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nice profit/\ 'Alimera Sciences (ALIM)' ?????
$$$$$ALIM, I AM SEEING OVER 0.30 ?????
$ALIM/\Recent Trades - Last 10 of 13
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09:07:46 Q 0.2838 0.0238 10
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08:59:01 Q 0.2705 0.0105 300
08:59:01 Q 0.275 0.015 1
08:56:09 Q 0.2527 -0.0073 50
* * $ALIM Video Chart 11-13-19 * *
Link to Video - click here to watch the technical chart video
News: $ALIM Alimera Sciences Terminates Equity Purchase Agreement
ATLANTA, Nov. 13, 2019 (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 it has terminated its $20.0 mill...
Find out more ALIM - Alimera Sciences Terminates Equity Purchase Agreement
$ALIM/ Recent Trades - Last 10 of 479
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09:53:04 Q 0.27 0.04 200
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this is huge item, cancelled deal for cash/ Alimera Sciences Terminates Equity Purchase Agreement.
November, 13 2019 08:00 AM | GlobeNewswire |
ATLANTA, Nov. 13, 2019 (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 it has terminated
its $20.0 million common stock purchase agreement with Lincoln Park Capital Fund, LLC (“LPC”), effective November 12, 2019.
“After assessing our expectations for the remainder of this year
and plans for 2020,
we have made the decision to terminate our equity purchase agreement.
Having completed the third quarter of 2019 at an annualized revenue
run rate in excess of $50 million,
we believe we have sufficient cash on hand to fund our operations throughout 2020,” said Rick Eiswirth, president and CEO of Alimera.
“Currently we believe that our common stock is
significantly undervalued
and we have no plans to issue equity at these levels.
We continue to expand the usage of ILUVIEN both domestically and internationally and believe the best course of action is to continue
to execute this plan without further dilution to our stockholders at this time.
We appreciate the commitment from LPC and their initial investment of $1.0 million.”
Other than the initial investment,
Alimera has not requested any additional purchases under the agreement.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization
and development of prescription ophthalmic pharmaceuticals for the management of retinal diseases.
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 our aging populations.
For more information, please visit http://www.alimerasciences.com.
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 MICRODOSINGTM technology, ILUVIEN is designed to release submicrogram levels of fluocinolone acetonide,
a corticosteroid,
for up to 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.
The 17 European countries include the U.K., Germany, France, Italy,
Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland,
Sweden, Poland, Czech Republic, the Netherlands, and Luxembourg.
The regulatory process is now in the national phase in which the European member states have finalized or are expected to finalize the label for the new indication to meet each country’s local requirements.
Timeline to this goal varies by each country. ILUVIEN is not approved for treatment of uveitis in the United States.
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 expectations that it has sufficient cash on hand to fund its operations throughout 2020, its belief that it has no plans to issue equity at the current trading price of its common stock, its expectations regarding its expansion of the usage of ILUVIEN both domestically and internationally and its belief that the best course of action is to continue to execute this plan without further dilution to its stockholders at this time. 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, (a) a slowdown or reduction in Alimera’s sales in due to a reduction in end user demand, unanticipated competition, regulatory issues, or other unexpected circumstances; and (b) other factors discussed in the “Special Note Regarding Forward-Looking Statements and Projections,” “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 its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2019, June 30, 2019, and September 30, 2019, which are on file with the Securities and Exchange Commission and available on its website at http://www.sec.gov.
For press inquiries:
Jules Abraham
for Alimera Sciences
917-885-7378
julesa@coreir.com
For investor inquiries:
Scott Gordon
for Alimera Sciences
scottg@coreir.com
I DRESSED IBOX UP SOME FOR ALL. Alimera Sciences (ALIM)'
WOW, LESS THAN 24 HR CALL FOR OVER $0.25 CENTS
$ALIM/ what ah pre-market opening. wow. ON TARGET AS I PROJECTED MY FRIEND
Nice call. I am in at $.20
I HAD IMPLANTS DONE, $5,000 EACH EYE. 'Alimera Sciences (ALIM)'
#2 $ALIM/\ILUVIEN® Patent Notices
Please see the following table for U.S. Patents covering ILUVIEN®. The absence of a U.S. Patent number as associated with ILUVIEN does not constitute a waiver of our patent, trademark, or other intellectual property rights concerning that product.
