UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)



x	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended ~~September 30, 2017~~March 31, 2019



o	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: 001-34703

Alimera Sciences, Inc.

(Exact name of registrant as specified in its charter)



Delaware		20-0028718
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)



6120 Windward Parkway, Suite 290 Alpharetta, GA		30005
(Address of principal executive offices)		(Zip Code)

(678) 990-5740

(Registrant’s telephone number, including area code)

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 x No ¨

Indicate by check mark whether the registrant has submitted electronically ~~and posted on its corporate Web site, if any,~~ every Interactive Data File required to be submitted ~~and posted~~ 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 ~~and post~~ such files). Yes x No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated ~~filer”~~filer,” “smaller reporting company” and ~~“smaller reporting~~“emerging growth company” in Rule 12b-2 of the Exchange Act. ~~(Check one):~~



Large accelerated filer	o		Accelerated filer	ox

Non-accelerated filer	o	~~(Do not check if a smaller reporting company)~~	Smaller reporting company	x

			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)~~(2)(B)~~ 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 ¨ No x

As of ~~November 2, 2017~~May 6, 2019, there were ~~69,148,344~~71,000,495 shares of the registrant’s Common Stock issued and outstanding.

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)

Table of Contents

ALIMERA SCIENCES, INC.

QUARTERLY REPORT ON FORM 10-Q

INDEX



PART I. FINANCIAL INFORMATION
Item 1. Interim Condensed Consolidated Financial Statements (unaudited)	4
Condensed Consolidated Balance Sheets as of ~~September 30, 2017~~March 31, 2019 and December 31, ~~2016~~2018	4
Condensed Consolidated Statements of Operations for the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2019 and ~~2016~~2018	5
Condensed Consolidated Statements of Comprehensive Loss for the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2019 and ~~2016~~2018	6
Condensed Consolidated Statements of Cash Flows for the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2019 and ~~2016~~2018	7
Condensed Consolidated Statement of Changes in Equity	8
Notes to Condensed Consolidated Financial Statements	89
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	2832
Item 3. Quantitative and Qualitative Disclosures about Market Risk	4542
Item 4. Controls and Procedures	4643
PART II. OTHER INFORMATION
Item 1. Legal Proceedings	4744
Item 1A. Risk Factors	4745
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	4846
Item 3. Defaults Upon Senior Securities	4846
Item 4. Mine Safety Disclosures	4846
Item 5. Other Information	4846
Item 6. Exhibits	4947
See the Exhibit Index immediately following the signature page of this Quarterly Report on Form 10-Q, which is incorporated herein by reference.

Table of Contents

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND PROJECTIONS

Various statements in this report of Alimera Sciences, Inc. (we, our, Alimera, the Company or the registrant) 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 ~~Alimera Sciences, Inc.’s (we,~~ our ~~Alimera or the Company)~~ 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 ~~but not limited to,~~ “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. Meaningful factors ~~which~~that could cause actual results to differ ~~include, but are not limited to:~~include:

a slowdown or reduction in our sales in due to a reduction in end user demand, unanticipated competition, regulatory issues, or other unexpected circumstances;


•	uncertainty ~~as to~~regarding our ability to achieve profitability and positive cash flow through the commercialization of ILUVIEN^® in the U.S., the European Economic Area ~~the United States~~(EEA) and other regions of the world where we sell ILUVIEN;

~~our ability to operate our business in compliance with the covenants and restrictions that we are subject to under our credit facility;~~

dependence on third-party manufacturers to manufacture ILUVIEN or any future products or product candidates in sufficient quantities and ~~quality.~~quality;

~~our ability to raise sufficient additional funding and~~uncertainty associated with our need to ~~raise such funds;~~replace our key third-party manufacturer of certain component parts of the ILUVIEN injector before our manufacturing contact with the manufacturer expires on September 30, 2020;

uncertainty ~~as to~~regarding the pricing and reimbursement guidelines for ILUVIEN or any future products or product candidates, including ~~ILUVIEN;~~ILUVIEN in new markets;

uncertainty associated with our pursuit of reimbursement with local health authorities in countries including the U.K., Ireland, Germany, Austria, Portugal, Italy, Spain and France for the recently obtained additional indication for ILUVIEN for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU);

uncertainty associated with our ability to meet any post-market requirements for NIPU in the EEA;

our ability to successfully commercialize ILUVIEN following regulatory approval in additional markets;

delay in or failure to obtain regulatory approval of ILUVIEN ~~for non-infectious posterior uveitis or diabetic macular edema in additional countries~~ or any future products or product ~~candidates;~~candidates in additional countries;

the possibility that we may again fail to comply with the continuing listing standards of the Nasdaq Global Market because the closing bid price of our common stock on the Nasdaq Global Market is below $1.00 for 30 consecutive business days;

our ability to operate our business in compliance with the covenants and restrictions in our credit facility;

current and future laws and regulations; and

~~the extent of government regulations.~~our possible need to raise additional financing.

All written and ~~verbal~~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 ~~publicly~~ any forward-looking statements, whether as a result of new information, future events or otherwise. ~~You are advised,~~Please see, however, ~~to consult~~ 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.~~Commission (SEC).

We encourage you to read the discussion and analysis of our financial condition and our ~~unaudited interim~~ condensed consolidated financial statements contained in this report. We also encourage you to read Item 1A of Part II of this Quarterly Report on Form 10-Q, entitled “Risk Factors” and Item 1A of Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, ~~2016,~~2018, which contains a more ~~complete~~detailed discussion of some of the risks and uncertainties associated with our business. In addition to the risks described above, 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 ~~anticipated by us will be realized~~we anticipate or, even if we do substantially ~~realized,~~realize them, that they will have the expected consequences to, or effects on, us. Therefore, we can give no ~~assurance can be given~~assurances that we will achieve the outcomes stated in ~~such~~those forward-looking statements and ~~estimates will be achieved.~~estimates.

Table of Contents

PART I. FINANCIAL INFORMATION

ITEM 1. Interim Condensed Consolidated Financial Statements (unaudited)

ALIMERA SCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS


	September 30, 2017			December 31, 2016			March 31, 2019			December 31, 2018
	(In thousands, except share and per share data)						(In thousands, except share and per share data)
CURRENT ASSETS:
Cash and cash equivalents	$	25,624		$	30,979		$	13,094		$	13,043
Restricted cash	34			31			33			32
Accounts receivable, net	13,454			13,839			15,417			17,259
Prepaid expenses and other current assets	2,752			2,107			2,469			2,109
Inventory, net (Note 5)	1,738			446
Inventory (Note 7)							1,860			2,405
Total current assets	43,602			47,402			32,873			34,848
NON-CURRENT ASSETS:
Property and equipment, net	1,514			1,787			1,259			1,355
Intangible asset, net (Note 6)	19,153			20,604
Right of use assets, net							775			—
Intangible asset, net (Note 8)							16,245			16,723
Deferred tax asset	489			436			1,158			1,182
TOTAL ASSETS	$	64,758		$	70,229		$	52,310		$	54,108
CURRENT LIABILITIES:
Accounts payable	$	5,303		$	4,986		$	6,602		$	6,355
Accrued expenses (Note 7)	3,514			3,758
Derivative warrant liability	—			188
Capital lease obligations	187			191
Accrued expenses (Note 9)							3,118			3,643
Finance lease obligations							253			236
Total current liabilities	9,004			9,123			9,973			10,234
NON-CURRENT LIABILITIES:
Note payable (Note 9)	34,016			33,084
Capital lease obligations — less current portion	199			274
Note payable (Note 11)							38,080			37,873
Finance lease obligations — less current portion							241			305
Other non-current liabilities	775			2,162			3,370			2,974
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY:
Preferred stock, $.01 par value — 10,000,000 shares authorized at September 30, 2017 and December 31, 2016:
Series A Convertible Preferred Stock, 1,300,000 authorized and 600,000 issued and outstanding at September 30, 2017 and December 31, 2016; liquidation preference of $24,000 at September 30, 2017 and December 31, 2016	19,227			19,227
Series B Convertible Preferred Stock, 8,417 authorized and 8,416.251 issued and outstanding at September 30, 2017 and December 31, 2016; liquidation preference of $50,750 at September 30, 2017 and December 31, 2016	49,568			49,568
Common stock, $.01 par value — 150,000,000 shares authorized, 69,105,380 shares issued and outstanding at September 30, 2017 and 64,862,904 shares issued and outstanding at December 31, 2016	691			649
Preferred stock, $.01 par value — 10,000,000 shares authorized at March 31, 2019 and December 31, 2018:
Series A Convertible Preferred Stock, 1,300,000 authorized and 600,000 issued and outstanding at March 31, 2019 and December 31, 2018; liquidation preference of $24,000 at March 31, 2019 and December 31, 2018							19,227			19,227
Series C Convertible Preferred Stock, 10,150 authorized issued and outstanding at March 31, 2019 and December 31, 2018; liquidation preference of $10,150 at March 31, 2019 and December 31, 2018							11,117			11,117
Common stock, $.01 par value — 150,000,000 shares authorized, 70,968,630 shares issued and outstanding at March 31, 2019 and 70,078,878 shares issued and outstanding at December 31, 2018							710			701
Additional paid-in capital	340,301			330,781			346,869			346,108
Common stock warrants	3,707			3,707			3,707			3,707
Accumulated deficit	(391,851		)	(377,074		)	(379,890		)	(377,127		)
Accumulated other comprehensive loss	(879		)	(1,272		)	(1,094		)	(1,011		)
TOTAL STOCKHOLDERS’ EQUITY	20,764			25,586			646			2,722
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	64,758		$	70,229		$	52,310		$	54,108

See Notes to Condensed Consolidated Financial Statements.

Table of Contents

ALIMERA SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

~~FOR THE THREE AND NINE MONTHS ENDED~~ ~~SEPTEMBER 30, 2017~~ ~~AND~~ ~~2016~~


	Three Months Ended September 30,						Nine Months Ended September 30,						Three months ended March 31,
	2017			2016			2017			2016			2019			2018
	(In thousands, except share and per share data)												(In thousands, except share and per share data)
NET REVENUE	$	9,784		$	8,298		$	26,770		$	23,656		$	12,890		$	9,630
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION	(1,039		)	(486		)	(2,395		)	(1,420		)	(1,600		)	(1,104		)
GROSS PROFIT	8,745			7,812			24,375			22,236			11,290			8,526

RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES	5,420			3,261			9,768			9,486			2,727			2,822
GENERAL AND ADMINISTRATIVE EXPENSES	3,320			3,645			9,596			11,079			3,393			3,855
SALES AND MARKETING EXPENSES	6,002			7,452			16,564			22,071			5,913			5,969
DEPRECIATION AND AMORTIZATION	679			697			2,012			2,082			652			649
RECOVERABLE COLLABORATION COSTS	(2,851		)	—			(2,851		)	—
OPERATING EXPENSES	12,570			15,055			35,089			44,718			12,685			13,295
NET LOSS FROM OPERATIONS	(3,825		)	(7,243		)	(10,714		)	(22,482		)	(1,395		)	(4,769		)

INTEREST EXPENSE, NET AND OTHER	(1,431		)	(1,330		)	(4,152		)	(3,842		)
UNREALIZED FOREIGN CURRENCY LOSS, NET	(6		)	(51		)	(6		)	(31		)
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY	—			(588		)	188			1,755
INTEREST EXPENSE AND OTHER													(1,228		)	(1,151		)
UNREALIZED FOREIGN CURRENCY (LOSS) GAIN, NET													(69		)	2
LOSS ON EARLY EXTINGUISHMENT OF DEBT	—			—			—			(2,564		)	—			(1,766		)
NET LOSS BEFORE TAXES	(5,262		)	(9,212		)	(14,684		)	(27,164		)	(2,692		)	(7,684		)
PROVISION FOR TAXES	(23		)	(33		)	(93		)	(84		)	(71		)	—
NET LOSS	$	(5,285	)	$	(9,245	)	$	(14,777	)	$	(27,248	)	(2,763		)	(7,684		)
NET LOSS PER SHARE — Basic and diluted	$	(0.08	)	$	(0.16	)	$	(0.22	)	$	(0.56	)	$	(0.04	)	$	(0.11	)
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted	68,430,856			56,103,534			66,272,691			48,759,381			70,740,851			69,883,012

See Notes to Condensed Consolidated Financial Statements.

Table of Contents

ALIMERA SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

~~FOR THE THREE AND NINE MONTHS ENDED~~ ~~SEPTEMBER 30, 2017~~ ~~AND~~ ~~2016~~


	Three Months Ended September 30,						Nine Months Ended September 30,						Three Months Ended March 31,
	2017			2016			2017			2016			2019			2018
	(In thousands)												(In thousands)
NET LOSS	$	(5,285	)	$	(9,245	)	$	(14,777	)	$	(27,248	)	$	(2,763	)	$	(7,684	)

OTHER COMPREHENSIVE INCOME
Foreign currency translation adjustments	118			30			393			79			(83		)	106
TOTAL OTHER COMPREHENSIVE INCOME	118			30			393			79			(83		)	106
COMPREHENSIVE LOSS	$	(5,167	)	$	(9,215	)	$	(14,384	)	$	(27,169	)	$	(2,846	)	$	(7,578	)

See Notes to Condensed Consolidated Financial Statements.

Table of Contents

ALIMERA SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

~~FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2017 AND 2016~~


	Nine Months Ended September 30,						Three Months Ended March 31,
	2017			2016			2019			2018
	(In thousands)						(In thousands)
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(14,777	)	$	(27,248	)	$	(2,763	)	$	(7,684	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	2,012			2,082			652			649
Inventory reserve	34			39
Unrealized foreign currency transaction loss	6			31
Unrealized foreign currency transaction loss (gain)							69			(2		)
Loss on early extinguishment of debt	—			2,564			—			1,766
Amortization of debt discount	1,055			795			206			214
Stock-based compensation expense	3,703			3,753			770			1,207
Change in fair value of derivative warrant liability	(188		)	(1,755		)
Changes in assets and liabilities:
Accounts receivable	594			(3,564		)	1,755			(867		)
Prepaid expenses and other current assets	(548		)	(514		)	(381		)	309
Inventory	(1,295		)	612			532			299
Accounts payable	98			(2,101		)	301			(992		)
Accrued expenses and other current liabilities	(333		)	1,256			(857		)	70
Other long-term liabilities	(1,528		)	1,354			—			(17		)
Net cash used in operating activities	(11,167		)	(22,696		)
Net cash provided by (used in) operating activities							284			(5,048		)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment	(234		)	(122		)	(15		)	(91		)
Net cash used in investing activities	(234		)	(122		)	(15		)	(91		)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of stock options	1			157			—			2
Proceeds from sale of common stock	6,042			27,547
Payment of issuance cost of common stock	(183		)	(1,227		)
Payment of debt costs	—			(715		)
Changes in restricted cash	(3		)	—
Payment of capital lease obligations	(110		)	(178		)
Net cash provided by financing activities	5,747			25,584
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS	299			12
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS	(5,355		)	2,778
CASH AND CASH EQUIVALENTS — Beginning of period	30,979			31,075
CASH AND CASH EQUIVALENTS — End of period	$	25,624		$	33,853
Issuance of debt							—			40,000
Payment of principal on notes payable							—			(35,000		)
Payment of extinguishment of debt costs							—			(2,544		)
Payment of deferred financing costs							—			(1,142		)
Payment of finance lease obligations							(110		)	(83		)
Net cash (used in) provided by financing activities							(110		)	1,233
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH							(107		)	93
NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH							52			(3,813		)
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — Beginning of period							13,075			24,101
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — End of period							$	13,127		$	20,288
SUPPLEMENTAL DISCLOSURES:
Cash paid for interest	$	3,068		$	2,977		$	1,012		$	932
Cash paid for income taxes	$	66		$	299		$	4		$	—
Supplemental schedule of non-cash investing and financing activities:
Property and equipment acquired under capital leases	$	175		$	76		$	64		$	252
Common stock issuance costs accrued but unpaid	$	—		$	114
Note payable end of term payment accrued but unpaid	$	1,400		$	1,400		$	—		$	1,800

~~There were no dividend payments made during the nine months ended September 30, 2017 and 2016.~~

See Notes to Condensed Consolidated Financial Statements.

Table of Contents

ALIMERA SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY



	Common Stock			Series A Convertible Preferred Stock			Series B Convertible Preferred Stock			Series C Convertible Preferred Stock			Additional Paid-In Capital			Common Stock Warrants		Accumulated Deficit			Accumulated Other Comprehensive Loss			Total
	Shares	Amount		Shares	Amount		Shares	Amount		Shares	Amount		Additional Paid-In Capital			Common Stock Warrants		Accumulated Deficit			Accumulated Other Comprehensive Loss			Total
2019	(In thousands, except share data)
Balance, December 31, 2018	70,078,878	$	701	600,000	$	19,227	—	$	—	10,150	$	11,117	$	346,108		$	3,707	$	(377,127	)	$	(1,011	)	$	2,722
Issuance of common stock, net of issuance costs	889,752	9		—	—		—	—		—	—		(9		)	—		—			—			—
Stock-based compensation	—	—		—	—		—	—		—	—		770			—		—			—			770
Net loss	—	—		—	—		—	—		—	—		—			—		(2,763		)	—			(2,763		)
Foreign currency translation adjustments	—	—		—	—		—	—		—	—		—			—		—			(83		)	(83		)
Balance, March 31, 2019	70,968,630	$	710	600,000	$	19,227	—	$	—	10,150	$	11,117	$	346,869		$	3,707	$	(379,890	)	$	(1,094	)	$	646

2018
Balance, December 31, 2017	69,146,381	$	691	600,000	$	19,227	8,416	$	49,568	—	$	—	$	341,622		$	3,707	$	(399,074	)	$	(821	)	$	14,920
Issuance of common stock, net of issuance costs	839,285	9		—	—		—	—		—	—		(9		)	—		—			—			—
Exercise of stock options	729	—		—	—		—	—		—	—		2			—		—			—			2
Stock-based compensation	—	—		—	—		—	—		—	—		1,207			—		—			—			1,207
Net loss	—	—		—	—		—	—		—	—		—			—		(7,684		)	—			(7,684		)
Foreign currency translation adjustments	—	—		—	—		—	—		—	—		—			—		—			106			106
Balance, March 31, 2018	69,986,395	$	700	600,000	$	19,227	8,416	$	49,568	—	$	—	$	342,822		$	3,707	$	(406,758	)	$	(715	)	$	8,551

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS


1.	NATURE OF OPERATIONS

Alimera Sciences, Inc., together with its wholly-owned subsidiaries (the Company), is a pharmaceutical company that specializes in the commercialization and development of ~~prescription~~ ophthalmic pharmaceuticals. The Company was formed on June 4, 2003 under the laws of the State of Delaware.

The Company is presently focused on diseases affecting the back of the eye, or retina, because the Company’s management believes these diseases are not well treated with current therapies and represent a significant market opportunity. The Company’s only commercial product is ILUVIEN^®, which has received marketing authorization in the United States (U.S.), Austria, Belgium, Canada, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Lebanon, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, the United Arab Emirates and the United Kingdom. In the U.S., Canada, Kuwait, Lebanon and the United Arab Emirates, ILUVIEN is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). In the European Economic Area (EEA) countries in which ILUVIEN has received marketing authorization, it is indicated for the treatment of vision impairment associated with DME considered insufficiently responsive to available ~~therapies.~~

~~As part~~therapies and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the ~~approval process~~eye in ~~the EEA,~~countries where the Company ~~committed~~has satisfied the country's labeling requirements and the Company is now permitted to ~~conduct~~market ILUVIEN.

The Company has completed enrollment into a five-year, post-authorization, open label registry study in ~~800~~ patients treated with ~~ILUVIEN per the labeled indication.~~ILUVIEN. In the fourth quarter of 2016, the Company requested approval to modify its protocol to cap enrollment in the study due to its post market safety surveillance not showing any unexpected safety signals. The Company received regulatory approval to cap enrollment in the study from the Medicines & Healthcare products Regulatory Agency (MHRA) in July 2017. As of September 30, 2017,total, 562 patients ~~were~~ enrolled in this ~~study.~~study, and the Company anticipates the follow up period to be completed in early 2020.

The Company ~~launched~~commercially markets ILUVIEN directly in the U.S., Germany, ~~and~~ the United Kingdom, ~~in the second quarter of 2013, in the U.S.~~Portugal, Austria and Portugal in the first quarter of 2015. The Company began selling ILUVIEN in Austria in the first quarter of 2017 and the Company expects to begin sales of ILUVIEN in Ireland in the fourth quarter of 2017.

Ireland. In addition, the Company has entered into various agreements under which distributors will provide regulatory, reimbursement or sales and marketing support for commercialization or future commercialization of ILUVIEN in ~~several countries in the Middle East, as well as~~ France, Italy, Spain, Australia, New Zealand, Canada and ~~Canada.~~several countries in the Middle East. In ~~the third quarter of~~ 2016, the Company’s Middle East distributor launched ILUVIEN and initiated named patient sales in the United Arab Emirates. The Company’s Italian distributor launched ILUVIEN in Italy in 2017. The Company’s Spanish distributor began selling on a named patient basis in 2017 and is currently pursuing reimbursement at the ~~second quarter of 2017.~~national level. The Company’s French distributor received pricing and reimbursement approval in March 2019 for ILUVIEN for DME and began selling in April 2019. The Company’s Canadian distributor is currently pursuing reimbursement. As of ~~September 30, 2017,~~March 31, 2019, the Company has recognized sales of ILUVIEN to ~~our~~the Company’s international distributors in the Middle East, France, Italy and Spain.

In July 2017, the Company amended its license with EyePoint Pharmaceuticals US, Inc. (EyePoint) formerly known as pSivida US, Inc. ~~(pSivida)~~ for the technology underlying ILUVIEN to include the treatment of uveitis, including non-infectious posterior uveitis (NIPU) in Europe, the Middle East and Africa ~~(Note 8)~~(See Note 10). Uveitis is an inflammatory disease of the uveal tract, which is comprised of the iris, ciliary body and choroid, that can lead to severe vision loss and blindness. ~~The~~In December 2017, the Company ~~plans to file~~filed an application for a new indication for ILUVIEN for NIPU in the 17 EEA countries where ILUVIEN is currently approved for the treatment of DME. The regulatory authorities requested additional follow-up data from the clinical trials to support the application, which was submitted in October 2018. In March 2019, the Company received the Final Variation Assessment Report (FVAR) for ILUVIEN from the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) based on the Company’s submission to the MHRA through the Mutual Recognition Procedure. Under that procedure, the United Kingdom has acted as the Reference Member State and prepared an assessment report to share with the 16 other countries in the EEA in which the Company applied for an additional indication. The FVAR states that ILUVIEN is approved for the additional indication for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye, or NIPU.

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

2. BASIS OF PRESENTATION

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~~ the instructions to Form 10-Q and Article 10-01 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, they 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~~interim financial statements reflect all adjustments, which include normal recurring adjustments, necessary to present fairly the Company’s interim financial information.

