Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of disclosure controls and procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2021. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s
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management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2021, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Management’s annual report on internal control over financial reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting for the company. Internal control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, the company’s principal executive and principal financial officers and effected by the company’s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
● Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company;
● Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and
● Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2021. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control—Integrated Framework (2013). Based on that assessment, our management concluded that, as of December 31, 2021, our internal control over financial reporting was effective.
As an “emerging growth company”, as defined in the JOBS Act, our independent registered public accounting firm is not required to issue an attestation report on the internal control over financial reporting.
Changes in internal control over financial reporting
No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fourth quarter ended December 31, 2021 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information .
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
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Part III
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this Item is incorporated by reference from the information that will be contained in our Proxy Statement for our 2022 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates pursuant to General Instruction G(3) of Form 10-K.
Item 11. Executive Compensation
The information required by this Item is incorporated by reference from the information that will be contained in our Proxy Statement for our 2022 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates pursuant to General Instruction G(3) of Form 10-K.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this Item is incorporated by reference from the information that will be contained in our Proxy Statement for our 2022 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates pursuant to General Instruction G(3) of Form 10-K.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this Item is incorporated by reference from the information that will be contained in our Proxy Statement for our 2022 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates pursuant to General Instruction G(3) of Form 10-K.
Item 14. Principal Accountant Fees and Services
The information required by this Item is incorporated by reference from the information that will be contained in our Proxy Statement for our 2022 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates pursuant to General Instruction G(3) of Form 10-K.
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Part I V
Item 15. Exhibits, Financial Statement Schedules
(1) Financial Statements.
The following documents are included beginning on page F-1 attached hereto and are filed as part of this Annual Report on Form 10-K.
KALA PHARMACEUTICALS, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 34 )
F-1
Consolidated Balance Sheets as of December 31, 2021 and 2020
F-2
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2021 and 2020
F-3
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2021 and 2020
F-4
Consolidated Statements of Cash Flows for the years ended December 31, 2021 and 2020
F-5
Notes to Consolidated Financial Statements
F-6
(2) Financial Statement Schedules.
No financial statement schedules have been filed as part of this Annual Report on Form 10-K because they are not applicable, not required or because the information is otherwise included in our financial statements or notes thereto.
(3) Exhibits .
The following is a list of exhibits filed or furnished as part of this Annual Report on Form 10-K.
Exhibit
Number
Description of Exhibit
2.1#
Agreement and Plan of Merger, dated as of November 15, 2021, by and among Kala Pharmaceuticals, Inc., Ceres Merger Sub, Inc., Combangio, Inc. and, solely in its capacity as Combangio Equityholder Representative, Fortis Advisors LLC. (incorporated by reference to Exhibit 2.1 of the Registrant’s current report on Form 8-K (File No. 001-38150) filed on November 15, 2021)
3.1
Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s current report on Form 8-K (File No. 001-38150) filed on July 25, 2017)
3.2
Amended and Restated By-laws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s current report on Form 8-K (File No. 001-38150) filed on July 25, 2017)
4.1
Specimen Stock Certificate evidencing the shares of common stock (incorporated by reference to Exhibit 4.1 to the Registrant’s registration statement on Form S-1/A (File No. 333-218936) filed on July 10, 2017)
4.2
Third Amended and Restated Registration Rights Agreement of the Registrant dated April 4, 2016, as amended by Amendment No. 1 dated December 13, 2017, of the Registrant (incorporated by reference to Exhibit 4.2 to the Registrant’s annual report on Form 10-K (File No. 001-38150) filed on February 25, 2021)
4.3
Description of the Registrant’s Securities Registered under Section 12 of the Exchange Act (incorporated by reference to Exhibit 4.3 of the Registrant’s annual report on Form 10-K (File No. 001-38150) filed on February 12, 2020)
10.1+
2009 Employee, Director and Consultant Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to the Registrant’s registration statement on Form S-1 (File No. 333-218936) filed on June 23, 2017)
10.2+
Form of Stock Option Agreement under the 2009 Employee, Director and Consultant Equity Incentive Plan (incorporated by reference to Exhibit 10.2 to the Registrant’s registration statement on Form S-1 (File No. 333-218936) filed on June 23, 2017)
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Exhibit
Number
Description of Exhibit
10.3+
Amended and Restated 2017 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.1 to the Registrant’s quarterly report on Form 10-Q (File No. 001-38150) filed on May 9, 2019)
10.4+
2017 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 99.1 to the Registrant’s Current Report on Form 8-K (File No. 001-38150) filed on June 26, 2020)
10.5+
Form of Incentive Stock Option Agreement under 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.5 to the Registrant’s registration statement on Form S-1/A (File No. 333-218936) filed on July 10, 2017)
10.6+
Forms of Non-Qualified Option Agreement under 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.6 to the Registrant’s registration statement on Form S-1/A (File No. 333-218936) filed on July 10, 2017)
10.7+
Form of Non-Employee Director Restricted Stock Unit Award under 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.2 to the Registrant’s quarterly report on Form 10-Q (File No. 001-38150) filed on May 7, 2020)
10.8+
Form of Non-Employee Director Deferred Restricted Stock Unit Award under 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.3 to the Registrant’s quarterly report on Form 10-Q (File No. 001-38150) filed on May 7, 2020)
10.9+
Form of Employee Restricted Stock Unit Award under 2017 Equity Incentive Plan (incorporated by reference to Exhibit 10.3 to the Registrant’s quarterly report on Form 10-Q (File No. 001-38150) filed on August 6, 2020)
10.10+
Form of Inducement Stock Option Agreement (incorporated by reference to Exhibit 10.1 to the Registrant’s quarterly report on Form 10-Q (File No. 001-38150) filed on November 8, 2018)
10.11#
Exclusive License Agreement, dated November 10, 2009, by and between the Registrant and The Johns Hopkins University, as amended by the First Amendment dated November 19, 2012, the Second Amendment dated May 23, 2014 and the Third Amendment dated August 26, 2014 (incorporated by reference to Exhibit 10.2 to the Registrant’s quarterly report on Form 10-Q (File No. 001-38150) filed on August 5, 2021)
10.12†
Fourth Amendment to Exclusive License Agreement, dated June 22, 2018, by and between the Johns Hopkins University and the Registrant (incorporated by reference to Exhibit 10.1 to the Registrant’s quarterly report on Form 10-Q (File No. 001-38150) filed on August 9, 2018)
10.13#
Fifth Amendment to Exclusive License Agreement, date July 6, 2020, by and between the Johns Hopkins University and the Registrant (incorporated by reference to Exhibit 10.2 to the Registrant’s quarterly report on Form 10-Q (File No. 001-38150) filed on August 6, 2020)
10.14†
Exclusive License Agreement, effective as of May 1, 2017, by and between the Registrant and The Johns Hopkins University (incorporated by reference to Exhibit 10.15 to the Registrant’s registration statement on Form S-1 (File No. 333-218936) filed on June 23, 2017)
10.15†
Assignment, dated April 26, 2017, by and between the Registrant and The Johns Hopkins University (incorporated by reference to Exhibit 10.16 to the Registrant’s registration statement on Form S-1 (File No. 333-218936) filed on June 23, 2017)
10.16†
Assignment, dated April 26, 2017, by and between the Registrant and The Johns Hopkins University (incorporated by reference to Exhibit 10.17 to the Registrant’s registration statement on Form S-1 (File No. 333-218936) filed on June 23, 2017)
10.17#
Settlement and License Agreement, dated October 24, 2014, by and between the Registrant and GrayBug, LLC (incorporated by reference to Exhibit 10.3 to the Registrant’s quarterly report on Form 10-Q (File No. 001-38150) filed on August 5, 2021)
10.18#*
Exclusive License Agreement, dated October 11, 2019, by and between Combangio, Inc. and The Board of Trustees of the Leland Stanford Junior University
10.19+
Inducement Stock Option Agreement by and between the Registrant and Eric L. Trachtenberg (incorporated by reference to Exhibit 10.2 to the Registrant’s quarterly report on Form 10-Q (File No. 001-38150) filed on August 9, 2018)
10.20+
Letter Agreement, dated March 25, 2018, by and between the Registrant and Eric L. Trachtenberg (incorporated by reference to Exhibit 10.3 to the Registrant’s quarterly report on Form 10-Q (File No. 001-38150) filed on August 9, 2018)
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Table of Contents
Exhibit
Number
Description of Exhibit
10.21+
Amended and Restated Letter Agreement, dated September 10, 2015, by and between the Registrant and Mark Iwicki, as amended by the First Amendment, dated September 28, 2017 (incorporated by reference to Exhibit 10.1 to the Registrant’s quarterly report on Form 10-Q (File No. 001-38150) filed on November 7, 2017)
10.22+
Letter Agreement, dated November 6, 2017, by and between the Registrant and Todd Bazemore (incorporated by reference to Exhibit 10.12 of the Registrant’s annual report on Form 10-K (File No. 001-38150) filed on April 2, 2018)
10.23+
Amended and Restated Letter Agreement, dated May 10, 2016, by and between the Registrant and Kim Brazzell (incorporated by reference to Exhibit 10.13 to the Registrant’s registration statement on Form S-1 (File No. 333-218936) filed on June 23, 2017)
10.24+
Form of Amendment to Offer Letters (incorporated by reference to Exhibit 10.30 to the Registrant’s annual report on Form 10-K (File No. 001-38150) filed on March 12, 2019)
10.25+
Form of Indemnification Agreement between the Registrant and each of its Executive Officers and Directors (incorporated by reference to Exhibit 10.14 to the Registrant’s registration statement on Form S-1/A (File No. 333-218936) filed on July 10, 2017)
10.26†
Amended and Restated Master Services Agreement, dated October 4, 2017, by and between the Registrant and Altasciences company (formerly Alliance Contract Pharma, LLC) (incorporated by reference to Exhibit 10.18 of the Registrant’s annual report on Form 10-K (File No. 001-38150) filed on April 2, 2018)
10.27#
Amendment No. 1 to Amended and Restated Master Services Agreement, dated August 25, 2020 by and between the Registrant and Altasciences company (formerly Alliance Contract Pharma, LLC) (incorporated by reference to Exhibit 10.26 of the Registrant’s annual report on Form 10-K (File No. 001-38150) filed on February 25, 2021)
10.28†
Manufacturing and Supply Agreement, dated January 10, 2017, by and between the Registrant and Chemo Iberica SA (incorporated by reference to Exhibit 10.20 to the Registrant’s registration statement on Form S-1 (File No. 333-218936) filed on June 23, 2017)
10.29†
Commercial Supply Agreement, dated June 27, 2016, by and between the Registrant and Woodstock Sterile Solutions, Inc. (formerly known as Catalent Pharma Solutions, LLC) (incorporated by reference to Exhibit 10.19 to the Registrant’s registration statement on Form S-1 (File No. 333-218936) filed on June 23, 2017)
10.30†
Amendment No. 1 to Commercial Supply Agreement, dated February 16, 2018, by and between the Registrant and Woodstock Sterile Solution, Inc. (incorporated by reference to Exhibit 10.21 of the Registrant’s annual report on Form 10-K (File No. 001-38150) filed on April 2, 2018)
10.31#
Amendment No. 2 to Commercial Supply Agreement, dated March 27, 2020, by and between the Registrant and Woodstock Sterile Solution, Inc. (incorporated by reference to Exhibit 10.1 to the Registrant’s quarterly report on Form 10-Q (File No. 001-38150) filed on May 7, 2020)
10.32#
Amendment No. 3 to Commercial Supply Agreement, dated December 11, 2020, by and between the Registrant and Woodstock Sterile Solution, Inc. (incorporated by reference to Exhibit 10.31 of the Registrant’s annual report on Form 10-K (File No. 001-38150) filed on February 25, 2021)
10.33*#
Amendment No. 4 to Commercial Supply Agreement, effective January 6, 2021, by and between the Registrant and Woodstock Sterile Solution, Inc.
