Company plans Phase 2 trial in first-recurrence head & neck cancer,
in combination with immune checkpoint inhibitor
Atlanta, GA, July 31, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced the next steps for the clinical development of its Gedeptin® cancer therapy, following a clinical advisory committee review.
GeoVax and a specially convened clinical advisory committee have completed a comprehensive review of the recently completed PNP-002 Phase 1b/2a trial, together with the previously completed PNP-001 Phase 1 trial. The Phase 1b/2a trial evaluated the safety and efficacy of repeat cycles of Gedeptin therapy in patients with advanced head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options. The protocol assessed up to five treatment cycles, each consisting of three intratumoral injections of Gedeptin over two days followed by infusion of a prodrug, fludarabine phosphate, once a day for three days. This review concluded that Gedeptin demonstrated acceptable safety and efficacy to support continued development. No new safety signals were identified in the PNP-002 trial in heavily pretreated head & neck cancer patients. The therapy demonstrated sufficient tumor stabilization/reduction activity to support plans to advance clinical development of Gedeptin in an expanded Phase 2 clinical trial.
The primary goal of the planned Phase 2 trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in first-recurrence squamous cell head and neck cancer. This trial is anticipated to be a single cycle trial with surgery to follow in approximately 36 patients with pathologic response rate as the primary endpoint. The Company has initiated the necessary planning activities, including protocol development, manufacturing, and CRO selection with the trial activation anticipated during the first half of 2025.
“Based on the review of the two clinical trials completed with Gedeptin, we believe that this therapy, combined with an immune checkpoint inhibitor, has the potential to represent an active therapy against solid tumors. As such, in alignment with the Gedeptin clinical advisory committee, we have initiated efforts in support of an expanded Phase 2 trial, combining Gedeptin with an immune checkpoint inhibitor as therapy in squamous cell head and neck cancer,” stated J. Marc Pipas, M.D., GeoVax Executive Medical Director, Oncology.
“We are pleased to announce the plans for this novel, expanded Phase 2 clinical trial of Gedeptin, seeking to demonstrate efficacy and safety of Gedeptin and an immune checkpoint inhibitor combination therapy in support of such neoadjuvant therapy. We look forward to activation of this trial and are pursuing development plans in additional solid tumor indications in partnership with leading academic oncology centers. Further updates will be provided during the remainder of 2024,” added David Dodd, GeoVax’s Chairman and CEO.
About Gedeptin®
Gedeptin is a novel patented product/technology for the treatment of solid tumors through a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT). In GDEPT, a vector is used to selectively transduce tumor cells with a non-human gene, which expresses an enzyme that converts a nontoxic prodrug into a highly active antitumor compound in situ.
The Phase 1b/2a trial (ClinicalTrials.gov Identifier: NCT03754933) evaluated the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options. The protocol entailed up to five treatment cycles, each consisting of three intratumoral injections of Gedeptin over two days followed by infusion of a prodrug, fludarabine phosphate, once a day for three days. A previously completed Phase 1 dose-ranging study demonstrated that treating a tumor with a single cycle of Gedeptin, followed by fludarabine infusions, was well tolerated, with evidence of a reduction in tumor size in patients with solid tumors.
The current study is being funded in part by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. The FDA has also granted Gedeptin orphan drug status for the intratumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland, and other oral cavities.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Fibromyalgia is a “diagnosable condition” in people suffering from Long COVID according to NASEM1
Diagnosing fibromyalgia in Long COVID patients is expected to expand the potential addressable market for Tonmya relative to pre-COVID-19 pandemic estimates2
Tonmya is a potential new first-line non-opioid analgesic under development for the management of fibromyalgia with Fast Track designation: NDA submission target is second half of 2024, with potential for FDA approval in 2025
CHATHAM, N.J., July 31, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today provided an update on the potential impact on the size of the fibromyalgia market for its development candidate Tonmya (TNX-102 SL or cyclobenzaprine HCl sublingual tablets), based on the new definition of Long COVID by the U.S. National Academies of Sciences, Engineering and Medicine (NASEM) announced on June 11, 20241.
“The consensus report from the NASEM concludes that fibromyalgia is a ‘diagnosable condition’ in people suffering from Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “It has long been recognized that fibromyalgia can arise after a viral illness and is considered an infection-associated chronic condition.2,3 The NASEM definition confirms that fibromyalgia occurs after infection with the SARS-CoV-2 virus in some patients with Long COVID. Tonix is planning to file a New Drug Application (NDA) for Tonmya in the second half of this year for the indication of fibromyalgia with the U.S. Food and Drug Administration (FDA). We believe that diagnosing fibromyalgia in Long COVID patients will increase the potential market for Tonmya following approval as compared to market estimates from before the COVID-19 pandemic.”
