Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 10, 2022 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-38150 | |
Entity Registrant Name | KALA PHARMACEUTICALS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 27-0604595 | |
Entity Address, Address Line One | 1167 Massachusetts Avenue | |
Entity Address, City or Town | Arlington | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02476 | |
City Area Code | 781 | |
Local Phone Number | 996-5252 | |
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Trading Symbol | KALA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 73,208,140 | |
Entity Central Index Key | 0001479419 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 42,569 | $ 92,136 |
Short-term investments | 1,999 | |
Short-term restricted cash | 450 | 2,042 |
Accounts receivable, net | 13,822 | 15,345 |
Inventory | 25 | 8,639 |
Prepaid expenses and other current assets | 2,143 | 6,204 |
Current assets held for sale (Note 3) | 22,507 | |
Total current assets | 83,515 | 124,366 |
Non-current assets: | ||
Property and equipment, net | 891 | 2,722 |
Long-term inventory | 9,578 | |
Right-of-use assets | 51 | 1,299 |
Restricted cash and other long-term assets | 519 | 1,462 |
Total assets | 84,976 | 139,427 |
Current liabilities: | ||
Accounts payable | 10,542 | 4,899 |
Accrued expenses and other current liabilities | 18,306 | 20,986 |
Current portion of lease liabilities | 52 | 711 |
Current portion of contingent consideration | 3,772 | 3,817 |
Current portion of deferred purchase consideration | 219 | 7,009 |
Total current liabilities | 32,891 | 37,422 |
Long-term liabilities: | ||
Long-term lease liabilities | 548 | |
Long-term debt | 79,800 | 78,929 |
Long-term contingent consideration | 3,839 | 4,841 |
Long-term deferred purchase consideration | 883 | |
Total long-term liabilities | 83,639 | 85,201 |
Total liabilities | 116,530 | 122,623 |
Commitments and Contingencies (Note 16) | ||
Stockholders' equity: | ||
Common stock, $0.001 par value; 120,000,000 shares authorized as of June 30, 2022 and December 31, 2021; 72,673,785 and 65,500,275 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively | 73 | 66 |
Additional paid-in capital | 571,814 | 559,126 |
Accumulated other comprehensive loss | (1) | |
Accumulated deficit | (603,440) | (542,388) |
Total stockholders' (deficit) equity | (31,554) | 16,804 |
Total liabilities and stockholders' (deficit) equity | $ 84,976 | $ 139,427 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
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 | 72,673,785 | 65,500,275 |
Common stock, shares outstanding | 72,673,785 | 65,500,275 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
Product revenues, net | $ 2,100 | $ 3,051 | $ 3,472 | $ 6,317 |
Costs and expenses: | ||||
Cost of product revenues | 1,774 | 1,016 | 2,549 | 1,771 |
Selling, general and administrative | 22,673 | 27,986 | 49,655 | 55,685 |
Research and development | 4,473 | 3,094 | 8,939 | 6,220 |
(Gain) loss on fair value remeasurement of deferred purchase consideration | (789) | 262 | ||
Gain on fair value remeasurement of contingent consideration | (59) | (1,047) | ||
Total costs and expenses | 28,072 | 32,096 | 60,358 | 63,676 |
Loss from operations | (25,972) | (29,045) | (56,886) | (57,359) |
Other income (expense): | ||||
Interest and other income | 68 | 33 | 76 | 76 |
Interest and other expense | (2,207) | (2,091) | (4,242) | (4,232) |
Loss on extinguishment of debt | (5,395) | (5,395) | ||
Total interest and other expense | (2,139) | (7,453) | (4,166) | (9,551) |
Net loss | $ (28,111) | $ (36,498) | $ (61,052) | $ (66,910) |
Net loss per share-basic (in dollar per share) | $ (0.38) | $ (0.57) | $ (0.83) | $ (1.06) |
Net loss per share- diluted (in dollar per share) | $ (0.38) | $ (0.57) | $ (0.83) | $ (1.06) |
Weighted average shares outstanding-basic (in shares) | 73,676,819 | 64,554,506 | 73,658,924 | 63,113,194 |
Weighted average shares outstanding-diluted (in shares) | 73,676,819 | 64,554,506 | 73,658,924 | 63,113,194 |
Statement of Comprehensive Loss | ||||
Net loss | $ (28,111) | $ (36,498) | $ (61,052) | $ (66,910) |
Other comprehensive loss: | ||||
Change in unrealized gains on investments | 1 | (3) | (1) | (4) |
Total other comprehensive loss | 1 | (3) | (1) | (4) |
Total comprehensive loss | $ (28,110) | $ (36,501) | $ (61,053) | $ (66,914) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Total |
Balance as of beginning of period at Dec. 31, 2020 | $ 59 | $ 499,715 | $ 4 | $ (399,783) | $ 99,995 |
Balance as of beginning of period (in shares) at Dec. 31, 2020 | 58,915,375 | ||||
Stockholders' Equity | |||||
At the market offering, net of sales agent commission | $ 6 | 40,724 | 40,730 | ||
At the market offering, net of sales agent commission (in shares) | 5,583,329 | ||||
Exercise of stock options | 248 | 248 | |||
Exercise of stock options (in shares) | 88,888 | ||||
Issuance of common stock for vested restricted stock units (in shares) | 107,780 | ||||
Issuance of common stock under employee stock purchase plan | 431 | 431 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 74,847 | ||||
Stock-based compensation expense | 9,780 | 9,780 | |||
Change in fair value of investments | (4) | (4) | |||
Net loss | (66,910) | (66,910) | |||
Balance as of end of period at Jun. 30, 2021 | $ 65 | 550,898 | (466,693) | 84,270 | |
Balance as of end of period (in shares) at Jun. 30, 2021 | 64,770,219 | ||||
Balance as of beginning of period at Dec. 31, 2020 | $ 59 | 499,715 | 4 | (399,783) | 99,995 |
Balance as of beginning of period (in shares) at Dec. 31, 2020 | 58,915,375 | ||||
Balance as of end of period at Dec. 31, 2021 | $ 66 | 559,126 | (542,388) | 16,804 | |
Balance as of end of period (in shares) at Dec. 31, 2021 | 65,500,275 | ||||
Balance as of beginning of period at Mar. 31, 2021 | $ 64 | 539,920 | 3 | (430,195) | 109,792 |
Balance as of beginning of period (in shares) at Mar. 31, 2021 | 63,805,108 | ||||
Stockholders' Equity | |||||
At the market offering, net of sales agent commission | $ 1 | 6,020 | 6,021 | ||
At the market offering, net of sales agent commission (in shares) | 837,257 | ||||
Exercise of stock options | 64 | 64 | |||
Exercise of stock options (in shares) | 20,074 | ||||
Issuance of common stock for vested restricted stock units (in shares) | 107,780 | ||||
Stock-based compensation expense | 4,894 | 4,894 | |||
Change in fair value of investments | (3) | (3) | |||
Net loss | (36,498) | (36,498) | |||
Balance as of end of period at Jun. 30, 2021 | $ 65 | 550,898 | (466,693) | 84,270 | |
Balance as of end of period (in shares) at Jun. 30, 2021 | 64,770,219 | ||||
Balance as of beginning of period at Dec. 31, 2021 | $ 66 | 559,126 | (542,388) | 16,804 | |
Balance as of beginning of period (in shares) at Dec. 31, 2021 | 65,500,275 | ||||
Stockholders' Equity | |||||
Exercise of stock options | 3 | 3 | |||
Exercise of stock options (in shares) | 5,088 | ||||
Issuance of common stock for vested restricted stock units (in shares) | 198,244 | ||||
Issuance of common stock to satisfy deferred purchase consideration | $ 7 | 7,929 | 7,936 | ||
Issuance of common stock to satisfy deferred purchase consideration (in shares) | 6,815,072 | ||||
Issuance of common stock under employee stock purchase plan | 160 | 160 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 155,106 | ||||
Stock-based compensation expense | 4,596 | 4,596 | |||
Change in fair value of investments | (1) | (1) | |||
Net loss | (61,052) | (61,052) | |||
Balance as of end of period at Jun. 30, 2022 | $ 73 | 571,814 | (1) | (603,440) | (31,554) |
Balance as of end of period (in shares) at Jun. 30, 2022 | 72,673,785 | ||||
Balance as of beginning of period at Mar. 31, 2022 | $ 73 | 569,974 | (2) | (575,329) | (5,284) |
Balance as of beginning of period (in shares) at Mar. 31, 2022 | 72,594,005 | ||||
Stockholders' Equity | |||||
Issuance of common stock for vested restricted stock units (in shares) | 79,780 | ||||
Stock-based compensation expense | 1,840 | 1,840 | |||
Change in fair value of investments | 1 | 1 | |||
Net loss | (28,111) | (28,111) | |||
Balance as of end of period at Jun. 30, 2022 | $ 73 | $ 571,814 | $ (1) | $ (603,440) | $ (31,554) |
Balance as of end of period (in shares) at Jun. 30, 2022 | 72,673,785 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) - (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) | ||
Sales agent commission | $ 170 | |
Offering costs | $ 1,161 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Cash flows from operating activities: | |||||
Net loss | $ (61,052) | $ (66,910) | |||
Adjustments to reconcile net loss to cash used in operating activities: | |||||
Depreciation and amortization | 306 | 504 | |||
Non-cash operating lease cost | 403 | 1,118 | |||
Loss on extinguishment of debt | $ 5,395 | 5,395 | |||
Loss on fair value remeasurement of deferred purchase consideration | $ (789) | 262 | |||
Gain on fair value remeasurement of contingent consideration | (59) | (1,047) | |||
Amortization of debt discount and other non-cash interest | 871 | 645 | |||
Stock-based compensation | 4,721 | 9,412 | |||
Other non-cash (gains) losses | (27) | 22 | |||
Change in operating assets and liabilities: | |||||
Accounts receivable | 1,523 | (2,255) | |||
Prepaid expenses and other current assets | 3,467 | 826 | |||
Inventory | (1,584) | (5,387) | |||
Accounts payable | 5,643 | 1,250 | |||
Accrued expenses and other current liabilities | (2,670) | 1,966 | |||
Lease liabilities and other long-term liabilities | (324) | (834) | |||
Net cash used in operating activities | (49,508) | (54,248) | |||
Cash flows from investing activities: | |||||
Purchases of property and equipment and other assets | (253) | (545) | |||
Purchases of short-term investments | (4,992) | ||||
Proceeds from sales or maturities of short-term investments | 3,000 | 71,250 | |||
Net cash (used in) provided by investing activities | (2,245) | 70,705 | |||
Cash flows from financing activities: | |||||
Proceeds from issuance of debt, net of debt issuance costs of $2,218 | 77,782 | ||||
Payment of principal, prepayment premium and exit fee on debt | (78,010) | ||||
Proceeds from common stock offerings, net of offering costs | 40,730 | ||||
Payment of principal on finance lease | (19) | (17) | |||
Proceeds from exercise of stock options and issuance of common stock under employee stock purchase plan | 163 | 679 | |||
Net cash provided by financing activities | 144 | 41,164 | |||
Net (decrease) increase in cash, cash equivalents and restricted cash: | (51,609) | 57,621 | |||
Cash, cash equivalents and restricted cash at beginning of period | 94,878 | 89,756 | $ 89,756 | ||
Cash, cash equivalents and restricted cash at end of period | 43,269 | 147,377 | 43,269 | 147,377 | 94,878 |
Reconciliation of cash, cash equivalents and restricted cash: | |||||
Cash, cash equivalents, and restricted cash at end of period | 43,269 | 147,377 | 43,269 | 147,377 | 94,878 |
Less restricted cash (Notes 9 and 10) | (700) | (2,742) | (700) | (2,742) | |
Cash and cash equivalents at end of period | $ 42,569 | $ 144,635 | 42,569 | 144,635 | $ 92,136 |
Non-cash investing and financing activities: | |||||
Purchases of property and equipment in accounts payable and accrued expenses | 139 | 318 | |||
Supplemental disclosure: | |||||
Cash paid for interest | 3,315 | 3,030 | |||
Right-of-use assets obtained in exchange of operating lease obligations | $ 424 | $ 1,218 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) $ in Thousands | Jun. 30, 2021 USD ($) |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |
Debt issuance costs | $ 2,218 |
NATURE OF BUSINESS AND BASIS OF
NATURE OF BUSINESS AND BASIS OF PRESENTATION | 6 Months Ended |
Jun. 30, 2022 | |
