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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D) OF

THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): May 14, 2024

ALIMERA SCIENCES, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-34703

20-0028718

(State or other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

6310 Town Square, Suite 400

Alpharetta, Georgia

30005

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: (678) 990-5740

6120 Windward Parkway, Suite 290

Alpharetta, Georgia 30005

(Former name or former address if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.01 par value per share

ALIM

The Nasdaq Stock Market LLC

(Nasdaq Global Market)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o


Item 2.02. Results of Operations and Financial Condition.

On May 14, 2024, Alimera issued a press release regarding its results of operations and financial condition for the three months ended March 31, 2024 as well as recent corporate highlights. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

The information in Item 2.02 of this Current Report on Form 8-K and the press release furnished as Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.


2


Item 9.01. Financial Statements and Exhibits.

(d)    Exhibits

The following exhibit relating to Item 2.02 of this Form 8-K shall be deemed to be furnished and not filed:

Exhibit No.

Description

99.1

Press Release of Alimera Sciences, Inc. dated May 14, 2024

104

Cover Page Interactive Data File (embedded within the inline XBRL document)


3


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

ALIMERA SCIENCES, INC.

Dated: May 14, 2024

By:

/s/ Elliot Maltz

Name:

Elliot Maltz

Title:

Chief Financial Officer

4

Exhibit 99.1

A picture containing text

Description automatically generated









FOR IMMEDIATE RELEASE





Alimera Sciences Reports First Quarter 2024 Results



·

Net Revenue up 70% to  $23 Million vs. Q1 2023

·

Global End User Demand Up 23% vs. Q1 2023

·

Reiterates Improved 2024 Net Revenue and Adjusted EBITDA Guidance



ATLANTA, May 14, 2024 -- Alimera Sciences, Inc. (Nasdaq: ALIM) (Alimera), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, today announced financial results for the first quarter of 2024.  Alimera will host a conference call today at 9:00 a.m. EDT to discuss these results.

 

Our results in this quarter were consistent with our expectations as we continue to integrate YUTIQ into our U.S. business and support the acceleration of growth in international markets, providing further confidence in our ability to achieve $105 million in revenue and at least 20% EBITDA margins this year," said Rick Eiswirth, Alimera’s President and Chief Executive Officer. "This quarter provided some key clinical milestones with the completion of enrollment in the Synchronicity Study and the randomization of the first patient in the DRCR Retina Network study where ILUVIEN is being studied as a treatment for radiation retinopathy. We also continue to advance plans for potential indication expansion opportunities and were pleased that the National Institute for Health and Care Excellence (NICE) recommended that chronic DME patients with a natural lens gain access to ILUVIEN in the United Kingdom."

 


 

Key First Quarter Financial Highlights:



·

Net revenue of $23.0 million up 70% vs Q1 2023

·

Net loss of $6.3 million compared to a net loss of $5.0 million in Q1 2023

·

Positive adjusted EBITDA of $1.8 million vs. adjusted EBITDA loss of $(2.4) million in Q1 2023

·

U.S. net revenue of $14.6 million up 92% vs. Q1 2023

·

International net revenue of $8.5 million up 42% vs. Q1 2023

·

Global end user demand up 23% over Q1 2023 at 4,028 units for the quarter

·

Increased term loan agreement with its current lenders, investment affiliates managed by SLR Capital Partners, LLC, by $5.0 million



First Quarter Corporate Highlights:



·

First patient randomized in Protocol AL, a DRCR Retina Network study with ILUVIEN or faricimab injections versus observation in patients at risk of radiation retinopathy. Over 40% of radiation retinopathy patients have been shown to experience the devastating vision loss associated with radiotherapy within three years of treatment, and currently there are no FDA approved pharmacotherapies for radiation retinopathy. 

·

Received positive final draft guidance from the National Institute for Health and Care Excellence (NICE) recommending that chronic diabetic macular edema patients with a natural lens (phakic patients) be given access to ILUVIEN. Phakic patients represent up to 75% of the broader DME population in the United Kingdom. 

·

Completed enrollment of 110 patient eyes across 25 sites in the Synchronicity Study, a prospective, open-label clinical study evaluating the safety and efficacy of YUTIQ (fluocinolone acetonide intravitreal implant 0.18mg) in the treatment of chronic non-infectious uveitis and related intraocular inflammation. The study included a broader retinal physician base to better understand the way they treat chronic non-infectious uveitis affecting the posterior segment.



First Quarter 2024 Financial Results



Net Revenue 

Consolidated global net revenue was up 70% to approximately $23.0 million for Q1 2024, compared to $13.5 million for Q1 2023, driven by the addition of YUTIQ in the U.S. segment, as well as increased unit sales volumes in the International segment of the business. 



 


 

U.S. net revenue increased 92% to approximately  $14.6 million for Q1 2024 compared to U.S. net revenue of $7.6 million for Q1 2023.  The increase was primarily driven by net revenue from YUTIQ, which Alimera acquired in May 2023.



