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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): August 10, 2023

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

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:

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 On August 10, 2023, Alimera Sciences, Inc. (“Alimera”) issued a press release regarding its results of operations and financial condition for the three and six months ended June 30, 2023 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.


#x200e


Item 2.02. Results of Operations and Financial Condition.

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

Exhibit

No.

Description

99.1

Press Release of Alimera Sciences, Inc. dated August 10, 2023

104

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


2


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 10, 2023

By:

/s/ Russell L. Skibsted

Name:

Russell L. Skibsted

Title:

Chief Financial Officer and Senior Vice President

3

EX-99.1 2 alim-20230810xex99_1.htm EX-99.1 EX-99.1

 

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FOR IMMEDIATE RELEASE

 

 

 

Alimera Sciences Reports Second Quarter 2023 Results



·

Alimera Acquired U.S. Commercial Rights to YUTIQ®  

·

Landmark NEW DAY Study Completed Enrollment with over 300 Patients

·

Consolidated Net Revenue of $17.5 Million Up 20%  vs. Second Quarter of 2022

·

Global End User Demand for ILUVIEN Up 13.5% vs. Second Quarter of 2022 





ATLANTA, August 10, 2023 -- 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 2023.  

 

“This was a pivotal quarter for Alimera. We completed a transformational transaction to add YUTIQ to our portfolio, enabling us to further leverage our extensive commercial infrastructure in the U.S., adopt learning from our experience selling behind a uveitis indication in Europe and bring critical mass to our revenue base. The transaction has provided immediate results, despite planned costs of combining the two products in our infrastructure, contributing to the generation of positive Adjusted EBITDA in the second quarter,” said Rick Eiswirth, Alimera’s President and Chief Executive Officer. “In addition, we completed enrollment in the NEW DAY study which we expect will support consideration of ILUVIEN as a first-line treatment option for DME that can maintain vision longer with fewer injections while highlighting the value of long term, consistent drug delivery in managing the recurrence of retinal disease.”























 


 

 

 Key Second Quarter Highlights:



·

Acquisition of additional commercialization rights for YUTIQ (fluocinolone acetonide intravitreal insert) 0.18mg for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye

·

Revenue of $17.5 million up 20% vs. second quarter of 2022

·

Global ILUVIEN end user demand growth of 13.5%  over Q2 2022; YUTIQ added an additional 440 units of end user demand

·

Net loss of $10.7 million versus $3.1 million in Q2 2022 driven primarily by cost associated with financings this year

·

Positive adjusted EBITDA of $900,000 vs. a loss of $1 million in Q2 2022

·

Completion of the NEW DAY Study enrollment with 306 patients; anticipating data in early 2025



Second Quarter 2023 Financial Results



Revenue 

Product revenue was up 20% to approximately $17.5 million for Q2 2023, compared to $14.6 million for Q2 2022. The increase was primarily due to the addition of YUTIQ into the U.S. portfolio.  Global end user demand for ILUVIEN in Q2 2023 was 2,601 units, up 13.5% compared to Q2 2022.  In addition, YUTIQ generated an additional 440 units of end user demand in the second quarter from the date of acquisition in late May.



U.S. product revenue increased 34% to approximately $11.9 million for Q2 2023 compared to U.S. product revenue of $8.9 million for Q2 2022. U.S. end user demand for ILUVIEN and YUTIQ in Q2 2023 was 1,500 units, compared to 1,063 of ILUVIEN in Q2 2022.    

 

International net product revenue remained flat at approximately $5.7 million in Q2  2023, compared to approximately $5.7 million in Q2 2022 as a result of deferred shipments to our distributor partners.  International segment end user demand was up 26% to 1,541 units compared to 1,220 units in Q2 2022.

 

Operating Expenses

Total operating expenses were approximately $16.3 million for Q2 2023, compared to approximately $14.4 million for Q2 2022.   The increase was primarily attributable to approximately $630,000 in bad debt expense, and approximately $1.2 million in amortization of the new intangible asset related to the YUTIQ transaction.

 

 


 

 

Cash and Cash Equivalents

As of June 30, 2023, Alimera had cash and cash equivalents of approximately $18.8 million, compared to $13.1 million at March 31, 2023. 



About Alimera Sciences, Inc.

www.alimerasciences.com

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 .

Non-GAAP Financial Measures

This press release presents Adjusted EBITDA and Adjusted net product revenue, each as defined below, which are non-GAAP financial measures. Alimera uses these measures 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, losses on extinguishment of debt, preferred stock dividends, severance expenses, change in fair value of common stock warrants 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 and six months ended June 30, 2023 and 2022, 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.”

