UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number:
(Exact name of registrant as specified in its charter)
(State or other jurisdiction | (IRS Employer |
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class |
| Trading Symbol | Name of Each Exchange on which Registered |
---|---|---|---|
The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the 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 | ☐ |
☒ | 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
As of May 11, 2023,
INDEX
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PART I – FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
RESHAPE LIFESCIENCES INC.
Condensed Consolidated Balance Sheets
(unaudited)
(dollars in thousands, except per share amounts)
March 31, | December 31, | |||||
| 2023 |
| 2022 | |||
ASSETS | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | |
| $ | | |
Restricted cash | | | ||||
Accounts and other receivables (net of allowance for doubtful accounts of $ |
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Inventory |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use assets | | | ||||
Deferred tax asset, net | | | ||||
Other intangible assets, net | | | ||||
Other assets |
| |
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| | |
Total assets | $ | |
| $ | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
Current liabilities: | ||||||
Accounts payable | $ | |
| $ | | |
Accrued and other liabilities |
| |
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| | |
Warranty liability, current | | | ||||
Operating lease liabilities, current | | | ||||
Total current liabilities |
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Common stock warrant liability | | — | ||||
Total liabilities | |
| | |||
Commitments and contingencies (Note 13) | ||||||
Stockholders’ equity: | ||||||
Preferred stock, | ||||||
Series C convertible preferred stock, $ | ||||||
Common stock, $ |
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| | |
Additional paid-in capital |
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Accumulated deficit |
| ( |
|
| ( | |
Accumulated other comprehensive loss | ( | ( | ||||
Total stockholders’ equity |
| |
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Total liabilities and stockholders’ equity | $ | |
| $ | |
See accompanying notes to Condensed Consolidated Financial Statements.
3
RESHAPE LIFESCIENCES INC.
Condensed Consolidated Statements of Operations
(unaudited)
(dollars in thousands, except per share amounts)
Three Months Ended March 31, | |||||||
2023 |
| 2022 | |||||
Revenue | $ | | $ | | |||
Cost of revenue |
| |
| | |||
Gross profit |
| |
| | |||
Operating expenses: | |||||||
Sales and marketing |
| |
| | |||
General and administrative | | | |||||
Research and development |
| |
| | |||
Total operating expenses | | | |||||
Operating loss | ( | ( | |||||
Other expense (income), net: | |||||||
Interest expense (income), net |
| |
| ( | |||
Gain on changes in fair value of liability warrants |
| ( |
| — | |||
Gain on foreign currency exchange, net | ( | ( | |||||
Other | ( | ( | |||||
Loss before income tax provision | ( | ( | |||||
Income tax benefit | | | |||||
Net loss | $ | ( | $ | ( | |||
Net loss per share - basic and diluted: | |||||||
Net loss per share - basic and diluted | ( | ( | |||||
Shares used to compute basic and diluted net loss per share | | |
See accompanying notes to Condensed Consolidated Financial Statements.
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RESHAPE LIFESCIENCES INC.
Condensed Consolidated Statements of Comprehensive Loss
(unaudited)
(dollars in thousands)
Three Months Ended March 31, | ||||||
2023 |
| 2022 | ||||
Net loss | $ | ( | $ | ( | ||
Foreign currency translation adjustments | ( | | ||||
Other comprehensive income, net of tax | ( | | ||||
Comprehensive loss | $ | ( | $ | ( |
See accompanying notes to Condensed Consolidated Financial Statements.
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RESHAPE LIFESCIENCES INC.
