Form 8-K ALIMERA SCIENCES INC For: Mar 02
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E-mailUNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 2, 2016
ALIMERA SCIENCES, INC.
(Exact name of registrant as specified in its charter)
(Exact name of registrant as specified in its charter)
Delaware | 001-34703 | 20-0028718 | ||||
(State or other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||
6120 Windward Parkway Suite 290 Alpharetta, Georgia | 30005 | |||||
(Address of Principal Executive Offices) | (Zip Code) | |||||
Registrant’s telephone number, including area code: (678) 990-5740
Not Applicable |
(Former name or former address if changed since last report.) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition.
On March 2, 2016, Alimera Sciences, Inc. (“Alimera”) issued a press release regarding its results of operations and financial condition for the fourth quarter and full year ended December 31, 2015. Alimera will be hosting a conference call, as well as a live webcast on the Investor Relations section of its corporate website at www.alimerasciences.com, on March 3, 2016 at 10:00 A.M. ET to discuss its fourth quarter and full year ended December 31, 2015 financial results and to provide regulatory and commercial updates. The full text of the press release, which includes information regarding Alimera’s use of non-GAAP financial measures, is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Due to less than expected sales of ILUVIEN in January and February of 2016, Alimera is not currently in compliance with the revenue covenants of its debt facility with Hercules Technology Growth Capital, Inc. (“Hercules”). Alimera and Hercules are currently in discussions regarding an amendment to the debt facility which would bring Alimera into compliance with the revenue covenant. Hercules has not accelerated or otherwise made demand for any amounts owing under the debt facility. Alimera currently anticipates completing this amendment prior to the filing later this month of its Annual Report on Form 10-K for the year ended December 31, 2015.
Various statements to be made during the conference call and webcast, including the slide deck presentation discussed in Item 7.01 of this Current Report on Form 8-K, are “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, the ability of the ILLUVIEN J-code to drive use and market acceptance of ILUVIEN, the opportunity for further growth in 2016 for ILUVIEN, Alimera’s ability to reach agreement with Hercules on an amendment to bring Alimera in compliance with revenue covenants under the debt facility and Alimera’s ability to complete an amendment with Hercules before Alimera files its Annual Report on Form 10-K for the year ended December 31, 2015. 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, a decision by Hercules to call the debt facility and request immediate repayment of the amounts owing under the debt facility, accelerate amounts owing under the debt facility, other action taken by Hercules under the debt facility to the detriment of Alimera due to Alimera’s failure to comply with the revenue covenants, the ability of Alimera to negotiate an amendment to the debt facility that is on commercially reasonable terms or the cost of any amendment to the debt facility with Hercules which could materially affect Alimera’s ability to continue its commercial launch of ILUVIEN, and market acceptance of ILUVIEN in the U.S. and Europe, including physicians' ability to obtain reimbursement, the potential impact of the J-code on U.S. revenues and revenue growth in 2016 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, 2014 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, which are on file with the Securities and Exchange Commission (“SEC”) and available free of charge on the SEC’s website at 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, 2015, to be filed with the SEC in the first 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 made during the conference call and webcast 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 on which they are made (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.
The information in Item 2.02 of this Current Report on Form 8-K and the press release furnished as Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing
under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 7.01. Regulation FD.
Alimera is furnishing under this Item 7.01 a copy of a slide deck presentation which will be available March 3, 2016 on Alimera’s earnings webcast for the fiscal year ended December 31, 2015. The presentation is incorporated by reference herein. Certain financial information relating to completed fiscal periods that will be part of the earnings webcast is included in the presentation that will accompany the earnings webcast, a copy of which is attached hereto as Exhibit 99.2. The earnings webcast will include certain non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the comparable measures calculated and presented in accordance with GAAP are included in Alimera’s press release issued March 2, 2016 and attached hereto as part of Exhibit 99.1.