10.34
Lease Termination Agreement, dated November 12, 2021, by and between the Registrant and Columbia Massachusetts Arsenal Office Properties, LLC. (incorporated by reference to Exhibit 10.1 of the Registrant’s current report on Form 8-K (File No. 001-38150) filed on November 15, 2021)
10.35*
First Amendment to Lease Termination Agreement, dated December 22, 2021, by and between the Registrant and Columbia Massachusetts Arsenal Office Properties, LLC
10.36
Common Stock Purchase Warrant, dated October 1, 2018, by and among the Registrant and Athyrium Opportunities III Acquisition LP (incorporated by reference to Exhibit 10.4 to the Registrant’s current report on Form 8-K (File No. 001-38150) filed on October 2, 2018)
10.37#
Loan and Security Agreement, dated May 4, 2021, by and among the Registrant and Oxford Finance LLC, as collateral agent and lender (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-38150) filed on May 5, 2021)
10.38
Amended and Restated Sales Agreement, dated May 7, 2020, by and between the Registrant and Jefferies LLC (incorporated by reference to Exhibit 1.2 to the Registrant’s Registration Statement on Form S-3 (File No. 333-238087) filed on May 7, 2020)
21.1*
Subsidiaries of the Registrant
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Exhibit
Number
Description of Exhibit
23.1*
Consent of Deloitte & Touche LLP
31.1*
Rule 13a-14(a) Certification of Principal Executive Officer
31.2*
Rule 13a-14(a) Certification of Principal Financial Officer
32.1*
Certification of Principal Executive Officer pursuant to 18 U.S.C. §1350
32.2*
Certification of Principal Financial Officer pursuant to 18 U.S.C. §1350
101.INS
Inline XBRL Instance Document.
101.SCH
Inline XBRL Taxonomy Extension Schema Document.
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104
Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101)
* Filed herewith.
† Confidential treatment granted as to portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
# Portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
+ Management contract or compensatory plan or arrangement filed in response to Item 15(a)(3) of the Instructions to the Annual Report on Form 10-K.
Item 16. Form 10-K Summary
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
KALA PHARMACEUTICALS, INC.
Dated: March 29, 2022
By:
/s/ Mark Iwicki
Mark Iwicki
Chief Executive Officer and
Chairman of the Board of Directors
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
/s/ Mark Iwicki
Mark Iwicki
Chief Executive Officer and Chairman of the Board of Directors (Principal Executive Officer)
March 29, 2022
/s/ Mary Reumuth
Mary Reumuth
Chief Financial Officer (Principal Financial and Accounting Officer)
March 29, 2022
/s/ Mark Blumenkranz
Mark Blumenkranz
Director
March 29, 2022
/s/ Gregory Grunberg
Gregory Grunberg, M.D.
Director
March 29, 2022
/s/ Andrew I. Koven
Andrew I. Koven
Director
March 29, 2022
/s/ C. Daniel Myers
Daniel C. Myers
Director
March 29, 2022
/s/ Robert Paull
Robert Paull
Director
March 29, 2022
/s/ Gregory Perry
Gregory Perry
Director
March 29, 2022
/s/ Howard Rosen
Howard Rosen
Director
March 29, 2022
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the stockholders and the Board of Directors of Kala Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Kala Pharmaceuticals, Inc. and subsidiaries (the “Company”) as of December 31, 2021 and 2020, the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows, for the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
March 29, 2022
We have served as the Company's auditor since 2013 .
F-1
Table of Contents
KALA PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
December 31,
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
92,136
$
77,264
Short-term investments
—
76,276
Short-term restricted cash
2,042
—
Accounts receivable, net
15,345
9,604
Inventory
8,639
5,229
Prepaid expenses and other current assets
6,204
3,006
Total current assets
124,366
171,379
Non-current assets:
Property and equipment, net
2,722
3,166
Long-term inventory
9,578
6,219
Right-of-use assets
1,299
27,853
Restricted cash and other long-term assets
1,462
12,989
Total assets
$
139,427
$
221,606
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable
$
4,899
$
1,724
Accrued expenses and other current liabilities
20,986
18,971
Current portion of lease liabilities
711
1,530
Current portion of contingent consideration
3,817
—
Current portion of deferred purchase consideration
7,009
—
Total current liabilities
37,422
22,225
Long-term liabilities:
Long-term lease liabilities
548
27,143
Long-term debt
78,929
72,243
Long-term contingent consideration
4,841
—
Long-term deferred purchase consideration
883
—
Total long-term liabilities
85,201
99,386
Total liabilities
122,623
121,611
Commitments and Contingencies (Note 17)
Stockholders' equity:
Common stock, $ 0.001 par value; 120,000,000 shares authorized as of December 31, 2021 and December 31, 2020; 65,500,275 and 58,915,375 shares issued and outstanding as of December 31, 2021 and December 31, 2020 , respectively
66
59
Additional paid-in capital
559,126
499,715
Accumulated other comprehensive income
—
4
Accumulated deficit
( 542,388 )
( 399,783 )
Total stockholders' equity
16,804
99,995
Total liabilities and stockholders' equity
$
139,427
$
221,606
The accompanying notes are an integral part of these consolidated financial statements.
F-2
Table of Contents
KALA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
Year Ended
December 31,
2021
2020
Product revenues, net
$
11,240
$
6,362
Costs and expenses:
Cost of product revenues
4,097
3,173
Selling, general and administrative
105,061
81,068
Research and development
11,515
18,352
Acquired in-process research and development
26,617
—
Gain on fair value remeasurement of deferred purchase consideration
( 5,805 )
—
Total costs and expenses
141,485
102,593
Loss from operations
( 130,245 )
( 96,231 )
Other income (expense):
Interest and other income
104
493
Interest and other expense
( 8,380 )
( 8,589 )
Loss on extinguishment of debt
( 5,395 )
—
Gain on lease modification
1,311
—
Total interest and other expense
( 12,360 )
( 8,096 )
Net loss
$
( 142,605 )
$
( 104,327 )
Net loss per share—basic and diluted
$
( 2.19 )
$
( 1.99 )
Weighted average shares outstanding—basic and diluted
65,202,832
52,377,526
Net loss
$
( 142,605 )
$
( 104,327 )
Other comprehensive loss:
Change in unrealized gains on investments
( 4 )
4
Total other comprehensive loss
( 4 )
4
Total comprehensive loss
$
( 142,609 )
$
( 104,323 )
The accompanying notes are an integral part of these consolidated financial statements.
F-3
Table of Contents
KALA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In thousands, except share amounts)
Common Stock
Additional
Accumulated
Total
$0.001 Par Value
Paid-In
Other Comprehensive
Accumulated
Stockholders'
Shares
Amount
Capital
Income
Deficit
Equity
Balance as of December 31, 2019
36,086,254
$
36
$
325,112
$
—
$
( 295,456 )
$
29,692
At the market offering, net of offering costs of $ 1,026
5,173,730
5
33,129
—
—
33,134
Exercise of stock options
345,479
1
1,086
—
—
1,087
Common stock offering, net of issuance cost and underwriting fees of $ 8,475
16,979,371
17
125,406
—
—
125,423
Issuance of common stock under employee stock purchase plan
314,397
—
1,016
—
—
1,016
Stock-based compensation expense
—
—
13,966
—
—
13,966
Warrant exercises
16,144
—
—
—
—
—
Change in fair value of investments
—
—
—
4
—
4
Net loss
—
—
—
—
( 104,327 )
( 104,327 )
Balance as of December 31, 2020
58,915,375
$
59
$
499,715
$
4
$
( 399,783 )
$
99,995
At the market offering, net of offering costs $ 1,176
5,760,198
6
41,226
—
—
41,232
Exercise of stock options
88,888
—
248
—
—
248
Issuance of vested restricted stock units
460,090
1
—
—
—
1
Issuance of common stock under employee stock purchase plan
275,724
—
1,337
—
—
1,337
Stock-based compensation expense
—
—
16,600
—
—
16,600
Change in fair value of investments
—
—
—
( 4 )
—
( 4 )
Net loss
—
—
—
—
( 142,605 )
( 142,605 )
Balance as of December 31, 2021
65,500,275
$
66
$
559,126
$
—
$
( 542,388 )
$
16,804
The accompanying notes are an integral part of these consolidated financial statements.
