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): August 6, 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)

 

(678) 990-5740

 

Not Applicable


(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:

 

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

 

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

 

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

 

☐ 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 ☐

 

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 August 6, 2024, Alimera issued a press release regarding its results of operations and financial condition for the three and six months ended June 30, 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, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

 

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 August 6, 2024

104

 

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

 

 

 

 

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: August 6, 2024

By:

/s/ Elliot Maltz

 

Name:

Elliot Maltz

 

Title:

Chief Financial Officer

 

 

 

 

Exhibit 99.1

 



alimlogo1.jpg





FOR IMMEDIATE RELEASE





Alimera Sciences Reports Second Quarter 2024 Results



 

Net Revenue up 54% to $27 Million vs. Q2 2023

 

Global End User Demand Up 6% vs. Q2 2023

 

Company Recently Announced Definitive Merger Agreement with ANI Pharmaceuticals Inc.



ATLANTA, August 6, 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 second quarter of 2024. Alimera will not host a conference call today due to the recently announced agreement to be acquired by ANI Pharmaceuticals, Inc. (“ANI”).

 

“We are pleased with our strong second quarter results, in line with our expectations, as we completed the integration of YUTIQ into our U.S. business and delivered $50 million in revenue in the first half this year," said Rick Eiswirth, Alimera’s President and Chief Executive Officer. "Further, we believe the acquisition agreement entered into with ANI Pharmaceuticals late in the second quarter is a testament to the value we have created at Alimera, and we look forward to completing the transaction later this quarter."

 

Key Second Quarter Financial Highlights:

 

 

Net revenue of $27.0 million up 54% vs Q2 2023

 

Net loss improved to $(3.3) million vs. $(10.7) million in Q2 2023

 

Adjusted EBITDA of $6.7 million vs. $0.9 million in Q2 2023

 

U.S. net revenue of $17.6 million, up 48% vs.$11.9 million in Q2 2023

 

International net revenue of $9.4 million, up 65% vs. $5.7 million in Q2 2023

 

Global end user demand of 3,821 up 6% vs. Q2 2023 on a pro-forma basis

 

Second Quarter Corporate Highlights:



 

On June 21, 2024, Alimera entered into an agreement and plan of merger with ANI. Under the proposed merger, Alimera will be acquired for $5.50 per share in cash at closing and one non-tradable contingent value right (CVR) representing the right to receive up to $0.50 per share upon the achievement of certain net revenue targets in 2026 and 2027. The transaction, which values Alimera’s equity at approximately $320 million in up front consideration, was approved by the ANI and Alimera Boards of Directors and is expected to close later this year. For more information, visit ANI’s website www.anipharmaceuticals.com

 

Modified the terms associated with royalty payments Alimera is obligated to pay SWK Funding LLC (“SWK”), reducing the royalty to 3.125% of net revenues, and defining any product containing fluocinolone acetonide (“FAc”) as being subject to such royalty, including ILUVIEN and YUTIQ.

 

 

 

Second Quarter 2024 Financial Results



Net Revenue

 

Consolidated global net revenue was up 54% to approximately $27 million for Q2 2024, compared to $17.5 million for Q2 2023, driven by the addition of YUTIQ in the U.S. segment, as well as increased sales volumes in the International segment of the business.

 

U.S. net revenue increased 48% to approximately $17.6 million for Q2 2024 compared to U.S. net revenue of $11.9 million for Q2 2023. The increase was primarily driven by net revenue from YUTIQ, which Alimera acquired in May 2023. U.S. end user demand grew by 6% in Q2 2024 to 2,189 units vs Q2 2023 on a pro-forma basis.

 

International net revenue increased 65% to approximately $9.4 million in Q2 2024, compared to approximately $5.7 million in Q2 2023. The increase in international net revenue in Q2 2024 was driven both by increased stocking of our international distributors and growth in end user demand. International end user demand grew 6% in Q2 2024 to 1,632 units vs Q2 2023.

 

Operating Expenses

 

Total operating expenses were approximately $23.2 million for Q2 2024, compared to approximately $16.3 million for Q2 2023. The increase was primarily attributable to $2.2 million in general and administrative expenses related to the merger agreement with ANI Pharmaceuticals Inc., $1.8 million of additional sales and marketing expenses driven by expansion of our commercial infrastructure to support selling two products in the U.S., $1.2 million in additional amortization expense attributable to the YUTIQ acquisition in May 2023, and $1.2 million in additional stock-based compensation expense.

 

Cash and Cash Equivalents

 

As of June 30, 2024, Alimera had cash and cash equivalents of approximately $10.8 million, compared to $14.3 million at March 31, 2024 and $12.1 million at December 31, 2023. During the second quarter of 2024, the Company made $1.9 million of accrued licensor payments to EyePoint Pharmaceuticals, Inc. related to the acquisition of YUTIQ in May 2023, and $2.4 million of accrued exit fee payments as required by the Company’s existing loan agreements with SLR Capital Partners, LLC due to the achievement of certain revenue milestones.

 

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, expenses incurred with Merger Agreement, 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 June 30, 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, 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 U.S. 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.



