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908 Devices Inc. - Quarter Report: 2022 September (Form 10-Q)

Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended September 30, 2022

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: 001-39815

908 DEVICES INC.

(Exact name of registrant as specified in its charter)

Delaware

45-4524096

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

645 Summer Street, Boston, MA

02210

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (857) 254-1500

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange

  on which registered

Common Stock, par value $0.001 per share

MASS

The Nasdaq Global Market

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 definitions 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  

As of November 9, 2022, the registrant had 31,711,284 shares of common stock, $0.001 par value per share, issued and outstanding.

Table of Contents

Table of Contents

908 DEVICES INC.

Table of Contents

    

Page

PART I.

FINANCIAL INFORMATION

5

Item 1.

Condensed Consolidated Financial Statements (Unaudited)

5

Condensed Consolidated Balance Sheets

5

Condensed Consolidated Statements of Operations

6

Condensed Consolidated Statements of Comprehensive Loss

7

Condensed Consolidated Statements of Stockholders’ Equity

8

Condensed Consolidated Statements of Cash Flows

9

Notes to Unaudited Condensed Consolidated Financial Statements

10

Item 2.

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

28

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

44

Item 4.

Controls and Procedures

44

PART II.

OTHER INFORMATION

46

Item 1.

Legal Proceedings

46

Item 1A.

Risk Factors

46

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

48

Item 3.

Defaults Upon Senior Securities

48

Item 4.

Mine Safety Disclosures

48

Item 5.

Other Information

48

Item 6.

Exhibits

49

Signatures

50

3

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Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements, which reflect our current views with respect to, among other things, our operations and financial performance. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy and plans and our objectives for future operations, are forward-looking statements, and are made under the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “could,” “target,” “predict,” “seek” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those referenced in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Moreover, we operate in a very competitive and rapidly changing environment and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Quarterly Report on Form 10-Q may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

The forward-looking statements included in this Quarterly Report on Form 10-Q are made only as of the date of this report. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q to conform these statements to actual results or to changes in our expectations.

We own various trademark registrations and applications, and unregistered trademarks, including MX908, Rebel, ZipChip, 908 Devices and our corporate logo. All other trade names, trademarks and service marks of other companies appearing in this Quarterly Report on Form 10-Q are the property of their respective holders. Solely for convenience, the trademarks and trade names in this Quarterly Report on Form 10-Q may be referred to without the ®,™ or RTM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend to use or display other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

 

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PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements (Unaudited)

908 DEVICES INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(In thousands, except share and per share amounts)

September 30, 

December 31, 

    

2022

    

2021

Assets

 

 

  

Current assets:

 

 

  

Cash and cash equivalents

$

193,698

$

224,073

Accounts receivable, net of allowance for doubtful accounts of $1,750

 

15,231

 

16,375

Inventory

 

11,731

 

7,918

Prepaid expenses and other current assets

 

3,222

 

4,527

Total current assets

 

223,882

 

252,893

Operating lease, right-of-use assets

 

4,271

 

5,182

Property and equipment, net

 

2,761

 

1,603

Goodwill

9,200

Intangible assets, net

7,969

Other long-term assets

 

1,198

 

1,228

Total assets

$

249,281

$

260,906

Liabilities and Stockholders' Equity

 

 

  

Current liabilities:

 

 

  

Accounts payable

$

1,663

$

1,371

Accrued expenses

 

8,564

 

6,961

Deferred revenue

 

7,419

 

5,160

Operating lease liabilities

 

1,432

 

1,344

Total current liabilities

 

19,078

 

14,836

Long-term debt

 

15,000

 

15,000

Operating lease liabilities, net of current portion

 

3,429

 

4,508

Deferred revenue, net of current portion

 

12,162

 

11,958

Deferred income taxes

 

2,570

 

Other long-term liabilities

 

542

 

Total liabilities

 

52,781

 

46,302

Commitments and contingencies (Note 10)

 

 

  

Stockholders' equity:

 

 

  

Preferred stock, $0.001 par value; 5,000,000 shares authorized, no shares issued or outstanding at September 30, 2022 and December 31, 2021, respectively

Common stock, $0.001 par value; 100,000,000 shares authorized; 31,652,058 shares and 31,077,004 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

 

32

 

31

Additional paid-in capital

 

321,491

 

315,210

Accumulated other comprehensive loss

(613)

Accumulated deficit

 

(124,410)

 

(100,637)

Total stockholders' equity

 

196,500

 

214,604

Total liabilities and stockholders' equity

$

249,281

$

260,906

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

5

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908 DEVICES INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except share and per share amounts)

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2022

    

2021

    

2022

    

2021

Revenue:

Product and service revenue

$

15,437

$

12,285

$

34,074

$

25,557

License and contract revenue

 

360

 

260

 

1,135

 

808

Total revenue

 

15,797

 

12,545

 

35,209

 

26,365

Cost of revenue:

 

 

 

 

Product and service cost of revenue

 

6,366

 

5,656

 

14,768

 

12,062

License and contract cost of revenue

 

93

 

77

 

340

 

204

Total cost of revenue

 

6,459

 

5,733

 

15,108

 

12,266

Gross profit

 

9,338

 

6,812

 

20,101

 

14,099

Operating expenses:

 

 

 

 

Research and development

 

4,666

 

3,302

 

12,864

 

9,322

Selling, general and administrative

 

11,826

 

8,786

 

32,281

 

23,318

Total operating expenses

 

16,492

 

12,088

 

45,145

 

32,640

Loss from operations

 

(7,154)

 

(5,276)

 

(25,044)

 

(18,541)

Other income (expense):

 

 

 

 

Interest expense

 

(33)

 

(31)

 

(68)

 

(446)

Other income, net

 

928

 

122

 

1,340

 

283

Total other income (expense), net

 

895

 

91

 

1,272

 

(163)

Net loss

$

(6,259)

$

(5,185)

$

(23,772)

$

(18,704)

Net loss per share

Basic and diluted

$

(0.20)

$

(0.19)

$

(0.76)

$

(0.68)

Weighted average common shares outstanding

 

 

 

 

Basic and diluted

31,606,484

27,707,858

31,441,611

27,446,149

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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908 DEVICES INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)

(in thousands, except share amounts)

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2022

2021

2022

2021

Net loss

$

(6,259)

$

(5,185)

$

(23,772)

$

(18,704)

Other comprehensive loss

Foreign translation adjustment

 

(613)

 

 

(613)

 

Total other comprehensive loss

$

(613)

$

$

(613)

$

Comprehensive loss

$

(6,872)

$

(5,185)

$

(24,385)

$

(18,704)

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908 DEVICES INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

(in thousands, except share amounts)

Accumulated

Additional

Other

Total

Common Stock

Paid-in

Comprehensive

Accumulated

Stockholders'

    

Shares

    

Amount

    

Capital

Loss

    

Deficit

    

Equity

Balances at December 31, 2021

31,077,004

$

31

$

315,210

$

$

(100,637)

$

214,604

Issuance of common stock upon exercise of stock options

 

243,842

 

 

324

 

 

 

324

Stock-based compensation expense

 

 

 

1,289

 

 

 

1,289

Vesting of restricted stock units

12,936

Net loss

 

 

 

 

 

(9,415)

 

(9,415)

Balances at March 31, 2022

31,333,782

$

31

$

316,823

$

$

(110,052)

$

206,802

Issuance of common stock upon exercise of stock options

164,638

1

275

276

Stock-based compensation expense

1,894

1,894

Issuance of common stock upon ESPP purchase

16,052

242

242

Vesting of restricted stock units

16,643

Net loss

(8,099)

(8,099)

Balances at June 30, 2022

31,531,115

$

32

$

319,234

$

$

(118,151)

$

201,115

Issuance of common stock upon exercise of stock options

109,354

237

237

Stock-based compensation expense

2,020

2,020

Vesting of restricted stock units

11,589

Net loss

(6,259)

(6,259)

Foreign currency translation adjustments

(613)

(613)

Balances at September 30, 2022

 

31,652,058

$

32

$

321,491

$

(613)

$

(124,410)

$

196,500

Additional

Total

Common Stock

Paid-in

Accumulated

Stockholders'

    

Shares

    

Amount

    

Capital

    

Deficit

    

Equity

Balances at December 31, 2020

27,273,095

$

27

$

217,482

$

(78,468)

$

139,041

Issuance of common stock upon exercise of stock options

 

24,776

 

 

27

 

 

27

Stock-based compensation expense

 

 

 

339

 

 

339

Net loss

 

 

 

 

(6,095)

 

(6,095)

Balances at March 31, 2021

27,297,871

$

27

$

217,848

$

(84,563)

$

133,312

Issuance of common stock upon exercise of stock options

250,234

1

297

298

Stock-based compensation expense

481

481

Net loss

(7,424)

(7,424)

Balances at June 30, 2021

27,548,105

$

28

$

218,626

$

(91,987)

$

126,667

Issuance of common stock upon exercise of stock options

316,965

483

483

Stock-based compensation expense

811

811

Net loss

(5,185)

(5,185)

Balances at September 30, 2021

 

27,865,070

$

28

$

219,920

$

(97,172)

$

122,776

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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908 DEVICES INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

Nine Months Ended September 30, 

    

2022

    

2021

Cash flows from operating activities:

  

  

Net loss

$

(23,772)

$

(18,704)

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

 

 

Depreciation and amortization expense

 

1,037

 

636

Stock-based compensation expense

 

5,203

 

1,631

Noncash interest expense and loss on extinguishment of debt

 

10

 

171

Provision for inventory obsolescence

 

46

 

48

Provision for doubtful accounts

1,725

Changes in operating assets and liabilities:

 

 

Accounts receivable, net

 

1,306

 

(3,186)

Inventory

 

(4,108)

 

(4,446)

Prepaid expenses and other current assets

 

2,198

 

(1,705)

Other long-term assets

 

131

 

(997)

Accounts payable and accrued expenses

 

(175)

 

1,447

Deferred revenue

 

2,463

 

3,561

Right-of-use operating lease assets

 

911

 

832

Operating lease liabilities

 

(991)

 

(875)

Other long-term liabilities

 

(73)

Net cash used in operating activities

 

(15,814)

 

(19,862)

Cash flows from investing activities:

 

 

Purchases of property and equipment

 

(1,433)

 

(683)

Acquisitions, net of cash acquired

(13,762)

Net cash used in investing activities

 

(15,195)

 

(683)

Cash flows from financing activities:

 

 

Payments for withholding taxes on vested awards

(199)

Proceeds from issuance of common stock upon option exercise

1,079

808

Payments of public offering costs

(112)

(576)

Proceeds from borrowings on revolving line of credit

 

45,000

 

15,000

Repayment on revolving line of credit

(45,000)

(15,000)

Payments of debt issuance costs

 

 

(39)

Net cash provided by financing activities

 

768

 

193

Effect of foreign exchange rate changes on cash and cash equivalents

(23)

Net decrease in cash, cash equivalents and restricted cash

 

(30,264)

 

(20,352)

Cash, cash equivalents and restricted cash at beginning of period

 

224,133

 

159,227

Cash, cash equivalents and restricted cash at end of period

$

193,869

$

138,875

Supplemental disclosure of noncash investing and financing information:

 

 

Transfers of inventory to property and equipment

$

598

$

694

Reconciliation of cash, cash equivalents and restricted cash:

Cash and cash equivalents

$

193,698

$

138,815

Restricted cash included in prepaid expenses and other current assets

60

 

60

Restricted cash included in other long-term assets

111

Total cash, cash equivalents and restricted cash shown in the statement of cash flows

$

193,869

$

138,875

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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908 DEVICES INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1. Nature of the Business and Basis of Presentation

908 Devices Inc. (the “Company”) was incorporated in the State of Delaware on February 10, 2012. The Company is a commercial-stage technology company providing a suite of purpose-built handheld and desktop mass spectrometry devices for the point-of-need to interrogate unknown and invisible materials in a broad array of markets including life sciences research, bioprocessing, industrial biotech, forensics and adjacent markets.

The Company is subject to risks and uncertainties common to technology companies in the device industry and of similar size, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, uncertainty of market acceptance of products, and the need to obtain additional financing to fund operations. Potential risks and uncertainties also include, without limitation, uncertainties regarding rising inflation, higher interest rates, and the duration and magnitude of the impact of the COVID-19 pandemic on the Company’s business and the economy generally. Products currently under development will require additional research and development efforts prior to commercialization and will require additional capital and adequate personnel and infrastructure. The Company’s research and development may not be successfully completed, adequate protection for the Company’s technology may not be obtained, the Company may not obtain necessary government regulatory approval, and approved products may not prove commercially viable. The Company operates in an environment of rapid change in technology and competition.

In March 2020, the World Health Organization declared the global novel coronavirus disease 2019 (“COVID-19”) outbreak a pandemic. The impact of this pandemic has been and may continue to be extensive in many aspects of society, which has resulted in and may continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world.

Future impacts to the Company’s business as a result of COVID-19 could include disruptions to the Company’s manufacturing operations and supply chain caused by facility closures, reductions in operating hours, staggered shifts and other social distancing efforts; labor shortages; decreased productivity and unavailability of materials or components; limitations on its employees’ and customers’ ability to travel, and delays in shipments to and from affected countries and within the United States.

While the Company maintains an inventory of finished products and raw materials used in its products, a prolonged pandemic could lead to shortages in the raw materials necessary to manufacture its products. An additional potential impact to the Company’s business is the negative impact to the Company’s customers’ and potential customer’s ability to make investments and timely payments for purchased products as a result of allocating resources to address COVID-19 issues or in response to the rising inflation.

Underwritten Public Offerings

On December 22, 2020, the Company completed its initial public offering (“IPO”), pursuant to which it issued and sold 7,475,000 shares of common stock, inclusive of 975,000 shares pursuant to the full exercise of the underwriters’ option to purchase additional shares. The Company received net proceeds of $136.6 million after deducting underwriting discounts and commissions and other offering costs. Upon the closing of the IPO, all of the shares of the Company’s outstanding redeemable convertible preferred stock then outstanding automatically converted into 14,691,929 shares of common stock.