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 On November 15, 2021, the Company and its newly formed, direct wholly owned subsidiary, Ceres Merger Sub, Inc. (the “Merger Subsidiary”), entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Combangio, Inc. (“Combangio”) and Fortis Advisors LLC, solely in its capacity as Combangio Equityholder Representative in connection with the Merger Agreement, pursuant to which on November 15, 2021, the Merger Subsidiary merged with and into Combangio with Combangio surviving such merger and becoming a direct wholly owned subsidiary of the Company (the “Combangio Acquisition”). Combangio is a clinical-stage biotechnology company focused on developing regenerative biotherapeutics for severe ocular diseases based on mesenchymal stem cell secretomes (“MSC-S”) platform, including its lead product candidate, CMB-012 for the treatment of persistent corneal epithelial defects (“PCED”), which the Company now refers to as KPI-012. The Company expects to commercialize in the United States any of its product candidates that receive marketing approval. In connection with the determination to focus its research and development efforts on KPI-012, The Company previously developed and commercialized two marketed products, 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, and INVELTYS ® (loteprednol etabonate ophthalmic suspension) 1%, a topical twice-a-day ocular steroid for the treatment of post-operative inflammation and pain following ocular surgery. Both products applied a proprietary mucus-penetrating particle drug delivery technology, which the Company referred to as the AMPPLIFY ® Drug Delivery Technology. On July 8, 2022, the Company closed the transaction (the “Alcon Transaction”), contemplated by the asset purchase agreement, dated as of May 21, 2022 (the “Asset Purchase Agreement”), by and between the Company, Alcon Pharmaceuticals Ltd. and Alcon Vision, LLC (together referred to as “Alcon”), pursuant to which Alcon purchased the rights to manufacture, sell, distribute, market and commercialize EYSUVIS and INVELTYS and to develop, manufacture, market and otherwise exploit the Company’s AMPPLIFY Drug Delivery Technology (collectively, the “Commercial Business”). Alcon also assumed certain liabilities with respect to the Commercial Business. See Note 3, “Assets Held for Sale”, and Note 17, “Subsequent Events”, for additional information about the Alcon Transaction. The Company’s success is dependent upon its ability to develop, obtain regulatory approval for and commercialize KPI-012 and any other product candidate it may develop in the future, the success of its research and development efforts, whether it receives the commercial-based sales milestone payments from Alcon, its ability to raise additional capital when needed and, ultimately, attain profitable operations. Liquidity research and development, including preclinical studies and clinical trials, and, prior to the sale of its Commercial Business to Alcon in July 2022, engaging in activities to launch and commercialize EYSUVIS and INVELTYS. As a result of the Combangio Acquisition and the sale of the Company’s Commercial Business to Alcon, the Company intends to devote substantial financial resources to the research and development and potential commercialization of KPI-012. Although the Company is eligible to receive up to $325,000 in payments from Alcon based upon the achievement of specified commercial sales-based milestones with respect to EYSUVIS and INVELTYS, there can be no assurance when the Company may receive such milestone payments or the amount of milestone payments the Company may receive, if any. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future, including in connection with its continued development, regulatory approval efforts and commercialization, if any, of KPI-012. The Company may never achieve or maintain profitability. Net losses may fluctuate significantly from quarter-to-quarter and year-to-year. The Company expects that its cash, cash equivalents and short-term investments as of June 30, 2022, together with the upfront payment of $60,000 received from Alcon upon the closing of the Alcon Transaction in July 2022 and the cash purchase by Alcon of $5,026 for EYSUVIS and INVELTYS inventory on-hand at the closing of the sale of the Commercial Business, net of a $40,000 prepayment to Oxford Finance, 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. This evaluation also assumes that the Company remains in compliance with the covenants under the Loan Agreement (defined below), including as a result of the delisting of the Company’s common stock from the Nasdaq Global Select Market. On May 24, 2022, the Company received a deficiency letter from the Nasdaq Stock Market LLC (“Nasdaq”) notifying it that, for 30 consecutive business days, the bid price of its common stock had closed below the $1.00 per share minimum bid price requirement for continued inclusion on Nasdaq pursuant to Nasdaq Listing Rule 5450(a)(1), and on July 6, 2022, the Company received another deficiency letter from Nasdaq notifying it that it was not in compliance with Nasdaq Listing Rule 5450(b)(2)(A), as the market value of its common stock was less than $50,000,000 for the previous 30 consecutive business days. Each of the deficiency letters indicated that if the Company is unable to cure such deficiency or otherwise regain compliance with the Nasdaq Listing Rules within 180 calendar days from the date of the respective deficiency letter, the Company’s common stock will be subject to delisting. COVID-19 In addition, government restrictions have at times led to moratoria on elective ocular surgeries in many jurisdictions, which had significantly reduced the demand for INVELTYS, which is indicated for the treatment of post-operative inflammation and pain following ocular surgery. While surgeries have returned to historical levels, the COVID-19 pandemic had negatively impacted revenues from INVELTYS in prior periods. In addition, the COVID-19 pandemic has generally had an adverse impact on the launch of pharmaceutical products, and the Company believes the pandemic impacted the launch of EYSUVIS. The Company cannot predict whether the COVID-19 pandemic will impact Alcon’s ability to commercialize EYSUVIS and INVELTYS, and as a result, it cannot be certain whether the COVID-19 pandemic might adversely affect when the Company may receive milestone payments from Alcon, which milestone payments the Company may receive and if the Company will receive any milestone payments at all. The Company also does not know the extent to which the COVID-19 pandemic will impact its development of KPI-012 or any other product candidate it develops. commercialization efforts of EYSUVIS and INVELTYS, the Company’s development of KPI-012 and any other product candidate it may develop in the future and the Company’s virus, the availability and effectiveness of vaccines, and the impact of the foregoing on 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 Net Loss per Share 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 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 the three and six months ended June 30, 2022 and 2021. (See Note 14). Unaudited Interim Financial Information The unaudited condensed consolidated financial statements include the accounts of Kala Pharmaceuticals, Inc. and its wholly owned subsidiaries, Kala Pharmaceuticals Security Corporation and Combangio, Inc. All intercompany transactions and balances have been eliminated in consolidation. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2022 | |
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 three months ended June 30, 2022 , other than as described below Assets Held for Sale The Company classifies its long-lived assets to be sold as held for sale, as specified by ASC 360, Property, Plant, and Equipment As of June 30, 2022, certain assets met the criteria to be classified as held for sale in connection with the Alcon Transaction and the Company concluded that there was no impairment loss related to held for sale assets for the three or six months ended June 30, 2022. The Company reclassified the property and equipment, inventory, and certain other assets, which had a combined carrying value of $22,507, to current assets held for sale on the condensed consolidated balance sheet as of June 30, 2022. Fair value was determined based on the estimated proceeds from the sale of the Commercial Business utilizing the purchase price as defined in the Asset Purchase Agreement. The sale of these assets was completed on July 8, 2022. See Note 3, “Assets Held for Sale”, and Note 17, “Subsequent Events”, for additional information. There were no assets that met the criteria for classification as held for sale as of December 31, 2021. Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) , public business entities that meet the definition of an SEC filer, excluding entities eligible to be , for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years and for all other entities, including SRCs, The Company is currently evaluating the impact of the on its consolidated financial statements. The |
ASSETS HELD FOR SALE
ASSETS HELD FOR SALE | 6 Months Ended |
Jun. 30, 2022 | |
ASSETS HELD FOR SALE | |
ASSETS HELD FOR SALE | 3. ASSETS HELD FOR SALE As of June 30, 2022, the Company presented assets to be disposed of in connection with the Alcon Transaction Presentation of Financial Statements—Discontinued Operations The following is a summary of the major categories of assets that have been reclassified to held for sale on the : June 30, 2022 Inventories $ 19,651 Prepaid expenses and other current assets 594 Property and equipment, net 1,828 Restricted cash and other long-term assets 434 Total assets held for sale $ 22,507 See Note 2, “Summary of Significant Accounting Policies”, and Note 17, “Subsequent Events”, for further information on the sale of the Company’s Commercial Business. |
FAIR VALUE OF FINANCIAL INSTRUM
FAIR VALUE OF FINANCIAL INSTRUMENTS | 6 Months Ended |
Jun. 30, 2022 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | 4. FAIR VALUE OF FINANCIAL INSTRUMENTS The Company from time to time has short-term investments which are considered financial instruments that are measured on a recurring basis. Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures, ● 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 as of June 30, 2022 consisted primarily of cash equivalents, short-term investments in U.S. treasury securities and contingent consideration. The Company’s financial instruments as of December 31, 2021 consisted primarily of cash equivalents and contingent consideration. Cash equivalents, short-term investments and contingent consideration are reported at their respective fair values on the Company’s condensed consolidated balance sheets. See Note 5, “Investments” for additional information. T he Company acquired Combangio in November 2021 and in connection with the closing of the Combangio Acquisition, an aggregate of 7,788,637 shares (the “Deferred Purchase Consideration”) of the Company’s common stock to former Combangio stockholders and other equityholders (the “Combangio Equityholders”) consisting of (i) an aggregate of 6,815,072 shares of common stock issued on January 3, 2022 (the “Upfront Shares”) and (ii) an aggregate of 973,565 shares of common stock that have been held back by the Company and will be issuable subject to the terms of the Merger Agreement to the Combangio Equityholders on the date that is fifteen months after the closing (the “Escrow Release Date”). The Company established liabilities for the Deferred Purchase Consideration. T Additionally, the purchase price in connection with the Combangio Acquisition included potential future payments of up to $105,000 that are contingent upon the achievement of specified development, regulatory and commercialization milestones and are required to be recorded at fair value. Contingent consideration liabilities related to acquisitions are measured at fair value each reporting period using Level 3 unobservable inputs. The fair values of the contingent consideration liabilities were based on a probability-adjusted discounted cash flow calculation using Level 3 fair value measurements. Changes in these estimates and assumptions could have a significant impact on the fair value of the contingent consideration liabilities. Any changes in the fair value of these contingent consideration liabilities are included in loss from operations in the condensed consolidated statements of operations and comprehensive loss. During the three and six months ended June 30, 2022, the change in fair value of the contingent consideration liabilities was $59 and $1,047, respectively, primarily due to changes in discount rates, partially offset by the passage of time, and were recognized as a gain on fair value remeasurement of contingent consideration in the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2022. The