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 |
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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 November 10, 2021,
INDEX
3 | ||
Condensed Consolidated Balance Sheets at September 30, 2021 and December 31, 2020 | 3 | |
4 | ||
5 | ||
6 | ||
8 | ||
9 | ||
Management’s Discussion and Analysis of Financial Condition and Results of Operations | 24 | |
34 | ||
34 | ||
34 | ||
34 | ||
35 | ||
35 | ||
35 | ||
35 | ||
36 | ||
37 |
2
PART I – FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
RESHAPE LIFESCIENCES INC.
Condensed Consolidated Balance Sheets
(unaudited)
(dollars in thousands, except per share amounts)
September 30, | December 31, | |||||
| 2021 |
| 2020 | |||
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 | | | ||||
Other intangible assets, net | | | ||||
Goodwill | | — | ||||
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 | | | ||||
Debt, current portion, net of deferred financing costs | | | ||||
Operating lease liabilities, current | | | ||||
Total current liabilities |
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Debt, noncurrent portion | — | | ||||
Operating lease liabilities, noncurrent | — | | ||||
Warranty liability, noncurrent | | | ||||
Deferred income taxes | | | ||||
Total liabilities | |
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Commitments and contingencies | ||||||
Stockholders’ equity: | ||||||
Preferred stock, | ||||||
Series B convertible preferred stock, $ | ||||||
Series C convertible preferred stock, $ | | |||||
Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
| ( |
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| ( | |
Accumulated other comprehensive loss | ( | ( | ||||
Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | |
| $ | |
3
See accompanying notes to Condensed Consolidated Financial Statements.
RESHAPE LIFESCIENCES INC.
Condensed Consolidated Statements of Operations
(unaudited)
(dollars in thousands, except per share amounts)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2021 | 2020 |
| 2021 | 2020 | ||||||||
Revenue | $ | | $ | | $ | | $ | | ||||
Cost of revenue | |
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Gross profit | |
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Operating expenses: | ||||||||||||
Sales and marketing | |
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General and administrative | | | | | ||||||||
Research and development | |
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Total operating expenses | |
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Operating loss | ( |
| ( |
| ( |
| ( | |||||
Other expense (income), net: | ||||||||||||
Interest expense, net | | | | | ||||||||
Warrant expense | | — | | — | ||||||||
Loss on extinguishment of debt, net | — | | | | ||||||||
Gain on foreign currency exchange, net | ( | ( | ( | ( | ||||||||
Loss before income tax provision | ( | ( | ( | ( | ||||||||
Income tax expense (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 | |
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| |
| |
See accompanying notes to Condensed Consolidated Financial Statements.
4
RESHAPE LIFESCIENCES INC.
Condensed Consolidated Statements of Comprehensive Loss
(unaudited)
(dollars in thousands)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2021 |
| 2020 |
| 2021 | 2020 | |||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Foreign currency translation adjustments | | ( | | ( | ||||||||
Other comprehensive income (loss), net of tax | | ( | | ( | ||||||||
Comprehensive loss | $ | ( | $ | ( | $ | ( | $ | ( |
See accompanying notes to Condensed Consolidated Financial Statements.
5
RESHAPE LIFESCIENCES INC.
Condensed Consolidated Statements of Stockholders’ Equity
(unaudited)
(dollars in thousands)
Three Months Ended September 30, 2021 | |||||||||||||||||||||||||||
Series B Convertible | Series C Convertible | Additional | Accumulated Other | Total | |||||||||||||||||||||||
Preferred Stock | Preferred Stock | Common Stock | Paid-in | Accumulated | Comprehensive | Stockholders’ | |||||||||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Deficit |
| Income (Loss) |
| Equity | ||||||||
Balance June 30, 2021 | — | $ | — | | $ | — | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||||||
Net loss | — | — | — | — | — | — | — | ( | — | ( | |||||||||||||||||
Other comprehensive loss, net of tax | — | — | — | — | — | — | — | — | | | |||||||||||||||||
Stock compensation | — | — | — | — | — | — | | — | — | | |||||||||||||||||
Stock options exercised | — | — | — | — | | — | | — | — | | |||||||||||||||||
Issuance of stock from RSUs | — | — | — | — | | | ( | — | — | — | |||||||||||||||||
Issuance of warrants | — | — | — | — | — | — | | — | — | | |||||||||||||||||
Institutional exercise of warrants | — | — | — | — | | | | — | — | | |||||||||||||||||
Warrant liability reclassified to equity | — | — | — | — | — | — | | | |||||||||||||||||||
Restricted shares issued for consulting services | — | — | — | — | | — | | — | — | | |||||||||||||||||
Balance September 30, 2021 | — | $ | — | | $ | — | | $ | | $ | | $ | ( | $ | ( | $ | |
Nine Months Ended September 30, 2021 | |||||||||||||||||||||||||||
Series B Convertible | Series C Convertible | Additional | Accumulated Other | Total | |||||||||||||||||||||||
Preferred Stock | Preferred Stock | Common Stock | Paid-in | Accumulated | Comprehensive | Stockholders’ | |||||||||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Deficit |
| Loss |
| Equity | ||||||||
Balance December 31, 2020 | | $ | — | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||||||
Net loss | — | — | — | — | — | — | — | ( | — | ( | |||||||||||||||||
Other comprehensive income, net of tax | — | — | — | — | — | — | — | — | | | |||||||||||||||||
Issuance of common stock pursuant to reverse acquisition | ( | — | — | ( | | | | — | — | | |||||||||||||||||
Stock compensation | — | — | — | — | — | — | | — | — | | |||||||||||||||||
Stock options exercised | — | — | — | — | | — | | — | — | | |||||||||||||||||
Issuance of stock from RSUs | — | — | — | — | | | ( | — | — | — | |||||||||||||||||
Issuance of warrants | — | — | — | — | — | — | | — | — | | |||||||||||||||||
Institutional exercise of warrants | — | — | — | — | | | | — | — | | |||||||||||||||||
Warrant liability reclassified to equity | — | — | — | — | — | — | | — | — | | |||||||||||||||||
Restricted shares issued for consulting services | — | — | — | — | | — | | — | — | | |||||||||||||||||
Balance September 30, 2021 | — | $ | — | | $ | — | | $ | | $ | | $ | ( | $ | ( | $ | |
See accompanying Notes to Condensed Consolidated Financial Statements
6
RESHAPE LIFESCIENCES INC.
Condensed Consolidated Statements of Stockholders’ Equity (Continued)
(unaudited)
(dollars in thousands)
Three Months Ended September 30, 2020 | |||||||||||||||||||||||||||
Series B Convertible | Series C Convertible | Additional | Accumulated | Total | |||||||||||||||||||||||
Preferred Stock | Preferred Stock | Common Stock | Paid-in | Accumulated | Comprehensive | Stockholders’ | |||||||||||||||||||||
Shares |
| Amount |
| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Deficit | Income (Loss) |
| Equity | ||||||||||
Balance at June 30, 2020 | | $ | — | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||||||
Net loss | — | — | — | — | — | — | — | ( | — | ( | |||||||||||||||||
Other comprehensive income (loss), net of tax | — | — | — | — | — | — | — | — | ( | ( | |||||||||||||||||
Stock-based compensation expense | — | — | — | — | — | — | | — | — | | |||||||||||||||||
Issuance of warrants | — | — | — | — | — | — | | | |||||||||||||||||||
Balance September 30, 2020 | | $ | — | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | |
Nine Months Ended September 30, 2020 | |||||||||||||||||||||||||||
Series B Convertible | Series C Convertible | Additional | Accumulated Other | Total | |||||||||||||||||||||||
Preferred Stock | Preferred Stock | Common Stock | Paid-in | Accumulated | Comprehensive | Stockholders’ | |||||||||||||||||||||
Shares |
| Amount |
| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Deficit | Loss |
| Equity | ||||||||||
Balance December 31, 2019 | | $ | — | | $ | | | $ | — | $ | | $ | ( | $ | ( | $ | | ||||||||||
Net loss | — | — | — | — | — | — | — | ( | — | ( | |||||||||||||||||
Other comprehensive loss, net of tax | — | — | — | — | — | — | — | — | ( | ( | |||||||||||||||||
Stock-based compensation expense | — | — | — | — | — | — | | — | — | | |||||||||||||||||
Issuance of warrants | — | — | — | — | — | — | | — | — | | |||||||||||||||||
Institutional exercise of warrants | — | — | — | — | | | | — | — | | |||||||||||||||||
Cashless exercise of warrants | — | — | — | — | | — | — | — | — | — | |||||||||||||||||
Common stock issued for professional services | — | — | — | — | | — | | — | — | | |||||||||||||||||
Balance September 30, 2020 | | $ | — | | $ | | | $ | | $ | | $ | ( | $ | ( | $ | |
See accompanying Notes to Condensed Consolidated Financial Statements.