On November 15, 2021, the Company completed an underwritten public offering, pursuant to which it issued and sold 3,150,000 shares of common stock at a public offering price of $32.00 per share ( “ November 2021 Offering”). The Company received net proceeds of $94.4 million after deducting underwriting discounts and commissions and other offering costs.

Acquisition

The Company acquired TRACE Analytics GmbH, located in Braunschweig, Germany (“Trace”) in August 2022. Trace is a leading provider of online analysis systems for biotech applications in research, development and production. Trace’s products are used for monitoring and control of complex processes in industrial pharmaceutical productions under continuous measurement

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conditions. With the acquisition of Trace, the Company has acquired enabling sampling technology that it expects to integrate within future product offerings. See Note 11, Acquisition, for further information.

Basis of Presentation

The Company’s condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, 908 Devices Securities Corporation and Trace. All intercompany balances and transactions have been eliminated.

The accompanying condensed consolidated financial statements have been prepared based on continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has incurred recurring losses since inception, including net losses of $23.8 million for the nine months ended September 30, 2022 and $22.2 million for the year ended December 31, 2021. As of September 30, 2022, the Company had an accumulated deficit of $124.4 million. The Company expects to continue to generate operating losses in the foreseeable future. The Company expects that its cash and cash equivalents and revenue from product and service will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of the condensed consolidated financial statements. The Company may seek additional funding through private or public equity financings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into collaborations or other arrangements. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs, product expansion or commercialization efforts, or the Company may be unable to continue operations.

2. Summary of Significant Accounting Policies

Unaudited Condensed Interim Financial Information

The condensed consolidated balance sheet at December 31, 2021 was derived from audited consolidated financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of September 30, 2022 and for the three and nine months ended September 30, 2022 and 2021 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the consolidated financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. Therefore, these condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 on file with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2022 and results of operations for the three and nine months ended September 30, 2022 and 2021 and statements of stockholders’ equity for the three and nine months ended September 30, 2022 and cash flows for the nine months ended September 30, 2022 and 2021 have been made. The Company’s results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022 or any other period.

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Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, revenue recognition and accounts receivable, the valuation of inventory, fair value of assets acquired and liabilities assumed in acquisitions and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Due to the COVID-19 pandemic, rising inflation and higher interest rates, there has been uncertainty and disruption in the global economy and financial markets. The Company is not aware of any specific event or circumstance that would require further updates to its estimates or judgments or a revision of the carrying value of its assets or liabilities as of the date of issuance of these condensed consolidated financial statements. These estimates may change, as new events occur and additional information is obtained. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions.

Concentrations of Credit Risk and of Significant Customers

Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company maintains its cash and cash equivalents with two financial institutions that management believes to be of high credit quality. The Company has not experienced any other-than-temporary losses with respect to its cash and cash equivalents and does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

Significant customers are those that accounted for 10% or more of the Company’s total revenue or accounts receivable. For the three months ended September 30, 2022 and 2021, one customer represented 41% and 58% of total revenue, respectively. For the nine months ended September 30, 2022 and 2021, one customer represented 29% and 36% of total revenue, respectively. As of September 30, 2022, two customers accounted for 47% and 11%, respectively, of gross accounts receivable. As of December 31, 2021, two customers accounted for 63% and 11%, respectively, of gross accounts receivable.

The credit and economic conditions within countries in Europe, Middle East and Africa that the Company does business with have been weak in recent years. These conditions have continued to deteriorate as a result of COVID-19, rising inflation and higher interest rates, and may continue to increase the average length of time that it takes to collect on the accounts receivables outstanding in these countries. As of September 30, 2022, the gross accounts receivable balance from these countries amounted to $3.9 million, of which $1.7 million is more than 90 days past due and for which the Company has provided for an allowance for doubtful accounts of $1.7 million.

Certain of the components included in the Company’s products are obtained from a sole source, a single source or a limited group of suppliers. Although the Company seeks to reduce dependence on those limited sources of suppliers and manufacturers, the partial or complete loss of certain of these sources, or the requirement to establish a new supplier for the components, could have a material adverse effect on the Company’s operating results, financial condition and cash flows and damage its customer relationships.

Accounts Receivable

The Company provides credit to customers in the ordinary course of business and believes its credit policies are prudent and reflect industry practices and business risk. Management reviews accounts receivable on a periodic basis and reserves for receivables in the Company’s allowance for doubtful accounts on a specific identification basis when they are determined to be uncollectible. After the Company has exhausted all collection efforts, the outstanding receivable is written off against the allowance. In June 2021, the Company deemed certain receivables from a customer in the Middle East uncollectible due to credit and economic conditions, including the impact of COVID-19, and recorded a provision for bad debts of $1.7 million.

Fair Value Measurements

Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability

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in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

Level 1 — Quoted prices in active markets for identical assets or liabilities.
Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

The Company's financial instruments consist primarily of accounts receivable, accounts payable, accrued expenses and contingent consideration. The Company’s cash equivalents are carried at fair value, determined according to the fair value hierarchy described above (see Note 3, Fair value measurements). The carrying values of the Company’s accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. The carrying value of the Company’s long-term debt approximates its fair value (a level 2 measurement) at each balance sheet date due to its variable interest rate, which approximates a market interest rate. The Company’s contingent consideration is measured at its fair value at each balance sheet date using unobservable inputs in the valuation methodology (a level 3 measurement).

Goodwill and Intangible Assets

Goodwill is not amortized, but is evaluated for impairment on an annual basis, or on an interim basis when events or changes in circumstances indicate that the carrying value may not be recoverable. In assessing the recoverability of goodwill, the Company must make assumptions regarding the estimated future cash flows, and other factors, to determine the fair value of these assets. If these estimates or their related assumptions change in the future, the Company may be required to record impairment charges against these assets in the reporting period in which the impairment is determined.

The Company tests goodwill for impairment at the reporting unit level, which is the operating segment. The Company has the option of performing a qualitative assessment to determine whether further impairment testing is necessary before performing the quantitative assessment. If as a result of the quantitative assessment, it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount, a quantitative impairment test will be required. The quantitative goodwill impairment test requires the management to estimate and compare the fair value of the reporting unit with its carrying value. If the fair value of the reporting unit exceeds the carrying value of the net assets, goodwill is not impaired. If the fair value of the reporting unit is less than the carrying value, the difference is recorded as an impairment loss up to the amount of goodwill.

Intangible assets with a finite useful life are recorded at cost, net of accumulated amortization and are amortized on a straight-line basis over their estimated useful lives as follows:

Customer Relationships

8 years

Developed Technology

15 years

Software

3 years

Trade Name

2 years

The Company reviews other long-lived assets for impairment whenever events or changes in circumstances indicate the carrying amount of an asset or an asset group may not be recoverable. In evaluating long-lived assets for recoverability, we estimate the future cash flows that are expected from the use of each assets. Impairment losses are measured and recorded for the excess of an asset's carrying value over its fair value. To determine the fair value of long-lived assets, the Company utilizes the valuation technique or techniques deemed most appropriate based on the nature of the asset or asset group, which may include the use of quoted market prices, prices for similar assets or other valuation techniques such as discounted future cash flows or earnings.

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Revenue Recognition

The Company recognizes revenue from sales to customers under ASC 606, Revenue from Contracts with Customers (“ASC 606”), by applying the following five steps: (1) identification of the contract, or contracts, with a customer, (2) identification of the performance obligations in the contract, (3) determination of the transaction price, (4) allocation of the transaction price to the performance obligations in the contract and (5) recognition of revenue when, or as, performance obligations are satisfied.

For a contract with multiple performance obligations, the Company allocates the contract’s transaction price to each performance obligation on a relative standalone selling price basis using the Company’s best estimate of the standalone selling price of each distinct product or service in the contract. The primary method used to estimate standalone selling price is the price observed in standalone sales to customers; however, when prices in standalone sales are not available the Company may use third party pricing for similar products or services or estimate the standalone selling price, which is set by management. Allocation of the transaction price is determined at the contract’s inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied.

Product and Service Revenue

The Company derives product and service revenue primarily from the sale of handheld and desktop products and related consumables and services. Revenue is recognized when control of the promised products, consumables or services is transferred to the Company’s customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those products, consumables or services (the transaction price). A performance obligation is a promise in a contract to transfer a distinct product or service to a customer and is the unit of accounting under ASC 606. For devices and consumables sold by the Company, control transfers to the customer at a point in time. To indicate the transfer of control, the Company must have a present right to payment, legal title must have passed to the customer, the customer must have the significant risks and rewards of ownership, and where acceptance is other than perfunctory, the customer must have accepted the product or service. The Company’s principal terms of sale are freight on board (“FOB”) shipping point, or equivalent, and, as such, the Company primarily transfers control and records revenue for product sales upon shipment. Sales arrangements with delivery terms that are not FOB shipping point are not recognized upon shipment and the transfer of control for revenue recognition is evaluated based on the associated shipping terms and customer obligations. If a performance obligation to the customer with respect to a sales transaction remains to be fulfilled following shipment (typically installation or acceptance by the customer), revenue recognition for that performance obligation is deferred until such commitments have been fulfilled. For extended warranty and support, control transfers to the customer over the term of the arrangement. Revenue for extended warranty and support is recognized based upon the period of time elapsed under the arrangement as this period represents the transfer of benefits or services under the agreement.

The Company recognizes a receivable at the point in time at which it has an unconditional right to payment. Such receivables are not contract assets. Payment terms for customer orders, including for each of the Company’s primary performance obligations, are typically 30 to 90 days after the shipment or delivery of the product, and such payments typically do not include payments that are variable, dependent on specified factors or events. In limited circumstances, there exists a right of return for a product if agreed to by the Company. Revenue is only recognized for those goods that are not expected to be returned such that it is probable that there will not be a significant reversal of cumulative revenue. Service arrangements commonly call for payments in advance of performing the work (e.g., extended warranty/service contracts), upon completion of the service or a mix of both. The Company does not enter into significant financing agreements or other forms of variable consideration.

Contract assets arise from unbilled amounts in customer arrangements when revenue recognized exceeds the amount billed to the customer and the Company’s right to payment is not only subject to the passage of time. The Company had no contract assets related to product or service revenue as of September 30, 2022 or December 31, 2021.

Contract liabilities represent the Company’s obligation to transfer goods or services to a customer for which it has received consideration (or the amount is due) from the customer. The Company has determined that its only contract liability related to product and service revenue is deferred revenue, which consists of amounts that have been invoiced but that have not been recognized as revenue. Amounts expected to be recognized as revenue within 12 months of the balance sheet date are classified as current deferred revenue and amounts expected to be recognized as revenue beyond 12 months of the balance sheet date are classified as noncurrent deferred revenue.

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The following is a summary of the activity of the Company’s deferred revenue related to product and service revenue (in thousands):

Nine Months Ended September 30, 

    

2022

    

2021

Balances at beginning of period

$

14,521

$

8,938

Recognition of revenue included in balance at beginning of the period

 

(3,521)

 

(1,735)

Revenue deferred during the period, net of revenue recognized

 

5,891

 

5,550

Balances at end of period

$

16,891

$

12,753

The amount of deferred revenue equals the transaction price allocated to unfulfilled performance obligations for the period presented. Such deferred revenue amounts related to product and service revenue are expected to be recognized in the future as follows (in thousands):

September 30, 

    

2022

    

2021

Deferred revenue expected to be recognized in:

 

  

 

  

One year or less

$

7,285

$

4,843

One to two years

 

4,678

 

2,780

Three years and beyond

 

4,928

 

5,130

$

16,891

$

12,753

License and Contract Revenue

The Company generates revenue from short and long-term contracts associated with the design and development and delivery of detection devices or related design and support services. To date, these contracts are primarily with the U.S. government or commercial entities contracting with the U.S. government, but the Company has also had such contracts with commercial partners. The Company’s contracts with the U.S. government typically are subject to the Federal Acquisition Regulation (“FAR”) and are priced based on estimated or actual costs of producing goods or providing services. The FAR provides guidance on the types of costs that are allowable in establishing prices for goods or services provided under U.S. government contracts. The pricing for non-U.S. government contracts is based on the specific negotiations with each customer.

Under the typical payment terms of U.S. government fixed-price contracts, the customer pays in accordance with the terms of the specific agreement, but generally through progress payments. If these progress payments are made in advance, these payments are recorded as a contract liability, classified as deferred revenue within the accompanying condensed consolidated balance sheet, until the Company provides the underlying services. For U.S. government cost-type contracts, the customer generally pays for actual costs incurred within a short period of time. For contracts with commercial partners, payments are made in accordance with the terms of the specific agreement. For agreements which call for milestone payments, to the extent the Company does not conclude that it is probable that a significant reversal of cumulative revenue will occur, a contract asset is generated until the Company is permitted to bill for costs incurred, which is classified as prepaid expense and other current assets in the accompanying condensed consolidated balance sheet. In some cases, payments received in advance under license agreements are recorded as deferred revenue and recognized over the respective contract term, absent any other performance obligations.

Generally, revenue for long-term contracts is recognized based upon the cost-to-cost measure of progress, provided that the Company meets the criteria associated with transferring control of the good or service over time such as not creating an asset with an alternative use and having an enforceable right to payment for completed performance. However, the Company evaluates the proper revenue recognition on a contract by contract basis, as each contract generally contains terms specific to the underlying agreement which result in differing performance obligations and payment terms (cost plus, fixed price agreements among others). For revenue recognized under the cost-to-cost measure of progress basis, the Company continually assesses total costs expected to be incurred and if such costs require adjustment to the measure of progress, the Company records such adjustment as a change in estimate on a cumulative catch-up basis in the period of adjustment.

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The Company includes the unconstrained amount of consideration in the transaction price. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, as required under ASC 606, the Company re-evaluates the estimated consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment.

