EX-99.1 2 pr.htm EXHIBIT 99.1 Exhibit


Exhibit 99.1
primage1a06.jpg
Alimera Sciences Reports Fourth Quarter and Full Year 2017 Financial Results
GAAP Net Loss cut by 34% from $33.2 in 2016 to $22.0 million in 2017
Adjusted EBITDA loss reduced by 61% from $22.8 million in 2016 to $8.8 million 2017
Filed for Type II variation for uveitis in Europe for ILUVIEN in Q4 of 2017
Refinanced previous debt facility with new debt facility from Solar Capital in January 2018
ATLANTA, February 28, 2018 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (Alimera), a global pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced financial results for the three months and full-year ended December 31, 2017. Alimera will host a conference call on March 1, 2018 at 9:00 a.m. ET to discuss these results.
“In 2017, pursuant to our plans, we significantly reduced both our GAAP net loss and our Adjusted EBITDA net loss by 34% and 61%, respectively. Physician demand in the U.S. for ILUVIEN has continued to grow throughout the fourth quarter and into 2018, and we have expanded our sales presence to leverage this opportunity moving forward,” said Dan Myers, Alimera’s Chief Executive Officer. “Our end user demand in the fourth quarter of 2017 was higher than in the fourth quarter of 2016, and end user demand in the first two months of 2018 is significantly higher than in the same two months in 2017. We believe that end user demand for ILUVIEN will continue to increase as our sales force utilizes our USER data and other real-world results to emphasize ILUVIEN’s unique benefit of continuous microdosing to treat diabetic macular edema consistently every day. We are also pleased that our submission of a Type II variation for ILUVIEN in 17 European countries has been accepted for regulatory review.”
Fourth Quarter and Full Year 2017 Financial Results
Net revenue for Q4 2017. Net revenue was adversely impacted by the timing of orders from Alimera’s two large U.S. distributors, which increased inventory levels in the fourth quarter of 2016 and decreased inventory levels in the fourth quarter of 2017. As a result, net revenue decreased by approximately $1.6 million, or 15%, to approximately $9.1 million for the three months ended December 31, 2017, compared to net revenue of approximately $10.7 million for the three months ended December 31, 2016. Net revenue decreased despite an 8% increase in U.S. end user demand, which refers to ILUVIEN purchases by physician offices, pharmacies and hospitals from our distributors.
Net revenue for FY 2017. Net revenue increased by approximately $1.6 million, or 5%, to approximately $35.9 million for the year ended December 31, 2017, compared to net revenue of approximately $34.3 million for the year ended December 31, 2016. U.S. net revenue increased approximately $300,000, or 1%, to approximately $26.1 million for the year ended December 31, 2017, compared to U.S. net revenue of approximately $25.8 million for the year ended December 31, 2016. Our annual U.S. net revenue was also adversely impacted by the timing of orders from our two large U.S. distributors, who increased inventory levels in 2016 and decreased inventory levels in 2017, as noted above, despite a 12% increase in end user demand. International net revenue increased by approximately $1.2 million, or 14%, to approximately $9.8 million for the year ended December 31, 2017, compared to approximately $8.6 million for the year ended December 31, 2016. The increase was primarily due to increases in the value of the British pound sterling and the Euro, compared to the U.S. dollar, and increased sales to our international distributors.