The information in this Current Report on Form 8-K under Item 7.01, including Exhibit 99.2 attached hereto and incorporated herein, is being “furnished” and not “filed” with the U.S. Securities and Exchange Commission for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities under such section. Furthermore, such information shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), unless specifically identified as being incorporated therein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. | Description | |
99.1 | Press Release of Alimera Sciences, Inc. dated March 2, 2016 | |
99.2 | Set of slides that will accompany the March 3, 2016 earnings webcast | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ALIMERA SCIENCES, INC. | ||
Dated: March 3, 2016 | By: | /s/ RICHARD S. EISWIRTH, JR. |
Name: | Richard S. Eiswirth, Jr. | |
Title: | President and Chief Financial Officer | |
EXHIBIT INDEX
Exhibit No. | Description | |
99.1 | Press Release of Alimera Sciences, Inc. dated March 2, 2016 | |
99.2 | Set of slides that will accompany the March 3, 2016 earnings webcast | |
Exhibit 99.1
Alimera Sciences Reports Record Fourth Quarter and Full Year 2015 Financial Results
• | Annual revenue increased 167% for 2015 compared to 2014 due to launch of ILUVIEN in the U.S. |
• | Record fourth quarter 2015 revenue; increased 241% over fourth quarter 2014 |
• | Company to host conference call on March 3, 2016 at 10:00 AM ET |
ATLANTA, MARCH 2, 2015 /GLOBENEWSWIRE/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced record top-line financial results for the fourth quarter and year ended December 31, 2015.
"We are pleased with our growth in 2015, finishing the year 167% above 2014 revenue. During 2015, we launched ILUVIEN in the U.S. and Portugal and re-launched our German business, re-establishing the sales levels of the summer of 2014. Global sales in 2015 were $22.4 million, in line with expectations set on our third quarter 2015 earnings call," said Dan Myers, Alimera's Chief Executive Officer. "In the fourth quarter of 2015, we saw further expansion of our customer base in the U.S. and received positive news with the granting of the J-code for ILUVIEN. With this expansion, and an encouraging performance in Germany and Portugal, we look forward to further growth in 2016. Additionally, we expanded our platform for future growth with the addition of a distribution partnership in the Middle East. "
Fourth Quarter and Full Year 2015 Financial Results
Consolidated net revenue increased by approximately $4.1 million, or 241%, to approximately $5.8 million for the three months ended December 31, 2015, compared to net revenue of approximately $1.7 million for the three months ended December 31, 2014. Consolidated net revenue increased by approximately $14.0 million, or 167%, to approximately $22.4 million for the year ended December 31, 2015, compared to net revenue of approximately $8.4 million for the year ended December 31, 2014. These increases were primarily driven by increased sales of ILUVIEN in the U.S. following its launch in the U.S. in the first quarter of 2015.
Fourth quarter 2015 revenues were affected by typical seasonality, as well as some U.S. accounts deferring treatment of patients into 2016 to take advantage of the newly announced J-code for ILUVIEN. Alimera believes that the specific J-code reimbursement will drive additional use and reduce some reimbursement concerns from U.S. practices in 2016.
U.S. net revenue was $3.9 million in the fourth quarter of 2015. For the year ended December 31, 2015, U.S. net revenue was approximately $15.2 million. U.S. net revenue in 2015 was a result of the commercial launch and use of ILUVIEN by U.S. retinal physicians. There were no significant ILUVIEN sales in the U.S. in 2014.
International net revenue increased by approximately $200,000, or 12%, to approximately $1.9 million for the three months ended December 31, 2015, compared to approximately $1.7 million for the three months ended December 31, 2014. The increase was primarily attributable to increased unit sales in Germany compared to the prior year, offset by lower sales in the UK and the impact of decreases in the value of the British pound sterling and the Euro.
International net revenue decreased by approximately $1.1 million, or 13%, to approximately $7.3 million for the year ended December 31, 2015, compared to approximately $8.4 million for the year ended December 31, 2014. The decrease was primarily attributable to a decrease in German unit sales and decreases in the value of the British pound sterling and the Euro, offset by incremental sales associated with the commercial launch of ILUVIEN in Portugal in 2015.
