Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a leader in the
commercialization and development of prescription ophthalmology
treatments for the management of retinal diseases, announces
financial results for the quarter ended June 30, 2019.
Alimera will host a conference call on Tuesday, July 30, 2019 at
9:00 AM ET to review these financial results and provide an update
on corporate developments.
“During the second quarter we continued to advance our business
strategy in many areas, including obtaining a positive outcome from
NICE for non-infectious posterior uveitis and launching our
direct-to-patient pilot campaign,” said Rick Eiswirth, president
and CEO of Alimera. “Although we were disappointed in the
consolidated net revenue this quarter, we are pleased with our
international segment growth year over year. Our U.S. sales were
impacted by greater than expected turnover in our sales force due
to several new ophthalmic product launches by other companies in
the first half of the year. We aggressively addressed this issue
during the quarter and were fully staffed by early July.”
ILUVIEN showed a strong performance in markets outside the U.S.,
with international segment sales up 21% compared to the same period
last year. International geographic expansion remains a strategic
focus for Alimera, with new country approvals and launches for
ILUVIEN expected in the latter half of this year. Alimera had
previously announced the positive outcome for NICE on June 20 and
the launching of the direct-to-patient campaign on May 22.
Mr. Eiswirth added, “We are now focused on returning to growth
domestically, and with the recent approval of ILUVIEN for
non-infectious posterior uveitis in our European markets, as well
as the second quarter launch of ILUVIEN in France, we look forward
to increasing share in all markets in the second half of this year.
We intend to continue pursuing our strategy to leverage our global
sales infrastructure and build a leading company focused on the
treatment of retinal diseases.”
Second Quarter 2019 Financial Results Net
RevenueConsolidated net revenue grew 2% to $10.9 million, compared
to $10.7 million during the second quarter of 2018. U.S. net
revenue was $7.3 million during the second quarter of 2019, down 6%
from $7.8 million during the same period in 2018. End user demand,
which represents units purchased by physicians and pharmacies from
Alimera’s U.S. distributors, decreased 4% in the quarter ended June
30, 2019, decreasing to 917 units compared to 955 units from the
second quarter of 2018.
The difference between our U.S. GAAP revenue and U.S. end user
demand was negligible during the second quarter of 2019.
International net revenue increased 21% to $3.5 million during
the second quarter of 2019, compared to $2.9 million for the same
period during 2018. Revenue in the international segment will
fluctuate from quarter to quarter depending primarily on the timing
and size of our international distributor ordering patterns. For
example, our Q1 2019 revenues were significantly impacted by orders
related to our expansion into Spain and France.
Operating Expenses Total operating expenses during the quarter
ended June 30, 2019 increased by $700,000, or 6%, to $13.3 million,
compared to $12.6 million during the same period of 2018.
General and administrative expenses for the second quarter ended
June 30, 2019 increased 16% to $3.7 million, compared to $3.2
million for the same period in the prior year. The increase was
primarily attributable to professional fees and logistics costs,
some of which are attributable to Brexit preparation.
Net Loss and Non-GAAP Adjusted EBITDADuring the second quarter
of 2019, Alimera reported a net loss of $5.0 million, compared
to a net loss of $4.0 million for the same period in 2018.
“Adjusted EBITDA,” a non-GAAP financial measure defined below, was
a loss of $2.1 million for the second quarter of 2019, compared to
an Adjusted EBITDA loss of $980,000 during the quarter ended June
30, 2018. GAAP basic and diluted net loss per share for the three
months ended June 30, 2019 was $0.07 on approximately 71 million
weighted average shares outstanding. This compares to basic and
diluted net loss per share of $0.06 on approximately 70 million
weighted average shares outstanding during the same period in
2018.
Cash and Cash EquivalentsAs of June 30, 2019, Alimera had cash
and cash equivalents of approximately $12.2 million, compared
to $13.0 million in cash and cash equivalents reported on
December 31, 2018.