The ~~Interim Financial Statements~~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, ~~2016~~2018 and related notes included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on ~~March 3, 2017.~~February 25, 2019. The financial results for any interim period are not necessarily indicative of the expected financial results for the full year.

~~Modification of Segment Footnote~~

The Company modified its segment footnote for the three and nine months ended September 30, 2016 for an immaterial change and removed, within the segment footnote, certain non-cash expenses including $1,134,000 of stock-based compensation expense and $697,000 of depreciation and amortization from the Company’s U.S. and International segments for the three months ended September 30, 2016 and $3,753,000 of stock-based compensation expense and $2,082,000 of depreciation and amortization from the Company’s U.S. and International segments for the nine months ended September 30, 2016. These amounts are appropriately classified as Other within the segment footnote of these Interim Financial Statements. Additionally, in the Company’s Annual Report on Form 10-K filing for the year ended December 31, 2016, the Company disclosed that the Company’s chief operating decision maker separately managed and evaluated each segment primarily upon net loss from operations. The modification made in these financial statements clarifies that the chief operating decision maker manages and evaluates each segment based on net loss from operations adjusted for certain non-cash items, such as stock-based compensation expense and depreciation and amortization.

910

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

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, ~~2016.~~2018.

Research and Development Expenses

Research and development expenses were ~~$3,299,000~~$197,000 and ~~$514,000~~$104,000 for the three months ended ~~September 30, 2017~~March 31, 2019 and ~~2016,~~2018, respectively. ~~Research~~

Prior period reclassification

An immaterial reclassification of prior period amounts related to revenue and ~~development expenses were $3,652,000~~cost of goods sold, excluding depreciation and ~~$1,616,000 for~~amortization has been made to conform to the ~~nine months ended September 30, 2017 and 2016, respectively. These research and development expenses do~~current period presentation. This reclassification did not include medical affairs expenses. Included in expenses for the three and nine months ended September 30, 2017, was a non-cash charge of $2,851,000 for in-process Research and Development for the license of uveitis, including NIPU, in Europe, the Middle East and Africa,have any impact on gross profit, net loss from ~~pSivida (Note 8).~~operations or net loss.

Recent Accounting Pronouncements

From time to time, ~~new accounting pronouncements are issued by~~ the Financial Accounting Standards Board (FASB) or other standard setting bodies issue new accounting pronouncements that ~~are adopted by us~~we adopt as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption.

Adoption of New Accounting Standards

In ~~August 2014,~~February 2016, the FASB issued ~~Accounting Standards Update (ASU) 2014-15,~~ASU 2016-02, ~~Disclosure~~Leases (ASC 842), to increase transparency and comparability among organizations for lease recognition and disclosure. ASU 2016-02 requires lessees to recognize lease assets and lease liabilities on the balance sheet, while recognizing expenses on the income statements in a manner similar to current guidance. ASU 2016-02 became effective for fiscal years and interim periods for the Company in the first quarter of ~~Uncertainties about an Entity’s Ability to Continue~~2019. ASU 2016-02 requires that leases be recognized and measured as ~~a Going Concern. ASU 2014-15 requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year~~ of the ~~date~~earliest period presented, using a modified retrospective approach, with all periods presented being adjusted and presented under the new standard. In July 2018, the FASB issued ASU 2018-11, Leases (ASC 842): Targeted Improvements, which provides companies an optional adoption method to ASU 2016-02 whereby a company does not have to adjust comparative period financial statements for the new standard.

The Company adopted this ASU on January 1, 2019 and did not restate comparative periods. The Company elected the transition package of three practical expedients permitted within the standard. In accordance with the package of practical expedients, the Company did not reassess initial direct costs, lease classification, or whether its contracts contain or are leases. The Company also made an accounting policy election to not recognize right of use assets and liabilities for leases with a term of 12 months or less, unless the leases include options to renew or purchase the underlying asset that are reasonably certain to be exercised. See Note 5 for expanded disclosures.

In February 2018, the FASB issued ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income, to allow reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and ~~provides guidance~~Jobs Act. Upon adoption of the ASU, entities are required to describe the accounting policy for releasing income tax effects from accumulated other comprehensive income. The Company adopted this standard on determining when and how to disclose going concern uncertainties in the financial statements. ASU 2014-15 applies to all entities and is effective for annual and interim reporting periods ending after December 15, 2016, with early adoption permitted.January 1, 2019. The adoption of this guidance did not have a material impact on the Company’s financial statements.

In ~~July 2015,~~June 2018, the FASB issued ASU ~~2015-11,~~No. 2018-07, ~~Inventory (Topic 330): Simplifying~~Stock-based Compensation: Improvements to Nonemployee Share-based Payment Accounting, which amends the ~~Measurement of Inventory. This update requires entities~~existing accounting standards for share-based payments to measure inventory at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method.nonemployees. This ASU aligns much of the guidance on measuring and classifying nonemployee awards with that of awards to employees. Under the new guidance, the measurement of nonemployee equity awards is fixed on the grant date. This ASU became effective ~~for~~on January 1, 2019, and the Company adopted it at that time. Entities will apply the ASU by recognizing a cumulative-effect adjustment to retained earnings as of the beginning of the annual ~~reporting periods beginning after December 15, 2016 and interim periods within those years.~~period of adoption. The adoption of this guidance did not have a material impact on the Company’s financial statements.

~~In March 2016, the FASB issued ASU 2016-09,~~ ~~Compensation—Stock Compensation (Topic 718)~~. This standard makes several modifications to Topic 718 related to the accounting for forfeitures, employer tax withholding on share-based compensation and the financial statement presentation of excess tax benefits or deficiencies. ASU 2016-09 also clarifies the statement of cash flows presentation for certain components of share-based awards. The standard is effective for interim and annual reporting periods beginning after December 15, 2016, although early adoption is permitted. 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 May 2014, the FASB issued ASU 2014-09,~~ ~~Revenue from Contracts with Customers (Topic 606)~~, as subsequently amended. ASU 2014-09 provides a single, comprehensive revenue recognition model for all contracts with customers. The revenue guidance contains principles that an entity will apply to determine the measurement of revenue and timing of when it is recognized. The underlying principle is that an entity will recognize revenue to depict the transfer of goods or services to customers at an amount that the entity expects to be entitled to in exchange for those goods or services. The standard is effective for the first interim period within annual reporting periods beginning after December 15, 2017 for public entities, with early adoption permitted in the annual reporting period beginning after December 15, 2016. The Company is currently analyzing the effect of the standard to evaluate the impact of the new standard on its revenue recognition for customer contracts. This includes reviewing current accounting policies and practices to identify potential differences that would result from applying the requirements under the new standard. The Company currently recognizes revenue upon shipment of products. The assessment at this stage is that the Company does not expect the adoption of the new revenue recognition standard to have a material impact on its financial statements. The Company has completed a preliminary review of its contracts with its customers and identified the variable consideration provisions of the new guidance as potentially having the most

1011

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

impact on the Company’s method of recognizing revenue. The Company will adopt the standard in the first quarter of 2018 using the modified retrospective method by recognizing the cumulative effect of initially applying the new standard as an adjustment to the opening balance of retained earnings.Accounting Standards Issued but Not Yet Effective

In ~~February~~June 2016, the FASB issued ASU ~~2016-02,~~No. 2016-13, ~~Leases~~Financial Instruments - Credit losses (Topic ~~842)~~326): Measurement of Credit Losses on Financial Instruments. This ~~standard~~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 ~~all leases with durations greater than twelve months~~consideration of a broader range of reasonable and supportable information, including forecasted information, to be recognized on the balance sheet and is effective for interim and annual reporting periods beginning after December 15, 2018, although early adoption is permitted. The Company is currently in the process of evaluating the impact of the adoption on its financial statements.

~~In August 2016, the FASB issued ASU 2016-15,~~ ~~Classification of Certain Cash Receipts and Cash Payments (Topic 230)~~. ASU 2016-15 is intended to add or clarify guidance on the classification of certain cash receipts and payments in the statement of cash flows and to eliminate the diversity in practice related to such classifications.develop credit loss estimates. The standard is effective for annual ~~reporting~~ periods beginning after December 15, ~~2017,~~2019, including interim periods within those annual periods, with early adoption ~~permitted.~~available. The Company ~~has evaluated~~is in the process of determining the effect that the adoption ~~on its financial statements and other than certain reclassifications within the Company's cash flow statements, the Company does not expect the impact of the adoption to~~will have ~~a material effect~~ on its financial statements.

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

4. REVENUE RECOGNITION

Net Revenue

The Company sells its products to major pharmaceutical distributors, pharmacies, hospitals and wholesalers (collectively, its Customers). In ~~November 2016,~~addition to distribution agreements with Customers, the ~~FASB issued ASU 2016-18,~~ ~~Statement~~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 ~~Cash Flows (Topic 230) - Restricted Cash. ASU 2016-18 requires~~the Company’s products. All of the Company’s current contracts have a ~~statement~~single performance obligation, as the promise to transfer the individual goods is not separately identifiable from other promises in the contracts and is, therefore, not distinct.

Currently, all of ~~cash flows~~the Company’s revenue is derived from product sales. 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 ~~explain~~product sales and remitted to governmental authorities are excluded from revenues.

As of March 31, 2019, the ~~change during~~Company had received a total of $1,000,000 of payments that it has not recognized as revenue based on the Company’s analysis in connection with Topic 606. These deferred revenues are included as a component of other non-current liabilities on the Company’s balance sheets.

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.

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 ~~total~~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 three months before and up to one year after the expiration date of the related product, and the related product is destroyed after it is returned. The Company may either refund the sales price paid by the Customer by issuing a credit or exchanging the returned product for replacement inventory. The Company typically does not provide cash ~~cash equivalents,~~refunds. The Company estimates the proportion of recorded revenue that will result in a return by considering relevant factors, including historical returns experience, the estimated level of inventory in the distribution channel, the shelf life of products and ~~amounts~~product recalls, if any.

The estimation process for product returns involves, in each case, a number of 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.

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

Other 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 these arrangements may include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides; and a revenue share on net sales of licensed products. Each of these payments is recognized as other revenues.

As part of the accounting for these arrangements, the Company must develop estimates that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. Performance obligations are promises in a contract to transfer a distinct good or service to the Customer, and the Company recognizes revenue when, or as, performance obligations are satisfied. The Company uses key assumptions to determine the stand-alone selling price; these assumptions may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical, regulatory and commercial success.

Certain of these agreements include consideration in the form of milestone payments. At the inception of each arrangement that includes milestone payments, the Company evaluates the recognition of milestone payments. Typically, milestone payments are associated with events that are not entirely within the control of the Company or the licensee, such as regulatory approvals; are included in the transaction price; and are subject to a constraint until it is probable that there will not be a significant revenue reversal, typically upon achievement of the milestone. At the end of each reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price.

Customer Payment Obligations

The Company receives payments from its Customers based on billing schedules established in each contract, which vary across the Company’s locations, but generally ~~described~~range between 30 to 120 days. Occasionally, the timing of receipt of payment for the Company’s international Customers can be extended. Amounts are recorded as ~~restricted cash or restricted cash equivalents. Amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents~~accounts receivable when ~~reconciling~~ the ~~beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The standard~~Company’s right to consideration is ~~effective for interim and annual reporting periods beginning after December 15, 2017, with early adoption permitted.~~unconditional. The Company does not ~~expect~~assess whether a contract has a significant financing component if the ~~impact~~expectation is that the Customer will pay for the product or services in one year or less of receiving those products or services.

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

5. LEASES

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. The Company elected the transition package of three practical expedients permitted within the standard. In accordance with the package of practical expedients, the Company did not reassess initial direct costs, lease classification, or whether its contracts contain or are leases. The Company made an accounting policy election not to recognize right of use assets and liabilities for leases with a term of 12 months or less, or those that do not meet the Company’s capitalization threshold, unless the leases include options to renew or purchase the underlying asset that are reasonably certain to be exercised. Lease costs associated with those leases are recognized as incurred. The Company has also chosen the practical expedient that allows it to combine lease and non-lease components as a single lease component.

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 determined it is not 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.

Operating Leases

The Company’s operating lease activities primarily consist of leases for office space in the U.S., the United Kingdom and Germany. Most of these leases include options to renew, with renewal terms generally ranging from one to seven years. The exercise of lease renewal options is at the Company’s sole discretion. The Company has determined it is not reasonably certain it will exercise any of its renewal options. Certain of the Company’s operating lease agreements include variable lease costs that are based on common area maintenance and property taxes. The Company expenses these payments as incurred. The Company’s operating lease agreements do not contain any material residual value guarantees or material restrictive covenants.

Supplemental balance sheet information as of March 31, 2019 for the Company’s operating leases is as follows:



	(in thousands)
NON-CURRENT ASSETS:
Right of use assets, net	$	775
Total lease assets	$	775

CURRENT LIABILITIES:
Accrued expenses (Note 9)	$	433
NON-CURRENT LIABILITIES:
Other non-current liabilities	560
Total lease liabilities	$	993

The Company’s operating lease cost for the three months ended March 31, 2019 was $123,000 and is included in general and administrative expenses in its Condensed Consolidated Statement of Operations.

As of March 31, 2019, a schedule of maturity of lease liabilities under all of the Company’s operating leases is as follows:



Years Ending December 31	(In thousands)
2019 (remaining)	$	394
2020	412
2021	299
Total	1,105
Less amount representing interest	(112		)
Present value of minimum lease payments	993
Less current portion	(433		)
Non-current portion	$	560

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

Cash paid for operating leases was $100,000 during the three months ended March 31, 2019. An insignificant amount of right of use assets was obtained in exchange for operating leases for the three months ended March 31, 2019.

As of March 31, 2019, the weighted average remaining lease terms of the Company’s operating leases was 2.1 years. The weighted average discount rate used to determine the lease liabilities was 10.2%. When available, the Company uses the rate implicit in the lease or sublease to discount lease payments to present value; however, most of the Company's leases do not provide a readily determinable implicit rate. Therefore, the Company must estimate 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. In using the Company’s incremental borrowing rate, management has elected to utilize a portfolio approach and applies the rates to a portfolio of leases with similar underlying assets and terms. Upon adoption of the new lease standard, discount rates used for existing leases were established at January 1, 2019.

Finance Leases

The Company’s finance lease activities primarily consist of leases for office equipment and automobiles. The property and equipment is 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 March 31, 2019 and December 31, 2018 for the Company’s finance leases are as follows:



	March 31, 2019		December 31, 2018
	(In thousands)
NON-CURRENT ASSETS:
Property and equipment, net	$	602	$	615
Total lease assets	$	602	$	615

CURRENT LIABILITIES:
Finance lease obligations	$	253	$	236
NON-CURRENT LIABILITIES:
Finance lease obligations — less current portion	241		305
Total lease liabilities	$	494	$	541

Depreciation expense associated with property and equipment under finance leases was approximately $76,000 and $49,000 for the three months ended March 31, 2019 and 2018, respectively. Interest expense associated with finance leases was $9,000 and $6,000 for the three months ended March 31, 2019 and 2018, respectively.

As of March 31, 2019, a schedule of maturity of lease liabilities under finance leases, together with the present value of minimum lease payments, is as follows:



Years Ending December 31	(In thousands)
2019 (remaining)	$	211
2020	253
2021	65
2022	3
Total	532
Less amount representing interest	(38		)
Present value of minimum lease payments	494
Less current portion	(253		)
Non-current portion	$	241

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

Cash paid for finance leases was $100,000 during the three months ended March 31, 2019. The Company acquired $64,000 of property and equipment in exchange for finance leases for the three months ended March 31, 2019.

As of March 31, 2019, the weighted average remaining lease terms of the Company’s financing leases was 1.8 years. The weighted average discount rate used to determine the financing lease liabilities was 7.0%. When available, the Company uses the rate implicit in the lease or sublease to discount lease payments to present value; however, most of the Company's leases do not provide a readily determinable implicit rate. Therefore, the Company must estimate 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 ~~material effect on its financial statements.~~collateralized basis and over a similar term, an amount equal to the lease payments in a similar economic environment. In using the Company’s incremental borrowing rate, management has elected to utilize a portfolio approach and applies the rates to a portfolio of leases with similar underlying assets and terms.

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

6. GOING CONCERN

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 negative cash flow from operations and has accumulated a deficit of ~~$391,851,000~~$379,890,000 from inception through ~~September 30, 2017.~~March 31, 2019. As of ~~September 30, 2017,~~March 31, 2019, the Company had approximately ~~$25,624,000~~$13,094,000 in cash and cash equivalents. The Company’s ability to achieve profitability and positive cash flow ~~is dependent~~depends upon its ability to increase revenue and contain its expenses.

Further, the Company must maintain compliance with the debt covenants of ~~the Term~~its $40,000,000 Loan and Security Agreement (as defined below) (Notes 9 and 17). For September 2017, the Consolidated Group did not meet the six-month revenue covenant required under the Term Loan Agreement. As a result, the Consolidated Group was required to demonstrate it had $35,000,000 in liquidity (as defined in the Term Loan Agreement)dated January 5, 2018 with Solar Capital Ltd. as of the last business day in September 2017. On the last business day in September 2017, the Consolidated Group was not able to demonstrate it had $35,000,000 in liquidity. However, the Consolidated Group was able to demonstrate that it had $35,000,000 in liquidity on the business day immediately before the last business day in September 2017, the first business day in October 2017Collateral Agent, and the ~~last business day~~parties signing such agreement from time to time as Lenders, including Solar Capital in ~~October 2017. As~~its capacity as a ~~result, Hercules Capital, Inc. (Hercules) waived the Company’s non-compliance with the $35,000,000 liquidity requirement for September 2017.~~

During the nine months ended September 30, 2017, the Company raised $6,001,000 of additional equity via the Company’s at-the-market offering facility, which expired on August 13, 2017, in order to raise additional funds for operations and ensure compliance with its debt covenants.Lender (see Note 11). In management’s opinion, the uncertainty regarding future revenues raises substantial doubt about the Company’s ability to continue as a going concern without access to ~~alternate or~~ additional debt and/or equity financing, over the course of the next twelve months.

~~In order to~~To meet the Company’s future working capital needs, ~~through the next twelve months and maintain compliance with its debt covenants,~~ the Company may need to raise ~~alternate or~~ additional debt or equity financing. ~~The Company implemented a cost savings program in late 2016 that the Company believes will help decrease cash burn over the next twelve months.~~ While the Company has historically been able to raise additional capital through issuance of equity and/or debt financing, and while the Company has implemented a plan ~~in place~~ to ~~reduce spending in order~~control its expenses to satisfy its obligations due within one year from the date of issuance of these ~~financial statements, there can~~Interim Financial Statements, the Company cannot guarantee that it will be ~~no guarantees on the Company’s ability~~able to maintain debt compliance, raise additional equity, contain expenses, or ~~successfully implement its cost reduction plans.~~increase revenue. Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these ~~financial statements~~Interim Financial Statements are issued.

1118

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

5.7. INVENTORY

Inventory consisted of the following:


	September 30, 2017		December 31, 2016			March 31, 2019		December 31, 2018
	(In thousands)					(In thousands)
Component parts (1)	$	687	$	115		$	413	$	129
Work-in-process (2)	308		18			111		924
Finished goods	743		353			1,336		1,352
Total inventory	1,738		486
Inventory reserve	—		(40		)
Inventory — net	$	1,738	$	446
Total Inventory						$	1,860	$	2,405

(1) Component parts inventory consists of manufactured components of the ILUVIEN applicator.

(2) Work-in-process ~~primarily~~ 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 in Europe and the U.S.~~authorities.

6.8. INTANGIBLE ASSET

As a result of the approval of ILUVIEN by the U.S. Food and Drug ~~Administration’s~~Administration (FDA) ~~approval of the New Drug Application (NDA) for ILUVIEN~~ in ~~September~~ 2014, the Company was required to pay ~~pSivida~~EyePoint a milestone payment of $25,000,000 (the ~~pSivida~~EyePoint Milestone Payment) ~~in October 2014. The Company had no intangible assets prior to September 2014.~~(see Note 10).

The gross carrying amount of the intangible asset is $25,000,000, which is being amortized over approximately 13 years from the ~~payment~~acquisition date. The amortization expense related to the intangible asset was ~~$489,000~~approximately $478,000 for both the three months ended ~~September 30, 2017~~March 31, 2019 and ~~2016, respectively. The amortization expense related to the intangible asset was $1,451,000 and $1,457,000 for the nine months ended September 30, 2017 and 2016,~~2018, respectively. The net book value of the intangible asset was ~~$19,153,000~~$16,245,000 and ~~$20,604,000~~$16,723,000 as of ~~September 30, 2017~~March 31, 2019 and December 31, ~~2016,~~2018, respectively.

The estimated future amortization expense as of ~~September 30, 2017~~March 31, 2019 for the remaining periods in the next five years and thereafter is as follows:


Years Ending December 31	(In thousands)		(In thousands)
2017	$	489
2018	1,940
2019	1,940		$	1,462
2020	1,946		1,946
2021	1,940		1,940
2022			1,940
2023			1,940
Thereafter	10,898		7,017
Total	$	19,153	$	16,245

1219

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

7.9. ACCRUED EXPENSES

Accrued expenses consisted of the following:


	September 30, 2017		December 31, 2016		March 31, 2019		December 31, 2018
	(In thousands)				(In thousands)
Accrued clinical investigator expenses	$	556	$	1,122	$	840	$	781
Accrued compensation expenses	514		1,020		1,212		1,427
Accrued rebate, chargeback and other revenue reserves	300		809		385		346
Accrued End of Term Payment (Note 9)	1,400		—
Accrued lease liabilities (Note 5)					433		—
Other accrued expenses	744		807		248		1,089
Total accrued expenses	$	3,514	$	3,758	$	3,118	$	3,643

8.10. LICENSE AGREEMENTS

~~pSivida~~EyePoint Agreement

~~The~~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 ~~pSivida’s~~EyePoint’s proprietary ~~delivery device in February 2005, which~~insert technology. This agreement was subsequently amended a number of times (as amended, the ~~pSivida~~EyePoint Agreement). The ~~pSivida~~EyePoint Agreement provides the Company with a worldwide exclusive license to utilize certain underlying technology used in the development and commercialization of ILUVIEN.