Research, development and medical affairs expenses. Research, development and medical affairs expenses for the three months ended December 31, 2017 increased by approximately $200,000, or 7%, to approximately $3.1 million, compared to $2.9 million for the three months ended December 31, 2016. Research, development and medical affairs expenses for the year ended December 31, 2017 increased by approximately $400,000, or 3%, to approximately $12.8 million, compared to $12.4 million for the year ended December 31, 2016. The increase for the full year comparison was primarily due to an approximate $2.9 million non-cash charge for the additional license rights to uveitis that Alimera acquired from pSivida in July of 2017, offset by the cost savings programs Alimera implemented in late 2016, a decrease in costs associated with the capping of the enrollment by Alimera in its post-market study of ILUVIEN in Europe and a one-time reduction in regulatory costs associated with maintaining the registration of ILUVIEN.
General and administrative expenses. General and administrative expenses for the three months ended December 31, 2017 decreased by approximately $800,000, or 19%, to $3.4 million, compared to $4.2 million for the three months ended December 31, 2016. General and administrative expenses for the year ended December 31, 2017 decreased $2.3 million, or 15%, to approximately $13.0 million, compared to $15.3 million for the year ended December 31, 2016. These decreases were primarily attributable to higher costs in 2016 associated with the shutdown of Alimera’s French operation and Alimera’s search for alternate debt financing.
Sales and marketing expenses. Sales and marketing expenses decreased $800,000, or 11%, to $6.6 million for the three months ended December 31, 2017, compared to $7.4 million reported for the three months ended December 31, 2016. Sales and marketing expenses decreased $6.2 million, or 21%, to $23.2 million for the year ended December 31, 2017, compared to $29.4 million reported for the year ended December 31, 2016. The decreases were primarily attributable to cost savings programs Alimera implemented in late 2016 and carried out in 2017.
Operating Expenses. Operating expenses were approximately $13.8 million for the three months ended December 31, 2017, compared to approximately $15.1 million for the three months ended December 31, 2016, a decrease of 9%. “Adjusted Operating Expenses,” a non-GAAP financial measure defined below, were approximately $11.9 million for the three months ended December 31, 2017, compared to Adjusted Operating Expenses of approximately $13.3 million for the three months ended December 31, 2016, a decrease of 11%. Operating expenses were approximately $48.9 million for the year ended December 31, 2017, compared to approximately $59.8 million for the year ended December 31, 2016, a decrease of 18%. Adjusted Operating Expenses were approximately $41.3 million for the year ended December 31, 2017, compared to Adjusted Operating Expenses of approximately $52.2 million for the year ended December 31, 2016, a decrease of 21%.
Net loss for Q4 2017. Net loss for the three months ended December 31, 2017 was approximately $7.2 million, compared to a net loss of approximately $5.9 million for the three months ended December 31, 2016. Basic and diluted net loss per share for the fourth quarter of 2017 was $(0.10) per share on 69,133,011 weighted average shares outstanding, compared with basic and diluted net loss per share of $(0.09) per share on 64,840,394 weighted average shares outstanding during the fourth quarter of 2016.
Net loss for FY 2017. Net loss for the year ended December 31, 2017 was approximately $22.0 million, compared to a net loss of approximately $33.2 million reported for the year ended December 31, 2016. Basic and diluted net loss per share for the year ended 2017 was $(0.33) per share on 66,993,649 weighted average shares outstanding, compared with basic and diluted net loss per share of $(0.63) per share on 52,801,603 weighted average shares outstanding during the year ended December 31, 2016.
Adjusted EBITDA. “Adjusted EBITDA,” a non-GAAP financial measure defined below, was approximately a $3.8 million loss for the three months ended December 31, 2017, compared to





Adjusted EBITDA of approximately a $3.5 million loss for the three months ended December 31, 2016. Adjusted EBITDA was approximately an $8.8 million loss for the year ended December 31, 2017, compared to Adjusted EBITDA of approximately a $22.8 million loss for the year ended December 31, 2016, a beneficial change of 61%.
Definitions of Non-GAAP Financial Measures. For purposes of this press release, “Adjusted Operating Expenses” is operating expenses minus depreciation, amortization and stock-based compensation expenses. “Adjusted EBITDA” is earnings before interest, taxes, depreciation, amortization, stock-based compensation expenses, net unrealized gains and losses from foreign currency exchange transactions and gains and losses from the change in the fair value of derivative warrant liability. Alimera provides non-GAAP financial information because it believes that this information can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the sections of this press release entitled “Non-GAAP Financial Measures” and “Reconciliation of GAAP Measures to Non-GAAP Adjusted Measures,” which includes Adjusted Operating Expenses and Adjusted EBITDA.
Cash and cash equivalents. As of December 31, 2017, Alimera had cash and cash equivalents of approximately $24.1 million.
Solar Loan Agreement.
As previously disclosed, in early January 2018 Alimera entered into a $40 million term loan agreement with Solar Capital Ltd. (2018 Loan Agreement). Alimera used the proceeds to pay off its then existing $35 million term loan, along with related fees and expenses, and to provide additional working capital for general corporate purposes. Unlike the previous loan facility, the 2018 Loan Agreement removed a stringent liquidity requirement, which Alimera believes will allow it to focus on initiatives and opportunities that will grow the business successfully.
Conference Call to be Held March 1, 2018
An accompanying conference call will be hosted by Dan Myers, Chief Executive Officer, and Rick Eiswirth, President and Chief Financial Officer, to discuss the results. The call will be held at 9:00 a.m. ET, on March 1, 2018. Please refer to the information below for conference call dial-in information and webcast registration.
Conference date: March 1, 2018, 9:00 AM ET
Conference dial-in: 877-269-7756
International dial-in: 201-689-7817
Conference Call Name: Alimera Sciences Fourth Quarter and Full Year Ended 2017 Results Call
Webcast Registration: Click Here
Following the live call, a replay will be available on Alimera’s website, www.alimerasciences.com, under “Investor Relations.”
About Alimera Sciences
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals. Alimera’s focus is on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and will affect millions of people in aging populations. Alimera’s commitment to retina specialists and their patients is manifest in its product and in its development portfolio designed to treat early- and late-stage diseases. For more information, please visit www.alimerasciences.com.
Non-GAAP Financial Measures





