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Exhibit 99.1









Picture 2





 

 

 



FOR IMMEDIATE RELEASE

 

 



Alimera Sciences Announces Second Quarter 2020 Financial Results and Provides Corporate Update



Second Quarter and Recent Company Highlights:

·

Consolidated Net Revenue Down 8% Compared to Second Quarter 2019

·

International Net Revenue Up 89% Compared to Second Quarter 2019

·

Net Loss of $2.5 Million vs. $5.0 Million in Second Quarter 2019

·

Adjusted EBITDA Loss of $0.3 Million vs. $2.1 Million in Second Quarter 2019



ATLANTA (July 29, 2020) – 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 three months ended June 30, 2020. Alimera will host a conference call on Thursday,  July 30, 2020 at 9:00 AM ET to review these financial results and provide an update on corporate developments.



The second quarter of 2020 was a successful quarter for Alimera Sciences in the context of the COVID-19 pandemic, having delivered $10 million in revenue, decreasing only 8% versus the second quarter of 2019, despite limited access to patients. We leveraged our geographic diversity and the late 2019 European launch of ILUVIEN for uveitis while managing our expenses. These results led to improvements in net loss and adjusted EBITDA compared to the second quarter of 2019,” said Rick Eiswirth, Alimera’s President and Chief Executive Officer.  “As we move through the COVID-19 pandemic, we believe that physicians will see ILUVIEN in a new light. Having not made any changes to our staffing levels across the organization, we believe we are positioned to communicate how ILUVIEN provides significant long-term clinical benefits while reducing the number of visits for high-risk patients. ILUVIEN can also help doctors work through their backlog of patients who have been left untreated or undertreated during the pandemic. 

Second Quarter 2020 Financial Results


Net Revenue

Consolidated net revenue for Q2 2020 was down 8% to $10.0 million, compared to $10.9 million for Q2 2019.  



 


 

 

 

U.S. net revenue was $3.4 million for Q2 2020,  down 53% from $7.3 million during the same period in 2019. End user demand, which represents units purchased by physicians and pharmacies from Alimera’s U.S. distributors, was 625 units in Q2 2020 compared to 917 units in Q2 2019, a decrease of 32%, as a result of lower demand due to COVID-19. Additionally, our distributors lowered their inventory levels and purchased approximately 36% fewer units than they sold to end users as weekly volumes decreased in the second quarter due to COVID-19.



International net revenue increased 89% to approximately $6.6 million in Q2 2020, compared to approximately $3.5 million for the same period during 2019, driven primarily by increasing sales behind the posterior uveitis indication in the U.K. and Germany and by increased business in our distributor markets.



Operating Expenses
Total operating expenses for Q2 2020 decreased by $3.4 million or 26% to $9.9 million, compared to $13.3 million during Q2 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 activities.  



Net Loss and Non-GAAP Adjusted EBITDA

For Q2 2020, Alimera reported a net loss of approximately $2.5 million, compared to a net loss of $5.0 million for Q2 2019. “Adjusted EBITDA,” a non-GAAP financial measure defined below, was a loss of approximately $0.3 million for Q2 2020, compared to a loss of approximately $2.1 million for Q2 2019.



Net Loss per Share

Basic and diluted net loss per share for Q2 2020 was $(0.51). This compares to basic and diluted net loss per share for Q2 2019 of $(1.06). 



Cash and Cash Equivalents

As of June 30, 2020, Alimera had cash and cash equivalents of approximately $13.5 million, compared to $12.2 million in cash and cash equivalents as of March 31, 2020.



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 July 30, 2020

Management will host a conference call at 9:00 AM ET on Thursday, July 30, 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 through the following link: http://dpregister.com/10145768. 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 can be accessed through the following link: https://services.choruscall.com/links/alimera200730.html, which is also available through the company’s website at https://investors.alimerasciences.com/ALIM/events/3819.



A webcast replay of the call will be available approximately one hour after the end of the call through October 30, 2020. 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 10145768. The telephonic replay will be available until August 13, 2020.

About Alimera Sciences, Inc.

www.alimerasciences.com

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 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 six months ended June 30, 2020 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.

