NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. Organization
Vericel Corporation, a Michigan corporation (together with its consolidated subsidiaries referred to herein as the Company, Vericel, we, us or our), was incorporated in March 1989 and began employee-based operations in 1991. The Company is a fully-integrated, commercial-stage biopharmaceutical company and is a leader in advanced cell therapies for the sports medicine and severe burn care markets. Vericel currently markets two cell therapy products, MACI® and Epicel®, in the United States. Vericel obtained both products in May 2014, as part of the acquisition of certain assets and the assumption of certain liabilities from Sanofi, a French société anonyme (Sanofi).
MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. The Company also markets Epicel® (cultured epidermal autografts), a permanent skin replacement Humanitarian Use Device (HUD) for the treatment of adult and pediatric patients with deep-dermal or full-thickness burns comprising greater than or equal to 30 percent of total body surface area (TBSA). The Company operates its business primarily in the U.S. in one reportable segment — the research, product development, manufacture and distribution of biopharmaceuticals for use in the treatment of specific diseases.
COVID-19
The novel coronavirus (COVID-19) outbreak was first reported by China in late December 2019 and rapidly spread globally. The World Health Organization (WHO) declared the outbreak a pandemic on March 11, 2020 and the President of the United States declared a national health emergency two days later. Subsequently most states' governments, including those in Massachusetts and Michigan where the Company's operations are located, issued orders requiring businesses that do not conduct essential services to temporarily close their physical workplaces to employees and customers. The status of such orders varies on a state-by-state basis and is likely to continue to vary. Because Vericel is deemed an essential business, the Company is exempt from these state orders in their current form.
Notwithstanding being an essential business, the Company’s business and operations have been, and are expected to continue to be, adversely impacted by the effects of COVID-19 as a result of various factors including, without limitation, patients’ potential reluctance to undergo elective surgical procedures, healthcare facility restrictions regarding elective surgical procedures, the recent economic downturn due to the pandemic, the imposition of related public health measures and travel and business restrictions and disruptions to the ability of the Company’s employees to perform their jobs.
The implantation of MACI is an elective surgical procedure. On March 13, 2020 and March 14, 2020, the American College of Surgeons and United States Surgeon General, respectively, recommended that each hospital, health system, and surgeon minimize, postpone, or cancel electively scheduled surgeries, which has resulted in a reduction in MACI sales. The stated purpose for these recommendations was that every elective surgery could spread COVID-19 within a facility, use up personal protective equipment (PPE) which may be needed by healthcare workers treating COVID-19 patients, and burden hospital workforce who may be needed to respond to COVID-19. These recommendations were followed by numerous state level executive orders either banning or partially banning elective surgeries. As a result of these restrictions, beginning in mid-March 2020, the Company started to experience a significant increase in cancellations of scheduled MACI procedures as well as a slowdown in new MACI orders. By early April 2020, 45 states, representing over 95% of total U.S. surgical capacity had issued either mandates or recommendations and guidelines suspending elective surgical procedures. These restrictions began to ease in May and, by the end of June 2020, states representing an estimated 90% total U.S. surgical capacity had lifted restrictions suspending elective procedures. It is likely that restrictions will continue to be both lifted and re-imposed as regional COVID 19 cases rates fall and rise. The Company’s MACI business will continue to be negatively impacted so long as multiple state orders and/or facilities restrict elective surgical procedures.
Going Concern
The accompanying condensed consolidated financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. As of June 30, 2020, the Company had an accumulated deficit of $391.7 million and incurred a net loss of $8.3 million and $13.0 million for the three and six months ended June 30, 2020, respectively. The Company had cash and cash equivalents of $55.8 million and investments of $25.1 million as of June 30, 2020. The Company expects that existing cash, cash equivalents and investments will be sufficient to support the Company’s current operations through at least 12 months from the issuance of these financial statements. However, the continuing effects of the COVID-19 pandemic may require the Company to engage in layoffs, furloughs and/or reductions in salary, all of which may result in irrecoverable losses of customers and significantly impact long-term liquidity. If elective surgery restrictions are reinstated on a widespread basis, significantly impacting the Company's business, the Company may need to access additional capital; however, the Company may not be able to obtain financing on acceptable terms or at all, particularly in light of the impact of COVID-19 on the global economy and financial markets. The terms of any financing may adversely affect the holdings or the rights of the Company’s shareholders.
