First Quarter and Recent Company
Highlights:
Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a leader in the
commercialization and development of prescription ophthalmic
pharmaceuticals, announces financial results for the three months
ended March 31, 2019. The Company will conduct a conference
call on Tuesday, April 30, 2019 at 9:00 AM ET to review these
financial results and provide an update on corporate developments.
“We are pleased to have delivered strong financial performance
in the first quarter of this year, as ILUVIEN continues to gain
traction in both the U.S. and international markets,” said Rick
Eiswirth, President and CEO of Alimera. “In addition to
delivering 34% revenue growth in the quarter compared to Q1 of
2018, we received regulatory approval for a new indication in
non-infectious posterior uveitis in major countries in the EU
through the mutual recognition process, and our partner in France
received pricing and reimbursement approval of ILUVIEN for the
treatment of DME. We believe this quarter represents an
inflection point for the Company, with the expansion of ILUVIEN’s
label, Dr. Kaba joining us as our first Chief Medical Officer, and
our growing presence into the large European intravitreal steroid
markets of Spain and France.”
First Quarter 2019 Financial Results Net
RevenueConsolidated net revenue grew 34% to $12.9 million, compared
to $9.6 million during the first quarter of 2018. U.S. net
revenue was approximately $6.8 million during the first quarters of
both 2019 and 2018. However, end user demand, which
represents units purchased by physicians and pharmacies from the
Company’s distributors, increased 10% in the first quarter of 2019
to 939 units, compared to 851 units in the first quarter of
2018.
The discrepancy between GAAP revenue and end user demand is due
to the timing of distributor purchases in Q1 2019. During the
first quarter of 2019, Alimera's distributors purchased
approximately 14% fewer units than they sold to end users,
decreasing their stock on hand during the quarter.
International net revenue increased 118% to approximately $6.1
million during the first quarter of 2019, compared to approximately
$2.8 million for the same period during 2018. The growth of
revenue in the international segment was the result of increased
sales volume in the markets where Alimera sells direct, continued
expansion into new markets through our distributors and a shortage
of Allergan's Ozurdex®, a competing product, in certain European
countries where ILUVIEN is marketed.
Operating Expenses Total operating expenses during the quarter
ended March 31, 2019 were approximately $12.7 million compared
to approximately $13.3 million for the same period in 2018.
General and administrative expenses decreased by 13% to
approximately $3.4 million, compared to approximately $3.9 million
for the first quarter of 2018. The decrease was primarily
attributable to decreases in personnel costs.
Net Loss and Non-GAAP Adjusted EBITDADuring the first quarter of
2019, the company reported a net loss of approximately
$2.8 million, compared to a net loss of approximately $7.7
million for the same period in 2018. “Adjusted EBITDA,” a
non-GAAP financial measure defined below, was $27,000 for the first
quarter of 2019, compared to an Adjusted EBITDA loss of $2.9
million during the quarter ended March 31, 2018. GAAP
basic and diluted net loss per share for the three months ended
March 31, 2019 was $0.04 on approximately 70.7 million
weighted average shares outstanding. This compares to basic
and diluted net loss per share of $0.11 on approximately 69.9
million weighted average shares outstanding during the same period
of 2018.
Cash and Cash EquivalentsAs of March 31, 2019, Alimera Sciences
had cash and cash equivalents of approximately $13.1 million,
compared to the $13.0 million in cash and cash equivalents reported
on December 31, 2018.
Prior Period ReclassificationAn immaterial reclassification of
prior period amounts related to revenue and cost of goods sold,
excluding depreciation and amortization has been made to conform to
the current period presentation. These reclassifications did not
have any impact on gross profit, net loss from operations or net
loss.
Definition of Non-GAAP Financial MeasureFor
purposes of this press release, “Adjusted EBITDA” is earnings
before interest, taxes, depreciation, amortization, stock-based
compensation expenses, net unrealized gains and losses from foreign
currency exchange transactions and losses on extinguishment of
debt. Please refer to the sections of this press release
entitled “Non-GAAP Financial Measure” and “Reconciliation of GAAP
Net Loss to Non-GAAP Adjusted EBITDA.”