Definition of Non-GAAP Financial MeasureFor
purposes of this press release, “Adjusted EBITDA” is defined as
earnings before interest, taxes, depreciation, amortization,
stock-based compensation expenses, net unrealized gains and losses
from foreign currency exchange transactions, losses on
extinguishment of debt and non-cash accrued severance expenses.
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 July 30, 2019A
conference call will be hosted on July 30, 2019 at 9:00am eastern
time by Rick Eiswirth, president and chief executive officer, and
Phil Jones, chief financial officer, to discuss Alimera’s financial
results. Please refer to the information below for conference
call dial-in information and webcast registration.
Conference date: Tuesday July 30, 2019, 9:00 AM ET Conference
dial-in: 866-777-2509International dial-in: 412-317-5413Conference
Call Name: Alimera Sciences (Nasdaq: ALIM) Second Quarter 2019
Financial Results and Corporate Update Conference Call Conference
Call Pre-registration: Participants can register for the
conference by navigating to http://dpregister.com/10131060Please
note that 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
A replay will be available on Alimera’s
website, www.alimerasciences.com, under
“Investor Relations” one hour following the live call.Conference
Call replay: US Toll Free: 1-877-344-7529International Toll:
1-412-317-0088Canada Toll Free: 855-669-9658Replay Access Code:
10131060End Date: September 13, 2019
About Alimera Sciences, Inc.
www.alimerasciences.com
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 and six months ended
June 30, 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 new
country approvals and launches are to be expected in the latter
half of this year, Alimera’s intentions to leverage its global
sales infrastructure and build a leading company focused on the
treatment of retinal diseases and Alimera’s statement that it is
looking forward to increasing share in all markets in the second
half of this year. 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, and
Alimera’s Quarterly Report on Form 10-Q for the first quarter of
2019, 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 will also be described in those sections of
Alimera’s Quarterly Report on Form 10-Q for the second quarter of
2019, to be filed with the SEC soon.
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: Jules
Abrahamfor Alimera Sciencesjulesa@coreir.com |
ALIMERA SCIENCES,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(in thousands)
|
|
|
|
|
|
|
|
June 30,2019 |
|
December 31,2018 |
|
(unaudited) |
|
|
CURRENT ASSETS: |