This press release contains a discussion of non-GAAP financial measures, as defined in Regulation G promulgated under the Securities Exchange Act of 1934, as amended. Alimera reports its financial results in compliance with GAAP but believes that the non-GAAP measures of Adjusted Operating Expenses and Adjusted EBITDA are useful measures in evaluating Alimera’s operating performance. Alimera uses Adjusted Operating Expenses and Adjusted EBITDA in the management of its business. Accordingly, Adjusted Operating Expenses and Adjusted EBITDA for the fourth quarter of 2017 and the year ended December 31, 2017 have been presented in certain instances excluding items identified in the reconciliations provided. For a reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures, see the tables below.
These non-GAAP financial measures, as presented, may not be comparable to similarly titled measures reported by other companies because not all companies may calculate these measures in an identical manner. Therefore, they are not necessarily an accurate measure of comparison between companies.
The presentation of these non-GAAP financial measures is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of these non-GAAP financial measures is that they exclude significant elements that are required by GAAP to be recorded in Alimera’s financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management in determining these non-GAAP financial measures. To compensate for these limitations, Alimera presents its non-GAAP financial results in connection with its GAAP results. Investors are encouraged to review the reconciliation of each of our non-GAAP financial measures to its most directly comparable GAAP financial measure.
Forward Looking Statements
This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, the possible increase of end user demand based on the benefits of ILUVIEN and the possible outcome, and its effects, of Alimera’s submission of the Type II variation for ILUVIEN in 17 European countries, including the ability of physicians to treat recurrent and persistent non-infectious uveitis affecting the posterior segment in Europe.
Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, (a) whether the use by Alimera’s sales force of USER data and other real-world results to emphasize ILUVIEN’s unique benefit will in fact increase end user demand and (b) continued market acceptance of ILUVIEN in the U.S. and Europe, as well as (c) other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2016 and Alimera’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at http://www.sec.gov. Additional factors may also be set forth in those sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2017, to be filed with the SEC in the near future.
In addition to the risks described above and in Alimera’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors could affect Alimera’s results. There can be no assurance that the actual results or developments anticipated by Alimera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Alimera. Therefore, no





assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.













ALIMERA SCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2017 AND 2016
(in thousands)
 
December 31,
 
2017
 
2016
 
(unaudited)
 
 
CURRENT ASSETS:
 
 
 
Cash and cash equivalents
$
24,067

 
$
30,979

Restricted cash
34
 
 
31
 
Accounts receivable, net
11,435
 
 
13,839
 
Prepaid expenses and other current assets
2,278
 
 
2,107
 
Inventory
1,508
 
 
446
 
Total current assets
39,322
 
 
47,402
 
NON-CURRENT ASSETS:
 
 
 
 
 
Property and equipment, net
1,410
 
 
1,787
 
Intangible asset, net
18,664
 
 
20,604
 
Deferred tax asset
528
 
 
436
 
TOTAL ASSETS
$
59,924

 
$
70,229

CURRENT LIABILITIES:
 
 
 
Accounts payable
$
5,905

 
$
4,986

Accrued expenses
3,582
 
 
3,758
 
Derivative warrant liability
 
 
188
 
Capital lease obligations
184
 
 
191
 
Total current liabilities
9,671
 
 
9,123
 
NON-CURRENT LIABILITIES:
 
 
 