PRODUCT
PATENT NO.
ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg
U.S. 6,217,895
U.S. 6,375,972
U.S. 6,548,078
U.S. 8,252,307
U.S. 8,574,659
U.S. 8,871,241
$ALIM/\Recent Trades - Last 10 of 1534
Time ET Ex Price Change Volume
13:37:55 Q 0.2002 -0.0198 16,000
13:36:35 Q 0.2002 -0.0198 900
13:34:19 Q 0.2003 -0.0197 1
13:33:54 Q 0.205 -0.015 100
13:33:41 Q 0.2026 -0.0174 100
13:33:41 Q 0.2026 -0.0174 100
13:33:41 Q 0.2026 -0.0174 100
13:33:41 Q 0.2026 -0.0174 100
13:33:41 Q 0.2026 -0.0174 100
13:33:41 Q 0.2026 -0.0174 1,100
https://alimerasciences.com/
For press inquiries:
Jules Abraham
for Alimera Sciences
917-885-7378
julesa@coreir.com For investor inquiries:
Scott Gordon
for Alimera Sciences
scot
huge read/\Alimera Sciences Announces Third Quarter 2019 Financial Results and Provides Corporate Update
Tue October 29, 2019 4:42 PM|GlobeNewswire|About: ALIM
Q3: 10-29-19 Earnings Summary
10-Q Transcript
EPS of $-0.0426 misses by $-0.01 Revenue of $12.85M (15.38% Y/Y) beats by $0.05M
Third Quarter and Recent Company Highlights:
Consolidated Net Revenue Up 16% Compared to Third Quarter 2018
International Net Revenue Up 62% Compared to Third Quarter 2018
Launch of ILUVIEN® for Non-Infectious Posterior Uveitis in U.K. and Germany
Approval of ILUVIEN for Non-Infectious Posterior Uveitis Indication in Portugal
ATLANTA, Oct. 29, 2019 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (ALIM) (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 September 30, 2019. Alimera will host a conference call on Wednesday, October 30, 2019
at 9:00 AM ET to review these financial results and provide an update on corporate developments.
“We are pleased to report consolidated revenue of $12.9 million for the third quarter of 2019, a 16% gain over the third quarter of last year and significant growth over the recently reported second quarter of 2019,” said Rick Eiswirth, President and CEO of Alimera. “Our international business contributed greatly to our growth, delivering a 62% increase in revenue on a combined basis, and our U.S. sales team, which was fully staffed, delivered increases in end user demand month-to-month during the quarter.”
Third Quarter 2019 Financial Results
Net Revenue
Consolidated net revenue for the third quarter of 2019 grew 16% to $12.9 million, compared to $11.1 million for the third quarter of 2018. U.S. net revenue was $8.7 million during the third quarter of 2019, up 2% from $8.5 million during the same period in 2018, and up 19% over the second quarter of 2019. End user demand, which represents units purchased by physicians and pharmacies from Alimera’s U.S. distributors, decreased slightly for the third quarter of 2019, to 973 units compared to 978 units from the third quarter of 2018, but increased sequentially from 917 units in the second quarter of 2019 after the sales force was fully staffed.
The discrepancy between GAAP revenue and end user demand in the U.S. is due to the timing of distributor purchases from quarter to quarter. In the third quarter of 2018, Alimera’s distributors purchased approximately 5% more units than they sold to end users, increasing their stock on hand during that quarter. In the third quarter of 2019, Alimera’s distributors purchased approximately 9% more units than they sold to end users, increasing their stock on hand during the quarter.
International net revenue increased 62% to approximately $4.2 million during the third quarter of 2019, compared to approximately $2.6 million for the same period during 2018, driven by increased unit sales across all markets. We expect revenue in the international segment to fluctuate from quarter to quarter depending primarily on the timing and size of our international distributor ordering patterns.
Operating Expenses
Total operating expenses for the third quarter of 2019 increased by $600,000 or 5% to $13.0 million, compared to $12.4 million during the same period of 2018. The increase was primarily attributable to an approximately $900,000 increase in sales and marketing expenses, partially offset by a $300,000 decrease in general and administrative expenses. The increase in sales and marketing expenses was due to increases in personnel costs and marketing costs, including those related to our direct-to-patient campaign.