Dr. Lederman continued, “Prior to the COVID-19 pandemic, the prevalence of fibromyalgia was estimated to be more than 10 million adults in the U.S.4 The U.S. Census Bureau, the National Center for Health Statistics Household Pulse Survey and the Centers for Disease Control and Prevention (CDC) estimate that approximately 5.3% of U.S. adults suffer from Long COVID, or 14 million people.5 Fibromyalgia is commonly diagnosed in Long COVID patients6-8. Although it is unknown how many Long COVID patients meet the diagnostic criteria for fibromyalgia, the National Institutes of Health (NIH)-sponsored RECOVER study found many Long COVID patients suffer from pain at multiple sites9. The Company has previously presented its analysis of real-world evidence from the TriNetX claims database suggesting that over 40% of Long COVID patients present with a constellation of symptoms that overlap with fibromyalgia.10,11 The Company completed a proof-of-concept study in Long COVID patients who presented with multisite pain and found a nominal benefit in fatigue with TNX-102 SL treatment with no new safety signals. We hope this new definition of Long COVID will allow patients suffering from chronic pain and other debilitating symptoms to access the care they need.”
About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6 million to 12 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including anxiety and depression, headaches, and abdominal pain or cramps. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.
About Tonmya* (also known as TNX-102 SL)
Tonmya™ (cyclobenzaprine HCl sublingual tablets) is a centrally acting, non-opioid, non-addictive, investigational drug being developed as a daily bedtime medication for the management of fibromyalgia, alcohol use disorder and agitation in Alzheimer’s disease. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride TNX-102 SL provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, the second pivotal Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all six key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first statistically significant Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study). Tonix has recently announced receipt of the formal minutes from both recent pre-New Drug Application (NDA) meetings with the U.S. Food and Drug Administration (FDA) for Tonmya for the management of fibromyalgia. At these meetings, the Company and the FDA agreed on the proposed content and timing of an NDA submission. The Company reaffirmed its guidance to submit the NDA for Tonmya to the FDA in the second half of 2024 which would allow for a potential FDA approval in 2025. Tonmya for the management of fibromyalgia has been granted FDA Fast Track designation.
About the Phase 2 PREVAIL Study
The Phase 2 PREVAIL study was a 14-week double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-102 SL taken daily at bedtime in patients with multi-site pain associated with Long COVID. The trial was conducted at approximately 30 sites in the U.S. The study was not significant on the primary efficacy endpoint of the change from baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. Nominal activity of TNX-102 SL was shown in fatigue.
For more information, see ClinicalTrials.gov Identifier: NCT05472090.
About Long COVID
Long COVID is an infection-associated chronic condition (IACC) that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems. Long COVID is the term widely recognized for the post-COVID syndrome formerly known as Post-acute sequelae of COVID-19, or PASC. Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develops Long COVID. These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems.
Tonix Pharmaceuticals Holding Corp.**
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
**Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Total revenue was €51.7 mm in Q2 2024, while net gaming revenue1 was €54.4 mm in the period, 39% above Q1 2023.
Mexico revenue was €25.3 mm in Q2 2024, while net gaming revenue was €28.2 mm in the period, 57% above Q2 2023.
Spain revenue (and net gaming revenue) reached €21.8 mm in Q2 2024, 25% above Q2 2023.
Net income excluding the non-cash variation in fair value of public warrants2 was €5.5 mm in H1 2024 versus a net loss of €0.7 mm in H1 2023.
Total cash position of €40.5 mm as of June 30, 2024.
Increasing full year 2024 net gaming revenue outlook to €205 – 215 mm and Adj. EBITDA3 outlook to positive €2.5 – 7.5 mm.
Madrid, Spain and Tel Aviv, Israel, July 31, 2024 – (GLOBE NEWSWIRE) Codere Online (Nasdaq: CDRO / CDROW, the “Company”), a leading online gaming operator in Spain and Latin America, has released its preliminary unaudited4 financial results for the quarter ended June 30, 2024.
