UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
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(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
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(Address of principal executive offices) |
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(Registrant’s telephone number, including area code)
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
The (Nasdaq Global Market) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No o
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer | o |
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| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No
As of November 2, 2021, there were
ALIMERA SCIENCES, INC.
QUARTERLY REPORT ON FORM 10-Q
INDEX
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND PROJECTIONS
Various statements in this report of Alimera Sciences, Inc. (we, our, Alimera or the Company) are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this report regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. These statements are subject to risks and uncertainties and are based on information currently available to our management. Words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “contemplates,” “predict,” “project,” “target,” “likely,” “potential,” “continue,” “ongoing,” “will,” “would,” “should,” “could,” or the negative of these terms and similar expressions or words, identify forward-looking statements. The events and circumstances reflected in our forward-looking statements may not occur and actual results could differ materially from those projected in our forward-looking statements.
All written and oral forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. We caution investors not to rely too heavily on the forward-looking statements we make or that are made on our behalf. We undertake no obligation and specifically decline any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Please see, however, any further disclosures we make on related subjects in any annual, quarterly or current reports that we may file with the Securities and Exchange Commission (SEC).
We encourage you to read the discussion and analysis of our financial condition and the accompanying unaudited interim condensed consolidated financial statements and notes thereto (Interim Financial Statements) contained in this Quarterly Report on Form 10-Q. We also encourage you to read Item 1A of Part 1 of our Annual Report on Form 10-K for FY 2020, entitled “Risk Factors,” which contains a more detailed discussion of some of the risks and uncertainties associated with our business. In addition to the risks summarized below and in “Risk Factors” in our Annual Report on Form 10-K, other unknown or unpredictable factors also could affect our results. There can be no assurance that we will in fact achieve the actual results or developments we anticipate or, even if we do substantially realize them, that they will have the expected consequences to, or effects on, us. Therefore, we can give no assurances that we will achieve the outcomes stated in those forward-looking statements and estimates. Meaningful factors that could cause actual results to differ include:
Risks Related to the COVID-19 Pandemic
•the adverse effects of the COVID-19 pandemic, and its unpredictable duration, in the regions where we have customers, employees and distributors;
•the adverse effects of the COVID-19 pandemic on sales of ILUVIEN® resulting from (a) limitations on in-person access to physicians for treatment imposed by governments or healthcare facilities, including those imposed in the U.K. and Europe (notably in Germany), and (b) the unwillingness of patients to visit their physicians in person for fear of contracting the COVID-19 coronavirus;
•the financial uncertainty associated with the adverse effects of the COVID-19 pandemic and the duration and severity of those effects, which had an adverse effect on our revenue beginning late in the first quarter of 2020 and continuing to the date of this report, and if these adverse effects continue in the future, they may (a) adversely affect our revenue, financial condition and cash flows, and (b) affect certain estimates we use to prepare our quarterly financial results, including impairment of intangible assets, the income tax provision and recoverability of certain receivables;
•the possibility that the restrictions placed on regulatory and pricing bodies will delay or defer market access for ILUVIEN as we seek to secure reimbursement;
•the possibility that the economic impact of the COVID-19 pandemic will lead to changes in reimbursement policies and reduce market access for ILUVIEN in countries where we sell ILUVIEN;
•the possibility that staffing shortages resulting from the COVID-19 pandemic will recur at the third-party manufacturer where the ILUVIEN implant is made and the ILUVIEN applicator is assembled and packaged that may lead to product shortages;
•the possibility that distribution of the ILUVIEN insert or applicator may be disrupted by government action related to COVID-19 or by the effect of the pandemic on our manufacturers’ or distributors’ workforces or our supply chain;
•the possibility of reduced efficiency and potential distractions of our employees resulting from the prolonged impact of the COVID-19 pandemic, and the resulting loss of productivity;
•the possibility that the economic impact of the COVID-19 pandemic will cause our distributors to vary the way they manage inventory, which could cause our revenue to be inconsistent quarter to quarter;
Operational Risks
•our dependence on the commercial success of our only product, ILUVIEN, and our inability to expand our portfolio of ophthalmic products;
•the competition we face, given that our competitors include larger, more established, fully integrated pharmaceutical companies and biotechnology companies that have substantially greater capital resources, existing competitive products, larger research and development staffs and facilities, greater marketing capabilities, and greater experience in drug development and in obtaining regulatory approvals than we do;
•uncertainty associated with our ability to retain our current employees and to recruit and retain the new employees we need in the future, in particular a productive sales force;
•the possibility that the NEW DAY Study may (a) fail to demonstrate the efficacy of ILUVIEN as baseline therapy in patients with early diabetic macular edema (DME) or to generate data demonstrating the benefits of ILUVIEN when compared to the current leading therapy for DME, and (b) take longer to enroll or be more costly to complete than we currently anticipate;
Manufacturing Risks
•uncertainty associated with our transition from the previous third-party manufacturer of certain component parts of the ILUVIEN applicator to Cadence, Inc., the successor manufacturer;
•the possibility that the necessary regulatory approvals and qualification may not be obtained from the FDA in time to permit Cadence, Inc. to manufacture the components used in the ILUVIEN applicator to satisfy our inventory needs within the U.S. market;
•uncertainty associated with obtaining the appropriate raw materials from our third-party vendors due to (a) supply chain constraints and (b) the replacement by the sole manufacturer of a type of resin used to make the ILUVIEN applicator with another form of resin for which we will need FDA approval in 2023;
•our dependence on third-party manufacturers to manufacture ILUVIEN or any future products or product candidates in sufficient quantities and quality, in a timely manner (particularly during the COVID-19 pandemic), and at an acceptable price;
•the possibility that we may fail to plan appropriately to meet the demand of our customers for ILUVIEN, which could lead either to (a) ILUVIEN being out of stock or (b) our investment of a greater amount of cash in inventory than we need;
•the possibility that global supply chain shortages of goods may impair our ability to source components for the manufacture of our product in a timely manner or at a sustainable level of costs of goods;
Financial Risks
•the possibility that we may fail to comply with the financial covenants in our $45.0 million Loan and Security Agreement with SLR Investment Corp. (SLR, f/k/a Solar Capital Ltd.) as Collateral Agent (Agent), and certain other lenders, including SLR in its capacity as a lender, dated December 31, 2019, as amended, and be unable to obtain a waiver from SLR for any resulting default (see the risk factor regarding this loan agreement in Part II, Item 1A, Risk Factors below);
•our possible need to raise additional financing, the terms of which may restrict our operations and, if the capital we raise is equity or a debt security that is convertible into equity, could dilute our stockholders’ investment;
•uncertainty regarding our ability to achieve profitability and positive cash flow through the commercialization of ILUVIEN in the U.S., the European Economic Area (EEA) and other regions of the world where we sell ILUVIEN;
•a slowdown or reduction in our sales due to, among other things, a reduction in end user demand, unexpected competition, regulatory issues, the occurrence of COVID-19 pandemic “waves” in individual countries, or other unexpected circumstances;
Regulatory Risks
•uncertainty associated with our pursuit of reimbursement from local health authorities in certain countries for the additional indication for ILUVIEN for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS);
•delay in or failure to obtain regulatory approval and reimbursement of ILUVIEN or any future products or product candidates in additional markets where we do not currently sell ILUVIEN;
•uncertainty associated with our ability to successfully commercialize ILUVIEN following regulatory approval in additional markets; and
Intellectual Property Risks
•the possibility that we may be adversely affected by the expiration of patents that protect key aspects of ILUVIEN.
Unless the context otherwise requires, throughout this Quarterly Report on Form 10-Q, the words “Alimera” “we,” “us,” the “registrant” or the “Company” refer to Alimera Sciences, Inc. and its subsidiaries (as applicable).
PART I. FINANCIAL INFORMATION
ITEM 1. Financial Statements (unaudited)
ALIMERA SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
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CURRENT ASSETS: |
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Cash and cash equivalents | $ | |
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Restricted cash |
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Accounts receivable, net |
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Prepaid expenses and other current assets |
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Inventory (Note 7) |
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Total current assets |
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NON-CURRENT ASSETS: |
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Property and equipment, net |
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Right of use assets, net |
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Intangible asset, net (Note 8) |
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Deferred tax asset |
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Warrant asset |
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TOTAL ASSETS | $ | |
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CURRENT LIABILITIES: |
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Accounts payable | $ | |
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Accrued expenses |
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Paycheck Protection Program (PPP) loan (Note 10) |
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Finance lease obligations |
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Total current liabilities |
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NON-CURRENT LIABILITIES: |
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Notes payable, net of discount (Note 10) |
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Other non-current liabilities |
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COMMITMENTS AND CONTINGENCIES |
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STOCKHOLDERS’ EQUITY (DEFICIT): |
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Preferred stock, $. par value — |
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Series A Convertible Preferred Stock, |
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Common stock, $. par value — |
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Additional paid-in capital |
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Common stock warrants |
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Accumulated deficit |
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Accumulated other comprehensive loss |
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TOTAL STOCKHOLDERS’ EQUITY (DEFICIT) |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | $ | |
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See Notes to Unaudited Interim Condensed Consolidated Financial Statements (Interim Financial Statements).
ALIMERA SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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REVENUE: |
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PRODUCT REVENUE, NET | $ | |
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LICENSE REVENUE |
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NET REVENUE |
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COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION |
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GROSS PROFIT |
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RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES |
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GENERAL AND ADMINISTRATIVE EXPENSES |
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DEPRECIATION AND AMORTIZATION |
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OPERATING EXPENSES |
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(LOSS) INCOME FROM OPERATIONS |
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INTEREST EXPENSE AND OTHER |
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UNREALIZED FOREIGN CURRENCY GAIN, NET |
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GAIN ON EXTINGUISHMENT OF DEBT |
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CHANGE IN FAIR VALUE OF WARRANT ASSET |
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NET (LOSS) INCOME BEFORE TAXES |
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INCOME TAX BENEFIT (PROVISION) |
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NET LOSS | $ | ( |
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NET LOSS PER SHARE — Basic and Diluted | $ | ( |
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WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and Diluted |
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See Notes to Interim Financial Statements.
ALIMERA SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
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NET LOSS | $ | ( |
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OTHER COMPREHENSIVE (LOSS) INCOME |
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Foreign currency translation adjustments |
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TOTAL OTHER COMPREHENSIVE (LOSS) INCOME |
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COMPREHENSIVE LOSS | $ | ( |
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See Notes to Interim Financial Statements.
ALIMERA SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss | $ | ( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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Non-cash consideration received as revenue |
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Unrealized foreign currency transaction gain, net |
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Amortization of debt discount |
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Stock-based compensation expense |
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Gain on extinguishment of debt |
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Change in fair value of warrant asset |
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Changes in assets and liabilities: |
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Prepaid expenses and other current assets |
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Inventory |
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Accounts payable |
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Accrued expenses and other current liabilities |
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Other long-term liabilities |
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Net cash provided by (used in) operating activities |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Net cash used in investing activities |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from exercise of stock options |
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Issuance of debt |
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Payment of debt costs |
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Payment of finance lease obligations |
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Net cash provided by financing activities |
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EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH |
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NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH |
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CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — Beginning of period |
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CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — End of period | $ | |
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SUPPLEMENTAL DISCLOSURES: |
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Cash paid for income taxes | $ | |
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Supplemental schedule of non-cash investing and financing activities: |
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Note payable end of term payment accrued but unpaid | $ | |
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See Notes to Interim Financial Statements.
ALIMERA SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
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| Series A |
| Series C |
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| Convertible |
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| Paid-In |
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| Amount |
| Shares |
| Amount |
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| Amount |
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| Deficit |
| Loss |
| Total | ||||||||
2020 | (In thousands, except share data) | ||||||||||||||||||||||||||||
Balance, December 31, 2019 | |
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Issuance of common stock, net of issuance costs | |
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Stock-based compensation expense | — |
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Other | — |
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Net loss | — |
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Foreign currency translation adjustments | — |
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Balance, March 31, 2020 | |
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Issuance of common stock, net of issuance costs | |
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Stock-based compensation expense | — |
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Net loss | — |
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Foreign currency translation adjustments | — |
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Balance, June 30, 2020 | |
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Preferred stock conversion | |
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Stock-based compensation expense | — |
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Net loss | — |
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Foreign currency translation adjustments | — |
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Balance, September 30, 2020 | |
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2021 |
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Balance, December 31, 2020 | |
| $ | |
| |
| $ | |
| — |
| $ | — |
| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | ( |
Issuance of common stock, net of issuance costs | |
|
| |
| — |
|
| — |
| — |
|
| — |
|
| — |
|
| — |
|
| — |
|
| — |
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| |
Stock option exercises | |
|
| — |
| — |
|
| — |
| — |
|
| — |
|
| — |
|
| — |
|
| — |
|
| — |
|
| — |
Forfeitures of restricted stock | ( |
|
| — |
| — |
|
| — |
| — |
|
| — |
|
| — |
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| — |
|
| — |
|
| — |
|
| — |
Stock-based compensation expense | — |
|
| — |
| — |
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| — |
| — |
|
| — |
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| |
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| — |
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| — |
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| — |
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| |
Net loss | — |
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| — |
| — |
|
| — |
| — |
|
| — |
|
| — |
|
| — |
|
| ( |
|
| — |
|
| ( |
Foreign currency translation adjustments | — |
|
| — |
| — |
|
| — |
| — |
|
| — |
|
| — |
|
| — |
|
| — |
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| ( |
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| ( |
Balance, March 31, 2021 | |
|
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| |
|
| |
| — |
|
| — |
|
| |
|
| |
|
| ( |
|
| ( |
|
| ( |
Issuance of common stock, net of issuance costs | |
|
| |
| — |
|
| — |
| — |
|
| — |
|
| |
|
| — |
|
| — |
|
| — |
|
| |
Stock option exercises | |
|
| — |
| — |
|
| — |
| — |
|
| — |
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| |
|
| — |
|
| — |
|
| — |
|
| |
Stock-based compensation expense | — |
|
| — |
| — |
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| — |
| — |
|
| — |
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| |
|
| — |
|
| — |
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| — |
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Net income | — |
|
| — |
| — |
|
| — |
| — |
|
| — |
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| — |
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| — |
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| |
|
| — |
|
| |
Foreign currency translation adjustments | — |
|
| — |
| — |
|
| — |
| — |
|
| — |
|
| — |
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| — |
|
| — |
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| |
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| |
Balance, June 30, 2021 | |
|
| |
| |
|
| |
| — |
|
| — |
|
| |
|
| |
|
| ( |
|
| ( |
|
| |
Issuance of common stock, net of issuance costs | |
|
| — |
| — |
|
| — |
| — |
|
| — |
|
| — |
|
| — |
|
| — |
|
| — |
|
| — |
Stock-based compensation expense | — |
|
| — |
| — |
|
| — |
| — |
|
| — |
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| |
|
| — |
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| — |
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| — |
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| |
Net loss | — |
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| — |
| — |
|
| — |
| — |
|
| — |
|
| — |
|
| — |
|
| ( |
|
| — |
|
| ( |
Foreign currency translation adjustments | — |
|
| — |
| — |
|
| — |
| — |
|
| — |
|
| — |
|
| — |
|
| — |
|
| ( |
|
| ( |
Balance, September 30, 2021 | |
| $ | |
| |
| $ | |
| — |
| $ | — |
| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
See Notes to Interim Financial Statements.
