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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024

 

or

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                  to                 

 

Commission File Number: 000-52607

 

logo01.jpg

 

Universal Biosensors, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

98-0424072

(State or other jurisdiction of incorporation or

organization)

 

(I.R.S. Employer Identification Number)

     

Universal Biosensors, Inc.

1 Corporate Avenue,

Rowville, 3178, Victoria

Australia

 

Not Applicable

(Address of principal executive offices)

 

(Zip Code)

 

Telephone: +61 3 9213 9000

 

(Registrants telephone number, including area code)

 

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.

Yes ☑ No ☐

 

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).

Yes ☑ No ☐

 

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:

 

Large accelerated filer

Accelerated filer

 

Non-accelerated filer

Smaller reporting company

 

Emerging growth company

     

 

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 No ☑

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 298,067,435 shares of Common Stock, U.S.$0.0001 par value, outstanding as of October 31, 2024.

 

 

  

 

UNIVERSAL BIOSENSORS, INC.

 

TABLE OF CONTENTS

 

 

Page

PART I

FINANCIAL INFORMATION

 
     

Item 1

Financial Statements (unaudited)

 
     
 

1)

Consolidated condensed balance sheets at September 30, 2024 and December 31, 2023

1

       
 

2)

Consolidated condensed statements of comprehensive income/(loss) for the three and nine months ended September 30, 2024 and 2023

2

       
 

3)

Consolidated condensed statements of changes in stockholders’ equity and comprehensive income/(loss) for the three and nine months ended September 30, 2024 and 2023

3

       
 

4)

Consolidated condensed statements of cash flows for the nine months ended September 30, 2024 and 2023

4

       
 

5)

Notes to consolidated condensed financial statements

5

       

Item 2

Management’s Discussion and Analysis of Financial Condition and Results of Operations

17

     

Item 3

Quantitative and Qualitative Disclosures About Market Risk

23

     

Item 4

Controls and Procedures

23

     

PART II

OTHER INFORMATION

 
     

Item 1

Legal Proceedings

24

     

Item 1A

Risk Factors

24

     

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds

24

     

Item 3

Defaults Upon Senior Securities

25

     

Item 4

Mine Safety Disclosures

25

     

Item 5

Other Information

25

     

Item 6

Exhibits

25

 

Exhibit 31.1

 
 

Exhibit 31.2

 
  Exhibit 32  
  Exhibit 101  
 

Exhibit 104

 
     

SIGNATURES

26

 

 

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.

 

 

 

Universal Biosensors, Inc.

  

 

Item1

Financial Statements

 

Consolidated Condensed Balance Sheets (Unaudited)

 

   

September 30, 2024

   

December 31, 2023

 
   

A$

   

A$

 

ASSETS

               

Current assets:

               

Cash and cash equivalents

    12,349,700       10,240,429  

Inventories

    5,504,799       4,377,933  

Accounts receivable

    1,660,467       2,125,500  

Prepayments

    762,020       1,200,188  

Restricted cash

    35,000       35,000  

Research and development tax incentive receivable

    1,130,175       3,774,343  

Other current assets

    283,874       249,540  

Total current assets

    21,726,035       22,002,933  

Non-current assets:

               

Property, plant and equipment

    32,611,345       32,304,310  

Less accumulated depreciation

    (28,081,097 )     (27,456,376 )

Property, plant and equipment - net

    4,530,248       4,847,934  

Right-of-use asset - operating leases

    2,404,810       2,662,885  

Right-of-use asset - finance leases

    42,063       49,074  

Restricted cash

    320,000       320,000  

Other non-current assets

    88,088       90,045  

Total non-current assets

    7,385,209       7,969,938  

Total assets

    29,111,244       29,972,871  
                 

LIABILITIES AND STOCKHOLDERS EQUITY

               

Current liabilities:

               

Accounts payable

    855,327       1,240,902  

Accrued expenses

    1,537,719       2,056,929  

Contract liabilities

    14,947       36,132  

Lease liability - operating leases

    868,562       825,475  

Lease liability - finance leases

    9,566       9,236  

Employee entitlements liabilities

    1,036,325       869,195  

Short-term loan

    0       911,082  

Total current liabilities

    4,322,446       5,948,951  

Non-current liabilities:

               

Asset retirement obligations

    1,274,992       1,214,255  

Employee entitlements liabilities

    105,035       76,165  

Lease liability - operating leases

    2,464,731       3,179,294  

Lease liability - finance leases

    39,180       46,397  

Total non-current liabilities

    3,883,938       4,516,111  

Total liabilities

    8,206,384       10,465,062  
                 

Commitments and contingencies

    0       0  
                 

Stockholdersequity:

               

Preferred stock, US$0.01 par value. Authorized 1,000,000 shares; issued & outstanding nil at September 30, 2024 (nil at December 31, 2023). Common stock, US$0.0001 par value. Authorized 750,000,000 shares; issued & outstanding 298,067,435 shares at September 30, 2024 (Authorized 300,000,000 shares; issued & outstanding 212,369,435 at December 31, 2023)

    29,807       21,237  

Additional paid-in capital

    131,364,223       119,239,087  

Accumulated deficit

    (99,420,347 )     (92,678,783 )

Current year loss

    (10,642,262 )     (6,741,564 )

Accumulated other comprehensive loss

    (426,561 )     (332,168 )

Total stockholders equity

    20,904,860       19,507,809  

Total liabilities and stockholders equity

    29,111,244       29,972,871  

 

See accompanying Notes to the Consolidated Condensed Financial Statements.

 

1

Universal Biosensors, Inc.
 

 

Consolidated Condensed Statements of Comprehensive Income/(Loss) (Unaudited)

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 
   

2024

   

2023

   

2024

   

2023

 
   

A$

   

A$

   

A$

   

A$

 

Revenue

                               

Revenue from products

    1,721,725       1,516,171       4,273,546       3,807,457  

Revenue from services

    145,126       399,041       688,381       706,956  

Total revenue

    1,866,851       1,915,212       4,961,927       4,514,413  

Operating costs and expenses

                               

Cost of goods sold

    996,238       455,683       1,821,654       1,228,027  

Cost of services

    91,809       69,674       313,288       206,804  

Total cost of goods sold and services

    1,088,047       525,357       2,134,942       1,434,831  

Gross profit

    778,804       1,389,855       2,826,985       3,079,582  

Other operating costs and expenses

                               

Depreciation and amortization

    165,181       248,381       640,888       707,310  

Research and development

    1,039,583       808,001       3,013,916       3,965,966  

Selling, general and administrative

    3,584,709       4,091,182       11,326,063       11,127,848  

Total operating costs and expenses

    4,789,473       5,147,564       14,980,867       15,801,124  

Loss from operations

    (4,010,669 )     (3,757,709 )     (12,153,882 )     (12,721,542 )

Other income/(expense)

                               

Interest income

    149,952       207,908       345,513       600,562  

Interest expense

    (6,633 )     (4,236 )     (19,980 )     (19,715 )

Financing costs

    (21,336 )     (39,249 )     (60,736 )     (132,970 )

Research and development tax incentive income

    452,219       373,569       1,146,593       1,468,871  

Exchange loss

    (9,459 )     (30,295 )     (44,578 )     (45,967 )

Other income

    36,539       649,563       144,808       5,860,318  

Total other income

    601,282       1,157,260       1,511,620       7,731,099  

Net loss before tax

    (3,409,387 )     (2,600,449 )     (10,642,262 )     (4,990,443 )

Income tax benefit/(expense)

    0       0       0       0  

Net loss after tax

    (3,409,387 )     (2,600,449 )     (10,642,262 )     (4,990,443 )
                                 

Net loss per share

                               

Net loss per share - basic and diluted

    (0.01 )     (0.01 )     (0.04 )     (0.02 )

Average weighted number of shares - basic and diluted

    298,067,435       212,369,435       261,089,459       212,369,435  
                                 

Other comprehensive income/(loss), net of tax:

                               

Foreign currency translation reserve

    (99,868 )     59,708       (94,393 )     (5,780 )

Other comprehensive income/(loss)

    (99,868 )     59,708       (94,393 )     (5,780 )

Comprehensive loss

    (3,509,255 )     (2,540,741 )     (10,736,655 )     (4,996,223 )

 

See accompanying Notes to the Consolidated Condensed Financial Statements.

