0001558370-21-007229 | 10-Q | XBRL Viewer

Print Document View Excel Document

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2021	May 03, 2021
Document and Entity Information
Document Type	10-Q
Document Period End Date	Mar. 31, 2021
Entity Registrant Name	TELA Bio, Inc.
Title of 12(b) Security	Common Stock, $0.001 par value per share
Trading Symbol	TELA
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		14,440,412
Entity Central Index Key	0001561921
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q1
Amendment Flag	false

Consolidated Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Current assets:
Cash and cash equivalents	$ 65,829	$ 74,394
Accounts receivable, net	2,795	2,683
Inventory	4,688	3,907
Prepaid expenses and other assets	1,892	2,241
Total current assets	75,204	83,225
Property and equipment, net	584	626
Intangible assets, net	2,531	2,607
Total assets	78,319	86,458
Current liabilities:
Accounts payable	965	652
Accrued expenses and other current liabilities	4,673	5,953
Total current liabilities	5,638	6,605
Long-term debt with related party	30,982	30,827
Other long-term liabilities	8
Total liabilities	36,628	37,432
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; 14,440,411 and 14,437,289 shares issued and 14,440,275 and 14,437,107 shares outstanding at March 31, 2021 and December 31, 2020, respectively	14	14
Additional paid-in capital	246,548	245,736
Accumulated other comprehensive loss	(82)	(71)
Accumulated deficit	(204,789)	(196,653)
Total stockholders’ equity	41,691	49,026
Total liabilities and stockholders’ equity	$ 78,319	$ 86,458

Consolidated Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2021	Dec. 31, 2020
Consolidated Balance Sheets
Preferred stock, Par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, Par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	200,000,000	200,000,000
Common stock, shares issued (in shares)	14,440,411	14,437,289
Common stock, shares outstanding (in shares)	14,440,275	14,437,107

Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Consolidated Statements of Operations and Comprehensive Loss
Revenue	$ 5,877	$ 3,726
Cost of revenue (excluding amortization of intangible assets)	2,336	1,450
Amortization of intangible assets	76	76
Gross profit	3,465	2,200
Operating expenses:
Sales and marketing	6,299	5,269
General and administrative	2,756	2,518
Research and development	1,679	912
Total operating expenses	10,734	8,699
Loss from operations	(7,269)	(6,499)
Other (expense) income:
Interest expense	(889)	(879)
Other income	22	158
Total other expense	(867)	(721)
Net loss	$ (8,136)	$ (7,220)
Net loss per common share, basic and diluted	$ (0.56)	$ (0.63)
Weighted average common shares outstanding, basic and diluted	14,438,405	11,406,783
Comprehensive loss:
Net loss	$ (8,136)	$ (7,220)
Foreign currency translation adjustment	(11)	27
Comprehensive loss	$ (8,147)	$ (7,193)

Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Common stock	Additional paid-in capital	Accumulated other comprehensive income	Accumulated deficit	Total
Balance at Beginning of period at Dec. 31, 2019	$ 11	$ 198,829	$ (19)	$ (167,859)	$ 30,962
Balance at Beginning of period (in shares) at Dec. 31, 2019	11,406,221
Vesting of common stock previously subject to repurchase (in shares)	90
Vesting of common stock previously subject to repurchase		1			1
Exercise of stock options (in shares)	1,289
Exercise of stock options		8			8
Foreign currency translation adjustment			27		27
Stock-based compensation expense		449			449
Net loss				(7,220)	(7,220)
Balance at Ending period at Mar. 31, 2020	$ 11	199,287	8	(175,079)	24,227
Balance at Ending period (in shares) at Mar. 31, 2020	11,407,600
Balance at Beginning of period at Dec. 31, 2020	$ 14	245,736	(71)	(196,653)	$ 49,026
Balance at Beginning of period (in shares) at Dec. 31, 2020	14,437,107
Vesting of common stock previously subject to repurchase (in shares)	46
Exercise of stock options (in shares)	3,122				3,122
Exercise of stock options		36			$ 36
Foreign currency translation adjustment			(11)		(11)
Stock-based compensation expense		694			694
Reclassification of liability-classified stock-based compensation		82			82
Net loss				(8,136)	(8,136)
Balance at Ending period at Mar. 31, 2021	$ 14	$ 246,548	$ (82)	$ (204,789)	$ 41,691
Balance at Ending period (in shares) at Mar. 31, 2021	14,440,275

