TSO3 Reports Third Quarter 2018 Results

QUEBEC CITY and MYRTLE BEACH, SC, Nov. 6, 2018 /PRNewswire/ - TSO3 Inc. (TSX: TOS) ("TSO(3)" or the "Company"), an innovator in sterilization technology for medical devices in healthcare settings, reported financial results for the third fiscal quarter ended September 30, 2018.

Business Highlights

In the third quarter of 2018, TSO(3) shipped four STERIZONE(®) VP4 Sterilizers to end users. As of November 6, 2018, a cumulative 68 STERIZONE(®) VP4 Sterilizers have been shipped to end users (59 installed, nine to be installed). In addition, the Company has a further 22 units of backlog for future shipments through customer purchase orders or commitments, ten of which were received subsequent to the end of the quarter and were directly related to TSO(3) only activity. The Company now has a total of 90 sterilizers either installed, to be installed or committed to be shipped.

On August 1, 2018, TSO(3) announced that it and a fund of which Courage Capital Management LLC, ("Courage") is the investment advisor, entered into a binding US$20 million debt financing to fund commercialization initiatives for its STERIZONE(®) VP4 Sterilizer. Courage is a Nashville, TN headquartered alternative asset management firm with a 20-year track record of investments in health care services, medical devices, and pharmaceuticals.

Concurrent with the Courage financing, TSO(3) and Getinge mutually decided not to renew the distribution agreements that had existed between the parties and agreed to provide TSO(3) unrestricted independent commercialization of its STERIZONE(®) VP4 Sterilizers, enable the Company's purchase of STERIZONE(®) VP4 Sterilizers from Getinge and transition the existing sales pipeline along with the service, maintenance and consumables sales of all existing STERIZONE(®) VP4 Sterilizer customers in the United States and Canada to TSO(3).

"TSO(3) has established a goal to ship or receive commitments for 200 STERIZONE(®) VP4 Sterilizers by the end of 2019", stated R.M. (Ric) Rumble, President and CEO of TSO(3). "We have now purchased the inventory we need at favourable pricing, raised capital and hired and trained a team of experienced sales and service personnel in support of this goal."

2018 Third Quarter Financial Summary

    --  Revenues equaled $0.8 million, as compared to $0.4 million in the second
        quarter of 2018 and $5.1 million in the third quarter of 2017. TSO(3)
        revenues in the third quarter of 2018 reflect sales of sterilizers,
        consumables, accessories and service parts.  The Company shipped four
        sterilizers to hospitals in the third quarter of 2018 as opposed to 44
        sterilizers to its former distributor in the same period last year.
    --  Gross profit was $1.2 million, as compared to $0.1 million in the second
        quarter of 2018 and $2.0 million in the third quarter of 2017.  The
        Company generated gross profit from sales of sterilizers, consumables,
        accessories and service parts. Gross profit includes a $0.8 million
        reversal of the warranty provision associated with inventory purchased
        from the Company's former distributor.
    --  Financial income was $0.6 million, as compared to immaterial amounts in
        both the second quarter of 2018 and third quarter of 2017. The Company
        recorded $0.5 million of accrued interest expense related to a $20.0
        million debt financing it obtained on August 1, 2018 and a non-cash gain
        of $1.1 million on the revaluation of the embedded derivative within the
        Convertible Note associated with this financing.
    --  The Company's net loss was $(2.1) million or $(0.02) per share in the
        third quarter of 2018, as compared to $(4.0) million, or $(0.04) per
        share, in the second quarter of 2018 and to $(1.8) million or $(0.02)
        per share in the year-ago quarter.
    --  The Company had $16.1 million in cash, cash equivalents and investments
        as of September 30, 2018, as compared to $14.8 million at the end of
        2017.  In the third quarter of 2018, the Company raised $20 million in
        debt financing ($19.7 million net of expenses) and used $1.7 million for
        operations excluding changes in non-cash working capital, and $8.7
        million for changes in non-cash working capital, which includes $7.9
        million used for the repurchase of 230 STERIZONE(®) VP4 Sterilizers and
        associated accessories from its former distribution partner.
    --  Inventories were $4.0 million as of September 30, 2018, as compared to
        $2.0 million at the end of 2017. During the third quarter of 2018, the
        Company bought 230 sterilizers and associated accessories for $7.9
        million from its former distributor and applied an unamortized $6.0
        million balance of deferred license fees associated with its former
        distribution agreement to these repurchased units.  In addition, the
        Company also applied the repurchase provision of $0.5 million it
        recorded in the second quarter of 2018 in relation to the upgrades of 47
        STERIZONE(®) VP4 sterilizers against finished goods.

