Alimera Sciences Reports Fourth Quarter and Full Year 2023 Results
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Insights
The reported 88% increase in Q4 net revenues and 49% increase in annual net revenues for Alimera Sciences represents significant growth for the company. Such a substantial rise in revenues typically indicates effective market penetration and product acceptance, which for a pharmaceutical company, can be the result of successful marketing strategies, product efficacy and competitive positioning. The positive Adjusted EBITDA, despite consistent net losses, suggests that the company is managing its operational costs effectively relative to its revenue growth, although it's important to consider the increased expenses due to interest and amortization from the YUTIQ acquisition.
Increasing the 2024 revenue guidance is a bullish signal to investors, showing management's confidence in the company's continued growth trajectory. This could potentially lead to increased investor confidence and a positive impact on the stock price. However, it's crucial for stakeholders to evaluate the sustainability of this growth, considering the competitive landscape of the retinal health market and the company's ability to maintain its sales momentum and manage debt levels.
The success mentioned in the sales of ILUVIEN and YUTIQ, particularly in the U.S. market, indicates a strong performance by the sales team and potentially high product demand. For stakeholders, the expansion of the sales team and the strong international demand are key indicators of market reach and the company's ability to scale operations. The pharmaceutical industry is often influenced by regulatory approvals, patent cliffs and market dynamics such as the entry of generics. Therefore, the company's future growth will likely depend on its ability to innovate, defend its market share and possibly expand its product portfolio.
Understanding the nuances of the retinal health market, including disease prevalence and competitor products, will be critical in assessing Alimera's market position and the potential for its revenue guidance to materialize. This also includes the analysis of market trends, reimbursement scenarios and the impact of healthcare policies on drug pricing and patient access.
Alimera Sciences' focus on retinal health and products like ILUVIEN and YUTIQ suggests a specialization in a niche but growing segment of the pharmaceutical market. The effectiveness and safety profile of these products, as well as their comparative performance to existing treatments, are essential factors for their adoption and sustained sales growth. The retinal disease treatment market is driven by an aging population and the rising prevalence of diseases such as diabetic macular edema (DME) and retinal vein occlusion (RVO), which ILUVIEN and YUTIQ target.
For the medical community and patients, the value provided by these treatments in terms of efficacy, side effects and cost compared to alternative therapies will be critical in determining their long-term success. Clinical data and real-world evidence supporting these products will be key in securing physician recommendations and favorable reimbursement policies, which in turn can significantly impact the company's financial performance.
Q4 Net Revenues up
2023 Net Revenues up
Increases 2024 Revenue Guidance
ATLANTA, March 07, 2024 (GLOBE NEWSWIRE) -- 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 fourth quarter and full year 2023. Alimera will host a conference call today at 9:00 a.m. EDT to discuss these results.
“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 U.S. is evident, and we are further encouraged by the strong demand we continue to see in our international markets, leading us to be incredibly excited about the opportunities for sustained sales growth of both YUTIQ and ILUVIEN. As a result, we are increasing our revenue guidance for 2024 and expect to deliver over
Elliot Maltz, CFO, added, “As a result of our strong revenue growth in the second half of 2023 and early in 2024, we have triggered multiple revenue-based milestone payments embedded in our debt agreements with SLR earlier than expected. To preserve cash for working capital purposes as we continue to grow ILUVIEN and YUTIQ, we are pleased to report that SLR has agreed to increase our loan facility by
Key Fourth Quarter Financial Highlights:
- Net revenue of
$26.3 million up88% 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 up104% vs. fourth quarter of 2022 - International net revenue of
$7.1 million up54% vs. fourth quarter of 2022
Full Year 2023 Financial Highlights:
- Net revenue of
$80.8 million up49% 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 up66% vs. 2022 - International net revenue of
$24.0 million up21% 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 and Elliot 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 9:00 a.m. ET to discuss these results. Details for the call can be found below.
Fourth Quarter and Full Year 2023 Financial Results
Net Revenue for Q4 2023
Consolidated net revenue was up
U.S. net revenue increased
International net revenue increased
Net Revenue for FY 2023
For 2023, consolidated net revenue increased
For 2023, U.S. net revenue increased
For 2023, international net revenue increased
Operating Expenses
Total operating expenses were 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 December 31, 2023, Alimera had cash and cash equivalents of approximately
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 March 7, 2024
A live conference call will be hosted today, at 9:00 a.m. EST by Rick Eiswirth, President and Chief Executive Officer, and Elliot Maltz, Chief Financial Officer, to discuss Alimera’s financial results and provide an update on corporate developments. Please refer to the information below for conference call dial-in information and webcast registration.
Conference date: Thursday, March 7, 2024, 9:00 a.m. EST
Conference dial-in: 844-839-2190
International dial-in: 412-717-9583
Conference Call Name: Alimera Sciences (Nasdaq: ALIM) Fourth Quarter and Full Year 2023 Earnings and Business Update
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 Alimera Sciences call.
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 June 7, 2024.
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: March 21, 2024
Webcast Replay End Date: June 7, 2024
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 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 December 31, 2023 and 2022 has been presented in certain instances excluding items identified in the reconciliations provided in the table entitled “Reconciliation of GAAP Measures to Non-GAAP Adjusted Measures – GAAP Net Income or Loss to Non-GAAP Adjusted EBITDA.” GAAP net income or loss is the most directly comparable GAAP financial measure to Adjusted EBITDA.
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 December 31, 2022, and (ii) Alimera’s most recently filed Quarterly Reports on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2023, all of which are on file with the SEC and are available on the SEC’s website at http://www.sec.gov.
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 December 31, 2023 are not yet complete. These estimates are not a comprehensive statement of Alimera’s financial results for the fourth quarter and the full year, and actual results may differ materially from these estimates as a result of the completion of quarter-end financial reporting process and the subsequent occurrence or identification of events prior to the formal issuance of the audited financial statements for the full year ended December 31, 2023.
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: Scott Gordon for Alimera Sciences scottg@coreir.com | For media inquiries: Jules Abraham for Alimera Sciences julesa@coreir.com |
| ALIMERA SCIENCES, INC. CONSOLIDATED BALANCE SHEETS (In thousands, unaudited) | ||||||||
| December 31, | ||||||||
| 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 | ||||
| ALIMERA SCIENCES, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except share and per share data) (Unaudited) | ||||||||||||||||
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 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 | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 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 | ) | ||||||
FAQ
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