Aviv Sher, CEO of Codere Online, commented on the results, “We are very pleased with our performance in the second quarter of 2024, with net gaming revenue of €54.4 million, a 39% increase over the prior year period. In the quarter we saw improved customer engagement and customer acquisitions in part due to targeted additional marketing investments made around certain major sports betting events (i.e. Eurocup and Copa America). As a result, performance in our core Mexican and Spanish businesses was strong (notwithstanding all the Spanish victories in the Eurocup), with net gaming revenue growing by 57% in the second quarter in Mexico to over €28 million and 25% in Spain to nearly €22 million.”
Oscar Iglesias, CFO of Codere Online, stated, “We are pleased to have delivered positive Adjusted EBITDA for the second consecutive quarter despite the increased marketing spend around the Eurocup and Copa America. The €1.3 million in Adjusted EBITDA in the second quarter is nearly €6 million better than the prior year period and for the year-to-date period we have generated €3.0 million.”
Mr. Iglesias further added, “Thanks to this solid performance in the first half of the year, we are well on track to meet the profitability and cash generation expectations we set out to achieve in the beginning of the year, while still delivering significant top line growth. As such, we are raising our outlook for the full year 2024 and now expect to generate between €205 – 215 million of net gaming revenue, which represents a growth of 22% year-on-year at the midpoint, and between €2.5 – 7.5 million of positive Adjusted EBITDA.”
Recent Events
Board Changes
In the AGM held on June 24, 2024, Mr. Gabriel Saenz de Buruaga, Mr. Taavi Davies and Mr. Claude Noesen were appointed as directors, succeeding Mr. Patrick Ramsey, Ms. Michal Elimelech, and Mr. Laurent Teitgen.
Mr. Gonzaga Higuero, CEO of Codere Group, was re-appointed as director and named Chairman of the Board.
Research Coverage
On July 11, 2024, Craig-Hallum Capital Group initiated coverage of Codere Online6.
For more information about research firms currently covering Codere Online please access the Analyst Coverage section of our website.
Conference Call Information
Codere Online’s management will host a conference call to discuss the results and provide a business update at 8:30 am US Eastern Time today, July 31, 2024. Dial-in details as well as the audio webcast and presentation will be accessible on Codere Online’s website at www.codereonline.com. A recording of the webcast will also be available following the conference call.
About Codere Online Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile applications. Codere currently operates in its core markets of Spain, Mexico, Colombia, Panama and Argentina. Codere Online’s online business is complemented by Codere Group’s physical presence in Spain and throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence.
About Codere Group Codere Group is a multinational group devoted to entertainment and leisure. It is a leading player in the private gaming industry, with four decades of experience and with presence in seven countries in Europe (Spain and Italy) and Latin America (Argentina, Colombia, Mexico, Panama, and Uruguay).
Note on Rounding. Due to decimal rounding, numbers presented throughout this report may not add up precisely to the totals and subtotals provided, and percentages may not precisely reflect the absolute figures.
Forward-Looking Statements Certain statements in this document may constitute “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding Codere Online Luxembourg, S.A. and its subsidiaries (collectively, “Codere Online”) or Codere Online’s or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this document may include, for example, statements about Codere Online’s financial performance and, in particular, the potential evolution and distribution of its net gaming revenue; any prospective and illustrative financial information; and changes in Codere Online’s strategy, future operations and target addressable market, financial position, estimated revenues and losses, projected costs, prospects and plans.
These forward-looking statements are based on information available as of the date of this document and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing Codere Online’s or its management team’s views as of any subsequent date, and Codere Online does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
As a result of a number of known and unknown risks and uncertainties, Codere Online’s actual results or performance may be materially different from those expressed or implied by these forward-looking statements. There may be additional risks that Codere Online does not presently know or that Codere Online currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Some factors that could cause actual results to differ include (i) changes in applicable laws or regulations, including online gaming, privacy, data use and data protection rules and regulations as well as consumers’ heightened expectations regarding proper safeguarding of their personal information, (ii) the impacts and ongoing uncertainties created by regulatory restrictions, changes in perceptions of the gaming industry, changes in policies and increased competition, and geopolitical events such as war, (iii) the ability to implement business plans, forecasts, and other expectations and identify and realize additional opportunities, (iv) the risk of downturns and the possibility of rapid change in the highly competitive industry in which Codere Online operates, (v) the risk that Codere Online and its current and future collaborators are unable to successfully develop and commercialize Codere Online’s services, or experience significant delays in doing so, (vi) the risk that Codere Online may never achieve or sustain profitability, (vii) the risk that Codere Online will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all, (viii) the risk that Codere Online experiences difficulties in managing its growth and expanding operations, (ix) the risk that third-party providers, including the Codere Group, are not able to fully and timely meet their obligations, (x) the risk that the online gaming operations will not provide the expected benefits due to, among other things, the inability to obtain or maintain online gaming licenses in the anticipated time frame or at all, (xi) the risk that Codere Online is unable to secure or protect its intellectual property, and (xii) the possibility that Codere Online may be adversely affected by other political, economic, business, and/or competitive factors. Additional information concerning certain of these and other risk factors is contained in Codere Online’s filings with the U.S. Securities and Exchange Commission (the “SEC”). All subsequent written and oral forward-looking statements concerning Codere Online or other matters and attributable to Codere Online or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above.