F-4
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KALA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Year Ended
December 31,
2021
2020
Cash flows from operating activities:
Net loss
$
( 142,605 )
$
( 104,327 )
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation and amortization
975
912
Non-cash operating lease cost
1,335
1,928
Loss on extinguishment of debt
5,395
—
Gain on lease modification
( 1,311 )
—
Acquired in-process research and development
26,617
—
Gain on fair value remeasurement of deferred purchase consideration
( 5,805 )
—
Amortization of debt discount and other non-cash interest
1,519
1,059
Stock-based compensation
16,088
13,312
Amortization of discount on available-for-sale securities
22
( 5 )
Other non-cash charges
151
—
Change in operating assets and liabilities:
Accounts receivable
( 5,756 )
1,959
Prepaid expenses and other current assets
( 2,859 )
818
Inventory
( 6,257 )
( 2,368 )
Accounts payable
3,231
( 924 )
Accrued expenses and other current liabilities
1,714
( 1,763 )
Lease liabilities and other long-term liabilities
( 689 )
( 1,295 )
Net cash used in operating activities
( 108,235 )
( 90,694 )
Cash flows from investing activities:
Cash paid for acquisition of in-process research and development, net of cash acquired
( 4,653 )
—
Purchases of property and equipment and other assets
( 886 )
( 1,942 )
Proceeds from sale of property and equipment
92
—
Purchases of short-term investments
—
( 113,592 )
Proceeds from sales or maturities of short-term investments
76,250
37,325
Net cash provided by (used in) investing activities
70,803
( 78,209 )
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
41,232
158,557
Payment of principal on finance lease
( 35 )
( 32 )
Proceeds from exercise of stock options and issuance of common stock under employee stock purchase plan
1,585
2,103
Net cash provided by financing activities
42,554
160,628
Net increase (decrease) in cash, cash equivalents and restricted cash:
5,122
( 8,275 )
Cash, cash equivalents and restricted cash at beginning of period
89,756
98,031
Cash, cash equivalents and restricted cash at end of period
$
94,878
$
89,756
Reconciliation of cash, cash equivalents and restricted cash:
Cash, cash equivalents, and restricted cash at end of period
$
94,878
$
89,756
Less restricted cash (Notes 10 and 11)
( 2,742 )
( 12,492 )
Cash and cash equivalents at end of period
$
92,136
$
77,264
Non-cash investing and financing activities:
Purchases of property and equipment in accounts payable and accrued expenses
$
139
$
130
Supplemental disclosure:
Cash paid for interest
$
6,837
$
7,528
Right-of-use assets obtained in exchange of operating lease obligations
1,210
—
The accompanying notes are an integral part of these consolidated financial statements.
F-5
Table of Contents
KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
Note 1: Nature of business
Nature of Business — Kala Pharmaceuticals, Inc. (the “Company”) was incorporated on July 7, 2009, and is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye. The Company has worldwide rights to a portfolio of innovative products and product candidates that include two marketed products utilizing its proprietary mucus penetrating particle drug delivery technology, which it refers to as its AMPPLIFY® technology, to address medical needs for the front of the eye. The Company’s product candidates and programs include a proprietary regenerative biotherapy for severe ocular diseases and a pipeline of preclinical new chemical entities (“NCEs”), targeted to address front and back of the eye diseases.
The Company’s two marketed products are 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 apply the Company’s AMPPLIFY technology to loteprednol etabonate, a corticosteroid designed for ocular applications. The AMPPLIFY technology uses selectively-sized nanoparticles that each have a proprietary coating. The Company believes that these two key attributes enable even distribution of drug particles on mucosal surfaces and significantly increase drug delivery to target tissues by enhancing mobility of drug particles through mucus and preventing drug particles from becoming trapped and eliminated by mucus.
In January 2019, the Company launched its first commercial product, INVELTYS, in the United States and began shipping its second commercial product, EYSUVIS, to wholesalers in the United States in late December 2020 with the full promotional launch commencing in early January 2021. The Company is engaged in the commercialization of EYSUVIS and INVELTYS, research and development activities for its clinical-stage product candidate, KPI-012 for the treatment of persistent corneal epithelial defects (“PCED”), raising capital and recruiting skilled personnel. The Company is subject to a number of risks similar to those of other companies conducting high-risk, research and development of pharmaceutical product candidates and launching products for the first time. Principal among these risks are dependence on key individuals and intellectual property, competition from other products and companies and the technical risks associated with the successful research, development and marketing of its product candidates. The Company’s success is dependent upon its ability to successfully commercialize its products, the success of its research and development efforts, its ability to obtain regulatory approval of its product candidates, its ability to raise additional capital when needed and, ultimately, attain profitable operations.
The Company is also progressing its pipeline of proprietary NCE preclinical development programs targeted to address both front and back of the eye diseases. These preclinical development programs include KPI-287, its receptor Tyrosine Kinase Inhibitor and its selective glucocorticoid receptor modulators (“SEGRMs”).
KPI-287 is designed to inhibit the vascular endothelial growth factor and platelet derived growth factor pathways, and is administered by suprachoroidal injection for the treatment of retinal diseases, including wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. SEGRMs are a novel class of therapies designed to modify the downstream activity of the glucocorticoid receptors to exhibit the anti-inflammatory and immunomodulatory properties of the corticosteroid class of therapies while markedly reducing their associated side effects, which we are developing for the treatment of inflammatory diseases.
Combangio, Inc. Acquisition — 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 “Acquisition”). Combangio is a clinical-stage biotechnology company focused on developing regenerative biotherapeutics for severe ocular diseases based on mesenchymal stem cell
F-6
Table of Contents
KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
(“MSCs”) secretomes, including, its lead product candidate, CMB-012 for the treatment of PCED. Following the Acquisition, the Company refers to CMB-012 as KPI-012.
Refer to Note 3 for further discussion of the Acquisition.
Recent 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”). In connection with the filing of the 2018 Shelf Registration, the Company entered into a sales agreement (the “2018 Sales Agreement”) with Jefferies, LLC (“Jefferies”) pursuant to which the Company may issue and sell, from time to time, up to an aggregate of $ 50,000 of its common stock in an at-the-market equity offering (“ATM Offering”) through Jefferies, LLC, as sales agent. Through the first quarter of 2020, the Company issued an aggregate of 4,945,605 shares of its common stock under the ATM Offering, resulting in net proceeds to the Company of $ 25,605 . On March 10, 2020, the Company notified Jefferies that it was suspending and terminating the prospectus related to the 2018 Sales Agreement.
On March 11, 2020, the Company sold 16,000,000 shares of its common stock (the “2020 Offering Shares”) in an underwritten offering (the “2020 Offering”), pursuant to the 2018 Shelf Registration, at a public offering price of $ 7.89 per share, resulting in net proceeds of $ 118,207 , after underwriting discounts, commissions, and offering expenses. In addition, the underwriters of the 2020 Offering were granted the option for a period of 30 days to purchase up to an additional 2,400,000 shares of common stock offered in the public offering at the public offering price, less underwriting discounts, commissions and offering expenses. On April 3, 2020, the underwriters exercised their option and purchased an additional 979,371 shares of common stock at $ 7.89 per share, resulting in net proceeds to the Company of $ 7,216 , after underwriting discounts, commissions, and offering expenses. The total number of shares sold by the Company in the 2020 Offering was 16,979,371 , resulting in total net proceeds to the Company, after underwriting discounts, commissions, and offering expenses, of $ 125,423 . 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 it may issue and sell, from time to time, up to an aggregate of $ 75,000 of its common stock under its ATM Offering through Jefferies, as a sales agent. During the fourth quarter of 2020, the Company issued an aggregate of 2,821,059 shares of its common stock under the ATM Offering, resulting in net proceeds of $ 20,612 . During the year ended December 31, 2021, the Company issued and sold an additional 5,760,198 shares of its common stock under its ATM Offering resulting in net proceeds of $ 41,232 . As of December 31, 2021, 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.
Refer to Note 11 for a discussion of debt financing activity.
F-7
Table of Contents
KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
COVID-19 – In order to safeguard the health of its employees from the ongoing novel coronavirus pandemic, or COVID-19, the Company is following, and will continue to follow, recommendations from the U.S. Centers for Disease Control and Prevention, as well as federal, state and local governments, regarding working-from-home practices for non-essential employees. The Company previously suspended its sales force from substantially all in-person interactions with physicians and was limited to conducting educational and promotional activities virtually. Commencing in the fourth quarter of 2020, the Company’s sales force resumed substantially all in-person interactions in the field, but if the Company suspends all or some in-person interactions with physicians in the future, or to the extent physicians limit in-person interactions, the Company may be limited to conducting educational and promotional activities virtually, which may continue to hamper its ability to market and commercialize EYSUVIS and INVELTYS.
In addition, government restrictions have at times led to moratoria on elective ocular surgeries in many jurisdictions, which had significantly reduced, and may in the future continue to significantly reduce, the demand for INVELTYS, which is indicated for the treatment of post-operative inflammation and pain following ocular surgery. In addition, the COVID-19 pandemic has generally had an adverse impact on the launch of pharmaceutical products, and the Company believes the pandemic has impacted, and may continue to impact, the launch of EYSUVIS. 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 we develop. The extent of the impact of the COVID-19 pandemic on the Company’s commercialization efforts of EYSUVIS and INVELTYS, its clinical development of KPI-012 and its preclinical developments programs, and its operational and financial performance will depend on certain developments, including the length and severity of this pandemic , the timing and extent of any resurgence of the COVID-19 virus or any variant strains of the virus, the availability and effectiveness of vaccines, and the impact of the foregoing on its customers, employees, vendors and government agencies, all of which are uncertain and cannot be predicted. The Company cannot reasonably estimate the extent to which the disruption may materially impact its consolidated results of operations or financial position.
Note 2: Summary of Significant Accounting Policies
Principles of Consolidation— The accompanying consolidated financial statements include the accounts of Kala Pharmaceuticals, Inc. and its wholly owned subsidiaries, Kala Pharmaceuticals Security Corporation, which is a Massachusetts subsidiary created to buy, sell and hold securities, and Combangio, Inc . All intercompany transactions and balances have been eliminated.
Basis of Presentation —The accompanying consolidated financial statements have been prepared on a going concern basis which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has generated only limited revenues to date from product sales and has incurred recurring losses and negative cash flows from operations, including a net loss of $ 142,605 and $ 104,327 , for the years ended December 31, 2021 and 2020, respectively, and used cash in operations of $ 108,235 and $ 90,694 , in the years ended December 31, 2021 and 2020, respectively. The Company has financed its operations to date primarily through proceeds from its initial public offering of common stock (“IPO”), follow-on public offerings of common stock and sales of its common stock under its ATM Offering facility, private placements of preferred stock, borrowings under credit facilities and the Loan and Security Agreement with Oxford Finance LLC, (the “Loan Agreement”), convertible promissory notes and warrants. The Company has devoted substantially all of its financial resources and efforts to research and development, including preclinical studies and clinical trials and engaging in activities to launch and commercialize EYSUVIS and INVELTYS. The Company expects to continue to incur significant expenses and operating losses. Net losses may fluctuate from quarter-to-quarter and year-to-year.
The Company expects that its cash and cash equivalents as of December 31, 2021, together with anticipated net revenue from sales of EYSUVIS and INVELTYS, will enable it to fund its operating expenses, debt service obligations and capital expenditure requirements for at least 12 months from the date these consolidated financial statements were issued. This evaluation is based on relevant conditions and events that are known and reasonably knowable at the date
F-8
Table of Contents
KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
that the consolidated financial statements are issued. The Company believes the COVID-19 pandemic has impacted and may continue to impact anticipated net revenues in the future. As a result, the Company could deplete its available capital resources sooner than it currently expects.
Use of Estimates— The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expense, and related disclosures. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. Estimates and assumptions relied upon in preparing these consolidated financial statements relate to, but are not limited to, revenue recognition, inventory, the present value of lease liabilities and the corresponding right-of-use assets, the fair value of warrants, contingent consideration and acquired in-process research and development (“IPR&D”), stock-based compensation, accrued expenses and the recoverability of the Company’s net deferred tax assets and related valuation allowance. Actual results may differ from these estimates under different assumptions or conditions.
