0001558370-20-012835 | 10-Q | XBRL Viewer

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Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2020	Nov. 04, 2020
Document and Entity Information
Entity Registrant Name	KALA PHARMACEUTICALS, INC.
Entity Central Index Key	0001479419
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2020
Document Transition Report	false
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity File Number	001-38150
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	27-0604595
Entity Address, Address Line One	490 Arsenal Way, Suite 120
Entity Address, City or Town	Watertown
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02472
City Area Code	781
Local Phone Number	996-5252
Title of 12(b) Security	Common Stock, $0.001 par value per share
Trading Symbol	KALA
Security Exchange Name	NASDAQ
Entity Interactive Data Current	Yes
Entity Current Reporting Status	Yes
Entity Filer Category	Accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Common Stock, Shares Outstanding		56,075,211
Entity Shell Company	false
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q3

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Current assets:
Cash and cash equivalents	$ 45,526	$ 85,449
Short-term investments	113,594
Accounts receivable, net	7,455	11,563
Inventory	7,538	4,648
Prepaid expenses and other current assets	4,043	3,824
Total current assets	178,156	105,484
Non-current assets:
Property and equipment, net	2,822	2,698
Long-term inventory	2,689	3,778
Right-of-use assets	28,344	29,781
Restricted cash and other long-term assets	13,085	12,582
Total assets	225,096	154,323
Current liabilities:
Accounts payable	2,222	2,518
Accrued expenses and other current liabilities	15,851	20,929
Current portion of lease liabilities	1,477	1,327
Total current liabilities	19,550	24,774
Long-term liabilities:
Long-term lease liabilities - less current portion	27,549	28,673
Long-term debt	71,967	71,184
Total long-term liabilities	99,516	99,857
Total liabilities	119,066	124,631
Commitments and Contingencies (Note 14)
Stockholders' equity:
Common stock, $0.001 par value; 120,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 56,061,365 and 36,086,254 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively	56	36
Additional paid-in capital	474,648	325,112
Accumulated other comprehensive income	(3)
Accumulated deficit	(368,671)	(295,456)
Total stockholders' equity	106,030	29,692
Total liabilities and stockholders' equity	$ 225,096	$ 154,323

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2020	Dec. 31, 2019
CONDENSED CONSOLIDATED BALANCE SHEETS
Common stock, par value	$ 0.001	$ 0.001
Common stock, authorized	120,000,000	120,000,000
Common stock, shares issued	56,061,365	36,086,254
Common stock, shares outstanding	56,061,365	36,086,254

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Product revenues, net	$ 2,220	$ 1,451	$ 4,124	$ 4,894
Costs and expenses:
Cost of product revenues	701	668	1,814	1,261
Selling, general and administrative	23,893	15,280	54,602	50,523
Research and development	3,468	7,070	14,955	21,137
Total costs and expenses	28,062	23,018	71,371	72,921
Loss from operations	(25,842)	(21,567)	(67,247)	(68,027)
Other income (expense):
Interest and other income	51	571	451	1,973
Interest and other expense	(2,157)	(2,180)	(6,419)	(6,335)
Total interest and other expense	(2,106)	(1,609)	(5,968)	(4,362)
Net loss	$ (27,948)	$ (23,176)	$ (73,215)	$ (72,389)
Net loss per share-basic and diluted	$ (0.50)	$ (0.68)	$ (1.44)	$ (2.13)
Weighted average shares outstanding-basic and diluted	56,030,717	34,168,282	50,851,167	33,977,477
Statement of Comprehensive Income
Net loss	$ (27,948)	$ (23,176)	$ (73,215)	$ (72,389)
Other comprehensive income (loss):
Change in unrealized gains/losses on investments	14		(3)
Total other comprehensive income (loss)	14		(3)
Total comprehensive loss	$ (27,934)	$ (23,176)	$ (73,218)	$ (72,389)

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Common Stock	Additional Paid-In Capital	Accumulated Other Comprehensive Loss	Accumulated Deficit	Total
Balance as of beginning of period at Dec. 31, 2018	$ 34	$ 306,053		$ (201,109)	$ 104,978
Balance as of beginning of period (in shares) at Dec. 31, 2018	33,863,077
Stockholders' Equity
At the market offering, net of sales agent commission	$ 1	2,129			2,130
At the market offering, net of sales agent commission (in shares)	532,304
Exercise of stock options		42			42
Exercise of stock options (in shares)	24,714
Issuance under employee stock purchase plan		545			545
Issuance under employee stock purchase plan (in shares)	123,664
Stock-based compensation expense		7,750			7,750
Net loss				(72,389)	(72,389)
Balance as of end of period at Sep. 30, 2019	$ 35	316,519		(273,498)	43,056
Balance as of end of period (in shares) at Sep. 30, 2019	34,543,759
Balance as of beginning of period at Dec. 31, 2018	$ 34	306,053		(201,109)	104,978
Balance as of beginning of period (in shares) at Dec. 31, 2018	33,863,077
Balance as of end of period at Dec. 31, 2019	$ 36	325,112		(295,456)	29,692
Balance as of end of period (in shares) at Dec. 31, 2019	36,086,254
Balance as of beginning of period at Jun. 30, 2019	$ 34	311,354		(250,322)	61,066
Balance as of beginning of period (in shares) at Jun. 30, 2019	33,882,967
Stockholders' Equity
At the market offering, net of sales agent commission	$ 1	2,129			2,130
At the market offering, net of sales agent commission (in shares)	532,304
Exercise of stock options		3			3
Exercise of stock options (in shares)	4,824
Issuance under employee stock purchase plan		545			545
Issuance under employee stock purchase plan (in shares)	123,664
Stock-based compensation expense		2,488			2,488
Net loss				(23,176)	(23,176)
Balance as of end of period at Sep. 30, 2019	$ 35	316,519		(273,498)	43,056
Balance as of end of period (in shares) at Sep. 30, 2019	34,543,759
Balance as of beginning of period at Dec. 31, 2019	$ 36	325,112		(295,456)	29,692
Balance as of beginning of period (in shares) at Dec. 31, 2019	36,086,254
Stockholders' Equity
Common stock offering, net of issuance cost and underwriting fees	$ 17	125,406			125,423
Common stock offering, net of issuance cost and underwriting fees (in shares)	16,979,371
Warrant exercises (in shares)	16,144
At the market offering, net of sales agent commission	$ 3	12,543			12,546
At the market offering, net of sales agent commission (in shares)	2,352,671
Exercise of stock options		945			945
Exercise of stock options (in shares)	312,528
Issuance under employee stock purchase plan		1,016			1,016
Issuance under employee stock purchase plan (in shares)	314,397
Stock-based compensation expense		9,626			9,626
Change in fair value of investments			$ (3)		(3)
Net loss				(73,215)	(73,215)
Balance as of end of period at Sep. 30, 2020	$ 56	474,648	(3)	(368,671)	106,030
Balance as of end of period (in shares) at Sep. 30, 2020	56,061,365
Balance as of beginning of period at Jun. 30, 2020	$ 56	469,627	(17)	(340,723)	128,943
Balance as of beginning of period (in shares) at Jun. 30, 2020	55,831,021
Stockholders' Equity
Exercise of stock options		7			7
Exercise of stock options (in shares)	1,500
Issuance under employee stock purchase plan		746			746
Issuance under employee stock purchase plan (in shares)	228,844
Stock-based compensation expense		4,268			4,268
Change in fair value of investments			14		14
Net loss				(27,948)	(27,948)
Balance as of end of period at Sep. 30, 2020	$ 56	$ 474,648	$ (3)	$ (368,671)	106,030
Balance as of end of period (in shares) at Sep. 30, 2020	56,061,365
Stockholders' Equity
Accumulated other comprehensive income					$ (3)

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - (Parenthetical) $ in Thousands	9 Months Ended
	Sep. 30, 2020 USD ($)
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
Issuance cost and underwriting fees	$ 8,475
Sales agent commission	$ 388

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Cash flows from operating activities:
Net loss	$ (73,215)	$ (72,389)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation	674	614
Non-cash operating lease cost	1,437	1,307
Amortization of debt discount and other non-cash interest	782	709
Stock-based compensation	9,249	7,666
Change in operating assets and liabilities:
Accounts receivable	4,108	(7,171)
Prepaid expenses and other current assets	(223)	(167)
Inventory	(1,423)	(4,379)
Accounts payable	(332)	(3,284)
Accrued expenses and other current liabilities	(4,882)	3,454
Lease liabilities and other long-term liabilities	(950)	(868)
Net cash used in operating activities	(64,775)	(74,508)
Cash flows from investing activities:
Purchases of property and equipment and intangible assets	(1,459)	(1,147)
Purchases of short-term investments	(113,592)
Net cash used in investing activities	(115,051)	(1,147)
Cash flows from financing activities:
Proceeds from common stock offerings, net of underwriters' discounts and offering cost	137,969	2,130
Payment of principal on finance lease	(24)	(30)
Proceeds from exercise of stock options and issuance of common stock under employee stock purchase plan	1,961	587
Net cash provided by financing activities	139,906	2,687
Net decrease in cash, cash equivalents and restricted cash:	(39,920)	(72,968)
Cash, cash equivalents and restricted cash at beginning of period	98,031	183,104
Cash, cash equivalents and restricted cash at end of period	58,111	110,136
Reconciliation of cash, cash equivalents and restricted cash:
Cash, cash equivalents, and restricted cash at end of period	58,111	110,136
Cash and cash equivalents at end of period	45,526	97,556
Non-cash investing and financing activities:
Right-of-use asset obtained in exchange for finance lease obligation		136
Purchases of property and equipment in accounts payable	34
Supplemental disclosure:
Cash paid for interest	$ 5,636	5,626
Right-of-use assets obtained in exchange of operating lease obligations		$ 1,852

NATURE OF BUSINESS AND BASIS OF PRESENTATION

9 Months Ended

Sep. 30, 2020

NATURE OF BUSINESS AND BASIS OF PRESENTATION

NATURE OF BUSINESS AND BASIS OF PRESENTATION

1. NATURE OF BUSINESS AND BASIS OF PRESENTATION

Nature of Business— Kala Pharmaceuticals, Inc. (the “Company”) was incorporated on July 7, 2009, and is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye. The Company has applied its AMPPLIFY^® mucus-penetrating particle (“MPP”) Drug Delivery Technology to loteprednol etabonate (“LE”), a corticosteroid designed for ocular applications, resulting in the U.S. Food and Drug Administration’s (the “FDA”) approval of EYSUVIS^TM (loteprednol etabonate ophthalmic suspension) 0.25%, for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease, and INVELTYS^® (loteprednol etabonate ophthalmic suspension) 1% as the first and only topical twice-daily ocular corticosteroid for treatment of post-operative inflammation and pain following ocular surgery.

In January 2019, the Company launched its first commercial product, INVELTYS, in the United States. The Company expects to begin shipping its second commercial product, EYSUVIS, to wholesalers in the U.S. by the end of 2020 and for the full promotional launch to begin in January of 2021. The Company is engaged in preparing for the launch of EYSUVIS, the commercialization of INVELTYS, research and development activities, raising capital and recruiting skilled personnel. The Company is subject to a number of risks similar to those of other companies conducting high-risk, research and development of pharmaceutical product candidates and launching products for the first time. Principal among these risks are dependence on key individuals and intellectual property, competition from other products and companies and the technical risks associated with the successful research, development and marketing of its product candidates. The Company’s success is dependent upon its ability to successfully commercialize its products, the success of its research and development efforts, its ability to obtain regulatory approval of its product candidates, its ability to raise additional capital when needed and, ultimately, attain profitable operations.

