TSO3 Reports Third Quarter 2016 Results

Repeats Record Shipments and Receives Industry-Changing Regulatory Clearances

QUÉBEC CITY, Nov. 7, 2016 /PRNewswire/ - TSO₃ Inc. (TSX: TOS) ("TSO₃" or the "Company"), an innovator in sterilization technology for medical devices in healthcare settings, reported its financial and operating results for the third fiscal quarter ended September 30, 2016. All figures are in U.S. dollars unless otherwise noted.

Q3 2016 Highlights

• Record revenues of $3.5 million, a sequential increase of 17% compared to $3.0 million in the second quarter of 2016, and a year over year increase of 284% over $0.9 million of Q3 2015.
• Shipped 30 STERIZONE® VP4 Sterilizers to Getinge Infection Control, the Company's exclusive distribution partner, in the U.S., as well as associated accessories and consumables.
• Gross margin of 32%, as compared to 28% in Q2 2016 and 27% in Q3 2015.
• Adjusted EBITDA of negative $1.0 million as compared to negative $1.1 million in both Q2 2016 and Q3 2015.
• Net loss of $1.5 million, or $0.02 per share, which was unchanged from Q2 2016, and compares to $1.3 million, or $0.02 per share in Q3 2015.
• Cash, cash equivalents and short-term investments at quarter-end of $20.7 million, as compared to $21.3 million at the end of Q2 2016.
• Early in the quarter, TSO₃ announced that it had received Food and Drug Administration (FDA) clearance for TSO₃'s expanded indications for use of its universal STERIZONE® VP4 Sterilizer, which then became the world's first low temperature sterilizer validated to terminally sterilize multi-channeled endoscopes (with four or fewer channels) such as video colonoscopes and gastroscopes.

Management Commentary

"During the third quarter, we assembled and shipped 30 sterilizers to Getinge, our exclusive distribution partner, driving record revenues of $3.5 million," said TSO₃ President and CEO R.M. (Ric) Rumble, "and we announced FDA clearance of our expanded indications for use of our STERIZONE® VP4 Sterilizer. It is now the only sterilizer with such claims. These extended claims further expand our technology leadership – offering enhanced patient protection in applications where terminal sterilization was not previously possible."

"While this clearance is supportive of our next generation technology, we are not done yet. During the quarter, we continued rigorous scientific testing with a goal to create sufficient documentation to add duodenoscopes, which represent a major health safety concern to many hospitals, to our existing claims of endoscopes. We expect this testing to be complete by year end."

"As we look ahead, we remain focused on supporting Getinge accelerate adoption of our sterilizers into hospitals throughout North America. This includes building our sales, marketing and operating infrastructure to support anticipated future growth. In addition, we continue to prepare for the introduction of our sterilizer in Europe and other selected markets."

Subsequent Event

Subsequent to the third quarter of 2016, a peer-reviewed paper titled "The First Dual-sterilant Low-temperature Sterilization System" highlighting the STERIZONE® VP4 Sterilizer was published in an issue of the Canadian Journal of Infection Control. The paper highlights our innovative approach of controlling the sterilization process by use of pressure rather than the traditional sterilization method of sterilant dose and time, underlining TSO₃'s commitment to advancing the science of sterilization.

Q3 2016 Conference Call

TSO₃ President and CEO R.M. (Ric) Rumble and CFO Glen Kayll, will host the conference call, followed by a question and answer period.

Analysts and institutional investors are invited to participate on the call. Please call the conference telephone number 5-10 minutes prior to the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Liolios Group at 1-949-574-3860.

Other interested parties may listen to the live webcast of the conference call at
http://event.on24.com/r.htm?e=1282126&s=1&k=925FF1F86E7FCF88CBB618B5582002E0
which will be available for replay in the Investors section of the Company's website at www.tso3.com.

Q3 2016 Results Disclosure

The 2016 Third Quarter Report is available on TSO₃'s website at the following address http://www.tso3.com/en/investors/financial_reporting/quarterly_reports/ and will shortly be available on SEDAR (www.sedar.com).

