8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D) OF

THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): May 9, 2022

ALIMERA SCIENCES, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-34703		20-0028718
(State or other Jurisdiction of Incorporation)	(Commission File Number)		(IRS Employer Identification No.)
6310 Town Square, Suite 400 Alpharetta, Georgia		30005
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (678) 990-5740

Not Applicable

(Former name or former address if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.01 par value per share	ALIM	The Nasdaq Stock Market LLC (Nasdaq Global Market)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company o

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

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Item 2.02. Results of Operations and Financial Condition.

On May 9, 2022, Alimera Sciences, Inc. (“Alimera”) issued a press release regarding its results of operations and financial condition for the first quarter ended March 31, 2022 as well as a corporate update. On May 9, 2022 at 9:00 A.M. ET, Alimera will host a conference call and a live webcast on the Investor Relations section of its corporate website at www.alimerasciences.com. During the conference call, Alimera’s executives will discuss the company’s financial results for the first quarter ended March 31, 2022 and provide an update on corporate developments. The full text of the press release, which includes information regarding Alimera’s use of a non-GAAP financial measure, is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

Various statements made during the conference call and webcast will or may be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera’s expectations (i) regarding the continuing positive trend for Alimera’s business in the U.S. market, (ii) regarding the beneficial effect of Alimera’s marketing expenditures as they increase engagement with physicians, and (iii) that sales in its direct markets in Europe will begin recovering in the second quarter of 2022 and contribute to Alimera’s overall growth toward the middle of the year. 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) the continued effects of COVID-19 on the ability or willingness of patients to visit their retina specialists for ILUVIEN injections, particularly in the EU; (b) governmental orders and policies adopted by healthcare facilities to address the COVID-19 pandemic, and the duration of these limitations; (c) the emergence of COVID-19 variants that may increase the transmissibility of the coronavirus or be more deadly, or both; (d) the success or failure of the vaccine campaigns in Alimera’s markets; and (e) the other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2021, which is on file with the SEC and available on the SEC’s website at http://www.sec.gov. Additional factors may also be described in those sections of Alimera’s Quarterly Report on Form 10-Q for the first quarter of 2022, to be filed with the SEC soon.

In addition to the risks described above and in Alimera’s reports and other filings with the SEC, other unknown or unpredictable factors also could affect Alimera’s results. There can be no assurance that the actual results or developments anticipated by Alimera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Alimera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. All forward-looking statements contained in the conference call and webcast and in the press release are expressly qualified by the cautionary statements contained or referred to herein and therein. These forward-looking statements speak only as of the date of the conference call and webcast and the press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

The information in Item 2.02 of this Current Report on Form 8-K and the press release furnished as Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.

2

Item 7.01. Regulation FD.

The conference call and webcast, and the press release, include or will include a non-GAAP financial measure, Adjusted EBITDA. A reconciliation of this non-GAAP financial measure to the comparable measure calculated and presented in accordance with GAAP is included in Alimera’s press release issued May 9, 2022 and attached hereto as Exhibit 99.1.

The information in this Current Report on Form 8-K under Item 7.01 is being “furnished” and not “filed” with the SEC for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities under such section. Furthermore, such information shall not be deemed incorporated by reference in any filing under the Securities Act, or the Exchange Act, unless specifically identified as being incorporated therein by reference.

3

Item 9.01. Financial Statements and Exhibits.

(d)    Exhibits

Exhibit No.	Description
99.1	Press Release of Alimera Sciences, Inc. dated May 9, 2022
104	Cover Page Interactive Data File (embedded within the inline XBRL document)

‎

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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 hereunto duly authorized.

	ALIMERA SCIENCES, INC.
Dated: May 9, 2022	By:	/s/ J. Philip Jones
	Name:	J. Philip Jones
	Title:	Chief Financial Officer

5

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

Alimera Sciences Reports First Quarter 2022 Results

· Consolidated Net Revenue of $11.9 Million Up 6% vs. First Quarter of 2021

· U.S. Net Revenue Increased 23% vs. First Quarter of 2021

· U.S. End User Demand Up 25% vs. First Quarter of 2021

ATLANTA, May 9, 2022 -- 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 first quarter of 2022. Alimera will host a conference call on May 9th, 2022, at 9:00 a.m. ET to discuss these results and provide an update on corporate developments.

“We are pleased with the continuing trend that we see in the U.S. market as we report another consecutive quarter of end user demand growth over the prior year period,” said Rick Eiswirth, Alimera’s President and Chief Executive Officer. “We believe that our strategy of investing behind raising our share of voice and other outreach is proving beneficial as it is increasing our engagement with physicians. In Europe, we are seeing signs of recovery with the lifting of COVID-19 restrictions.At the end of April, we have seen the trailing three months of end user demand across our international distributor markets reach an all-time high and have already received distributor orders in 2022 exceeding total distributor shipments in 2021. We expect sales in our direct markets in Europe to begin recovering this quarter as well and contribute to our overall growth toward the middle of the year.”