Alimera Sciences, Inc., together with its wholly owned subsidiaries (the Company), is a pharmaceutical company that specializes in the commercialization and development of ophthalmic pharmaceuticals. The Company’s only product is ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg, which has received marketing authorization in
The Company markets ILUVIEN directly in the U.S., Germany, the U.K., Portugal and Ireland and has made ILUVIEN available in the Nordic Region (Denmark, Finland, Norway and Sweden) with the support of an exclusive wholesaler. In addition, the Company has entered into various agreements under which distributors are providing or will provide regulatory, reimbursement and sales and marketing support for ILUVIEN in Austria, Belgium, the Czech Republic, France, Italy, Luxembourg, the Netherlands, Spain, Australia, New Zealand and several countries in the Middle East. In addition, the Company has granted an exclusive license to Ocumension Therapeutics for the development and commercialization of the Company’s 0.19mg fluocinolone acetonide intravitreal injection in China, East Asia and the Western Pacific. As of September 30, 2021, the Company has recognized sales of ILUVIEN to its international distributors covering the Middle East, Austria, Belgium, France, Italy, Luxembourg, Spain and the Netherlands.
Effects of the COVID-19 Pandemic
The public health crisis caused by the COVID-19 pandemic and the measures being taken by governments, businesses, and the public at large to limit the COVID-19 pandemic’s spread have had, and the Company expects will continue to have, certain negative effects on, and present certain risks to, the Company’s business. These limitations and other effects of the COVID-19 pandemic have had an adverse impact on our revenues beginning late in the first quarter of 2020 and continuing through the third quarter of 2021. The Company expects these factors to continue to adversely impact our revenue, and the extent and duration of that impact is uncertain at this time, particularly in light of the emergence of COVID-19 variants that increase the transmissibility of the coronavirus and may be more deadly. Depending on the duration of these limitations and the severity and duration of other effects of the COVID-19 pandemic, our liquidity and financial condition may be adversely affected in the future as well. This uncertainty could have an impact in future periods on certain estimates used in the preparation of the Company’s quarterly financial results, including impairment of intangible assets, the income tax provision and realizability of certain receivables. Should the pandemic continue for an extended period, the continued impact on the Company’s operations could have an adverse effect on the Company’s revenue, financial condition and cash flows.
In response to the COVID-19 pandemic, the Company has implemented measures to mitigate the impact of the pandemic on its financial position and operations. These measures include the following:
•The Company is continuing to monitor the effects of the SARS-CoV-2 variants and to manage its cost structure where possible to mitigate any anticipated loss of revenue in those markets that are affected.
•The Company is focusing its spending in certain countries where access is less restricted in order to serve our customers and patients through either direct or alternative forms of engagement.
The Company has prepared the accompanying unaudited interim condensed consolidated financial statements and notes thereto (Interim Financial Statements) in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, these Interim Financial Statements do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of the Company’s management, the accompanying Interim Financial Statements reflect all adjustments, which include normal recurring adjustments, necessary to present fairly the Company’s interim financial information.
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The accompanying Interim Financial Statements and related notes should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2020 and related notes included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on March 5, 2021. The financial results for any interim period are not necessarily indicative of the expected financial results for the full year.
The Company’s accounting policies followed for quarterly financial reporting are the same as those disclosed in the Notes to Financial Statements included in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2020.
Within the operating expenses section of the Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2020 as well as within the International segment (see Note 15), the Company reclassified $
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (ASC 740): Simplifying the Accounting for Income Taxes. The standard eliminates the need for an organization to analyze whether the following apply in a given period: (1) exception to the incremental approach for intra-period tax allocation; (2) exceptions to accounting for basis differences when there are ownership changes in foreign investments; and (3) exceptions in interim period income tax accounting for year-to-date losses that exceed anticipated losses. The ASU also is designed to improve financial statement preparers’ application of income tax-related guidance and simplify GAAP for (1) franchise taxes that are partially based on income, (2) transactions with a government that result in a step-up in the tax basis of goodwill, (3) separate financial statements of legal entities that are not subject to tax and (4) enacted changes in tax laws in interim periods. The standard became effective for the Company on January 1, 2021. The adoption of this guidance did not have a material impact on the Company’s financial statements.
Accounting Standards Issued but Not Yet Effective
In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments - Credit Losses (Accounting Standards Codification (ASC) 326): Measurement of Credit Losses on Financial Instruments. This ASU replaces the current incurred loss impairment methodology for financial assets measured at amortized cost with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information, including forecasted information, to develop credit loss estimates. The standard becomes effective for the Company on January 1, 2023. The Company does not anticipate the adoption of this ASU will have a material impact on its financial statements.
In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (ASC 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting. This standard provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. ASU 2020-04 is effective for all entities as of March 12, 2020 through December 31, 2022. The Company is currently assessing the impact of the optional guidance on the Company’s consolidated financial statements and disclosures.
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Overview
The Company recognizes revenue when a customer obtains control of the related good or service. The amount recognized reflects the consideration the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, Revenue from Contracts with Customers, the Company performs the following steps as outlined in the guidance: (1) identify the contract with the customer, (2) identify the performance obligations within the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when the entity satisfies a performance obligation. At the inception of a contract, the contract is evaluated to determine if it falls within the scope of ASC 606, followed by the Company’s assessment of the goods or services promised within each contract, assessment of whether the promised good or service is distinct and determination of the performance obligations. The Company then recognizes revenue based on the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied.
If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions related to the performance obligations.
Net Product Sales
The Company sells its products to major pharmaceutical distributors, pharmacies, hospitals and wholesalers (collectively, its Customers). In addition to distribution agreements with Customers, the Company enters into arrangements with healthcare providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenues from product sales at a point in time when the Customer obtains control, typically upon delivery. The Company accrues for fulfillment costs when the related revenue is recognized. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues.
Estimates of Variable Consideration
Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for reserves related to statutory rebates to State Medicaid and other government agencies; commercial rebates and fees to Managed Care Organizations (MCOs), Group Purchasing Organizations (GPOs), distributors, and specialty pharmacies; product returns; sales discounts (including trade discounts); distributor costs; wholesaler chargebacks; and allowances for patient assistance programs relating to the Company’s sales of its products.
These reserves are based on estimates of the amounts earned or to be claimed on the related sales. Management’s estimates take into consideration historical experience, current contractual and statutory requirements, specific known market events and trends, industry data, and Customer buying and payment patterns. Overall, these reserves 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 included in the net sales price is limited to the amount that is probable not to result in a significant reversal in the amount of the cumulative revenue recognized in a future period. If actual results vary, the Company may adjust these estimates, which could have an effect on earnings in the period of adjustment.
With respect to the Company’s international contracts with third-party distributors, certain contracts have elements of variable consideration, and management reviews those contracts on a regular basis and makes estimates of revenue based on historical ordering patterns and known market trends and data. The amount of variable consideration included in net sales in each period could vary depending on the terms of these contracts and the probability of reversal in future periods.
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Consideration Payable to Customers
Distribution service fees are payments issued to distributors for compliance with various contractually-defined inventory management practices or services provided to support patient access to a product. Distribution service fees reserves are based on the terms of each individual contract and are classified within accrued expenses and are recorded as a reduction of revenue.
Product Returns
The Company’s policies provide for product returns in the following circumstances: (a) expiration of shelf life on certain products; (b) product damaged while in the Customer’s possession; and (c) following product recalls. Generally, returns for expired product are accepted
The estimation process for product returns involves, in each case, several interrelating assumptions, which vary for each Customer. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue from product sales in the period the related revenue is recognized, and because this returned product cannot be resold, there is no corresponding asset for product returns. To date, product returns have been minimal.
License Revenue
The Company enters into agreements in which it licenses certain rights to its products to partner companies that act as distributors. The terms of the license agreement may include payment to the Company of non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. The Company recognizes revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer.
The Company will recognize sales-based milestone payments as revenue upon the achievement of the cumulative sales amount specified in the contract in accordance with ASC 606. For those milestone payments which are contingent on the occurrence of particular future events, the Company determines that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the expected value method. As such, the Company assesses each milestone to determine the probability of and substance behind achieving each milestone. Given the inherent uncertainty associated with these future events, the Company will not recognize revenue from such milestones until there is a high probability of occurrence, which typically occurs near or upon achievement of the event.
Customer Payment Obligations
The Company receives payments from its Customers based on billing schedules established in each contract, which vary across the Company’s markets, but generally range between 30 to 120 days. Occasionally, the Company extends the timing of its receipt of payment from the Company’s international Customers. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation is that the Customer will pay for the product or services in one year or less of receiving those products or services.
The Company evaluates all of its contracts to determine whether it is or contains a lease at inception. The Company reviews its contracts for options to extend, terminate or purchase any right-of-use assets and accounts for these, as applicable, at inception of the contract. Lease renewal options are not recognized as part of the lease liability until the Company determines it is reasonably certain it will exercise any applicable renewal options. The Company has not recorded any liability for renewal options in these Interim Financial Statements. The useful lives of leased assets as well as leasehold improvements, if any, are limited by the expected lease term.
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Operating Leases
The Company’s operating lease activities primarily consist of leases for office space in the U.S., the U.K., Ireland and Germany. Most of these leases include options to renew, with renewal terms generally ranging from to
In the third quarter of 2021, the Company gained access to newly constructed office space in Alpharetta, GA for the Company’s U.S. headquarters. The Company has agreed to occupy approximately
When available, the Company uses the rate implicit in the lease or sublease to discount lease payments to present value; however, the lease explained above did not provide a readily determinable implicit rate. Therefore, the Company estimated its incremental borrowing rate to discount the lease payments based on information available at lease commencement. The incremental borrowing rate is defined as the rate of interest that the Company would have to pay to borrow, on a collateralized basis and over a similar term, an amount equal to the lease payments in a similar economic environment. The discount rate used to determine the above amounts was
Supplemental balance sheet information as of September 30, 2021 and December 31, 2020 for the Company’s operating leases is as follows:
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| September 30, |
| December 31, | ||
| 2021 |
| 2020 | ||
| (In thousands) | ||||
NON-CURRENT ASSETS: |
|
|
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|
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Right of use assets, net | $ | |
| $ | |
Total lease assets | $ | |
| $ | |
CURRENT LIABILITIES: |
|
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Accrued expenses | $ | |
| $ | |
NON-CURRENT LIABILITIES: |
|
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|
|
|
Other non-current liabilities |
| |
|
| |
Total lease liabilities | $ | |
| $ | |
The Company’s operating lease cost for the three and nine months ended September 30, 2021 was $
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
As of September 30, 2021, a schedule of maturity of lease liabilities under all of the Company’s operating leases is as follows:
|
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|
Years Ending December 31 | (In thousands) | |
2021 (remaining) | $ | |
2022 |
| |
2023 |
| |
2024 |
| |
2025 |
| |
Thereafter |
| |
Total |
| |
Less amount representing interest |
| ( |
Present value of minimum lease payments |
| |
Less lease incentives |
| ( |
Less current portion (as a portion of accrued expenses) |
| ( |
Non-current portion (as a portion of other non-current liabilities) | $ | |
Cash paid for operating leases was $
As of September 30, 2021, the weighted average remaining lease terms of the Company’s operating leases was
Finance Leases
The Company’s finance lease activities primarily consist of leases for office equipment and automobiles. Property and equipment leases are capitalized at the lesser of fair market value or the present value of the minimum lease payments at the inception of the leases using the Company’s incremental borrowing rate. The Company’s finance lease agreements do not contain any material residual value guarantees or material restrictive covenants.
Supplemental balance sheet information as of September 30, 2021 and December 31, 2020 for the Company’s finance leases is as follows:
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| September 30, |
| December 31, | ||
| 2021 |
| 2020 | ||
| (In thousands) | ||||
NON-CURRENT ASSETS: |
| ||||
Property and equipment, net | $ | |
| $ | |
Total lease assets | $ | |
| $ | |
CURRENT LIABILITIES: |
|
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Finance lease obligations | $ | |
| $ | |
NON-CURRENT LIABILITIES: |
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Finance lease obligations — less current portion |
| |
|
| |
Total lease liabilities | $ | |
| $ | |
Depreciation expense associated with property and equipment under finance leases was approximately $
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
As of September 30, 2021, a schedule of maturity of lease liabilities under finance leases, together with the present value of minimum lease payments, is as follows:
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Years Ending December 31 | (In thousands) | |
2021 (remaining) | $ | |
2022 |
| |
2023 |
| |
Total |
| |
Less amount representing interest |
| ( |
Present value of minimum lease payments |
| |
Less current portion |
| ( |
Non-current portion | $ | |
Cash paid for finance leases was $
As of September 30, 2021, the weighted average remaining lease terms of the Company’s finance leases was
The accompanying Interim 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 Interim Financial Statements do not include any adjustments that might result from the outcome of this uncertainty.
To date, the Company has incurred recurring losses and has accumulated a deficit of $
Further, the Company must maintain compliance with the debt covenants of its $
The Company’s operations and thus its net product revenues have continued to be adversely affected by the COVID-19 pandemic. During the six months ended September 30, 2021, the Company did not generate sufficient revenue to meet the trailing six-month revenue covenant included in the 2019 Loan Agreement. The lenders provided a consent that permitted the Company not to maintain the revenue covenant as of September 30, 2021 and waived any event of default that has occurred or may be deemed to have occurred. The Company expects to comply with the revenue covenant at the next reportable date, which is December 31, 2021.
To meet the Company’s future working capital needs, the Company may need to raise additional debt or equity financing. While the Company from time to time has been able to raise additional capital through issuance of equity and/or debt financing, the Company cannot guarantee that it will be able to maintain debt compliance, raise additional equity, contain or reduce expenses, or increase revenue. Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these Interim Financial Statements are issued.
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
7. INVENTORY
Inventory consisted of the following:
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| September 30, |
| December 31, | ||
| 2021 |
| 2020 | ||
| (In thousands) | ||||
Component parts (1) | $ | |
| $ | |
Work-in-process (2) |
| |
|
| |
Finished goods |
| |
|
| |
Total Inventory | $ | |
| $ | |
(1) Component parts inventory consists of manufactured components of the ILUVIEN applicator.
(2) Work-in-process consists of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing or stability testing as required by U.S. or EEA regulatory authorities.