following tables set forth the fair value of the Company’s financial instruments by level within the fair value hierarchy as of June 30, 2022 and December 31, 2021: June 30, 2022 Fair Value Level 1 Level 2 Level 3 Assets: Cash equivalents $ 34,184 $ 34,184 $ — $ — Short-term investments 1,999 1,999 — — Total Assets $ 36,183 $ 36,183 $ — $ — Liabilities: Deferred purchase consideration $ 219 $ — $ — $ 219 Contingent consideration 7,611 — — 7,611 Total Liabilities $ 7,830 $ — $ — $ 7,830 December 31, 2021 Fair Value Level 1 Level 2 Level 3 Assets: Cash equivalents $ 86,135 $ 86,135 $ — $ — Total Assets $ 86,135 $ 86,135 $ — $ — Liabilities: Deferred purchase consideration $ 7,892 $ — $ — $ 7,892 Contingent consideration 8,658 — — 8,658 Total Liabilities $ 16,550 $ — $ — $ 16,550 The following tables summarize quantitative information and assumptions pertaining to the fair value measurement of the Level 3 inputs as of June 30, 2022 and December 31, 2021: Fair Value at June 30, Range Financial Instrument 2022 Valuation Technique Unobservable Input (Average) Deferred purchase consideration $ 219 Option pricing model Discount for lack of marketability 25% Contingent consideration $ 7,611 Probability-adjusted Period of expected milestone achievement 2022 - 2027 (2025) discounted cash flow model Probabilities of achievement 18.9% - 90.0% (42.5%) Discount rate 17.5% Discount for lack of marketability 20.0% Fair Value at December 31, Range Financial Instrument 2021 Valuation Technique Unobservable Input (Average) Deferred purchase consideration $ 7,892 Option pricing model Discount for lack of marketability 15.0% - 25.0% (20.0%) Contingent consideration $ 8,658 Probability-adjusted Period of expected milestone achievement 2022 - 2027 (2025) discounted cash flow model Probabilities of achievement 18.9% - 90.0% (42.5%) Discount rate 10.3% Discount for lack of marketability 12.0% The following table summarizes the changes in the Deferred Purchase Consideration and contingent consideration liabilities measured at fair value using Level 3 inputs for the three and six months ended June 30, 2022: Deferred purchase consideration Balance at January 1, 2022 $ 7,892 Fair value adjustments 1,051 Settlements (7,935) Balance at March 31, 2022 $ 1,008 Fair value adjustments (789) Balance at June 30, 2022 $ 219 Contingent consideration Balance at January 1, 2022 $ 8,658 Fair value adjustments (988) Balance at March 31, 2022 $ 7,670 Fair value adjustments (59) Balance at June 30, 2022 $ 7,611 During the three and six months ended June 30, 2022 and the year ended December 31, 2021, there were no transfers between Level 1 , Level 2 , and Level 3 . |
INVESTMENTS
INVESTMENTS | 6 Months Ended |
Jun. 30, 2022 | |
INVESTMENTS | |
INVESTMENTS | 5. INVESTMENTS Investments by security type consisted of the following as of June 30, 2022: June 30, 2022 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. treasury securities $ 2,000 $ — $ (1) $ 1,999 Total $ 2,000 $ — $ (1) $ 1,999 As of June 30, 2022, 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. The Company held no short-term investments as of December 31, 2021. |
REVENUE & ACCOUNTS RECEIVABLE,
REVENUE & ACCOUNTS RECEIVABLE, NET | 6 Months Ended |
Jun. 30, 2022 | |
REVENUE & ACCOUNTS RECEIVABLE, NET | |
REVENUE & ACCOUNTS RECEIVABLE, NET | 6. REVENUE & ACCOUNTS RECEIVABLE, NET The Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers Product revenues, net The Company sells EYSUVIS and INVELTYS primarily to wholesalers 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 third-party 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. 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 and other third-party payors 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, actual payment history, 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 for variable consideration 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 generally 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 other discounts 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 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 as well as historical returns, which develop over time. 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 EYSUVIS and INVELTYS 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 actual payment history, and 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 Programs The Company offers co-pay assistance programs (the “co-pay programs”), which are intended to provide financial assistance to patients who may or may not be covered by commercial insurance or, with respect to INVELTYS, who opt out of Medicare Part D programs. The calculation of accruals for the co-pay programs 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 tables summarize activity in each of the Company’s product revenue provision and allowance categories for the three and six months ended June 30, 2022 and 2021: Trade Discounts, Allowances and Rebates and Chargebacks (1) Product Returns (2) Incentives (3) Balance as of December 31, 2021 $ 2,672 $ 1,140 $ 11,280 Provision related to current period sales 2,133 210 13,359 Changes in estimate related to prior period sales (1) (138) (242) Credit/payments made (3,261) (415) (10,108) Balance as of March 31, 2022 $ 1,543 $ 797 $ 14,289 Provision related to current period sales 2,602 214 15,413 Changes in estimate related to prior period sales (41) (199) (107) Credit/payments made (2,041) (112) (14,878) Balance as of June 30, 2022 $ 2,063 $ 700 $ 14,717 Trade Discounts, Allowances and Rebates and Chargebacks (1) Product Returns (2) Incentives (3) Balance as of December 31, 2020 $ 1,157 $ 600 $ 4,904 Provision related to current period sales 2,201 245 10,216 Changes in estimate related to prior period sales 3 30 (26) Credit/payments made (1,823) (419) (7,880) Balance as of March 31, 2021 $ 1,538 $ 456 $ 7,214 Provision related to current period sales 2,103 356 11,193 Changes in estimate related to prior period sales 30 142 (353) Credit/payments made (2,260) (253) (9,801) Balance as of June 30, 2021 $ 1,411 $ 701 $ 8,253 (1) Trade discounts, allowances and chargebacks include fees for distribution service fees, prompt pay and other discounts, and chargebacks. Estimated 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 on the Company’s condensed consolidated balance sheets. (2) Estimated 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 on 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. Estimated 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 on 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 other discounts, contractual fees for service arrangements and chargebacks 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 June 30, 2022 or December 31, 2021. The Company recorded an allowance of $2,063 and $2,672 for expected sales discounts, related to prompt pay discounts and other discounts, contractual fee for service arrangements and chargebacks, to wholesalers and distributors as of June 30, 2022 and December 31, 2021, respectively. |
INVENTORY
INVENTORY | 6 Months Ended |
Jun. 30, 2022 | |
INVENTORY | |
INVENTORY | 7. INVENTORY Inventory held and used consisted of the following: June 30, December 31, 2022 2021 Raw materials $ — $ 1,328 Work in progress — 9,799 Finished goods 25 7,090 Total inventory $ 25 $ 18,217 As of June 30, 2022, the Company had $25 of current inventory and $19,651 of inventory classified as held for sale (s ee Note 3, “Assets Held for Sale”) |
ACCRUED EXPENSES
ACCRUED EXPENSES | 6 Months Ended |
Jun. 30, 2022 | |
ACCRUED EXPENSES | |
ACCRUED EXPENSES | 8. ACCRUED EXPENSES Accrued expenses consisted of the following: June 30, December 31, 2022 2021 Accrued revenue reserves (1) $ 7,320 $ 10,300 Compensation and benefits 5,480 6,324 Commercial costs 2,293 2,134 Professional services 1,147 881 Contract manufacturing 1,075 396 Development costs 522 127 Other 469 824 Accrued expenses $ 18,306 $ 20,986 (1) There were additional revenue reserves included in accounts payable of $8,097 and $2,120, as of June 30, 2022 and December 31, 2021, respectively. |
LEASES
LEASES | 6 Months Ended |
Jun. 30, 2022 | |
LEASES | |
LEASES | 9. LEASES Operating leases Terminated Watertown Lease On February 28, 2018, the Company entered into a lease agreement with 480 Arsenal Group LLC for the lease of a portion of the building located at 490 Arsenal Way, Watertown, Massachusetts (the “Watertown Lease”). The initial term of the Watertown Lease was eight years with an option to extend On November 12, 2021, the Company entered into a lease termination agreement (the “Lease Termination Agreement”) with the landlord of the Watertown Lease, which Lease Termination Agreement was amended on December 22, 2021, which modified the lease to accelerate the lease termination date to January 11, 2022 (the “Lease Termination Date”). Under the terms of the Lease Termination Agreement, the Company was entitled to receive a payment of $2,000 due from the landlord in January 2022, which was collected during the six months ended June 30, 2022. The Company was obligated to make rent payments outlined in the lease agreement until the Lease Termination Date. In connection with the signing of the Lease Termination Agreement, the Company remeasured the lease liability and right-of-use asset and recognized a gain of approximately $1,311 , which was included in gain on lease modification in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2021. Additionally, pursuant to the Lease Termination Agreement, $ 2,042 of restricted cash was released during the six months June 30, 2022 that was pledged as collateral under a letter of credit with cash on deposit. The restricted cash was included within short-term restricted cash on the consolidated balance sheet as of December 31, 2021. Vehicle Fleet lease During the year ended December 31, 2019, the Company entered into a master fleet lease agreement (the “Vehicle Fleet Lease”). The Vehicle Fleet Lease commenced upon the delivery of the initial vehicles in March 2019 and has been subject to modifications as the number of leased vehicles has increased or decreased. As of June 30, 2022 and in connection with the closing of the Alcon Transaction, the Company initiated the termination of the Vehicle Fleet Lease and remeasured the right-of-use asset and corresponding lease liability for the estimated lease term of two months which were de minimis The components of lease expense and related cash flows were as follows: Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Lease cost Operating lease cost $ 219 $ 1,268 $ 395 $ 2,484 Short-term lease cost 54 — 94 — Variable lease cost 179 584 626 1,093 Total lease cost $ 452 $ 1,852 $ 1,115 $ 3,577 Operating cash outflows from operating leases $ 251 $ 1,659 $ 970 $ 3,243 The weighted average remaining lease term and weighted average discount rate of operating leases are as follows: June 30, December 31, 2022 2021 Weighted average remaining lease term 0.8 years 2.4 years Weighted average discount rate 10.2% 2.6% |
DEBT
DEBT | 6 Months Ended |
Jun. 30, 2022 | |
DEBT | |