7
RESHAPE LIFESCIENCES INC.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(dollars in thousands)
Nine Months Ended September 30, | ||||||
2021 | 2020 | |||||
Cash flows from operating activities: |
|
| ||||
Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
Depreciation expense |
| |
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Amortization of intangible assets | | | ||||
Noncash interest expense | | | ||||
Loss on extinguishment of debt, net | | | ||||
Stock-based compensation | | | ||||
Bad debt expense | | | ||||
Provision for inventory excess and obsolescence | | | ||||
Warrant expense | | — | ||||
Amortization of debt discount and deferred debt issuance costs | | | ||||
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 received from acquisition | | — | ||||
Cash provided by (used in) investing activities: | | ( | ||||
Cash flows from financing activities: | ||||||
Payments of financing costs |
| ( |
| ( | ||
Proceeds from institutional exercise of warrants |
| |
| | ||
Proceeds from stock options exercised | | — | ||||
Proceeds from credit agreement | | | ||||
Payment of credit agreement | ( | — | ||||
Proceeds from PPP loan | — | | ||||
Net cash provided by financing activities |
| |
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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: | ||||||
Purchase price, net of cash received | $ | | $ | — | ||
Fair value of warrants included as a component of loss on extinguishment of debt | | | ||||
Fair value of common stock and warrants issued related to the fundamental transaction exchange | | — | ||||
Capital expenditures accruals | | | ||||
Relative fair value of warrants classified as debt issuance costs | — | |
See accompanying notes to Condensed Consolidated Financial Statements.
8
ReShape Lifesciences Inc.
Notes to Condensed Consolidated Financial Statements
(dollars in thousands, except per share amounts; unaudited)
(1) Basis of Presentation
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, 2020, filed on March 11, 2021. 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.
Revision of Previously Issued Financial Statement for Correction of Immaterial Errors
The Company revised the accompanying statement of operations for the period ended June 30, 2020, and condensed consolidated balance sheet and condensed consolidated statement of equity as of December 31, 2020, to reflect the correction of an immaterial error for amounts previously not reflected in the statements attributable to the share ratio adjustment to the Company’s common stock related to the merger with Obalon Therapeutics, Inc. (“Obalon”). This revision has no impact on the Company’s net income or retained earnings.
The following table summarizes the effect of the revision on each financial statement line item for the periods ended, as indicated (in thousands, except per share information):
Condensed Consolidated Balance Sheet | |||||||||
As Previously | |||||||||
Reported | Adjustment | As Revised | |||||||
As of December 31, 2020 | |||||||||
Common stock | $ | | $ | ( | $ | | |||
Additional paid in capital | | | |
Condensed Consolidated Statement of Operations | |||||||||
As Previously | |||||||||
Reported | Adjustment | As Revised | |||||||
Three months ended June 30, 2020 | |||||||||
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 | | ( | | ||||||
Six months ended June 30, 2020 | |||||||||
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 | | ( | | ||||||
For the year ended December 31, 2020 | |||||||||
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 | | ( | |
9
Condensed Consolidated Statement of Stockholders' Equity | |||||||||
As Previously | |||||||||
Reported | Adjustment | As Revised | |||||||
Balance December 31, 2020 | |||||||||
Common stock (shares) | | ( | | ||||||
Common stock (amount) | $ | | $ | ( | $ | | |||
Additional paid in capital | | | |
Reverse Stock Split
On June 15, 2021, and immediately prior to the closing of the merger, the Company effected the reverse stock split. Accordingly, all share and per share amounts for the period presented in the accompanying consolidated financial statements 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. Unless otherwise noted, all references to shares of the Company’s common stock and per share amounts have also been adjusted to reflect the exchange ratio.
Acquisition
The Company accounts for business combinations in accordance with Accounting Standards Codification (“ASC”) 805, Business Combinations. The results of businesses acquired in a business combination are included in the Company’s consolidated financial statements from the date of the acquisition. Purchase accounting results in assets and liabilities of an acquired business generally being recorded at their estimated fair values on the acquisition date. Any excess consideration over the fair value of assets acquired and liabilities assumed is recognized as goodwill. Transaction costs associated with business combinations are expensed as incurred and are included in general and administrative related costs in the consolidated statements of operations. The Company performs valuations of assets acquired and liabilities assumed and allocates the purchase price to its respective assets and liabilities. Determining the fair value of assets acquired and liabilities assumed requires management to use significant judgment and estimates.
Upon completion of the business combination on June 15, 2021, with Obalon, the transaction was treated as a “reverse acquisition” for financial accounting purposes. As a result of the controlling interest of the former shareholders of ReShape, for financial statement reporting and accounting purposes, ReShape was considered the acquirer under the acquisition method of accounting in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 805-10-55. The reverse acquisition is deemed a capital transaction in substance whereas the historical assets and liabilities of Obalon before the business combination were replaced with the historical financial statements of ReShape in all future filings with the SEC.
Goodwill and Long-Lived Assets
Goodwill represents the excess of the cost of an acquired business over the fair value of the identifiable tangible and intangible assets acquired and liabilities assumed in a business combination.
Indefinite-lived intangible assets relate to in-process research and development ("IPR&D") acquired in business combinations. The estimated fair values of IPR&D projects acquired in a business combination which have not reached technological feasibility are capitalized and accounted for as indefinite-lived intangible assets until completion or abandonment of the projects. In accordance with guidance within FASB ASC 350 “Intangibles - Goodwill and Other,” goodwill and identifiable intangible assets with indefinite lives are not subject to amortization but must be evaluated for impairment.
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.
10
For goodwill and indefinite-lived intangible assets, in-process research and development, we review for impairment annually and upon the occurrence of certain events as required by ASC Topic 350, “Intangibles — Goodwill and Other.” Goodwill and indefinite-lived intangible assets are tested at least annually for impairment and more frequently if events or changes in circumstances indicate that the asset might be impaired. We review goodwill for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform the two-step goodwill impairment test. If we are able to determine that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, we would conclude that goodwill is not impaired. If the carrying amount of a reporting unit is zero or negative, the second step of the impairment test is performed to measure the amount of impairment loss, if any, when it is more likely than not that a goodwill impairment exists. The Company did not record any impairment loss for goodwill or indefinite-lived intangible assets for the three and nine months ended September 30, 2021 and 2020.
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 5 regarding the fair value of debt instruments and Note 9 regarding fair value measurements and inputs of warrants.
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:
September 30, | ||||
| 2021 |
| 2020 | |
Stock options |
| |
| |
Convertible preferred stock | | | ||
Warrants |
| |
| |
Recent Accounting Pronouncements
New accounting standards adopted by the Company in 2021 are discussed below or in the related notes, where appropriate.
In May 2021, the FASB issued Accounting Standards Update (“ASU”) No. 2021-04, Earnings Per Share (Topic 260), Debt – Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock Compensation (Topic 718), and Derivatives and Hedging Contracts in Entity’s Own Equity (Subtopic 815-40). This update provides guidance to clarify and reduce diversity in an accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that is not within the scope of another Topic. An entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange as an exchange of the original instrument for a new instrument. This update additionally provides further guidance on measuring the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange on the basis of the substance of the transaction, in the same manner as if cash had been paid as consideration. This guidance is effective for the fiscal years and interim periods within those years beginning after December 15, 2021. Early adoption is permitted, including adoption in an interim period. The Company adopted this guidance early and the adoption did not have a material impact on the Company’s consolidated financial statements.
In December 2019, the FASB issued authoritative guidance intended to simplify the accounting for income taxes: ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. This guidance eliminates certain exceptions to the general approach to the income tax accounting model and adds new guidance to reduce the complexity in accounting for income taxes. The adoption of this guidance on January 1, 2021 did not have a material impact on the Company’s consolidated financial statements.
11
New accounting standards not yet adopted are discussed below.
In June 2016, the FASB issued 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 is effective for the fiscal years and interim periods within those years beginning after December 15, 2022. The Company is currently evaluating the impact the guidance will have on its consolidated financial statements.