Financial Information and Non-GAAP Financial Measures Codere Online’s financial statements are prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”), which can differ in certain significant respects from generally accepted accounting principles in the United States of America (“U.S. GAAP”).
This document includes certain financial measures not presented in accordance with U.S. GAAP or IFRS (“non-GAAP”), such as, without limitation, net gaming revenue and Adjusted EBITDA. These non-GAAP financial measures are not measures of financial performance in accordance with U.S. GAAP or IFRS and may exclude items that are significant in understanding and assessing Codere Online’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to revenue, net income, cash flows from operations or other measures of profitability, liquidity or performance under U.S. GAAP or IFRS. You should be aware that Codere Online’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. In addition, the audit of Codere Online’s financial statements in accordance with PCAOB standards, may impact how Codere Online currently calculates its non-GAAP financial measures, and we cannot assure you that there would not be differences, and such differences could be material.
Codere Online believes that the use of these non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends in comparing Codere Online’s financial measures with other similar companies, many of which present similar non-GAAP financial measures to investors. These non-GAAP financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-GAAP financial measures. Reconciliations of non-GAAP financial measures to their most directly comparable measure under IFRS are included herein.
This document may include certain projections of non-GAAP financial measures. Codere Online is unable to quantify certain amounts that would be required to be included in the most directly comparable U.S. GAAP or IFRS financial measures without unreasonable effort, due to the inherent difficulty and variability of accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such comparable measures or such reconciliation that have not yet occurred, are out of our control, or cannot be reasonably predicted, ascertained or assessed, which could have a material impact on its future IFRS financial results. Consequently, no disclosure of estimated comparable U.S. GAAP or IFRS measures is included and no reconciliation of the forward-looking non-GAAP financial measures is included.
Use of Projections This document contains financial forecasts with respect to Codere Online’s business and projected financial results, including net gaming revenue and adjusted EBITDA. Codere Online’s independent auditors have not audited, reviewed, compiled or performed any procedures with respect to the projections for the purpose of their inclusion in this document, and accordingly, they did not express an opinion or provide any other form of assurance with respect thereto for the purpose of this document. These projections should not be relied upon as being necessarily indicative of future results. The assumptions and estimates underlying the prospective financial information are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the prospective financial information. See “Forward-Looking Statements” above. Accordingly, there can be no assurance that the prospective results are indicative of the future performance of Codere Online or that actual results will not differ materially from those presented in the prospective financial information. Inclusion of the prospective financial information in this document should not be regarded as a representation by any person that the results contained in the prospective financial information will be achieved.
For further information on the limitations and assumptions underlying these projections, please refer to Codere Online’s filings with the SEC.
Preliminary Information This document contains figures, financial metrics, statistics and other information that is preliminary and subject to change (the “Preliminary Information”). The Preliminary Information has not been audited, reviewed, or compiled by any independent registered public accounting firm. This Preliminary Information is subject to ongoing review including, where applicable, by Codere Online’s independent auditors. Accordingly, no independent registered public accounting firm has expressed an opinion or any other form of assurance with respect to the Preliminary Information. During the course of finalizing such Preliminary Information, adjustments to such Preliminary Information presented herein may be identified, which may be material. Codere Online undertakes no obligation to update or revise the Preliminary Information set forth in this document as a result of new information, future events or otherwise, except as otherwise required by law. The Preliminary Information may differ from actual results. Therefore, you should not place undue reliance upon this Preliminary Information. The Preliminary Information is not a comprehensive statement of financial results, and should not be viewed as a substitute for full financial statements prepared in accordance with IFRS. In addition, the Preliminary Information is not necessarily indicative of the results to be achieved in any future period.