DEBT | 10. 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, which bore interest at a rate of 9.875% per annum, with quarterly, interest-only payments until the fourth anniversary of the Term Loan A. The maturity date of the Athyrium Credit Facility was October 1, 2024, the six-year anniversary of the close. As of March 31, 2021, the unpaid principal balance on the Athyrium Credit Facility was $75,000. On May 4, 2021, the Company repaid all amounts owed under the Athyrium Credit Facility and terminated all commitments by Athyrium to extend further credit thereunder and all guarantees and security interests granted by the Company to the lenders thereunder. In connection with the termination of the Athyrium Credit Facility, the Company paid to the lenders a prepayment premium of $2,250 and an exit fee of $750. The transaction resulted in a loss on extinguishment of debt of $5,395 for the year ended December 31, 2021, consisting of the prepayment premium, the unamortized debt discount and issuance costs and the unaccreted exit fee. Additionally, in May 2021, the Company released $10,000 of restricted Athyrium Credit Facility. Loan and Security Agreement On May 4, 2021 (the “Closing Date”), the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Oxford Finance, in its capacity as lender (in such capacity, the “Lender”), and in its capacity as collateral agent (in such capacity, the “Agent”), pursuant to which a term loan of up to an aggregate principal amount of $125,000 is available to the Company, consisting of (i) a tranche A term loan that was disbursed on the Closing Date in the aggregate principal amount of $80,000; (ii) a contingent tranche B term loan in the aggregate principal amount of $20,000 available to the Company through June 30, 2023 and within 90 days of the Company achieving trailing 6-month product revenue equal to or greater than $75,000, subject to certain other terms and conditions; and (iii) a contingent tranche C term loan in the aggregate principal amount of $25,000 available to the Company through December 31, 2023 and within 90 days of the Company achieving trailing 6-month The term loans bear interest at a floating rate equal to the greater of (i) 30-day LIBOR and (ii) 0.11%, plus 7.89%. The Loan Agreement, prior to the Loan Amendment (as defined below), provided for interest-only payments until December 1, 2024 if neither the tranche B term loan nor the tranche C term loan are made, and until June 1, 2025 if either the tranche B term loan or the tranche C term loan is made (the “Amortization Date”). The aggregate outstanding principal balance of the term loans were required to be repaid in monthly installments starting on the Amortization Date based on a repayment schedule equal to (i) 18 months if neither the tranche B term loan nor the tranche C term loan is made and (ii) 12 months if either the tranche B term loan or the tranche C term loan is made. All unpaid principal and accrued and unpaid interest with respect to each term loan is due and payable in full on May 1, 2026 (the “Maturity Date”). The Company paid a facility fee of $400 on the Closing Date and has agreed to pay a facility fee of $100 upon closing of the tranche B term loan and a $125 facility fee upon the closing of the tranche C term loan. The Company will be required to make a final payment fee of 7.00% of the original principal amount of any funded term loan payable on the earlier of (i) the prepayment of the term loan in full or (ii) the Maturity Date. At the Company’s option, the Company may elect to make partial repayments of the term loan to the Lender, subject to specified conditions, including the payment of applicable fees and accrued and unpaid interest on the principal amount of the term loan being repaid. In connection with its entry into the Loan Agreement, the Company granted the Agent a security interest in substantially all of the Company’s personal property owned or later acquired, including intellectual property and the Commercial Business. The Loan Agreement also contains customary representations and warranties and affirmative and negative covenants, as well as customary events of default, including the delisting of its common stock from The Nasdaq Global Select Market. On May 24, 2022, the Company received a deficiency letter from the Nasdaq Stock Market LLC (“Nasdaq”) notifying it that, for 30 consecutive business days, the bid price of its common stock had closed below the $1.00 per share minimum bid price requirement for continued inclusion on Nasdaq pursuant to Nasdaq Listing Rule 5450(a)(1), and on July 6, 2022, the Company received another deficiency letter from Nasdaq notifying it that it was not in compliance with Nasdaq Listing Rule 5450(b)(2)(A), as the market value of its common stock was less than $50,000,000 for the previous 30 consecutive business days. Each of the deficiency letters indicated that if the Company is unable to cure such deficiency or otherwise regain compliance with the Nasdaq Listing Rules within 180 calendar days from the date of the respective deficiency letter, the Company’s common stock will be subject to delisting. Certain of the customary negative covenants limit the ability of the Company and certain of its subsidiaries, among other things, to incur future debt, grant liens, make investments, make acquisitions, distribute dividends, make certain restricted payments and sell assets, subject in each case to certain exceptions. The Loan Agreement includes features requiring (i) additional interest rate upon an event of default accrued at an additional 5% , and (ii) 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 June 30, 2022. 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 and comprehensive loss. In addition, in connection with the Loan Agreement, the Company paid certain fees to the Lender and other third-party service providers. The fees paid to the Lender were recorded as a debt discount while the fees paid to other third-party service providers were recorded as debt issuance cost. These costs are being amortized using the effective interest method over the term of the Loan Agreement. The amortization of debt discount and debt issuance cost is included in interest expense within the condensed consolidated statements of operations and comprehensive loss. As of June 30, 2022, the effective interest rate was 11.43%, which takes into consideration the non-cash accretion of the exit fee and the amortization of the debt discount and issuance costs. On May 21, 2022, in connection with its entry into the Asset Purchase Agreement, the Company entered into an amendment to the Loan Agreement (the “Loan Amendment”). Pursuant to the Loan Amendment, the Lender and Agent consented to the entry by the Company into the Asset Purchase Agreement and the sale of the Commercial Business to Alcon and agreed to release its liens on the Commercial Business in consideration for the payment by the Company at the closing of the Alcon Transaction of an aggregate amount of $40,000 (the “Prepayment”) to the Lender and Agent, representing a partial prepayment of principal in the amount of $36,697 of the $80,000 principal amount outstanding under the term loan advanced by the Lender under the Loan Agreement, plus a prepayment fee of $734 and a final payment fee of $2,569. In addition, the Company was required to pay all accrued and unpaid interest on the principal amount of the term loan being repaid. In addition, under the Loan Amendment, the Lender and Agent agreed that, following the closing of the Alcon Transaction and the Prepayment, the Amortization Date would be extended from December 1, 2024 to January 1, 2026, at which time the aggregate principal balance of the term loan then outstanding under the Loan Agreement is required to be repaid in five monthly installments. Pursuant to the Loan Amendment, the Company may also make partial prepayments of the term loan to the Lender, subject to specified conditions, including the payment of applicable fees and accrued and unpaid interest on the principal amount of the term loan being repaid. On July 8, 2022, the Prepayment was paid in connection with the closing of Alcon Transaction, and as such, the Amortization Date was extended to January 1, 2026. See Note 17, “Subsequent Events” for more information. During the three months ended June 30, 2022, the Company recognized interest expense of $2,124 for the Loan Agreement and during the three months ended June 30, 2021, the Company recognized interest expense of $2,077 for the Athyrium Credit Facility This consisted of amortization of debt discount of $116 and $150 for the three months ended June 30, 2022 and June 30, 2021, respectively, accretion of the final payment fee of $323 and $217 for the three months ended June 30, 2022 and June 30, 2021, respectively, and the contractual coupon interest expense of $1,685 and $1,710 for the three months ended June 30, 2022 and June 30, 2021, respectively. for the Athyrium Credit Facility This consisted of amortization of debt discount of $229 and $390 for the six months ended June 30, 2022 and June 30, 2021, respectively, accretion of the final payment fee of $642 and $254 for the six months ended June 30, 2022 and June 30, 2021, respectively, and the contractual coupon interest expense of $3,285 and $3,562 for the six months ended June 30, 2022 and June 30, 2021, respectively. The components of the carrying value of the debt as of June 30, 2022 and December 31, 2021 are detailed below: June 30, December 31, 2022 2021 Principal loan balance $ 80,000 $ 80,000 Unamortized debt discount and issuance cost (1,698) (1,927) Cumulative accretion of exit fee 1,498 856 Long-term debt, net $ 79,800 $ 78,929 The annual principal payments due under the Loan Agreement as of June 30, 2022 were as follows: Years Ending December 31, 2022 (remaining six months) $ — 2023 — 2024 4,445 2025 53,333 2026 22,222 Total (1) $ 80,000 (1) In connection with the entry into the Loan Amendment, the remaining principal payments all became due in the year ended December 31, 2026. |
WARRANTS
WARRANTS | 6 Months Ended |
Jun. 30, 2022 | |
WARRANTS. | |
WARRANTS | 11. WARRANTS The following table summarizes the common stock warrants outstanding as of June 30, 2022 and December 31, 2021, each exercisable into the number of shares of common stock set forth below as of the specified dates: Shares Exercisable at Exercise Expiration Exercisable June 30, December 31, Issued Price Date From 2022 2021 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 184,660 184,660 215,172 215,172 |
EQUITY FINANCINGS
EQUITY FINANCINGS | 6 Months Ended |
Jun. 30, 2022 | |
EQUITY FINANCINGS | |
EQUITY FINANCINGS | 12. 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”) and registered up to $250,000 of a variety of securities, including common stock. Under the 2018 Shelf Registration, which expired in August 2021, the Company issued an aggregate of 30,549,976 shares of common stock, including under the ATM Offering, resulting in aggregate gross proceeds of $231,666. 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 of $75,000 of its common stock under its ATM Offering through Jefferies, as a sales agent. Through December 31, 2021, the Company issued and sold an aggregate of 8,581,257 shares of its common stock under the ATM Offering, resulting in net proceeds of $61,843, which included 837,257 and 5,583,329 shares of common stock issued and sold during the three and six months ended June 30, 2021, respectively, resulting in net proceeds of $6,021 and $40,730, respectively. The Company did not sell any shares of its common stock under the ATM Offering during the six months ended June 30, 2022. As of June 30, 2022, there were $11,344 of shares of common stock remaining under the ATM Offering and, excluding the shares of common stock that may be offered under the ATM Offering, there was approximately $275,000 of securities available to be issued under the 2020 Shelf Registration. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 6 Months Ended |
Jun. 30, 2022 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | 13. STOCK‑BASED COMPENSATION During the six months ended June 30, 2022, the Company granted options for the purchase of 4,001,408 shares of common stock, including options with performance criteria as described below, options to directors and inducement grant options to purchase 65,000 shares of common stock to new employees made outside of our 2017 Equity Incentive Plan and 345,865 restricted stock units. In January 2022, employees of the Company purchased an aggregate of 155,106 shares under the Employee Stock Purchase Plan. The assumptions used in determining fair value of the stock options granted during the six months ended June 30, 2022 are as follows: Six Months Ended June 30, 2022 Expected volatility 72.9% – 84.3% Risk-free interest rate 1.43% – 3.36% Expected dividend yield 0% Expected term (in years) 5.50 – 6.10 During the six months ended June 30, 2022, the weighted average grant-date fair value of options granted was $0.83. In January 2022, the Company granted stock options to purchase up to 742,500 shares of common stock to certain executives tied to certain performance criteria. The options will vest, if at all, upon satisfying the performance criteria. The Company has assessed the probability of achievement of the performance criteria and has recorded related stock compensation expense to the extent they are determined to be probable as of June 30, 2022. In June 2020, the Company issued 693,537 PSUs to certain executives and other employees tied to certain performance criteria, which vested as to 50% of the PSUs in October 2021 on the first anniversary of satisfying the performance criteria and the remaining 50% will vest upon the second anniversary of satisfying the performance criteria. The Company has determined that the performance criteria for these awards has been achieved but not all of the awards have vested as of June 30, 2022. As of June 30, 2022, a total of 853,478 RSUs and PSUs were outstanding, consisting of 680,478 unvested shares and 173,000 vested and deferred shares by directors. Stock-based compensation expense was classified in the condensed consolidated statements of operations and comprehensive loss as follows for the three and six months ended June 30, 2022 and 2021: Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Cost of product revenues $ 114 $ 37 $ 162 $ 71 Research and development 322 986 847 1,952 Selling, general and administrative 1,480 3,687 3,712 7,389 Total $ 1,916 $ 4,710 $ 4,721 $ 9,412 |