Supplemental Non-IFRS Financial Measures

In addition to IFRS financial measures, management uses non-IFRS financial measures to assess the Company's operational performance. It is likely that the non-IFRS financial measures used by the Company will not be comparable to similar measures reported by other issuers or those used by financial analysts as their measures may have different definitions. The measures used by the Company are intended to provide additional information and should not be considered in isolation or as a substitute for IFRS financial performance measures.

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.

Management is assessing its operational performance using supplemental non-IFRS measures which remove significant unusual items that do not reflect the recurring and ongoing operating results and trends.



       
              Additional Third Quarter 2018 Financial information




                                                                      2018                                        2017

        
            
              $000's

    ---

                                Q3    
            Q2   
            Q1   
            Q4   
          Q3   
          Q2   
          Q1

                               ---


       Net loss                          (2,104)       (3,952)       (4,512)     (1,449)     (1,771)     (2,254)    (1,980)


        Financial expenses
         (income)                           (599)          (12)          (14)          74           48           49        (39)


        Amortization and
         depreciation                         270            292            315          246          331          221         168


        Share-based
         compensation
         expense                              688            627            371          301          632          592         609


        Income taxes                           11              7                       (59)          33           29          27

    ---

        Adjusted Ebitda                   (1,734)       (3,038)       (3,840)       (887)       (727)     (1,363)    (1,215)

    ---

Adjusted EBITDA 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) financial expenses (income), (3) amortization and depreciation expenses (4) share-based compensation expense, (5) write-downs of certain tangible and intangible assets, (6) one-time write-off of inventory, (7) income taxes, and (8) other significant unusual items.



              
                Summary of Results
    Periods ended September 30, 2018 and 2017 (Unaudited, IFRS Basis, in thousands of US dollars, except per share
     amounts)




                                                                                Third Quarter                              Nine months


                                                                            2018            2017                         2018            2017

                                                       
              
                $   
              $   
              
                $   
              $



                            Revenues                                         782           5,105                        1,410          13,946


                            Cost of sales                                  (394)          3,102                          451           8,613

    ---

                                                                           1,176           2,003                          959           5,333





                            Expenses


               Research and development                                    1,260           1,562                        4,452           4,456


               Selling, general and
                administrative                                             2,608           2,131                        7,681           6,735


               Financial (income)
                expenses                                                   (599)             48                        (624)             58

    ---

                            Total Expenses                                 3,269           3,741                       11,509          11,249

    ---

                            Net loss before income
                             taxes                                       (2,093)        (1,738)                    (10,550)        (5,916)



              Income taxes                                                   11              33                           18              89

    ---

                            Net loss and
                             comprehensive loss                          (2,104)        (1,771)                    (10,568)        (6,005)

    ---

                            Weighted average number
                             of outstanding shares

                            (in thousands)                                93,208          92,842                       93,009          92,258

    ---

                            Basic and diluted net
                             loss per share                               (0.02)         (0.02)                      (0.11)         (0.07)

    ---

                            Basic and diluted net
                             comprehensive loss per
                             share                                        (0.02)         (0.02)                      (0.11)         (0.07)

    ---



              
                Interim Consolidated Statements of Financial Position
    (Unaudited, in thousands of US dollars)




                                                                               September 30, 
     December 31,
                                                                                        2018            2017
                                                        
              
              
                $   
              $



                            Current Assets


               Cash and Cash Equivalents                                              16,082           8,044


               Short-term Investments                                                                 6,764



              Accounts Receivable                                                       855             651



              Inventories                                                             3,976           2,040



              Prepaid Expenses                                                          238             150

    ---

                                                                                      21,151          17,649


                            Non-current Assets


               Property, Plant and Equipment                                           2,592           3,184



              Intangible Assets                                                       1,839           1,886

    ---

                                                                                       4,431           5,070



                                                                                      25,582          22,719



                            Current Liabilities


               Accounts Payable and Accrued
                Liabilities                                                            2,055           2,430



              Warranty Provision                                                        251           1,263


               Current Tax Liabilities                                                    11              68



              Deferred Revenues                                                          16               6

    ---

                                                                                       2,333           3,767


                            Non-current Liabilities


               Deferred Tax Liabilities                                                   17              17



              Debt                                                                   17,364



              Embedded Derivative                                                     1,693



              Deferred Revenues                                                                      6,044

    ---

                                                                                      21,407           9,828




              
                Equity



              Share Capital                                                         111,471         111,215


               Reserve - Share-based
                Compensation                                                           8,170           6,574



              Deficit                                                             (113,754)      (103,186)


               Accumulated Other Comprehensive
                Loss                                                                 (1,712)        (1,712)