Consolidated gross profit increased by $3.8 million, or 238%, to approximately $5.4 million for three months ended December 31, 2015, compared to approximately $1.6 million for the three months December 31, 2014. Gross margin was 93% and 94% for the three months ended December 31, 2015 and 2014, respectively. Consolidated gross profit increased by $13.7 million, or 196%, to $20.7 million for year ended December 31, 2015, compared to approximately $7.0 million for the year ended December 31, 2014. Gross margin was 92% and 83% for the years ended December 31, 2015 and 2014, respectively.
Consolidated research, development and medical affairs expenses for the fourth quarter of 2015 increased to approximately $3.6 million, compared to approximately $3.0 million during the fourth quarter of 2014. Consolidated research, development and medical affairs expenses for fiscal year 2015 increased to approximately $14.8 million, compared to $11.8 million during fiscal year 2014. These increases were primarily due to the hiring of medical sales liaisons and expanded scientific and medical communication in 2015 to support the U.S. commercial launch of ILUVIEN and ongoing post-marketing studies of ILUVIEN.
Consolidated general and administrative expenses remained flat for the fourth quarter of 2015 compared to the fourth quarter of 2014 at $3.7 million. Consolidated general and administrative expenses for year ended 2015 increased to approximately $14.2 million, compared to approximately $12.4 million during fiscal year 2014. This increase is due to the growth in the Alimera’s infrastructure to support its global business.
Consolidated sales and marketing expenses increased $1.8 million, or 34%, to approximately $7.1 million for the three months ended December 31, 2015, compared to approximately $5.3 million for the three months ended December 31, 2014. Consolidated sales and marketing expenses increased $13.0 million, or 86%, to approximately $28.1 million for the year ended December 31, 2015, compared to approximately $15.1 million for the year ended December 31, 2014. This increase in expense was primarily related to Alimera's investment in the U.S. commercial team that supported the launch of ILUVIEN in the U.S.
Alimera's GAAP net loss applicable to common stockholders for the three months ended December 31, 2015 was approximately $10.7 million, compared to approximately $10.0 million for the three months ended December 31, 2014. GAAP basic and diluted net loss per share for the fourth quarter of 2015 was $(0.24) per share on 44,616,666 weighted average shares outstanding, compared with GAAP basic and diluted net loss per share of $(0.23) per share on 44,296,485 weighted average shares outstanding during the fourth quarter of 2014. Alimera's GAAP net loss applicable to common stockholders for the year ended December 31, 2015 was approximately $30.6 million, compared to approximately $36.7 million for the year ended December 31, 2014. GAAP basic and diluted net loss per share for year ended 2015 was $(0.69) per share on 44,450,216 weighted average shares outstanding, compared with GAAP basic and diluted net loss per share of $(0.91) per share on 40,397,224 weighted average shares outstanding during the year ended December 31, 2014. The GAAP net loss attributable to common stockholders and GAAP basic and diluted net loss per share were affected by certain non-cash items, including unrealized foreign currency gains and losses, loss on the early extinguishment of debt, accretion of a preferred stock beneficial conversion feature, changes in the fair value of a derivative warrant liability and reserves for potential inventory expiration.
Non-GAAP adjusted net loss attributable to common stockholders for the three months ended December 31, 2015 was approximately $10.7 million, compared to a non-GAAP adjusted net loss attributable to common stockholders for the three months ended December 31, 2014 of approximately $12.2 million. Non-GAAP adjusted basic and diluted loss per share for the three months ended December 31, 2015 and 2014 were $(0.24) per share and $(0.27) per share, respectively. Net loss for basic and diluted weighted average shares outstanding attributable to common stockholders per share and non-GAAP adjusted net loss attributable to common stockholders per share was based on 44,616,666 weighted average shares outstanding for the three months ended December 31, 2015 and 44,296,485 weighted average shares outstanding for the three months ended December 31, 2014.
