ITEM 1. FINANCIAL STATEMENTS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Note 1: Basis of Presentation
Biomerica, Inc. and Subsidiaries (collectively "the Company") are primarily engaged in the development, manufacture and marketing of medical diagnostic products.
The Company develops, manufactures, and markets medical diagnostic products designed for the early detection and monitoring of chronic diseases and other medical conditions. The Companys medical diagnostic products are sold worldwide in two markets: 1) clinical laboratories and 2) point of care (physicians' offices and over-the-counter drugstores). The diagnostic test kits are used to analyze blood, urine or fecal samples from patients in the diagnosis of various diseases and other medical complications, by measuring or detecting the existence and/or level of specific bacteria, hormones, antibodies, antigens or other substances, which may exist in a patients body, stools, or blood, often in extremely small concentrations.
The information set forth in these condensed consolidated statements is unaudited and reflects all adjustments which, in the opinion of management, are necessary to present a fair statement of the consolidated results of operations of Biomerica, Inc. and subsidiaries (collectively the Company), for the periods indicated. It does not include all information and footnotes necessary for a fair presentation of financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America. All adjustments that were made are of a normal recurring nature.
The unaudited Condensed Consolidated Financial Statements and notes are presented as permitted by the requirements for Form 10-Q and do not contain certain information included in our annual financial statements and notes. The condensed consolidated balance sheet data as of May 31, 2019 was derived from audited financial statements. The accompanying interim condensed consolidated financial statements should be read in conjunction with the financial statements and related notes included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on August 29, 2019 for the fiscal year ended May 31, 2019. The results of operations for our interim periods are not necessarily indicative of results to be achieved for our full fiscal year.
Note 2: Significant Accounting Policies
Principles of Consolidation
The condensed consolidated financial statements include the accounts of Biomerica, Inc. as well as its German subsidiary (BioEurope GmbH) and Mexican subsidiary (Biomerica de Mexico). All significant intercompany accounts and transactions have been eliminated in consolidation.
Accounting Estimates
The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reported period. Estimates that are made include the reserve for bad debt, which is estimated based on current as well as historical history with a customer; stock option forfeiture rates, which are calculated based on historical data; inventory reserves, which are based on projected and historical usage of materials; and lease liability and right-of-use estimates, which are calculated based on certain assumptions such as borrowing rate, likelihood of lease extensions to occur, asset valuation, among other things; (and other items that may be necessary to estimate using current, historical and judgment based). Actual results could materially differ from those estimates.
Concentration of Credit Risk
The Company maintains cash balances at certain financial institutions in excess of amounts insured by federal agencies. The Company does not believe it is exposed to significant credit risks.
The Company provides credit in the normal course of business to customers throughout the United States and foreign markets. At August 31, 2019 and May 31, 2019, the Company had one customer which accounted for 59.1% and two customers which accounted for 68.1%, respectively, of gross accounts receivable. The Company performs ongoing credit evaluations of its customers and requires accelerated prepayment in some circumstances. The Company had one customer which accounted for approximately 45.8% and 45.5%, of consolidated sales for the three months ended August 31, 2019 and August 31, 2018, respectively.
6
For the quarters ended August 31, 2019 and 2018, two vendors accounted for approximately 47.5% and one vendor which accounted for 21.3% of the purchases or raw materials, respectively. At August 31, 2019 and May 31, 2019 there was one company which accounted for 30.7% and 32.1% of accounts payable, respectively.
Cash and Cash Equivalents
Cash and cash equivalents consist of demand deposits and money market accounts with original maturities of less than three months.
Accounts Receivable
The Company extends unsecured credit to its customers on a regular basis. International accounts are required to prepay until they establish a history with the Company and at that time, they are extended credit at levels based on a number of criteria. Based on various criteria, initial credit levels for individual distributors are approved by designated officers and managers of the company. All increases in credit limits are also approved by designated upper level management. Management evaluates receivables on a quarterly basis and adjusts the allowance for doubtful accounts accordingly. Balances over ninety days old are usually reserved for unless collection is reasonably assured.