2. Basis of Presentation
The accompanying condensed consolidated financial statements as of June 30, 2020 and for the three and six months ended June 30, 2020 are unaudited and have been prepared in accordance with the rules and regulations of the U.S. Securities and Exchange Commission (SEC). The preparation of condensed consolidated financial statements in conformity with generally accepted accounting principles in U.S. GAAP requires management to make estimates, judgments, and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to such rules and regulations. The financial statements reflect, in the opinion of management, all adjustments (consisting only of normal, recurring adjustments) necessary to state fairly the financial position and results of operations as of and for the periods indicated. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses. The full extent to which the COVID-19 pandemic will continue to directly or indirectly impact our business, results of operations and financial condition, including sales, expenses, reserves and allowances, manufacturing, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to continue to contain it or treat COVID-19, as well as the economic impact on our customers. We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods. Actual results may differ from these estimates. As of June 30, 2020, the Company has not recorded impairments to investments, inventory, other current assets or long-lived assets as a result of the COVID-19 pandemic and does not expect material impairments in the future. The Company has assessed the impact of COVID-19 on accounts receivables (see note 4).
These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the SEC on February 25, 2020 (Annual Report).
Consolidated Statement of Cash Flows
The following table presents certain supplementary cash flows information for the six months ended June 30, 2020 and 2019:
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Six Months Ended June 30,
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|
(In thousands)
|
2020
|
|
2019
|
|
|
Supplementary Cash Flows information:
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|
Non-cash information:
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|
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|
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|
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|
Right-of-use asset and lease liability recognized
|
$
|
429
|
|
|
$
|
560
|
|
|
|
Additions to property, plant and equipment included in accounts payable
|
55
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|
365
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|
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|
Cash information:
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|
Interest paid (net of interest capitalized)
|
$
|
3
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|
|
$
|
4
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|
|
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|
|
|
|
|
Total cash, cash equivalents, and restricted cash of $55.8 million as of June 30, 2020, shown in the statement of cash flows is comprised of cash and cash equivalents of $55.7 million and restricted cash of $0.1 million which is included in other long term assets on the consolidated balance sheet. As of June 30, 2019, cash and cash equivalents were $14.0 million and the Company did not have any restricted cash.
3. Recent Accounting Pronouncements
Measuring Credit Losses on Financial Instruments
The FASB issued updated guidance on measuring credit losses on financial instruments. The guidance removes the thresholds that companies apply to measure credit losses on financial instruments measured at amortized cost, such as loans, receivables, and held-to-maturity debt securities. Prior to the updated guidance, credit losses are recognized when it is probable that the loss has been incurred. The revised guidance removes all recognition thresholds and requires companies to recognize an allowance for credit losses for the difference between the amortized cost basis of a financial instrument and the amount of amortized cost that a company expected to collect over the instrument’s contractual life. The Accounting Standard Update (ASU) 2016-13, Financial Instruments-Credit Losses (Topic 326), became effective for the Company January 1, 2020. See note 4 and note 8 for further discussion.
Fair Value Measurement Disclosure
The FASB issued updated guidance through ASU 2018-13, Fair Value Measurement (Topic 820) Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement. The revised guidance is intended to develop a more consistent disclosure framework that will increase clarity, remove, modify and add certain fair value disclosures to improve the effectiveness of the Company’s disclosures in the notes of the financial statements. This guidance became effective for the Company January 1, 2020 and had no impact to its condensed consolidated financial statements.
Simplifying the Accounting for Income Taxes
In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes (ASC 740). The ASU enhances and simplifies various aspects of the income tax accounting guidance in ASC 740, including requirements related to hybrid tax regimes, the tax basis step-up in goodwill obtained in a transaction that is not a business combination, separate financial statements of entities not subject to tax, the intra-period tax allocation exception to the incremental approach, ownership changes in investments, changes from a subsidiary to an equity method investment, interim-period accounting for enacted changes in tax law, and the year-to-date loss limitation in interim-period tax accounting. This guidance is effective for the Company for annual and interim periods beginning after December 31, 2020; however, early adoption is permitted. The Company is currently in the process of evaluating the impact to its condensed consolidated financial statements.
4. Revenue
Revenue Recognition and Net Product Sales
The Company recognizes product revenue from sales of MACI kits, MACI implants and Epicel grafts following the five-step model in Accounting Standards Codification 606, Revenue Recognition, (ASC 606).
MACI Kits
MACI kits are sold directly to hospitals based on contracted rates in the approved contract or sales order. The Company recognizes MACI kit revenue upon delivery of the biopsy kit at which time the customer (the facility) is in control of the kit. The kit provides the doctor the ability to biopsy a sampling of cells to provide to the Company that can be used later to manufacture the implant. The ordering of the kit does not obligate the Company to manufacture an implant nor does the receipt of the cell tissue. The customer’s order of an implant is separate from the process of ordering the kit. Therefore, the sale of the kit and any subsequent sale of an implant are distinct contracts and are accounted for separately.
