Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the
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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. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Annual Report on Form 10-K. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2021.
Management’s Report on Internal Control Over Financial Reporting
Internal control over financial reporting refers to the process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial Officer, and effected by our board of directors, management and other personnel, 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, and includes those policies and procedures that: (1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.
Internal control over financial reporting may not prevent or detect all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are achieved. Further, the design of a control system must be balanced against resource constraints, and therefore the benefits of controls must be considered relative to their costs. Given the inherent limitations in all systems of controls, no evaluation of controls can provide absolute assurance all control issues and instances of fraud, if any, within a company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Accordingly, given the inherent limitations in a cost-effective system of internal control, financial statement misstatements due to error or fraud may occur and may not be detected. Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance of achieving their objectives. We conduct periodic evaluations of our systems of controls to enhance, where necessary, our control policies and procedures.
Management is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting. Management has used the framework set forth in the report entitled “Internal Control—Integrated Framework (2013)” published by the Committee of Sponsoring Organizations of the Treadway Commission to evaluate the effectiveness of our internal control over financial reporting. Based on its evaluation, management has concluded that our internal control over financial reporting was effective as of December 31, 2021.
Changes in Internal Control over Financial Reporting
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During the fourth quarter ended December 31, 2021, there were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) which materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
The disclosure set forth below is provided in lieu of a separate Form 8-K filing pursuant to Item 5.02 of Form 8-K.
On March 22, 2022, the Board approved a reduced work schedule for E. Skott Greenhalgh, Ph.D., the Chief Technology Officer of the Company, effective immediately. Dr. Greenhalgh’s annual base salary was reduced from $360,500 to $90,125. Subject to the conditions and provisions of the Company’s equity incentive plans, equity awards held by Dr. Greenhalgh will continue to vest and become exercisable according to their respective terms.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information concerning directors and compliance with Section 16(a) of the Exchange Act and our Code of Conduct that applies to our principal executive officer, principal financial officer, principal accounting officer or controller called for by Item 10 of Form 10-K will be set forth in our definitive proxy statement for the 2022 annual meeting of stockholders, to be filed within 120 days after the end of the fiscal year covered by this annual report on Form 10-K, and is incorporated herein by reference.
ITEM 11. EXECUTIVE COMPENSATION
The information required by Item 11 of Form 10-K is incorporated by reference to the information contained in our definitive proxy statement for the 2022 annual meeting of stockholders.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by Item 12 of Form 10-K is incorporated by reference to the information contained in our definitive proxy statement for the 2022 annual meeting of stockholders.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by Item 13 of Form 10-K is incorporated by reference to the information contained in our definitive proxy statement for the 2022 annual meeting of stockholders.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Our independent registered public accounting firm is KPMG LLP , Philadelphia, PA , Auditor Firm ID: 185 .
The information required by Item 14 of Form 10-K is incorporated by reference to the information contained in our definitive proxy statement for the 2022 annual meeting of stockholders.
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) 1. Financial Statements
See Index to the Consolidated Financial Statements on page F-1 of this Annual Report.
2. Financial Statement Schedules
None, as all information required in these schedules is included in the Notes to the Consolidated Financial Statements.
3. Exhibits
Reference is made to the Exhibit Index on page 96 of this Annual Report for a list of exhibits required by Item 601 of Regulation S-K to be filed as part of this Annual Report.
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ITEM 16 . FORM 10-K SUMMARY
None.
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TELA BIO, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm
F-2
Consolidated Balance Sheets
F-3
Consolidated Statements of Operations and Comprehensive Loss
F-4
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
F-5
Consolidated Statements of Cash Flows
F-6
Notes to Consolidated Financial Statements
F-7
F-1
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and Board of Directors
TELA Bio, Inc.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of TELA Bio, Inc. and subsidiary (the Company) as of December 31, 2021 and 2020, the related consolidated statements of operations and comprehensive loss, redeemable convertible preferred stock and stockholders’ equity (deficit), and cash flows for each of the years in the three-year period ended December 31, 2021, and the related notes (collectively, the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2021, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ KPMG LLP
We have served as the Company’s auditor since 2013.
Philadelphia, Pennsylvania
March 23, 2022
F-2
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TELA Bio, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
c
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
43,931
$
74,394
Accounts receivable, net
4,234
2,683
Inventory
7,658
3,907
Prepaid expenses and other assets
3,232
2,241
Total current assets
59,055
83,225
Property and equipment, net
1,186
626
Intangible assets, net
2,303
2,607
Total assets
$
62,544
$
86,458
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$
2,414
$
652
Accrued expenses and other current liabilities
8,161
5,953
Total current liabilities
10,575
6,605
Long‑term debt with related party
31,491
30,827
Other long‑term liabilities
380
—
Total liabilities
42,446
37,432
Commitments and contingencies (Note 11)
Stockholders’ equity:
Preferred stock; $ 0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding
—
—
Common stock; $ 0.001 par value: 200,000,000 shares authorized; 14,529,606 and 14,437,289 shares issued and 14,529,577 and 14,437,107 shares outstanding at December 31, 2021 and December 31, 2020, respectively
15
14
Additional paid-in capital
250,064
245,736
Accumulated other comprehensive loss
( 52 )
( 71 )
Accumulated deficit
( 229,929 )
( 196,653 )
Total stockholders’ equity
20,098
49,026
Total liabilities and stockholders’ equity
$
62,544
$
86,458
See accompanying notes to consolidated financial statements.
F-3
Table of Contents
TELA Bio, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
Year ended December 31,
2021
2020
2019
Revenue
$
29,463
$
18,213
$
15,446
Cost of revenue (excluding amortization of intangible assets)
10,346
6,675
5,870
Amortization of intangible assets
304
304
304
Gross profit
18,813
11,234
9,272
Operating expenses:
Sales and marketing
29,062
22,111
18,060
General and administrative
12,459
10,143
6,223
Research and development
6,743
4,255
4,151
Total operating expenses
48,264
36,509
28,434
Loss from operations
( 29,451 )
( 25,275 )
( 19,162 )
Other (expense) income:
Interest expense
( 3,597 )
( 3,564 )
( 3,609 )
Change in fair value of preferred stock warrant liability
—
—
( 5 )
Other (expense) income
( 228 )
45
351
Total other expense
( 3,825 )
( 3,519 )
( 3,263 )
Net loss
( 33,276 )
( 28,794 )
( 22,425 )
Accretion of redeemable convertible preferred stock to redemption value
—
—
( 7,783 )
Net loss attributable to common stockholders
$
( 33,276 )
$
( 28,794 )
$
( 30,208 )
Net loss per common share, basic and diluted
$
( 2.30 )
$
( 2.23 )
$
( 17.10 )
Weighted average common shares outstanding, basic and diluted
14,473,213
12,934,421
1,766,412
Comprehensive loss:
Net loss
$
( 33,276 )
$
( 28,794 )
$
( 22,425 )
Foreign currency translation adjustment
19
( 52 )
( 15 )
Unrealized loss on short-term investments
—
—
( 4 )
Comprehensive loss
$
( 33,257 )
$
( 28,846 )
$
( 22,444 )
See accompanying notes to consolidated financial statements.
F-4
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TELA Bio, Inc.
