908 Devices 10Q 2022 Q2 Quarterly report

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 June 30, 2022

☐	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

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 August 4, 2022, the registrant had 31,590,177 shares of common stock, $0.001 par value per share, issued and outstanding.

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908 DEVICES INC.

Table of Contents


		Page
PART I.	FINANCIAL INFORMATION	4
Item 1.	Condensed Consolidated Financial Statements (Unaudited)	4
	Condensed Consolidated Balance Sheets	4
	Condensed Consolidated Statements of Operations and Comprehensive Loss	5
	Condensed Consolidated Statements of Stockholders’ Equity	6
	Condensed Consolidated Statements of Cash Flows	7
	Notes to Unaudited Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	20
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	35
Item 4.	Controls and Procedures	35
PART II.	OTHER INFORMATION	36
Item 1.	Legal Proceedings	36
Item 1A.	Risk Factors	36
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	36
Item 3.	Defaults Upon Senior Securities	36
Item 4.	Mine Safety Disclosures	36
Item 5.	Other Information	37
Item 6.	Exhibits	38
Signatures		39

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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 and 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)


	June 30,		December 31,
	2022		2021
Assets
Current assets:
Cash and cash equivalents	$	212,994	$	224,073
Accounts receivable, net of allowance for doubtful accounts of $1,750		11,098		16,375
Inventory		11,178		7,918
Prepaid expenses and other current assets		3,408		4,527
Total current assets		238,678		252,893
Operating lease, right-of-use assets		4,583		5,182
Property and equipment, net		2,419		1,603
Other long-term assets		1,315		1,228
Total assets	$	246,995	$	260,906
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	1,234	$	1,371
Accrued expenses		5,957		6,961
Deferred revenue		6,841		5,160
Operating lease liabilities		1,402		1,344
Total current liabilities		15,434		14,836
Long-term debt		15,000		15,000
Operating lease liabilities, net of current portion		3,797		4,508
Deferred revenue, net of current portion		11,649		11,958
Total liabilities		45,880		46,302
Commitments and contingencies (Note 9)
Stockholders' equity:
Preferred stock, $0.001 par value; 5,000,000 shares authorized, 0 shares issued or outstanding at June 30, 2022 and December 31, 2021, respectively		—		—
Common stock, $0.001 par value; 100,000,000 shares authorized; 31,531,115 shares and 31,077,004 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively		32		31
Additional paid-in capital		319,234		315,210
Accumulated deficit		(118,151)		(100,637)
Total stockholders' equity		201,115		214,604
Total liabilities and stockholders' equity	$	246,995	$	260,906

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 OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(In thousands, except share and per share amounts)


	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Revenue:
Product and service revenue	$	10,608	$	7,915	$	18,637	$	13,272
License and contract revenue		498		362		775		548
Total revenue		11,106		8,277		19,412		13,820
Cost of revenue:
Product and service cost of revenue		4,361		3,846		8,402		6,406
License and contract cost of revenue		111		52		247		127
Total cost of revenue		4,472		3,898		8,649		6,533
Gross profit		6,634		4,379		10,763		7,287
Operating expenses:
Research and development		4,293		3,055		8,198		6,020
Selling, general and administrative		10,710		8,779		20,455		14,532
Total operating expenses		15,003		11,834		28,653		20,552
Loss from operations		(8,369)		(7,455)		(17,890)		(13,265)
Other income (expense):
Interest expense		(15)		(39)		(35)		(415)
Other income, net		285		70		411		161
Total other income (expense), net		270		31		376		(254)
Net loss and comprehensive loss	$	(8,099)	$	(7,424)	$	(17,514)	$	(13,519)
Net loss per share
Basic and diluted	$	(0.26)	$	(0.27)	$	(0.56)	$	(0.49)
Weighted average common shares outstanding
Basic and diluted		31,413,431		27,335,637		31,312,559		27,313,125

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 STOCKHOLDERS’ EQUITY

(Unaudited)

(in thousands, except share amounts)


				Additional				Total
	Common Stock			Paid-in		Accumulated		Stockholders'
	Shares	Amount		Capital		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 of stock options	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


				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

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)