Condensed Consolidated Statements of Stockholders’ Equity
(unaudited)
(dollars in thousands)
Three Months Ended March 31, 2023 | ||||||||||||||||||||||
Series C Convertible | Additional | Accumulated Other | Total | |||||||||||||||||||
Preferred Stock | Common Stock | Paid-in | Accumulated | Comprehensive | Stockholders’ | |||||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Deficit |
| Loss |
| Equity | |||||||
Balance December 31, 2022 | | $ | — | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||||
Net loss | — | — | — | — | — | ( | — | ( | ||||||||||||||
Other comprehensive income, net of tax | — | — | — | — | — | — | ( | ( | ||||||||||||||
Issuance of common stock pursuant to reverse stock split | — | — | | — | — | — | ||||||||||||||||
Stock compensation | — | — | — | — | | — | — | | ||||||||||||||
Common stock purchased | | | — | | ||||||||||||||||||
Equity issuance costs | — | — | — | — | | | ||||||||||||||||
Issuance of stock from RSUs | — | — | | — | — | — | — | — | ||||||||||||||
Exercise of warrants | — | — | | | | — | — | | ||||||||||||||
Balance March 31, 2023 | | $ | — | | $ | | $ | | $ | ( | $ | ( | $ | |
Three Months Ended March 31, 2022 | ||||||||||||||||||||||
Series C Convertible | Additional | Accumulated | Total | |||||||||||||||||||
Preferred Stock | Common Stock | Paid-in | Accumulated | Comprehensive | Stockholders’ | |||||||||||||||||
Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Deficit | Income (Loss) |
| Equity | |||||||||
Balance December 31, 2021 | | $ | — | | $ | — | $ | | $ | ( | $ | ( | $ | | ||||||||
Net loss | — | — | — | — | — | ( | — | ( | ||||||||||||||
Other comprehensive income, net of tax | — | — | — | — | — | — | | | ||||||||||||||
Stock compensation | — | — | — | — | | — | — | | ||||||||||||||
Issuance of stock from RSUs | — | — | | — | — | — | — | — | ||||||||||||||
Balance March 31, 2022 | | $ | — | | $ | — | $ | | $ | ( | $ | ( | $ | |
See accompanying Notes to Condensed Consolidated Financial Statements.
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RESHAPE LIFESCIENCES INC.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(dollars in thousands)
Three Months Ended March 31, | ||||||
2023 | 2022 | |||||
Cash flows from operating activities: |
| |||||
Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
Depreciation expense |
| |
| | ||
Amortization of intangible assets | | | ||||
Noncash interest expense | — | — | ||||
Impairment of intangible assets | — | — | ||||
Loss on extinguishment of debt, net | — | — | ||||
Loss on disposal of assets, net | — | — | ||||
Stock-based compensation | | | ||||
Bad debt expense | | | ||||
Provision for inventory excess and obsolescence | | | ||||
Deferred income tax | ( | — | ||||
Gain on changes in fair value of liability warrants | ( | — | ||||
Offering cost | | — | ||||
Other noncash items | | ( | ||||
Change in operating assets and liabilities, net of business combination: |
|
| ||||
Accounts and other receivables |
| |
| | ||
Inventory |
| |
| ( | ||
Prepaid expenses and other current assets |
| ( |
| ( | ||
Accounts payable and accrued liabilities | | | ||||
Warranty liability |
| ( |
| ( | ||
Other |
| ( |
| — | ||
Net cash used in operating activities | ( | ( | ||||
Cash flows from investing activities: | ||||||
Capital expenditures | ( | ( | ||||
Proceeds from sale of capital assets | — | | ||||
Cash (used in) provided by investing activities: | ( | | ||||
Cash flows from financing activities: | ||||||
Proceeds from sale and issuance of securities | | — | ||||
Net cash provided by financing activities | | — | ||||
Effect of currency exchange rate changes on cash and cash equivalents |
| ( |
| | ||
Net increase (decrease) in cash, cash equivalents and restricted cash |
| |
| ( | ||
Cash, cash equivalents and restricted cash at beginning of period | | | ||||
Cash, cash equivalents and restricted cash at end of period | $ | | $ | | ||
Supplemental disclosure: | ||||||
Cash paid for income taxes | $ | — | $ | — | ||
Cash paid for interest | — | — | ||||
Noncash investing and financing activities: | ||||||
Capital expenditures accruals | $ | | $ | |
See accompanying notes to Condensed Consolidated Financial Statements.
7
ReShape Lifesciences Inc.