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Cash flows from operating activities:
Net loss	$ (8,136)	$ (7,220)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense	64	56
Noncash interest expense	156	134
Amortization of intangible assets	76	76
Inventory excess and obsolescence charge	582	405
Stock-based compensation expense	694	449
Change in operating assets and liabilities:
Accounts receivable, net	(112)	781
Inventory	(1,360)	(617)
Prepaid expenses and other assets	349	544
Accounts payable	312	(1,261)
Accrued expenses and other current liabilities	(1,193)	(692)
Foreign currency remeasurement (gain) loss	(17)	38
Net cash used in operating activities	(8,585)	(7,307)
Cash flows from investing activities:
Proceeds from the sale and maturity of short-term investments		4,000
Purchase of property and equipment	(22)	(68)
Net cash (used in) provided by investing activities	(22)	3,932
Cash flows from financing activities:
Payment of initial public offering costs		(522)
Proceeds from exercise of stock options	36	8
Net cash provided by (used in) financing activities	36	(514)
Effect of exchange rate on cash and cash equivalents	6	(2)
Net decrease in cash and cash equivalents	(8,565)	(3,891)
Cash and cash equivalents, beginning of period	74,394	45,302
Cash and cash equivalents, end of period	65,829	41,411
Supplemental disclosure of cash flow information:
Cash paid during the period for interest	733	745
Supplemental disclosures of noncash investing and financing activities:
Property and equipment in accounts payable		4
Issuance of common stock for early exercised stock options		$ 1
Reclassification of liability-classified stock-based compensation to equity-classified	$ 82

Background	3 Months Ended
Background	Mar. 31, 2021
Background
Background	(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 focused on the commercialization and sale of OviTex Reinforced Tissue Matrix (“OviTex”), which utilizes surgical reconstruction medical device technology licensed from a strategic partner, Aroa Biosurgery Ltd. (“Aroa”) and on the research and development of additional medical devices with Aroa and on other internally developed technologies. In April 2019, the Company received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for OviTex PRS Reinforced Tissue Matrix (“OviTex PRS”), which addresses unmet needs in plastic and reconstructive surgery. The Company’s principal corporate office and research facility is located in Malvern, Pennsylvania.

Risks and Liquidity	3 Months Ended
Risks and Liquidity	Mar. 31, 2021
Risks and Liquidity
Risks and Liquidity	(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 $204.8 million as of March 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 on the business, ongoing economic uncertainty, 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.

Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2021

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

(3) Summary of Significant Accounting Policies

The Company’s complete summary of significant accounting policies can be found in “Note 3, Summary of Significant Accounting Policies” in the December 31, 2020 consolidated financial statements included in the Company’s Annual Report. Any reference in these notes to applicable guidance is meant to refer to generally accepted accounting principles (“GAAP”) in the United States as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) promulgated by the Financial Accounting Standards Board (“FASB”).

Interim Financial Statements

The accompanying unaudited interim consolidated financial statements have been prepared from the books and records of the Company in accordance with GAAP for interim financial information and Rule 10‑01 of Regulation S‑X promulgated by the SEC, which permits reduced disclosures for interim periods. All adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the accompanying consolidated balance sheets and statements of operations and comprehensive loss, stockholders’ equity and cash flows have been made. Although these interim consolidated financial statements do not include all of the information and footnotes required for complete annual consolidated financial statements, management believes the disclosures are adequate to make the information presented not misleading. Unaudited interim results of operations and cash flows are not necessarily indicative of the results that may be expected for the full year. Unaudited interim consolidated financial statements and footnotes should be read in conjunction with the December 31, 2020 consolidated financial statements and footnotes included in the Annual Report.

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 the fair value of 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.

The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including revenue, expenses, manufacturing, 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, as well as the economic impact on local, regional, national and international customers and markets. Management has made estimates of the impact of COVID-19 within the Company’s consolidated financial statements and there may be changes to those estimates in future periods. Actual results may differ from these estimates.

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.