The Company is also evaluating other opportunities for MPP nanosuspensions of LE, compounds in its receptor Tyrosine Kinase Inhibitor program, that inhibit the vascular endothelial growth factor, pathway, for the potential treatment of a number of retinal diseases, and novel next-generation anti-inflammatories designed to exhibit steroid-like anti-inflammatory action for eye disease with the goal of eliminating the risk of interocular pressure increase and cataract formation.

Liquidity— Since inception, the Company has incurred significant losses from operations and negative cash flows from operations. As of September 30, 2020, the Company had an accumulated deficit of $368,671. The Company has generated only limited revenues to date from product sales and has financed operations primarily through proceeds from its initial public offering of common stock (“IPO”), public common stock offerings and sales of its common stock under its at-the-market offering facility, private placements of preferred stock, convertible debt financings, borrowings under credit facilities and warrants. The Company has devoted substantially all of its financial resources and efforts to research and development, including preclinical studies and clinical trials and engaging in activities to launch and commercialize EYSUVIS and INVELTYS. The Company expects to continue to incur significant expenses and operating losses. Net losses may fluctuate significantly from quarter-to-quarter and year-to-year.

The Company believes that its existing cash, cash equivalents and short-term investments as of September 30, 2020, will enable it to fund its operating expenses, debt service obligations and capital expenditure requirements for at least twelve months from the date these condensed consolidated financial statements were issued. This evaluation is based on relevant conditions and events that are known and reasonably knowable at the date that the condensed consolidated financial statements are issued. As a result, the Company could deplete its available capital resources sooner than it currently expects.

COVID-19 – The ongoing novel coronavirus pandemic, commonly referred to as COVID-19, which was declared a global pandemic by the World Health Organization on March 11, 2020, has caused federal, state, and local governments to implement measures to slow the spread of the outbreak through quarantines, strict travel restriction and bans, heightened border scrutiny and other measures. The Company is following, and will continue to follow, recommendations from the U.S. Centers for Disease Control and Prevention as well as federal, state, and local governments regarding working-from-home practices for non-essential employees. As a result, the Company previously suspended substantially all in-person interactions with customers, including visits to physician offices, clinics, and

hospitals, and was limited to conducting educational and promotional activities virtually, and the Company may be forced to suspend all or some in-person interactions again in the future. In addition, all office-based personnel have been instructed to work from home and the Company’s laboratory facilities, that support the Company’s early-stage research activities, are being utilized as necessary. The moratoria on routine medical appointments and elective surgeries that have occurred at times in many jurisdictions, including ocular surgeries, has adversely affected the market for INVELTYS, which is indicated for the treatment of inflammation and pain following ocular surgery, resulting in a significant reduction in the demand for INVELTYS. The effects of COVID-19 may also disrupt the launch and commercialization of EYSUVIS. The extent of the impact of COVID-19 on the Company’s operational and financial performance will depend on certain developments, including the length and severity of this pandemic and the impact on its customers, employees, vendors, and government agencies, all of which are uncertain and cannot be predicted. The Company cannot reasonably estimate the extent to which the disruption may materially impact its condensed consolidated results of operations or financial position.

Use of Estimates—The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expense, and related disclosures. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. Estimates and assumptions relied upon in preparing these condensed consolidated financial statements relate to, but are not limited to, revenue recognition, inventory, the present value of lease liabilities and the corresponding right-of-use assets, the fair value of warrants, stock compensation, accrued expenses and the recoverability of the Company’s net deferred tax assets and related valuation allowance. Actual results may differ from these estimates under different assumptions or conditions.

Net Loss per Share—Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the sum of the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options, warrants and the assumed issuance of unvested restricted stock units (“RSUs”) and performance-based restricted stock units (“PSUs”).

The weighted average number of common shares included in the computation of diluted net loss gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, warrants and the assumed issuance of unvested RSUs and PSUs. Common stock equivalent shares are excluded from the computation of diluted net loss per share if their effect is antidilutive. In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss attributable to common stockholders for each of the three and nine months ended September 30, 2020 and 2019.

Unaudited Interim Financial Information—The condensed consolidated financial statements of the Company included herein have been prepared, without audit, pursuant to the rules and regulations of the Securities Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. The accompanying condensed consolidated financial statements reflect all adjustments consisting of normal, recurring adjustments, that are necessary for a fair presentation of the financial position, results of operations, statement of stockholders’ equity and cash flows for the interim periods presented. Interim results are not necessarily indicative of results for a full year. Accordingly, these condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (the “Annual Report”).

The unaudited condensed consolidated financial statements include the accounts of Kala Pharmaceuticals, Inc. and its wholly owned subsidiary, Kala Pharmaceuticals Security Corporation. All intercompany transactions and balances have been eliminated in consolidation.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

9 Months Ended

Sep. 30, 2020

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies,” to the consolidated financial statements included in the Annual Report. There have been no material changes to the significant accounting policies during the nine months ended September 30, 2020, other than the addition of the Investments section and certain updates to the Inventory section below.

Investments — The Company determines the appropriate classification of its investments at the time of purchase. The Company’s investments are classified as available-for-sale in accordance with Accounting Standards Codification (“ASC”) Topic 320. The Company classifies investments available to fund current operations as current assets on its condensed consolidated balance sheets. Investments are classified as long-term assets on the condensed consolidated balance sheets if (i) the Company has the intent and ability to hold the investments for a period of at least one year and (ii) the contractual maturity date of the investments is greater than one year.

Available-for-sale investments are recorded at fair value, with unrealized gains or losses included in comprehensive loss on the condensed consolidated statements of operations and in accumulated other comprehensive loss on the condensed consolidated balance sheets. Realized gains and losses, interest income earned on the Company’s cash, cash equivalents and investments, and amortization or accretion of discounts and premiums on investments are included within other income (expense).

The Company reviews investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time.

Inventory — Inventory is stated at the lower of cost or net realizable value, on a first-in, first-out (“FIFO”) method. Costs include amounts related to third party manufacturing, transportation, internal labor and overhead. The Company capitalizes pre-launch inventory when it believes regulatory approval and subsequent commercialization of the product candidate is probable and expects the future economic benefit from the sale of the drug to be realized. In doing so, management must consider a number of factors in order to determine the amount of inventory to be capitalized, including the historical experience of achieving regulatory approvals for the Company’s similar products, the amount of inventory that is likely to be used in commercial production, receipt and analysis of positive Phase 3 clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications and the compilation of the regulatory application. The Company also monitors the status of the product within the regulatory review and approval process, including all relevant communication with regulatory authorities. For inventories capitalized in preparation for product launch, anticipated future sales, expected shelf life and expected approval date are taken into account when evaluating realizability. The shelf life of a product is determined as part of the regulatory approval process; however, in assessing whether to capitalize pre-launch inventory, the Company considers the product stability data of all of the pre-approval inventory procured or produced to date to determine whether there is adequate shelf life. If management is aware of any specific material risks or contingencies other than the normal regulatory review and approval process, or if the criteria for capitalizing inventory produced prior to regulatory approval are otherwise not met, the Company would not capitalize such inventory costs, choosing instead to recognize such costs as a research and development expense in the period incurred. For INVELTYS, capitalization of costs as inventory began upon U.S. regulatory approval. For EYSUVIS, capitalization of costs as inventory began in the third quarter of 2020 when the Company believed regulatory approval and subsequent commercialization of the product candidate was probable and expected the future economic benefit from the sale of the drug to be realized.

Inventory produced that will be used in a promotional sample program is expensed to selling, general and administrative expense when it is designated as a sample. Long-term inventory includes raw materials, work-in-progress and/or finished goods inventory with an anticipated consumption or sale beyond one year based on the Company’s forecasted expectations.

Recent Accounting Pronouncements

In August 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-13, Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”). ASU 2018-13 is intended to improve the effectiveness of disclosures in the notes to financial statements related to fair value measurements in Topic 820. The ASU was effective on January 1, 2020 and the adoption of ASU 2018-13 did not have a material effect on the Company’s condensed consolidated financial statements.

In August 2018, the FASB issued ASU 2018-15, Intangibles - Goodwill and Other - Internal-Use Software -Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (“ASU 2018-15”). ASU 2018-15 aligns the accounting for implementation costs incurred in a hosting arrangement that is a service contract with the guidance on capitalizing costs associated with developing or obtaining internal-use software. The ASU was effective on January 1, 2020 and the adoption of ASU 2018-15 did not have a material effect on the Company’s condensed consolidated financial statements.

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 significantly changes the impairment model for most financial assets and certain other instruments. ASU 2016-13 will require immediate recognition of estimated credit losses expected to occur over the remaining life of many financial assets, which will generally result in earlier recognition of allowances for credit losses on loans and other financial instruments. In November 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) (“ASU 2019-10”), which is effective for public business entities that meet the definition of an SEC filer, excluding entities eligible to be Smaller Reporting Companies (“SRCs”) as defined by the SEC, for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years and for all other entities, including SRCs, for fiscal years beginning December 15, 2022, including interim periods within those fiscal years. Upon adoption, beginning January 1, 2023, the Company does not expect ASU 2019-10 to have a material effect on its condensed consolidated financial statements.

FAIR VALUE OF FINANCIAL INSTRUMENTS

9 Months Ended

Sep. 30, 2020

FAIR VALUE OF FINANCIAL INSTRUMENTS

FAIR VALUE OF FINANCIAL INSTRUMENTS

3. FAIR VALUE OF FINANCIAL INSTRUMENTS

The Company has short-term investments which are considered financial instruments that are measured on a recurring basis. ASC 820, Fair Value Measurements and Disclosures, establishes a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and its own assumptions (unobservable inputs). The hierarchy consists of three levels:

●

Level 1—Quoted prices in active markets for identical assets or liabilities.

●

Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

●

Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

The Company’s financial instruments consist primarily of cash, cash equivalents, and short-term investments in money market funds and short-term securities. Cash, cash equivalents and short-term investments are reported at their respective fair values on the Company’s condensed consolidated balance sheets. See Note 4, “Investments” for additional information.

The following table sets forth the fair value of the Company’s financial assets by level within the fair value hierarchy as of September 30, 2020:


	Carrying Amount		Fair Value		Level 1		Level 2		Level 3
Assets:
Cash and cash equivalents	$	45,526	$	45,526	$	45,526	$	—	$	—
Short-term investments		113,594		113,594		113,594		—		—
Total Assets	$	159,120	$	159,120	$	159,120	$	—	$	—

During the three and nine months ended September 30, 2020, there were no transfers between Level 1, Level 2, and Level 3.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

INVESTMENTS

9 Months Ended

Sep. 30, 2020

INVESTMENTS

INVESTMENTS

4. INVESTMENTS

Investments by security type consisted of the following as of September 30, 2020:


		September 30, 2020
			Gross		Gross
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
U.S. treasury securities	$	50,484	$	1	$	—	$	50,485
U.S. government agencies securities		63,113		—		(4)		63,109
Total	$	113,597	$	1	$	(4)	$	113,594

As of September 30, 2020, all of the Company’s investments had a contractual maturity within one year. The fair value of all of the Company’s investments are classified as short-term on its condensed consolidated balance sheets.

REVENUE & ACCOUNTS RECEIVABLE, NET

9 Months Ended

Sep. 30, 2020

REVENUE & ACCOUNTS RECEIVABLE, NET

REVENUE & ACCOUNTS RECEIVABLE, NET

5. REVENUE & ACCOUNTS RECEIVABLE, NET

The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers. Under ASC Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to be entitled in exchange for those goods or services. 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.