Notes to Condensed Consolidated Financial Statements
(dollars in thousands, except per share amounts; unaudited)
(1)
The accompanying interim condensed consolidated financial statements and related disclosures of Reshape Lifesciences Inc. (the “Company” or “ReShape”) have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC") and should be read in conjunction with the consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed on April 17, 2023. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States of America ("GAAP") have been condensed or omitted.
In the opinion of management, the interim consolidated condensed financial statements reflect all adjustments considered necessary for a fair statement of the interim periods. All such adjustments are of a normal, recurring nature. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year.
Reverse Stock Split and Merger Exchange Ratio
On December 23, 2022, at the commencement of trading, the Company effected a
-for-50 reverse stock split. Accordingly, all share and per share amounts for the periods presented in the accompanying consolidated financial statement and notes thereto have been adjusted retroactively, where applicable, to reflect the reverse stock split. No fractional shares were issued in connection with the reverse stock split.Summary of Significant Accounting Policies
The Company’s significant accounting policies are described in Note 4 to its audited consolidated financial statements for the year ended December 31, 2022, which are included in the Company’s Annual Report on Form 10-K which was filed with the SEC on April 17, 2023.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may materially differ from these estimates. The Company reviews its estimates on an ongoing basis or as new information becomes available to ensure that these estimates appropriately reflect changes in its business.
Long-Lived Assets
We evaluate long-lived assets, including finite-lived intangible assets, for impairment by comparison of the carrying amounts to future net undiscounted cash flows expected to be generated by such assets when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset’s fair value or estimates of future discounted cash flows.
Fair Value of Financial Instruments
The carrying amounts of cash equivalents, accounts receivable, accounts payable and certain accrued and other liabilities approximate fair value due to their short-term maturities. Refer to Note 7 regarding fair value measurements and inputs of warrants.
8
Net Loss Per Share
The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented:
March 31, | ||||
| 2023 |
| 2022 | |
Stock options |
| |
| |
Unvested restricted stock units | | | ||
Convertible preferred stock | | | ||
Warrants |
| |
| |
Recent Accounting Pronouncements
New accounting standards adopted are discussed below.
In June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which is intended to provide financial statement users with more useful information about expected credit losses on financial assets held by a reporting entity at each reporting date. In May 2019, the FASB issued ASU No. 2019-05, which amended the new standard by providing targeted transition relief. The new guidance replaces the existing incurred loss impairment methodology with a methodology that requires consideration of a broader range of reasonable and supportable forward-looking information to estimate all expected credit losses. In November 2019, the FASB issued ASU No. 2019-11, which amended the new standard by providing additional clarification. This guidance became effective on January 1, 2023 and did not have a material impact to the consolidated financial statements.
(2) Liquidity and Management’s Plans
The Company currently does not generate revenue sufficient to offset operating costs and anticipates such shortfalls to continue as the Company has modified its strategy to a metrics-driven approach through a sustainable and scalable business model, via a digital lead generation and re-engagement strategy. As of March 31, 2023, the Company had net working capital of approximately $
The Company’s anticipated operations include plans to (i) grow sales and operations of the Company with the Lap-Band product line both domestically and internationally as well as to obtain cost savings synergies, (ii) introduce to the market place ReShapeCare and ReShape Marketplace as an extension, (iii) marketing efforts to increase brand recognition, create customer awareness and increase the patient demand, (iv) continue development of the DBSN device, (v) seek opportunities to leverage our intellectual property portfolio and custom development services to provide third-party sales and licensing opportunities, and (vi) explore and capitalize on synergistic opportunities to expand our portfolio and offer future minimally invasive treatments and therapies in the obesity continuum of care, including Lap-Band 2.0. The Company believes that it has the flexibility to manage the growth of its expenditures and operations depending on the amount of available cash flows, which could include reducing expenditures for marketing, clinical and product development activities.
The Company may be required to raise additional capital, however, there can be no assurance as to whether additional financing will be available on terms acceptable to the Company, if at all. If sufficient funds on acceptable terms are not available when needed, it would have a negative impact on the Company’s financial condition and could force the Company to delay, limit, reduce, or terminate product development or future commercialization efforts or grant rights to develop and market product candidates or testing products that the Company would otherwise plan to develop.
