ALIM Alimera Sciences Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Iluvien
Diabetic macular edema
|
Approved
Approved
|
CRL Nov 2011. Second CRL Oct 17 2013. Approved Sept 26 2014
|
Latest News
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ATLANTA, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, today announces that Rick Eiswirth, Alimera's President and Chief Executive Officer, will participate in the Craig-Hallum Capital Group's annual Alpha Select Conference on Tuesday November 17, 2020. The conference consists of one-on-one and small group meetings, which will take place via video conference.
Attendees of the conference can schedule a meeting with Mr. Eiswirth here.
About Alimera Sciences, Inc.
Alimera Sciences 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.
For press inquiries:
Jules Abraham
for Alimera Sciences
917-885-7378
[email protected]For investor inquiries:
Scott Gordon
for Alimera Sciences
[email protected] -
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ATLANTA, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, today announces that new real-world clinical data for ILUVIEN® will be featured in 3 posters at the American Academy of Ophthalmology 2020 Virtual Conference. The posters will be available to registered attendees beginning Friday, November 13, 2020.
Posters include:
- Abstract # 30064808: "Outcomes from the prospective IDEAL registry study – results achieved with the 0.2 µg/day fluocinolone acetonide implant" – Khoramnia, et. al.
- Abstract # 30064802: "Three-year real-world outcomes from the IRISS registry study, using the 0.2 µg/day fluocinolone acetonide (FAc) implant" – Khoramnia, et. al.
- Abstract # 30065140: "Predictive value IOP challenge and other safety measures of PALADIN 2yr. data" – Malik, et. al.
"ILUVIEN is a uniquely durable therapy, providing physicians the opportunity to reduce the recurrence of diabetic macular edema, and therefore reduce the need for frequent injections of the current standard of care," said Rick Eiswirth, President and CEO of Alimera."We are very excited to have these abstracts showcased at the American Academy of Ophthalmology, highlighting the longer term three-year outcomes that support ILUVIEN's ability to give more DME patients the potential to see better, longer, with fewer injections."
Registration to the conference can be accessed here.
About ILUVIEN
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for up to 36 months, to reduce the recurrence of disease. ILUVIEN enables patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Australia, Canada, Kuwait, Lebanon and the U.A.E. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. ILUVIEN is indicated in 17 European countries for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies and in 16 European countries for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU). Alimera does not have the contractual right to pursue approval to treat uveitis in the U.S., and therefore does not have a regulatory license in the U.S. to treat NIPU. For important safety information on ILUVIEN, see https://iluvien.com/#isi
About Alimera Sciences, Inc.
Alimera Sciences 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.
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 beleif that ILUVIEN reduces the need for frequent injections of the current standard of care. 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 include but are not limited to the willingness of physicians to consider ILUVIEN as an alternative to the current standard of care, as well as the 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, 2019 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020, and September 30, 2020 which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov.
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.
For press inquiries:
Jules Abraham
for Alimera Sciences
917-885-7378
[email protected]For investor inquiries:
Scott Gordon
for Alimera Sciences
[email protected]
- Abstract # 30064808: "Outcomes from the prospective IDEAL registry study – results achieved with the 0.2 µg/day fluocinolone acetonide implant" – Khoramnia, et. al.
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Third Quarter Highlights:
- Consolidated Net Revenue of $12.5 Million Up 25% vs. Second Quarter 2020
- U.S. Net Revenue of $7.0 Million Up 106% vs. Second Quarter 2020
- Consolidated Net Revenue Down 3% vs. Third Quarter 2019
- International Net Revenue Up 31% vs. Third Quarter 2019
- Net Loss of ($0.6) Million vs. ($3.1) Million in Third Quarter 2019
- Adjusted EBITDA of $1.4 Million vs. Negative $(0.5) Million Adjusted EBITDA in Third Quarter 2019
ATLANTA, Oct. 28, 2020 (GLOBE NEWSWIRE) -- 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 third quarter of 2020. Alimera will host a conference call on Thursday, October 29, 2020 at 9:00 AM ET to review these financial results and provide an update on corporate developments.
"Our strategy to retain our entire work force through the COVID-19 pandemic is paying off as we were able to drive a 25% sequential increase in global net revenue over the second quarter of 2020 and maintain sales through the first nine months of 2020 despite the challenges of the current environment," said Rick Eiswirth, Alimera's President and Chief Executive Officer. "Importantly, we are achieving our goal of delivering positive adjusted EBITDA, reporting $1.4 million for the third quarter and $2.4 million year to date."