Product Revenues, Net — The Company sells EYSUVIS for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease, and INVELTYS, its topical twice-a-day ocular steroid for the treatment of post-operative inflammation and pain following ocular surgery, primarily to wholesalers in the United States (“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 its products.
The Company accounts for revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers . Under ASC Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to be entitled in exchange for those goods or services. The Company performs the following five steps to recognize revenue under ASC Topic 606: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only recognizes revenue when it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services that will be transferred to the customer.
Performance Obligations
The Company determined that performance obligations are satisfied and revenue is recognized when a customer takes control of the Company’s products, which occurs at a point in time. This generally occurs upon delivery of the products to customers, at which point the Company recognizes revenue and records accounts receivable. Payment is typically received 70 to 90 days after satisfaction of the Company’s performance obligations.
F-9
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
Transaction Price and Variable Consideration
Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products to a customer (“transaction price”). The transaction price for product sales includes variable consideration related to chargebacks, rebates, sales incentives and allowances, distribution service fees, and returns. The Company will estimate the amount of variable consideration that should be included in the transaction price. These estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. These provisions reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained and is included in net sales only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. In general, performance obligations do not include any estimated amounts of variable consideration that are constrained. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.
The following table summarizes activity in each of the Company’s product revenue provision and allowance categories for the years ended December 31, 2021 and 2020:
Trade Discounts,
Allowances and
Rebates and
Chargebacks (1)
Product Returns (2)
Incentives (3)
Balance as of January 1, 2020
$
1,783
$
180
$
10,044
Provision related to current period sales
3,937
207
23,265
Changes in estimate related to prior period sales
21
213
74
Credit/payments made
( 4,584 )
—
( 28,479 )
Balance as of December 31, 2020
$
1,157
$
600
$
4,904
Provision related to current period sales
9,443
973
48,007
Changes in estimate related to prior period sales
44
1,338
( 646 )
Credit/payments made
( 7,972 )
( 1,771 )
( 40,985 )
Balance as of December 31, 2021
$
2,672
$
1,140
$
11,280
(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 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 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 consolidated balance sheets.
As of December 31, 2021 and 2020, the Company did not have any transaction price allocated to remaining performance obligations and any costs to obtain contracts with customers, including pre-contract costs and set up costs, were immaterial.
F-10
Table of Contents
KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
Accounts Receivable, net —Accounts receivable are reported on the 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 December 31, 2021 or December 31, 2020. The Company recorded an allowance of $ 2,672 and $ 1,157 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 December 31, 2021 and December 31, 2020, respectively.
Acquired IPR&D— A key provision within ASC 805 , Business Combinations, is the single or similar asset threshold. When substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets, the acquired set is not a business. In evaluating the Acquisition, the Company concluded that s ubstantially all of the fair value of the gross assets acquired was concentrated in a single asset, KPI-012, and the Company accounted for the transaction as an asset acquisition.
Acquired IPR&D expense consists of the initial up-front payments and any future milestone payments that are recorded at fair value incurred in connection with the acquisition or licensing of product candidates that do not meet the definition of a business. Acquired IPR&D is expensed immediately in the period in which it is incurred. For the year ended December 31, 2021, the Company recorded an expense for the IPR&D acquired in the Acquisition of $ 26,617 as there is no alternative future use.
Contingent Consideration— In addition to upfront consideration and Deferred Purchase Consideration (as defined below) (see Note 3) , the Company’s asset acquisitions may also include contingent consideration payments to be made for future milestone events or royalties on net sales of future products. The Company assesses whether such contingent consideration is required to be recorded at fair value on the date of the acquisition and subsequently remeasured to fair value at each reporting date. Contingent consideration payments in an asset acquisition not required to be accounted for at fair value are recognized when the contingency is resolved, and the consideration is paid or becomes payable. Changes to contingent consideration obligations can result from changes to discount rates, accretion of the liability due to the passage of time, changes in our estimates of the likelihood or timing of achieving certain milestones. Any changes in the fair value of these contingent consideration liabilities are included in loss from operations in the consolidated statements of operations and comprehensive loss.
Cost of Product Revenues— The cost of product revenues consists primarily of materials, third-party manufacturing costs, freight and distribution costs, royalty expense, allocation of labor, quality control and assurance, reserves for defective inventory as well as excess or obsolete inventory, and other manufacturing overhead costs. The Company recorded the cost of product revenues related to INVELTYS as research and development expenses prior to regulatory approval and recorded the cost of product revenues related to EYSUVIS as research and development expenses prior to the determination that FDA approval was probable and before the future economic benefit of the drug was expected to be realized.
Cash and Concentration of Credit Risk —Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents, short-term investments and accounts receivable. Periodically, the Company maintains cash, cash equivalents, short-term investments in accredited financial institutions in excess of federally insured limits. The Company deposits its cash, cash equivalents, short-term investments in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not
F-11
Table of Contents
KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
Three Customers comprised 10% or more of the Company’s accounts receivable balance as of December 31, 2021 and 2020. These Customers comprised 44 %, 31 % and 24 % of the accounts receivable balance, respectively, as of December 31, 2021 and 39 %, 33 % and 25 % of the accounts receivable balance, respectively, as of December 31, 2020. To date, losses with respect to the collection of the Company’s accounts receivable have been de minimis and the Company believes that its entire accounts receivable balances is collectible as of December 31, 2021. The same three Customers comprised 10% or more of the Company’s revenue during the years ended December 31, 2021 and 2020. These Customers comprised 48 %, 29 % and 22 % of revenue, respectively, during the year ended December 31, 2021 and 40 %, 29 % and 28 % of revenue, respectively, during the year ended December 31, 2020. The Company has no financial instruments with off-balance sheet risk of loss.
Cash Equivalents —The Company considers all short-term, highly liquid investments with original maturities of 90 days or less at acquisition date to be cash equivalents.
Restricted Cash —As of December 31, 2021, the Company had short-term restricted cash of $ 2,042 , which represented cash held to serve as collateral for its facility lease in Watertown, Massachusetts (see Note 10) and long-term restricted cash of $ 700 which primarily represented cash held to serve as collateral for its vehicle fleet lease (see Note 10). As of December 31, 2020, the Company had long-term restricted cash of $ 12,492 , which represented cash held to satisfy its prior financial covenant (see Note 11) and serve as collateral for the Company’s vehicle fleet lease, credit cards and its facility lease in Watertown, Massachusetts (see Note 10).
Investments— The Company determines the appropriate classification of its investments at the time of purchase. The Company’s investments are classified as available-for-sale in accordance with ASC Topic 320. The Company classifies investments available to fund current operations as current assets on its consolidated balance sheets. Investments are classified as long-term assets on the consolidated balance sheets if (i) the Company has the intent and ability to hold the investments for a period of at least one year and (ii) the contractual maturity date of the investments is greater than one year.
Available-for-sale investments are recorded at fair value, with unrealized gains or losses included in comprehensive loss on the consolidated statements of operations and comprehensive loss and in accumulated other comprehensive income or loss on the consolidated balance sheets. Realized gains and losses, interest income earned on the Company’s cash, cash equivalents and investments, and amortization or accretion of discounts and premiums on investments are included within other income (expense).
The Company reviews investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. The Company did not record any such impairments during the years ended December 31, 2021 or 2020.
Inventory —Inventory is stated at the lower of cost or net realizable value, on a first-in, first-out method. Costs include amounts related to third party manufacturing, transportation, internal labor and overhead. The Company capitalizes pre-launch inventory when it believes regulatory approval and subsequent commercialization of the product candidate is probable and expects the future economic benefit of the drug to be realized. In doing so, management must consider a number of factors in order to determine the amount of inventory to be capitalized, including the historical experience of achieving regulatory approvals for the Company’s similar products, the amount of inventory that is likely to be used in commercial production, receipt and analysis of positive Phase 3 clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications and the compilation of the regulatory application. The Company also monitors the status of the product
F-12
Table of Contents
KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
within the regulatory review and approval process, including all relevant communication with regulatory authorities. For inventories capitalized in preparation for product launch, anticipated future sales, expected shelf life and expected approval date are taken into account when evaluating realizability. The shelf life of a product is determined as part of the regulatory approval process; however, in assessing whether to capitalize pre-launch inventory, the Company considers the product stability data of all of the pre-launch inventory procured or produced to date to determine whether there is adequate shelf life. If management is aware of any specific material risks or contingencies other than the normal regulatory review and approval process, or if the criteria for capitalizing inventory produced prior to regulatory approval are otherwise not met, the Company would not capitalize such inventory costs, choosing instead to recognize such costs as a research and development expense in the period incurred. For INVELTYS, capitalization of costs as inventory began when the Company believed regulatory approval and subsequent commercialization of the product candidate was probable and expected the future economic benefit of the drug to be realized, which was concluded to be upon U.S. regulatory approval. For EYSUVIS, capitalization of costs as inventory began in the third quarter of 2020 when the Company believed regulatory approval and subsequent commercialization of the product candidate was probable and expected the future economic benefit of the drug to be realized.
The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, including quality control and assurance reserves for defective inventories, and also writes-down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of product revenues, unless associated with the Company’s samples inventory, in which case the charges are recorded to selling, general and administrative expense. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required which would be recorded as a cost of product revenues in the consolidated statements of operations and comprehensive loss.
Shipping and handling costs for product shipments are recorded as incurred in costs of revenues along with costs associated with manufacturing the product, and any inventory write-downs. Inventory produced that will be used in a promotional sample program is expensed to selling, general and administrative expense when it is designated as a sample. Long-term inventory includes raw materials, work-in-progress and/or finished goods inventory with an anticipated consumption or sale beyond one year based on the Company’s forecasted expectations.
Leases —At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize on the balance sheet leases with terms of one-year or less. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes the appropriate incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received.
The components of a lease should be split into three categories: lease components (e.g., land, building, etc.), non-lease components (e.g., common area maintenance, maintenance, consumables, etc.), and non-components (e.g., property taxes, insurance, etc.). Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on fair values to the lease components and non-lease components. Although separation of lease and non-lease components is required, certain practical expedients are available to entities. Entities electing the practical expedient would not separate lease and non-lease components. Rather, they would account for each lease component and the related non-lease component together as a single component. The Company’s facilities operating leases had lease and non-lease components which the Company has elected to use the practical expedient and account for each lease component and related non-lease component as one single component. The lease component
F-13
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
resulted in a right-of-use asset being recorded on the consolidated balance sheets and amortized as lease expense on a straight-line basis to the consolidated statements of operations and comprehensive loss.