International net revenue increased 42% to approximately $8.5 million in Q1 2024, compared to approximately $6.0 million in Q1 2023.  The increase in international net revenue in Q1 2024 was driven both by growth in end user demand and restocking of our international distributors.  



Operating Expenses



Total operating expenses were approximately $22.0 million for Q1 2024, compared to approximately $14.8 million for Q1 2023.  The increase was primarily attributable to $3.3 million of additional sales and marketing expenses driven by expansion of our commercial infrastructure to support selling two products in the U.S., $2.4 million in additional amortization expense attributable to the YUTIQ acquisition in May 2023, and a $1.3 million increase in general administrative expenses relating to $0.7 million of personnel costs and $0.5 million of stock-based compensation expense.



Cash and Cash Equivalents



As of March 31, 2024, Alimera had cash and cash equivalents of approximately $14.3 million, compared to $12.1 million at December 31, 2023.



About Alimera Sciences, Inc.

Alimera Sciences is a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer. For more information, please visit www.alimerasciences.com.



Non-GAAP Financial Measures

This press release presents Adjusted EBITDA, as defined below, which is a non-GAAP financial measure. Alimera uses this measure to supplement the financial information presented on a GAAP basis. Alimera believes that excluding certain items from its GAAP financial results allows management to better understand its ongoing operations and analyze its financial performance from period to period and provides meaningful supplemental information to its investors.

Alimera defines “Adjusted EBITDA” as earnings before interest, taxes, depreciation, amortization, stock-based compensation expenses, net unrealized gains and losses from foreign currency exchange transactions, gains on extinguishment of debt,

 


 

preferred stock dividends, severance expenses and change in fair value of warrant asset. 

Alimera believes that Adjusted EBITDA, when taken together with its corresponding GAAP financial measure, provides meaningful supplemental information to its investors regarding its performance by excluding certain items that may not be indicative of its business, results of operations, or outlook. Accordingly, Adjusted EBITDA for the three months ended March 31, 2024, and 2023, together with a reconciliation to GAAP net income or loss, its most directly comparable GAAP financial measure, has been presented in the table entitled “Reconciliation of GAAP Loss to Non-GAAP Adjusted EBITDA.”

This non-GAAP financial measure may not be comparable to similarly titled measures reported by other companies, including companies in Alimera’s industry, because not all companies calculate Adjusted EBITDA in an identical manner or may use other financial measures to evaluate their performance. Therefore, this non-GAAP financial measure may be limited in usefulness for comparison between companies.

The presentation of this non-GAAP financial measure is not intended to be considered in isolation from or as a substitute for other financial performance measures prepared in accordance with GAAP and should be read only in conjunction with financial information presented on a GAAP basis. 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, this non-GAAP financial measure is subject to inherent limitations because it reflects the exercise of judgments by management. Investors are encouraged not to rely on any single financial measure to evaluate Alimera’s business.

Forward Looking Statements

This press release, includes “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 growth opportunities, the commencement, enrollment, timing and outcome of its and others' clinical studies, the effect of an expanded label, demand for its product, its business strategy, future operations, future financial position including the timeline for achieving positive Adjusted EBITDA, future revenues, projected costs, prospects, plans and objectives. Words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “contemplates,” “predict,” “project,” “target,” “likely,” “potential,” “continue,” “ongoing,” “will,” “would,” “should,” “could,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based on current expectations and involve inherent risks and uncertainties (some of which are beyond Alimera’s control), including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s most recently filed Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q, and

 


 

any of Alimera’s subsequent filings 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 on the forward-looking statements Alimera makes or that are made on its behalf as predictions of future events. These forward-looking statements speak only as of the date of this press release. Alimera undertakes no obligation to publicly update or revise any of the forward-looking statements made in this press release, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.





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.

CONSOLIDATED BALANCE SHEETS

(UNAUDITED)





 

 

 

 

 



 

 

 

 

 



March 31,

 

December 31,



2024

 

2023



(In thousands, except share and per share data)

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

$

14,314 

 

$

12,058 

Restricted cash

 

32 

 

 

32 

Accounts receivable, net

 

34,224 

 

 

34,545 

Prepaid expenses and other current assets

 

3,693 

 

 

3,909 

Inventory

 

2,206 

 

 

1,879 

Total current assets

 

54,469 

 

 

52,423 

Property and equipment, net

 

2,377 

 

 

2,466 

Right-of-use assets, net

 

1,060 

 

 

1,124 

Intangible assets, net

 

94,471 

 

 

97,355 

Deferred tax asset

 

102 

 

 

104 

Warrant asset

 

 

 

52 

Total assets

$

152,485 

 

$

153,524 

Liabilities and Stockholders Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

$

10,308 

 

$

8,252 

Accrued expenses

 

4,779 

 