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
(In thousands, except share amounts)
Redeemable Convertible Preferred Stock
Stockholders’ Equity (Deficit)
Accumulated
Additional
other
Series A
Series B
Common stock
paid ‑ in
comprehensive
Accumulated
Shares
Amount
Shares
Amount
Shares
Amount
capital
income (loss)
deficit
Total
Balance at January 1, 2019
22,501,174
$
33,112
63,032,500
$
91,038
295,717
$
—
$
—
$
—
$
( 137,860 )
$
( 137,860 )
Vesting of common stock previously subject to repurchase
—
—
—
—
628
—
4
—
—
4
Exercise of stock options
—
—
—
—
2,527
—
14
—
—
14
Sale of Series B redeemable convertible preferred stock, net of stock issue costs of $ 165
—
—
12,527,956
14,367
—
—
—
—
—
—
Unrealized loss on short-term investments
—
—
—
—
—
—
—
( 4 )
—
( 4 )
Foreign currency translation adjustment
—
—
—
—
—
—
—
( 15 )
—
( 15 )
Stock ‑ based compensation expense
—
—
—
—
—
—
457
—
—
457
Accretion of redeemable convertible preferred stock to redemption value
—
1,563
—
6,220
—
—
( 209 )
—
( 7,574 )
( 7,783 )
Conversion of convertible preferred stock to common stock in connection with the initial public offering
( 22,501,174 )
( 34,675 )
( 75,560,456 )
( 111,625 )
6,708,649
7
146,293
—
—
146,300
Issuance of common stock upon initial public offering, net of underwriting discounts, commissions and offering costs
—
—
—
—
4,398,700
4
50,625
—
—
50,629
Conversion of preferred stock warrants to common stock warrants
—
—
—
—
—
—
1,645
—
—
1,645
Net loss
—
—
—
—
—
—
—
—
( 22,425 )
( 22,425 )
Balance at December 31, 2019
—
—
—
—
11,406,221
11
198,829
( 19 )
( 167,859 )
30,962
Vesting of common stock previously subject to repurchase
—
—
—
—
306
—
3
—
—
3
Exercise of stock options
—
—
—
—
27,783
—
175
—
—
175
Issuance of common stock under the employee stock purchase plan
—
—
—
—
2,797
—
34
—
—
34
Foreign currency translation adjustment
—
—
—
—
—
—
—
( 52 )
—
( 52 )
Stock ‑ based compensation expense
—
—
—
—
—
—
1,976
—
—
1,976
Issuance of common stock upon follow-on offering, net of underwriting discounts, commissions and offering costs
—
—
—
—
3,000,000
3
44,719
—
—
44,722
Net loss
—
—
—
—
—
—
—
—
( 28,794 )
( 28,794 )
Balance at December 31, 2020
—
—
—
—
14,437,107
14
245,736
( 71 )
( 196,653 )
49,026
Vesting of common stock previously subject to repurchase
—
—
—
—
153
—
1
—
—
1
Exercise of stock options
—
—
—
—
77,154
1
546
—
—
547
Issuance of common stock under the employee stock purchase plan
—
—
—
—
3,163
—
38
—
—
38
Foreign currency translation adjustment
—
—
—
—
—
—
—
19
—
19
Stock ‑ based compensation expense
—
—
—
—
12,000
—
3,661
—
—
3,661
Reclassification of liability-classified stock-based compensation awards
—
—
82
—
—
82
Net loss
—
—
—
—
—
—
—
—
( 33,276 )
( 33,276 )
Balance at December 31, 2021
—
$
—
—
$
—
14,529,577
$
15
$
250,064
$
( 52 )
$
( 229,929 )
$
20,098
See accompanying notes to consolidated financial statements.
F-5
Table of Contents
TELA Bio, Inc.
Consolidated Statements of Cash Flows
(In thousands)
Year ended December 31,
2021
2020
2019
Cash flows from operating activities:
Net loss
$
( 33,276 )
$
( 28,794 )
$
( 22,425 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
231
221
278
Noncash interest expense
664
584
523
Amortization of intangible assets
304
304
304
Inventory excess and obsolescence charge
1,439
1,327
1,591
Change in fair value of warrants
—
—
5
Stock ‑ based compensation expense
3,661
2,058
457
Loss on disposal of fixed assets
2
—
—
Change in operating assets and liabilities:
Accounts receivable, net
( 1,553 )
149
( 1,528 )
Inventory
( 5,194 )
( 620 )
( 1,839 )
Prepaid expenses and other assets
( 992 )
66
( 1,977 )
Accounts payable
1,597
( 2,002 )
( 773 )
Accrued expenses and other current and long-term liabilities
2,673
2,321
( 118 )
Foreign currency remeasurement loss
12
( 70 )
( 21 )
Net cash used in operating activities
( 30,432 )
( 24,456 )
( 25,523 )
Cash flows from investing activities:
Purchases of short-term investments
—
—
( 9,284 )
Proceeds from the sale and maturity of short-term investments
—
9,289
—
Payment for intangible asset
—
—
( 2,500 )
Purchase of property and equipment
( 627 )
( 167 )
( 197 )
Net cash (used in) provided by investing activities
( 627 )
9,122
( 11,981 )
Cash flows from financing activities:
Proceeds from follow-on offering, net of underwriting discounts, commissions and offering costs
—
44,722
—
Proceeds from initial public offering, net of underwriting discounts, commissions and offering costs
—
—
51,151
Proceeds from issuance of Series B redeemable convertible preferred stock, net of offering costs
—
—
14,367
Payment of initial public offering costs
—
( 522 )
—
Proceeds from exercise of stock options
547
175
14
Proceeds from issuance of common stock under the employee stock purchase plan
38
34
—
Net cash provided by financing activities
585
44,409
65,532
Effect of exchange rate on cash and cash equivalents
11
17
( 4 )
Net (decrease) increase in cash and cash equivalents
( 30,463 )
29,092
28,024
Cash and cash equivalents, beginning of year
74,394
45,302
17,278
Cash and cash equivalents, end of year
$
43,931
$
74,394
$
45,302
Supplemental disclosure of cash flow information:
Cash paid during the period for interest
$
2,933
$
2,980
$
3,086
Supplemental disclosures of noncash investing and financing activities:
Accretion of redeemable convertible preferred stock
$
—
$
—
$
7,783
Conversion of convertible preferred stock to common stock in connection with the initial public offering
$
—
$
—
$
146,300
Conversion of outstanding preferred stock warrants
$
—
$
—
$
1,645
Offering costs in accounts payable and accrued expenses and other current liabilities
$
—
$
—
$
522
Property and equipment in accounts payable
$
166
$
3
$
—
Issuance of common stock for early exercised stock options
$
1
$
3
$
4
Unrealized loss on short-term investments
$
—
$
—
$
4
Liability-classified stock-based compensation in accrued expenses and other current liabilities
$
—
$
82
$
—
Reclassification of liability-classified stock-based compensation awards to equity-classified
$
82
$
—
$
—
See accompanying notes to consolidated financial statements.
F-6
Table of Contents
TELA BIO, INC.