Contract assets arise from unbilled amounts in customer arrangements when revenue recognized exceeds the amount billed to the customer and the Company’s right to payment is not just subject to the passage of time. The Company includes contract assets within prepaid and other current assets in the accompanying condensed consolidated balance sheet. The Company had contract assets related to contract or license revenue totaling $0.1 million and $0.2 million, respectively, as of September 30, 2022 and December 31, 2021.

Contract liabilities represent the Company’s obligation to transfer goods or services to a customer for which it has received consideration (or the amount is due) from the customer. As of September 30, 2022, the Company had contract liabilities totaling $2.7 million related to contract and license revenue, which the Company expects to recognize in 2022 and 2023. As of December 31, 2021, the Company had contract liabilities totaling $2.6 million related to contract and license revenue, of which the Company recognized $0.1 million during the nine months ended September 30, 2022. The Company recognizes deferred revenue by first allocating from the beginning deferred revenue balance to the extent that the beginning deferred revenue balance exceeds the revenue to be recognized. Billings during the period are added to the deferred revenue balance to be recognized in future periods. As of September 30, 2022, the Company’s wholly- or partially-unsatisfied performance obligations totaled $0.3 million related to contract and license agreements entered prior to period end, which the Company expects to recognize during the years ended December 31, 2022 and 2023.

Distribution Channels

A majority of the Company’s revenue is generated by sales in conjunction with its distribution partners, such as its international distributors and, in the United States, for end customers where a government contract is required or a customer has a pre-existing relationship. When the Company transacts with a distribution partner, its contractual arrangement is with the partner and not with the end-use customer. Whether the Company transacts business with and receives the order from a distribution partner or directly from an end-use customer, its revenue recognition policy and resulting pattern of revenue recognition for the order are the same.

Disaggregated Revenue

The Company’s product and service revenue consists of sales of devices and consumables and the sale of service and extended warranty plans. The following table presents the Company’s revenue by revenue stream (in thousands):

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2022

    

2021

    

2022

    

2021

Product and service revenue:

 

  

 

  

 

  

 

  

Device sales revenue

$

10,952

$

10,075

$

24,239

$

20,167

Consumables and service revenue

 

4,485

 

2,210

 

9,835

 

5,390

Total product and service revenue

 

15,437

 

12,285

 

34,074

 

25,557

License and contract revenue

 

360

 

260

 

1,135

 

808

Total revenue

$

15,797

$

12,545

$

35,209

$

26,365

The following table presents the Company’s product and service revenue by device type (in thousands):

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2022

    

2021

    

2022

    

2021

Handheld

$

11,019

$

9,359

$

22,426

$

17,877

Desktop

4,418

 

2,926

11,648

 

7,680

Total product and service revenue

$

15,437

$

12,285

$

34,074

$

25,557

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Revenue based on the end-user entity type for the Company’s product and service revenue are presented below (in thousands):

Three Months Ended September 30, 

Nine Months Ended September 30, 

2022

    

2021

    

2022

    

2021

Government

$

11,069

$

9,505

$

22,788

$

18,018

Pharmaceutical/Biotechnology

4,327

 

2,766

11,032

 

7,475

Academia

41

 

14

254

 

64

Total product and service revenue

$

15,437

$

12,285

$

34,074

$

25,557

The following table disaggregates the Company’s revenue from contracts with customers by geography, which are determined based on the customer location (in thousands):

Three Months Ended September 30, 

Nine Months Ended September 30, 

2022

    

2021

    

2022

    

2021

Americas

$

12,440

$

11,067

$

27,978

$

21,556

Europe, Middle East and Africa

2,361

 

839

4,961

 

3,010

Asia Pacific

996

 

639

2,270

 

1,799

$

15,797

$

12,545

$

35,209

$

26,365

International sales are comprised primarily of product and service revenue, with the majority of license and contract revenue being attributable to North America.

Foreign currency

The Company translates assets and liabilities of its foreign subsidiaries at rates in effect at the end of the reporting period. Revenues and expenses are translated at average rates in effect during the reporting period. Translation adjustments are included in accumulated other comprehensive loss.

Other Comprehensive Loss

        Other comprehensive loss refers to revenues, expenses, gains and losses that are excluded from net loss as these amounts are recorded directly as an adjustment to shareholders' equity, net of tax. The Company's other comprehensive loss was composed of foreign currency translation adjustments.

Net Income (Loss) per Share

The Company has one class of shares outstanding and basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period, including potential dilutive common shares assuming the dilutive effect of any potential dilutive securities outstanding for the fiscal year. Potential dilutive securities include warrants, stock options, restricted stock units, and shares to be purchased under the Company’s employee stock purchase plan. For periods in which the Company reports a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.

Business combination

Under the acquisition method of accounting, the Company generally recognizes the tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values on the date of acquisition. The fair values assigned, defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between willing market participants, are based on estimates and assumptions determined by management. The excess consideration over the aggregate value of tangible and intangible assets, net of liabilities assumed, is recorded as goodwill. These valuations require significant estimates and assumptions, especially with respect to intangible assets.

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The Company estimates the fair value of the contingent consideration earnouts using the Monte Carlo Simulation or probability weighted scenario depending on the nature of the contingent consideration and updates the fair value of the contingent consideration at each reporting period based on the estimated probability of achieving the earnout targets and applying a discount rate that captures the risk associated with the expected contingent payments. To the extent that these estimates change in the future regarding the likelihood of achieving these targets, the Company may need to record material adjustments to its accrued contingent consideration. Such changes in the fair value of contingent consideration are recorded as contingent consideration expense or income in the consolidated statements of operations.

The Company uses the income approach to determine the fair value of certain identifiable intangible assets including customer relationships and developed technology. This approach determines fair value by estimating after-tax cash flows attributable to these assets over their respective useful lives and then discounting these after-tax cash flows back to a present value. The Company bases its assumptions on estimates of future cash flows, expected growth rates, expected trends in technology, probabilities of customer renewals, etc. The Company bases the discount rates used to arrive at a present value as of the date of acquisition on the time value of money and certain industry-specific risk factors. The Company believes the estimated purchased customer relationships, developed technology, software and trade name amounts determined represent the fair value at the date of acquisition and do not exceed the amount a third-party would pay for the assets.

Segment Information

The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. Operating segments are defined as components of an enterprise for which separate financial information is regularly evaluated by the Company’s chief operating decision maker, or decision-making group, in deciding how to allocate resources and assess performance. The Company has determined that its chief operating decision maker is its Chief Executive Officer. The Company’s chief operating decision maker reviews the Company’s financial information on a consolidated basis for purposes of allocating resources and assessing financial performance.

Recently Adopted Accounting Pronouncements

The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has elected not to “opt out” of the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company will adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and will do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company.

In December 2019, the FASB issued ASU 2019-12, Income Taxes (ASC 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various areas related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in ASC 740 and also clarifies and amends existing guidance to improve consistent application. For public entities the guidance is effective for annual reporting periods beginning after December 15, 2020 and for interim periods within those fiscal years. For non-public entities, the guidance is effective for annual reporting periods beginning after December 15, 2021 and for interim periods within years beginning after December 15, 2022, with early adoption permitted. The Company adopted this guidance as of January 1, 2022 and the adoption did not have a material impact on its consolidated financial statements.

Recently Issued Accounting Pronouncements

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326). The new standard adjusts the accounting for assets held at amortized costs basis, including marketable securities accounted for as available for sale, and trade receivables. The standard eliminates the probable initial recognition threshold and requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. For public entities except smaller reporting companies, the guidance is effective for annual reporting periods beginning after December 15, 2019 and for interim periods within those fiscal years. For non-public entities and smaller reporting companies, the guidance was effective for annual reporting periods beginning after December 15, 2021. In November 2019, the FASB issued ASU No. 2019-10, which deferred the effective date for non-public entities to annual reporting periods beginning after December 15, 2022, including interim periods within those fiscal years. Early application

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is allowed. The Company expects to adopt this standard effective January 1, 2023 and is assessing the impact of the adoption of this guidance on its consolidated financial statements.

3. Fair Value Measurements

The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis (in thousands):

Fair Value Measurements at September 30, 2022 Using:

    

Level 1

    

Level 2

    

Level 3

    

Total

Assets:

 

  

 

  

 

  

 

  

Cash equivalents - Money market funds

$

729

$

$

$

729

 

$

729

 

$

 

$

 

$

729

Other current liabilities:

Acquisition-related contingent consideration

$

$

$

195

$

195

Other long-term liabilities:

Acquisition-related contingent consideration

542

542

Acquisition-related contingent consideration - pension liability

900

900

Total liabilities measured at fair value

$

$

$

1,637

$

1,637

Fair Value Measurements at December 31, 2021 Using:

    

Level 1

    

Level 2

    

Level 3

    

Total

Assets:

 

  

 

  

 

  

 

  

Cash equivalents:

 

  

 

  

 

  

 

  

Money market funds

$

634

$

$

$

634

Money Market Funds

Money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. There were no transfers into or out of Level 3 during the nine months ended September 30, 2022 or 2021.

Contingent Consideration

Acquisition-related contingent consideration is measured and reported at fair value using the Monte Carlo simulation method or probability weighted scenario based on the unobservable inputs, which are significant to the fair value and classified with Level 3 of the fair value hierarchy. The amount is contingent based on the acquired business’ performance for the milestones ranging from the date of acquisition to June 30, 2024.

The unobservable inputs used in the fair value measurements include the probabilities of successful achievement of certain technological integration targets, forecasted results or targets, volatility, and discount rates. The total maximum payments due related to the technological integration and revenue targets is approximately $2 million, of which the value as of September 30, 2022 is approximately $0.7 million. The payment contingent on the seller completing the assignment of the pension liability is $0.9 million.

The weighted average probability of achieving the technology integration target is approximately 95%. The average estimated revenue volatility and discount rate are approximately 40.9% and 23.0%, respectively. Increases or decreases in these

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assumptions may result in a higher or lower fair value measurement, respectively. The following table provides a roll-forward of the fair value of the Company’s contingent consideration, for which fair value is determined using Level 3 inputs (in thousands):

Balances as of December 31, 2021

$

Acquisition date fair value of contingent consideration - earnout

 

737

Acquisition date fair value of contingent consideration - pension liability

900

Change in fair value

Balance as of September 30, 2022

$

1,637

Please refer to Note 11, Acquisition, for further detail. Changes in the fair value of contingent consideration resulting from a change in the underlying inputs are recognized in our consolidated statements of operations until the arrangement is settled.

4. Inventory

Inventory consisted of the following (in thousands):

September 30, 

December 31, 

    

2022

    

2021

Raw materials

$

8,325

$

6,242

Work-in-progress

2,462

 

551

Finished goods

944

 

1,125

$

11,731

$

7,918

5. Goodwill and Intangible Assets, net

Goodwill

As of September 30, 2022, the carrying amount of goodwill was $9.2 million. The following is a rollforward of the Company’s goodwill balance (in thousands):

Nine Months Ended September 30, 

    

2022

Balances at beginning of period

$

Goodwill acquired

 

9,566

Foreign currency impact

(366)

Balances at end of period

$

9,200

The Company evaluates goodwill at least annually on November 1, as well as whenever events or changes in circumstances suggest that the carrying amount may not be recoverable.

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Intangible Assets, net

Intangible assets, net consists of the following (in thousands):

September 30, 2022

Cost

Accumulated Amortization

Translation adjustments

Net Book Value

Customer Relationships

$

3,142

$

(64)

$

(119)

$

2,959

Developed Technology

4,967

(54)

(189)

4,724

Software

254

(12)

(10)

232

Trade Name

61

(5)

(2)

54

$

8,424

$

(135)

$

(320)

$

7,969

Amortization expense for intangible assets was recorded in the following expense categories of its condensed consolidated statements of operations (in thousands):

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

    

2022

    

2021

    

2022

    

2021

Product and service cost of revenue

$

66

$

$

66

$

Selling, general and administrative expenses

69

69

$

135

$

$

135

$

Estimated future amortization expense for the intangible assets as of September 30, 2022 are as following (in thousands):

Reminder of 2022

$

201

2023

804

2024

791

2025

775

2026

707

Thereafter

4,691

$

7,969

6. Accrued Expenses

Accrued expenses consisted of the following (in thousands):

September 30, 

December 31, 

    

2022

    

2021

Accrued employee compensation and benefits

$

4,263

$

3,271

Accrued warranty

1,354

 

1,593

Accrued professional fees

847

 

710

Contingent consideration

1,095

Accrued other

1,005

 

1,387

$

8,564

$

6,961

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Changes in the Company’s product warranty obligation were as follows (in thousands):

Nine Months Ended September 30, 

    

2022

    

2021

Accrual balance at beginning of period

$

1,550

$

1,265

Provision for new warranties

 

1,194

 

1,028

Settlements and adjustments made during the period

 

(1,390)

 

(1,112)

Accrual balance at end of period

$

1,354

$

1,181

7. Long-Term Debt

2021 Revolver

As of December 31, 2020, the Company had outstanding borrowings under a Loan and Security Agreement, as amended (the “2019 Loan”). On March 11, 2021, the Company entered into an Amended and Restated Loan and Security Agreement (the “2021 Revolver”) to replace the 2019 Loan. This agreement created a revolving line of credit totaling $25.0 million and eliminated the existing term loan. Borrowings under the revolving line of credit bear interest at an annual rate equal to the greater of (i) one-half percent (0.5%) above the prime rate or (ii) 4.0% and mature on March 11, 2024. Borrowings are collateralized by substantially all of the Company’s property, excluding intellectual property, which is subject to a negative pledge. The 2021 Revolver subjects the Company to various customary covenants, including requirements as to financial reporting and financial covenants (including an unrestricted minimum cash level of $10.0 million), and restrictions on the Company’s ability to dispose of its business or property, to change its line of business, to liquidate or dissolve, to enter into any change in control transaction, to merge or consolidate with any other entity or to acquire all or substantially all the capital stock or property of another entity, to incur additional indebtedness, to incur liens on the Company’s property, to pay any dividends or make other distributions on capital stock other than dividends payable solely in capital stock, to redeem capital stock, to enter into in-bound licensing agreements, to engage in transactions with affiliates, and to encumber the Company’s intellectual property. Events of default under the 2021 Revolver include failure to make payments when due, insolvency events, failure to comply with covenants or material adverse events with respect to the Company. Upon the occurrence of an event of default and until such event of default is no longer continuing, the annual interest rate will be 5.0% above the otherwise applicable rate. As of September 30, 2022, the Company was in compliance with all financial covenants under the 2021 Revolver.