2008 Amended and Restated Collaboration Agreement

Pursuant to the payment terms of the 2008 Amended and Restated Agreement (the 2008 Agreement), the Company was required to share with EyePoint 20% of the net profits of ILUVIEN, determined on a cash basis and 33% of any lump sum milestone payments received from a sub-licensee of ~~ILUVIEN, as defined by the 2008 Agreement.~~ILUVIEN. In connection with ~~the 2008 Agreement,~~this arrangement, the Company was entitled to recover ~~20%~~out of ~~commercial losses associated with~~EyePoint’s share of the net profits of ILUVIEN, as20% of ILUVIEN’s commercialization costs (as defined in the ~~pSivida Agreement,~~EyePoint Agreement) that ~~could be offset in any~~were incurred prior to product profitability. (The Company’s future ~~quarter out of payments of pSivida’s share of net profits (the~~rights to recover these amounts from EyePoint are referred to as the Future ~~Offset). As of December 31, 2016, the total Future Offsets available to reduce future net profit payments to pSivida, as defined in the 2008 Agreement, was $24,475,000.~~Offset.) In connection with the New Collaboration Agreement discussed below, the ~~Company and pSivida agreed to cap the Future Offset amount at June 30, 2017 to $25,000,000. The~~ Future Offset was ~~not previously reflected on the Company’s balance sheet due to the uncertainty of future realizability.~~

~~May 2017 Amendment~~

In the second quarter of 2016, pSivida disputed portions of the Company’s claimed commercialization costs for the year ended December 31, 2014. On May 3, 2017, the Company and pSivida settled this dispute and amended and clarified certain definitions and clauses of the 2008 Agreement. As part of this settlement, the Company and pSivida agreed no additional amounts would be due for the year ended December 31, 2014 and effectively no audits would occur for the years ended December 31, 2015 and 2016. As a result of this settlement and amendment, Future Offsets was reduced from $25,828,000 to $24,475,000 as of December 31, 2016.further amended.

New Collaboration Agreement - Second Amended and Restated Collaboration Agreement

On July 10, 2017, the Company and ~~pSivida~~EyePoint entered into a Second Amended and Restated Collaboration Agreement (the New Collaboration Agreement), which amends and restates the ~~pSivida~~EyePoint Agreement.

Prior to entering into the New Collaboration Agreement, the Company held the worldwide license from ~~pSivida~~EyePoint for the use of ~~FAc in pSivida’s~~EyePoint’s proprietary ~~delivery device~~insert technology for the treatment of all ocular diseases other than uveitis. The New Collaboration Agreement expands the license to include uveitis, including NIPU, in Europe, the Middle East and Africa and also allows the Company to ~~also~~ pursue an indication for posterior uveitis for ILUVIEN in those territories.

The New Collaboration Agreement ~~converts~~converted the Company’s ~~obligation to~~previous profit share ~~20% of its net profits~~obligation to a royalty payable on global net revenues of ILUVIEN. The Company ~~will begin~~began paying a 2% royalty on net revenues and other related consideration to ~~pSivida beginning effective~~EyePoint on July 1, 2017. This royalty amount ~~will increase~~increased to 6% ~~upon~~effective December 12, 2018. Pursuant to the ~~earliest of January 1, 2019,~~New Collaboration Agreement, the ~~receipt of the first marketing approval for ILUVIEN for the treatment of NIPU, or one year from the Company’s filing of a marketing authorization application in the EU for NIPU. The~~ Company ~~will~~is required to pay an additional 2% royalty on global

~~Table of Contents~~

~~ALIMERA SCIENCES, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)~~

net revenues and other related consideration in excess of $75,000,000 in any year. During the three months ended ~~September 30, 2017,~~March 31, 2019 and 2018, the Company recognized approximately ~~$196,000~~$516,000 and $193,000 of royalty expense, respectively, which is included in cost of goods sold, excluding depreciation and ~~amortization, due to this royalty.~~amortization. As of ~~September 30, 2017, this amount~~March 31, 2019, approximately $516,000 of royalty expense was included in the Company’s accounts payable.

~~The New Collaboration Agreement did not require an upfront cash payment by the Company.~~

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

In connection with the New Collaboration Agreement, the Company and EyePoint first agreed to cap the Future Offset amount at $25,000,000 as of June 30, 2017 and the Company then agreed to forgive $10,000,000 of the total $25,000,000 of the Future Offset at the July 10, 2017 amendment date. Following the signing of the New Collaboration Agreement, the Company ~~retains~~retained a right to recover up to the remaining $15,000,000 of the Future Offset. Due to the uncertainty of future net profits, the Company has fully reserved the Future Offset in the accompanying Interim Financial Statements. In March 2019, pursuant to the New Collaboration Agreement, the Company forgave $5,000,000 of the Future Offset in connection with the approval of ILUVIEN for NIPU in the United Kingdom. As of March 31, 2019, the balance of the Future Offset was approximately $9,820,000. The Company will be able to recover ~~up to $15,000,000~~the balance of the Future Offset as a reduction of future royalties that would otherwise be owed to EyePoint as follows:

In the first two years following the December 12, 2018 increase in royalty amount to 6%, the royalty will be reduced to 4% for net revenues and other related consideration up to $75,000,000 annually and 5%, rather than 8%, for net revenues and other related consideration in excess of $75,000,000 on an annual basis; and

Beginning with the third year following the December 12, 2018 increase in royalty amount to 6%, the royalty will be reduced to approximately 5.2% for net revenues and other related consideration up to $75,000,000 annually and to approximately 6.8%, rather than 8%, for net revenues and other related consideration in excess of $75,000,000 on an annual basis.

~~The Company will forgive up to $5,000,000~~Possible Reversion of the remaining $15,000,000 of Future Offsets upon the earlier of the approval of ILUVIEN for posterior uveitis in any EU country or January 1, 2020, unless certain conditions under the New Collaboration Agreement are not met. If the amounts recoverable by the Company associated with the Future Offsets are less than $5,000,000 at that time, the Company will pay pSivida the difference in cash.

The Company valued the transaction utilizing a present value analysis at approximately $2,851,000. Because there was no approved indication for ILUVIEN for uveitis at the time, the Company expensed the $2,851,000 as a non-cash charge as in-process Research and Development Expense in the third quarter of 2017. The Company also recognized $2,851,000 for Recoverable Collaboration Costs for the value of the right of offset as a reduction of operating expenses. As a result, there was no impact on the Company’s ~~operating loss or net loss for the three and nine months ended September 30, 2017.~~

~~General Discussion of pSivida Agreement~~License Rights to EyePoint

The Company’s license rights to ~~pSivida’s~~EyePoint’s proprietary delivery device could revert to ~~pSivida~~EyePoint if the Company were to (i) fail twice to cure its breach of an obligation to make certain payments to pSivida following receipt of written notice thereof; (ii) fail to cure other breaches of material terms of the pSivida Agreement within 30 days after notice of such breaches or such longer period (up to 90 days) as may be reasonably necessary if the breach cannot be cured within such 30-day period; (iii) file for protection under the bankruptcy laws, make an assignment for the benefit of creditors, appoint or suffer appointment of a receiver or trustee over its property, file a petition under any bankruptcy or insolvency act or have any such petition filed against it and such proceeding remains undismissed or unstayed for a period of more than 60 days; or (iv) notify pSivida in writing of its decision to abandon its license with respect to a certain product using pSivida’s proprietary delivery device.to:


(i)	fail twice to cure its breach of an obligation to make certain payments to EyePoint following receipt of written notice thereof;


(ii)	fail to cure other breaches of material terms of the New Collaboration Agreement within 30 days after notice of such breaches or such longer period (up to 90 days) as may be reasonably necessary if the breach cannot be cured within such 30-day period;


(iii)	file for protection under the bankruptcy laws, make an assignment for the benefit of creditors, appoint or suffer appointment of a receiver or trustee over its property, file a petition under any bankruptcy or insolvency act or have any such petition filed against it and such proceeding remains undismissed or unstayed for a period of more than 60 days; or


(iv)	notify EyePoint in writing of its decision to abandon its license with respect to a certain product using EyePoint’s proprietary delivery device.

1421

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

9.11. LOAN AGREEMENTS

Hercules Loan Agreement

~~2014 Loan Agreement~~

In April 2014, Alimera Sciences Limited (Alimera UK), a subsidiary of the Company, entered into a loan and security agreement ~~(2014~~(Hercules Loan Agreement) with Hercules Capital, Inc. (Hercules) providing for a term loan of up to $35,000,000 ~~(2014 Term~~(Hercules Loan)~~, which Limited~~. The Company amended the Hercules Loan Agreement several times. On October 20, 2016 Alimera UK and Hercules ~~amended in November 2015 (the First~~entered into a fourth amendment to the Hercules Loan ~~Amendment), March 2016 (the Second Loan Amendment), May 2016 (the Third Loan Amendment), October 2016~~Agreement (the Fourth Loan Amendment) ~~and May~~, which provided the operative loan agreement terms during 2017 ~~(the Fifth Loan Amendment and, collectively with the 2014 Loan Agreement, the First Loan Amendment, the Second Loan Amendment, the Third Loan Amendment~~ and the beginning of 2018. On January 5, 2018, the Company paid off the Hercules Loan on behalf of Alimera UK.

The Fourth Loan Amendment the Term Loan Agreement). Under the 2014 Loan Agreement, Hercules made an advance in the initial principal amount of $10,000,000 to Limited at closing to provide Limited with additional working capital for general corporate purposes and to repay a 2013 term loan with Silicon Valley Bank. Hercules made an additional advance of $25,000,000 to Limited in September 2014, following the approval of ILUVIEN by the FDA to fund the pSivida Milestone Payment. The 2014 Loan Agreement provided for interest only payments through November 2015. Interest on the 2014 Term Loan accrued at a floating per annum rate equal to the greater of (i) 10.90%, or (ii) the sum of (A) 7.65%, plus (B) the prime rate. Following the interest only period the 2014 Term Loan was due and payable to Hercules in equal monthly payments of principal and interest through May 1, 2018.

~~First Loan Amendment~~

In November 2015, Limited and Hercules amended the 2014 Loan Agreement to extend the interest only payments through May 2017. In connection with the First Loan Amendment, Limited paid to Hercules an amendment fee of $262,500 and agreed to make an additional payment of $1,050,000, equal to 3% of the 2014 Term Loan at the time of the final payment (End of Term Payment).

Limited and the Company, on a consolidated basis with the Company’s other subsidiaries (the Consolidated Group), agreed to customary affirmative and negative covenants and events of default in connection with these arrangements. The occurrence of an event of default could result in the acceleration of Limited’s obligations under the Term Loan Agreement and an increase to the applicable interest rate and would permit Hercules to exercise remedies with respect to the collateral under the Term Loan Agreement. In connection with the First Loan Amendment, Limited agreed to covenants regarding certain revenue thresholds and a liquidity threshold.

~~Second Loan Amendment~~

In January 2016, the revenue threshold covenant was not met by the Consolidated Group and as a result, in March 2016, Limited and Hercules entered into the Second Loan Amendment, which further amended certain terms of the 2014 Loan Agreement. In conjunction with the Second Loan Amendment, Hercules waived this covenant violation.

The Second Loan Amendment adjusted the revenue covenant to a rolling three-month calculation, first measured for the three months ended May 31, 2016. In addition, the Second Loan Amendment increased the liquidity covenant. Upon execution of the Second Loan Amendment, Limited paid Hercules an amendment fee of $350,000 and agreed to increase the End of Term Payment to $1,400,000 from $1,050,000, which is payable in May 2018.

~~The Company concluded~~ that ~~the Second Loan Amendment resulted in a substantial modification of the terms of debt when considered with the First Loan Amendment in accordance with the guidance in ASC 470-50,~~ ~~Debt~~. As a result, the Company accounted for the Second Loan Amendment as an extinguishment and recognized a loss on early extinguishment of debt of approximately $2,564,000 within the consolidated statement of operations for the year ended December 31, 2016. The loss on early extinguishment consisted primarily of the unamortized debt discount associated with the warrant and debt issuance costs incurred prior to the Second Loan Amendment, the incremental fair value of the warrant as a result of modifying the terms of the warrant and the debt issuance costs of $360,000 paid to Hercules for the Second Loan Amendment.

~~Third Loan Amendment and July 2016 Waiver~~

In May 2016, Limited and Hercules entered into the Third Loan Amendment to expand the definition of liquidity to allow for the inclusion of cash of up to $2,000,000 in bank accounts outside of the U.S. and the United Kingdom.

In July 2016, Limited obtained a waiver of the requirements of the liquidity covenant (the Waiver) because the Consolidated Group was not in compliance with the liquidity covenant as of June 30, 2016. The Waiver cured the default of the liquidity covenant then existing under the Term Loan Agreement and decreased the liquidity requirement. In addition, the

~~Table of Contents~~

~~ALIMERA SCIENCES, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)~~

Waiver modified the three-month revenue covenant so that it was not measured at July 31, 2016 and reduced the three-month revenue target to be measured at August 31, 2016. Following execution of the Waiver, Limited incurred a weekly ticking fee equal to 0.05% multiplied by the outstanding principal amount through the closing of the Company’s public offering in August 2016 (Note 12), totaling $65,000. Further, Limited paid Hercules a fee of $350,000 associated with the Waiver.

~~Fourth Loan Amendment~~

In October 2016, Limited entered into the Fourth Loan Amendment with Hercules, which further amended certain terms of the Term Loan Agreement. Pursuant to the terms of the Fourth Loan Amendment, Hercules agreed to provide up to an additional $10,000,000 to Limited with (i) the first $5,000,000 available at Limited’s option through June 30, 2017 subject to (A) the Consolidated Group’s achievement of $12,000,000 in trailing three month net product revenue and (B) no event of default having occurred since October 20, 2016 (the Effective Date) and (ii) the second $5,000,000 available at Limited’s option through December 31, 2017 subject to (A) the Consolidated Group’s achievement of $15,000,000 in trailing three month net product revenue, (B) no event of default having occurred since the Effective Date and (C) the prior $5,000,000 having been advanced to Limited (the Additional Advances and, together with the 2014 Term Loan, the Term Loan). The Consolidated Group did not achieve the trailing three month net product revenue threshold prior to June 30, 2017 and as a result the additional $10,000,000 is not available to Limited.

~~The Fourth Loan Amendment provides for interest only payments~~were scheduled through November 30, ~~2018 (the Interest-Only Period).~~2018. Pursuant to the Fourth Loan Amendment, interest on the ~~Term~~Hercules Loan ~~accrues~~accrued at a floating per annum rate equal the greater of (i) 11.0% ~~and~~or (ii) the sum of (A) 11.0% plus (B) the prime rate as reported in The Wall Street Journal, or if not reported, the prime rate most recently reported in The Wall Street Journal, minus 3.5%. In addition to the interest described above, the principal balance of the ~~Term~~Hercules Loan ~~will bear~~bore “payment-in kind” interest at the rate of 1.0% (PIK Interest), which PIK Interest ~~will be~~was added to the outstanding principal balance of the Term Loan so as to increase the outstanding principal balance of the Term Loan on each payment date for the Term Loan and which amount will be payable when the aggregate outstanding principal amount of the Term Loan is payable. The Term Loan will be due and payable to Hercules ~~in 24 equal monthly payments of principal and interest following the Interest-Only Period beginning on December 1, 2018 and matures in full on November 1, 2020.~~Loan. The interest rate on the ~~Term~~Hercules Loan Agreement was ~~11.75% as of September 30, 2017.~~12.0% when the Company paid it off.

~~Limited paid~~Under the Hercules a facility charge of $337,500 and reimbursed Hercules for legal and diligence fees incurred in connection with the Fourth Loan Amendment. If Limited prepays the Term Loan, it will pay Hercules a prepayment penalty (i) if such amounts are prepaid in any of the first 12 months following the Effective Date, equal to 3.0% of the principal amount of the Term Loan being repaid, (ii) if such amounts are prepaid after 12 months but prior to 24 months following the Effective Date, equal to 2.0% of the principal amount of the Term Loan being repaid, and (iii) if such amounts are prepaid at any time thereafter, equal to 1.0% of the principal amount of the Term Loan being repaid.

The Consolidated Group also agreed to customary affirmative and negative covenants, including, without limitation, covenants relating to minimum liquidity, minimum trailing six-month net revenue and adjusted EBITDA and events of default in connection with these arrangements. The occurrence of an event of default could result in the acceleration of Limited’s obligations under the Term Loan Agreement as amended by the Fourth Loan Amendment, ~~and an increase to~~any principal prepayment of the ~~applicable interest rate and would permit~~ Hercules ~~to exercise remedies with respect to~~loan triggered a prepayment penalty based on when the ~~collateral under~~prepayment occurred. When the ~~Term~~Company prepaid the Hercules Loan Agreement ~~as amended by~~on January 5, 2018, the Company paid 2.0% of the principal amount repaid, or $709,000, which is included in loss on early extinguishment of debt for the three months ended March 31, 2018. Before Alimera UK entered into the Fourth Loan ~~Amendment. In the event that~~Agreement, Alimera UK was already obligated to pay an end of term payment of $1,400,000, which was paid when the Company ~~maintains $35,000,000 in liquidity, including cash and eligible accounts receivable, at~~paid off the ~~end of the month and has not been and is not in breach of the amended debt facility, the six-month trailing revenue covenant is waived for such month.~~

~~Fifth Loan Amendment~~

~~In May 2017, Limited entered into the Fifth Loan Amendment with~~ Hercules ~~which further amended and clarified certain terms of the Term Loan Agreement. The amendment was not material.~~

~~October 2017 Waiver~~

For September 2017, the Consolidated Group did not meet the six-month revenue covenant required under the Term Loan Agreement. As a result, the Consolidated Group was required to demonstrate it had $35,000,000 in liquidity as of the last business day in September 2017. On the last business day in September 2017, the Consolidated Group was not able to demonstrate it had $35,000,000 in liquidity. However, the Consolidated Group was able to demonstrate that it had $35,000,000 in liquidityloan on the business day immediately before the last business day in September 2017, the first business day in October 2017 and the last business day in October 2017. As a result, Hercules waived the Company’s non-compliance with the $35,000,000 liquidity requirement at the end of September 2017.

~~Table of Contents~~

~~ALIMERA SCIENCES, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)~~

~~General Discussion of the Term Loan Agreement~~

Pursuant to the Term Loan Agreement, Limited’s obligations to Hercules are secured by a first-priority security interest in substantially all of Limited’s assets, excluding intellectual property. Hercules does, however, maintain a negative pledge on Limited’s intellectual property requiring Hercules’ consent prior to the sale of such intellectual property. The Company and certain of the Company’s other subsidiaries are guarantors of the obligations of Limited to Hercules under the Term Loan Agreement pursuant to separate guaranty agreements between Hercules and each of Limited and such subsidiaries (Guaranties). Pursuant to the Guaranties, the Company and these subsidiaries granted Hercules a first-priority security interest in substantially all of their respective assets excluding intellectual property. The Term Loan Agreement also places limitations on the Company’s ability to declare or pay any dividend or distribution on any shares of capital stock.January 5, 2018.

2014 Warrant

In connection with ~~Limited~~Alimera UK entering into the ~~2014~~Hercules Loan Agreement, the Company issued a warrant tothat granted Hercules the right to purchase up to 285,016 shares of the Company’s common stock at an exercise price of $6.14 per share (the 2014 Warrant). ~~Sixty percent of~~The Company amended the 2014 Warrant ~~was exercisable at the closing in April 2014 and the remaining forty percent became exercisable upon the funding of the additional $25,000,000 to Limited in September 2014.~~

~~The Company agreed to amend the 2014 Warrant in connection with the First Loan Amendment to increase the~~a number of shares issuable upon exercise to 660,377 and decrease the exercise price to $2.65 per share. Upon entering into the Second Loan Amendment, the Company agreed to further amend the 2014 Warrant to increase the number of shares issuable upon exercise to 862,069 and decrease the exercise price to $2.03 per share. In connection with the July 2016 Waiver, the Company agreed to further amend the 2014 Warranttimes to increase the number of shares issuable upon exercise to 1,258,993 and decrease the exercise price to $1.39 per share. The right to exercise this warrant expires on November 2, 2020.

2016 Warrant

In connection with ~~Limited~~Alimera UK entering into the Fourth Loan Amendment, the Company agreed to issue a new warrant to Hercules (the 2016 Warrant) that granted Hercules the right to purchase up to 458,716 shares of the Company’s common stock at an exercise price of $1.09 per ~~share, which was equal~~share. The right to ~~$500,000 divided by~~exercise this warrant expires on October 20, 2021.

Solar Capital Loan Agreement

On January 5, 2018, the ~~lowest volume-weighted average sale price for~~Company entered into a ~~share~~$40,000,000 Loan and Security Agreement (2018 Loan Agreement) with Solar Capital Ltd. (Solar Capital), as Collateral Agent (Agent), and the parties signing the 2018 Loan Agreement from time to time as Lenders, including Solar Capital in its capacity as a Lender (collectively, the Lenders). Under the 2018 Loan Agreement, the Company borrowed the entire $40,000,000 as a term loan that matures on July 1, 2022.

The Company used the proceeds of the ~~Company’s common stock reported over any ten consecutive trading days during~~term loan to extinguish the ~~period commencing~~Hercules Loan Agreement and pay related expenses. The Company used the remaining loan proceeds to provide additional working capital for general corporate purposes.

Interest on ~~and including September 23, 2016 and~~the 2018 Loan Agreement is payable at one-month LIBOR plus 7.65% per annum. The 2018 Loan Agreement provides for interest only payments for the first 30 months ending on July 1, 2020, followed by 24 months of payments of principal and interest. If the ~~earlier~~Company meets certain revenue thresholds and no event of default shall have occurred and is continuing, the Company can extend the interest only period an additional six months to ~~occur~~end on January 1, 2021, followed by 18 months of ~~(i) December 30, 2016 (inclusive~~payments of ~~such date),~~principal and ~~(ii)~~interest. As of March 31, 2019, the ~~second trading day immediately preceding~~interest rate on the 2018 Loan Agreement was approximately 10.1%.

As part of the fees and expenses incurred in conjunction with the 2018 Loan Agreement discussed above, the Company paid Solar Capital a $400,000 fee at closing. The Company is obligated to pay a $1,800,000 fee upon repayment of the term loan in full ($2,000,000 if the interest only period has been extended to 36 months). The Company may elect to prepay the outstanding principal balance of the 2018 Loan Agreement in increments of $10,000,000 or more. The Company must pay a

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

prepayment premium upon any prepayment of the 2018 Loan Agreement before its maturity date, whether by mandatory or voluntary prepayment, acceleration or otherwise, equal to:


a.	2.00% of the principal amount prepaid for a prepayment made on or after January 5, 2018 through and including January 5, 2019;


b.	1.00% of the principal amount prepaid for a prepayment made after January 5, 2019 through and including January 5, 2020; and


c.	0.50% of the principal amount prepaid for a prepayment made after January 5, 2020 and greater than 30 days before the maturity date.

The Company is also obligated to pay additional fees under the Exit Fee Agreement (Exit Fee Agreement) dated as of ~~closing~~January 5, 2018 by and among the Company, Solar Capital as Agent, and the Lenders. The Exit Fee Agreement survives the termination of the 2018 Loan Agreement and has a ~~merger event~~term of 10 years. The Company is obligated to pay up to, but no more than, $2,000,000 in fees under the Exit Fee Agreement.

Specifically, the Company is obligated to pay an exit fee of $2,000,000 upon a “change in control” (as defined in the ~~2016 Warrant)~~Exit Fee Agreement). To the extent that Alimera has not already paid the $2,000,000 fee, the Company is also obligated to pay a fee of $1,000,000 on achieving each of the following milestones:


a.	first, if the Company achieves revenues of $80,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured on a trailing 12-month basis during the term of the agreement, tested at the end of each month; and


b.	second, if the Company achieves revenues of $100,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured in the same manner.