Property and Equipment, net —Property and equipment are recorded at cost. Depreciation is provided using the straight-line method over the estimated useful lives of the related assets. Depreciation expense is included in loss from operations on the consolidated statements of operations and comprehensive loss. Laboratory equipment and office and computer equipment is depreciated over three to five years . Leasehold improvements are depreciated over the shorter of their useful life or the life of the lease. Major additions and upgrades are capitalized; maintenance and repairs, which do not improve or extend the life of the respective assets, are expensed as incurred. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in loss from operations on the consolidated statements of operations and comprehensive loss.
Patent Costs —Costs to secure and defend patents are expensed as incurred and are classified as selling, general and administrative expenses in the Company’s consolidated statements of operations and comprehensive loss.
Advertising Costs —Advertising costs are expensed as incurred. For the years ended December 31, 2021 and 2020, advertising expenses were $ 11,962 and $ 7,593 , respectively, and are included in selling, general and administrative expenses in the accompanying consolidated statements of operations and comprehensive loss.
Impairment of Long-Lived Assets —Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If the undiscounted cash flows are insufficient to recover the carrying value, the assets are recorded at the lesser of the carrying value or fair value. For the year ended December 31, 2021, impairment charges recorded were de minimis . For the year ended December 31, 2020, no impairment charges were recorded.
Segment Information —Operating segments are identified as components of an enterprise about which separate discrete financial information is made available for evaluation by the chief operating decision maker (“CODM”) in making decisions regarding resource allocation and assessing performance. The CODM is the Company’s Chief Executive Officer. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is on the development and commercialization of innovative therapies for diseases of the eye. All of the Company’s tangible assets are held in the United States. To date, all of the Company’s revenue has been generated in the United States.
Research and Development Costs —Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, an allocation of facilities expenses, overhead expenses and other outside expenses. Research and development costs are expensed as incurred. The Company expenses costs relating to the production of inventory for its product candidates as research and development expenses within its consolidated statements of operations and comprehensive loss in the period incurred, until the point the Company believes regulatory approval and subsequent commercialization of the product candidate is probable and it expects the future economic benefit from sales of the drug to be realized. Research and development costs that are paid in advance of performance, including nonrefundable prepayments for goods or services, are deferred and capitalized as a prepaid expense. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered.
Accrued Expenses — The Company accrues for variable consideration related to rebates, sales incentives and allowances, and returns. Such estimates are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of the accrued expense. The Company also accrues expenses related to development activities performed by third parties based on an evaluation of services received and efforts expended
F-14
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
pursuant to the terms of the contractual arrangements. Payments under some of these contracts depend on clinical trial milestones. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of expenses. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual or prepaid expense accordingly.
Stock-Based Compensation —The Company accounts for all stock-based awards granted as compensation expense at fair value. The Company generally issues stock-based awards with the measurement date for awards as the date of grant. Stock-based compensation costs are recognized as expense over the employees’ requisite service period, which is the vesting period, on a straight-line basis. For performance awards whose vesting is contingent upon a specified event, the Company recognizes stock-based compensation expense over the derived service period, based on the probability of achievement of the specified event. The Company recognizes compensation expense for the portion of awards that have vested. Forfeitures are recorded as they occur. Stock-based compensation is classified in the accompanying consolidated statements of operations and comprehensive loss based on the function to which the related services are provided, or capitalized with inventory until related expense is recognized.
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The assumptions used in calculating the fair value of stock-based payment awards represent management’s best estimates. The Company lacks sufficient company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies in addition to its own historical volatility and will continue to do so until it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The fair value of restricted stock units (“RSUs”) and performance stock units (“PSUs”) are equal to the closing sale price of the Company’s common stock on the date of grant.
Income Taxes —Deferred tax assets and liabilities are recognized for the expected future tax consequences of events that have been included in the Company’s consolidated financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences between the consolidated financial statement carrying amounts and the tax basis of existing assets and liabilities and for loss and credit carryforwards using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized.
The Company provides reserves for potential payments of tax to various tax authorities related to uncertain tax positions and other issues. The Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the position will be sustained on examination by the taxing authorities based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such a position is measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. As a result, reserves are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized following resolution of any potential contingencies present.
Net Loss per Share —Basic net loss per share is computed using the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options and warrants and the issuance of unvested RSUs and PSUs .
F-15
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
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 years ended December 31, 2021 and 2020. (See Note 15).
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 (“ASU 2016-13”). ASU 2016-13 significantly changes the impairment model for most financial assets and certain other instruments. ASU 2016-13 will require immediate recognition of estimated credit losses expected to occur over the remaining life of many financial assets, which will generally result in earlier recognition of allowances for credit losses on loans and other financial instruments. In November 2019, the FASB issued ASU 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) (“ASU 2019-10”) , which is effective for public business entities that meet the definition of an SEC filer, excluding entities eligible to be Smaller Reporting Companies (“SRCs”) as defined by the SEC, for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years and for all other entities, including SRCs, for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company is currently evaluating the impact of the adoption of ASU 2016-13, beginning January 1, 2023, on its consolidated financial statements. The Company does not expect that the adoption of this standard will have a material impact on its consolidated financial statements.
Note 3: Acquisition of Combangio, Inc.
In connection with the closing of the Acquisition on November 15, 2021 (the “Closing”), the Company made an upfront payment of an aggregate of $ 5,000 in cash to former Combangio stockholders and other equityholders (the “Combangio Equityholders”), subject to customary adjustments, and agreed to issue an aggregate of 7,788,637 shares (the “Deferred Purchase Consideration”) of the Company’s common stock to the Combangio Equityholders with an aggregate value of approximately $ 16,123 , 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 (the “Holdback Shares”) on the date that is fifteen months after the Closing (the “Escrow Release Date). The aggregate value of the Deferred Purchase Consideration was calculated using the closing price of the Company’s common stock on the Nasdaq Global Select Market on November 12, 2021, the last trading day prior to the Closing.
In addition, pursuant to the Merger Agreement, the Combangio Equityholders, in the aggregate and subject to the terms and conditions of the Merger Agreement, will also be entitled to receive from the Company the following contingent consideration (the “Contingent Consideration”):
● up to $ 105,000 in contingent milestone consideration, of which (i) $ 2,300 would become payable in cash and $ 2,700 would be payable in shares of the Company’s common stock upon the first patient dosed with any product candidate whose active ingredient comprises one or more biological factors secreted by MSCs or their progenitors, including KPI-012 (the “Product Candidate”) in a Phase 2 clinical trial (the “Dosing Milestone”), (ii) $ 2,300 would become payable in cash and $ 2,700 would be payable in shares of the Company’s common stock upon the first patient dosed with a Product Candidate in a pivotal clinical trial, (iii) $ 12,500 would become payable (with up to $ 6,250 payable, at the option of the Company, in shares of the Company’s common stock and the remainder in cash) upon regulatory approval by the U.S. Food and Drug Administration (the “FDA”) of marketing and sale of a Product Candidate in the United States, subject to certain specified
F-16
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
reductions; (iv) $ 17,500 would become payable (with up to $ 8,750 payable, at the option of the Company, in shares of the Company’s common stock and the remainder in cash) upon the first commercial sale of a Product Candidate in the United States, subject to certain specified reductions, and (v) an aggregate of up to $ 65,000 would become payable in cash upon the achievement of specified sales milestones;
● tiered cash royalties at percentage rates in the mid-to-high single digits payable on annual net sales of all Product Candidates; and
● a cash payment at a percentage rate in the high single digits of all income, including earnout payments, received by the Company or any of its affiliates from a product license granted by the Company to a third party to sell or otherwise commercialize the Product Candidate in countries where neither the Company nor its affiliates conduct sales of such Product Candidate, subject to certain exceptions set forth in the Merger Agreement.
The portion of any payment of Contingent Consideration payable in shares of the Company’s common stock is referred to herein as “Contingent Stock Consideration” and the portion of any payment of Contingent Consideration payable in cash is referred to herein as “Contingent Cash Consideration”.
If the issuance of the Deferred Purchase Consideration or any Contingent Stock Consideration would result in the aggregate number of shares of the Company’s common stock issued under the Merger Agreement equaling or exceeding 19.9 % of the total number of shares of the Company’s common stock issued and outstanding immediately prior to the Closing (the “Share Cap”), then the Company will be required to pay the portion of the Deferred Purchase Consideration or any Contingent Stock Consideration in excess of the Share Cap in cash. If the aggregate amount of Contingent Cash Consideration payable in any calendar year (after giving effect to the Share Cap) exceeds $ 2,500 (the “Excess Cash Cap”), such excess portion (“Carry Forward Contingent Cash Consideration”) will be carried forward and, subject to application of the Excess Cash Cap in the following calendar year, become payable on the first business day of the following calendar year. Any Carry Forward Contingent Cash Consideration outstanding on June 1, 2026 is payable in full on June 1, 2026.
For accounting purposes, the transaction was accounted for as an asset acquisition , as substantially all of the fair value of the gross assets acquired was concentrated in a single asset, KPI-012.
Pursuant to the Merger Agreement, following the Acquisition, the Company owns 100 % of the outstanding common stock of Combangio. The cost of the Acquisition, which represents the total consideration transferred to Combangio stockholders in the Acquisition consists of the following:
Cash
$
3,821
Transaction expenses
901
Deferred Purchase Consideration (1)
13,698
Contingent consideration (2)
8,658
Total consideration
$
27,078
(1) Deferred Purchase Consideration consists of 6,815,072 Upfront Shares issued on January 3, 2022 recorded at $ 1.79 per share and 973,565 Holdback Shares, which will not be issued until the Escrow Release Date of February 15, 2023 recorded at $ 1.58 per share based on the transaction date fair value.
(2)
Contingent consideration consists of the fair value of certain milestone payments. The total potential maximum payout for the milestone payments, which are recorded at fair value is $ 40,000 and such milestone payments and are contingent upon the achievement of specified development and regulatory milestones. Additionally, pursuant to the Merger Agreement, the Company could trigger potential future sales-based milestone payments of up to $ 65,000 . Because the achievement of these sales-based milestones related to KPI-012 was not considered probable as of December 31, 2021, such contingencies have not been recorded in the Company’s financial statements.
F-17
Table of Contents
KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
The following is the allocation of the purchase consideration based on the fair value of assets acquired and the liabilities assumed by the Company in the Acquisition:
Cash and cash equivalents
$
69
Prepaid expense and other current assets
121
Property and equipment
38
Other assets
46
Workforce
307
Acquired in-process research and development
26,617
Liabilities
( 120 )
Total consideration
$
27,078
Note 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. ASC 820, Fair Value Measurements and Disclosures , establishes a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and its own assumptions (unobservable inputs). The hierarchy consists of three levels:
● Level 1—Quoted prices in active markets for identical assets or liabilities.
● Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
● Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
The Company’s financial instruments as of December 31, 2021 consisted primarily of cash equivalents and contingent consideration. The Company’s financial instruments as of December 31, 2020 consisted primarily of cash equivalents and short-term investments in money market funds and short-term securities. Cash equivalents, short-term investments and contingent consideration are reported at their respective fair values on the Company’s consolidated balance sheets. See Note 5, “Investments” for additional information.
As discussed in Notes 2 and 3, the Company acquired Combangio in November 2021 and in connection with the closing of the Acquisition, the Company agreed to issue Deferred Purchase Consideration for which the Company has established liabilities for these considerations. The Deferred Purchase Consideration related to the Acquisition is measured at fair value each reporting period using Level 3 unobservable inputs. The fair value of the Deferred Purchase Consideration was based on the fair value of the underlying stock and a discount for lack of marketability. Changes in these estimates and assumptions could have a significant impact on the fair value of the Deferred Purchase Consideration. Any change in the fair value of the Deferred Purchase Consideration is included in loss from operations in the consolidated statements of operations and comprehensive loss. During the year ended December 31, 2021, the change in the fair value of the Deferred Purchase Consideration was $ 5,805 primarily due to the change in the fair value of the underlying stock price and is recognized as the gain on fair value remeasurement of deferred purchase consideration in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2021.
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
Additionally, the purchase price of the Acquisition included potential future payments that are contingent upon the achievement of specified development, regulatory and commercialization milestones and are required to 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 consolidated statements of operations and comprehensive loss. During the year ended December 31, 2021, the change in the fair value of the contingent consideration liabilities was de minimis .
The following table sets forth the fair value of the Company’s financial instruments by level within the fair value hierarchy as of December 31, 2021 and 2020:
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
December 31, 2020
Fair Value
Level 1
Level 2
Level 3
Assets:
Cash equivalents
$
63,811
$
63,811
$
—
$
—
Short-term investments
76,276
76,276
—
—
Total Assets
$
140,087
$
140,087
$
—
$
—
The following tables summarizes quantitative information and assumptions pertaining to the fair value measurement of the Level 3 inputs as of December 31, 2021:
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 %
During the year ended December 31, 2021 and 2020 there were no transfers between Level 1, Level 2, and Level 3.
The carrying value reported on the accompanying consolidated balance sheets of cash, restricted cash, accounts receivable, accounts payable and accrued expenses approximate their fair value due to their short-term nature. Management believes that the Company’s long-term debt (see Note 11) bears interest at the prevailing market rate for instruments with similar characteristics and, accordingly, the carrying value of long-term debt, also approximates its fair value.
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
Note 5: Investments
The Company held no short-term investments as of December 31, 2021. Investments by security type consisted of the following as of December 31, 2020:
December 31, 2020
Gross
Gross
Amortized
Unrealized
Unrealized
Fair
Cost
Gains
Losses
Value
U.S. treasury securities
$
26,744
$
2
$
—
$
26,746
U.S. government agencies securities
49,528
2
—
49,530
Total
$
76,272
$
4
$
—
$
76,276
As of December 31, 2020, all of the Company’s investments had a contractual maturity within one year . The fair value of all of the Company’s investments are classified as short-term on its consolidated balance sheets.
Note 6: Inventory
Inventory consists of the following:
December 31,
December 31,
2021
2020
Raw materials
$
1,328
$
801
Work in progress
9,799
6,437
Finished goods
7,090
4,210
Total inventory
$
18,217
$
11,448
As of December 31, 2021, the Company had $ 8,639 of current inventory and $ 9,578 of long-term inventory. As of December 31, 2020, the Company had $ 5,229 of current inventory and $ 6,219 of long-term inventory.
Note 7: Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets, consists of the following:
December 31,
December 31,
2021
2020
Non-trade receivables
$
2,110
$
250
Insurance
1,307
1,201
Deposits
911
606
Other
1,876
949
Prepaid expenses and other current assets
$
6,204
$
3,006
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
Note 8: Property and Equipment, Net
Property and equipment, net, consists of the following:
December 31,
December 31,
2021
2020
Equipment
$
2,647
$
2,652
Computer hardware and software
1,184
1,108
Furniture and office equipment
37
1,144
Leasehold improvements
—
356
Construction in progress
1,715
1,330
Property and equipment — at cost
5,583
6,590
Less: Accumulated depreciation
( 2,861 )
( 3,424 )
Property and equipment—net
$
2,722
$
3,166
Depreciation expense for the years ended December 31, 2021 and 2020 was $ 933 and $ 908 , respectively.
In connection with the lease termination agreement entered into in November 2021 to accelerate the lease termination o f the Company’s Watertown Lease (as defined below) (see Note 10) , the Company disposed of and sold certain property and equipment. Additionally, in conjunction with the termination of the Watertown Lease, the Company had $ 211 of assets held for sale as of December 31, 2021 included within prepaid expenses and other current assets on the consolidated balance sheet, which were subsequently sold in the first quarter of 2022.
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
Note 9: Accrued Expenses
Accrued expenses consist of the following:
December 31,
December 31,
2021
2020
Accrued revenue reserves (1)
$
10,300
$
5,224
Compensation and benefits
6,324
9,676
Commercial costs
2,134
2,103
Professional services
881
926
Contract manufacturing
396
336
Development costs
127
154
Other
824
552
Accrued expenses
$
20,986
$
18,971
(1) As of December 31, 2021 and 2020, $ 2,120 and $ 280 of additional revenue reserves were in accounts payable, respectively.
Note 10: Lease
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 for an additional five years , which were recognized as part of the Company’s right-of-use asset and lease liability. The Company occupied the premises in Watertown in early 2019 as its corporate headquarters and for research and development. The lease commencement date was November 15, 2018 and the Company concluded that it controlled the space, as of the lease commencement date.
On November 12, 2021, the Company entered into the Lease Termination Agreement with the landlord of the Watertown Lease, which Lease Termination Agreement was amended on December 22, 2021, modifying 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 after December 31, 2021. 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 is 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 on the Lease Termination Date that was pledged as collateral under a letter of credit with cash on deposit required by the terminated lease. The restricted cash was included within short-term restricted cash on the consolidated balance sheet as of December 31, 2021 and included within restricted cash and other long-term assets on the consolidated balance sheet as of December 31, 2020.
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
Vehicle Fleet lease
During the year ended December 31, 2019, the Company entered into a master fleet lease agreement (the “Vehicle Fleet Lease”), pursuant to which it currently leases approximately 65 vehicles. In connection with the Vehicle Fleet Lease, the Company issued a letter of credit for $ 450 , which is reported as restricted cash on the consolidated balance sheets as of December 31, 2021 and December 31, 2020. The Vehicle Fleet Lease has an expected term of three years , which commenced upon the delivery of the vehicles in March 2019.
During the year ended December 31, 2021, the Company modified the Vehicle Fleet Lease to add 54 additional vehicles to the fleet. The new component of the lease has an expected term of approximately three years , which commenced upon the delivery of the additional vehicles in March 2021.
The components of lease expense and related cash flows were as follows:
Year Ended
December 31,
2021
2020
Lease cost
Operating lease cost
$
3,822
$
4,741
Short-term lease cost
20
—
Variable lease cost
2,270
1,848
Total lease cost
$
6,112
$
6,589
Operating cash outflows from operating leases
$
7,350
$
5,981
Maturities of lease liability due under these operating lease agreements as of December 31, 2021 are as follows:
Years Ending December 31,
2022
$
727
2023
406
2024
141
Total minimum lease payments
1,274
Less: amount representing interest
( 15 )
Present value of lease liabilities
$
1,259
The weighted average remaining lease term and weighted average discount rate of operating leases are as follows:
December 31,
December 31,
2021
2020
Weighted average remaining lease term
2.4 years
10.3 years
Weighted average discount rate
2.6 %
9.8 %
Note 11: 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
F-23
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
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.
In connection with the Athyrium Credit Facility, the Company issued a warrant (“Warrant”), to purchase up to 270,835 shares of the Company’s common stock, at an exercise price per share of $ 12.18456 . The Warrant is immediately exercisable as to 184,660 shares. The remaining 86,175 shares under the Warrant were exercisable only upon the Company’s draw of the Term Loan B and, as a result, the remaining 86,175 shares under the Warrant are no longer exercisable. The Warrant is exercisable through October 1, 2025 and is classified as an equity instrument. The Company allocated the proceeds from the Term Loan A to the Warrant using the relative fair value method. The fair value of the Warrant of $ 1,900 was recognized as equity with a corresponding debt discount of $ 1,980 .
As of December 31, 2020, the unpaid principal balance under the Athyrium Credit Facility was $ 75,000 and the unamortized debt discount was $ 3,088 . 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 , consisting of the prepayment premium, the unamortized debt discount and issuance costs and the unaccreted exit fee. Additionally, the Company released $ 10,000 of restricted cash previously recorded to comply with a financial covenant required by the Athyrium Credit Facility.
Oxford Finance 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 LLC, 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 product revenue equal to or greater than $ 100,000 , subject to certain other terms and conditions. The Company utilized substantially all of the proceeds from the tranche A term loan to repay the Athyrium Credit Facility (as more fully described above).
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 provides 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 are 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 prepay all, but not less than all, of the outstanding loans, subject to a prepayment fee equal to the following percentage of the principal amount being prepaid: 3.00 % if an advance is prepaid during the first 12 months following
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
the applicable advance date, 2.00 % if an advance is prepaid after 12 months but prior to 24 months following the applicable advance date, and 1.00 % if an advance is prepaid any time after 24 months following the applicable advance date but prior to the Maturity Date.
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. The Loan Agreement also contains customary representations and warranties and affirmative and negative covenants, as well as customary events of default. 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 December 31, 2021. 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 were 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 December 31, 2021, the effective interest rate was 10.41 %, which takes into consideration the non-cash accretion of the exit fee and the amortization of the debt discount and issuance costs.
During the year ended December 31, 2021, the Company recognized interest expense of $ 7,446 for the Loan Agreement and the Athyrium Credit Facility . This consisted of amortization of debt discount of $ 613 and the contractual coupon interest expense of $ 6,833 . During the year ended December 31, 2020, the Company recognized interest expense of $ 8,440 for the Athyrium Credit Facility. This consisted of amortization of debt discount of $ 910 and the contractual coupon interest expense of $ 7,530 .
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
The components of the carrying value of the debt as of December 31, 2021 and December 31, 2020 are detailed below:
December 31,
December 31,
2021
2020
Principal loan balance
$
80,000
$
75,000
Unamortized debt discount and issuance cost
( 1,927 )
( 3,088 )
Cumulative accretion of exit fee
856
331
Long-term debt, net
$
78,929
$
72,243
The annual principal payments due under the Loan Agreement as of December 31, 2021 were as follows:
Years Ending December 31,
2022
$
—
2023
—
2024
4,445
2025
53,333
2026
22,222
Total
$
80,000
Note 12: Warrants
The Company has issued warrants in connection with debt transactions that were completed prior to 2017.
