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OPSENS ANNOUNCES THIRD QUARTER FISCAL 2022 FINANCIAL RESULTS WITH RECORD QUARTERLY REVENUES

T.OPS

Conference call will be held today at 11:00 a.m. ET

QUEBEC CITY, July 14, 2022 /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 released results for its third quarter ended May 31, 2022.

Opsens Logo (CNW Group/OpSens Inc.)

Third Quarter Highlights
  • Record consolidated sales of $10.1 million in the third quarter of 2022, compared to $9.2 million in the third quarter of 2021;
  • Record sales in coronary artery disease of $6.6 million in the third quarter of 2022, compared to $6.2 million in the third quarter of 2021;
  • Record sales of optical medical products led by the recently signed four-year extension of our agreement with Abiomed;
  • Received Health Canada approval for the SavvyWire™ ("SavvyWire"), OpSens' new guidewire for transcatheter aortic valve replacement procedures, or TAVR;
  • First commercial TAVR procedures completed with the SavvyWire in Canada;
  • Dr. Rodés-Cabau published the results of his clinical data in EuroIntervention Journal;
  • Dr. Philippe Genereux published the results of his clinical data in JSCAI; and
  • Cash and cash equivalents of $28 million as of May 31, 2022.
Management Commentary

"I am pleased with the financial performance of the third quarter, as we achieved record revenues surpassing $10 million with a number of significant milestones that include Health Canada approval of our SavvyWire, as well as the first successful procedures and revenues for the SavvyWire, as part of the controlled commercial launch in Canada," said Louis Laflamme, President and Chief Executive Officer of OpSens.

"We continue to make meaningful progress in our initial launch sites which will support the full commercialization of the SavvyWire in Canada. During the third quarter, Dr. Josep Rodés-Cabau and Dr. Réda Ibrahim successfully performed the first commercial TAVR procedures using the SavvyWire in Canada. The medical teams at both hospitals were very enthusiastic with the SavvyWire's operational results and improved workflow. Outside of Canada, our 510(K) submissions with the FDA for regulatory clearance in the U.S. and for CE Mark approval in Europe are currently under review for SavvyWire. While we work to secure regulatory clearance, we are investing to support successful global commercial product launch upon approval," concluded Mr. Laflamme.

Third Quarter Ended May 31, 2022

Consolidated sales reached $10.1 million in the third quarter of 2022, compared to $9.2 million in the third quarter of 2021, a 9% increase over the third quarter of 2021, which was our previous record. This is the first quarter OpSens exceeded the $10 million mark.

Sales of coronary artery disease products, Fractional Flow Reserve ("FFR") and diastolic pressure ratio ("dPR"), amounted to $6.6 million in the third quarter of 2022, compared to $6.2 million in the same period in 2021, a 6% increase over the third quarter of 2021, our previous record quarter.

Sales of optical medical products, including the supply agreement with Abiomed, totaled $2.6 million in the third quarter of 2022, compared to $2.3 million in the third quarter of 2021.

Industrial sales increased 22% to $0.9 million in the third quarter of 2022, compared to $0.7 million in the third quarter of 2021.

Gross margin decreased to 51% in the third quarter of 2022 from 59% in the third quarter of 2021, mainly due to the end-of-life production for the OptoWire 2, the ongoing supply chain issues affecting manufacturing costs and the increased weighting of distributor sales over direct sales.

Operating expenses in the third quarter of 2022 were $7.8 million, an increase of $2.2 million, compared to $5.6 million in in the third quarter of 2021. The increase in operating expenses was in line with our growth initiatives resulting in increased headcount in research and development, sales and marketing and administration.

Net loss was $2.9 million in the third quarter of 2022, compared to $570,000 in the third quarter of 2021.

OpSens had a cash position of $28 million as of May 31, 2022, compared to $38.6 million as of August 31, 2021.

Table A

(In thousands of Canadian dollars, except for
information per share)

Three-month

period ended

May 31, 2022

Three-month

period ended

May 31, 2021

Nine-month

period ended

May 31, 2022

Nine-month

period ended

May 31, 2021

$

$

$

$






Revenues





Sales





Medical

9,170

8,501

23,478

23,651

Industrial

874

713

2,596

2,692


10,044

9,214

26,074

26,343

Other

32

19

197

56


10,076

9,233

26,271

26,399

Cost of sales

4,938

3,809

12,846

11,734

Gross margin

5,138

5,424

13,425

14,665

Gross margin percentage

51 %

59 %

51 %

56 %






Operating expenses





Administrative

1,886

1,722

5,950

4,679

Sales and marketing

3,639

2,316

8,237

5,458

Research and development

2,322

1,590

6,114

4,170


7,847

5,628

20,301

14,307






Other income

-

(121)

-

(721)

Financial expenses

75

144

311

496

Loss on foreign currency translation

63

327

120

484






Income (loss) before income taxes

(2,847)

(554)

(7,307)

99

Current income tax expense

9

16

43

35






Net income (loss)

(2,856)

(570)

(7,350)

64






Basic and diluted net income (loss) per share

(0.03)

(0.01)

(0.07)

0.00






Table B

CONSOLIDATED BALANCE SHEET HIGHLIGHTS

(in thousands of Canadian dollars)

As at

As at

May 31, 2022

August 31,2021

$

$




Cash and cash equivalents

28,030

38,563

Trade and other receivables

5,267

4,135

Inventories

5,624

6,115

Total Current Assets

41,035

49,783

Property, plant, and equipment

2,517

2,731

Intangible assets

1,809

1,677

Right-of-use assets

5,197

4,322

Total Assets

50,558

58,513




Current liabilities

6,993

7,395

Long-term debt

775

4,595

Lease liabilities

5,146

4,193

Total Liabilities

12,914

16,183

Shareholders' equity

37,644

42,330

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, July 14, 2022.

Interested parties can access the conference call by dialing 1-833-756-0865 or 1-412-317-5754 or can listen via a live webcast, from the link available in the Investors section of the Company's website at https://opsens.com/investors/ or at https://app.webinar.net/y85X9w0qkGv, 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 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.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/July2022/14/c7862.html

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