Occasionally certain long-standing customers, who routinely place large orders, will have unusually large receivables balances relative to the total gross receivables. Management monitors the payments for these large balances closely and very often requires payment of existing invoices before shipping new sales orders.
Inventories
The Company values inventory at the lower of cost (determined using a combination of specific lot identification and the first-in, first-out methods) or net realizable value. Management periodically reviews inventory for excess quantities and obsolescence. Management evaluates quantities on hand, physical condition, and technical functionality as these characteristics may be impacted by anticipated customer demand for current products and new product introductions. The reserve is adjusted based on such evaluation, with a corresponding provision included in cost of sales. Abnormal amounts of idle facility expenses, freight, handling costs and wasted material are recognized as current period charges and the allocation of fixed production overhead is based on the normal capacity of the Companys production facilities.
Inventories approximate the following at:
|
August 31,
2019
|
|
May 31,
2019
|
| |
|
|
|
|
|
|
Raw materials
|
$
|
1,217,000
|
|
$
|
1,208,000
|
Work in progress
|
831,000
|
|
|
771,000
|
Finished products
|
|
158,000
|
|
|
172,000
|
Total
|
$
|
2,206,000
|
|
$
|
2,151,000
|
Reserves for inventory obsolescence are recorded as necessary to reduce obsolete inventory to estimated realizable value or to specifically reserve for obsolete inventory that the Company intends to dispose of. As of August 31, 2019 and May 31, 2019, inventory reserves were approximately $52,000 and $49,000, respectively.
Property and Equipment, net
Property and equipment are stated at cost. Expenditures for additions and major improvements are capitalized. Repairs and maintenance costs are charged to operations as incurred. When property and equipment are retired or otherwise disposed of, the related cost and accumulated depreciation or amortization is removed from the accounts, and gains or losses from retirements and dispositions are credited or charged to income.
Depreciation and amortization are provided over the estimated useful lives of the related assets, ranging from 5 to 10 years, using the straight-line method. Leasehold improvements are amortized over the lesser of the estimated useful life of the asset or the term of the lease. Depreciation and amortization expense on property and equipment and leasehold improvements amounted to $29,498 and $27,295 for the three months ended August 31, 2019 and 2018, respectively.
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Intangible Assets, net
Intangible assets include trademarks, product rights, licenses, technology rights and patents, and are accounted for based on Accounting Standards Codification (ASC) 350, Intangibles Goodwill and Other (ASC 350). In that regard, intangible assets that have indefinite useful lives are not amortized but are tested at least annually for impairment or more frequently if events or changes in circumstances indicate that the asset might be impaired. Intangible assets are being amortized using the straight-line method over the useful life; not to exceed 18 years for marketing and distribution rights, 10 years for purchased technology use rights, licenses, and 17 years for patents. Amortization amounted to $5,780 and $16,665 for the three months ended August 31, 2019 and 2018, respectively.
Share-Based Compensation
The Company follows the guidance of the accounting provisions of ASC 718, Share-based Compensation (ASC 718), which requires the use of the fair-value based method to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments (options). The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model that uses assumptions for expected volatility, expected dividends, expected forfeiture rate, expected term, and the risk-free interest rate.
Expected volatilities are based on weighted averages of the historical volatility of the Companys stock and other factors estimated over the expected term of the options. The expected forfeiture rate is based on historical forfeitures experienced. The expected term of options granted is derived using the simplified method which computes expected term as the average of the sum of the vesting term plus the contract term as historically the Company had limited activity surrounding its options. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term.
The Company has not paid dividends historically and does not expect to pay them in the future.
