GlobeNewswire Inc | Oct 28, 2021 07:30AM EDT

October 28, 2021

-- Consolidated Net Revenue of $12.2 Million Down 2% vs. Third Quarter of 2020 andUp 14% vs. Second Quarter of 2021 -- U.S. End User Demand up 15% vs. Third Quarter of 2020 and Second Quarter of 2021

ATLANTA, Oct. 28, 2021 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (Alimera), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, today announced financial results for the third quarter of 2021. Alimera will host a conference call today at 9:00 a.m. EDT to discuss these results.

The third quarter marks continued improvement in top line revenue from ILUVIEN as we recover from the challenges of the COVID-19 pandemic, with sequential growth in net revenue for both our U.S. and international segments, said Rick Eiswirth, Alimeras President and Chief Executive Officer. Importantly, as more patients return to physicians offices in the U.S., our largest market, we continue to see improved end user demand, demonstrated by a 15% increase versus both the third quarter of 2020 and the recently completed second quarter. We believe the incremental investments we initiated during the third quarter to reestablish awareness of ILUVIEN, following the prolonged period of limited access to physicians and patients, are having a positive impact on utilization. We look forward to the recovery continuing in 2022 and increasing utilization of ILUVIEN.

Third Quarter 2021 Financial Results

Net Revenue Consolidated Q3 2021 net revenue decreased 2% to approximately $12.2 million, compared to $12.5 million for Q3 2020.

U.S. net revenue was unchanged at $7.0 million for Q3 2021 compared to Q3 2020. However, end user demand, which represents units purchased by physicians and pharmacies from Alimeras distributors, increased 15% from 728 units during Q3 2020 to 837 units during Q3 2021. End user demand also increased sequentially in Q3 2021 by 15% compared to 722 units in Q2 2021.

The difference between the unchanged GAAP revenue and the growth in end user demand is due to the timing of U.S. distributor purchases in Q3 2021 versus Q3 2020. During Q3 2021, Alimeras distributors purchased approximately the same number of units that they sold to end users, while in Q3 2020 Alimeras U.S. distributors rebuilt inventory due to increasing demand, purchasing 19% more units than they sold.

International net revenue decreased 5% to approximately $5.2million for Q3 2021, compared to approximately $5.5million for Q3 2020.

Alimera did not recognize any license revenue in Q3 2021 or Q3 2020.

Operating ExpensesTotal operating expenses were approximately$12.5 millionfor Q3 2021, compared to approximately $10.5 million for Q3 2020. In Q3 2021, Alimera began executing its investment strategy to strengthen share of voice and advocacy through targeted spending programs.

Net Loss and Adjusted EBITDANet loss for Q3 2021 was $(4.2) million, compared to a net loss of approximately $(0.6) million for Q3 2020. Adjusted EBITDA, a non-GAAP financial measure defined below, was approximately $(1.1) million for Q3 2021, compared to Adjusted EBITDA of approximately $1.4 million for Q3 2020.

A new significant component of net loss in Q3 2021 compared to Q3 2020 is the revaluation of the warrant for Ocumension common stock that Alimera received in the licensing transaction completed in April 2021. That revaluation resulted in an incremental loss of $1.1 million.

The decrease in Adjusted EBITDA resulted from Alimeras investments initiated in Q3 to strengthen share of voice and advocacy through targeted spending programs. These initiatives, along with the return of normalized travel and entertainment compared to Q3 2020, brought the spending back to pre-pandemic levels.

Net Loss per ShareBasic and diluted net loss per share for Q3 2021 was approximately $(0.60) compared to basic and diluted net loss per share of $(0.12) for Q3 2020.

Cash and Cash EquivalentsOn September 30, 2021, Alimera had cash and cash equivalents of approximately $21.5 million, compared to $24.8 million in cash and cash equivalents on June 30, 2021. This amount compares to $11.2 million of cash and cash equivalents on hand at December 31, 2020.

Definition of Non-GAAP Financial MeasureFor purposes of this press release, Adjusted EBITDA is defined as earnings before interest, taxes, depreciation, amortization, stock-based compensation expenses, net unrealized gains and losses from foreign currency exchange transactions, losses on extinguishment of debt, severance expenses and change in fair value of warrant asset. Please refer to the sections of this press release entitled Non-GAAP Financial Measure and Reconciliation of GAAP Net Income or Loss to Non-GAAP Adjusted EBITDA.

Conference Call to Be Held TodayA live conference call will be hosted today, October 28, 2021, at 9:00 a.m. EDT by Rick Eiswirth, President and Chief Executive Officer, and Phil Jones, Chief Financial Officer, to discuss Alimeras financial results and provide an update on corporate developments. Please refer to the information below for conference call dial-in information and webcast registration.

