UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
or
For the transition period from ________ to ________
Commission File Number:
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification Number) |
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Universal Biosensors, Inc. |
Not Applicable |
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(Address of principal executive offices) |
(Zip Code) |
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Telephone: +61 |
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(Registrant’s telephone number, including area code) |
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Securities registered pursuant to Section 12(b) of the Act: None
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definition of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
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Large accelerated filer |
☐ |
Accelerated filer |
☐ |
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☑ |
Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:
UNIVERSAL BIOSENSORS, INC.
TABLE OF CONTENTS
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Page |
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PART I |
FINANCIAL INFORMATION |
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Item 1 |
Financial Statements (unaudited) |
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1) |
Consolidated condensed balance sheets at March 31, 2023 and December 31, 2022 |
1 |
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2) |
Consolidated condensed statements of comprehensive income/(loss) for the three months ended March 31, 2023 and 2022 |
2 |
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3) |
Consolidated condensed statements of changes in stockholders’ equity and comprehensive income/(loss) for the three months ended March 31, 2023 and 2022 |
3 |
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4) |
Consolidated condensed statements of cash flows for the three months ended March 31, 2023 and 2022 |
4 |
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5) |
Notes to consolidated condensed financial statements |
5 |
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Item 2 |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
16 |
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Item 3 |
Quantitative and Qualitative Disclosures About Market Risk |
23 |
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Item 4 |
Controls and Procedures |
23 |
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PART II |
OTHER INFORMATION |
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Item 1 |
Legal Proceedings |
24 |
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Item 1A |
Risk Factors |
24 |
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Item 2 |
Unregistered Sales of Equity Securities and Use of Proceeds |
24 |
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Item 3 |
Defaults Upon Senior Securities |
24 |
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Item 4 |
Mine Safety Disclosures |
24 |
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Item 5 |
Other Information |
24 |
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Item 6 |
Exhibits |
24 |
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Exhibit 31.1 |
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Exhibit 31.2 |
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Exhibit 32 |
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| Exhibit 101 | |||
| Exhibit 104 | |||
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SIGNATURES |
25 |
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Unless otherwise noted, references in this Form 10-Q to “Universal Biosensors”, the “Company,” “Group,” “we,” “our” or “us” means Universal Biosensors, Inc. (“UBI”) a Delaware corporation and, when applicable, its wholly owned Australian operating subsidiary, Universal Biosensors Pty Ltd (“UBS”), its wholly owned US operating subsidiary, Universal Biosensors LLC (“UBS LLC”) and UBS’ wholly owned Canadian operating subsidiary, Hemostasis Reference Laboratory Inc. (“HRL”) and wholly owned Dutch operating subsidiary, Universal Biosensors B.V. (“UBS BV”). Unless otherwise noted, all references in this Form 10-Q to “$”, “A$” or “dollars” and dollar amounts are references to Australian dollars. References to “US$”, “CAD$” and “€” are references to United States dollars, Canadian dollars and Euros respectively.
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Item 1 |
Financial Statements |
Consolidated Condensed Balance Sheets (Unaudited)
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March 31, 2023 |
December 31, 2022 |
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A$ |
A$ |
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| ASSETS | ||||||||
| Current assets: | ||||||||
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Cash and cash equivalents |
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Inventories |
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Accounts receivable |
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Prepayments |
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Restricted cash |
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Research and development tax incentive income |
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Other current assets |
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Total current assets |
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| Non-current assets: | ||||||||
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Property, plant and equipment |
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Less accumulated depreciation |
( |
) | ( |
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Property, plant and equipment - net |
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Intangible assets |
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Less amortization of intangible assets |
( |
) | ||||||
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Less impairment of intangible assets |
( |
) | ||||||
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Intangible assets - net |
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Right-of-use asset - operating leases |
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Right-of-use asset - finance leases |
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Restricted cash |
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Other non-current assets |
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Total non-current assets |
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Total assets |
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| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
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Accounts payable |
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Accrued expenses |
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Contingent consideration |
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Other liabilities |
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Contract liabilities |
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Lease liability - operating leases |
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Lease liability - finance leases |
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Employee entitlements liabilities |
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Short-term loan - secured |
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Short-term loan - unsecured |
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Total current liabilities |
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| Non-current liabilities: | ||||||||
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Asset retirement obligations |
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Employee entitlements liabilities |
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Lease liability - operating leases |
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Lease liability - finance leases |
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Total non-current liabilities |
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Total liabilities |
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Commitments and contingencies |
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| Stockholders’ equity: | ||||||||
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Preferred stock, US$ |
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Additional paid-in capital |
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Accumulated deficit |
( |
) | ( |
) | ||||
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Current year loss |
( |
) | ( |
) | ||||
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Accumulated other comprehensive loss |
( |
) | ( |
) | ||||
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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See accompanying Notes to the Consolidated Condensed Financial Statements.
Consolidated Condensed Statements of Comprehensive Income/(Loss) (Unaudited)
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Three Months Ended March 31, |
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2023 |
2022 |
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A$ |
A$ |
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| Revenue | ||||||||
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Revenue from products |
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Revenue from services |
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Total revenue |
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| Operating costs and expenses | ||||||||
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Cost of goods sold |
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Cost of services |
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Total cost of goods sold and services |
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Gross profit |
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| Other operating costs and expenses | ||||||||
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Product support |
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Depreciation and amortization |
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Research and development |
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Selling, general and administrative |
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Total other operating costs and expenses |
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Loss from operations |
( |
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| Other income/(expense) | ||||||||
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Interest income |
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Interest expense |
( |
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) | ||||
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Financing costs |
( |
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Research and development tax incentive income |
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Exchange gain/(loss) |
( |
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Other income |
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Total other income |
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Net loss before tax |
( |
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Income tax benefit/(expense) |
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Net loss |
( |
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| Loss per share | ||||||||
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Net loss per share - basic and diluted |
( |
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Average weighted number of shares - basic and diluted |
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| Other comprehensive gain/(loss), net of tax: | ||||||||
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Foreign currency translation reserve |
( |
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Other comprehensive income/(loss) |
( |
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Comprehensive loss |
( |
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) | ||||
See accompanying Notes to the Consolidated Condensed Financial Statements.