MACI Implants
The Company contracts with two specialty pharmacies, Orsini Pharmaceutical Services, Inc. (Orsini) and AllCare Plus Pharmacy, Inc. (AllCare) to distribute its MACI product in arrangements whereby the Company retains the credit and collection risk from the end customer. The Company pays both specialty pharmacies a fee for each patient to whom MACI is dispensed. Both Orsini and AllCare perform collection activities to receive payment from customers. The Company has engaged a third-party to provide services in connection with a patient support program to manage patient cases and to ensure complete and correct billing information is provided to the insurers and hospitals. In addition, the Company also sells MACI directly to DMS Pharmaceutical (DMS) for military implants. The sales directly to DMS are sold at a contracted rate.
Prior authorization and confirmation of coverage level by the patient’s private insurance plan, hospital or government payer is a prerequisite to the shipment of product to a patient. The Company recognizes product revenues from sales of all MACI implants upon delivery at which time the customer obtains control of the implant and the claim is billable. The total consideration which the Company expects to collect in exchange for MACI implants (the transaction price) may be fixed or variable. Direct sales to hospitals or distributors are recorded at a contracted price, and other than customary prompt pay discounts, there are typically no forms of variable consideration.
When the Company sells MACI the patient is responsible for payment, however, the Company is typically reimbursed by a third-party insurer or government payer, subject to a patient co-pay amount. Reimbursements from third-party insurers and government payers vary by patient and payer and are based on either contracted rates, publicly available rates or a fee schedule. Net product revenue is recognized net of contractual allowances, which considers historical collection experience from both the payer and patient and the terms of the Company’s contractual arrangements. The Company estimates expected collections for these transactions using the portfolio approach. These estimates include the impact of contractual allowances, which considers historical collection experience from both the payer and patient, denial rates and the terms of the Company’s contractual arrangements. The Company records a reduction to revenue at the time of sale for its estimate of the amount of consideration that will not be collected. In addition, potential credit risk exposure has been evaluated for the Company's accounts receivable in accordance with ASC 326, Financial Instruments - Credit Losses. The Company assesses risk and determines a loss percentage by pooling account receivables based on similar risk characteristics. The loss percentage is based on current and historical information as well as reasonable and supportable forecasts. This loss percentage was applied to the accounts receivables as of June 30, 2020. The total allowance for uncollectible consideration was $4.4 million as of June 30, 2020 and $3.9 million at December 31, 2019. The allowance includes less than $0.1 million of which is related to COVID-19 potential impacts on accounts receivable from third-party insurers, government payers, hospitals and patients. Changes to the estimate of the amount of consideration that will not be collected could have a material impact to the revenue recognized. A 0.5% change to the estimated uncollectible percentage could result in approximately a $0.1 million decrease in the revenue recognized for the six months ended June 30, 2020.
Changes in estimates of the transaction price are recorded through revenue in the period in which such change occurs. Changes in estimates related to prior period sales for the three and six months ended June 30, 2020 resulted in a decrease to revenue of $0.2 million and increase to revenue of $1.1 million, respectively, and an increase to revenue of $0.09 million and $0.05 million, respectively for the same period in 2019. The changes in estimates recorded during the three and six months ended June 30, 2020, were primarily due to completion of the billing claims process for implants that occurred in late 2019. Upon completion of the billing claims process, the Company concluded that it was probable that a significant reversal in the amount of revenue recognized would not occur.
Epicel
The Company sells Epicel directly to hospitals based on contracted rates stated in the approved contract or purchase order. Similar to MACI, there is no obligation to manufacture skin grafts upon receipt of a skin biopsy, and Vericel has no contractual right to receive payment until the product is delivered to the hospital. The Company recognizes product revenues from sales of Epicel upon delivery to the hospital at which time the customer is in control of the skin grafts and the claim is billable to the hospital.