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 by our portfolio of products (in thousands):


	Three months ended March 31,
	2021		2020
OviTex	$	4,667	$	3,239
OviTex PRS		1,210		487
Total revenue	$	5,877	$	3,726

Sales outside of the United States were immaterial for the three months ended March 31, 2021 and 2020.

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 the credit facility (the “OrbiMed Credit Facility”) with OrbiMed Royalty Opportunities IP, LP (“OrbiMed”) (Note 5), it is impractical to determine the fair value of the debt.

The Company follows the provisions of FASB 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).

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 (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)
March 31, 2021:
Cash equivalents – money market fund	$	28,393	$	—	$	—
Cash equivalents – government agency securities	$	35,000	$	—	$	—

December 31, 2020:
Cash equivalents – money market fund	$	72,889	$	—	$	—

Net loss per share

Basic and diluted net loss per common share is determined by dividing net loss by the weighted‑average shares of common stock outstanding during the reporting period. A net loss cannot be diluted, so when the Company is in a net loss position, basic and diluted loss per common share are the same.

The following potentially dilutive securities have been excluded from the computation of diluted weighted‑average shares outstanding for the periods presented, as they would be antidilutive.


	Three months ended March 31,
	2021	2020
Stock options (including shares subject to repurchase)	1,634,458	1,482,819
Restricted stock units	185,877	—
Common stock warrants	88,556	88,556
Total	1,908,891	1,571,375

Amounts in the above table reflect the common stock equivalents of the noted instrument.

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 is currently evaluating the expected impact that the standard could have on its consolidated financial statements and related disclosures.

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. Early adoption is permitted for any annual periods for which financial statements have not been issued and interim periods therein. The adoption of this guidance did not have any impact on the Company’s consolidated financial statements and related disclosures.

Accrued Expenses and Other Current Liabilities

3 Months Ended

Mar. 31, 2021

Accrued Expenses and Other Current Liabilities

Accrued Expenses and Other Current Liabilities

(4) Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):


	March 31,		December 31,
	2021		2020
Compensation and related benefits	$	2,234	$	3,666
Interest		40		40
Third-party and professional fees		1,740		1,626
Research and development expenses		43		7
Other		616		614
	$	4,673	$	5,953

Long-term Debt

3 Months Ended

Mar. 31, 2021

Debt Disclosure [Abstract]

Long-term Debt

(5) Long‑term Debt

Long‑term debt consisted of the following (in thousands):


	March 31,		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		(2,018)		(2,173)
Long-term debt with related party	$	30,982	$	30,827

OrbiMed Term Loan (Related Party)

In November 2018, the Company entered into the OrbiMed Credit Facility with 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 (the “OrbiMed Term Loans”). The OrbiMed Term Loans 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 March 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 for the three months ended March 31, 2021, was $0.9 million, of which $0.2 million was related to the amortization of debt issuance costs. Interest expense associated with the OrbiMed Credit Facility recorded for the three months ended March 31, 2020, was $0.9 million, of which $0.1 million was related to the amortization of debt issuance costs.

Stockholders’ Equity

3 Months Ended

Mar. 31, 2021

Stockholders' Equity

Stockholders’ Equity

(6) Stockholders’ Equity

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 three months ended March 31, 2021.

Warrants

The Company had the following warrants outstanding to purchase common stock at March 31, 2021:


			Exercise	Expiration
	Outstanding		price	dates
Common stock warrants issued to MidCap	8,379	$	28.65	2028
Common stock warrants issued to note payable holders	15,712		28.65	2027
Common stock warrants issued to convertible promissory note holders	64,465	$	28.65	2027
	88,556

Stock-Based Compensation

3 Months Ended

Mar. 31, 2021

Stock-Based Compensation

Stock-Based Compensation

(7) 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 March 31, 2021, 873,688 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 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 and comprehensive loss (in thousands):


	Three months ended March 31,
	2021		2020
Sales and marketing	$	184	$	161
General and administrative		366		209
Research and development		144		79
Total stock‑based compensation	$	694	$	449

Stock Options

The Company’s stock options vest based on the terms in each award agreement and generally vest over four years and have a term of 10 years. 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, 2021	1,498,208		10.87
Granted	180,575		16.99
Exercised	(3,122)		11.46
Canceled/forfeited	(41,339)		12.72
Outstanding at March 31, 2021	1,634,322	$	11.50	7.80
Vested and expected to vest at March 31, 2021	1,570,634	$	11.41	7.76
Exercisable at March 31, 2021	729,909	$	8.86	6.50

At March 31, 2021, the aggregate intrinsic value of outstanding options and exercisable options was $6.1 million and $4.4 million, respectively.