Note payable
34,635
 
 
33,084
 
Capital lease obligations — less current portion
203
 
 
274
 
Other non-current liabilities
766
 
 
2,162
 
COMMITMENTS AND CONTINGENCIES
 
 
 
 
 
STOCKHOLDERS’ EQUITY:
 
 
 
 
 
Preferred stock:
 
 
 
 
 
Series A Convertible Preferred Stock
19,227
 
 
19,227
 
Series B Convertible Preferred Stock
49,568
 
 
49,568
 
Common stock
691
 
 
649
 
Additional paid-in capital
341,622
 
 
330,781
 
Common stock warrants
3,707
 
 
3,707
 
Accumulated deficit
(399,075
)
 
(377,074
)
Accumulated other comprehensive loss
(821
)
 
(1,272
)
TOTAL STOCKHOLDERS’ EQUITY
14,919
 
 
25,586
 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
59,924

 
$
70,229















ALIMERA SCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2017 AND 2016
(in thousands, except share and per share data)

 
Three Months Ended
December 31,
 
Years Ended
December 31,
 
2017
 
2016
 
2017
 
2016
 
(unaudited)
 
(unaudited)
 
(unaudited)
 
 
 
 
 
 
 
 
 
 
NET REVENUE
$
9,142

 
$
10,677

 
$
35,912

 
$
34,333

COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
(1,043
)
 
(924
)
 
(3,438
)
 
(2,344
)
GROSS PROFIT
8,099
 
 
9,753
 
 
32,474
 
 
31,989
 
 
 
 
 
 
 
 
 
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
3,076
 
 
2,889
 
 
12,844
 
 
12,375
 
GENERAL AND ADMINISTRATIVE EXPENSES
3,443
 
 
4,184
 
 
13,039
 
 
15,263
 
SALES AND MARKETING EXPENSES
6,646
 
 
7,360
 
 
23,210
 
 
29,431
 
DEPRECIATION AND AMORTIZATION
672
 
 
685
 
 
2,684
 
 
2,767
 
RECOVERABLE COLLABORATION COSTS
 
 
 
 
(2,851
)
 
 
OPERATING EXPENSES
13,837
 
 
15,118
 
 
48,926
 
 
59,836
 
NET LOSS FROM OPERATIONS
(5,738
)
 
(5,365
)
 
(16,452
)
 
(27,847
)
 
 
 
 
 
 
 
 
INTEREST EXPENSE AND OTHER
(1,427
)
 
(1,336
)
 
(5,579
)
 
(5,178
)
UNREALIZED FOREIGN CURRENCY GAIN (LOSS), NET
11
 
 
(9
)
 
5
 
 
(40
)
LOSS ON EARLY EXTINGUISHMENT OF DEBT
 
 
 
 
 
 
(2,564
)
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY
 
 
872
 
 
188
 
 
2,627
 
NET LOSS BEFORE TAXES
(7,154
)
 
(5,838
)
 
(21,838
)
 
(33,002
)
PROVISION FOR TAXES
(70
)
 
(88
)
 
(163
)
 
(172
)
NET LOSS
$
(7,224
)
 
$
(5,926
)
 
$
(22,001
)
 
$
(33,174
)
NET LOSS PER SHARE — Basic and diluted
$
(0.10
)
 
$
(0.09
)
 
$
(0.33
)
 
$
(0.63
)
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted
69,133,011
 
 
64,840,394
 
 
66,993,649
 
 
52,801,603
 










RECONCILIATION OF GAAP MEASURES TO NON-GAAP ADJUSTED MEASURES
GAAP NET LOSS TO NON-GAAP ADJUSTED EBITDA
 
 
 
 
 
 
 
 
 
 
Three Months Ended
December 31,
 
Years Ended
December 31,
 
2017
 
2016
 
2017
 
2016
 
(in thousands, unaudited)
GAAP NET LOSS
$
(7,224
)
 
$
(5,926
)
 
$
(22,001
)
 
$
(33,174
)
Adjustments to net loss:
 
 
 
 
 
 
 
Interest Expense, Net and Other
1,427
 
 
1,336
 
 
5,579
 
 
5,178
 
Depreciation and Amortization
672
 
 
685
 
 
2,684
 
 
2,767
 
Provision for Taxes
70
 
 
88
 
 
163
 
 
172
 
Stock-Based Compensation
1,279
 
 
1,137
 
 
4,981
 
 
4,889
 
Unrealized Foreign Currency Exchange (Gains) Losses
(11
)
 