Non-GAAP adjusted net loss attributable to common stockholders for the year ended December 31, 2015 was approximately $43.4 million, compared to a non-GAAP adjusted net loss attributable to common stockholders for the year ended December 31, 2014 of approximately $34.4 million. Non-GAAP adjusted basic and diluted loss per share for the year ended December 31, 2015 and 2014 were $(0.98) per share and $(0.85) per share, respectively. Net loss for basic and diluted weighted average shares outstanding attributable to common stockholders per share and non-GAAP adjusted net loss attributable to common stockholders per share was based on 44,450,216 weighted
average shares outstanding for the year ended December 31, 2015 and 40,397,224 weighted average shares outstanding during the year ended December 31, 2014.
Reconciliations of GAAP cost of goods sold to non-GAAP adjusted costs of goods sold, GAAP net loss attributable to common stockholders to non-GAAP adjusted net loss attributable to common stockholders and GAAP net loss per share to non-GAAP adjusted net loss per share is included below in the table titled "Reconciliation of GAAP Measures to Non-GAAP Adjusted Measures."
As of December 31, 2015, Alimera had cash and cash equivalents of $31.1 million. Due to less than expected sales of ILUVIEN in January and February of 2016, Alimera is not currently in compliance with the revenue covenants of its debt facility with Hercules Technology Growth Capital, Inc. (Hercules). Alimera and Hercules are currently in discussions regarding an amendment to the debt facility which would bring Alimera into compliance with the revenue covenant. Hercules has not accelerated or otherwise made demand for any amounts owing under the debt facility. Alimera currently anticipates completing this amendment prior to the filing later this month of its Annual Report on Form 10-K for the year ended December 31, 2015.
Conference Call to be Held March 3, 2016
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 10:00 AM ET, on March 3, 2016. Please refer to the information below for conference call dial-in information and webcast registration.
Conference date: March 3, 2016, 10:00 AM ET
Conference dial-in: 877-269-7756
International dial-in: 201-689-7817
Conference Call Name: Alimera Sciences Fourth Quarter 2015 Results Call
Webcast Registration: Click Here
Following the live call, a replay will be available on the Company's website, www.alimerasciences.com, under "Investor Relations".
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the research, development and commercialization 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 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
Alimera believes the metrics non-GAAP adjusted cost of goods sold, non-GAAP adjusted net loss attributable to common stockholders and non-GAAP adjusted net loss per share are useful financial measures for investors in evaluating Alimera's performance for the periods presented. Non-GAAP adjusted net loss attributable to common stockholders and non-GAAP adjusted net loss per share exclude certain non-cash items. These non-GAAP metrics, however, are not measures of financial performance under GAAP and should not be considered a substitute for net loss attributable to common stockholders or net loss per share in accordance with GAAP and may not be comparable to similarly titled measures reported by other companies. Alimera's management believes that these non-GAAP metrics are useful supplements for it and investors to Alimera's GAAP financial information because these measures exclude non-cash items which management believes are not reflective of Alimera's operating results. These non-GAAP financial measures also facilitate management's internal comparison to Alimera's historical financial performance and the financial performance of other companies. However, non-GAAP financial measures should only be read in conjunction with financial information reported under GAAP when understanding Alimera's operating performance. For a reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measure, see the table below.
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 ability of the ILUVIEN J-code to drive use and market acceptance of ILUVIEN, the opportunity for further growth in 2016 for ILUVIEN, Alimera's ability to reach agreement with Hercules on an amendment to bring Alimera in compliance with its revenue covenant under the debt facility and Alimera's ability to complete an amendment with Hercules before Alimera files its Annual Report on Form 10-K for the year ended December 31, 2015. 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 decision by Hercules to call the debt facility and request immediate repayment of such amounts, accelerate amounts owing under the debt facility, other action taken by Hercules under the debt facility to the detriment of Alimera due to Alimera’s failure to comply with its revenue covenant, the ability of Alimera to negotiate an amendment to the debt facility that is on commercially reasonable terms or the cost of any amendment to the debt facility with Hercules which could materially affect Alimera’s ability to continue its commercial launch of ILUVIEN, and market acceptance of ILUVIEN in the U.S. and Europe, including physicians' ability to obtain reimbursement, the potential impact of the ILUVIEN J-code on U.S. revenues and revenue growth in 2016 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, 2014 and Alimera's Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, 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 Report on Form 10-K for the year ended December 31, 2015, to be filed with the SEC in the first 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 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.