LOSS PER SHARE
LOSS PER SHARE | 6 Months Ended |
Jun. 30, 2022 | |
LOSS PER SHARE | |
LOSS PER SHARE | 14. LOSS PER SHARE Basic and diluted net loss per share attributable to common stockholders was calculated as follows for the three and six months ended June 30, 2022 and 2021: Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Numerator: Net loss attributable to common stockholders $ (28,111) $ (36,498) $ (61,052) $ (66,910) Denominator: Weighted-average common shares outstanding, basic and diluted (1) 73,676,819 64,554,506 73,658,924 63,113,194 Net loss per share attributable to common stockholders, basic and diluted $ (0.38) $ (0.57) $ (0.83) $ (1.06) (1) Included in the weighted-average common shares outstanding, basic and diluted for the three and six months ended June 30, 2022 is an aggregate of 973,565 shares of common stock that have been held back by the Company and will be issuable subject to the terms of the Merger Agreement to the Combangio Equityholders on the Escrow Release Date of February 15, 2023. The following potential common stock equivalents, presented based on amounts outstanding at each period end, were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect for the three and six months ended June 30: 2022 2021 Options to purchase shares of common stock 12,414,950 10,043,748 Unvested RSUs and PSUs 680,478 1,282,830 Unexercised warrants 215,172 215,172 13,310,600 11,541,750 |
INCOME TAXES
INCOME TAXES | 6 Months Ended |
Jun. 30, 2022 | |
INCOME TAXES | |
INCOME TAXES | 15. INCOME TAXES The Company did not record a provision or benefit for income taxes during the three and six months ended June 30, 2022 and 2021. 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 previously completed an analysis and determined that an ownership 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, 2021. 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 June 30, 2022 and December 31, 2021, 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 six months ended June 30, 2022 and 2021. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2022 | |
COMMITMENTS AND CONTINGENCIES. | |
COMMITMENTS AND CONTINGENCIES | 16. COMMITMENTS AND CONTINGENCIES Johns Hopkins University License Agreement 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 $113. The Company was obligated to pay JHU low single-digit running royalties based upon a percentage of net sales of the licensed products, which was applied to the annual minimum payment. During the three and six months ended June 30, 2022 and 2021, amounts paid to JHU for royalties were de minimis The Company paid JHU a $150 milestone payment during the six months ended June 30, 2021, which was triggered by the first commercial sale of EYSUVIS in the United States in December 2020. de minimis Stanford License Agreement agreement with Stanford (the “Stanford Agreement”), the Company has a worldwide, exclusive, sublicensable license under certain patent rights (“licensed patents”), directed to methods to promote eye wound healing, to make, have made, use, import, offer to sell and sell products (“licensed products”) that are covered by the licensed patents for use in all fields. Under the Stanford Agreement, the Company is required to pay Stanford annual license maintenance fees and milestone payments upon the achievement of specified development, regulatory and sales milestones, as well as tiered royalties on net sales of licensed products that are covered by a valid claim of a licensed patent. Amounts paid to Stanford in the three and six months ended June 30, 2022 were de minimis Litigation Other Commitments The commercial supply agreement contains annual minimum purchase requirements, which follow the contract year from July 1st to June 30th. The Company had the following remaining minimum purchase obligations for EYSUVIS and INVELTYS as of June 30, 2022: Years Ending December 31, 2022 (remaining six months) (1) $ 3,033 2023 6,190 2024 6,380 2025 (2) 9,370 2026 (2) 7,028 Thereafter (2) 14,411 Total minimum purchase commitments $ 46,412 (1) Amount presented is net of amounts paid towards the minimum purchase obligation as of June 30, 2022. (2) Beginning with the contract year July 1, 2025 to June 30, 2026, the minimum contract amounts above are 75% of the actual dollar value of the units ordered for commercial products, in the aggregate, in the contract year immediately prior to the applicable contract year. The table above assumes purchases are 75% of the prior year purchases in each contract year beginning July 1, 2025. The commitments due under the commercial supply agreement for 2023 and beyond were transferred to Alcon upon the closing of the Alcon Transaction. Contingencies related to the Merger Agreement |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2022 | |
SUBSEQUENT EVENTS. | |
SUBSEQUENT EVENTS | 17. SUBSEQUENT EVENTS Sale of Commercial Business to Alcon On July 8, 2022, the Company closed the Alcon Transaction contemplated by the Asset Purchase Agreement, pursuant to which Alcon purchased the Commercial Business and assumed certain liabilities with respect to the Commercial Business. Alcon paid to the Company an upfront cash payment of $60,000 upon the closing of the Alcon Transaction. In addition, pursuant to the Asset Purchase Agreement, the Company is eligible to receive from Alcon up to four commercial-based sales milestone payments as follows: (1) $25,000 upon the achievement of $50,000 or more in aggregate worldwide net sales of EYSUVIS and INVELTYS in a calendar year from 2023 to 2028, (2) $65,000 upon the achievement of $100,000 or more in aggregate worldwide net sales of EYSUVIS and INVELTYS in a calendar year from 2023 to 2028, (3) $75,000 upon the achievement of $175,000 or more in aggregate worldwide net sales of EYSUVIS and INVELTYS in a calendar year from 2023 to 2029 and (4) $160,000 upon the achievement of $250,000 or more in aggregate worldwide net sales of EYSUVIS and INVELTYS in a calendar year from 2023 to 2029. Each milestone payment will only become payable once, if at all, upon the first time such milestone is achieved, and only one milestone payment will be paid with respect to a calendar year. In the event that more than one milestone is achieved in a calendar year, the higher milestone payment will become payable and the lower milestone payment will become payable only if the corresponding milestone is achieved again in a subsequent calendar year. Pursuant to the Asset Purchase Agreement, on July 8, 2022, the Company entered into supply and commercial agreements under which the Company agreed to supply EYSUVIS and INVELTYS to Alcon and distribute EYSUVIS and INVELTYS to third-party customers of the Commercial Business on behalf of Alcon for a period of six months following the closing of the Alcon Transaction, subject to early termination. In addition, the Company entered into a transition services agreement under which the Company agreed to provide agreed upon transition services to Alcon on a cost-plus pricing arrangement for up to six months following the closing of the Alcon Transaction. Pursuant to the supply agreement, Alcon purchased from the Company, at the closing of the Alcon Transaction, $5,026 of EYSUVIS and INVELTYS inventory on-hand at the Company. The Asset Purchase Agreement further provides that the Company and the Buyers will indemnify each other for losses arising from certain breaches of the Asset Purchase Agreement, including breaches of certain representations and warranties, and for certain other matters and subject to certain limitations as more fully described in the Asset Purchase Agreement. Amendment to Loan and Security Agreement and Partial Prepayment On May 21, 2022, in connection with its entry into the Asset Purchase Agreement, the Company entered into the Loan Amendment. Pursuant to the Loan Amendment, the Lender and Agent consented to the entry by the Company into the Asset Purchase Agreement and the sale of the Commercial Business to Alcon and agreed to release its liens on the Commercial Business in consideration for the Prepayment at the closing of the Alcon Transaction of an aggregate amount of $40,000 to the Lender and Agent. The Prepayment, which represented a partial prepayment of principal in the amount of $36,697 of the $80,000 principal amount outstanding under the term loan advanced by the Lender under the Loan Agreement, plus a prepayment fee of $734 and a final payment fee of $2,569, was paid on July 8, 2022 in connection with the closing of the Alcon Transaction. The Company was also required to pay all accrued and unpaid interest on the principal amount of the term loan being repaid. In addition, under the Loan Amendment, the Lender and Agent agreed that, following the closing of the Alcon Transaction and the Prepayment, the Amortization Date would be extended from December 1, 2024 to January 1, 2026, at which time the aggregate principal balance of the term loan then outstanding under the Loan Agreement is required to be repaid in five monthly installments. Pursuant to the Loan Amendment, the Company may also make partial prepayments of the term loan to the Lender, subject to specified conditions, including the payment of applicable fees and accrued and unpaid interest on the principal amount of the term loan being repaid. Workforce Reduction On June 16, 2022, the Board of Directors of the Company committed to a course of action to terminate 113 employees, consisting of the Company’s entire commercial sales force and certain employees in its commercial, scientific, manufacturing, finance and administrative functions. The determination to proceed with the workforce reduction was made in the context of the anticipated closing of the Alcon Transaction and the Company’s determination to focus its resources on the development of KPI-012. The Company expects to incur a charge of approximately $2,500 primarily in the third quarter of 2022 related to the workforce reduction, consisting of severance, benefits and related costs, all of which are anticipated to be paid prior to the end of the first quarter of 2023. The Company expects to substantially complete the workforce reduction by December 31, 2022. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Assets Held for sale | Assets Held for Sale The Company classifies its long-lived assets to be sold as held for sale, as specified by ASC 360, Property, Plant, and Equipment As of June 30, 2022, certain assets met the criteria to be classified as held for sale in connection with the Alcon Transaction and the Company concluded that there was no impairment loss related to held for sale assets for the three or six months ended June 30, 2022. The Company reclassified the property and equipment, inventory, and certain other assets, which had a combined carrying value of $22,507, to current assets held for sale on the condensed consolidated balance sheet as of June 30, 2022. Fair value was determined based on the estimated proceeds from the sale of the Commercial Business utilizing the purchase price as defined in the Asset Purchase Agreement. The sale of these assets was completed on July 8, 2022. See Note 3, “Assets Held for Sale”, and Note 17, “Subsequent Events”, for additional information. There were no assets that met the criteria for classification as held for sale as of December 31, 2021. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) , public business entities that meet the definition of an SEC filer, excluding entities eligible to be , for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years and for all other entities, including SRCs, The Company is currently evaluating the impact of the on its consolidated financial statements. The |