(2) Liquidity and Management’s Plans
As of September 30, 2021, the Company had net working capital of approximately $
The Company’s anticipated operations include plans to (i) manufacture, and promote the sales and operations of the LAP-BAND® product line in order to expand sales domestically and internationally as well as to obtain cost savings synergies, (ii) introduce to the market place reshapecareTM and ReShape Marketplace as an extension of reshapecare (iii) continue clinical testing of the ReShape Vest, (iv) continue development of the Diabetes Bloc-Stim Neuromodulation, (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, which includes the Obalon product line from the recently finalized merger with Obalon that was completed on June 15, 2021. With the recent equity raise the Company believes that it has the flexibility to manage the growth of its expenditures and operations.
COVID-19 Risk and Uncertainties and CARES Act
Since the first quarter of 2020, the COVID-19 pandemic led to unprecedented restrictions on, distributions in, and other related impacts on business and personal activities, including a shift in healthcare priorities, which resulted in a significant decline in medical procedures in 2020 in the United States and foreign countries. Concerns remain regarding the pace of economic recovery due to virus resurgence across the globe from the Delta variant and other virus mutations as well as vaccine distribution and hesitancy. The United States and other foreign governments may continue existing measures or implement new restrictions and other requirements in light of the continuing spread of the COVID-19 pandemic. Due to the uncertainty caused by the COVID-19 pandemic, the full extent to which the pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including sales, expenses, manufacturing, clinical trials, research and development costs, reserves and allowances, will depend on future developments that are highly uncertain and difficult to predict. These developments include, but are not limited to, the duration and spread of the outbreak (including new and more contagious variance of COVID-19), its severity, the actions to contain the virus or address its impact, the timing, distribution, public acceptance and efficacy of vaccines and other treatments, United States and foreign governments actions to respond to the reduction of global activity, and how quickly and to what extent normal economic and operating conditions can resume.
On March 27, 2020, President Trump signed into law the “Coronavirus Aid, Relief, and Economic Security (CARES) Act.” The CARES Act, among other things, includes provisions relating to refundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations, increased limitations on qualified charitable contributions, and technical corrections to tax depreciation methods for qualified improvement property. The CARES Act established the Paycheck Protection Program (“PPP”) under which the Company received a PPP loan. On February 3, 2021, the Company submitted the application for PPP loan forgiveness according to the terms and conditions of the
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United States Small Business Administration’s (“SBA”) Loan Forgiveness Application (Revised June 24, 2002). On March 1, 2021, the Company received confirmation from the SBA that, the PPP Loan had been forgiven in full including all interest incurred. This may still be subject to audit by the SBA or relevant authorities, subject to terms and conditions of the PPP program. The Company was also able to benefit from the employee recognition credit. For further details on the PPP loan and the employee recognition credit, see Note 5 below.
(3) Supplemental Balance Sheet Information
Components of selected captions in the condensed consolidated balance sheets consisted of the following:
Inventory:
September 30, | December 31, | |||||
2021 |
| 2020 | ||||
Raw materials | $ | | $ | | ||
Sub-assemblies | | | ||||
Finished goods |
| |
| | ||
Total inventory | $ | | $ | |
Prepaid expenses and other current assets:
September 30, | December 31, | |||||
2021 |
| 2020 | ||||
Prepaid insurance | $ | | $ | | ||
Prepaid advertising and marketing | | — | ||||
Prepaid contract research organization expenses | — | | ||||
Other | | | ||||
Total prepaid expenses and other current assets | $ | | $ | |
Accrued and other liabilities:
September 30, | December 31, | |||||
2021 |
| 2020 | ||||
Accrued professional services | $ | | $ | | ||
Payroll and benefits | | | ||||
Accrued insurance premium | | | ||||
Customer deposits | | | ||||
Taxes | | | ||||
Other |
| |
| | ||
Total accrued and other liabilities | $ | | $ | |
(4) Goodwill and Intangible Assets
Indefinite-lived intangible assets consist of IPR&D for the ReShape Vest recorded in connection with the Company’s acquisition of BarioSurg, Inc and developed technology recorded in connection with the Obalon acquisition. The Company’s finite-lived intangible assets consists of developed technology, trademarks and tradenames, and covenant not to compete. The estimated useful lives of these finite-lived intangible assets range from
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amortization expenses for both the three months ended September 30, 2021, and 2020, was $
In connection with the merger with Obalon, ReShape recorded $
The changes in the carrying amount of goodwill were as follows:
Goodwill at December 31, 2020 | $ | — | |
Goodwill acquired during the year | | ||
Adjustments to goodwill | ( | ||
Goodwill at September 30, 2021 | $ | |
(5) Debt
September 30, | December 31, | |||||
2021 |
| 2020 | ||||
Asset purchase consideration | $ | | $ | | ||
Credit agreement | — | | ||||
PPP loan | — | | ||||
Total debt | | | ||||
Less: unamortized debt discount | | | ||||
Less: current portion of debt | | | ||||
Debt, noncurrent portion | $ | — | $ | |
CARES Act
On April 24, 2020, the Company entered into a PPP Loan agreement with Silicon Valley Bank (“SVB”) under the PPP, which is part of the CARES Act administered by the United States Small Business Administration (“SBA”). As part of the application for these funds, the Company in good faith, has certified that the current economic uncertainty made the loan request necessary to support the ongoing operations of the Company. This certification further requires the Company to take into account our current business activity and our ability to access other sources of liquidity sufficient to support ongoing operations in a manner that is not significantly detrimental to the business. Under this program, the Company received proceeds of $
On February 23, 2021, the Company submitted the application for PPP loan forgiveness, in accordance with the terms and conditions of the SBA’s Loan Forgiveness Application (revised June 24, 2020). On March 1, 2021, the Company received confirmation from the SBA that the PPP Loan was forgiven in full including all interest incurred, which resulted in a gain on debt extinguishment of $
Under the provisions of the CARES Act, the Company is eligible for a refundable employee retention credit subject to certain criteria. The Company recognized a $
14
ended September 30, 2021. There was
Credit Agreement
On March 25, 2020, the Company executed a credit agreement up to $
On September 14, 2020, the Company and the Lender entered into an amendment to the credit agreement that increased the amount available under delayed draw term loans by $
On December 16, 2020, the Company and the Lender entered into the third amendment to the credit agreement that increased the amount available under delayed draw term loans by an additional $
On January 19, 2021, the Company and the Lender entered into an amendment to the credit agreement that increased the amount available under delayed draw term loans by $
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On March 10, 2021, the Company and the Lender entered into an amendment to the credit agreement that extended the maturity date from March 31, 2021 to March 31, 2022. The Company has accounted for this amendment as a debt modification. The associated unamortized debt discount on the January 19, 2021 amendment of $
On June 28, 2021, the Company entered into a warrant exercise agreement with existing accredited investors, including the Lender, to exercise certain outstanding warrants. For further details on this transaction see Note 9. The Company used some of the proceeds from this transaction to pay off the $
Asset Purchase Consideration Payable
The asset purchase consideration payable related to the Company’s December 2018 acquisition of the Lap-Band product line from Apollo Endosurgery, Inc. (“Apollo”), was initially recorded at net present value using a discount rate of
(6) Leases
The Company has noncancelable operating leases for office and warehouse space in San Clemente and Carlsbad, California, as well as noncancelable operating leases for certain office equipment that expire at various dates through 2022. The Company does not have any short-term leases or financing lease arrangements and the effects of any lease modifications have not been material. Certain of the Company’s equipment leases include variable lease payments that are adjusted periodically based on actual usage. Lease and non-lease components are accounted for separately.