Product revenues, net

The Company sells INVELTYS to wholesalers and/or specialty distributors in the United States (collectively, “Customers”). These Customers subsequently resell the Company’s products to specialty and other retail pharmacies. In addition to agreements with Customers, the Company enters into arrangements with payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts for the purchase of the Company’s products.

The goods promised in the Company’s product sales contracts represent a single performance obligation; as the promise to transfer the individual products to the Customer is not separately identifiable from other promises in the contracts and, therefore, not distinct. The Company recognizes revenue from product sales at the point the Customer

obtains control of the product, which occurs upon delivery. The transaction price (“net sales price”) that is recognized as revenue for product sales includes the selling price to the Customer and an estimate of variable consideration. Components of variable consideration include prompt pay and other discounts, product returns, government rebates, third-party payor rebates, coverage gap rebates, incentives such as patient co-pay assistance, and other fees paid to Customers where a distinct good or service is not received. Variable consideration is recorded on the condensed consolidated balance sheet as either a reduction of accounts receivable, if payable to a Customer, or as a current liability, if payable to a third-party other than a Customer. The Company considers all relevant information when estimating variable consideration such as assessment of its current and anticipated sales and demand forecasts, information from third parties regarding the payor mix for products, information from third parties regarding the units remaining in the distribution channel, specific known market events and trends, industry data and current contractual and statutory requirements that are reasonably available. The Company includes estimated amounts in the net sales price to the extent it is determined probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved.

Payment terms with Customers do not exceed one year and, therefore, the Company does not account for a significant financing component in its arrangements. The Company expenses incremental cost of obtaining a contract with a Customer when incurred as the period of benefit is less than one year.

Reserves for Variable Consideration:

Trade Discounts and Allowances

The Company provides its Customers with certain trade discounts and allowances including discounts for prompt payments and fees paid for distribution, data and administrative services. These discounts and fees are based on contractually-determined percentages and are recorded as a reduction of revenue and accounts receivable in the period in which the related product revenue is recognized.

Chargebacks

Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These components of variable consideration are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Reserves for chargebacks consist of credits the Company expects to issue for units that remain in the distribution channel at the end of each reporting period and that the Company expects will be sold to qualified healthcare providers, as well as chargebacks that Customers have claimed, but for which the Company has not yet issued a credit.

Product Returns

Consistent with industry practice, the Company has a product returns policy that provides Customers a right of return for product purchased within a specified period prior to and subsequent to the product’s expiration date. The Company estimates the amount of its products that may be returned and presents this amount as a reduction of revenue in the period the related product revenue is recognized, in addition to establishing a liability. The Company’s estimates for product returns are based upon available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel.

Commercial Payor and Medicare Part D Rebates

The Company contracts with certain third-party payors, primarily pharmacy benefit managers (“PBMs”) and health plans (“Plans”), for the payment of rebates with respect to utilization of its product. These rebates are based on contractual percentages applied to the amount of product prescribed to patients who are covered by the PBMs or the

Plans with which it contracts. The Company estimates the rebates for commercial and Medicare Part D payors based on the contractual discount percentage, the various payor mix for the product as well as future rebates that will be made for product that has been recognized as revenue but remains in the distribution channel at the end of each reporting period. The Company also estimates the number of patients in the prescription drug coverage gap for whom it will owe an additional liability under the Medicare Part D program. Such estimates are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability.

Government Rebates

The Company is subject to discount obligations under Medicaid and other government programs. For Medicaid, reserves are based on estimates of future Medicaid beneficiary utilization applied to the Medicaid unit rebate formula established by the Centers for Medicaid and Medicare Services. The Company’s liability for these rebates consists of estimates of claims for the current period and estimated future claims that will be made for product that has been recognized as revenue but remains in the distribution channel at the end of each reporting period. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability.

Co-pay Assistance Program

The Company offers a co-pay assistance program (the “co-pay program”), which is intended to provide financial assistance to patients who may or may not be covered by commercial insurance or who opt out of Medicare Part D programs. The calculation of accruals for the co-pay program is based on actual claims processed during the period as well as an estimate of the number and cost per claim that the Company expects to receive associated with product that has been recognized as revenue but remains in the distribution channel at the end of each reporting period. Allowances for estimated co-pay claims are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability.

The following table summarizes activity in each of the Company’s product revenue provision and allowance categories for the nine months ended September 30, 2020:


	Trade Discounts,
	Allowances and				Rebates and
	Chargebacks (1)		Product Returns (2)		Incentives (3)
Balance as of December 31, 2019	$	1,783	$	180	$	10,044
Provision related to current period sales		725		—		4,576
Changes in estimate related to prior period sales		2		(66)		93
Credit/payments made		(1,114)		—		(8,090)
Balance as of March 31, 2020	$	1,396	$	114	$	6,623
Provision related to current period sales		335		—		2,194
Changes in estimate related to prior period sales		3		(51)		(234)
Credit/payments made		(1,336)		1		(3,013)
Balance as of June 30, 2020	$	398	$	64	$	5,570
Provision related to current period sales		1,235		—		7,584
Changes in estimate related to prior period sales		(1)		(1)		(93)
Credit/payments made		(815)		1		(6,347)
Balance as of September 30, 2020	$	817	$	64	$	6,714

(1)

Trade discounts, allowances and chargebacks include fees for distribution service fees, prompt pay and other discounts, and chargebacks. Trade discounts, allowances and chargebacks are deducted from gross revenue at the time revenues are recognized and are recorded as a reduction to accounts receivable in the Company’s condensed consolidated balance sheets.

(2)	Provisions for product returns are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses and other current liabilities in the Company’s condensed consolidated balance sheets.

(3)

Rebates and incentives include managed care rebates, government rebates, co-pay program incentives, and sales incentives and allowances. Provisions for rebates and discounts are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses and other current liabilities in the Company’s condensed consolidated balance sheets.

Accounts Receivable, net

Accounts receivable are reported on the condensed consolidated balance sheets at outstanding amounts due from Customers for product sales. The Company deducts sales discounts for prompt payments and contractual fees for service arrangements from accounts receivable. The Company evaluates the collectability of accounts receivable on a regular basis, by reviewing the financial condition and payment history of Customers, an overall review of collections experience on other accounts, and economic factors or events expected to affect future collections experience. An allowance for doubtful accounts is recorded when a receivable is deemed to be uncollectible.

The Company recorded no allowance for doubtful accounts as of September 30, 2020 or September 30, 2019. The Company recorded an allowance of $817 and $1,107 for expected sales discounts, related to prompt pay discounts and contractual fee for service arrangements, to wholesalers and distributors as of September 30, 2020 and September 30, 2019, respectively.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI http://asc.fasb.org/topic&trid=49130388

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 10
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130551-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130556-203045

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 9
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130550-203045

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (e)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (d)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 15
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130558-203045

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

+ Details

INVENTORY

9 Months Ended

Sep. 30, 2020

INVENTORY

INVENTORY

6. INVENTORY

Inventory consists of the following:


	September 30,		December 31,
	2020		2019

Raw materials	$	1,025	$	1,387
Work in progress		4,979		4,166
Finished goods		4,223		2,873
Total inventory	$	10,227	$	8,426

As of September 30, 2020, the Company had $7,538 of current inventory and $2,689 of long-term inventory. As of December 31, 2019, the Company had $4,648 of current inventory and $3,778 of long-term inventory. Work in progress inventory as of September 30, 2020 includes $1,127 related to the commercial production of pre-launch inventories of EYSUVIS to support the FDA approval of the product with an indication for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease, which occurred in October 2020.

ACCRUED EXPENSES

9 Months Ended

Sep. 30, 2020

ACCRUED EXPENSES

ACCRUED EXPENSES

7. ACCRUED EXPENSES

Accrued expenses consist of the following:


	September 30,		December 31,
	2020		2019

Compensation and benefits	$	6,212	$	6,502
Accrued revenue reserves (1)		6,308		9,482
Development costs		172		1,600
Professional services		1,335		760
Commercial cost		788		930
Contract manufacturing		416		630
Other		620		1,025
Accrued expenses	$	15,851	$	20,929

(1) There were additional revenue reserves included in accounts payable of $470 and $741, as of September 30, 2020 and December 31, 2019, respectively.

LEASES

9 Months Ended

Sep. 30, 2020

LEASES

LEASES

8. LEASES

Operating leases

On February 28, 2018, the Company entered into a lease agreement for the lease of a portion of the building located at 490 Arsenal Way, Watertown, Massachusetts (the “Watertown Lease”) to be used as the Company’s corporate headquarters. The Company recognized the right-of-use asset and corresponding lease liability on November 15, 2018, by calculating the present value of lease payments, discounted at 9.9%, the Company’s estimated incremental borrowing rate, over the 13-year expected term.

In connection with the Watertown Lease, the Company issued a letter of credit to the landlord for $2,057. The Company secured the letter of credit for the full amount of the letter with cash on deposit, which is reported as restricted cash on the condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019.

For the nine months ended September 30, 2020 and 2019, the variable lease expense for the Watertown Lease, which includes common area maintenance and real estate taxes, was $1,472 and $882 respectively. The remaining lease term was 11.1 years as of September 30, 2020.

Vehicle Fleet lease

During the year ended December 31, 2019, the Company entered into a master fleet lease agreement (the “Vehicle Fleet Lease”), pursuant to which it currently leases approximately 65 vehicles. In connection with the Vehicle Fleet Lease, the Company issued a letter of credit for $453, which was reported as restricted cash on the condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019. The lease has an expected term of three years, which commenced upon the delivery of the vehicles in March 2019. As of September 30, 2020, the remaining lease term was 1.4 years.

The components of lease expense and related cash flows were as follows:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2020		2019		2020		2019
Lease cost
Operating lease cost	$	1,185	$	1,185	$	3,556	$	3,428
Variable lease cost		404		371		1,472		882
Total lease cost	$	1,589	$	1,556	$	5,028	$	4,310

Operating cash outflows from operating leases	$	1,431	$	1,443	$	4,561	$	3,097

DEBT

9 Months Ended

Sep. 30, 2020

DEBT

DEBT

9. DEBT

Athyrium Credit Facility

On October 1, 2018, the Company entered into a credit agreement (the “Athyrium Credit Facility”), with Athyrium Opportunities III Acquisition LP (“Athyrium”) for up to $110,000. The Athyrium Credit Facility provided for a Term Loan A in the aggregate principal amount of $75,000 (the “Term Loan A”), and a Term Loan B in the aggregate principal amount of $35,000 (the “Term Loan B”). On October 1, 2018, the Company borrowed the entire principal amount of the Term Loan A. The Company did not satisfy the conditions to draw down any of the Term Loan B funds, and as a result, the Term Loan B funds are no longer available. The maturity date of the Athyrium Credit Facility is October 1, 2024, the six-year anniversary of the close.

The Term Loan A bears interest at a rate of 9.875% per annum, with quarterly, interest-only payments until the fourth anniversary of the Term Loan A. The unpaid principal amount of the Term Loan A is due and payable in quarterly installments starting on the fourth anniversary of the loan. The Company may make voluntary prepayments, in whole or in part, and subject to certain exceptions, is required to make mandatory prepayments upon the occurrence of certain events of default as defined in the agreement, including but not limited to, the occurrence of a change of control. In addition, upon payment or repayment of any outstanding balance under the Athyrium Credit Facility, the Company will have to pay a 1% exit fee of the total principal payments (whether mandatory, voluntary, or at maturity) made throughout the term. The exit fee of $750 based on the $75,000 principal amount outstanding, will be accreted to the carrying amount of the debt using the effective interest method over the term of the loan.