	Six Months Ended June 30,
	2022		2021
Cash flows from operating activities:
Net loss	$	(17,514)	$	(13,519)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense		578		375
Stock-based compensation expense		3,183		820
Noncash interest expense and loss on extinguishment of debt		6		171
Provision for inventory obsolescence		39		48
Provision for doubtful accounts		—		1,725
Changes in operating assets and liabilities:
Accounts receivable, net		5,277		(224)
Inventory		(3,857)		(3,943)
Prepaid expenses and other current assets		1,119		(2,188)
Other long-term assets		18		(1,177)
Accounts payable and accrued expenses		(1,043)		482
Deferred revenue		1,372		519
Right-of-use operating lease assets		599		551
Operating lease liabilities		(653)		(578)
Net cash used in operating activities		(10,876)		(16,938)
Cash flows from investing activities:
Purchases of property and equipment		(689)		(625)
Net cash used in investing activities		(689)		(625)
Cash flows from financing activities:
Payments for withholding taxes on vested awards		(133)		—
Proceeds from issuance of common stock upon option exercise		842		325
Payments of public offering costs		(112)		(576)
Proceeds from borrowings on revolving line of credit		30,000		15,000
Repayment of notes payable		(30,000)		(15,000)
Payments of debt issuance costs		—		(39)
Net cash provided by (used in) financing activities		597		(290)
Net decrease in cash, cash equivalents and restricted cash		(10,968)		(17,853)
Cash, cash equivalents and restricted cash at beginning of period		224,133		159,227
Cash, cash equivalents and restricted cash at end of period	$	213,165	$	141,374
Supplemental disclosure of noncash investing and financing information:
Property and equipment included in Account payable	$	147	$	—
Transfers of inventory to property and equipment	$	558	$	510
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents	$	212,994	$	141,314
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	$	213,165	$	141,374

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 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 will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world. The Company cannot at this time predict the specific extent, duration, or full impact that the COVID-19 pandemic will have on its future financial condition and operations. The impact of the COVID-19 coronavirus outbreak on the Company’s financial performance will depend on future developments, including the duration and spread of the pandemic and related governmental advisories and restrictions. These developments and the impact of COVID-19 on the financial markets and the overall economy are highly uncertain and cannot be predicted. If the financial markets and/or the overall economy are impacted for an extended period, the Company’s results may be materially adversely affected.

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.

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, or the November 2021 Offering. The Company received net proceeds of $94.4 million after deducting underwriting discounts and commissions and other offering costs.

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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 subsidiary, 908 Devices Securities Corporation. 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 $17.5 million for the six months ended June 30, 2022 and $22.2 million for the year ended December 31, 2021. As of June 30, 2022, the Company had an accumulated deficit of $118.2 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 June 30, 2022 and for the three and six months ended June 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 June 30, 2022 and results of operations for the three and six months ended June 30, 2022 and 2021 and cash flows for the six months ended June 30, 2022 and 2021 have been made. The Company’s results of operations for the three and six months ended June 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 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, 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 June 30, 2022 and 2021, 1 customer represented 17% and 14% of total revenue, respectively. For the six months ended June 30, 2022 and 2021, 1 customer represented 19% and 16% of total revenue, respectively. As of June 30, 2022, 1 customer accounted for 13% of gross accounts receivable. As of December 31, 2021, 2 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 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 June 30, 2022, the gross accounts receivable balance from these countries amounted to $3.2 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 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

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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 cash equivalents are carried at fair value, determined according to the fair value hierarchy described above (see Note 3). The carrying values of the Company’s accounts receivable, unbilled receivables, 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.

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

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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 0 contract assets related to product or service revenue as of June 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.

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


	Six Months Ended June 30,
	2022		2021
Balances at beginning of period	$	14,521	$	8,938
Recognition of revenue included in balance at beginning of the period		(2,494)		(1,211)
Revenue deferred during the period, net of revenue recognized		3,863		1,984
Balances at end of period	$	15,890	$	9,711

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):


	June 30,
	2022		2021
Deferred revenue expected to be recognized in:
One year or less	$	6,753	$	3,965
One to two years		4,204		2,001
Three years and beyond		4,933		3,745
	$	15,890	$	9,711

As of June 30, 2022, the Company’s wholly- or partially-unsatisfied performance obligations totaled $3.9 million related to product and service agreements entered prior to period end, which the Company expects to recognize through 2024.

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

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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.

