Attached files
| file | filename |
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| EX-99.1 - EXHIBIT 99.1 - ALIMERA SCIENCES INC | a991pressreleaseq2.htm |
| 8-K - 8-K - ALIMERA SCIENCES INC | alimera8-kaugust32016.htm |
Investor Presentation
January 2015
Results Conference Call
Second Quarter 2016
Safe Harbor Statement
This presentation contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding,
among other things, that sales are escalating as practices are being reimbursed regularly and on a timely basis, the opportunity for significant
growth and market penetration of ILUVEN and that the data on ILUVIEN will drive growth, that Alimera will be able to refinance prior to the end
of the quarter, that Alimera’s refinancing plans will provide additional liquidity and improved financial flexibility, that the waiver will allow
Alimera additional time to accomplish its refinancing plans, that Alimera’s belief that the change in payment terms to 90 days in the U.S. will have
a positive impact on Alimera’s cash position and Alimera’s belief that only one Phase 3 clinical trial will be able to establish adequate evidence of
safety and efficacy for ILUVIEN and obtain FDA approval for additional indications of ILUVIEN. 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. Words such as “anticipate,” “believe,” “estimate,”
“expect,” “intend,” “may,” “plan,” “contemplate,” “predict,” “project,” “target,” “likely,” “potential,” “continue,” “ongoing,” “will,” “would,”
“should,” “could,” or the negative of these terms and similar expressions are intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. 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,
Alimera’s ability to close on additional or alternative debt or equity financing in an appropriate fashion, Alimera failing to meet its financial
covenants under its amended loan facility with Hercules Capital, Inc., which could materially affect Alimera’s commercialization of ILUVIEN,
market acceptance of ILUVIEN in the U.S. and Europe, including physicians’ ability to obtain reimbursement and seasonality, as well as other
factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of
Alimera’s Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended March
31, 2016, 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, to be
filed with the SEC in the third quarter of 2016. In addition to the risks described above and in Alimera’s Annual Report on Form 10-K, Quarterly
Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect
Alimera’s results. There can be no assurance that the actual results or developments anticipated by Alimera will be realized or, even if
substantially realized, that they will have the expected consequences to, or effects on, Alimera. Therefore, no assurance can be given that the
outcomes stated in such forward-looking statements and estimates will be achieved. All forward-looking statements contained in this presentation
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
presentation (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.
2 © 2016 Alimera Sciences, All Rights Reserved 2
Q2 2016 Highlights
3 © 2016 Alimera Sciences, All Rights Reserved 3
$2
$9.6M
$5.8M
Overall Revenue Growth
+66%
1Q16 2Q16 EYES TREATED WITH
ILUVIEN® TO DATE
4 © 2016 Alimera Sciences, All Rights Reserved 4
United States
Significant Growth
Record Quarterly
Revenue
Driven by growth in new accounts as well as
increased penetration into historical accounts
Increased acceptance
of continuous
microsdosing
1Q16 2Q16
US Revenue Growth
$7.2M
$4.1M
+76%
5 © 2016 Alimera Sciences, All Rights Reserved 5
Europe
Back on Track
German Unit Volume
Increases
5th consecutive quarter
1Q16 2Q16
Europe Revenue Growth
$2.3M
$1.7M
+35%
UK Return to Growth
26% growth over Q1 2016
Portuguese Unit
Volume Increases
1st half 2016 > all of 2015
Real World Evidence
Real world experience consistent with FAME pivotal trials
patients
Real world results from 550
patients in two studies consistent
with FAME pivotal trials
“These data demonstrate that in the real world, ILUVIEN® can improve or preserve vision with a side
effect profile similar to that seen in the Phase III FAME studies in the majority of patients with cDMO,
even when previous anti-VEGF treatments have failed to deliver a sufficient response and we are very
pleased to have it as a treatment option for our patients following NICE approval.”
FDA Meetings
Real world experience mimicking FAME pivotal trials
Engaged in
discussions with the
FDA regarding two
potential new
indications:
• Retinal Vein Occlusion
• Non-proliferative diabetic
retinopathy
Financial Overview
Rick Eiswirth, President & CFO
9 © 2016 Alimera Sciences, All Rights Reserved 9
Select Income Statement Data
($000’s)
Three Months Ended
June 30th, 2016
Three Months Ended
June 30th, 2015
Revenue $9,557 $5,776
Gross Profit $9,001 $5,400
Gross Margin 94.2% 93.5%
Net (Loss) From
Operations
($6,449) ($9,800)
Net (Loss) Applicable to
Common Stockholders
($6,858) ($8,596)
10 © 2016 Alimera Sciences, All Rights Reserved 10
Select Balance Sheet Data
($000’s)
As of June
30th, 2016
As of December
31st, 2015
Cash & Cash Equivalents $16,627 $31,075
Total Current Assets $34,664 $45,159
Total Assets $58,766 $70,484
Total Current Liabilities $45,188 $39,933
Total Stockholder’s
Equity
$11,803 $26,320
Closing Remarks
Dan Myers, CEO
Investor Presentation
January 2015
Results Conference Call
Second Quarter 2016