OpSens Announces Fourth Quarter And Fiscal Year 2021 Financial Results

Conference call on the results today at 11 a.m. ET

QUEBEC CITY, Nov. 23, 2021 /CNW Telbec/ - OpSens Inc. ("OpSens" or the "Company") (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, today reported its results for the fourth quarter and fiscal year 2021 ended August 31, 2021.

Fiscal Year Highlights

• Record total revenue of $34.5 million in FY 2021 compared with $29.5 million in FY 2020, a 17% increase;
• Record sales of coronary artery disease products at $22.9 million in FY 2021, compared with $18.7 million in FY 2020, a 22% increase;
• Signed two agreements with major U.S. Group Purchasing Organizations (GPO) to provide its members with the Company's OptoWire;
• OpSens Solutions received funding to develop an optical-based fuel monitoring system for aerospace applications, including civil aircrafts;
• Awarded a contract to supply fiber optic absolute and differential pressure sensors for the International Thermonuclear Experimental Reactor (ITER);
• The Company closed a $28.75 million bought deal public offering in February 2021;
• Cash and cash equivalents at $38.6 million as of August 31, 2021, an increase of $27.7 million versus last year period ended August 31, 2020.

Recent Highlights

• OpSens successfully completed first in-man study with the SavvyWire, its new guidewire for transcatheter aortic valve replacement (TAVR or TAVI) procedures, can file product for regulatory 510(k) clearance with the U.S. Food and Drug Administration ("FDA").

Management Commentary 

"I am pleased with the strong progress made on both the operating and development sides of our business, as we report record annual revenues of $34.5 million in fiscal 2021, while advancing our TAVR pipeline product with the completion of our in-man study. The many exciting developments of the past few months are setting OpSens up for continued growth, as we remain on track to commercialize our innovative product for TAVR in 2022," said Louis Laflamme, President and CEO of OpSens. "The closing of the $28.75 million financing in February will contribute to the enhancement of the commercialization and marketing strategy for TAVR and coronary artery disease products."

"The Company made great progress in the U.S. market, signing two, three-year contracts with major U.S. GPOs. An agreement signed with Cathmedical in Spain enables the integration of the OpSens system into the Picasso hemodynamic system and opens up additional seamless integrations like this in other markets," Laflamme added.

"We are optimistic as we look ahead to fiscal 2022 and beyond. Our continued progress over the past few years to create, manufacture and deliver innovative medical products was highlighted throughout the year. I congratulate the OpSens team for their determination to provide customers with continued access to our technology," concluded Mr. Laflamme. 

Fiscal Year Financial Results - Year Ended August 31, 2021

Total revenue was $34.5 million in FY 2021 compared with $29.5 million in FY 2020 an increase of $5 million or 17%. The increase was reduced by a negative exchange rate impact of $1.4 million for the year.

Sales of products for the measurement of coronary artery disease (Fractional Flow Reserve ("FFR") and diastolic pressure ratio ("dPR")) were $22.9 million in FY 2021 compared with $18.7 million in FY 2020. The $4.2 million increase was primarily related to the increase in the U.S. and EMEA markets.

Sales of optical medical systems, including the Company's partnership for ventricular assist device sensors, were $8.1 million in FY 2021 compared with $8.3 million in FY 2020.

Industrial sales increased 36% to $3.4 million in FY 2021, compared with $2.5 million in FY 2020. The increase was driven by a higher volume of orders in the nuclear fields.

Operating expenses in FY 2021 reached $19.6 million compared with $19.3 million in FY 2020. The increase is mostly attributable to additional expenses of $1.4 million in our general and administrative costs pertaining to higher headcount and professional fees partially offset by a decrease of $1.1 million in sales and marketing as activities throughout much of the year were restrained by COVID-19.

Gross margins were 54% in FY 2021 compared to 53% in FY 2020 driven by increased higher sales volumes and related economies combined with enhanced productivity and lower cost of goods sold for the OptoWire III.

Net loss was $1.2 million during FY 2021 compared with a net loss of $2.6 million in FY 2020. The improvement is primarily driven by increased sales of coronary artery disease products.

OpSens had a cash position of $38.6 million as of August 31, 2021.

Fourth Quarter Financial Results – Three-Month Period Ended August 31, 2021

Total revenue was $8.1 million in the Q4 2021 compared with $7.6 million in Q4 2020 an increase of $0.5 million or 7%. The increase was reduced by a negative exchange rate impact of $0.5 million for the quarter.