All mandatory and voluntary prepayments of the Athyrium Credit Facility are subject to the payment of prepayment premiums as follows: (i) if prepayment occurs prior to the second anniversary of the applicable date of issuance, an amount equal to the amount by which (a) the present value of 105% of the principal prepaid plus all interest that would have accrued on such principal through such second anniversary exceeds (b) the amount of principal prepaid, (ii) if prepayment occurs on or after the second anniversary of the applicable date of issuance but prior to the third anniversary of such issuance, an amount equal to 3% of the principal prepaid, and (iii) if prepayment occurs on or after the third anniversary of the applicable date of issuance but prior to the fourth anniversary of such issuance, an amount equal to 2% of the principal prepaid. No prepayment premium is due on any principal prepaid after the fourth anniversary of the applicable date of issuance.

The Athyrium Credit Facility includes features requiring (1) additional interest rate upon an event of default accrued at an additional 3%, or a total interest rate of 12.875%, and (2) the lender’s right to declare all outstanding principal and interest immediately payable upon an event of default. These two features were analyzed and determined to be embedded derivatives to be valued as separate financial instruments. These embedded derivatives were bundled and valued as one compound derivative in accordance with the applicable accounting guidance for derivatives and hedging transactions. The Company determined that, due to the unlikely event of default, the embedded derivatives have a de minimis value as of September 30, 2020. The derivative liability will be remeasured at fair value at each reporting

date, with changes in fair value being recorded as other income (expense) in the condensed consolidated statements of operations.

The Athyrium Credit Facility is secured by a pledge of substantially all of the Company’s assets and contains affirmative and negative covenants customary for financings of this type, including limitations on the Company’s and its subsidiaries’ ability to, among other things, incur and prepay additional debt, grant or permit additional liens, make investments and acquisitions, merge or consolidate with others, dispose of assets, change in the nature of business, enter into sale and leaseback transactions, make distributions, and enter into affiliate transactions, in each case, subject to certain exceptions. In addition, the Athyrium Credit Facility also contains a financial covenant requiring the Company to maintain at least $10,000 of cash and cash equivalents. As a result of this financial covenant, the Company has recorded $10,000 as restricted cash as of September 30, 2020 and December 31, 2019.

In connection with the Athyrium Credit Facility, the Company issued a warrant (“Warrant”), to purchase up to 270,835 shares of the Company’s common stock, at an exercise price per share of $12.18456. The Warrant is immediately exercisable as to 184,660 shares. The remaining 86,175 shares under the Warrant were exercisable only upon the Company’s draw of the Term Loan B and, as a result, the remaining 86,175 shares under the Warrant are no longer exercisable. The Warrant is exercisable through October 1, 2025 and is classified as an equity instrument. The Company allocated the proceeds from the Term Loan A to the Warrant using the relative fair value method. The fair value of the Warrant of $1,899 was recognized as equity with a corresponding debt discount of $1,980.

In addition, the Company paid certain fees to Athyrium and other third-party service providers. These fees paid to Athyrium were recorded as a debt discount while the fees paid to other third-party service providers were recorded as debt issuance cost. These costs, along with the fair value of the Warrant of $1,899 are being amortized using the effective interest method over the term of the Athyrium Credit Facility. The amortization of debt discount and debt issuance cost is included in interest expense within the condensed consolidated statements of operations. As of September 30, 2020 and September 30, 2019, the effective interest rate was 11.63%, which takes into consideration the non-cash accretion of the exit fee and the amortization of the debt discount and issuance costs. During each of the three months ended September 30, 2020 and September 30, 2019, the Company recognized interest expense of $2,125, which consisted of amortization of the debt discount of $232, and the contractual coupon interest expense of $1,893. During the nine months ended September 30, 2020, and September 30, 2019, the Company recognized interest expense of $6,308 and $6,211, respectively. This consisted of amortization of debt discount of $671 and $595 for the periods ended September 30, 2020 and September 30, 2019, and the contractual coupon interest expense of $5,637 and $5,616 as of September 30, 2020 and September 30, 2019, respectively.

The components of the carrying value of the debt as of September 30, 2020 and December 31, 2019 are detailed below:


	September 30,		December 31,
	2020		2019
Principal loan balance	$	75,000	$	75,000
Unamortized debt discount and issuance cost		(3,327)		(3,999)
Cumulative accretion of exit fee		294		183
Long-term debt, net	$	71,967	$	71,184

The annual principal payments due under the Athyrium Credit Facility as of September 30, 2020 were as follows:


Years Ending December 31,
2020 (remaining three months)	$	—
2021		—
2022		16,665
2023		33,330
2024		25,005
Total	$	75,000

WARRANTS

9 Months Ended

Sep. 30, 2020

WARRANTS

WARRANTS

10. WARRANTS

The following table summarizes the common stock warrants outstanding as of September 30, 2020 and December 31, 2019, each exercisable into the number of shares of common stock set forth below as of the specified dates:


					Shares Exercisable at
	Exercise		Expiration	Exercisable	September 30,	December 31,
Issued	Price		Date	From	2020	2019
2013	$	7.50	April 2021	July 2017	33,333	82,816
2014	$	7.50	November 2024	July 2017	16,000	16,000
2016	$	8.27	October 2026	September 2017	14,512	14,512
2018	$	12.18	October 2025	October 2018	184,660	184,660
					248,505	297,988

EQUITY FINANCINGS

9 Months Ended

Sep. 30, 2020

EQUITY FINANCINGS

EQUITY FINANCINGS

11. EQUITY FINANCINGS

On August 9, 2018, the Company filed a shelf registration statement on Form S-3 with the SEC, which was declared effective on August 27, 2018 (the “2018 Shelf Registration”). Under the 2018 Shelf Registration, the Company may offer and sell up to $250,000 of a variety of securities including common stock, preferred stock, warrants, depositary shares, debt securities, purchase contracts, purchase units or any combination of such securities during the three-year period that commenced upon the 2018 Shelf Registration becoming effective.

In connection with the filing of the 2018 Shelf Registration, the Company entered into a sales agreement (the “2018 Sales Agreement”) with Jefferies, LLC (“Jefferies”) pursuant to which the Company could issue and sell, from time to time, up to an aggregate of $50,000 of its common stock in an at-the-market equity offering (“ATM Offering”) through Jefferies, as sales agent. As of December 31, 2019, the Company issued 2,592,934 shares of its common stock under the ATM Offering, resulting in net proceeds to the Company of $13,059. During the first quarter of 2020, the Company issued an aggregate of 2,352,671 shares of its common stock under the ATM Offering, resulting in net

proceeds to the Company of $12,546. On March 10, 2020, the Company notified Jefferies that it was suspending and terminating the prospectus related to the 2018 Sales Agreement.

On March 11, 2020, the Company sold 16,000,000 shares of the Company’s common stock (the “2020 Offering Shares”) in an underwritten offering (the “2020 Offering”), pursuant to the 2018 Shelf Registration, at a public offering price of $7.89 per share, before underwriting discounts, commissions, and offering expenses, resulting in net proceeds of $118,207. In addition, the underwriters of the 2020 Offering were granted the option for a period of 30 days to purchase up to an additional 2,400,000 shares of common stock offered in the public offering at the public offering price, less underwriting discounts, commissions and offering expenses.

On April 3, 2020, the underwriters exercised their option and purchased an additional 979,371 shares of common stock at $7.89 per share, before underwriting discounts, commissions, and offering expenses, resulting in net proceeds to the Company of $7,216. The total number of shares sold by the Company in the 2020 Offering was 16,979,371, resulting in total net proceeds to the Company, after underwriting discounts, commissions, and offering expenses, of $125,423. As of September 30, 2020, there was $18,334 of securities available to be issued under the 2018 Shelf Registration.

On May 7, 2020, the Company filed a shelf registration statement on Form S-3 with the SEC, which was declared effective on May 19, 2020 (the “2020 Shelf Registration”). Under the 2020 Shelf Registration, the Company may offer and sell up to $350,000 of a variety of securities including common stock, preferred stock, warrants, depositary shares, debt securities or units during the three-year period that commenced upon the 2020 Shelf Registration becoming effective.

In connection with the filing of the 2020 Shelf Registration, the Company entered into an amended and restated sales agreement with Jefferies pursuant to which the Company may issue and sell, from time to time, up to an aggregate of $75,000 of its common stock under its ATM Offering through Jefferies, as a sales agent.

STOCKBASED COMPENSATION

9 Months Ended

Sep. 30, 2020

STOCKBASED COMPENSATION

STOCK-BASED COMPENSATION

12. STOCK‑BASED COMPENSATION

Stock Incentive Plans—In December 2009, the Board of Directors (the “Board”) adopted the 2009 Employee, Director and Consultant Equity Incentive Plan (the “2009 Plan”) for the issuance of common stock and stock options to employees, officers, directors, consultants, and advisors.

In July 2017, the Company’s 2017 Equity Incentive Plan (the “2017 Plan”) became effective. The 2017 Plan was established to provide equity-based ownership opportunities for employees, officers, directors, consultants, and advisors. On June 25, 2020, the 2017 Plan was amended to increase the number of shares of common stock authorized for issuance thereunder by 2,000,000 shares. As of September 30, 2020, there were 1,275,550 shares of common stock available for grant under the 2017 Plan. In addition, any shares of common stock subject to awards under the 2009 Plan that expire, are forfeited, or are otherwise surrendered, without having been fully exercised or resulting in any common stock being issued will become available for issuance under the 2017 Plan, up to an additional 2,262,070 shares, which is the number of shares issuable pursuant to outstanding awards granted under the prior plan.

Also approved under the 2017 Plan is an annual increase for each of the years through December 31, 2027, equal to the least of (i) 3,573,766 shares of common stock, (ii) 4% of the shares of common stock outstanding on December 31 of the prior year and (iii) an amount determined by the Board.

Under the plans, the Board determines the number of shares of common stock to be granted pursuant to the awards, as well as the exercise price and terms of such awards. The exercise price of incentive stock options cannot be less than the fair value of the common stock on the date of grant. Stock options awarded under the plans expire 10 years after the grant date, unless the Board sets a shorter term. Options granted under the plans generally vest over a four-year period. A portion of the unvested stock options will vest upon the sale of all or substantially all of the stock or assets of the Company.

Inducement Stock Option Awards—During the nine months ended September 30, 2020 and 2019, the Company granted non-statutory stock options to purchase an aggregate of 40,800 shares and 175,500 shares of the Company’s common stock, respectively. These stock options will vest over a four-year period, with 25% of the shares underlying each option award vesting on the one-year anniversary of the applicable employees’ new hire date and the remaining 75% of the shares underlying each award vesting monthly thereafter for three-years. Vesting of each option is subject to such employee’s continued service with the Company through the applicable vesting dates. These stock options were granted outside of the 2017 Plan as an inducement material to each employee’s acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

A summary of option activity for employee awards under the 2009 Plan, the 2017 Plan and inducement grants for the nine months ended September 30, 2020 is as follows:


				Weighted
		Weighted		Average
		Average		Remaining	Aggregate
	Number of	Exercise		Contractual	Intrinsic
	Shares	Price		Term	Value
				(Years)	(in thousands)
Outstanding as of January 1, 2020	7,453,076	$	7.46	7.7	$	1,313
Granted	1,506,222		4.00
Exercised	(312,528)		3.02
Forfeited	(130,607)		7.43
Outstanding as of September 30, 2020	8,516,163	$	7.01	7.4	$	20,963
Vested or expected to vest as of September 30, 2020	8,516,163	$	7.01	7.4	$	20,963
Options exercisable as of September 30, 2020	5,031,572	$	7.42	6.7	$	12,277

The Company records stock-based compensation related to stock options granted at fair value. The Company utilizes the Black-Scholes option-pricing model to estimate the fair value of stock option grants and to determine the related compensation expense. The assumptions used in calculating the fair value of stock-based payment awards represent management’s best estimates. The assumptions used in determining fair value of the stock options granted during the nine months ended September 30, 2020 and 2019, are as follows:


	Nine Months Ended September 30,
	2020			2019
Expected volatility	80%	–	81%	61%	–	82%
Risk-free interest rate	0.37%	–	1.73%	1.44%	–	2.58%
Expected dividend yield		0%			0%
Expected term (in years)	5.91	–	6.08	0.50	–	6.63

The Company derived the risk-free interest rate assumption from the U.S. Treasury rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the awards being valued. The Company based the expected dividend yield on its expectation of not paying dividends in the foreseeable future. The Company calculated the weighted-average expected term of options using the simplified method, as the Company lacks relevant historical data due to the Company’s limited operating experience. The expected volatility is based upon the historical volatility of comparable companies with publicly available share prices. The impact of forfeitures on compensation expense is recorded as they occur.