Operating lease costs was $
Supplemental information related to operating leases is as follows:
Balance sheet information at September 30, 2021 | |||
Operating lease ROU assets | $ | | |
Operating lease liabilities, current portion | $ | | |
Operating lease liabilities, long-term portion | - | ||
Total operating lease liabilities | $ | | |
Cash flow information for the nine months ended September 30, 2021 | |||
Cash paid for amounts included in the measurement of operating leases liabilities | $ | |
16
Maturities of operating lease liabilities were as follows:
Twelve months ending September 30, 2021 |
|
| |
2022 | $ | | |
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 |
(7) Acquisition
On June 15, 2021, the Company completed the previously announced merger with Obalon, which was treated as a reverse acquisition for accounting purposes, for an aggregate purchase price of $
Tangible and intangible assets acquired were recorded based on their estimated fair values at the acquisition date. The excess of the purchase price over the fair value of the net assets acquired was recorded to goodwill. The following table summarizes the preliminary fair values of the assets acquired and liabilities assumed, primarily related to inventory, developed technology, goodwill (including the deductibility for tax purposes) and income tax related accruals:
Current assets | $ | | |
Property and equipment, net | | ||
Right-of-use assets | | ||
Other assets | | ||
Goodwill | | ||
Developed technology | | ||
Liabilities assumed | ( | ||
Total purchase price | | ||
Less: cash acquired | ( | ||
Total purchase price, net of cash acquired | $ | |
As part of the warrants agreements there was a fundamental transaction provision that would provide the holders a cash payment based on a Black-Scholes valuation of the warrants. This clause was valid for 30 days subsequent to the date of the transaction. The Company performed a preliminary valuation of the warrants and recorded a liability at the time of the merger of $
The size of the Obalon acquisition necessitates use of the allowable measurement period to adequately analyze all the factors used in establishing the asset and liability fair values as of the acquisition date. The preliminary acquisition
17
accounting is based upon the Company’s estimates of fair value. The primary areas of the preliminary acquisition accounting that are not yet finalized include the following: (i) finalizing the review and valuation of property and equipment (including the models, key assumptions, estimates and inputs used), (ii) finalizing the review and valuation of related intangible assets (including key assumptions, inputs and estimates), (iii) finalizing the valuation of certain in-place contracts or contractual relationships (including but not limited to leases), (iv) finalizing our review of certain assets acquired and liabilities assumed, (v) finalizing our estimate of the impact of acquisition accounting on deferred income taxes or liabilities. As the initial acquisition accounting is based on our preliminary assessments, actual values may differ (possibly materially) when final information becomes available that differs from our current estimates. We will continue to evaluate these items, until they are satisfactorily resolved and adjust our acquisition accounting accordingly, within the allowable measurement period (not to exceed one year from the date of acquisition), as defined by ASC 805.
Goodwill includes expected synergies and other benefits the Company believes will result from the acquisition. The developed technology has been capitalized at fair value as an intangible asset with an estimated life of
Pro Forma Results of Operations
The following table summarizes the results of operations of the above mentioned acquisition from their respective dates of acquisition included in our consolidated results of operations and the unaudited pro forma results of operations of the combined entity had the date of acquisition been January 1, 2020:
Revenue | Net Loss | |||||
Acquired entities only: Actual from acquisition date to September 30, 2021 | ||||||
Obalon Therapeutics | $ | — | $ | ( | ||
Combined entity: Supplemental pro forma from July 1, 2021 to September 30, 2021 | | ( | ||||
Combined entity: Supplemental pro forma from July 1, 2020 to September 30, 2020 | | ( | ||||
Combined entity: Supplemental pro forma from January 1, 2021 to September 30, 2021 | | ( | ||||
Combined entity: Supplemental pro forma from January 1, 2020 to September 30, 2020 | | ( |
The information presented above is for illustrative purposes only and is not necessarily indicative or results that would have been achieved if the acquisitions had occurred as of the beginning of our 2020 reporting period.
(8) Equity
August 2021 Issuance of Common Stock for Services
On August 11, 2021, the Company entered into a consulting agreement in which the Company issued to the consultant
July 2021 Exchange of Warrants for Common Stock
On July 16, 2021, the Company entered into an exchange agreement (the “Exchange Agreement”) with existing institutional investors to exchange certain outstanding warrants (the “Exchange Warrants”) for shares of common stock and new warrants to purchase common stock. The investors held common stock purchase warrants issued by the Company prior to the merger of Obalon Therapeutics, Inc. and ReShape Lifesciences Inc. The merger constituted a fundamental transaction under the Exchange Warrants and, as a result thereof, pursuant to the terms and conditions of the Exchange Warrants, the investors were entitled to a cash payment equal to the Black Scholes value of the Exchange Warrants, calculated in accordance with the terms of the Exchange Warrants (the “Black Scholes Payment”).
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Subject to the terms and conditions set forth in the Exchange Agreement and, in reliance on Section 3(a)(9) of the Securities Act, in lieu of the Black Scholes Payment, the Company and the Investors agreed to exchange all of the Exchange Warrants for (a) a total of
June 2021 Exercises of Warrants for Common Stock
On June 28, 2021, the Company entered into a warrant exercise agreement with existing accredited investors to exercise certain outstanding warrants to purchase up to an aggregate of
The gross proceeds to the Company from the Exercise and the sale of the New Warrants was approximately $
On June 18, 2021, the Company issued
Common Stock Issued related to stock awards and options
Restricted Stock Units
On July 22, 2021, the Company issued restricted stock units (“RSUs”) to certain members of the management and Board of Directors. During the three and nine months ended September 30, 2021, the Company issued
Exercise of Stock Options
On September 15, 2021, the Company issued
On July 13, 2021, the Company issued
On June 18, 2021, the Company issued
December 2020 Exercise of Warrants for Common Stock
On December 3, 2020, the Company issued
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connection with the June 2019 and September 2019 private placement transactions. The Company received approximately $
June 2020 Cashless Exercise of Warrants for Common Stock
On June 23, 2020, the Company issued
May 2020 Common Stock Issued for Professional Services
On May 28, 2020, the Company issued
April 2020 Exercise of Warrants for Common Stock
As discussed in Note 5 above, in connection with the credit agreement, the lender exercised its Series C and Series F warrants to purchase an aggregate of
(9) Warrants
On July 16, 2021, the Company entered into an exchange agreement with an existing accredited investor to exchange certain outstanding warrants for shares of common stock and issued new warrants to purchase up to total of
On June 28, 2021, the Company entered into a warrant exercise agreement with existing accredited investors to exercise certain outstanding warrants. As part of this agreement the Company modified the Series E warrants issued September 23, 2019 from an exercise price of $
On January 19, 2021, the Company issued
On December 16, 2020, the Company issued
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On September 14, 2020, the Company issued
On March 25, 2020, the Company issued
(10) 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 and nine months ended September 30, 2021 and 2020, the Company primarily only sold the LAP-BAND product line. The following table presents the Company’s revenue disaggregated by geography:
Three Months Ended | Nine Months Ended | |||||||||||
September 30, | September 30, | |||||||||||
| 2021 |
| 2020 |
| 2021 |
| 2020 | |||||
United States | $ | | $ | | $ | | $ | | ||||
Australia | | | | | ||||||||
Europe | | | | | ||||||||
Rest of world | | | | | ||||||||
Total revenue | $ | | $ | | $ | $ |
*The next largest individual country outside the United States was the United Kingdom for the three months ended September 30, 2021 and 2020, which was
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 product line, which consisted of nearly all our revenue and gross profit for the three and nine months ended September 30, 2021 and 2020. During the second half of 2020 the Company launched reshapecare, which had minimal revenue for the three and nine months ended September 30, 2021, and
(11) Income Taxes
During the three and nine months ended September 30, 2021, a $
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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 September 30, 2021 and December 31, 2020.
Additionally, as stated above, upon completion of the business combination on June 16, 2021 with Obalon, the transaction was treated as a “reverse acquisition” for financial accounting purposes. Due to the fact that more than
(12) 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 and nine months ended September 30, 2021 and 2020 were as follows:
Three Months Ended | Nine Months Ended | |||||||||||
September 30, | September 30, | |||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||
Sales and marketing | $ | | $ | — | $ | | $ | — | ||||
General and administrative | | | | | ||||||||
Research and development | | — | | — | ||||||||
Total stock-based compensation expense | $ | | $ | | $ | | $ | |
As part of the merger agreement with Obalon, all of the outstanding, vested and unvested stock option awards granted by ReShape were forfeited and cancelled. As a result, the Company reversed the previously recognized expense for the unvested awards at the time the merger was completed.
Stock Options
On August 18, 2021, the Company granted
A summary of the status of the Company’s stock options as of September 31, 2021 and changes during the nine months ended September 30, 2021 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, 2020 |
| | $ | | $ | — | ||||
Vested options obtained due to merger |
| | | |||||||
Options granted |
| | | |||||||
Options exercised |
| ( | | |||||||
Options cancelled |
| ( | | |||||||
Outstanding at September 30, 2021 |
| | | $ | | |||||
Exercisable at September 30, 2021 | | | | |||||||
Vested and expected to vest at September 30, 2021 | | | |
The total intrinsic value of the options outstanding as of September 30, 2021, was $
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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
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 the 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.
The Company’s weighted average assumptions used to estimate fair value of stock options granted during the nine months ended September 30, 2021 were as follows:
Risk-free interest rate | |||
Expected term (in years) | |||
Expected dividend yield | |||
Expected volatility |
Restricted Stock Units
On July 22, 2021, the Company issued
A summary of the Company’s unvested RSUs award activity for the nine months ended September 30, 2021, were as follows:
Weighted | |||||
Average | |||||
| Grant Date | ||||
Shares | Fair Value | ||||
Unvested RSUs at December 31, 2020 |
| — | $ | — | |
Granted |
| | | ||
Vested (1) |
| ( | | ||
Cancelled/Forfeited |
| — | — | ||
Non-vested RSUs at September 30, 2021 |
| | |
(1) | At September 30, 2021, 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 September 30, 2021 was $
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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 ReShape Vest, an investigational device to help treat more patients with obesity, 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 ReShape Vest or the Diabetes Bloc-Stim Neuromodulation as these products are still in the development stage.