As a result of the approval of ILUVIEN by the U.S. Food and Drug Administration (FDA) in 2014, the Company was required to pay EyePoint Pharmaceuticals, Inc. (EyePoint) a milestone payment of $
The gross carrying amount of the intangible asset is $
The estimated future amortization expense as of September 30, 2021 for the remaining periods in the next five years and thereafter is as follows:
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|
|
|
Years Ending December 31 | (In thousands) | |
2021 (remaining) | $ | |
2022 |
| |
2023 |
| |
2024 |
| |
2025 |
| |
Thereafter |
| |
Total | $ | |
EyePoint Agreement
In February 2005, the Company entered into an agreement with EyePoint (formerly known as pSivida US, Inc.) for the use of fluocinolone acetonide (FAc) in EyePoint’s proprietary insert technology. This agreement was subsequently amended a number of times (as amended, the EyePoint Agreement). The EyePoint Agreement provides the Company with a worldwide exclusive license to utilize certain underlying technology used in the development and commercialization of ILUVIEN.
In July 2017, the Company amended and restated its EyePoint license agreement, which was made effective July 1, 2017 (the New Collaboration Agreement). Under the New Collaboration Agreement, the Company has the right to the technology underlying ILUVIEN for the treatment of (a) human eye diseases, including uveitis, in Europe, the Middle East, and Africa, and (b) human eye diseases other than uveitis worldwide. The New Collaboration Agreement converted the Company’s previous profit share obligation to a royalty payable on global net revenues of ILUVIEN.
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Following the signing of the New Collaboration Agreement, the Company retained a right to recover up to $
During the three and nine months ended September 30, 2020, the royalty amount was
Ocumension License Agreement
On April 14, 2021, the Company entered into an exclusive license agreement (the License Agreement) with Ocumension (Hong Kong) Limited (“Ocumension HK”), a wholly owned subsidiary of Ocumension Therapeutics, for the development and commercialization under Ocumension HK’s own brand name(s), either directly or through its affiliates or approved third-party sublicensees, of the Company’s 190 microgram fluocinolone acetonide intravitreal implant in applicator (the “Product”; currently marketed in the United States, Europe, and the Middle East as “ILUVIEN®”) for the treatment and prevention of eye diseases in humans, other than uveitis, in a specified territory. The “Territory” is defined as the People’s Republic of China, including Hong Kong SAR and Macau SAR, region of Taiwan, South Korea, Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam.
The Company received a nonrefundable upfront payment of $
The term of the License will continue (a) until the 10th anniversary of the latest first commercial sale of the Product in any country or jurisdiction in the Territory or (b) for as long as Ocumension HK is commercializing the Product in any part of the Territory, whichever is later. The term is subject to the Company’s right to partially terminate the Agreement beginning on the 10th anniversary of the effective date with respect to any country or jurisdiction in the Territory in which Ocumension has not achieved at the time of termination first commercial sale and is not continuing to commercialize the Product. Ocumension will purchase Product from the Company at a fixed transfer price without royalty obligation on future sale (other than milestone payments as described above). Ocumension HK is responsible for all costs of development and commercialization in the Territory.
When the Company entered into the license agreement, it also entered into a share purchase agreement and a warrant subscription agreement (warrant agreement), which are discussed in Note 16.
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Loan Agreements with SLR Investment Corp. (formerly named Solar Capital Ltd.)
As of January 5, 2018, the Company entered into a $
2018 Exit Fee Agreement
Notwithstanding the repayment of the outstanding loan under the 2018 Loan Agreement with part of the SLR Loan, the Company remains obligated to pay additional fees under the Exit Fee Agreement (2018 Exit Fee Agreement) dated as of January 5, 2018 by and among the Company, SLR, as Agent, and the Lenders. The 2018 Exit Fee Agreement survived the termination of the 2018 Loan Agreement upon the repayment of the outstanding loan under the 2018 Loan Agreement and has a term of
Specifically, the Company is obligated to pay an exit fee of $
• first, if the Company achieves revenues of $
• second, if the Company achieves revenues of $
2019 Exit Fee Agreement
The Company is also obligated to pay additional fees under the Exit Fee Agreement dated as of December 31, 2019 by and among the Company, SLR as Agent, and the Lenders (2019 Exit Fee Agreement). The 2019 Exit Fee Agreement will survive the termination of the 2019 Loan Agreement and has a term of
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
First Amendment to 2019 Loan Agreement
On May 1, 2020, the Company entered into a First Amendment (the First Amendment) to the 2019 Loan Agreement. The First Amendment also included revised covenants that applied to the Company’s financial performance during 2020, all of which were met. The First Amendment, among other things, required that a revenue covenant be measured at March 31, 2021 and at the last day of each quarter thereafter, with the minimum revenue amount equal to a percentage of the Company’s projected revenues in accordance with a plan the Company submitted to Agent in February 2021, and with such plan to be approved by the Company’s board of directors (the Board) and SLR in its sole discretion.
Second Amendment to 2019 Loan Agreement
On March 30, 2021, the Company entered into a Second Amendment (the Second Amendment) to the 2019 Loan Agreement. The Second Amendment, among other things:
(a)reflected Agent’s consent to the Company’s delivery of Board-approved annual financial projections for 2021 by April 1, 2021 (which the Company delivered in a timely manner);
(b)specified the minimum revenue amount, calculated on a trailing basis and tested at the end of each calendar quarter in 2021, that the Company must achieve for each such period (the Revenue Covenant);
(c)required that the Revenue Covenant be tested at March 31, 2022 and at the last day of each quarter thereafter, with the minimum revenue amount equal to a percentage of the Company’s projected revenues in accordance with an annual plan submitted by the Company to Agent by January 15th of such year, such plan to be approved by the Board and Agent in its sole discretion; and
(d)provided that in future years the Company must deliver to Agent and the Lenders as soon as available after approval thereof by the Board, but no later than the earlier of (x)
The Company’s operations and thus its net product revenues have continued to be adversely affected by the COVID-19 pandemic. During the six months ended September 30, 2021, the Company did not generate sufficient revenue to meet the trailing six-month revenue covenant included in the 2019 Loan Agreement. The lenders provided a consent that permitted the Company not to maintain the revenue covenant as of September 30, 2021 and waived any event of default that has occurred or may be deemed to have occurred. The Company expects to comply with the revenue covenant at the next reportable date, which is December 31, 2021.
Modification of Debt
In accordance with the guidance in ASC 470-50, Debt, the Company entered into and accounted for the 2019 Loan Agreement as a modification and capitalized approximately $
In accordance with the guidance in ASC 470-50, Debt, the Company entered into and accounted for the First Amendment and the Second Amendment as modifications and expensed, as they were incurred, an insignificant amount of legal costs associated with third parties as costs of modifications. The Company did not capitalize any additional costs associated with either Amendment.
Paycheck Protection Program Loan
On April 22, 2020, the Company received a $
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Company submitted an application to HSBC for forgiveness of the PPP Loan. The PPP Loan was forgiven in its entirety, including interest, on April 16, 2021. As a result of forgiveness, the Company recognized a gain on extinguishment of debt of $
Fair Value of Debt
The weighted average interest rates of the Company’s notes payable approximate the rate at which the Company could obtain alternative financing. Therefore, the carrying amount of the notes approximated their fair value at September 30, 2021 and December 31, 2020.
Hercules Loan Agreement and Related Warrant
In connection with the previous loan with Hercules Capital, Inc. (Hercules), on October 20, 2016, the Company issued a warrant to Hercules Capital, Inc. that granted Hercules the right to purchase up to
The Company follows ASC 260, Earnings Per Share (ASC 260), which requires the reporting of both basic and diluted earnings per share. Because the Company’s preferred stockholders participate in dividends equally with common stockholders (if the Company were to declare and pay dividends), the Company uses the two-class method to calculate EPS. However, the Company’s preferred stockholders are not contractually obligated to share in losses.
Basic EPS is computed by dividing net income or loss available to stockholders by the weighted average number of shares outstanding for the period. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average shares outstanding for the dilutive effect of common stock options, restricted stock units and warrants. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be anti-dilutive.
Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because they were either not classified as participating or would have been anti-dilutive, were as follows:
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| Three and Nine Months Ended | ||||
| September 30, | ||||
| 2021 |
| 2020 | ||
Series A convertible preferred stock |
| |
|
| |
Series C convertible preferred stock |
| — |
|
| |
Common stock warrants |
| |
|
| |
Stock options |
| |
|
| |
Total |
| |
|
| |
Series A Convertible Preferred Stock
As of September 30, 2021, there were
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
13. EQUITY INCENTIVE PLANS
Under the Company’s 2019 Omnibus Incentive Plan (the 2019 Plan), the Compensation Committee of the Board is authorized to grant equity-based incentive awards that include stock options, restricted stock units (RSUs) and shares of restricted stock to officers, directors, employees and contractors. Equity-based awards are also outstanding under the Company’s 2010 Equity Incentive Plan, although no new awards can be granted under that plan. The Company also has an employee stock purchase plan.
Stock Options
During the three months ended September 30, 2021 and 2020, the Company recorded compensation expense related to stock options of approximately $
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| Three Months Ended | ||||||||||
| September 30, | ||||||||||
| 2021 |
| 2020 | ||||||||
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|
| Weighted |
|
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|
| Weighted |
|
|
|
|
| Average |
|
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|
|
| Average |
|
|
|
|
| Exercise |
|
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|
| Exercise |
| Options |
|
| Price ($) |
| Options |
|
| Price ($) | ||
Options outstanding at beginning of period |
| |
|
| |
|
| |
|
| |
Grants |
| |
|
| |
|
| |
|
| |
Forfeitures and expirations |
| ( |
|
| |
|
| ( |
|
| |
Exercises |
|
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|
|
|
|
|
|
|
|
|
Options outstanding at period end |
| |
|
| |
|
| |
|
| |
Options exercisable at period end |
| |
|
| |
|
| |
|
| |
Weighted average per share fair value of options granted during the period | $ | |
|
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|
| $ | |
|
|
|
The following table presents a summary of stock option activity for the nine months ended September 30, 2021 and 2020:
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| Nine Months Ended | ||||||||||
| September 30, | ||||||||||
| 2021 |
| 2020 | ||||||||
|
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| Weighted |
|
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|
| Weighted |
|
|
|
|
| Average |
|
|
|
|
| Average |
|
|
|
|
| Exercise |
|
|
|
|
| Exercise |
| Options |
|
| Price ($) |
| Options |
|
| Price ($) | ||
Options outstanding at beginning of period |
| |
|
| |
|
| |
|
| |
Grants |
| |
|
| |
|
| |
|
| |
Forfeitures |
| ( |
|
| |
|
| ( |
|
| |
Exercises |
| ( |
|
| |
|
|
|
|
|
|
Options outstanding at period end |
| |
|
| |
|
| |
|
| |
Options exercisable at period end |
| |
|
| |
|
| |
|
| |
Weighted average per share fair value of options granted during the period | $ | |
|
|
|
| $ | |
|
|
|
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
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|
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|
| Weighted |
|
|
| |
|
|
|
| Weighted |
| Average |
|
|
| ||
|
|
|
| Average |
| Remaining |
| Aggregate | |||
|
|
|
| Exercise |
| Contractual |
| Intrinsic | |||
| Shares |
| Price ($) |
| Term |
| Value ($) | ||||
|
|
|
|
|
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|
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|
| (In thousands) | |
Outstanding |
| |
|
| |
|
|
|
| — | |
Exercisable |
| |
|
| |
|
|
|
| — | |
Outstanding, vested and expected to vest |
| |
|
| |
|
|
|
| — | |
The following table provides additional information related to outstanding stock options as of December 31, 2020:
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| Weighted |
|
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| |
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| Weighted |
| Average |
|
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| ||
|
|
|
| Average |
| Remaining |
| Aggregate | |||
|
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|
| Exercise |
| Contractual |
| Intrinsic | |||
| Shares |
| Price ($) |
| Term |
| Value ($) | ||||
|
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|
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|
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|
| (In thousands) | |
Outstanding |
| |
|
| |
|
|
|
| — | |
Exercisable |
| |
|
| |
|
|
|
| — | |
Outstanding, vested and expected to vest |
| |
|
| |
|
|
|
| — | |
As of September 30, 2021,
Restricted Stock and Restricted Stock Units
|
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| Three Months Ended | ||||||||||
| September 30, | ||||||||||
| 2021 |
| 2020 | ||||||||
|
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|
| Weighted |
|
|
| Weighted | |||
|
|
| Average |
|
|
| Average | ||||
| Restricted |
| Grant Date |
| Restricted |
| Grant Date | ||||
| Stock & RSUs |
| Fair Value ($) |
| Stock & RSUs |
| Fair Value ($) | ||||
Restricted stock & RSUs outstanding at beginning of period |
| |
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| |
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| |
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| |
Grants |
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| |
Vested units |
| |
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| |
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| |
Forfeitures |
| |
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| |
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| |
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| |
Restricted stock & RSUs outstanding at period end |
| |
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| Nine Months Ended | ||||||||||
| September 30, | ||||||||||
| 2021 |
| 2020 | ||||||||
|
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| Weighted |
|
|
| Weighted | |||
|
|
| Average |
|
|
| Average | ||||
| Restricted |
| Grant Date |
| Restricted |
| Grant Date | ||||
| Stock & RSUs |
| Fair Value ($) |
| Stock & RSUs |
| Fair Value ($) | ||||
Restricted stock & RSUs outstanding at beginning of period |
| |
|
| |
|
| |
|
| |
Grants |
| |
|
| |
|
| |
|
| |
Vested units |
| ( |
|
| |
|
| ( |
|
| |
Forfeitures |
| ( |
|
| |
|
| — |
|
| — |
Restricted stock & RSUs outstanding at period end |
| |
|
| |
|
| |
|
| |
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Employee stock-based compensation expense related to restricted stock and RSUs recognized in accordance with ASC 718, Compensation - Stock Compensation (ASC 718) was $
As of September 30, 2021, the total unrecognized compensation cost related to restricted stock was $
Employee Stock Purchase Plan
During the three months ended September 30, 2021 and 2020, the Company recorded compensation expense related to its employee stock purchase plan of approximately $
In accordance with ASC 740, Income Taxes, the Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of its assets and liabilities at the enacted tax rates in effect for the year in which the differences are expected to reverse. The Company records a valuation allowance against its net deferred tax asset to reduce the net carrying value to an amount that is more likely than not to be realized. At the end of each interim period, the Company makes its best estimate of the effective tax rate expected to be applicable for the full fiscal year. This estimate reflects, among other items, the Company’s best estimate of operating results and foreign currency exchange rates.
The Company also applies the provisions for income taxes related to, among other things, accounting for uncertain tax positions and disclosure requirements. There has been no change to the Company’s policy that recognizes potential interest and penalties related to uncertain tax positions. The Company conducts business globally and, as a result, files income tax returns in the U.S. federal jurisdiction and various state and foreign jurisdictions. In the normal course of business, the Company is subject to examination by taxing authorities throughout the world.
