OpSens Announces Fourth Quarter and Fiscal Year 2022 Financial Results

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OpSens announces fourth quarter and fiscal year 2022 financial results

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

Quebec City, Quebec, November 22, 2022 – 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 fourth quarter and fiscal year 2022 ended August 31, 2022.

Recent Highlights

  • Health Canada approval for SavvyWire marked the launch of the controlled and full-scale market release in Canada;
  • SavvyWire 510(k) regulatory clearance from the U.S. Food & Drug Administration (“FDA”) marked a controlled market release in the U.S.;
  • The first Transcatheter Aortic Valve Replacement or TAVR procedure performed with the SavvyWire in the United States by Dr. Philippe Genereux of Morristown Medical Center;
  • Presentation of clinical data on the performance of the SavvyWire on cardiology platforms by leading cardiologists in conventions and medical journals;
  • Extension of the supply agreement with Abiomed up to 2028.

Fiscal Year Highlights

  • Record consolidated sales of $35.3 million in FY 2022, compared with $34.5 million in FY 2021;
  • Sales in coronary artery disease products at $21.8 million in FY 2022, compared with $22.9 million in FY 2021;
  • Optical medical products sales increased by 17% to $9.5 million in FY 2022;
  • Industrial sales increased by 6% to $3.6 million in FY 2022;
  • Cash and cash equivalents at $23.8 million as of August 31, 2022.

Management Commentary

“The past year has been marked by both record fiscal sales and successful completion of regulatory steps for the SavvyWire in Canada and most recently in the United States, allowing us to proceed with our commercialization plans in both markets in FY2023,” said Louis Laflamme, President and Chief Executive Officer of OpSens. “We have successfully completed the controlled release phase for the SavvyWire in Canada and are now entering the full-scale release. In the U.S. we are entering the controlled release phase that will lead to the full-scale launch of the SavvyWire in calendar year 2023. Medical teams who have had the opportunity to use the SavvyWire for TAVR procedures have been very enthusiastic about its operational results and workflow,” concluded Mr. Laflamme.

“Commercially, the second half of the year was  stronger than the first half as the subsidence of the pandemic resulted in a commensurate uptick in hospital procedure volumes, particularly those that leverage the OptoWire. With an improved operating environment, investments into our sales and marketing efforts, as well as  the upcoming full-scale launch of SavvyWire throughout North America, I believe we are in a good  position to capture the significant opportunities we have in front of us,” concluded Mr. Laflamme.

Fiscal Year Financial Results – Year Ended August 31, 2022

Total revenue was $35.3 million in FY 2022, compared with $34.5 million in FY 2021, an increase of $0.8 million or 2%. Sales growth in the second half of the fiscal year was 11%, compared with a decrease of 5% in the first half of the fiscal year. The improved second half results were due to the subsidence of pandemic and commensurate uptick in procedure volumes. Total revenues were reduced by $0.6 million due to a negative foreign exchange impact.

Sales of coronary artery disease products, Fractional Flow Reserve (“FFR”) and diastolic pressure ratio (“dPR”), amounted to $21.8 million in FY 2022 compared with $22.9 million in FY 2021.  Sales growth in the second half of the fiscal year was 7%, compared with a decrease of 16% in the first half of the fiscal year. The decrease in sales for the year was due in part to the aforementioned impact of negative foreign exchange rates and lower procedure volumes during the first half of fiscal 2022 brought on by COVID-19 across the segment.

Sales of optical medical products, including the supply agreement with Abiomed, were $9.5 million in FY 2022, compared with $8.1 million in FY 2021, an increase of 17%.

Industrial sales increased by 6% to $3.6 million in FY 2022 from $3.4 million in FY 2021. This increase was due to a higher volume of orders in the military market.

Gross margins were 50% in FY 2022, compared with 54% in FY 2021. The decrease is mainly explained by the costs related to the phasing out of the production of the OptoWire 2, by non-recurring costs related to the supply chain that affected production costs and by negative currency effects.

Operating expenses for FY 2022 were $28.8 million compared with $19.6 million for FY 2021. The increase in operating expenses is primarily due to increased headcount in sales and marketing, research and development, and administration in preparation for the Company’s launch of the SavvyWire for which the Company received regulatory clearance in Canada and United States.

Net loss was at $11.4 million in FY 2022, compared with net loss of $1.2 million in FY 2021. The change is primarily due to the increase in operating expenses associated with the aforementioned SavvyWire regulatory clearance and planned commercial launch.

OpSens had $23.8 million in cash and cash equivalents as of August 31, 2022.