Recent Developments
On January 19, 2021, the Company entered into the fourth amendment to the credit agreement that increased the amount available under the delayed draw term loans by $1.0 million, of which all funds were received upfront and used for the escrow fund securing the termination fee under the Merger Agreement. The maturity date of the loans under the credit agreement, including those under the amendment was March 31, 2021, which as subsequently been paid in full.
On March 1, 2021, the Company received confirmation from the SBA that the PPP Loan was forgiven in full including all interest incurred.
On March 10, 2021, the Company entered into the fifth amendment to the credit agreement that extended the maturity date from March 31, 2021 to March 31, 2022.
On June 15, 2021, the Company completed its merger with Obalon, pursuant to which a wholly owned subsidiary of Obalon merged with and into ReShape. As a result of the merger, Obalon was renamed “ReShape Lifesciences Inc.” and ReShape Lifesciences Inc. was renamed “ReShape Weightloss Inc.”, which is now a wholly owned subsidiary of ReShape Lifesciences Inc.
On June 28, 2021, the Company entered into a warrant exercise agreement with existing accredited investors to exercise certain outstanding warrants to purchase up to an aggregate of 7.9 million shares of the Company’s common stock. In consideration for the immediate exercise of the existing warrants for cash, the investors were granted new unregistered warrants to purchase up to 5.9 million shares of common stock with an exercise price of $6.00 per share. The Company received approximately $45.5 million in proceeds, of which $10.8 million was used to pay off the credit agreement, including $10.5 million of debt and $0.3 million of accrued interest. The remaining proceeds will be used for working capital and general corporate purposes.
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On October 12, 2021, the Company announced the launch of a multi-platform consumer advertising campaign utilizing national television, print, social media, and public relations to market the Next-Generation Lap-Band program with available aftercare supported through reshapecare, the reimbursable virtual health coaching platform to create consumer awareness and increase patient demand.
On November 4, 2021, the Company announced the launch of an advanced line of supplements for bariatric surgery and medical weight loss patients, ReShape OptimizeTM by ProCare Health®. Products form the new supplement line will be available for purchase in the ReShape Marketplace, and extension of reshapecare.
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 September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||||||||||
Revenue | $ | 3,708 | 100.0 | % | $ | 3,602 | 100.0 | % | $ | 10,458 | 100.0 | % | $ | 8,092 | 100.0 | % | ||||||||
Cost of goods sold | 1,573 | 42.4 | % | 1,321 | 36.7 | % | 3,886 | 37.2 | % | 3,471 | 42.9 | % | ||||||||||||
Gross profit | 2,135 | 57.6 | % | 2,281 | 63.3 | % | 6,572 | 62.8 | % | 4,621 | 57.1 | % | ||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Sales and marketing | 3,496 | 94.3 | % | 1,160 | 32.2 | % | 6,186 | 59.2 | % | 3,446 | 42.6 | % | ||||||||||||
General and administrative | 12,052 | 325.0 | % | 2,434 | 67.6 | % | 19,085 | 182.5 | % | 7,809 | 96.5 | % | ||||||||||||
Research and development | 1,571 | 42.4 | % | 859 | 23.8 | % | 2,245 | 21.5 | % | 2,619 | 32.4 | % | ||||||||||||
Total operating expenses | 17,119 | 461.7 | % | 4,453 | 123.6 | % | 27,516 | 263.1 | % | 13,874 | 171.5 | % | ||||||||||||
Operating loss | (14,984) | (404.1) | % | (2,172) | (60.3) | % | (20,944) | (200.3) | % | (9,253) | (114.3) | % | ||||||||||||
Other expense (income), net: | ||||||||||||||||||||||||
Interest expense, net | 33 | 0.9 | % | 739 | 20.5 | % | 804 | 7.7 | % | 1,632 | 20.2 | % | ||||||||||||
Warrant expense | 2,813 | 76 | % | — | — | % | 2,813 | 26.9 | % | — | — | % | ||||||||||||
Loss on extinguishment of debt, net | — | — | % | 2,435 | 68 | % | 2,061 | 19.7 | % | 2,435 | 30 | % | ||||||||||||
Gain on foreign currency | (101) | (2.7) | % | (128) | (3.6) | % | (170) | (1.6) | % | (118) | (2) | % | ||||||||||||
Loss before income tax provision | (17,729) | (478.1) | % | (5,218) | (144.9) | % | (26,452) | (252.9) | % | (13,202) | (163.1) | % | ||||||||||||
Income tax expense (benefit) | (30) | (0.8) | % | (39) | (1.1) | % | 23 | 0.2 | % | (108) | (1.3) | % | ||||||||||||
Net loss | $ | (17,699) | (477.3) | % | $ | (5,179) | (143.8) | % | $ | (26,475) | (253.2) | % | $ | (13,094) | (161.8) | % |
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 and that, in some respects, these non-GAAP financial measures are more indicative of the Company’s ongoing core operating performance than their GAAP equivalents.
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, derivative instruments, 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
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measurement process. Adjusted EBITDA is defined as net loss before interest, taxes, depreciation and amortization, stock-based compensation, and other one-time costs.
The following table contains a reconciliation of non-GAAP net loss to GAAP net loss attributable to common stockholders for the three and nine months ended September 30, 2021 and 2020 (in thousands):
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||
GAAP net loss | $ | (17,699) | $ | (5,179) | $ | (26,475) | $ | (13,094) | |||
Adjustments: | |||||||||||
Interest expense, net | 33 | 739 | 804 | 1,632 | |||||||
Income tax expense (benefit) | (30) | (39) | 23 | (108) | |||||||
Depreciation and amortization | 548 | 419 | 1,416 | 1,257 | |||||||
Stock-based compensation expense | 10,720 | 255 | 10,457 | 1,029 | |||||||
Loss on extinguishment of debt, net | — | 2,435 | 2,061 | 2,435 | |||||||
Warrant expense | 2,813 | — | 2,813 | — | |||||||
Professional fees incurred in connection with the Obalon merger | — | — | 2,277 | — | |||||||
Non-GAAP loss | $ | (3,615) | $ | (1,370) | $ | (6,624) | $ | (6,849) |
Comparison of Results of Operations
Three months ended September 30, 2021 and September 30, 2020
Revenue: The following table summarizes our unaudited revenue by geographic location based on the location of customers for the three months ended September 30, 2021 and 2020, 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 September 30, | Amount | Percentage | |||||||||||||||
2021 | 2020 | Change | Change | ||||||||||||||
United States | $ | 2,745 | 74.0 | % | $ | 2,594 | 72.0 | % | $ | 151 | 5.8 | % | |||||
Australia | 278 | 7.5 | % | 307 | 8.5 | % | (29) | (9.4) | % | ||||||||
Europe | 653 | 17.6 | % | 637 | 17.7 | % | 16 | 2.5 | % | ||||||||
Rest of world | 32 | 0.9 | % | 64 | 1.8 | % | (32) | (50.0) | % | ||||||||
Total revenue | $ | 3,708 | 100.0 | % | $ | 3,602 | 100.0 | % | $ | 106 | 2.9 | % |
Revenue totaled $3.7 million for the three months ended September 30, 2021, compared to $3.6 million for the same period in 2020. The primary reason for the increase in revenue of $0.1 million, or 2.9%, is due to a $0.2 million increase in sales for the United States, offset by a $0.1 million decrease internationally. The increase domestically is primarily due to an improved and expanded sales force, coupled with increased sales and marketing efforts. There has also been a rise in obesity awareness due to the complications associated with COVID-19 from obesity. Internationally, in certain regions, there continues to be a slowdown in procedures primarily due to the Delta variant of COVID-19.