9
 
 
(5
)
 
40
 
Change in the Fair Value of Derivative Warrant Liability
 
 
(872
)
 
(188
)
 
(2,627
)
NON-GAAP ADJUSTED EBITDA
$
(3,787
)
 
$
(3,543
)
 
$
(8,787
)
 
$
(22,755
)

GAAP OPERATING EXPENSES TO NON-GAAP ADJUSTED OPERATING EXPENSES
 
 
 
 
 
 
 
 
 
Three Months Ended
December 31,
 
Years Ended
December 31,
 
2017
 
2016
 
2017
 
2016
 
(in thousands, unaudited)
GAAP OPERATING EXPENSES
$
13,837

 
$
15,118

 
$
48,926

 
$
59,836

Adjustments to Operating Expenses:
 
 
 
 
 
 
 
 
Depreciation and Amortization
(672
)
 
(685
)
 
(2,684
)
 
(2,767
)
Stock-Based Compensation
(1,279
)
 
(1,137
)
 
(4,981
)
 
(4,889
)
NON-GAAP ADJUSTED OPERATING EXPENSES
$
11,886

 
$
13,296

 
$
41,261

 
$
52,180












ALIMERA SCIENCES, INC.
CONSOLIDATING STATEMENTS OF OPERATIONS
FOR THE TWELVE MONTHS ENDED DECEMBER 31, 2017 AND 2016
(in thousands)

 
Year Ended
December 31, 2017
 
U.S.
 
International
 
Other
 
Consolidated
 
(unaudited)
NET REVENUE
$
26,146

 
$
9,766

 
$

 
$
35,912

COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
(2,482
)
 
(956
)
 
 
 
(3,438
)
GROSS PROFIT
23,664
 
 
8,810
 
 
 
 
32,474
 
 
 
 
 
 
 
 
 
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
5,780
 
 
3,314
 
 
3,750
 
 
12,844
 
GENERAL AND ADMINISTRATIVE EXPENSES
7,580
 
 
2,605
 
 
2,854
 
 
13,039
 
SALES AND MARKETING EXPENSES
16,588
 
 
5,394
 
 
1,228
 
 
23,210
 
DEPRECIATION AND AMORTIZATION
 
 
 
 
2,684
 
 
2,684
 
RECOVERABLE COLLABORATION COSTS
 
 
 
 
(2,851
)
 
(2,851
)
OPERATING EXPENSES
29,948
 
 
11,313
 
 
7,665
 
 
48,926
 
SEGMENT LOSS FROM OPERATIONS
(6,284
)
 
(2,503
)
 
(7,665
)
 
(16,452
)
OTHER INCOME AND EXPENSES, NET
 
 
 
 
 
 
(5,386
)
NET LOSS BEFORE TAXES
 
 
 
 
 
 
$
(21,838
)

 
Year Ended
December 31, 2016
 
U.S.
 
International
 
Other
 
Consolidated
 
 
NET REVENUE
$
25,765

 
$
8,568

 
$

 
$
34,333

COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION
(1,694
)
 
(650
)
 
 
 
(2,344
)
GROSS PROFIT
24,071
 
 
7,918
 
 
 
 
31,989
 
 
 
 
 
 
 
 
 
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES
7,183
 
 
4,289
 
 
903
 
 
12,375
 
GENERAL AND ADMINISTRATIVE EXPENSES
8,918
 
 
3,517
 
 
2,828
 
 
15,263
 
SALES AND MARKETING EXPENSES
21,252
 
 
7,021
 
 
1,158
 
 
29,431
 
DEPRECIATION AND AMORTIZATION
 
 
 
 
2,767
 
 
2,767
 
OPERATING EXPENSES
37,353
 
 
14,827
 
 
7,656
 
 
59,836
 
SEGMENT LOSS FROM OPERATIONS
(13,282
)
 
(6,909
)
 
(7,656
)
 
(27,847
)
OTHER INCOME AND EXPENSES, NET
 
 
 
 
 
 
(5,155
)
NET LOSS BEFORE TAXES
 
 
 
 
 
 
$
(33,002
)

For investor inquiries:
CG Capital
for Alimera Sciences
877-889-1972
investorrelations@cg.capital