Sales of products for the diagnosis and treatment of coronary artery disease (FFR and dPR) were $5.3 million in Q4 2021 compared with $4.8 million in Q4 2020. The $0.5 million increase was primarily attributed to the increase in the Canadian and U.S. markets.

Sales of optical medical systems, including the Company's partnership for ventricular assist device sensors, were $2.0 million in Q4 2021 compared with $2.3 million in Q4 2020.

Industrial sales increased to $0.7 million in Q4 2021, compared with $0.5 million in Q4 2020.

Gross margins were stable at 50% in Q4 2021 compared in Q4 2020. 

Operating expenses in Q4 2021 were $5.3 million compared with $3.8 million in Q4 2020. The increase of $1.5 million in operating expenses is mostly attributable to additional expenses of $0.8 million in our general and administrative costs pertaining to higher headcount and professional fees, and by an increase of $0.8 million in sales and marketing as activities were strongly impacted by COVID-19 last year.

Net loss was $1.2 million during Q4 2021 compared with a net income of $0.6 million in Q4 2020. The $1.8 million decrease in net earnings is mainly the result of an increase  expenses to drive growth in our coronary artery disease products and development our TAVR product, as well as the recognition of a non-recuring grant of $0.9 million from the Canadian government last year.

Table A

Consolidated statement of results (In thousands of Canadian dollars, except for information per share)	Three-month period ended August 31, 2021				Three-month period ended August 31, 2020	For the year ended August 31, 2021	For the year ended August 31, 2020
	$				$	$	$
Revenues
Sales
Medical	7,335				7,060	30,985	26,996
Industrial	671				516	3,363	2,457
	8,006				7,576	34,348	29,453
Other	60				-	116	-
	8,066				7,576	34,464	29,453
Cost of Sales	4,050				3,760	15,783	13,834
Gross margin	4,016				3,816	18,681	15,619
Gross margin (%)	50%				50%	54%	53%
Operating Expenses
Administration	1,794				1,015	6,473	5,041
Sales and marketing	2,191				1,458	7,649	8,780
R&D	1,340				1,312	5,510	5,441
	5,325				3,785	19,632	19,262
Other income	(19)				(882)	(740)	(1,683)
Financial expenses (income)				(62)	356	918	684
Income (loss) before income taxes	(1,200)				557	(1,129)	(2,644)
Income taxes	15				-	21	-
Net income (loss)	(1,215)				557	(1,150)	(2,644)
Net income (loss) per share – Basic and diluted	(0.01)				0.01	(0.01)	(0.03)

Table B

CONSOLIDATED BALANCE SHEET HIGHLIGHTS (in thousands of Canadian dollars)	As at	As at
	August 31, 2021	August 31, 2020
	$	$
Cash and cash equivalents	38,563	10,884
Trade and other receivables	4,135	4,041
Inventories	6,115	6,505
Total Current Assets	49,783	22,543
Property, plant, and equipment	2,731	3,230
Intangible assets	1,677	1,622
Right-of-use assets	4,322	4,513
Total Assets	58,513	31,908
Current liabilities	7,395	5,655
Long-term debt	4,595	6,608
Lease liabilities	4,193	4,298
Total Liabilities	16,183	16,561
Shareholders' equity	42,330	15,347

Conference Call Today

Louis Laflamme, President and Chief Executive Officer, and Robin Villeneuve, Chief Financial Officer, will hold a conference call to discuss the quarter's financial results at 11:00 a.m. (Eastern Time) today, November 23, 2021.

Interested parties can access the conference call by dialing [phone] or [phone] or can listen via a live webcast, from the link available in the Investors section of the Company's website or at Investors section of the Company's website or at https://www.webcaster4.com/Webcast/Page/2512/43575, 5 to 10 minutes before the beginning of the conference call.

A replay will be available after the call, in the Investors section of the Company's website at https://opsens.com/investors/.

About OpSens Inc. (www.OpSens.com or www.OpSensmedical.com)
OpSens focuses mainly in interventional cardiology. The Company offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of over 150,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

OpSens is also involved in industrial activities in developing, manufacturing, and installing innovative fiber optic sensing solutions for critical applications.

Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, and achievements of OpSens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.

Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

SOURCE OPSENS Inc.

please contact: Louis Laflamme, CPA, CA, Chief Executive Officer, 418.781.0333; Robin Villeneuve, CPA, CA Chief Financial Officer, 418.781.0333

Related Links

https://opsens.com/