At December 31, 2020, the Company had U.S. federal NOL carry-forwards of approximately $
As of December 31, 2020, the Company had cumulative book losses in foreign subsidiaries of $
During the three months ended September 30, 2021, the Company recognized income in its U.K. subsidiary associated with the agreements with Ocumension Therapeutics. This income will cause the U.K. subsidiary to be taxable in 2021 and will result in local country income tax expense in the U.K. The Company has calculated its income tax expense for the three and nine months ended September 30, 2021 in accordance with ASC 740-270. The increase in the effective tax rate compared to prior periods is primarily due to the income recognized in association with the Ocumension Therapeutics agreements.
During the three months ended September 30, 2021 and 2020,
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
consolidated product revenues. These same
During the first quarter of 2021, the Chief Executive Officer (CEO), who is the chief operating decision maker (CODM), changed the manner in which the CODM monitors performance, aligns strategies and allocates resources, which resulted in a change in the operating segments. The Company’s operations are now managed as three operating segments: U.S., International and Operating Cost. The Company determined that each of these operating segments represented a reportable segment. Previously, the Company was managed as two operating segments: U.S. and International.
The Company’s U.S. and International segments represent the sales and marketing, general and administrative and research & development activities dedicated to the respective geographies. The Operating Cost segment primarily represents the general & administrative and research & development activities not specifically associated with the U.S. or International segments and includes expenses such as executive management; information technology administration and support; legal; compliance; clinical studies; and business development.
Each of the Company’s U.S., International and Operating Cost segments is separately managed and is evaluated primarily upon segment income or loss from operations. Other is presented to reconcile to the Company’s consolidated totals. The Company does not report balance sheet information by segment because the Company’s CODM does not review that information. The Company allocates certain operating expenses among its reporting segments based on activity-based costing methods. These activity-based costing methods require the Company to make estimates that affect the amount of each expense category that is attributed to each segment. Changes in these estimates will directly affect the amount of expense allocated to each segment and therefore the operating profit of each reporting segment.
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| Three Months Ended | |||||||||||||
| September 30, 2021 | |||||||||||||
| U.S. |
| International |
| Operating Cost |
| Other |
| Consolidated | |||||
| (In thousands) | |||||||||||||
REVENUE: |
|
|
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|
|
|
|
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|
|
|
|
|
PRODUCT REVENUE, NET | $ | |
| $ | |
| $ | — |
| $ | — |
| $ | |
LICENSE REVENUE |
| — |
|
| — |
|
| — |
|
| — |
|
| — |
NET REVENUE |
| |
|
| |
|
| — |
|
| — |
|
| |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION |
| ( |
|
| ( |
|
| — |
|
| — |
|
| ( |
GROSS PROFIT |
| |
|
| |
|
| — |
|
| — |
|
| |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
GENERAL AND ADMINISTRATIVE EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
SALES AND MARKETING EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
DEPRECIATION AND AMORTIZATION |
| — |
|
| — |
|
| — |
|
| |
|
| |
OPERATING EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
SEGMENT INCOME (LOSS) FROM OPERATIONS |
| |
|
| |
|
| ( |
|
| ( |
|
| ( |
OTHER INCOME AND EXPENSES, NET |
| — |
|
| — |
|
| — |
|
| ( |
|
| ( |
NET LOSS BEFORE TAXES |
|
|
|
|
|
|
|
|
|
|
|
| $ | ( |
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
|
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|
| Three Months Ended | |||||||||||||
| September 30, 2020 | |||||||||||||
| U.S. |
| International |
| Operating Cost |
| Other |
| Consolidated | |||||
| (In thousands) | |||||||||||||
REVENUE: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PRODUCT REVENUE, NET | $ | |
| $ | |
| $ | — |
| $ | — |
| $ | |
LICENSE REVENUE |
| — |
|
| — |
|
| — |
|
| — |
|
| — |
NET REVENUE |
| |
|
| |
|
| — |
|
| — |
|
| |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION |
| ( |
|
| ( |
|
| — |
|
| — |
|
| ( |
GROSS PROFIT |
| |
|
| |
|
| — |
|
| — |
|
| |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
GENERAL AND ADMINISTRATIVE EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
SALES AND MARKETING EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
DEPRECIATION AND AMORTIZATION |
| — |
|
| — |
|
| — |
|
| |
|
| |
OPERATING EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
SEGMENT INCOME (LOSS) FROM OPERATIONS |
| |
|
| |
|
| ( |
|
| ( |
|
| |
OTHER INCOME AND EXPENSES, NET |
| — |
|
| — |
|
| — |
|
| ( |
|
| ( |
NET LOSS BEFORE TAXES |
|
|
|
|
|
|
|
|
|
|
|
| $ | ( |
|
|
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| Nine Months Ended | |||||||||||||
| September 30, 2021 | |||||||||||||
| U.S. |
| International |
| Operating Cost |
| Other |
| Consolidated | |||||
| (In thousands) | |||||||||||||
REVENUE: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PRODUCT REVENUE, NET | $ | |
| $ | |
| $ | — |
| $ | — |
| $ | |
LICENSE REVENUE |
| — |
|
| |
|
| — |
|
| — |
|
| |
NET REVENUE |
| |
|
| |
|
| — |
|
| — |
|
| |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION |
| ( |
|
| ( |
|
| — |
|
| — |
|
| ( |
GROSS PROFIT |
| |
|
| |
|
| — |
|
| — |
|
| |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
GENERAL AND ADMINISTRATIVE EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
SALES AND MARKETING EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
DEPRECIATION AND AMORTIZATION |
| — |
|
| — |
|
| — |
|
| |
|
| |
OPERATING EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
SEGMENT INCOME (LOSS) FROM OPERATIONS |
| |
|
| |
|
| ( |
|
| ( |
|
| |
OTHER INCOME AND EXPENSES, NET |
| — |
|
| — |
|
| — |
|
| ( |
|
| ( |
NET INCOME BEFORE TAXES |
|
|
|
|
|
|
|
|
|
|
|
| $ | |
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
|
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|
| Nine Months Ended | |||||||||||||
| September 30, 2020 | |||||||||||||
| U.S. |
| International |
| Operating Cost |
| Other |
| Consolidated | |||||
| (In thousands) | |||||||||||||
REVENUE: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PRODUCT REVENUE, NET | $ | |
| $ | |
| $ | — |
| $ | — |
|
| |
LICENSE REVENUE |
| — |
|
| — |
|
| — |
|
| — |
|
| — |
NET REVENUE |
| |
|
| |
|
| — |
|
| — |
|
| |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION |
| ( |
|
| ( |
|
| — |
|
| — |
|
| ( |
GROSS PROFIT |
| |
|
| |
|
| — |
|
| — |
|
| |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
GENERAL AND ADMINISTRATIVE EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
SALES AND MARKETING EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
DEPRECIATION AND AMORTIZATION |
| — |
|
| — |
|
| — |
|
| |
|
| |
OPERATING EXPENSES |
| |
|
| |
|
| |
|
| |
|
| |
SEGMENT INCOME (LOSS) FROM OPERATIONS |
| |
|
| |
|
| ( |
|
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OTHER INCOME AND EXPENSES, NET |
| — |
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NET LOSS BEFORE TAXES |
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| $ | ( |
Share Purchase Agreement
On April 14, 2021, the Company entered into a Share Purchase Agreement with Ocumension Therapeutics, pursuant to which the Company offered and sold to Ocumension
The aggregate gross proceeds from the sale of the Shares were $
Pursuant to the Share Purchase Agreement and subject to certain limited exceptions, Ocumension is prohibited from selling, transferring, or otherwise disposing of the Shares for a year following the closing date.
Ocumension is entitled to certain purchase rights if the Company elects to offer or sell new securities (a “Subsequent Financing”) in either a private or public offering.
Warrant Subscription Agreement
ALIMERA SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
The Company applies ASC 820, Fair Value Measurements, in determining the fair value of certain assets and liabilities. Under this standard, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date.
In determining fair value, the Company uses various valuation approaches. The hierarchy of those valuation approaches is broken down into three levels based on the reliability of inputs as follows:
Level 1 inputs are quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. An active market for the asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. The valuation under this approach does not entail a significant degree of judgment.
Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include: quoted prices for similar assets or liabilities in active markets, inputs other than quoted prices that are observable for the asset or liability, (e.g., interest rates and yield curves observable at commonly quoted intervals or current market) and contractual prices for the underlying financial instrument, as well as other relevant economic measures.
Level 3 inputs are unobservable inputs for the asset or liability. Unobservable inputs shall be used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date.
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| September 30, 2021 | ||||||||||
| Level 1 |
| Level 2 |
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Assets: |
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Warrant asset (1) | $ | — |
| $ | |
| $ | — |
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Assets measured at fair value | $ | — |
| $ | |
| $ | — |
| $ | |
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis should be read in conjunction with our unaudited interim condensed consolidated financial statements and the related notes (Interim Financial Statements) that appear elsewhere in this quarterly report on Form 10-Q. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. Actual results may differ materially from those discussed in these forward-looking statements due to a number of factors. For further information regarding forward-looking statements, please refer to the “Special Note Regarding Forward-Looking Statements and Projections” immediately after the index to this report above.
Overview
Alimera Sciences, Inc., and its subsidiaries (we, our or us), is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. We focus on diseases affecting the back of the eye, or retina, because we believe these diseases are not well treated with current therapies and affect millions of people globally. Our only product is ILUVIEN®, which has received marketing authorization and reimbursement in numerous countries for the treatment of DME. In the U.S. and certain other countries outside Europe, ILUVIEN is indicated for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. In 17 countries in Europe, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. ILUVIEN is also now indicated in 16 countries in Europe for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS).
We market ILUVIEN directly in the U.S., Germany, the U.K., Portugal, and Ireland, and have made ILUVIEN available in the Nordic Region (Denmark, Finland, Norway and Sweden) with the support of an exclusive wholesaler. In addition, we have entered into various agreements under which distributors are providing or will provide regulatory, reimbursement and sales and marketing support for ILUVIEN in Austria, Belgium, the Czech Republic, France, Italy, Luxembourg, the Netherlands, Spain, Australia, New Zealand and several countries in the Middle East. In addition, we have granted an exclusive license to Ocumension Therapeutics for the development and commercialization of our 0.19mg fluocinolone acetonide intravitreal implant in China, East Asia and the Western Pacific. As of September 30, 2021, we have recognized sales of ILUVIEN to our international distributors covering the Middle East, Austria, Belgium, France, Italy, Spain, Luxembourg and the Netherlands.
Where We Market ILUVIEN to Treat Diabetic Macular Edema (DME)
ILUVIEN has received marketing authorization for the use of ILUVIEN to treat DME for the indications and in the countries shown in the following table:
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Indication for the Treatment of DME |
| Countries Where ILUVIEN Has Received Marketing Authorization to Treat DME |
| Countries Where ILUVIEN Has Received Reimbursement Approval to Treat DME |
| Countries Where ILUVIEN is Currently Available to Treat DME | |
Treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure |
| U.S., Australia, Canada, Kuwait, Lebanon and the United Arab Emirates |
| U.S., Kuwait, Lebanon and the United Arab Emirates |
| U.S., Kuwait, Lebanon and the United Arab Emirates | |
Treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies
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| The United Kingdom (U.K.), Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czech Republic, the Netherlands and Luxembourg |
| The U.K., Germany, France, Italy, Spain, Portugal, Ireland, Luxembourg and the Netherlands |
| The U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Luxembourg, Denmark, Norway, Finland and the Netherlands | |
Where We Market ILUVIEN to Treat Recurrent Non-Infectious Uveitis Affecting the Posterior Segment of the Eye (NIU-PS)
ILUVIEN has received marketing authorization for the use of ILUVIEN to treat NIU-PS for the indications and in the countries shown in the following table:
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Indication for the Treatment of NIU-PS |
| Countries Where ILUVIEN Has Received Marketing Authorization to Treat NIU-PS |
| Countries Where ILUVIEN Has Received Reimbursement Approval to Treat NIU-PS |
| Countries Where ILUVIEN is Currently Marketed to Treat NIU-PS |
The prevention of relapse in recurrent NIU-PS
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| The U.K., Germany, France, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czech Republic, the Netherlands and Luxembourg |
| The U.K., Germany, Ireland (private sector), Luxembourg and the Netherlands |
| The U.K. Germany, Ireland, Luxembourg, Denmark, Norway, Sweden, Finland and the Netherlands |
We launched ILUVIEN for the NIU-PS indication in Germany and the U.K. during the third quarter of 2019, the Netherlands during the fourth quarter of 2020 and Luxembourg in the first quarter of 2021. In addition, we secured reimbursement of ILUVIEN for NIU-PS with the major private insurers in Ireland in the first quarter of 2021.
ILUVIEN became commercially available in Finland and Denmark during the first quarter of 2021 and in Norway during the second quarter of 2021. ILUVIEN is commercialized in the Nordic Region through a direct commercial team and our contracted wholesaler partner.
We signed an agreement on August 4, 2021 with Tanner Pharma to make ILUVIEN accessible to doctors wishing to use it on a named-patient basis in territories where ILUVIEN is not licensed or commercialized while ensuring compliance with regulations.
Effects of the COVID-19 Pandemic
The unprecedented events of the COVID-19 pandemic, and its unpredictable duration, in the regions where we have customers, employees and distributors have had an adverse effect on our sales of ILUVIEN and thus on our net revenues and may in the future have an adverse effect on our liquidity and financial condition. These adverse effects of the pandemic on us have resulted from the following, among other factors:
•Limitations imposed by governments and private parties on in-person access to physicians adversely affect us in at least two ways. First, these limitations can affect patient access to treatment. Because ILUVIEN is administered only by an injection into the eye, telemedicine is not a viable substitute when administration of treatment is required. Second, limitations on in-person access to physicians, such as obtaining access to government-controlled facilities, also makes it difficult or impossible for our sales representatives (including those employed by our distributors) to meet with retina specialists and their staff to educate them about ILUVIEN. We currently or have recently faced these limitations in Veterans Administration hospitals, Kaiser Permanente hospitals, and certain hospitals in Germany and the other countries where we market ILUVIEN
•Patients’ concerns about their personal health during the COVID-19 pandemic have also negatively affected our business. Prior to the pandemic, most of our ILUVIEN sales were driven by the use of ILUVIEN to treat diabetic macular edema, or DME. Given that health authorities have cited diabetes as a factor that places a person at higher risk for severe illness from the COVID-19 pandemic, many DME patients have been hesitant or even unwilling to visit their physicians in person (even if otherwise permitted) for fear of contracting the COVID-19 coronavirus. In addition, the adverse effect of DME on a patient’s vision can progress slowly over time, and patients may defer seeking treatment until their loss of vision is significant, which we believe may negatively affect user demand for ILUVIEN.
•In addition to the effects of limitations on in-person access to physicians, limitations on travel earlier in 2021 within and between the countries in which we market and sell ILUVIEN, as well as various types of lockdown or restricted access orders, curtailed our in-person marketing activities, and those limitations could be imposed again in the future.