Net Loss and Non-GAAP Adjusted EBITDA
For the third quarter of 2019, Alimera reported a net loss of approximately $3.1 million, compared to a net loss of $3.5 million for the same period in 2018. “Adjusted EBITDA,” a non-GAAP financial measure defined below, was a loss of approximately $500,000 for the third quarter of 2019, compared to a similar Adjusted EBITDA loss for the third quarter of 2018.
Net (Loss) Income per Share
Basic and diluted net loss per share for the third quarter of 2019 was $0.04 on approximately 71.0 million weighted average shares outstanding. This compares to basic net income per share for the third quarter of 2018 of $0.40 on approximately 88.0 million weighted average shares outstanding, which includes approximately 17.9 million participating securities. Diluted net income per share for the third quarter of 2018 was $0.39 on approximately 88.5 million weighted average shares outstanding, which includes approximately 18.5 million dilutive and participating securities. Net income available to stockholders for the third quarter of 2018 was primarily attributable to the gain on the extinguishment of Alimera’s Series B Convertible Preferred Stock resulting from its exchange in September 2018 for new Series C Convertible Preferred Stock.
Cash and Cash Equivalents
As of September 30, 2019, Alimera had cash and cash equivalents of approximately $7.9 million, compared to $13.0 million in cash and cash equivalents as of December 31, 2018.
On October 25, 2019, Alimera announced a $20.0 million equity purchase agreement with Lincoln Park Capital Fund, LLC. Under that agreement, Lincoln Park has purchased $1.0 million of Alimera’s registered common stock. This agreement will provide a flexible and efficient option to invest in Alimera’s current business to pursue strategies to leverage its global sales infrastructure and build a leading company focused on the treatment of retinal diseases.
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 and losses from foreign currency exchange transactions, losses on extinguishment of debt 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 30, 2019
A live conference call will be hosted on October 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: Wednesday, October 30, 2019, 9:00 AM ET
Conference dial-in: 866-777-2509
International dial-in: 412-317-5413
Conference Call Name: Alimera Sciences (Nasdaq: ALIM) Third 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/10136395
Please 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/alimera191030.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: 1-877-344-7529
International Toll: 1-412-317-0088
Canada Toll Free: 855-669-9658
Replay Access Code: 10136395
End Date: November 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 nine months ended September 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 expectation regarding its use of the Lincoln Park purchase agreement to obtain capital and Alimera’s expectation that revenue in its international segment will fluctuate from quarter to quarter depending primarily on the timing and size of its international distributor ordering patterns. 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, (a) Alimera’s ability to satisfy the conditions in the purchase agreement to direct Lincoln Park to make purchases of common stock, (b) the possible negative effects on the market liquidity of Alimera’s common stock of the reverse stock split that Alimera expects to implement if its stockholders approve it at the upcoming special stockholders meeting on November 4, 2019, (c) changes in Alimera’s international sales 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 (d) 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 Reports on Form 10-Q for the first and second quarters 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 third 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.
$ALIM/\PPS $0.25 OR BETTER BEFORE REVERSE SPLIT ????? ANYONE ?????
$ALIM/\Alimera Sciences EPS in-line, beats on revenue,Oct. 29, 2019 4:45 PM ET|About: Alimera Sciences, Inc. (ALIM)|By: Pranav Ghumatkar, SA News Editor
Alimera Sciences (NASDAQ:ALIM): Q3 GAAP EPS of -$0.04 in-line.
Revenue of $12.85M (+15.4% Y/Y) beats by $0.05M.
Shares +9.55%.
Press Release
See all stocks on the move »
$ALIM/\WITH BETTER REVENUES REPORTED , I SEE AH SPIKE WHEN REVERSE SPLIT DONE.
NEWS/\Alimera Sciences Announces Equity Purchase Agreement for up to $20 Million with Lincoln Park Capital
ATLANTA, Oct. 25, 2019 (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 it has entered into a $20.0 million common stock purchase agreement with Lincoln Park Capital Fund, LLC (“LPC”), a Chicago-based institutional investor.