 

2

Universal Biosensors, Inc.
 

 

Consolidated Condensed Statements of Changes in Stockholders Equity and Comprehensive Income/(Loss) (Unaudited)

 

Three Months Ended September 30, 2024

 
   

Ordinary shares

   

 

   

 

   

Other

   

Total

 
   

Shares

   

Amount

   

 Additional

paid-in capital

   

 Accumulated

deficit

   

comprehensive

income/ (loss)

   

 stockholders

equity

 
           

A$

   

A$

   

A$

   

A$

   

A$

 
                                                 

Balances at July 1, 2024

    298,067,435       29,807       131,329,812       (106,653,222 )     (326,693 )     24,379,704  

Net loss

    0       0       0       (3,409,387 )     0       (3,409,387 )

Issuance of common stock at A$0.15 per share, net of issuance costs

    0       0       0               0       0  

Other comprehensive loss

    0       0       0               (99,868 )     (99,868 )

Stock-based compensation expense

    0       0       34,411       0       0       34,411  

Balances at September 30, 2024

    298,067,435       29,807       131,364,223       (110,062,609 )     (426,561 )     20,904,860  

 

Nine Months Ended September 30, 2024

 
   

Ordinary shares

   

 

   

 

   

Other

   

Total

 
   

Shares

   

Amount

   

Additional

paid-in capital

   

Accumulated

deficit

   

comprehensive

income/ (loss)

   

stockholders

equity

 
           

A$

   

A$

   

A$

   

A$

   

A$

 
                                                 

Balances at January 1, 2024

    212,369,435       21,237       119,239,087       (99,420,347 )     (332,168 )     19,507,809  

Net loss

    0       0       0       (10,642,262 )     0       (10,642,262 )

Issuance of common stock at A$0.15 per share, net of issuance costs

    83,333,334       8,334       11,533,534       0       0       11,541,868  

Other comprehensive loss

    0       0       0       0       (94,393 )     (94,393 )

Performance awards and exercise of stock options

    2,364,666       236       472,697       0       0       472,933  

Stock-based compensation expense

    0       0       118,905       0       0       118,905  

Balances at September 30, 2024

    298,067,435       29,807       131,364,223       (110,062,609 )     (426,561 )     20,904,860  

 

Three Months Ended September 30, 2023

 
   

Ordinary shares

   

 

   

 

   

Other

   

Total

 
   

Shares

   

Amount

   

Additional

paid-in capital

   

Accumulated

deficit

   

comprehensive

income/ (loss)

   

stockholders

equity

 
           

A$

   

A$

   

A$

   

A$

   

A$

 
                                                 

Balances at July 1, 2023

    212,369,435       21,237       119,139,053       (95,068,777 )     (357,202 )     23,734,311  

Net loss

    0       0       0       (2,600,449 )     0       (2,600,449 )

Other comprehensive income

    0       0       0       0       59,708       59,708  

Stock-based compensation expense

    0       0       49,988       0       0       49,988  

Balances at September 30, 2023

    212,369,435       21,237       119,189,041       (97,669,226 )     (297,494 )     21,243,558  

 

Nine Months Ended September 30, 2023

 
   

Ordinary shares

   

 

   

 

   

Other

   

Total

 
   

Shares

   

Amount

   

Additional

paid-in capital

   

Accumulated

deficit

   

comprehensive

income/ (loss)

   

stockholders

equity

 
           

A$

   

A$

   

A$

   

A$

   

A$

 
                                                 

Balances at January 1, 2023

    211,844,435       21,184       119,040,784       (92,678,783 )     (291,714 )     26,091,471  

Net loss

    0       0       0       (4,990,443 )     0       (4,990,443 )

Other comprehensive loss

    0       0       0       0       (5,780 )     (5,780 )

Performance awards and exercise of stock options

    525,000       53       (53 )     0       0       0  

Stock-based compensation expense

    0       0       148,310       0       0       148,310  

Balances at September 30, 2023

    212,369,435       21,237       119,189,041       (97,669,226 )     (297,494 )     21,243,558  

 

See accompanying Notes to the Consolidated Condensed Financial Statements.

 

3

Universal Biosensors, Inc.
 
 

Consolidated Condensed Statements of Cash Flows (Unaudited)

 

   

Nine Months Ended September 30,

 
   

2024

   

2023

 
   

A$

   

A$

 

Cash flows from operating activities:

               

Net loss

    (10,642,262 )     (4,990,443 )

Adjustments to reconcile net loss to net cash used in operating activities:

               

Depreciation and amortization

    640,888       717,773  

Stock-based compensation expense

    118,905       148,310  

Non-cash lease (benefit)/expense

    (35,828 )     78,954  
Cash lease (expense)/benefit     (456,332 )     0  

Unrealized foreign exchange gains

    (32,622 )     (11,275 )

Change in assets and liabilities:

               

Other liabilities

    0       (5,739,912 )

Inventories

    (1,126,866 )     (600,655 )

Accounts receivable

    465,033       (719,146 )

Prepayments and other assets

    3,048,000       2,687,202  

Other non-current assets

    0       (4,319 )

Contract liabilities

    (36,132 )     31,332  

Employee entitlements

    196,001       134,081  

Accounts payable and accrued expenses

    (682,362 )     (835,833 )

Net cash used in operating activities

    (8,543,577 )     (9,103,931 )

Cash flows from investing activities:

               

Purchases of property, plant and equipment

    (366,652 )     (1,074,364 )

Net cash used in investing activities

    (366,652 )     (1,074,364 )

Cash flows from financing activities:

               

Proceeds from borrowings

    0       1,056,059  

Repayment of borrowings

    (917,692 )     (1,056,059 )

Proceeds from issuance of common stock, net of issuance costs

    12,015,280       0  

Other

    0       (36,190 )

Net cash provided by/(used in) financing activities

    11,097,588       (36,190 )

Net increase/(decrease) in cash, cash equivalents and restricted cash

    2,187,359       (10,214,485 )

Cash, cash equivalents and restricted cash at beginning of period

    10,595,429       26,824,851  

Effect of exchange rate fluctuations on the balances of cash held in foreign currencies

    (78,088 )     30,669  

Cash, cash equivalents and restricted cash at end of period

    12,704,700       16,641,035  

 

See accompanying Notes to the Consolidated Condensed Financial Statements.

 

 

4

Universal Biosensors, Inc.
 
Notes to Consolidated Condensed Financial Statements (Unaudited)

 

 

1. Summary of Significant Accounting Policies

 

Basis of Presentation

 

The consolidated condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP” or “GAAP”) and with the instructions to Form 10-Q and Article 10 of Regulation S-X for interim financial information. Accordingly, they do not include all information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of the Company’s management, the consolidated condensed financial statements reflect all adjustments, which are normal and recurring in nature, necessary for fair financial statement presentation. Operating results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024. These consolidated condensed financial statements and accompanying notes should be read in conjunction with the Company’s annual consolidated financial statements and accompanying notes included in its Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Form 10-K” or “Annual Report”) filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 29, 2024. The year-end consolidated condensed balance sheet data as at December 31, 2023 was derived from audited financial statements but does not include all disclosures required by U.S. GAAP.

 

Principles of Consolidation

 

The consolidated condensed financial statements include the financial statements of the Company and its wholly owned subsidiaries, UBS, UBS LLC, HRL and UBS BV. All intercompany balances and transactions have been eliminated on consolidation.

 

Use of Estimates

 

The preparation of the consolidated condensed financial statements requires management of the Company to make a number of estimates and assumptions relating to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated condensed financial statements and the reported amounts of revenues and expenses during the period. Significant items subject to such estimates and assumptions include the adequacy of the provision for expected credit losses, deferred income taxes, research and development tax incentive income, impairment of definite-lived intangible assets and stock-based compensation expenses. Actual results could differ from those estimates.