The 2012 Stock Incentive Plan provided the holders of stock options an election to early exercise prior to vesting. The Company has 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 March 31, 2021, $1,000 of proceeds from early exercised options are recognized as a current liability in 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, 2021		182
Vested		(46)
Unvested balance at March 31, 2021		136

The weighted average grant‑date fair value per share of options granted was $10.01 during the three months ended March 31, 2021. The aggregate intrinsic value of options exercised was $12,000 for the three ended March 31, 2021. At March 31, 2021, the total unrecognized compensation expense related to unvested employee and nonemployee stock option awards was $5.8 million, which is expected to be recognized in expense over a weighted‑average period of approximately 2.6 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 requires 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:


	Three months ended
	March 31, 2021
Expected dividend yield	—
Expected volatility	64.3	%
Risk‑free interest rate	0.82	%
Expected term (in years)	6.25

Restricted Stock Units

The Company’s restricted stock units 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		186,732
Canceled/forfeited		(855)
Outstanding at March 31, 2021		185,877

The weighted average grant‑date fair value per restricted stock unit granted was $16.63 during the three months ended March 31, 2021. The aggregate intrinsic value of restricted stock units was $2.8 million at March 31, 2021. The total unrecognized compensation expense at March 31, 2021 related to restricted stock units was $2.2 million, which is expected to be recognized in expense over a weighted‑average period of approximately 3.9 years.

Related-Party Transactions	3 Months Ended
Related-Party Transactions	Mar. 31, 2021
Related-Party Transactions
Related-Party Transactions	(8) 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 5.

Summary of Significant Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2021

Summary of Significant Accounting Policies

Interim Financial Statements

Use of Estimates

Revenue Recognition

The following table presents revenue disaggregated by our portfolio of products (in thousands):


	Three months ended March 31,
	2021		2020
OviTex	$	4,667	$	3,239
OviTex PRS		1,210		487
Total revenue	$	5,877	$	3,726

Sales outside of the United States were immaterial for the three months ended March 31, 2021 and 2020.

Fair value of financial instruments

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).

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 (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)
March 31, 2021:
Cash equivalents – money market fund	$	28,393	$	—	$	—
Cash equivalents – government agency securities	$	35,000	$	—	$	—

December 31, 2020:
Cash equivalents – money market fund	$	72,889	$	—	$	—

Net loss per share

The following potentially dilutive securities have been excluded from the computation of diluted weighted‑average shares outstanding for the periods presented, as they would be antidilutive.


	Three months ended March 31,
	2021	2020
Stock options (including shares subject to repurchase)	1,634,458	1,482,819
Restricted stock units	185,877	—
Common stock warrants	88,556	88,556
Total	1,908,891	1,571,375

Amounts in the above table reflect the common stock equivalents of the noted instrument.

Recently Issued Accounting Pronouncement

Recently Issued Accounting Pronouncements

Summary of Significant Accounting Policies (Tables)

3 Months Ended

Mar. 31, 2021

Summary of Significant Accounting Policies

Disaggregation of Revenue

The following table presents revenue disaggregated by our portfolio of products (in thousands):


	Three months ended March 31,
	2021		2020
OviTex	$	4,667	$	3,239
OviTex PRS		1,210		487
Total revenue	$	5,877	$	3,726

Schedule of fair value of assets and liabilities measured on recurring basis

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 (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)
March 31, 2021:
Cash equivalents – money market fund	$	28,393	$	—	$	—
Cash equivalents – government agency securities	$	35,000	$	—	$	—

December 31, 2020:
Cash equivalents – money market fund	$	72,889	$	—	$	—

Schedule of dilutive securities excluded


	Three months ended March 31,
	2021	2020
Stock options (including shares subject to repurchase)	1,634,458	1,482,819
Restricted stock units	185,877	—
Common stock warrants	88,556	88,556
Total	1,908,891	1,571,375

- Definition

Tabular disclosure of financial instruments measured at fair value, including those classified in shareholders' equity measured on a recurring or nonrecurring basis. Disclosures include, but are not limited to, fair value measurements recorded and the reasons for the measurements, level within the fair value hierarchy in which the fair value measurements are categorized and transfers between levels 1 and 2. Nonrecurring fair value measurements are those that are required or permitted in the statement of financial position in particular circumstances.