Conference date: Thursday October 28, 2021, 9;00 a.m. EDTConference dial-in: 844-839-2190International dial-in: 412-317-9583Conference Call Name: Alimera Sciences (Nasdaq: ALIM) Third Quarter 2021 Financial Results Conference CallConference Call Pre-registration:Participants are asked to pre-register for the call by navigating to https://dpregister.com/sreg/10161286/eed863afa2

Please note that registered participants will receive their dial-in number upon registration and will dial directly into the call without delay. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Alimera Sciences call.

The conference call will also be available through a live webcast which is also available through the companys website.Live Webcast URL: https://services.choruscall.com/mediaframe/webcast.html?webcastid=pAWxPxFH

A replay will be available on Alimeras website,www.alimerasciences.com, under Investor Relations one hour following the live call.

Conference Call replay: US Toll Free: 1-877-344-7529International Toll: 1-412-317-0088Canada Toll Free: 855-669-9658Replay Access Code: 10161286End Date: November 11, 2021Webcast Replay End Date: January 28, 2022

About Alimera Sciences, Inc.

Alimera Sciences is a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer. For more information, please visit www.alimerasciences.com.

Non-GAAP Financial Measure

This press release contains a discussion of a non-GAAP financial measure, as defined in Regulation G promulgated under the Securities Exchange Act of 1934, as amended. Alimera reports its financial results in compliance with GAAP but believes that the non-GAAP measure of Adjusted EBITDA provides useful information to investors regarding Alimeras operating performance. Alimera uses Adjusted EBITDA in the management of its business. Accordingly, Adjusted EBITDA for the three and nine months ended September 30, 2021 and 2020 has been presented in certain instances excluding items identified in the reconciliations provided in the table entitled Reconciliation of GAAP Net Income or Loss to non-GAAP Adjusted EBITDA. GAAP net income or loss is the most directly comparable GAAP financial measure to Adjusted EBITDA. Consistent with our prior practice when we had a warrant asset with a value that was subject to quarterly revision and with how we use Adjusted EBITDA in the management of our business, we have added change in fair value of warrant asset as an adjustment in the calculation of Adjusted EBITDA beginning with our results for Q2 2021.

Adjusted EBITDA, as presented, may not be comparable to similarly titled measures reported by other companies because not all companies may calculate Adjusted EBITDA in an identical manner. Therefore, Adjusted EBITDA is not necessarily an accurate measure of comparison between companies.

The presentation of Adjusted EBITDA is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of this non-GAAP financial measure is that it excludes significant elements required by GAAP to be recorded in Alimeras financial statements. In addition, Adjusted EBITDA is subject to inherent limitations as it reflects the exercise of judgments by management in determining this non-GAAP financial measure.

Forward Looking Statements

This press release contains, and the conference call in which executives of Alimera will discuss this press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, (a) Alimeras belief that its incremental investments will result in increased awareness and use of ILUVIEN and (b)Alimeras anticipation of a continued recovery of its business. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change these expectations, and could cause actual results to differ materially from those projected in these forward-looking statements.

Meaningful factors that could cause actual results to differ include, but are not limited to, uncertainties associated with (a) whether Alimeras investments to reestablish awareness will continue to have a positive effect on utilization; (b) the continued effects of COVID-19 on the ability or willingness of patients to visit their retina specialists for ILUVIEN injections; (c)current and future governmental orders and policies adopted by healthcare facilities to address the COVID-19 pandemic, and the duration of these limitations; (d) the recent resurgence of the pandemic in parts of both Europe and the U.S.; (e) the emergence of COVID-19 variants that increase the transmissibility of the coronavirus and are more deadly; (f) the success or failure of the vaccine campaigns in Alimeras markets; and (g) the other factors discussed in the Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations sections of Alimeras Annual Report on Form 10-K for the year ended December31, 2020, which is on file with the SEC and is available on the SECs website at http://www.sec.gov. Additional factors will also be described in those sections of Alimeras Quarterly Report on Form 10-Q for the third quarter of 2021, to be filed with the SEC soon.

Alimera undertakes no obligation to publicly update or revise any of the forward-looking statements made in this press release, whether as a result of new information, future events or otherwise, except as required by law. Therefore, you should not rely on these forward-looking statements as representing Alimeras views as of any date after today.