 

Recent Accounting Pronouncements           

 

The Company assesses the adoption impacts of recently issued accounting standards by the Financial Accounting Standards Board on the Company's financial statements as well as material updates to previous assessments, if any, from the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

 

(a) Recent issued accounting standards not yet adopted

 

Nil

 

(b) Recent adopted accounting standards

 

ASU No. 2023-09, Improvement to Income Tax Disclosures

 

In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures, which requires disaggregated information about a reporting entity's effective tax rate reconciliation as well as information on income taxes paid. The standard is intended to benefit investors by providing more detailed income tax disclosures that would be useful in making capital allocation decisions. The amendments in this ASU are effective for annual periods beginning on January 1, 2025, and should be applied on a prospective basis with the option to apply the standard retrospectively. Early adoption is permitted.

 

On January 1, 2024, the Company adopted the new accounting pronouncement ASU No. 2023-09. The adoption of ASU No. 2023-09 did not have any impact on the consolidated condensed financial statements or results of operations.

 

ASU No. 2023-07 Improvements to Reportable Segment Disclosures”

 

In November 2023, the FASB issued ASU No. 2023-07, Improvements to Reportable Segment Disclosures, which improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. In addition, the amendments enhance interim disclosure requirements, clarify circumstances in which an entity can disclose multiple segment measures of profit or loss, provide new segment disclosure requirements for entities with a single reportable segment, and contain other disclosure requirements. The purpose of the amendments is to enable investors to better understand an entity's overall performance and assess potential future cash flows. For public business entities, the amendments in this ASU are effective for annual periods beginning on January 1, 2024 and interim periods beginning on January 1, 2025, and should be applied on a retrospective basis for all periods presented. For entities other than public business entities, the ASU is effective for annual periods beginning after December 15, 2025.

 

5

Universal Biosensors, Inc.
 
Notes to Consolidated Condensed Financial Statements (Unaudited)

 

On January 1, 2024, the Company adopted the new accounting pronouncement ASU No. 2023-07. The adoption of ASU No. 2023-07 did not have any impact on the consolidated condensed financial statements or results of operations.

 

Net Profit/(Loss) per Share and Anti-dilutive Securities

 

Basic and diluted net profit/(loss) per share is presented in conformity with ASC 260 – Earnings per Share. Basic and diluted net profit/(loss) per share has been computed using the weighted-average number of common shares outstanding during the period. Diluted net profit/(loss) per share is calculated by adjusting the basic net profit/(loss) per share by assuming all dilutive potential ordinary shares are converted.

 

Foreign Currency

 

Functional and Reporting Currency

 

Items included in the financial statements of each of the Company’s entities are measured using the currency of the primary economic environment in which the entity operates (“the functional currency”). The functional currency of UBI and UBS is A$ for all years presented. The functional currencies of UBS LLC, HRL and UBS BV are US$, CAD$ and €, respectively, for all years presented.

 

The consolidated condensed financial statements are presented using a reporting currency of A$.

 

Transactions and Balances

 

Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at period end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the consolidated condensed statements of comprehensive income/(loss).

 

The results and financial position of all the Group entities that have a functional currency different from the reporting currency are translated into the reporting currency as follows:

 

assets and liabilities for each balance sheet item reported are translated at the closing rate at the date of that balance sheet;

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

all resulting exchange differences are recognized as a separate component of equity.

 

On consolidation, exchange differences arising from the translation of any net investment in foreign entities are taken to the Accumulated Other Comprehensive Income/(Loss).

 

Fair Value of Financial Instruments

 

The carrying value of all current assets and current liabilities approximates fair value because of their short-term nature. The estimated fair value of all other amounts has been determined, depending on the nature and complexity of the assets or the liability, by using one or all of the following approaches:

 

 

Market approach – based on market prices and other information from market transactions involving identical or comparable assets or liabilities.

 

Cost approach – based on the cost to acquire or construct comparable assets less an allowance for functional and/or economic obsolescence.

 

Income approach – based on the present value of a future stream of net cash flows.

 

These fair value methodologies depend on the following types of inputs:

 

 

Quoted prices for identical assets or liabilities in active markets (Level 1 inputs).

 

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).

 

Unobservable inputs that reflect estimates and assumptions (Level 3 inputs).

 

6

Universal Biosensors, Inc.
 
Notes to Consolidated Condensed Financial Statements (Unaudited)

 

Concentration of Credit Risk and Other Risks and Uncertainties

 

Cash, cash equivalents, restricted cash and accounts receivable consist of financial instruments that potentially subject the Company to concentration of credit risk to the extent of the amount recorded on the consolidated condensed balance sheets. The Company’s cash, cash equivalents and restricted cash are primarily invested with one of Australia’s largest banks. The Company is exposed to credit risk in the event of default by the banks holding the cash, cash equivalents and restricted cash to the extent of the amount recorded on the consolidated condensed balance sheets. The Company has not experienced any losses on its deposits of cash, cash equivalents and restricted cash. In relation to receivables the Company performs ongoing credit evaluations of our customers. The provision for expected credit losses is determined principally on the basis of past collection experience as well as consideration of current economic conditions and changes in our customer collection trends.

 

Cash, Cash Equivalents and Restricted Cash

 

The Company considers all highly liquid investments purchased with an initial maturity of three months or less to be cash equivalents. For cash and cash equivalents, the carrying amount approximates fair value due to the short maturity of those instruments.

 

The Company maintains cash and restricted cash, which includes collateral for facilities.

 

Inventory

 

Inventories are stated at the lower of cost or net realizable value. Net realizable value is the estimated selling price in the ordinary course of business less the estimated costs of completion and estimated costs necessary to dispose. Inventories are principally determined under the average cost method which approximates cost. Cost comprises direct materials, direct labour and an appropriate portion of variable and fixed overhead expenditure, the latter being allocated on the basis of normal operating capacity. Costs of purchased inventory are determined after deducting rebates and discounts. The Company recognizes inventory on the consolidated condensed balance sheets when they have concluded that the substantial risks and rewards of ownership, as well as the control of the asset, have been transferred.

 

Receivables

 

Trade accounts receivable are recorded at the invoiced amount and do not bear interest. The allowance for credit losses is the best estimate of the amount of probable credit losses in the existing accounts receivable. The Company evaluates the collectability of accounts receivable and records a provision for expected credit losses based on factors including the length of time the receivables are past due, the current business environment and the Company’s historical experience. The expense to adjust the provision for expected credit losses, if any, is recorded within selling, general and administrative expenses in the consolidated condensed statements of comprehensive income/(loss). Account balances are charged against the allowance when it is probable the receivable will not be recovered.

 

Prepayments

 

Prepaid expenses represent expenditures that have not yet been recorded by the Company as an expense but have been paid for in advance. The Company’s prepayments are primarily represented by insurance premiums paid annually in advance.

 

Other Current Assets

 

The Company’s other current assets are primarily represented by sundry receivables.

 

Property, Plant and Equipment

 

Property, plant and equipment are recorded at acquisition cost, less accumulated depreciation.

 

Depreciation on plant and equipment is calculated using the straight-line method over the estimated useful lives of the assets. The estimated useful life of machinery and equipment is three to ten years. Leasehold improvements are amortized on the straight-line method over the shorter of the remaining lease term or estimated useful life of the asset. Maintenance and repairs that do not extend the life of the asset are charged to operations as incurred and include normal services and do not include items of a capital nature.

 

Impairment of Long-Lived Assets

 

The Company reviews its long-lived assets, including property, plant 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 recognize an impairment loss based on the excess of the carrying value amount over the fair value of the asset.

 

7

Universal Biosensors, Inc.
 
Notes to Consolidated Condensed Financial Statements (Unaudited)

 

Australian Goods and Services Tax, Canadian Harmonized Sales Tax, US Sales Tax and European Value Added Tax, collectively Sales Tax

 

Revenues, expenses and assets are recognized net of the amount of associated Sales Tax, unless the Sales Tax incurred is not recoverable from the taxation authority. In this case it is recognized as part of the cost of acquisition of the asset or as part of the expense. Receivables and payables are stated inclusive of the amount of Sales Tax receivable or payable. The net amount of Sales Tax recoverable from, or payable to, the taxation authority is included with other current assets or accrued expenses in the consolidated condensed balance sheets dependent on whether the balance owed to the taxation authorities is in a net receivable or payable position.