Mr. Eiswirth continued, "During this challenging year we are continuing to invest in ILUVIEN® and to expand geographically to fuel our significant international growth. In the third quarter we initiated the NEW DAY study, our landmark clinical trial that we believe has the potential to position ILUVIEN as the preferred first-line treatment for diabetic macular edema, and we entered into partnerships to make ILUVIEN available in six additional countries in the future."
Third Quarter 2020 Financial Results
Net Revenue
Consolidated net revenue for Q3 2020 was down 3% to $12.5 million, compared to $12.9 million for Q3 2019, and up 25% over Q2 2020.U.S. net revenue was $7.0 million for Q3 2020, down 20% from $8.7 million during the same period in 2019 but was up 106% over Q2 2020. End user demand, which represents units purchased by physicians and pharmacies from Alimera's U.S. distributors, was 728 units in Q3 2020 compared to 973 units in Q3 2019, a decrease of 25%, but up sequentially from 625 units in Q2 2020, as some recovery from the COVID-19 impact was realized.
The difference between GAAP revenue and end user demand in the U.S. is due to the timing of distributor purchases from quarter to quarter. In both Q3 2020 and Q3 2019, Alimera's distributors purchased more units than they sold to end users, increasing their stock on hand during that quarter. Distributors purchased approximately 19% and 9% more units than they sold to end users in Q3 2020 and Q3 2019, respectively.
International net revenue increased 31% to approximately $5.5 million in Q3 2020, compared to approximately $4.2 million for the same period during 2019, primarily as a result of increased sales in the markets where we sell direct. These direct sales included sales revenue for our posterior uveitis indication.
Operating Expenses
Total operating expenses for Q3 2020 decreased by $2.5 million or 19% to $10.5 million, compared to $13.0 million during Q3 2019. Alimera achieved major expense reductions by reducing travel costs, decreasing attendance at medical conferences that were cancelled or converted to virtual meetings and reducing its spending on external commercial and medical affairs activities. Additionally, Alimera benefitted from a one-time favorable impact of approximately $400,000 associated with recovery of previously paid VAT expense in Germany for the years 2014 through 2018.Net Loss and Non-GAAP Adjusted EBITDA
For Q3 2020, Alimera reported a net loss of approximately $(0.6) million, compared to a net loss of $(3.1) million for Q3 2019. Adjusted EBITDA, a non-GAAP financial measure defined below, was approximately $1.4 million for Q3 2020, an improvement of approximately $1.9 million compared to negative Adjusted EBITDA of approximately $0.5 million for Q3 2019.Net Loss per Share
Basic and diluted net loss per share for Q3 2020 was $(0.12). This compares to basic and diluted net loss per share for Q3 2019 of $(0.66). (The per share amounts in this press release reflect the impact from Alimera's one-for-15 reverse stock split in November 2019.)Cash and Cash Equivalents
As of September 30, 2020, Alimera had cash and cash equivalents of approximately $11.3 million, compared to $9.4 million as of December 31, 2019 and $13.5 million as of June 30, 2020. The sequential decrease in cash of $2.2 million from Q2 2020 reflects the impact of lower Q2 2020 revenue on working capital in 2020 and the planned one-time build-up of inventory for the transition of Alimera's component manufacturing to the United States and related transition expenses.Definition of Non-GAAP Financial Measure
For purposes of this press release, "Adjusted EBITDA" is defined as earnings before interest, taxes, depreciation, amortization, stock-based compensation expenses, net unrealized gains (losses) from foreign currency exchange transactions and 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 October 29, 2020
Management will host a conference call at 9:00 AM ET on Thursday, October 29, 2020, to review financial results and provide an update on corporate developments. Following management's formal remarks, there will be a question and answer session.Participants are asked to pre-register for the call. Please note that registered participants will receive their dial in number upon registration and will dial directly into the call without delay. Those without internet access or unable to pre-register may dial in by calling: 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Alimera Sciences call. The conference call will also be available through a live webcast which is also available through the company's website.
A webcast replay of the call will be available approximately one hour after the end of the call through January 29, 2021. The replay can be accessed through the above links or by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10149051. The telephonic replay will be available until November 12, 2020.
About Alimera Sciences, Inc.
Alimera 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 globally. For more information, please visit www.alimerasciences.com.