Additional Information and Where to Find It

 

In connection with the Merger, Alimera intends to file a preliminary and definitive proxy statement. The definitive proxy statement and proxy card will be delivered to Alimera’s stockholders in advance of the special meeting relating to the proposed acquisition. Each of ANI and Alimera also plan to file other relevant materials with the SEC in connection with the Merger. INVESTORS IN AND SECURITY HOLDERS OF ALIMERA ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE, AS WELL AS ANY OTHER RELEVANT DOCUMENTS THAT ARE FILED OR FURNISHED OR WILL BE FILED OR WILL BE FURNISHED BY EACH OF ANI AND ALIMERA WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE MERGER, RELATED MATTERS AND THE PARTIES TO THE MERGER. Materials filed by ANI and Alimera can be obtained free of charge at the SEC’s website, www.sec.gov. In addition, materials filed by ANI can be obtained free of charge at ANI’s website, www.anipharmaceuticals.com, and materials filed by Alimera can be obtained free of charge at Alimera’s website, www.alimerasciences.com.

 

 

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)

 

   

June 30,

   

December 31,

 
   

2024

   

2023

 
   

(In thousands, except share and per share data)

 

Assets

               

Current assets:

               

Cash and cash equivalents

  $ 10,828     $ 12,058  

Restricted cash

    33       32  

Accounts receivable, net

    37,079       34,545  

Prepaid expenses and other current assets

    4,013       3,909  

Inventory

    3,455       1,879  

Total current assets

    55,408       52,423  

Property and equipment, net

    2,278       2,466  

Right-of-use assets, net

    996       1,124  

Intangible assets, net

    91,587       97,355  

Deferred tax asset

    101       104  

Warrant asset

    7       52  

Total assets

  $ 150,377     $ 153,524  

Liabilities and Stockholders’ Equity

               

Current liabilities:

               

Accounts payable

  $ 10,208     $ 8,252  

Accrued expenses

    5,708       6,192  

Accrued licensor payment

    3,677       7,275  

Finance lease obligations

    245       194  

Total current liabilities

    19,838       21,913  

Non-current liabilities:

               

Notes payable, net of discount

    69,731       64,489  

Accrued licensor payments

    16,111       15,136  

Other non-current liabilities

    5,909       5,816  

Total liabilities

    111,589       107,354  

Commitments and contingencies (note 8)

               

Stockholders’ equity:

               

Preferred stock, $.01 par value — 10,000,000 shares authorized at June 30, 2024 and December 31, 2023, none issued

           

Common stock, $.01 par value — 150,000,000 shares authorized, 52,387,763 shares issued and outstanding at June 30, 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

    464,825       462,446  

Accumulated deficit

    (428,052 )     (418,490 )

Accumulated other comprehensive loss

    (2,905 )     (2,706 )

Total stockholders’ equity

    38,788       46,170  

Total liabilities and stockholders’ equity

  $ 150,377     $ 153,524  

  

 

 

ALIMERA SCIENCES, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)



   

Three Months Ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2024

   

2023

   

2024

   

2023

 
   

(In thousands, except share and per share data)

 
                                 

Net revenue

  $ 27,000     $ 17,538     $ 50,011     $ 31,084  

Cost of goods sold, excluding depreciation and amortization

    (3,831 )     (2,425 )     (7,184 )     (4,453 )

Gross profit

    23,169       15,113       42,827       26,631  

Operating expenses:

                               

Research, development and medical affairs expenses

    4,263       3,648       8,624       7,812  

General and administrative expenses

    7,379       4,373       12,811       8,544  

Sales and marketing expenses

    8,511       6,434       17,593       12,238  

Depreciation and amortization

    3,093       1,866       6,178       2,547  

Total operating expenses

    23,246       16,321       45,206       31,141  

Loss from operations

    (77 )     (1,208 )     (2,379 )     (4,510 )

Interest expense and other, net

    (3,153 )     (1,694 )     (6,892 )     (3,361 )

Unrealized foreign currency loss, net

    (125 )     (7 )     (321 )     (20 )

Loss on extinguishment of debt

          (1,079 )           (1,079 )

Change in fair value of common stock warrant

          (5,911 )           (5,911 )

Change in fair value of warrant asset

    1       (105 )     (45 )     (91 )

Net loss before income taxes

    (3,354 )     (10,004 )     (9,637 )     (14,972 )

Income tax benefit (provision)

    43       (25 )     75       (25 )

Net loss

    (3,311 )     (10,029 )     (9,562 )     (14,997 )

Preferred stock dividends

          (669 )           (683 )

Net loss applicable to common stockholders

  $ (3,311 )   $ (10,698 )   $ (9,562 )   $ (15,680 )

Net loss per share — basic and diluted

  $ (0.06 )   $ (1.32 )   $ (0.18 )   $ (2.07 )

Weighted average shares outstanding — basic and diluted

    54,383,604       8,093,640       54,370,216       7,565,868  



 

 

RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EBITDA

(UNAUDITED)

 







   

Three Months Ended

   

Six Months Ended

 
   

June 30,

   

June 30,

 
   

2024

   

2023

   

2024

   

2023

 
   

(In thousands)

 

U.S. GAAP net loss

  $ (3,311 )   $ (10,029 )   $ (9,562 )   $ (14,997 )

Adjustments to U.S. GAAP net loss:

                               

Interest expense and other, net

    3,153       1,694       6,892       3,361  

Expenses incurred with Merger Agreement

    2,226             2,226        

Income tax (benefit) provision

    (43 )     25       (75 )     25  

Depreciation and amortization

    3,093       1,866       6,178       2,547  

Stock-based compensation

    1,457       217       2,302       442  

Foreign currency exchange losses

    125       7       321       20  

Extinguishment of debt

          1,079             1,079  

Change in fair value of warrant asset

    (1 )     105       45       91  

Change in fair value of common stock warrant

          5,911             5,911  

Severance expenses

    15             191        

Non-GAAP adjusted EBITDA

  $ 6,714     $ 875     $ 8,518     $ (1,521 )



 

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