 


 

 

 







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., 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 and 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 (a) how physicians will view ILUVIEN in light of current circumstances, and (b) Alimera being positioned to communicate how ILUVIEN provides significant long-term clinical benefits while reducing the number of visits for high-risk patients.  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, physicians may elect to continue to use anti-VEGF treatments as before without adding ILUVIEN to the treatment regimen or substituting ILUVIEN for anti-VEGF treatments, or other unexpected circumstances, and risks that include continuing risks relating to the COVID-19 pandemic, such as increased COVID-19 cases in certain states 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. 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 Report on Form 10-Q for the quarter ended March 31, 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 second 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 as a result of new information, future events or otherwise.



For investor inquiries:                                                  For media inquiries:

Scott Gordon                                                                   Jules Abraham

for Alimera Sciences                                                      for Alimera Sciences
scottg@coreir.com                                                         julesa@coreir.com


 #  #

     

















































 


 

 

 

ALIMERA SCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)



 

 

 

 

 



 

 

 

 

 



June 30,

 

December 31,



2020

 

2019



(unaudited)

 

 

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

$

13,496 

 

$

9,426 

Restricted cash

 

31 

 

 

33 

Accounts receivable, net

 

14,034 

 

 

19,331 

Prepaid expenses and other current assets

 

2,942 

 

 

2,565 

Inventory (Note 7)

 

1,968 

 

 

1,390 

Total current assets

 

32,471 

 

 

32,745 

NON-CURRENT ASSETS:

 

 

 

 

 

Property and equipment, net

 

1,205 

 

 

940 

Right of use assets, net

 

867 

 

 

1,107 

Intangible asset, net (Note 8)

 

13,816 

 

 

14,783 

Deferred tax asset

 

735 

 

 

734 

TOTAL ASSETS

$

49,094 

 

$

50,309 

CURRENT LIABILITIES:

 

 

 

 

 

Accounts payable

$

5,884 

 

$

7,077 

Accrued expenses

 

3,140 

 

 

4,716 

Notes payable

 

889 

 

 

 —

Finance lease obligations

 

226 

 

 

255 

Total current liabilities

 

10,139 

 

 

12,048 

NON-CURRENT LIABILITIES:

 

 

 

 

 

Note payable, net of discount (Note 10)

 

42,510 

 

 

38,658 

Finance lease obligations — less current portion

 

311 

 

 

94 

Other non-current liabilities

 

3,664 

 

 

3,954 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

STOCKHOLDERS’ DEFICIT:

 

 

 

 

 

Preferred stock, $.01 par value — 10,000,000 shares authorized at June 30, 2020 and December 31, 2019:

 

 

 

 

 

Series A Convertible Preferred Stock, 1,300,000 authorized and 600,000 issued and outstanding at June 30, 2020 and December 31, 2019; liquidation preference of $24,000 at June 30, 2020 and December 31, 2019

 

19,227 

 

 

19,227 

Series C Convertible Preferred Stock, 10,150 authorized issued and outstanding at June 30, 2020 and December 31, 2019; liquidation preference of $10,150 at June 30, 2020 and December 31, 2019

 

11,117 

 

 

11,117 

Common stock, $.01 par value — 150,000,000 shares authorized, 5,031,745 shares issued and outstanding at June 30, 2020 and 4,965,949 shares issued and outstanding at December 31, 2019

 

50 

 

 

50 

Additional paid-in capital

 

350,769 

 

 

350,117 

Common stock warrants

 

3,707 

 

 

3,707 

Accumulated deficit

 

(391,314)

 

 

(387,570)

Accumulated other comprehensive loss

 

(1,086)

 

 

(1,093)

TOTAL STOCKHOLDERS’ DEFICIT

 

(7,530)

 

 

(4,445)

TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT

$

49,094 

 

$

50,309 

 


 

 

 

ALIMERA SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2020 AND 2019

(in thousands, except share and per share data)





 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 



Three Months Ended

 

Six Months Ended



June 30,

 

June 30,



2020

 

2019

 

2020

 

2019



(unaudited)

NET REVENUE

$

10,038 

 

$

10,855 

 

$

24,573 

 

$

23,745 

COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION

 

(1,485)

 

 

(1,174)

 

 

(3,412)

 

 

(2,774)

GROSS PROFIT

 

8,553 

 

 

9,681 

 

 

21,161 

 

 

20,971 

RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES

 