Non-GAAP Financial Measure
This press release contains a discussion of Adjusted EBITDA, 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 nine months ended September 30, 2020 and 2019 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 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.
About ILUVIEN
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for up to 36 months, to reduce the recurrence of disease. ILUVIEN enables patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Australia, Canada, Kuwait, Lebanon and the U.A.E. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. ILUVIEN is indicated in 17 European countries for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies and in 16 European countries for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU). Alimera does not have the contractual right to pursue approval to treat uveitis in the U.S., and therefore does not have a regulatory license in the U.S. to treat NIPU. For important safety information on ILUVIEN, see https://iluvien.com/#isi.
Forward Looking Statements
This press release contains, and the remarks by Alimera's officers on the conference call may contain, "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera's expectations with respect to its strategy to retain its work force through the COVID-19 pandemic to continue to drive revenue, its ability to continue to deliver positive adjusted EBITDA, its ability to continue investing in ILUVIEN and expanding geographically, its ability to position ILUVIEN as the preferred first-line treatment for DME through the NEW DAY Study and the ability of new partners to make ILUVIEN available in additional countries. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change 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, continuing risks relating to the COVID-19 pandemic that could (a) reverse the current trends in Alimera's revenues and Adjusted EBITDA, due to increased COVID-19 cases in certain states within the U.S. and in Alimera's international markets that have resulted or may again result in reduced access to medical facilities for patient visits with their physicians and continuing concerns of patients with diabetes who may be unwilling to visit their physicians in person (even if otherwise permitted) due to their fear of contracting COVID-19, (b) adversely affect Alimera's ability to maintain its work force and (c) limit Alimera's ability to continue investing in ILUVIEN and expanding geographically. Other meaningful factors that could cause actual results to differ include (i) risks associated with conducting the NEW DAY study during a pandemic and other risks of such a study, including the risk that the results may not meet Alimera's expectations that it will position ILUVIEN as the preferred first-line treatment for DME, and (ii) regulatory and business risks in the countries in which Alimera's new partners are or will be seeking proper authorization for the sale of ILUVIEN. Other factors are 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, 2019 and Alimera's Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, which are on file with the Securities and Exchange Commission (SEC) and are available on the SEC's website at http://www.sec.gov. Applicable risk factors will also be described in those sections of Alimera's Quarterly Report on Form 10-Q for the third quarter of 2020, 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 due to new information, future events or otherwise.
For investor inquiries: For media inquiries: Scott Gordon Jules Abraham for Alimera Sciences for Alimera Sciences [email protected] [email protected]
ALIMERA SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)September 30, December 31, 2020 2019 (unaudited) CURRENT ASSETS: Cash and cash equivalents $ 11,254 $ 9,426 Restricted cash 32 33 Accounts receivable, net 15,628 19,331 Prepaid expenses and other current assets 3,177 2,565 Inventory 2,522 1,390 Total current assets 32,613 32,745 NON-CURRENT ASSETS: Property and equipment, net 1,582 940 Right of use assets, net 791 1,107 Intangible asset, net 13,327 14,783 Deferred tax asset 767 734 TOTAL ASSETS $ 49,080 $ 50,309 CURRENT LIABILITIES: Accounts payable $ 5,356 $ 7,077 Accrued expenses 3,475 4,716 Notes payable 1,185 — Finance lease obligations 219 255 Total current liabilities 10,235 12,048 NON-CURRENT LIABILITIES: Note payable, net of discount 42,459 38,658 Finance lease obligations — less current portion 452 94 Other non-current liabilities 3,567 3,954 COMMITMENTS AND CONTINGENCIES STOCKHOLDERS' DEFICIT: Preferred stock: Series A Convertible Preferred Stock 19,227 19,227 Series C Convertible Preferred Stock 9,474 11,117 Common stock 51 50 Additional paid-in capital 352,728 350,117 Common stock warrants 3,707 3,707 Accumulated deficit (391,932 ) (387,570 ) Accumulated other comprehensive loss (888 ) (1,093 ) TOTAL STOCKHOLDERS' DEFICIT (7,633 ) (4,445 ) TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT $ 49,080 $ 50,309
ALIMERA SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019
(in thousands, except share and per share data)Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 (unaudited) NET REVENUE $ 12,473 $ 12,850 $ 37,046 $ 36,595 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (1,537 ) (1,579 ) (4,949 ) (4,353 ) GROSS PROFIT 10,936 11,271 32,097 32,242 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 2,469 2,761 7,162 8,322 GENERAL AND ADMINISTRATIVE EXPENSES 2,619 3,121 8,775 10,189 SALES AND MARKETING EXPENSES 4,764 6,437 14,818 18,458 DEPRECIATION AND AMORTIZATION 677 668 2,016 1,974 OPERATING EXPENSES 10,529 12,987 32,771 38,943 NET INCOME (LOSS) FROM OPERATIONS 407 (1,716 ) (674 ) (6,701 ) INTEREST EXPENSE AND OTHER (1,285 ) (1,232 ) (3,928 ) (3,696 ) UNREALIZED FOREIGN CURRENCY GAIN (LOSS), NET 267 (115 ) 295 (135 ) NET LOSS BEFORE TAXES (611 ) (3,063 ) (4,307 ) (10,532 ) PROVISION FOR TAXES (7 ) (77 ) (55 ) (409 ) NET LOSS $ (618 ) $ (3,140 ) $ (4,362 ) $ (10,941 ) NET LOSS PER COMMON SHARE — Basic and diluted $ (0.12 ) $ (0.66 ) $ (0.87 ) $ (2.31 ) WEIGHTED AVERAGE COMMON SHARES OUTSTANDING — Basic and diluted 5,068,701 4,733,484 5,026,905 4,727,472
ALIMERA SCIENCES, INC.