|
|
|
Cash and cash equivalents |
$ |
12,157 |
|
|
$ |
13,043 |
|
Restricted cash |
32 |
|
|
32 |
|
Accounts receivable, net |
13,892 |
|
|
17,259 |
|
Prepaid expenses and other
current assets |
2,691 |
|
|
2,109 |
|
Inventory |
2,141 |
|
|
2,405 |
|
Total current assets |
30,913 |
|
|
34,848 |
|
NON-CURRENT ASSETS: |
|
|
|
Property and equipment,
net |
1,095 |
|
|
1,355 |
|
Right of use assets, net |
1,299 |
|
|
— |
|
Intangible asset, net |
15,761 |
|
|
16,723 |
|
Deferred tax asset |
1,174 |
|
|
1,182 |
|
TOTAL ASSETS |
$ |
50,242 |
|
|
$ |
54,108 |
|
CURRENT LIABILITIES: |
|
|
|
Accounts payable |
$ |
7,875 |
|
|
$ |
6,355 |
|
Accrued expenses |
3,468 |
|
|
3,643 |
|
Finance lease obligations |
247 |
|
|
236 |
|
Total current liabilities |
11,590 |
|
|
10,234 |
|
NON-CURRENT LIABILITIES: |
|
|
|
Note payable |
38,288 |
|
|
37,873 |
|
Finance lease obligations —
less current portion |
172 |
|
|
305 |
|
Other non-current
liabilities |
3,874 |
|
|
2,974 |
|
COMMITMENTS AND
CONTINGENCIES |
|
|
|
STOCKHOLDERS’ (DEFICIT)
EQUITY: |
|
|
|
Preferred stock: |
|
|
|
Series A Convertible Preferred
Stock |
19,227 |
|
|
19,227 |
|
Series C Convertible Preferred
Stock |
11,117 |
|
|
11,117 |
|
Common stock |
710 |
|
|
701 |
|
Additional paid-in
capital |
347,524 |
|
|
346,108 |
|
Common stock warrants |
3,707 |
|
|
3,707 |
|
Accumulated deficit |
(384,928 |
) |
|
(377,127 |
) |
Accumulated other
comprehensive loss |
(1,039 |
) |
|
(1,011 |
) |
TOTAL STOCKHOLDERS’ (DEFICIT)
EQUITY |
(3,682 |
) |
|
2,722 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ (DEFICIT) EQUITY |
$ |
50,242 |
|
|
$ |
54,108 |
|
ALIMERA SCIENCES,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONSFOR THE THREE AND SIX MONTHS ENDED
JUNE 30, 2019 AND 2018(in thousands, except
share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
(Unaudited) |
NET REVENUE |
$ |
10,855 |
|
|
$ |
10,717 |
|
|
$ |
23,745 |
|
|
$ |
20,347 |
|
COST OF GOODS SOLD, EXCLUDING
DEPRECIATION AND AMORTIZATION |
(1,174 |
) |
|
(913 |
) |
|
(2,774 |
) |
|
(2,017 |
) |
GROSS PROFIT |
9,681 |
|
|
9,804 |
|
|
20,971 |
|
|
18,330 |
|
|
|
|
|
|
|
|
|
RESEARCH, DEVELOPMENT AND
MEDICAL AFFAIRS EXPENSES |
2,834 |
|
|
2,777 |
|
|
5,561 |
|
|
5,599 |
|
GENERAL AND ADMINISTRATIVE
EXPENSES |
3,675 |
|
|
3,229 |
|
|
7,068 |
|
|
7,084 |
|
SALES AND MARKETING
EXPENSES |
6,108 |
|
|
5,926 |
|
|
12,021 |
|
|
11,895 |
|
DEPRECIATION AND
AMORTIZATION |
654 |
|
|
650 |
|
|
1,306 |
|
|
1,299 |
|
OPERATING EXPENSES |
13,271 |
|
|
12,582 |
|
|
25,956 |
|
|
25,877 |
|
NET LOSS FROM OPERATIONS |
(3,590 |
) |
|
(2,778 |
) |
|
(4,985 |
) |
|
(7,547 |
) |
|
|
|
|