Upon entering into the agreement, LPC purchased $1.0 million of Alimera’s registered common stock at $0.50 per share, which represents a 35% premium to the closing market price of the stock on October 24, 2019.
Thereafter and upon satisfaction of the conditions in the agreement, Alimera, from time to time over a 36-month period, will have the right, in its sole discretion, to sell up to an additional $19.0 million of its common stock to LPC. Alimera will control the timing and amount of any future sale of shares of common stock to LPC, and LPC is obligated to make purchases according to Alimera’s direction, as governed by the agreement. There are no upper limits to the price per share LPC may pay to purchase common stock from Alimera, and the purchase price of the shares will be based on the prevailing market prices of Alimera’s common shares at the time of each sale to LPC.
“The LPC commitment affords Alimera a flexible option to invest in our current business to pursue strategies to leverage our global sales infrastructure and build a leading company focused on the treatment of retinal diseases,” said Rick Eiswirth, president and CEO of Alimera. “The terms of the Agreement provide a low-cost option with no restrictive covenants or warrants. In addition, we have gained an institutional investor that has made a commitment in support of our company, as evidenced by their initial investment at a premium to the market, as we make progress in the business and build shareholder value.”
Alimera will use the net proceeds from the sales for general corporate purposes, including funding intended to facilitate the continued commercialization and growth of ILUVIEN® in the United States and in international territories, launches of ILUVIEN in new international territories, launches of ILUVIEN’s second indication for non-infectious posterior uveitis in international markets, and for potential strategic initiatives.
LPC has agreed not to engage in any direct or indirect short selling or hedging of Alimera’s shares of common stock. There are no limitations on the use of proceeds, and there are no rights of first refusal, participation rights, penalties or liquidated damages in the purchase agreement. As consideration for Lincoln Park’s commitment to purchase shares of common stock pursuant to the purchase agreement, Alimera issued 1,363,636 shares of common stock to Lincoln Park. Alimera may terminate the purchase agreement at any time, at its discretion, without any additional cost or penalty. The common stock purchase agreement and a related registration rights agreement are summarized in Alimera’s Current Report on Form 8-K filed today with the Securities and Exchange Commission (SEC).
This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals for the management of retinal diseases. 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 our aging populations. For more information, please visit www.alimerasciences.com.
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, 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. The 17 European countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czech Republic, the Netherlands, and Luxembourg. The regulatory process is now in the national phase in which the European member states have finalized or are expected to finalize the label for the new indication to meet each country’s local requirements. Timeline to this goal varies by each country. ILUVIEN is not approved for treatment of uveitis in the United States.
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 expectations regarding its use of the common stock purchase agreement to obtain capital. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change these expectations, and could cause actual results to differ materially from those projected in these forward-looking statements. Meaningful factors that could cause actual results to differ include, but are not limited to, the ability of Alimera to meet the terms and conditions of the agreement, the possible negative effects on the market liquidity of Alimera’s common stock of the reverse stock split that Alimera expects to implement if its stockholders approve it at the upcoming special stockholders meeting on November 4, 2019, Alimera’s ability to satisfy the conditions in the purchase agreement to direct Lincoln Park to make purchases of common stock, the effect such capital may have on the success of ILUVIEN in current markets or on any expansion into new markets, the receptiveness of current and future markets to ILUVIEN and 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 its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2019, and June 30, 2019, which are on file with the Securities and Exchange Commission and available on its website at http://www.sec.gov.
For press inquiries:
Jules Abraham
for Alimera Sciences
917-885-7378
julesa@coreir.com For investor inquiries:
Scott Gordon
for Alimera Sciences
scottg@coreir.com
Source: Alimera Sciences, Inc.
© 2019 GlobeNewswire, Inc.
PEOPLE WITH RETINA PROBLEMS , PEOPLE DID GO EUROPE FOR THIS PROCURE,
$ALIM/\thank you charting, rock btm but going to be strong recovery pps imho
$ALIM REVIEW/ Alimera Sciences Launches ILUVIEN(R) in Germany For Non-Infectious Uveitis Indication
8:02 am ET September 3, 2019 (Globe Newswire) Print
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 it will immediately commence the launch of ILUVIEN in Germany for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU).