The following summary presents the options and warrants granted, exercised, expired, cancelled and outstanding as of August 31, 2019:
|
|
|
Exercise
Price
Weighted
Average
|
| |
|
Option
Shares
|
| |
Outstanding May 31, 2019
|
1,476,209
|
|
$
|
2.07
|
Granted
|
--
|
|
|
--
|
Forfeited
|
(18,000)
|
|
|
3.41
|
Exercised
|
(41,625)
|
|
|
0.83
|
Outstanding August 31, 2019
|
1,416,584
|
|
$
|
2.09
|
In the quarter ended August 31, 2019, options to purchase 41,625 shares of common stock were exercised at prices ranging from $0.82 to $1.04. Net proceeds to the Company were $34,028.
Revenue Recognition
The Company has various contracts with customers. All of the contracts specify that revenues from product sales are recognized at the time the product is shipped, customarily FOB shipping point, at which point title passes. Revenue is recognized only when collectability is reasonably assured. The Company does not allow for returns except in the event of defective merchandise and therefore does not establish an allowance for returns. In conjunction with sales to certain customers, the Company provides free products upon attaining certain levels of purchases by the customer. The Company accounts for these free products as zero sales and recognizes the cost of the product as part of cost of sales.
8
Investments
From time-to-time, the Company makes investments in privately-held companies. The Company determines whether the fair values of any investments in privately-held entities have declined below their carrying value whenever adverse events or changes in circumstances indicate that recorded values may not be recoverable. If the Company considers any such decline to be other than temporary (based on various factors, including historical financial results, and the overall health of the investees industry), a write-down to estimated fair value is recorded. The Company currently has not written down the investment and no events have occurred which could indicate the carrying value to be less than the fair value. Investments represent the Companys investment in a Polish distributor which is primarily engaged in distributing medical devices. The Company owns approximately 6% of the investee, and accordingly, applies the cost method to account for the investment. Under the cost method, investments are recorded at cost, with gains and losses recognized as of the sale date, and income recorded when received.
Shipping and Handling Fees and Costs
Shipping and handling fees billed to customers are required to be classified as net sales, and shipping and handling costs are required to be classified as either cost of sales or disclosed in the notes to the consolidated financial statements. The Company included shipping and handling fees billed to customers in net sales. The Company included shipping and handling costs associated with inbound freight and unreimbursed shipping to customers in cost of sales.
Research and Development
Research and development costs are expensed as incurred.
Income Taxes
The Company has provided a valuation allowance on deferred tax assets of approximately $2,564,000 and $2,459,000 as of August 31, 2019 and May 31, 2019, respectively.
Foreign Currency Translation
The subsidiary located in Mexico operates primarily using the Mexican peso. The subsidiary located in Germany operates primarily using the U.S. dollar, with an immaterial amount of transactions occurring using the Euro. Accordingly, assets and liabilities of these subsidiaries are translated using exchange rates in effect at the end of the year, and revenues and costs are translated using average exchange rates for the year. The resulting adjustments to assets and liabilities are presented as a separate component of accumulated other comprehensive loss.
Deferred Rent
Incentive payments received from landlords was recorded as deferred lease incentives and were amortized over the underlying lease term on a straight-line basis as a reduction of rent expense. When the terms of an operating lease provide for periods of free rent, rent concessions, and/or rent escalations, the Company established a deferred rent liability for the difference between the scheduled rent payment and the straight-line rent expense recognized. This deferred rent liability was amortized over the underlying lease term on a straight-line basis as a reduction of rent expense. During the period ended August 31, 2019, the Company adopted ASC 842, Leases. As a result, the existing deferred rent liability was netted against the Right of Use Asset which was capitalized at that time.