Conference Call to Be Held April 30, 2019A
conference call will be hosted by Rick Eiswirth, President and
Chief Executive Officer, and Phil Jones, Chief Financial Officer,
to discuss the Company’s financial results. The call will be
held at 9:00 AM ET on April 30, 2019. Please refer to the
information below for conference call dial-in information and
webcast registration.
Conference date: Tuesday April 30, 2019, 9:00 AM ET Conference
dial-in: 866-777-2509International dial-in: 412-317-5413Conference
Call Name: Alimera Sciences (Nasdaq: ALIM) First Quarter 2019
Results Call Conference Call
Preregistration: http://dpregister.com/10131060
- registered participants will receive their dial-in
number upon registration and will dial directly into the call
without delay.Live Webcast
URL: https://services.choruscall.com/links/alimera190430.html
Following the live call, a replay will be available on
Alimera’swebsite, www.alimerasciences.com,
under “Investor Relations.”Conference Call replay: US Toll Free:
1-877-344-7529International Toll: 1-412-317-0088Canada Toll Free:
855-669-9658Replay Access Code: 10131060End Date: May 14, 2019
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that
specializes in the commercialization and development of
prescription ophthalmic pharmaceuticals. Alimera is presently
focused on diseases affecting the back of the eye, or retina,
because these diseases are not well treated with current therapies
and affect millions of people in our aging populations. For
more information, please visit www.alimerasciences.com.
Non-GAAP Financial Measure
This press release contains a discussion of a non-GAAP financial
measure, as defined in Regulation G promulgated under the
Securities Exchange Act of 1934, as amended. Alimera reports
its financial results in compliance with GAAP but believes that the
non-GAAP measure of Adjusted EBITDA provides useful information to
investors regarding Alimera’s operating performance. Alimera
uses Adjusted EBITDA in the management of its business.
Accordingly, Adjusted EBITDA for the three months ended March 31,
2019 and 2018 has been presented in certain instances excluding
items identified in the reconciliations provided in the table
entitled “Reconciliation of GAAP Net Loss to non-GAAP Adjusted
EBITDA.” GAAP net loss is the most directly comparable GAAP
financial measure to Adjusted EBITDA. Adjusted EBITDA, as
presented, may not be comparable to similarly titled measures
reported by other companies because not all companies may calculate
Adjusted EBITDA in an identical manner. Therefore, Adjusted
EBITDA is not necessarily an accurate measure of comparison between
companies.
The presentation of Adjusted EBITDA is not intended to be
considered in isolation or as a substitute for guidance prepared in
accordance with GAAP. The principal limitation of this
non-GAAP financial measure is that it excludes significant elements
required by GAAP to be recorded in Alimera’s financial statements.
In addition, Adjusted EBITDA is subject to inherent
limitations as it reflects the exercise of judgments by management
in determining this non-GAAP financial measure.
Forward Looking Statements
This press release contains “forward-looking statements,” within
the meaning of the Private Securities Litigation Reform Act of
1995, regarding, among other things, Alimera’s belief that ILUVIEN
continues to gain traction in both the U.S. and international
markets, and that this quarter represents an inflection point for
Alimera. Such forward-looking statements are based on current
expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change either of
them, and could cause actual results to differ materially from
those projected in the forward-looking statements. Meaningful
factors that could cause actual results to differ include, but are
not limited to, (a) a slowdown or reduction in Alimera’s sales in
2019 due to a reduction in end user demand, unanticipated
competition, regulatory issues, including delays in obtaining
reimbursement approval in various countries in the EU for the
treatment of non-infectious posterior uveitis, or other unexpected
circumstances, and (b) 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, 2018, which is
on file with the Securities and Exchange Commission and available
on its website at http://www.sec.gov.