•The occurrence of COVID-19 pandemic “waves” in individual countries and the uneven level of vaccination across countries have created further difficulty in planning and forecasting business activity and resulted in a reduced ability to consistently and effectively market ILUVIEN in affected countries; and
•As physicians gain increased access to patients, they may give a higher priority to patients with acute illnesses before treating patients with chronic illnesses such as DME, thereby reducing or delaying the number of ILUVIEN treatments that might otherwise have been performed.
These limitations and other effects of the COVID-19 pandemic have had an adverse impact on our revenues beginning late in the first quarter of 2020 and continuing through the date of this report. We expect these factors to continue to adversely impact our revenue and capital resources, and the extent and duration of that impact is uncertain at this time, particularly in light of the emergence of COVID-19 variants that increase the transmissibility of the coronavirus. (Please refer to “Special Note Regarding Forward-Looking Statements and Projections” above.)
In response to these developments, we have implemented measures to mitigate the impact of the pandemic on our financial position and operations. These measures include the following:
•We are continuing to monitor the effects of the SARS-CoV-2 variants and to manage our cost structure where possible to mitigate any anticipated loss of revenue in those markets that are affected.
•We are focusing our spending in certain countries where access is less restricted in order to serve our customers and patients through either direct or alternative forms of engagement.
Transactions with Ocumension Therapeutics
On April 14, 2021, we entered into a transaction with Ocumension Therapeutics, incorporated in the Cayman Islands with limited liability (Ocumension), or one of its affiliates. In the Ocumension transaction, we received a total of $20.0 million in cash under two agreements:
•a Share Purchase Agreement with Ocumension, pursuant to which we offered and sold to Ocumension 1,144,945 shares of our common stock at a purchase price of $8.734044 per share, or $10.0 million in total; and
•an Exclusive License Agreement (the Ocumension License Agreement) with a wholly owned subsidiary of Ocumension, pursuant to which we granted an exclusive license for the development and commercialization of our 190 microgram fluocinolone acetonide intravitreal implant in applicator under Ocumension’s own branded label in China, East Asia, and the Western Pacific, in exchange for a nonrefundable upfront payment of $10.0 million and aggregated potential sales milestone payments of up to $89.0 million upon achievement by the Ocumension subsidiary of specified amounts of net sales of the licensed product in in the future. We recognized $11.0 million in license revenue from the Ocumension transaction (including the value of a warrant subscription agreement, which we received as consideration, to purchase 1,000,000 shares of Ocumension Therapeutics during a period of four years), in accordance with ASC 606, Revenue from Contracts with Customers, with the remaining approximate $300,000 in consideration received classified as deferred revenue that will be recognized over the remaining term of the license agreement once Ocumension begins to sell products. Revenue from the Ocumension License Agreement is included within net revenue in the accompanying condensed consolidated statements of operations.
For more information about the Ocumension transaction, see Notes 9 and 16 of our notes to the accompanying Unaudited Interim Condensed Consolidated Financial Statements (Interim Financial Statements) and our Current Report on Form 8-K filed with the SEC on April 14, 2021.
Sources of Revenues
Our revenues for the three months ended September 30, 2021 and 2020 were generated from product sales primarily in the U.S., Germany and the U.K. Our revenues for the nine months ended September 30, 2021 and 2020 were generated from (a) product sales primarily in the U.S., Germany and the U.K., including the recognition of $1.0 million of deferred revenue associated with the termination of our Canadian distribution agreement with Knight Therapeutics, and (b) for the nine months ended September 30, 2021, under an analysis performed utilizing ASC 606, Revenue from Contracts with Customers, the upfront license payment and the value of the warrant agreement resulted in license revenue of $11.0 million. In the U.S., two large pharmaceutical distributors accounted for 57% and 56% of our consolidated product revenues for the three months ended September 30, 2021 and 2020, respectively, and 54% and 47% of our consolidated product revenues for the nine months ended September 30, 2021 and 2020, respectively. These U.S.-based distributors purchase ILUVIEN from us, maintain inventories of ILUVIEN and sell downstream to physician offices, pharmacies and hospitals. Internationally, in countries where we sell direct, our customers are hospitals, clinics and pharmacies. We sometimes refer to physician offices, pharmacies, hospitals and clinics as end users. In international countries where we sell to distributors, these distributors maintain inventory levels of ILUVIEN for sale to their customers.
License Agreement with EyePoint Pharmaceuticals US, Inc.
Under the July 2017 New Collaboration Agreement with EyePoint Pharmaceuticals US, Inc. (EyePoint), we have rights to the technology underlying ILUVIEN for the treatment of (a) human eye diseases, including uveitis, in Europe, the Middle East, and Africa, and (b) human eye diseases other than uveitis worldwide. During the three and nine months ended September 30, 2020, the royalty amount was 4%. During the three and nine months ended September 30, 2021, the royalty amount was 5.2%. We will pay an additional 2% royalty on future global net revenues and other related consideration in excess of $75,000,000 in any year. (For more information about our agreement with EyePoint, including how we calculate the royalty percentages we are required to pay, see Note 9 of our notes to the accompanying Interim Financial Statements.)
Results of Operations
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| Three Months Ended |
| Nine Months Ended | ||||||||
| September 30, |
| September 30, | ||||||||
| 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
| (In thousands, except share and per share data) | ||||||||||
REVENUE: |
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PRODUCT REVENUE, NET | $ | 12,153 |
| $ | 12,473 |
| $ | 34,022 |
| $ | 37,046 |
LICENSE REVENUE |
| — |
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| — |
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| 11,048 |
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| — |
NET REVENUE |
| 12,153 |
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| 12,473 |
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| 45,070 |
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| 37,046 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION |
| (1,689) |
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| (1,537) |
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| (5,064) |
|
| (4,949) |
GROSS PROFIT |
| 10,464 |
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| 10,936 |
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| 40,006 |
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| 32,097 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES |
| 3,278 |
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| 2,469 |
|
| 10,058 |
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| 7,162 |
GENERAL AND ADMINISTRATIVE EXPENSES |
| 2,808 |
|
| 2,421 |
|
| 9,577 |
|
| 8,194 |
SALES AND MARKETING EXPENSES |
| 5,751 |
|
| 4,962 |
|
| 15,900 |
|
| 15,399 |
DEPRECIATION AND AMORTIZATION |
| 649 |
|
| 677 |
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| 1,920 |
|
| 2,016 |
OPERATING EXPENSES |
| 12,486 |
|
| 10,529 |
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| 37,455 |
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| 32,771 |
(LOSS) INCOME FROM OPERATIONS |
| (2,022) |
|
| 407 |
|
| 2,551 |
|
| (674) |
INTEREST EXPENSE AND OTHER |
| (1,360) |
|
| (1,285) |
|
| (4,050) |
|
| (3,928) |
UNREALIZED FOREIGN CURRENCY GAIN, NET |
| 142 |
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| 267 |
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| 323 |
|
| 295 |
GAIN ON EXTINGUISHMENT OF DEBT |
| — |
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| — |
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| 1,792 |
|
| — |
CHANGE IN FAIR VALUE OF WARRANT ASSET |
| (1,112) |
|
| — |
|
| (411) |
|
| — |
NET (LOSS) INCOME BEFORE TAXES |
| (4,352) |
|
| (611) |
|
| 205 |
|
| (4,307) |
INCOME TAX BENEFIT (PROVISION) |
| 169 |
|
| (7) |
|
| (471) |
|
| (55) |
NET LOSS | $ | (4,183) |
| $ | (618) |
| $ | (266) |
| $ | (4,362) |
NET LOSS PER SHARE — Basic and Diluted | $ | (0.60) |
| $ | (0.12) |
| $ | (0.04) |
| $ | (0.87) |
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and Diluted |
| 6,924,174 |
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| 5,068,701 |
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| 6,480,952 |
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| 5,026,905 |
Net Revenue
We generate revenue from ILUVIEN, our only product. In addition to generating revenue from product sales, we seek to generate revenue from other sources such as upfront fees, milestone payments in connection with collaborative or strategic relationships, and royalties resulting from the licensing of ILUVIEN or any future product candidates and other intellectual property. In that regard, we recognized $11.0 million in revenue in the nine months ended September 30, 2021 from our transactions with Ocumension. Revenue from our international distributors fluctuates depending on the timing of the shipment of ILUVIEN to the distributors and the distributors’ sales of ILUVIEN to their customers.
Net revenue decreased by approximately $300,000, or 2%, to approximately $12.2 million for the three months ended September 30, 2021, compared to approximately $12.5 million for the three months ended September 30, 2020. The COVID-19 pandemic continued to negatively impact our international product sales and, to a lesser degree, our U.S. product sales.
Net revenue increased by approximately $8.1 million, or 22%, to approximately $45.1 million for the nine months ended September 30, 2021, compared to approximately $37.0 million for the nine months ended September 30, 2020. The increase was primarily attributable to (a) the $11.0 million of recognized license revenue from our transactions with Ocumension and (b) the recognition of $1.0 million of deferred revenue associated with the termination of our Canadian distribution agreement with Knight Therapeutics, both of which were
recognized during the nine months ended September 30, 2021. For the nine months ended September 30, 2021, the COVID-19 pandemic continued to negatively impact our international product sales and, to a lesser degree, our U.S. product sales.
Cost of Goods Sold, Excluding Depreciation and Amortization, and Gross Profit
Gross profit is affected by costs of goods sold, which includes costs of manufactured goods sold and royalty payments to EyePoint under the New Collaboration Agreement. Additionally, cost of goods sold by our international distributors fluctuates depending on the revenue share attributable to the respective contract.
Cost of goods sold, excluding depreciation and amortization, increased by approximately $100,000, or 6%, to approximately $1.7 million for the three months ended September 30, 2021, compared to approximately $1.6 million for the three months ended September 30, 2020. The increase was primarily attributable to our increased royalty expense payable on net revenue due to the increased royalty percentage payable to EyePoint from 4% in 2020 to 5.2% in 2021.
Cost of goods sold, excluding depreciation and amortization, increased by approximately $200,000, or 4%, to approximately $5.1 million for the nine months ended September 30, 2021, compared to approximately $4.9 million for the nine months ended September 30, 2020. The increase was primarily attributable to our increased royalty expense payable on net revenue due to the increased royalty percentage payable to EyePoint from 4% in 2020 to 5.2% in 2021, with an additional impact due to royalty expense on the license revenue associated with the Ocumension transaction.
Gross profit decreased by approximately $400,000, or 4%, to approximately $10.5 million for the three months ended September 30, 2021, compared to approximately $10.9 million for the three months ended September 31, 2020. Gross margin was 86% and 88% for the three months ended September 30, 2021 and 2020, respectively.
Gross profit increased by approximately $7.9 million, or 25%, to approximately $40.0 million for the nine months ended September 30, 2021, compared to approximately $32.1 million for the nine months ended September 31, 2020. Gross margin was 89% and 87% for the nine months ended September 30, 2021 and 2020, respectively. While the license revenue we recognized had no product cost of goods sold associated with it, we did have additional royalty expense that reduced our gross margin for the nine months ended September 30, 2021.
Research, Development and Medical Affairs Expenses
Currently, our research, development and medical affairs expenses are primarily focused on activities that support ILUVIEN and include salaries and related expenses for research and development and medical affairs personnel, including medical science liaisons. Our research, development and medical affairs expenses also include costs related to clinical studies such as the NEW DAY Study and the provision of medical affairs support, including symposia development for physician education, and costs related to compliance with FDA, EEA or other regulatory requirements. We expense both internal and external research and development costs as they are incurred.
Research, development and medical affairs expenses increased by approximately $800,000, or 32%, to approximately $3.3 million for the three months ended September 30, 2021, compared to approximately $2.5 million for the three months ended September 30, 2020. The increase was primarily attributable to increases of approximately $750,000 of administrative and pass-through costs associated with clinical trials, primarily consisting of costs associated with our NEW DAY Study and $180,000 in consultant costs. These increases were offset by a decrease of approximately $210,000 in drug safety and ILUVIEN quality costs.
Research, development and medical affairs expenses increased by approximately $2.9 million, or 40%, to approximately $10.1 million for the nine months ended September 30, 2021, compared to approximately $7.2 million for the nine months ended September 30, 2020. The increase was primarily attributable to increases of approximately $2.4 million of administrative and pass-through costs associated with clinical trials, primarily consisting of costs associated with our NEW DAY Study, $500,000 in personnel costs and $440,000 in consultant costs. These increases were offset by a decrease of approximately $210,000 in drug safety and ILUVIEN quality costs.
General and Administrative Expenses
General and administrative expenses consist primarily of compensation for employees in executive and administrative functions, including finance, accounting, information technology, training and employee development. Other significant costs include facilities costs and professional fees for accounting and legal services, including legal services associated with obtaining and maintaining patents and managing license agreements. We expect to continue to incur significant costs to comply with the corporate governance, internal control and similar requirements applicable to public companies.
General and administrative expenses increased by approximately $400,000, or 17%, to approximately $2.8 million for the three months ended September 30, 2021, compared to approximately $2.4 million for the three months ended September 30, 2020. The increase was primarily attributable to increases of approximately $340,000 in personnel costs.
General and administrative expenses increased by approximately $1.4 million, or 17%, to approximately $9.6 million for the nine months ended September 30, 2021, compared to approximately $8.2 million for the nine months ended September 30, 2020. The increase was primarily attributable to increases of approximately $1.1 million in personnel costs, and $340,000 in professional fees, some of which were associated with the Ocumension transaction.
Sales and Marketing Expenses
Sales and marketing expenses consist primarily of third-party service fees and compensation for employees for the commercial promotion of, the assessment of the commercial opportunity of, the development of market awareness for, the pursuit of reimbursement approval for, and the commercialization of ILUVIEN, including launch plans for ILUVIEN in new markets. Other costs include professional fees associated with developing plans for ILUVIEN or any future products or product candidates and maintaining public relations.
Sales and marketing expenses increased by approximately $800,000, or 16%, to approximately $5.8 million for the three months ended September 30, 2021, compared to approximately $5.0 million for the three months ended September 30, 2020. The increase was primarily attributable to increases of (a) approximately $470,000 in marketing costs, including costs for targeted health care providers and patient brand awareness campaigns; and (b) approximately $430,000 of personnel costs, including expenses associated with hiring additional employees, and additional travel expenses as our sales force has begun to return to the field in 2021.
Sales and marketing expenses increased by approximately $500,000, or 3%, to approximately $15.9 million for the nine months ended September 30, 2021, compared to approximately $15.4 million for the nine months ended September 30, 2020. The increase was primarily attributable to an increase in personnel costs, including expenses associated with hiring additional employees, and to additional travel expenses as our sales force has begun to return to the field in 2021.
Operating Expenses
As a result of the increases in various expenses described above, total operating expenses increased by approximately $2.0 million, or 19%, to approximately $12.5 million for the three months ended September 30, 2021, compared to approximately $10.5 million for the three months ended September 30, 2020. The increase was primarily attributable to an increase of approximately $1.0 million in sales and marketing expenses, $800,000 in research, development and medical affairs expenses and $200,000 in general and administrative expenses as described above.