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 $0.3 million and $0.2 million, respectively, as of June 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. Contract liabilities arising from contract and license agreements typically represent payments received for the license of symbolic intellectual property for a defined term. As of June 30, 2022, the Company had contract liabilities totaling $2.6 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 six months ended June 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 June 30, 2022, the Company’s wholly- or partially-unsatisfied performance obligations totaled $1.0 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.

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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 June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Product and service revenue:
Device sales revenue	$	7,755	$	6,181	$	13,287	$	10,092
Consumables and service revenue		2,853		1,734		5,350		3,180
Total product and service revenue		10,608		7,915		18,637		13,272
License and contract revenue		498		362		775		548
Total revenue	$	11,106	$	8,277	$	19,412	$	13,820

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


	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Handheld	$	6,938	$	5,278	$	11,408	$	8,518
Desktop		3,670		2,637		7,229		4,754
Total product and service revenue	$	10,608	$	7,915	$	18,637	$	13,272

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


	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Government	$	7,002	$	5,279	$	11,719	$	8,513
Pharmaceutical/Biotechnology		3,577		2,609		6,705		4,709
Academia		29		27		213		50
Total product and service revenue	$	10,608	$	7,915	$	18,637	$	13,272

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 June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Americas	$	9,470	$	5,815	$	15,538	$	10,489
Europe, Middle East and Africa		1,245		1,725		2,601		2,171
Asia Pacific		391		737		1,273		1,160
	$	11,106	$	8,277	$	19,412	$	13,820

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

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.

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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 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 June 30, 2022 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	347	$	—	$	—	$	347


	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 were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. There were 0 transfers into or out of Level 3 during the six months ended June 30, 2022 or 2021.

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4. Inventory

Inventory consisted of the following (in thousands):


	June 30,		December 31,
	2022		2021
Raw materials	$	7,621	$	6,242
Work-in-progress		2,666		551
Finished goods		891		1,125
	$	11,178	$	7,918

5. Accrued Expenses

Accrued expenses consisted of the following (in thousands):


	June 30,		December 31,
	2022		2021
Accrued employee compensation and benefits	$	2,793	$	3,271
Accrued warranty		1,283		1,593
Accrued professional fees		905		710
Accrued other		976		1,387
	$	5,957	$	6,961

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


	Six Months Ended June 30,
	2022		2021
Accrual balance at beginning of period	$	1,593	$	1,265
Provision for new warranties		1,166		500
Settlements and adjustments made during the period		(1,476)		(775)
Accrual balance at end of period	$	1,283	$	990

6. Long-Term Debt

As of December 31, 2020, the Company had outstanding borrowings under a Loan and Security Agreement, as amended (the “2019 Loan”) with a financial institution (the “Lender”). On March 11, 2021, the Company entered into an Amended and Restated Loan and Security Agreement, (the “2021 Revolver”), with the Lender 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 June 30, 2022, the Company was in compliance with all financial covenants under the 2021 Revolver.

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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 June 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.

7. Equity and Net Income (Loss) per Share

Equity

As of June 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 1 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 June 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 six months ended June 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 six months ended June 30, 2022 and 2021 as the impact of including such common stock equivalents would have been anti-dilutive:


	June 30,
	2022	2021
Warrants to purchase common stock	92,703	92,703
Options to purchase common stock	2,764,916	3,233,949
Restricted stock units	254,482	—
	3,112,101	3,326,652

8. 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 and comprehensive loss (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Cost of revenue	$	86	$	14	$	149	$	17
Research and development expenses		421		85		681		145
Selling, general and administrative expenses		1,387		382		2,353		658
	$	1,894	$	481	$	3,183	$	820

As of June 30, 2022, unrecognized compensation expense was $18.5 million, related to unvested restricted stock units and stock options, which is expected to be recognized over a weighted average period of 2.99 years.

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9. Commitments and Contingencies

Operating Leases

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

There have been no material changes to the Company’s leases during the six months ended June 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.

On July 17, 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.

Royalty Arrangements

The Company has entered into royalty arrangements with 2 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 each employee contributes to the plan, capped at a maximum of $3,500 per year per employee. During the six months ended June 30, 2022, the Company made $0.3 million in contributions to the plan.

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 June 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

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authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings.

10. Subsequent events

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 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 $15.3 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.

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. With the acquisition of Trace, the Company has acquired enabling sampling technology that it expects to integrate within future product offerings.