1,810 

 

 

2,834 

 

 

4,693 

 

 

5,561 

GENERAL AND ADMINISTRATIVE EXPENSES

 

2,975 

 

 

3,675 

 

 

6,156 

 

 

7,068 

SALES AND MARKETING EXPENSES

 

4,382 

 

 

6,108 

 

 

10,054 

 

 

12,021 

DEPRECIATION AND AMORTIZATION

 

685 

 

 

654 

 

 

1,339 

 

 

1,306 

OPERATING EXPENSES

 

9,852 

 

 

13,271 

 

 

22,242 

 

 

25,956 

NET LOSS FROM OPERATIONS

 

(1,299)

 

 

(3,590)

 

 

(1,081)

 

 

(4,985)

INTEREST EXPENSE AND OTHER

 

(1,351)

 

 

(1,236)

 

 

(2,643)

 

 

(2,464)

UNREALIZED FOREIGN CURRENCY INCOME (LOSS), NET

 

109 

 

 

49 

 

 

28 

 

 

(20)

NET LOSS BEFORE TAXES

 

(2,541)

 

 

(4,777)

 

 

(3,696)

 

 

(7,469)

PROVISION FOR TAXES

 

(5)

 

 

(261)

 

 

(48)

 

 

(332)

NET LOSS

$

(2,546)

 

$

(5,038)

 

$

(3,744)

 

$

(7,801)

NET LOSS PER COMMON SHARE — Basic and diluted

$

(0.51)

 

$

(1.06)

 

$

(0.75)

 

$

(1.65)

WEIGHTED AVERAGE COMMON SHARES OUTSTANDING — Basic and diluted

 

5,030,833 

 

 

4,732,687 

 

 

5,005,777 

 

 

4,724,417 



 


 

 

 

ALIMERA SCIENCES, INC.

CONSOLIDATING STATEMENTS OF OPERATIONS

FOR THE THREE MONTHS ENDED JUNE 30, 2020 AND 2019

(in thousands)





 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



Three Months Ended

 

Three Months Ended



June 30, 2020

 

June 30, 2019



U.S.

 

International

 

Other

 

Consolidated

 

U.S.

 

International

 

Other

 

Consolidated



(unaudited)

NET REVENUE

$

3,420 

 

$

6,618 

 

$

 —

 

$

10,038 

 

$

7,320 

 

$

3,535 

 

$

 —

 

$

10,855 

COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION

 

(423)

 

 

(1,062)

 

 

 —

 

 

(1,485)

 

 

(808)

 

 

(366)

 

 

 —

 

 

(1,174)

GROSS PROFIT

 

2,997 

 

 

5,556 

 

 

 —

 

 

8,553 

 

 

6,512 

 

 

3,169 

 

 

 —

 

 

9,681 

RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES

 

1,098 

 

 

664 

 

 

48 

 

 

1,810 

 

 

1,630 

 

 

1,090 

 

 

114 

 

 

2,834 

GENERAL AND ADMINISTRATIVE EXPENSES

 

1,943 

 

 

838 

 

 

194 

 

 

2,975 

 

 

2,150 

 

 

946 

 

 

579 

 

 

3,675 

SALES AND MARKETING EXPENSES

 

3,207 

 

 

1,100 

 

 

75 

 

 

4,382 

 

 

4,217 

 

 

1,779 

 

 

112 

 

 

6,108 

DEPRECIATION AND AMORTIZATION

 

 —

 

 

 —

 

 

685 

 

 

685 

 

 

 —

 

 

 —

 

 

654 

 

 

654 

OPERATING EXPENSES

 

6,248 

 

 

2,602 

 

 

1,002 

 

 

9,852 

 

 

7,997 

 

 

3,815 

 

 

1,459 

 

 

13,271 

SEGMENT (LOSS) INCOME FROM OPERATIONS

 

(3,251)

 

 

2,954 

 

 

(1,002)

 

 

(1,299)

 

 

(1,485)

 

 

(646)

 

 

(1,459)

 

 

(3,590)

OTHER INCOME AND EXPENSES, NET

 

 —

 

 

 —

 

 

(1,242)

 

 

(1,242)

 

 

 —

 

 

 —

 

 

(1,187)

 

 

(1,187)

NET LOSS BEFORE TAXES

 

 

 

 

 

 

 

 

 

$

(2,541)

 

 

 

 

 

 

 

 

 

 

$

(4,777)



 


 

 

 

ALIMERA SCIENCES, INC.