    ---

                                                                                       4,175          12,891



                                                                                      25,582          22,719


                            Interim Consolidated Statements of Cash Flows
    As of September 30, 2018, and 2017 (Unaudited, in
     thousands of US dollars)




                                                                            Nine months


                                                                       2018           2017

                                                  
              
                $  
              $



                            Cash flows
                             from
                             operating
                             activities


               Net loss                                            (10,568)       (6,005)


               Adjustments
                for:


                Depreciation
                and
                amortization                                            877            715


               Loss on
                write-
                down of
                property,
                plant and
                equipment                                                66             39


               Deferred
                income tax
                liabilities                                                            89


               Share-
                based
                compensation                                          1,686          1,833


               Capitalized
                interest on
                long term
                debt                                                    445


               Embedded
                derivative
                (gain)
                recognized
                in net
                loss                                                (1,103)


               Investment
                income                                                 (69)         (138)

    ---

                                                                    (8,666)       (3,467)


               Changes in
                non-cash
                operating
                working
                capital
                items                                               (9,772)           883


               Interest
                received                                                106            127

    ---

                            Cash flows
                             used in by
                             operating
                             activities                            (18,332)       (2,457)

    ---

                            Cash flows
                             from
                             investing
                             activities


               Acquisition
                of
                investments                                                       (2,909)


               Disposal of
                investments                                           6,726         11,015


               Acquisition
                of
                property,
                plant and
                equipment                                             (136)       (1,057)


               Acquisition
                of
                intangible
                assets                                                (102)         (190)


               Proceed
                from
                disposal
                of
                property,
                plant and
                equipment                                                               2

    ---

                            Cash flows
                             generated
                             by
                             investing
                             activities                               6,488          6,861

    ---

                            Cash flows
                             from
                             financing
                             activities


               Issuance of
                debt net
                of
                financing
                fees                                                 19,666


               Financing
                fee
                recognized
                in net
                loss                                                     50


               Options
                exercised                                               166            540

    ---

                            Cash flows
                             generated
                             by
                             financing
                             activities                              19,882            540

    ---

                            Increase in
                             cash and
                             cash
                             equivalents                              8,038          4,944


                            Cash and
                             cash
                             equivalents
                             at the
                             beginning                                8,044          2,698

    ---

                            Cash and
                             cash
                             equivalents
                             at the end                              16,082          7,642

    ---

Results Conference Call

Date: Wednesday, November 7, 2018
Time: 8:30 a.m. EST
Toll-free dial-in number: 1-888-231-8191
International dial-in number: 1-514-807-9895 (Montreal); 1-647-427-7450 (Toronto)
Conference ID: 4598474

Analysts and investors are invited to participate to 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 to the conference call, please contact Gilmartin Group at 1-610-368-6505.

Other interested parties may listen to the live webcast of the conference call at https://event.on24.com/wcc/r/1863190/0A8CDB0936AF81795D977C263FE1FCCC which will be available for replay in the Investors section of the Company's website at www.tso3.com.

About the STERIZONE(®) VP4 Sterilizer

The STERIZONE(®) VP4 Sterilizer is a low-temperature sterilization system that utilizes the dual sterilants of vaporized hydrogen peroxide (H(2)O(2)) and ozone (O(3)) 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(TM) 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 terminal sterilization method that is FDA 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, duodenoscopes and gastroscopes - an industry first for any medical device sterilization process.

The STERIZONE(®) VP4 Sterilizer is also the only 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. 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).

More information about the STERIZONE(®) VP4 Sterilizer is available through TSO(3)'s website, under the Products section.

About TSO(3)

Founded in 1998, TSO(3)'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. TSO(3) also offers services related to the maintenance of sterilization equipment and compatibility testing of medical devices with such processes.

For more information about TSO(3), visit the Company's website at www.tso3.com.

The statements in this release and oral statements made by representatives of TSO(3) relating to matters that are not historical facts are forward-looking statements that involve certain risks, uncertainties and hypotheses, including, but not limited to, the limited history of sales or distribution of the Company, the ability of the Company to obtain the required regulatory clearances to market its products, general business and economic conditions, the condition of the financial markets, the ability of TSO(3) to obtain financing on favourable terms and other risks and uncertainties. Although TSO(3) believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to have been correct. The complete versions of the cautionary note regarding forward-looking statements as well as a description of the relevant assumptions and risk factors likely to affect TSO(3)'s actual or projected results are included in the Management's Discussion and Analysis for the year ended December 31, 2017, which is available on the Company's website. The forward-looking statements contained in this press release are made as of the date hereof, and TSO(3) does not assume any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise unless expressly required by applicable securities laws.

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SOURCE TSO3 Inc.