The terms of the 2021 Revolver required that the existing term loan outstanding under the 2019 Loan be repaid with an advance under the line of credit. Accordingly, on March 11, 2021, the Company used $14.5 million of proceeds from the revolving line of credit to repay all amounts then due on the existing term loan. The Company accounted for the transaction as a debt extinguishment and recorded a loss on extinguishment of $0.2 million, which was included in interest expense in the condensed consolidated statements of operations and comprehensive loss.

As of September 30, 2022, and December 31, 2021, the Company had $15.0 million outstanding under the 2021 Revolver and it is classified as long-term debt in the condensed consolidated balance sheet. On November 2, 2022, the Company satisfied in full all of its outstanding obligations and voluntarily terminated the 2021 Revolver. The Company did not incur any early termination penalties in connection with the termination of the 2021 Revolver. The amount outstanding under the 2021 Revolver at September 30, 2022 of $15 million was repaid in October 2022 and no amounts were outstanding upon termination of the 2021 Revolver.

2022 Loan Revolver

On November 2, 2022, the Company entered into a Loan and Security Agreement (the “2022 Revolver”), by and between, the Company, as borrower, and Silicon Valley Bank, as lender.

The 2022 Revolver provides for a revolving line of credit of up to $35.0 million. The Company is permitted to make interest-only payments on the revolving line of credit through November 2, 2025, at which time all outstanding indebtedness shall be immediately due and payable. The outstanding principal amount of any advance shall accrue interest at a floating rate per annum equal to the greater of (i) three and one-half percent (3.50%) and (ii) the “prime rate” as published in The Wall Street Journal for the relevant period minus one-half percent (0.50%). The Company’s obligations under the 2022 Revolver are secured by substantially all

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of the Company’s assets, excluding its intellectual property, which is subject to a negative pledge. The revolving line of credit under the 2022 Revolver terminates on November 2, 2025. As of November 2, 2022, no amounts were outstanding under the 2022 Revolver.

The 2022 Revolver also contains certain financial covenants, including a requirement that the amount of unrestricted and unencumbered cash minus advances under the 2022 Revolver, is not less than the amount equal to the greater of (i) $10.0 million or (ii) nine (9) months of cash burn. The 2022 Revolver contains customary representations and warranties, as well as certain non-financial covenants, including limitations on, among other things, the Company’s ability to change the principal nature of its business, dispose of the Company’s business or property, engage in any change of control transaction, merge or consolidate with any other entity or to acquire all or substantially all the capital stock or property of another entity, incur additional indebtedness or liens, pay dividends or make other distributions on capital stock, redeem the Company’s capital stock, engage in transactions with affiliates or otherwise encumber the Company’s intellectual property, in each case, subject to customary exceptions.

8. Equity and Net Income (Loss) per Share

Equity

As of September 30, 2022, the Company’s certificate of incorporation authorized the Company to issue up to 5,000,000 shares of preferred stock, all of which is undesignated.

Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are not entitled to receive dividends, unless declared by the board of directors.

As of September 30, 2022, and December 31, 2021, the Company had outstanding warrants for the purchase of 92,703 shares of common stock at an exercise price of $9.17 per share, of which warrants for the purchase of 49,078 shares and 43,625 shares expire in 2027 and 2028, respectively.

Net Income (Loss) per Share

The Company only has one class of shares outstanding and basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock awards. For periods in which the Company reports a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. As the Company has reported a net loss during the three and nine months ended September 30, 2022 and 2021, basic net loss per share is the same as diluted net loss per share. The Company excluded the following potential shares of common stock, presented based on amounts outstanding at each period end, from the computation of diluted net income (loss) per share attributable to common stockholders for three and nine months ended September 30, 2022 and 2021 as the impact of including such common stock equivalents would have been anti-dilutive:

September 30, 

    

2022

    

2021

Warrants to purchase common stock

92,703

92,703

Options to purchase common stock

 

2,640,822

 

2,819,379

Restricted stock units

866,104

115,895

 

3,599,629

 

3,027,977

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9. Stock-Based Compensation

The Company recorded stock-based compensation expense for all stock awards in the following expense categories of its condensed consolidated statements of operations (in thousands):

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2022

    

2021

    

2022

    

2021

Cost of revenue

$

72

$

41

$

221

$

58

Research and development expenses

474

 

132

1,154

 

277

Selling, general and administrative expenses

1,474

 

638

3,828

 

1,296

$

2,020

$

811

$

5,203

$

1,631

As of September 30, 2022, unrecognized compensation expense was $18.4 million, related to unvested restricted stock units and stock options, which is expected to be recognized over a weighted average period of 2.84 years.

10. Commitments and Contingencies

Operating Leases

The Company’s primary operating lease obligations consists of various leases for office space in Boston, Massachusetts; North Carolina; Pennsylvania; and Braunschweig, Germany.

There have been no material changes to the Company’s leases during the nine months ended September 30, 2022. For additional information, read Note 11, Leases, to the consolidated financial statements in the Company’s Form 10-K for the year ended December 31, 2021.

In July 2022, the Company entered into a new operating lease agreement in Morrisville, North Carolina (the “New NC Lease”), to expand the Company’s research and development activities focused on its desktop offerings and enable the ability to standup an additional manufacturing site for the Company. The New NC Lease is for approximately 13,300 rentable square feet and occupancy is expected in the first half of 2023. The New NC Lease is for a term of 88 months with total lease costs of approximately $4.0 million, which will be commenced upon occupancy of the facility.

In October 2022, Trace entered into a new operating lease agreement in Braunschweig, Germany, as its existing lease was expiring and to increase the existing manufacturing site and set up European base of operations for the Company. The lease in Braunschweig is for approximately 7,500 rentable square feet and occupancy is expected in December 2022. The lease in Braunschweig is for a term of 60 months with total lease costs of approximately $0.4 million which will be commenced upon occupancy of the facility.

Royalty Arrangements

The Company has entered into royalty arrangements with two parties whereby the Company owes low- to mid-single digit royalty percentages related to revenue that is derived pursuant to in-licensed technologies. Royalty obligations are expensed when incurred or over the minimum royalty periods and have not been material. Some of the arrangements include minimum royalties over a defined term.

The future minimum royalty payments are $0.1 million per year through the end of the patents’ lives. The Company has the right to terminate the agreements with written notice.

401(k) Savings Plan

The Company has a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code. This plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. Company contributions to the plan may be made at the discretion of the board of directors. On October 1, 2021, the Company commenced an employer match program whereby the Company matches 100% of the first 3% that

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each employee contributes to the plan, capped at a maximum of $3,500 per year per employee. During the nine months ended September 30, 2022, the Company made $0.4 million in contributions to the plan.

Contingent Consideration – Earnout and Pension Liability

The Company agreed to pay three milestone based earnouts under the Trace purchase agreement for the total potential payout of $2.0 million. Milestones are based on target revenues and technical integration of Trace systems and knowledge and range from the closing date of August 3, 2022 to June 30, 2024. In addition, the Company withheld $0.9 million of consideration which will be paid to the seller contingent on the seller discharging or transferring the assumed pension liability from Trace. See Note 11, Acquisition.

Indemnification Agreements

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with its executive officers and members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or services as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not currently aware of any indemnification claims and had not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of September 30, 2022.

Legal Proceedings

The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings.

11. Acquisition

On August 3, 2022, the Company entered into a share purchase and transfer agreement and completed its acquisition of 100% of the registered share capital of Trace, for total purchase price consideration of $17.3 million, comprised of (i) a $14.4 million initial cash payment, (ii) up to $2.0 million contingent cash consideration upon achievement of certain milestones over a twenty four month period and (iii) $0.9 million contingent pension liability holdback to be released upon discharging or transferring of such liability from Trace.

Trace is a leading provider of online analysis systems for biotech applications in research, development and production. Trace’s products are used for monitoring and controlling of complex processes in industrial pharmaceutical productions under continuous measurement conditions. The Company expects to integrate acquired sampling technology within future product offerings.

The Company has accounted for the acquisition of Trace as a purchase of a business under U.S. GAAP. Under the acquisition method of accounting, the assets acquired and liabilities assumed from Trace have been recorded as of the acquisition date, at their respective fair values, and consolidated with those of the Company.

The Company has preliminarily allocated the purchase price to the net tangible and intangible assets based on their estimated fair values as of August 3, 2022. The valuation of assets acquired and liabilities assumed has not yet been finalized as of September 30, 2022. Finalization of the valuation during the measurement period could result in a change in the amounts recorded for the acquired intangible assets, assumed pension liability, indemnification assets, goodwill and income taxes among other items. The completion of the valuation will occur no later than one year from the acquisition date.

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The following table presents the preliminary allocation of the acquisition date purchase consideration for the transaction including the contingent consideration and the preliminary allocation of the purchase consideration (in thousands):

Consideration Transferred:

Cash paid

$

14,400

Net cash and working capital adjustment

113

Contingent consideration - pension liability

900

Contingent consideration - earnout

737

Total consideration transferred

$

16,150

Assets acquired and liabilities assumed:

Cash and cash equivalents

$

638

Accounts receivable

168

Inventory

364

Prepaid expenses and other current assets

11

Property and equipment, net

32

Intangible assets

Customer Relationships

3,142

Developed Technology

4,967

Software

254

Trade Name

61

Goodwill

9,566

Indemnification assets

917

Pension liability

(917)

Accounts payable, accrued expenses and other current liabilities

(306)

Deferred tax liability, net

(2,672)

Other liabilities

(75)

Total

$

16,150

The excess of the purchase price over the fair value of the acquired businesses' net assets represents cost and revenue synergies specific to the companies, and has been allocated to goodwill, which is not tax deductible. Intangible assets acquired have finite life and are amortized per our accounting policy. See Note 2 for the amortization periods.

Revenue and net loss related to Trace’s operations was $0.2 million and $0.2 million, respectively, for the period following the acquisition date, and is included in the Company’s consolidated statements of operations for the three and nine months ended September 30, 2022.

The following unaudited pro forma information presents the condensed consolidated results of operations of the Company and Trace for the nine months ended September 30, 2022 and 2021 and the three month period ended September 30, 2022 and 2021 as if the acquisition of Trace had been completed on January 1, 2021 and have been calculated after applying the Company’s accounting policies. These pro forma condensed consolidated financial results have been prepared for comparative purposes only and include certain adjustments that reflect pro forma results of operations, such as increased amortization for the fair value of acquired intangible assets, transaction related costs that were incurred in 2022 related to the acquisition which are reflected in the pro forma results for 2021, and consequential adjustments relating to the tax effect of these adjustments in combining the Company and Trace businesses.

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The unaudited pro forma results do not reflect any operating efficiencies or potential cost savings which may result from the consolidation of the operations of the Company and Trace. Accordingly, these unaudited pro forma results are presented for informational purposes only and are not necessarily indicative of the results of operations that would have been achieved had the acquisition occurred as of January 1, 2021, nor are they intended to represent or be indicative of future results of operations (in thousands):

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

    

2022

    

2021

    

2022

    

2021

Revenue (unaudited)

$

15,950

$

12,869

$

36,341

$

27,602

Pre-tax loss (unaudited)

$

(5,947)

$

(5,389)

$

(23,369)

$

(19,495)

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on March 11, 2022 (“2021 Form 10-K”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in “Item 1.A. Risk Factors” section of our 2021 Form 10-K, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

We have developed an innovative suite of purpose-built handheld and desktop mass spectrometry, or Mass Spec, devices for the point-of-need. Leveraging our proprietary platform technology, we make the extraordinary analytical power of Mass Spec available in devices that are significantly smaller and more accessible than conventional laboratory instruments. Our Mass Spec devices are used at the point-of-need to interrogate unknown and invisible materials and provide quick, actionable answers to directly address some of the most critical problems in life sciences research, bioprocessing, industrial biotech, forensics and adjacent markets.

We create simplified measurement devices that our customers can use as accurate tools where and when their work needs to be done, rather than overly complex and centralized analytical instrumentation. We believe the insights and answers our devices provide will accelerate workflows, reduce costs, and offer transformational opportunities for our end users.

Front-line workers rely upon our handheld devices to combat the opioid crisis and detect counterfeit pharmaceuticals and illicit materials in the air or on surfaces at levels 1,000 times below their lethal dose. Our desktop devices are accelerating development and production of biotherapeutics by identifying and quantifying extracellular species in bioprocessing critical to cell health and productivity. They sit alongside bioreactors and fermenters producing drug candidates, functional proteins, cell and gene therapies, and synthetic biology derived products. We believe the insights and answers our devices provide accelerate workflows, reduce costs, and offer transformational opportunities for our end users. The term “products” as used in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” refers to the MX908, Rebel and ZipChip Interface.

Since inception, we have focused substantially all of our resources on designing, developing and building our proprietary Mass Spec platform and associated technologies, supporting software improvements and data analysis, organizing and staffing our company, planning our business, raising capital, and providing general and administrative support for these operations. To date, we have funded our operations primarily with proceeds from sales of preferred stock and borrowings under loan agreements and, more recently, with the proceeds from two public equity offerings. On December 22, 2020, we completed our initial public offering, or IPO, pursuant to which we issued and sold 7,475,000 shares of common stock, inclusive of 975,000 shares pursuant to the full exercise of the underwriters’ option to purchase additional shares. We received net proceeds of $136.6 million after deducting underwriting discounts and commissions and other offering costs. On November 15, 2021, we completed an underwritten public offering, pursuant to which we issued and sold 3,150,000 shares of common stock at a public offering price of $32.00 per share, or the November 2021 Offering. We received net proceeds of $94.4 million after deducting underwriting discounts and commissions and other offering costs.