Contact:
COCKRELL GROUP
877.889.1972
cockrellgroup.com
ALIMERA SCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2015 AND 2014
(in thousands, except share and per share data)
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
(unaudited) | (unaudited) | (unaudited) | |||||||||||||
NET REVENUE | $ | 5,823 | $ | 1,741 | $ | 22,438 | $ | 8,423 | |||||||
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (469 | ) | (130 | ) | (1,762 | ) | (1,442 | ) | |||||||
GROSS PROFIT | 5,354 | 1,611 | 20,676 | 6,981 | |||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 3,618 | 2,987 | 14,840 | 11,811 | |||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 3,719 | 3,728 | 14,190 | 12,371 | |||||||||||
SALES AND MARKETING EXPENSES | 7,087 | 5,308 | 28,090 | 15,087 | |||||||||||
DEPRECIATION AND AMORTIZATION | 691 | 508 | 2,555 | 659 | |||||||||||
OPERATING EXPENSES | 15,115 | 12,531 | 59,675 | 39,928 | |||||||||||
NET LOSS FROM OPERATIONS | (9,761 | ) | (10,920 | ) | (38,999 | ) | (32,947 | ) | |||||||
INTEREST EXPENSE AND OTHER | (1,103 | ) | (1,228 | ) | (4,693 | ) | (2,090 | ) | |||||||
UNREALIZED FOREIGN CURRENCY LOSS | (72 | ) | (85 | ) | (106 | ) | (542 | ) | |||||||
LOSS ON EARLY EXTINGUISHMENT OF DEBT | — | — | — | (440 | ) | ||||||||||
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY | 198 | 3,035 | 13,283 | 283 | |||||||||||
NET LOSS BEFORE TAXES | (10,738 | ) | (9,198 | ) | (30,515 | ) | (35,736 | ) | |||||||
PROVISION FOR TAXES | 25 | (60 | ) | (130 | ) | (174 | ) | ||||||||
NET LOSS | (10,713 | ) | (9,258 | ) | (30,645 | ) | (35,910 | ) | |||||||
BENEFICIAL CONVERSION FEATURE OF PREFERRED STOCK | — | (750 | ) | — | (750 | ) | |||||||||
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS | $ | (10,713 | ) | $ | (10,008 | ) | $ | (30,645 | ) | $ | (36,660 | ) | |||
NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS — Basic and diluted | $ | (0.24 | ) | $ | (0.23 | ) | $ | (0.69 | ) | $ | (0.91 | ) | |||
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted | 44,616,666 | 44,296,485 | 44,450,216 | 40,397,224 | |||||||||||
RECONCILIATION OF GAAP MEASURES TO NON-GAAP ADJUSTED MEASURES
(in thousands, except share and per share data)
(unaudited)
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
GAAP COST OF GOODS SOLD | $ | (469 | ) | $ | (130 | ) | $ | (1,762 | ) | $ | (1,442 | ) | |||
Adjustments to costs of goods sold: | |||||||||||||||
Reserve for potential product expiration | 133 | 34 | 445 | 857 | |||||||||||
NON-GAAP ADJUSTED COST OF GOODS SOLD | $ | (336 | ) | $ | (96 | ) | $ | (1,317 | ) | $ | (585 | ) | |||
GAAP GROSS PROFIT | $ | 5,354 | $ | 1,611 | $ | 20,676 | $ | 6,981 | |||||||
Adjustments to gross profit: | |||||||||||||||
Reserve for potential product expiration | 133 | 34 | 445 | 857 | |||||||||||
NON-GAAP ADJUSTED GROSS PROFIT | $ | 5,487 | $ | 1,645 | $ | 21,121 | $ | 7,838 | |||||||
GAAP NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (10,713 | ) | $ | (10,008 | ) | $ | (30,645 | ) | $ | (36,660 | ) | |||
Adjustments to net loss: | |||||||||||||||
Unrealized foreign currency loss, net | 72 | 85 | 106 | 542 | |||||||||||
Loss on early extinguishment of debt | — | — | — | 440 | |||||||||||
Accretion of preferred stock beneficial conversion feature | — | 750 | — | 750 | |||||||||||