Consolidated Condensed Statements of Changes in Stockholders’ Equity and Comprehensive Income/(Loss) (Unaudited)
Three Months Ended March 31, 2022
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Ordinary shares
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Additional Paid-in Capital |
Accumulated Deficit |
Other comprehensive Income/(Loss) |
Total Stockholders’ Equity |
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Shares |
Amount |
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A$ |
A$ |
A$ |
A$ |
A$ |
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Balances at January 1, 2022 |
( |
) | ( |
) | ||||||||||||||||||||
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Net loss |
0 | ( |
) | ( |
) | |||||||||||||||||||
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Other comprehensive income |
0 | |||||||||||||||||||||||
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Exercise of stock options issued to employees |
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Stock-based compensation expense |
0 | |||||||||||||||||||||||
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Balances at March 31, 2022 |
( |
) | ( |
) | ||||||||||||||||||||
Three Months Ended March 31, 2023
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Ordinary shares
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Additional Paid-in Capital |
Accumulated Deficit |
Other comprehensive Income/(Loss) |
Total Stockholders’ Equity |
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Shares |
Amount |
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A$ |
A$ |
A$ |
A$ |
A$ |
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Balances at January 1, 2023 |
( |
) | ( |
) | ||||||||||||||||||||
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Net loss |
0 | ( |
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Other comprehensive income |
0 | ( |
) | ( |
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Performance awards and exercise of stock options issued to employees |
( |
) | ||||||||||||||||||||||
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Stock-based compensation expense |
0 | 0 | ||||||||||||||||||||||
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Balances at March 31, 2023 |
( |
) | ( |
) | ||||||||||||||||||||
See accompanying Notes to the Consolidated Condensed Financial Statements.
Consolidated Condensed Statements of Cash Flows (Unaudited)
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Three Months Ended March 31, |
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2023 |
2022 |
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A$ |
A$ |
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| Cash flows from operating activities: | ||||||||
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Net loss |
( |
) | ( |
) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
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Depreciation and amortization |
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Stock-based compensation expense |
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Non-cash lease expense |
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Unrealized foreign exchange (gains)/losses |
( |
) | ||||||
| Change in assets and liabilities: | ||||||||
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Inventories |
( |
) | ||||||
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Accounts receivable |
( |
) | ( |
) | ||||
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Prepayments and other assets |
( |
) | ( |
) | ||||
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Other non-current assets |
( |
) | ( |
) | ||||
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Contract liabilities |
( |
) | ||||||
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Employee entitlements |
( |
) | ||||||
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Accounts payable and accrued expenses |
( |
) | ||||||
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Net cash used in operating activities |
( |
) | ( |
) | ||||
| Cash flows from investing activities: | ||||||||
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Purchases of property, plant and equipment |
( |
) | ( |
) | ||||
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Net cash used in investing activities |
( |
) | ( |
) | ||||
| Cash flows from financing activities: | ||||||||
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Proceeds from borrowings |
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Repayment of borrowings |
( |
) | ( |
) | ||||
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Other |
( |
) | ||||||
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Net cash provided by financing activities |
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Net decrease in cash, cash equivalents and restricted cash |
( |
) | ( |
) | ||||
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Cash, cash equivalents and restricted cash at beginning of period |
||||||||
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Effect of exchange rate fluctuations on the balances of cash held in foreign currencies |
( |
) | ( |
) | ||||
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Cash, cash equivalents and restricted cash at end of period |
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See accompanying Notes to the Consolidated Condensed Financial Statements.
1. Summary of Significant Accounting Policies
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● |
assets and liabilities for each balance sheet item reported are translated at the closing rate at the date of that balance sheet; |
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● |
income and expenses for each income statement item reported are translated at average exchange rates (unless this is not a reasonable approximation of the effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the dates of the transactions); and |
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● |
all resulting exchange differences are recognized as a separate component of equity. |
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● |
Market approach – based on market prices and other information from market transactions involving identical or comparable assets or liabilities. |
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● |
Cost approach – based on the cost to acquire or construct comparable assets less an allowance for functional and/or economic obsolescence. |
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● |
Income approach – based on the present value of a future stream of net cash flows. |
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● |
Quoted prices for identical assets or liabilities in active markets (Level 1 inputs). |
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● |
Quoted prices for similar assets or liabilities in active markets or quoted prices for identical or similar assets or liabilities in markets that are not active or are directly or indirectly observable (Level 2 inputs). |
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● |
Unobservable inputs that reflect estimates and assumptions (Level 3 inputs). |
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● |
periods covered by an option to extend the lease if the Company is reasonably certain to exercise the extension option; and |
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● |
periods covered by an option to terminate the lease if the Company is reasonably certain not to exercise the termination option. |
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a) |
Identifying the contract with a customer; |
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b) |
Identifying the performance obligations within the customer contract; |
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c) |
Determining the transaction price; |
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d) |
Allocating the transaction price to the performance obligation; and |
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e) |
Recognizing revenue when/as performance obligations are satisfied. |
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Products and services |
Nature, timing of satisfaction of performance obligations and significant payment terms |
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Coagulation testing products |
Our point-of-care coagulation testing products use electrochemical cell technology to measure Prothrombin Time (PT/INR), a test used to monitor the effect of the anticoagulant therapy warfarin.
The performance obligation for the sale of these products is satisfied at a point-in-time when the Company transfers control of the products to its customer. The point of transfer of control of the products is dictated by individual terms contained within a customer agreement, as are the payment terms. The transaction price is fixed. |
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Laboratory testing services |
HRL provides non-diagnostic laboratory services and performs these services on behalf of customers.