The Company has not determined its initial accounting for the acquisition. As of August 9, 2022, the preliminary purchase price allocation related to the acquisition of Trace is incomplete. The Company has retained an independent valuation firm to assess the fair value of the identified intangible assets and certain tangible assets acquired and liabilities assumed. During the three and six months ended June 30, 2022, the Company incurred approximately $0.2 million in costs associated with the acquisition of Trace, which are recorded as selling, general, and administrative expenses within the consolidated statements of operations.

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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.

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 $19.4 million and $13.8 million for the six months ended June 30, 2022 and 2021, respectively, and incurred net losses of $17.5 million and $13.5 million for those same periods. As of June 30, 2022, we had an accumulated deficit of $118.2 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 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.

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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.”

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 impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world.

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. In 2022, we are continuing to see these impacts, which also include lockdowns in China related to the COVID-19 pandemic.

We do not yet know the net impact that the COVID-19 pandemic may have on our business and cannot guarantee that it will not be materially negative. For example, in 2021, 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. Currently, as a result of the work and travel restrictions related to the COVID-19 pandemic, and the precautionary measures that we have adopted, a significant portion of our field sales and professional services activities continue to be conducted remotely, which has resulted in a decrease in our travel expenditures. However, we have recently permitted certain of our employees to travel to our customers and industry conferences where permitted by local authorities, and expect that our travel expenditures will also begin to increase. Any prolonged restrictive measures put in place in order to control the spread of COVID-19, including new variants, or other adverse 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.

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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 24% of total product and service revenue for the six months ended June 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 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.

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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 six months ended June 30, 2022 and 2021, our product placements (units recognized as revenue) by device type were as follows:


	Three Months Ended June 30,		Six Months Ended June 30,
	2022	2021	2022	2021
Product Placements:
MX908	102	84	165	137
Rebel	14	12	29	21
ZipChip Interface	8	7	13	11
Total Product Placements	124	103	207	169

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:


	June 30,
	2022	2021
Cumulative Product Placements:
MX908	1,815	1,295
Rebel	129	67
ZipChip Interface	198	168
Cumulative Product Placements	2,142	1,530

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 76% of our product and service revenue for the six months ended June 30, 2022 and 2021, respectively. Consumables and service revenue accounted for 29% and 24% of our product and service revenue for the six months ended June 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 six months ended June 30, 2022 and one customer during the three and six months ended June 30, 2021.

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


	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Product and service revenue:
Device sales revenue	$	7,755	$	6,181	$	13,287	$	10,092
Consumables and service revenue		2,853		1,734		5,350		3,180
Total product and service revenue		10,608		7,915		18,637		13,272
License and contract revenue		498		362		775		548
Total revenue	$	11,106	$	8,277	$	19,412	$	13,820

Our product and service revenue is comprised of leverage 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 June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Government	$	7,002	$	5,279	$	11,719	$	8,513
Pharmaceutical/Biotechnology		3,577		2,609		6,705		4,709
Academia		29		27		213		50
Total product and service revenue	$	10,608	$	7,915	$	18,637	$	13,272

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 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 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 the Company’s 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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Results of Operations

Comparison of the Three Months Ended June 30, 2022 and 2021

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


	Three Months Ended June 30,
	2022		2021		Change

	(in thousands)
Revenue:
Product and service revenue	$	10,608	$	7,915	$	2,693
License and contract revenue		498		362		136
Total revenue		11,106		8,277		2,829
Cost of revenue:
Product and service cost of revenue		4,361		3,846		515
License and contract cost of revenue		111		52		59
Total cost of revenue		4,472		3,898		574
Gross profit		6,634		4,379		2,255
Operating expenses:
Research and development		4,293		3,055		1,238
Selling, general and administrative		10,710		8,779		1,931
Total operating expenses		15,003		11,834		3,169
Loss from operations		(8,369)		(7,455)		(914)
Other income (expense):
Interest expense		(15)		(39)		24
Other income, net		285		70		215
Total other income, net		270		31		239
Net loss	$	(8,099)	$	(7,424)	$	(675)

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 June 30,						Change
	2022			2021			Amount			%

	(dollars in thousands)
Product and service revenue	$	10,608		$	7,915		$	2,693		34	%
Product and service cost of revenue		4,361			3,846			515		13	%
Gross profit	$	6,247		$	4,069		$	2,178		54	%
Gross profit margin		59	%		51	%		8	%


