Q4 Net Revenues up 88% to
2023 Net Revenues up 49% to
Increases 2024 Revenue Guidance
“Our outstanding fourth quarter and full year 2023 net revenue of
“The success of our expanded sales team in selling both ILUVIEN and YUTIQ in the
Key Fourth Quarter Financial Highlights:
- Net revenue of
$26.3 million up 88% vs. fourth quarter of 2022 - Net loss of
$3.8 million consistent with fourth quarter of 2022 - Positive adjusted EBITDA of
$5.0 million vs. adjusted EBITDA loss of$(1.2) million in fourth quarter of 2022 U.S. net revenue of$19.2 million up 104% vs. fourth quarter of 2022- International net revenue of
$7.1 million up 54% vs. fourth quarter of 2022
Full Year 2023 Financial Highlights:
- Net revenue of
$80.8 million up 49% vs. 2022 - Net loss of
$20.1 million vs.$18.1 million in 2022 - Positive adjusted EBITDA of
$8.7 million vs. adjusted EBITDA loss of$(7.9) million in 2022 U.S. net revenue of$56.7 million up 66% vs. 2022- International net revenue of
$24.0 million up 21% vs. 2022
Corporate Highlights:
- Acquired
U.S. commercial rights to YUTIQ (fluocinolone acetonide intravitreal insert) 0.18mg for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, leveraging existing commercial infrastructure. - Completed recruitment in the landmark NEW DAY Study for ILUVIEN, which is a multicenter, masked, randomized, controlled trial designed to generate prospective data evaluating ILUVIEN as a baseline therapy in the treatment of DME and demonstrate its potential advantages over the current standard of care of repeat anti-VEGF (aflibercept) injections. If successful, the NEW DAY Study could support a change to the current paradigm of DME treatment, offering patients a first-line, baseline treatment option that can maintain vision longer with fewer injections than other therapies. The NEW DAY Study currently has enrolled approximately 300 treatment-naïve, or near naïve, DME patients in approximately 42 sites around the
U.S. - Completed recruitment in the Synchronicity Study for YUTIQ, which is a prospective, open-label clinical study evaluating the safety and efficacy of YUTIQ for the treatment of macular edema associated with chronic, non-infectious uveitis affecting the posterior segment of the eye and related intraocular inflammation.
- Strengthened management team with additions of
Jason Werner ,Todd Wood andElliot Maltz . - Increased term loan agreement with its current lenders, investment affiliates managed by
SLR Capital Partners, LLC , by$5 million . - Achieved Adjusted EBITDA-based milestone trigger, extending the interest-only period of the Company’s term loan agreement to May of 2026 so long as the Company maintains covenant compliance.
Alimera will host a conference call today at
Fourth Quarter and Full Year 2023 Financial Results
Net Revenue for Q4 2023
Consolidated net revenue was up 88% to approximately
International net revenue increased 52% to approximately
Net Revenue for FY 2023
For 2023, consolidated net revenue increased 49% to approximately
For 2023,
For 2023, international net revenue increased 21% to approximately
Operating Expenses
Total operating expenses were approximately $22.0 million for Q4 2023, compared to approximately
Net Loss
Net loss for Q4 2023 was
Basic and diluted net loss per share for Q4 2023 was approximately
Basic and diluted net loss per share for 2023 was
Adjusted EBITDA
Adjusted EBITDA, a non-GAAP financial measure defined below, was approximately
Cash and Cash Equivalents
As of
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, severance expenses and change in fair value of warrant asset. Please refer to the sections of this press release entitled “Non-GAAP Financial Measure” and “Reconciliation of GAAP Measures to Non-GAAP Adjusted Measures –GAAP Net Income or Loss to Non-GAAP Adjusted EBITDA.”
ALIM Call Details - Fourth Quarter and Full Year 2023 Earnings and Business Update
Conference Call to Be Held
A live conference call will be hosted today, at
Conference date:
Conference dial-in: 844-839-2190
International dial-in: 412-717-9583
Conference Call Name:
Conference Call Pre-registration: Participants are asked to pre-register for the call by navigating to: https://dpregister.com/sreg/10186495/fb9ad32c9b
Please note that registered participants will receive their dial-in number upon registration and will dial directly into the call without delay. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the
The conference call will also be available through a live webcast which is also available via the company’s website.
Live Webcast URL: A replay will be available on Alimera’s website, www.alimerasciences.com, under “Investor Relations” one hour following the live call and will remain available until
Conference Call replay: US Toll Free: 1-877-344-7529
International Toll: 1-412-317-0088
Canada Toll Free: 855-669-9658
Replay Access Code: 3648198
End Date:
Webcast Replay End Date:
About
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 twelve months ended
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.
Forward Looking Statements
This press release contains, and the conference call in which executives of Alimera will discuss this press release may include “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, outlook and guidance, 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.
Such 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 these expectations, 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, factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of (i) Alimera’s most recently filed Annual Report on Form 10-K for the year ended
The expected financial results discussed in this press release are preliminary and unaudited and represent the most current information available to Alimera’s management, as financial closing procedures for the three months and full year ended
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. Therefore, you should not rely on these forward-looking statements as representing Alimera’s views as of any date after today.