Notes to Consolidated Financial Statements
(1) Background
TELA Bio, Inc. (the “Company”) was incorporated in the state of Delaware on April 17, 2012 and wholly owns TELA Bio Limited, a company incorporated in the United Kingdom. The Company is commercial-stage medical technology company focused on providing innovation soft-tissue reconstruction solutions that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy. OviTex Reinforced Tissue Matrix (“OviTex”), the Company’s first portfolio of products, addresses unmet needs in hernia repair and abdominal wall reconstruction by combining the benefits of biologic matrices and polymer materials while minimizing their shortcomings, at a cost-effective price. OviTex PRS Reinforced Tissue Matrix (“OviTex PRS”), the Company’s second portfolio of products, addresses unmet needs in plastic and reconstructive surgery. The Company’s principal corporate office and research facility is located in Malvern, Pennsylvania.
The Company has been impacted by the pandemic resulting from the novel coronavirus and the disease it causes, including variants thereof (“COVID-19”). To date, among other impacts on its business related to the pandemic, physicians and their patients are required by state mandates, or are choosing to defer elective surgery procedures in which its products otherwise would be used. There remains uncertainty and lack of visibility regarding the Company’s near-term revenue growth prospects and product development plans due to the rapidly evolving environment and continued uncertainties resulting from the ongoing COVID-19 pandemic. While certain regions are experiencing a reduction in COVID-19 cases and a relaxing of governmental restrictions, at this time, the full extent of the impact of the ongoing COVID-19 pandemic on its business, results of operations and financial condition, including revenue, expenses, manufacturing capability, supply chain integrity, research and development costs and employee-related compensation, will depend on future developments that are highly uncertain, including new information that may emerge concerning COVID-19 and the actions taken to mitigate the spread of or treat COVID-19, the emergence of new variants of COVID-19, as well as the economic impact on local, regional, national and international customers and markets.
(2) Risks and Liquidity
The Company’s operations to date have focused on commercializing products, developing and acquiring technology and assets, business planning, raising capital and organization and staffing. The Company has incurred recurring losses and negative cash flows from operations since inception and has an accumulated deficit of $ 229.9 million as of December 31, 2021. The Company anticipates incurring additional losses until such time, if ever, it can generate sufficient revenue from its products to cover its expenses.
The operations of the Company are subject to certain risks and uncertainties including, among others, uncertainty of product development, the impact of COVID-19 and the development of any variants, on the business, ongoing economic uncertainty, including as a result of geopolitical factors such as hostilities and the conflict between Russia and Ukraine, technological uncertainty, commercial acceptance of any developed products, alternative competing technologies, dependence on collaborative partners, uncertainty regarding patents and proprietary rights, comprehensive government regulations, and dependence on key personnel.
(3) Summary of Significant Accounting Policies
Basis of Presentation and Principals of Consolidation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) promulgated by the Financial Accounting Standards Board (“FASB”). The consolidated financial statements include the accounts of TELA Bio, Inc. and its wholly owned subsidiary TELA Bio Limited. All intercompany accounts and transactions have been eliminated in consolidation.
F-7
Table of Contents
TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
Use of Estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and contingent liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. The most significant judgments are employed in estimates used to determine stock-based awards issued and recoverability of the carrying value of the Company’s inventory. As future events and their effects cannot be determined with precision, actual results may differ significantly from these estimates.
Segments
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment.
Concentration of Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company places its cash with high-credit-quality financial institutions and primarily invests in money market funds. The Company has established guidelines relative to credit ratings and maturities that seek to maintain safety and liquidity.
As described in Note 11, the Company has licensed patents and other intellectual property from Aroa Biosurgery Ltd. (“Aroa”). As part of this agreement, Aroa is also the sole manufacturer of the Company’s products. The inability of Aroa to fulfill supply requirements of the Company could materially impact future operating results. A change in the relationship with Aroa, or an adverse change in their business, could materially impact future operating results.
Cash and Cash Equivalents
The Company considers cash equivalents to be highly liquid investments with maturities of three months or less from the date of purchase. Cash equivalents consist of investments in a money market fund. The Company’s cash and cash equivalents are carried at the fair value based on quoted market prices.
Inventory
Inventory consists of finished goods and is identified and tracked by lot and stated at the lower of cost or net realizable value, with cost being determined on a first-in, first-out basis. The Company periodically analyzes its inventory levels and writes down inventory that has become obsolete or that has a cost basis in excess of its expected net realizable value based on expected customer demand. As of December 31, 2021 and 2020, the Company had $ 1.7 million and $ 1.4 million, respectively, in finished goods consigned to others.
Property and Equipment
Property and equipment are stated at the aggregate cost incurred to acquire and place the asset in service. Expenditures for routine maintenance and repairs are charged to expense as incurred and costs of improvements and renewals are capitalized. Depreciation is provided over the estimated useful lives of the assets using the straight-line method.
F-8
Table of Contents
TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
Intangible Assets
Upfront payments and milestone payments due related to licenses or commercialization rights prior to future economic benefit being established are recorded as research and development expenses. Milestone payments due related to licenses or commercialization rights after future economic benefit is established are recorded as intangible assets. In 2021, 2020 and 2019, the Company recorded $ 0.3 million of amortization expense in each year related to intangible assets. At December 31, 2021, the remaining life of intangible assets was 7.6 years. The Company anticipates recognizing amortization expense of $ 0.3 million for the next five years and $ 0.8 million thereafter.
Long-Lived Assets
Long-lived assets, such as property and equipment and intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. If circumstances require a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by such asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group exceeds the undiscounted cash flows, an impairment is recognized to the extent the carrying value exceeds its fair value. Fair value is determined using various valuation techniques, including discounted cash flow models, quoted market values, and third-party independent appraisals, as considered necessary. No impairment losses were recognized during the years ended December 31, 2021, 2020 or 2019.
Debt Issuance Costs
Debt issuance costs incurred in connection with debt (Note 6) are amortized to interest expense over the term of the respective financing arrangement using the effective-interest method, and debt issuance costs incurred under the revolver are amortized to interest expense over the term of the respective financing arrangement using the straight-line method. Debt issuance costs, net of related amortization are deducted from the carrying value of the related debt.
Revenue Recognition
Under ASC Topic 606, Revenue from Contracts with Customers , an entity recognizes revenue when its customer obtains control of the promised good, in an amount that reflects the consideration that the entity expects to be entitled in exchange for those goods. The Company performs the following five steps to recognize revenue under ASC Topic 606: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only recognizes revenue when it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services that will be transferred to the customer.
A significant portion of the Company’s revenue is generated from product shipped to a customer or from consigned inventory maintained at hospitals. Revenue from the sale of consigned products is recognized when control is transferred to the customer, which occurs at the time the product is used in a surgical procedure. For product that is not held on consignment, the Company recognizes revenue when control transfers to the customer which occurs at the time the product is shipped or delivered. For all of the Company’s contracts, the only identified performance obligation is providing the product to the customer.
Revenue is recognized at the estimated net sales price which includes estimates of variable consideration. The Company contracts with certain third-party payors for the payment of rebates with respect to the utilization of its products. These rebates are based on contractual percentages. The Company estimates these rebates and records in the same period the related revenue is recognized, resulting in a reduction of product revenue.
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TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
Payment terms with customers do not exceed one year and, therefore, the Company does not account for a financing component in its arrangements. There are no incremental costs of obtaining a contract that would rise to or enhance an asset other than product costs, which are a component of inventory. The Company expenses incremental costs of obtaining a contract with a customer (e.g., sales commissions) when incurred as the period of benefit is less than one year. Fees charged to customers for shipping are recognized as revenue.