During the three months ended September 30, 2020 and 2019, the weighted average grant-date fair value of options granted was $7.06 and $2.82, respectively. During the nine months ended September 30, 2020 and 2019, the weighted average grant-date fair value of options granted was $4.00 and $3.70, respectively. The fair value is being expensed over the vesting period of the options on a straight-line basis as the services are being provided. As of September 30, 2020 and 2019, there was $17,483 and $20,469, respectively, of unrecognized compensation cost related

to the stock options granted, which is expected to be expensed over a weighted-average period of 2.40 years and 2.46 years, respectively.

Stock-based compensation costs capitalized into inventory totaled $234 and $19 for the three months ended September 30, 2020 and 2019, respectively, and $535 and $355 for the nine months ended September 30, 2020 and 2019, respectively. Capitalized stock-based compensation is recognized as an expense in cost of product revenues when the related product is sold or in selling, general and administrative expense when the related sample is issued.

Restricted Stock Units and Performance-Based Restricted Stock Units—In June 2020, the Company issued RSUs to certain executives and Board members, as well as PSUs to certain executives and other employees. The Company granted 135,560 RSUs to certain executives which vest 50% on the first anniversary of the grant date, and 50% on the second anniversary of the grant date. Additionally, the Company issued 128,000 RSUs to members of the Board which will vest upon the earlier of the first anniversary of the 2020 Annual Meeting of Stockholders or the date of the 2021 Annual Meeting of Stockholders. The Company issued 693,537 PSUs to certain executives and other employees tied to certain performance criteria, which will vest, if at all, as to 50% on the first anniversary of satisfying the performance criteria and the remaining 50% vesting upon the second anniversary of satisfying the performance criteria. The Company has assessed the probability of achievement of the performance criteria and has recorded related stock compensation expense to this extent as of September 30, 2020. As of September 30, 2020, a total of 946,767 RSUs and PSUs were unvested and outstanding, which results in unrecognized stock-based compensation of $8,586 to be recognized as stock-based compensation expense over the remaining weighted-average vesting period of 1.41 years.

A summary of the outstanding RSUs and PSUs as of September 30, 2020 is as follows:


			Weighted Average
			Grant Date
	Shares		Fair Value
Unvested and outstanding balance as of December 31, 2019	—	$	—
Changes during the period:
RSUs granted	263,560		11.70
PSUs granted	693,537		11.70
PSUs forfeited	(10,330)		11.70
Unvested and outstanding balance as of September 30, 2020	946,767	$	11.70

Employee Stock Purchase Plan—In 2017, the Company approved the 2017 Employee Stock Purchase Plan, which was amended and restated in December 2018 (as amended, the “ESPP”). The ESPP reserved an aggregate of 223,341 shares of common stock and provides for an annual increase on the first day of each fiscal year, beginning on January 1, 2019 and ending on December 31, 2029, in an amount equal to the lowest of: (1) 893,441 shares of the Company’s common stock; (2) 1% of the total number of shares of the Company’s common stock outstanding on the first day of the applicable fiscal year; and (3) an amount determined by the Company’s board of directors.

The ESPP provides for two six-month offering periods each year; the first offering period begins on the first trading day on or after each January 1; the second offering period begins on the first trading day on or after each July 1. Under the ESPP, participating employees can authorize the Company to withhold a portion of their base pay during consecutive six-month payment periods for the purchase of shares of the Company’s common stock. At the conclusion of the period, participating employees can purchase shares of the Company’s common stock at 85% of the lesser of the closing price of the common stock on (i) the first business day of the plan period or (ii) the exercise date. The fair value of the purchase rights granted under the ESPP was estimated on the date of grant, using the Black-Scholes option-pricing model. In January 2020, employees of the Company purchased an aggregate of 85,553 shares under the ESPP. In July 2020, employees of the Company purchased an aggregate of 228,844 shares under the ESPP.

Stock-based compensation expense was classified in the condensed consolidated statements of operations as follows for the three and nine months ended September 30, 2020 and 2019:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2020		2019		2020		2019

Cost of product revenues	$	32	$	60	$	60	$	101
Research and development		985		913		2,259		2,315
Selling, general and administrative		3,244		1,599		6,930		5,250
Total	$	4,261	$	2,572	$	9,249	$	7,666

Reserved Shares—As of September 30, 2020 and December 31, 2019, the Company had reserved the following shares of common stock issuable upon exercise of rights under equity compensation plans, inducement stock option awards, and warrant rights to acquire common stock:


	September 30,	December 31,
	2020	2019

Warrant rights to acquire common stock	334,680	384,163
ESPP	484,772	438,307
Outstanding inducement stock option awards	746,300	705,500
2009 Plan	2,262,070	2,530,586
2017 Plan	7,832,923	4,429,849
Total	11,660,745	8,488,405

INCOME TAXES

9 Months Ended

Sep. 30, 2020

INCOME TAXES

INCOME TAXES

13. INCOME TAXES

The Company did not record a provision or benefit for income taxes during the three months ended September 30, 2020 and 2019. The Company continues to maintain a full valuation allowance for its U.S. federal and state deferred tax assets.

The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets. Management has considered the Company’s history of cumulative net losses incurred since inception and its generation of limited revenue from product sales since inception and has concluded that it is more likely than not that the Company will not realize the benefits of the deferred tax assets. Management reevaluates the positive and negative evidence at each reporting period.

Realization of the future tax benefits is dependent on many factors, including the Company’s ability to generate taxable income within the net operating loss carryforward period. Under the provisions of Section 382 of the Internal Revenue Code of 1986, as amended, certain substantial changes in the Company’s ownership, including a sale of the Company, or significant changes in ownership due to sales of equity, may have limited, or may limit in the future, the amount of net operating loss carryforwards, which could be used annually to offset future taxable income. The Company recently completed an analysis and determined that an ownership change had occurred prior to December 31, 2019 and that such change has materially limited the net operating loss carryforwards and research and development tax credits available to offset future tax liabilities. The Company may be further limited by any changes that may have occurred or may occur subsequent to December 31, 2019.

The Company files its corporate income tax returns in the United States and various states. All tax years since the date of incorporation remain open to examination by the major taxing jurisdictions (state and federal) to which the Company is subject, as carryforward attributes generated in years past may still be adjusted upon examination by the

Internal Revenue Service (“IRS”) or other authorities if they have or will be used in a future period. The Company is not currently under examination by the IRS or any other jurisdictions for any tax year.

As of September 30, 2020 and 2019, the Company had no uncertain tax positions. The Company’s policy is to recognize interest and penalties related to income tax matters as a component of income tax expense, of which no interest or penalties were recorded for the three and nine months ended September 30, 2020 and 2019.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References + Details

COMMITMENTS AND CONTINGENCIES

9 Months Ended

Sep. 30, 2020

COMMITMENTS AND CONTINGENCIES.

COMMITMENTS AND CONTINGENCIES.

14. COMMITMENTS AND CONTINGENCIES

License Agreement—In 2009, the Company entered into an exclusive license agreement with The Johns Hopkins University (“JHU”), as amended in November 2012, May 2014, August 2014, October 2014, June 2018 and July 2020, which licensed to the Company a portfolio of specified patent rights and remains in full force and effect. Pursuant to the terms of the agreement, as amended, the Company agreed to pay an initial license fee, minimum annual payments beginning in 2017, certain development and commercial milestone payments, royalties on product sales and reimburse all or a portion of the costs associated with the preparation, filing, prosecution and maintenance of the agreed-upon patents and patent applications to JHU.

After 2016 and until the first commercial sale of product, which occurred in January 2019, the minimum annual payment was $38. Upon the first commercial sale of INVELTYS, the annual minimum payment increased to $112. The Company is obligated to pay JHU low single-digit running royalties based upon a percentage of net sales of the licensed products, which is applied to the annual minimum payment. The Company also has an obligation to pay JHU certain one-time development and commercial milestone payments. During the three months ended September 30, 2020 and 2019, the Company paid JHU $8 and $34, respectively, in royalty payments associated with the sale of INVELTYS. During the nine months ended September 30, 2020 and 2019, the Company paid JHU $44 and $334, respectively, in royalty payments associated with the sale of INVELTYS.

The Company recorded other expenses related to the JHU agreement of $44 and $116 for the three months ended September 30, 2020 and 2019, respectively. The Company recorded other expenses related to the JHU agreement of $121 and $197 for the nine months ended September 30, 2020 and 2019, respectively.

The Company is obligated to pay JHU a $150 milestone payment within 60 days of the first commercial sale of EYSUVIS in the United States.

Litigation—The Company is not currently subject to any material legal proceedings.

Other Commitments — The Company entered into a commercial supply agreement with Catalent Pharma Solutions, LLC to manufacture commercial supplies of INVELTYS and EYSUVIS. The commercial supply agreement contains annual minimum purchase requirements, which increased upon FDA approval of EYSUVIS on October 26, 2020.

The Company has the following minimum purchase obligations for INVELTYS and EYSUVIS:


Years Ending December 31,
2020 (remaining three months)	$	—
2021		2,295
2022		5,390
2023		6,285
2024		7,875
Thereafter		26,124
Total minimum purchase commitments	$	47,969

SUBSEQUENT EVENTS

9 Months Ended

Sep. 30, 2020

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

15. SUBSEQUENT EVENTS

On October 26, 2020, the FDA approved the Company’s New Drug Application for EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.