On August 3, 2022, we entered into a share purchase and transfer agreement and completed our acquisition of 100% of the registered share capital of Trace, for a total purchase price consideration of $17.3 million, comprised of (i) a $14.4 million initial cash payment, (ii) up to $2.0 million contingent cash consideration upon achievement of certain milestones over a twenty-four-month period and (iii) $0.9 million contingent pension liability holdback to be released upon discharging or transferring of such liability from Trace. Trace is a leading provider of online analysis systems for biotech applications in research, development and production. Trace’s products are used for monitoring and control of complex processes in industrial pharmaceutical productions under continuous measurement conditions. We expect to integrate acquired sampling technology within future product offerings.

Since our inception, we have incurred significant operating losses. Our ability to generate revenue sufficient to achieve profitability will depend on the successful further development and commercialization of our products. We generated revenue of $35.2 million and $26.4 million for the nine months ended September 30, 2022 and 2021, respectively, and incurred net losses of $23.8 million and $18.7 million for those same periods. As of September 30, 2022, we had an accumulated deficit of $124.4 million. We expect to continue to incur net losses as we focus on growing commercial sales of our products in both the United States and

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international markets, including growing our sales teams, scaling our manufacturing operations, continuing research and development efforts to develop new products and further enhance our existing products. Further, we expect to incur additional costs associated with operating as a public company. As a result, we may need additional funding for expenses related to our operating activities, including selling, general and administrative expenses and research and development expenses.

Because of the numerous risks and uncertainties associated with product development and commercialization, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. Until such time, if ever, as we can generate substantial revenue sufficient to achieve profitability, we expect to finance our operations through a combination of equity offerings, debt financings and strategic alliances. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we are unable to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the further development and commercialization efforts of one or more of our products, or may be forced to reduce or terminate our operations.

We believe that our existing cash and cash equivalents and revenue from product and service, will enable us to fund our operating expenses, capital expenditure requirements and debt service payments for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Liquidity and Capital Resources.”

Economic Uncertainty and Rising Inflation

We are closely monitoring increased economic uncertainty in the United States and abroad. General inflation in the United States, Europe, EMEA and other geographies has risen to levels not experienced in recent decades. General inflation, including rising prices for our raw materials and other inputs, as well as rising salaries and travel expenses, negatively impact our business by increasing our cost of sales and operating expenses. General inflation also negatively impacts our business by decreasing the capital available for our customers to deploy to purchase our products and services.

In addition, the United States Federal Reserve has raised, and may again raise, interest rates in response to concerns about inflation. Inflation, together with increased interest rates, may cause our customers to reduce or delay orders for our goods and services thereby causing a decrease in or change in timing of sales of our products and services. The impact of future inflation and interest rate fluctuations on the results of our operations cannot be accurately predicted.

COVID-19

In December 2019, a novel strain of coronavirus, or COVID-19, emerged in Wuhan, Hubei Province, China. Less than four months later, in March 2020, the World Health Organization declared COVID-19 a pandemic. The situation surrounding the COVID-19 pandemic remains fluid and the full extent of the impact of the COVID-19 pandemic on our business will depend on certain developments including the duration and severity of the pandemic, the emergence of new variants that may continue to prolong the pandemic, the amount of time it will take for normal economic activity to resume, future government actions that may be taken, the impact on consumer activity and behaviors and the effect on our customers, employees, suppliers, partners and stockholders, all of which are uncertain and cannot be predicted. For example, in 2021, we experienced extended lead times on our supply chain, limitations on travel for our employees and customers, and delays in product installations, trainings, or shipments to and from affected countries, and we recorded an increase to our allowance for doubtful accounts of $1.7 million for a customer in the Middle East where due to the credit and economic conditions, including the impact of COVID-19, we determined that it is probable that collection will not occur. Although we continue to monitor the situation and may adjust our current policies as more information and public health guidance become available, the ongoing effects of the COVID-19 pandemic and/or the precautionary measures that we have adopted may create operational and other challenges, any of which could harm our business and results of operations. While we maintain an inventory of finished products and raw materials used in our products, a prolonged pandemic could lead to shortages in the raw materials necessary to manufacture our products. If we experience a prolonged disruption in our manufacturing, supply chains or commercial operations, or if demand for our products or our customers’ ability to make payments is significantly reduced as a result of the COVID-19 pandemic, we would expect to experience a material adverse impact on our business, financial condition, results of operations and prospects.

Historically, a significant portion of our field sales, customer training events and other application services have been conducted in person, and the rollout of our new products has historically been supported by our participation at industry conferences. Any prolonged restrictive measures put in place in order to control the spread of COVID-19, including new variants, or other adverse

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public health developments in any of our targeted markets may have a material and adverse effect on our business operations and results of operations. We do not yet know the extent of the negative impact of such restrictions and precautionary measures, including the lifting of our travel restrictions in limited circumstances, on our ability to attract new customers or retain and expand our relationships with existing customers over the near and long term.

Factors Affecting Our Performance

We believe that our financial performance has been and in the foreseeable future will continue to be primarily driven by the following factors. While each of these factors presents significant opportunities for our business, they also pose important challenges that we must successfully address to sustain our growth and improve our results of operations. Our ability to successfully address the factors below is subject to various risks and uncertainties.

Device sales

Our financial performance has largely been driven by, and in the future will continue to be impacted by, the rate of sales of our handheld and desktop devices. Management focuses on device sales as an indicator of current business success and a leading indicator of likely future recurring revenue from consumables and services. We expect our device sales to continue to grow as we increase penetration in our existing markets and expand into, or offer new features and solutions that appeal to, new markets.

We plan to grow our device sales in the coming years through multiple strategies including expanding our sales efforts domestically and globally and continuing to enhance the underlying technology and applications for life sciences research related to our Rebel and ZipChip Interface. We regularly solicit feedback from our customers and focus our research and development efforts on enhancing our devices and enabling our customers to use additional applications that address their needs, which we believe in turn helps to drive additional sales of our devices and consumables.

Our sales process varies considerably depending upon the type of customer to whom we are selling. Historically, our handheld devices have been used by state, federal and foreign governments and governmental agencies. Our sales process with government customers is often long and involves multiple levels of approvals, testing and, in some cases, trials. Device orders from a government customer are typically large orders and can be impacted by the timing of their capital budgets. As a result, the revenue for our handheld devices can vary significantly from period-to-period and has been and may continue to be concentrated in a small number of customers in any given period.

Our desktop devices are typically used by the pharmaceutical, biotechnology and academia markets. Our sales cycles within these markets tend to vary based on the size of the customer and the number of devices they purchase. Our shortest sales cycles are typically for small laboratories and individual researchers where, in some cases, we receive purchase orders from these customers within three months. Our sales process with other institutions can be longer with most customers submitting purchase orders within six to twelve months. Given the variability of our sales cycle, we have in the past experienced, and likely will in the future experience, fluctuations in our desktop device sales on a period-to-period basis. Additionally, we have experienced and may continue to experience the impact of laboratory shutdowns related to COVID-19 on device and consumable sales to these markets.

Recurring revenue

We regularly assess trends relating to recurring revenue which includes consumables and services based on our product offerings, our customer base and our understanding of how our customers use our products. Consumables and service revenue was 29% and 21% of total product and service revenue for the nine months ended September 30, 2022 and 2021, respectively. Our recurring revenue as a percentage of total product and service revenue will vary based upon new device placements in the period. As our device installed base expands, recurring revenue on an absolute basis is expected to increase and over time should be an increasingly important contributor to our revenue.

Revenue from the sales of consumables will vary by type of device. We expect that recurring revenue as a percentage of the original device price to be higher for our desktop devices (Rebel and ZipChip Interface) than for our handheld device (MX908). While we sell single-use swab samplers for MX908 to be used in liquid and solid materials analysis, there are a number of other applications that the MX908 can be used for that do not require consumables. Rebel and ZipChip Interface require consumables kits for all areas of operations. Currently, Rebel customers, who are actively utilizing the device, are consuming on average one 200-sample kit per month; however, Rebel is a new product and purchasing patterns related to our consumables kits are evolving. We expect that the

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number of kits sold per month will vary over the short term. In time, we expect Rebel consumables kits sales to become more consistent as our installed base grows and our customers establish usage patterns. At maximum potential capacity, with continuous operation, the Rebel can consume approximately one 200-sample kit per day.

Revenue mix and gross margin

Our revenue is derived from sales of our devices, consumables and services. There will be fluctuations in mix between devices and consumables from period-to-period. Over time, as our device installed base grows and we see adoption of Rebel, we expect consumables revenue to constitute a larger percentage of product and service revenue. However, the percentage will be subject to fluctuation based upon our handheld sales in a period. In addition, our selling price and, consequently, our margins, are higher for those devices and consumables that we sell directly to customers as compared to those that we sell through distributors. While we expect the mix of direct sales as compared to sales through distributors to remain relatively constant in the near term, we are currently evaluating increasing our direct sales capabilities in certain geographies.

Future device and consumable selling prices and gross margins may fluctuate due to a variety of factors, including the introduction by others of competing products and solutions. We aim to mitigate downward pressure on our average selling prices by increasing the value proposition offered by our devices and consumables, primarily by expanding the applications for our devices and increasing the quantity and quality of data that can be obtained using our consumables.

Product adoption

We monitor our customers’ stage of adoption of our products to provide insight into the timing of future potential sales and to help us formulate financial projections. Typical stages of adoption include testing, trials, pilot and deployment as follows:

Testing—a customer is actively engaged with internal or external testing of our products. This may include an onsite or virtual demonstration with a salesperson, a customer submitting samples for testing in one of our facilities or testing by a third party.
Trials—a customer has committed to a trial of one of our products, which may include a defined period to assess functionality of the device in their operational environment (in the field or onsite within the customer’s facility).
Pilot—a customer commits to the purchase of an initial quantity of devices to deploy in their operational environment to assess a broader opportunity that may grow to tens or hundreds of devices.
Deployment—a customer has completed testing, a trial, and/or a pilot and intends to roll out the technology across their enterprise (either at a site or throughout the entire organization).

Key Business Metrics

We regularly review the number of product placements and cumulative product placements as key metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections, and make strategic decisions. We believe that these metrics are representative of our current business; however, we anticipate these will change or may be substituted for additional or different metrics as our business grows.

During the three and nine months ended September 30, 2022 and 2021, our product placements (units recognized as revenue) by device type were as follows:

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2022

    

2021

    

2022

    

2021

Product Placements:

  

  

MX908

 

150

 

164

 

315

 

301

 

Rebel

 

18

 

13

 

47

 

34

 

ZipChip Interface

 

7

 

7

 

20

 

18

 

Total Product Placements

 

175

 

184

 

382

 

353

 

The number of product placements vary considerably from period-to-period due to the type and size of our customers and concentrations among larger government customers as described above. We expect continued fluctuations in our period-to-period number of product placements.

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Our cumulative product placements consist of the following number of devices:

September 30, 

    

2022

    

2021

Cumulative Product Placements:

  

MX908

 

1,965

 

1,459

 

Rebel

 

147

 

80

 

ZipChip Interface

 

205

 

175

 

Cumulative Product Placements

 

2,317

 

1,714

 

Components of Our Results of Operations

Revenue

Product and Service Revenue

We generate product and service revenue from the sale of our devices and recurring revenue from the sale of consumables and services. Device sales accounted for 71% and 79% of our product and service revenue for the nine months ended September 30, 2022 and 2021, respectively. Consumables and service revenue accounted for 29% and 21% of our product and service revenue for the nine months ended September 30, 2022 and 2021, respectively.

Our current device offerings include:

Handheld devices—MX908; and
Desktop devices—Rebel and ZipChip Interface.

We sell our devices directly to customers and through distributors. Each of our device sales drives various streams of recurring revenue comprised of consumable product sales and service revenue.

Our consumables consist of:

MX908—accessories and swabs;
Rebel—consumables kit with a microfluidic chip and standards; and
ZipChip Interface—microfluidic chip, reagent and assay kits.

Rebel and ZipChip Interface consumables can only be used with our devices and there are no alternative after-market options that can be used as a substitute. Each chip is used for a defined number of samples (or runs). We recognize revenue from the sale of consumables as the consumable products are shipped.

We also offer our customers extended warranty and service plans. Our extended warranty and service plans are offered for periods beyond the standard one-year warranty that all of our customers receive. These extended warranty and service plans generally have fixed fees and terms ranging from one additional year to four additional years. We recognize revenue from the sale of extended warranty and service plans over the respective coverage period, which approximates the service effort provided by us.

We expect consumables and service revenue to increase in future periods as our installed base grows and we are able to generate recurring sales.

Licenses and contract revenue

License and contract agreements are arrangements whereby we provide engineering services for the development of our technology platform for specific programs or new and expanding applications of our technologies for future commercial endeavors. Our license and contract agreements are with the U.S. government and commercial entities (who may be contracting with the government). Contracts typically include compensation for labor effort and materials incurred related to the deliverables under the contract. Our license and contract revenue was primarily related to two customers during the three and nine months ended September 30, 2022 and one customer during the three and nine months ended September 30, 2021.