The performance obligation for the services is satisfied when the testing has been finalized and results have been reported to the customer. In some cases, the performance obligations will be satisfied as predetermined milestones have been achieved by the Company. |
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Wine testing products |
Our Sentia wine analyzer is used to measure Free SO₂, Malic Acid, Glucose, Fructose, Total Sugar and Acetic Acid levels in wine.
The performance obligation for the sale of this product is satisfied at a point-in-time when the Company transfers control of the products to its customer. The point of transfer of control of the products is dictated by the individual terms contained within a customer agreement, as are the individual payment terms. The transaction price is fixed. |
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(1) |
as a |
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(2) |
as a |
2. Cash, cash equivalents and restricted cash
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated condensed balance sheets that sum to the total of the same such amounts shown in the consolidated condensed statements of cash flows.
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March 31, 2023 |
December 31, 2022 |
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A$ |
A$ |
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Cash and cash equivalents |
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Restricted cash – current assets |
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Restricted cash – non-current assets |
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Restricted cash maintained by the Company in the form of term deposits is as follows:
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March 31, 2023 |
December 31, 2022 |
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A$ |
A$ |
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Performance guarantee (a) - current assets |
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Collateral for facilities (b) - non-current assets |
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(a) |
The performance guarantee expired in March 2023 and represented letter of credit issued in favour of Siemens pursuant to the 2019 Siemens Agreements. |
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(b) |
Collateral for facilities represents bank guarantee of A$ |
Interest earned on the restricted cash for the three months ended March 31, 2023 and 2022 was A$
3. Inventories
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March 31, 2023 |
December 31, 2022 |
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A$ |
A$ |
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Raw materials |
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Work in progress |
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Finished goods |
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4. Receivables
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March 31, 2023 |
December 31, 2022 |
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A$ |
A$ |
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Accounts receivables |
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Allowance for credit losses |
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5. Leases
The Company’s lease portfolio consists primarily of operating leases for office space and equipment with contractual terms expiring from December 2022 to February 2032. Lease contracts may include one or more renewal options that allow the Company to extend the lease term. The exercise of lease options is generally at the discretion of the Company. None of the Company’s leases contain residual value guarantees, substantial restrictions, or covenants. The Company’s leases are substantially within Australia and Canada.
Operating Leases
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March 31, 2023 |
December 31, 2022 |
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A$ |
A$ |
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| Operating lease right-of-use assets: | ||||||||
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Non-current |
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| Operating lease liabilities: | ||||||||
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Current |
||||||||
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Non-current |
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Weighted average remaining lease terms (in years) |
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Weighted average discount rate |
% | % | ||||||
The components of lease income/expense were as follows:
|
Three Months ended March 31, |
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2023 |
2022 |
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|
A$ |
A$ |
|||||||
|
Fixed payment operating lease expense |
||||||||
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Short-term lease expense |
||||||||
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Sub-lease income |
||||||||
The sub-lease income is deemed an operating lease.
The components of the fixed payment operating and short-term lease expense as classified in the consolidated condensed statements of comprehensive income/(loss) are as follows:
|
Three Months ended March 31, |
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2023 |
2022 |
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A$ |
A$ |
|||||||
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Cost of goods sold |
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Cost of services |
||||||||
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Research and development |
||||||||
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Selling, general and administrative |
||||||||
Supplemental cash flow information related to the Company’s leases was as follows:
|
Three Months ended March 31 |
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2023 |
2022 |
|||||||
|
A$ |
A$ |
|||||||
|
Operating cash outflows from operating leases |
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Supplemental noncash information related to the Company’s leases was as follows:
|
Three Months ended March 31, |
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2023 |
2022 |
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|
A$ |
A$ |
|||||||
|
Right-of-use assets obtained in exchange for lease liabilities |
||||||||
|
Right-of-use asset modifications |
||||||||
Future lease payments are as follows:
|
March 31, 2023 |
December 31, 2022 |
|||||||
|
A$ |
A$ |
|||||||
|
2023 |
||||||||
|
2024 |
||||||||
|
2025 |
||||||||
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2026 |
||||||||
|
2027 |
||||||||
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Thereafter |
||||||||
|
Total future lease payments |
||||||||
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Less: imputed interest |
( |
) | ( |
) | ||||
|
Total operating lease liabilities |
||||||||
|
Current |
||||||||
|
Non-current |
||||||||
On October 22, 2021, UBS entered into a lease arrangement to install solar panels and inverters ("panels"). The lease commenced in January 2022 upon installation of the panels. The panels were installed at the Company’s 1 Corporate Avenue premises. The lease has a term of seven years and an option to buy at the end of the term.
As of March 31, 2023, the Company has not entered into any operating or finance lease agreements that have not yet commenced.
6. Contingent Consideration
Pursuant to the Siemens Acquisition and the agreement dated September 2019, the Company has agreed to pay US$
7. Other Liabilities
Other liabilities represent a marketing support payment due to one of our partners and is payable in US dollars. The balance will be paid once supporting documentation has been provided to the Company.