Revenue by Product and Customer
The following table and description below shows the products from which the Company generated its revenue:
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Three Months Ended June 30,
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Six Months Ended June 30,
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Revenue by product (in thousands)
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2020
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2019
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2020
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2019
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MACI implants and kits
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|
|
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|
|
|
|
|
Implants based on contracted rate sold through a specialty pharmacy (a)
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$
|
9,790
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|
|
$
|
12,989
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|
|
$
|
21,218
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|
|
$
|
22,776
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|
Implants subject to third party reimbursement sold through a specialty pharmacy (b)
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|
2,819
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|
|
3,459
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|
|
6,335
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|
|
6,202
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|
Implants sold direct based on contracted rates (c)
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|
1,806
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|
|
3,450
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|
|
4,916
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|
|
6,676
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|
Implants sold direct subject to third party reimbursement (d)
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|
589
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|
|
281
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|
|
1,016
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|
|
603
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|
Biopsy kits - direct bill
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|
348
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|
|
557
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|
|
811
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|
|
1,099
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|
Change in estimates related to prior periods (e)
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(248)
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|
87
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|
|
1,095
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|
50
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|
Epicel
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|
|
|
|
|
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Direct bill (hospital)
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4,910
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|
|
5,328
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|
|
11,301
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|
|
10,555
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|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
20,014
|
|
|
$
|
26,151
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|
|
$
|
46,692
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|
|
$
|
47,961
|
|
|
|
|
|
|
|
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|
(a) Represents implants sold through Orsini and AllCare in both 2020 and 2019 in which such specialty pharmacies have entered into a direct contract with the underlying insurance provider. The amount of reimbursement is based on contracted rates at the time of sale supported by the pharmacy's direct contracts. Also represents direct sales under a contract to the specialty distributor DMS.
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(b) Represents implants sold through Orsini or AllCare in which such specialty pharmacy does not have a direct contract with the underlying payer. The amount of reimbursement is established based on a payer or state fee schedule and/or payer history.
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(c) Represents implants sold directly from the Company to the facility based on a contract and known price agreed upon prior to the surgery date.
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|
(d) Represents implants sold directly from the Company to the facility based on a contract and known price agreed upon prior to the surgery date. The payment terms are subject to third-party reimbursement from an underlying insurance provider.
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(e) Primarily represents changes in estimates related to implants sold through Orsini or AllCare in which such specialty pharmacy does not have a direct contract with the underlying payer. The initial estimate of the amount of reimbursement is established based on a payer or state fee schedule and/or payer history. The change in estimates is a result of additional information or actual cash collections received in the current period.
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Concentration of Credit Risk
The table below shows the Company’s total Epicel revenue and accounts receivable balances from customers whose revenue or accounts receivable concentration is greater than 10% in any of the periods disclosed below. The Company did not have MACI revenue or accounts receivable concentrations greater than 10% in any of the periods disclosed below.
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Revenue Concentration
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|
Accounts Receivable Concentration
|
|
|
|
Three Months Ended June 30,
|
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|
|
Six Months Ended June 30,
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|
|
June 30,
|
|
December 31,
|
|
2020
|
|
2019
|
|
2020
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
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|
Epicel
|
6
|
%
|
|
6
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%
|
|
10
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%
|
8
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%
|
|
3
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%
|
|
2
|
%
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|
5. Selected Balance Sheet Components
Inventory
Inventory as of June 30, 2020 and December 31, 2019:
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|
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|
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|
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|
|
(In thousands)
|
|
June 30, 2020
|
|
December 31, 2019
|
Raw materials
|
|
$
|
7,853
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|
|
$
|
6,085
|
|
Work-in-process
|
|
513
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|
|
541
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|
Finished goods
|
|
51
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|
|
190
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|
Inventory
|
|
$
|
8,417
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|
|
$
|
6,816
|
|
Property and Equipment
Property and Equipment, net as of June 30, 2020 and December 31, 2019:
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|
|
|
|
|
|
|
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|
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(In thousands)
|
|
June 30, 2020
|
|
December 31, 2019
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Machinery and equipment
|
|
$
|
3,279
|
|
|
$
|
3,152
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|
Furniture, fixtures and office equipment
|
|
810
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|
|
775
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|
Computer equipment and software
|
|
6,393
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|
|
6,174
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|
Leasehold improvements
|
|
5,256
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|
|
5,256
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|
Construction in process
|
|
1,311
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|
|
859
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|
Financing right-of-use lease
|
|
129
|
|
|
148
|
|
Total property and equipment, gross
|
|
17,178
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|
|
16,364
|
|
Less accumulated depreciation
|
|
(10,138)
|
|
|
(9,220)
|
|
|
|
$
|
7,040
|
|
|
$
|
7,144
|
|
Depreciation expense for the three and six months ended June 30, 2020 was $0.5 million and $1.1 million, respectively, and $0.4 million and $0.7 million for the same periods in 2019.
