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EX-99.1 - EXHIBIT 99.1 - ALIMERA SCIENCES INC | pr.htm |
8-K - 8-K - ALIMERA SCIENCES INC | alim8k.htm |
First Quarter 2018 Earnings Presentation
Thursday, May 3rd 2018
Exhibit 99.2
This presentation contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among
other things,, the potential approval and commercialization of ILUVIEN for the treatment of posterior uveitis 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. 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, that the estimated size of
the DME market is not a $2 billion opportunity and the market for uveitis is not 20% of DME, continued market acceptance of ILUVIEN in the U.S. and
Europe, including physicians' ability to obtain reimbursement, 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, 2017,
which is 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 three months ended March 31, 2018, to be filed 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.
Safe Harbor Statement
2
© 2018 Alimera Sciences | NASDAQ: ALIM
3
First Quarter 2018 Overview
Significant Revenue Growth
• 48% increase compared to 1Q17
© 2018 Alimera Sciences | NASDAQ: ALIM
U.S.
• $7.0 million in 1Q18; 59% revenue increase in
the U.S. compared to 1Q17
• 21% increase in end user demand
International
• $2.8 million in 1Q18
• 27% revenue increase internationally
compared to 1Q17
$6.7M
$9.8M
Revenue
+48%
Revenue
Growth
1Q17 1Q18
4
ILUVIEN Presentations at ARVO*
© 2018 Alimera Sciences | NASDAQ: ALIM
19 ILUVIEN presentations at ARVO 2018
Data from multiple countries represented
• Eight U.S. presentations on diabetic macular edema (DME)
• Ten EU/Middle East Presentations on DME
• One European presentation on uveitis
Real world support for ILUVIEN for DME
• Three-year experience
• Improved treatment burden for patients
• Predictability of intraocular pressure (IOP) response
• Improvement of the retinal nerve fiber layer
*Association for Research in Vision and Ophthalmology
5
ILUVIEN for Non-Infectious Posterior Uveitis
90.5%
59.6%
27.6%
25.7%
PSV-FAI-001 PSV-FAI-005
Percentage of Patients with Uveitis
Recurrence
FAI InsertSham
• Application for non-infectious posterior uveitis indication
submitted in 17 countries in Europe in December of 2017.
• Alimera plans to file additional requested follow-up
clinical data by end of 2018.
• Expected approval 1H19.
• Data from two phase 3 clinical trials of the FAI insert
demonstrated:
• A sustained prevention of recurrence of noninfectious
posterior uveitis.
• Significantly reduced need for adjunctive therapy.
• Estimated market size -- 20% of DME market.
• Steroids are the current standard of care, no anti-VEGF
competition (i.e. Lucentis, Eylea).
© 2018 Alimera Sciences | NASDAQ: ALIM
6
Growth of ILUVIEN Usage in United States
© 2018 Alimera Sciences | NASDAQ: ALIM
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
~Cumulative Eyes Treated with ILUVIEN - U.S.
7
U.S. Distributor and Demand Orders
© 2018 Alimera Sciences | NASDAQ: ALIM
167
467
536
502
533
777 788
827
705
850 837
896
851
293
460
608
475
501
873
750
1004
500
980
864
804
853
0
200
400
600
800
1000
1200
1Q15 2Q15 3Q15 4Q15 1Q16 2Q16 3Q16 4Q16 1Q17 2Q17 3Q17 4Q17 1Q18
Demand Revenue
Distributor Order Volume
• Distributor order
volumes differed from
end user demand on a
quarter by quarter basis
• 1Q18 distributor volume
was in line with end user
demand.
8
U.S. Demand Orders
© 2018 Alimera Sciences | NASDAQ: ALIM
167
467
536
502
533
777 788
827
705
850 837
896
851
0
100
200
300
400
500
600
700
800
900
1000
First Quarter Second Quarter Third Quarter Fourth Quarter
2015 2016 2017 2018
U.S. End User Demand
• Units sold from our distributor
partners to physicians and pharmacies
• Represents actual usage of ILUVIEN.