The following table presents revenue disaggregated (in thousands):
Year ended December 31,
2021
2020
2019
OviTex
$
22,990
$
15,093
$
14,041
OviTex PRS
6,473
3,120
1,405
Total revenue
$
29,463
$
18,213
$
15,446
Sales outside of the U.S. were immaterial for the years ended December 31, 2021, 2020 and 2019.
Research and Development
Research and development costs are charged to expense as incurred and consist primarily of salaries, benefits, and other related costs, including stock-based compensation for personnel serving in the research and development functions as well as costs incurred with Aroa under development agreements related to technology transfer, laboratory materials and supplies. At the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. Costs incurred in obtaining patent and other intellectual property licenses for which there are no alternative future uses are charged to expense as incurred.
Stock-Based Compensation
The Company accounts for stock-based awards in accordance with provisions of ASC Topic 718, Compensation—Stock Compensation , under which the Company recognizes the grant-date fair value of stock-based awards issued to employees and nonemployee board members as compensation expense on a straight-line basis over the vesting period of the award while awards containing a performance condition are recognized as expense when the achievement of the performance criteria is considered probable. The Company uses the Black-Scholes option pricing model to determine the grant-date fair value of stock options. The Company estimates forfeitures that it expects will occur and adjusts expense for actual forfeitures in the periods they occur.
Income Taxes
Income taxes are accounted for under the asset-and-liability method as required by ASC Topic 740 - (“ASC 740”), Income Taxes . Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period corresponding to the enactment date. Under ASC 740, a valuation allowance is required when it is more likely than not all or some portion of the deferred tax assets will not be realized through generating sufficient future taxable income.
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TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
ASC Subtopic 740-10 (“ASC 740-10”), Accounting for Uncertainty of Income Taxes , defines the criterion an individual tax position must meet for any part of the benefit of the tax position to be recognized in consolidated financial statements prepared in conformity with GAAP. The Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not such tax position will be sustained on examination by the taxing authorities, based solely on the technical merits of the respective tax position. The tax benefits recognized in the consolidated financial statements from such a tax position should be measured based on the largest benefit having a greater than 50% likelihood of being realized upon ultimate settlement with the tax authority. In accordance with the disclosure requirements of ASC 740-10, the Company’s policy on income statement classification of interest and penalties related to income tax obligations is to include such items as part of income tax expense.
Fair value of financial instruments
Fair value is the price that could be received to sell an asset or paid to transfer a liability in an orderly transaction among market participants. Fair value determination in accordance with applicable accounting guidance requires that a number of significant judgments are made. Additionally, fair value is used on a nonrecurring basis to evaluate assets for impairment or as required for disclosure purposes by applicable accounting guidance on disclosures about fair value of financial instruments. Depending on the nature of the assets and liabilities, various valuation techniques and assumptions are used when estimating fair value. The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable and other assets, and accounts payable are shown at cost, which approximates fair value due to the short-term nature of these instruments. Due to the related-party relationship of our OrbiMed Credit Facility (Note 6), it is impractical to determine the fair value of the debt. Items measured at fair value on a recurring basis included the Company’s preferred stock warrants. The warrants were carried at their estimated fair value. All outstanding warrants to purchase shares of preferred stock were converted into warrants to purchase shares of common stock after our IPO.
The Company follows the provisions of ASC Topic 820, Fair Value Measurement , for financial assets and liabilities measured on a recurring basis. The guidance requires fair value measurements be classified and disclosed in one of the following three categories:
● Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.
● Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liabilities.
● Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).
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TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
The following fair value hierarchy table presents information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2021 and 2020 (in thousands):
Fair value measurement at reporting date using
Quoted prices in
active markets
Significant other
Significant
for identical
observable
unobservable
assets
inputs
inputs
(Level 1)
(Level 2)
(Level 3)
December 31, 2021:
Cash equivalents – money market fund
$
41,396
$
—
$
—
December 31, 2020:
Cash equivalents – money market fund
$
72,889
$
—
$
—
A rollforward of the warrant liability (Level 3 measurement) was as follows (in thousands):
January 1, 2019
$
1,640
Change in fair value of warrants
5
Conversion into common stock warrants
( 1,645 )
December 31, 2019
$
—
The fair value of the warrants at November 13, 2019 was determined using the Black-Scholes option pricing model with the following assumptions:
Convertible
MidCap Credit
promissory
Facility
notes
Notes payable
Expected dividend yield
—
—
—
Expected volatility
57.5
%
57.4
%
57.5
%
Risk-free interest rate
2.04
%
1.79
%
1.79
%
Remaining contractual term in years
8.4
7.2
7.4
Net loss per share
Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average shares of common stock outstanding during the reporting period. The Company’s outstanding redeemable convertible preferred stock contractually entitled the holders of such shares to participate in distributions but contractually did not require the holders of such shares to participate in losses of the Company. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since dilutive shares are not assumed to have been issued if their effect is antidilutive. Therefore, the weighted-average shares used to calculate both basic and diluted loss per share are the same.
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TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding as of December 31, 2021, 2020 and 2019, as they would be antidilutive.
Year ended December 31,
2021
2020
2019
Stock options (including shares subject to repurchase)
1,706,438
1,498,390
1,421,697
Unvested restricted stock units
163,043
—
—
Common stock warrants
88,556
88,556
88,556
Total
1,958,037
1,586,946
1,510,253
Recently Issued Accounting Pronouncements
The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.
In February 2016, the FASB issued ASU No. 2016-02, Leases , which requires a lessee to record a right-of-use asset and a corresponding lease liability on the balance sheet for all leases with terms longer than 12 months. A modified retrospective transition approach is required, applying the new standard to all leases existing at the date of initial application. An entity may choose to use either (1) its effective date or (2) the beginning of the earliest comparative period presented in the consolidated financial statements as its date of initial application. If an entity chooses the second option, the transition requirements for existing leases also apply to leases entered into between the date of initial application and the effective date. The standard is effective for the Company beginning January 1, 2022, with early adoption permitted. The Company plans to adopt this standard on January 1, 2022 and anticipates the recognition of a right-of-use asset of approximately $ 1.2 million to $ 1.6 million and a lease liability of approximately $ 1.5 million to $ 1.9 million. The Company is continuing its assessment of potential changes to its disclosures under the standard.
In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes . This guidance applies to all entities and aims to reduce the complexity of tax accounting standards while enhancing reporting disclosures. This guidance is effective for fiscal years beginning after December 15, 2020 and interim periods therein. The adoption of this guidance did not have any impact on the Company’s consolidated financial statements and related disclosures.
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TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
(4) Property and Equipment
Property and equipment consisted of the following (in thousands):
December 31,
Asset description
Estimated useful lives
2021
2020
Lab equipment
5 Years
$
2,352
$
2,304
Furniture and fixtures
5 Years
242
118
Computer equipment and software
3 Years
468
577
Leasehold improvements
Lesser of useful life or lease term
1,881
1,360
Total
4,943
4,359
Less accumulated depreciation and amortization
( 3,757 )
( 3,733 )
Property and equipment, net
$
1,186
$
626
The cost of property and equipment at both December 31, 2021 and 2020 includes $ 0.2 million of equipment located at Aroa. Depreciation expense was $ 0.2 million, $ 0.2 million and $ 0.3 million for the years ended December 31, 2021, 2020 and 2019, respectively.