No Offer or Solicitation This document does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities will be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.
Industry and Market Data In this document, Codere Online relies on and refers to certain information and statistics obtained from publicly available information and third-party sources, which it believes to be reliable. Codere Online has not independently verified the accuracy or completeness of any such publicly-available and third-party information, does not make any representation as to the accuracy or completeness of such data and does not undertake any obligation to update such data after the date of this document. You are cautioned not to give undue weight to such industry and market data.
Contacts:
Investors and Media Guillermo Lancha Director, Investor Relations and Communications [email protected] (+34) 628 928 152
1 Net Gaming Revenue is a non-IFRS measure. Please see reconciliation of Net Gaming Revenue to Revenue at the end of the report. 2 Net income excluding the non-cash variation in fair value of public warrants is a non-IFRS measure. Reconciliation: H1 2024 figure reflects a net loss of €0.2 mm (€0.3 mm in H1 2023) excluding a €5.8 mm loss (€0.3 gain in H1 2023) from the variation in fair value of public warrants. Figures presented for illustrative purposes and do not include any potential impacts on the provision for corporate income taxes. 3 Adjusted EBITDA outlook is a forward-looking non-IFRS measure. Please see important disclaimers at the end of the report. 4 See “Preliminary Information” below. 5 Average Monthly Active Players include real money (i.e. exclude free bets) sports betting and casino actives. 6 Codere Online does not endorse, recommend, or have any affiliation with Craig-Hallum Capital Group LLC or their research. The views, opinions, and recommendations expressed by Craig-Hallum Capital Group LLC are their own and do not reflect the views or opinions of Codere Online. Investors should conduct their own independent research and consult with a financial advisor before making any investment decisions. Codere Online is not responsible for any losses or damages arising from the use of this information. 7 Figures primarily reflect differences in recognition of revenue related to certain partner and affiliate agreements in place in Colombia, VAT impact from entry fees in Mexico and the impact from the application of inflation accounting (IAS 29) in Argentina.
Atlanta, GA, July 30, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it will report second quarter 2024 financial results on Tuesday, August 6, 2024, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.
A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
Presentation to highlight statistically significant Phase 3 results of Tonmya™ for the management of fibromyalgia, including improvement in pain and sleep quality
Tonix granted FDA Fast Track Designation for Tonmya™; NDA submission on track for the second half of 2024
CHATHAM, N.J., July 30, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced a poster presentation at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain, being held August 5-9, 2024 in Amsterdam, Netherlands. Details on the presentation can be found below.
A copy of the Company’s poster presentations will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the IASP website here.
Poster Presentation Details
Presenter:
Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals
Title:
Targeting Fibromyalgia Non-Restorative Sleep with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl): Results of the Positive Phase 3 RESILIENT Trial Consistent with Syndromic Improvement
Abstract:
#WE685
Date/Time:
Wednesday, August 7, 2024, 3:15 p.m. CEST
Tonix Pharmaceuticals Holding Corp.**
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya*, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to Tonmya for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
**Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
SKYX will Offer a Variety of its Advanced and Smart Plug & Play Products including Retrofit Kits, Smart Light Fixtures, Smart Ceiling Fans, Ceiling Outlet Receptacles, Recessed Lights and More
MIAMI, July 30, 2024 (GLOBE NEWSWIRE) — SKYX (NASDAQ: SKYX) (d/b/a “SKYX Technologies”), a highly disruptive smart platform technology company with over 94 issued and pending patents in the U.S. and globally, and which owns over 60 lighting and home décor websites with a mission to make homes and buildings become smart, safe, and advanced as the new standard, announced today a collaboration with world leading home improvement retailer, Home Depot, for its advanced and smart plug & play products.
SKYX will offer a variety of its Advanced and Smart Plug & Play Products including Retrofit Kits, Smart Light Fixtures, Smart Ceiling Fans, Ceiling Outlet Receptacles, and Recessed Lights among others. A large assortment of these advanced and smart products is expected to be offered on Home Depot’s website in the next coming months, while some advanced and smart plug & play retrofit kit products are expected to arrive in select stores and online to be offered as a fixture upgrade.
Steve Schmidt President of SKYX Platform said: “We are truly excited that we are collaborating with the world leading home improvement company Home Depot. Our technology offers a variety of products for both retail and professional segments; therefore, I view this collaboration as a tremendous growth opportunity for us that can have a significant impact on our business”.