U.S. Usage Growth
• U.S. end user demand grew 21% in
1Q18.
9
Income Statement
© 2018 Alimera Sciences | NASDAQ: ALIM
($000’s)
Three Months Ended
March 31, 2018
Three Months Ended
March 31, 2017
Revenue $9,802 $6,618
Operating Expenses $13,295 $11,542
Net Loss ($7,684) ($6,735)
Adj. EBITDA* ($2,913) ($3,679)
*Adjusted EBITDA is earnings before interest taxes, depreciation, amortization, stock-based compensation expenses, net unrealized gains and losses from foreign currency
exchange transactions, gains and losses from the change in the fair value of derivative warrant liability and losses on extinguishment of debt. See slides 11 and 12 of this
presentation for reconciliation of this Non-GAAP financial measure.
10
First Quarter 2018 Overview
Significant Revenue Growth
• 48% increase compared to 1Q17
© 2018 Alimera Sciences | NASDAQ: ALIM
U.S. Revenue
• $7.0 million in 1Q18; 59% revenue increase in
the U.S. compared to 1Q17
• 21% increase in end user demand
International
• $2.8 million in 1Q18
• 27% revenue increase internationally
compared to 1Q17
$6.7M
$9.8M
Revenue
+48%
Revenue
Growth
1Q17 1Q18
11
Reconciliation of GAAP Net Loss to NON-GAAP Adjusted EBITDA
© 2018 Alimera Sciences | NASDAQ: ALIM
Alimera believes that the non-GAAP financial information provided in this presentation can assist investors in the overall understanding of its financial
performance when considered together with GAAP figures.
This presentation contains a discussion of non-GAAP financial measures, as defined in Regulation G of 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 EBITDA will be a more relevant
measure of Alimera's operating performance. For the purpose of this presentation, “Adjusted EBITDA” is adjusted earnings before interest, taxes,
depreciation, amortization, non-cash stock-based compensation expense, and to the extent they are included in the calculation of earnings, net
unrealized gain (loss) from foreign currency exchange transactions, gains (losses) from the change in the fair value of derivative warrant liability and
losses on the extinguishment of debt. Alimera uses Adjusted EBITDA in the management of its business. Accordingly, Adjusted EBITDA for the first
quarter of 2018 has been presented in certain instances excluding items identified in the reconciliations provided.
This non-GAAP financial measure, as presented, may not be comparable to similarly titled measures reported by other companies since not all
companies may calculate these measures in an identical manner and, therefore, they are not necessarily an accurate measure of comparison between
companies.
The presentation of this non-GAAP financial measure 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 they exclude significant elements that are required by GAAP to be
recorded in Alimera's financial statements. In addition, this measure is subject to inherent limitations as it reflects the exercise of judgments by
management in determining this non-GAAP financial measures. In order 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 this non-GAAP financial measures to its most directly
comparable GAAP financial measure as set forth on page 12 of this presentation.
12
Reconciliation of GAAP Net Loss to NON-GAAP Adjusted EBITDA
© 2018 Alimera Sciences | NASDAQ: ALIM
Three Months Ended March 31,
($000’s) 2018 2017
GAAP Net Loss ($7,684) ($6,735)
Adjustments to Net Loss
Interest Expense, Net and Other $1,151 $1,337
Provision for Taxes - $26
Depreciation and Amortization $649 $666
Stock-Based Compensation $1,207 $1,166
Unrealized Foreign Currency Exchange
(Gains) Losses
(2) 28
Change in the Fair Value of Derivative
Warrant Liability
- ($167)
Loss on Early Extinguishment of Debt $1,766 -
Non-GAAP Adjusted EBITDA ($2,913) ($3,679)
First Quarter 2018 Earnings Presentation
Thursday, May 3rd 2018