9
Therefore, the plans cannot be deemed probable of being implemented. As a result, the Company’s plans do not alleviate substantial doubt about our ability to continue as a going concern.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
COVID-19 Risk
The impact of the COVID-19 outbreak has subsided substantially in the U.S. but continues to result in reduced activity levels outside of the U.S., such as continued restrictions on travel and business operations and advising or requiring individuals to limit or forego their time outside of their homes or places of business.
(3) Supplemental Balance Sheet Information
Components of selected captions in the condensed consolidated balance sheets consisted of the following:
Inventory:
March 31, | December 31, | |||||
2023 |
| 2022 | ||||
Raw materials | $ | | $ | | ||
Sub-assemblies | | | ||||
Finished goods |
| |
| | ||
Total inventory | $ | | $ | |
Prepaid expenses and other current assets:
March 31, | December 31, | |||||
2023 |
| 2022 | ||||
Prepaid insurance | $ | | $ | | ||
Patents | | — | ||||
Prepaid advertising and marketing | | | ||||
Taxes | | — | ||||
Other current assets | | | ||||
Total prepaid expenses and other current assets | $ | | $ | |
Accrued and other liabilities:
March 31, | December 31, | |||||
2023 |
| 2022 | ||||
Payroll and benefits | $ | | $ | | ||
Accrued legal settlements | | | ||||
Customer deposits | | | ||||
Taxes | | | ||||
Accrued professional | | | ||||
Other liabilities |
| |
| | ||
Total accrued and other liabilities | $ | | $ | |
10
(4) Intangible Assets
The Company’s finite-lived intangible assets consists of developed technology, and trademarks and tradenames. The estimated useful lives of these finite-lived intangible assets is
March 31, 2023 | |||||||||||
| Weighted Average Useful Life (years) |
| Gross Carrying Amount |
| Accumulated Amortization |
| Net Book Value | ||||
Finite-lived intangible assets: | |||||||||||
Developed technology | $ | $ | ( | $ | |||||||
Trademarks/Tradenames | ( | ||||||||||
Total | $ | $ | ( | $ |
December 31, 2022 | |||||||||||
| Weighted Average Useful Life (years) |
| Gross Carrying Amount |
| Accumulated Amortization |
| Net Book Value | ||||
Finite-lived intangible assets: | |||||||||||
Developed technology | $ | $ | ( | $ | |||||||
Trademarks/Tradenames | ( | ||||||||||
Total | $ | $ | ( | $ |
(5) Leases
The Company has a noncancelable operating lease for office and warehouse space in San Clemente, which was extended by
The Company does not have any short-term leases or financing lease arrangements. Lease and non-lease components are accounted for separately.
Operating lease costs were $
Supplemental information related to operating leases is as follows:
March 31, | December 31, | |||||
Balance Sheet information | 2023 | 2022 | ||||
Operating lease ROU assets | $ | | $ | | ||
Operating lease liabilities, current portion | $ | | $ | | ||
Total operating lease liabilities | $ | | $ | | ||
Cash flow information for the three months ended March 31, | 2023 | 2022 | ||||
Cash paid for amounts included in the measurement of operating leases liabilities | $ | | $ | |
11
Maturities of operating lease liabilities were as follows:
2023 | | |||
Total lease payments | | |||
Less: imputed interest | | |||
Total lease liabilities | $ | | ||
Weighted-average remaining lease term at end of period (in years) | ||||
Weighted-average discount rate at end of period | % |
(6) Equity
Common Stock Issued Related to Restricted Stock Units
During the three months ended March 31, 2023 and 2022, the Company issued
February Public Offering of Common Stock and Warrants
On February 8, 2023, the Company closed a public offering of
Gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, are approximately $
The Company also granted the underwriters an option to purchase an additional
(7) Warrants
On February 8, 2023, the Company completed a public offering in which
12
Cash Exercise | Cashless Exercise | |||||
Stock Price | $ | $ | ||||
Exercise Price | $ | $ | ||||
Term (years) | ||||||
Volatility | ||||||
Risk Free Rate | ||||||