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Cost of Goods Sold and Gross Profit: The following table summarizes our unaudited cost of revenue and gross profit for the three months ended September 30, 2021 and 2020, as well as the percentage compared to total revenue and amount of change and percentage of change (dollars in thousands):
Three Months Ended September 30, | Amount | Percentage | |||||||||||||||
2021 | 2020 | Change | Change | ||||||||||||||
Revenue | $ | 3,708 | 100.0 | % | $ | 3,602 | 100.0 | % | $ | 106 | 2.9 | % | |||||
Cost of goods sold | 1,573 | 42.4 | % | 1,321 | 36.7 | % | 252 | 19.1 | % | ||||||||
Gross profit | $ | 2,135 | 57.6 | % | $ | 2,281 | 63.3 | % | $ | (146) | (6.4) | % |
Gross Profit. Gross profit for the three months ended September 30, 2021, was $2.1 million, compared to $2.3 million for the same period in 2020, a decrease of $0.2 million. Gross profit as a percentage of total revenue for the three months ended September 30, 2021, was 57.6% compared to 63.3% for the same period in 2020. The decrease in gross profit margin is primarily due to increased department expenses, which includes increased consulting fees, payroll related expenses, and depreciation, along with increased freight costs. In addition, during the three months ended September 31, 2021, the Company incurred cost of sales related to Obalon, as the Company is preparing to reintroduce the Obalon Balloon into the market at some point in the near future.
Operating Expenses: The following table summarizes our unaudited operating expenses for the three months ended September 30, 2021, and 2020, as well as the percentage of total revenue and the amount of change and percentage of change (dollars in thousands):
Three Months Ended September 30, | Amount | Percentage | |||||||||||||||
2021 | 2020 | Change | Change | ||||||||||||||
Sales and marketing | $ | 3,496 | 94.3 | % | $ | 1,160 | 32.2 | % | $ | 2,336 | 201.4 | % | |||||
General and administrative | 12,052 | 325.0 | % | 2,434 | 67.6 | % | 9,618 | 395.2 | % | ||||||||
Research and development | 1,571 | 42.4 | % | 859 | 23.8 | % | 712 | 82.9 | % | ||||||||
Total operating expenses | $ | 17,119 | 461.7 | % | $ | 4,453 | 123.6 | % | $ | 12,666 | 284.4 | % |
Total operating expenses increased by $12.7 million, primarily due to an increase in stock-based compensation expense of $10.7 million. After the Obalon merger, and subsequent listing on NASDAQ, the Company issued either restricted stock units or stock options to the entire company, its first grant since 2017. The vesting schedules of these grants were retroactive to hire dates, so there was a catch-up expense of $8.9 million. Due to this, the Company expects stock-based compensation expense to normalize going forward. In addition, the Company has begun to focus on increasing brand recognition through improving our marketing strategies, including television and print advertisements, and social media presence which has increased our payroll related costs as we have expanded our workforce, and increased consulting and other professional fees.
Sales and Marketing Expense. Sales and marketing expenses for the three months ended September 30, 2021, increased by $2.3 million, or 201.4%, to $3.5 million, compared to $1.2 million for the same period in 2020. The increase is due to an increase of $1.1 million in stock-based compensation expense, as during the third quarter the company issued both RSUs and stock options containing a look back provision to begin vesting at the one-year anniversary of the date of employment, resulting in an expense of $0.9 million at the time the awards were granted. In addition, the Company began to ramp up its marketing efforts, with an increase in advertising and marketing expenses of $0.8 million, an increase in payroll related expenses of $0.2 million, from an expanded and improved sales force, and higher commissions from increased sales. There was also an increase of $0.1 million in both software costs and travel and entertainment expenses. With funds from the recent equity raise, the Company expects to devote more resources toward sales and marketing, particularly through our national direct to consumer campaign, and hence increase sales and marketing expenses as a percentage of revenue through the remainder of the year.
General and Administrative Expense. General and administrative expenses for the three months ended September 30, 2021, increased by $9.6 million, or 395.2%, to $12.0 million, compared to $2.4 million for the same period in 2020. The increase is primarily due to an increase of $8.1 million in stock-based compensation expense, as during the third quarter the company issued both RSUs and stock options containing a look back provision to begin vesting at the one-year anniversary of the date of employment, resulting in an expense of $6.8 million at the time the
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awards were granted. In addition, there was an increase in audit, consulting, legal and other professional services of $0.2 million, an increase in payroll related expenses of $0.8 million, primarily related to increased bonus expenses of $0.6 million, an increase in rent and facility expenses of $0.2 million from an entire quarter of the Obalon facility, and an increase in insurance expenses of $0.1 million.
Research and Development Expense. Research and development expenses for the three months ended September 30, 2021, increased by $0.7 million, or 82.9%, to $1.6 million, compared to $0.9 million for the same period in 2020. The increase is primarily due to an increase of $1.2 million in stock-based compensation expense, as during the third quarter the company issued both RSUs and stock options containing a look back provision to begin vesting at the one-year anniversary of the date of employment, resulting in an expense of $1.2 million at the time the awards were granted. This was offset by a decrease of $0.5 million in consulting and clinical trial expenses as a result of the slowdown in clinical trials for the ReShape Vest due to the COVID-19 pandemic.
Net Interest Expense. Net interest expense for the three months ended September 30, 2021, decreased by $0.7 million to $33 thousand compared to $0.7 million for the same period in 2020. The reason for the decrease is due to the Company paying off their credit agreement in the second quarter of 2021 and the forgiveness of the PPP loan including accrued interest during the first quarter of this year.
Warrant Expense. Warrant expense was $2.8 million for the three months ended September 30, 2021. The warrant expense relates the issuance of warrants and common stock in connection with the exchange agreement entered into with an investor that held Obalon warrants and exercised the fundamental transaction provision of their warrants.
Gain on Foreign Currency. Gain on foreign currency for both the three months ended September 30, 2021, and 2020, was $0.1 million. Foreign currency gains relate to the foreign currency fluctuations in our global trade and intercompany receivable and payable balances.
Income Tax Expense (Benefit). Income tax benefit was $30 thousand for the three months ended September 30, 2021, compared to a benefit of $39 thousand for the three months ended September 30, 2020.
Nine months ended September 30, 2021 and September 30, 2020
Revenue: The following table summarizes our unaudited revenue by geographic location based on the location of customers for the nine months ended September 30, 2021 and 2020, as well as the percentage of each location to total revenue and the amount of change and percentage of change (dollars in thousands):
Nine Months Ended September 30, | Amount | Percentage | |||||||||||||||
2021 | 2020 | Change | Change | ||||||||||||||
United States | $ | 7,897 | 75.5 | % | $ | 6,006 | 74.2 | % | $ | 1,891 | 31.5 | % | |||||
Australia | 849 | 8.1 | % | 725 | 9.0 | % | 124 | 17.1 | % | ||||||||
Europe | 1,622 | 15.5 | % | 1,273 | 15.7 | % | 349 | 27.4 | % | ||||||||
Rest of world | 90 | 0.9 | % | 88 | 1.1 | % | 2 | 2.3 | % | ||||||||
Total revenue | $ | 10,458 | 100.0 | % | $ | 8,092 | 100.0 | % | $ | 2,366 | 29.2 | % |
Revenue totaled $10.5 million for the nine months ended September 30, 2021, compared to $8.1 million for the same period in 2020. The primary reason for the increase in revenue of $2.4 million, or 29.2%, is due to a $1.9 million increase in sales for the United States, and a $0.5 million increase internationally. The increase both domestically and internationally, is primarily due to lessened COVID 19 pandemic restrictions for elective surgeries in 2021 as compared to 2020. There has also been a rise in obesity awareness due to the complications associated with COVID-19 for obesity, and the Company has increased its overall sales and marketing efforts, which has helped increase sales.
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Cost of Goods Sold and Gross Profit: The following table summarizes our unaudited cost of revenue and gross profit for the nine months ended September 30, 2021 and 2020, as well as the percentage compared to total revenue and amount of change and percentage of change (dollars in thousands):
Nine Months Ended September 30, | Amount | Percentage | |||||||||||||||
2021 | 2020 | Change | Change | ||||||||||||||
Revenue | $ | 10,458 | 100.0 | % | $ | 8,092 | 100.0 | % | $ | 2,366 | 29.2 | % | |||||
Cost of goods sold | 3,886 | 37.2 | % | 3,471 | 42.9 | % | 415 | 12.0 | % | ||||||||
Gross profit | $ | 6,572 | 62.8 | % | $ | 4,621 | 57.1 | % | $ | 1,951 | 42.2 | % |
Gross Profit. Gross profit for the nine months ended September 30, 2021, was $6.6 million compared to $4.6 million for the same period in 2020, an increase of $2.0 million. Gross profit as a percentage of total revenue for the nine months ended September 30, 2021, was 62.8%, compared to 57.1% for the same period in 2020. The increase in gross profit margin is primarily due to increased volume, as revenue increased 29.2%, reduced period expenses, and improved product mix with higher domestic sales as a percentage of revenue, which have a higher gross profit margin than international sales.