(5) Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
December 31,
2021
2020
Compensation and related benefits
$
4,976
$
3,666
Interest
—
40
Third-party and professional fees
2,233
1,626
Amounts due to Aroa
842
498
Research and development expenses
31
7
Other
79
116
Total accrued expenses and other current liabilities
$
8,161
$
5,953
(6) Debt
Long-term debt consisted of the following (in thousands):
December 31,
2021
2020
OrbiMed Term Loan (related party)
$
30,000
$
30,000
End of term charge
3,000
3,000
Unamortized end of term charge and issuance costs
( 1,509 )
( 2,173 )
Long-term debt with related party
$
31,491
$
30,827
OrbiMed Term Loan (Related Party)
In November 2018, the Company entered into a senior secured term loan facility (“OrbiMed Credit Facility”) with OrbiMed Royalty Opportunities II, LP (“OrbiMed”), a related party as the lender is affiliated with a stockholder of the Company, which consists of up to $ 35.0 million in term loans (“OrbiMed Term Loans”). The OrbiMed Term Loans
F-14
Table of Contents
TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
consist of two tranches, a $ 30.0 million Tranche 1 (“Tranche 1”) and a $ 5.0 million Tranche 2 (“Tranche 2”). In November 2018, the Company borrowed $ 30.0 million of Tranche 1. The Company elected not to borrow Tranche 2 prior to its expiration on December 31, 2019.
Pursuant to the OrbiMed Credit Facility, the Company provided a first priority security interest in all existing and future acquired assets, excluding intellectual property and certain other assets, owned by the Company. The OrbiMed Credit Facility contains a negative pledge on intellectual property owned by the Company. The OrbiMed Credit Facility also contains customary indemnification obligations and customary events of default, including, among other things, (i) nonpayment, (ii) breach of warranty, (iii) nonperformance of covenants and obligations, (iv) default on other indebtedness, (v) judgments, (iv) change of control, (vii) bankruptcy and insolvency, (viii) impairment of security, (ix) key permit events, (x) key person events, (xi) regulatory matters, (xii) and key contracts. In addition, the Company must maintain a minimum cash balance of $ 2.0 million. If an event of default occurs under the OrbiMed Credit Facility, the Company may become obligated to immediately pay all outstanding principal and interest and all other due and unpaid obligations at the current rate in effect plus 3 %.
The OrbiMed Term Loan matures on November 16, 2023 and bears interest at a rate equal to 7.75 % plus the greater of one-month LIBOR or 2.0 %. At December 31, 2021, the interest rate was 9.75 %. The Company is required to make 60 monthly interest payments beginning on November 30, 2018, with the entire principal payment due at maturity. The OrbiMed Term Loans have a prepayment penalty equal to 10.0 % of the prepaid principal amount prior to the second anniversary of the Term Loans, 5.0 % of the prepaid principal amount after the second anniversary but prior to the third anniversary and 2.5 % of the prepaid principal amount after the third anniversary. The Company is also required to pay an exit fee at the time of maturity or prepayment event equal to 10.0 % of all principal borrowings (the “End of Term Charge”) and an administration fee equal to $ 10,000 on the last day of each quarter until all obligations have been paid in full. In conjunction with the closing of the OrbiMed Term Loans, the Company incurred $ 0.3 million of third party and lender fees, which along with the End of Term Charge of $ 3.0 million were recorded as debt issuance costs, and are being recognized as interest expense over the term of the loan using the effective-interest method. Interest expense associated with the OrbiMed Credit Facility recorded during each of 2021, 2020 and 2019 was $ 3.6 million.
(7) Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Public Stock Offerings
In November 2019, the Company closed its initial public offering (“IPO”) in which the Company issued and sold 4,398,700 shares of its common stock at a public offering price of $ 13.00 per share, including 398,700 shares of the Company’s common stock sold pursuant to the underwriters’ option to purchase additional shares. The Company received net proceeds of $ 50.6 million after deducting underwriting discounts, commissions and other offering expenses. In addition, immediately prior to the closing of the IPO, all of the Company’s outstanding shares of redeemable convertible preferred stock, including accrued dividends payable converted into an aggregate of 6,708,649 shares of common stock and the Company’s outstanding warrants to purchase shares of preferred stock were automatically converted into warrants to purchase an aggregate of 88,556 shares of common stock.
In June 2020, the Company completed a follow-on public offering in which the Company issued and sold 3,000,000 shares of its common stock at a public offering price of $ 16.00 per share. The Company received net proceeds of $ 44.7 million after deducting underwriting discounts, commissions and other offering expenses.
In December 2020, the Company entered into an Equity Distribution Agreement (the “Equity Agreement”) with Piper Sandler & Co (the “Agent”) in connection with the establishment of an at-the-market offering program under which it may sell up to an aggregate of $ 50.0 million of shares of the Company’s common stock, from time to time through the Agent as sales agent. No sales were made under the Equity Agreement during the years ended December 31, 2021 or 2020.
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TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
Preferred Stock
Prior to the IPO, all of the Company’s redeemable convertible preferred stock was classified outside of stockholders’ deficit because the shares contain certain redemption features that were not solely within the control of the Company. At the time of issuance, the redeemable convertible preferred stock was recorded at its issuance price, less issuance costs.
Throughout 2019, the Company entered into various stock purchase agreements with new and existing investors pursuant to which the Company sold an aggregate 12,527,956 shares of the Company’s Series B preferred stock at $ 1.16 per share for aggregate gross proceeds of $ 14.5 million. Transaction fees of $ 0.2 million were recorded as a reduction of the carrying value of the Series B preferred stock.
Warrants
The Company had the following warrants outstanding at December 31, 2021:
Exercise
Expiration
Outstanding
price
dates
Common stock warrants
8,379
$
28.65
2028
Common stock warrants
80,177
28.65
2027
88,556
(8) Stock-Based Compensation
The Company has two equity incentive plans: the 2012 Stock Incentive Plan and the Amended and Restated 2019 Equity Incentive Plan. New awards can only be granted under the Amended and Restated 2019 Equity Incentive Plan (the “Plan”). At December 31, 2021, 1,299,218 shares were available for future issuances under the Plan. The Plan is subject to an annual increase, subject to prior approval by the Company’s board of directors, equal to the lesser of (i) 432,442 shares, (ii) 4 % of the shares outstanding on the last day of the immediately preceding fiscal year and (iii) such smaller number of shares as determined by the board of directors. The Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock awards, restricted stock units and/or stock appreciation rights to employees, directors, and other persons, as determined by the Company’s board of directors. The Company’s stock options vest based on the terms in each award agreements and generally vest over four years and have a term of 10 years . The Company estimates forfeitures that it expects will occur and adjusts expense for actual forfeitures in the periods they occur.