CONSOLIDATING STATEMENTS OF OPERATIONS
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019
(in thousands)Three Months Ended Three Months Ended September 30, 2020 September 30, 2019 U.S. International Other Consolidated U.S. International Other Consolidated (unaudited) NET REVENUE $ 6,962 $ 5,511 $ — $ 12,473 $ 8,692 $ 4,158 $ — $ 12,850 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (746 ) (791 ) — (1,537 ) (1,001 ) (578 ) — (1,579 ) GROSS PROFIT 6,216 4,720 — 10,936 7,691 3,580 — 11,271 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,560 861 48 2,469 1,573 1,100 88 2,761 GENERAL AND ADMINISTRATIVE
EXPENSES1,952 475 192 2,619 2,032 768 321 3,121 SALES AND MARKETING EXPENSES 3,461 1,226 77 4,764 4,502 1,840 95 6,437 DEPRECIATION AND AMORTIZATION — — 677 677 — — 668 668 OPERATING EXPENSES 6,973 2,562 994 10,529 8,107 3,708 1,172 12,987 SEGMENT (LOSS) INCOME FROM OPERATIONS (757 ) 2,158 (994 ) 407 (416 ) (128 ) (1,172 ) (1,716 ) OTHER INCOME AND EXPENSES, NET — — (1,018 ) (1,018 ) — — (1,347 ) (1,347 ) NET LOSS BEFORE TAXES $ (611 ) $ (3,063 )
ALIMERA SCIENCES, INC.
CONSOLIDATING STATEMENTS OF OPERATIONS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019
(in thousands)Nine Months Ended Nine Months Ended September 30, 2020 September 30, 2019 U.S. International Other Consolidated U.S. International Other Consolidated (unaudited) NET REVENUE $ 17,449 $ 19,597 $ — $ 37,046 $ 22,778 $ 13,817 $ — $ 36,595 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (1,928 ) (3,021 ) — (4,949 ) (2,494 ) (1,859 ) — (4,353 ) GROSS PROFIT 15,521 16,576 — 32,097 20,284 11,958 — 32,242 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 4,580 2,418 164 7,162 4,629 3,361 332 8,322 GENERAL AND ADMINISTRATIVE EXPENSES 5,867 2,250 658 8,775 6,116 2,876 1,197 10,189 SALES AND MARKETING EXPENSES 10,948 3,618 252 14,818 12,760 5,324 374 18,458 DEPRECIATION AND AMORTIZATION — — 2,016 2,016 — — 1,974 1,974 OPERATING EXPENSES 21,395 8,286 3,090 32,771 23,505 11,561 3,877 38,943 SEGMENT (LOSS) INCOME FROM OPERATIONS (5,874 ) 8,290 (3,090 ) (674 ) (3,221 ) 397 (3,877 ) (6,701 ) OTHER INCOME AND EXPENSES, NET — — (3,633 ) (3,633 ) — — (3,831 ) (3,831 ) NET LOSS BEFORE TAXES $ (4,307 ) $ (10,532 )
RECONCILIATION OF GAAP MEASURES TO NON-GAAP ADJUSTED MEASURES
GAAP NET INCOME OR LOSS TO NON-GAAP ADJUSTED EBITDA
(in thousands)Three Months Ended
September 30,Nine Months Ended
September 30,2020 2019 2020 2019 (unaudited) GAAP NET LOSS $ (618 ) $ (3,140 ) $ (4,362 ) $ (10,941 ) Adjustments to net loss: Interest expense and other 1,285 1,232 3,928 3,696 Provision for taxes 7 77 55 409 Depreciation and amortization 677 668 2,016 1,974 Stock-based compensation expenses 317 504 1,074 1,903 Unrealized foreign currency exchange (gains) losses (267 ) 115 (295 ) 135 Severance expenses — 23 — 198 NON-GAAP ADJUSTED EBITDA $ 1,401 $ (521 ) $ 2,416 $ (2,626 ) -
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ATLANTA, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) ("Alimera" or the "Company"), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, announces today that it will report third quarter 2020 financial results on Wednesday, October 28, 2020 after the market close.