Following the European Union's Mutual Recognition Procedure in March 2019, Germany is the second country in Europe in which ILUVIEN is now commercially available to be prescribed to patients suffering from NIPU, a disease with no sustained treatment options. In June 2019, Alimera announced a positive recommendation by the National Institute for Health and Care Excellence (NICE), facilitating launch of the NIPU indication in the United Kingdom.
"New therapeutics for non-infectious uveitis are urgently needed, as there are few options available while potential for vision loss is very real.
The availability of ILUVIEN now provides a long-acting, intravitreal treatment option for our patients that closes a gap in the care needs of this chronic disease," said Professor Dr. med. Carsten Heinz FEBO, Augenzentrum am St. Franziskus-Hospital, Munster, Germany. "ILUVIEN has a well-established efficacy and safety profile for the continuous treatment of diabetic macular edema and now patients with non-infectious uveitis affecting the posterior segment can expect similar benefits and
- due to the local application
- no occurrence of the unwanted systemic effects of long-term corticosteroid therapy."
Launch of the NIPU indication follows the establishment of national pricing and receipt of the required regulatory approval by the Federal Institute for Drugs and Medical Devices (Bundesinstitut fur Arzneimittel und Medizinprodukte or BfArM),
the medical regulatory authority in Germany. Germany is Alimera's largest direct market in Europe based on current sales for ILUVIEN's diabetic macular edema (DME) indication, and it is estimated that the number of patients diagnosed with NIPU is approximately 15-20% of the DME patient population.
"The launch in Germany represents our second country rollout for ILUVIEN's expanded European indication for uveitis, a retinal disease that anti-VEGF drugs do not treat," said Rick Eiswirth, president and CEO of Alimera Sciences.
"We continue to receive encouraging feedback from physicians regarding ILUVIEN's unique CONTINUOUS MICRODOSING(TM) technology, with its ability to reduce the recurrence of disease in patients diagnosed with either non-infectious posterior uveitis or DME."
About Non-Infectious Posterior Uveitis
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 non-infectious posterior uveitis (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 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 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.
The 17 European countries include the
U.K., Germany, France, Italy, Spain,
Portugal, Ireland, Austria, Belgium, Denmark,
Norway, Finland, Sweden, Poland, Czech Republic,
the Netherlands, and Luxembourg.
The regulatory process is now in the national phase in which the European member states have finalized or are expected to finalize the label for the new indication to meet each country's local requirements.
Timeline to this goal varies by each country. ILUVIEN is not approved for treatment of uveitis in the United States.
See www.ILUVIEN.com for important safety information.
About Alimera Sciences, Inc.
http://www.alimerasciences.com
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals for the management of retinal diseases.
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 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 belief that ILUVIEN's CONTINUOUS MICRODOSING technology has the ability to reduce the recurrence of disease in patients diagnosed with non-infectious posterior uveitis or DME, and that ILUVIEN will launch as planned in Germany.
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 its forward-looking statements.
Meaningful factors that could cause actual results to differ include, but are not limited to, 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, which is on file with the Securities and Exchange Commission and available on its website at http://www.sec.gov.
For press inquiries: For investor inquiries:
Jules Abraham Scott Gordon
for Alimera Sciences for Alimera Sciences
917-885-7378 scottg@coreir.com
julesa@coreir.com
https://ml.globenewswire.com/media/2c43c8f6-cf4d-40bd-a9b2-9a240f7961b8/small/alimera-sciences-inc-logo-jpg.jpg
$ALIM/\Recent Trades - Last 10 of 1155
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INTERESTING REVERSE SPLIT. $ALIM
HI PETER, WELCOME TO $ALIM, LOT AH ROOM FOR PROFIT/
Nice news... Vol spike last 3 days here
News: $ALIM Alimera Sciences Announces Equity Purchase Agreement for up to $20 Million with Lincoln Park Capital
ATLANTA, Oct. 25, 2019 (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 it has entered into a $20.0 mill...
Read the whole news ALIM - Alimera Sciences Announces Equity Purchase Agreement for up to $20 Million with Lincoln Park Capital
Alimera Sciences Announces Equity Purchase Agreement for up to $20 Million with Lincoln Park Capital
ATLANTA, October 25, 2019 – 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 it has entered into a $20.0 million common stock purchase agreement with Lincoln Park Capital Fund, LLC (“LPC”), a Chicago-based institutional investor.