ASSETS HELD FOR SALE (Tables)
ASSETS HELD FOR SALE (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
ASSETS HELD FOR SALE | |
Schedule of the major categories of assets that have been reclassified to held for sale | June 30, 2022 Inventories $ 19,651 Prepaid expenses and other current assets 594 Property and equipment, net 1,828 Restricted cash and other long-term assets 434 Total assets held for sale $ 22,507 |
FAIR VALUE OF FINANCIAL INSTR_2
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | |
Schedule of assets and liabilities measured at fair value on a recurring basis | June 30, 2022 Fair Value Level 1 Level 2 Level 3 Assets: Cash equivalents $ 34,184 $ 34,184 $ — $ — Short-term investments 1,999 1,999 — — Total Assets $ 36,183 $ 36,183 $ — $ — Liabilities: Deferred purchase consideration $ 219 $ — $ — $ 219 Contingent consideration 7,611 — — 7,611 Total Liabilities $ 7,830 $ — $ — $ 7,830 December 31, 2021 Fair Value Level 1 Level 2 Level 3 Assets: Cash equivalents $ 86,135 $ 86,135 $ — $ — Total Assets $ 86,135 $ 86,135 $ — $ — Liabilities: Deferred purchase consideration $ 7,892 $ — $ — $ 7,892 Contingent consideration 8,658 — — 8,658 Total Liabilities $ 16,550 $ — $ — $ 16,550 |
Schedule of fair values of warrants, using the Black Scholes option pricing model | Fair Value at June 30, Range Financial Instrument 2022 Valuation Technique Unobservable Input (Average) Deferred purchase consideration $ 219 Option pricing model Discount for lack of marketability 25% Contingent consideration $ 7,611 Probability-adjusted Period of expected milestone achievement 2022 - 2027 (2025) discounted cash flow model Probabilities of achievement 18.9% - 90.0% (42.5%) Discount rate 17.5% Discount for lack of marketability 20.0% Fair Value at December 31, Range Financial Instrument 2021 Valuation Technique Unobservable Input (Average) Deferred purchase consideration $ 7,892 Option pricing model Discount for lack of marketability 15.0% - 25.0% (20.0%) Contingent consideration $ 8,658 Probability-adjusted Period of expected milestone achievement 2022 - 2027 (2025) discounted cash flow model Probabilities of achievement 18.9% - 90.0% (42.5%) Discount rate 10.3% Discount for lack of marketability 12.0% |
Schedule of changes in Level 3 fair value measurements | Deferred purchase consideration Balance at January 1, 2022 $ 7,892 Fair value adjustments 1,051 Settlements (7,935) Balance at March 31, 2022 $ 1,008 Fair value adjustments (789) Balance at June 30, 2022 $ 219 Contingent consideration Balance at January 1, 2022 $ 8,658 Fair value adjustments (988) Balance at March 31, 2022 $ 7,670 Fair value adjustments (59) Balance at June 30, 2022 $ 7,611 |
INVESTMENTS (Tables)
INVESTMENTS (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
INVESTMENTS | |
Schedule of investments by security type | June 30, 2022 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. treasury securities $ 2,000 $ — $ (1) $ 1,999 Total $ 2,000 $ — $ (1) $ 1,999 |
REVENUE & ACCOUNTS RECEIVABLE_2
REVENUE & ACCOUNTS RECEIVABLE, NET (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2021 $ 2,672 $ 1,140 $ 11,280 Provision related to current period sales 2,133 210 13,359 Changes in estimate related to prior period sales (1) (138) (242) Credit/payments made (3,261) (415) (10,108) Balance as of March 31, 2022 $ 1,543 $ 797 $ 14,289 Provision related to current period sales 2,602 214 15,413 Changes in estimate related to prior period sales (41) (199) (107) Credit/payments made (2,041) (112) (14,878) Balance as of June 30, 2022 $ 2,063 $ 700 $ 14,717 Trade Discounts, Allowances and Rebates and Chargebacks (1) Product Returns (2) Incentives (3) Balance as of December 31, 2020 $ 1,157 $ 600 $ 4,904 Provision related to current period sales 2,201 245 10,216 Changes in estimate related to prior period sales 3 30 (26) Credit/payments made (1,823) (419) (7,880) Balance as of March 31, 2021 $ 1,538 $ 456 $ 7,214 Provision related to current period sales 2,103 356 11,193 Changes in estimate related to prior period sales 30 142 (353) Credit/payments made (2,260) (253) (9,801) Balance as of June 30, 2021 $ 1,411 $ 701 $ 8,253 (1) Trade discounts, allowances and chargebacks include fees for distribution service fees, prompt pay and other discounts, and chargebacks. Estimated 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 on the Company’s condensed consolidated balance sheets. (2) Estimated 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 on 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. Estimated 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 on the Company’s condensed consolidated balance sheets. |
INVENTORY (Tables)
INVENTORY (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
INVENTORY | |
Schedule of Inventory | June 30, December 31, 2022 2021 Raw materials $ — $ 1,328 Work in progress — 9,799 Finished goods 25 7,090 Total inventory $ 25 $ 18,217 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
ACCRUED EXPENSES | |
Schedule of accrued expenses | June 30, December 31, 2022 2021 Accrued revenue reserves (1) $ 7,320 $ 10,300 Compensation and benefits 5,480 6,324 Commercial costs 2,293 2,134 Professional services 1,147 881 Contract manufacturing 1,075 396 Development costs 522 127 Other 469 824 Accrued expenses $ 18,306 $ 20,986 (1) There were additional revenue reserves included in accounts payable of $8,097 and $2,120, as of June 30, 2022 and December 31, 2021, respectively. |
LEASES (Tables)
LEASES (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
LEASES | |
Schedule of lease cost | Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Lease cost Operating lease cost $ 219 $ 1,268 $ 395 $ 2,484 Short-term lease cost 54 — 94 — Variable lease cost 179 584 626 1,093 Total lease cost $ 452 $ 1,852 $ 1,115 $ 3,577 Operating cash outflows from operating leases $ 251 $ 1,659 $ 970 $ 3,243 |
Schedule of weighted average remaining lease term and weighted average discount rate of operating leases | June 30, December 31, 2022 2021 Weighted average remaining lease term 0.8 years 2.4 years Weighted average discount rate 10.2% 2.6% |
DEBT (Tables)
DEBT (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
DEBT | |
Schedule of carrying value of debt | June 30, December 31, 2022 2021 Principal loan balance $ 80,000 $ 80,000 Unamortized debt discount and issuance cost (1,698) (1,927) Cumulative accretion of exit fee 1,498 856 Long-term debt, net $ 79,800 $ 78,929 |
Schedule of maturities of long-term debt | Years Ending December 31, 2022 (remaining six months) $ — 2023 — 2024 4,445 2025 53,333 2026 22,222 Total (1) $ 80,000 (1) In connection with the entry into the Loan Amendment, the remaining principal payments all became due in the year ended December 31, 2026. |
WARRANTS (Tables)
WARRANTS (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
WARRANTS. | |
Schedule of outstanding warrants | Shares Exercisable at Exercise Expiration Exercisable June 30, December 31, Issued Price Date From 2022 2021 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 184,660 184,660 215,172 215,172 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
STOCK-BASED COMPENSATION | |
Schedule of assumptions used in determining fair value of the stock options granted | Six Months Ended June 30, 2022 Expected volatility 72.9% – 84.3% Risk-free interest rate 1.43% – 3.36% Expected dividend yield 0% Expected term (in years) 5.50 – 6.10 |
Schedule of stock based compensation expense | Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Cost of product revenues $ 114 $ 37 $ 162 $ 71 Research and development 322 986 847 1,952 Selling, general and administrative 1,480 3,687 3,712 7,389 Total $ 1,916 $ 4,710 $ 4,721 $ 9,412 |
LOSS PER SHARE (Tables)
LOSS PER SHARE (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
LOSS PER SHARE | |
Schedule of computation of basic and diluted net loss per share | Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Numerator: Net loss attributable to common stockholders $ (28,111) $ (36,498) $ (61,052) $ (66,910) Denominator: Weighted-average common shares outstanding, basic and diluted (1) 73,676,819 64,554,506 73,658,924 63,113,194 Net loss per share attributable to common stockholders, basic and diluted $ (0.38) $ (0.57) $ (0.83) $ (1.06) (1) Included in the weighted-average common shares outstanding, basic and diluted for the three and six months ended June 30, 2022 is an aggregate of 973,565 shares of common stock that have been held back by the Company and will be issuable subject to the terms of the Merger Agreement to the Combangio Equityholders on the Escrow Release Date of February 15, 2023. |
Schedule of outstanding securities excluded from the computation of diluted weighted average shares outstanding as they would have been anti-dilutive | 2022 2021 Options to purchase shares of common stock 12,414,950 10,043,748 Unvested RSUs and PSUs 680,478 1,282,830 Unexercised warrants 215,172 215,172 13,310,600 11,541,750 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
COMMITMENTS AND CONTINGENCIES. | |
Schedule of minimum purchase obligations | Years Ending December 31, 2022 (remaining six months) (1) $ 3,033 2023 6,190 2024 6,380 2025 (2) 9,370 2026 (2) 7,028 Thereafter (2) 14,411 Total minimum purchase commitments $ 46,412 (1) Amount presented is net of amounts paid towards the minimum purchase obligation as of June 30, 2022. (2) Beginning with the contract year July 1, 2025 to June 30, 2026, the minimum contract amounts above are 75% of the actual dollar value of the units ordered for commercial products, in the aggregate, in the contract year immediately prior to the applicable contract year. The table above assumes purchases are 75% of the prior year purchases in each contract year beginning July 1, 2025. |
NATURE OF BUSINESS AND BASIS _2
NATURE OF BUSINESS AND BASIS OF PRESENTATION (Details) - USD ($) $ in Thousands | 6 Months Ended | |||
Jul. 08, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | Nov. 15, 2021 | |
Acquisition of Combangio, Inc | ||||
Accumulated deficit | $ 603,440 | $ 542,388 | ||
Loan and Security Agreement with Oxford Finance LLC | ||||
Acquisition of Combangio, Inc | ||||
Upfront payment | $ 40,000 | |||
Loan and Security Agreement with Oxford Finance LLC | Subsequent Events | ||||
Acquisition of Combangio, Inc | ||||
Debt repayments | $ 40,000 | |||
Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | Subsequent Events | ||||
Acquisition of Combangio, Inc | ||||
Amount receivable upon the achievement of specified commercial sales-based milestones | 325,000 | |||
Upfront payment | 60,000 | |||
Proceeds from inventory transfer | $ 5,026 | |||
Combangio, Inc | Maximum | ||||
Acquisition of Combangio, Inc | ||||
Contingent milestone consideration | $ 105,000 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - Disposed of by sale not discontinued operations - Commercial Business Sale to Alcon $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Impairment loss related to held for sale assets | $ 0 | $ 0 |
Assets reclassified to current assets held for sale | $ 22,507 | $ 22,507 |
ASSETS HELD FOR SALE (Details)
ASSETS HELD FOR SALE (Details) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | |
Major categories of assets that have been reclassified to held for sale on the condensed consolidated balance sheet a | ||
Inventories | $ 19,651 | $ 19,651 |
Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Assets reclassified to current assets held for sale | 22,507 | 22,507 |
Impairment loss related to held for sale assets | 0 | 0 |
Transaction costs | 758 | 758 |
Major categories of assets that have been reclassified to held for sale on the condensed consolidated balance sheet a | ||
Inventories | 19,651 | 19,651 |
Prepaid expenses and other current assets | 594 | 594 |
Property and equipment, net | 1,828 | 1,828 |
Restricted cash and other long-term assets | 434 | 434 |
Total assets held for sale | $ 22,507 | $ 22,507 |
FAIR VALUE OF FINANCIAL INSTR_3