Accrued Expenses
Accrued Expenses as of June 30, 2020 and December 31, 2019 are as follows:
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|
(In thousands)
|
|
June 30, 2020
|
|
December 31, 2019
|
Bonus related compensation
|
|
$
|
2,872
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|
|
$
|
5,116
|
|
Employee related accruals
|
|
2,578
|
|
|
1,785
|
|
Other accrued expenses
|
|
2,525
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|
|
1,047
|
|
Accrued expenses
|
|
$
|
7,975
|
|
|
$
|
7,948
|
|
6. Leases
The Company leases facilities in Ann Arbor, Michigan and Cambridge, Massachusetts. The Ann Arbor facility includes office space, and the Cambridge facility includes clean rooms, laboratories for MACI and Epicel manufacturing and office space. The Company also leases offsite warehouse space, vehicles and computer equipment. Certain of the Company’s lease agreements include lease payments that are adjusted periodically for an index or rate. The leases are initially measured using the projected payments adjusted for the index or rate in effect at the commencement date. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. All operating lease commitments with a lease term greater than 12 months are recognized as right to use assets and liabilities, on a discounted basis on the balance sheet. Leases with an initial term of 12 months or less are not recorded on the balance sheet and for both the three and six months ended June 30, 2020 and 2019, lease expense of less than $0.1 million was recorded related to short-term leases.
The contribution toward the cost of tenant improvements is recorded as a reduction of the operating lease assets. For the three and six months ended June 30, 2020, the Company recognized $1.4 million and $2.9 million of operating lease expense and $1.3 million and $2.6 million for the same periods in 2019.
For both the three and six months ended June 30, 2020 and 2019, the Company recognized less than $0.1 million of financing lease expense. The Company’s leases contain non-lease components and activities that do not transfer a good or service to the Company. The Company elected not to combine lease and non-lease components and therefore non-lease costs were not included in the net lease assets or lease liabilities.
Total leased assets and liabilities as reassessed under the updated guidance and classified on the balance sheet, as of June 30, 2020 and December 31, 2019 are as follows:
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|
|
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|
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(In thousands)
|
|
Classification
|
|
June 30, 2020
|
|
December 31, 2019
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Operating
|
|
Right-of-use assets
|
|
$
|
23,800
|
|
|
$
|
25,103
|
|
|
|
Finance
|
|
Property and equipment, net
|
|
129
|
|
|
148
|
|
|
|
|
|
|
|
$
|
23,929
|
|
|
$
|
25,251
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
|
|
|
|
Operating
|
|
Current portion of operating lease liabilities
|
|
$
|
5,570
|
|
|
$
|
5,461
|
|
|
|
Finance
|
|
Other liabilities
|
|
41
|
|
|
41
|
|
|
|
|
|
|
|
$
|
5,611
|
|
|
$
|
5,502
|
|
|
|
Non-current
|
|
|
|
|
|
|
|
|
Operating
|
|
Operating lease liabilities
|
|
$
|
20,881
|
|
|
$
|
22,242
|
|
|
|
Finance
|
|
Other long-term liabilities
|
|
93
|
|
|
110
|
|
|
|
|
|
|
|
$
|
20,974
|
|
|
$
|
22,352
|
|
|
|
7. Stock-Based Compensation
Stock Option, Restricted Stock Units and Equity Incentive Plans
The Company has historically had various stock incentive plans and agreements that provide for the issuance of nonqualified and incentive stock options and restricted stock units as well as other equity awards. Such awards may be granted by the Company’s Board of Directors to certain of the Company’s employees, directors and consultants.
Options and restricted stock units granted to employees and non-employees under these plans expire no later than ten years from the date of grant and generally become exercisable over a four year period, under a graded-vesting methodology for stock options and annually on the anniversary grant date for restricted stock units, following the date of grant. The Company generally issues new shares upon the exercise of stock options or vesting of restricted stock units.
The 2019 Omnibus Incentive Plan (2019 Plan) was approved on May 1, 2019 and provides incentives through the grant of stock options, stock appreciation rights, restricted stock awards and restricted stock units. The exercise price of stock options granted under the 2019 Plan shall not be less than the fair market value of the Company’s common stock on the date of grant. The 2019 Plan replaced the 1992 Stock Option Plan, the 2001 Stock Option Plan, the Amended and Restated 2004 Equity Incentive Plan, the 2009 Second Amended and Restated Omnibus Incentive Plan and the 2017 Omnibus Incentive Plan (Prior Plans), and no new grants have been granted under the Prior Plans after approval. However, the expiration or forfeiture of options previously granted under the Prior Plans will increase the number of shares available for issuance under the 2019 Plan.