In February 2016, the Financial Accounting Standards Board issued an accounting standards update which requires lessees to recognize most leases on the balance sheet with a corresponding right-of-use asset. Right-of-use assets represent the Companys right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the estimated present value of fixed lease payments over the lease term. Leases will be classified as financing or operating which will drive the expense recognition pattern. For lessees, the statement of operations presentation and expense recognition pattern for financing and operating leases is similar to the current model for capital and operating leases, respectively. The Company has elected to exclude short-term leases. The update also requires additional disclosures that will better enable users of financial statements to assess the amount, timing, and uncertainty of cash flows arising from leases. The Company adopted this guidance as of June 1, 2019, the required effective date, using the effective date transition method. As permitted under the effective date transition method, financial information and disclosure for periods prior to the date of initial application will not be updated. An adjustment to opening accumulated deficit was not required in conjunction with adoption. For additional information, see Note 6 Leases. The Company has elected not to reassess whether expired or existing contracts contain leases, or reassess the classification of existing leases as of the adoption date. The Company leases office space and copy machines, all of which are operating leases. Most leases include the option to renew and the exercise of the renewals options is at the Companys sole discretion. Options to extend or terminate a lease are considered in the lease term to the extent that the option is reasonably certain of exercise. The leases do not include the options to purchase the leased property. The depreciable life of assets and leasehold improvements are limited by the expected lease term.
9
Net Loss Per Share
Basic loss per share is computed as net loss divided by the weighted average number of common shares outstanding for the period. Diluted loss per share reflects the potential dilution that could occur from common shares issuable through stock options using the treasury stock method. The total amount of anti-dilutive options not included in the earnings per share calculation for the three months ended August 31, 2019 and 2018 was 1,416,584 and 1,113,625 respectively.
The following table illustrates the required disclosure of the reconciliation of the numerators and denominators of the basic and diluted earnings per share computations:
|
Three Months Ended
August 31,
|
|
|
|
2019
|
|
2018
|
Numerator
|
|
|
|
|
|
Loss from continuing operations
|
$
|
(506,296)
|
|
$
|
(451,740)
|
Denominator for basic net loss per common share
|
|
9,744,461
|
|
|
8,930,251
|
Effect of dilutive securities:
|
|
|
|
| |
Options
|
|
--
|
|
|
--
|
|
|
|
|
| |
Denominator for diluted net loss
per common share
|
|
9,744,461
|
|
|
8,930,251
|
|
|
|
|
| |
Basic net loss per common share
|
$
|
(0.05)
|
|
$
|
(0.05)
|
Diluted net loss per common share
|
$
|
(0.05)
|
|
$
|
(0.05)
|
Recent Accounting Pronouncements
On February 25, 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (ASU 2016-02). ASU 2016-02 defines whether a contract is a lease. If it is a lease, the Company is required to recognize the lease assets and liabilities. ASU 2016-02 is effective for public companies for the annual periods beginning December 15, 2018. During the quarter ended August 31, 2019, the Company adopted the provisions of this statement and is taking them into account in the preparation of the financial statements for the quarter ended August 31, 2019. The adoption of this statement resulted in a Right of Use Asset being recorded in the amount of $1,942,999 and a lease liability being recorded in the amount of $1,980,970. Both will be amortized over the life of the underlying leases.
On February 15, 2018, the FASB issued ASU 2018-02, Reclassification of Certain Tax Effects From Accumulated Comprehensive Income (ASU 2018-02). ASU 2018-02 will give companies the option to reclassify stranded tax effects caused by the newly-enacted U.S. TAX Cuts and Jobs Act (TCJA) from accumulated other comprehensive income (ASCI) to retained earnings. ASU 2018-02 took effect for all companies for the fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. During the quarter ended August 31, 2019, the Company adopted the provisions of this statement and is taking them into account in the preparation of the financial statements for the quarter ended August 31, 2019. The adoption of this standard has not had a significant impact on the Companys financial statements.
On June 20, 2018, the FASB issued ASU 2018-07, CompensationStock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (ASU 2018-07). ASU 2018-07 is intended to reduce cost and complexity and to improve financial reporting for share-based payments to nonemployees (for example, service providers, external legal counsel, suppliers, etc.). ASU 2018-07 was effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. During the quarter ended August 31, 2019, the Company adopted the provisions of this statement and is taking them into account in the preparation of the financial statements for the quarter ended August 31, 2019. The adoption of this standard has not had a significant impact on the Companys financial statements.
10
Other recent ASU's issued by the FASB and guidance issued by the Securities and Exchange Commission did not, or are not believed by management to, have a material effect on the Companys present or future consolidated financial statements.