 

Leases

 

At contract inception, the Company determines if the new contractual arrangement is a lease or contains a leasing arrangement. If a contract contains a lease, the Company evaluates whether it should be classified as an operating or a finance lease. Upon modification of the contract, the Company will reassess to determine if a contract is or contains a leasing arrangement.

 

The Company records lease liabilities based on the future estimated cash payments discounted over the lease term, defined as the non-cancellable time period of the lease, together with all the following:

 

 

periods covered by an option to extend the lease if the Company is reasonably certain to exercise the extension option; and

 

periods covered by an option to terminate the lease if the Company is reasonably certain not to exercise the termination option.

 

Leases may also include options to terminate the arrangement or options to purchase the underlying lease property. The Company does not separate lease and non-lease components of contracts. Lease components provide the Company with the right to use an identified asset, which consist of the Company’s real estate properties and office equipment. Non-lease components consist primarily of maintenance services.

 

As an implicit discount rate is not readily determinable in the Company’s lease agreements, the Company uses its estimated secured incremental borrowing rate based on the information available at the lease commencement date in determining the present value of future lease payments. For certain leases with original terms of twelve months or less, the Company recognizes lease expense as incurred and does not recognize any lease liabilities. Short-term and long-term portions of operating and finance lease liabilities are classified as lease liabilities in the Company’s consolidated condensed balance sheets.

 

A right-of-use (“ROU”) asset is measured as the amount of the lease liability with adjustments, if applicable, for lease incentives, initial direct costs incurred by the Company and lease prepayments made prior to or at lease commencement. ROU assets are classified as operating or finance lease right-of-use assets, net of accumulated amortization, on the Company’s consolidated condensed balance sheets. The Company evaluates the carrying value of ROU assets if there are indicators of potential impairment and performs the analysis concurrent with the review of the recoverability of the related asset group. If the carrying value of the asset group is determined to not be fully recoverable and is in excess of its estimated fair value, the Company will record an impairment loss in its consolidated condensed statements of income and comprehensive income/(loss).

 

Lease payments may be fixed or variable, however, only fixed payments or in-substance fixed payments are included in the Company’s lease liability calculation. Variable lease payments are recognized in operating expenses in the period in which the obligation for those payments is incurred.

 

Asset Retirement Obligations

 

Asset retirement obligations (“ARO”) are legal obligations associated with the retirement and removal of long-lived assets. ASC 410 – Asset Retirement and Environmental Obligations requires entities to record the fair value of a liability for an asset retirement obligation when it is incurred. When the liability is initially recorded, the Company capitalizes the cost by increasing the carrying amounts of the related property, plant and equipment. Over time, the liability increases for the change in its present value, while the capitalized cost depreciates over the useful life of the asset. The Company derecognizes ARO liabilities when the related obligations are settled.

 

The ARO is in relation to our premises where in accordance with the terms of the lease, the lessee has to restore part of the building upon vacating the premises.

 

Revenue Recognition

 

The Group recognizes revenue predominantly from the sale of analyzers and test strips and the provision of laboratory testing services based on the provisions of ASC 606 Revenue from Contracts with Customers. In accordance with this provision, to determine whether to recognize revenue, the Group follows a five-step process:

 

 

a)

Identifying the contract with a customer;

 

b)

Identifying the performance obligations within the customer contract;

 

8

Universal Biosensors, Inc.
 
Notes to Consolidated Condensed Financial Statements (Unaudited)

 

 

c)

Determining the transaction price;

 

d)

Allocating the transaction price to the performance obligation; and

 

e)

Recognizing revenue when/as performance obligations are satisfied.

 

Nature of goods and services

 

The following is a description of products and services from which the Company generates its revenue.

 

Products and

services

Nature, timing of satisfaction of performance obligations and significant payment terms

Coagulation

testing

products

(“Xprecia”)

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.

   

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.

   

Wine testing

products

(“Sentia”)

Our Sentia wine analyzer is used to measure Free SO₂, Malic Acid, Glucose, Fructose, Total Sugar, Acetic Acid and Titratable Acidity 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.

   

Veterinary

diabetes

product

(“Petrackr”)

Our veterinary blood glucose product, Petrackr, is a blood glucose monitoring product for dogs and cats with diabetes.

 

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.

 

See Note 8 to the Consolidated Condensed Financial Statements for a disaggregation of revenue.

 

Interest Income

 

Interest income is recognized as it accrues, taking into account the effective yield and consists of interest earned on cash, cash equivalents and restricted cash in interest-bearing accounts.

 

Research and Development Tax Incentive Income         

 

Research and development tax incentive income is recognized when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred and the consideration can be reliably measured.

 

The research and development tax incentive is one of the key elements of the Australian Government’s support for Australia’s innovation system and is supported by legislative law primarily in the form of the Australian Income Tax Assessment Act 1997 as long as eligibility criteria are met. Subject to meeting a number of conditions, an entity involved in eligible research and development (“R&D”) activities may claim research and development tax incentive income as follows:

 

 

(1)

as a 43.5% refundable tax offset if aggregate turnover (which generally means an entity’s total income that it derives in the ordinary course of carrying on a business, subject to certain exclusions) of the entity is less than A$20,000,000, or

 

 

(2)

as a 38.5% non-refundable tax offset if aggregate turnover of the entity is more than A$20,000,000.

 

In accordance with SEC Regulation S-X Article 5-03, the Company’s research and development tax incentive income has been recognized as non-operating income as it is not indicative of the core operating activities or revenue producing goals of the Company. Management has assessed the Company’s R&D activities and expenditures to determine which activities and expenditures are likely to be eligible under the tax incentive regime described above. At each period end management estimates the refundable tax offset available to the Company based on available information at the time. This estimate is also reviewed by external tax advisors on an annual basis.

 

9

Universal Biosensors, Inc.
 
Notes to Consolidated Condensed Financial Statements (Unaudited)

 

The Company has recorded research and development tax incentive income of A$452,219 and A$1,146,593 for the three and nine months ended September 30, 2024, respectively. In the nine months ended September 30, 2024 there is reasonable assurance that the aggregate turnover of the Company for the year ended December 31, 2024 will not exceed A$20,000,000.

 

Research and Development Expenditure

 

R&D expenses consist of costs incurred to further the Company’s research and product development activities and include salaries and related employee benefits, costs associated with clinical trial and preclinical development, regulatory activities, research-related overhead expenses, costs associated with the manufacture of clinical trial material, costs associated with developing a commercial manufacturing process, costs for consultants and related contract research, facility costs and depreciation. R&D costs are expensed as incurred as they fall in the scope of ASC 730 ‘Research and Development’.

 

Clinical Trial Expenses

 

Clinical trial costs are a component of R&D expenses. These expenses include fees paid to participating hospitals and other service providers, which conduct certain testing activities on behalf of the Company. Depending on the timing of payments to the service providers and the level of service provided, the Company records prepaid or accrued expenses relating to these costs.

 

Stock-based Compensation

 

We measure stock-based compensation at grant date, based on the estimated fair value of the award and recognize the cost as an expense on a straight-line basis over the vesting period of the award. We estimate the fair value of stock options using the Trinomial Lattice model.

 

We record deferred tax assets for awards that will result in deductions on our income tax returns, based on the amount of compensation cost recognized and our statutory tax rate in the jurisdiction in which we will receive a deduction. Differences between the deferred tax assets recognized for financial reporting purposes and the actual tax deduction reported in our income tax return are recorded in expense or in capital in excess of par value if the tax deduction exceeds the deferred tax assets or to the extent that previously recognized credits to paid-in-capital are still available if the tax deduction is less than the deferred tax asset.