The Amended and Restated 2019 Omnibus Incentive Plan (Amended and Restated 2019 Plan) was approved on April 29, 2020. Amendments to the Amended and Restated 2019 Omnibus Plan included increasing the total number of shares of the Company's common stock reserved for issuance under the 2019 Plan by 2,400,000 shares, a revised ratio at which "full- value" awards are counted against the share reserve from 1.25 to 1.4, and extending the term of the plan to April 29, 2030.
As of June 30, 2020, there were 4,267,255 shares available for future grant under the Amended and Restated 2019 Plan.
Employee Stock Purchase Plan
Employees are able to purchase stock under the Vericel Corporation Employee Stock Purchase Plan (ESPP). The ESPP allows for the issuance of an aggregate of 1,000,000 shares of common stock of which 672,907 have been issued since the inception of the benefit in 2015. Participation in this plan is available to substantially all employees. The ESPP is a compensatory plan accounted for under the expense recognition provisions of the share-based payment accounting standards. Compensation expense is recorded based on the fair market value of the purchase options at the grant date, which corresponds to the first day of each purchase period and is amortized over the purchase period. In July 2020, employees purchased 44,137 shares resulting in proceeds from the sale of common stock of $0.3 million under the ESPP for the second quarter of 2020.
Service-Based Stock Options
During the three and six months ended June 30, 2020, the Company granted service-based options to purchase common stock of 110,750 and 1,296,890, respectively, and 152,500 and 1,638,510, respectively, for the same periods in 2019. The exercise price of the options is the fair market value per share of common stock on the grant date, generally vest over four years (other than non-employee director options which vest over one year) and have a term of ten years. The Company issues new shares upon the exercise of stock options. The weighted average grant-date fair value of service-based options granted during the three and six months ended June 30, 2020 was $8.82 and $8.66, respectively and $11.94 and $12.74, respectively, for the same periods in 2019.
Restricted Stock Units
During the three and six months ended June 30, 2020 and 2019, the Company granted 10,700 and 196,836, service-based restricted stock units, respectively and 10,500 and 186,922, respectively, for the same periods in 2019. The restricted stock units vest annually over four years in equal installments commencing on the first anniversary of the grant date (other than non-employee director options which vest over one year from the grant date). The Company issues new shares upon the vesting of restricted stock units. Restricted stock awards are recorded at fair value at the date of grant, which is based on the closing share price on the grant date. Compensation expense is recorded for restricted stock units that are expected to vest based on their fair value at grant date and is amortized over the expected vesting period. The weighted average grant-date fair value of restricted stock units granted during the three and six months ended June 30, 2020 was $14.49 and $11.41, respectively and $16.62 and $17.71, respectively, for the same periods in 2019. The aggregate fair value of restricted stock units granted in the three and six months ended June 30, 2020 was $0.2 million and $2.2 million, respectively and $0.2 million and $3.3 million, respectively, for the same periods in 2019.
As a result of 36,212 units vesting during the three months ended March 31, 2020, 13,872 shares were withheld for payment of taxes on the employee's behalf and retired from the 2019 Plan. During the three months ended June 30, 2020, 10,500 units vested and no shares were withheld for payment of taxes, as no shares are withheld at vesting for shares awarded to the Company's Board of Directors.
Stock Compensation Expense
Non-cash stock-based compensation expense (employee stock purchase plan, service-based stock options and restricted stock units) included in cost of goods sold, research and development expenses and selling, general and administrative expenses is summarized in the following table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
|
Six Months Ended June 30,
|
|
|
(in thousands)
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Cost of goods sold
|
|
$
|
568
|
|
|
$
|
716
|
|
|
$
|
997
|
|
|
$
|
976
|
|
Research and development
|
|
484
