QUEBEC CITY and MYRTLE BEACH, SC, Nov. 6, 2018 /PRNewswire/ - TSO3 Inc. (TSX: TOS) ("TSO3" 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, TSO3 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 TSO3 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, TSO3 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, TSO3 and Getinge mutually decided not to renew the distribution agreements that had existed between the parties and agreed to provide TSO3 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 TSO3.
"TSO3 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 TSO3. "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. TSO3 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 |
|||||||
$000's |
2018 |
2017 |
|||||
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 |
||||
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 |
||
September 30, |
December 31, |
|
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 |
||
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 (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 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 TSO3's website, under the Products section.
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.
For more information about TSO3, visit the Company's website 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 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 TSO3 to obtain financing on favourable terms and other risks and uncertainties. Although TSO3 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 TSO3'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 TSO3 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.
SOURCE TSO3 Inc.
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