As a result of the increases and decreases in various expenses described above, total operating expenses increased by approximately $4.7 million, or 14%, to approximately $37.5 million for the nine months ended September 30, 2021, compared to approximately $32.8 million for the nine months ended September 30, 2020. The increase was primarily attributable to increases of approximately $2.9 million in research, development and medical affairs expenses, $1.1 million in sales and marketing expenses and $800,000 in general and administrative expenses as described above.
Interest Expense and Other
Interest Expense and Other increased by approximately $100,000, or 8%, to approximately $1.4 million for the three months ended September 30, 2021, compared to approximately $1.3 million for the three months ended September 30, 2020.
Interest Expense and Other increased by approximately $200,000, or 5%, to approximately $4.1 million for the nine months ended September 30, 2021, compared to approximately $3.9 million for the nine months ended September 30, 2020.
Basic and Diluted Net Loss Applicable to Common Stockholders per Share of Common Stock
We follow FASB Accounting Standards Codification, Earnings Per Share (ASC 260), which requires the reporting of both basic and diluted earnings per share. Because our preferred stockholders participate in dividends equally with common stockholders (if we were to declare and pay dividends), we use the two-class method to calculate EPS. However, our preferred stockholders are not contractually obligated to share in losses.
Basic EPS is computed by dividing net loss available to stockholders by the weighted average number of shares outstanding for the period. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average shares outstanding for the dilutive effect of common stock options, restricted stock units and warrants. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, because the effect would be anti-dilutive.
Common stock equivalent securities that would potentially dilute basic EPS in the future but were not included in the computation of diluted EPS because they were either classified as participating and do not share in losses or would have been anti-dilutive, were approximately 1,713,324 for the three and nine months ended September 30, 2021, and 2,338,872 for the three and nine months ended September 30, 2020.
Results of Operations - Segment Review
The following selected unaudited financial and operating data are derived from our Interim Financial Statements. The results and discussions that follow reflect how executive management monitors the performance of our reporting segments.
During the first quarter of 2021, our Chief Executive Officer (CEO), who is our chief operating decision maker (CODM), changed the manner in which the CODM monitors performance, aligns strategies and allocates resources, which resulted in a change in our operating segments. Our operations are now managed as three operating segments: U.S., International and Operating Cost. We determined that each of these operating segments represented a reportable segment. Previously, the business was managed as two operating segments: U.S. and International.
Our U.S. and International segments represent the sales and marketing, general and administrative and research & development activities dedicated to the respective geographies. The Operating Cost segment primarily represents the general & administrative and research & development activities not specifically associated with the U.S. or International segments and include expenses such as executive management; information technology administration and support; legal; compliance; clinical studies; and business development.
Each of our U.S., International and Operating Cost segments is separately managed and is evaluated primarily upon segment income or loss from operations. Other is presented to reconcile to our consolidated totals. We do not report balance sheet information by segment because our CODM does not review that information. We allocate certain operating expenses between our reporting segments based on activity-based costing methods. These activity-based costing methods require us to make estimates that affect the amount of each expense category that is attributed to each segment. Changes in these estimates will directly affect the amount of expense allocated to each segment and therefore the operating profit of each reporting segment.
U.S. Segment
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| Three Months Ended |
| Nine Months Ended | ||||||||
| September 30, |
| September 30, | ||||||||
| 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
| (In thousands) | ||||||||||
REVENUE: |
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|
PRODUCT REVENUE, NET | $ | 6,917 |
| $ | 6,962 |
| $ | 18,352 |
| $ | 17,449 |
LICENSE REVENUE |
| — |
|
| — |
|
| — |
|
| — |
NET REVENUE |
| 6,917 |
|
| 6,962 |
|
| 18,352 |
|
| 17,449 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION |
| (830) |
|
| (746) |
|
| (2,285) |
|
| (1,928) |
GROSS PROFIT |
| 6,087 |
|
| 6,216 |
|
| 16,067 |
|
| 15,521 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES |
| 1,042 |
|
| 864 |
|
| 2,641 |
|
| 2,720 |
GENERAL AND ADMINISTRATIVE EXPENSES |
| 224 |
|
| 168 |
|
| 694 |
|
| 689 |
SALES AND MARKETING EXPENSES |
| 3,943 |
|
| 3,328 |
|
| 10,889 |
|
| 10,580 |
OPERATING EXPENSES |
| 5,209 |
|
| 4,360 |
|
| 14,224 |
|
| 13,989 |
SEGMENT INCOME FROM OPERATIONS | $ | 878 |
| $ | 1,856 |
| $ | 1,843 |
| $ | 1,532 |
U.S. Segment - three months ended September 30, 2021 compared to the three months ended September 30, 2020
Net revenue. Net revenue decreased by approximately $100,000, or 1%, to approximately $6.9 million for the three months ended September 30, 2021, compared to approximately $7.0 million for the three months ended September 30, 2020. Despite the decrease in net
revenue, end user demand, which represents units purchased by physicians and pharmacies from our distributors, increased 15% in the three months ended September 30, 2021, increasing to 837 units compared to 728 units in the three months ended September 30, 2020.
Cost of goods sold, excluding depreciation and amortization. Cost of goods sold, excluding depreciation and amortization, increased by approximately $80,000, or 11%, to approximately $830,000 for the three months ended September 30, 2021, compared to approximately $750,000 for the three months ended September 30, 2020. The increase was primarily attributable to our increased royalty percentage payable to EyePoint which increased from 4% in the 2020 period to 5.2% in the 2021 period.
Research, development and medical affairs expenses. Research, development and medical affairs expenses increased by approximately $140,000, or 16%, to approximately $1.0 million for the three months ended September 30, 2021, compared to approximately $860,000 for the three months ended September 30, 2020.
General and administrative expenses. General and administrative expenses increased by approximately $50,000, or 29%, to approximately $220,000 for the three months ended September 30, 2021, compared to approximately $170,000 for the three months ended September 30, 2020.
Sales and marketing expenses. Sales and marketing expenses increased by approximately $600,000, or 18%, to approximately $3.9 million for the three months ended September 30, 2021, compared to approximately $3.3 million for the three months ended September 30, 2020. The increase was primarily attributable to increases of approximately $330,000 in marketing costs, including costs for targeted health care providers and patient brand awareness campaigns and $250,000 in personnel and travel expenses.
U.S. Segment - nine months ended September 30, 2021 compared to the nine months ended September 30, 2020
Net revenue. Net revenue increased by approximately $900,000, or 5%, to approximately $18.4 million for the nine months ended September 30, 2021, compared to approximately $17.5 million for the nine months ended September 30, 2020. End user demand, which represents units purchased by physicians and pharmacies from our distributors, increased 4% in the nine months ended September 30, 2021, compared to the nine months ended September 30, 2020.
Cost of goods sold, excluding depreciation and amortization. Cost of goods sold, excluding depreciation and amortization, increased by approximately $400,000, or 21%, to approximately $2.3 million for the nine months ended September 30, 2021, compared to approximately $1.9 million for the nine months ended September 30, 2020. The increase was primarily attributable to our increased royalty percentage payable to EyePoint, which increased from 4% in the 2020 period to 5.2% in the 2021 period.
Research, development and medical affairs expenses. Research, development and medical affairs expenses decreased by approximately $100,000, or 4%, to approximately $2.6 million for the nine months ended September 30, 2021, compared to approximately $2.7 million for the nine months ended September 30, 2020.
General and administrative expenses. General and administrative expenses were approximately $690,000 for both the nine months ended September 30, 2021, and 2020.
Sales and marketing expenses. Sales and marketing expenses increased by approximately $300,000, or 3%, to approximately $10.9 million for the nine months ended September 30, 2021, compared to approximately $10.6 million for the nine months ended September 30, 2020. The increase was primarily attributable to increases in personnel and travel expenses.
International Segment
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| Three Months Ended |
| Nine Months Ended | ||||||||
| September 30, |
| September 30, | ||||||||
| 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
| (In thousands) | ||||||||||
REVENUE: |
|
|
|
|
|
|
|
|
|
|
|
PRODUCT REVENUE, NET | $ | 5,236 |
| $ | 5,511 |
| $ | 15,670 |
| $ | 19,597 |
LICENSE REVENUE |
| — |
|
| — |
|
| 11,048 |
|
| — |
NET REVENUE |
| 5,236 |
|
| 5,511 |
|
| 26,718 |
|
| 19,597 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION |
| (859) |
|
| (791) |
|
| (2,779) |
|
| (3,021) |
GROSS PROFIT |
| 4,377 |
|
| 4,720 |
|
| 23,939 |
|
| 16,576 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES |
| 979 |
|
| 805 |
|
| 3,005 |
|
| 2,236 |
GENERAL AND ADMINISTRATIVE EXPENSES |
| 6 |
|
| 97 |
|
| 1,064 |
|
| 1,139 |
SALES AND MARKETING EXPENSES |
| 1,610 |
|
| 1,425 |
|
| 4,407 |
|
| 4,200 |
OPERATING EXPENSES |
| 2,595 |
|
| 2,327 |
|
| 8,476 |
|
| 7,575 |
SEGMENT INCOME FROM OPERATIONS | $ | 1,782 |
| $ | 2,393 |
| $ | 15,463 |
| $ | 9,001 |
International Segment - three months ended September 30, 2021 compared to the three months ended September 30, 2020
Net revenue. Net revenue decreased by approximately $300,000, or 5%, to approximately $5.2 million for the three months ended September 30, 2021, compared to approximately $5.5 million for the three months ended September 30, 2020. The COVID-19 pandemic continued to negatively impact our international product sales.
Cost of goods sold, excluding depreciation and amortization. Cost of goods sold, excluding depreciation and amortization, increased by approximately $70,000, or 9%, to approximately $860,000 for the three months ended September 30, 2021, compared to approximately $790,000 for the three months ended September 30, 2020. This was primarily attributable to our increased royalty expense payable to EyePoint which increased from 4% in the 2020 period to 5.2% in the 2021 period.
Research, development and medical affairs expenses. Research, development and medical affairs expenses increased by approximately $170,000, or 21%, to approximately $980,000 for the three months ended September 30, 2021, compared to approximately $810,000 for the three months ended September 30, 2020. The increase was primarily due to increases in consultant costs.
General and administrative expenses. General and administrative expenses decreased by approximately $90,000, or 90%, to approximately $10,000 for the three months ended September 30, 2021, compared to approximately $100,000 for the three months ended September 30, 2020. General and administrative expenses were insignificant for each of the three months ended September 30, 2021 and 2020, due the recovery of VAT expenses in Germany in each period.
Sales and marketing expenses. Sales and marketing expenses increased by approximately $200,000, or 14%, to approximately $1.6 million for the three months ended September 30, 2021, compared to approximately $1.4 million for the three months ended September 30, 2020. The increase was primarily attributable to an increase in personnel costs.
International Segment - nine months ended September 30, 2021 compared to the nine months ended September 30, 2020
Net revenue. Net revenue increased by approximately $7.1 million, or 36%, to approximately $26.7 million for the nine months ended September 30, 2021, compared to approximately $19.6 million for the nine months ended September 30, 2020. The increase was primarily attributable to (a) $11.0 million of recognized license revenue from our transactions with Ocumension and (b) the recognition of $1.0 million in deferred revenue associated with the termination of our Canadian distribution agreement with Knight Therapeutics, both of which were recognized during the second quarter of 2021. The COVID-19 pandemic continued to negatively impact our international product sales.
Cost of goods sold, excluding depreciation and amortization. Cost of goods sold, excluding depreciation and amortization, decreased by approximately $200,000, or 7%, to approximately $2.8 million for the nine months ended September 30, 2021, compared to approximately $3.0 million for the nine months ended September 30, 2020. The decrease was primarily attributable to lower sales to our international distributors. This decrease was offset by our increased royalty expense payable to EyePoint which increased from 4% in the 2020 period to
5.2% in the 2021 period, with an additional impact due to royalty expense associated with license revenue associated with the Ocumension transaction.
Research, development and medical affairs expenses. Research, development and medical affairs expenses increased by approximately $800,000, or 36%, to approximately $3.0 million for the nine months ended September 30, 2021, compared to approximately $2.2 million for the nine months ended September 30, 2020. The increase was primarily due to increases of approximately $550,000 in consultant costs and $250,000 in personnel costs.
General and administrative expenses. General and administrative expenses were approximately $1.1 million for both the nine months ended September 30, 2021 and 2020.
Sales and marketing expenses. Sales and marketing expenses increased by approximately $200,000, or 5%, to approximately $4.4 million for the nine months ended September 30, 2021, compared to approximately $4.2 million for the nine months ended September 30, 2020. The increase was primarily attributable to an increase in personnel costs.
Operating Cost Segment
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| Three Months Ended |
| Nine Months Ended | ||||||||
| September 30, |
| September 30, | ||||||||
| 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
| (In thousands) | ||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | $ | 1,221 | $ |
| 752 |
| $ | 4,343 | $ |
| 2,042 |
GENERAL AND ADMINISTRATIVE EXPENSES |
| 2,429 |
|
| 1,964 |
|
| 7,311 |
|
| 5,708 |
SALES AND MARKETING EXPENSES |
| 138 |
|
| 132 |
|
| 423 |
|
| 367 |
OPERATING EXPENSES |
| 3,788 |
|
| 2,848 |
|
| 12,077 |
|
| 8,117 |
SEGMENT LOSS FROM OPERATIONS | $ | (3,788) |
| $ | (2,848) |
| $ | (12,077) |
| $ | (8,117) |
Operating Cost Segment - three months ended September 30, 2021 compared to the three months ended September 30, 2020
Research, development and medical affairs expenses. Research, development and medical affairs expenses increased by approximately $450,000, or 60%, to approximately $1.2 million for the three months ended September 30, 2021, compared to approximately $750,000 for the three months ended September 30, 2020. The increase was primarily attributable to administrative and pass-through costs associated clinical trials, largely consisting of costs associated with our NEW DAY Study.
General and administrative expenses. General and administrative expenses increased by approximately $500,000, or 25%, to approximately $2.5 million for the three months ended September 30, 2021, compared to approximately $2.0 million for the three months ended September 30, 2020. The increase was primarily attributable to increases in personnel costs.
Sales and marketing expenses. Sales and marketing expenses increased by approximately $10,000, or 8%, to approximately $140,000 for the three months ended September 30, 2021, compared to approximately $130,000 for the three months ended September 30, 2020.
Operating Cost Segment - nine months ended September 30, 2021 compared to the nine months ended September 30, 2020
Research, development and medical affairs expenses. Research, development and medical affairs expenses increased by approximately $2.3 million, or 115%, to approximately $4.3 million for the nine months ended September 30, 2021, compared to approximately $2.0 million for the nine months ended September 30, 2020. The increase was primarily attributable to an increase in administrative and pass-through costs associated with clinical trials, primarily consisting of costs associated with our NEW DAY Study.