Refer to Note 14, “Commitments and Contingencies” for additional commitments identified as a result of the FDA approval of EYSUVIS.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	Sep. 30, 2020
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Investments	Investments — The Company determines the appropriate classification of its investments at the time of purchase. The Company’s investments are classified as available-for-sale in accordance with Accounting Standards Codification (“ASC”) Topic 320. The Company classifies investments available to fund current operations as current assets on its condensed consolidated balance sheets. Investments are classified as long-term assets on the condensed consolidated balance sheets if (i) the Company has the intent and ability to hold the investments for a period of at least one year and (ii) the contractual maturity date of the investments is greater than one year. Available-for-sale investments are recorded at fair value, with unrealized gains or losses included in comprehensive loss on the condensed consolidated statements of operations and in accumulated other comprehensive loss on the condensed consolidated balance sheets. Realized gains and losses, interest income earned on the Company’s cash, cash equivalents and investments, and amortization or accretion of discounts and premiums on investments are included within other income (expense). The Company reviews investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time.
Inventory	Inventory — Inventory is stated at the lower of cost or net realizable value, on a first-in, first-out (“FIFO”) method. Costs include amounts related to third party manufacturing, transportation, internal labor and overhead. The Company capitalizes pre-launch inventory when it believes regulatory approval and subsequent commercialization of the product candidate is probable and expects the future economic benefit from the sale of the drug to be realized. In doing so, management must consider a number of factors in order to determine the amount of inventory to be capitalized, including the historical experience of achieving regulatory approvals for the Company’s similar products, the amount of inventory that is likely to be used in commercial production, receipt and analysis of positive Phase 3 clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications and the compilation of the regulatory application. The Company also monitors the status of the product within the regulatory review and approval process, including all relevant communication with regulatory authorities. For inventories capitalized in preparation for product launch, anticipated future sales, expected shelf life and expected approval date are taken into account when evaluating realizability. The shelf life of a product is determined as part of the regulatory approval process; however, in assessing whether to capitalize pre-launch inventory, the Company considers the product stability data of all of the pre-approval inventory procured or produced to date to determine whether there is adequate shelf life. If management is aware of any specific material risks or contingencies other than the normal regulatory review and approval process, or if the criteria for capitalizing inventory produced prior to regulatory approval are otherwise not met, the Company would not capitalize such inventory costs, choosing instead to recognize such costs as a research and development expense in the period incurred. For INVELTYS, capitalization of costs as inventory began upon U.S. regulatory approval. For EYSUVIS, capitalization of costs as inventory began in the third quarter of 2020 when the Company believed regulatory approval and subsequent commercialization of the product candidate was probable and expected the future economic benefit from the sale of the drug to be realized. Inventory produced that will be used in a promotional sample program is expensed to selling, general and administrative expense when it is designated as a sample. Long-term inventory includes raw materials, work-in-progress and/or finished goods inventory with an anticipated consumption or sale beyond one year based on the Company’s forecasted expectations.
Recent Accounting Pronouncements	Recent Accounting Pronouncements In August 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-13, Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”). ASU 2018-13 is intended to improve the effectiveness of disclosures in the notes to financial statements related to fair value measurements in Topic 820. The ASU was effective on January 1, 2020 and the adoption of ASU 2018-13 did not have a material effect on the Company’s condensed consolidated financial statements. In August 2018, the FASB issued ASU 2018-15, Intangibles - Goodwill and Other - Internal-Use Software -Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (“ASU 2018-15”). ASU 2018-15 aligns the accounting for implementation costs incurred in a hosting arrangement that is a service contract with the guidance on capitalizing costs associated with developing or obtaining internal-use software. The ASU was effective on January 1, 2020 and the adoption of ASU 2018-15 did not have a material effect on the Company’s condensed consolidated financial statements. In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 significantly changes the impairment model for most financial assets and certain other instruments. ASU 2016-13 will require immediate recognition of estimated credit losses expected to occur over the remaining life of many financial assets, which will generally result in earlier recognition of allowances for credit losses on loans and other financial instruments. In November 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) (“ASU 2019-10”), which is effective for public business entities that meet the definition of an SEC filer, excluding entities eligible to be Smaller Reporting Companies (“SRCs”) as defined by the SEC, for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years and for all other entities, including SRCs, for fiscal years beginning December 15, 2022, including interim periods within those fiscal years. Upon adoption, beginning January 1, 2023, the Company does not expect ASU 2019-10 to have a material effect on its condensed consolidated financial statements.

- Definition

Disclosure of inventory accounting policy for inventory classes, including, but not limited to, basis for determining inventory amounts, methods by which amounts are added and removed from inventory classes, loss recognition on impairment of inventories, and situations in which inventories are stated above cost.

+ References + Details

FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables)

9 Months Ended

Sep. 30, 2020

FAIR VALUE OF FINANCIAL INSTRUMENTS

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


	Carrying Amount		Fair Value		Level 1		Level 2		Level 3
Assets:
Cash and cash equivalents	$	45,526	$	45,526	$	45,526	$	—	$	—
Short-term investments		113,594		113,594		113,594		—		—
Total Assets	$	159,120	$	159,120	$	159,120	$	—	$	—

INVESTMENTS (Tables)

9 Months Ended

Sep. 30, 2020

INVESTMENTS

Schedule of investments by security type


		September 30, 2020
			Gross		Gross
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
U.S. treasury securities	$	50,484	$	1	$	—	$	50,485
U.S. government agencies securities		63,113		—		(4)		63,109
Total	$	113,597	$	1	$	(4)	$	113,594

REVENUE & ACCOUNTS RECEIVABLE, NET (Tables)

9 Months Ended

Sep. 30, 2020

REVENUE & ACCOUNTS RECEIVABLE, NET

Schedule of co-pay assistance program


	Trade Discounts,
	Allowances and				Rebates and
	Chargebacks (1)		Product Returns (2)		Incentives (3)
Balance as of December 31, 2019	$	1,783	$	180	$	10,044
Provision related to current period sales		725		—		4,576
Changes in estimate related to prior period sales		2		(66)		93
Credit/payments made		(1,114)		—		(8,090)
Balance as of March 31, 2020	$	1,396	$	114	$	6,623
Provision related to current period sales		335		—		2,194
Changes in estimate related to prior period sales		3		(51)		(234)
Credit/payments made		(1,336)		1		(3,013)
Balance as of June 30, 2020	$	398	$	64	$	5,570
Provision related to current period sales		1,235		—		7,584
Changes in estimate related to prior period sales		(1)		(1)		(93)
Credit/payments made		(815)		1		(6,347)
Balance as of September 30, 2020	$	817	$	64	$	6,714

(1)

(2)	Provisions for product returns are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses and other current liabilities in the Company’s condensed consolidated balance sheets.

(3)

INVENTORY (Tables)

9 Months Ended

Sep. 30, 2020

INVENTORY

Schedule of Inventory

Inventory consists of the following:


	September 30,		December 31,
	2020		2019

Raw materials	$	1,025	$	1,387
Work in progress		4,979		4,166
Finished goods		4,223		2,873
Total inventory	$	10,227	$	8,426

ACCRUED EXPENSES (Tables)

9 Months Ended

Sep. 30, 2020

ACCRUED EXPENSES

Schedule of accrued expenses


	September 30,		December 31,
	2020		2019

Compensation and benefits	$	6,212	$	6,502
Accrued revenue reserves (1)		6,308		9,482
Development costs		172		1,600
Professional services		1,335		760
Commercial cost		788		930
Contract manufacturing		416		630
Other		620		1,025
Accrued expenses	$	15,851	$	20,929

(1) There were additional revenue reserves included in accounts payable of $470 and $741, as of September 30, 2020 and December 31, 2019, respectively.

LEASES (Tables)

9 Months Ended

Sep. 30, 2020

LEASES

Schedule of components of lease expense and related cash flows

The components of lease expense and related cash flows were as follows:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2020		2019		2020		2019
Lease cost
Operating lease cost	$	1,185	$	1,185	$	3,556	$	3,428
Variable lease cost		404		371		1,472		882
Total lease cost	$	1,589	$	1,556	$	5,028	$	4,310

Operating cash outflows from operating leases	$	1,431	$	1,443	$	4,561	$	3,097

DEBT (Tables)

9 Months Ended

Sep. 30, 2020

DEBT

Schedule of carrying value of debt

The components of the carrying value of the debt as of September 30, 2020 and December 31, 2019 are detailed below:


	September 30,		December 31,
	2020		2019
Principal loan balance	$	75,000	$	75,000
Unamortized debt discount and issuance cost		(3,327)		(3,999)
Cumulative accretion of exit fee		294		183
Long-term debt, net	$	71,967	$	71,184

Schedule of maturities of long-term debt


	September 30,		December 31,
	2020		2019
Principal loan balance	$	75,000	$	75,000
Unamortized debt discount and issuance cost		(3,327)		(3,999)
Cumulative accretion of exit fee		294		183
Long-term debt, net	$	71,967	$	71,184

WARRANTS (Tables)

9 Months Ended

Sep. 30, 2020

WARRANTS

Schedule of outstanding warrants


					Shares Exercisable at
	Exercise		Expiration	Exercisable	September 30,	December 31,
Issued	Price		Date	From	2020	2019
2013	$	7.50	April 2021	July 2017	33,333	82,816
2014	$	7.50	November 2024	July 2017	16,000	16,000
2016	$	8.27	October 2026	September 2017	14,512	14,512
2018	$	12.18	October 2025	October 2018	184,660	184,660
					248,505	297,988

STOCKBASED COMPENSATION (Tables)

9 Months Ended

Sep. 30, 2020

STOCKBASED COMPENSATION

Summary of option activity for employee and non employee awards


				Weighted
		Weighted		Average
		Average		Remaining	Aggregate
	Number of	Exercise		Contractual	Intrinsic
	Shares	Price		Term	Value
				(Years)	(in thousands)
Outstanding as of January 1, 2020	7,453,076	$	7.46	7.7	$	1,313
Granted	1,506,222		4.00
Exercised	(312,528)		3.02
Forfeited	(130,607)		7.43
Outstanding as of September 30, 2020	8,516,163	$	7.01	7.4	$	20,963
Vested or expected to vest as of September 30, 2020	8,516,163	$	7.01	7.4	$	20,963
Options exercisable as of September 30, 2020	5,031,572	$	7.42	6.7	$	12,277

Schedule of assumptions used in determining fair value of the stock options granted


	Nine Months Ended September 30,
	2020			2019
Expected volatility	80%	–	81%	61%	–	82%
Risk-free interest rate	0.37%	–	1.73%	1.44%	–	2.58%
Expected dividend yield		0%			0%
Expected term (in years)	5.91	–	6.08	0.50	–	6.63

Schedule of stock based compensation expense


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2020		2019		2020		2019

Cost of product revenues	$	32	$	60	$	60	$	101
Research and development		985		913		2,259		2,315
Selling, general and administrative		3,244		1,599		6,930		5,250
Total	$	4,261	$	2,572	$	9,249	$	7,666

Summary of the outstanding RSUs


			Weighted Average
			Grant Date
	Shares		Fair Value
Unvested and outstanding balance as of December 31, 2019	—	$	—
Changes during the period:
RSUs granted	263,560		11.70
PSUs granted	693,537		11.70
PSUs forfeited	(10,330)		11.70
Unvested and outstanding balance as of September 30, 2020	946,767	$	11.70

Schedule of reserved common stock shares upon exercise of rights under equity compensation plans


	September 30,	December 31,
	2020	2019

Warrant rights to acquire common stock	334,680	384,163
ESPP	484,772	438,307
Outstanding inducement stock option awards	746,300	705,500
2009 Plan	2,262,070	2,530,586
2017 Plan	7,832,923	4,429,849
Total	11,660,745	8,488,405

COMMITMENTS AND CONTINGENCIES. (Tables)

9 Months Ended

Sep. 30, 2020

COMMITMENTS AND CONTINGENCIES.