Dividend Yield |
The following table presents the changes in the fair value of warrant liabilities:
Common Stock | |||
Purchase Warrants | |||
Fair value as of February 8, 2023 (issuance date) | $ | | |
Exercises of liability warrants | ( | ||
Gain on changes in fair value of liability warrants | ( | ||
Fair value as of March 31, 2023 | $ | |
In addition,
As part of the terms of the offering the Company issued
(8) Revenue Disaggregation and Operating Segments
The Company conducts operations worldwide and has sales in the following regions: United States, Australia, Europe and Rest of World. For the three months ended March 31, 2023 and 2022, the Company primarily only sold the Lap-Band system. The following table presents the Company’s revenue disaggregated by geography:
Three Months Ended | ||||||
March 31, | ||||||
| 2023 |
| 2022 | |||
United States | $ | | $ | | ||
Australia | | | ||||
Europe | | | ||||
Rest of world | | | ||||
Total revenue | $ | $ |
Operating Segments
The Company conducts operations worldwide and is managed in the following geographical regions: United States, Australia, Europe and the Rest of World (primarily in the Middle East). All regions sell the Lap-Band system, which consisted of nearly all our revenue and gross profit for the three months ended March 31, 2023 and 2022. During the three months ended March 31, 2023 and 2022, there was minimal revenue for ReShapeCare. There was
13
(9) Income Taxes
During the three months ended March 31, 2023 and March 31, 2022, the Company recorded income tax expense of $
In assessing the realization of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during periods in which those temporary differences become deductible. Based on the level of historical losses, projections of losses in future periods and potential limitations pursuant to changes in ownership under Internal Revenue Code Section 382, the Company provided a valuation allowance at both March 31, 2023 and December 31, 2022.
(10) Stock-based Compensation
Stock-based compensation expense related to stock options and RSUs issued under the ReShape Lifesciences Inc. Second Amended and Restated 2003 Stock Incentive Plan (the “Plan”) for the three months ended March 31, 2023 and 2022 were as follows:
Three Months Ended | ||||||
March 31, | ||||||
2023 | 2022 | |||||
Sales and marketing | $ | | $ | | ||
General and administrative | | | ||||
Research and development | | | ||||
Total stock-based compensation expense | $ | | $ | |
Stock Options
A summary of the status of the Company’s stock options as of March 31, 2023, and changes during the three months ended March 31, 2023 are as follows:
| Weighted | |||||||||
Weighted | Average | Aggregate | ||||||||
Average | Remaining | Intrinsic | ||||||||
| Exercise Price | Contractual | Value | |||||||
Shares | Per Share | Life (years) | (in thousands) | |||||||
Outstanding at December 31, 2022 |
| | | $ | — | |||||
Options granted |
| — | — | |||||||
Options exercised |
| — | — | |||||||
Options cancelled |
| ( | | |||||||
Outstanding at March 31, 2023 |
| | | $ | — | |||||
Exercisable at March 31, 2023 | | | — | |||||||
Vested and expected to vest at March 31, 2023 | | | — |
There was
Stock option awards outstanding under the Company’s incentive plans have been granted at exercise prices that are equal to the market value of its common stock on the date of grant. Such options generally vest over a period of
14
Expected Term – The estimate of expected term is based on the historical exercise behavior of grantees, as well as the contractual life of the options granted.
Expected Volatility – The expected volatility factor is based on the volatility of the Company’s common stock for a period equal to the term of the stock options.
Risk-free Interest Rate – The risk-free interest rate is determined using the implied yield for a traded zero-coupon U.S. Treasury bond with a term equal to the expected term of the stock options.
Expected Dividend Yield – The expected dividend yield is based on the Company’s historical practice of paying dividends on its common stock.
