- 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
“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
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
International net product revenue remained flat at approximately
Operating Expenses
Total operating expenses were approximately $16.3 million for Q2 2023, compared to approximately
Cash and Cash Equivalents
As of
About
www.alimerasciences.com
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
Alimera is subject to variability of its reported
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
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: |
for | for |
scottg@coreir.com | julesa@coreir.com |
CONSOLIDATED BALANCE SHEETS | |||||||
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 | |||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2023 AND 2022 | |||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||
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 | Six Months Ended | ||||||||||||||||||
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) | 7 | (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 | ||||||||||||||||
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 | |||||||||
Source:
2023 GlobeNewswire, Inc., source