 

Employee Benefit Costs

 

The Company contributes a portion of each employee’s salary to standard defined contribution superannuation funds on behalf of all eligible UBS employees in line with legislative requirements. The contribution rate increased from 10.5% to 11.0% for the period commencing July 1, 2023 and increased to 11.5% on July 1, 2024. Superannuation is an Australian compulsory savings program plan for retirement whereby employers are required to pay a portion of an employee’s remuneration to an approved superannuation fund that the employee is typically not able to access until they have reached the statutory retirement age. Whilst the Company has a third-party default superannuation fund, it permits UBS employees to choose an approved and registered superannuation fund into which the contributions are paid. Contributions are charged to the consolidated condensed statements of comprehensive income/(loss) as the expense is incurred.

 

Registered Retirement Savings Plan and Deferred Sharing Profit Plan

 

The Company provides eligible HRL employees with a retirement plan. The retirement plan includes a Registered Retirement Savings Plan (“RRSP”) and Deferred Profit Sharing Plan (“DPSP”). The RRSP is voluntary and the employee contributions are matched by the Company up to a maximum of 5% based on their continuous years of service and placed into the RRSP. The Company contributes 1% to 2% of the employee’s base earnings towards the DPSP. The DPSP contributions are vested immediately.

 

Benefit Plan

 

The Company provides eligible HRL employees a Benefit Plan. In general, the Benefit Plan includes extended health care, dental care, basic life insurance, basic accidental death and dismemberment and disability insurance.

 

401k Plan

 

The Company acts as a plan sponsor for a 401K plan for eligible UBS LLC employees. A 401K plan is a US-based defined-contribution pension account into which the employees can elect to have a percentage of their salary deducted and contributed to the plan.  Their contributions are matched by the Company up to a maximum of 10% of their salary. 

 

10

Universal Biosensors, Inc.
 
Notes to Consolidated Condensed Financial Statements (Unaudited)

 

Employee Entitlements Liabilities

 

Employee entitlements to annual leave and long service leave are recognized when they accrue to employees. A provision is made for the estimated liability for annual leave and long-service leave as a result of services rendered by employees up to the balance sheet date.

 

Income Taxes

 

We are subject to income taxes in Australia, Canada, the Netherlands and the United States. The Company applies ASC 740 - Income Taxes which establishes financial accounting and reporting standards for the effects of income taxes that result from a Company’s activities during the current and preceding years. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

 

Where it is more likely than not that some portion or all of the deferred tax assets will not be realized, the deferred tax assets are reduced by a valuation allowance. The valuation allowance is sufficient to reduce the deferred tax assets to the amount that is more likely than not to be realized.

 

Pursuant to the U.S. tax reform rules, UBI is subject to regulations addressing Global Intangible Low-Taxed Income ("GILTI"). The GILTI rules are provisions of the U.S. tax code enacted as a part of tax reform legislation in the U.S. passed in December 2017. Mechanically, the GILTI rule functions as a global minimum tax for all U.S. shareholders of controlled foreign corporations (“CFCs”) and applies broadly to certain income generated by a CFC. The Company can make an accounting policy election to either: (1) treat GILTI as a period cost if and when incurred; or (2) recognize deferred taxes for basis differences that are expected to reverse as GILTI in future years. The Company has elected to treat GILTI as a period cost.  

 

Reclassification

 

Certain prior year amounts have been reclassified to conform with current year presentation.

 

 

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 amounts shown in the consolidated condensed statements of cash flows.

 

   

September 30, 2024

   

December 31, 2023

 
   

A$

   

A$

 

Cash and cash equivalents

    12,349,700       10,240,429  

Restricted cash – current assets

    35,000       35,000  

Restricted cash – non-current assets

    320,000       320,000  
      12,704,700       10,595,429  

 

Restricted cash maintained by the Company in the form of term deposits is as follows:

 

   

September 30, 2024

   

December 31, 2023

 
   

A$

   

A$

 

Collateral for facilities - current assets

    35,000       35,000  

Collateral for facilities - non-current assets

    320,000       320,000  
      355,000       355,000  

 

Collateral for facilities represents a letter of credit for A$35,000 issued in favour of American Express Australia Ltd (current), bank guarantee of A$250,000 for commercial lease of UBS’ premises (non-current) and security deposit on Company’s credit cards of A$70,000 (non-current).

 

Interest earned on the restricted cash for the three months ended September 30, 2024 and 2023 was A$3,990 and A$4,087, respectively and A$11,688 and A$9,988 for the nine months ended September 30, 2024 and 2023, respectively.

 

11

Universal Biosensors, Inc.
 
Notes to Consolidated Condensed Financial Statements (Unaudited)

  

 

3. Inventories

 

   

September 30, 2024

   

December 31, 2023

 
   

A$

   

A$

 

Raw materials

    438,024       261,753  

Work in progress

    432,121       273,965  

Finished goods

    4,634,654       3,842,215  
      5,504,799       4,377,933  

  

 

4. Receivables

 

   

September 30, 2024

   

December 31, 2023

 
   

A$

   

A$

 

Accounts receivable

    1,801,689       2,125,500  

Allowance for credit losses

    (141,222 )     0  
      1,660,467       2,125,500  

 

 

5. Property, Plant and Equipment

 

   

September 30, 2024

   

December 31, 2023

 
   

A$

   

A$

 

Plant and equipment

    23,269,934       22,962,369  

Leasehold improvements

    9,341,411       9,341,941  
      32,611,345       32,304,310  

Accumulated depreciation

    (28,081,097 )     (27,456,376 )

Property, plant & equipment - net

    4,530,248       4,847,934  

 

 

6. Leases

 

The Company’s lease portfolio consists primarily of operating leases for office space and equipment with contractual terms expiring from December 2025 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.

 

   

September 30, 2024

   

December 31, 2023

 
   

A$

   

A$

 

Operating lease right-of-use assets:

               

Non-current

    2,404,810       2,662,885  

Operating lease liabilities:

               

Current

    868,562       825,475  

Non-current

    2,464,731       3,179,294  
                 

Weighted average remaining lease terms (in years)

    6.0       6.3  

Weighted average discount rate

    4.8 %     4.8 %

 

The components of lease income/expense were as follows:

 

   

Nine Months Ended September 30,

 
   

2024

   

2023

 
   

A$

   

A$

 

Fixed payment operating lease expense

    331,492       689,101  

Short-term lease expense

    5,402       0  

Sub-lease income

    110,036       100,428  

 

The sub-lease income is deemed an operating lease.

 

12

Universal Biosensors, Inc.
 
Notes to Consolidated Condensed Financial Statements (Unaudited)

 

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:

 

   

Nine Months Ended September 30,

 
   

2024

   

2023

 
   

A$

   

A$

 

Cost of services

    12,383       29,549  

Research and development

    15,135       103,713  

Selling, general and administrative

    303,974       555,839  
      331,492       689,101  

 

Supplemental cash flow information related to the Company’s leases was as follows:

 

   

Nine Months Ended September 30,

 
   

2024

   

2023

 
   

A$

   

A$

 

Operating cash outflows from operating leases

    653,387       733,129  

 

Supplemental non-cash information related to the Company’s leases was as follows:

 

   

Nine Months Ended September 30,

 
   

2024

   

2023

 
   

A$

   

A$

 

Right-of-use assets obtained in exchange for lease liabilities

    28,353       28,353  

Right-of-use asset modifications

    0       (1,234,247 )

 

Future lease payments are as follows:

 

   

September 30, 2024

   

December 31, 2023

 
   

A$

   

A$

 

1 year

    1,016,285       998,418  

2 years

    561,114       1,022,251  

3 years

    414,165       407,413  

4 years

    418,255       416,427  

5 years

    425,935       418,875  

Thereafter

    1,068,102       1,388,933  

Total future lease payments

    3,903,856       4,652,317  

Less: imputed interest

    (570,563 )     (647,548 )

Total operating lease liabilities

    3,333,293       4,004,769  

Current

    868,562       825,475  

Non-current

    2,464,731       3,179,294  

 

On March 1, 2024, HRL entered into a tenancy agreement for an office space for a 12-month period in Hamilton, Canada. As of September 30, 2024, the Company has not entered into any operating or finance lease agreements that have not yet commenced.