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During the three and nine months ended September 30, 2022 and 2021, our revenue was comprised of revenue from the following sources:

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2022

    

2021

    

2022

    

2021

Product and service revenue:

 

  

 

  

 

  

 

  

Device sales revenue

$

10,952

$

10,075

$

24,239

$

20,167

Consumables and service revenue

 

4,485

 

2,210

 

9,835

 

5,390

Total product and service revenue

 

15,437

 

12,285

 

34,074

 

25,557

License and contract revenue

 

360

 

260

 

1,135

 

808

Total revenue

$

15,797

$

12,545

$

35,209

$

26,365

Our product and service revenue is comprised of sales of our handheld and desktop devices and related consumables and service contracts to end-users in the government, pharmaceuticals/biotechnology and academia markets as follows:

Three Months Ended September 30, 

Nine Months Ended September 30, 

2022

    

2021

    

2022

    

2021

Government

$

11,069

$

9,505

$

22,788

$

18,018

Pharmaceutical/Biotechnology

4,327

 

2,766

11,032

 

7,475

Academia

41

 

14

254

 

64

Total product and service revenue

$

15,437

$

12,285

$

34,074

$

25,557

We sell our products primarily in the United States; however, we continue to expand our global sales efforts as we see traction in our products and assess global market needs. The majority of our international sales are through a distribution channel.

Cost of Revenue, Gross Profit and Gross Margin

Product cost of revenue primarily consists of costs for raw material parts and associated freight, shipping and handling costs, royalties, contract manufacturer costs, salaries and other personnel costs, overhead, amortization of intangibles and other direct costs related to those sales recognized as product revenue in the period.

Cost of revenue for services primarily consists of salaries and other personnel costs, travel related to services provided, facility costs associated with training, warranties and other costs of servicing equipment on a return-to-factory basis and at customer sites. License and contract cost of revenue primarily consists of salaries and other personnel costs, materials, travel and other direct costs related to the revenue recognized in the period. The license and contract cost of revenue will vary based upon the type of contract, including whether it is primarily for development services or for both materials and development services.

We expect that our cost of revenue will increase or decrease to the extent that our revenue increases and decreases and depending on how many contracts we have ongoing at any given point in time and the stage of those contracts.

Gross profit is calculated as revenue less cost of revenue. Gross profit margin is gross profit expressed as a percentage of revenue. Our gross profit in future periods will depend on a variety of factors, including: market conditions that may impact our pricing, sales mix among devices, sales mix changes among consumables, excess and obsolete inventories, our cost structure for manufacturing operations relative to volume, and product warranty obligations. Our gross profit in future periods will vary based upon our channel mix and may decrease based upon our distribution channels and the potential to establish original equipment manufacturing channels for certain components of our technology platform which would have a lower gross margin.

We expect that our gross profit margin for product and service will increase over the long term as our sales and production volumes increase and our cost per unit decreases due to efficiencies of scale. We intend to use our design, engineering and manufacturing capabilities to further advance and improve the efficiency of our manufacturing, which we believe will reduce costs and increase our gross margin. We expect that our gross profit margin for license and contract will remain consistent for our contracts that are cost reimbursement contracts.

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Operating Expenses

Research and development expenses

Research and development expenses consist primarily of costs incurred for our research activities, product development, hardware and software engineering and consultant services and other costs associated with our technology platform and products, which include:

employee-related expenses, including salaries, related benefits and stock-based compensation expense for employees engaged in research and hardware and software development functions;
the cost of maintaining and improving our product designs, including third party development costs for new products and materials for prototypes;
research materials and supplies; and
facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities and insurance.

We believe that our continued investment in research and development is essential to our long-term competitive position and expect these expenses to increase in future periods.

Selling, general and administrative expenses

Selling, general and administrative expenses consist primarily of salaries and other personnel costs, and stock-based compensation for our sales and marketing, finance, legal, human resources and general management, as well as professional services, such as legal, audit and accounting services. We expect selling, general and administrative expenses, amortization of customer relationship and tradename intangibles to increase in future periods as the number of sales, sales application specialists and marketing and administrative personnel grows and we continue to introduce new products, invest in demonstration equipment, broaden our customer base and grow our business. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with operating as a public company.

Other Income (Expense)

Interest expense

Interest expense consists of interest expense associated with outstanding borrowings under our loan and security agreements and the amortization of deferred financing costs and debt discounts associated with such arrangements.

Other income (expense), net

Other income (expense), net consists of interest income from our cash and cash equivalents, miscellaneous other income and expense unrelated to our core operations.

Provision for Income Taxes

We have not recorded any U.S. federal or state income tax benefits for the net operating losses we have incurred in each year or for the research and development tax credits we generated in the United States, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credits will not be realized. As of December 31, 2021, we had U.S. federal and state net operating loss carryforwards of $80.4 million and $52.3 million, respectively, which may be available to offset future taxable income and begin to expire in 2032 and 2025, respectively, of which $46.0 million of federal net operating losses do not expire. As of December 31, 2021, we also had U.S. federal and state research and development tax credit carryforwards of $4.8 million and $2.7 million, respectively, which may be available to offset future tax liabilities and begin to expire in 2032 and 2029, respectively. We have recorded a full valuation allowance against our net deferred tax assets at each balance sheet date.

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In August 2022, the U.S. Inflation Reduction Act (the Act) was enacted into law. The Act includes various tax provisions, including an excise tax on stock repurchases, expanded tax credits for clean energy incentives and a corporate alternative minimum tax that generally applies to U.S. corporations with adjusted financial statement income in excess of $1.0 billion. We do not expect the Act to have a material impact on our condensed consolidated financial statements.

Results of Operations

Comparison of the Three months ended September 30, 2022 and 2021

The following table summarizes our results of operations for the three months ended September 30, 2022 and 2021:

Three Months Ended September 30, 

    

2022

    

2021

    

Change

(in thousands)

Revenue:

 

  

 

  

 

  

Product and service revenue

$

15,437

$

12,285

$

3,152

License and contract revenue

 

360

 

260

 

100

Total revenue

 

15,797

 

12,545

 

3,252

Cost of revenue:

 

  

 

  

 

  

Product and service cost of revenue

 

6,366

 

5,656

 

710

License and contract cost of revenue

 

93

 

77

 

16

Total cost of revenue

 

6,459

 

5,733

 

726

Gross profit

 

9,338

 

6,812

 

2,526

Operating expenses:

 

  

 

  

 

  

Research and development

 

4,666

 

3,302

 

1,364

Selling, general and administrative

 

11,826

 

8,786

 

3,040

Total operating expenses

 

16,492

 

12,088

 

4,404

Loss from operations

 

(7,154)

 

(5,276)

 

(1,878)

Other income (expense):

 

  

 

  

 

  

Interest expense

 

(33)

 

(31)

 

(2)

Other income, net

 

928

 

122

 

806

Total other income, net

 

895

 

91

 

804

Net loss

$

(6,259)

$

(5,185)

$

(1,074)

Revenue, Cost of Revenue and Gross Profit

Product and service

Our product and service revenue is comprised of revenue from sales of devices and related consumables and service as follows:

Three Months Ended September 30, 

Change

    

2022

    

2021

    

Amount

    

%

(dollars in thousands)

Product and service revenue

$

15,437

$

12,285

$

3,152

 

26

%

Product and service cost of revenue

 

6,366

 

5,656

 

710

 

13

%

Gross profit

$

9,071

$

6,629

$

2,442

 

37

%

Gross profit margin

 

59

%

 

54

%

 

5

%

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Three Months Ended September 30, 

Change

    

2022

    

2021

    

Amount

    

%

(dollars in thousands)

Device sales revenue

 

$

10,952

$

10,075

$

877

 

9

%

Consumables and service revenue

 

4,485

 

2,210

 

2,275

 

103

%

Total product and service revenue

$

15,437

$

12,285

$

3,152

 

26

%

Product and service revenue increased by $3.2 million, or 26%, for the three months ended September 30, 2022, compared to the three months ended September 30, 2021. Device sales accounted for 71% and 82% of our product and service revenue for the three months ended September 30, 2022 and 2021, respectively. The increase in device sales of $0.9 million was primarily due to an increase of $1.0 million in desktop device sales, primarily related to a five unit increase in Rebel devices and a higher average selling price for desktop devices based upon distributor mix and annual list price increases. Consumables and service revenue increased by $2.3 million primarily due to an increase in consumables of $1.3 million driven by aero modules and handheld consumable kits and a $1.0 million increase in service revenue which was related to approximately 100% growth in service for both handheld and desktops.

Product and service cost of revenue increased by $0.7 million, or 13%, for the three months ended September 30, 2022, compared to the three months ended September 30, 2021. The increase in product and service cost of revenue was primarily related to $0.4 million in costs from higher product volume, a $0.3 million increase in salaries and related costs, and a $0.1 million increase in intangible amortization offset in part by a decrease in royalty obligations and timing of the capitalization of labor and overhead from the build of devices within the quarter.

Product and service gross profit increased by $2.4 million, or 37%, and gross profit margin increased by five percentage points for the three months ended September 30, 2022 as compared to the three months ended September 30, 2021, primarily due to $1.0 million in higher service revenue and higher average selling prices for our MX908 and Rebel devices, offset in part by the higher personnel and operating costs.

License and contract

Three Months Ended September 30, 

Change

    

2022

    

2021

    

Amount

    

%

(dollars in thousands)

License and contract revenue

$

360

$

260

$

100

 

38

%

License and contract cost of revenue

 

93

 

77

 

16

 

21

%

Gross profit

$

267

$

183

$

84

 

46

%

Gross profit margin

74

%

70

%

4

%

License and contract revenue increased by $0.1 million, or 38%, for the three months ended September 30, 2022, compared to the three months ended September 30, 2021. The majority of license and contract revenue in the three months ended September 30, 2022 and 2021, was related to activities under our subcontract agreement with a commercial entity that holds a U.S. government prime contract.

License and contract cost of revenue was relatively unchanged in absolute dollars, but was an increase of 21% for the three months ended September 30, 2022, compared to the three months ended September 30, 2021.

License and contract gross profit increased and gross profit margin increased by four percentage points for the three months ended September 30, 2022 as compared to the three months ended September 30, 2021, primarily due to the mix in contract deliverables, including a mix of labor versus materials during the three months ended September 30, 2022, which resulted in a slightly higher gross profit margin percentage.

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Operating Expenses

Research and development

Three Months Ended September 30, 

Change

    

2022

    

2021

    

Amount

    

%

(dollars in thousands)

Research and development expenses

$

4,666

$

3,302

 

$

1,364

 

41

%

Percentage of total revenue

 

30

%

 

26

%

 

Our research and development expenses were $4.7 million for the three months ended September 30, 2022, an increase of $1.4 million from research and development expenses of $3.3 million for the three months ended September 30, 2021. The increase was due primarily to a $0.7 million increase in salaries and related costs from growing headcount, a $0.3 million increase in stock-based compensation and a $0.2 million increase in materials and supplies related to product development efforts.

Selling, general and administrative expenses

Three Months Ended September 30, 

Change

    

2022

    

2021

    

Amount

    

%

(dollars in thousands)

Selling, general and administrative expenses

$

11,826

$

8,786

$

3,040

 

35

%

Percentage of total revenue

 

75

%

 

70

%

Our selling, general and administrative expenses were $11.8 million for the three months ended September 30, 2022, an increase of $3.0 million from selling, general and administrative expenses of $8.8 million for the three months ended September 30, 2021. The increase was due primarily to a $1.5 million increase in salaries and related costs from growing headcount, a $0.8 million increase in stock-based compensation, a $0.5 million increase in travel expenses, a $0.1 million in intangibles amortization and a $0.1 million net increase in all other costs.

Other Income (Expense)

Interest expense

Interest expense was relatively unchanged for the three months ended September 30, 2022 compared to the three months ended September 30, 2021.

Other income (expense), net

Other income, net was $0.9 million for the three months ended September 30, 2022, an increase of $0.8 million from other income, net of $0.1 million for the three months ended September 30, 2021. The increase was primarily due to our higher cash and cash equivalent balances from the proceeds from the November 2021 Offering as well as higher interest rates on our interest bearing accounts based upon recent increases in the market.

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Comparison of the Nine months ended September 30, 2022 and 2021

The following table summarizes our results of operations for the nine months ended September 30, 2022 and 2021:

Nine Months Ended September 30, 

    

2022

    

2021

    

Change

(in thousands)

Revenue:

  

  

  

Product and service revenue

$

34,074

$

25,557

$

8,517

License and contract revenue

 

1,135

 

808

 

327

Total revenue

 

35,209

 

26,365

 

8,844

Cost of revenue:

 

  

 

  

 

  

Product and service cost of revenue

 

14,768

 

12,062

 

2,706

License and contract cost of revenue

 

340

 

204

 

136

Total cost of revenue

 

15,108

 

12,266

 

2,842

Gross profit

 

20,101

 

14,099

 

6,002

Operating expenses:

 

  

 

 

  

Research and development

 

12,864

 

9,322

 

3,542

Selling, general and administrative

 

32,281

 

23,318

 

8,963

Total operating expenses

 

45,145

 

32,640

 

12,505

Loss from operations

 

(25,044)

 

(18,541)

 

(6,503)

Other income (expense):

 

  

 

  

 

  

Interest expense

 

(68)

 

(446)

 

378

Other income, net

1,340

 

283

 

1,057

Total other income (expense), net

 

1,272

 

(163)

 

1,435

Net loss

$

(23,772)

$

(18,704)

$

(5,068)

Revenue, Cost of Revenue and Gross Profit

Product and service

Our product and service revenue is comprised of revenue from sales of devices and related consumables and service as follows:

Nine Months Ended September 30, 

Change

    

2022

    

2021

    

Amount

    

%

(dollars in thousands)

 

Product and service revenue

$

34,074

$

25,557

$

8,517

 

33

%

Product and service cost of revenue

 

14,768

 

12,062

 

2,706

 

22

%

Gross profit

$

19,306

$

13,495

$

5,811

 

43

%

Gross profit margin

 

57

%

 

53

%

 

4

%  

  

Nine Months Ended September 30, 

Change

    

2022

    

2021

    

Amount

    

%

(dollars in thousands)

 

Device sales revenue

$

24,239

$

20,167

$

4,072

 

20

%

Consumables and service revenue

9,835

 

5,390

 

4,445

 

82

%

Total product and service revenue

$

34,074

$

25,557

$

8,517

 

33

%

Product and service revenue increased by $8.5 million, or 33%, for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021. Device sales accounted for 71% and 79% of our product and service revenue for the nine months ended September 30, 2022 and 2021, respectively. Consumables and service revenue accounted for 29% and 21% of our product and service revenue for the nine months ended September 30, 2022 and 2021, respectively. The increase in device sales of $4.1 million was primarily due to an increase of $2.5 million in desktop device sales, representing a 15 unit increase, primarily related to Rebel device placements driven by adoption of our technology within process development labs to obtain information and analytics within their bioprocessing batches. The increase in device sales was also due to an increase of $1.6 million in handheld device sales for the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021, attributable to a 14 unit

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increase in sales of our handheld products, mainly driven by an increase in state and local placements in the United States as a result of funding to address detection capabilities with the opioid epidemic. Consumables and service revenue increased by $4.4 million primarily due to a $2.7 million increase in service revenue and a $1.3 million increase in handheld aero modules, accessories and consumables sales.