General and administrative expenses. General and administrative expenses increased by approximately $1.6 million, or 28%, to approximately $7.3 million for the nine months ended September 30, 2021, compared to approximately $5.7 million for the nine months ended September 30, 2020. The increase was primarily attributable to increases of approximately $980,000 in personnel costs, and $380,000 in professional fees, some of which were associated with the Ocumension transaction.
Sales and marketing expenses. Sales and marketing expenses increased by approximately $50,000, or 14%, to approximately $420,000 for the nine months ended September 30, 2021, compared to approximately $370,000 for the nine months ended September 30, 2020.
Other
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| Three Months Ended |
| Nine Months Ended | ||||||||
| September 30, |
| September 30, | ||||||||
| 2021 |
| 2020 |
| 2021 |
| 2020 | ||||
| (In thousands) | ||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | $ | 36 |
| $ | 48 |
| $ | 69 |
| $ | 164 |
GENERAL AND ADMINISTRATIVE EXPENSES |
| 149 |
|
| 192 |
|
| 508 |
|
| 658 |
SALES AND MARKETING EXPENSES |
| 60 |
|
| 77 |
|
| 181 |
|
| 252 |
DEPRECIATION AND AMORTIZATION |
| 649 |
|
| 677 |
|
| 1,920 |
|
| 2,016 |
OPERATING EXPENSES |
| 894 |
|
| 994 |
|
| 2,678 |
|
| 3,090 |
SEGMENT LOSS FROM OPERATIONS | $ | (894) |
| $ | (994) |
| $ | (2,678) |
| $ | (3,090) |
Our CEO, who is our chief operating decision maker, manages and evaluates our U.S., International and Operating Cost segments based upon segment income or loss from operations adjusted for certain non-cash items, such as stock-based compensation expense and depreciation and amortization. We classify the non-cash expenses included in research, development and medical affairs expenses, general and administrative expenses, and sales and marketing expenses within Other in our Interim Financial Statements.
Operating expenses. Operating expenses in Other decreased by approximately $60,000, or 6%, to $880,000 for the three months ended September 30, 2021, compared to approximately $940,000 for the three months ended September 30, 2020. This decrease is primarily attributable to a decrease in global stock-based compensation expenses.
Operating expenses. Operating expenses in Other decreased by approximately $400,000, or 14%, to $2.7 million for the nine months ended September 30, 2021, compared to approximately $3.1 million for the nine months ended September 30, 2020. This decrease is primarily attributable to a decrease in global stock-based compensation expenses.
Depreciation and amortization. Depreciation and amortization was approximately $650,000 and $680,000 for the three months ended September 30, 2021 and 2020, respectively.
Depreciation and amortization. Depreciation and amortization was approximately $1.9 million and $2.0 million for the nine months ended September 30, 2021 and 2020, respectively.
Liquidity and Capital Resources
Overview
Since inception, we have incurred recurring losses, negative cash flow from operations and have accumulated a deficit in stockholders’ equity of $393.2 million as of September 30, 2021. As of September 30, 2021, we had approximately $21.5 million in cash and cash equivalents. In mid-April 2021 we received a total of $20.0 million in cash from the Ocumension transaction described above. We are using these funds to continue to commercialize ILUVIEN, to fund our NEW DAY clinical trial and for general corporate purposes, which may include working capital, capital expenditures, other clinical trial expenditures, acquisitions of new technologies, products or businesses in ophthalmology, and investments.
As explained above in “Effects of the COVID-19 Pandemic,” the unprecedented events of the COVID-19 pandemic, and its unpredictable duration, in the regions where we have customers, employees and distributors have had an adverse effect on our sales of ILUVIEN and thus on our net revenues and capital resources. The extent and duration of that impact is uncertain at this time, particularly in light of the emergence of COVID-19 variants that increase the transmissibility of the coronavirus.
Since January 2019, we have funded our operations through (a) cash received from our sales; (b) net proceeds of the loans that we obtained in January 2018 and December 2019, respectively, from a group of lenders led by SLR Investment Corp. (formerly named Solar Capital Ltd.); (c) a $1.0 million sale of common stock to a private investor in October 2019; (d) an approximately $1.8 million loan (the PPP Loan) we obtained in April 2020 under the Paycheck Protection Program established as part of the Coronavirus Aid, Relief and Economic Security Act, or the CARES Act; which was forgiven in its entirety, including interest, on April 16, 2021; and (e) the $20.0 million in funds we obtained in April 2021 as a result of the Ocumension transaction. Our loans do not include a revolving loan feature and have been fully advanced by the respective lenders. We currently have no additional borrowing capacity, and the 2019 Loan Agreement generally prohibits any additional debt unless we obtain the prior consent of SLR.
Indebtedness
Loans from SLR Investment Corp. (formerly known as Solar Capital Ltd.). On January 5, 2018, we entered into a $40.0 million loan and security agreement with Solar Capital Ltd., as Collateral Agent, and the parties signatory thereto from time to time as Lenders, including Solar Capital Ltd. in its capacity as a Lender (the 2018 Loan Agreement). On December 31, 2019, we refinanced the 2018 Loan Agreement by entering into a $45.0 million loan and security agreement (the 2019 Loan Agreement) with Solar Capital Ltd., as Agent, and the parties signing the loan agreement from time to time as Lenders, including Solar Capital Ltd. in its capacity as a Lender (collectively, the Lenders). Under the 2019 Loan Agreement, we borrowed $42.5 million on December 31, 2019 and borrowed the remaining $2.5 million on February 21, 2020. The two borrowings under the 2019 Loan Agreement totaled $45.0 million and are referred to as the SLR Loan, given that Solar Capital Ltd. changed its name to SLR Investment Corp. (SLR) in February 2021. The SLR Loan matures on July 1, 2024. We used the initial proceeds of the SLR Loan to pay off the outstanding loan under the 2018 Loan Agreement, along with related prepayment, legal and other fees and expenses of approximately $2,300,000, which included $2,200,000 in fees to SLR, along with related prepayment, legal and other fees and expenses totaling approximately $2.3 million, which included $2.2 million in fees to SLR. We used the remaining proceeds of the SLR Loan to provide additional working capital for general corporate purposes during 2020 and the first half of 2021.
On May 1, 2020, we entered into a First Amendment (the First Amendment) to the 2019 Loan Agreement. The First Amendment included revised covenants that applied to our financial performance during 2020, all of which we met. The First Amendment, among other things, required that a minimum revenue covenant be measured at March 31, 2021 and at the last day of each quarter thereafter, with the minimum revenue amount equal to a percentage of our projected revenues in accordance with a plan we submitted to Agent in February 2021, and with such plan to be approved by our board of directors (the Board) and Agent in its sole discretion.
On March 30, 2021, we entered into a Second Amendment (the Second Amendment) to the 2019 Loan Agreement. The Second Amendment, among other things:
(a)reflected Agent’s consent to our delivery of Board-approved annual financial projections for 2021 by April 1, 2021 (which we delivered in a timely manner);
(b)specified the minimum revenue amount, calculated on a trailing six-month basis and tested at the end of each calendar quarter in 2021, that we must achieve for each such period (the Revenue Covenant);
(c)required that the Revenue Covenant be tested at March 31, 2022 and at the last day of each quarter thereafter, with the minimum revenue amount equal to a percentage of our projected revenues in accordance with an annual plan submitted by us to Agent by January 15th of such year, such plan to be approved by our Board and Agent in its sole discretion; and
(d)provided that in future years we must deliver to Agent and the Lenders as soon as available after approval thereof by our Board, but no later than the earlier of (x) 15 days after such approval and (y) February 28 of such year, our annual financial projections for the entire current fiscal year as approved by our Board; provided that any revisions to such projections approved by our Board shall be delivered to Agent and the Lenders no later than seven days after such approval.
Our operations and thus our net product revenues have continued to be adversely affected by the COVID-19 pandemic. During the six months ended September 30, 2021, we did not generate sufficient revenue to meet the trailing six-month revenue covenant included in the 2019 Loan Agreement. The lenders provided a consent that permitted us not to maintain the revenue covenant as of September 30, 2021 and waived any event of default that has occurred or may be deemed to have occurred. We expect to comply with the revenue covenant at the next reportable date, which is December 31, 2021. See the risk factor related to the 2019 Loan Agreement in Part II, Item 1A below.
Paycheck Protection Program Loan. On April 22, 2020, we received an approximately $1.8 million loan (the PPP Loan) under the Paycheck Protection Program established by the U.S. Small Business Administration as part of the Coronavirus Aid, Relief and Economic Security Act, or the CARES Act. The PPP Loan was unsecured and was evidenced by a note in favor of HSBC Bank USA, National Association (HSBC) as the lender. On July 21, 2020, we submitted an application to HSBC for forgiveness of the PPP Loan. The PPP Loan was forgiven in its entirety, including interest, on April 16, 2021.
$20.0 million Capital Infusion from Ocumension
On April 14, 2021, we entered into the Share Purchase Agreement with Ocumension Therapeutics, pursuant to which we offered and sold to Ocumension 1,144,945 shares of our common stock, at a purchase price of $8.734044 per share. The number of shares sold was equal to 19.9% of the number of shares of common stock outstanding immediately before the closing. The aggregate gross proceeds from the sale of the shares were $10.0 million. In addition, we received a nonrefundable upfront license payment of $10.0 million pursuant to the
Ocumension License Agreement. Under that agreement, we granted an exclusive license for the development and commercialization of our 190 microgram fluocinolone acetonide intravitreal implant in applicator under Ocumension’s own branded label in China, East Asia and the Western Pacific. For more information about the Ocumension transaction, see Transactions with Ocumension Therapeutics above in this Item 2, Notes 9 and 16 of our notes to the accompanying Interim Financial Statements, and our Current Report on Form 8-K filed with the SEC on April 14, 2021.
Current Cash Position
As of September 30, 2021, we had approximately $21.5 million in cash and cash equivalents, a decrease of $3.3 million from the $24.8 million in cash and cash equivalents that we reported as of June 30, 2021. In mid-April 2021, we received gross proceeds of $20.0 million in cash from the Ocumension transaction described above. Even after the Ocumension transaction, we may need to raise additional capital to fund our business strategy, including the continued commercialization of ILUVIEN and the retention and in certain areas, the expansion, of our current employees and staff. The actual amount of funds that we may need will depend on many factors, some of which are beyond our control. See “Effects of the COVID-19 Pandemic” in this Item 2 above for an explanation of our strategy to manage our cash and otherwise mitigate the impact of the pandemic on our financial position and operations.
We cannot be sure that additional financing will be available when needed or that, if available, the additional financing could be obtained on terms that are not significantly detrimental to us or our stockholders. If we were to raise additional funds by issuing equity securities, substantial dilution to existing stockholders could result, and the terms of any new equity securities may have a preference over our common stock. If we were to attempt to raise additional funds through strategic collaboration agreements, we may not be successful in obtaining those agreements, or in receiving milestone or royalty payments under them. If we were to attempt to raise additional funds through debt financing, we would be required to obtain the permission or participation of SLR, which we might not be able to obtain. Our recurring losses and any potential needs to raise capital create substantial doubt about our ability to continue as a going concern for the next 12 months following the issuance of the Interim Financial Statements for the filing of this Form 10-Q.
Sources and Uses of Cash for the nine months ended September 30, 2021 compared to the nine months ended September 30, 2020
For the nine months ended September 30, 2021, cash provided by our operations was approximately $1.5 million. The cash provided by our operations was impacted by our net loss of approximately $270,000, $1.9 million of non-cash depreciation and amortization, a gain on extinguishment of debt of $1.8 million, $970,000 of non-cash consideration received as revenue, $760,000 of non-cash stock-based compensation expense, $720,000 of non-cash interest expense associated with the amortization of our debt discount and a $410,000 change in fair value of warrant asset. Further increasing cash from operations was and a decrease of $760,000 in accounts receivable, a net increase of $720,000 in accounts payable, accrued expenses and other current liabilities and a decrease of $400,000 in inventory. These increases were offset by decrease of $720,000 in long-term liabilities and an increase of $160,000 in prepaid expenses and other current assets.
For the nine months ended September 30, 2020, cash used in our operations was approximately $1.9 million. The cash used in our operations was primarily due to our net loss of $4.4 million, a decrease in accounts payable, accrued expenses and other current liabilities of $3.2 million, an increase in inventory of $1.1 million, a decrease in other long-term liabilities of $410,000 and an increase in prepaid expenses and other current assets of $300,000. Cash used in operations for the nine months ended September 30, 2020 was offset by a decrease in accounts receivable of $3.9 million, $2.0 million of non-cash depreciation and amortization, $1.1 million of non-cash stock-based compensation expense and $730,000 for non-cash interest expense associated with the amortization of our debt discount.
For the nine months ended September 30, 2021, net cash used in our investing activities was approximately $500,000, which was primarily due to capital expenditures associated with the transfer of manufacturing to the facility at Cadence, Inc.
For the nine months ended September 30, 2020, net cash used in our investing activities was approximately $540,000, which was primarily due to capital expenditures associated with the transfer of manufacturing to the facility at Cadence, Inc.
For the nine months ended September 30, 2021, net cash provided by our financing activities was approximately $9.8 million, which was primarily due to $10.0 million of proceeds from the issuance of common stock, offset by $160,000 of payments of finance lease obligations and $80,000 in common stock issuance costs.
For the nine months ended September 30, 2020, net cash provided by our financing activities was approximately $3.9 million, which is primarily due to borrowing the remaining $2.5 million under the 2019 Solar Loan Agreement and receiving the $1.8 million PPP Loan, offset by $340,000 of payments of finance lease obligations.
Contractual Obligations and Commitments
On October 30, 2020, we entered into a Manufacturing Services Agreement (the Cadence Agreement) with Cadence, Inc., under which Cadence will manufacture certain component parts of the ILUVIEN applicator (the components) at its facility near Pittsburgh, Pennsylvania. Under the Cadence Agreement, we will pay certain per-unit prices based on regularly scheduled shipments of a minimum number of components. The initial term of the Cadence Agreement expires on October 30, 2025. After the expiration of the initial term, the Cadence Agreement will automatically renew for separate but successive one-year terms unless either party provides written notice to the other party that it does not intend to renew the Cadence Agreement at least 24 months before the end of the term. The Cadence Agreement may be terminated by either party under certain circumstances. To date, we have been in the process of transferring the manufacturing of parts to Cadence and have spent cash resources to purchase new equipment, to update clean room facilities and to assist in the regulatory approval process.
In January 2020, we entered into an agreement with the first of two contract research organizations (CROs) for clinical and data management services to be performed in connection with a multicenter, single masked, randomized and controlled trial designed to generate prospective data evaluating ILUVIEN as a baseline therapy in the treatment of DME and demonstrate its advantages over using the current standard of care of repeat anti-VEGF injections (the NEW DAY Study). The NEW DAY Study is planned to enroll 320 treatment-naïve, or almost naïve, DME patients in approximately 42 sites around the U.S. For the three and nine months ended September 30, 2021, we incurred approximately $920,000 and $2.9 million, respectively, of expense associated with the NEW DAY Study. For the three and nine months ended September 30, 2020, we incurred approximately $200,000 and $670,000, respectively, of expense associated with the NEW DAY Study. As of September 30, 2021, we expect to incur approximately an additional $12.9 million of expense associated with the study through December 31, 2024.