FAIR VALUE OF FINANCIAL INSTRUMENTS (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Nov. 15, 2021 | Jun. 30, 2022 | Jun. 30, 2022 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Settled liability upon the issuance of Upfront Shares | $ 7,935 | ||
Gain (loss) on fair value remeasurement of deferred purchase consideration | $ 789 | $ (262) | |
Shares Not Issued Until Escrow Release date of February 15, 2023 | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Number of shares | 973,565 | 973,565 | |
Combangio, Inc | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Number of shares | 7,788,637 | ||
Combangio, Inc | Shares Issued on January 3, 2022 | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Number of shares | 6,815,072 | ||
Combangio, Inc | Shares Not Issued Until Escrow Release date of February 15, 2023 | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Number of shares | 973,565 | ||
Combangio, Inc | Maximum | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Contingent milestone consideration | $ 105,000 |
FAIR VALUE OF FINANCIAL INSTR_4
FAIR VALUE OF FINANCIAL INSTRUMENTS - Recurring and Nonrecurring Fair value Measurements Within Hierarchy (Details) - Fair Value - Recurring - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Fair Value Assets Measured on Recurring and Non recurring Basis | ||
Financial assets by level within fair value hierarchy | $ 36,183 | $ 86,135 |
Fair Value Liabilities Measured on Recurring and Non recurring Basis | ||
Financial liabilities by level within fair value hierarchy | 7,830 | 16,550 |
Deferred purchase consideration | ||
Fair Value Liabilities Measured on Recurring and Non recurring Basis | ||
Financial liabilities by level within fair value hierarchy | 219 | 7,892 |
Contingent Consideration | ||
Fair Value Liabilities Measured on Recurring and Non recurring Basis | ||
Financial liabilities by level within fair value hierarchy | 7,611 | 8,658 |
Cash equivalents | ||
Fair Value Assets Measured on Recurring and Non recurring Basis | ||
Financial assets by level within fair value hierarchy | 34,184 | 86,135 |
Short-term investments. | ||
Fair Value Assets Measured on Recurring and Non recurring Basis | ||
Financial assets by level within fair value hierarchy | 1,999 | |
Level 1 | ||
Fair Value Assets Measured on Recurring and Non recurring Basis | ||
Financial assets by level within fair value hierarchy | 36,183 | 86,135 |
Level 1 | Cash equivalents | ||
Fair Value Assets Measured on Recurring and Non recurring Basis | ||
Financial assets by level within fair value hierarchy | 34,184 | 86,135 |
Level 1 | Short-term investments. | ||
Fair Value Assets Measured on Recurring and Non recurring Basis | ||
Financial assets by level within fair value hierarchy | 1,999 | |
Level 3 | ||
Fair Value Liabilities Measured on Recurring and Non recurring Basis | ||
Financial liabilities by level within fair value hierarchy | 7,830 | 16,550 |
Level 3 | Deferred purchase consideration | ||
Fair Value Liabilities Measured on Recurring and Non recurring Basis | ||
Financial liabilities by level within fair value hierarchy | 219 | 7,892 |
Level 3 | Contingent Consideration | ||
Fair Value Liabilities Measured on Recurring and Non recurring Basis | ||
Financial liabilities by level within fair value hierarchy | $ 7,611 | $ 8,658 |
FAIR VALUE OF FINANCIAL INSTR_5
FAIR VALUE OF FINANCIAL INSTRUMENTS - Quantitative information and assumptions (Details) - Level 3 $ in Thousands | Jun. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) |
Deferred purchase consideration | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Financial liabilities by level within fair value hierarchy | $ 219 | $ 7,892 |
Deferred purchase consideration | Option pricing model | Discount for lack of marketability | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Measurement input | 25 | |
Deferred purchase consideration | Option pricing model | Discount for lack of marketability | Minimum | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Measurement input | 15 | |
Deferred purchase consideration | Option pricing model | Discount for lack of marketability | Maximum | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Measurement input | 25 | |
Deferred purchase consideration | Option pricing model | Discount for lack of marketability | Average | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Measurement input | 20 | |
Contingent Consideration | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Financial liabilities by level within fair value hierarchy | $ 7,611 | $ 8,658 |
Contingent Consideration | Discounted cash flow model | Discount for lack of marketability | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Measurement input | 20 | 12 |
Contingent Consideration | Discounted cash flow model | Probabilities of achievement | Minimum | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Measurement input | 18.9 | 18.9 |
Contingent Consideration | Discounted cash flow model | Probabilities of achievement | Maximum | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Measurement input | 90 | 90 |
Contingent Consideration | Discounted cash flow model | Probabilities of achievement | Average | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Measurement input | 42.5 | 42.5 |
Contingent Consideration | Discounted cash flow model | Discount rate | ||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Measurement input | 17.5 | 10.3 |
FAIR VALUE OF FINANCIAL INSTR_6
FAIR VALUE OF FINANCIAL INSTRUMENTS - Fair value measurement levels (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | |
Transfer from level 1 to level 2, Assets | $ 0 | $ 0 | $ 0 | |
Transfer from level 2 to level 1, Assets | 0 | 0 | 0 | |
Transfer from level 1 to level 2, Liability | 0 | 0 | 0 | |
Transfer from level 2 to level 1, Liability | 0 | 0 | 0 | |
Transfer into level 3, Assets | 0 | 0 | 0 | |
Transfer out of level 3, Assets | 0 | 0 | 0 | |
Transfer into level 3, Liability | 0 | 0 | 0 | |
Transfer out of level 3, Liability | 0 | 0 | 0 | |
Settlements | (7,935) | |||
Level 3 | Deferred purchase consideration | ||||
Beginning balance | 1,008 | $ 7,892 | 7,892 | |
Fair value adjustments | (789) | 1,051 | ||
Settlements | (7,935) | |||
Ending balance | 219 | 1,008 | 219 | 7,892 |
Level 3 | Contingent Consideration | ||||
Beginning balance | 7,670 | 8,658 | 8,658 | |
Fair value adjustments | (59) | (988) | ||
Settlements | 59 | 1,047 | ||
Ending balance | $ 7,611 | $ 7,670 | $ 7,611 | $ 8,658 |
INVESTMENTS (Details)
INVESTMENTS (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Dec. 31, 2021 | |
Investments by security type | ||
Amortized Cost | $ 2,000 | |
Gross Unrealized Losses | (1) | |
Fair Value | $ 1,999 | $ 0 |
Investments contractual maturity term | 1 year | |
U.S. treasury securities | ||
Investments by security type | ||
Amortized Cost | $ 2,000 | |
Gross Unrealized Losses | (1) | |
Fair Value | $ 1,999 |
REVENUE & ACCOUNTS RECEIVABLE_3
REVENUE & ACCOUNTS RECEIVABLE, NET - Product Revenue Provision and Allowance Categories (Details) - USD ($) $ in Thousands | 3 Months Ended | ||||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2021 | |
Product Information [Line Items] | |||||
Allowance for doubtful accounts | $ 0 | $ 0 | |||
Sales discounts and contractual fee for service arrangements | |||||
Product Information [Line Items] | |||||
Beginning balance | $ 2,672 | ||||
Ending balance | 2,063 | ||||
Trade Discounts, Allowances and Chargebacks | |||||
Product Information [Line Items] | |||||
Beginning balance | 1,543 | 2,672 | $ 1,538 | $ 1,157 | |
Provision related to current period sales | 2,602 | 2,133 | 2,103 | 2,201 | |
Changes in estimate related to prior period sales | (41) | (1) | 30 | 3 | |
Credit/payments made | (2,041) | (3,261) | (2,260) | (1,823) | |
Ending balance | 2,063 | 1,543 | 1,411 | 1,538 | |
Product Returns | |||||
Product Information [Line Items] | |||||
Beginning balance | 797 | 1,140 | 456 | 600 | |
Provision related to current period sales | 214 | 210 | 356 | 245 | |
Changes in estimate related to prior period sales | (199) | (138) | 142 | 30 | |
Credit/payments made | (112) | (415) | (253) | (419) | |
Ending balance | 700 | 797 | 701 | 456 | |
Rebates and Incentives | |||||
Product Information [Line Items] | |||||
Beginning balance | 14,289 | 11,280 | 7,214 | 4,904 | |
Provision related to current period sales | 15,413 | 13,359 | 11,193 | 10,216 | |
Changes in estimate related to prior period sales | (107) | (242) | (353) | (26) | |
Credit/payments made | (14,878) | (10,108) | (9,801) | (7,880) | |
Ending balance | $ 14,717 | $ 14,289 | $ 8,253 | $ 7,214 |
INVENTORY (Details)
INVENTORY (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
INVENTORY | ||
Raw Materials | $ 1,328 | |
Work in Progress | 9,799 | |
Finished Goods | $ 25 | 7,090 |
Total inventory | 25 | 18,217 |
Current inventory | 25 | 8,639 |
Inventories classified as held for sale | $ 19,651 | |
Long-term inventory | $ 9,578 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Accrued revenue reserves (1) | $ 7,320 | $ 10,300 |
Compensation and benefits | 5,480 | 6,324 |
Commercial costs | 2,293 | 2,134 |
Professional services | 1,147 | 881 |
Contract manufacturing | 1,075 | 396 |
Development costs | 522 | 127 |
Other | 469 | 824 |
Accrued expenses | 18,306 | 20,986 |
Accounts payable | ||
Accrued revenue reserves (1) | $ 8,097 | $ 2,120 |
LEASES (Details)
LEASES (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Feb. 28, 2018 | Jan. 31, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Leases | |||||||
Short-term restricted cash | $ 450 | $ 450 | $ 2,042 | ||||
Term of vehicle lease | 2 months | ||||||
Amount borrowed | 450 | $ 450 | $ 450 | ||||
Lease cost | |||||||
Operating lease cost | 219 | $ 1,268 | 395 | $ 2,484 | |||
Short-term lease cost | 54 | 94 | |||||
Variable lease cost | 179 | 584 | 626 | 1,093 | |||
Total lease cost | 452 | 1,852 | 1,115 | 3,577 | |||
Operating cash outflows from operating leases | $ 251 | $ 1,659 | $ 970 | $ 3,243 | |||
Weighted average remaining lease term | 9 months 18 days | 9 months 18 days | 2 years 4 months 24 days | ||||
Weighted average discount rate | 10.20% | 10.20% | 2.60% | ||||
Watertown Lease | |||||||
Leases | |||||||
Lease term | 8 years | ||||||
Existence of option to extend | true | ||||||
Payment received from lease termination | $ 2,000 | ||||||
Restricted cash | $ 2,042 | $ 2,042 | |||||
Renewal term | 5 years | ||||||
Watertown Lease | Gain on lease termination | |||||||
Leases | |||||||
Remeasured the lease liability and right-of-use asset and recognized | $ 1,311 |
DEBT- Athyrium Credit Facility
DEBT- Athyrium Credit Facility (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
May 04, 2021 USD ($) | Oct. 01, 2018 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Jun. 30, 2022 USD ($) item | Mar. 31, 2021 USD ($) | |
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 80,000 | $ 80,000 | |||||
Restricted Cash, Statement of Financial Position [Extensible Enumeration] | Restricted Cash And Other Assets Noncurrent | ||||||
Loss on extinguishment of debt | $ 5,395 | $ 5,395 | |||||
Athyrium Credit Facility | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 75,000 | ||||||
Restricted Cash | $ 10,000 | ||||||
Prepayment fees paid | 2,250 | ||||||
Exit fees paid | $ 750 | ||||||
Loss on extinguishment of debt | $ (5,395) | ||||||
Athyrium | |||||||
Debt Instrument [Line Items] | |||||||
Number of derivatives | item | 1 | ||||||
Athyrium | Athyrium Credit Facility | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 110,000 | ||||||
Debt term (in years) | 6 years | ||||||
Additional interest rate upon an event of default accrued (as a percent) | 5% | ||||||
Athyrium | Tranche A term loan | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 75,000 | ||||||
Interest rate (as a percent) | 9.875% | ||||||
Athyrium | Contingent tranche B term loan | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 35,000 |
DEBT - Oxford Finance Loan and
DEBT - Oxford Finance Loan and Security Agreement (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||
Jul. 08, 2022 USD ($) installment | May 04, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Mar. 31, 2021 USD ($) | |
Debt instruments | ||||||||
Aggregate principal amount | $ 80,000 | $ 80,000 | $ 80,000 | |||||
Interest expense | 2,207 | $ 2,091 | 4,242 | $ 4,232 | ||||
Athyrium Credit Facility | ||||||||
Debt instruments | ||||||||
Aggregate principal amount | $ 75,000 | |||||||