Management will host a conference call at 9:00 AM ET on Thursday, October 29, 2020 to review financial results and provide an update on corporate developments. Following management's formal remarks, there will be a question and answer session.
Participants are asked to pre-register for the call.
Please note that registered participants will receive their dial-in number upon registration and will dial directly into the call without delay. Those without Internet access or who are unable to pre-register may dial in by calling 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Alimera Sciences call.
The conference call will also be available through a live webcast, which is also available through the company's website.
A webcast replay of the call will be available approximately one hour after the end of the call through January 29, 2021. The webcast replay can be accessed through the above links or by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10149051. The telephonic replay will be available until November 12, 2020.
About Alimera Sciences, Inc.
Alimera Sciences 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.
For press inquiries: For investor inquiries: Jules Abraham Scott Gordon for Alimera Sciences for Alimera Sciences 917-885-7378 [email protected] [email protected] -
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ATLANTA, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, announces that clinical data for ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19mg will be featured in over 20 papers and presentations during the EURETINA 2020 Virtual Congress, to be held on October 2-4, 2020.
Key presentations include data supporting the safety and efficacy of ILUVIEN as a durable three-year continuous delivery system for the treatment of both diabetic macular edema and the prevention of relapse of non-infectious uveitis affecting the posterior segment.
Select ILUVIEN papers include:
Title: "3-year outcomes from the European Registry Safety Study: long-term observational data from patients with DME treated with the 0.19 FAc implant in clinical practice"
Author: Ramin Khoramnia, Associate Professor, Department of Ophthalmology, University of Heidelberg, Heidelberg, GermanyTitle: "NIU-PS treated with the FAc implant: a 3-year fellow eye subgroup analysis of the PSV-FAI-001 study"
Author: Carlos Pavesio, Consultant Ophthalmologist, Moorfields Eye Hospital, UKTitle: "UK Real-life long-term outcomes for patients treated with the 0.19 mg FAc implant for DME: 3-year follow-up from the Medisoft Audit Group"
Author: Claire Bailey, Consultant Ophthalmologist, Bristol Eye Hospital, UKAbout ILUVIEN
Alimera's primary product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Canada, Kuwait, Lebanon and the U.A.E to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. In 17 European countries, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In March 2019, ILUVIEN received approval in the 17 countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. These countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, the Czech Republic, the Netherlands, and Luxembourg. The non-infectious posterior uveitis indication for ILUVIEN was launched in Germany and the U.K. in 3Q 2019. ILUVIEN is not approved for treatment of uveitis in the United States.
About Diabetic Macular Edema (DME)
DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME.
About Non-Infectious Posterior Uveitis (NIPU)
Posterior segment non-infectious uveitis is a chronic, inflammatory disease affecting the posterior segment of the eye, often involving the retina, and is a leading cause of blindness in developed and developing countries. It affects people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. Patients with NIPU are typically treated with systemic steroids, which are effective, but over time frequently lead to serious side effects, ranging from acne, weight gain, sleep and mood disorders to hypertension and osteoporosis that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which also can have severe side effects, including an increased risk of cancer and infection. As a result, there remains a significant need for new therapies with improved efficacy, tolerability, and safety profiles to manage this disease.
About Alimera Sciences, Inc.
Alimera Sciences 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.
For press inquiries: For investor inquiries: Jules Abraham Scott Gordon for Alimera Sciences for Alimera Sciences 917-885-7378 [email protected] [email protected]