Upon entering into the agreement, LPC purchased $1.0 million of Alimera’s registered common stock at $0.50 per share, which represents a 35% premium to the closing market price of the stock on October 24, 2019.
Thereafter and upon satisfaction of the conditions in the agreement, Alimera, from time to time over a 36-month period, will have the right, in its sole discretion, to sell up to an additional $19.0 million of its common stock to LPC. Alimera will control the timing and amount of any future sale of shares of common stock to LPC, and LPC is obligated to make purchases according to Alimera’s direction, as governed by the agreement. There are no upper limits to the price per share LPC may pay to purchase common stock from Alimera, and the purchase price of the shares will be based on the prevailing market prices of Alimera’s common shares at the time of each sale to LPC.
“The LPC commitment affords Alimera a flexible option to invest in our current business to pursue strategies to leverage our global sales infrastructure and build a leading company focused on the treatment of retinal diseases,” said Rick Eiswirth, president and CEO of Alimera. “The terms of the Agreement provide a low-cost option with no restrictive covenants or warrants. In addition, we have gained an institutional investor that has made a commitment in support of our company, as evidenced by their initial investment at a premium to the market, as we make progress in the business and build shareholder value.”
Alimera will use the net proceeds from the sales for general corporate purposes, including funding intended to facilitate the continued commercialization and growth of ILUVIEN® in the United States and in international territories, launches of ILUVIEN in new international territories, launches of ILUVIEN’s second indication for non-infectious posterior uveitis in international markets, and for potential strategic initiatives.
LPC has agreed not to engage in any direct or indirect short selling or hedging of Alimera’s shares of common stock. There are no limitations on the use of proceeds, and there are no rights of first refusal, participation rights, penalties or liquidated damages in the purchase agreement. As consideration for Lincoln Park’s commitment to purchase shares of common stock pursuant to the purchase agreement, Alimera issued 1,363,636 shares of common stock to Lincoln Park. Alimera may terminate the purchase agreement at any time, at its discretion, without any additional cost or penalty. The common stock purchase agreement and a related registration rights agreement are summarized in Alimera’s Current Report on Form 8-K filed today with the Securities and Exchange Commission (SEC).
News: $ALIM Alimera Announces Expansion of Agreement with Distribution Partner Horus Pharma to Include Marketing ILUVIEN® in Benelux Countries
ATLANTA, Sept. 12, 2019 (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 it has expanded its relationship wit...
Read the whole news ALIM - Alimera Announces Expansion of Agreement with Distribution Partner Horus Pharma to Include Marketing ILUVIEN® in Benelux Countries
R/S !!! .00000000001
Alimera Sciences Launches ILUVIEN(R) in Germany For Non-Infectious Uveitis Indication
8:02 am ET September 3, 2019 (Globe Newswire) Print
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 it will immediately commence the launch of ILUVIEN in Germany for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU).
Following the European Union's Mutual Recognition Procedure in March 2019, Germany is the second country in Europe in which ILUVIEN is now commercially available to be prescribed to patients suffering from NIPU, a disease with no sustained treatment options. In June 2019, Alimera announced a positive recommendation by the National Institute for Health and Care Excellence (NICE), facilitating launch of the NIPU indication in the United Kingdom.
"New therapeutics for non-infectious uveitis are urgently needed, as there are few options available while potential for vision loss is very real.
The availability of ILUVIEN now provides a long-acting, intravitreal treatment option for our patients that closes a gap in the care needs of this chronic disease," said Professor Dr. med. Carsten Heinz FEBO, Augenzentrum am St. Franziskus-Hospital, Munster, Germany. "ILUVIEN has a well-established efficacy and safety profile for the continuous treatment of diabetic macular edema and now patients with non-infectious uveitis affecting the posterior segment can expect similar benefits and
- due to the local application
- no occurrence of the unwanted systemic effects of long-term corticosteroid therapy."
Launch of the NIPU indication follows the establishment of national pricing and receipt of the required regulatory approval by the Federal Institute for Drugs and Medical Devices (Bundesinstitut fur Arzneimittel und Medizinprodukte or BfArM),
the medical regulatory authority in Germany. Germany is Alimera's largest direct market in Europe based on current sales for ILUVIEN's diabetic macular edema (DME) indication, and it is estimated that the number of patients diagnosed with NIPU is approximately 15-20% of the DME patient population.