CONSOLIDATING STATEMENTS OF OPERATIONS

FOR THE SIX MONTHS ENDED JUNE 30, 2020 AND 2019

(in thousands)



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



Six Months Ended

 

Six Months Ended



June 30, 2020

 

June 30, 2019



U.S.

 

International

 

Other

 

Consolidated

 

U.S.

 

International

 

Other

 

Consolidated



(unaudited)

NET REVENUE

$

10,487 

 

$

14,086 

 

$

 —

 

$

24,573 

 

$

14,086 

 

$

9,659 

 

$

 —

 

$

23,745 

COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION

 

(1,182)

 

 

(2,230)

 

 

 —

 

 

(3,412)

 

 

(1,493)

 

 

(1,281)

 

 

 —

 

 

(2,774)

GROSS PROFIT

 

9,305 

 

 

11,856 

 

 

 —

 

 

21,161 

 

 

12,593 

 

 

8,378 

 

 

 —

 

 

20,971 

RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES

 

3,020 

 

 

1,557 

 

 

116 

 

 

4,693 

 

 

3,057 

 

 

2,261 

 

 

243 

 

 

5,561 

GENERAL AND ADMINISTRATIVE EXPENSES

 

3,915 

 

 

1,775 

 

 

466 

 

 

6,156 

 

 

4,084 

 

 

1,933 

 

 

1,051 

 

 

7,068 

SALES AND MARKETING EXPENSES

 

7,487 

 

 

2,392 

 

 

175 

 

 

10,054 

 

 

8,258 

 

 

3,484 

 

 

279 

 

 

12,021 

DEPRECIATION AND AMORTIZATION

 

 —

 

 

 —

 

 

1,339 

 

 

1,339 

 

 

 —

 

 

 —

 

 

1,306 

 

 

1,306 

OPERATING EXPENSES

 

14,422 

 

 

5,724 

 

 

2,096 

 

 

22,242 

 

 

15,399 

 

 

7,678 

 

 

2,879 

 

 

25,956 

SEGMENT (LOSS) INCOME FROM OPERATIONS

 

(5,117)

 

 

6,132 

 

 

(2,096)

 

 

(1,081)

 

 

(2,806)

 

 

700 

 

 

(2,879)

 

 

(4,985)

OTHER INCOME AND EXPENSES, NET

 

 —

 

 

 —

 

 

(2,615)

 

 

(2,615)

 

 

 —

 

 

 —

 

 

(2,484)

 

 

(2,484)

NET LOSS BEFORE TAXES

 

 

 

 

 

 

 

 

 

$

(3,696)

 

 

 

 

 

 

 

 

 

 

$

(7,469)



 


 

 

 

RECONCILIATION OF GAAP MEASURES TO NON-GAAP ADJUSTED MEASURES

GAAP NET INCOME OR LOSS TO NON-GAAP ADJUSTED EBITDA

(in thousands)



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

June 30,

 

Six Months Ended

June 30,

 

2020

 

2019

 

2020

 

2019

 

(unaudited)

GAAP NET LOSS

$

(2,546)

 

 

 

$

(5,038)

 

 

 

$

(3,744)

 

 

 

$

(7,801)

 

 

Adjustments to net loss:

 

 

 

 

 

 

 

Interest expense and other

1,351 

 

 

1,236 

 

 

2,643 

 

 

2,464 

 

Provision for taxes

 

 

261 

 

 

48 

 

 

332 

 

Depreciation and amortization

685 

 

 

654 

 

 

1,339 

 

 

1,306 

 

Stock-based compensation expenses

317 

 

 

629 

 

 

757 

 

 

1,399 

 

Unrealized foreign currency exchange (gains) losses

(109)

 

 

(49)

 

 

(28)

 

 

20 

 

Non-cash accrued severance expenses

 

 

175 

 

 

 

 

175 

 

NON-GAAP ADJUSTED EBITDA (LOSS) INCOME

$

(297)

 

 

 

$

(2,132)

 

 

 

$

1,015 

 

 

 

$

(2,105)