Schedule of minimum purchase obligations


Years Ending December 31,
2020 (remaining three months)	$	—
2021		2,295
2022		5,390
2023		6,285
2024		7,875
Thereafter		26,124
Total minimum purchase commitments	$	47,969

NATURE OF BUSINESS AND BASIS OF PRESENTATION (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
NATURE OF BUSINESS AND BASIS OF PRESENTATION
Accumulated deficit	$ 368,671	$ 295,456

FAIR VALUE OF FINANCIAL INSTRUMENTS - Recurring and Nonrecurring Fair value Measurements Within Hierarchy (Details) - Recurring $ in Thousands	Sep. 30, 2020 USD ($)
Level 1
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Financial assets by level within fair value hierarchy	$ 159,120
Level 1 \| Short-term investments
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Financial assets by level within fair value hierarchy	113,594
Level 1 \| Cash and cash equivalents
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Financial assets by level within fair value hierarchy	45,526
Carrying Value
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Financial assets by level within fair value hierarchy	159,120
Carrying Value \| Short-term investments
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Financial assets by level within fair value hierarchy	113,594
Carrying Value \| Cash and cash equivalents
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Financial assets by level within fair value hierarchy	45,526
Fair Value
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Financial assets by level within fair value hierarchy	159,120
Fair Value \| Short-term investments
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Financial assets by level within fair value hierarchy	113,594
Fair Value \| Cash and cash equivalents
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis
Financial assets by level within fair value hierarchy	$ 45,526

FAIR VALUE OF FINANCIAL INSTRUMENTS - Fair value measurement levels (Details) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2020 USD ($)	Sep. 30, 2020 USD ($)
FAIR VALUE OF FINANCIAL INSTRUMENTS
Transfer from level 1 to level 2, Assets	$ 0	$ 0
Transfer from level 1 to level 2, Liabilities	0	0
Transfer from level 2 to level 1, Liabilities	0	0
Transfer into level 3, Assets	0	0
Transfer out of level 3, Assets	0	0
Transfer into level 3, Liability	0	0
Transfer out of level 3, Liability	$ 0	$ 0

INVESTMENTS (Details) $ in Thousands	9 Months Ended
INVESTMENTS (Details) $ in Thousands	Sep. 30, 2020 USD ($)
Investments by security type
Amortized Cost	$ 113,597
Gross Unrealized Gains	1
Gross Unrealized Losses	(4)
Fair Value	113,594
U.S. treasury securities
Investments by security type
Amortized Cost	50,484
Gross Unrealized Gains	1
Fair Value	50,485
U.S. government agencies securities
Investments by security type
Amortized Cost	63,113
Gross Unrealized Losses	(4)
Fair Value	$ 63,109

REVENUE & ACCOUNTS RECEIVABLE, NET - Co-pay Assistance Program (Details) - USD ($) $ in Thousands	3 Months Ended
	Sep. 30, 2020	Jun. 30, 2020	Mar. 31, 2020
Trade Discounts, Allowances and Chargebacks
Beginning balance	$ 398	$ 1,396	$ 1,783
Provision related to current period sales	1,235	335	725
Changes in estimate related to prior period sales	(1)	3	2
Credit/payments made	(815)	(1,336)	(1,114)
Ending balance	817	398	1,396
Product Returns
Beginning balance	64	114	180
Changes in estimate related to prior period sales	(1)	(51)	(66)
Credit/payments made	1	1
Ending balance	64	64	114
Rebates and Incentives
Beginning balance	5,570	6,623	10,044
Provision related to current period sales	7,584	2,194	4,576
Changes in estimate related to prior period sales	(93)	(234)	93
Credit/payments made	(6,347)	(3,013)	(8,090)
Ending balance	$ 6,714	$ 5,570	$ 6,623

REVENUE & ACCOUNTS RECEIVABLE, NET - Accounts Receivable, net (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Jun. 30, 2020	Sep. 30, 2019
Allowance for doubtful accounts		$ 0	$ 1,107
Sales discounts and contractual fee for service arrangements
Allowance for doubtful accounts	$ 817

INVENTORY (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Inventory
Raw Materials	$ 1,025	$ 1,387
Work in Progress	4,979	4,166
Finished Goods	4,223	2,873
Total inventory	10,227	8,426
Inventory	7,538	4,648
Long-term inventory	2,689	$ 3,778
Commercial production of pre-launch inventories
Inventory
Work in Progress	$ 1,127

ACCRUED EXPENSES (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Compensation and benefits	$ 6,212	$ 6,502
Accrued revenue reserves	6,308	9,482
Development costs	172	1,600
Professional services	1,335	760
Commercial cost	788	930
Contract manufacturing	416	630
Other	620	1,025
Accrued expenses	15,851	20,929
Accounts payable
Accrued revenue reserves	$ 470	$ 741

LEASES (Details) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
LEASES (Details) $ in Thousands	Sep. 30, 2020 USD ($) item	Sep. 30, 2019 USD ($)	Sep. 30, 2020 USD ($) item	Sep. 30, 2019 USD ($)	Dec. 31, 2019 USD ($)	Nov. 15, 2018
Leases
Restricted cash	$ 12,585	$ 12,580	$ 12,585	$ 12,580
Variable lease cost	$ 404	371	$ 1,472	882
Remaining lease term			1 year 4 months 24 days
Number of vehicles leased under a master fleet lease agreement \| item	65		65
Term of vehicle lease					3 years
Amount borrowed					$ 453
Lease cost
Operating lease cost	$ 1,185	1,185	$ 3,556	3,428
Variable Lease, Cost	404	371	1,472	882
Total lease cost	1,589	1,556	5,028	4,310
Operating cash outflows from operating leases	1,431	$ 1,443	4,561	3,097
Operating Lease, Right-of-Use Asset	$ 28,344		$ 28,344		$ 29,781
Watertown Lease
Leases
Lease term	13 years		13 years
Restricted cash	$ 2,057		$ 2,057
Discount rate (as a percent)						9.90%
Variable lease cost			$ 1,472	882
Remaining lease term			11 years 1 month 6 days
Lease cost
Variable Lease, Cost			$ 1,472	$ 882

DEBT (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
DEBT (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Oct. 01, 2018
Debt instruments
Amount borrowed					$ 453
Interest expense	$ 2,157	$ 2,180	$ 6,419	$ 6,335
Term Loan A
Debt instruments
Interest rate (as a percent)						9.875%
Aggregate principal amount						$ 75,000
Term Loan B
Debt instruments
Aggregate principal amount						$ 35,000

- Definition

The carrying value as of the balance sheet date of the current and noncurrent portions of long-term obligations drawn from a line of credit, which is a bank's commitment to make loans up to a specific amount. Examples of items that might be included in the application of this element may consist of letters of credit, standby letters of credit, and revolving credit arrangements, under which borrowings can be made up to a maximum amount as of any point in time conditional on satisfaction of specified terms before, as of and after the date of drawdowns on the line. Includes short-term obligations that would normally be classified as current liabilities but for which (a) postbalance sheet date issuance of a long term obligation to refinance the short term obligation on a long term basis, or (b) the enterprise has entered into a financing agreement that clearly permits the enterprise to refinance the short-term obligation on a long term basis and the following conditions are met (1) the agreement does not expire within 1 year and is not cancelable by the lender except for violation of an objectively determinable provision, (2) no violation exists at the BS date, and (3) the lender has entered into the financing agreement is expected to be financially capable of honoring the agreement.

+ References + Details

DEBT - Athyrium Credit Facility (Details)		3 Months Ended				9 Months Ended		12 Months Ended
DEBT - Athyrium Credit Facility (Details)	Oct. 01, 2018 USD ($) $ / shares shares	Sep. 30, 2020 USD ($) item $ / shares	Jun. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Jun. 30, 2019 USD ($)	Sep. 30, 2020 USD ($) item $ / shares shares	Sep. 30, 2019 USD ($)	Dec. 31, 2019 USD ($) shares
Debt instruments
Warrant exercisable \| shares						248,505		297,988
Effective interest rate		11.63%		11.63%		11.63%	11.63%
Interest expense		$ 2,157,000		$ 2,180,000		$ 6,419,000	$ 6,335,000
Warrants 2018
Debt instruments
Exercise Price \| $ / shares		$ 12.18				$ 12.18
Warrant exercisable \| shares						184,660		184,660
Athyrium Credit Facility
Debt instruments
Aggregate principal amount	$ 110,000,000	$ 75,000,000				$ 75,000,000		$ 75,000,000
Cumulative accretion of exit fee		$ 294,000				$ 294,000		183,000
Present value of prepayments if prepayment occurs prior to the second anniversary (as a percent)	105.00%
Prepayments if prepayment occurs on or after the second anniversary of the applicable date of issuance but prior to the third anniversary (as a percent)	3.00%
Prepayments if prepayment occurs on or after the third anniversary (as a percent)	2.00%
Prepayments if prepayment occurs after the fourth anniversary (as a percent)	0.00%
Additional interest rate upon an event of default accrued (as a percent)	3.00%
Total interest rate (as a percent)	12.875%
Number of features of embedded derivative \| item						2
Number of derivatives \| item		1				1
Financial covenant amount	$ 10,000,000
Restricted Cash and Cash Equivalents			$ 10,000,000					10,000,000
Debt issuance costs		$ 3,327,000				$ 3,327,000		$ 3,999,000
Interest expense			2,125,000		$ 2,125,000	6,308,000	6,211,000
Amortization of debt discount			232,000		232,000	671,000	595,000
Contractual coupon interest			$ 1,893,000		$ 1,893,000	$ 5,637,000	$ 5,616,000
Athyrium Credit Facility \| Warrants 2018
Debt instruments
Warrant to purchase shares of common stock \| shares	270,835
Exercise Price \| $ / shares	$ 12.18456
Warrant exercisable \| shares	184,660
Remaining warrant exercisable upon condition \| shares	86,175
Initial fair value of the Warrant	$ 1,899,000
Unamortized discount	1,980,000
Term Loan A
Debt instruments
Aggregate principal amount	$ 75,000,000
Interest rate (as a percent)	9.875%
Exit fee of the total principal payments (as a percent)	1.00%
Cumulative accretion of exit fee	$ 750
Term Loan B
Debt instruments
Aggregate principal amount	$ 35,000,000

DEBT - Carrying Value (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019	Oct. 01, 2018
Debt instruments
Long-term debt, net	$ 71,967	$ 71,184
Athyrium Credit Facility
Debt instruments
Principal Loan Balance	75,000	75,000	$ 110,000
Unamortized debt discount and issuance cost	(3,327)	(3,999)
Cumulative accretion of exit fee	294	183
Long-term debt, net	$ 71,967	$ 71,184

DEBT - Future annual principal payments (Details) - Athyrium Credit Facility $ in Thousands	Sep. 30, 2020 USD ($)
Maturities of long-term debt
2022	$ 16,665
2023	33,330
2024	25,005
Total	$ 75,000

WARRANTS (Details) - $ / shares	9 Months Ended	12 Months Ended
WARRANTS (Details) - $ / shares	Sep. 30, 2020	Dec. 31, 2019
Preferred stock warrants
Shares Exercisable	248,505	297,988
Warrants 2013
Preferred stock warrants
Exercise Price	$ 7.50
Shares Exercisable	33,333	82,816
Warrants 2014
Preferred stock warrants
Exercise Price	$ 7.50
Shares Exercisable	16,000	16,000
Warrants 2016
Preferred stock warrants
Exercise Price	$ 8.27
Shares Exercisable	14,512	14,512
Warrants 2018
Preferred stock warrants
Exercise Price	$ 12.18
Shares Exercisable	184,660	184,660