The Company agreed, for itself and its subsidiaries, to customary affirmative and negative covenants and events of default in connection with the 2018 Loan Agreement. The occurrence of an event of default could result in the acceleration of the Company’s obligations under the 2018 Loan Agreement and an increase to the applicable interest rate, and would permit Solar Capital to exercise remedies with respect to the collateral under the 2018 Loan Agreement.

The Company’s obligations to Agent and the Lenders are secured by a first priority security interest in substantially all of the assets, excluding intellectual property, of the Company and its wholly owned subsidiary, Alimera Sciences (DE), LLC (Alimera DE), which is a guarantor of the loan, provided that only 65% of the voting interests in AS C.V., a Dutch subsidiary owned by the Company and Alimera DE, are pledged to the Lenders, and no assets or equity interests in the direct or indirect subsidiaries of AS C.V. are subject to the Lenders’ security interests. The Lender does, however, maintain a negative pledge on the property of the Company and all of its subsidiaries, including the Company’s intellectual property, requiring the Lender’s consent for any liens (other than typical permitted liens) on, or the sale of, such property.

Extinguishment of Debt

In accordance with the guidance in ASC 470-50, Debt, the Company accounted for the extinguishment of the Hercules Loan Agreement as an extinguishment and recognized a loss on early extinguishment of debt of approximately $1,766,000 within the condensed consolidated statements of operations for the three months ended March 31, 2018. The loss on early extinguishment consisted primarily of the early termination fee paid to Hercules and unamortized debt discounts including the remaining portion of warrant values and debt issuance costs.

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 and the fair value of the warrants that were issued in connection with the Company’s notes payable are immaterial.~~financing. Therefore, the carrying amount of the notes approximated their fair value at ~~September 30, 2017~~March 31, 2019 and December 31, ~~2016.~~2018.

~~10. LOSS~~

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

12. EARNINGS (LOSS) PER SHARE (EPS)

~~Basic EPS is calculated in accordance with~~The Company follows ASC 260, Earnings ~~per~~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 attributable~~(loss) available to ~~common~~ stockholders by the weighted average ~~common stock outstanding.~~number shares outstanding for the period. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average ~~common~~ shares outstanding for the dilutive effect of common stock options, ~~warrants~~restricted stock units and ~~convertible preferred stock.~~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 ~~to do so~~they were either classified as participating or would have been anti-dilutive, were as follows:



	Three Months Ended March 31,
	2019	2018
Series A convertible preferred stock	9,022,556	9,022,556
Series B convertible preferred stock	—	8,416,251
Series C convertible preferred stock	10,150,000	—
Common stock warrants	1,795,663	1,795,663
Stock options	13,407,536	12,343,820
Restricted stock units	480,400	1,039,370
Total	34,856,155	32,617,660

~~Table of Contents~~

~~ALIMERA SCIENCES, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)~~

Three Months Ended
September 30,
Nine Months Ended
September 30,
2017 2016 2017 2016
Series A convertible preferred stock 9,022,556
9,022,556
9,022,556
9,022,556
Series B convertible preferred stock 8,416,251
8,416,251
8,416,251
8,416,251
Series A convertible preferred stock warrants 4,511,279
4,511,279
4,511,279
4,511,279
Common stock warrants 1,795,663
1,336,947
1,795,663
1,336,947
Stock options 11,432,526
11,231,644
11,432,526
11,231,644
Restricted stock units 851,920
—
851,920
—
Total 36,030,195
34,518,677
36,030,195
34,518,677

1824

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

~~11.~~13. PREFERRED STOCK

Series A Convertible Preferred Stock

On October 2, 2012, the Company closed its preferred stock financing in which it sold units consisting of 1,000,000 shares of Series A Convertible Preferred Stock (Series A Preferred Stock) and warrants to purchase 300,000 shares of Series A ~~Convertible~~ Preferred Stock for gross proceeds of $40,000,000, prior to the payment of approximately $560,000 of related issuance costs. The powers, preferences and rights of the Series A ~~Convertible~~ Preferred Stock are set forth in the certificate of designation for the Series A Preferred Stock filed by the Company with the Delaware Secretary of State as part of the ~~State~~Company’s certificate of ~~Delaware on October 1, 2012.~~incorporation. Each share of Series A ~~Convertible~~ Preferred Stock ~~including any shares of Series A Convertible Preferred Stock issued upon exercise of the warrants,~~ is convertible into shares of the Company’s common stock at any time at the option of the holder at the rate equal to $40.00 divided by $2.66 (Conversion Price). The initial Conversion Price was subject to adjustment based on certain customary price based anti-dilution adjustments. These adjustment features lapsed in September 2014. Each share of Series A ~~Convertible~~ Preferred Stock shall automatically be converted into shares of common stock at the then-effective Conversion Price upon ~~the occurrence of the later to occur of both (i) the Company receives and publicly announces the approval by the FDA of the Company’s NDA for ILUVIEN and (ii)~~ the date on which the Company consummates an equity financing transaction pursuant to which the Company sells to one or more third party investors either (a) shares of common stock or (b) other equity securities that are convertible into shares of common stock and that have rights, preference or privileges, senior to or on a parity with, the Series A ~~Convertible~~ Preferred Stock, in each case having an as-converted per share of common stock price of not less than ~~$10.00~~$10.00 and that results in total gross proceeds to the Company of at least $30,000,000. The rights and preferences of Series A ~~Convertible~~ Preferred Stock also place limitations on the Company’s ability to declare or pay any dividend or distribution on any shares of capital stock.

Each unit sold in the preferred stock financing included a warrant to purchase ~~0.30~~additional shares of Series A ~~Convertible~~ Preferred ~~Stock at an exercise price equal to~~ ~~$44.00~~ per share. At the election of the holder of a warrant, the warrant may be exercised for the number of shares of common stock then issuable upon conversion of the Series A Convertible Preferred Stock that would otherwise be issued upon such exercise at the then-effective Conversion Price.

These warrants are considered derivative instruments because the agreements provide for settlement in Series A Convertible Preferred Stock shares or common stock shares at the option of the holder, an adjustment to the warrant exercise price for common shares at some point in the future and contain anti-dilution provisions whereby the number of shares for which the warrants are exercisable and/or the exercise price of the warrants are subject to change in the event of certain issuances of stock at prices below the then-effective exercise price of the warrants. Therefore, the warrants were recorded as a liability at issuance. The warrant anti-dilution provisions lapsed in September 2014. At September 30, 2017 and December 31, 2016, the fair market value of the warrants was estimated to be approximately $0 and $188,000, respectively. During the three months ended September 30, 2017, the Company did not record a gain or a loss as a result of the change in fair value of the warrants. During the three months ended September 30, 2016, the Company recorded a loss of $588,000 as a result of the change in fair value of the warrants. During the nine months ended September 30, 2017 and 2016, the Company recorded gains of $188,000 and $1,755,000, respectively, as a result of the change in fair value of the warrants.Stock. The rights to exercise these warrants expired on October 1, 2017.

In 2014, the Company issued 6,015,037 shares of common stock ~~were issued~~ pursuant to the conversion of 400,000 shares of Series A ~~Convertible~~ Preferred Stock. As of ~~September 30, 2017,~~March 31, 2019, there were 600,000 shares of Series A ~~Convertible~~ Preferred Stock issued and outstanding.

~~Table of Contents~~

~~ALIMERA SCIENCES, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)~~

Series B Convertible Preferred Stock

On December 12, 2014, the Company closed a preferred stock financing in which it sold 8,291.873 shares of Series B Convertible Preferred Stock (Series B Preferred Stock) for a purchase price of $6,030 per share, or an aggregate purchase price of $50,000,000, prior to the payment of approximately $432,000 of related issuance costs. The Company issued an additional 124.378 shares of Series B ~~Convertible~~ Preferred Stock as a subscription premium to the purchasers. On September 4, 2018, all of the outstanding shares of Series B Preferred Stock were exchanged for shares of Series C Convertible Preferred Stock (see below).

On September 4, 2018, following the closing of the exchange of all outstanding shares of Series B Preferred Stock for shares of Series C Convertible Preferred Stock, the Company filed with the Delaware Secretary of State a Certificate of Elimination of Series B Convertible Preferred Stock of Alimera Sciences, Inc., which eliminated from the Company’s amended and restated certificate of incorporation, as amended, the Alimera Sciences, Inc. Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock. As a result, all shares of the Company’s preferred stock previously designated as Series B Convertible Preferred Stock were eliminated and returned to the status of authorized but unissued shares of preferred stock, without designation as to series.

Series C Convertible Preferred Stock

On September 4, 2018, the Company entered into and closed a Series B Preferred Stock Exchange Agreement (Exchange Agreement) with the holders of all of the outstanding approximately 8,416 shares of Series B Preferred Stock. Under the Exchange Agreement, the holders of Series B Preferred Stock exchanged their shares of Series B Preferred Stock for an aggregate of 10,150 shares of Series C Convertible Preferred Stock, par value $0.01 per share (Series C Preferred Stock). The powers, preferences and rights of the Series ~~B Convertible~~C Preferred Stock are set forth in the certificate of designation filed by the Company with the Delaware Secretary of State as part of the ~~State~~Company’s certificate of ~~Delaware. Each share~~incorporation, as amended. All of the outstanding shares of Series B ~~Convertible~~ Preferred Stock iswere canceled in the exchange. The Company incurred approximately $122,000 in legal costs related to the Exchange Agreement.

The 10,150 issued and outstanding shares of Series C Preferred Stock have an aggregate stated value of $10,150,000 and are convertible into ~~1,000~~ shares of the Company’s common stock at $1.00 per share, or 10,150,000 shares of the Company’s common stock in total, at any time at the option of the holder, provided that the holder will be prohibited from converting shares of Series ~~B Convertible~~C Preferred Stock into shares of the Company’s common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.98% of the total number of shares of the Company’s common stock then issued and outstanding. The Series ~~B Convertible~~C Preferred Stock is not redeemable at the option of the holder. In the event of a liquidation, dissolution or winding up of the Company and in the event of certain mergers, tender offers and asset sales, the holders of the Series C

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

Preferred Stock will receive the greater of (a) the liquidation preference equal to $10,150,000 in the aggregate, plus any declared but unpaid dividends, or (b) the amount such holders would receive had all shares of the Series C Preferred Stock been converted into the Company’s common stock immediately before such event. With respect to rights upon liquidation, the Series C Preferred Stock ranks junior to the Company’s ~~existing~~ Series A ~~Convertible~~ Preferred Stock and senior to the Company’s common ~~stock, with respect to rights upon liquidation.~~stock. The Series ~~B Convertible~~C Preferred Stock ranks junior to all existing and future indebtedness. Except as otherwise required by law (or with respect to approval of certain actions), the Series ~~B Convertible~~C Preferred Stock dodoes not have voting rights. The Series ~~B Convertible Preferred Stock is not redeemable at the option of the holder. The Series B Convertible~~C Preferred Stock is not subject to any price-based ~~or other~~ anti-dilution protections and does not provide for any accruing dividends.

The Company determined that the ~~conversion option~~Exchange Agreement resulted in an extinguishment of the Series B ~~Convertible~~Preferred Stock. As a result, the Company recognized a gain of $38,330,000 on the extinguishment of preferred stock during the third quarter of 2018. As of the transaction date, the Company made an assessment of the fair market value of the Series C Preferred Stock ~~represented a beneficial conversion feature, as~~and calculated the ~~conversion feature had intrinsic~~ value to be $11,239,000, prior to the ~~holder on the commitment date as a result~~payment of ~~the subscription premium. Therefore, the~~approximately $122,000 of related transaction costs. The Company recorded ~~a beneficial conversion feature of $750,000~~this gain within stockholders’ equity and as an increase to earnings available to stockholders during the third quarter of 2018. The $38,330,000 gain on extinguishment of preferred stock was derived by the difference in ~~additional paid in capital. Because~~ the ~~Series B Convertible Preferred Stock was immediately convertible into common stock at the option of the holder at issuance, the Company immediately accreted the full~~fair market value of the ~~beneficial conversion feature to~~Series C Preferred Stock and the carrying value of the Series B ~~Convertible~~ Preferred ~~Stock on that date.~~

~~12. COMMON STOCK~~

In September 2014, the Company entered into a sales agreement with Cowen and Company, LLC (Cowen) to offer shares of its common stock from time to time through Cowen for the offer and sale of the shares up to an aggregate offering price of $35,000,000. During the nine months ended September 30, 2017, the Company sold a total of 4,203,015 shares of its common stock at a weighted average purchase price of $1.45 per share resulting in gross proceeds of approximately $6,001,000, prior to the payment of approximately $183,000 of sales agent discounts and commissions and related issuance costs. During the year ended December 31, 2016, the Company sold a total of 662,779 shares of its common stock at a weighted average purchase price of $1.83 per share, resulting in gross proceeds of $1,211,000, prior to the payment of approximately $62,000 of sales agent discounts and commissions and related issuance costs. Proceeds from the offering were used for general corporate and working capital purposes. The Company’s sales agreement with Cowen to sell additional shares expired on August 13, 2017.

In addition, in August 2016, pursuant to an underwriting agreement with Cowen, as representative of the several underwriters named therein, the Company closed a public offering in which it sold 18,900,000 shares of its common stock at a price to the public of $1.40 per share. The offering resulted in gross proceeds of $26,460,000, prior to the payment of approximately $1,309,000 of underwriter discounts and commissions and related issuance costs.

During the three and nine months ended September 30, 2017 and 2016, 38,732 and 41,413 shares of the Company’s common stock were acquired through its employee stock purchase plan resulting in proceeds of $41,000 and $78,000, respectively.Stock.

2026

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

~~13.~~14. STOCK INCENTIVE PLANS

Stock Option Plans

During the three months ended ~~September 30, 2017~~March 31, 2019 and ~~2016,~~2018, the Company recorded compensation expense related to stock options of approximately ~~$1,054,000~~$545,000 and ~~$1,116,000, respectively. During the nine months ended September 30, 2017 and 2016, the Company recorded compensation expense related to stock options of approximately $3,033,000 and $3,683,000,~~$866,000, respectively. As of ~~September 30, 2017,~~March 31, 2019, the total unrecognized compensation cost related to non-vested stock options granted was ~~$5,905,000~~$2,964,000 and is expected to be recognized over a weighted average period of ~~2.03~~2.52 years. The following table presents a summary of stock option activity for the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2019 and ~~2016:~~2018:


	Three Months Ended September 30,										Nine Months Ended September 30,										Three Months Ended March 31,
	2017					2016					2017					2016					2019					2018
	Options			Weighted Average Exercise Price		Options			Weighted Average Exercise Price		Options			Weighted Average Exercise Price		Options			Weighted Average Exercise Price		Options			Weighted Average Exercise Price		Options			Weighted Average Exercise Price
Options outstanding at beginning of period	11,481,801			$	2.96	10,648,702			$	3.30	10,804,412			$	3.22	9,475,890			$	3.43	12,447,355			$	2.63	11,595,510			$	2.90
Grants	74,000			1.50		749,250			1.53		1,722,800			1.24		2,169,750			2.06		1,174,750			0.87		1,233,000			1.16
Forfeitures	(122,546		)	3.06		(114,837		)	4.03		(1,093,957		)	2.93		(313,297		)	3.44		(214,569		)	1.99		(483,127		)	2.34
Exercises	(729		)	1.49		(51,471		)	1.33		(729		)	1.49		(100,699		)	1.56		—			—		(1,563		)	1.06
Options outstanding at period end	11,432,526			2.95		11,231,644			3.18		11,432,526			2.95		11,231,644			3.18		13,407,536			2.48		12,343,820			2.75
Options exercisable at period end	8,018,852			3.21		7,116,615			3.26		8,018,852			3.21		7,116,615			3.26		9,536,065			3.02		8,168,883			3.24
Weighted average per share fair value of options granted during the period	$	1.12				$	1.17				$	0.95				$	1.56				$	0.55				$	0.78

The following table provides additional information related to outstanding stock options, exercisable stock options and stock options that were expected to vest as of ~~September 30, 2017~~March 31, 2019:


	Shares	Weighted Average Exercise Price		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value		Shares	Weighted Average Exercise Price		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value
					(In thousands)						(In thousands)
Outstanding	11,432,526	$	2.95	6.44 years	$	223	13,407,536	$	2.48	6.29 years	$	321
Exercisable	8,018,852	3.21		5.51 years	36		9,536,065	3.02		5.24 years	53
Outstanding, vested and expected to vest	11,036,592	2.98		6.35 years	193		12,885,031	2.54		6.17 years	276

The following table provides additional information related to outstanding stock options, exercisable stock options and stock options that were expected to vest as of December 31, ~~2016:~~2018:


	Shares	Weighted Average Exercise Price		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value		Shares	Weighted Average Exercise Price		Weighted Average Remaining Contractual Term	Aggregate Intrinsic Value
					(In thousands)						(In thousands)
Outstanding	10,804,412	$	3.22	6.45 years	$	—	12,447,355	$	2.63	6.25 years	$	—
Exercisable	7,363,400	3.29		5.42 years	—		9,138,544	3.09		5.37 years	—
Outstanding, vested and expected to vest	10,374,846	3.23		6.35 years	—		12,044,311	2.67		6.16 years	—

As of March 31, 2019, the Company was authorized to grant options to purchase up to an additional 833,417 shares under the 2010 Equity Incentive Plan, taking into account the annual increase in the number of shares available for issuance under the Company’s 2010 Equity Incentive Plan and the options and restricted stock units (RSUs) granted and forfeited during the three months ended March 31, 2019.

2127

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

Employee Stock Purchase Plan

During the three months ended ~~September 30, 2017~~March 31, 2019 and ~~2016,~~2018, the Company recorded compensation expense related to its employee stock purchase plan of approximately ~~$10,000~~$6,000 and $18,000, respectively. During the nine months ended September 30, 2017 and 2016, the Company recorded compensation expense related to its employee stock purchase plan of approximately $30,000 and $69,000,$10,000, respectively.

Restricted Stock Units

~~During~~A summary of RSU transactions under the ~~nine months ended September 30, 2017, the Company granted 964,720 restricted stock units (RSUs) to its employees in lieu of a cash bonus program for 2017.~~ plans are as follows:



	Three Months Ended March 31,
	2019				2018
	RSUs		Weighted Average Grant Date Fair Value		RSUs		Weighted Average Grant Date Fair Value
Restricted stock units outstanding at beginning of period	900,252		$	1.15	839,285		$	1.21
Grants	480,400		0.86		1,061,170		1.16
Vested units	(889,752	)	1.15		(839,285	)	1.21
Forfeitures	(10,500	)	1.16		(21,800	)	1.16
Restricted stock units outstanding at year end	480,400		0.86		1,039,370		1.16

As of ~~September 30, 2017, 851,920~~December 31, 2018, there was approximately $352,000 of total unrecognized compensation cost related to outstanding RSUs ~~were outstanding. During~~that will be recognized through the ~~three and nine months ended September 30, 2017, the Company recorded~~first quarter of 2020. Employee stock-based compensation expense related ~~these~~to RSUs ~~of approximately $238,000~~recognized in accordance with ASC 718 was $219,000 and ~~$639,000,~~$331,000 for the three months ended March 31, 2019 and 2018, respectively.

~~14.~~

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

15. INCOME TAXES

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’s quarterly income tax rate may differ from its estimated annual effective tax rate because accounting standards require the Company to exclude the actual results of certain entities expected to generate a pretax loss when applying the estimated annual effective tax rate to the Company’s consolidated pretax results in interim periods. In estimating the annual effective tax rate, the Company does not include the estimated impact of unusual and/or infrequent items, including the reversal of valuation allowances, which may cause significant variations in the customary relationship between income tax expense (benefit) and pretax income (loss) in quarterly periods. The income tax expense (benefit) for such unusual and/or infrequent items is recorded in the quarterly period such items are incurred.

The Company’s income tax expense and resulting effective tax rate are based upon the respective estimated annual effective tax rates applicable for the respective periods adjusted for the effects of items required to be treated as discrete to the period, including changes in tax laws, changes in estimated exposures for uncertain tax positions and other items. The Company’s effective tax rate for the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2019 properly excluded tax benefits associated with year-to-date pre-tax losses generated in the U.S. and the Netherlands. Income tax positions are considered for uncertainty in accordance with ASC 740-10. The Company has recorded unrecognized tax benefits related to research and development tax credits. In accordance with ASC 740-10, such attributes are reduced to the amount that is expected to be recognized in the future. The Company has not accrued interest or penalties as no research and development credits have been utilized due to significant net operating losses (NOLs) available. The Company does not expect any decreases to the unrecognized tax benefits within the next twelve months due to any lapses in statute of limitations. Tax years ~~since 2003~~ remain subject to examination ~~in Georgia, Tennessee and~~ at the U.S. federal ~~level. The time period is longer than the standard statutory 3-year period due~~level between 2010 and 2017, and subject to ~~NOLs from 2003 being available for utilization.~~examinations at various state levels between 2005 and 2017. The statute of limitations on these years will close when the NOLs expire or when the statute closes on the years in which the NOLs are utilized. Tax years since 2012 remain subject to examination in the United Kingdom and the Netherlands. Tax years since 2013 remain subject to examination in Germany.

Significant management judgment is involved in determining the provision for income taxes, deferred tax assets and liabilities and any valuation allowance recorded against net deferred tax assets. Due to uncertainties with respect to the realization of deferred tax assets due to the history of operating losses, a valuation allowance has been established against the net deferred tax asset balance in the U.S. and the Netherlands. The valuation allowance is based on management’s estimates of taxable income in the jurisdictions in which the Company operates and the period over which deferred tax assets will be recoverable. In the event that actual results differ from these estimates or the Company adjusts these estimates in future periods, a change in the valuation allowance may be needed, which could materially impact ~~its~~the Company’s financial position and results of operations.

At December 31, ~~2016,~~2018, the Company had federal NOL carry-forwards of approximately ~~$104,892,000~~$122,455,000 and state NOL carry-forwards of approximately ~~$80,622,000~~$153,333,000 available to reduce future taxable income. The Company’s federal NOL carry-forwards remain fully reserved as of ~~September 30, 2017.~~March 31, 2019. If not utilized, the federal NOL carry-forwards will expire at various dates between 2029 and ~~2036~~2037 and the state NOL carry-forwards will expire at various dates between 2020 and ~~2036.~~2037.