In connection with and in consideration for the commitment of the Athyrium Credit Facility, on October 1, 2018, the Company issued to Athyrium the Warrant as described in Note 11.
The following table summarizes the common stock warrants outstanding as of December 31, 2021 and 2020, each exercisable into the number of shares of common stock set forth below as of the specified dates:
Shares Exercisable at
Exercise
Expiration
Exercisable
December 31,
December 31,
Issued
Price
Date
From
2021
2020
2013
$
7.50
April 2021
July 2017
—
33,333
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
248,505
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
Note 13: Common and Preferred Stock
Preferred Stock
The Company was authorized to issue up to 5,000,000 shares of preferred stock as of December 31, 2021 and 2020. There was no preferred stock outstanding as of December 31, 2021 and 2020.
Common Stock
The Company was authorized to issue up to 120,000,000 shares of common stock with a $ 0.001 par value per share as of December 31, 2021 and 2020. The Company had 65,500,275 and 58,915,375 shares of common stock issued and outstanding as of December 31, 2021 and 2020 , respectively.
Holders of the Company’s common stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders and do not have cumulative voting rights. Each election of directors by the Company’s stockholders will be determined by a plurality of the votes cast by the stockholders entitled to vote on the election. Holders of common stock are entitled to receive proportionately any dividends as may be declared by the Company’s Board of Directors (the “Board”), subject to any preferential dividend rights of outstanding preferred stock that it may issue in the future.
In the event of the Company’s liquidation or dissolution, the holders of its common stock are entitled to receive proportionately all assets available for distribution to stockholders after the payment of all debts and other liabilities and subject to the prior rights of any of its outstanding preferred stock. Holders of the Company’s common stock have no preemptive, subscription, redemption or conversion rights. The rights, preferences and privileges of holders of the Company’s common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of its preferred stock that it may designate and issue in the future.
Voting, dividend and liquidation rights of the holders of the common stock are subject to and qualified by the rights, powers and preferences of the holders of preferred stock that the Company may issue in the future.
Voting
Each holder of outstanding shares of common stock shall be entitled to one vote in respect of each share. The holders of outstanding shares of common stock, voting together as a single class, shall be entitled to elect one director. The number of authorized shares of common stock may be increased or decreased by the affirmative vote of a majority of the outstanding shares of common stock and preferred stock voting together as a single class.
Dividends
Subject to the payment in full of all preferential dividends to which the holders of preferred stock may be entitled, the holders of common stock shall be entitled to receive dividends out of funds legally available therefor at such times and in such amounts as the Board may determine in its sole discretion, with holders of preferred stock and common stock sharing pari passu in such dividends.
Liquidation Rights
Upon any liquidation, after the payment or provision for payment of all debts and liabilities of the Company and all preferential amounts to which the holders of preferred stock may be entitled with respect to the distribution of assets in liquidation, the holders of common stock shall be entitled to share ratably in the remaining assets of the Company available for distribution.
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
Reserved Shares
As of December 31, 2021 and 2020, the Company has reserved shares of common stock for issuance upon exercise of rights under warrants, under the Amended and Restated 2017 Employee Stock Purchase Plan (as amended, the “ESPP”), upon the exercise of stock options, upon the vesting of RSUs and PSUs and upon the issuance of Upfront Shares and Holdback Shares in connection with the Acquisition as follows (see Note 14):
December 31,
December 31,
2021
2020
Warrant rights to acquire common stock
215,172
248,505
ESPP
798,201
484,772
Outstanding inducement stock option awards
1,291,909
945,842
2009 Plan
2,142,661
2,251,570
2017 Plan
9,734,830
7,813,784
Deferred Purchase Consideration
7,788,637
—
Total
21,971,410
11,744,473
Note 14: Stock-based Compensation
Stock Incentive Plans
In December 2009, the Board adopted the 2009 Employee, Director and Consultant Equity Incentive Plan (the “2009 Plan”) for the issuance of common stock and stock options to employees, officers, directors, consultants, and advisors. Upon the closing of the Company’s IPO, no further awards will be made under the 2009 Plan.
In July 2017, the Company’s 2017 Equity Incentive Plan (the “2017 Plan”) became effective. The 2017 Plan was established to provide equity-based ownership opportunities for employees, officers, directors, consultants, and advisors. On June 25, 2020, the 2017 Plan was amended to increase the number of shares of common stock authorized for issuance thereunder by 2,000,000 shares. As of December 31, 2021, there were 2,266,601 shares of common stock available for grant under the 2017 Plan. In addition, any shares of common stock subject to awards under the 2009 Plan that expire, are forfeited, or are otherwise surrendered, without having been fully exercised or resulting in any common stock being issued will become available for issuance under the 2017 Plan, up to an additional 2,142,661 shares, which is the number of shares issuable pursuant to outstanding awards granted under the 2009 Plan.
Also approved under the 2017 Plan is an annual increase for each of the years through December 31, 2027, equal to the least of (i) 3,573,766 shares of common stock, (ii) 4 % of the shares of common stock outstanding on December 31 of the prior year and (iii) an amount determined by the Board.
Under the plans, the Board determines the number of shares of common stock to be granted pursuant to the awards, as well as the exercise price and terms of such awards. The exercise price of incentive stock options cannot be less than the fair value of the common stock on the date of grant. Stock options awarded under the plans expire 10 years after the grant date, unless the Board sets a shorter term. Options granted under the plans generally vest over a four-year period. A portion of the unvested stock options will vest upon the sale of all or substantially all of the stock or assets of the Company.
Inducement Stock Option Awards
During the years ended December 31, 2021 and December 31, 2020, the Company granted non-statutory stock options to purchase an aggregate of 649,400 shares and 350,800 shares of the Company’s common stock, respectively, to new employees. These stock options will vest over a four-year period, with 25 % of the shares underlying each option
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
award vesting on the one-year anniversary of the applicable employees’ new hire date and the remaining 75 % of the shares underlying each option award vesting monthly thereafter for three-years . Vesting of each option award is subject to such employee’s continued service with the Company through the applicable vesting dates. These stock options were granted outside of the 2017 Plan as an inducement material to each employee’s acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).
A summary of option activity for employee awards under the 2009 Plan, the 2017 Plan and inducement grants for the year ended December 31, 2021 is as follows:
Weighted
Weighted
Average
Average
Remaining
Aggregate
Number of
Exercise
Contractual
Intrinsic
Shares
Price
Term
Value
(Years)
(in thousands)
Outstanding as of January 1, 2021
8,745,127
$
7.03
7.3
$
16,275
Granted
2,239,664
5.66
Exercised
( 88,888 )
2.79
Forfeited
( 894,973 )
6.92
Outstanding as of December 31, 2021
10,000,930
$
6.77
6.4
$
14
Vested or expected to vest as of December 31, 2021
10,000,930
$
6.77
6.4
$
14
Options exercisable as of December 31, 2021
6,826,887
$
7.49
5.5
$
14
The Company records stock-based compensation related to stock options granted at fair value. The Company utilizes the Black-Scholes option-pricing model to estimate the fair value of stock option grants and to determine the related compensation expense. The assumptions used in calculating the fair value of stock-based payment awards represent management’s best estimates. The assumptions used in determining fair value of the stock options granted during the years ended December 31, 2021 and 2020 are as follows:
Year Ended December 31,
2021
2020
Expected volatility
72.7 %
–
74.2 %
79.6 %
–
82.5 %
Risk-free interest rate
0.50 %
–
1.39 %
0.37 %
–
1.73 %
Expected dividend yield
0 %
0 %
Expected term (in years)
5.13
–
6.10
5.91
–
6.08
The Company derived the risk-free interest rate assumption from the U.S. Treasury rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the awards being valued. The Company based the expected dividend yield on its expectation of not paying dividends in the foreseeable future. The Company calculated the expected term of options using the simplified method, as the Company lacks relevant historical data due to the Company’s limited operating experience. The expected volatility is based upon the historical volatility of the Company as well as the volatility of comparable companies with publicly available share prices. The impact of forfeitures on compensation expense is recorded as they occur.
F-29
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
The weighted average grant-date fair value of options granted during the years ended December 31, 2021 and 2020, was $ 3.63 and $ 3.20 , respectively. The fair value is being expensed over the vesting period of the options on a straight-line basis as the services are being provided. As of December 31, 2021, there was $ 10,408 of unrecognized compensation cost related to the stock options granted, which is expected to be expensed over a weighted-average period of 2.40 years. Stock-based compensation expense was classified in the consolidated statements of operations and comprehensive loss as follows:
Year Ended
December 31,
2021
2020
Cost of product revenues
$
169
$
92
Research and development
3,145
3,083
Selling, general and administrative
12,774
10,137
Total
$
16,088
$
13,312
Stock-based compensation costs capitalized into inventory totaled $ 1,157 and $ 888 for the years ended December 31, 2021 and 2020, respectively. Capitalized stock-based compensation is recognized as an expense in cost of product revenues when the related product is sold or in selling, general and administrative expense when the related product is designated as a sample.
The Company received cash proceeds from the exercise of stock options of $ 248 and $ 1,087 during the years ended December 31, 2021 and 2020, respectively. The total intrinsic value of options exercised for the year ended December 31, 2021 and 2020, was $ 406 and $ 2,124 , respectively.
Restricted Stock Units and Performance-Based Restricted Stock Units —In June 2020, the Company issued RSUs to certain executives and Board members, as well as PSUs to certain executives and other employees. In 2020, the Company granted 135,560 RSUs to certain executives which vest 50 % on the first anniversary of the grant date, and 50 % on the second anniversary of the grant date. Additionally, the Company issued 128,000 RSUs to members of the Board which vested upon the date of the 2021 Annual Meeting of Stockholders. In 2020, the Company issued 693,537 PSUs to certain executives and other employees tied to certain performance criteria, which will vest, if at all, as to 50 % on the first anniversary of satisfying the performance criteria and the remaining 50 % vesting upon the second anniversary of satisfying the performance criteria. The Company has determined that the performance criteria for these awards has been achieved but not all of the awards have vested as of December 31, 2021.
In 2021, the Company issued 431,333 RSUs to certain executives and other employees which will vest no sooner than one -third per year over three years on the anniversary of the date of grant as well as 125,000 RSUs to members of the Board which will vest upon the earlier of the first anniversary of the 2021 Annual Meeting of Stockholders or the date of the 2022 Annual Meeting of Stockholders.