Note 3: Accounts Payable and Accrued Expenses
The Companys accounts payable and accrued expense balances consist of the following at:
|
August 31,
2019
|
|
May 31,
2019
|
| |
Accounts payable
|
$
|
943,875
|
|
$
|
999,593
|
Deferred rent
|
|
--
|
|
|
37,972
|
Total
|
$
|
943,875
|
|
$
|
1,037,565
|
Note 4: Shareholders Equity
As described in the Companys Form 10Q, filed with the Securities and Exchange Commission on April 15, 2019, the Form 10K report, filed with the Securities and Exchange Commission on August 29, 2019, and the Form S-3 Registration Statement and Prospectus filed on June 30, 2017 and December 4, 2017, respectively, the Company entered into an At Market Issuance Sales Agreement, whereby, the Company may raise additional working capital and funds for continued development of current research projects. These funds will be needed to fund current research and development projects and bring them to the next state of completion. Management expects to raise additional funds throughout the year from the At Market Issuance Agreement to fund operations as necessary. During the quarter that ended August 31, 2019, the Company received $112,608 in net proceeds from the sale of its common stock through this Agreement.
Note 5: Geographic Information
Financial information about foreign and domestic operations and export sales is approximately as follows:
|
Three Months Ended
August 31,
|
|
|
2019
|
|
2018
|
Revenues from sales to unaffiliated customers:
|
|
|
|
|
|
United States
|
$
|
115,000
|
|
$
|
143,000
|
Asia
|
|
663,000
|
|
|
648,000
|
Europe
|
|
301,000
|
|
|
392,000
|
South America
|
|
47,000
|
|
|
71,000
|
Middle East
|
|
68,000
|
|
|
19,000
|
|
$
|
1,194,000
|
|
$
|
1,273,000
|
No other geographic concentrations exist where net sales exceed 10% of total net sales.
As of August 31, 2019 and May 31, 2019, approximately $667,000 and $665,000 of Biomericas gross inventory and approximately $37,000 and $39,000, of Biomericas property and equipment, net of accumulated depreciation and amortization, was located in Mexicali, Mexico, respectively.
Note 6: Leases
On June 18, 2009, the Company entered into an agreement to lease a building in Irvine, California. The lease commenced September 1, 2009 and ended August 31, 2016. The initial base rent was set at $18,490 per month with scheduled annual increases through the end of the lease term. The rent was $22,080. In November 2015, the Company signed the First Amendment to Lease to extend the lease until August 31, 2021. The initial base rent for the lease amendment which started September 1, 2016 is $21,000 per month. September 1, 2019 the rent increased to $22,948 per month.
In November 2016, the Companys Mexican subsidiary, Biomerica de Mexico, entered into a 10-year lease for approximately 8,100 square feet of manufacturing space with initial base rent of $2,926 per month. The rent is currently set at $3,140 per month. The Company has a one 10-year option to renew at the end of the initial lease period. Biomerica, Inc. is not a guarantor of such lease. Biomerica de Mexico also leases a smaller unit on a month-to-month basis for use in one manufacturing process. In addition, the Company leases a small office on a month-to-month basis in Lindau, Germany, as headquarters for BioEurope GmbH, its Germany subsidiary.
11
Components of lease expense include fixed lease expense of approximately $85,946 for the three months ended August 31, 2019. For purposes of determining straight-line rent expense, the lease term is calculated from the date the Company first takes possession of the facility, including any periods of free rent and any renewal options periods that the Company is reasonably certain of exercising. The Companys office and equipment leases generally have contractually specified minimum rent and annual rent increases are included in the measurement of the right-of-use asset and related lease liability. Additionally, under these lease arrangements, the Company may be required to pay directly, or reimburse the lessors, for some maintenance and operating costs. Such amounts are generally variable and therefore not included in the measurement of the right-of-use asset and related lease liability but are instead recognized as variable lease expense in the condensed Consolidated Statements of Operations and Comprehensive Loss when they are incurred.