~~Table~~Sections 382 and 383 of ~~Contents~~

~~ALIMERA SCIENCES, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)~~

the Internal Revenue Code (IRC) limit the annual use of NOL carry-forwards and tax credit carry-forwards, respectively, following an ownership change. NOL carry-forwards may be subject to annual limitations under ~~Internal Revenue Code (IRC)~~IRC Section 382 (Section 382) (or comparable provisions of state law) ~~in the event that~~if certain changes in ownership ~~of the Company~~ were to occur. The Company periodically evaluates its NOL carry-forwards and whether certain changes in ownership have occurred that would limit the Company’s ability to utilize a portion of its NOL carry-forwards. If it is determined that significant ownership changes have occurred since the Company generated its NOL carry-forwards, it may be subject to annual limitations on the use of these NOL carry-forwards under Section 382 (or comparable provisions of state law). The Company ~~has~~ determined that a Section 382 change in ownership occurred in late 2015. ~~Therefore,~~As a result of this change in ownership, the ~~annual utilization~~Company estimated that approximately $18.6 million of the Company’s federal NOLs ~~are subject~~and approximately $382,000 of federal tax credits generated prior to ~~certain limitations under Section 382 and other limitations under state tax laws.~~the change in ownership will not be utilized in the future. The Company is currently in the process of ~~calculating~~refining and finalizing these ~~limitations. Any~~calculations, and upon finalization, will determine if a write-off is necessary. The reduction to the Company’s NOL deferred tax

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

asset due to the annual Section 382 limitation and the NOL carryforward period would result in an offsetting reduction in valuation allowance recorded against the NOL deferred tax asset. Therefore, any limitation would not have an impact on the statements of operations for the periods presented. The results of the analysis on the impact to the Company’s NOLs will be disclosed at a later date.

As of December 31, ~~2016,~~2018, the Company had cumulative book losses in foreign subsidiaries of ~~$92,939,000.~~$126,648,000. The Company has not recorded a deferred tax asset for the excess of tax over book basis in the stock of its foreign subsidiaries. The Company anticipates that its foreign subsidiaries will be profitable and have earnings in the future. Once the foreign subsidiaries do have earnings, the Company intends to indefinitely reinvest in its foreign subsidiaries all undistributed earnings of and original investments in such subsidiaries. As a result, the Company has not recorded a deferred tax liability related to excess of book over tax basis in the stock of its foreign subsidiaries in accordance with ASC 740-30-25.

~~15. FAIR VALUE~~

~~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.

~~There have been no changes in the methodologies used at September 30, 2017 and December 31, 2016.~~

~~Table of Contents~~

~~ALIMERA SCIENCES, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)~~

~~The following fair value table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis:~~

~~September~~ 30 ~~2017~~

~~Level 1~~

~~Level 2~~

~~Level 3~~

~~Total~~

~~(In thousands)~~

~~Assets:~~

~~Cash equivalents (1)~~

—

~~Assets measured at fair value~~

—

~~Liabilities:~~

~~Derivative warrant liability (2)~~

—

~~Liabilities measured at fair value~~

—

December 31, 2016
Level 1 Level 2 Level 3 Total
(In thousands)
Assets:
Cash equivalents (1) $ —
$ —
$ —
$ —
Assets measured at fair value $ —
$ —
$ —
$ —

Liabilities:
Derivative warrant liability (2) $ —
$ 188
$ —
$ 188
Liabilities measured at fair value $ —
$ 188
$ —
$ 188


~~(1)~~	~~The carrying amounts approximate fair value due to the short-term maturities of the cash equivalents.~~


~~(2)~~	The Company uses the Black-Scholes option pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments.

Table of Contents

ALIMERA SCIENCES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

16. SEGMENT INFORMATION

~~For~~During the three ~~and nine~~ months ended ~~September 30, 2017~~March 31, 2019 and ~~2016, there were three~~2018, two customers within the U.S. ~~segment. Two of these customers, which~~segment that are large pharmaceutical distributors accounted for ~~73%~~52% and ~~75%~~71%, respectively, of the Company’s consolidated revenues for the three months ended September 30, 2017 and 2016, respectively. These two customers also accounted for 73% and 74% of the Company’s consolidated revenues for the nine months ended September 30, 2016 and 2017, respectively.revenues. These same two customers within the U.S. segment accounted for approximately ~~83% and 90%~~73% of the Company’s consolidated accounts receivable at ~~September 30, 2017~~both March 31, 2019 and at December 31, ~~2016, respectively.~~2018.

The Company’s chief operating decision maker is the Chief Executive Officer (CEO). While the CEO is apprised of a variety of financial metrics and information, the business is principally managed and organized based upon geographic and regulatory environment. Each segment is separately managed and is evaluated primarily upon segment ~~income or~~ loss from operations. Non-cash items including stock-based compensation expense and depreciation and amortization are categorized as Other within the table below. The Company does not report balance sheet information by segment because that information is not reviewed by the Company’s chief operating decision maker.

The following table presents a summary of the Company’s reporting segments for the three months ended ~~September 30, 2017~~March 31, 2019 and ~~2016:~~2018:


	Three Months Ended September 30, 2017												Three Months Ended September 30, 2016												Three Months Ended March 31, 2019												Three Months Ended March 31, 2018
	U.S.			International			Other			Consolidated			U.S.			International			Other			Consolidated			U.S.			International			Other			Consolidated			U.S.			International			Other			Consolidated
	(In thousands)																								(In thousands)
NET REVENUE	$	7,143		$	2,641		$	—		$	9,784		$	6,184		$	2,114		$	—		$	8,298		$	6,766		$	6,124		$	—		$	12,890		$	6,805		$	2,825		$	—		$	9,630
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION	(720		)	(319		)	—			(1,039		)	(374		)	(112		)	—			(486		)	(685		)	(915		)	—			(1,600		)	(713		)	(391		)	—			(1,104		)
GROSS PROFIT	6,423			2,322			—			8,745			5,810			2,002			—			7,812			6,081			5,209			—			11,290			6,092			2,434			—			8,526

RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES	1,360			984			3,076			5,420			1,984			1,083			194			3,261			1,427			1,170			130			2,727			1,640			950			232			2,822
GENERAL AND ADMINISTRATIVE EXPENSES	1,879			673			768			3,320			2,207			778			660			3,645			1,933			988			472			3,393			2,293			907			655			3,855
SALES AND MARKETING EXPENSES	4,141			1,551			310			6,002			5,410			1,762			280			7,452			4,041			1,705			167			5,913			4,371			1,278			320			5,969
DEPRECIATION AND AMORTIZATION	—			—			679			679			—			—			697			697			—			—			652			652			—			—			649			649
RECOVERABLE COLLABORATION COSTS	—			—			(2,851		)	(2,851		)	—			—			—			—
OPERATING EXPENSES	7,380			3,208			1,982			12,570			9,601			3,623			1,831			15,055			7,401			3,863			1,421			12,685			8,304			3,135			1,856			13,295
SEGMENT LOSS FROM OPERATIONS	(957		)	(886		)	(1,982		)	(3,825		)	(3,791		)	(1,621		)	(1,831		)	(7,243		)
SEGMENT (LOSS) INCOME FROM OPERATIONS																									(1,320		)	1,346			(1,421		)	(1,395		)	(2,212		)	(701		)	(1,856		)	(4,769		)
OTHER INCOME AND EXPENSES, NET	—			—			(1,437		)	(1,437		)	—			—			(1,969		)	(1,969		)	—			—			(1,297		)	(1,297		)	—			—			(2,915		)	(2,915		)
NET LOSS BEFORE TAXES										$	(5,262	)										$	(9,212	)										$	(2,692	)										$	(7,684	)

~~Table of Contents~~

~~ALIMERA SCIENCES, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)~~

~~The following table presents a summary of the Company’s reporting segments for the nine months ended September 30, 2017 and 2016:~~

Nine Months Ended
September 30, 2017 Nine Months Ended
September 30, 2016
U.S. International Other Consolidated U.S. International Other Consolidated
(In thousands)
NET REVENUE $ 19,643
$ 7,127
$ —
$ 26,770
$ 17,511
$ 6,145
$ —
$ 23,656
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (1,671 ) (724 ) —
(2,395 ) (964 ) (456 ) —
(1,420 )
GROSS PROFIT 17,972
6,403
—
24,375
16,547
5,689
—
22,236

RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 4,016
2,243
3,509
9,768
5,560
3,217
709
9,486
GENERAL AND ADMINISTRATIVE EXPENSES 5,410
2,068
2,118
9,596
6,254
2,656
2,169
11,079
SALES AND MARKETING EXPENSES 11,707
3,930
927
16,564
15,904
5,292
875
22,071
DEPRECIATION AND AMORTIZATION —
—
2,012
2,012
—
—
2,082
2,082
RECOVERABLE COLLABORATION COSTS —
—
(2,851 ) (2,851 ) —
—
—
—
OPERATING EXPENSES 21,133
8,241
5,715
35,089
27,718
11,165
5,835
44,718
SEGMENT LOSS FROM OPERATIONS (3,161 ) (1,838 ) (5,715 ) (10,714 ) (11,171 ) (5,476 ) (5,835 ) (22,482 )
OTHER INCOME AND EXPENSES, NET —
—
(3,970 ) (3,970 ) —
—
(4,682 ) (4,682 )
NET LOSS BEFORE TAXES $ (14,684 ) $ (27,164 )

~~Table of Contents~~

~~ALIMERA SCIENCES, INC.~~

~~NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued)~~

~~17. SUBSEQUENT EVENTS~~

As discussed in Notes 4 and 9, for September 2017, the Consolidated Group did not meet the six-month revenue covenant required under the Term Loan Agreement. As a result, the Consolidated Group was required to demonstrate it had $35,000,000 in liquidity as of the last business day in September 2017. On the last business day in September 2017, the Consolidated Group was not able to demonstrate it had $35,000,000 in liquidity. However, the Consolidated Group was able to demonstrate that it had $35,000,000 in liquidity on the business day immediately before the last business day in September 2017, the first business day in October 2017 and the last business day in October 2017. As a result, Hercules waived the Company’s non-compliance with the $35,000,000 liquidity requirement for September 2017.

On October 20, 2017, the Company entered into a Common Stock Sales Agreement (the Sales Agreement) with H.C. Wainwright & Co., LLC (HCW). The Sales Agreement provides that, upon the terms and subject to the conditions set forth therein, the Company may issue and sell through HCW, acting as sales agent, shares (the Shares) of the Company’s common stock having an aggregate offering price of up to $25,000,000. The Company has no obligation to sell any Shares under the Sales Agreement. The issuance and sale, if any, of the Shares under the Sales Agreement is subject to the effectiveness of the Company’s Registration Statement on Form S-3, filed with the Securities and Exchange Commission on October 20, 2017 (the Registration Statement). The Company makes no assurances as to if or whether the Registration Statement will become effective or, if it does become effective, as to the continued effectiveness of the Registration Statement. As of the filing of this Report on Form 10-Q, the Company has not sold any shares of common stock pursuant to the Sales Agreement.

2731

Table of Contents

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Overview

The following discussion and analysis should be read in conjunction with our unaudited interim condensed consolidated financial statements and the related notes 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, including those set forth in the section entitled “Risk Factors” in our most recent annual report on Form 10-K. 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 quarterly report on Form 10-Q.

Alimera Sciences, Inc., and its subsidiaries (we ~~Alimera~~ or ~~the Company)~~Alimera), is a pharmaceutical company that specializes in the commercialization ~~research~~ and development of prescription ophthalmic pharmaceuticals. We ~~are~~ presently ~~focused~~focus on diseases affecting the back of the eye, or retina, because we believe these diseases are not well treated with current therapies and represent a significant market opportunity.

Our only commercial product is ILUVIEN^®, which ~~is approved to treat diabetic macular edema (DME). DME is a disease of the retina that affects individuals with diabetes and can lead to severe vision loss and blindness. ILUVIEN~~ has received marketing authorization in the ~~United States (U.S.)~~U.S., Austria, Belgium, Canada, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Lebanon, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, the United Arab Emirates and the United Kingdom. In the U.S., Canada, Kuwait, Lebanon and the United Arab Emirates, ILUVIEN is indicated for the treatment of ~~DME~~diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). In the European Economic Area (EEA) countries in which ILUVIEN has received marketing authorization, it is indicated for the treatment of vision impairment associated with DME considered insufficiently responsive to available ~~therapies.~~

~~As part~~therapies and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye in countries where the local assessment process is closed.

We commercially market ILUVIEN in the U.S., Germany, the United Kingdom, Portugal, Austria and Ireland. In addition, we have entered into various agreements under which distributors are providing or will provide regulatory, reimbursement or sales and marketing support for ILUVIEN in France, Italy, Spain, Australia, New Zealand, Canada and several countries in the Middle East. In 2016, our Middle East distributor launched ILUVIEN and initiated named patient sales in the United Arab Emirates. Our Italian distributor launched ILUVIEN in Italy in 2017. Our Spanish distributor began selling on a named patient basis in 2017 and upon receiving reimbursement, plans a full-scale launch in 2019. Our French distributor received pricing and reimbursement approval ~~process~~in March 2019 for ILUVIEN for DME and began selling in ~~Europe,~~April 2019. Our Canadian distributor is currently pursuing reimbursement. As of March 31, 2019, we ~~committed~~have recognized sales of ILUVIEN to ~~conduct a five-year, post-authorization, open label registry study in 800 patients treated with ILUVIEN. In~~ the ~~fourth quarter of 2016, we requested approval to modify our protocol to cap enrollment~~Company’s international distributors in the study due to our post market safety surveillance not showing any unexpected safety signals. As of September 30, 2017, 562 patients were enrolled in this study. We received regulatory approval to cap enrollment in the study from the Medicines & Healthcare products Regulatory Agency (MHRA) in July 2017.Middle East, France, Italy and Spain.

In July 2017, we amended and restated our license ~~for~~agreement with EyePoint Pharmaceuticals US, Inc. (EyePoint), formerly known as pSivida US, Inc., which was made effective July 1, 2017 (the New Collaboration Agreement). Under the New Collaboration Agreement, the technology underlying ILUVIEN ~~to include~~now includes the treatment of uveitis, including non-infectious posterior uveitis (NIPU), in Europe, the Middle East and ~~Africa from pSivida US, Inc. (pSivida).~~Africa. In December 2017, we filed an application for a new indication for ILUVIEN for the treatment of non-infectious posterior uveitis (NIPU) in the 17 EEA countries where ILUVIEN is currently approved for the treatment of DME. Uveitis is an inflammatory disease of the uveal tract, which is comprised of the iris, ciliary body and choroid, that can lead to severe vision loss and blindness. ~~We plan~~The regulatory authorities requested additional follow-up data from the clinical trials to ~~file~~support the application, which was submitted in October 2018. In March 2019, we received the Final Variation Assessment Report (FVAR) for ILUVIEN from the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) based on our submission to the MHRA through the Mutual Recognition Procedure. Under that procedure, the United Kingdom has acted as the Reference Member State and prepared an ~~application~~assessment report to share with the 16 other countries in the EEA in which we applied for ~~a new~~an additional indication. The FVAR states that ILUVIEN is approved for the additional indication for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye.

The New Collaboration Agreement converted our previous profit share obligation to a royalty payable on global net revenues of ILUVIEN. We began paying a 2% royalty on net revenues and other related consideration to EyePoint effective July 1, 2017. The royalty amount increased to 6% as of December 12, 2018. We will pay an additional 2% royalty on global net revenues and other related consideration in excess of $75.0 million in any year. During the three months ended March 30, 2019 and 2018, we recognized approximately $516,000 and $193,000 of royalty expense, respectively, which is included in cost of goods sold, excluding depreciation and amortization. As of March 31, 2019, approximately $516,000 of this royalty expense was included in our accounts payable.

Table of Contents

Following the signing of the New Collaboration Agreement, we retained a right to offset $15.0 million of future royalty payments. In March 2019, pursuant to the New Collaboration Agreement, we forgave $5,000,000 of the Future Offset in connection with the approval of ILUVIEN for NIPU in the ~~17 EEA countries where ILUVIEN is currently approved for the treatment of DME.~~

~~We launched ILUVIEN in Germany and the~~ United Kingdom in the second quarter of 2013, in the U.S. and Portugal in the first quarter of 2015. We began selling ILUVIEN in Austria in the first quarter of 2017 and we expect to begin sales of ILUVIEN in Ireland in the fourth quarter of 2017.

In addition, we have entered into various agreements under which distributors will provide regulatory, reimbursement or sales and marketing support for future commercialization of ILUVIEN in several countries in the Middle East, as well as France, Italy, Spain, Australia, New Zealand and Canada. In the third quarter of 2016, our Middle East distributor launched ILUVIEN and initiated named patient sales in the United Arab Emirates. Our Italian distributor launched ILUVIEN in Italy in the second quarter of 2017.Kingdom. As of ~~September 30, 2017, we have recognized sales~~March 31, 2019, the balance of ~~ILUVIEN~~the Future Offset was approximately $9,820,000. (See Note 10 of our notes to ~~our distributors in~~ the ~~Middle East, Italy~~accompanying unaudited interim condensed consolidated financial statements and ~~Spain.~~notes thereto (Interim Financial Statements).)

We commenced operations in June 2003. Since our inception we have incurred significant losses. As of ~~September 30, 2017,~~March 31, 2019, we ~~have~~had accumulated a deficit of ~~$391.9~~$379.9 million. We expect to ~~continue to~~ incur ~~losses~~additional expenses as we:

continue the commercialization of ILUVIEN in the U.S. and ~~the EEA;~~

~~seek the regulatory approval of ILUVIEN for NIPU in Europe, the Middle East and Africa;~~EEA, where we sell direct;

continue to seek regulatory approval of ILUVIEN for ~~DME~~other indications and in other ~~jurisdictions~~jurisdictions;

evaluate the use of ILUVIEN for the treatment of other diseases; and

advance the clinical development of any future products or product candidates either currently in our pipeline, or that we may license or acquire in the future.

As of ~~September 30, 2017,~~March 31, 2019, we had approximately ~~$25.6~~$13.1 million in cash and cash equivalents.

As a result of the limited revenue generated by ILUVIEN to date, our negative cash flow from operations and accumulated deficit raise substantial doubt about our ability to continue as a going concern. Our Interim Financial Statements do not include any adjustments that might result from the outcome of this uncertainty. We believe thatOn January 5, 2018, we have sufficient funds to allow us to become cash flow positive in the countries in which we sell ILUVIEN. However, it is possible that we may determine that we may need to raise additional funds in the future in order to support our business in these countries, to expand ILUVIEN into new geographies, to allow us to expand the indication of ILUVIEN, to maintain compliance with our debt

~~Table of Contents~~

covenants or other business development activities. We cannot be sure that additional financing will be available when needed or that, if available, the additional financing will be obtained on terms favorable to us or our stockholders.

~~Our Agreement with pSivida~~

~~pSivida Agreement~~

~~General Discussion of pSivida Agreement~~

We entered into an agreement with pSivida for the use of fluocinolone acetonide (FAc) in pSivida’s proprietary delivery device in February 2005, which was subsequently amended and restated a number of times (as amended, the pSivida Agreement). The pSivida Agreement provides us with a worldwide exclusive license to utilize certain underlying technology used in the development and commercialization of ILUVIEN. ILUVIEN consists of a tiny polyimide tube with a permeable membrane cap on one end and an impermeable silicone cap on the other end that is filled with FAc in a polyvinyl alcohol matrix for delivery to the back of the eye for the treatment and prevention of eye diseases in humans (other than uveitis). The pSivida Agreement also provides us with a worldwide non-exclusive license to utilize pSivida’s proprietary delivery device to deliver other corticosteroids to the back of the eye for the treatment and prevention of eye diseases in humans (other than uveitis) or to treat DME by delivering a compound to the back of the eye through a direct delivery method through an incision required for a 25-gauge or larger needle. We do not have the right to utilize pSivida’s proprietary delivery device in connection with indications for diseases outside of the eye or for the treatment of uveitis. Further, the pSivida Agreement permits pSivida to grant to any other party the right to use its intellectual property (i) to treat DME through an incision smaller than that required for a 25-gauge needle, unless using a corticosteroid delivered to the back of the eye, (ii) to deliver any compound outside the back of the eye unless it is to treat DME through an incision required for a 25-gauge or larger needle, or (iii) to deliver non-corticosteroids to the back of the eye, unless it is to treat DME through an incision required for a 25-gauge or larger needle.

~~As a result of the U.S. Food and Drug Administration (FDA) approval of ILUVIEN in September 2014, we paid pSivida a milestone payment of $25.0 million (the pSivida Milestone Payment) in October 2014.~~

~~2008 Amended and Restated Collaboration Agreement~~

Pursuant to the payment terms of the 2008 Amended and Restated Agreement (the 2008 Agreement), we were required to share 20% of the net profits of ILUVIEN, determined on a cash basis and 33% of any lump sum milestone payments received from a sub-licensee of ILUVIEN, as defined by the 2008 Agreement. In connection with the 2008 Agreement, we were entitled to recover 20% of commercial losses associated with ILUVIEN, as defined in the pSivida Agreement, that could be offset in any future quarter out of payments of pSivida’s share of net profits (the Future Offset). As of December 31, 2016, the total Future Offsets available to reduce future net profit payments to pSivida, as defined in the 2008 Agreement, was $24.5 million. In connection with the New Collaboration Agreement discussed below, we and pSivida agreed to cap the Future Offset amount at June 30, 2017 to $25.0 million. The Future Offset was not previously reflected on our balance sheet due to the uncertainty of future realizability.

~~May 2017 Amendment~~

In the second quarter of 2016, pSivida disputed portions of our claimed commercialization costs for the year ended December 31, 2014. On May 3, 2017, we and pSivida settled this dispute and amended and clarified certain definitions and clauses of the 2008 Agreement. As part of this settlement, we and pSivida agreed no additional amounts would be due for the year ended December 31, 2014 and effectively no audits would occur for the years ended December 31, 2015 and 2016. As a result of this settlement and amendment, Future Offsets was reduced from $25.8 million to $24.5 million as of December 31, 2016.

~~New Collaboration Agreement - Second Amended and Restated Collaboration Agreement~~

~~On July 10, 2017, we and pSivida~~ entered into a ~~Second Amended~~$40.0 million Loan and ~~Restated Collaboration~~Security Agreement ~~(the New Collaboration~~(2018 Loan Agreement)~~, which amends and restates~~ with Solar Capital Ltd. (Solar Capital). Under the ~~pSivida Agreement.~~

~~Prior to entering into the New Collaboration~~2018 Loan Agreement, we ~~held~~borrowed the worldwide license from pSivida for the use of FAc in pSivida’s proprietary delivery device for the treatment of all ocular diseases other than uveitis. The New Collaboration Agreement expands the license to include uveitis, including NIPU, in Europe, the Middle East and Africa and allows us to also pursue an indication for posterior uveitis for ILUVIEN in those territories.

The New Collaboration Agreement converts our obligation to share 20% of our net profits to a royalty payable on global net revenues of ILUVIEN. We will begin paying a 2% royalty on net revenues and other related consideration to pSivida beginning effective July 1, 2017. This royalty amount will increase to 6% upon the earliest of January 1, 2019, the receipt of

~~Table of Contents~~

the first marketing approval for ILUVIEN for the treatment of NIPU, or one year from our filing of a marketing authorization application in the EU for NIPU. We will pay an additional 2% royalty on global net revenues and other related consideration in excess of $75.0 million in any year. During the three months ended September 30, 2017, we recognized approximately $196,000 of royalty expense, which is included in cost of goods sold, excluding depreciation and amortization, due to this royalty. As of September 30, 2017, this amount was included in our accounts payable.