|
|
|
886
|
|
|
$
|
1,060
|
|
|
1,410
|
|
Selling, general and administrative
|
|
3,325
|
|
|
2,581
|
|
|
$
|
6,087
|
|
|
4,424
|
|
Total non-cash stock-based compensation expense
|
|
$
|
4,377
|
|
|
$
|
4,183
|
|
|
$
|
8,144
|
|
|
$
|
6,810
|
|
8. Cash Equivalents and Investments
Marketable debt securities held by the Company are classified as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities, and carried at fair value in the accompanying consolidated balance sheets on a settlement date basis. The following tables summarize the gross unrealized gains and losses of the Company’s marketable securities as of June 30, 2020 and December 31, 2019:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Unrealized
|
|
|
|
|
|
Estimated Fair Value
|
|
|
Amortized Cost
|
|
Gains
|
|
Losses
|
|
Credit Losses
|
|
|
Money market funds
|
|
$
|
44,985
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
44,985
|
|
Commercial paper
|
|
3,685
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,685
|
|
Corporate notes
|
|
8,840
|
|
|
55
|
|
|
—
|
|
|
—
|
|
|
8,895
|
|
U.S. government securities
|
|
7,776
|
|
|
67
|
|
|
—
|
|
|
—
|
|
|
7,843
|
|
U.S. asset-backed securities
|
|
4,640
|
|
|
23
|
|
|
—
|
|
|
—
|
|
|
4,663
|
|
|
|
$
|
69,926
|
|
|
$
|
145
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
70,071
|
|
Classified as:
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents
|
|
|
|
|
|
|
|
|
|
$
|
44,985
|
|
Short term investments
|
|
|
|
|
|
|
|
|
|
25,086
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
70,071
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2019
|
|
|
|
|
|
|
|
|
|
|
Gross Unrealized
|
|
|
|
Estimated Fair Value
|
(In thousands)
|
|
Amortized Cost
|
|
Gains
|
|
Losses
|
|
|
Money market funds
|
|
$
|
5,381
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,381
|
|
|
|
|
|
|
|
|
|
|
Commercial paper
|
|
11,892
|
|
|
—
|
|
|
—
|
|
|
11,892
|
|
Corporate notes
|
|
18,369
|
|
|
11
|
|
|
—
|
|
|
18,380
|
|
U.S. government securities
|
|
11,291
|
|
|
4
|
|
|
—
|
|
|
11,295
|
|
U.S. asset-backed securities
|
|
10,503
|
|
|
6
|
|
|
—
|
|
|
10,509
|
|
|
|
$
|
57,436
|
|
|
$
|
21
|
|
|
$
|
—
|
|
|
$
|
57,457
|
|
Classified as:
|
|
|
|
|
|
|
|
|
Cash equivalents
|
|
|
|
|
|
|
|
$
|
5,381
|
|
Short-term investments
|
|
|
|
|
|
|
|
42,829
|
|
Long term investments
|
|
|
|
|
|
|
|
9,247
|
|
|
|
|
|
|
|
|
|
$
|
57,457
|
|
As of June 30, 2020 and December 31, 2019, we held both short-term and long-term investments. Investments classified as short-term have maturities of less than one year. Investments classified as long-term are those that: (i) have a maturity of greater than one year, and (ii) we do not intend to liquidate within the next twelve months, although these funds are available for use and, therefore, are classified as available-for-sale. The Company's investment strategy is to buy short-duration marketable securities with a high credit rating. As of June 30, 2020, all marketable securities held by the Company had remaining contractual maturities of three years or less.
Unrealized gains are included as a component of accumulated other comprehensive income in the condensed consolidated balance sheets and statements of stockholders’ equity and a component of total comprehensive loss in the condensed consolidated statements of comprehensive loss, until realized. Unrealized losses are evaluated for impairment under ASC 326, Financial Instruments - Credit Losses, to determine if the impairment is credit-related or non credit-related. Credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings, and non credit-related impairment is recognized in other comprehensive income, net of taxes. There were no material realized losses on marketable securities for the three and six months ended June 30, 2020 and 2019.
The Company evaluated its investments for impairment under ASC 326. Any allowance for credit losses are recorded at the lower of either the fair market value less book value or the difference between the present value of future cash flows and the book value. As of June 30, 2020, the analysis under ASU 2016-13 and the current macroeconomic impact of the COVID-19 pandemic did not result in material allowances for credit losses. There have been no impairments of the Company’s assets measured and carried at fair value as of June 30, 2020.
9. Fair Value Measurements
The Company’s fair value measurements are 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 liability;
•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).