8. Borrowings
The unsecured loan is a government guaranteed loan called Canada Emergency Business Account (CEBA) of CAD$
|
● |
the loan is interest-free, and no principal repayment is required before December 31, 2023; |
|
● |
if the Company chooses to repay at least CAD$ |
|
● |
if the loan is not repaid by the above-mentioned date, it will be converted into a 2-year term loan and will be charged an interest rate of 5% per annum. Interest-only payments are required each month; and |
|
● |
at the end of the 2-year term, the entire balance of the loan is due for repayment by December 31, 2025. |
The secured loan is a short-term loan facility the Company entered into with BOQF Cashflow Finance Pty Ltd to finance its 2023 insurance premium. The total amount financed was A$
|
● |
the facility is repayable in |
|
● |
interest is being charged at an effective annual interest rate of |
|
● |
The short-term borrowing is secured by proceeds of or payable under any insurance including proceeds or refunds from the cancellation or termination of any insurance. |
9. Revenue
Disaggregation of Revenue
In the following table, revenue is disaggregated by major product and service lines and timing of revenue recognition.
|
Three Months ended March 31 |
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|
2023 |
2022 |
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|
A$ |
A$ |
|||||||
|
Major product/service lines |
||||||||
|
Coagulation testing products |
||||||||
|
Laboratory testing services |
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|
Wine testing products |
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|
Timing of revenue recognition |
||||||||
|
Products and services transferred at a point in time |
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Contract Balances
The following table provides information about receivables and contract liabilities from contracts with customers.
|
March 31, |
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|
2023 |
2022 |
|||||||
|
A$ |
A$ |
|||||||
|
Receivables |
||||||||
|
Contract liabilities |
||||||||
The Company’s contract liabilities represent the Company’s obligation to transfer products to customers for which the Company has received consideration from customers, but the transfer has not yet been completed.
Significant changes in the contract assets and the contract liabilities balances during the period are as follows:
|
Three Months ended March 31, |
||||||||
|
2023 |
2022 |
|||||||
|
A$ |
A$ |
|||||||
| Contract Liabilities - Current | ||||||||
|
Opening balance |
||||||||
|
Closing balance |
||||||||
|
Net increase/(decrease) |
( |
) | ||||||
The Company expects all of the Company’s contract liabilities to be realized by December 31, 2023.
10. Other Income
Other income is recognized when there is reasonable assurance that the income will be received, and the consideration can be reliably measured.
Other income is as follows for the relevant periods:
|
Three Months Ended March 31 |
||||||||
|
2023 |
2022 |
|||||||
|
A$ |
A$ |
|||||||
|
Federal and state government subsidies |
||||||||
|
Rental income |
||||||||
|
Other income |
||||||||
11. Total Comprehensive Income/(Loss)
The Company follows ASC 220 – Comprehensive Income. Comprehensive income/(loss) is defined as the total change in shareholders’ equity during the period other than from transactions with shareholders and for the Company, includes net income/(loss).
The tax effect allocated to each component of other comprehensive income/(loss) is as follows:
|
Before-Tax Amount |
Tax (Expense)/ Benefit |
Net-of-Tax Amount |
||||||||||
|
A$ |
A$ |
A$ |
||||||||||
|
Three Months Ended March 31, 2023 |
||||||||||||
|
Foreign currency translation reserve |
( |
) | ( |
) | ||||||||
|
Reclassification for gains realized in net income/(loss) |
||||||||||||
|
Other comprehensive loss |
0 | 0 | 0 | |||||||||
|
Other comprehensive loss |
( |
) | ( |
) | ||||||||
|
Three Months Ended March 31, 2022 |
||||||||||||
|
Foreign currency translation reserve |
||||||||||||
|
Reclassification for gains realized in net income/(loss) |
||||||||||||
|
Other comprehensive income |
0 | 0 | 0 | |||||||||
|
Other comprehensive income |
||||||||||||
12. Related Party Transactions
Details of related party transactions material to the operations of the Group other than compensation arrangements, expense allowances and other similar items in the ordinary course of business, are set out below:
Mr. Coleman is a Non-Executive Director of the Company and Executive Chairman and Associate of Viburnum Funds Pty Ltd (“Viburnum”). Viburnum, as an investment manager for its associated funds, holds a beneficial interest and voting power over approximately
On April 20, 2022, the Company announced a fully underwritten non-renounceable rights issue of new CHESS depositary interests over fully paid ordinary shares in UBI (“New CDIs”) to raise approximately A$
In connection with the Entitlement Offer, on April 19, 2022, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Viburnum (the “Underwriter”). Pursuant to the terms of the Underwriting Agreement, the Underwriter agreed to take up its full entitlement under the Entitlement Offer and fully underwrite the Entitlement Offer, which meant that the Underwriter agreed to subscribe for or procure others to subscribe for all securities (if any) not subscribed for by the Company’s eligible securityholders under the Entitlement Offer. Following the close of the Entitlement Offer,
The Company also agreed, subject to the approval of the stockholders of the Company, to issue to the Underwriter (or its nominee) unlisted options to purchase up to
On May 27, 2022, Viburnum acquired from a member of management, unlisted options to purchase up to
There were no material related party transactions or balances as at March 31, 2023 other than as disclosed above.
13. Commitments and Contingencies
Liabilities for loss contingencies, arising from claims, assessments, litigation, fines and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount of the assessment can be reasonably estimated. These were as at March 31, 2023 and December 31, 2022. Purchase commitments are entered into with various parties to purchase products and services such as equipment, technology and consumables used in R&D and commercial activities. Purchase commitments contracted for as at March 31, 2023 and December 31, 2022 were A$
Refer to note 6 for details of the Company’s Contingent Consideration.
14. Segment Information
We operate in one segment. We are a specialist biosensors Company focused on the development, manufacture and commercialization of a range of point of use devices for measuring different analytes across different industries.
Our operations are in Australia, US, Europe and Canada. The chief operating decision maker of the Company is the Chief Executive Officer.
The Company’s material long-lived assets are predominantly based in Australia.
|
Item 2 |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
The following discussion and analysis provides information that we believe is relevant to an assessment and understanding of our results of operations and financial condition. You should read this analysis in conjunction with our audited consolidated financial statements and related footnotes and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our most recent Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (“SEC”). This Form 10-Q contains, including this discussion and analysis, certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) which are intended to be covered by the safe harbors created by such acts. For this purpose, any statements that are not statements of historical fact may be deemed to be forward-looking statements, including statements relating to future events and our future financial performance. Those statements in this Form 10-Q containing the words “anticipates”, “assumes”, “believes”, “can”, “could”, “estimates”, “expects”, “future”, “illustration”, “intends”, “may”, “plans”, “predicts”, “will”, “would” and similar expressions constitute forward-looking statements, although not all forward-looking statements contain such identifying words.