	Three Months Ended June 30,				Change
	2022		2021		Amount		%

	(dollars in thousands)
Device sales revenue	$	7,755	$	6,181	$	1,574	25	%
Consumables and service revenue		2,853		1,734		1,119	65	%
Total product and service revenue	$	10,608	$	7,915	$	2,693	34	%

Product and service revenue increased by $2.7 million, or 34%, for the three months ended June 30, 2022, compared to the three months ended June 30, 2021. Device sales accounted for 73% and 78% of our product and service revenue for the three months

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ended June 30, 2022 and 2021, respectively. The increase in device sales of $1.6 million was primarily due to an increase of $1.1 million in device sales related to our handheld products primarily 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. The increase in device sales was also due to an increase of $0.5 million in desktop device sales, primarily related to a two 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 $1.1 million primarily due to a $0.8 million increase in service revenue.

Product and service cost of revenue increased by $0.5 million, or 13%, for the three months ended June 30, 2022, compared to the three months ended June 30, 2021. The increase in product and service cost of revenue was primarily related to $0.3 million in costs from higher product volume, a $0.2 million increase in salaries and related costs, and a $0.1 million increase in stock-based compensation offset in part by timing of the capitalization of labor and overhead from the build of devices within the quarter.

Product and service gross profit increased by $2.2 million, or 54%, and gross profit margin increased by eight percentage points for the three months ended June 30, 2022 as compared to the three months ended June 30, 2021, primarily due to $0.8 million in higher service revenue, favorable product mix for our MX908 and higher average selling prices for our Rebel devices, offset in part by the higher personnel and operating costs.

License and contract


	Three Months Ended June 30,						Change
	2022			2021			Amount			%

	(dollars in thousands)
License and contract revenue	$	498		$	362		$	136		38	%
License and contract cost of revenue		111			52			59		113	%
Gross profit	$	387		$	310		$	77		25	%
Gross profit margin		78	%		86	%		(8)	%

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

License and contract cost of revenue increased $0.1 million, or 113% for the three months ended June 30, 2022, compared to the three months ended June 30, 2021 due to the mix of contract deliverables across the Company’s current contracts. The mix of contract deliverables for the three months ended June 30, 2022 had higher material costs compared to the contract deliverables for the three months ended June 30, 2021.

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

Operating Expenses

Research and development


	Three Months Ended June 30,						Change
	2022			2021			Amount		%

	(dollars in thousands)
Research and development expenses	$	4,293		$	3,055		$	1,238	41	%
Percentage of total revenue		39	%		37	%

Our research and development expenses were $4.3 million for the three months ended June 30, 2022, an increase of $1.2 million from research and development expenses of $3.1 million for the three months ended June 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

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compensation and a $0.2 million increase in materials and supplies related to product development efforts.

Selling, general and administrative expenses


	Three Months Ended June 30,						Change
	2022			2021			Amount		%

	(dollars in thousands)
Selling, general and administrative expenses	$	10,710		$	8,779		$	1,931	22	%
Percentage of total revenue		96	%		106	%

Our selling, general and administrative expenses were $10.7 million for the three months ended June 30, 2022, an increase of $1.9 million from selling, general and administrative expenses of $8.8 million for the three months ended June 30, 2021. The increase was due primarily to a $1.8 million increase in salaries and related costs from growing headcount, a $1.0 million increase in stock-based compensation, a $0.4 million increase in travel expenses and a $0.4 million net increase in all other costs. These increases were partially offset by a $1.7 million decrease in allowance for bad debt recorded in the three months ended June 30, 2021.

Other Income (Expense)

Interest expense

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

Other income (expense), net

Other income, net was $0.3 million for the three months ended June 30, 2022, an increase of $0.2 million from other income, net of $0.1 million for the three months ended June 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 Six Months Ended June 30, 2022 and 2021

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


	Six Months Ended June 30,
	2022		2021		Change

	(in thousands)
Revenue:
Product and service revenue	$	18,637	$	13,272	$	5,365
License and contract revenue		775		548		227
Total revenue		19,412		13,820		5,592
Cost of revenue:
Product and service cost of revenue		8,402		6,406		1,996
License and contract cost of revenue		247		127		120
Total cost of revenue		8,649		6,533		2,116
Gross profit		10,763		7,287		3,476
Operating expenses:
Research and development		8,198		6,020		2,178
Selling, general and administrative		20,455		14,532		5,923
Total operating expenses		28,653		20,552		8,101
Loss from operations		(17,890)		(13,265)		(4,625)
Other income (expense):
Interest expense		(35)		(415)		380
Other income, net		411		161		250
Total other income (expense), net		376		(254)		630
Net loss	$	(17,514)	$	(13,519)	$	(3,995)