 

 

7. Short-Term Loan

 

In December 2023 the Company entered into a short-term loan facility to finance its 2024 Insurance Premium. The total amount available and drawn down under the facility is A$911,082. The facility is repayable in nine monthly installments which commenced in January 2024 and has an effective annual interest rate of 1.99%. 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. The secured loan has been fully repaid as at September 30, 2024.

 

13

Universal Biosensors, Inc.
 
Notes to Consolidated Condensed Financial Statements (Unaudited)

  

 

8. 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 September 30,

   

Nine Months ended September 30,

 
   

2024

   

2023

   

2024

   

2023

 
   

A$

   

A$

   

A$

   

A$

 

Major product/service lines

                               

Coagulation testing products

    1,021,493       721,594       2,449,221       1,547,219  

Laboratory testing services

    145,126       399,041       688,381       706,956  

Wine testing products

    694,552       722,414       1,762,923       1,880,031  

Veterinary diabetes products

    5,680       72,163       61,402       380,207  
      1,866,851       1,915,212       4,961,927       4,514,413  
                                 

Timing of revenue recognition

                               

Products and services transferred at a point in time

    1,866,851       1,915,212       4,961,927       4,514,413  

 

Contract Balances

 

The following table provides information about receivables and contract liabilities from contracts with customers.

 

   

Nine Months Ended September 30,

 
   

2024

   

2023

 
   

A$

   

A$

 

Receivables

    1,660,467       1,668,153  

Contract liabilities

    14,947       35,867  

 

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:

 

   

Nine Months Ended September 30,

 
   

2024

   

2023

 
   

A$

   

A$

 

Contract Liabilities - current:

               

Opening balance

    36,132       29,851  

Closing balance

    14,947       35,867  

Net increase/(decrease)

    (21,185 )     6,016  

 

The Company expects all of the Company’s contract liabilities to be realized by December 31, 2024.

 

 

9. 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 September 30,

   

Nine Months Ended September 30,

 
   

2024

   

2023

   

2024

   

2023

 
   

A$

   

A$

   

A$

   

A$

 

Federal and state government subsidies

    0       0       0       20,000  

Rental income

    36,823       33,474       110,036       100,428  

Other income

    0       (13,037 )     0       (22 )

Sundry

    (284 )     629,126       34,772       5,739,912  
      36,539       649,563       144,808       5,860,318  

 

Sundry income represents the following:

 

 

Previously accrued marketing support payment of A$2,896,764 derecognized in June 2023

 

14

Universal Biosensors, Inc.
 
Notes to Consolidated Condensed Financial Statements (Unaudited)

 

 

Previously accrued license fee payable to Siemens of A$2,214,022 derecognized in June 2023

 

A$629,126 as a result of change in ARO liability in September 2023

 

 

10. 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 September 30, 2024

                       

Foreign currency translation reserve

    (99,868 )     0       (99,868 )

Other comprehensive loss

    (99,868 )     0       (99,868 )
                         

Three Months Ended September 30, 2023

                       

Foreign currency translation reserve

    59,708       0       59,708  

Other comprehensive income

    59,708       0       59,708  
                         

Nine Months Ended September 30, 2024

                       

Foreign currency translation reserve

    (94,393 )     0       (94,393 )

Other comprehensive loss

    (94,393 )     0       (94,393 )
                         

Nine Months Ended September 30, 2023

                       

Foreign currency translation reserve

    (5,780 )     0       (5,780 )

Other comprehensive loss

    (5,780 )     0       (5,780 )

  

 

11. 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:

 

On May 8, 2024, the Company announced that a fully underwritten non-renounceable rights issue of new CHESS depositary interests over fully paid ordinary shares in UBI (“New CDIs”) raised A$10 million (“Entitlement Offer”) at a ratio of 1 New CDI for approximately every 3.47 existing CDIs held at the record date, being April 16, 2024. In addition, participants in the Entitlement Offer received one attaching option to acquire CDIs for each New CDI acquired under the Entitlement Offer at an exercise price of A$0.20 (“Options”). The Options vested upon issue, expire 3 years from the date of issue, are exercisable in multiple tranches and each entitle the option holder to 1 CDI upon exercise (subject to any adjustments for reconstructions or bonus issues in accordance with the Listing Rules).

 

In connection with the Entitlement Offer, the Company received a binding commitment from the Underwriter, Viburnum Funds Pty Ltd (“Viburnum”) to fully underwrite the Entitlement Offer. Following the close of the Entitlement Offer, 29,289,424 New CDIs and Options were issued to Viburnum.

 

Mr. Craig Coleman is a Non-Executive Director of the Company and an Executive Chairman and associate of the Underwriter. Viburnum, as investment manager for its associated funds and entities currently holds voting power over approximately 29% of the Company’s shares.

 

The Company, after receiving the approval of the stockholders of the Company at a special meeting of stockholders held on April 10, 2024 (the “Meeting”), issued Viburnum 13,849,567 options, as its underwriting fee ("Underwriter Options"), equal in value to 5.0% of the underwritten amount of A$10 million. The Underwriter Options were issued on the same terms as the Options issued to investors under the Entitlement Offer.

 

The Securities have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States or to, or for the account of, a U.S. Person (within the meaning of Regulation S under the Securities Act), absent registration or an applicable exemption from the registration requirements. Hedging transactions involving these securities may not be conducted unless in compliance with the Securities Act.

 

In addition, the Company received stockholder approval at the Meeting to amend its certificate of incorporation to increase the number of authorized shares of common stock available for issuance.

 

15

Universal Biosensors, Inc.
 
Notes to Consolidated Condensed Financial Statements (Unaudited)
 

 

On May 27, 2022, Viburnum acquired from Mr. Sharman, unlisted options to purchase up to 1,000,000 ordinary shares at A$0.57 per option. The options fully vested on March 25, 2020, had an exercise price of A$0.20 and have an expiry date of March 24, 2024. These options were exercised on March 22, 2024. In March 2024, Mr. Sharman and his associates exercised 1,364,666 options at an exercise price of A$0.20 per option.

 

There were no material related party transactions or balances as at September 30, 2024 other than as disclosed above.

 

 

12. 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 nil as at September 30, 2024 and December 31, 2023. 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 September 30, 2024 and December 31, 2023 were A$4,275,536 and A$3,484,474, respectively.

 

 

13. 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 and Canada.

 

16

  

 

Item 2

Managements 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 Managements 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, women’s health and fertility, non-human and environmental testing using our patented platform technology and hand-held point-of-use devices.

 

Key developments include:

 

 

Total revenue grew 10% for the nine months ended September 30, 2024 when compared to the same period in the previous financial year

 

Total operating costs and expenses and R&D expenses decreased 5% and 24% respectively, for the nine months ended September 30, 2024 when compared to the same period in the previous financial year

 

A$2.50 million raised pursuant to a placement in Q1 2024 and A$10.00 million raised pursuant to a fully underwritten entitlement offer which closed on May 1, 2024 and completed on May 8, 2024 both at an issue price of A$0.15. Total amount raised net of issuance costs was A$11.5 million (costs of issuance of $0.96 million). In addition, participants in the capital raise received one attaching option to acquire CDIs for each New CDI acquired at an exercise price of A$0.20

 

Receipt of FDA 510(k) and CLIA Waiver approval for Xprecia Prime for the full measuring range of 0.8 – 8.0 INR which allows the Company to sell Xprecia Prime into healthcare professional settings (including CLIA waived facilities) such as hospitals, clinics and doctor’s office in the U.S.

 

Winning a tender to supply two Health Authorities with Xprecia Prime in Italy and other tenders in Chile and Australia

 

Agreeing revised terms with a major partner in India for the continued supply of Xprecia Prime

 

Results of Operations

 

Analysis of Consolidated Revenue

 

The financial results of the products and services we generated revenues during the three and nine months ended September 30, 2024 and 2023 are as follows:

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 
   

2024

   

2023

   

2024

   

2023

 
   

A$

   

A$

   

A$

   

A$

 

Revenue from products & services

    1,866,851       1,915,212       4,961,927       4,514,413  

Cost of goods sold and services

    (1,088,047 )     (525,357 )     (2,134,942 )     (1,434,831 )

Gross profit

    778,804       1,389,855       2,826,985       3,079,582  

 

Revenue from products and services decreased by 3% during the three months ended September  30, 2024 when compared to the same period in the previous financial year and increased by 10% during the nine months ended September 30, 2024 when compared to the same period in the previous financial year. Gross profit decreased by 44% and 8% during the three and nine months ended September 30, 2024 when compared to the same period in the previous financial year. Several large sales orders for devices negatively impacted the gross margin. Strips’ sales margin remained strong at an average of more than 70%.