As of December 31, 2021, a total of 813,869 RSUs and PSUs were unvested and outstanding , which results in unrecognized stock-based compensation of $ 3,291 to be recognized as stock-based compensation expense over the remaining weighted-average vesting period of 1.27 years.
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
A summary of activity for RSUs and PSUs for the year ended December 31, 2021 is as follows:
Weighted Average
Grant Date
Shares
Fair Value
Unvested and outstanding balance as of January 1, 2021
942,222
$
11.70
Changes during the period:
Granted
556,333
6.51
Vested
( 548,090 )
$
11.35
Forfeited
( 136,596 )
$
9.01
Unvested and outstanding balance as of December 31, 2021
813,869
$
8.84
Vested and deferred balance as of December 31, 2021
88,000
Employee Stock Purchase Plan —In 2017, the Company approved the 2017 Employee Stock Purchase Plan, which was amended and restated in December 2018 (as amended, the “ESPP”). The ESPP reserved an aggregate of 223,341 shares of common stock and provides for an annual increase on the first day of each fiscal year, beginning on January 1, 2019 and ending on December 31, 2029, in an amount equal to the lowest of: (1) 893,441 shares of the Company’s common stock; (2) 1 % of the total number of shares of the Company’s common stock outstanding on the first day of the applicable fiscal year; and (3) an amount determined by the Company’s board of directors.
The ESPP provides for two six-month offering periods each year; the first offering period begins on the first trading day on or after each January 1; the second offering period begins on the first trading day on or after each July 1. Under the ESPP, participating employees can authorize the Company to withhold a portion of their base pay during consecutive six-month payment periods for the purchase of shares of the Company’s common stock. At the conclusion of the period, participating employees can purchase shares of the Company’s common stock at 85 % of the lesser of the closing price of the common stock on (i) the first business day of the plan period or (ii) the exercise date. The fair value of the purchase rights granted under the ESPP was estimated on the date of grant, using the Black-Scholes option-pricing model. During the year ended December 31, 2021, employees of the Company purchased an aggregate of 275,724 shares under the ESPP. During the year ended December 31, 2020, employees of the Company purchased an aggregate of 314,397 shares under the ESPP.
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
Note 15: Loss Per Share
Basic and diluted net loss per share attributable to common stockholders was calculated as follows for the years ended December 31, 2021 and 2020:
Year Ended
December 31,
2021
2020
Numerator:
Net loss attributable to common stockholders
$
( 142,605 )
$
( 104,327 )
Denominator:
Weighted-average common shares outstanding, basic and diluted (1)
65,202,832
52,377,526
Net loss per share attributable to common stockholders, basic and diluted
$
( 2.19 )
$
( 1.99 )
(1) Included in the weighted-average common shares outstanding, basic and diluted for the year ended December 31, 2021 is an aggregate of 6,815,072 shares of common stock issued to Combangio Equityholders on January 3, 2022 and 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:
Year Ended
December 31,
2021
2020
Options to purchase shares of common stock
10,000,930
8,745,127
Unvested RSUs and PSUs
813,869
942,222
Unexercised warrants
215,172
248,505
11,029,971
9,935,854
Note 16: Income Taxes
The Company has had no income tax expense due to operating losses incurred for the years ended December 31, 2021 and 2020. The Company has also not recorded any income tax benefits for the net operating losses incurred in each period due to its uncertainty of realizing a benefit from those items. All of the Company’s losses before income taxes were generated in the United States.
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Table of Contents
KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows:
Year Ended
December 31,
2021
2020
Federal statutory income tax rate
21.0
%
21.0
%
Effect of:
Change in valuation allowance
( 23.0 )
( 22.2 )
Acquired in-process research and development
( 3.9 )
—
Stock-based compensation
( 1.3 )
( 0.9 )
State income taxes, net of federal benefit
4.8
1.2
Losses limited by Section 382
1.3
—
Research and development tax credits
0.5
0.9
Other
0.6
—
Effective income tax rate
—
%
—
%
Net deferred tax assets as of December 31, 2021 and 2020 consisted of the following:
December 31,
2021
2020
Deferred tax assets:
Net operating loss carryforwards
$
102,935
$
67,368
Stock-based compensation
8,408
7,413
Capitalized research and development and start-up expenditures
4,615
5,258
Research and development tax credit carryforwards
3,591
2,398
Rebates, incentives, trade discounts and allowances
3,334
2,177
Lease liabilities
321
8,152
Other
1,260
2,609
Total deferred tax assets
$
124,464
$
95,375
Deferred tax liabilities:
Right-of-use assets
( 331 )
( 7,810 )
Total deferred tax liabilities
$
( 331 )
$
( 7,810 )
Valuation allowance
$
( 124,133 )
$
( 87,565 )
Net 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 has concluded that it is more likely than not that the Company will not realize the benefits of the deferred tax assets. Accordingly, a full valuation allowance has been established against the deferred tax assets as of December 31, 2021 and 2020. The valuation allowance increased by $ 36,568 and $ 17,492 during the years ended December 31, 2021 and 2020, respectively, due to an increase in the net operating loss carryforwards and research and development tax credits, partially offset by limitations caused by ownership changes under the provisions of Section 382 and Section 383 of the Internal Revenue Code of 1986. Management reevaluates the positive and negative evidence at each reporting period.
As of December 31, 2021 and 2020, the Company had federal net operating loss carryforwards of $ 364,425 and $ 243,155 , respectively, which may be available to offset future federal tax liabilities and expire at various dates beginning in 2030. As of December 31, 2021 and 2020, the Company had state net operating loss carryforwards of $ 352,863 and $ 214,989 , respectively, which may be available to offset future state income tax liabilities and expire at various dates beginning in 2030. As of December 31, 2021 and 2020, the Company also had federal and state research
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KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
and development credit carryforwards of approximately $ 3,591 and $ 2,398 , respectively, which begin to expire in 2040 (federal) and 2035 (state).
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, 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, which limitation is reflected in the numbers presented above.
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 December 31, 2021 and 2020 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 years ended December 31, 2021 and 2020.
Note 17: Commitments and Contingencies
JHU License Agreement — In 2009, the Company entered into an exclusive license agreement with The Johns Hopkins University (“JHU”), as amended in November 2012, May 2014, August 2014, October 2014, June 2018, and July 2020, which licensed to the Company a portfolio of specified patent rights and remains in full force and effect. Pursuant to the terms of the agreement, as amended, the Company agreed to pay an initial license fee, minimum annual payments beginning in 2017, certain development and commercial milestone payments, royalties on product sales and reimburse all or a portion of the costs associated with the preparation, filing, prosecution and maintenance of the agreed-upon patents and patent applications to JHU.
After 2016 and until the first commercial sale of product, which occurred in January 2019, the minimum annual payment was $ 38 . Upon the first commercial sale of INVELTYS, the annual minimum payment increased to $ 113 . The Company is obligated to pay JHU low single-digit running royalties based upon a percentage of net sales of the licensed products, which is applied to the annual minimum payment. During the years ended December 31, 2021 and 2020, amounts paid to JHU for royalties were de minimis . The Company also has an obligation to pay JHU certain one-time development and commercial milestone payments. The Company paid JHU a $ 150 milestone payment during the year ended December 31, 2021, which was triggered by the first commercial sale of EYSUVIS in the United States in December 2020. Additional amounts paid to JHU during the years ended December 31, 2021 and 2020 were de minimis .
Stanford License Agreement —In October 2019, Combangio entered into a license agreement with The Board of Trustees of The Leland Stanford Junior University (“Stanford”), which was amended in February 2020 and subsequently transferred to the Company by operation of law upon the Acquisition. Pursuant to the license agreement with Stanford (the “Stanford Agreement”), the Company has a worldwide, exclusive, sublicensable license under certain patent rights, or licensed patents, directed to methods to promote eye wound healing, to make, have made, use, import, offer to sell and sell products that are covered by the licensed patents (“licensed products”) 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.
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Table of Contents
KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
The Company’s minimum obligations due under its license agreements as of December 31, 2021, are as follows:
Years Ending December 31,
2022
$
131
2023
143
2024
143
2025
178
2026
178
Thereafter
1,240
Total minimum license payments
$
2,013
Commercial Supply Agreement — The Company entered into a commercial supply agreement with Woodstock Sterile Solutions, Inc. (formerly known as Catalent Pharma Solutions, LLC) to manufacture commercial supplies of EYSUVIS and INVELTYS. The commercial supply agreement contains annual minimum purchase requirements, which follow the contract year from July 1st to June 30th. The minimum purchase requirements increased upon FDA approval of EYSUVIS on October 26, 2020.
The Company has the following minimum purchase obligations for EYSUVIS and INVELTYS:
Years Ending December 31,
2022 (1)
$
4,044
2023
6,190
2024
6,380
2025 (2)
9,370
2026 (2)
7,028
Thereafter (2)
14,411
Total minimum purchase commitments
$
47,423
(1) Amount presented is net of amounts paid towards the minimum purchase obligation as of December 31, 2021.
(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 each contract year beginning July 1, 2025, purchases are 75 % of the prior year purchases.
Contingencies related to the Merger Agreement —In connection with the acquisition of Combangio, the Company agreed to make additional payments based on the achievement of certain milestone events related to KPI-012. The Company recognized certain contingent consideration liabilities at fair value on the acquisition date, and revalues the remaining obligations each reporting period. The total potential maximum payout for the milestone payments, which have been recorded as liabilities at fair value, is $ 40,000 and the milestone payments are contingent upon the achievement of specified development, regulatory and commercialization milestones. Additionally, pursuant to the Merger Agreement, the Company could trigger potential future sales-based milestone payments of up to $ 65,000 . Because the achievement of these sales-based milestones related to KPI-012 was not considered probable as of December 31, 2021, such contingencies have not been recorded in the Company’s financial statements. Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement of certain development, regulatory or commercial milestones.
Litigation —The Company is not currently subject to any material legal proceedings.
Guarantees and Indemnifications —The Company’s Certificate of Incorporation authorizes the Company to indemnify and advance expenses to its officers and directors and agents to the fullest extent permitted by law.
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Table of Contents
KALA PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share amounts)
The Company’s equity agreements and certain other arrangements include standard indemnifications against claims, actions, or other matters that may arise in connection with these arrangements.
As of December 31, 2021 and 2020, the Company had not experienced any losses related to these indemnification obligations, and no claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and has no amount accrued related to these contingencies. The Company does not expect these indemnifications to have a material adverse effect on these consolidated financial statements.
Note 18: Defined Contribution Plan
The Company has a 401(k) defined contribution plan (the ‘‘401(k) Plan’’) for substantially all of its employees. Eligible employees may make pretax contributions to the 401(k) Plan up to statutory limits.
The Company made discretionary matching contributions of $ 612 and $ 446 to the 401(k) Plan during for the years ended December 31, 2021 and 2020, respectively.
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