The forward-looking statements in this press release 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.
For investor
inquiries: Scott Gordon for Alimera Sciences
scottg@coreir.com |
For
media inquiries:Cassy Dumpfor Alimera
Sciencescassy@pascalecommunications.com |
ALIMERA SCIENCES, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(in thousands) |
|
|
|
March 31, 2019 |
|
December 31, 2018 |
CURRENT ASSETS |
|
|
|
|
Cash and cash equivalents |
$ |
13,094 |
|
|
$ |
13,043 |
|
Restricted cash |
|
33 |
|
|
|
32 |
|
Accounts receivable, net |
|
15,417 |
|
|
|
17,259 |
|
Prepaid expenses and other current assets |
|
2,469 |
|
|
|
2,109 |
|
Inventory, net |
|
1,860 |
|
|
|
2,405 |
|
Total current assets |
|
32,873 |
|
|
|
34,848 |
|
NON-CURRENT
ASSETS: |
|
|
|
Property and equipment, net |
|
1,259 |
|
|
|
1,355 |
|
Right of use assets, net |
|
775 |
|
|
|
- |
|
Intangible asset, net |
|
16,245 |
|
|
|
16,723 |
|
Deferred tax asset, net |
|
1,158 |
|
|
|
1,182 |
|
TOTAL
ASSETS |
|
$ |
52,310 |
|
|
$ |
54,108 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
CURRENT
LIABILITIES |
|
|
|
Accounts payable |
$ |
6,602 |
|
|
$ |
6,355 |
|
Accrued expenses |
|
3,118 |
|
|
|
3,643 |
|
Finance lease obligations |
|
253 |
|
|
|
236 |
|
Total current liabilities |
|
9,973 |
|
|
|
10,234 |
|
NON-CURRENT
LIABILITIES |
|
|
|
Notes payable, net of discount - less current portion |
|
38,080 |
|
|
|
37,873 |
|
Finance lease obligations - less current portion |
|
241 |
|
|
|
305 |
|
Other long-term liabilities |
|
3,370 |
|
|
|
2,974 |
|
|
|
|
|
|
STOCKHOLDERS' EQUITY |
|
|
|
Preferred stock - Series A |
|
19,227 |
|
|
|
19,227 |
|
Preferred stock - Series C |
|
11,117 |
|
|
|
11,117 |
|
Common stock |
|
710 |
|
|
|
701 |
|
Additional paid-in capital |
|
346,869 |
|
|
|
346,108 |
|
Common stock warrants |
|
3,707 |
|
|
|
3,707 |
|
Accumulated deficit |
|
(379,890 |
) |
|
|
(377,127 |
) |
Accumulated other comprehensive loss |
|
(1,094 |
) |
|
|
(1,011 |
) |
TOTAL STOCKHOLDERS' EQUITY |
|
646 |
|
|
|
2,722 |
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY |
$ |
52,310 |
|
|
$ |
54,108 |
|
|
|
|
|
|
ALIMERA SCIENCES, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in thousands, except share and per share
data) |
|
|
Three Months Ended |
|
March 31, |
|
2019 |
|
2018 |
|
(Unaudited) |
|
|
|
|
NET REVENUE |
$ |
12,890 |
|
|
$ |
9,630 |
|
COST OF GOODS SOLD,
EXCLUDING DEPRECIATION AND AMORTIZATION |
|
(1,600 |
) |
|
|
(1,104 |
) |
GROSS PROFIT |
|
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 |
|
12,685 |
|
|
|
13,295 |
|
NET LOSS FROM
OPERATIONS |
|
(1,395 |
) |
|
|
(4,769 |
) |
|
|
|
|