+ References + Details

Accrued Expenses and Other Current Liabilities (Tables)

3 Months Ended

Mar. 31, 2021

Accrued Expenses and Other Current Liabilities

Schedule of Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):


	March 31,		December 31,
	2021		2020
Compensation and related benefits	$	2,234	$	3,666
Interest		40		40
Third-party and professional fees		1,740		1,626
Research and development expenses		43		7
Other		616		614
	$	4,673	$	5,953

Long-term Debt (Tables)

3 Months Ended

Mar. 31, 2021

Debt Disclosure [Abstract]

Schedule of long term debt

Long‑term debt consisted of the following (in thousands):


	March 31,		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		(2,018)		(2,173)
Long-term debt with related party	$	30,982	$	30,827

Stockholders’ Equity (Tables)

3 Months Ended

Mar. 31, 2021

Stockholders' Equity

Schedule of warrants outstanding to purchase common stock


			Exercise	Expiration
	Outstanding		price	dates
Common stock warrants issued to MidCap	8,379	$	28.65	2028
Common stock warrants issued to note payable holders	15,712		28.65	2027
Common stock warrants issued to convertible promissory note holders	64,465	$	28.65	2027
	88,556

Stock-Based Compensation (Tables)

3 Months Ended

Mar. 31, 2021

Stock-Based Compensation

Schedule of stock based compensation expense categories in statement of operations

The Company recorded stock‑based compensation expense in the following expense categories of its accompanying consolidated statements of operations and comprehensive loss (in thousands):


	Three months ended March 31,
	2021		2020
Sales and marketing	$	184	$	161
General and administrative		366		209
Research and development		144		79
Total stock‑based compensation	$	694	$	449

Schedule of stock option activity


				Weighted
				average
		Weighted		remaining
	Number of	average exercise		contractual term
	shares	price per share		(years)
Outstanding at January 1, 2021	1,498,208		10.87
Granted	180,575		16.99
Exercised	(3,122)		11.46
Canceled/forfeited	(41,339)		12.72
Outstanding at March 31, 2021	1,634,322	$	11.50	7.80
Vested and expected to vest at March 31, 2021	1,570,634	$	11.41	7.76
Exercisable at March 31, 2021	729,909	$	8.86	6.50

Schedule of activity relating to early exercise of stock options


		Number of
		shares
Unvested balance at January 1, 2021		182
Vested		(46)
Unvested balance at March 31, 2021		136

Schedule of weighted average assumptions


	Three months ended
	March 31, 2021
Expected dividend yield	—
Expected volatility	64.3	%
Risk‑free interest rate	0.82	%
Expected term (in years)	6.25

Schedule of restricted stock units


		Number of
		shares
Outstanding at January 1, 2021		—
Granted		186,732
Canceled/forfeited		(855)
Outstanding at March 31, 2021		185,877

Risks and Liquidity (Details) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Risks and Liquidity
Accumulated deficit	$ (204,789)	$ (196,653)

Summary of Significant Accounting Policies - Revenue Recognition (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2021 USD ($)
Summary of Significant Accounting Policies
Incremental costs of obtaining a contract	$ 0

Summary of Significant Accounting Policies - Revenue Disaggregated (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Disaggregation of Revenue [Line Items]
Revenue	$ 5,877	$ 3,726
OviTex [Member]
Disaggregation of Revenue [Line Items]
Revenue	4,667	3,239
OviTex PRS [Member]
Disaggregation of Revenue [Line Items]
Revenue	$ 1,210	$ 487

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8906-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 40
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9031-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 41
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9038-108599

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 4
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130543-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 42
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9054-108599

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 5
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130545-203045

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 924
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-URI http://asc.fasb.org/extlink&oid=6472922&loc=d3e499488-122856