Amount of principal outstanding | 80,000 | 80,000 | ||||||
Prepayment fees paid | $ 2,250 | |||||||
Accretion of final prepayment fee | 323 | 217 | 642 | 254 | ||||
Interest expense | 2,124 | 2,077 | 4,156 | 4,206 | ||||
Amortization of debt discount | 116 | 150 | 229 | 390 | ||||
Contractual coupon interest | $ 1,685 | $ 1,710 | $ 3,285 | $ 3,562 | ||||
Loan and Security Agreement with Oxford Finance LLC | ||||||||
Debt instruments | ||||||||
Aggregate principal amount | $ 125,000 | |||||||
Floating interest rate (as a percent) | 0.11% | |||||||
Facility fees paid | $ 400 | |||||||
Percentage of final payment fees | 7% | |||||||
Effective interest rate | 11.43% | 11.43% | ||||||
Loan and Security Agreement with Oxford Finance LLC | Subsequent Events | ||||||||
Debt instruments | ||||||||
Debt repayments | $ 40,000 | |||||||
Partial prepayment | 36,697 | |||||||
Amount of principal outstanding | 80,000 | |||||||
Prepayment fees paid | 734 | |||||||
Final prepayment fee | $ 2,569 | |||||||
Number of monthly installments | installment | 5 | |||||||
Loan and Security Agreement with Oxford Finance LLC | Neither the tranche B term loan nor the tranche C term loan is made | ||||||||
Debt instruments | ||||||||
Duration of periodic monthly payment installments under a scenario | 18 months | |||||||
Loan and Security Agreement with Oxford Finance LLC | Either tranche B term loan nor tranche C term loan is made | ||||||||
Debt instruments | ||||||||
Duration of periodic monthly payment installments under a scenario | 12 months | |||||||
Loan and Security Agreement with Oxford Finance LLC | 30-day LIBOR | ||||||||
Debt instruments | ||||||||
Spread on variable rate | 7.89% | |||||||
Tranche A term loan | ||||||||
Debt instruments | ||||||||
Aggregate principal amount | $ 80,000 | |||||||
Contingent tranche B term loan | ||||||||
Debt instruments | ||||||||
Aggregate principal amount | $ 20,000 | |||||||
Revenue achievement trailing period | 6 months | |||||||
Minimum target revenue | $ 75,000 | |||||||
Facility fees paid | 100 | |||||||
Contingent tranche C term loan | ||||||||
Debt instruments | ||||||||
Aggregate principal amount | $ 25,000 | |||||||
Revenue achievement trailing period | 6 months | |||||||
Minimum target revenue | $ 100,000 | |||||||
Facility fees paid | $ 125 |
DEBT - Carrying Value (Details)
DEBT - Carrying Value (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
DEBT | ||
Principal Loan Balance | $ 80,000 | $ 80,000 |
Unamortized debt discount and issuance cost | (1,698) | (1,927) |
Cumulative accretion of exit fee | 1,498 | 856 |
Long-term debt, net | $ 79,800 | $ 78,929 |
DEBT - Future annual principal
DEBT - Future annual principal payments (Details) - Athyrium Credit Facility $ in Thousands | Jun. 30, 2022 USD ($) |
Maturities of long-term debt | |
2024 | $ 4,445 |
2025 | 53,333 |
2026 | 22,222 |
Total | $ 80,000 |
WARRANTS (Details)
WARRANTS (Details) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Preferred stock warrants | ||
Shares Exercisable | 215,172 | 215,172 |
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)
EQUITY FINANCINGS (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
May 07, 2020 | Aug. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2021 | Dec. 31, 2021 | Jun. 30, 2022 | Aug. 27, 2018 | |
Shelf Registration | |||||||
Equity Offerings | |||||||
Additional authorized value of securities | $ 275,000 | ||||||
Common stock offering, net of issuance cost and underwriting fees (in shares) | 30,549,976 | ||||||
Common stock offering, net of issuance cost and underwriting fees | $ 231,666 | ||||||
Registration period | 3 years | ||||||
Shelf Registration | Maximum | |||||||
Equity Offerings | |||||||
Additional authorized value of securities | $ 350,000 | $ 250,000 | |||||
ATM | |||||||
Equity Offerings | |||||||
Additional authorized value of securities | $ 11,344 | ||||||
Common stock offering, net of issuance cost and underwriting fees (in shares) | 837,257 | 5,583,329 | 8,581,257 | ||||
Net proceeds | $ 6,021 | $ 40,730 | $ 61,843 | ||||
ATM | Maximum | |||||||
Equity Offerings | |||||||
Additional authorized value of securities | $ 75,000 |
STOCK-BASED COMPENSATION - Indu
STOCK-BASED COMPENSATION - Inducement Stock Option Awards (Details) - $ / shares | 1 Months Ended | 6 Months Ended |
Jan. 31, 2022 | Jun. 30, 2022 | |
Stock-based compensation | ||
Granted (in shares) | 4,001,408 | |
Weighted average grant date fair value of options granted | $ 0.83 | |
Stock Options | ||
Stock-based compensation | ||
Granted (in shares) | 65,000 | |
Stock Options | Executive Officer | Maximum | ||
Stock-based compensation | ||
Number of common stock issuable upon exercise of rights under equity compensation plans | 742,500 | |
ESPP | ||
Stock-based compensation | ||
Issuance of common stock under employee stock purchase plan (in shares) | 155,106 | |
RSU | ||
Stock-based compensation | ||
Granted (in shares) | 345,865 |
STOCK-BASED COMPENSATION - Fair
STOCK-BASED COMPENSATION - Fair Value Assumptions (Details) | 6 Months Ended |
Jun. 30, 2022 | |
Assumptions used in determining fair value of the stock options granted | |
Expected volatility (minimum) | 72.90% |
Expected volatility (maximum) | 84.30% |
Risk-free interest rate (minimum) | 1.43% |
Risk-free interest rate (maximum) | 3.36% |
Expected dividend yield | 0% |
Minimum | |
Assumptions used in determining fair value of the stock options granted | |
Expected term (in years) | 5 years 6 months |
Maximum | |
Assumptions used in determining fair value of the stock options granted | |
Expected term (in years) | 6 years 1 month 6 days |
STOCK-BASED COMPENSATION - RSUs
STOCK-BASED COMPENSATION - RSUs and PSUs (Details) | 1 Months Ended | |
Jun. 30, 2020 shares | Jun. 30, 2022 USD ($) shares | |
RSU and PSU | ||
Stock-based compensation | ||
Outstanding balance at end of period (in shares) | 853,478 | |
Unvested outstanding balance at end of period (in shares) | $ | 680,478 | |
Vested and deferred (in shares) | 173,000 | |
Executive Officer | PSU | First anniversary | ||
Stock-based compensation | ||
Granted (in shares) | 693,537 | |
Vesting percentage | 50% | |
Executive Officer | PSU | Second anniversary | ||
Stock-based compensation | ||
Vesting percentage | 50% |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Stock-based compensation | ||||
Stock based compensation expense | $ 1,916 | $ 4,710 | $ 4,721 | $ 9,412 |
Cost of product revenues | ||||
Stock-based compensation | ||||
Stock based compensation expense | 114 | 37 | 162 | 71 |
Research and development | ||||
Stock-based compensation | ||||
Stock based compensation expense | 322 | 986 | 847 | 1,952 |
Selling, general and administrative | ||||
Stock-based compensation | ||||
Stock based compensation expense | $ 1,480 | $ 3,687 | $ 3,712 | $ 7,389 |
LOSS PER SHARE (Details)
LOSS PER SHARE (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Net loss attributable to common stockholders | $ (28,111) | $ (36,498) | $ (61,052) | $ (66,910) |
Numerator: | ||||
Weighted Average Number of Shares Outstanding, Basic | 73,676,819 | 64,554,506 | 73,658,924 | 63,113,194 |
Weighted Average Number of Shares Outstanding, Diluted | 73,676,819 | 64,554,506 | 73,658,924 | 63,113,194 |
Denominator: | ||||
Net loss per share-basic (in dollar per share) | $ (0.38) | $ (0.57) | $ (0.83) | $ (1.06) |
Net loss per share- diluted (in dollar per share) | $ (0.38) | $ (0.57) | $ (0.83) | $ (1.06) |
Shares Not Issued Until Escrow Release date of February 15, 2023 | ||||
Denominator: | ||||
Number of shares | 973,565 | 973,565 |
LOSS PER SHARE - Antidilutive s
LOSS PER SHARE - Antidilutive securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Outstanding securities excluded from the computation of diluted weighted average shares outstanding as they would have been anti dilutive: | ||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding (in shares) | 13,310,600 | 11,541,750 |
Stock Options | ||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding as they would have been anti dilutive: | ||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding (in shares) | 12,414,950 | 10,043,748 |
RSU and PSU | ||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding as they would have been anti dilutive: | ||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding (in shares) | 680,478 | 1,282,830 |
Warrants | ||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding as they would have been anti dilutive: | ||
Outstanding securities excluded from the computation of diluted weighted average shares outstanding (in shares) | 215,172 | 215,172 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
INCOME TAXES | |||||
Uncertain tax positions | $ 0 | $ 0 | $ 0 | ||
Interest or penalties recorded | $ 0 | $ 0 | $ 0 | $ 0 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - License Agreement (Details) - The Johns Hopkins University ("JHU") $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Contingencies | |
Minimum annual payment | $ 38 |
License fee, if the company achieves the first commercial sale | 113 |
Milestone payment | $ 150 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Purchase obligations (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
COMMITMENTS AND CONTINGENCIES. | |
2022 (remaining six months) | $ 3,033 |
2023 | 6,190 |
2024 | 6,380 |
2025 | 9,370 |
2026 | 7,028 |
Thereafter | 14,411 |
Total minimum purchase commitments | $ 46,412 |
Minimum contract amount (as a percent) | 75% |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES - Contingencies related to the Merger Agreement (Details) - Combangio, Inc $ in Thousands | Nov. 15, 2021 USD ($) |
Other Commitments [Line Items] | |
Contingent upon specified development, regulatory and commercialization milestones | $ 40,000 |
Achievement of sales based milestone relating to KPI-012 product | |
Other Commitments [Line Items] | |
Potential maximum payout for contingent consideration | $ 65,000 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) $ in Thousands | 3 Months Ended | ||
Jul. 08, 2022 USD ($) installment item | Sep. 30, 2022 USD ($) | Jun. 16, 2022 employee | |
Subsequent Event [Line Items] | |||
Number of employees to be terminated | employee | 113 | ||
Subsequent Events | Forecast | |||
Subsequent Event [Line Items] | |||
Workforce reduction costs | $ 2,500 | ||
Subsequent Events | Loan and Security Agreement with Oxford Finance LLC | |||
Subsequent Event [Line Items] | |||
Debt repayments | $ 40,000 | ||
Partial prepayment | 36,697 | ||
Amount of principal outstanding | 80,000 | ||
Prepayment fees paid | 734 | ||
Final prepayment fee | $ 2,569 | ||
Number of monthly installments | installment | 5 | ||
Subsequent Events | Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | |||
Subsequent Event [Line Items] | |||
Upfront payment | $ 60,000 | ||
Number of commercial-based sales milestone payments | item | 4 | ||
Amount receivable upon the achievement of specified commercial sales-based milestones | $ 325,000 | ||
Proceeds from inventory transfer | 5,026 | ||
Subsequent Events | Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | Achievement of $50,000 or more in aggregate worldwide net sales | |||
Subsequent Event [Line Items] | |||
Sales based milestone achivement | 50,000 | ||
Amount receivable upon the achievement of specified commercial sales-based milestones | 25,000 | ||
Subsequent Events | Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | Achievement of $100,000 or more in aggregate worldwide net sales | |||
Subsequent Event [Line Items] | |||
Sales based milestone achivement | 100,000 | ||
Amount receivable upon the achievement of specified commercial sales-based milestones | 65,000 | ||
Subsequent Events | Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | Achievement of $175,000 or more in aggregate worldwide net sales | |||
Subsequent Event [Line Items] | |||
Sales based milestone achivement | 175,000 | ||
Amount receivable upon the achievement of specified commercial sales-based milestones | 75,000 | ||
Subsequent Events | Commercial Business Sale to Alcon | Disposed of by sale not discontinued operations | Achievement of $250,000 or more in aggregate worldwide net sales | |||
Subsequent Event [Line Items] | |||
Sales based milestone achivement | 250,000 | ||
Amount receivable upon the achievement of specified commercial sales-based milestones | $ 160,000 |