Alimera Sciences, Inc. (NASDAQ:ALIM), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced financial results for the quarter ended September 30, 2016.
Highlights
| • | U.S. revenue increased 24% in the third quarter of 2016 compared to the third quarter of 2015. |
| • | International revenue increased 11% in the third quarter of 2016 compared to the third quarter of 2015. |
| • | Closing of $26.5 million public offering in 3rd quarter and restructuring of Alimera’s existing loan facility in October provides working capital to drive towards profitability |
| • | First shipments to the Middle East market. |
“Despite seasonality effects on our July business, we had very strong August and September sales reflecting the need for an alternative to anti-VEGF therapy and the increasing acceptance of corticosteroid use in treating DME,” said Dan Myers, Alimera’s Chief Executive Officer. “We are pleased to see the rising awareness that ILUVIEN is the only drug therapy that can treat the disease consistently every day by providing a continuous daily microdose,” continued Mr. Myers. “This represents a significant paradigm shift for physicians who are in the habit of using shorter duration high dose therapies that must be frequently repeated for many patients to achieve control of their DME. Change takes time, but we remain confident that that we have the most effective therapy to treat DME supported by our generation of real world data in Europe that reinforces the efficacy and safety benefits of ILUVIEN,” concluded Mr. Myers.
Middle East Distributor
Alimera recently announced that it had begun shipping ILUVIEN to MEAgate International FZLLC, its distribution partner headquartered in Dubai, for named patient sales in the Middle East. Alimera also announced that the first patient was treated in the Middle East in the third quarter of 2016. Further, a pricing code was published in Abu Dhabi in October of 2016, providing for reimbursement in that emirate of the United Arab Emirates. It is anticipated that other emirates and countries in the Middle East will adopt similar reimbursement coding.
Financing Activities
During the third quarter of 2016, Alimera closed an underwritten public offering in which it sold 18,900,000 shares of its common stock at a price to the public of $1.40 per share, resulting in gross proceeds of $26.5 million. In October 2016, Alimera amended its $35 million loan facility with Hercules Capital, Inc. to provide for an extended interest only period and term and provide up to $10 million in additional financing upon the achievement of certain revenue milestones.
“The third quarter equity raise and recent amendment of our loan facility strengthen our financial position for the continued commercialization of ILUVIEN in the U.S., the United Kingdom, Germany and Portugal. We believe that we have mitigated the need to seek additional financing and that we are positioned to achieve positive cash flow with our existing resources,” said Rick Eiswirth, Alimera’s President and Chief Financial Officer. “Further, the loan facility amendment provides us with the potential to access additional funds in the future for expansion elsewhere in Europe or, upon the achievement of positive cash flow, clinical trials for possible extension of the ILUVIEN label.”
Third Quarter 2016 Financial Results
Consolidated net revenues increased by $1.4 million, or 20%, to $8.3 million for the three months ended September 30, 2016, compared to consolidated net revenues of $6.9 million for the three months ended September 30, 2015. The increase was primarily driven by an increase in sales volume as ILUVIEN continues to gain market acceptance in the U.S.
U.S. net revenue increased by approximately $1.2 million, or 24%, to $6.2 million for the three months ended September 30, 2016, compared to $5.0 million for the three months ended September 30, 2015.
International net revenue increased by approximately $200,000, or 11%, to $2.1 million for the three months ended September 30, 2016, compared to $1.9 million for the three months ended September 30, 2015.
Consolidated gross profit increased by $1.5 million, or 24%, to $7.8 million for the three months ended September 30, 2016, compared to $6.3 million for the three months ended September 30, 2015.
Gross margin for the three months ended September 30, 2016 increased to 94.1%, compared to 90.8% for the three months ended September 30, 2015.
Consolidated research, development and medical affairs expenses for the three months ended September 30, 2016 decreased to $3.3 million, compared to $4.1 million for the three months ended September 30, 2015.
Consolidated general and administrative expenses for the three months ended September 30, 2016 increased to $3.6 million, compared to $3.0 million for the three months ended September 30, 2015.
Consolidated sales and marketing expenses for the three months ended September 30, 2016 increased to $7.5 million, compared to $6.9 million for the three months ended September 30, 2015.
Alimera’s GAAP net loss attributable to common stockholders for the three months ended September 30, 2016 was $9.2 million, compared to $1.5 million for the three months ended September 30, 2015.
Basic and diluted net loss per share for the three months ended September 30, 2016 was $0.16 on approximately 56.1 million weighted average shares outstanding, compared with basic and diluted net loss per share of $0.03 on approximately 44.4 million weighted average shares outstanding for the three months ended September 30, 2015.
GAAP net loss attributable to common stockholders and basic and diluted net loss per share were affected by certain non-cash items including unrealized foreign currency gains and losses, changes in the fair value of a derivative warrant liability, and a loss on the early extinguishment of debt.
Non-GAAP adjusted net loss attributable to common stockholders for the three months ended September 30, 2016 was approximately $8.6 million, compared to a non-GAAP adjusted net loss attributable to common stockholders for the three months ended September 30, 2015 of approximately $9.8 million.
Reconciliations of GAAP net loss attributable to common stockholders to non-GAAP adjusted net loss attributable to common stockholders are included below in the table titled “Reconciliation of GAAP Measures to Non-GAAP Adjusted Measures.”
As of September 30, 2016, Alimera had $33.9 million in cash and cash equivalents.
Conference Call to be Held November 3, 2016
A conference call will be hosted by Dan Myers, Chief Executive Officer and Rick Eiswirth, President and Chief Financial Officer to discuss the results and provide commercial and other business updates. The call will be held at 10:00 AM ET, on November 3, 2016. Please refer to the information below for conference call dial-in information and webcast registration.
Conference date: November 3, 2016, 10:00 AM ET
Conference dial-in: 877-269-7756
International dial-in: 201-689-7817
Conference Call Name: Alimera Sciences’ Third Quarter 2016 Results Call
Webcast Registration: Click Here
Following the live call, a replay will be available on Alimera’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 affect millions of people in aging populations.
Alimera’s commitment to retina specialists and their patients is manifest in Alimera’s product and development portfolio designed to treat early- and late-stage diseases. For more information, please visit www.alimerasciences.com.