+ Details

Summary of Significant Accounting Policies - Fair value of financial instruments (Details) - Recurring - Level 1 - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Money market funds
Fair value of financial instruments
Cash equivalents	$ 28,393	$ 72,889
Agency securities
Fair value of financial instruments
Cash equivalents	$ 35,000

Summary of Significant Accounting Policies - Potentially dilutive securities (Details) - shares	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Potentially dilutive securities
Potentially dilutive securities excluded from computation of diluted weighted average shares	1,908,891	1,571,375
Stock Options
Potentially dilutive securities
Potentially dilutive securities excluded from computation of diluted weighted average shares	1,634,458	1,482,819
Restricted Stock Units
Potentially dilutive securities
Potentially dilutive securities excluded from computation of diluted weighted average shares	185,877
Common Stock Warrants
Potentially dilutive securities
Potentially dilutive securities excluded from computation of diluted weighted average shares	88,556	88,556

Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Accrued Expenses and Other Current Liabilities
Compensation and related benefits	$ 2,234	$ 3,666
Interest	40	40
Third-party and professional fees	1,740	1,626
Research and development expenses	43	7
Other	616	614
Accrued Expenses and Other Current Liabilities	$ 4,673	$ 5,953

Long-term Debt - Schedule of long term debt (Details) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Debt
Long‑term debt with related party	$ 30,982	$ 30,827
OrbiMed Term Loans (related party)
Debt
Long Term Debt	30,000	30,000
End of term charge	3,000	3,000
Unamortized end of term charge and issuance costs	(2,018)	(2,173)
Long‑term debt with related party	$ 30,982	$ 30,827

Long-term Debt - OrbiMed Term Loan (related party) (Details)	3 Months Ended
	Mar. 31, 2021 USD ($) tranche	Mar. 31, 2020 USD ($)	Nov. 30, 2018 USD ($)
OrbiMed Term Loans (related party)
Debt
Number of Tranches \| tranche	2
Minimum Cash Balance	$ 2,000,000
Interest due to unpaid obligation	3.00%
Interest Rate (as a percent)	9.75%		7.75%
Number of Installment	60 months
Exit fee (as a percent)	10.00%
Administration Fees	$ 10,000
Debt issuance costs	300,000
End of term charge	3,000,000
Interest Expenses	900,000	$ 900,000
Amortization of debt issuance costs	$ 200,000	$ 100,000
OrbiMed Term Loans (related party) \| Prior to second anniversary
Debt
Percentage of prepayment penalty on prepaid principal amount	10.00%
OrbiMed Term Loans (related party) \| After second anniversary but prior to third anniversary
Debt
Percentage of prepayment penalty on prepaid principal amount	5.00%
OrbiMed Term Loans (related party) \| After third anniversary
Debt
Percentage of prepayment penalty on prepaid principal amount	2.50%
OrbiMed Term Loans (related party) \| LIBOR
Debt
Variable Interest Rate (as a percent)	2.00%
OrbiMed Term Loans (related party) \| Maximum
Debt
Debt Amount	$ 35,000,000
Tranche One
Debt
Debt Amount	30,000,000		$ 30,000,000
Tranche Two
Debt
Debt Amount	$ 5,000,000

Stockholders’ Equity - Public Stock Offerings (Details) - USD ($) $ in Millions	Mar. 31, 2021	Dec. 31, 2020
Equity Distribution Agreement
Stockholders’ Equity
Value Of Shares Authorized To Be Sold	$ 0.0	$ 50.0

Stockholders’ Equity - Warrants outstanding (Details)	3 Months Ended
Stockholders’ Equity - Warrants outstanding (Details)	Mar. 31, 2021 $ / shares shares
Stockholders’ Equity
Warrants outstanding	88,556
MidCap Credit Facility \| Warrants
Stockholders’ Equity
Warrants outstanding	8,379
warrants exercise price \| $ / shares	$ 28.65
Expiration dates	2028
Notes payable \| Warrants
Stockholders’ Equity
Warrants outstanding	15,712
warrants exercise price \| $ / shares	$ 28.65
Expiration dates	2027
Convertible promissory notes \| Warrants
Stockholders’ Equity
Warrants outstanding	64,465
warrants exercise price \| $ / shares	$ 28.65
Expiration dates	2027