Operating Expenses: The following table summarizes our unaudited operating expenses for the nine months ended September 30, 2021 and 2020, as well as the percentage of total revenue and the amount of change and percentage of change (dollars in thousands):
Nine Months Ended September 30, | Amount | Percentage | |||||||||||||||
2021 | 2020 | Change | Change | ||||||||||||||
Sales and marketing | $ | 6,186 | 59.2 | % | $ | 3,446 | 42.6 | % | $ | 2,740 | 79.5 | % | |||||
General and administrative | 19,085 | 182.5 | % | 7,809 | 96.5 | % | 11,276 | 144.4 | % | ||||||||
Research and development | 2,245 | 21.5 | % | 2,619 | 32.4 | % | (374) | (14.3) | % | ||||||||
Total operating expenses | $ | 27,516 | 263.2 | % | $ | 13,874 | 171.5 | % | $ | 13,642 | 98.3 | % |
Total operating expenses increased by $13.6 million, primarily due to an increase in stock-based compensation expense of $10.5 million. After the Obalon merger, and subsequent listing on NASDAQ, the Company issued either restricted stock units or stock options to the entire company, its first grant since 2017. The vesting schedules for these grants were retroactive to hire dates, so there was a catch-up expense of $8.9 million. Due to this, the Company expects for stock-based compensation expense to normalize going forward. In addition, the Company has begun focusing on increasing brand recognition through improving our marketing strategies, including television and print advertisements, and social media presence which has increased our payroll related costs as we have expanded our workforce, and increased consulting and other professional fees to aid with these efforts.
Sales and Marketing Expense. Sales and marketing expenses for the nine months ended September 30, 2021 increased by $2.7 million, or 79.5%, to $6.2 million, compared to $3.5 million for the same period in 2020. The increase is due to an increase of $1.1 million in stock-based compensation expense, as during the third quarter the company issued both RSUs and stock options containing a look back provision to begin vesting at the one-year anniversary of the date of employment, resulting in an expense of $0.9 million at the time the awards were granted. The Company has begun to ramp up its marketing efforts with an increase in advertising and marketing expenses of $1.3 million. In addition, commissions increased $0.2 million from higher revenue and software costs increased by $0.1 million, offset by a decrease of $0.1 million in consulting fees. With funds from the recent equity raise, the Company expects to devote more resources toward sales and marketing, particularly through our national direct to consumer campaign, and hence increase sales and marketing expenses as a percentage of revenue through the remainder of the year.
General and Administrative Expense. General and administrative expenses for the nine months ended September 30, 2021, increased by $11.3 million, or 144.4%, to $19.1 million, compared to $7.8 million for the same period in 2020. The increase is primarily due to an increase of $7.1 million in stock-based compensation expense, as during the third quarter the Company issued both RSUs and stock options containing a look back provision to begin vesting at the one-year anniversary of the date of employment, resulting in an expense of $6.8 million at the time the awards were granted. In addition, the Company had increases in audit, consulting, legal and other professional services of $3.1 million, of which $2.3 million is directly related to the merger with Obalon, an increase in legal fees of $0.3
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million, an increase in other payroll related expenses of $0.8 million due to a $0.6 million increase in bonus fees, and an increase of $0.1 million in rent and facilities due to the merger with Obalon. This is offset by a decrease of $0.1 million in bad debt expenses.
Research and Development Expense. Research and development expenses for the nine months ended September 30, 2021, decreased by $0.4 million, or 14.3%, to $2.2 million, compared to $2.6 million for the same period in 2020. The decrease is primarily due to a $1.5 million reduction in consulting, and clinical trial expenses as a result of a slowdown in clinical trials for the ReShape Vest due to the COVID-19 pandemic. This was offset by an increase of $1.2 million in stock-based compensation expense, as during the third quarter the company issued both RSUs and stock options containing a look back provision to begin vesting at the one-year anniversary of the date of employment, resulting in an expense of $1.2 million at the time the awards were granted.
Net Interest Expense. Net interest expense for the nine months ended September 30, 2021, decreased by $0.8 million to $0.8 million compared to $1.6 million for the same period in 2020. The reason for the decrease is due to the Company paying off the credit agreement during the second quarter of 2021 and the forgiveness of the PPP loan including accrued interest during the first quarter of this year.
Loss on Extinguishment of Debt, Net. Loss on extinguishment of debt, net for the nine months ended September 30, 2021, was $2.1 million, which consisted of losses of $3.0 million related to the fair value of the warrants issued in connection with the January 19, 2021, credit agreement amendments and $0.1 million related to the early payment of the debt. These losses were offset by a $1.0 million gain on the full extinguishment of our PPP loan, as we received official confirmation of forgiveness on March 1, 2021.
Warrant Expense. Warrant expense was $2.8 million for the nine months ended September 30, 2021. The warrant expense relates the issuance of warrants and common stock in connection with the exchange agreement entered with an investor that held Obalon warrants and exercised the fundamental transaction provision of their warrants.
Gain on Foreign Currency. Gain on foreign currency for the nine months ended September 30, 2021, was $0.2 million compared to a gain of $0.1 million for the same period in 2020. Foreign currency gains and losses relate to the foreign currency fluctuations in our global trade and intercompany receivable and payable balances.
Income Tax Expense (Benefit). Income tax expense was $23 thousand for the nine months ended September 30, 2021, compared to a benefit of $0.1 million for the nine months ended September 30, 2020.
Liquidity and Capital Resources
We have financed our operations to date principally through the sale of equity securities and debt financings. During the nine months ended September 30, 2021 and 2020, we received proceeds of $45.6 million and $0.6 million, respectively, from exercises of warrants by institutional investors, and $1.0 million and $4.5 million, respectively, from the credit agreement with an institutional investor. As of September 30, 2021, we had $29.3 million of cash and cash equivalents, which includes $5.2 million of cash received in connection with the acquisition of Obalon and $50 thousand of restricted cash. During March of 2021, the Company received confirmation from the SBA that the PPP Loan was forgiven in full including all interest incurred and in June of 2021, the credit agreement was paid in full.
In January 2021, we entered into an agreement to merge with Obalon resulting in the removal of the going concern opinion. During June of 2021, the Company completed the merger with Obalon and obtained approval for the combined Company’s common stock to be traded on the NASDAQ Capital Market.
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The following table summarizes our change in cash and cash equivalents and restricted cash (in thousands):
Nine Months Ended | ||||||
September 30, | ||||||
2021 |
| 2020 | ||||
Net cash used in operating activities | $ | (11,949) | $ | (6,788) | ||
Net cash used in investing activates | 4,922 | (230) | ||||
Net cash provided in financing activities |
| 33,299 |
| 6,006 | ||
Effect of exchange rate changes | 14 | (66) | ||||
Net change in cash and cash equivalents | $ | 26,286 | $ | (1,078) |
Net Cash Used in Operating Activities
Net cash used in operating activities from operations was $12.0 million and $6.8 million for the nine months ended September 30, 2021 and 2020, respectively. For the nine months ended September 30, 2021, net cash used in operating activities was primarily the result of our net loss of $26.5 million, partially offset by non-cash adjustments for stock-based compensation expense of $10.5 million, amortization of intangible assets of $1.3 million, net loss on extinguishment of debt of $2.1 million, warrant expense of $2.8 million and amortization of debt discount of $0.5 million. We show a negative cash impact to accounts receivable of $0.9 million, as we had an increase in sales late in the third quarter, a negative impact due to increase prepaids of $0.4 million and a cash outflow for accounts payable and accruals of $1.8 million as the Company paid its vendors with the funds received in the equity raise during June of 2021. These decreases were partially offset by a change in other assets of $0.4 million.
For the nine months ended September 30, 2020, net cash used in operating activities was primarily the result of our net loss of $13.1 million, partially offset by non-cash adjustments for amortization of intangible assets of $1.2 million, noncash interest expense of $0.2 million, loss on extinguishment of debt of $2.4 million, stock-based compensation expense of $1.0 million, bad debt expense of $0.2 million, provision for inventory excess and obsolescence of $0.2 million and amortization of debt discount and deferred debt issuance cost of $1.4 million. In addition, the Company has focused on collection of accounts receivable, which resulted in an increase to cash of $1.0 million, which was offset by an increase in change of inventory of $0.9 million primarily due to expected inventory buildup related to our impending manufacturing transfer, and a decrease in accounts payable and accrued liabilities of $1.3 million.
Net Cash Provided by Investing Activities
Net cash provided by investing activities for the nine months ended September 30, 2021 was $4.9 million, which was comprised of $5.2 million of cash received in connection with the merger with Obalon, offset by capital expenditures of $0.3 million, primarily related to the completion of moving manufacturing from Costa Rica to the United States.