The New Collaboration Agreement did not require an upfront cash payment from us. In connection with the New Collaboration Agreement, we agreed to forgive $10.0 million of the total $25.0 million of the Future Offset at the amendment date. Following the signing of the New Collaboration Agreement, we retain a right to recover up to an additional $15.0 million of the Future Offset. We will be able to recover up to $15.0entire $40.0 million as a ~~reduction of future royalties as follows:~~

Interm loan that matures on July 1, 2022 (Solar Capital Loan). We used the first two years following the increase in royalty amount to 6%, the royalty will be reduced to 4% for net revenues and other related consideration up to $75.0 million annually and 5% for net revenues and other related consideration in excess of $75.0 million on an annual basis; and

Beginning with the third year following the increase in royalty amount to 6%, the royalty will be reduced to 5.2% for net revenues and other related consideration up to $75.0 million annually and to 6.8% for net revenues and other related consideration in excess of $75.0 million on an annual basis.

~~We will forgive up to $5.0 million~~proceeds of the ~~remaining $15.0 million of Future Offsets upon~~Solar Capital Loan to refinance the ~~earlier of the approval of ILUVIEN for posterior uveitis in any EU country or January 1, 2020, unless certain conditions~~then outstanding loan (Hercules Loan) under ~~the New Collaboration Agreement are not met. If the amounts recoverable by us associated with the Future Offsets are less than $5.0 million at that time, we will pay pSivida the difference in cash.~~

We valued the transaction utilizing a present value analysis at approximately $2.9 million. Because there was no approved indication for ILUVIEN for uveitis at the time, we expensed the $2.9 million as a non-cash charge as in-process Research and Development Expense in the third quarter of 2017. We also recognized $2.9 million for Recoverable Collaboration Costs for the value of the right of offset as a reduction of operating expenses. As a result, there was no impact on our ~~operating loss or net loss for the three and nine months ended September 30, 2017.~~

~~Table of Contents~~

~~Our Credit Facility~~

~~Hercules Loan Agreement~~

~~2014 Loan Agreement~~

~~In April 2014, Alimera Sciences Limited (Limited), our subsidiary, entered into a~~previous loan ~~and security~~ agreement ~~(2014 Loan Agreement)~~ with Hercules Capital, Inc. ~~(Hercules) providing for a term loan of up~~(Hercules Loan Agreement) and to $35.0 million (2014 Term Loan), which Limited and Hercules amended in November 2015 (the First Loan Amendment), March 2016 (the Second Loan Amendment), May 2016 (the Third Loan Amendment), October 2016 (the Fourth Loan Amendment) and May 2017 (the Fifth Loan Amendment and, collectivelypay closing expenses associated with the ~~2014~~2018 Loan ~~Agreement,~~Agreement. We used the ~~First Loan Amendment, the Second Loan Amendment, the Third Loan Amendment and the Fourth Loan Amendment, the Term Loan Agreement). Under the 2014 Loan Agreement, Hercules made an advance~~remaining loan proceeds in ~~the initial principal amount of $10.0 million~~2018 to ~~Limited at closing to~~ provide ~~Limited with~~ additional working capital for general corporate ~~purposes and~~purposes. (See Note 11 of our notes to repay a 2013 term loan with Silicon Valley Bank. Hercules made an additional advance of $25.0 million to Limited in September 2014, following the approval of ILUVIEN by the FDA to fund the pSivida Milestone Payment. The 2014 Loan Agreement provided for interest only payments through November 2015. Interest on the 2014 Term Loan accrued at a floating per annum rate equal to the greater of (i) 10.90%, or (ii) the sum of (A) 7.65%, plus (B) the prime rate. Following the interest only period, the 2014 Term Loan was due and payable to Hercules in equal monthly payments of principal and interest through May 1, 2018.Interim Financial Statements.)

~~First Loan Amendment~~

We and Limited, on a consolidated basis with our other subsidiaries (the Consolidated Group), agreed to customary affirmative and negative covenants and events of default in connection with these arrangements. The occurrence of an event of default could result in the acceleration of Limited’s obligations under the Term Loan Agreement and an increase to the applicable interest rate and would permit Hercules to exercise remedies with respect to the collateral under the Term Loan Agreement. In connection with the First Loan Amendment, Limited agreed to covenants regarding certain revenue thresholds and a liquidity threshold.

~~Second Loan Amendment~~

~~The Second Loan Amendment adjusted the revenue covenant to a rolling three-month calculation, first measured~~Our revenues for the three months ended ~~May~~March 31, ~~2016. In addition,~~2019 and 2018 were generated from product sales primarily in the Second Loan Amendment increased the liquidity covenant. Upon execution of the Second Loan Amendment, Limited paid Hercules an amendment fee of $350,000 and agreed to increase the End of Term Payment to $1,400,000 from $1,050,000, which was payable on the date that the 2014 Term Loan was to be paid in full.

We concluded that the Second Loan Amendment resulted in a substantial modification of the terms of debt when considered with the First Loan Amendment in accordance with the guidance in Accounting Standard Codification (ASC) 470-50, Debt. As a result, we accounted for the Second Loan Amendment as an extinguishment and recognized a loss on early extinguishment of debt of approximately $2.6 million within the consolidated statement of operations for the year ended December 31, 2016. The loss on early extinguishment consisted primarily of the unamortized debt discount associated with the warrant and debt issuance costs incurred prior to the Second Loan Amendment, the incremental fair value of the warrant as a result of modifying the terms of the warrant and the debt issuance costs of $360,000 paid to Hercules for the Second Loan Amendment.

~~Third Loan Amendment and July 2016 Waiver~~

~~In May 2016, Limited and Hercules entered into the Third Loan Amendment to expand the definition of liquidity to allow for the inclusion of cash of up to $2.0 million in bank accounts outside of the~~ U.S., Germany and the United Kingdom.

In ~~July 2016, Limited obtained a waiver of~~ the requirements of the liquidity covenant (the Waiver) because the Consolidated Group was not in compliance with the liquidity covenant as of June 30, 2016. The Waiver cured the default of the liquidity covenant then existing under the Term Loan AgreementU.S., two large pharmaceutical distributors accounted for 52% and ~~decreased the liquidity requirement. In addition, the Waiver modified the three-month revenue covenant so that it was not measured at July 31, 2016 and reduced the three-month~~

~~Table of Contents~~

revenue target to be measured at August 31, 2016. Following execution of the Waiver, Limited incurred a weekly ticking fee equal to 0.05% multiplied by the outstanding principal amount through the closing71% of our ~~public offering in August 2016, totaling $65,000. Further, Limited paid Hercules a fee of $350,000 associated with the Waiver.~~

~~Fourth Loan Amendment~~

In October 2016, Limited entered into the Fourth Loan Amendment with Hercules, which further amended certain terms of the Term Loan Agreement. Pursuant to the terms of the Fourth Loan Amendment, Hercules agreed to provide up to an additional $10.0 million to Limited with (i) the first $5.0 million available at Limited’s option through June 30, 2017 subject to (A) the Consolidated Group’s achievement of $12.0 million in trailing three month net product revenue and (B) no event of default having occurred since October 20, 2016 (the Effective Date) and (ii) the second $5.0 million available at Limited’s option through December 31, 2017 subject to (A) the Consolidated Group’s achievement of $15.0 million in trailing three month net product revenue, (B) no event of default having occurred since the Effective Date and (C) the prior $5.0 million having been advanced to Limited (the Additional Advances and, together with the 2014 Term Loan, the Term Loan). We did not achieve the trailing three month net product revenue threshold prior to June 30, 2017 and as a result the additional $10.0 million is not available to Limited.

The Fourth Loan Amendment provides for interest only payments through November 30, 2018 (the Interest-Only Period). Pursuant to the Fourth Loan Amendment, interest on the Term Loan accrues at a floating per annum rate equal to the greater of (i) 11.0% and (ii) the sum of (A) 11.0% plus (B) the prime rate as reported in The Wall Street Journal, or if not reported, the prime rate most recently reported in The Wall Street Journal, minus 3.5%. In addition to the interest described above, the principal balance of the Term Loan will bear “payment-in kind” interest at the rate of 1.0% (PIK Interest), which PIK Interest will be added to the outstanding principal balance of the Term Loan so as to increase the outstanding principal balance of the Term Loan on each payment dateconsolidated revenues for the ~~Term Loan~~three months ended March 31, 2019 and ~~which amount will be payable when the aggregate outstanding principal amount~~2018, respectively. These U.S.-based distributors purchase ILUVIEN from us, maintain inventories of ~~the Term Loan is payable. The Term Loan will be due~~ILUVIEN and ~~payable~~sell downstream to ~~Hercules~~physician offices, pharmacies and hospitals. Internationally, in ~~24 equal monthly payments~~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 ~~principal~~ILUVIEN and ~~interest following the Interest-Only Period beginning on December 1, 2018 and matures in full on November 1, 2020. The interest rate on the Term Loan Agreement was 11.75% as of September 30, 2017.~~

Limited paid Hercules a facility charge of $337,500 and reimbursed Hercules for legal and diligence fees incurred in connection with the Fourth Loan Amendment. If Limited prepays the Term Loan, it will pay Hercules a prepayment penalty (i) if such amounts are prepaid in any of the first 12 months following the Effective Date, equalsell to 3.0% of the principal amount of the Term Loan being repaid, (ii) if such amounts are prepaid after 12 months but prior to 24 months following the Effective Date, equal to 2.0% of the principal amount of the Term Loan being repaid, and (iii) if such amounts are prepaid at any time thereafter, equal to 1.0% of the principal amount of the Term Loan being repaid.

~~Fifth Loan Amendment~~

~~In May 2017, Limited entered into the Fifth Loan Amendment with Hercules, which further amended and clarified certain terms of the Term Loan Agreement. The amendment was not material.~~

~~October 2017 Waiver~~

For September 2017, the Consolidated Group did not meet the six-month revenue covenant required under the Term Loan Agreement. As a result, the Consolidated Group was required to demonstrate it had $35.0 million in liquidity (as defined in the Term Loan Agreement) as of the last business day in September 2017. On the last business day in September 2017, the Consolidated Group was not able to demonstrate it had $35.0 million in liquidity. However, the Consolidated Group was able to demonstrate that had $35.0 million in liquidity on the business day immediately before the last business day in September 2017, the first business day in October 2017 and the last business day in October 2017. As a result, Hercules waived the Consolidated Group’s non-compliance with the $35.0 million liquidity requirement for September 2017.

~~Table of Contents~~

~~General Discussion of the Term Loan Agreement~~

Pursuant to the Term Loan Agreement, Limited’s obligations to Hercules are secured by a first-priority security interest in substantially all of Limited’s assets, excluding intellectual property. Hercules does, however, maintain a negative pledge on Limited’s intellectual property requiring Hercules’ consent prior to the sale of such intellectual property. We and certain of our other subsidiaries are guarantors of the obligations of Limited to Hercules under the Term Loan Agreement pursuant to separate guaranty agreements between Hercules and each of Limited and such subsidiaries (Guaranties). Pursuant to the Guaranties, we and our subsidiaries granted Hercules a first-priority security interest in substantially all of their ~~respective assets excluding intellectual property. The Term Loan Agreement also places limitations on our ability to declare or pay any dividend or distribution on any shares of capital stock.~~

~~2014 Warrant~~

In connection with Limited entering into the 2014 Loan Agreement, we issued a warrant to Hercules to purchase up to 285,016 shares of our common stock at an exercise price of $6.14 per share (the 2014 Warrant). Sixty percent of the 2014 Warrant was exercisable at the closing in April 2014 and the remaining forty percent became exercisable upon the funding of the additional $25.0 million to Limited in September 2014.

We agreed to amend the 2014 Warrant in connection with the First Loan Amendment to increase the number of shares issuable upon exercise to 660,377 and decrease the exercise price to $2.65 per share. Upon entering into the Second Loan Amendment, we agreed to further amend the 2014 Warrant to increase the number of shares issuable upon exercise to 862,069 and decrease the exercise price to $2.03 per share. In connection with the July 2016 Waiver, we agreed to further amend the 2014 Warrant to increase the number of shares issuable upon exercise to 1,258,993 and decrease the exercise price to $1.39 per share.

~~2016 Warrant~~

In connection with Limited entering into the Fourth Loan Amendment, we agreed to issue a new warrant to Hercules (the 2016 Warrant) to purchase up to 458,716 shares of our common stock at an exercise price of $1.09 per share which was equal to $500,000 divided by the lowest volume-weighted average sale price for a share of our common stock reported over any ten consecutive trading days during the period commencing on and including September 23, 2016 and ending on the earlier to occur of (i) December 30, 2016 (inclusive of such date), and (ii) the second trading day immediately preceding the date of closing of a merger event (as defined in the 2016 Warrant).

~~Fair Value of Debt~~

The weighted average interest rates of our notes payable approximate the rate at which we could obtain alternative financing and the fair value of the warrants that were issued in connection with our notes payable are immaterial. Therefore, the carrying amount of the notes approximated their fair value at September 30, 2017 and December 31, 2016.customers.

Table of Contents

~~Financial~~Results of Operations ~~Overview~~


	Three Months Ended September 30,						Nine Months Ended September 30,						Three months ended March 31,
	2017			2016			2017			2016			2019			2018
	(In thousands)												(In thousands, except share and per share data)
NET REVENUE	$	9,784		$	8,298		$	26,770		$	23,656		$	12,890		$	9,630
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION													(1,600		)	(1,104		)
GROSS PROFIT	8,745			7,812			24,375			22,236			11,290			8,526

RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES													2,727			2,822
GENERAL AND ADMINISTRATIVE EXPENSES													3,393			3,855
SALES AND MARKETING EXPENSES													5,913			5,969
DEPRECIATION AND AMORTIZATION													652			649
OPERATING EXPENSES	12,570			15,055			35,089			44,718			12,685			13,295
NET LOSS FROM OPERATIONS	(3,825		)	(7,243		)	(10,714		)	(22,482		)	(1,395		)	(4,769		)

INTEREST EXPENSE AND OTHER													(1,228		)	(1,151		)
UNREALIZED FOREIGN CURRENCY (LOSS) GAIN, NET													(69		)	2
LOSS ON EARLY EXTINGUISHMENT OF DEBT													—			(1,766		)
NET LOSS BEFORE TAXES													(2,692		)	(7,684		)
PROVISION FOR TAXES													(71		)	—
NET LOSS	(5,285		)	(9,245		)	(14,777		)	(27,248		)	(2,763		)	(7,684		)
NET INCOME (LOSS) AVAILABLE TO STOCKHOLDERS													$	(2,763	)	$	(7,684	)
NET LOSS PER SHARE — Basic and diluted													$	(0.04	)	$	(0.11	)
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted													70,740,851			69,883,012

Net Revenue

We began generating revenue from ILUVIEN in ~~the second quarter of~~ 2013. In addition to generating revenue from product sales, we intend to 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. We expect any revenue we generate will fluctuate from quarter to quarter as a result of the nature, timing and amount of any milestone payments we may receive from potential collaborative and strategic relationships, as well as revenue we may receive upon the sale of our products to the extent any are successfully commercialized.

Net revenue increased by approximately $1.5 million, or 18%, to approximately $9.8 million for the three months ended September 30, 2017 and by approximately $3.1 million, or 13%, to approximately $26.8 million for the nine months ended September 30, 2017. The increase was primarily attributable to increased sales volume in the U.S. and international segments.

~~Gross Profit~~

~~Gross profit is impacted by costs of goods sold which includes costs of manufactured goods sold, royalty expenses, and net profit amounts owed to pSivida, as defined in the pSivida Agreement.~~ Additionally, revenue from our U.S. distributors and revenue from our partners in the markets in our international ~~distributors will fluctuate~~segment where we do not sell direct fluctuates depending on the timing of the shipment of ILUVIEN to the ~~distributor~~distributors and the distributors’ sales of ILUVIEN to their customers.

~~Gross profit~~Net revenue increased by approximately ~~$900,000,~~$3.3 million, or ~~12%~~34%, to ~~$8.7 million for three months ended September 30, 2017, compared to $7.8~~approximately $12.9 million for the three months ended September 30, 2016. Gross margin was 89% and 94% for the three months ended September 30, 2017 and 2016, respectively. The change in gross margin was primarily impacted by royalty expense payable to pSivida.

~~Gross profit increased by approximately $2.2 million, or 10%, to $24.4 million for nine months ended September 30, 2017,~~March 31, 2019, compared to ~~$22.2 million for the nine months ended September 30, 2016. Gross margin was 92% and 94% for the nine months ended September 30, 2017 and 2016, respectively.~~

~~Operating Expenses~~

~~Operating expenses decreased by~~ approximately ~~$2.5 million, or 17%, to approximately $12.6~~$9.6 million for the three months ended ~~September 30, 2017,~~March 31, 2018. The increase was primarily asattributable to a ~~result of decreases~~revenue increase in ~~sales and marketing expenses~~our international segment, including increases of approximately ~~$1.5~~$1.7 million in ~~research, development~~the international markets where we sell direct and ~~medical affairs expenses~~$1.6 million in the international markets where we sell to distributors.

Cost of ~~approximately $700,000~~Goods Sold, Excluding Depreciation and Amortization, and Gross Profit

Gross profit is affected by costs of goods sold, which includes (a) costs of manufactured goods sold and (b) payments to EyePoint in ~~general~~the form of royalty payments under the New Collaboration Agreement. Additionally, cost of goods sold from our international distributors fluctuates depending on the timing of the shipment of ILUVIEN to the distributor.

Cost of goods sold, excluding depreciation and ~~administrative expenses of approximately $300,000.~~

~~Operating expenses decreased~~amortization, increased by approximately ~~$9.6 million,~~$500,000, or ~~21%~~45%, to approximately ~~$35.1~~$1.6 million for the ~~nine~~three months ended ~~September 30, 2017,~~March 31, 2019, compared to approximately $1.1 million for the three months ended March 31, 2018. The increase was primarily ~~as a result of decreases~~attributable to increased sales in ~~sales~~our international segment, including increases in both the international markets where we sell direct and marketing expenses of approximately $5.5 million, in research, development and medical affairs expenses of approximately $2.6 million and in general and administrative expenses of approximately $1.5 million.

~~Research, Development and Medical Affairs Expenses~~

~~Substantially all of our research, development and medical affairs expenses incurred~~the international markets where we sell to date related to our continuing operations have been related to the development of ILUVIEN. We anticipate that we will incur additional research, development and medical affairs expenses in the future as we expand the availability of ILUVIEN in additional geographies, evaluate and possibly pursue the regulatory approval of ILUVIEN in additional jurisdictions, the development of ILUVIEN fordistributors.

Table of Contents

~~additional indications,~~Gross profit increased by approximately $2.8 million, or ~~develop additional products or product candidates. We recognize research, development~~33%, to approximately $11.3 million for the three months ended March 31, 2019, compared to approximately $8.5 million for the three months ended March 31, 2018. Gross margin was 88% and ~~medical affairs expenses as they are incurred. Our research, development~~89% for the three months ended March 31, 2019 and ~~medical affairs expenses consist primarily of:~~2018, respectively.

~~salaries~~Research, Development and ~~related expenses for personnel, including medical science liaisons;~~

~~costs related to the provision of medical affairs support, including symposia development for physician education;~~

~~costs related to compliance with FDA, EEA or other regulatory requirements;~~

~~costs related to seeking the regulatory approval of ILUVIEN for NIPU in Europe, the Middle East and Africa;~~

fees paid to consultants and contract research organizations (CRO) in conjunction with independently monitoring clinical trials and acquiring and evaluating data in conjunction with clinical trials, including all related fees such as investigator grants, patient screening, lab work and data compilation and statistical analysis;

~~costs incurred with third parties related to the establishment of a commercially viable manufacturing process for products or product candidates;~~

~~costs related to production of clinical materials;~~

~~costs related to post marketing authorization studies;~~

~~consulting fees paid to third-parties involved in research, development and medical affairs activities; and~~

~~costs related to stock options or other stock-based compensation granted to personnel in research, development and medical affairs functions.~~

~~We expense both internal and external development costs as they are incurred.~~Medical Affairs Expenses

Currently, our research, development and medical affairs expenses are primarily focused on activities that support ~~ILUVIEN. Until we reach profitability, if at all, we do not expect~~ILUVIEN and includes salaries and related expenses for research and development and medical affairs personnel, including medical sales liaisons, costs related to ~~change~~ the ~~focus~~provision of ~~these activities. However, once we reach profitability we expect that a large percentage of our research,~~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 development costs as they are incurred.

Research, development and medical affairs expenses ~~in the future will be incurred in support of our current and future technical, preclinical and clinical development programs. These expenditures are subject~~decreased by approximately $100,000, or 4%, to numerous uncertainties in terms of both their timing and total cost to completion. Assuming we reach profitability, we expect to continue to develop stable formulations of ILUVIEN or any future products or product candidates, test such formulations in preclinical studies for toxicology, safety and efficacy and to conduct clinical trials for each future product candidate. We anticipate funding these clinical trials ourselves, but we may engage collaboration partners at certain stages of clinical development. As we obtain results from these clinical trials, we may elect to discontinue or delay them for certain products or product candidates or programs in order to focus our resources on more promising products or product candidates or programs. Completion of these clinical trials by us or our future collaborators may take several years or more, the length of time generally varying with the type, complexity, novelty and intended use of a product candidate.

Our only commercial product is ILUVIEN, which has received marketing authorization in the U.S., Austria, Belgium, the Czech Republic, Denmark, Finland, Germany, France, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden and the United Kingdom. In the U.S., ILUVIEN is indicatedapproximately $2.7 million 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 IOP. In the EEA countries in which ILUVIEN has received marketing authorization, it is indicatedthree months ended March 31, 2019, compared to approximately $2.8 million for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Our distributor partners are assisting us with obtaining approvals in the Middle East and in other jurisdictions for DME.

~~We plan to file an application for a new indication for marketing approval of ILUVIEN for NIPU in the 17 EEA countries where ILUVIEN is currently approved for the treatment of DME.~~

In order to grant marketing approval, a health authority such as the FDA or foreign regulatory agencies must conclude that clinical and preclinical data establish the safety and efficacy of ILUVIEN or any future products or product candidates with an appropriate benefit to risk profile relevant to a particular indication and that the product can be manufactured under current Good Manufacturing Practice in a reproducible manner to deliver the product’s intended performance in terms of its stability, quality, purity and potency. Until our submissions are reviewed by health authorities, there is no way to predict the outcome of their review. Even if the clinical studies meet their predetermined primary endpoints and a registration dossier is accepted for filing, a health authority could still determine that an appropriate benefit to risk relationship does not exist for the indication that we are seeking. We cannot forecast with any degree of certainty whether ILUVIEN or any future products or product candidates will be subject to future collaborations or how such arrangements would affect our development plan or capital requirements. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of

~~Table of Contents~~

~~our development projects or when and to what extent we will receive cash inflows from the commercialization and sale of an approved product candidate.~~three months ended March 31, 2018.

General and Administrative Expenses

General and administrative expenses consist primarily of compensation for employees in executive and administrative functions, including finance, accounting, information technology and human resources. Other significant costs include facilities costs and professional fees for accounting and legal services, including legal services associated with obtaining and maintaining patents. 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 decreased by approximately $500,000, or 13%, to approximately $3.4 million for the three months ended March 31, 2019, compared to approximately $3.9 million for the three months ended March 31, 2018. The decrease was primarily attributable to decreases in personnel costs.