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:


	Six Months Ended June 30,						Change
	2022			2021			Amount			%

	(dollars in thousands)
Product and service revenue	$	18,637		$	13,272		$	5,365		40	%
Product and service cost of revenue		8,402			6,406			1,996		31	%
Gross profit	$	10,235		$	6,866		$	3,369		49	%
Gross profit margin		55	%		52	%		3	%


	Six Months Ended June 30,				Change
	2022		2021		Amount		%

	(dollars in thousands)
Device sales revenue	$	13,287	$	10,092	$	3,195	32	%
Consumables and service revenue		5,350		3,180		2,170	68	%
Total product and service revenue	$	18,637	$	13,272	$	5,365	40	%

Product and service revenue increased by $5.4 million, or 40%, for the six months ended June 30, 2022, compared to the six months ended June 30, 2021. Device sales accounted for 71% and 76% of our product and service revenue for the six months ended June 30, 2022 and 2021, respectively. Consumables and service revenue accounted for 29% and 24% of our product and service revenue for the six months ended June 30, 2022 and 2021, respectively. The increase in device sales of $3.2 million was primarily due to an increase of $1.7 million in handheld device sales for the three months ended June 30, 2022 compared to the three months ended June 30, 2021, attributable to a 28 unit increase in sales of our handheld products, was 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. The increase in device sales was also due to an increase of $1.5 million in desktop device sales, representing a ten unit increase, primarily related to Rebel

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device placements. Consumables and service revenue increased by $2.2 million primarily due to a $1.7 million increase in service revenue and a $0.4 million increase in desktop consumables sales.

Product and service cost of revenue increased by $2.0 million, or 31%, for the six months ended June 30, 2022, compared to the six months ended June 30, 2021. The increase in product and service cost of revenue was primarily related to $0.9 million in costs from higher product volume, a $0.8 million increase in salaries and related costs from growing headcount, and a $0.1 million increase in stock-based compensation.

Product and service gross profit increased by $3.4 million, or 49%, and gross profit margin increased by three percentage points for the six months ended June 30, 2022, as compared to the six months ended June 30, 2021, primarily due to $1.7 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


	Six Months Ended June 30,						Change
	2022			2021			Amount			%

	(dollars in thousands)
License and contract revenue	$	775		$	548		$	227		41	%
License and contract cost of revenue		247			127			120		94	%
Gross profit	$	528		$	421		$	107		25	%
Gross profit margin		68	%		77	%		(9)	%

License and contract revenue increased by $0.2 million, or 41%, for the six months ended June 30, 2022, compared to the six months ended June 30, 2021. The majority of license and contract revenue 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 six months ended June 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 $0.1 million, or 94% for the six months ended June 30, 2022, compared to the six months ended June 30, 2021 due to mix of contract deliverables across the current contracts. The mix of contract deliverables for the six months ended June 30, 2022 had higher material costs compared to the mix of contract deliverables for the prime contract held directly with the U.S. government that did not have any cost of revenue during the six months ended June 30, 2021.

License and contract gross profit increased by $0.1 million and gross profit margin decreased by nine percentage points for the six months ended June 30, 2022 as compared to the three months ended June 30, 2021, primarily due to the mix in contract deliverables, including a mix of materials with higher costs during the six months ended June 30, 2022 which resulted in a lower gross profit margin for that period, as compared to the six months ended June 30, 2021.

Operating Expenses

Research and development


	Six Months Ended June 30,						Change
	2022			2021			Amount		%

	(dollars in thousands)
Research and development expenses	$	8,198		$	6,020		$	2,178	36	%
Percentage of total revenue		42	%		44	%

Our research and development expenses were $8.2 million for the six months ended June 30, 2022, an increase of $2.2 million from research and development expenses of $6.0 million for the six months ended June 30, 2021. The increase was due primarily to a $1.5 million increase in salaries and related costs from growing headcount, a $0.5 million increase in stock-based compensation and a $0.2 million increase in materials and supplies related to product development efforts.