Off-Balance Sheet Arrangements
We do not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, that would have been established to facilitate off-balance sheet arrangements (as that term is defined in Item 303(a)(4)(ii) of SEC Regulation S-K) or other contractually narrow or limited purposes. As such, we are not exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in those types of relationships. We enter into guarantees in the ordinary course of business related to the guarantee of our own performance and the performance of our subsidiaries.
Impact of Recent Accounting Pronouncements
See Note 3 of our notes to Interim Financial Statements for a description of recent accounting pronouncements, including the expected dates of adoption and expected effects on results of operations and financial condition, if known.
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
Not required for smaller reporting companies.
ITEM 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including the Chief Executive Officer and the Chief Financial Officer, we evaluated the effectiveness of the design and operation of our “disclosure controls and procedures” (as defined in Rule 13a-15(e) under the Exchange Act) as of the end of the period covered by this report. Based on that evaluation, the Chief Executive Officer and the Chief Financial Officer concluded that our disclosure controls and procedures were effective as of September 30, 2021.
Changes in Internal Control over Financial Reporting
There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the nine months ended September 30, 2021 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Limitations on the Effectiveness of Controls
Control systems, no matter how well conceived and operated, are designed to provide a reasonable, but not an absolute, level of assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. Because of the inherent limitations in any control system, misstatements due to error or fraud may occur and not be detected.
PART II. OTHER INFORMATION
ITEM 1. Legal Proceedings
We are not a party to any material pending legal proceedings, and management is not aware of any contemplated proceedings by any governmental authority against us.
ITEM 1A. Risk Factors
In our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the SEC on March 5, 2021, we identify under Item 1A of Part I important factors that could affect our business, financial condition, results of operations and future operations and could cause our actual results for future periods to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statements made in this Quarterly Report on Form 10-Q. Except as described below, there have been no material changes in our risk factors after the filing of our Annual Report on Form 10-K for the fiscal year ended December 31, 2020. However, the risks described in our Form 10-K are not the only risks we face. Additional risks and uncertainties that we currently deem to be immaterial or not currently known to us, as well as other risks reported from time to time in our reports to the SEC, also could cause our actual results to differ materially from our anticipated results or other expectations.
You should read the following information in conjunction with the Interim Financial Statements and related notes in Part I, Item 1, Financial Information and the discussion and analysis of our financial condition in Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
The COVID-19 pandemic has had, and we expect will continue to have, certain negative impacts on our business, and those impacts may have an adverse effect on our results of operations, financial condition and cash flows.
The public health crisis caused by the COVID-19 pandemic and the measures being taken by governments, health authorities, businesses, and the public at large to limit the COVID-19 pandemic’s spread have had, and we expect will continue to have, certain negative effects on, and present certain risks to, our business. We have experienced decreases in sales of ILUVIEN in the U.S. (which have rebounded to a degree) and in our international markets that have been affected by the COVID-19 pandemic resulting from, among other things:
•Governments and private parties at times have imposed limitations on in-person access to physicians, which can (and in certain instances already have):
◦affect patient access to treatment, given that ILUVIEN is administered only by an injection into the eye, which means telemedicine is not a viable substitute; and
◦make it difficult or impossible for our sales representatives (including those employed by our distributors) to meet with retina specialists and their staff to educate them about the benefits of ILUVIEN and to provide support for insurance pre-certifications.
•Our business is also negatively affected by patient behavior in the current environment. Most of our ILUVIEN sales are driven by the use of ILUVIEN to treat diabetic macular edema, or DME. Given that governmental authorities have cited diabetes as a factor that places a person at higher risk for severe illness from the COVID-19 pandemic, patients may be unwilling to visit their physicians in person (even if otherwise permitted) for fear of contracting the COVID-19 coronavirus. In addition, the adverse effect of DME on a patient’s vision can progress slowly over time, and patients may defer seeking treatment until their loss of vision is acute, which we believe may negatively affect user demand for ILUVIEN.
These limitations had an adverse impact on our revenues beginning late in the first quarter of 2020 and continuing through the date of this report despite sequential growth from second quarter of 2021 to the third quarter of 2021. We expect these factors to continue to adversely impact our revenue, and the extent and duration of that impact is uncertain at this time. If the COVID-19 pandemic intensifies again or its duration persists, its negative effect on our sales and thus our liquidity and financial condition could be more prolonged and may be severe. Financial uncertainty associated with the adverse effects of the COVID-19 pandemic, and the duration of those effects, could have an impact in future periods on certain estimates used in the preparation of our quarterly financial results, including impairment of intangible assets, the income tax provision and realizability of certain receivables.
Other effects or possible effects of the COVID-19 pandemic on us include:
•Limitations on travel earlier in 2021 within and between the countries in which we market and sell ILUVIEN curtailed our in-person marketing activities, which have in turn contributed to lower sales of ILUVIEN, and those limitations could be imposed again in the future.
•While most of our personnel in our headquarters have returned to work in the office, we may in the future experience reductions in productivity and disruptions to our business routines if remote work requirements are reinstated in Georgia. Governmental directives continue to affect the ability of non-U.S. office-based personnel in some countries to return to full-time work in the office.
•We may fail to plan appropriately to meet the demand of our customers for ILUVIEN, which could lead either to (a) ILUVIEN being out of stock or (b) our investment of a greater amount of cash in inventory than we need. Either event could have an adverse effect on our results of operations, financial condition and cash flows.
•As the result of lower sales of ILUVIEN, we may fail to comply with financial covenants in our $45.0 million 2019 Loan Agreement, as amended, that are based on minimum trailing six months’ revenues (the Revenue Covenant). If we fail to comply with the Revenue Covenant and an event of default under the 2019 Loan Agreement occurs, SLR may accelerate all of our repayment obligations and take control of our pledged assets, potentially requiring us to raise additional financing, renegotiate the 2019 Loan Agreement on terms less favorable to us or immediately cease operations. See the risk factor below regarding our 2019 Loan Agreement.
The terms of the 2019 Loan Agreement with SLR and certain other lenders require us to meet certain operating covenants and restrict our operating and financial flexibility, and any breach of the covenants in that agreement, if SLR elected to accelerate the due date of the loan, could significantly harm our business and prospects and lead to the liquidation of our business.
The 2019 Loan Agreement contains certain operating covenants and restricts our operating and financial flexibility. The 2019 Loan Agreement is secured by a lien covering all of our U.S. assets (and certain ownership interests in one of our foreign subsidiaries), other than our intellectual property. The 2019 Loan Agreement contains customary affirmative and negative covenants and events of default. Affirmative covenants include covenants requiring us to comply with applicable laws, maintain our legal existence, deliver certain financial reports and maintain insurance coverage. Negative covenants restrict our ability to transfer any part of our business or property, to change our business or key management, to incur additional indebtedness, to engage in mergers or acquisitions, to pay dividends or make other distributions, to make investments, to create other liens on our assets and to allow revenues from the sale of ILUVIEN to fall below certain minimums, in each case subject to customary exceptions.
If an event of default under the 2019 Loan Agreement occurs, SLR may accelerate all of our repayment obligations and take control of our pledged assets, potentially requiring us to raise additional financing, renegotiate the 2019 Loan Agreement on terms less favorable to us or immediately cease operations. Any declaration by SLR of an event of default could significantly harm our business and prospects and could cause the price of our common stock to decline significantly after we publicly disclose that event. Further, if we are liquidated, SLR’s right to repayment would be senior to the rights of our stockholders. Any declaration by SLR of an unwaived event of default could significantly harm our business and prospects and could cause the price of our common stock to decline significantly after we publicly disclose that event in an SEC filing. Further, if we were liquidated, SLR’s right to repayment would be senior to the rights of our stockholders. During the six months ended September 30, 2021, we did not generate sufficient revenue to meet the trailing six-month revenue covenant included in the 2019 Loan Agreement. The lenders provided a consent that permitted us not to maintain the revenue covenant at September 30, 2021 and waived any event of default that has occurred or may be deemed to have occurred. We can offer no assurances, however, that SLR will accommodate such a request for a consent and waiver if in the future we fail to meet the Revenue Covenant or any other covenant that would result in an event of default under the 2019 Loan Agreement.
We may fail to effect the transition of the manufacturing of essential component parts of our ILUVIEN applicator by our new contract manufacturer before we exhaust our current inventory of those parts.
Under the Flextronics Agreement dated March 2, 2012, Flextronics agreed to manufacture the component parts of the ILUVIEN applicator (the components) for us. As we reported in a Current Report on Form 8-K dated March 28, 2019, we received notice from Flextronics on that date that it intended to terminate the Flextronics Agreement on September 30, 2020. The Flextronics Agreement
terminated in accordance with the notice on September 30, 2020. Before the Flextronics Agreement expired, Flextronics manufactured a supply of components that has served and is serving as a safety stock until the components can be supplied by the replacement manufacturer.
On October 30, 2020, we entered into a Manufacturing Services Agreement with Cadence, Inc., to manufacture the components used in the ILUVIEN applicator. Cadence is in the final stages of process qualification and began manufacturing production components during the second quarter of 2021. In March 2021, we received the necessary approvals from European Regulatory Agencies for Cadence to manufacture components to be used in ILUVIEN sold in Europe. We filed a Prior Approval Supplement (PAS) with the FDA during the third quarter of 2021. We believe we have sufficient safety stock produced by Flextronics to meet the anticipated demand of our distributors and end users in the U.S. until FDA approval is obtained and throughout 2021 and the first quarter of 2022. Until the transition to Cadence is complete, however, there can be no assurances that Cadence will manufacture the components in a timely and otherwise acceptable manner. Significant disruption in this transition, or unanticipated costs related to the transition, could materially and adversely affect our business, financial condition and cash flows, and results of operations.
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
ITEM 3. Defaults Upon Senior Securities
None.
ITEM 4. Mine Safety Disclosures
Not applicable.
ITEM 5. Other Information
Compensatory Arrangements of Philip Ashman, Ph.D., our Chief Operating Officer and Senior Vice President Commercial Operations Europe
In July 2021, after a review of the benefits available to Dr. Ashman compared to those of our senior executives in the U.S., the compensation committee of our board of directors determined that all of our other executive officers are parties to employment agreements of more recent date than Dr. Ashman’s, all of which include certain change in control severance provisions not included in Dr. Ashman’s contract of employment. The compensation committee then determined that it would be appropriate for Alimera to enter into a change in control severance agreement (the Agreement) with Dr. Ashman to give him the same change-in-control severance provisions as Alimera’s other key executives. We entered into the Agreement with Dr. Ashman as of July 16, 2021. In the event of a change in control, as defined in the Agreement, the terms of the Agreement will supersede any conflicting provisions in his current employment agreement.
Acceleration Provisions for Equity Awards in Event of Change in Control. The Agreement includes acceleration provisions for unvested equity awards in the event of a change in control. Under these provisions, if change in control occurs, Dr. Ashman will receive 12 months of additional vesting for any equity awards that are outstanding and unvested as of the date of such transaction. In addition, his unvested equity awards will vest in full if (a) Alimera is subject to a change in control before his employment with us terminates and (b) within 12 months after the change in control, we terminate his employment with us without cause or he terminates his employment for good reason. Further, if Alimera is a party to a merger or consolidation, his unvested equity awards will vest in full unless the agreement evidencing the merger or consolidation provides for one or more of the following: (a) the continuation of his equity awards by Alimera if Alimera is the surviving corporation; (b) the assumption of his equity awards by the surviving corporation or its parent; (c) the substitution by the surviving corporation of its parent of new equity awards for his existing equity awards; (d) full exercisability of equity awards and full vesting of the stock underlying such awards, followed by the cancellation of such equity awards; or (e) the cancellation of his outstanding equity awards and a payment to him equal to the excess of (i) the fair market value of the stock subject to such equity awards (whether or not such equity awards are then exercisable or vested, as applicable) as of the closing date of such merger or consolidation over (ii) the exercise price (for stock options).
Termination Without Cause/Resignation for Good Reason in Connection with a Change in Control. In addition, the Agreement provides that if we terminate the Dr. Ashman’s employment without cause or if he resigns for good reason, either more than three months prior to a change in control or more than 18 months after a change in control, subject to the conditions in the Agreement, we will pay his earned but unpaid base salary plus 100% of the sum of (i) his current total annual base salary plus (ii) his annual target bonus (subject to such withholdings as required by law), payable in twelve equal monthly installments (the “Severance Payments”). In addition, we will pay Dr. Ashman, no later than 2½ months following the close of the fiscal year of termination, a cash payment equal to his earned bonus, determined based on the actual performance of Alimera for the full fiscal year in which his employment terminates, prorated based on the number of days during such year that he was employed. In addition, we will pay Dr. Ashman the taxable value of any accrued benefit entitlements (subject to such withholdings as required by law, including income tax and national insurance contributions) for the 12-month period following the termination of employment. The Severance Payments and other payments referred to above are inclusive of, and will be reduced by the value of, any payments to which Dr. Ashman is entitled pursuant to his employment agreement on termination of his employment.
The description of the Agreement is qualified by reference to the full text of the Agreement, a copy of which is attached as Exhibit 10.7.H to this Quarterly Report on Form 10-Q and incorporated herein by reference.
ITEM 6. Exhibits
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Exhibit Number |
| Description |
3.1 |
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3.2 |
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10.5.A† |
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10.5.E† |
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10.5.F† |
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10.7.H*† |
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31.1* |
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31.2* |
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32.1* |
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101 |
| The following financial statements from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, formatted in Inline XBRL: (i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Operations, (iii) Condensed Consolidated Statements of Comprehensive Loss, (iv) Condensed Consolidated Statements of Cash Flows, (v) Condensed Consolidated Statements of Changes in Stockholders’ (Deficit) and (vi) Notes to Condensed Consolidated Financial Statements, tagged as blocks of text and including detailed tags. |
104 |
| Cover Page Interactive Data File (Embedded within the Inline XBRL document and included in Exhibit 101).
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*Filed herewith.
†Management contracts and compensatory plans and arrangements.
The certification attached as Exhibit 32.1 that accompanies this Quarterly Report on Form 10-Q is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Alimera Sciences, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.
Signatures
Pursuant to the requirements 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.
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| ALIMERA SCIENCES, INC. | |
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November 5, 2021 | By: | /s/ Richard S. Eiswirth, Jr. |
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| Richard S. Eiswirth, Jr. |
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| President and Chief Executive Officer |
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| (Principal Executive Officer) |
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November 5, 2021 | By: | /s/ J. Philip Jones |
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| J. Philip Jones |
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| Chief Financial Officer |
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| (Principal Financial and Accounting Officer) |
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