Product and service cost of revenue increased by $2.7 million, or 22%, for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021. The increase in product and service cost of revenue was primarily related to $1.3 million in costs from higher product volume, a $1.1 million increase in salaries and related costs from growing headcount, a $0.2 million increase in stock-based compensation and $0.1 million in intangibles amortization.

Product and service gross profit increased by $5.8 million, or 43%, and gross profit margin increased by four percentage points for the nine months ended September 30, 2022, as compared to the nine months ended September 30, 2021, primarily due to $2.7 million in higher service revenue, as well as higher product revenue volume and favorable product mix and pricing, offset in part by the higher personnel and operating costs to support the higher volume.

License and contract

Nine Months Ended September 30, 

Change

    

2022

    

2021

    

Amount

    

%

(dollars in thousands)

 

License and contract revenue

$

1,135

$

808

$

327

 

40

%

License and contract cost of revenue

 

340

 

204

 

136

 

67

%

Gross profit

$

795

$

604

$

191

 

32

%

Gross profit margin

 

70

%

75

%

(5)

%  

  

License and contract revenue increased by $0.3 million, or 40%, for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021. The majority of license and contract revenue, for the nine months ended September 2022 and 2021, was related to activities under our subcontract agreement with a commercial entity that holds a U.S. government prime contract. The increase in license and contract revenue for the nine months ended September 30, 2022 is primarily related to a $0.3 million increase in revenue related work performed under a prime contract held directly with the U.S. government.

License and contract cost of revenue increased by $0.1 million, or 67% for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021 due to mix of contract deliverables across the current contracts. The mix of contract deliverables for the nine months ended September 30, 2022 had higher material costs as part of the contract deliverables for the prime contract held directly with the U.S. government compared to the nine months ended September 30, 2021.

License and contract gross profit increased by $0.2 million and gross profit margin decreased by five percentage points for the nine months ended September 30, 2022 as compared to the three months ended September 30, 2021, primarily due to the mix in contract deliverables, including a mix of materials with higher costs during the nine months ended September 30, 2022 which resulted in a lower gross profit margin for that period, as compared to the nine months ended September 30, 2021.

Operating Expenses

Research and development

Nine Months Ended September 30, 

Change

    

2022

    

2021

    

Amount

    

%

(dollars in thousands)

 

Research and development expenses

$

12,864

$

9,322

$

3,542

 

38

%

Percentage of total revenue

 

37

%  

 

35

%  

 

  

 

  

Our research and development expenses were $12.9 million for the nine months ended September 30, 2022, an increase of $3.5 million from research and development expenses of $9.3 million for the nine months ended September 30, 2021. The increase was due primarily to a $2.2 million increase in salaries and related costs from growing headcount, a $0.9 million increase in stock-based compensation and a $0.3 million increase in materials and supplies related to product development efforts.

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Selling, general and administrative expenses

Nine Months Ended September 30, 

Change

    

2022

    

2021

    

Amount

    

%

(dollars in thousands)

 

Selling, general and administrative expenses

$

32,281

$

23,318

$

8,963

 

38

%

Percentage of total revenue

 

92

%

 

88

%

 

  

 

  

Our selling, general and administrative expenses were $32.3 million for the nine months ended September 30, 2022, an increase of $9.0 million from selling, general and administrative expenses of $23.3 million for the nine months ended September 30, 2021. The increase was due primarily to a $5.3 million increase in salaries and related costs from growing headcount, a $2.5 million increase in stock-based compensation, a $1.2 million increase in travel expenses, a $0.5 million increase in IT related subscription fees, a $0.4 million increase in marketing activities, a $0.1 million in intangibles amortization and a $0.8 million net increase in all other costs. These increases were partially offset by a $1.8 million decrease in allowance for bad debt recorded in the nine months ended September 30, 2021.

Other Income (Expense)

Interest expense

Interest expense decreased by $0.4 million for the nine months ended September 30, 2022, from $0.4 million for the nine months ended September 30, 2021. The decrease was primarily due to lower average outstanding borrowings during the nine months ended September 30, 2022 and a loss on extinguishment of debt of $0.2 million recorded for the comparative prior year period.

Other income (expense), net

Other income (expense), net increased by $1.0 million for the nine months ended September 30, 2022, from $0.3 million for the nine months ended September 30, 2021. The increase was primarily due to a $1.0 million increase in interest earned from our higher cash and cash equivalent balances from the proceeds from the November 2021 Offering, as well as higher interest rates on our interest bearing accounts.

Liquidity and Capital Resources

Since our inception, we have incurred significant operating losses. To date, we have funded our operations primarily with proceeds from sales of redeemable preferred stock, borrowings under loan agreements and revenue from sales of our products and services and license and contract revenue, proceeds from our IPO in December 2020, and, most recently, with proceeds from the November 2021 Offering. As of September 30, 2022, we had cash and cash equivalents of $193.7 million. We believe that our existing cash and cash equivalents will enable us to fund our operating expenses, capital expenditure requirements and debt service payments for at least the next twelve months.

We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. Our future funding requirements will depend on many factors, including:

market uptake of our products and growth into new and existing markets;
the cost of our research and development efforts to expand the applications of our current devices and to create enhanced products with our platform of technologies;
the cost of expanding our commercial operations, including distribution capabilities, and accelerating planned investments, such as hiring additional support, service, and sales management in Europe, Asia Pacific and Latin America, bolstering our infrastructure in these regions;
the cost of acquiring complementary businesses, products, services or technologies, when and if required;

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the success of our existing collaborations and our ability to enter additional collaborations in the future;
the effect of competing technological and market developments; and
the level of our selling, general and administrative expenses.

On March 11, 2021, we entered into an Amended and Restated Loan and Security Agreement, or the 2021 Revolver, with Signature Bank, to replace our 2019 Loan and Security Agreement, or the 2019 Loan. The 2021 Revolver created a revolving line of credit totaling $25.0 million and eliminated the existing term loan. Borrowings under the revolving line of credit bear interest at an annual rate equal to the greater of (i) one-half percent (0.5%) above the prime rate or (ii) 4.0% and mature on March 11, 2024. Borrowings are collateralized by substantially all of our property, excluding intellectual property, which is subject to a negative pledge. The 2021 Revolver subjects us to various customary covenants, including requirements as to financial reporting and financial covenants (including an unrestricted minimum cash level of $10.0 million), and restrictions on our ability to dispose of our business or property, to change our line of business, to liquidate or dissolve, to enter into any change in control transaction, to merge or consolidate with any other entity or to acquire all or substantially all the capital stock or property of another entity, to incur additional indebtedness, to incur liens on our property, to pay any dividends or make other distributions on capital stock other than dividends payable solely in capital stock, to redeem capital stock, to enter into in-bound licensing agreements, to engage in transactions with affiliates, and to encumber our intellectual property. Events of default under the 2021 Revolver include failure to make payments when due, insolvency events, failure to comply with covenants or material adverse events with respect to us. Upon the occurrence of an event of default and until such event of default is no longer continuing, the annual interest rate will be 5.0% above the otherwise applicable rate.

The terms of the 2021 Revolver required that the existing term loan outstanding under the 2019 Loan be repaid with an advance under the line of credit. Accordingly, on March 11, 2021, we used $14.5 million of proceeds from the revolving line of credit to repay all amounts then due on the existing term loan. We also borrowed an additional $0.5 million from the 2021 Revolver in March 2021. On November 2, 2022, we satisfied in full all of our obligations and voluntarily terminated 2021 Revolver. We did not incur any early termination penalties in connection with the termination of the 2021 Revolver. The amount outstanding under the 2021 Revolver at September 30, 2022 of $15 million was repaid in October 2022 and no amounts were outstanding upon termination of the 2021 Revolver.

On November 2, 2022, we entered into a Loan and Security Agreement (the “2022 Revolver”), by and between, 908 Devices Inc., as borrower, and Silicon Valley Bank, as lender.

The 2022 Revolver provides for a revolving line of credit of up to $35.0 million. We are permitted to make interest-only payments on the revolving line of credit through November 2, 2025, at which time all outstanding indebtedness shall be immediately due and payable. The outstanding principal amount of any advance shall accrue interest at a floating rate per annum equal to the greater of (i) three and one-half percent (3.50%) and (ii) the “prime rate” as published in The Wall Street Journal for the relevant period minus one-half percent (0.50%). Our obligations under the 2022 Revolver are secured by substantially all of our assets, excluding our intellectual property, which is subject to a negative pledge. The revolving line of credit under the 2022 Revolver terminates on November 2, 2025. As of November 2, 2022, no amounts were outstanding under the 2022 Revolver.

The 2022 Revolver also contains certain financial covenants, including a requirement that the amount of unrestricted and unencumbered cash minus advances under the 2022 Revolver, is not less than the amount equal to the greater of (i) $10.0 million or (ii) nine (9) months of cash burn. The 2022 Revolver contains customary representations and warranties, as well as certain non-financial covenants, including limitations on, among other things, our ability to change the principal nature of our business, dispose of our business or property, engage in any change of control transaction, merge or consolidate with any other entity or to acquire all or substantially all the capital stock or property of another entity, incur additional indebtedness or liens, pay dividends or make other distributions on capital stock, redeem our capital stock, engage in transactions with affiliates or otherwise encumber our intellectual property, in each case, subject to customary exceptions.

We may seek additional funding through private or public equity financings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. We cannot assure you that we will be able to obtain additional funds on acceptable terms, or at all. If we raise additional funds by issuing equity or equity-linked securities, our stockholders may experience dilution. Future debt financing, if available, may involve covenants, in addition to our existing covenants, restricting our operations or our ability to incur additional debt or potentially limiting our ability to obtain new debt financing or the refinance of our existing debt.

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Any debt or equity financing that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish some rights to our technologies or our products, or grant licenses on terms that are not favorable to us. If we do not have or are not able to obtain sufficient funds, we may have to delay development or commercialization of our products. We also may have to reduce marketing, customer support or other resources devoted to our products or cease operations.

Cash Flows

The following table summarizes our sources and uses of cash for each of the periods presented:

Nine Months Ended September 30, 

    

2022

    

2021

(in thousands)

Cash used in operating activities

$

(15,814)

$

(19,862)

Cash used in investing activities

 

(15,195)

 

(683)

Cash provided by financing activities

 

768

 

193

Net decrease in cash, cash equivalents and restricted cash

$

(30,241)

$

(20,352)

Operating Activities

During the nine months ended September 30, 2022, net cash used in operating activities was $15.8 million, primarily resulting from our net loss of $23.8 million, partially offset by net cash provided by changes in our operating assets and liabilities of $1.7 million and noncash charges of $6.3 million. Net cash provided by changes in our operating assets and liabilities for the nine months ended September 30, 2022 consisted primarily of a $2.5 million increase from changes in deferred revenue and a $2.2 million increase from changes in prepaid expenses and other current assets, $1.3 million increase from changes in account receivable, partially offset by a $4.1 million decrease from changes in inventory.

During the nine months ended September 30, 2021, net cash used in operating activities was $19.9 million, primarily resulting from our net loss of $18.7 million and net cash used by changes in our operating assets and liabilities of $5.4 million, partially offset by noncash charges of $4.2 million. Net cash used by changes in our operating assets and liabilities for the nine months ended September 30, 2021 consisted primarily of a $4.4 million decrease from changes in inventory, a $3.2 million decrease from changes in accounts receivable and a $2.7 million decrease from changes in prepaid expenses and other current and non-current assets, partially offset by a $3.6 million increase from changes in deferred revenue and a $1.4 million increase from changes in account payable and accrued expenses.

Investing Activities

During the nine months ended September 30, 2022, net cash used in investing activities was $15.2 million, due to $13.8 million increase from the acquisition of Trace occurred in August, 2022 and purchases of other property and equipment.

During the nine months ended September 30, 2021, net cash used in investing activities was $0.7 million, due to purchases of property and equipment.

Financing Activities

Cash provided by financing activities during the nine months ended September 30, 2022, was $0.8 million, consisting primarily of proceeds from issuance of common stock upon option exercises. We also paid off and drew down $45.0 million under the 2021 Revolver resulting in no net proceeds by September 30, 2022.

Cash provided by financing activities during the nine months ended September 30, 2021, was $0.2 million, consisting primarily of payments of offering costs related to our IPO, partially offset by proceeds from issuance of common stock upon option exercise. We also received net proceeds from borrowings under the 2021 Revolver of $15.0 million. We used proceeds of $14.5 million from the revolving line of credit to repay our previously outstanding borrowings under our loan and security agreement. Prior to repayment of our loan and security agreement, we had made principal payments of $0.5 million.