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Selling, general and administrative expenses


	Six Months Ended June 30,						Change
	2022			2021			Amount		%

	(dollars in thousands)
Selling, general and administrative expenses	$	20,455		$	14,532		$	5,923	41	%
Percentage of total revenue		105	%		105	%

Our selling, general and administrative expenses were $20.5 million for the six months ended June 30, 2022, an increase of $5.9 million from selling, general and administrative expenses of $14.5 million for the six months ended June 30, 2021. The increase was due primarily to a $3.7 million increase in salaries and related costs from growing headcount, a $1.7 million increase in stock-based compensation, a $0.6 million increase in travel expenses, a $0.5 million increase in marketing activities and a $1.1 million net increase in all other costs. These increases were partially offset by a $1.7 million decrease in allowance for bad debt recorded in the three months ended June 30, 2021.

Other Income (Expense)

Interest expense

Interest expense decreased by $0.4 million for the six months ended June 30, 2022, from $0.4 million for the three months ended June 30, 2021. The decrease was primarily due to lower average outstanding borrowings during the three months ended June 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 $0.3 million for the six months ended June 30, 2022, from $0.2 million for the six months ended June 30, 2021. The increase was primarily due to a $0.2 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 June 30, 2022, we had cash and cash equivalents of $213.0 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, or the Lender, 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.

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. 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:


	Six Months Ended June 30,
	2022		2021

	(in thousands)
Cash used in operating activities	$	(10,876)	$	(16,938)
Cash used in investing activities		(689)		(625)
Cash provided by (used in) financing activities		597		(290)
Net decrease in cash, cash equivalents and restricted cash	$	(10,968)	$	(17,853)

Operating Activities

During the six months ended June 30, 2022, net cash used in operating activities was $10.9 million, primarily resulting from our net loss of $17.5 million, partially offset by net cash provided by changes in our operating assets and liabilities of $2.8 million and noncash charges of $3.8 million. Net cash provided by changes in our operating assets and liabilities for the six months ended June 30,

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2022 consisted primarily of a $5.3 million increase from changes in accounts receivable and a $1.4 million increase from changes in deferred revenue, partially offset by a $3.9 million decrease from changes in inventory and a $1.0 million decrease from changes in accounts payable and accrued expenses.

During the six months ended June 30, 2021, net cash used in operating activities was $16.9 million, primarily resulting from our net loss of $13.5 million and net cash used by changes in our operating assets and liabilities of $6.6 million, partially offset by noncash charges of $3.1 million. Net cash used by changes in our operating assets and liabilities for the six months ended June 30, 2021 consisted primarily of a $3.9 million increase from changes in inventory, a $3.3 million increase from changes in prepaid expenses and other current and non-current assets, and a $0.2 million increase from changes in accounts receivable, partially offset by a $0.5 million increase from changes in deferred revenue, a $0.5 million increase from changes in accounts payable and a $0.5 million increase from changes in accrued expenses.

Investing Activities

During the six months ended June 30, 2022, net cash used in investing activities was $0.7 million, due to purchases of property and equipment.

During the six months ended June 30, 2021, net cash used in investing activities was $0.6 million, due to purchases of property and equipment.

Financing Activities

Cash provided by financing activities during the six months ended June 30, 2022, was $0.6 million, consisting primarily of proceeds from issuance of common stock upon option exercises. We also paid off and drew down $30.0 million under the 2021 Revolver resulting in no net proceeds by June 30, 2022.

Cash used in financing activities during the six months ended June 30, 2021, was $0.3 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 2021 Revolver to repay our previously outstanding borrowings under the 2019 Loan. Prior to repayment of our loan and security agreement, we had made principal payments of $0.5 million on the 2019 Loan.

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.

There have been no material changes to our critical accounting policies and estimates from those disclosed in Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, of our 2021 Form 10-K, as well as our consolidated financial statements.

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.

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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.

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.

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PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

The Company is 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.

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.

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Item 5. Other Information.

None.

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Item 6. Exhibits.


Exhibit Number		Description

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: August 9, 2022	By:	/s/ Kevin J. Knopp, Ph.D.
		Kevin J. Knopp, Ph.D. Chief Executive Officer (Principal Executive Officer)

Date: August 9, 2022	By:	/s/ Joseph H. Griffith IV
		Joseph H. Griffith IV Chief Financial Officer (Principal Financial Officer)

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908 Devices (MASS) 10-Q2022 Q2 Quarterly report

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