de novo classification and clearance could also be declined by the FDA, that the FDA isn’t required to and will not reply to the Firm’s request within the timeframe indicated by its de novo evaluation objectives or within the time the Firm expects, whether or not the Firm’s response might be passable to the FDA, whether or not the FDA would require further data, whether or not the Firm will be capable of present it in a well timed method and whether or not such further data might be passable to the FDA, the impression of the COVID-19 pandemic, uncertainties related to scientific trial enrollments and the outcomes of the deliberate research, uncertainties related to the scientific growth course of and FDA regulatory submission and approval course of, together with the Firm’s capital necessities to attain its enterprise targets and different dangers detailed infrequently within the filings made by the Firm with securities regulators, and together with the dangers and uncertainties in regards to the Firm’s enterprise described within the “Threat Components” sections of the Firm’s Annual Report on Type 10-Okay for the yr ended December 31, 2020 and its different filings with america Securities and Change Fee and the Canadian securities regulators, which could be obtained from both at www.sec.gov or www.sedar.com.
The reader is cautioned to not place undue reliance on any forward-looking assertion. The forward-looking statements contained on this information launch are made as of the date of this information launch and the Firm assumes no obligation to replace any forward-looking assertion or to replace the the reason why precise outcomes may differ from such statements besides to the extent required by regulation.
The Toronto Inventory Change has not reviewed and doesn’t settle for duty for the adequacy or accuracy of the content material of this information launch.
Helius Medical Applied sciences, Inc.
Unaudited Consolidated Steadiness Sheets
(Aside from share knowledge, quantities in 1000’s)
|December 31, 2020||December 31, 2019|
|Accounts receivable, internet||74||210|
|Pay as you go bills||735||610|
|Whole present property||4,685||7,241|
|Property and gear, internet||486||712|
|Intangible property, internet||527||582|
|Working lease right-of-use asset, internet||90||552|
|Whole different property||1,376||2,394|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Working lease legal responsibility||59||172|
|Spinoff monetary devices||—||5|
|Whole present liabilities||2,424||3,802|
|Working lease legal responsibility||32||465|
|Most popular inventory, $0.001 par worth; 10,000,000 shares licensed; no shares issued and excellent as of December 31, 2020 and December 31, 2019||—||—|
|Class A Widespread inventory, $0.001 par worth; 150,000,000 shares licensed; 1,484,362 and 877,672 shares issued and excellent as of December 31, 2020 and December 31, 2019, respectively||1||1|
|Further paid-in capital||123,872||111,509|
|Accrued different complete loss||(1,099||)||(902||)|
|TOTAL STOCKHOLDERS’ EQUITY||3,871||5,835|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||6,547||$||10,347|
Helius Medical Applied sciences, Inc.
Unaudited Consolidated Statements of Operations and Complete Loss
(Quantities in 1000’s besides share and per share knowledge)
|Three Months Ended||Yr Ended|
|December 31,||December 31,|
|Product gross sales, internet||$||184||$||159||$||625||$||1,454|
|Whole working income||191||152||661||1,496|
|Value of gross sales:|
|Value of product gross sales||201||308||388||846|
|Analysis and growth||827||1,599||4,582||8,061|
|Promoting, basic and administrative||2,089||3,806||9,714||16,521|
|Whole working bills||2,992||5,469||14,659||24,646|
|Change in truthful worth of spinoff monetary devices||—||80||4||14,113|
|Overseas change achieve||468||154||189||7|
|Whole different earnings||468||294||256||14,215|
|Different complete loss:|
|Overseas foreign money translation changes||(406||)||(143||)||(197||)||(311||)|
|Web loss per share|
|Weighted common shares excellent|
Helius Medical Applied sciences, Inc.
Unaudited Condensed Consolidated Statements of Money Flows
(Quantities in 1000’s)
|Money flows from working actions:|
|Changes to reconcile internet loss to internet money utilized in working actions:|
|Change in truthful worth of spinoff monetary devices||(4||)||(14,113||)|
|Inventory-based compensation expense||2,529||4,691|
|Unrealized overseas change (achieve) loss||(182||)||70|
|Provision for uncertain accounts||140||220|
|Provision for stock reserve||205||50|
|Intangible asset impairment||184||—|
|Loss from disposal of property and gear||110||—|
|Acquire from lease modification||(56||)||—|
|Adjustments in working property and liabilities:|
|Pay as you go bills||(125||)||(163||)|
|Different present property||—||264|
|Working lease legal responsibility||(28||)||(13||)|
|Web money utilized in working actions||(11,738||)||(20,999||)|
|Money flows from investing actions:|
|Buy of property and gear||(63||)||(278||)|
|Proceeds from sale of property and gear||61||—|
|Enterprise acquisitions, internet of money acquired||—||(416||)|
|Internally developed software program||(7||)||(75||)|
|Web money utilized in investing actions||(9||)||(769||)|
|Money flows from financing actions:|
|Proceeds from the issuance of widespread inventory and accompanying warrants||10,653||1,685|
|Share issuance prices||(1,015||)||(247||)|
|Proceeds from the train of inventory choices and warrants||—||215|
|Proceeds from Paycheck Safety Program same day loans||323||—|
|Compensation of Paycheck Safety Program Mortgage||(323||)||—|
|Web money offered by financing actions||9,638||1,653|
|Impact of overseas change price adjustments on money||(19||)||(9||)|
|Web lower in money||(2,128||)||(20,124||)|
|Money at starting of yr||5,459||25,583|
|Money at finish of yr||$||3,331||$||5,459|
Investor Relations Contact:
Westwicke Companions on behalf of Helius Medical Applied sciences, Inc.
Jack Powell, Vice President