Alimera is subject to variability of its reported U.S. dollar results due to changes in foreign currency exchange rates. Those changes have been volatile over the past several years. The adjustment of the effects of foreign currency exchange in its international segment as if foreign exchange rates had remained constant with the same periods of 2022, or what Alimera refers to as Adjusted net product revenue, is a non-GAAP measure. Alimera believes that this non-GAAP measure provides additional information that enables enhanced comparison to prior periods and additional insight into the underlying performance of its business outside of the U.S. Accordingly, Adjusted net product revenue for the three and six months ended June 30, 2023 and 2022, together with a reconciliation to GAAP net product revenue, its most directly comparable GAAP financial measure, has been presented in the table entitled “Reconciliation of GAAP Net Product Revenue to Non-GAAP Adjusted Net Product Revenue.”

 


 

 

These non-GAAP financial measures 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 or Adjusted net product revenue in an identical manner or may use other financial measures to evaluate their performance. Therefore, these non-GAAP financial measures may be limited in their usefulness for comparison between companies.

The presentation of these non-GAAP financial measures 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 these non-GAAP financial measures is that they exclude significant elements required by GAAP to be recorded in Alimera’s financial statements. In addition, these non-GAAP financial measures are subject to inherent limitations because they reflect 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 its business strategy, future operations, future financial position, Adjusted EBITDA, future revenues and projected costs, Alimera’s prospects, plans and objectives, and timing and outcome of its clinical trials. 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





 

 

 

 

 



June 30,

 

December 31,



2023

 

2022



(unaudited)

 

 



(In thousands, except share and per share data)

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

$

18,775 

 

$

5,274 

Restricted cash

 

32 

 

 

30 

Accounts receivable, net

 

22,589 

 

 

19,612 

Prepaid expenses and other current assets

 

3,571 

 

 

2,892 

Inventory

 

1,055 

 

 

1,605 

Total current assets

 

46,022 

 

 

29,413 

NON-CURRENT ASSETS:

 

 

 

 

 

Property and equipment, net

 

2,465 

 

 

2,525 

Right of use assets, net

 

1,277 

 

 

1,395 

Intangible assets, net

 

104,935 

 

 

8,957 

Deferred tax asset

 

131 

 

 

129 

Warrant asset

 

93 

 

 

183 

TOTAL ASSETS

$

154,923 

 

$

42,602 

CURRENT LIABILITIES:

 

 

 

 

 

Accounts payable

$

8,040 

 

$

10,088 

Accrued expenses

 

6,002 

 

 

3,998 

Notes payable

 

 —

 

 

25,313 

Finance lease obligations

 

203 

 

 

333 

Total current liabilities

 

14,245 

 

 

39,732 

NON-CURRENT LIABILITIES:

 

 

 

 

 

Notes payable, net of discount

 

63,954 

 

 

18,683 

Common stock warrants

 

3,471 

 

 

 —

Accrued licensor payments

 

21,079 

 

 

 —

Other non-current liabilities

 

5,944 

 

 

4,995 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

STOCKHOLDERS’ EQUITY (DEFICIT):

 

 

 

 

 

Preferred stock:

 

 

 

 

 

Series A Convertible Preferred Stock

 

 —

 

 

19,227 

Series B Convertible Preferred Stock

 

74,725 

 

 

 —

Common stock

 

88 

 

 

70 

Additional paid-in capital

 

386,979 

 

 

378,238 

Accumulated deficit

 

(412,779)

 

 

(415,388)

Accumulated other comprehensive loss

 

(2,783)

 

 

(2,955)

TOTAL STOCKHOLDERS’ EQUITY (DEFICIT)

 

46,230 

 

 

(20,808)

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

$

154,923 

 

$

42,602 

 


 

 

ALIMERA SCIENCES, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 AND 2022





 

 

 

 

 

 

 

 

 

 

 



Three Months Ended

 

Six Months Ended



June 30,

 

June 30,



2023

 

2022

 

2023

 

2022



(In thousands, except share and per share data)



(unaudited)

REVENUE:

 

 

 

 

 

 

 

 

 

 

 

PRODUCT REVENUE, NET

$

17,538 

 

$

14,604 

 

$

31,084 

 

$

26,502 

COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION

 

(2,425)

 

 

(2,166)

 

 

(4,453)

 

 

(3,846)

GROSS PROFIT

 

15,113 

 

 

12,438 

 

 

26,631 

 

 

22,656 

RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES

 

3,648 

 

 

3,932 

 

 

7,812 

 

 

