OpSens Announces Record First Quarter fiscal 2023 Financial Results

Quebec City, Quebec, January 12, 2023 – 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 first quarter of fiscal year 2023 ended November 30, 2022.

First Quarter Fiscal 2023 Financial Highlights (all metrics compared to first quarter fiscal 2022 unless otherwise noted)

• Consolidated revenues of $10.2 million, compared with $8.1 million, a 26% increase and a new quarterly record.
• Increased gross margin to 58% in the first quarter of 2023 compared with 51%.
• Coronary artery disease sales of $5.2 million in the first quarter of 2023 compared with $4.9 million, a 6% increase.
• TAVR sales of $0.4 million in the first quarter of 2023.
• Sales of optical medical products, including the supply agreement with Abiomed, were $3.3 million in the first quarter of 2023, an increase of 38%, compared with $2.4 million.
• Cash and cash equivalents of $17.5 million at November 30, 2022 ($23.8 million at August 31, 2022).
• In December 2022, the Company closed a $11.5 million bought-deal offering.

Recent Highlights

• FDA clearance for the use of SavvyWire in transcatheter aortic valve replacement (TAVR) procedures in the United States.
• First clinical cases with the SavvyWire in Europe and launch of the SAFE-TAVI study.
• First procedure completed with the SavvyWire in New Zealand.

Management Commentary

“We experienced growth in each of our business lines during the first quarter, with particular strength in the U.S. where we have placed a strategic focus to enhance sales of OptoWire and launch our recently cleared SavvyWire for TAVR procedures,” said Louis Laflamme, President and CEO of OpSens. “Fiscal 2023 will be an exciting year as we expect growth in each of our historical business lines and expand upon the successful launch of our SavvyWire. The medical teams who have had the opportunity to use the SavvyWire have been enthusiastic about its performance. We are still in the early days of the launch cycle but to this point, we have achieved or exceeded nearly every key milestone or timeline in our TAVR commercialization plans, and believe we have the opportunity to continue that momentum into the future.”

Segmented Revenues Information

Financial Commentary

Consolidated revenues were $10.2 million in the first quarter of 2023, a 26% increase, compared with the $8.1 million recorded in the first quarter of 2022.

Coronary Artery Disease

Sales of coronary artery disease products (Fractional Flow Reserve (“FFR”) and diastolic pressure ratio (“dPR”)) were $5.2 million in the first quarter of 2023, compared with $4.9 million in the first quarter of 2022, an increase of 6%. The increase was primarily due to a combined 15% increase in sales in the U.S., Canada and EMEA. U.S. sales were particularly strong with an increase of 38% generated by higher volumes following the strategic focus to increase sales in the country through both direct sales and group purchasing agreements, as well as benefits from currency exchange rates. Sales in Japan decreased 31% compared to the first quarter of 2022 due to increased inventory levels with the distributor following a large shipment in the third quarter of fiscal 2022, coupled with slower demand than expected.

Optical Medical Systems

Sales of optical medical systems, including the Company’s multi-year supply contract of sensors for ventricular assist devices, were $3.3 million in the first quarter of 2023, compared with $2.4 million in the first quarter of 2022, an increase of 38%. The Company is seeing increased demand for its sensors with expectations for continued growth in the future.

Structural Heart

Structural heart sales (TAVR) were $0.4 million in the first quarter of 2023.  There were no sales in this market in the first quarter of 2022. The company received Canadian clearance for its TAVR in April 2022 and U.S. clearance in September 2022. The Company launched its Canadian and U.S. limited market release ahead of schedule and has since launched the next stage of its commercialization efforts in Canada and the U.S. with initial results indicating strong acceptance by physicians and hospitals with premium pricing and rapid reorder rates.

Industrial

Industrial sales were at $1.0 million in the first quarter of 2023, compared with $0.7 million in the first quarter of 2022. During the quarter, the Company delivered solutions in optical temperature, pressure, strain, and other critical parameters for various industries, including aerospace, nuclear, and power electronics.

Gross Margin

Gross margin was 57.6%, an increase of 670 basis points, compared to 50.9% during the prior year period. The increase was driven by better product mix, more direct sales and higher volume sales.

Operating Expenses

Operating expenses in the first quarter of 2023 were $9.7 million, compared with $6.0 million in the first quarter of 2022. The $3.7 million increase was primarily due to an increase sales and marketing activities, including an increase in the Company’s direct U.S. sales force in advance of the launch of SavvyWire, coupled with an increase in R&D due to structural heart and coronary artery projects.

Net Loss

Net loss for the first quarter of fiscal 2023 was $(3.6) million, or $(0.03) per diluted share, compared to a net loss of $(2.1) million, or $(0.02) per diluted share in the first quarter of fiscal 2022.

Balance Sheet

OpSens had a cash position of $17.5 million at November 30, 2022 (August 31, 2022 was $23.8 million). In December 2022, the Company closed a $11.5 million bought-deal offering.

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Conference Call Today

Louis Laflamme, President and Chief Executive Officer, will hold a conference call to discuss the quarter’s financial results at 11:00 a.m. (Eastern Time) today, January 12, 2023.

Interested parties can access the conference call by dialing (833) 756-0865 or (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/rJaVjbNjoW1, 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 on 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 more than 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).

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.