|
|
|
|
INTEREST EXPENSE AND
OTHER |
(1,236 |
) |
|
(1,178 |
) |
|
(2,464 |
) |
|
(2,329 |
) |
UNREALIZED FOREIGN CURRENCY
GAIN (LOSS), NET |
49 |
|
|
32 |
|
|
(20 |
) |
|
34 |
|
LOSS ON EARLY EXTINGUISHMENT
OF DEBT |
— |
|
|
— |
|
|
— |
|
|
(1,766 |
) |
NET LOSS BEFORE TAXES |
(4,777 |
) |
|
(3,924 |
) |
|
(7,469 |
) |
|
(11,608 |
) |
PROVISION FOR TAXES |
(261 |
) |
|
(76 |
) |
|
(332 |
) |
|
(76 |
) |
NET LOSS |
$ |
(5,038 |
) |
|
$ |
(4,000 |
) |
|
$ |
(7,801 |
) |
|
$ |
(11,684 |
) |
NET LOSS PER SHARE — Basic and
diluted |
$ |
(0.07 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.17 |
) |
WEIGHTED AVERAGE SHARES
OUTSTANDING — Basic and diluted |
70,990,340 |
|
|
70,022,100 |
|
|
70,866,285 |
|
|
69,952,940 |
|
ALIMERA SCIENCES,
INC.CONSOLIDATING STATEMENTS OF
OPERATIONSFOR THE THREE AND SIX MONTHS ENDED
JUNE 30, 2019 AND 2018(in
thousands)
|
|
Three Months EndedJune 30,
2019 |
|
Three Months EndedJune 30,
2018 |
|
|
U.S. |
|
International |
|
Other |
|
Consolidated |
|
U.S. |
|
|
International |
|
Other |
|
Consolidated |
(unaudited) |
|
NET REVENUE |
$ |
7,320 |
|
|
$ |
3,535 |
|
|
$ |
— |
|
|
$ |
10,855 |
|
|
$ |
7,799 |
|
|
|
$ |
|
2,918 |
|
|
$ |
— |
|
|
$ |
10,717 |
|
|
COST OF GOODS
SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION |
(808 |
) |
|
(366 |
) |
|
— |
|
|
(1,174 |
) |
|
(656 |
) |
|
(257 |
) |
|
— |
|
|
(913 |
) |
|
GROSS PROFIT |
6,512 |
|
|
3,169 |
|
|
— |
|
|
9,681 |
|
|
7,143 |
|
|
2,661 |
|
|
— |
|
|
9,804 |
|
|
|
RESEARCH,
DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES |
1,630 |
|
|
1,090 |
|
|
114 |
|
|
2,834 |
|
|
1,602 |
|
|
954 |
|
|
221 |
|
|
2,777 |
|
|
GENERAL AND
ADMINISTRATIVE EXPENSES |
2,150 |
|
|
946 |
|
|
579 |
|
|
3,675 |
|
|
1,866 |
|
|
723 |
|
|
640 |
|
|
3,229 |
|
|
SALES AND
MARKETING EXPENSES |
4,217 |
|
|
1,779 |
|
|
112 |
|
|
6,108 |
|
|
4,142 |
|
|
1,493 |
|
|
291 |
|
|
5,926 |
|
|
DEPRECIATION AND
AMORTIZATION |
— |
|
|
— |
|
|
654 |
|
|
654 |
|
|
— |
|
|
— |
|
|
650 |
|
|
650 |
|
|
OPERATING
EXPENSES |
7,997 |
|
|
3,815 |
|
|
1,459 |
|
|
13,271 |
|
|
7,610 |
|
|
3,170 |
|
|
1,802 |
|
|
12,582 |
|
|
SEGMENT LOSS FROM
OPERATIONS |
(1,485 |
) |
|
(646 |
) |
|
(1,459 |
) |
|
(3,590 |
) |
|
(467 |
) |
|
(509 |
) |
|
(1,802 |
) |
|
(2,778 |
) |
|
OTHER INCOME AND
EXPENSES, NET |
— |
|
|
— |
|
|
(1,187 |
) |
|
(1,187 |
) |
|
— |
|
|
— |
|
|
(1,146 |
) |
|
(1,146 |
) |
|
NET LOSS BEFORE
TAXES |
|
|
|
|
|
|
$ |
(4,777 |
) |
|
|
|
|
|
|
|
$ |
(3,924 |
) |
|
Six Months EndedJune 30,
2019 |
|
Six Months EndedJune 30,
2018 |
|
U.S. |
|
International |
|
Other |
|
Consolidated |
|
U.S. |
|
International |
|
Other |
|