The forward-looking statements contained in this Form 10-Q are based on our current expectations, assumptions, estimates and projections about the Company and its businesses. All such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from those results expressed or implied by these forward-looking statements, including those set forth in this Quarterly Report on Form 10-Q. The Company assumes no obligation to revise or update any forward-looking statements for any reason, except as required by law.
Our Business
We are a specialist biosensors company focused on commercializing a range of biosensors in oenology (wine industry), human health including oncology, coagulation, COVID-19, women’s health and fertility, non-human and environmental testing using our patented platform technology and hand-held point-of-use devices.
Key developments from the beginning of the first quarter of 2023 include:
|
● |
Revenue from wine testing products increased by 88% |
|
● |
Revenue from coagulation sales was lower during the period because Siemens purchased A$732,105 of stock in the prior period (March 2022). Pursuant to our agreement with Siemens, it must cease to sell coagulation products as at March 31, 2023 |
|
● |
UBI direct sales to coagulation customers grew 150% |
|
● |
Revenue from laboratory services fell during the period |
|
● |
Gross profit increased 109% during the period |
|
|
● |
Completion of Xprecia Prime clinical trials and submission of 510K application to the US Food and Drug Administration |
|
|
● |
Global launch of Sentia’s Fructose, Acetic Acid and Titratable Acidity tests |
|
|
● |
Global launch of the Petrackr blood glucose product |
|
|
● |
First sales of next generation Xprecia prime in Europe |
|
|
● |
The continuing development and use of aptamer sensing technology on our hand-held platform device |
|
|
● |
The Company invested A$0.28 million in the manufacturing scale-up project which will add approximately 35 million strips annually |
|
|
● |
The company incurred A$1.85 million in the development of new products. A$0.51 million relates to the following non-recurring products: |
|
o |
A$0.41 million was incurred in the development of Xprecia Prime |
|
|
o |
A$0.10 million was incurred in the development of the Petrackr blood glucose product |
Results of Operations
Consolidated Revenue
|
● |
Revenue from wine testing products increased by 88% |
|
● |
Revenue from coagulation sales was lower during the period because Siemens purchased A$732,105 of stock in the prior period (March 2022). Pursuant to our agreement with Siemens, it must cease to sell coagulation products as at March 31, 2023 |
|
● |
UBI direct sales to coagulation customers grew 150% |
|
● |
Revenue from laboratory services fell during the period |
Revenue from Products
The financial results of the coagulation and wine testing products we sold during the respective periods are as follows:
|
Three Months Ended March 31, |
||||||||
|
2023 |
2022 |
|||||||
|
A$ |
A$ |
|||||||
|
Revenue from products |
1,174,959 | 1,280,325 | ||||||
|
Cost of goods sold |
(369,971 | ) | (663,861 | ) | ||||
|
Gross profit |
804,988 | 616,464 | ||||||
Our total revenue from products decreased by 8% during the three months ended March 31, 2023, compared to the same period in the previous financial year but gross profit increased by 31% to A$804,988 during the same period.
Whilst our revenue from the wine testing products increased by 88% during the three months ended March 31, 2023, compared to the previous financial year, revenues from coagulation testing products declined by 40% during the three months ended March 31, 2023, compared to the same period in the previous financial year.
The increase in revenue from wine testing products is primarily due to the number of test products available for sale in this platform. During the three months ended March 31, 2022, our revenues from wine testing products were primarily from the sale of Sentia analyzers and Free SO2 test strips. In addition to this, during the three months ended March 31, 2023, we are also generating revenues from the sale of the following additional tests – Malic Acid, Fructose, Glucose and Acetic Acid levels in wine.
Revenue from coagulation testing services during the current period was impacted by the inventory build-up order from Siemens of A$732,105 during the three months ended March 31, 2022.
Revenue from Services
The financial results of the laboratory testing services we provided during the respective periods are as follows:
|
Three Months Ended March 31, |
||||||||
|
2023 |
2022 |
|||||||
|
A$ |
A$ |
|||||||
|
Laboratory testing services |
120,505 | 442,888 | ||||||
|
Cost of services |
(48,717 | ) | (640,505 | ) | ||||
|
Gross profit/(loss) |
71,788 | (197,617 | ) | |||||
Revenue from laboratory testing services decreased by 73% during the three months ended March 31, 2023, compared to the same period in the previous financial year due to the early conclusion of a significant contract from a major customer in the 2022 financial year.
Adjusted EBITDA
We define adjusted EBITDA as net income/(loss) before interest, taxes, depreciation, amortization, accretion of asset retirement obligations, impairment of intangible assets and stock-based compensation expense. Adjusted EBITDA is a non-GAAP measurement. Management uses adjusted EBITDA because it believes that such measurements are widely accepted financial indicators used by investors and analysts to analyze and compare companies on the basis of operating performance and that these measurements may be used by investors to make informed investment decisions, including our ability to generate earnings sufficient to service our debt and enhances our understanding of our financial performance and highlights operational trends. These measures are not in accordance with, or an alternative for, U.S. GAAP. Consolidated adjusted EBITDA should not be considered in isolation or as a substitution for analysis of our results as reported under GAAP.