For investor inquiries: for scottg@coreir.com | For media inquiries: for julesa@coreir.com |
CONSOLIDATED BALANCE SHEETS (In thousands, unaudited) | ||||||||
2023 | 2022 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 12,058 | $ | 5,274 | ||||
Restricted cash | 32 | 30 | ||||||
Accounts receivable, net | 34,545 | 19,612 | ||||||
Prepaid expenses and other current assets | 3,909 | 2,892 | ||||||
Inventory | 1,879 | 1,605 | ||||||
Total current assets | 52,423 | 29,413 | ||||||
Property and equipment, net | 2,466 | 2,525 | ||||||
Right of use assets, net | 1,124 | 1,395 | ||||||
Intangible asset, net | 97,355 | 8,957 | ||||||
Deferred tax asset | 104 | 129 | ||||||
Warrant asset | 52 | 183 | ||||||
Total assets | $ | 153,524 | $ | 42,602 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 8,253 | $ | 10,088 | ||||
Accrued expenses | 6,193 | 3,998 | ||||||
Accrued licensor payments | 7,275 | - | ||||||
Notes payable | - | 25,313 | ||||||
Finance lease obligations | 194 | 333 | ||||||
Total current liabilities | 21,915 | 39,732 | ||||||
Notes payable | 64,489 | 18,683 | ||||||
Accrued licensor payments | 15,136 | - | ||||||
Other non-current liabilities | 5,815 | 4,995 | ||||||
Total liabilities | 107,355 | 63,410 | ||||||
Stockholders' equity (deficit): | ||||||||
Preferred stock: | ||||||||
Series A convertible preferred stock | - | 19,227 | ||||||
Common stock | 524 | 70 | ||||||
Common stock warrants | 4,396 | - | ||||||
Additional paid-in capital | 462,446 | 378,238 | ||||||
Accumulated deficit | (418,491 | ) | (415,388 | ) | ||||
Accumulated other comprehensive loss | (2,706 | ) | (2,955 | ) | ||||
Total stockholders' equity (deficit) | 46,169 | (20,808 | ) | |||||
Total liabilities stockholders' equity (deficit) | $ | 153,524 | $ | 42,602 | ||||
CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except share and per share data) (Unaudited) | ||||||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Net revenue | $ | 26,306 | $ | 14,029 | $ | 80,754 | $ | 54,129 | ||||||||
Cost of goods sold, excluding depreciation and amortization | (3,626 | ) | (2,125 | ) | (10,837 | ) | (7,977 | ) | ||||||||
Gross profit | 22,680 | 11,904 | 69,917 | 46,152 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research, development and medical affairs expenses | 4,769 | 4,230 | 16,626 | 16,228 | ||||||||||||
General and administrative expenses | 6,379 | 3,491 | 18,530 | 13,028 | ||||||||||||
Sales and marketing expenses | 7,768 | 5,765 | 27,946 | 25,987 | ||||||||||||
Depreciation and amortization | 3,040 | 683 | 8,747 | 2,706 | ||||||||||||
Total operating expenses | 21,956 | 14,169 | 71,849 | 57,949 | ||||||||||||
Income (loss) from operations | 724 | (2,265 | ) | (1,932 | ) | (11,797 | ) | |||||||||
Interest expense and other, net | (4,754 | ) | (1,634 | ) | (10,185 | ) | (5,881 | ) | ||||||||
Unrealized foreign currency gain, net | 274 | 170 | 116 | 249 | ||||||||||||
Loss on extinguishment of debt | - | - | (1,079 | ) | - | |||||||||||
Change in fair value of common stock warrant | - | - | (6,836 | ) | - | |||||||||||
Change in fair value of warrant asset | (18 | ) | (52 | ) | (131 | ) | (650 | ) | ||||||||
Net loss before income taxes | (3,774 | ) | (3,781 | ) | (20,047 | ) | (18,079 | ) | ||||||||
Income tax (provision) benefit | (7 | ) | 1 | (85 | ) | (28 | ) | |||||||||
Net loss | $ | (3,781 | ) | $ | (3,780 | ) | $ | (20,132 | ) | $ | (18,107 | ) | ||||
Preferred stock dividends | - | - | (1,259 | ) | - | |||||||||||
Net loss applicable to common shareholders | $ | (3,781 | ) | $ | (3,780 | ) | $ | (21,391 | ) | $ | (18,107 | ) | ||||
Net loss per share - basic and diluted | $ | (0.07 | ) | $ | (0.54 | ) | $ | (0.79 | ) | $ | (2.59 | ) | ||||
Weighted average shares outstanding - basic and diluted | 54,422,965 | 7,000,279 | 25,561,885 | 6,996,850 | ||||||||||||
RECONCILIATION OF GAAP NET LOSS TO NON-GAAP ADJUSTED EBITDA (In thousands, unaudited) | ||||||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
GAAP net loss | $ | (3,781 | ) | $ | (3,780 | ) | $ | (20,132 | ) | $ | (18,107 | ) | ||||
Adjustments to net loss: | ||||||||||||||||
Interest expense, net and other | 4,754 | 1,634 | 10,185 | 5,881 | ||||||||||||
Income tax provision (benefit) | 7 | (1 | ) | 85 | 28 | |||||||||||
Depreciation and amortization | 3,040 | 683 | 8,747 | 2,706 | ||||||||||||
Stock-based compensation expense | 805 | 187 | 1,435 | 910 | ||||||||||||
Unrealized foreign currency exchange gain, net | (274 | ) | (13 | ) | (116 | ) | (92 | ) | ||||||||
Loss on extinguishment of debt | - | - | 1,079 | - | ||||||||||||
Change in fair value of common stock warrants | - | - | 6,836 | - | ||||||||||||
Change in fair value of warrant asset | 18 | 52 | 131 | 650 | ||||||||||||
Severance expenses | 461 | - | 461 | 147 | ||||||||||||
Non-GAAP adjusted EBITDA | $ | 5,030 | $ | (1,238 | ) | $ | 8,711 | $ | (7,877 | ) | ||||||
Source:
2024 GlobeNewswire, Inc., source