Rani Kohen, Founder and Executive Chairman of SKYX Platforms, said: “We are excited to work together with Home Depot, a global leader in retail and professional industries. We strongly believe that this opportunity will have a significant effect on our business and market penetration for both our retail and professional sales channels”.
About SKYX Platforms Corp.
As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 94 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn.
Forward-Looking Statements
Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with third-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.
80 Participants (Two-thirds of Projected Recruitment) Enrolled
IRVINE, Calif., July 29, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that it has enrolled the 80th participant in its ongoing Phase 2 BESTOW trial assessing tegoprubart for the prevention of rejection in kidney transplantation.
“As of this week, we have already enrolled two-thirds of the projected study participants across sites in the United States, Europe and Latin America,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We are grateful to the participants and their clinical teams, whose high level of interest enabled us to achieve this level of enrollment in our Phase 2 BESTOW trial. This progress underscores the urgency and need for innovative solutions in preventing kidney transplant rejection. We remain on track to complete enrollment by the end of the year.”
BESTOW, a multicenter, two-arm, active comparator clinical study, will enroll approximately 120 participants undergoing kidney transplantation in the United States, Europe and Latin America to evaluate the safety, pharmacokinetics, and efficacy of the anti-CD40 ligand antibody tegoprubart compared to the calcineurin inhibitor tacrolimus. The study’s primary objective is to assess graft function at 12 months post-transplant, as measured by estimated glomerular filtration rate (eGFR), in participants treated with tegoprubart compared to tacrolimus. Better graft function as assessed by eGFR has been associated with improved long-term patient and graft survival.
Eledon is currently conducting a Phase 2 trial (BESTOW; NCT05983770), a Phase 1b trial (NCT05027906), and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Second quarter 2024 total revenue of $593.4 million, net income of $100.2 million, and EBITDA of $177.7 million
Coal sales price realizations of $65.30 per ton sold, up 3.8% year-over-year
Increased oil & gas royalty volumes to 817 MBOE, up 6.8% year-over-year
In June 2024, issued $400 million in 8.625% Senior Notes due 2029 and redeemed outstanding balance of Senior Notes due 2025
Extended revolving credit facility maturity to March 2028
Enhanced liquidity position to $666.0 million, which included $203.7 million in cash and $462.3 million of borrowings available under credit facilities
In July 2024, declared quarterly cash distribution of $0.70 per unit, or $2.80 per unit annualized
TULSA, Okla.–(BUSINESS WIRE)– In the Condensed Consolidated Statements of Income and Operating Data table the figure for INCOME FROM OPERATIONS for the Three Months Ended June 2023 should read: 183,929 (instead of 10183,929).
The updated release reads:
ALLIANCE RESOURCE PARTNERS, L.P. REPORTS SECOND QUARTER FINANCIAL AND OPERATING RESULTS; DECLARES QUARTERLY CASH DISTRIBUTION OF $0.70 PER UNIT AND UPDATES 2024 GUIDANCE
2024 Quarter Highlights
Second quarter 2024 total revenue of $593.4 million, net income of $100.2 million, and EBITDA of $177.7 million
Coal sales price realizations of $65.30 per ton sold, up 3.8% year-over-year
Increased oil & gas royalty volumes to 817 MBOE, up 6.8% year-over-year
In June 2024, issued $400 million in 8.625% Senior Notes due 2029 and redeemed outstanding balance of Senior Notes due 2025
Extended revolving credit facility maturity to March 2028
Enhanced liquidity position to $666.0 million, which included $203.7 million in cash and $462.3 million of borrowings available under credit facilities
In July 2024, declared quarterly cash distribution of $0.70 per unit, or $2.80 per unit annualized
Alliance Resource Partners, L.P. (NASDAQ: ARLP) (“ARLP” or the “Partnership”) today reported financial and operating results for the three and six months ended June 30, 2024 (the “2024 Quarter” and “2024 Period,” respectively). This release includes comparisons of results to the three and six months ended June 30, 2023 (the “2023 Quarter” and “2023 Period,” respectively) and to the quarter ended March 31, 2024 (the “Sequential Quarter”). All references in the text of this release to “net income” refer to “net income attributable to ARLP.” For a definition of EBITDA and related reconciliation to its comparable GAAP financial measure, please see the end of this release.