 

17

 

Revenue from Products

 

The financial results of the coagulation, wine testing and veterinary diabetes products we sold during the respective periods are as follows:

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 
   

2024

   

2023

   

2024

   

2023

 
   

A$

   

A$

   

A$

   

A$

 

Xprecia

    1,021,493       721,594       2,449,221       1,547,219  

Sentia

    694,552       722,414       1,762,923       1,880,031  

Petrackr

    5,680       72,163       61,402       380,207  
      1,721,725       1,516,171       4,273,546       3,807,457  

Cost of goods sold

    (996,238 )     (455,683 )     (1,821,654 )     (1,228,027 )

Gross profit

    725,487       1,060,488       2,451,892       2,579,430  

 

Our total revenue from products increased by 14% and 12% during the three and nine months ended September 30, 2024, compared to the same period in the previous financial year. Our gross profit decreased by 32% and 5% during the three and nine months ended September 30, 2024 when compared to the same period in the previous financial year. Gross profit was impacted due to the high volume of devices which were sold at lower margin in order to increase our market share. Gross margin for strips remained strong at more than 70%.  

 

Revenue from Xprecia increased by 42% and 58% during the three and nine months ended September 30, 2024, compared to the same period in the previous financial year through our sales and marketing initiatives. Sentia revenue decreased by 4% and 6% during the three and nine months ended September 30, 2024, compared to the same period in the previous financial year. Sentia revenue are recovering from the technical strip issues encountered in H1 2024 hence the decline in revenue. Petrackr revenue decreased by 92% and 84% during the three and nine months ended September 30, 2024, compared to the same period in the previous financial year. Revenue from Petrackr for the respective periods has declined as large stocking orders were placed initially upon its launch in H1 2023.

 

Revenue from Services

 

The financial results of the laboratory testing services we provided during the respective periods are as follows:

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 
   

2024

   

2023

   

2024

   

2023

 
   

A$

   

A$

   

A$

   

A$

 

Laboratory testing services

    145,126       399,041       688,381       706,956  

Cost of services

    (91,809 )     (69,674 )     (313,288 )     (206,804 )

Gross profit

    53,317       329,367       375,093       500,152  

 

Revenue from laboratory testing services decreased by 64% and 3% during the three and nine months ended September 30, 2024, compared to the same period in the previous financial year due to leadership challenges faced by HRL. A new management structure has been established to improve our laboratory testing services business.

 

Depreciation and Amortization Expenses

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 
   

2024

   

2023

   

2024

   

2023

 
   

A$

   

A$

   

A$

   

A$

 

Depreciation

    121,192       208,413       510,843       623,091  

Amortization

    45,131       43,493       133,470       94,682  

Depreciation allocated to cost of goods sold & services

    (1,142 )     (3,525 )     (3,425 )     (10,463 )
      165,181       248,381       640,888       707,310  

 

Depreciation of fixed assets is calculated on a straight-line basis over the useful life of property, plant and equipment. Decrease in depreciation over the respective periods is as a result of certain assets becoming fully depreciated.

 

Amortization expense for the 2024 financial year represents the Company’s software. Increase in amortization expense is as a result of certain software costs which were still in development during the 2023 financial year and were not amortized have since been completed and subject to amortization during 2024.

 

18

 

Research and Development Expenses

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 
   

2024

   

2023

   

2024

   

2023

 
   

A$

   

A$

   

A$

   

A$

 

Research and development expenses

    1,039,583       808,001       3,013,916       3,965,966  

 

Our research and development (“R&D”) expenditure declined by 24% during the nine months ended September 30, 2024, compared to the same period in the previous financial year. R&D expenditure increased by 29% for the three months ended September 30, 2024, compared to the same period in the previous financial year. The primary focus of the R&D activities during the nine months ended September 30, 2024 were:

 

activities undertaken to support Xprecia Prime’s submission to the FDA. FDA 510(k) and CLIA Waiver approval for the Xprecia Prime device was received in March 2024

 

further enhancement of certain Sentia tests that has already been launched

 

developing a device to detect heavy metals and other impurities in water (“Aqua Sense” project)

 

developing the Company’s Oncology platform biosensors used for the detection, staging and monitoring of cancer

 

developing the Company’s Aptamer based sensing platform

 

Research is focused on demonstrating technical feasibility of new technology applications and generally does not incur a large amount of expenses. Development activity is focused on turning these technology platforms into commercial-ready products and represents the majority of the Company’s research and development expenses. For the nine months ended September 30, 2023, we had a number of projects in the development phase which included Xprecia Prime (FDA submission made in March 2023), Petrackr (launched in May 2023) and certain Sentia tests (we finalized the development of and launched the Sentia Fructose and Acetic Acid tests in Q1 2023 and the Titratable Acidity test was launched in April 2023) hence the higher R&D expenses in 2023 compared to 2024 wherein most of the projects are in the research phase. Increase in R&D expenses in the current quarter compared to Q3 2023 as more resources invested in the current quarter; (a) for our Aqua Sense project as we target to launch in 2025 and; (b) to further improve our Sentia products already in the market.

 

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

 

   

Three Months Ended September 30,

   

Nine Months Ended September 30,

 
   

2024

   

2023

   

2024

   

2023

 
   

A$

   

A$

   

A$

   

A$

 

Selling, general and administrative

    3,584,709       4,091,182       11,326,063       11,127,848  

 

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 remained flat for the nine months ended September 30, 2024, compared to the same period in the previous financial year. Selling, general and administrative expenses decreased by 12% during the three months ended September 30, 2024, compared to the same period in the previous financial year as the Company is managing its non-core expenditure.

 

Interest Income

 

Interest income decreased by 28% and 42% during the three and nine months ended September 30, 2024, compared to the same period in the previous financial year. The decrease in interest income is attributable to the overall lower amount of funds available for investment throughout 2024.

 

19

 

Interest Expense

 

Interest expense relates to interest being charged on the secured short-term borrowing initiated by the Company for the 2024 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”). Decrease in financing costs is as a result of change of estimate for the ARO liability.

 

Research and Development Tax Incentive Income

 

As at September 30, 2024 there is reasonable likelihood that the aggregate turnover of the Company for the year ending December 31, 2024 will be less than A$20,000,000 and accordingly an estimated A$1,146,593 has been recorded as research and development tax incentive income for the nine months ended September 30, 2024. Included in this is an understatement of research and development tax incentive income of $16,418 for the year ended December 31, 2023. The decrease period on period is driven by the decrease in eligible research and development expenditure incurred in the three and nine months ended September 30, 2024 as compared to the same period in 2023.

 

Research and development tax incentive receivable for the 2023 financial year was received in June 2024.

 

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 September 30,

   

Nine Months Ended September 30,

 
   

2024

   

2023

   

2024

   

2023

 
   

A$

   

A$

   

A$

   

A$

 

Federal and state government subsidies

    0       0       0       20,000  

Rental income

    36,823       33,474       110,036       100,428  

Other income

    0       (13,037 )     0       (22 )

Sundry

    (284 )     629,126       34,772       5,739,912  
      36,539       649,563       144,808       5,860,318  

 

Sundry income represents the following:

 

Previously accrued marketing support payment of A$2,896,764 derecognized in June 2023

 

Previously accrued license fee payable to Siemens of A$2,214,022 derecognized in June 2023

 

A$629,126 as a result of change in ARO liability in September 2023

 

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 provision for expected credit losses research and development tax incentive income, stock-based compensation expenses and asset retirement obligations:

 

Provision for Expected Credit Losses

 

The Company evaluates the collectability of accounts receivable and records a provision for expected credit losses based on factors including the length of time the receivables are past due, the current business environment and the Company’s historical experience.