Sales and Marketing Expenses

Sales and marketing expenses consist primarily of professional fees and compensation for employees for the commercial promotion, the assessment of the commercial opportunity of, the development of market awareness for, the pursuit of market reimbursement for and the execution of launch plans for ILUVIEN. Other costs include professional fees associated with developing plans for ILUVIEN or any future products or product candidates and maintaining public relations.

~~We launched ILUVIEN~~Sales and marketing expenses decreased by approximately $100,000, or 2%, to approximately $5.9 million for the three months ended March 31, 2019, compared to approximately $6.0 million for the three months ended March 31, 2018.

Operating Expenses

As a result of the decreases in ~~Germany~~various expenses described above, total operating expenses decreased by approximately $600,000, or 5%, to approximately $12.7 million for the three months ended March 31, 2019, compared to approximately $13.3 million for the three months ended March 31, 2018. The decrease was primarily attributable to an approximately $500,000 decrease in general and administrative expenses, a $100,000 decrease in research, development and medical affairs expenses and a $100,000 decrease in sales and marketing expenses.

Interest Expense and Other

Interest expense and other was approximately $1.2 million for the ~~United Kingdom~~three months ended March 31, 2019 and 2018. For these periods, interest expense consisted primarily of interest and amortization of deferred financing costs and debt discounts associated with our outstanding debt under the 2018 Loan Agreement with Solar Capital. As discussed in Note 11 of our notes to Interim Financial Statements, we entered into a new loan facility with Solar Capital on January 5, 2018 and refinanced the ~~second quarter~~Hercules Loan Agreement with the proceeds.

Loss on early extinguishment of 2013, in the U.S. and Portugal in the first quarter of 2015. We began selling ILUVIEN in Austria in the first quarter of 2017, and we expect to begin sales of ILUVIEN in Ireland in the fourth quarter of 2017.debt

We ~~have an International marketing~~recorded a loss on early extinguishment of debt of approximately $1.8 million for the three months ended March 31, 2018 as a result of refinancing the Hercules Loan Agreement by entering into the 2018 Loan Agreement with Solar Capital on January 5, 2018.

Basic and ~~sales team, including local management~~Diluted Net Income (Loss) Applicable to Common Stockholders per Share of Common Stock

We follow ASC 260, Earnings Per Share (ASC 260), which requires the reporting of both basic and ~~sales teams~~diluted earnings per share. Because our preferred stockholders participate in ~~France, Germany, Portugal~~ dividends equally with common stockholders (if we were to declare

Table of Contents

and pay dividends), the ~~United Kingdom, totaling 27 persons as~~Company uses 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 income (loss) available to stockholders by the weighted average number of ~~September 30, 2017. We also have a U.S. marketing and field force, including sales personnel, reimbursement specialists and payor relations directors, totaling 49 persons as of September 30, 2017.~~

Inshares outstanding for the fourth quarter of 2016, after unsuccessfully negotiating with the French government to obtain an appropriate price, we decided to close operations in France. We expect the closing of operations to be completed in the fourth quarter of 2017. In August 2017, we signed a distribution agreement with a third party who will serve as our exclusive distributor in France.

~~Critical Accounting Policies and Estimates~~

Our discussion and analysis of our financial condition and results of operations are based on our unaudited interim condensed consolidated financial statements and notes (Interim Financial Statements) which have been preparedperiod. Diluted EPS is calculated in accordance with ~~accounting principles generally accepted~~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 U.S. The preparation of these Interim Financial Statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate these estimates and judgments, including those described below. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that arefuture, but were not ~~readily apparent from other sources. Actual results and experiences may differ materially from these estimates. We discuss our critical accounting policies~~included in the ~~Management’s Discussion and Analysis section~~computation of ~~our Annual Report on Form 10-K. There~~diluted EPS because they were either classified as participating or would have been ~~no significant changes in our critical accounting policies.~~anti-dilutive, were approximately 34,856,155 for the three months ended March 31, 2019 and 32,617,660 for the three months ended March 31, 2018.

Table of Contents

Results of Operations - Segment Review

The following selected unaudited financial and operating data are derived from our Interim Financial ~~Statements and should be read in conjunction with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements.~~Statements. The results and discussions that follow ~~are reflective of~~reflect how ~~our~~ executive management monitors the performance of our reporting segments. ~~Our chief operating decision maker is our Chief Executive Officer (CEO). While the CEO is apprised of a variety of financial metrics~~

We have three segments: U.S., International and ~~information, the business is principally managed and organized based upon geographic and regulatory environment.~~Other. Each segment is separately managed and is evaluated primarily upon segment loss from operations. ~~The tables below exclude non-cash~~Non-cash items including stock-based compensation expense, ~~and~~ depreciation and ~~amortization.~~amortization are categorized as Other. 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. There were no significant changes in our expense allocation methodology during 2019 or 2018.

U.S. Segment


	Three Months Ended September 30,						Nine Months Ended September 30,						Three Months Ended March 31,
	2017			2016			2017			2016			2019			2018
	(In thousands)												(In thousands)
NET REVENUE	$	7,143		$	6,184		$	19,643		$	17,511		$	6,766		$	6,805
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION	(720		)	(374		)	(1,671		)	(964		)	(685		)	(713		)
GROSS PROFIT	6,423			5,810			17,972			16,547			6,081			6,092

RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES	1,360			1,984			4,016			5,560			1,427			1,640
GENERAL AND ADMINISTRATIVE EXPENSES	1,879			2,207			5,410			6,254			1,933			2,293
SALES AND MARKETING EXPENSES	4,141			5,410			11,707			15,904			4,041			4,371
OPERATING EXPENSES	7,380			9,601			21,133			27,718			7,401			8,304
SEGMENT LOSS FROM OPERATIONS	$	(957	)	$	(3,791	)	$	(3,161	)	$	(11,171	)	$	(1,320	)	$	(2,212	)

~~Three~~U.S. Segment - three months ended ~~September 30, 2017~~March 31, 2019 compared to the three months ended ~~September 30, 2016~~March 31, 2018

Net ~~Revenue.~~revenue. Net revenue ~~increased by~~was approximately ~~$900,000, or 15%, to approximately $7.1~~$6.8 million for both the three months ended ~~September 30, 2017 compared to approximately $6.2 million for~~March 31, 2019 and 2018. However, end user demand, which represents units purchased by physicians and pharmacies from our distributors, increased 10% in the three months ended ~~September 30, 2016. The increase was primarily attributable~~March 31, 2019, increasing to ~~an increase~~939 units compared to 851 units in ~~end user unit demand.~~the three months ended March 31, 2018.

Cost of goods sold, excluding depreciation and amortization.Cost of goods sold, excluding depreciation and amortization ~~increased~~decreased by approximately ~~$350,000,~~$20,000, or ~~95%~~3%, to approximately ~~$720,000~~$690,000 for the three months ended ~~September 30, 2017~~March 31, 2019 compared to approximately ~~$370,000~~$710,000 for the three months ended ~~September 30, 2016, as a result of increased sales for the three months ended September 30, 2017 and royalty expense payable to pSivida of approximately $140,000.~~March 31, 2018.

Research, development and medical affairs expenses. Research, development and medical affairs expenses decreased by approximately ~~$600,000,~~$200,000, or ~~30%~~13%, to approximately $1.4 million for the three months ended ~~September 30, 2017~~March 31, 2019, compared to approximately ~~$2.0~~$1.6 million for the three months ended ~~September 30, 2016.~~March 31, 2018. The decrease was primarily attributable to decreases ~~of approximately $220,000~~ in costs associated with pharmacovigilance and scientific ~~communication costs, $200,000 in personnel costs and $110,000 of costs related to maintaining the U.S. registration of ILUVIEN.~~communications.

General and administrative expenses. General and administrative expenses decreased by approximately ~~$300,000,~~$400,000, or ~~14%~~17%, to approximately $1.9 million for the three months ended ~~September 30, 2017~~March 31, 2019, compared to approximately ~~$2.2~~$2.3 million for the three months ended ~~September 30, 2016.~~March 31, 2018. The decrease was primarily attributable to decreases in legal fees and personnel costs.

Sales and marketing expenses. Sales and marketing expenses decreased by approximately $400,000, or 9%, to approximately $4.0 million for the three months ended March 31, 2019, compared to approximately $4.4 million for the three months ended March 31, 2018. The decrease was primarily attributable to a decrease of approximately ~~$360,000 for certain professional fees associated with pursuing alternative debt options incurred during 2016,~~$470,000 in personnel costs offset by ~~increases in other various expenses.~~

~~Sales and Marketing expenses~~. Sales and marketing expenses decreased by approximately $1.3 million, or 24%, to approximately $4.1 million for the three months ended September 30, 2017 compared to approximately $5.4 million for the three months ended September 30, 2016. The decrease was primarily attributable to decreasesan increase of approximately ~~$620,000~~$120,000 in marketing ~~costs, $390,000 for personnel costs and $140,000 in market access~~ costs. ~~These reductions were a result of the cost savings program we implemented in late 2016.~~

~~Table of Contents~~

~~Nine months ended September 30, 2017 compared to the nine months ended September 30, 2016~~

~~Net Revenue.~~ Net revenue increased by approximately $2.1 million, or 12%, to approximately $19.6 million for the nine months ended September 30, 2017 compared to approximately $17.5 million for the nine months ended September 30, 2016. The increase was primarily attributable to an increase in end user unit demand.

~~Cost of goods sold, excluding depreciation and amortization.~~ Cost of goods sold, excluding depreciation and amortization increased by approximately $360,000, or 77%, to approximately $1.7 million for the nine months ended September 30, 2017 compared to approximately $960,000 for the nine months ended September 30, 2016, as a result of an increase in net profit amounts owed to pSivida, as defined in the pSivida Agreement from the first quarter of 2017, royalty expense payable to pSivida from the third quarter of 2017 and from increased sales for the nine months ended September 30, 2017.

~~Research, development and medical affairs expenses~~. Research, development and medical affairs expenses decreased by approximately $1.6 million, or 29%, to approximately $4.0 million for the nine months ended September 30, 2017 compared to approximately $5.6 million for the nine months ended September 30, 2016. The decrease was primarily attributable to decreases of approximately $650,000 in personnel costs, $390,000 in scientific communication costs and $320,000 of costs related to maintaining the U.S. registration of ILUVIEN.

~~General and administrative expenses.~~ General and administrative expenses decreased by approximately $900,000, or 14%, to approximately $5.4 million for the nine months ended September 30, 2017 compared to approximately $6.3 million for the nine months ended September 30, 2016. The decrease was primarily attributable to decreases of approximately $360,000 for certain professional fees associated with pursuing alternative debt options incurred during 2016, $290,000 in bonus expense as we granted restricted stock unit awards to our non-field personnel in lieu of a cash bonus program in 2017 and $200,000 in costs associated with the 2016 dispute between us and pSivida that was later settled in 2017.

~~Sales and Marketing expenses~~. Sales and marketing expenses decreased by approximately $4.2 million, or 26%, to approximately $11.7 million for the nine months ended September 30, 2017 compared to approximately $15.9 million for the nine months ended September 30, 2016. The decrease was primarily attributable to decreases of $1.8 million for personnel costs, $1.5 million in marketing costs, $370,000 in market access costs and $320,000 in travel and entertainment costs. These reductions were a result of the cost savings program we implemented in late 2016.

Table of Contents

International Segment


	Three Months Ended September 30,						Nine Months Ended September 30,						Three Months Ended March 31,
	2017			2016			2017			2016			2019			2018
	(In thousands)												(In thousands)
NET REVENUE	$	2,641		$	2,114		$	7,127		$	6,145		$	6,124		$	2,825
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION	(319		)	(112		)	(724		)	(456		)	(915		)	(391		)
GROSS PROFIT	2,322			2,002			6,403			5,689			5,209			2,434

RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES	984			1,083			2,243			3,217			1,170			950
GENERAL AND ADMINISTRATIVE EXPENSES	673			778			2,068			2,656			988			907
SALES AND MARKETING EXPENSES	1,551			1,762			3,930			5,292			1,705			1,278
OPERATING EXPENSES	3,208			3,623			8,241			11,165			3,863			3,135
SEGMENT LOSS FROM OPERATIONS	$	(886	)	$	(1,621	)	$	(1,838	)	$	(5,476	)
SEGMENT INCOME (LOSS) FROM OPERATIONS													$	1,346		$	(701	)

~~Three~~International Segment - three months ended ~~September 30, 2017~~March 31, 2019 compared to the three months ended ~~September 30, 2016~~March 31, 2018

Net ~~Revenue.~~revenue. Net revenue increased by approximately ~~$300,000,~~$3.3 million, or ~~14%~~118%, to approximately ~~$2.6~~$6.1 million for the three months ended ~~September 30, 2017~~March 31, 2019, compared to approximately ~~$2.1~~$2.8 million for the three months ended ~~September 30, 2016.~~March 31, 2018. The increase was primarily attributable to ~~increased sales~~revenue increases of ~~ILUVIEN in Germany as well as the initial shipments of ILUVIEN~~approximately $1.7 million where we sell direct and $1.6 million where we sell to ~~our distribution partner in Italy.~~

~~Cost of goods sold, excluding depreciation and amortization.~~ Cost of goods sold, excluding depreciation and amortization increased by approximately $210,000, or 191%, to approximately $320,000 for the three months ended September 30, 2017 compared to approximately $110,000 for the three months ended September 30, 2016. The increase was attributable to an increase in the number of units sold in our international segment, including to our international distributors and royalty expense payable to pSivida.

~~Research, development and medical affairs expenses~~. Research, development and medical affairs expenses decreased by approximately $120,000, or 11%, to approximately $980,000 for the three months ended September 30, 2017 compared to approximately $1.1 million for the three months ended September 30, 2016. The decrease was primarily attributable to a decrease in our international scientific study costs including the five-year, post-authorization, open label registry study in Europe.

~~General and administrative expenses.~~ General and administrative expenses decreased by approximately $110,000, or 14%, to approximately $670,000 for the three months ended September 30, 2017 compared to approximately $780,000 for the three months ended September 30, 2016. The decrease was primarily attributable to a decrease in personnel and travel and entertainment costs.

~~Sales and Marketing expenses~~. Sales and marketing expenses decreased by approximately $300,000, or 17%, to approximately $1.5 million for the three months ended September 30, 2017 compared to approximately $1.8 million for the three months ended September 30, 2016. The decrease was primarily attributable to decreases of $120,000 in marketing costs as a result of the cost savings program we implemented in late 2016 and $110,000 in market access costs.

~~Nine months ended September 30, 2017 compared to the nine months ended September 30, 2016~~

~~Net Revenue.~~ Net revenue increased by approximately $1.0 million, or 16%, to approximately $7.1 million for the nine months ended September 30, 2017 compared to approximately $6.1 million for the nine months ended September 30, 2016. The increase was primarily attributable to increased sales volume in the countries in which we operate directly in Europe and sales to our international distributors.

Cost of goods sold, excluding depreciation and amortization. Cost of goods sold, excluding depreciation and amortization, increased by approximately ~~$260,000,~~$530,000, or ~~57%~~136%, to approximately ~~$720,000~~$920,000 for the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2019 compared to approximately ~~$460,000~~$390,000 for the ~~nine~~three months ended ~~September 30, 2016.~~March 31, 2018. The increase was primarily attributable to ~~increases~~increased sales in ~~sales volume, in supplier~~both the markets where we sell direct and ~~manufacturing costs and royalty expense payable~~the markets where we sell to ~~pSivida from the third quarter of 2017.~~distributors.

~~Table of Contents~~

Research, development and medical affairs expenses. Research, development and medical affairs expenses ~~decreased~~increased by approximately ~~$1.0 million,~~$250,000, or ~~31%~~26%, to approximately ~~$2.2~~$1.2 million for the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2019, compared to approximately ~~$3.2 million~~$950,000 for the ~~nine~~three months ended ~~September 30, 2016.~~March 31, 2018. The ~~decrease~~increase was primarily attributable to decreases of $850,000 in our international scientific study costs including the five-year, post-authorization, open label registry study in Europe, $110,000 in pharmacovigilance costs and $110,000 of costs related to ~~maintaining~~ our ~~international registrations of ILUVIEN, offset by increases in other various expenses.~~ongoing clinical studies.

General and administrative expenses. General and administrative expenses ~~decreased~~increased by approximately ~~$600,000,~~$80,000, or ~~22%~~9%, to approximately ~~$2.1 million~~$990,000 for the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2019, compared to approximately ~~$2.7 million~~$910,000 for the ~~nine~~three months ended September 30, 2016. The decrease was primarily attributable to decreases of $460,000 in personnel and travel and entertainment costs, and $100,000 in professional fees including legal and tax preparation fees.March 31, 2018.

Sales and ~~Marketing~~marketing expenses. Sales and marketing expenses ~~decreased~~increased by approximately ~~$1.4 million,~~$400,000, or ~~26%~~31%, to approximately ~~$3.9~~$1.7 million for the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2019, compared to approximately ~~$5.3~~$1.3 million for the ~~nine~~three months ended ~~September 30, 2016.~~March 31, 2018. The ~~decrease~~increase was primarily attributable to ~~decreases~~increases of ~~$520,000~~approximately $220,000 in ~~marketing~~personnel costs ~~as a result of the cost savings program we implemented in late 2016, $410,000~~and $160,000 in market access ~~costs in the United Kingdom and Germany and $290,000 in personnel~~ costs.

Table of Contents

Other Segment



	Three Months Ended March 31,
	2019			2018
	(In thousands)
NET REVENUE	$	—		$	—
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION	—			—
GROSS PROFIT	—			—

RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES	130			232
GENERAL AND ADMINISTRATIVE EXPENSES	472			655
SALES AND MARKETING EXPENSES	167			320
DEPRECIATION AND AMORTIZATION	652			649
OPERATING EXPENSES	1,421			1,856
SEGMENT LOSS FROM OPERATIONS	$	(1,421	)	$	(1,856	)

Our chief operating decision maker manages and evaluates our U.S. and International segments based on net loss from operations adjusted for certain non-cash items, such as stock-based compensation expense and depreciation and amortization. Therefore, these non-cash expenses included in ~~Research, Development~~research, development and ~~Medical Affairs Expenses, General~~medical affairs expenses, general and ~~Administrative Expenses,~~administrative expenses, and ~~Sales~~sales and ~~Marketing Expenses~~marketing expenses are classified within the Other segment within our Interim Financial Statements.

Within the respective financial statement line items included in the Other segment, stock-based compensation expense, collectively, ~~increased by~~was approximately ~~$200,000, or 18%, to $1.3~~$770,000 and $1.2 million for three months ended September 30, 2017, compared to $1.1 million for the three months ended September 30, 2016. Stock-based compensation expense, collectively, decreased by approximately $100,000, or 3%, to $3.7 million for nine months ended September 30, 2017, compared to $3.8 million for the nine months ended September 30, 2016.March 31, 2019 and 2018, respectively.

Depreciation and amortization ~~decreased by~~was approximately ~~$20,000, or 3%, to $680,000~~$650,000 for three months ended ~~September 30, 2017, compared to $700,000 for the three months ended September 30, 2016. Depreciation~~March 31, 2019 and ~~amortization decreased by approximately $100,000, or 5%, to $2.0 million for nine months ended September 30, 2017, compared to $2.1 million for the nine months ended September 30, 2016.~~

In July 2017, we acquired the license rights to uveitis from pSivida for Europe, the Middle East and Africa and restructured our collaboration agreement. The restructuring included a conversion of our obligation to share profits from the commercialization of ILUVIEN to a royalty on net revenue. As consideration for the uveitis rights and the profit share conversion, we agreed to reduce its right to utilize pSivida’s share of previous losses associated with the commercialization of ILUVIEN which would have been used to partially offset future profit sharing payments under the prior collaboration agreement. This right of offset was previously fully reserved on our financial statements due to the uncertainty of future realizability. We valued the transaction utilizing a present value analysis at approximately $2.9 million. Because there was no approved indication for ILUVIEN for uveitis at the time, we expensed the $2.9 million as a non-cash charge as in-process Research and Development Expense in the third quarter of 2017. We also recognized a Recovery of Prior Collaboration Losses of $2.9 million for the value of the right of offset as a reduction of operating expenses. As a result, there was no impact on our operating loss or net loss for the three and nine months ended September 30, 2017.2018.

~~Table of Contents~~

~~Consolidated other income and expense~~

The following selected unaudited financial and operating data are derived from our consolidated financial statements and should be read in conjunction with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our Interim Financial Statements.

Three Months Ended
September 30,
Nine Months Ended
September 30,
2017 2016 2017 2016
(In thousands)
NET LOSS FROM OPERATIONS $ (3,825 ) $ (7,243 ) $ (10,714 ) $ (22,482 )

INTEREST EXPENSE, NET AND OTHER (1,431 ) (1,330 ) (4,152 ) (3,842 )
UNREALIZED FOREIGN CURRENCY LOSS, NET (6 ) (51 ) (6 ) (31 )
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY —
(588 ) 188
1,755
LOSS ON EARLY EXTINGUISHMENT OF DEBT —
—
—
(2,564 )
NET LOSS BEFORE TAXES (5,262 ) (9,212 ) (14,684 ) (27,164 )
PROVISION FOR TAXES (23 ) (33 ) (93 ) (84 )
NET LOSS $ (5,285 ) $ (9,245 ) $ (14,777 ) $ (27,248 )

~~Interest expense, net and other.~~

Interest expense, net and other was approximately $1.4 million for the three months ended September 30, 2017 and approximately $1.3 million for the three months ended September 30, 2016. Interest incurred in both periods was related to the 2014 Term Loan and related amendments with Hercules.

Interest expense, net and other was approximately $4.2 million for the nine months ended September 30, 2017 and approximately $3.8 million for the nine months ended September 30, 2016. Interest incurred in both periods was related to the 2014 Term Loan and related amendments with Hercules.

~~Unrealized foreign currency loss, net.~~

We recorded a non-cash unrealized foreign currency losses of approximately $6,000 and $50,000 for the three months ended September 30, 2017 and 2016, respectively. The unrealized foreign currency losses were primarily attributable to the changing values of the Euro and the British pound sterling during the three months ended September 30, 2017 and 2016, respectively.

We recorded a non-cash unrealized foreign currency losses of approximately $6,000 and $30,000 for the nine months ended September 30, 2017 and 2016, respectively. The unrealized foreign currency losses were primarily attributable to the changing values of the Euro and the British pound sterling during the nine months ended September 30, 2017 and 2016, respectively.

~~Change in fair value of derivative warrant liability.~~

There was no gain or loss for a change in fair value of derivative warrant liability for the three months ended September 30, 2016. An increase in the fair value of our derivative warrant liability resulted in a non-cash loss of approximately $590,000 for the three months ended September 30, 2016. For the nine months ended September 30, 2017 and 2016, we recorded gains of approximately $190,000 and $1.8 million, respectively, for the decrease in the fair value of our derivative warrant liability. The change in fair value was primarily attributable to the decreasing time remaining to exercise the warrants.