The following table provides a reconciliation of net income/(loss) to adjusted EBITDA.
|
Three Months Ended March 31, |
||||||||
|
2023 |
2022 |
|||||||
|
A$ |
A$ |
|||||||
|
Net loss |
(3,788,788 | ) | (4,530,557 | ) | ||||
|
Interest income |
(206,474 | ) | (4,603 | ) | ||||
|
Interest expense |
7,752 | 7,462 | ||||||
|
Depreciation and amortization |
219,337 | 651,580 | ||||||
|
Accretion expense |
46,860 | 31,907 | ||||||
|
Stock-based compensation expense |
48,885 | 74,639 | ||||||
|
Adjusted EBITDA |
(3,672,428 | ) | (3,769,572 | ) | ||||
Improvement in Adjusted EBITDA during the three months ended March 31, 2023, compared to the same period in the previous financial year primarily as a result of decline in our operating losses.
Product Support
Product support relates to post-market technical support provided by us for our products in the market. Product support has increased by A$13,578 during the three months ended March 31, 2023 compared to the same period in the previous financial year as a result of the launch of new wine testing products.
Depreciation and Amortization Expenses
|
Three Months Ended March 31, |
||||||||
|
2023 |
2022 |
|||||||
|
A$ |
A$ |
|||||||
|
Depreciation |
219,337 | 245,771 | ||||||
|
Amortization |
2,338 | 405,809 | ||||||
|
Total depreciation and amortization |
221,675 | 651,580 | ||||||
Depreciation of fixed assets is calculated on a straight-line basis over the useful life of property, plant and equipment. Although our property, plant and equipment has increased, the decline in depreciation during the three months ended March 31, 2023, compared to the same period in the previous financial year is due certain assets not being currently depreciated as they are not available for use.
Amortization expense for the three months ended March 31, 2023 represents the Company’s finance lease liabilities. Amortization expense has declined during the three months period ended March 31, 2023 compared to the same period in the previous financial year as the intangibles assets which were acquired in September 2019 pursuant to the Siemens acquisition were impaired and fully written off as at December 31, 2022.
Research and Development Expenses
The primary focus of the R&D activities during the three months ended March 31, 2023 were developing the Company's:
|
● |
Sentia wine testing platform (Fructose, Acetic Acid and Titratable Acidity tests) including further enhancement of certain Sentia tests that has already been launched; |
|
|
● |
Xprecia Prime next generation PT-INR Coagulation platform including U.S. Food and Drug Administration (“FDA”) Clinical Trial programs. The submission to FDA was made in March 2023; |
|
|
● |
Petrackr biosensor strip and meter to be used for the detection and monitoring of diabetes in non-humans; |
|
|
● |
Oncology platform Tn Antigen biosensor used for the detection, staging and monitoring of cancer; and |
|
|
● |
Aptamer based sensing platform including COVID-19 and female fertility testing. |
As we finalise the development of our products, obtain the necessary regulatory approval required for those products and subsequently launch the same, our R&D expenditure is expected to decline. During the current quarter, we finalized the development of and launched the Sentia Fructose and Acetic Acid tests. The Titratable Acidity test was launched in April 2023. We submitted to the FDA our Xprecia Prime clinical trial results. Once approved by the FDA, we will be able to launch this product in the United States. We launched our Petrackr product in May 2023. As a result of these activities our R&D expenditure declined by 48% during the three months ended March 31, 2023, compared to the same period in the previous financial year.
The timing and cost of any development program is dependent upon a number of factors including achieving technical objectives, which are inherently uncertain and subsequent regulatory approvals. We have project plans in place for all our development programs which we use to plan, manage and assess our projects. As part of this procedure, we also undertake commercial assessments of such projects to optimize outcomes and decision making.
R&D expenses consist of costs associated with research activities, as well as costs associated with our product development efforts, including pilot manufacturing costs. R&D expenses include:
|
● |
consultant and employee related expenses, which include consulting fees, salaries and benefits; |
|
● |
materials and consumables acquired for the research and development activities; |
|
● |
verification and validation work on the various R&D projects including clinical trials; |
|
● |
external research and development expenses incurred under agreements with third party organizations and universities; and |
|
● |
facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment and laboratory and other supplies. |
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist principally of salaries and related costs, including stock-based compensation expense for certain personnel. Other selling, general and administrative expenses include sales and marketing costs to support our products in the market, shipping and handling costs incurred when fulfilling customer orders, repairs and maintenance, insurance, facility costs not otherwise included in R&D expenses, consultancy fees and professional fees including legal services and maintenance fees incurred for patent applications, audit and taxation services.
Selling, general and administrative expenses increased by 72% during the three months ended March 31, 2023, compared to the same period in the previous financial year primarily due to an investment in the Company’s sales and marketing efforts. The Company has now multiple products in the market compared to the same period in the previous financial year and these products are supported by various marketing campaigns and awareness including sales personnel to support our pipeline of products.
Interest Income
Interest income increased by A$201,871 during the three months ended March 31, 2023, compared to the same period in the previous financial year. The increase in interest income is attributable to the higher amount of funds available for investment and higher interest rates.
Interest Expense
Interest expense relates to interest being charged on the secured short-term borrowing initiated by the Company for the 2023 financial year and the interest expense on finance lease liabilities.
Financing Costs
Disclosed in this account is accretion expense which is associated with the Company’s asset retirement obligations (“ARO”). Increase in financing costs is as a result of increase in the discount rate used.
Research and Development Tax Incentive Income
As at March 31, 2023 there is reasonable assurance that the aggregate turnover of the Company for the year ending December 31, 2023 will be less than A$20,000,000 and accordingly an estimated A$806,691 has been recorded as research and development tax incentive income for the three months ended March 31, 2023. Offset against was this an overstatement of research and development tax incentive income of $278,413 for the year ended December 31, 2022 and as a result the aggregate amount recognized as income is A$528,278. The decrease period on period is driven by the decrease in eligible research and development expenditure incurred in the three months ended March 31, 2023 as compared to the same period in 2022.
Research and development tax incentive income for the 2022 financial year has not yet been received and as such is recorded in “Research and development tax incentive income” in the consolidated condensed balance sheet.