Total revenues in the 2024 Quarter decreased 7.6% to $593.4 million compared to $641.8 million for the 2023 Quarter primarily as a result of reduced coal sales volumes, which declined 11.8% primarily due to transportation delays, partially offset by increased coal sales price realizations, which rose 3.8% to $65.30 per ton sold in the 2024 Quarter compared to $62.93 per ton sold in the 2023 Quarter. Net income for the 2024 Quarter was $100.2 million, or $0.77 per basic and diluted limited partner unit, compared to $169.8 million, or $1.30 per basic and diluted limited partner unit, for the 2023 Quarter as a result of lower revenues and increased total operating expenses. EBITDA for the 2024 Quarter was $177.7 million compared to $249.2 million in the 2023 Quarter.
Compared to the Sequential Quarter, total revenues in the 2024 Quarter decreased 9.0% primarily as a result of lower tons sold. Lower revenues and a $3.7 million reduction in the fair value of our digital assets, partially offset by reduced operating expenses, reduced net income and EBITDA by 36.6% and 24.4%, respectively, compared to the Sequential Quarter.
Total revenues decreased 4.6% to $1.25 billion for the 2024 Period compared to $1.30 billion for the 2023 Period primarily due to lower coal sales, partially offset by higher oil & gas royalties and other revenues. Net income for the 2024 Period was $258.2 million, or $1.98 per basic and diluted limited partner unit, compared to $361.0 million, or $2.75 per basic and diluted limited partner unit, for the 2023 Period as a result of lower revenues and increased total operating expenses. EBITDA for the 2024 Period was $412.7 million compared to $520.1 million in the 2023 Period.
CEO Commentary
“During the 2024 Quarter we enhanced our liquidity position,” highlighted Joseph W. Craft III, Chairman, President, and Chief Executive Officer. “The successful completion of our Senior Notes offering further strengthened our balance sheet and represents a vote of confidence from the capital markets for our business strategy and plans for execution. As we have said time and again, reliable, affordable, baseload energy is a cornerstone of our nation’s economy, and our strong financial position means we are well-positioned to provide strategic energy supply from our well-capitalized and strategically located coal mines and growing minerals acreage portfolio for many years to come.”
“Coal sales volumes during the 2024 Quarter were impacted by flooding on the Ohio River delaying barge deliveries. Rail and port logistics were disrupted by the Baltimore bridge incident, which as time progressed impacted shipments from our Appalachia rail operations. These delays, combined with lower export sales, lifted our inventories higher by 0.8 million tons compared to the Sequential Quarter,” commented Mr. Craft. “Our well-contracted order book continued to provide stability for our business, delivering improvements in coal sales pricing per ton compared to both the 2023 Quarter and the Sequential Quarter. Additionally, our Oil & Gas Royalties segment reported a 6.8% increase in BOE volumes year-over-year during the 2024 Quarter as our Permian-weighted minerals portfolio continues to realize production growth from recently drilled and completed wells.”
Balance Sheet and Liquidity
As of June 30, 2024, total debt and finance leases outstanding were $503.9 million, including $400 million in newly issued Senior Notes due 2029. The Partnership’s total and net leverage ratios were 0.61 times and 0.36 times debt to trailing twelve months Adjusted EBITDA, respectively, as of June 30, 2024. ARLP ended the 2024 Quarter with total liquidity of $666.0 million, which included $203.7 million of cash and cash equivalents and $462.3 million of borrowings available under its revolving credit and accounts receivable securitization facilities.
During the 2024 Quarter, the Partnership issued $400 million in 8.625% Senior Notes due 2029 and redeemed the outstanding balance of $284.6 million in ARLP’s 7.5% Senior Notes due 2025. The Partnership also amended its revolving credit facility to extend the maturity date to March 9, 2028.
Distributions
On July 26, 2024, we announced that the Board of Directors of ARLP’s general partner (the “Board”) approved a cash distribution to unitholders for the 2024 Quarter of $0.70 per unit (an annualized rate of $2.80 per unit), payable on August 14, 2024, to all unitholders of record as of the close of trading on August 7, 2024. The announced distribution is consistent with the cash distributions for the 2023 Quarter and Sequential Quarter.
Outlook
“For the first half of 2024, utility coal burn has been essentially flat with 2023,” commented Mr. Craft. “Since the start of this summer, cooling demand has been strong across many parts of the country driven by recent record-breaking temperatures and accelerating coal-based power generation. This is encouraging considering the very mild 2024 winter and persistently low natural gas prices. At the same time, while demand is holding up, U.S. thermal coal production has slowed significantly (Eastern U.S. production down 11% year-over-year) as utilities are relying on consuming coal from their elevated inventories to meet this demand. Weather forecasts suggest this heat wave will continue through August and an industry publication is projecting demand will exceed supply by close to 20 million tons in the second half of 2024.”