 

6,192 

Accrued licensor payment

 

5,482 

 

 

7,275 

Finance lease obligations

 

220 

 

 

194 

Total current liabilities

 

20,789 

 

 

21,913 

Long-term liabilities:

 

 

 

 

 

Notes payable, net of discount

 

69,436 

 

 

64,489 

Accrued licensor payments

 

15,616 

 

 

15,136 

Other non-current liabilities

 

5,991 

 

 

5,816 

Total liabilities

 

111,832 

 

 

107,354 

Commitments and contingencies

 

 

 

 

 

Stockholders equity:

 

 

 

 

 

Preferred stock, $.01 par value — 10,000,000 shares authorized at March 31, 2024 and December 31, 2023, none issued

 

 —

 

 

 —

Common stock, $.01 par value — 150,000,000 shares authorized, 52,374,687 shares issued and outstanding at March 31, 2024 and 52,354,450 shares issued and outstanding at December 31, 2023

 

524 

 

 

524 

Common stock warrants

 

4,396 

 

 

4,396 

Additional paid-in capital

 

463,328 

 

 

462,446 

Accumulated deficit

 

(424,741)

 

 

(418,490)

Accumulated other comprehensive loss

 

(2,854)

 

 

(2,706)

Total stockholders equity

 

40,653 

 

 

46,170 

Total liabilities and stockholders equity

$

152,485 

 

$

153,524 



 


 

ALIMERA SCIENCES, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)





 

 

 

 

 



 

 

 

 

 



Three Months Ended



March 31,



2024

 

2023



(In thousands, except share and per share data)



 

 

 

 

 

Net revenue

$

23,011 

 

$

13,546 

Cost of goods sold, excluding depreciation and amortization

 

(3,353)

 

 

(2,028)

Gross profit

 

19,658 

 

 

11,518 

Operating expenses:

 

 

 

 

 

Research, development and medical affairs expenses

 

4,361 

 

 

4,164 

General and administrative expenses

 

5,432 

 

 

4,171 

Sales and marketing expenses

 

9,082 

 

 

5,804 

Depreciation and amortization

 

3,085 

 

 

681 

Total operating expenses

 

21,960 

 

 

14,820 

Loss from operations

 

(2,302)

 

 

(3,302)

Interest expense and other, net

 

(3,739)

 

 

(1,667)

Unrealized foreign currency loss, net

 

(196)

 

 

(13)

Change in fair value of warrant asset

 

(46)

 

 

14 

Net loss before income taxes

 

(6,283)

 

 

(4,968)

Income tax benefit

 

32 

 

 

 —

Net loss

 

(6,251)

 

 

(4,968)

Preferred stock dividends

 

 —

 

 

(14)

Net loss applicable to common stockholders

$

(6,251)

 

$

(4,982)

Net loss per share — basic and diluted

$

(0.12)

 

$

(0.71)

Weighted average shares outstanding — basic and diluted

 

54,356,828 

 

 

7,032,231 



 


 

RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EBITDA

(UNAUDITED)









 

 

 

 

 



 

 

 

 

 



Three Months Ended



March 31,



2024

 

2023



(In thousands)

U.S. GAAP net loss

$

(6,251)

 

$

(4,968)

Adjustments to U.S. GAAP net loss:

 

 

 

 

 

Interest expense and other, net

 

3,739 

 

 

1,667 

Income tax benefit

 

(32)

 

 

 —

Depreciation and amortization

 

3,085 

 

 

681 

Stock-based compensation

 

845 

 

 

226 

Foreign currency exchange losses

 

196 

 

 

13 

Change in fair value of warrant asset

 

46 

 

 

(14)

Severance expenses

 

176 

 

 

 —

Non-GAAP adjusted EBITDA

$

1,804 

 

$

(2,395)























 


v3.24.1.1.u2
Document and Entity Information
May 14, 2024
Document Information [Line Items]  
Document Type 8-K
Document Period End Date May 14, 2024
Entity Registrant Name ALIMERA SCIENCES, INC.
Entity Incorporation, State or Country Code DE
Entity File Number 001-34703
Entity Tax Indentification Number 20-0028718
Entity Address, Address Line 1 6310 Town Square
Entity Address, Address Line 2 Suite 400
Entity Address, City or Town Alpharetta
Entity Address, State or Province GA
Entity Address, Postal Zip Code 30005
City Area Code 678
Local Phone Number 990-5740
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre -commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.01 par value per share
Trading Symbol ALIM
Security Exchange Name NASDAQ
Emerging Growth Company false
Entity Central Index Key 0001267602
Amendment Flag false
Former Address [Member]  
Document Information [Line Items]  
Entity Address, Address Line 1 6120 Windward Parkway
Entity Address, Address Line 2 Suite 290
Entity Address, City or Town Alpharetta
Entity Address, State or Province GA
Entity Address, Postal Zip Code 30005

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