Exchange Gain/(Loss)
Foreign exchange gains and losses arise from the settlement of foreign currency transactions that are translated into the functional currency using the exchange rates prevailing at the dates of the transactions and from the translation at period end exchange rates of monetary assets and liabilities denominated in foreign currencies.
Other Income
Other income is as follows for the relevant periods:
|
Three Months Ended March 31 |
||||||||
|
2023 |
2022 |
|||||||
|
A$ |
A$ |
|||||||
|
Federal and state government subsidies |
20,000 | 0 | ||||||
|
Rental income |
33,478 | 35,561 | ||||||
|
Other income |
0 | 181 | ||||||
| 53,478 | 35,742 | |||||||
Critical Accounting Estimates and Judgments
The preparation of financial statements and related disclosures in conformity with U.S. generally accepted accounting principles and the Company’s discussion and analysis of its financial condition and operating results require the Company’s management to make judgments, assumptions and estimates that affect the amounts reported. Significant items subject to such estimates and assumptions include impairment of intangible assets, deferred income taxes, research and development tax incentive income and stock-based compensation expenses:
Impairment of Long-Lived Assets
The Company reviews its long-lived assets, including property and equipment and definite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. An impairment loss is recognized when the undiscounted future cash flows expected to result from the use of the asset is less than the carrying amount of the asset. Accordingly, we recognise an impairment loss based on the excess of the carrying amount over the fair value of the asset.
Deferred Income Taxes
We compute our deferred income taxes based on the statutory tax rates, future forecasts and tax planning opportunities. Judgement is required in determining our future forecasts and evaluating our tax positions and whether it is probable that our tax losses will be utilised.
Our estimates are made based on the best available information at the time we prepare our consolidated condensed financial statements. In making our estimates, we consider the impact of legislative and judicial developments. As these developments evolve, we update our estimates, which, in turn, may result in adjustments to our effective tax rate.
We anticipate realization of a significant portion of our deferred tax assets through the reversal of existing deferred tax liabilities. Although realization is not assured, management believes it is more likely than not that our deferred tax assets, net of valuation allowances, will be realized.
Uncertain tax positions taken or expected to be taken in a tax return are recognized (or derecognized) in the financial statements when it is more likely than not that the position would be sustained on its technical merits upon examination by tax authorities, taking into account available administrative remedies and litigation. Assessment of uncertain tax positions requires significant judgments relating to the amounts, timing and likelihood of resolution.
Stock-based Compensation Expenses
Probability of attaining vesting conditions and the fair value of the stock-based compensation is highly subjective and requires judgement, and results could change materially if different estimates and assumptions were used. The probability assumptions are critically examined by management each reporting period and reviewed by the board of directors for reasonableness.
Research and Development Tax Incentive Income
The refundable tax offset is one of the key elements of the Australian Government’s support for Australia’s innovation system and if eligible, provides the recipient with cash based upon its eligible research and development activities and expenditures. The calculation of the refundable tax offset requires judgement as to what is eligible research and development activity and expenditure and the outcome will change if different assumptions were used.
Note 1, “Summary of Significant Accounting Policies” in Item 1 of this Form 10-Q and Note 1, “Summary of Significant Accounting Policies,” of the Notes to Consolidated Financial Statements in Part II, Item 8 of the 2022 Form 10-K describes in further detail the significant accounting policies and methods used in the preparation of the Company’s consolidated condensed financial statements. Management bases its estimates on historical experience and on various other assumptions it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recognition of revenue and expenses. Actual results may differ from these estimates.
Financial Condition, Liquidity and Capital Resources
Net Cash/(Debt)
Our net cash position is shown below:
|
March 31, 2023 |
December 31, 2022 |
|||||||
|
A$ |
A$ |
|||||||
|
Cash and cash equivalents |
||||||||
|
Cash and cash equivalents |
20,954,691 | 25,977,703 | ||||||
|
Total cash and cash equivalents |
20,954,691 | 25,977,703 | ||||||
|
Debt |
||||||||
|
Short and long term-debt |
770,190 | 65,768 | ||||||
|
Net cash |
20,184,501 | 25,911,935 | ||||||
Since inception, we have financed our business primarily through the issuance of equity securities, funding from strategic partners, government grants and rebates (including the research and development tax incentive income), cash flows generated from operations and a loan.
The decline in our net financial assets position is primarily a result of ongoing investment in our R&D activities and the general operations of the Company in particular our sales and marketing initiatives to support our business.
We believe we have sufficient cash and cash equivalents to fund our operations for at least the next twelve months from the date of issuance. Liquidity risk is the risk that the Company may encounter difficulty meeting obligations associated with financial liabilities. The Company manages liquidity risk through the management of its capital structure. The purpose of liquidity management is to ensure that there is sufficient cash to meet all the financial commitments and obligations of the Company as they come due. In managing the Company’s capital, management estimates future cash requirements by preparing a budget and a multi-year plan for review and approval by the Board of Directors (“the Board”). The budget is reviewed and updated periodically and establishes the approved activities for the next twelve months and estimates the costs associated with those activities. The multi-year plan estimates future activity along with the potential cash requirements and is based upon management’s assessment of current progress along with the expected results from the coming years’ activity. Budget to actual variances are prepared and reviewed by management and are presented on a regular basis to the Board.
The carrying value of the cash and cash equivalents and the accounts receivables approximates fair value because of their short-term nature.
We regularly review all our financial assets for impairment. A financial asset is a non-physical asset whose value is derived from a contractual claim and in our case includes cash and cash equivalents. There were no impairments recognized as at March 31, 2023 or for the year ended December 31, 2022.
The Company is continuing to monitor the potential impact of COVID-19, if any, on the Company’s business and financial position.