The Company measures employee and nonemployee stock-based awards at grant-date fair value and records compensation expense ratably over the vesting period of the award. The Company recorded stock-based compensation expense in the following expense categories of its accompanying consolidated statements of operations (in thousands):
Year ended December 31,
2021
2020
2019
Sales and marketing
$
961
$
696
$
164
General and administrative
1,542
1,030
225
Research and development
1,158
332
68
Total stock‑based compensation
$
3,661
$
2,058
$
457
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Table of Contents
TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
The following table summarizes stock option activity for the Plan:
Weighted
average
Weighted
remaining
Number of
average exercise
contractual term
shares
price per share
(years)
Outstanding at January 1, 2019
489,222
$
5.84
Granted
978,415
12.51
Exercised
( 2,527 )
5.93
Early exercised
( 471 )
5.93
Canceled/forfeited
( 43,697 )
8.58
Outstanding at December 31, 2019
1,420,942
10.35
Granted
175,086
15.03
Exercised
( 27,783 )
6.29
Canceled/forfeited
( 70,037 )
12.41
Outstanding at December 31, 2020
1,498,208
10.87
Granted
468,000
14.80
Exercised
( 77,154 )
7.08
Canceled/forfeited
( 182,645 )
13.08
Outstanding at December 31, 2021
1,706,409
$
11.88
7.36
Vested and expected to vest at December 31, 2021
1,657,511
$
11.83
7.31
Exercisable at December 31, 2021
917,602
$
10.23
6.18
At December 31, 2021, the aggregate intrinsic value of outstanding options and exercisable options was $ 3.0 million and $ 2.8 million, respectively.
The 2012 Stock Incentive Plan provided the holders of stock options an election to early exercise prior to vesting. The Company had the right, but not the obligation, to repurchase early exercised options without transferring any appreciation to the employee if the employee terminates employment before the end of the original vesting period. The repurchase price is the lesser of the original exercise price or the then fair value of the common stock. At December 31, 2021, an immaterial amount of proceeds from early exercised options are recognized as a current liability in accrued expenses and other current liabilities in the accompanying consolidated balance sheet.
The following table summarizes activity relating to early exercise of stock options:
Number of
shares
Unvested balance at January 1, 2019
912
Early exercised
471
Vested
( 628 )
Unvested balance at December 31, 2019
755
Vested
( 306 )
Forfeited
( 267 )
Unvested balance at December 31, 2020
182
Vested
( 153 )
Unvested balance at December 31, 2021
29
F-17
Table of Contents
TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
The weighted average grant-date fair value per share of options granted was $ 8.66 , $ 8.13 and $ 6.81 for the years ended December 31, 2021, 2020 and 2019, respectively. The aggregate intrinsic value of options exercised was $ 0.4 million and $ 0.2 million for the years ended December 31, 2021 and 2020, respectively, and nominal for the year ended December 31, 2019. As of December 31, 2021, the total unrecognized compensation expense related to unvested employee and nonemployee stock option awards was $ 5.1 million, which is expected to be recognized in expense over a weighted-average period of approximately 2.5 years.
Estimating Fair Value of Stock Options
The fair value of each grant of stock options was determined by the Company using the methods and assumptions discussed below. Certain of these inputs are subjective and generally require judgment to determine.
Expected term – The expected term of stock options represents the weighted average period the stock options are expected to be outstanding. The Company uses the simplified method for estimating the expected term as provided by the Securities and Exchange Commission. The simplified method calculates the expected term as the average time to vesting and the contractual life of the options.
Expected volatility – Due to the Company’s limited operating history and lack of adequate company-specific historical or implied volatility, the expected volatility assumption was determined by examining the historical volatilities of a group of industry peers whose share prices are publicly available.
Risk-free interest rate – The risk-free rate assumption is based on the U.S. Treasury instruments, the terms of which were consistent with the expected term of the Company’s stock options.
Expected dividend – The Company has not paid and does not intend to pay dividends.
The fair value of each option was estimated on the date of grant using the weighted average assumptions in the table below:
Year ended December 31,
2021
2020
2019
Expected dividend yield
—
—
—
Expected volatility
63.9
%
59.1
%
55.9
%
Risk‑free interest rate
0.99
%
0.87
%
1.82
%
Expected term (in years)
6.15
5.98
6.24
Restricted Stock Units
The Company’s restricted stock units (“RSUs”) vest based on the terms in each award agreement and generally vest over four years . The following table summarizes restricted stock units for the Plan:
Number of
shares
Outstanding at January 1, 2021
—
Granted
194,232
Vested
( 12,000 )
Canceled/forfeited
( 19,189 )
Outstanding at December 31, 2021
163,043
The weighted average grant-date fair value per RSU granted was $ 16.57 during the year ended December 31, 2021. The aggregate intrinsic value of RSUs outstanding was $ 2.1 million at December 31, 2021. The total unrecognized
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Table of Contents
TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
compensation expense at December 31, 2021 related to RSUs was $ 1.6 million, which is expected to be recognized in expense over a weighted-average period of approximately 3.2 years.
(9) Employee Benefit Plans
401(k) Defined Contribution Plan
The Company sponsors a 401(k) defined-contribution plan covering all employees. Participants are permitted to contribute up to 100 % of their eligible annual pretax compensation up to an established federal limit on aggregate participant contributions. Discretionary contributions made by the Company, if any, are determined annually by the board of directors. Effective January 1, 2020, the Company matched 50 % of employees’ contributions up to 6 %, subject to a maximum annual amount. The Company’s contributions were $ 0.3 million and $ 0.2 million for the years ended December 31, 2021 and 2020, respectively. The match was suspended from April to August 2020 due to COVID-19. Participants are immediately vested in their own contributions to the plan and are fully vested in discretionary profit sharing made by the Company after three years of service.
2019 Employee Stock Purchase Plan
In November 2019, the Company adopted the 2019 Employee Stock Purchase Plan (the “ESPP”). At December 31, 2021, 317,701 shares were available for future issuance under the ESPP. The ESPP is subject to an annual increase, subject to prior approval by the Company’s board of directors, equal to the least of (i) 107,887 shares of common stock, (ii) 1 % of the shares outstanding on the final day of the immediately preceding calendar year, and (iii) such smaller number of shares as determined by the board of directors. The ESPP provides the opportunity to purchase the Company’s common stock at a 5 % discount to the market price through payroll deductions. As of December 31, 2021 and 2020, 3,163 and 2,797 shares, respectively, have been issued under the ESPP. No shares were issued under the ESPP as of December 31, 2019.
(10) Income Taxes
The Company has incurred losses since inception. Deferred tax assets and liabilities are determined based on the differences between the financial statement carrying amounts and tax bases of assets and liabilities using enacted tax rates in effect for years in which differences are expected to reverse.
Significant components of the Company’s deferred tax assets for federal income taxes consisted of the following (in thousands):
December 31,
2021
2020
Deferred tax assets
Net operating loss carryforwards
$
47,737
$
39,937
Research and development credits
623
747
Depreciation and amortization
( 89 )
239
Accrued expenses and other
1,356
611
Inventory reserve
171
205
Gross deferred tax asset
49,798
41,739
Valuation allowance
( 49,798 )
( 41,739 )
Net deferred tax asset
$
—
$
—
The Company does no t have unrecognized tax benefits as of December 31, 2021 and 2020. The Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.
F-19
Table of Contents
TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
The Company’s net operating loss (“NOL”) carryforwards for federal and state income tax purposes consisted of the following (in thousands):
December 31,
2021
2020
NOL carryforwards
Federal
$
181,443
$
150,642
State
151,488
128,912
The NOL carryforwards begin expiring in 2032 for federal purposes and in 2026 for state income tax purposes. The Company recorded a valuation allowance on the deferred tax assets as of December 31, 2021 and 2020 because of the uncertainty of their realization. The valuation allowance increased by $ 8.1 million and $ 6.9 million for the years ended December 31, 2021 and 2020, respectively, mainly due to losses incurred.