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Critical Accounting Policies and Significant Judgments and Estimates

Our condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

We believe the following new critical accounting policies and estimates to be both those most important to the portrayal of our financial position and results of operations and those that require the most estimation and subjective judgment:

 

Goodwill

Goodwill is not amortized, but is evaluated for impairment on an annual basis, or on an interim basis when events or changes in circumstances indicate that the carrying value may not be recoverable. In assessing the recoverability of goodwill, we must make assumptions regarding the estimated future cash flows, and other factors, to determine the fair value of these assets. If these estimates or their related assumptions change in the future, we may be required to record impairment charges against these assets in the reporting period in which the impairment is determined.

We test goodwill for impairment at the reporting unit level, which is the operating segment. We have the option of performing a qualitative assessment to determine whether further impairment testing is necessary before performing the quantitative assessment. If as a result of the quantitative assessment, it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount, a quantitative impairment test will be required. The quantitative goodwill impairment test requires the management to estimate and compare the fair value of the reporting unit with its carrying value. If the fair value of the reporting unit exceeds the carrying value of the net assets, goodwill is not impaired. If the fair value of the reporting unit is less than the carrying value, the difference is recorded as an impairment loss up to the amount of goodwill.

We review other long-lived assets for impairment whenever events or changes in circumstances indicate the carrying amount of an asset or an asset group may not be recoverable. In evaluating long-lived assets for recoverability, we estimate the future cash flows that are expected from the use of each assets. Impairment losses are measured and recorded for the excess of an asset's carrying value over its fair value. To determine the fair value of long-lived assets, we utilize the valuation technique or techniques deemed most appropriate based on the nature of the asset or asset group, which may include the use of quoted market prices, prices for similar assets or other valuation techniques such as discounted future cash flows or earnings.

Business combination

Under the acquisition method of accounting, we generally recognize the tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values on the date of acquisition. The fair values assigned, defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between willing market participants, are based on estimates and assumptions determined by management. The excess consideration over the aggregate value of tangible and intangible assets, net of liabilities assumed, is recorded as goodwill. These valuations require significant estimates and assumptions, especially with respect to intangible assets.

We estimate the fair value of the contingent consideration earnouts using the Monte Carlo Simulation or probability weighted scenario depending on the nature of the contingent consideration and updates the fair value of the contingent consideration at each reporting period based on the estimated probability of achieving the earnout targets and applying a discount rate that captures the risk associated with the expected contingent payments. To the extent that these estimates change in the future regarding the likelihood of achieving these targets, we may need to record material adjustments to our accrued contingent consideration. Such changes in the fair value of contingent consideration are recorded as contingent consideration expense or income in the consolidated statements of operations.

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We use the income approach to determine the fair value of certain identifiable intangible assets including customer relationships and developed technology. This approach determines fair value by estimating after-tax cash flows attributable to these assets over their respective useful lives and then discounting these after-tax cash flows back to a present value. We base our assumptions on estimates of future cash flows, expected growth rates, expected trends in technology, probabilities of customer renewals, etc. We base the discount rates used to arrive at a present value as of the date of acquisition on the time value of money and certain industry-specific risk factors. We believe the estimated purchased customer relationships, developed technology, software and trade name amounts determined represent the fair value at the date of acquisition and do not exceed the amount a third-party would pay for the assets.

If the actual results differ from the estimates and judgments used in these estimates, the amounts recorded in the financial statements may be exposed to potential impairment of the intangible assets and goodwill. The determination of fair value is considered a critical accounting estimate because the valuation techniques mentioned use significant estimates and assumptions, including projected future revenues, a hypothetical royalty rate, the expected economic life of the asset, tax rates and a discount rate that reflects the level of risk associated with the future earnings attributable to the asset.

During the measurement period, which is up to one year from the acquisition date, adjustments to the assets acquired and liabilities assumed may be recorded, with the corresponding offset to goodwill.

For a further discussion of our critical accounting policies, please refer to Note 2 to our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2021. There were no significant changes to our critical accounting policies for the nine months ended September 30, 2022, except as discussed above.

Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q and is incorporated herein by reference.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

We are a smaller reporting company, as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, for this reporting period and are not required to provide the information required under this item.

Item 4. Controls and Procedures.

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a- 15(e) and 15d- 15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of the end of the period covered by this Quarterly Report on Form 10-Q. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a 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 Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a 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. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q, our principal executive officer and principal financial officer have concluded that as of such date, our disclosure controls and procedures were effective at a reasonable assurance level.

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Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during our most recently completed fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting, except for as described below.

During this quarterly period, we completed our first acquisition and accounted for the acquisition as a purchase of a business under U.S. GAAP. Under the acquisition method of accounting, the acquired assets have been recorded as of the acquisition date, at their respective fair values, and consolidated with our assets. We implemented new and enhanced controls to verify the appropriateness of authorities given during the acquisition process and to capture the complete and accurate purchase accounting considerations are given to contingent consideration and other assets acquired and liabilities assumed. We also implemented new controls to value appropriate goodwill and intangible assets that arose from the acquisition and is enhancing controls for accurate and complete subsequent measurements of such assets, including periodic fair value measurements and impairment assessments.

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PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

We are not currently party to any material legal proceedings.

Item 1A. Risk Factors.

Our operations and financial results are subject to various risks and uncertainties. A detailed discussion of the risks that affect our business is included in the section titled “Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on March 11, 2022, or 2021 Annual Report. There are no material changes to our risk factors discussed in our 2021 Annual Report, except as set forth below.

Our loan and security agreement contains covenants, which restrict our operating activities, and we may be required to repay the outstanding indebtedness in an event of default, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

On November 2, 2022, we entered into a Loan and Security Agreement, or the 2022 Revolver, with Silicon Valley Bank, or the Lender. This agreement created a revolving line of credit totaling $35.0 million and replaced the prior $25.0 million revolving line of credit. The 2022 Revolver subjects us to various customary covenants, including requirements as to financial reporting and financial covenants (including a requirement that the amount of unrestricted and unencumbered cash minus advances under the 2022 Revolver, is not less than the amount equal to the greater of (i) $10.0 million or (ii) nine (9) months of cash burn), and restrictions on our ability to change the principal nature of our business, dispose of our business or property, engage in any change of control transaction, merge or consolidate with any other entity or to acquire all or substantially all the capital stock or property of another entity, incur additional indebtedness or liens, pay dividends or make other distributions on capital stock, redeem our capital stock, engage in transactions with affiliates or otherwise encumber our intellectual property, in each case, subject to customary exceptions.

We are permitted to make interest-only payments on the revolving line of credit through November 2, 2025, at which time all outstanding indebtedness shall be immediately due and payable. However, we may be required to repay the outstanding indebtedness under the revolving line of credit if an event of default occurs under the 2022 Revolver. An event of default will occur if, among other things, we fail to make required payments under the 2022 Revolver; we breach any of our covenants under the 2022 Revolver, subject to specified cure periods with respect to certain breaches; the Lender determines that a material adverse change (as defined in the 2022 Revolver) has occurred; we or our assets become subject to certain legal proceedings, such as bankruptcy proceedings; we are unable to pay our debts as they become due; or we default on contracts with third parties which would permit the third party to accelerate the maturity of such indebtedness above certain thresholds or that could have a material adverse effect on our business or operations. We may not have enough available cash or be able to raise additional funds through equity or debt financings to repay such indebtedness at the time any such event of default occurs. In such a case, we may be required to delay, limit, reduce or terminate our product development or operations or grant to others rights to develop and market products that we would otherwise prefer to develop and market ourselves. The Lender could also exercise its rights as secured lender to take possession of and to dispose of the collateral securing the revolving line of credit, which collateral includes substantially all of our property (excluding intellectual property, which is subject to a negative pledge). Our business, financial condition, results of operations, and prospects could be materially adversely affected as a result of any of these events.

Raising additional capital may cause dilution to our existing stockholders or restrict our operations.

We may in the future seek additional capital through a combination of public and private equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements in the future to fund our operations. We, and indirectly, our stockholders, will bear the cost of issuing and servicing such securities. Because our decision to issue debt or equity securities in any future offering will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing, or nature of any future offerings. Our decision to issue debt or equity securities will also depend on contractual, legal, and other restrictions that may limit our ability to raise additional capital. For example, the terms of our 2022 Revolver prohibit, subject to certain exceptions, our ability to incur additional indebtedness. To the extent that we raise additional capital through the sale of equity or debt securities, your ownership interest will be diluted and the terms may include liquidation or other preferences that adversely

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affect your rights as a stockholder. The incurrence of indebtedness would result in increased fixed payment obligations and could involve restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights, and other operating restrictions that could adversely impact our ability to conduct our business. Certain of the foregoing transactions may require us to obtain stockholder approval, which we may not be able to obtain.

We may engage in future acquisitions that could disrupt our business, cause dilution to our stockholders and harm our financial condition and operating results.

On August 3, 2022, we entered into a share purchase and transfer agreement and completed its acquisition of 100% of the registered share capital of TRACE Analytics GmbH, a German limited liability company located in Braunschweig, Germany (Trace), for total potential purchase price consideration of $17.3 million, comprised of (i) a $14.4 million initial cash payment plus (ii) up to $2.0 million contingent cash consideration upon achievement of certain milestones over a twenty four month period and (iii) $0.9 million contingent pension liability holdback to be released upon discharging or transferring of such liability from Trace.

In the future, we may acquire additional companies, assets or technologies in an effort to complement our existing offerings or enhance our market position. We currently have no plans, proposals or arrangements with respect to any acquisition. We may not be able to find additional suitable acquisition candidates and we may not be able to complete additional acquisitions on favorable terms, if at all. The Trace acquisition, and any future acquisitions we make could subject us to a number of risks, including:

the purchase price we pay could significantly deplete our cash reserves, impair our future operating flexibility or result in dilution to our existing stockholders;
we may find that the acquired company, assets or technology does not further improve our financial and strategic position as planned;
we may find that we overpaid for the company, asset or technology, or that the economic conditions underlying our acquisition have changed;
we may have difficulty integrating the operations and personnel of the acquired company;
we may have difficulty retaining the employees with the technical skills needed to enhance and provide services with respect to the acquired assets or technologies;
the acquisition may be viewed negatively by customers, financial markets, or investors;
we may have difficulty incorporating the acquired technologies or products with our existing products;
we may encounter difficulty entering and competing in new product or geographic markets;
we may encounter a competitive response, including price competition or intellectual property litigation;
we may have product liability, customer liability or intellectual property liability associated with the sale of the acquired company’s products;
we may be subject to litigation by terminated employees or third parties;
we may incur debt and restructuring charges;
we may acquire goodwill and other intangible assets that are subject to impairment tests, which could result in future impairment charges;
our ongoing business and management’s attention may be disrupted or diverted by transition or integration issues and the complexity of managing geographically or culturally diverse enterprises; and
our due diligence process may fail to identify significant existing issues with the target company’s product quality, product architecture, financial disclosures, accounting practices, internal controls, legal contingencies, intellectual property and other matters.

Any acquisitions of businesses, technologies, products or services may not generate sufficient revenue to offset the associated costs of the acquisitions or may result in other adverse effects, which could have a material adverse effect on our business, operating results, and financial condition.

In addition, negotiations for acquisitions or investments that are not ultimately consummated could result in significant diversion of management time, as well as substantial out-of-pocket costs, any of which could have a material adverse effect on our business, operating results and financial condition.

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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

Unregistered Sales of Equity Securities

None.

Use of Proceeds

On December 22, 2020, we completed the IPO of our common stock pursuant to which we issued and sold 7,475,000 shares of our common stock, inclusive of 975,000 shares we sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $20.00 per share.

The offer and sale of all of the shares of our common stock in our IPO were registered under the Securities Act pursuant to a registration statement on Form S-1, as amended (File No. 333-250954), which was declared effective by the SEC on December 17, 2020, and a registration statement on Form S-1MEF (File No. 333-251441), which was automatically effective upon filing with the SEC on December 17, 2020. Following the sale of all of the shares offered in connection with the closing of our IPO, the offering terminated. Cowen and Company, LLC and SVB Leerink LLC acted as lead book-running managers, and William Blair & Company, L.L.C. and Stifel, Nicolaus & Company, Incorporated acted as book-running managers for the IPO.

We received aggregate gross proceeds from our IPO of $149.5 million, or aggregate net proceeds of $136.6 million after deducting underwriting discounts and commissions and other offering expenses. None of the underwriting discounts and commissions or offering expenses were incurred or paid, directly or indirectly, to directors or officers of ours or their associates or to persons owning 10% or more of our common stock or to any of our affiliates. Cash used since the IPO is described elsewhere in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of our periodic reports filed with the SEC. There has been no material change in the planned use of IPO proceeds from that described in the final prospectus for the IPO filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended, on December 18, 2020.

Issuer Purchases of Equity Securities

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

None.

Item 5. Other Information.

None.

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Item 6. Exhibits.

 

Exhibit

Number

    

Description 

10.1

Loan and Security Agreement between the Registrant and Silicon Valley Bank, dated November 2, 2022 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-039815) filed with the SEC on November 8, 2022)

31.1

Certification of Chief Executive Officer of the Registrant Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2

Certification of Chief Financial Officer of the Registrant Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1†

Certification of Chief Executive Officer of the Registrant Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2†

Certification of Chief Financial Officer of the Registrant Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101.INS

Inline XBRL Instance Document

101.SCH

Inline XBRL Taxonomy Extension Schema Document

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.LAB

Inline XBRL Taxonomy Extension Labels Linkbase Document

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

104

Cover Page Data File (the cover page XBRL tags are embedded within the iXBRL document).

+

Portions of this exhibit (indicated by asterisks) were omitted in accordance with the rules of the Securities and Exchange Commission.

The certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q, are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of 908 Devices Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.

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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.

908 DEVICES INC.

Date: November 14, 2022

By:

/s/ Kevin J. Knopp, Ph.D. 

 

Kevin J. Knopp, Ph.D.

Chief Executive Officer

(Principal Executive Officer)

Date: November 14, 2022

By:

/s/ Joseph H. Griffith IV 

 

Joseph H. Griffith IV

Chief Financial Officer

(Principal Financial Officer)

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