Stock-Based Compensation - Expenses (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Stock-Based Compensation
Total stock-based compensation	$ 694	$ 449
Sales and marketing
Stock-Based Compensation
Total stock-based compensation	184	161
General and administrative
Stock-Based Compensation
Total stock-based compensation	366	209
Research and development
Stock-Based Compensation
Total stock-based compensation	$ 144	$ 79

Stock-Based Compensation - Stock Option Activity (Details)	3 Months Ended
	Mar. 31, 2021 $ / shares shares
Number of shares
Balance at beginning of period \| shares	1,498,208
Granted \| shares	180,575
Exercised \| shares	(3,122)
Canceled/forfeited \| shares	(41,339)
Balance at end of period \| shares	1,634,322
Vested and expected to vest at end of period \| shares	1,570,634
Exercisable at end of period \| shares	729,909
Weighted average exercise price per share
Balance at beginning of period (in dollars per share) \| $ / shares	$ 10.87
Granted ( in dollars per share) \| $ / shares	16.99
Exercised (in dollars per share) \| $ / shares	11.46
Canceled/forfeited (in dollars per share) \| $ / shares	12.72
Balance at end of period (in dollars per share) \| $ / shares	11.50
Vested and expected to vest at end of period (in dollars per share) \| $ / shares	11.41
Exercisable at end of period (in dollars per share) \| $ / shares	$ 8.86
Weighted average remaining contractual term (years)
Weighted average remaining contractual term, outstanding	7 years 9 months 18 days
Weighted average remaining contractual term, Vested and expected to vest	7 years 9 months 4 days
Weighted average remaining contractual term, Exercisable	6 years 6 months

Stock-Based Compensation - Early Exercise Of Stock Options (Details)	3 Months Ended
	Mar. 31, 2021 shares
Stock-Based Compensation
Unvested balance at beginning of period	182
Vested	(46)
Unvested balance at end of period	136

Stock-Based Compensation - Weighted average assumptions (Details)	3 Months Ended
	Mar. 31, 2021
Stock-Based Compensation
Expected volatility	64.30%
Risk-free interest rate	0.82%
Expected term	6 years 3 months

Stock-Based Compensation - Restricted Stock Units (Details) - Restricted Stock Units	3 Months Ended
	Mar. 31, 2021 shares
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Granted	186,732
Canceled/forfeited	(855)
Outstanding at March 31, 2021	185,877

Stock-Based Compensation - Narratives (Details)	3 Months Ended
Stock-Based Compensation - Narratives (Details)	Mar. 31, 2021 USD ($) $ / shares shares
Stock-Based Compensation
Aggregate intrinsic value of outstanding options	$ 6,100,000
Aggregate intrinsic value of exercisable options	$ 4,400,000
Stock Options
Stock-Based Compensation
Weighted average grant date fair value (per share) \| $ / shares	$ 10.01
Aggregate intrinsic value of exercisable options	$ 12,000
Restricted Stock Units
Stock-Based Compensation
Vesting period	4 years
Weighted average grant date fair value (per share) \| $ / shares	$ 16.63
Aggregate intrinsic value of exercisable options	$ 2,800,000
Unrecognized compensation expense	$ 2,200,000
Weighted average period for recognition of unrecognized expenses	3 years 10 months 24 days
2012 Stock Incentive Plan \| Current Liability
Stock-Based Compensation
Proceeds from early exercise of option	$ 1,000
2012 Stock Incentive Plan \| Stock Options
Stock-Based Compensation
Unrecognized compensation expense	$ 5,800,000
Weighted average period for recognition of unrecognized expenses	2 years 7 months 6 days
2019 Equity Incentive Plan
Stock-Based Compensation
Shares available for future issuance \| shares	873,688
Common Stock Capital Shares Reserved For Future Annual Issuance \| shares	432,442
Common Stock Capital Shares Reserved For Future Issuance, Percentage Of Shares Outstanding Last Day Of Fiscal Year	4.00%
2019 Equity Incentive Plan \| Stock Options
Stock-Based Compensation
Vesting period	4 years
Vesting term	P10Y