First Quarter 2022 Financial Results

Net Revenue

Consolidated net revenue was up 6% to approximately $11.9 million for Q1 2022, compared to $11.2 million for Q1 2021.

U.S. net revenue increased 23% to approximately $6.9 million for Q1 2022 compared to U.S. net revenue of $5.6 million for Q1 2021. End user demand, which represents units

purchased by physicians and pharmacies from Alimera’s distributors, increased 25% to 918 units during Q1 2022 compared to 737 units during Q1 2021.

The difference between GAAP revenue and end user demand is due to the timing of distributor purchases. During Q1 2022, Alimera’s distributors sold approximately 8% more units to end users than they purchased from Alimera.

International net revenue decreased 11% to approximately $5.0 million in Q1 2022, compared to approximately $5.6 million in Q1 2021. The decrease in international net revenue in Q1 2022 was primarily due to the continued COVID-19 restrictions that limited patient volume in retina clinics and the ability of our sales personnel to call on customers in our direct markets. Additionally, our international net revenue, as reported in U.S. dollars, was negatively impacted by changes in the foreign exchange rates that reduced our international revenue by approximately 5% for Q1 2022.  Sales to our international distributor partners increased 55% to $1.7 million, driven by returning end user demand in those markets.

Operating Expenses

Total operating expenses were approximately $14.4 million for Q1 2022, compared to approximately $12.1 million for Q1 2021. Total operating expenses increased as Alimera re-invested to grow its business in markets where the impact of COVID-19 was easing and invested in the NEW DAY Study.

Net Loss

Net loss for Q1 2022 was $(6.0) million, compared to net loss of approximately $(3.6) million for Q1 2021. The loss in Q1 2022 was impacted negatively by approximately $556,000, or 9% of the net loss, associated with the change in the fair value of our warrant asset.  This asset did not exist as of Q1 2021, therefore there is no comparative change for that period.

Basic and diluted net loss per share for Q1 2022 was approximately $(0.85) compared to basic and diluted net loss per share of $(0.63) for Q1 2021.

Adjusted EBITDA

“Adjusted EBITDA,” a non-GAAP financial measure defined below, was approximately $(3.1) million for Q1 2022, compared to approximately $(1.3) million for Q1 2021. The increase in negative Adjusted EBITDA was a result of the targeted investments Alimera made to regain its engagement with physician practices in those markets that are no longer subject to COVID-19 lockdowns.

Cash and Cash Equivalents

As of March 31, 2022, Alimera had cash and cash equivalents of approximately $9.9 million, compared to $16.5 million at December 31, 2021.

Definition of Non-GAAP Financial Measure

For 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, 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 Measures to Non-GAAP Adjusted Measures –GAAP Net Income or Loss to Non-GAAP Adjusted EBITDA.”

ALIM Call Details - Q1 2022 Financial Results Conference Call

Conference Call to Be Held May 9, 2022

A live conference call will be hosted on May 9, 2022, at 9:00 a.m. ET by Rick Eiswirth, President and Chief Executive Officer, and Phil Jones, Chief Financial Officer, to discuss Alimera’s 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: Monday, May 9, 2022, 9:00 a.m. ET

Conference dial-in: 844-839-2190

International dial-in: 412-717-9583

Conference Call Name: Alimera Sciences (Nasdaq: ALIM) First Quarter 2022 Financial Results Conference Call

Conference Call Pre-registration: Participants are asked to pre-register for the call by navigating to: https://dpregister.com/sreg/10166659/f28bc03243

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 company’s website.

Live Webcast URL: https://services.choruscall.com/mediaframe/webcast.html?webcastid=3QofsRVV

A replay will be available on Alimera’s website, www.alimerasciences.com, under “Investor Relations” one hour following the live call and will remain available until August 9, 2022.

Conference Call replay: US Toll Free: 1-877-344-7529

International Toll: 1-412-317-0088

Canada Toll Free: 855-669-9658

Replay Access Code: 9842780

End Date: May 23, 2022

Webcast Replay End Date: August 9, 2022

About Alimera Sciences, Inc.

www.alimerasciences.com

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 Alimera’s operating performance. Alimera uses Adjusted EBITDA in the management of its business. Accordingly, Adjusted EBITDA for the three months ended March 31, 2022 and 2021 has been presented in certain instances excluding items identified in the reconciliations provided in the table entitled “Reconciliation of GAAP Measures to Non-GAAP Adjusted Measures – 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.

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 Alimera’s 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,

Alimera’s expectations (i) regarding the continuing positive trend for Alimera’s business in the U.S. market, (ii) regarding the beneficial effect of Alimera’s marketing expenditures as they increase engagement with physicians, and (iii) that sales in its direct markets in Europe will begin recovering in the second quarter of 2022 and contribute to Alimera’s overall growth toward the middle of the year.