~~Loss on early extinguishment of debt.~~

We recorded a loss on early extinguishment of debt of approximately $2.6 million for the nine months ended September 30, 2016, as a result of the Second Loan Amendment to our 2014 Term Loan with Hercules.

4139

Table of Contents

Liquidity and Capital Resources

~~To date,~~Since inception, we have incurred recurring losses, negative cash flow from operations and have accumulated a deficit of ~~$391.9~~$379.9 million ~~from~~through March 31, 2019. We have funded our ~~inception~~operations through ~~September 30, 2017.~~the public and private placement of common stock, convertible preferred stock, warrants, the sale of certain assets of the non-prescription business in which we were previously engaged and certain debt facilities.

On January 5, 2018, we entered into the $40.0 million 2018 Loan Agreement with Solar Capital. Under this agreement, we borrowed the entire $40.0 million as a term loan that matures on July 1, 2022. We used the proceeds of the 2018 Loan Agreement to repay the Hercules Loan Agreement and pay related expenses. We used the remaining loan proceeds in 2018 to provide additional working capital for general corporate purposes. (See Note 11 of our notes to Interim Financial Statements.)

As of ~~September 30, 2017,~~March 31, 2019, we had approximately ~~$25.6~~$13.1 million in cash and cash equivalents.

We launched ILUVIEN in Germany and the United Kingdom in the second quarter of 2013, in the U.S. and Portugal in the first quarter of 2015. We began selling ILUVIEN in Austria in the first quarter of 2017 and we expect Due to ~~begin sales of ILUVIEN in Ireland in the fourth quarter of 2017.~~

In October 2016, Limited entered into the Fourth Loan Amendment. Under the Fourth Loan Amendment, Hercules agreed to provide up to an additional $10.0 million to Limited with (i) the first $5.0 million available at Limited’s option through June 30, 2017 subject to (A) the achievement of $12.0 million in trailing three month net product revenue and (B) no event of default having occurred since the Effective Date and (ii) the second $5.0 million available at Limited’s option through December 31, 2017 subject to (A) the achievement of $15.0 million in trailing three month net product revenue, (B) no event of default having occurred since the Effective Date and (C) the prior $5.0 million having been advanced to Limited. We did not achieve the trailing three month net product revenue threshold prior to June 30, 2017 and as a result the additional $10.0 million is not available to Limited.

The Term Loan Agreement requires that we maintain at least $25.0 million in liquid assets, with a minimum of $12.5 million in cash. Additionally, in any month in which we have $35.0 million in liquidity, including cash and eligible accounts receivable, the revenue and adjusted EBITDA covenants requirement will be waived. For September 2017, the Consolidated Group did not meet the six-month revenue covenant required under the Term Loan Agreement. As a result, the Consolidated Group was required to demonstrate it had $35.0 million in liquidity as of the last business day in September 2017. On the last business day in September 2017, the Consolidated Group was not able to demonstrate it had $35.0 million in liquidity. However, the Consolidated Group was able to demonstrate that had $35.0 million in liquidity on the business day immediately before the last business day in September 2017, the first business day in October 2017 and the last business day in October 2017. As a result, Hercules waived the Consolidated Group’s non-compliance with the $35.0 million liquidity requirement for September 2017.

~~As a result of~~ the limited revenue generated by ILUVIEN to date, our negative cash flow from operations and accumulated deficit raise substantial doubt about our ability to continue as a going concern. Our Interim Financial Statements do not include any adjustments that might result from the outcome of this uncertainty. We believe that we may have sufficient funds to allow us to become cash flow positive in the countries in which we sell ILUVIEN. However, during the nine months ended September 30, 2017, we raised approximately $6.0 million of additional equity via the Company’s at-the-market offering facility in order to raise additional capital to fund the continued commercialization of ILUVIEN. If we are unable to raise additional financing, we will need to adjust our commercial plans so that we can continue to operate with our existing cash resources. The actual amount of funds ~~for operations and ensure compliance with its debt covenants. Our sales agreement with Cowen and Company, LLC to sell additional shares expired~~that we will need will depend on ~~August 13, 2017~~many factors, some of which are beyond our control. We may need funds sooner than currently anticipated.

We cannot be sure that ~~alternative or~~ additional financing will be available ~~if and~~ when needed or that, if available, the additional financing ~~will~~would be obtained on terms favorable to us or our stockholders. If we were to raise additional funds by issuing equity securities, substantial dilution to existing stockholders would likely 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 ~~and debt financing,~~ we may not be successful in obtaining collaboration agreements, or in receiving milestone or royalty payments under those ~~agreements, or~~agreements. If we were to attempt to raise additional funds through debt financing, (a) the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to commercialize ILUVIEN or any future products or product candidates or operate our ~~business.~~business; and (b) we would be required to obtain the permission or participation of Solar Capital, 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 financial statements.

For the ~~nine~~three months ended ~~September 30, 2017,~~March 31, 2019, cash ~~used~~provided by our operations was approximately $280,000. The cash provided by our operations was primarily due to our net increase in our working capital. Accounts receivable decreased by $1.8 million and inventory decreased by $530,000. These net cash increases were offset by a net increase of ~~$11.2~~$560,000 in accounts payable, accrued expenses and other current liabilities and an increase of $380,000 in prepaid expenses and other current assets. Further impacting our cash provided by operations was our net loss of $2.8 million, which was offset by $770,000 of non-cash stock-based compensation expense, $650,000 for non-cash depreciation and amortization and $210,000 for non-cash interest expense associated with the amortization of our debt discount.

For the three months ended March 31, 2018, cash used in our operations was $5.0 million. The cash used in our operations was primarily due to our net loss of ~~$14.8~~$7.7 million, offset by ~~non-cash items, including $3.7~~the $1.8 million loss on our early extinguishment of debt, $1.2 million of non-cash stock-based compensation expense, ~~$2.0 million~~$650,000 for non-cash depreciation and amortization and ~~$1.1 million~~$210,000 for non-cash interest expense associated with the amortization of our debt discount. ~~Increasing cash~~Cash used in operations for the three months ended March 31, 2018 was ~~a decrease~~further affected by an increase in ~~other long term liabilities~~accounts receivable of ~~$1.5 million and increases in inventory of $1.3 million, prepaid expenses and other current assets of $550,000~~$870,000 and a net decrease in accounts payable, accrued expenses and other current liabilities of ~~$240,000.~~approximately $920,000. These ~~increases~~amounts were offset by ~~a decrease in accounts receivable~~decreases of ~~$600,000.~~

For the nine months ended September 30, 2016, cash used by our operations of $22.7 million was primarily due to our net loss of $27.2 million, increased by a non-cash gain of $1.8 million for the change in our derivative warrant liability and offset by non-cash items including a $2.6 million loss on early debt extinguishment for the amendment to our Term Loan Agreement, $3.8 million of stock-based compensation expense, $2.1 million for depreciation and amortization and $800,000 for non-cash interest expense associated with our debt discount. Cash used in operations was also decreased by a decrease in inventory of approximately $600,000 and an increase in accounts payable, accrued expenses and other current liabilities and

~~Table of Contents~~

~~other non-current liabilities of approximately $510,000. Cash used by operations were offset by increases in accounts receivable of approximately $3.6 million and~~$310,000 in prepaid and other current assets and $300,000 of ~~approximately $510,000.~~inventory.

For the ~~nine~~three months ended ~~September 30, 2017,~~March 31, 2019, net cash used in our investing activities was approximately ~~$230,000, which was due to the purchase of property and equipment, primarily for the purchase of manufacturing equipment and software.~~$15,000.

For the ~~nine~~three months ended ~~September 30, 2016,~~March 31, 2018, net cash used in our investing activities was approximately ~~$120,000, which was due to the purchase of property and equipment, primarily the purchase of accounts payable software and leasehold improvements.~~$90,000.

For the ~~nine~~three months ended ~~September 30, 2017,~~March 31, 2019, net cash provided by our financing activities was approximately ~~$5.7 million. During the second and third quarters~~$110,000, which is due to payments of 2017, we sold a total of 4,203,015 shares of our common stock at a weighted average purchase price of $1.45 per share resulting in gross proceeds of approximately $6.0 million, prior to the payment of approximately $180,000 of sales agent discounts and commissions and related issuance costs.finance lease obligations.

For the ~~nine~~three months ended ~~September 30, 2016,~~March 31, 2018, net cash provided by our financing activities was approximately $25.6 million. In August 2016, we closed an underwritten public offering pursuant to which we sold and issued 18,900,000 shares of our common stock at a price to the public of $1.40 per share, resulting in gross proceeds of approximately $26.5 million. Offsetting this increase were payments of approximately $1.2 million, ~~in payments of~~which is primarily due to entering into the ~~issuance costs of common stock, $720,000 associated~~$40.0 million 2018 Loan Agreement with Solar Capital, offset by paying off the ~~amendments of our Term~~$35.0 million Hercules Loan Agreement and ~~$180,000 in payments on capital leases.~~payment of related debt costs of $3.7 million.

Contractual Obligations and Commitments

There have been no other material changes to our contractual obligations and commitments outside the ordinary course of business from those disclosed in our Annual Report on Form 10-K for the year ended December 31, ~~2016,~~2018, filed with the SEC on ~~March 3, 2017.~~February 25, 2019.

Table of Contents

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 ~~for the purpose of facilitating~~to facilitate off-balance sheet arrangements (as that term is defined in Item 303(a)(4)(ii) of 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.

~~Adoption~~Impact of ~~New~~Recent Accounting ~~Standards~~Pronouncements

~~In August 2014,~~See Note 3 of our notes to Interim Financial Statements for a description of recent accounting pronouncements, including the ~~Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2014-15,~~ ~~Disclosure~~expected dates of ~~Uncertainties about an Entity’s Ability to Continue as a Going Concern. ASU 2014-15 requires management to perform interim~~adoption and ~~annual assessments~~expected effects on results of ~~an entity’s ability to continue as a going concern within one year of the date the~~operations and financial statements are issued and provides guidance on determining when and how to disclose going concern uncertainties in the financial statements. ASU 2014-15 applies to all entities and is effective for annual and interim reporting periods ending after December 15, 2016, with early adoption permitted. The adoption of this guidance did not have a material impact on our financial statements.

~~In July 2015, the FASB issued ASU 2015-11,~~ ~~Inventory (Topic 330): Simplifying the Measurement of Inventory~~. This update requires entities to measure inventory at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method. This ASU is effective for annual reporting periods beginning after December 15, 2016 and interim periods within those years. The adoption of this guidance did not have a material impact on our financial statements.

~~Table of Contents~~

~~Accounting Standards Issued but Not Yet Effective~~

~~In May 2014, the FASB issued ASU 2014-09,~~ ~~Revenue from Contracts with Customers (Topic 606)~~. ASU 2014-09 provides a single, comprehensive revenue recognition model for all contracts with customers. The revenue guidance contains principles that an entity will apply to determine the measurement of revenue and timing of when it is recognized. The underlying principle is that an entity will recognize revenue to depict the transfer of goods or services to customers at an amount that the entity expects to be entitled to in exchange for those goods or services. The standard will be effective for the first interim period within annual reporting periods beginning after December 15, 2017 for public entities, with early adoption permitted in the annual reporting period beginning after December 15, 2016. We are currently analyzing the effect of the standard to evaluate the impact of the new standard on our revenue recognition for customer contracts. This includes reviewing current accounting policies and practices to identify potential differences that would result from applying the requirements under the new standard. We currently recognize revenue upon shipment of products. The assessment at this stage is that we do not expect the adoption of the new revenue recognition standard to have a material impact on our financial statements. We have completed a preliminary review of our contracts with our customers and identified the variable consideration provisions of the new guidance as potentially having the most impact on our method of recognizing revenue. We will adopt the standard in the first quarter of 2018 using the modified retrospective method by recognizing the cumulative effect of initially applying the new standard as an adjustment to the opening balance of retained earnings.

~~In February 2016, the FASB issued ASU 2016-02,~~ ~~Leases (Topic 842)~~. This standard requires all leases with durations greater than twelve months to be recognized on the balance sheet and is effective for interim and annual reporting periods beginning after December 15, 2018, although early adoption is permitted. We are currently in the process of evaluating the impact of the adoption on our financial statements.

~~In August 2016, the FASB issued ASU 2016-15,~~ ~~Classification of Certain Cash Receipts and Cash Payments (Topic 230)~~. ASU 2016-15 is intended to add or clarify guidance on the classification of certain cash receipts and payments in the statement of cash flows and to eliminate the diversity in practice related to such classifications. The standard is effective for annual reporting periods beginning after December 15, 2017, with early adoption permitted. We have evaluated the adoption on our financial statements and other than certain reclassifications within our cash flow statements, we do not expect the impact of the adoption to have a material effect on our financial statements.

~~In November 2016, the FASB issued ASU 2016-18,~~ ~~Statement of Cash Flows (Topic 230) - Restricted Cash~~. ASU 2016-18 requires a statement of cash flows to explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The standard is effective for interim and annual reporting periods beginning after December 15, 2017, with early adoption permitted. We do not expect the impact of the adoption to have a material effect on our financial statements.

4441

Table of Contents

ITEM 3. Quantitative and Qualitative Disclosures About Market Risk

~~Liquidity~~Not required for smaller reporting companies.

~~See the “Liquidity and Capital Resources” section of this Quarterly Report on Form 10-Q for additional discussion of liquidity and related risks.~~

~~Interest Rate Risk~~

Our earnings and cash flows are subject to fluctuations due to changes in interest rates, principally in connection with our loan agreement with Hercules. We do not believe we are materially exposed to changes in interest rates. We do not currently use interest rate derivative instruments to manage exposure to interest rate changes. We estimate that a 100 basis point, or 1%, unfavorable change in interest rates would have resulted in approximately a $89,000 and $265,000 increase in interest expense for the three and nine months ended September 30, 2017, respectively.

~~Credit Quality Risk~~

We are subject to credit risk in connection with accounts receivable from our product sales of ILUVIEN. We have contractual payment terms with each of our customers and we monitor our customers’ financial performance and credit worthiness so that we can properly assess and respond to any changes in their credit profile. During the three and nine months ended September 30, 2017 and 2016, we did not recognize any charges for write-offs of accounts receivable. As of September 30, 2017 and December 31, 2016, three U.S.-based distributors accounted for 83% and 90%, respectively, of our accounts receivable balances.

~~Foreign Exchange Risk~~

As discussed further above, we market ILUVIEN outside the U.S. Therefore, significant changes in foreign exchange rates of the countries outside the U.S. where our product is sold can impact our operating results and financial condition. As sales outside the U.S. continue to grow and as we expand our international operations, we will continue to assess potential steps, including foreign currency hedging and other strategies, to mitigate our foreign exchange risk.

4542

Table of Contents

ITEM 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

~~Our management,~~Under the supervision and with the participation of our management, including the Chief Executive Officer and ~~our~~the Chief Financial Officer, we evaluated the effectiveness of ~~our disclosure controls~~the design and ~~procedures as~~operation of ~~September 30, 2017. The term~~our “disclosure controls and ~~procedures,” as~~procedures” (as defined in ~~Rules~~Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange ~~Act is recorded, processed, summarized and reported, within~~Act) as of the ~~time periods specified in~~end of the ~~SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed~~period covered by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.this report. Based on ~~the~~that evaluation, ~~of our disclosure controls and procedures as of September 30, 2017, our~~the Chief Executive Officer and the Chief Financial Officer concluded that ~~as of such date,~~ our disclosure controls and procedures were effective ~~at the reasonable assurance level.~~as of March 31, 2019.

Changes in Internal Control over Financial Reporting

We have implemented new internal controls to ensure we adequately evaluated our contracts and properly assessed the impact of the new accounting standard related to leases on our financial statements as a result of its adoption on January 1, 2019. There ~~has~~have been no ~~change~~other changes in our internal control over financial reporting during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the three months ended ~~September 30, 2017~~March 31, 2019 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.

4643

Table of Contents

PART II. OTHER INFORMATION

ITEM 1. Legal Proceedings

On December 22, 2016, Cantor Fitzgerald & Co. (Cantor Fitzgerald) filed a complaint in the Supreme Court of the State of New York, County of New York against us. This complaint mirrored a complaint that Cantor Fitzgerald filed against us in November 2016 in the United States District Court for the Southern District of New York and then voluntarily dismissed.

In the operative complaint, Cantor Fitzgerald alleges breach of a letter agreement pursuant to which we had engaged Cantor Fitzgerald to assist us in obtaining bank or loan financing. Cantor Fitzgerald alleges that our agreement in October 2016 with Hercules Capital, Inc. (Hercules) to restructure and amend our existing $35.0 million debt facility with Hercules and to secure an additional $10.0 million in debt financing requires the payment to Cantor Fitzgerald of an advisory fee of 2% of $45 million, or $900,000, plus expenses of $24,890. Cantor Fitzgerald seeks compensatory and punitive damages, pre- and post-judgment interest, plus attorneys’ fees and costs.

On January 12, 2017, we filed a counterclaim against Cantor Fitzgerald for breach of contract. We allege in the counterclaim, among other things, that Cantor Fitzgerald failed to meet its obligations to provide services to us as required under the letter agreement. We seek compensatory and other damages, arising from, among other things, our additional out-of-pocket costs incurred as a result of Cantor Fitzgerald’s breach.

Both parties have answered each other’s complaint and counterclaims and denied liability. This lawsuit is currently in discovery. No trial date has been set and we do not expect a trial date to be set until the second quarter of 2018 at the earliest. We are not ~~able~~a party to ~~predict the outcome.~~any material pending legal proceedings, and management is not aware of any contemplated proceedings by any governmental authority against us.

Table of Contents

ITEM 1A. Risk Factors

In our Annual Report on Form 10-K for the fiscal year ended December 31, ~~2016,~~2018, filed with the SEC on ~~March 3, 2017,~~February 25, 2019, we identify under Item 1A of Part I important factors which 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. There have been no material changes in our risk factors subsequent to the filing of our Annual Report on Form 10-K for the fiscal year ended December 31, ~~2016.~~2018. 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.

4745

Table of Contents

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

None.

4846

Table of Contents

ITEM 6. Exhibits



Exhibit Number		Description

3.1		Restated Certificate of Incorporation of Registrant, as amended on various dates (filed as Exhibit ~~3.2 to Amendment No. 4~~3.1 to the ~~Registrant’s Registration Statement~~Registrant's Quarterly Report on Form ~~S-1 (SEC File No. 333-162782),~~10-Q, as filed on ~~April 6, 2010~~November 9, 2018, and incorporated herein by reference).

3.2		Amended and Restated Bylaws of the Registrant, as amended (filed as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, as filed on November 5, 2015 and incorporated herein by reference).

~~3.3~~10.57*		~~Certificate~~ Amended and Restated Succession and Consulting Agreement, dated as of ~~Designation of Series A Convertible Preferred Stock (filed as Exhibit 3.5 to the Registrant’s Current Report on Form 8-K, as filed on October 2, 2012~~March 27, 2019, by and ~~incorporated herein by reference).~~between Alimera Sciences, Inc. and Kenneth Green, Ph.D.

~~3.4~~31.1*		Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (filed as Exhibit 3.6 to the Registrant’s Current Report on Form 8-K, as filed on December 15, 2014 and incorporated herein by reference).

~~3.5~~		Certificate of Amendment to the Restated Certificate of Incorporation of the Registrant (filed as Exhibit 3.5 to the Registrant’s Annual Report on Form 10-K, as filed on March 3, 2017 and incorporated herein by reference).

~~10.50~~		Second Amended and Restated Collaboration Agreement by and between pSivida US Inc. and Alimera Sciences, Inc. dated July 10, 2017 (filed as Exhibit 10.23 to pSivida Corp.’s Annual Report on Form 10-K for the year ended June 30, 2017 (SEC File No. 000-51122) and incorporated herein by reference).

~~31.1~~		Certification of the Principal Executive Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002.

~~31.2~~ 31.2*		Certification of the Principal Financial Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002.

~~32.1~~ 32.1*		Certification of the Chief Executive Officer and Chief Financial Officer, as required by Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS+		XBRL Instance Document.

101.SCH+		XBRL Taxonomy Extension Schema Document.

101.CAL+		XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF+		XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB+		XBRL Taxonomy Extension Label Link Document.

101.PRE+		XBRL Taxonomy Extension Presentation Linkbase Document.

*	Filed herewith.

+	Users of this data are advised pursuant to Rule 406T of Regulation S-T that this interactive data file is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended and otherwise is not subject to liability under these sections.

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.

Table of Contents

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.



	ALIMERA SCIENCES, INC.

~~November 3, 2017~~	~~By:~~	~~/s/ C. Daniel Myers~~
		~~C. Daniel Myers~~
		~~Chief Executive Officer~~
		~~(Principal Executive Officer)~~


~~November 3, 2017~~May 7, 2019	By:	/s/ Richard S. Eiswirth, Jr.
		Richard S. Eiswirth, Jr.
		President and Chief Executive Officer
		(Principal Executive Officer)


May 7, 2019	By:	/s/ J. Philip Jones
		J. Philip Jones
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

5048



	December 31, 2016
	Level 1		Level 2		Level 3		Total
	(In thousands)
Assets:
Cash equivalents (1)	$	—	$	—	$	—	$	—
Assets measured at fair value	$	—	$	—	$	—	$	—

Liabilities:
Derivative warrant liability (2)	$	—	$	188	$	—	$	188
Liabilities measured at fair value	$	—	$	188	$	—	$	188



	Nine Months Ended September 30, 2017												Nine Months Ended September 30, 2016
	U.S.			International			Other			Consolidated			U.S.			International			Other			Consolidated
	(In thousands)
NET REVENUE	$	19,643		$	7,127		$	—		$	26,770		$	17,511		$	6,145		$	—		$	23,656
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION	(1,671		)	(724		)	—			(2,395		)	(964		)	(456		)	—			(1,420		)
GROSS PROFIT	17,972			6,403			—			24,375			16,547			5,689			—			22,236

RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES	4,016			2,243			3,509			9,768			5,560			3,217			709			9,486
GENERAL AND ADMINISTRATIVE EXPENSES	5,410			2,068			2,118			9,596			6,254			2,656			2,169			11,079
SALES AND MARKETING EXPENSES	11,707			3,930			927			16,564			15,904			5,292			875			22,071
DEPRECIATION AND AMORTIZATION	—			—			2,012			2,012			—			—			2,082			2,082
RECOVERABLE COLLABORATION COSTS	—			—			(2,851		)	(2,851		)	—			—			—			—
OPERATING EXPENSES	21,133			8,241			5,715			35,089			27,718			11,165			5,835			44,718
SEGMENT LOSS FROM OPERATIONS	(3,161		)	(1,838		)	(5,715		)	(10,714		)	(11,171		)	(5,476		)	(5,835		)	(22,482		)
OTHER INCOME AND EXPENSES, NET	—			—			(3,970		)	(3,970		)	—			—			(4,682		)	(4,682		)
NET LOSS BEFORE TAXES										$	(14,684	)										$	(27,164	)