"The launch in Germany represents our second country rollout for ILUVIEN's expanded European indication for uveitis, a retinal disease that anti-VEGF drugs do not treat," said Rick Eiswirth, president and CEO of Alimera Sciences.
"We continue to receive encouraging feedback from physicians regarding ILUVIEN's unique CONTINUOUS MICRODOSING(TM) technology, with its ability to reduce the recurrence of disease in patients diagnosed with either non-infectious posterior uveitis or DME."
About Non-Infectious Posterior Uveitis
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 non-infectious posterior uveitis (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 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 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.
The 17 European countries include the
U.K., Germany, France, Italy, Spain,
Portugal, Ireland, Austria, Belgium, Denmark,
Norway, Finland, Sweden, Poland, Czech Republic,
the Netherlands, and Luxembourg.
The regulatory process is now in the national phase in which the European member states have finalized or are expected to finalize the label for the new indication to meet each country's local requirements.
Timeline to this goal varies by each country. ILUVIEN is not approved for treatment of uveitis in the United States.
See www.ILUVIEN.com for important safety information.
About Alimera Sciences, Inc.
http://www.alimerasciences.com
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals for the management of retinal diseases.
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 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 belief that ILUVIEN's CONTINUOUS MICRODOSING technology has the ability to reduce the recurrence of disease in patients diagnosed with non-infectious posterior uveitis or DME, and that ILUVIEN will launch as planned in Germany.
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 its forward-looking statements.
Meaningful factors that could cause actual results to differ include, but are not limited to, 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, which is on file with the Securities and Exchange Commission and available on its website at http://www.sec.gov.
For press inquiries: For investor inquiries:
Jules Abraham Scott Gordon
for Alimera Sciences for Alimera Sciences
917-885-7378 scottg@coreir.com
julesa@coreir.com
https://ml.globenewswire.com/media/2c43c8f6-cf4d-40bd-a9b2-9a240f7961b8/small/alimera-sciences-inc-logo-jpg.jpg
ALIM News: Alimera Sciences Launches ILUVIEN® in Germany For Non-Infectious Uveitis Indication 08:00 AM
ALIM News: Quarterly Report (10-q) 08/06/2019 04:33:15 PM
ALIM News: Alimera Announces ILUVIEN® Regulatory Approval in Australia for the Treatment of Diabetic Macular Edema 08/05/2019 08:00:00 AM
ALIM News: Current Report Filing (8-k) 07/30/2019 08:11:34 AM
ALIM News: Alimera Sciences Announces Second Quarter 2019 Financial Results and Provides Corporate Update 07/29/2019 06:51:28 PM
News News Alert: Alimera Sciences Launches ILUVIEN® in Germany For Non-Infectious Uveitis Indication
IN GERMANY TODAY , NEWS- 'Alimera Sciences (ALIM)'
Alimera Sciences Inc (ALIM)
0.3802 ? -0.0358 (-8.61%)
Volume: 103,796 @09/03/19 4:45:22 PM EDT
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ALIM Detailed Quote
AWFULLY CHEAP $ALIM
Diabetic Macular Edema needs a more convenient therapy. DME is a $2 Billion Market Opportunity--GLOBAL.
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Alimera Sciences, Inc. (Alimera) is committed to conducting its business in compliance with all applicable laws, rules, and regulations and the highest standards of ethical conduct. To this end, we have established and will maintain a Comprehensive Compliance Program (“Compliance Program”) in accordance with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers (the “OIG Guidance”) published by the Office of Inspector General, U.S. Department of Health and Human Services. Our Compliance Program is a key component of our commitment to adhering to the highest standards of corporate responsibility and fostering a culture of compliance that places a premium on doing business with integrity. Our Program also incorporates the Code on Interactions with Healthcare Professionals published by the Pharmaceutical Research and Manufacturers of America.