INTEREST EXPENSE, NET
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 |
$ |
(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 |
|
|
ALIMERA SCIENCES, INC. |
RECONCILIATION OF GAAP NET LOSS TO NON-GAAP
ADJUSTED EBITDA |
(in
thousands) |
|
Three Months Ended |
|
March 31, |
|
2019 |
|
2018 |
|
(Unaudited) |
|
|
|
|
GAAP NET LOSS |
$ |
(2,763 |
) |
|
$ |
(7,684 |
) |
Adjustments to net loss: |
|
|
|
Interest
expense and other |
|
1,228 |
|
|
|
1,151 |
|
Provision
for taxes |
|
71 |
|
|
|
- |
|
Depreciation and amortization |
|
652 |
|
|
|
649 |
|
Stock-based compensation expenses |
|
770 |
|
|
|
1,207 |
|
Unrealized foreign currency exchange loss (gain) |
|
69 |
|
|
|
(2 |
) |
Loss on
early extinguishment of debt |
|
- |
|
|
|
1,766 |
|
NON-GAAP
ADJUSTED EBITDA |
$ |
27 |
|
|
$ |
(2,913 |
) |
|
|
|
|
ALIMERA SCIENCES, INC. |
CONSOLIDATING STATEMENTS OF
OPERATIONS |
(in thousands) |
|
|
Three Months Ended |
|
Three Months Ended |
|
March 31, 2019 |
|
March 31, 2018 |
|
U.S. |
|
International |
|
Other |
|
Consolidated |
|
U.S. |
|
International |
|
Other |
|
Consolidated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET REVENUE |
$ |
6,766 |
|
|
$ |
6,124 |
|
|
$ |
- |
|
|
$ |
12,890 |
|
|
$ |
6,805 |
|
|
$ |
2,825 |
|
|
$ |
- |
|
|
$ |
9,630 |
|
COST OF GOODS SOLD,
EXCLUDING DEPRECIATION AND AMORTIZATION |
|
(685 |
) |
|
|
(915 |
) |
|
|
- |
|
|
|
(1,600 |
) |
|
|
(713 |
) |
|
|
(391 |
) |
|
|
- |
|
|
|
(1,104 |
) |
GROSS PROFIT |
|
6,081 |
|
|
|
5,209 |
|
|
|
- |
|
|
|
11,290 |
|
|
|
6,092 |
|
|
|
2,434 |
|
|
|
- |
|
|
|
8,526 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RESEARCH, DEVELOPMENT
AND MEDICAL AFFAIRS EXPENSES |
|
1,427 |
|
|
|
1,170 |
|
|
|
130 |
|
|
|
2,727 |
|
|
|
1,640 |
|
|
|
950 |
|
|
|
232 |
|
|
|
2,822 |
|
GENERAL AND
ADMINISTRATIVE EXPENSES |
|
1,933 |
|
|
|
988 |
|
|
|
472 |
|
|
|
3,393 |
|
|
|
2,293 |
|
|
|
907 |
|
|
|
655 |
|
|
|
3,855 |
|
SALES AND MARKETING
EXPENSES |
|
4,041 |
|
|
|
1,705 |
|
|
|
167 |
|
|
|
5,913 |
|
|
|
4,371 |
|
|
|
1,278 |
|
|
|
320 |
|
|
|
5,969 |
|
DEPRECIATION AND
AMORTIZATION |
|
- |
|
|
|
- |
|
|
|
652 |
|
|
|
652 |
|
|
|
- |
|
|
|
- |
|
|
|
649 |
|
|
|
649 |
|
OPERATING EXPENSES |
|
7,401 |
|
|
|
3,863 |
|
|
|
1,421 |
|
|
|
12,685 |
|
|
|
8,304 |
|
|
|
3,135 |
|
|
|
1,856 |
|
|
|
13,295 |
|
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 |
|
- |
|
|
|
- |
|
|
|
(1,297 |
) |
|
|
(1,297 |
) |
|
|
- |
|
|
|
- |
|
|
|
(2,915 |
) |
|
|
(2,915 |
) |
NET LOSS
BEFORE TAXES |
|
|
|
|
|
|
$ |
(2,692 |
) |
|
|
|
|
|
|
|
$ |
(7,684 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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