Utilization of the net operating losses and general business tax credits carryforwards may be subject to a substantial limitation under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if changes in ownership of the company have occurred previously or occur in the future. Ownership changes may limit the amount of net operating losses and general business tax credits carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of 5% shareholders in the stock of a corporation by more than 50 percentage points over a three-year period. If the Company experiences a Section 382 ownership change, the tax benefits related to the NOL carryforwards may be further limited or lost. The Company has not performed an analysis under Section 382 and cannot predict or otherwise determine whether there would be any limitation to the amount of net operating losses and general business tax credits carryforwards that can be utilized.
A reconciliation of income tax benefit at the statutory federal income tax rate and as reflected in the consolidated financial statements is as follows:
Year ended December 31,
2021
2020
2019
Rate reconciliation
Federal tax benefit at statutory rate
( 21.0 )
%
( 21.0 )
%
( 21.0 )
%
State rate, net of federal benefit
( 3.5 )
( 4.2 )
( 2.9 )
Permanent differences
0.2
0.6
0.4
Research and development
0.4
0.7
( 0.7 )
Change in valuation allowance
24.2
24.0
24.2
Other
( 0.3 )
( 0.1 )
—
Total tax provision
—
%
—
%
—
%
The Company files income tax returns in the U.S. federal jurisdiction, various state jurisdictions and the United Kingdom. Tax years 2017 and forward remain open for examination for federal tax purposes and tax years 2017 and forward remain open for examination for the Company’s more significant state tax jurisdictions. Carryforward attributes from prior years may be adjusted upon examination by taxing authorities if used in an open period.
Many governments have enacted or are currently contemplating economic stimulus and financial aid measures. Many of these measures include deferring the due dates for tax payments, including both income tax and other taxes. The Coronavirus Aid, Relief, and Economic Security Act ("CARES Act") was enacted on March 27, 2020 in the United States to address the economic impacts of the COVID-19 pandemic. The CARES Act includes corporate income tax, payroll tax, and other provisions. While the Company may receive financial, tax, or other benefits under the bill, this
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TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
legislation did not impact the Company during the year ended December 31, 2020. During the year ended December 31, 2021, the Company claimed an employee retention payroll tax credit of $ 0.5 million for certain employment taxes.
(11) Commitments and Contingencies
Legal Proceedings
From time to time, the Company may be a party to various other lawsuits, claims, and other legal proceedings that arise in the ordinary course of its business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters will have a material adverse effect on the Company’s financial position, results of operations, or cash flows.
Agreements with Aroa
In August 2012, the Company entered into a License, Product Development, and Supply Umbrella Agreement (“Aroa Agreement”) with Aroa. The Aroa Agreement provides the Company a license to patent rights and other intellectual property related to Aroa’s products and technologies for use in certain indications and expires on the expiration of the last patent covering the products (currently April 19, 2031). The Company has the right to extend the term of the agreement by an additional 10 years following the expiration of the last patent covering the products on commercially reasonable terms to be negotiated by the parties. This agreement initially limited the Company’s license rights to the U.S. but was subsequently amended in March 2013 to include the European Union and certain former Union of Soviet Socialist Republic satellite nations. The Aroa Agreement required payments aggregating up to $ 4.0 million upon the achievement of U.S. and European cumulative product sales targets.
The Company paid $ 1.0 million to Aroa in 2018 related to one of the cumulative product sales targets and the remaining $ 2.0 million in 2019. With respect to the sales milestone payments in the European territory, a payment of $ 1.0 million is due when cumulative product net sales in the European territory reach certain amounts.
Other key terms of the amended Aroa agreement in addition to those disclosed above are as follows:
● The transfer price for product produced by Aroa is 200 % of Aroa’s cost of goods sold. The transfer price and the quarterly true-up amount continued to equal 27 % of Company’s net sales of licensed products. Upon a change in control of the Company (as defined in the amended agreement), the annual minimum amounts will be extended for a sixth year with a $ 5.0 million minimum amount for the North American territory and $ 1.0 million minimum amount for the European territory. If a change in control of the Company occurs prior to the first product launch in the applicable territory, then the annual minimum requirements shall commence upon such change in control. If the make whole payments, if any, are not made by the Company after a notice and cure period, then the license will convert to a nonexclusive basis in the territory for which the payment was required but not made.
● Provisions exist for the Company to step in and operate Aroa’s plant if a supply failure occurs and is not cured within a set timeframe. Under the amended agreement, the criteria for a supply failure was modified to mean a failure by Aroa to timely supply, during any consecutive 60-day period, at least 75 % of the products ordered by the Company under binding purchase orders. During the period that the Company steps in and assumes manufacturing responsibility, it shall not be required to purchase product from or pay transfer prices to Aroa, the annual minimums shall be proportionately reduced to reflect the lack of supply responsibility by Aroa and the Company shall pay a royalty of 6 % of net sales in lieu of 27 % of net sales of the licensed products.
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TELA BIO, INC.
Notes to Consolidated Financial Statements (continued)
The Company expects to enter into similar milestone-based agreements with its strategic partner for both product territories and new products in order to expand and extend its product portfolio.
As of December 31, 2021, the Company had $ 1.8 million in purchase commitments with Aroa and certain other suppliers to maintain exclusivity rights.
Other Commitments
In November 2021, the Company entered into an exclusive distribution agreement with Next Science, a medical technology company, granting the Company exclusive rights to sell and market Next Science’s proprietary antimicrobial surgical wash in the U.S. plastic reconstructive surgery market. To maintain exclusivity, the Company has $ 10.8 million in purchase commitments and annual license fees over a ten-year period.
Employment Agreements
The Company entered into employment agreements with key personnel providing for compensation and severance in certain circumstances, as defined in the respective employment agreements.
Operating Leases
The Company leases office and laboratory space in Malvern, Pennsylvania under a noncancelable lease, which was amended in December 2020 to extend the term of the lease from May 2021 to May 2028. The facility lease agreement has annual scheduled payment increases. The Company is recognizing the rent expense on a straight-line basis over the lease term. The Company recognized rent expense of $ 0.4 million, $ 0.3 million and $ 0.3 million for the years ended December 31, 2021, 2020 and 2019, respectively.
The future minimum lease payments under the facility operating lease agreement as of December 31, 2021 are as follows (in thousands):
2022
$
349
2023
358
2024
366
2025
375
2026
383
Thereafter
557
$
2,388
(12) Related-Party Transactions
On November 16, 2018, the Company entered into a senior secured term loan facility with OrbiMed, an entity affiliated with an owner of a material amount of the Company’s outstanding voting securities. The terms of the debt and related components are further described in more detail in Note 6.
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Exhibits.
The following exhibits are being filed herewith:
EXHIBIT INDEX
Exhibit No.
Exhibit
3.1
Fourth Amended and Restated Certificate of Incorporation (incorporated by reference to exhibit 3.1 of the Company’s Current Report on Form 8-K filed on November 19, 2019).
3.2
Second Amended and Restated Bylaws (incorporated by reference to exhibit 3.2 of the Company’s Current Report on Form 8-K filed on November 19, 2019).