Measures of Liquidity and Capital Resources
The following table provides certain relevant measures of liquidity and capital resources:
|
March 31, 2023 |
December 31, 2022 |
|||||||
|
A$ |
A$ |
|||||||
|
Cash and cash equivalents |
20,954,691 | 25,977,703 | ||||||
|
Working capital |
19,634,510 | 23,586,600 | ||||||
|
Ratio of current assets to current liabilities |
2.50 | 2.80 | ||||||
|
Shareholders’ equity per common share |
0.10 | 0.12 | ||||||
The movement in cash and cash equivalents and working capital (calculated as current assets less current liabilities) during the above periods was primarily the result of ongoing investment in our R&D activities and the general operations of the Company.
We have not identified any collection issues with respect to receivables.
Summary of Cash Flows
|
Three Months ended March 31, 2023 |
Year Ended December 31, 2022 |
|||||||
|
A$ |
A$ |
|||||||
|
Cash provided by/ (used in): |
||||||||
|
Operating activities |
(5,811,205 | ) | (14,702,153 | ) | ||||
|
Investing activities |
(404,382 | ) | (1,565,144 | ) | ||||
|
Financing activities |
672,639 | 25,011,276 | ||||||
|
Net increases/(decrease) in cash, cash equivalents and restricted cash |
(5,542,948 | ) | 8,743,979 | |||||
Our net cash used in operating activities for all periods represents receipts offset by payments for our R&D projects including efforts involved in establishing and maintaining our manufacturing operations and selling, general and administrative expenditure. Cash outflows from operating activities primarily represent the ongoing investment in our R&D activities and the general operations of the Company. As we continue launching products, we expect our inflows from the receipt from our customers to eventually exceed the cash outflows from operating activities.
Our net cash used in investing activities for all periods is primarily for the purchase of various equipment and for the various continuous improvement programs we are undertaking. Since 2022, we have also made investments in our manufacturing scale-up project and we expect finalization of the same during the first half of 2023.
Our net cash increase in financing activities for the year ended December 31, 2022 is primarily the result of A$26 million raised pursuant to a A$20 million fully underwritten rights issue and a A$6 million placement which occurred in May 2022. Our net cash increase in financing activities for the three months ended March 31, 2023 primarily represents proceeds received in the form of a short-term loan to finance our 2023 insurance program and repayment of the same.
Off-Balance Sheet Arrangement
As of March 31, 2023 and December 31, 2022, we did not have any off-balance sheet arrangements, as such term is defined under Item 303 of Regulation S-K, that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
Segment Operating Performance
We operate in one segment. We are a specialist biosensors Company focused on the development, manufacture and commercialization of a range of point of use devices for measuring different analytes across different industries.
Our operations are in Australia, US, Europe and Canada.
The Company’s material long-lived assets are predominantly based in Australia.
|
Item 3 |
Quantitative and Qualitative Disclosures About Market Risk |
As a “smaller reporting company”, we are not required to provide the information called for by this Item.
|
Item 4. |
Controls and Procedures |
Disclosure Controls and Procedures.
At the end of the period covered by this report, the Company and management evaluated the effectiveness of the design and operation of its disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e)). The Company’s disclosure controls and procedures are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. John Sharman, Principal Executive Officer and Salesh Balak, Principal Financial Officer, reviewed and participated in this evaluation. Based on this evaluation, Messrs. Sharman and Balak concluded that, as of the end of the period covered by this report, the Company’s disclosure controls and procedures were effective.
Changes in Internal Control over Financial Reporting.
During the fiscal quarter ended March 31, 2023, there were no changes in the Company’s internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
PART II
| Item |
1 |
Legal Proceedings |
None.
| Item |
1A |
Risk Factors |
The business, financial condition and operating results of the Company can be affected by a number of factors, whether currently known or unknown, including but not limited to those described in Part I, Item 1A of the 2022 Form 10-K under the heading “Risk Factors,” any one or more of which could, directly or indirectly, cause the Company’s actual financial condition and operating results to vary materially from past, or from anticipated future, financial condition and operating results. Any of these factors, in whole or in part, could materially and adversely affect the Company’s business, financial condition, operating results and stock price. There have been no material changes to the Company’s risk factors since the 2022 Form 10-K.
| Item |
2 |
Unregistered Sales of Equity Securities and Use of Proceeds |
None.
| Item |
3 |
Defaults Upon Senior Securities |
None.
| Item |
4 |
Mine Safety Disclosures |
Not applicable.
| Item |
5 |
Other Information |
None.
| Item |
6 |
Exhibits |
|
Exhibit No |
Description |
Location |
||
|
31.1 |
Rule 13a-14(a)/15d-14(a) Certification (Principal Executive Officer) |
Filed herewith |
||
|
31.2 |
Rule 13a-14(a)/15d-14(a) Certification (Principal Financial Officer) |
Filed herewith |
||
|
32 |
Furnished herewith |
|||
|
101 |
The following materials from the Universal Biosensors, Inc. Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 formatted in Inline Extensible Business Reporting Language (XBRL): (i) the Consolidated Condensed Balance Sheets, (ii) the Consolidated Condensed Statements of Comprehensive Income/(Loss), (iii) the Consolidated Condensed Statements of Changes in Stockholders’ Equity and Comprehensive Income/(Loss), (iv) the Consolidated Condensed Statements of Cash Flows and (v) the Notes to Consolidated Condensed Financial Statements |
As provided in Rule 406T of Regulation S-T, this information is furnished herewith and not filed for purposes of Sections 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Exchange Act of 1934. |
||
|
104 |
Cover page Interactive Data File (embedded within the Inline XBRL and contained in Exhibit 101) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
UNIVERSAL BIOSENSORS, INC. |
||||
|
By: |
/s/ John Sharman |
|||
|
Date: May 11, 2023 |
John Sharman |
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Principal Executive Officer |
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By: |
/s/ Salesh Balak |
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Date: May 11, 2023 |
Salesh Balak |
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Principal Financial Officer |