Change in fair value of derivative warrant liability | (198 | ) | (3,035 | ) | (13,283 | ) | (283 | ) | |||||||
Reserve for potential product expiration | 133 | 34 | 445 | 857 | |||||||||||
NON-GAAP ADJUSTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (10,706 | ) | $ | (12,174 | ) | $ | (43,377 | ) | $ | (34,354 | ) | |||
GAAP NET LOSS PER SHARE - Basic and diluted | $ | (0.24 | ) | $ | (0.23 | ) | $ | (0.69 | ) | $ | (0.91 | ) | |||
Adjustments to net loss: | |||||||||||||||
Unrealized foreign currency loss, net | — | — | — | 0.01 | |||||||||||
Loss on early extinguishment of debt | — | — | — | 0.01 | |||||||||||
Accretion of preferred stock beneficial conversion feature | — | 0.02 | — | 0.02 | |||||||||||
Change in fair value of derivative warrant liability | — | (0.06 | ) | (0.30 | ) | — | |||||||||
Reserve for potential product expiration | — | — | 0.01 | 0.02 | |||||||||||
NON-GAAP ADJUSTED NET LOSS PER SHARE - Basic and diluted | $ | (0.24 | ) | $ | (0.27 | ) | $ | (0.98 | ) | $ | (0.85 | ) | |||
WEIGHTED AVERAGE SHARES OUTSTANDING - Basic and diluted | 44,616,666 | 44,296,485 | 44,450,216 | 40,397,224 | |||||||||||
ALIMERA SCIENCES, INC.
CONSOLIDATING STATEMENTS OF OPERATIONS
FOR THE TWELVE MONTHS ENDED DECEMBER 31, 2015 AND 2014
(in thousands)
Twelve Months Ended December 31, 2015 | Twelve Months Ended December 31, 2014 | ||||||||||||||||||||||
U.S. | International | Consolidated | U.S. | International | Consolidated | ||||||||||||||||||
(Unaudited) | |||||||||||||||||||||||
NET REVENUE | $ | 15,170 | $ | 7,268 | $ | 22,438 | $ | 17 | $ | 8,406 | $ | 8,423 | |||||||||||
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (792 | ) | (970 | ) | (1,762 | ) | (1 | ) | (1,441 | ) | (1,442 | ) | |||||||||||
GROSS PROFIT | 14,378 | 6,298 | 20,676 | 16 | 6,965 | 6,981 | |||||||||||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 9,712 | 5,128 | 14,840 | 5,400 | 6,411 | 11,811 | |||||||||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 8,244 | 5,946 | 14,190 | 7,496 | 4,875 | 12,371 | |||||||||||||||||
SALES AND MARKETING EXPENSES | 19,777 | 8,313 | 28,090 | 4,704 | 10,383 | 15,087 | |||||||||||||||||
DEPRECIATION AND AMORTIZATION | 2,491 | 64 | 2,555 | 657 | 2 | 659 | |||||||||||||||||
OPERATING EXPENSES | 40,224 | 19,451 | 59,675 | 18,257 | 21,671 | 39,928 | |||||||||||||||||
NET LOSS FROM OPERATIONS | (25,846 | ) | (13,153 | ) | (38,999 | ) | (18,241 | ) | (14,706 | ) | (32,947 | ) | |||||||||||
OTHER INCOME AND EXPENSES, NET | 8,484 | (2,789 | ) | ||||||||||||||||||||
NET LOSS BEFORE TAXES | $ | (30,515 | ) | $ | (35,736 | ) | |||||||||||||||||
Exhibit 99.2 1
Results Conference Call Fourth Quarter 2015
FORWARD LOOKING STATEMENTS This presentation contains "forward-looking statements," within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, the ability of the ILUVIEN J-code to drive use and market acceptance of ILUVIEN, the opportunity for further growth in 2016 for ILUVIEN, Alimera's ability to reach agreement with Hercules on an amendment to bring Alimera in compliance with its revenue covenant under the debt facility and Alimera's ability to complete an amendment with Hercules before Alimera files its Annual Report on Form 10K for the year ended December 31, 2015, that our benefit investigations and the uptick in benefits investigations will actually