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 11, 2012

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.)
6120 Windward Parkway Suite 290 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:

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

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

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

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

Item 2.02. Results of Operations and Financial Condition.

On May 11, 2012, Alimera Sciences, Inc. (“Alimera”) issued a press release regarding its results of operations and financial condition for the first quarter ended March 31, 2012. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. Alimera will be hosting a conference call, as well as a live webcast on the Investor Relations section of its corporate website at http://www.alimerasciences.com, on May 11, 2012 at 8:30 A.M. E.T. to discuss its first quarter 2012 financial results and to provide a regulatory update.

Various statements to be made during the conference call and webcast are “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera’s future results of operations and financial position, business strategy and plans and objectives of management for Alimera’s future operations. Words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “contemplate,” “predict,” “project,” “target,” “likely,” “potential,” “continue,” “will,” “would,” “should,” “could,” or the negative of these terms and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The events and circumstances reflected in Alimera’s forward-looking statements may not occur and actual results could differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, delay in or failure to obtain regulatory approval of Alimera’s product candidates, uncertainty as to Alimera’s ability to commercialize (alone or with others), and market acceptance of, Alimera’s product candidates, including ILUVIEN in the EU, the extent of government regulations, uncertainty as to the pricing and reimbursement guidelines for Alimera’s product candidates, including ILUVIEN in the various EU countries, uncertainty as to relationship between the benefits of Alimera’s product candidates and the risks of their side-effect profiles, dependence on third-party manufacturers to manufacture Alimera’s product candidates in sufficient quantities and quality, uncertainty of clinical trial results, limited sales and marketing infrastructure, inability of Alimera to successfully market and sell ILUVIEN following regulatory approval and Alimera’s ability to operate its business in compliance with the covenants and restrictions that it is subject to under its credit facility, as well as 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, 2011, which is on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in Alimera’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K 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 made during the conference call are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date on which they are made (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, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press Release of Alimera Sciences, Inc. dated May 11, 2012

SIGNATURE

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.
By:	/s/ RICHARD S. EISWIRTH, JR.
	Name: Richard S. Eiswirth, Jr.
	Title:   Chief Operating Officer and Chief             Financial Officer

Dated: May 11, 2012

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

For investor inquiries: John Mills, ICR for Alimera Sciences 310-954-1105 John.Mills@ICRINC.com For press inquiries: Katie Brazel, Fleishman-Hillard for Alimera Sciences 404-739-0150 Katie.Brazel@fleishman.com

ALIMERA SCIENCES REPORTS FIRST QUARTER 2012 FINANCIAL RESULTS

Cash and Cash Equivalents at March 31, 2012 Totaled $27.6 Million

Alimera Will Host a Conference Call at 8:30 A.M. ET Today

ATLANTA, GA May 11, 2012 — Alimera Sciences, Inc., (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced financial results for the first quarter ended March 31, 2012.

“We believe we are on track with our previously stated plan to have ILUVIEN^® available for a commercial launch in Europe by the end of the year,” said Dan Myers, president and chief executive officer, Alimera Sciences. “During the past few weeks we have received marketing authorizations from the United Kingdom and Austria and anticipate receiving additional marketing authorizations in the coming months.”

The Company’s marketing authorizations received to date and the Final Assessment Report of the decentralized procedure are expected to support its potential pursuit of ILUVIEN approval in the remaining EU countries through the use of the EU’s Mutual Recognition Procedure.

“Our board of directors and management team continue to evaluate the long-term sales and marketing opportunities for ILUVIEN in Europe, which may include strategic partnerships, as well as developing our own sales and marketing capabilities,” continued Mr. Myers. “Meanwhile, we continue to advance our preparations for commercial availability later this year regardless of the strategy we pursue.”

FDA Update

Alimera plans to meet with the U.S. Food and Drug Administration (FDA) toward the end of the second quarter of 2012 to discuss the FDA’s November 2011 complete response letter regarding Alimera’s New Drug Application for ILUVIEN for the treatment of Diabetic Macular Edema (DME).

First Quarter 2012 Financial Results

Research and development expenses for the first quarter of 2012 decreased to $1.6 million, compared to $1.8 million for the first quarter of 2011.

General and administrative expenses in the first quarter of 2012 were $1.4 million, compared to $1.5 million in the first quarter of 2011.

Marketing expenses in the first quarter of 2012, as well as in the first quarter of 2011, were approximately $1.1 million. Marketing expenses were substantially reduced in the United States in the first quarter of 2012 in comparison to the prior year due to the cancellation of the previously expected commercial launch of ILUVIEN in the U.S. However, marketing expenses remained relatively flat year-over-year as Alimera increased its pre-launch activities in Europe.

Net loss for the quarter ended March 31, 2012 was $4.4 million, or $0.14 per common share, compared with a net loss of $4.7 million, or $0.15 per common share, for the quarter ended March 31, 2011. Net loss per share was based on 31,427,355 weighted average shares outstanding for the first quarter of 2012 and 31,277,697 weighted averages shares outstanding for the first quarter of 2011.