Supplemental cash flow information related to leases for
the three months ended August 31, 2019:
|
|
|
| |
|
|
|
|
Operating cash flows from operating leases
|
|
$
|
76,257
|
|
|
|
|
|
|
Right-of-use assets obtained in exchange for
new operating lease liabilities
|
|
|
--
|
|
Weighted average remaining lease term (in years)
|
|
|
7.02
|
|
Weighted average discount rate
|
|
|
6.5
|
%
|
|
The maturity of lease liabilities as of August 31, 2019 are as follows:
Years Ending
|
| |
2020
|
$
|
144,831
|
2021
|
|
211,946
|
2022
|
|
236,410
|
2023
|
|
262,830
|
2024
|
|
291,350
|
Thereafter
|
|
778,808
|
Total
|
$
|
1,926,175
|
Note 7: Commitments and Contingencies
On December 1, 2017, Biomerica, Inc. (the Company) entered into an At Market Issuance Sales Agreement (the At Market Issuance Sales Agreement) with an agent (Agent), pursuant to which the Company may offer and sell from time to time up to an aggregate of $7,000,000 of shares of the Companys common stock, par value $0.08 per share (the Placement Shares), through the Agent.
The Placement Shares have been registered under the Securities Act of 1933, as amended (the Securities Act), pursuant to the Registration Statement on Form S-3 (File No. 333-219130) (the Registration Statement), which was originally filed with the Securities and Exchange Commission (SEC) on June 30, 2017 and declared effective by the SEC on July 20, 2017, the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed with the SEC on December 1, 2017.
Sales of the Placement Shares, if any, pursuant to the At Market Issuance Sales Agreement, may be made in sales deemed to be at the market offerings as defined in Rule 415 promulgated under the Securities Act. The Agent will act as sales agent and will use commercially reasonable efforts to sell on the Companys behalf all of the Placement Shares requested to be sold by the Company, consistent with its normal trading and sales practices, on mutually agreed terms between the Agent and the Company.
The Company has no obligation to sell any of the Placement Shares under the At Market Issuance Sales Agreement, and may at any time suspend offers under the At Market Issuance Sales Agreement or terminate the At Market Issuance Sales Agreement. The Company intends to use the net proceeds from this offering for general corporate purposes, including, without limitation, sales and marketing activities, clinical studies and product development, making acquisitions of assets, businesses, companies or securities, capital expenditures, and for working capital needs.
During the quarter ended August 31, 2019, the Company sold 50,000 shares of common stock under the S-3 registration statement and received net proceeds of $112,608.
12
On July 22, 2019, the Company entered into a Clinical Trial Agreement with a research institution for the purpose of conducting a clinical trial of the Biomerica Infoods product. The term of the agreement shall be until completion of the work outlined and the charges will be invoiced monthly for work performed in the previous month. The maximum budgeted costs will be approximately $107,419.
Note 8: Subsequent Events
Subsequent to August 31, 2019, the Company sold 50,000 shares of its common stock under its At Market Issuance Sales Agreement and S-3 Registration Statement for total net proceeds of $158,603.
In September 2019, the Company agreed to extend MaxHealth Medical International, Limited and MaxHealth Medical Group Co., Ltd.s option to purchase up to 500,000 shares of Biomericas common stock for an additional 90 days at terms described in the agreement signed May 29, 2019.
On September 25, 2019, the Company entered into a Clinical Trial Agreement with a large, multi-physician medical group for the purpose of conducting a clinical trial of the Biomerica Infoods product. The term of the agreement shall be until completion of the work outlined and the charges will be invoiced monthly for work performed in the previous month. The maximum budgeted costs will be approximately $136,000.
On October 3, 2019, the Company entered into a Clinical Trial Agreement with a research institution for the purpose of conducting a clinical trial of the Biomerica H. pylori product. The term of the agreement shall be until completion of the work outlined and the charges will be invoiced monthly for work performed in the previous month. The maximum budgeted costs will be approximately $57,800.