 

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.

 

20

 

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.

 

Asset Retirement Obligations

 

ARO are legal obligations associated with the retirement and removal of long-lived assets. ARO reflects estimates of future costs directly attributable to remediating the liability, inflation, assumptions of risks associated with the future cash outflows, and the applicable risk-free interest rates for discounting future cash outflows. Changes in these factors can result in a change to the ARO recognized by the Company.

 

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 Condensed Financial Statements in Part II, Item 8 of the 2023 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:

 

   

September 30, 2024

   

December 31, 2023

 
   

A$

   

A$

 

Cash and cash equivalents

               

Cash and cash equivalents

    12,349,700       10,240,429  

Debt

               

Short term debt/ loan

    0       (911,082 )

Net cash

    12,349,700       9,329,347  

 

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 Group has experienced net cash outflows over recent periods, predominantly in conducting research & development activities, product approval and registrations, launch of our products and support of the same in the marketplace. We continue to reduce research & development expenditure and other operating expenditure in the foreseeable future and focus on increasing our commercialization efforts. We are closely monitoring the success of our commercialization efforts in relation to the newly launched product portfolio and their impact on our cash position. Given the natural uncertainty that arises with the launch of new products, if we were to experience delays or encounter issues in these commercialization efforts, we would need and expect to adjust our operating expenditure accordingly, to ensure sufficient cash remains available to fund our operations for at least the next twelve months from the date of issuance. We do not have any external debt obligations and are not subject to any covenant obligations.

 

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 is prepared and reviewed by management and are presented on a regular basis to the Board.

 

21

 

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, accounts receivables, fixed assets and equity shares. With the exception of a provision for expected credit losses on our accounts receivables balances as at September 30, 2024, there were no impairments recognized as at September 30, 2024 or for the year ended December 31, 2023.

 

Measures of Liquidity and Capital Resources

 

The following table provides certain relevant measures of liquidity and capital resources:

 

   

September 30, 2024

   

December 31, 2023

 
   

A$

   

A$

 

Cash and cash equivalents

    12,349,700       10,240,429  

Working capital

    17,403,589       16,053,982  

Ratio of current assets to current liabilities

    5.03       3.70  

Shareholders’ equity per common share

    0.07       0.07  

 

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. The Company also raised A$2.50 million via an institutional placement at an issue price of A$0.15 per New CDI in March 2024 and A$10.00 million pursuant to a fully underwritten entitlement offer in May 2024, at an issue price of $0.15 per New CDI. There were certain options exercised in March 2024 which raised A$0.47 million. The Company also received A$3.79 million of the research and development tax incentive receivable for the 2023 financial year in June 2024.

 

In relation to receivables, the Company performs ongoing credit evaluations of our customers. A provision for expected credit losses of A$141,222 has been determined principally on the basis of past collection experience as well as consideration of current economic conditions and changes in our customer collection trends.

 

Summary of Cash Flows

 

   

Nine Months Ended September 30,

 
   

2024

   

2023

 
   

A$

   

A$

 

Cash provided by/(used in):

               

Operating activities

    (8,543,577 )     (9,103,931 )

Investing activities

    (366,652 )     (1,074,364 )

Financing activities

    11,097,588       (36,190 )

Net increase/(decrease) in cash, cash equivalents and restricted cash

    2,187,359       (10,214,485 )

 

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 efforts to promote brand awareness of our products, R&D activities and the general operations of the Company. As our products capture increased market share, 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.

 

Our net cash increase in financing activities for the period ended September 30, 2024 is primarily the result of A$2.50 million raised via an institutional placement in March 2024 and A$10.00 million raised pursuant to a fully underwritten entitlement offer in May 2024. There were certain options exercised in March 2024 which raised A$0.47 million. The balance primarily represents proceeds received in the form of a short-term loan to finance our insurance program and repayment of the same.

 

 

Off-Balance Sheet Arrangement

 

As of September 30, 2024 and December 31, 2023, 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.

 

22

 

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 and Canada.

 

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 September 30, 2024, 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.

 

23

 

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 2023 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 2023 Form 10-K.

 

Item

2

Unregistered Sales of Equity Securities and Use of Proceeds

 

On March 25, 2024, the Company issued 16,666,667 CHESS Depositary Interests over fully paid shares of common stock of the Company (“CDIs”) at A$0.15 per CDI in a placement offering (the “Placement”) to selected institutional investors (the “Placement Participants”) and received aggregate gross proceeds of approximately A$2.5 million in connection therewith. Subsequent to receiving the stockholder approval at the Meeting, the Company issued to Placement Participants one option (the “Options”) to acquire CDIs for the exercise price of A$0.20 per CDI for each CDI acquired under the Placement. The issuance of CDIs in the Placement was made in reliance upon the exemption from registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and/or Regulation S promulgated under the Securities Act.

 

On May 8, 2024, the Company announced that a fully underwritten non-renounceable rights issue of new CHESS depositary interests over fully paid ordinary shares in UBI (“New CDIs”) raised A$10 million by issuing 66,666,667 shares of its common stock in the form of CHESS Depositary Interests (“CDIs”), each of which represents a beneficial interest of one (1) fully paid share of the Company’s common stock (“Entitlement Offer”). In addition, participants in the Entitlement Offer received one attaching option to acquire CDIs for each New CDI acquired under the Entitlement Offer at an exercise price of A$0.20 (the “Options”).

 

The Options vested upon issue, expire 3 years from the date of issue, are exercisable in multiple tranches and each entitle the option holder to 1 CDI upon exercise (subject to any adjustments for reconstructions or bonus issues in accordance with the Listing Rules).

 

In connection with the Entitlement Offer, the Company received a binding commitment from the Underwriter, Viburnum Funds Pty Ltd (“Viburnum”) to fully underwrite the Entitlement Offer. Following the close of the Entitlement Offer, 29,289,424 New CDIs and Options were issued to Viburnum.

 

Mr. Craig Coleman is a Non-Executive Director of the Company and an Executive Chairman and associate of the Underwriter. Viburnum, as investment manager for its associated funds and entities currently holds voting power over approximately 29% of the Company’s shares.

 

The Company, after receiving the approval of the stockholders of the Company at a special meeting of stockholders held on April 10, 2024 (the “Meeting”), issued Viburnum 13,849,567 options, as its underwriting fee ("Underwriter Options"), equal in value to 5.0% of the underwritten amount of A$10 million. The Underwriter Options were issued on the same terms as the Options issued to investors under the Entitlement Offer.

 

The Securities have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States or to, or for the account of, a U.S. Person (within the meaning of Regulation S under the Securities Act), absent registration or an applicable exemption from the registration requirements. Hedging transactions involving these securities may not be conducted unless in compliance with the Securities Act.

 

In addition, the Company received stockholder approval at the Meeting to amend its certificate of incorporation to increase the number of authorized shares of common stock available for issuance.

 

On May 27, 2022, Viburnum acquired from Mr. Sharman unlisted options to purchase up to 1,000,000 ordinary shares at A$0.57 per option. The options fully vested on March 25, 2020, had an exercise price of A$0.20 and have an expiry date of March 24, 2024. These options were exercised on March 22, 2024. In March 2024, Mr. Sharman and his associates exercised 1,364,666 options at an exercise price of A$0.20 per option.

 

Proceeds of the Placement and the Entitlement Offer shall be applied to sustain growth, support ongoing product development, fund short term operating losses and operate and expand marketing and sales development, particularly in relation to the sale of UBI’s Xprecia Prime device following its recent FDA approval.

 

24

 

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

 

Section 1350 Certificate

 

Furnished herewith

101

 

The following materials from the Universal Biosensors, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 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)

   

 

25

 

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.
(Registrant)

 
     
 

By:  

/s/ John Sharman

 

Date: October 31, 2024

 

John Sharman

 
   

Principal Executive Officer

 

 

 

 

 

By:  

/s/ Salesh Balak

 

Date: October 31, 2024

 

Salesh Balak

 
   

Principal Financial Officer

 

 

 

26