7,515 

GENERAL AND ADMINISTRATIVE EXPENSES

 

4,373 

 

 

2,945 

 

 

8,544 

 

 

6,185 

SALES AND MARKETING EXPENSES

 

6,434 

 

 

6,865 

 

 

12,238 

 

 

13,718 

DEPRECIATION AND AMORTIZATION

 

1,866 

 

 

670 

 

 

2,547 

 

 

1,359 

OPERATING EXPENSES

 

16,321 

 

 

14,412 

 

 

31,141 

 

 

28,777 

LOSS FROM OPERATIONS

 

(1,208)

 

 

(1,974)

 

 

(4,510)

 

 

(6,121)

INTEREST EXPENSE AND OTHER

 

(1,694)

 

 

(1,383)

 

 

(3,361)

 

 

(2,747)

UNREALIZED FOREIGN CURRENCY (LOSS) GAIN, NET

 

(7)

 

 

38 

 

 

(20)

 

 

146 

LOSS ON EXTINGUISHMENT OF DEBT

 

(1,079)

 

 

 —

 

 

(1,079)

 

 

 —

CHANGE IN FAIR VALUE OF WARRANT ASSET

 

(105)

 

 

221 

 

 

(91)

 

 

(331)

CHANGE IN FAIR VALUE OF WARRANT LIABILITY

 

(5,911)

 

 

 —

 

 

(5,911)

 

 

 —

NET LOSS BEFORE TAXES

 

(10,004)

 

 

(3,098)

 

 

(14,972)

 

 

(9,053)

INCOME TAX PROVISION

 

(25)

 

 

(17)

 

 

(25)

 

 

(17)

NET LOSS

 

(10,029)

 

 

(3,115)

 

 

(14,997)

 

 

(9,070)

PREFERRED STOCK DIVIDENDS

 

(669)

 

 

 —

 

 

(683)

 

 

 

NET LOSS APPLICABLE TO COMMON STOCKHOLDERS

$

(10,698)

 

$

(3,115)

 

$

(15,680)

 

$

(9,070)

NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS — Basic and Diluted

$

(1.32)

 

$

(0.45)

 

$

(2.07)

 

$

(1.30)

WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and Diluted

 

8,093,640 

 

 

6,999,707 

 

 

7,565,868 

 

 

6,995,247 

 


 

 

RECONCILIATION OF GAAP MEASURES TO NON-GAAP ADJUSTED MEASURES

RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EBITDA

(in thousands)





 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

June 30,

 

Six Months Ended

June 30,

 

2023

 

2022

 

2023

 

2022

 

(unaudited)

GAAP NET LOSS

$

(10,029)

 

 

 

$

(3,115)

 

 

 

$

(14,997)

 

 

 

$

(9,070)

 

Adjustments to net loss:

 

 

 

 

 

 

 

Interest expense and other

1,694 

 

 

1,383 

 

 

3,361 

 

 

2,747 

 

Provision for taxes

25 

 

 

17 

 

 

25 

 

 

17 

 

Depreciation and amortization

1,866 

 

 

670 

 

 

2,547 

 

 

1,359 

 

Stock-based compensation expenses

216 

 

 

268 

 

 

442 

 

 

581 

 

Unrealized foreign currency exchange losses (gains)

 

 

(38)

 

 

20 

 

 

(146)

 

Loss on extinguishment of debt

1,079 

 

 

 

 

1,079 

 

 

 

Change in fair value of common stock warrants

5,911 

 

 

 

 

5,911 

 

 

 

Change in fair value of warrant asset

105 

 

 

(221)

 

 

91 

 

 

331 

 

Severance expenses

 

 

37 

 

 

 

 

37 

 

NON-GAAP ADJUSTED EBITDA

$

874 

 

 

 

$

(999)

 

 

 

$

(1,521)

 

 

 

$

(4,144)

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

























 


 

 

RECONCILIATION OF GAAP NET PRODUCT REVENUE TO NON-GAAP ADJUSTED NET PRODUCT REVENUE





 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 



Three Months Ended

 

Six Months Ended



June 30,

 

June 30,



2023

 

2022

 

2023

 

2022



(In thousands)

GAAP NET PRODUCT REVENUE

$

17,538 

 

$

14,604 

 

$

31,084 

 

$

26,502 

Adjustment to net product revenue:

 

 

 

 

 

 

 

 

 

 

 

Foreign currency fluctuations, net

 

136 

 

 

 —

 

 

(137)

 

 

 —

NON-GAAP ADJUSTED NET PRODUCT REVENUE

$

17,674 

 

$

14,604 

 

$

30,947 

 

$

26,502