Net cash used in investing activities for the nine months ended September 30, 2020 was $0.2 million, comprised of capital expenditures related to the process of moving manufacturing from Costa Rica to the United States.
Net Cash Provided by Financing Activities
Net cash provided by financing activities was $33.3 million for the nine months ended September 30, 2021, due to proceeds of $45.6 million received from exercises of warrants from institutional investors, $1.0 million received from the credit agreement with an institutional investor, and $0.4 million in proceeds received from stock option exercises, offset by the early payment of $10.5 million to pay off the credit agreement and $3.2 million for financing costs.
Net cash provided by financing activities of $6.0 million for the nine months ended September 30, 2020, consisted of proceeds received from the credit agreement with an institutional investor of $4.5 million, $1.0 million received under the CARES Act in the form of a PPP Loan and $0.6 million in cash received from the exercise of warrants, offset by approximately $0.1 million of debt issuance costs.
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Operating Capital and Capital Expenditure Requirements
Our anticipated operations include plans to (i) integrate the sales and operations of the Company with the LAP-BAND product line in order to expand sales domestically and internationally as well as to obtain cost savings synergies, (ii) introduce to the market place reshapecare and ReShape Marketplace as an extension of reshapecare, (iii) ramp up marketing efforts to increase brand recognition, create customer awareness and increase in patient demand, (iv) continue clinical trials of the ReShape Vest, (v) continue development of the Diabetes Bloc-Stim Neuromodulation, (vi) seek opportunities to leverage our intellectual property portfolio and custom development services to provide third-party sales and licensing opportunities, and (vii) 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 the recently acquired Obalon balloon. 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.
Our forecast of the period of time through which our financial resources will be adequate to support our operations, the costs to complete development of products and the cost to commercialize our products are forward-looking statements and involve risks and uncertainties, and actual results could vary materially and negatively as a result of a number of factors, including the factors discussed in Part I, Item 1A, “Risk Factors”, of our Annual Report on Form 10-K. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.
Because of the numerous risks and uncertainties associated with the development of medical devices, such as our ReShape Vest and Diabetes Bloc-Stim Neuromodulation, we are unable to estimate the exact amounts of capital outlays and operating expenditures necessary to complete the development of the ReShape Vest and Diabetes Bloc-Stim Neuromodulation or other additional products and successfully deliver a commercial product to the market. Our future capital requirements will depend on many factors, including, but not limited to, the following:
● | the cost and timing of establishing sales, marketing and distribution capabilities; |
● | the cost of establishing clinical and commercial supplies of our ReShape Vest and Diabetes Bloc-Stim Neuromodulation, and any products that we may develop; |
● | the rate of market acceptance of our ReShape Vest and Diabetes Bloc-Stim Neuromodulation and any other product candidates; |
● | the cost of filing and prosecuting patent applications and defending and enforcing our patent and other intellectual property rights; |
● | the cost of defending, in litigation or otherwise, any claims that we infringe third-party patent or other intellectual property rights; |
● | the effect of competing products and market developments; |
● | the cost of explanting clinical devices; |
● | the terms and timing of any collaborative, licensing or other arrangements that we may establish; |
● | any revenue generated by sales of our Lap-Band, reshapecare, ReShape Vest, Diabetes Bloc-Stim Neuromodulation or future products; |
● | the scope, rate of progress, results and cost of our clinical trials and other research and development activities; |
● | the cost and timing of obtaining any further required regulatory approvals; and |
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● | the extent to which we invest in products and technologies, although we currently have no commitments or agreements relating to any of these types of transactions. |
Critical Accounting Policies and Estimates
The condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States which require us to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the condensed consolidated financial statements and revenues and expenses during the periods reported. Actual results could differ from those estimates. Information with respect to our critical accounting policies and estimates which we believe could have the most significant effect on our reported results and require subjective or complex judgments by management is contained in Item 7, “Management's Discussion and Analysis of Financial Condition and Results of Operations,” of our Annual Report on Form 10-K for the year ended December 31, 2020. There have been no significant changes from the information discussed therein.
During the nine months ended September 30, 2021 there were no material changes to our significant accounting policies above, which are fully described in Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2020, except for the acquisition and goodwill policies describe in Note 1 to Condensed Consolidated Financial Statements.
Off-Balance Sheet Arrangements
As of September 30, 2021, we did not have any off-balance sheet arrangements.
Recent Accounting Pronouncements
See Note 1 to our condensed consolidated financial statements for a discussion of recent accounting pronouncements.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As a smaller reporting company, we are not required to provide disclosure pursuant to this item.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), defines the term “disclosure controls and procedures” as those 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 recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information 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.
Based on their evaluation as of September 30, 2021, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) are designed at a reasonable level and effective as of the end of the period covered in the report in providing reasonable assurance that the information we are required to disclose in the reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management including the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal controls over financial reporting during the quarter ended September 30, 2021 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
The Company is not currently a party to any material litigation and the Company is not aware of any pending or threatened litigation against it that reasonably likely to have a material adverse effect on the Company’s business, operating results or financial condition. 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.
ITEM 1A. RISK FACTORS
Investing in our common stock involves a high degree of risk. Before making your decision to invest in shares of our common stock, you should carefully consider the risks described in the Annual Report on Form 10-K filed by Obalon Therapeutics, Inc. (our predecessor company) on March 12, 2021, and by ReShape Lifesciences Inc. (now known as ReShape Weightloss Inc.) on March 11, 2021, together with the other information contained in this Quarterly Report on Form 10-Q, our consolidated financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The risks and uncertainties described herein are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us. If any of those risks actually occurs, our business, financial condition, results of operations and future growth prospects could be materially and adversely affected. The market price of our common stock would likely decline, and you could lose all or part of your investment.
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ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Unregistered Sales of Equity Securities
None, except as described above in this Form 10-Q.
Uses of Proceeds from Sale of Registered Securities
None.
Purchases of Equity Securities
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Not applicable.
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ITEM 6. EXHIBITS
Exhibit No. | Description | |||
---|---|---|---|---|
31.1** | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||
31.2** | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |||
32.1** | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |||
32.2** | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |||
101** | Financial statements from the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2021, formatted in Extensible Business Reporting Language: (i) the Condensed Consolidated Balance Sheets, (ii) the Condensed Consolidated Statements of Operations, (iii) the Condensed Consolidated Statements of Stockholders’ Equity, (iv) the Condensed Consolidated Statements of Cash Flows and (v) the Notes to Condensed Consolidated Financial Statements. | |||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | |||
** | Filed herewith. |
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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.
RESHAPE LIFESCIENCES INC. | ||
BY: | /S/ BARTON P. BANDY | |
Barton P. Bandy | ||
President and Chief Executive Officer | ||
(principal executive officer) | ||
BY: | /S/ thomas stankovich | |
Thomas Stankovich | ||
Senior Vice President and Chief Financial Officer | ||
(principal financial and accounting officer) | ||
Dated: November 12, 2021 |
37
Exhibit 31.1
CERTIFICATION
I, Barton P. Bandy, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of ReShape Lifesciences Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| /S/ BARTON P. BANDY |
| Barton P. Bandy |
| President and Chief Executive Officer |
Date: November 12, 2021
No
Exhibit 31.2
CERTIFICATION
I, Thomas Stankovich certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of ReShape Lifesciences Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| /s/ Thomas Stankovich |
| Thomas Stankovich |
| Chief Financial Officer, Senior Vice President, Finance |
| |
Date: November 12, 2021
Exhibit 32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the Exchange Act), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Barton P. Bandy, in his capacity as Chief Executive Officer of ReShape Lifesciences Inc., hereby certifies that, to the best of his knowledge:
1. | The Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 to which this Certification is attached as Exhibit 32.1 (the Report) fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and the results of operations of ReShape Lifesciences Inc. as of, and for, the periods covered by the Report. |
| By: | /S/ BARTON P. BANDY |
| | Barton P. Bandy |
| | President and Chief Executive Officer |
Date: November 12, 2021
Exhibit 32.2
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the Exchange Act), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Thomas Stankovich, in his capacity as Chief Financial Officer of ReShape Lifesciences Inc., hereby certifies that, to the best of his knowledge:
1. | The Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 to which this Certification is attached as Exhibit 32.2 (the Report) fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and the results of operations of ReShape Lifesciences Inc. as of, and for, the periods covered by the Report. |
| By: | /s/ THOMAS STANKOVICH |
| | Thomas Stankovich |
| | Chief Financial Officer, Senior Vice President, Finance |
| | |
Date: November 12, 2021