lead to sales of ILUVIEN or increases in sales 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, a decision by Hercules to call the debt facility and request immediate repayment of such amounts, accelerate amounts owing under the debt facility, other action taken by Hercules under the debt facility to the detriment of Alimera due to Alimera’s failure to comply with its revenue covenant, the ability of Alimera to negotiate an amendment to the debt facility that is on commercially reasonable terms or the cost of any amendment to the debt facility with Hercules which could materially affect Alimera’s ability to continue its commercial launch of ILUVIEN, and market acceptance of ILUVIEN in the U.S. and Europe, including physicians' ability to obtain reimbursement, the potential impact of the ILUVIEN J-code on U.S. revenues and revenue growth in 2016 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 10K for the year ended December 31, 2014 and Alimera's Quarterly Report on Form 10Q for the quarter ended September 30, 2015, 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 Report on Form 10K for the year ended December 31, 2015, to be filed with the SEC in the first quarter of 2016. In addition to the risks described above and in Alimera's Annual Report on Form 10K, Quarterly Reports on Form 10Q, Current Reports on Form 8K 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. 3
4 ILUVIEN® Launched in US 2015 Accomplishments 167% Annual Revenue Growth ILUVIEN® Launched in Portugal, ILUVIEN® Re-launch in Germany 167% 2015 Revenue Growth
5 Full Year Revenue $22.4M 2015 2014 $8.4M US Sales EU Sales Fourth Quarter Revenue $5.8M 4Q15 4Q14 $1.7M 99% EU 33.2% EU 66.8% US 99.8% EU 0.2% US 32.4% EU 67.6% US Sales Growth $15.2M 2015 US Revenue $7.3M 2015 EU Revenue 1.0% US
6 J-Code Approval in US (Active 1/1/16) US User Base Grew to 312 Accounts 4Q15 Highlights 241% Year-Over-Year Fourth Quarter Growth German Unit Demand Equivalent to Highest Previous Quarter Licensing Agreement Completed in Middle East 241% Q415 Revenue Growth
7 J-Code Loaded in Majority of Systems Benefit Investigations Strong in Q1 2016 United States
United States 8 37 Sales Executives 312 Accounts at Year-end
9 Europe Germany Volume up 63% in Q4 2015 Versus Q4 2014 Reimbursement Coverage Continues to Grow
10 Portugal finished 2015 with record quarterly sales Slowdown in UK sales continues due to NICE endorsement Measures in place; moving toward growth again Europe Slowdown in UK Sales Continues Due to NICE Endorsement of Competitor Products Portugal Finished 2015 With Record Quarterly Sales
Financial Overview Rick Eiswirth
12 (000’s) Three Months Ended December 31 2015 Three Months Ended December 31 2014 12 Months Ended December 31 2015 12 Months Ended December 31 2014 Revenue $5,823 $1,741 $22,438 $8,423 Gross Profit $5,354 $1,611 $20,767 $6,981 Gross Margin 92% 93% 93% 83% Net Loss from Operations ($9,761) ($10,920) ($38,999) ($32,947) Net Loss ($10,713) ($9,258) ($30,645) ($35,910) Select Income Statement Data $31.1M Cash at Year End
Closing Remarks Dan Myers
14 Summary Initiated Commercial Operations in US EU Progressing Well, Will be Leveraging Real- World Data Middle East Expansion/International Expansion
Question & Answer Session
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