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) the continued effects of COVID-19 on the ability or willingness of patients to visit their retina specialists for ILUVIEN injections, particularly in the EU; (b) governmental orders and policies adopted by healthcare facilities to address the COVID-19 pandemic, and the duration of these limitations; (c) the emergence of COVID-19 variants that may increase the transmissibility of the coronavirus or be more deadly, or both; (d) the success or failure of the vaccine campaigns in Alimera’s markets; and (e) the other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2021, which is on file with the SEC and available on the SEC’s website at http://www.sec.gov. Additional factors may also be described in those sections of Alimera’s Quarterly Report on Form 10-Q for the first quarter of 2022, 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 Alimera’s views as of any date after today.  

For investor inquiries:                                                  For media inquiries:

Scott Gordon                                                                  Jules Abraham

for Alimera Sciences                                                      for Alimera Sciences
scottg@coreir.comjulesa@coreir.com

#  #  #

ALIMERA SCIENCES, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands)

	March 31,		December 31,
	2022		2021
	(unaudited)
CURRENT ASSETS:
Cash and cash equivalents	$	9,946	$	16,510
Restricted cash		33		34
Accounts receivable, net		18,776		19,128
Prepaid expenses and other current assets		3,546		3,809
Inventory		2,452		2,679
Total current assets		34,753		42,160
NON-CURRENT ASSETS:
Property and equipment, net		2,719		2,783
Right of use assets, net		1,624		1,710
Intangible asset, net		10,419		10,897
Deferred tax asset		134		137
Warrant asset		282		833
TOTAL ASSETS	$	49,931	$	58,520
CURRENT LIABILITIES:
Accounts payable	$	6,604	$	8,706
Accrued expenses		3,046		3,617
Notes payable		7,105		—
Finance lease obligations		251		269
Total current liabilities		17,006		12,592
NON-CURRENT LIABILITIES:
Notes payable, net of discount		36,245		43,080
Other non-current liabilities		5,283		5,453
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ DEFICIT:
Preferred stock:
Series A Convertible Preferred Stock		19,227		19,227
Common stock		70		69
Additional paid-in capital		377,541		377,229
Accumulated deficit		(403,236)		(397,281)
Accumulated other comprehensive loss		(2,205)		(1,849)
TOTAL STOCKHOLDERS’ DEFICIT		(8,603)		(2,605)
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$	49,931	$	58,520

ALIMERA SCIENCES, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE THREE MONTHS ENDED MARCH 31, 2022 AND 2021

(in thousands, except share and per share data)

	Three Months Ended
	March 31,
	2022		2021
	(unaudited)
REVENUE:
PRODUCT REVENUE, NET	$	11,898	$	11,214
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION		(1,680)		(1,562)
GROSS PROFIT		10,218		9,652
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES		3,583		3,213
GENERAL AND ADMINISTRATIVE EXPENSES		3,240		3,413
SALES AND MARKETING EXPENSES		6,853		4,818
DEPRECIATION AND AMORTIZATION		689		638
OPERATING EXPENSES		14,365		12,082
LOSS FROM OPERATIONS		(4,147)		(2,430)
INTEREST EXPENSE AND OTHER		(1,364)		(1,343)
UNREALIZED FOREIGN CURRENCY GAIN, NET		108		125
CHANGE IN FAIR VALUE OF WARRANT ASSET		(552)		—
NET LOSS	$	(5,955)	$	(3,648)
NET LOSS PER SHARE — Basic and Diluted	$	(0.85)	$	(0.63)
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and Diluted		6,990,737		5,755,424

RECONCILIATION OF GAAP MEASURES TO NON-GAAP ADJUSTED MEASURES

GAAP NET INCOME OR LOSS TO NON-GAAP ADJUSTED EBITDA

(in thousands)

	Three Months Ended
	March 31,
	2022		2021
	(Unaudited)
GAAP NET LOSS	$	(5,955)	$	(3,648)
Adjustments to net loss:
Interest expense and other		1,364		1,343
Depreciation and amortization		689		638
Stock-based compensation expenses		313		262
Unrealized foreign currency exchange (gains) losses		(108)		(125)
Severance expense		—		195
Change in fair value of warrant asset		552		—
NON-GAAP ADJUSTED EBITDA	$	(3,145)	$	(1,335)

XML

Document and Entity Information	May 09, 2022
Document and Entity Information [Abstract]
Document Type	8-K
Document Period End Date	May 09, 2022
Entity Registrant Name	ALIMERA SCIENCES, INC.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-34703
Entity Tax Identification Number	20-0028718
Entity Address, Address Line One	6310 Town Square
Entity Address, Address Line Two	Suite 400
Entity Address, City or Town	Alpharetta
Entity Address, State or Province	GA
Entity Address, Postal Zip Code	30005
City Area Code	678
Local Phone Number	990-5740
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.01 par value per share
Trading Symbol	ALIM
Security Exchange Name	NASDAQ
Emerging Growth Company	false
Entity Central Index Key	0001267602
Amendment Flag	false