We have designed our Compliance Program to (1) prevent, detect, and remediate violations of applicable laws, rules, and regulations, as well as Alimera’s policies and procedures and (2) promote a culture of the highest ethics within the company. It is Alimera’s expectation that employees will comply with our Code of Business Conduct and the policies and procedures established in support of that Code. As the OIG Guidance recognizes, however, the implementation of a Compliance Program cannot guarantee the elimination of improper employee conduct.
As recognized in the OIG Guidance, we have tailored our Compliance Program — the fundamental elements of which we have described below – to fit the unique environment of our company. Moreover, our Compliance Program is dynamic and we regularly review and enhance our Program to meet our evolving compliance needs.
You may obtain a copy of this Compliance Program description by calling 1-844-445-8843.
Compliance Officer. Alimera has appointed a Compliance Officer who is charged with developing, implementing, and monitoring the Compliance Program. We will ensure that the Compliance Officer has the ability to exercise independent judgment and, as necessary, effectuate change within the company. The Compliance Officer reports to the President and Chief Executive Officer of Alimera, is a member of Alimera’s Executive Management team, and has direct access to the Alimera Board of Directors.
Compliance Committee. Alimera has established a Compliance Committee made up of Alimera senior management. The role of the Compliance Committee is to advise and assist the Compliance Officer in the development, implementation, and ongoing oversight of the Compliance Program. The Compliance Committee meets on a regular basis to identify and manage areas of risk and areas of critical focus for the Compliance Program.
Alimera has established written policies and procedures, including our Code of Business Conduct, which articulates our fundamental principles and values and provides a framework for ethical conduct within our company. The Code of Business Conduct establishes our expectation that management, employees, and agents of Alimera act in accordance with all applicable laws, rules, and regulations; Alimera’s policies and procedures; and the highest standards of ethics.
In accordance with California law, Alimera has established an annual spending limit for certain promotional activities directed toward healthcare professionals who prescribe or may influence prescribing in California. At the present time our annual, per-prescriber spending limit is $1,500. Examples of items that fall within this spending limit are occasional modest meals in connection with informational presentations and educational items.
This annual spending limit does not include payments to healthcare professionals for bona fide consulting or other services.
It is Alimera’s policy to not provide any item of value to any healthcare professional with the intent of influencing that healthcare professional’s prescribing habits.
A crucial element of our Compliance Program is the education and training of our employees on their legal and ethical obligations under applicable laws, rules, regulations, and company policies and procedures. Alimera regularly communicates our policies and procedures to promote a thorough understanding of the company’s expectations and regularly reviews and updates our training initiatives.
Alimera actively fosters dialogue between management and employees. Our goal is that all employees should know to whom to turn when seeking answers to questions or reporting possible violations of company policies or procedures, and understand that they can make such reports without fear of retaliation. To that end, we have adopted open-door and non-retaliation policies. We have a toll-free compliance helpline to which employees of Alimera may anonymously raise questions or report any concerns or suspected violations of applicable laws, rules, regulations, or Alimera policies or procedures.
Alimera’s Compliance Program includes monitoring and auditing to evaluate adherence to Alimera’s policies and procedures.
We note that, in accordance with the OIG Guidance, the nature, extent, and frequency of our compliance monitoring and auditing
may vary according to new regulatory requirements, changes in business practices, and other considerations.
When Alimera becomes aware of potential violations of applicable laws, rules, or regulations or company policies or procedures,
the company will promptly investigate such matters and make a determination as to whether the facts substantiate the existence of a violation.
Alimera will document the conduct of such investigations.
While each substantiated violation will be considered on a case-by-case basis, where appropriate we will utilize disciplinary action consistent
with company policy to address violative conduct and to deter future violations.
We will also work to determine the root cause of the violation and assess whether the violation is due to gaps in company policies or procedures
and take appropriate corrective action designed to prevent future violations.
Alimera Sciences, Inc. hereby declares that, to the best of our knowledge, information, and belief,
and based upon our good-faith understanding of the statutory requirements, we have, as of March 3, 2015,
established a Comprehensive Compliance Program that is in material compliance with the requirements of California Health and Safety Code §§ 119400-119402.
While Alimera’s Comprehensive Compliance Program cannot completely eliminate the possibility that an individual employee will engage in improper conduct,
our Program is reasonably designed to prevent and detect violations of applicable laws, rules, and regulations, as well as our own internal policies and procedures.
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