Restricted Stock Units
A summary of the Company’s unvested RSUs award activity for the three months ended March 31, 2023, is as follows:
Weighted | |||||
Average | |||||
| Grant Date | ||||
Shares | Fair Value | ||||
Unvested RSUs at December 31, 2022 |
| | $ | | |
Granted |
| — | — | ||
Vested (1) |
| ( | | ||
Cancelled/Forfeited |
| — | — | ||
Non-vested RSUs at March 31, 2023 |
| | |
(1) | At March 31, 2023, there were |
The fair value of each RSU is the closing stock price on the Nasdaq of the Company’s common stock on the date of grant. Upon vesting, a portion of the RSU award may be withheld to satisfy the statutory income tax withholding obligation. The remaining RSUs will be settled in shares of the Company’s common stock after the vesting period. The unrecognized compensation cost related to the RSUs at March 31, 2023 was $
(11) Commitment and Contingencies
Litigation
On August 6, 2021, Cowen and Company, LLC filed a complaint against ReShape, as successor in interest to Obalon Therapeutics, in the Supreme Court of the State of New York based on an alleged breach of contract arising out of Cowen’s prior engagement as Obalon’s financial advisor. The complaint alleges that Cowen is entitled to be paid a $
The Company is not aware of any pending or threatened litigation against it that could have a material adverse effect on the Company’s business, operating results or financial condition, other than what was disclosed above. The medical device industry in which the Company operates is characterized by frequent claims and litigation, including claims regarding patent and other intellectual property rights as well as improper hiring practices. As a result, the Company may be involved in various legal proceedings from time to time.
15
Product Liability Claims
The Company is exposed to product liability claims that are inherent in the testing, production, marketing and sale of medical devices. Management believes any losses that may occur from these matters are adequately covered by insurance, and the ultimate outcome of these matters will not have a material effect on the Company’s financial position or results of operations. The Company is not currently a party to any product liability litigation and is not aware of any pending or threatened product liability litigation that is reasonably possible to have a material adverse effect on the Company’s business, operating results or financial condition.
(12) Subsequent Events
On April 20, 2023, ReShape Lifesciences Inc. (the “Company”) entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a certain institutional investor (the “Investor”), pursuant to which the Company agreed to issue and sell to the Investor in a registered direct offering (the “Registered Offering”) (i)
In connection with the Offering, the Company also agreed that certain existing warrants to purchase up to an aggregate of
The Company’s exclusive placement agent in connection with the Offering, Maxim Group LLC, received a cash fee equal to
The Offering closed on April 24, 2023.
16
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion should be read in conjunction with the condensed consolidated financial statements and notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q.
Except for the historical information contained herein, the matters discussed in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” are forward-looking statements that involve risks and uncertainties. In some cases, these statements may be identified by terminology such as “may,” “will,” “should,” “expects,” “could,” “intends,” “might,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” or “continue,” or the negative of such terms and other comparable terminology. These statements involve known and unknown risks and uncertainties that may cause our results, level of activity, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Factors that may cause or contribute to such differences include, among others, those discussed in the “Risk Factors” section included in Item 1A of our most recent Annual Report on Form 10-K.
Except as may be required by law, we undertake no obligation to update any forward-looking statement to reflect events after the date of this report.
Overview
We are the premier global weight-loss solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and associated metabolic disease. Our primary operations are in the following geographical areas: United States, Australia and certain European and Middle Eastern countries. Our current portfolio includes the Lap-Band Adjustable Gastric Banding System, the ReShapeCare virtual health coaching program, the ReShape Marketplace, the Obalon Balloon System, and the Diabetes Bloc-Stim Neuromodulation device, a technology under development as a new treatment for type 2 diabetes mellitus. There has been no revenue recorded for the Obalon Balloon System, and there has been no revenue recorded for the Diabetes Bloc-Stim Neuromodulation as this product is still in the development stage.
Recent Developments
On March 13, 2023 we entered into a lease for approximately 5,038 square feet of office/warehouse space at 18 Technology Drive, Suite 110, Irvine, California 92618 and intend to relocate our principal executive offices from our current San Clemente, California location to the Irvine, California location. The Irvine California lease has a term of 36 months commencing on May 1, 2023.