Consolidated |
(unaudited) |
NET REVENUE |
$ |
14,086 |
|
|
$ |
9,659 |
|
|
$ |
— |
|
|
$ |
23,745 |
|
|
$ |
14,604 |
|
|
$ |
5,743 |
|
|
$ |
— |
|
|
$ |
20,347 |
|
COST OF GOODS
SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION |
(1,493 |
) |
|
(1,281 |
) |
|
— |
|
|
(2,774 |
) |
|
(1,369 |
) |
|
(648 |
) |
|
— |
|
|
(2,017 |
) |
GROSS PROFIT |
12,593 |
|
|
8,378 |
|
|
— |
|
|
20,971 |
|
|
13,235 |
|
|
5,095 |
|
|
— |
|
|
18,330 |
|
|
RESEARCH,
DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES |
3,057 |
|
|
2,261 |
|
|
243 |
|
|
5,561 |
|
|
3,242 |
|
|
1,904 |
|
|
453 |
|
|
5,599 |
|
GENERAL AND
ADMINISTRATIVE EXPENSES |
4,084 |
|
|
1,933 |
|
|
1,051 |
|
|
7,068 |
|
|
4,159 |
|
|
1,630 |
|
|
1,295 |
|
|
7,084 |
|
SALES AND
MARKETING EXPENSES |
8,258 |
|
|
3,484 |
|
|
279 |
|
|
12,021 |
|
|
8,514 |
|
|
2,771 |
|
|
610 |
|
|
11,895 |
|
DEPRECIATION AND
AMORTIZATION |
— |
|
|
— |
|
|
1,306 |
|
|
1,306 |
|
|
— |
|
|
— |
|
|
1,299 |
|
|
1,299 |
|
OPERATING
EXPENSES |
15,399 |
|
|
7,678 |
|
|
2,879 |
|
|
25,956 |
|
|
15,915 |
|
|
6,305 |
|
|
3,657 |
|
|
25,877 |
|
SEGMENT (LOSS)
INCOME FROM OPERATIONS |
(2,806 |
) |
|
700 |
|
|
(2,879 |
) |
|
(4,985 |
) |
|
(2,680 |
) |
|
(1,210 |
) |
|
(3,657 |
) |
|
(7,547 |
) |
OTHER INCOME AND
EXPENSES, NET |
— |
|
|
— |
|
|
(2,484 |
) |
|
(2,484 |
) |
|
— |
|
|
— |
|
|
(4,061 |
) |
|
(4,061 |
) |
NET LOSS BEFORE
TAXES |
|
|
|
|
|
|
$ |
(7,469 |
) |
|
|
|
|
|
|
|
$ |
(11,608 |
) |
RECONCILIATION OF GAAP MEASURES TO
NON-GAAP ADJUSTED MEASURESGAAP NET LOSS TO
NON-GAAP ADJUSTED EBITDA(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
(Unaudited) |
GAAP NET LOSS |
$ |
(5,038 |
) |
|
|
$ |
(4,000 |
) |
|
|
$ |
(7,801 |
) |
|
|
$ |
(11,684 |
) |
|
Adjustments to net loss: |
|
|
|
|
|
|
|
Interest expense and
other |
1,236 |
|
|
|
1,178 |
|
|
|
2,464 |
|
|
|
2,329 |
|
|
Provision for taxes |
261 |
|
|
|
76 |
|
|
|
332 |
|
|
|
76 |
|
|
Depreciation and
amortization |
654 |
|
|
|
650 |
|
|
|
1,306 |
|
|
|
1,299 |
|
|
Stock-based compensation
expenses |
629 |
|
|
|
1,151 |
|
|
|
1,399 |
|
|
|
2,358 |
|
|
Unrealized foreign currency
exchange (gains) losses |
(49 |
) |
|
|
(32 |
) |
|
|
20 |
|
|
|
(34 |
) |
|
Loss on early extinguishment
of debt |
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,766 |
|
|
Non-cash accrued severance
expenses |
175 |
|
|
|
— |
|
|
|
175 |
|
|
|
— |
|
|
NON-GAAP ADJUSTED EBITDA |
$ |
(2,132 |
) |
|
|
$ |
(977 |
) |
|
|
$ |
(2,105 |
) |
|
|
$ |
(3,890 |
) |
|
Alimera Sciences (NASDAQ:ALIM)
Historical Stock Chart
From Aug 2024 to Sep 2024
Alimera Sciences (NASDAQ:ALIM)
Historical Stock Chart
From Sep 2023 to Sep 2024