There was no movement between Level 1 and Level 2 or between Level 2 and Level 3 from December 31, 2019 to June 30, 2020. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The commercial paper, corporate notes, U.S. government securities and asset-backed securities are classified as Level 2 as they were valued based upon quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. The following table summarizes the valuation of the Company’s financial instruments that are measured at fair value on a recurring basis:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2020
|
|
|
|
|
|
|
|
December 31, 2019
|
|
|
|
|
|
|
|
|
|
|
Fair value measurement category
|
|
|
|
|
|
|
|
Fair value measurement category
|
|
|
|
|
(In thousands)
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
44,985
|
|
|
$
|
44,985
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,381
|
|
|
$
|
5,381
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial paper
|
|
3,685
|
|
|
—
|
|
|
3,685
|
|
|
—
|
|
|
11,892
|
|
|
—
|
|
|
11,892
|
|
|
—
|
|
Corporate notes
|
|
8,895
|
|
|
—
|
|
|
8,895
|
|
|
—
|
|
|
18,380
|
|
|
—
|
|
|
18,380
|
|
|
—
|
|
U.S. government securities
|
|
7,843
|
|
|
—
|
|
|
7,843
|
|
|
—
|
|
|
11,295
|
|
|
—
|
|
|
11,295
|
|
|
—
|
|
U.S. asset-backed securities
|
|
4,663
|
|
|
—
|
|
|
4,663
|
|
|
—
|
|
|
10,509
|
|
|
—
|
|
|
10,509
|
|
|
—
|
|
|
|
$
|
70,071
|
|
|
$
|
44,985
|
|
|
$
|
25,086
|
|
|
$
|
—
|
|
|
$
|
57,457
|
|
|
$
|
5,381
|
|
|
$
|
52,076
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The fair values of the cash equivalents and marketable securities are based on observable market prices. See note 8 for impact of ASU 2016-13 on the investment valuation.
10. Net Loss Per Common Share
The following reflects the net loss attributable to common shareholders and share data used in the basic and diluted earnings per share computations using the two class method:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
|
Six Months Ended June 30,
|
|
|
|
|
(Amounts in thousands, except per share amounts)
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(8,269)
|
|
|
$
|
(19,792)
|
|
|
$
|
(12,974)
|
|
|
$
|
(22,636)
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted EPS: weighted-average common shares outstanding
|
|
45,137
|
|
|
43,956
|
|
|
45,031
|
|
|
43,841
|
|
|
|
Net loss per share attributable to common shareholders (basic and diluted)
|
|
$
|
(0.18)
|
|
|
$
|
(0.45)
|
|
|
$
|
(0.29)
|
|
|
$
|
(0.52)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anti-dilutive shares excluded from the calculation of diluted earnings per share(a) (amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
Stock options
|
|
6.0
|
|
|
5.6
|
|
|
6.0
|
|
|
5.6
|
|
|
|
Restricted stock unit awards
|
|
0.3
|
|
|
0.2
|
|
|
0.3
|
|
|
0.2
|
|
|
|
Warrants
|
|
—
|
|
|
0.1
|
|
|
—
|
|
|
0.1
|
|
|
|
(a) Common equivalent shares are not included in the diluted per share calculation where the effect of their inclusion would be anti-dilutive.
|
|
|
|
|
|
|
|
|
|
|
11. NexoBrid License and Supply Agreements
On May 6, 2019, the Company entered into exclusive license and supply agreements with MediWound Ltd. (MediWound) to commercialize NexoBrid® and any improvements to NexoBrid in all countries of North America. NexoBrid is a topically-administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns.
NexoBrid is currently in clinical development in North America, and pursuant to the terms of the license agreement, MediWound will continue to conduct all clinical activities described in the development plan to support the BLA filing with the United States Food and Drug Administration (FDA) under the supervision of a Central Steering Committee comprised of members of each party. On June 30, 2020, the Company announced the submission of the BLA to the FDA seeking the approval of NexoBrid. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic in the United States, European Union and other international markets.
In May 2019, the Company paid MediWound $17.5 million in consideration of the license. The $17.5 million upfront payment was recorded to research and development expense during 2019, as the license was considered in process research and development. The Company is also obligated to pay MediWound $7.5 million upon U.S. regulatory approval of the BLA for NexoBrid and up to $125 million contingent upon meeting certain sales milestones. The first sales milestone of $7.5 million would be triggered when annual net sales of NexoBrid or improvements to it in North America exceed $75 million. The Company also will pay MediWound tiered royalties on net sales ranging from mid-high single-digit to mid-teen percentages, subject to customary reductions. The U.S. Biomedical Advanced Research and Development Authority (BARDA) has committed to procure NexoBrid, and the Company will pay a percentage of gross profits to MediWound on initial committed amounts and a royalty on any additional BARDA purchases of NexoBrid beyond the initial committed amount. The Company also entered into a supply agreement with MediWound under which MediWound will manufacture NexoBrid for the Company on a unit price basis which may be increased based on a published index. MediWound is obligated to supply the Company with NexoBrid for sale in North America on an exclusive basis for the first five years of the term of the supply agreement. After the exclusivity period or upon supply failure, the Company will be permitted to establish an alternate source of supply. As of June 30, 2020, the milestone payments are not yet probable and therefore, not considered a liability.
12. Commitments and Contingencies
The Company's purchase commitments consist of minimum purchase amounts of materials used in the Company's cell manufacturing process to manufacture its marketed cell therapy products.