As of March 31, 2012, Alimera had cash, cash equivalents and investments of $27.6 million, compared to $33.6 million as of December 31, 2011.

Conference Call to be Held Today

Alimera will hold a conference call today at 8:30 A.M. ET to discuss these results and provide a regulatory update. The conference call will be hosted by Dan Myers, president and chief executive officer, and Rick Eiswirth, chief operating officer and chief financial officer.

To participate in the call, please dial (877) 369-6586 (U.S. and Canada) or (253) 237-1165 (international). A live webcast will be available on the Investor Relations section of the corporate website at http://www.alimerasciences.com.

A replay of the conference call will be available beginning May 11, 2012 at 11:30 a.m. ET and ending on May 25, 2012 by dialing (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international), Conference ID Number: 75754101. A replay of the webcast will be available on the corporate website for two weeks, through May 25, 2012.

About ILUVIEN^®

ILUVIEN (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal implant used to treat chronic DME. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). ILUVIEN is inserted in the back of the patient’s eye to a position that takes advantage of the eye’s natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound.

About FAME™ Safety

Safety was assessed among those patients treated with ILUVIEN who were in the subgroup of patients with DME for three years or more and were considered to have chronic DME. Intraocular pressure (IOP) increases to 30 millimeters of mercury (mmHg) or greater at any time point were seen in 12.7% of these patients by month 36, compared to 18.4% in the full ILUVIEN treated patient population. By month 36, 3.6% of these patients had undergone an incisional surgical procedure to reduce elevated IOP, compared to 4.8% in the full patient population. The incidence of cataracts among patients with a natural lens in their eye at the start of the study was 84.1% at month 36, with 87.3% undergoing a cataract operation, compared to 81.7% and 80.0%, respectively, in the full patient population.

About DME

DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition has progressed to DME. The onset of DME is painless and may go undetected by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. As the population of people with diabetes increases, it is anticipated that the annual incidence of diagnosed DME will increase.

About Alimera Sciences, Inc.

Alimera Sciences, Inc., based in Alpharetta, Georgia, is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently Alimera is focused on diseases affecting the back of the eye, or retina. Its primary product, ILUVIEN, is an intravitreal implant containing fluocinolone acetonide (FAc), a non-proprietary corticosteroid with demonstrated efficacy in the treatment of ocular disease.

Forward Looking Statements

This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera’s commercial plans for ILUVIEN in the European Union (EU). Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, uncertainty as to Alimera’s ability to commercialize (alone or with others), and market acceptance of, ILUVIEN in the EU, uncertainty as to the pricing and reimbursement guidelines for ILUVIEN in the various EU countries, as well as 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, 2011 which is on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. 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 this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this 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.

# # #

ALIMERA SCIENCES, INC.

BALANCE SHEETS

(In thousands)

	March 31,			December 31,
	2012			2011
	(Unaudited)
CURRENT ASSETS:
Cash and cash equivalents	$	27,625		$	33,108
Investments in marketable securities		—			500
Prepaid expenses and other current assets		742			692
Deferred financing costs		172			201
Total current assets		28,539			34,501
PROPERTY AND EQUIPMENT — at cost less accumulated depreciation		171			197
TOTAL ASSETS	$	28,710		$	34,698
CURRENT LIABILITIES:
Accounts payable	$	1,656		$	1,948
Accrued expenses		894			1,638
Outsourced services payable		229			658
Notes payable		2,462			2,462
Capital lease obligations		12			12
Total current liabilities		5,253			6,718
LONG-TERM LIABILITIES:
Notes payable, net of discount — less current portion		2,332			2,868
Other long-term liabilities		156			134
STOCKHOLDERS’ EQUITY:
Common stock		314			314
Additional paid-in capital		235,971			235,619
Common stock warrants		415			415
Accumulated deficit		(215,731	)		(211,370	)
TOTAL STOCKHOLDERS’ EQUITY		20,969			24,978
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	28,710		$	34,698

ALIMERA SCIENCES, INC.

STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)

	Three Months Ended March 31,
	2012			2011
	(Unaudited)
RESEARCH AND DEVELOPMENT EXPENSES	$	1,581		$	1,757
GENERAL AND ADMINISTRATIVE EXPENSES		1,434			1,540
MARKETING EXPENSES		1,113			1,117
TOTAL OPERATING EXPENSES		4,128			4,414
INTEREST INCOME		1			12
INTEREST EXPENSE		(234	)		(295	)
NET LOSS	$	(4,361	)	$	(4,697	)
NET LOSS PER SHARE — Basic and diluted	$	(0.14	)	$	(0.15	)
WEIGHTED-AVERAGE SHARES OUTSTANDING — Basic and diluted		31,427,355			31,277,697