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Results of Operations
The following table sets forth certain data from our unaudited consolidated statements of operations expressed as percentages of revenue (in thousands):
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Revenue | $ | 2,287 | 100.0 | % | $ | 2,440 | 100.0 | % | |||
Cost of revenue | 1,063 | 46.5 | % | 1,222 | 50.1 | % | |||||
Gross profit | 1,224 | 53.5 | % | 1,218 | 49.9 | % | |||||
Operating expenses: | |||||||||||
Sales and marketing | 2,182 | 95.4 | % | 4,694 | 192.4 | % | |||||
General and administrative | 4,220 | 184.5 | % | 3,892 | 159.5 | % | |||||
Research and development | 453 | 19.8 | % | 745 | 30.5 | % | |||||
Total operating expenses | 6,855 | 299.7 | % | 9,331 | 382.4 | % | |||||
Operating loss | (5,631) | (246.2) | % | (8,113) | (332.5) | % | |||||
Other expense (income), net: | |||||||||||
Interest expense (income), net | 5 | 0.2 | % | (1) | — | % | |||||
Gain on changes in fair value of liability warrants | (2,965) | (129.6) | % | — | — | % | |||||
Gain on foreign currency exchange, net | (21) | (0.9) | % | (16) | (0.7) | % | |||||
Other | (2) | (0.1) | % | (11) | (0.5) | % | |||||
Loss before income tax provision | (2,648) | (115.8) | % | (8,085) | (331.4) | % | |||||
Income tax benefit | 14 | 0.6 | % | 30 | 1.2 | % | |||||
Net loss | $ | (2,662) | (116.5) | % | $ | (8,115) | (332.6) | % |
Non-GAAP Disclosures
In addition to the financial information prepared in conformity with GAAP, we provide certain historical non-GAAP financial information. Management believes that these non-GAAP financial measures assist investors in making comparisons of period-to-period operating results.
Management believes that the presentation of this non-GAAP financial information provides investors with greater transparency and facilitates comparison of operating results across a broad spectrum of companies with varying capital structures, compensation strategies, and amortization methods, which provides a more complete understanding of our financial performance, competitive position, and prospects for the future. However, the non-GAAP financial measures presented in the Form 10-Q have certain limitations in that they do not reflect all of the costs associated with the operations of our business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. Further, the non-GAAP financial measures presented by the Company may be different from similarly named non-GAAP financial measures used by other companies.
Adjusted EBITDA
Management uses adjusted EBITDA in its evaluation of the Company’s core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Adjusted EBITDA is defined as net loss before interest, taxes, depreciation and amortization, stock-based compensation, and other one-time costs.
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The following table contains a reconciliation of GAAP net loss to Adjusted EBITDA net loss attributable to common stockholders for the months ended March 31, 2023 and 2022 (in thousands):
Three Months Ended March 31, | |||||
2023 | 2022 | ||||
GAAP net loss | $ | (2,662) | $ | (8,115) | |
Adjustments: | |||||
Interest expense (income), net | 5 | (1) | |||
Income tax benefit | 14 | 30 | |||
Depreciation and amortization | 48 | 550 | |||
Stock-based compensation expense | 222 | 719 | |||
Gain on changes in fair value of liability warrants | (2,965) | — | |||
Adjusted EBITDA | $ | (5,338) | $ | (6,817) |
Comparison of Results of Operations
Three months ended March 31, 2023 and March 31, 2022
Revenue. The following table summarizes our unaudited revenue by geographic location based on the location of customers for the three months ended March 31, 2023 and 2022, as well as the percentage of each location to total revenue and the amount of change and percentage of change (dollars in thousands):
Three Months Ended March 31, | Amount | Percentage | |||||||||||||||
2023 | 2022 | Change | Change | ||||||||||||||
United States | $ | 1,813 | 79.3 | % | $ | 1,844 | 75.6 | % | $ | (31) | (1.7) | % | |||||
Australia | 157 | 6.9 | % | 181 | 7.4 | % | (24) | (13.3) | % | ||||||||
Europe | 304 | 13.3 | % | 414 |