Fourth Quarter Financial Results – Three-Month Period Ended August 31, 2022

Total revenue was $9.1 million in the fourth quarter of 2022, compared with $8.1 million in the fourth quarter 2021, an increase of $1.0 million, or 12%.

Sales of coronary artery disease products, FFR and dPR products increased 7% to $5.7 million in the fourth quarter 2022, compared with $5.3 million in the fourth quarter 2021. The increase of $0.4 million is primarily attributed to the increase in the U.S. and Japanese markets.

Optical medical sales, including the supply agreement for Abiomed, were $2.2 million in the fourth quarter 2022, compared with $2.1 million in the fourth quarter 2021.

Industrial sales increased to $1.0 million in the fourth quarter 2022, an increase of $0.3 million, or 43% from $0.7 million in the fourth quarter 2021. This increase was due to a higher volume of orders in the military market.

Gross margins decreased to 48% in the fourth quarter 2022 from 50% in the fourth quarter 2021. The decrease is mainly explained by the costs related to the phasing out of the production of the OptoWire 2.

Operating expenses amounted to $8.5 million in the fourth quarter 2022, compared with $5.3 million in the fourth quarter 2021. The increase of $3.2 million in operating expenses is mainly attributable to increased headcount in sales and marketing in preparation of the SavvyWire product launch as well as research and development to improve our competitiveness and at achieving our growth objectives.

Net loss was $4.0 million in the fourth quarter 2022, compared with a net loss of $1.2 million in the fourth quarter 2021. The increase in loss of $2.8 million is primarily the result of increased operating expenses to drive growth in our coronary products and preparation of the large-scale launch of SavvyWire for TAVR.

Table A

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

 

3-month 

period ended

Aug 31, 2022

3-month

period ended

Aug 31, 2021

Financial year ended

Aug 31, 2022

Financial year ended

Aug 31, 2021

$ $ $

$

Revenues
  Sales
       Medical

7,948

7,335 31,427

30,985

       Industrial

981

671 3,577 3,363
8,929 8,006 35,004

34,348

  Other

123

60 320 116
  9,052 8,066 35,324

34,464

Cost of sales

4,677

4,050 17,523

15,783

Gross margin

4,375

4,016 17,801

18,681

Gross margin percentage

48%

50% 50%

54%

Operating expenses
     Administrative

1,872

1,794 7,822

6,473

     Sales and marketing

4,339

2,191 12,576

7,649

     Research and development

2,244

1,340 8,358 5,510
8,455 5,325 28,756

19,632

Other income

(19)

(740)

Financial expenses

1

141 312

637

Loss (gain) on foreign currency translation

(52)

(202) 68

281

Loss before income taxes

(4,029)

(1,229) (11,335)

(1,129)

Current income tax expense

(14) 43

21

Net loss

(4,029)

(1,215) (11,378)

(1,150)

Basic and diluted net loss per share

(0.04)

(0.01) (0.11)

(0.01)

 

Table B

CONSOLIDATED BALANCE SHEET HIGHLIGHTS

(in thousands of Canadian dollars)

As at

As at

Aug 31, 2022

Aug 31, 2021

$

$

Cash and cash equivalents

23,816

38,563

Trade and other receivables

5,855

4,135

Inventories

6,672

6,115

Total Current Assets

39,016

49,783

Property, plant, and equipment

2,683

2,731

Intangible assets

1,786

1,677

Right-of-use assets

5,026

4,322

Total Assets

 48,511

58,513

Current liabilities

8,601

7,395

Long-term debt

639

4,595

Lease liabilities

5,012

4,193

Total Liabilities

14,252

16,183

Shareholders’ equity

34,259

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 fourth quarter and fiscal year 2022 financial results at 11:00 a.m. (Eastern Time) today, November 22, 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/45mlLe4KeOD, 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 200,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

OpSens has recently received FDA clearance and Health Canada approval to commercialize the SavvyWire for transcatheter aortic valve replacement procedures (TAVR). This unique guidewire is a 3-in-1 solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and reliable left ventricular pacing without the need for adjunct devices or venous access.

The TAVR procedure is growing rapidly globally, driven by the aging population and recent studies that demonstrate its benefits for a broader array of patients. The global TAVR market is currently estimated at over 200,000 procedures and is expected to reach 400,000 in 2027.

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.

For further information, please contact:     

Louis Laflamme, CPA, CA, Chief Executive Officer, 418.781.0333

Robin Villeneuve, CPA, CA Chief Financial Officer, 418.781.0333

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