Summary of Results
(Unaudited, IFRS Basis, in thousands of US dollars except per share amounts)

Financial Position Analysis
(Unaudited, IFRS Basis, in thousands of US dollars)

Statement of Cash Flows
(Unaudited, IFRS Basis, in thousands of US dollars)

About Presentation of Adjusted EBITDA

TSO₃ reports adjusted EBITDA, a non-IFRS financial measure. Generally, a non-IFRS financial measure is a numerical measure of an entity's historical or future financial performance, financial position or cash flows that is neither calculated nor recognized under IFRS. Management believes that such non-IFRS financial measures are important as they provide users of the financial statements with a better understanding of the results of the Company's recurring operations and their related trends, while increasing transparency and clarity into its operating results. Management also believes these measures can be useful in assessing the Company's capacity to discharge its financial obligations.

The principal supplemental non-IFRS metric the Company uses to assess its operational performance is adjusted Earnings before Interest, Taxes, Depreciation, and Amortization (Adjusted EBITDA).  Adjusted EBITDA adjusts net income for (1) significant realized and unrealized foreign exchange gains or losses, (2) amortization and depreciation expenses, (3) share-based compensation expense, (4) amortization or write-downs of certain tangible and intangible assets, (5) income taxes, and (6) other significant unusual items.

Adjusted EBITDA⁽¹⁾

⁽¹⁾ Non-GAAP financial measure. Refer to the "Supplemental Non-IFRS Financial Measures" section of the Company's MD&A for further information.

About the STERIZONE^® VP4 Sterilizer

The STERIZONE^® VP4 Sterilizer is a low-temperature sterilization system that utilizes the dual-sterilants of vaporized hydrogen peroxide (H₂O₂) and ozone (O₃) to achieve terminal sterilization of heat and moisture sensitive medical devices. Its single pre-programmed cycle can sterilize a large number and wide range of compatible devices, creating a cost-effective sterilization process with error free cycle selection. The device's unique Dynamic Sterilant Delivery System™ automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. This capability removes the guesswork and potential for human error, as there is no need to sort instruments and choose the appropriate cycles as with other machines.

The STERIZONE^® VP4 Sterilizer is the only FDA cleared low temperature sterilizer that can process a mixed load consisting of general instruments, single channel flexible endoscopes, and single or double channel rigid endoscopes in the same cycle with load weights of up to 75 lb. It is also the only terminal sterilization method cleared to sterilize multi-channeled flexible endoscopes (with a maximum of four channels) of up to 3.5 meters in length, such as video colonoscopes and gastroscopes - an industry first for any medical device sterilization process. The ability to run mixed loads significantly reduces labor costs by minimizing the amount of instrument sorting required, while maximizing the device turns (more productivity from increased throughput capacity). Other H₂O₂ sterilizers are limited to load weights of up to only 25 lb and require dedicated fixed cycles for different types of instruments (reducing overall throughput).

More information about the STERIZONE^® VP4 Sterilizer is available through TSO₃'s website, under the Products section at http://www.tso3.com/en/products/sterizone-vp4/.

About TSO₃

Founded in 1998, TSO₃'s activities encompass the sale, production, maintenance, research, development and licensing of sterilization processes, related consumable supplies and accessories for heat-sensitive medical devices. The Company designs products for sterile processing areas in the hospital environment that offer an advantageous replacement solution to other low temperature sterilization processes currently used in hospitals. TSO₃ also offers services related to the maintenance of sterilization equipment and compatibility testing of medical devices with such processes.

TSO₃ announced in July 2016 that it received FDA clearance in the U.S. for extended claims relating to the terminal sterilization of multi-channel flexible endoscopes. The FDA clearance of additional claims represents an entirely new level of patient protection against ineffective device reprocessing resulting from the use of less robust systems like high-level disinfection, particularly for video colonoscopes and gastroscopes.

For more information about TSO₃, visit the Company's web site at www.tso3.com.

The statements in this release and oral statements made by representatives of TSO₃ relating to matters that are not historical facts (including, without limitation, those regarding the timing or outcome of TSO₃'s sales, business or operations) are forward-looking statements that involve certain risks, uncertainties and hypotheses, including, but not limited to, the ability of the Company to obtain the required regulatory clearance to market its products on a worldwide basis; general business and economic conditions, the condition of the financial markets, the ability of TSO₃ to obtain financing on favourable terms and other risks and uncertainties.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities, in any jurisdiction in which such offer, solicitation or sale would be unlawful.

SOURCE TSO3 Inc.

Related Links

http://www.tso3.com