For investor inquiries: For media inquiries:Scott Gordon Jules Abrahamfor Alimera Sciences for Alimera Sciencesscottg@coreir.com julesa@coreir.com

ALIMERA SCIENCES, INC.CONSOLIDATED BALANCE SHEETS(in thousands)

September30, December31, 2021 2020 (Unaudited) CURRENT ASSETS: Cash and cash equivalents $ 21,524 $ 11,208 Restricted cash 34 34 Accounts receivable, net 16,210 17,200 Prepaid expenses and other current assets 3,564 3,718 Inventory 2,301 2,746 Total current assets 43,633 34,906 NON-CURRENT ASSETS: Property and equipment, net 1,664 1,638 Right of use assets, net 1,719 720 Intangible asset, net (Note 8) 11,386 12,838 Deferred tax asset 712 753 Warrant asset 951 ? TOTAL ASSETS $ 60,065 $ 50,855 CURRENT LIABILITIES: Accounts payable $ 7,437 $ 7,461 Accrued expenses 3,673 3,197 Paycheck Protection Program (PPP) loan ? 1,481 Finance lease obligations 289 209 Total current liabilities 11,399 12,348 NON-CURRENT LIABILITIES: Notes payable, net of discount 42,838 42,408 Other non-current liabilities 4,326 4,077 COMMITMENTS AND CONTINGENCIES STOCKHOLDERS? EQUITY (DEFICIT): Preferred stock: Series A Convertible Preferred 19,227 19,227 Common stock 69 57 Additional paid-in capital 376,579 365,830 Common stock warrants 370 370 Accumulated deficit (393,175 ) (392,909 )Accumulated other comprehensive loss (1,568 ) (553 )TOTAL STOCKHOLDERS? EQUITY (DEFICIT) 1,502 (7,978 )TOTAL LIABILITIES AND STOCKHOLDERS? EQUITY $ 60,065 $ 50,855 (DEFICIT)

ALIMERA SCIENCES, INC.CONSOLIDATED STATEMENTS OF OPERATIONSFOR THE THREE AND NINE MONTHS ENDED SEPTEMBER30, 2021 AND 2020(Unaudited)

Three Months Ended Nine Months Ended September30, September30, 2021 2020 2021 2020 (In thousands, except share and per share data)REVENUE: PRODUCT REVENUE, $ 12,153 $ 12,473 $ 34,022 $ 37,046 NETLICENSE REVENUE ? ? 11,048 ? NET REVENUE 12,153 12,473 45,070 37,046 COST OF GOODSSOLD, EXCLUDING (1,689 ) (1,537 ) (5,064 ) (4,949 )DEPRECIATION ANDAMORTIZATIONGROSS PROFIT 10,464 10,936 40,006 32,097 RESEARCH,DEVELOPMENT AND 3,278 2,469 10,058 7,162 MEDICAL AFFAIRSEXPENSESGENERAL ANDADMINISTRATIVE 2,808 2,421 9,577 8,194 EXPENSESSALES AND 5,751 4,962 15,900 15,399 MARKETING EXPENSESDEPRECIATION AND 649 677 1,920 2,016 AMORTIZATIONOPERATING EXPENSES 12,486 10,529 37,455 32,771 (LOSS) INCOME FROM (2,022 ) 407 2,551 (674 )OPERATIONSINTEREST EXPENSE (1,360 ) (1,285 ) (4,050 ) (3,928 )AND OTHERUNREALIZED FOREIGN 142 267 323 295 CURRENCY GAIN, NETGAIN ONEXTINGUISHMENT OF ? ? 1,792 ? DEBTCHANGE IN FAIRVALUE OF WARRANT (1,112 ) ? (411 ) ? ASSETNET (LOSS) INCOME (4,352 ) (611 ) 205 (4,307 )BEFORE TAXESBENEFIT(PROVISION) FOR 169 (7 ) (471 ) (55 )TAXESNET LOSS $ (4,183 ) $ (618 ) $ (266 ) $ (4,362 )NET LOSS PER SHARE? Basic and $ (0.60 ) $ (0.12 ) $ (0.04 ) $ (0.87 )DilutedWEIGHTED AVERAGESHARES OUTSTANDING 6,924,174 5,068,701 6,480,952 5,026,905 ? Basic andDiluted

RECONCILIATION OF GAAP MEASURES TO NON-GAAP ADJUSTED MEASURESGAAP NET INCOME OR LOSS TO NON-GAAP ADJUSTED EBITDA(in thousands)

Three Months Ended Nine Months Ended September30, September30, 2021 2020 2021 2020 (In thousands, except share and per share data) GAAP NET (LOSS) INCOME $ (4,183 ) $ (618 ) $ (266 ) $ (4,362 )Adjustments to net income (loss):Interest expense and other 1,360 1,285 4,050 3,928 Benefit (Provision) for taxes (169 ) 7 471 55 Depreciation and amortization 649 677 1,920 2,016 Stock-based compensation 244 317 758 1,074 expensesUnrealized foreign currency (142 ) (267 ) (323 ) (295 )exchange (gains) lossesGain on extinguishment of debt ? ? (1,792 ) ? Change in fair value of 1,112 ? 411 ? warrant assetSeverance Expenses ? ? 195 ? NON-GAAP ADJUSTED EBITDA $ (1,129 ) $ 1,401 $ 5,424 $ 2,416