EQUITY FINANCINGS (Details) - USD ($) $ / shares in Units, $ in Thousands						3 Months Ended		9 Months Ended		12 Months Ended
	May 07, 2020	Apr. 03, 2020	Mar. 11, 2020	Oct. 05, 2018	Aug. 27, 2018	Mar. 31, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019
Equity Offerings
Net proceeds								$ 137,969	$ 2,130
Underwriters discount and offering costs							$ 66	8,475	$ 66
Underwriter's option
Equity Offerings
Issuance of common stock		979,371	2,400,000
Period granted			30 days
Price per share		$ 7.89
Net proceeds		$ 7,216
Shelf
Equity Offerings
Share authorized value (shelf)								$ 18,334
Registration period	3 years				3 years
Sales agreement				$ 50,000
Shelf \| Maximum
Equity Offerings
Additional authorized value of securities	$ 350,000				$ 250,000
2020 Offering
Equity Offerings
Issuance of common stock		16,979,371	16,000,000
Price per share			$ 7.89
Net proceeds		$ 125,423	$ 118,207
ATM
Equity Offerings
Issuance of common stock						2,352,671				2,592,934
Net proceeds						$ 12,546				$ 13,059
ATM \| Maximum
Equity Offerings
Additional authorized value of securities	$ 75,000

STOCK-BASED COMPENSATION - Narrative (Details) - shares	9 Months Ended	12 Months Ended
STOCK-BASED COMPENSATION - Narrative (Details) - shares	Sep. 30, 2020	Dec. 31, 2017	Jun. 25, 2020	Dec. 31, 2019
Stock-based compensation
Common stock available for future grant	11,660,745			8,488,405
2017 Equity Incentive Plan
Stock-based compensation
Common stock available for future grant	1,275,550		2,000,000
2017 Equity Incentive Plan \| Maximum
Stock-based compensation
Common stock available for future grant	2,262,070
2017 Equity Incentive Plan \| Minimum
Stock-based compensation
Common stock available for future grant		3,573,766
Percentage of aggregate number of common shares reserved for future issuance (as a percent)		4.00%
2009 plan
Stock-based compensation
Common stock available for future grant	2,262,070			2,530,586
Number of shares outstanding	8,516,163			7,453,076
Employee and Non-Employee Stock Options
Stock-based compensation
Common stock available for future grant	746,300			705,500
Employee and Non-Employee Stock Options \| 2009 plan
Stock-based compensation
Options Expiry Term	10 years
Vesting Period	4 years
ESPP
Stock-based compensation
Common stock available for future grant	484,772			438,307

STOCK-BASED COMPENSATION - Inducement Stock Option Awards (Details) - Non-statutory Stock Options - shares	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Stock-based compensation
Options Expiry Term	4 years
Vesting Period	3 years
Granted (in shares)	40,800	175,500
Percentage of vesting of share-based compensation awards on the one year anniversary of the grant date	25.00%
Anniversary of the share-based compensation arrangement	1 year
Percentage of vesting of share-based compensation awards after the year anniversary of the grant date	75.00%

STOCK-BASED COMPENSATION - Stock Options (Details) - 2009 plan $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2020 USD ($) $ / shares shares	Dec. 31, 2019 USD ($) $ / shares shares
Number of Shares
Outstanding at the beginning of the period (in shares) \| shares	7,453,076
Granted (in shares) \| shares	1,506,222
Exercised (in shares) \| shares	(312,528)
Forfeited \| shares	(130,607)
Outstanding at the end of the period (in shares) \| shares	8,516,163	7,453,076
Vested and expected to vest (in shares) \| shares	8,516,163
Options exercisable (in shares) \| shares	5,031,572
Weighted Average Exercise Price
Outstanding at the beginning of the period (in dollars per share) \| $ / shares	$ 7.46
Granted (in dollars per share) \| $ / shares	4.00
Exercised (in dollars per share) \| $ / shares	3.02
Forfeited (in dollars per share) \| $ / shares	7.43
Outstanding at the end of the period (in dollars per share) \| $ / shares	7.01	$ 7.46
Vested and expected to vest (in dollars per share ) \| $ / shares	7.01
Options exercisable (in dollars per shares) \| $ / shares	$ 7.42
Weighted Average Remaining Contractual Term
Weighted average period	7 years 4 months 24 days	7 years 8 months 12 days
Vested and expected to vest	7 years 4 months 24 days
Options exercisable	6 years 8 months 12 days
Aggregate Intrinsic Value
Outstanding at the beginning of the period (in dollars) \| $	$ 1,313
Outstanding at the end of the period (in dollars) \| $	20,963	$ 1,313
Vested and expected to vest (in dollars) \| $	20,963
Options exercisable (in dollars) \| $	$ 12,277

STOCK-BASED COMPENSATION - Fair Value Assumptions (Details)	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Assumptions used in determining fair value of the stock options granted
Expected volatility (minimum)	80.00%	61.00%
Expected volatility (maximum)	81.00%	82.00%
Risk-free interest rate (minimum)	0.37%	1.44%
Risk-free interest rate (maximum)	1.73%	2.58%
Expected dividend yield	0.00%	0.00%
Minimum
Assumptions used in determining fair value of the stock options granted
Expected term (in years)	5 years 10 months 28 days	6 months
Maximum
Assumptions used in determining fair value of the stock options granted
Expected term (in years)	6 years 29 days	6 years 7 months 17 days

STOCK-BASED COMPENSATION (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Stock-based compensation
Weighted average grant date fair value of options granted	$ 7.06	$ 2.82	$ 4.00	$ 3.70
2009 plan
Stock-based compensation
Unrecognized compensation expense	$ 17,483	$ 20,469	$ 17,483	$ 20,469
Weighted average expense recognition period			2 years 4 months 24 days	2 years 5 months 15 days

STOCK-BASED COMPENSATION - Stock-based compensation expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Stock-based compensation
Stock based compensation expense	$ 4,261	$ 2,572	$ 9,249	$ 7,666
Cost of product revenues
Stock-based compensation
Stock based compensation expense	32	60	60	101
Research and development
Stock-based compensation
Stock based compensation expense	985	913	2,259	2,315
Selling, general and administrative
Stock-based compensation
Stock based compensation expense	$ 3,244	$ 1,599	$ 6,930	$ 5,250

STOCK-BASED COMPENSATION - Compensation expense - INVELTYS (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Stock-based compensation
Stock based compensation expense	$ 4,261	$ 2,572	$ 9,249	$ 7,666
Inventories \| INVELTYS
Stock-based compensation
Stock based compensation expense	$ 234	$ 19	$ 535	$ 355

STOCK-BASED COMPENSATION - Restricted Stock Units narrative (Details) - USD ($) $ in Thousands	1 Months Ended	3 Months Ended		9 Months Ended
	Jun. 30, 2020	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock based compensation expense		$ 4,261	$ 2,572	$ 9,249	$ 7,666
Non-vested and outstanding balance at end of period (in shares)		946,767		946,767
RSU
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Granted (in shares)				263,560
RSU \| Second anniversary
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage				50.00%
PSU
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Granted (in shares)				693,537
RSU and PSU
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unamortized stock-based compensation expense		$ 8,586		$ 8,586
Weighted average expense recognition period				1 year 4 months 28 days
Executive Officer \| RSU \| First anniversary
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Granted (in shares)	135,560
Vesting percentage	50.00%
Executive Officer \| PSU \| First anniversary
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Granted (in shares)	693,537
Vesting percentage	50.00%
Executive Officer \| PSU \| Second anniversary
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage	50.00%
Director \| RSU
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Granted (in shares)	128,000

STOCK-BASED COMPENSATION - RSU (Details)	9 Months Ended
STOCK-BASED COMPENSATION - RSU (Details)	Sep. 30, 2020 $ / shares shares
Shares
Non-vested and outstanding balance at end of period (in shares) \| shares	946,767
Weighted Average Grant Date Fair Value
Non-vested and outstanding balance at end of period (in dollars per share) \| $ / shares	$ 11.70
RSU
Shares
Granted (in shares) \| shares	263,560
Forfeited (in shares) \| shares	(10,330)
Weighted Average Grant Date Fair Value
Granted (in dollars per share) \| $ / shares	$ 11.70
Forfeited (in dollars per shares) \| $ / shares	$ 11.70
PSU
Shares
Granted (in shares) \| shares	693,537
Weighted Average Grant Date Fair Value
Granted (in dollars per share) \| $ / shares	$ 11.70

STOCK-BASED COMPENSATION - Employee Stock Purchase Plan (Details) $ in Thousands	1 Months Ended		3 Months Ended		9 Months Ended
	Jul. 31, 2020 shares	Jan. 31, 2020 shares	Sep. 30, 2020 USD ($) shares	Sep. 30, 2019 USD ($)	Sep. 30, 2020 USD ($) item shares	Sep. 30, 2019 USD ($)	Dec. 31, 2018 shares
Stock-based compensation
Stock-based compensation expense \| $			$ 4,268	$ 2,488	$ 9,626	$ 7,750
2017 Employee Stock Purchase Plan
Stock-based compensation
Shares Authorized							223,341
Employee basic pay holding period					6 months
Number of offering periods \| item					2
Percentage of market value at which employee may purchase stock					85.00%
Issuance under employee stock purchase plan (in shares)	228,844	85,553
2017 Employee Stock Purchase Plan \| Maximum
Stock-based compensation
Shares Authorized			893,441		893,441
Threshold percentage of share available to grant					1.00%

STOCK-BASED COMPENSATION - ESPP Stock-based compensation expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Stock-based compensation
Stock based compensation expense	$ 4,261	$ 2,572	$ 9,249	$ 7,666
Cost of product revenues
Stock-based compensation
Stock based compensation expense	32	60	60	101
Research and development
Stock-based compensation
Stock based compensation expense	985	913	2,259	2,315
Selling, general and administrative
Stock-based compensation
Stock based compensation expense	$ 3,244	$ 1,599	$ 6,930	$ 5,250

STOCK-BASED COMPENSATION - Reserved Shares (Details) - shares	Sep. 30, 2020	Dec. 31, 2019
Stock-based compensation
Common stock shares reserved for future issuance	11,660,745	8,488,405
2017 Employee Stock Purchase Plan
Stock-based compensation
Common stock shares reserved for future issuance	7,832,923	4,429,849
ESPP
Stock-based compensation
Common stock shares reserved for future issuance	484,772	438,307
Employee and Non-Employee Stock Options
Stock-based compensation
Common stock shares reserved for future issuance	746,300	705,500
Warrants
Stock-based compensation
Common stock shares reserved for future issuance	334,680	384,163
2009 plan
Stock-based compensation
Common stock shares reserved for future issuance	2,262,070	2,530,586

INCOME TAXES (Details) - USD ($)	3 Months Ended		6 Months Ended
INCOME TAXES (Details) - USD ($)	Jun. 30, 2020	Jun. 30, 2019	Jun. 30, 2020	Jun. 30, 2019
INCOME TAXES
Uncertain tax positions	$ 0	$ 0	$ 0	$ 0
Interest or penalties recorded	$ 0	$ 0	$ 0	$ 0

COMMITMENTS AND CONTINGENCIES. - License Agreement (Details) - USD ($) $ in Thousands		3 Months Ended		9 Months Ended
	Oct. 26, 2020	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Contingencies
Research and development expenses		$ 3,468	$ 7,070	$ 14,955	$ 21,137
The Johns Hopkins University ("JHU")
Contingencies
Minimum annual payment				38
License fee, if the company achieves the first commercial sale				112
First commercial sale milestone		8	34	44	334
Research and development expenses		$ 44	$ 116	$ 121	$ 197
Subsequent Event \| The Johns Hopkins University ("JHU")
Contingencies
Milestone payment	$ 150
Time within milestone payment must be made by first commercial sale of the product	60 days

COMMITMENTS AND CONTINGENCIES. - Future minimum obligations (Details) $ in Thousands	Sep. 30, 2020 USD ($)
Minimum obligations due under its license agreements
2021	$ 2,295
2022	5,390
2023	6,285
2024	7,875
Thereafter	26,124
Total minimum purchase commitments	$ 47,969