4.1
Specimen Common Stock Certificate of the Company (incorporated by reference to exhibit 4.1 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019).
4.2
Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 (incorporated by reference to exhibit 4.2 to the Company’s Report on Form 10-K, filed on March 30, 2020) .
10.1
Form of Indemnification Agreement by and between the Company and its individual directors and officers (incorporated by reference to exhibit 10.1 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019).
10.2
TELA Bio, Inc. 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.2 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.3
Amendment to the TELA Bio, Inc. 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.3 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.4
Second Amendment to the TELA Bio, Inc. 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.4 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.5
Third Amendment to the TELA Bio, Inc. 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.5 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.6
Fourth Amendment to the TELA Bio, Inc. 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.6 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.7
Fifth Amendment to the TELA Bio, Inc. 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.7 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.8
Form of Incentive Stock Option Agreement pursuant to the 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.8 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.9
Form of Nonstatutory Stock Option Agreement pursuant to 2012 Stock Incentive Plan (incorporated by reference to exhibit 10.9 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019)
10.10
TELA Bio, Inc. Amended and Restated 2019 Equity Incentive Plan (incorporated by reference to exhibit 10.1 to the Company’s Current Report on Form 8-K filed on June 8, 2020) .
10.11
Form of TELA Bio, Inc. Amended and Restated 2019 Equity Incentive Plan Stock Option Grant Notice and Stock Option Agreement (incorporated by reference to exhibit 10.11 to the Company’s Report on Form 10-K, filed on March 25, 2021) .
10.12
Form of TELA Bio, Inc. Amended and Restated 2019 Equity Incentive Plan Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement (incorporated by reference to exhibit 10.12 to the Company’s Report on Form 10-K, filed on March 25, 2021) .
10.13
TELA Bio, Inc. 2019 Employee Stock Purchase Plan (incorporated by reference to exhibit 10.12 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019).
10.14
TELA Bio, Inc. Amended and Restated Non-Employee Director Compensation Policy (filed herewith).
10.15
Amended and Restated Employment Agreement, dated October 25, 2019, by and between the Company and Antony Koblish (incorporated by reference to exhibit 10.16 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019).
10.16
Amended and Restated Employment Agreement, dated October 25, 2019, by and between the Company and Skott Greenhalgh (incorporated by reference to exhibit 10.21 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019).
10.17
Employment Agreement, dated January 17, 2020, by and between the Company and Peter Murphy (incorporated by reference to exhibit 10.26 to the Company’s Report on Form 10-K, filed on March 30, 2020).
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10.18
Employment Agreement, dated August 27, 2021, by and between the Company and Roberto Cuca (incorporated by reference to exhibit 10.1 to the Company’s Report on Form 8-K, filed on September 27, 2021) .
10.19
Employment Agreement, dated September 15, 2020, by and between the Company and Paul Talmo (filed herewith).
1 0.20
Credit Agreement, dated November 16, 2018, by and between the Company and OrbiMed Royalty Opportunities II, LP (incorporated by reference to exhibit 10.22 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019).
10.21*
Second Amended and Restated License, Product Development and Supply Umbrella Agreement, dated July 16, 2015, by and between the Company and Aroa Biosurgery Ltd. (incorporated by reference to exhibit 10.23 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019) .
10.22*
Amendment to Second Amended and Restated License, Product Development and Supply Umbrella Agreement, dated November 26, 2015, by and between the Company and Aroa Biosurgery Ltd. (incorporated by reference to exhibit 10.24 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019) .
10.23*
Amendment to Second Amended and Restated License, Product Development and Supply Umbrella Agreement, dated January 3, 2019, by and between the Company and Aroa Biosurgery Ltd. (incorporated by reference to exhibit 10.25 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019) .
10.24*
Addendum to the Second Amended and Restated License, Product Development and Supply Umbrella Agreement, dated August 27, 2019, by and between the Company and Aroa Biosurgery Ltd. (incorporated by reference to exhibit 10.22 on the Company’s Report on Form 10-K filed on March 30, 2020).
10.25*
Addendum to the Second Amended and Restated License, Product Development and Supply Umbrella Agreement, dated February 15, 2020, by and between the Company and Aroa Biosurgery Ltd. (incorporated by reference to exhibit 10.2 on the Company’s Report on Form 10-Q filed on May 15, 2020).
10.26
Lease between the Company and Liberty Property Limited Partnership, dated January 31, 2013 (incorporated by reference to exhibit 10.26 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019) .
10.27
First Amendment to Lease between the Company and Liberty Property Partnership, dated June 19, 2014 (incorporated by reference to exhibit 10.27 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019) .
10.28
Second Amendment to Lease between the Company and WPT Land 2 LP (as successor in interest to Liberty Property Limited Partnership), dated January 17, 2018 (incorporated by reference to exhibit 10.28 to the Company’s Registration Statement on Form S-1 (File No. 333-234217), dated November 7, 2019).
10.29
Third Amendment to Lease between the Company and WPT Land 2 LP (as successor in interest to Liberty Property Limited Partnership), dated December 22, 2020 (incorporated by reference to exhibit 10.29 to the Company’s Report on Form 10-K, filed on March 25, 2021) .
10.30
Equity Distribution Agreement, dated December 18, 2020 (incorporated by reference to Exhibit 1.2 of the Company’s Registration Statement on Form S-3 (File No. 333-251505) filed on December 18, 2020).
21.1
Subsidiaries of the Registrant (filed herewith).
23.1
Consent of KPMG LLP (filed herewith) .
31.1
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
31.2
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
32.1
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
32.2
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
101 INS
XBRL Instance Document (filed herewith).
101 SCH
XBRL Taxonomy Extension Schema Document (filed herewith).
101 CAL
XBRL Taxonomy Extension Calculation Linkbase Document (filed herewith).
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101 DEF
XBRL Taxonomy Extension Definition Linkbase Document (filed herewith).
101 LAB
XBRL Taxonomy Extension Label Linkbase Document (filed herewith).
101 PRE
XBRL Taxonomy Extension Presentation Linkbase Document (filed herewith).
104
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101).
*
Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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.
TELA BIO, INC.
By:
/s/ ANTONY KOBLISH
Name: Antony Koblish
Title: President, Chief Executive Officer
and Director
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ ANTONY KOBLISH
President, Chief Executive Officer and Director (Principal Executive Officer)
March 23, 2022
Antony Koblish
/s/ ROBERTO CUCA
Chief Operating Officer and Chief Financial Officer
(Principal Financial Officer)
March 23, 2022
Roberto Cuca
/s/ MEGAN SMEYKAL
Chief Accounting Officer and Controller (Principal Accounting Officer)
March 23, 2022
Megan Smeykal
/s/ DOUG EVANS
Chairman, Board of Directors
March 23, 2022
Doug Evans
/s/ KURT AZARBARZIN
Director
March 23, 2022
Kurt Azarbarzin
/s/ VINCE BURGESS
Director
March 23, 2022
Vince Burgess
/s/ LISA COLLERAN
Director
March 23, 2022
Lisa Colleran
/s/ JOHN NOSENZO
Director
March 23, 2022
John Nosenzo
/s/ FEDERICA O’BRIEN
Director
March 23, 2022
Federica O’Brien
99