“Turning to the export markets, net back pricing for high sulfur Illinois Basin coal has declined to a level that we have decided it is prudent to slow down production for the back half of the year. Therefore, we are adjusting 2024 full-year guidance for our coal operations. At the midpoint, we now expect to sell approximately 34.0 million tons in 2024, or 2.6% below the mid-point of our original guidance for the year. Due to the increased summer burn, we now expect more than half of our uncontracted tonnage position will be sold in the domestic market.”
Mr. Craft continued, “Looking at our Oil & Gas Royalties platform, year-to-date performance and continued strong activity across our Permian Basin acreage has set the tone for another robust year. As a result, we are pleased to increase volumetric guidance across all three commodity streams within our Oil & Gas Royalties segment.”
Mr. Craft concluded, “The increase in coal-fired generation and inventory drawdown is constructive for the U.S. thermal coal market and for ARLP as we look forward to next year and beyond. We remain confident in the core fundamentals expected to drive rapid growth in electricity demand for many years to come, including the increasing power requirements stemming from AI, data centers, and the onshoring of U.S. manufacturing.”
Conference Call
A conference call regarding ARLP’s 2024 Quarter financial results is scheduled for today at 10:00 a.m. Eastern. To participate in the conference call, dial (877) 407-0784 and request to be connected to the Alliance Resource Partners, L.P. earnings conference call. International callers should dial (201) 689-8560 and request to be connected to the same call. Investors may also listen to the call via the “Investors” section of ARLP’s website at www.arlp.com .
An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial U.S. Toll Free (844) 512-2921; International Toll (412) 317-6671 and request to be connected to replay using access code 13747640.
About Alliance Resource Partners, L.P.
ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.
News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com . For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at [email protected] .
The statements and projections used throughout this release are based on current expectations. These statements and projections are forward-looking, and actual results may differ materially. These projections do not include the potential impact of any mergers, acquisitions or other business combinations that may occur after the date of this release. We have included more information below regarding business risks that could affect our results.
FORWARD-LOOKING STATEMENTS: With the exception of historical matters, any matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from projected results. Those forward-looking statements include expectations with respect to our future financial performance, coal and oil & gas consumption and expected future prices, our ability to increase unitholder distributions in future quarters, business plans and potential growth with respect to our energy and infrastructure transition investments, optimizing cash flows, reducing operating and capital expenditures, infrastructure projects at our existing properties, growth in domestic electricity demand, preserving liquidity and maintaining financial flexibility, and our future repurchases of units and senior notes, among others. These risks to our ability to achieve these outcomes include, but are not limited to, the following: decline in the coal industry’s share of electricity generation, including as a result of environmental concerns related to coal mining and combustion, the cost and perceived benefits of other sources of electricity and fuels, such as oil & gas, nuclear energy, and renewable fuels and the planned retirement of coal-fired power plants in the U.S.; our ability to provide fuel for growth in domestic energy demand, should it materialize; changes in macroeconomic and market conditions and market volatility, and the impact of such changes and volatility on our financial position; changes in global economic and geo-political conditions or changes in industries in which our customers operate; changes in commodity prices, demand and availability which could affect our operating results and cash flows; the outcome or escalation of current hostilities in Ukraine and the Israel-Gaza conflict; the severity, magnitude and duration of any future pandemics and impacts of such pandemics and of businesses’ and governments’ responses to such pandemics on our operations and personnel, and on demand for coal, oil, and natural gas, the financial condition of our customers and suppliers and operators, available liquidity and capital sources and broader economic disruptions; actions of the major oil-producing countries with respect to oil production volumes and prices could have direct and indirect impacts over the near and long term on oil & gas exploration and production operations at the properties in which we hold mineral interests; changes in competition in domestic and international coal markets and our ability to respond to such changes; potential shut-ins of production by the operators of the properties in which we hold oil & gas mineral interests due to low commodity prices or the lack of downstream demand or storage capacity; risks associated with the expansion of and investments into the infrastructure of our operations and properties; our ability to identify and complete acquisitions and to successfully integrate such acquisitions into our business and achieve the anticipated benefits therefrom; our ability to identify and invest in new energy and infrastructure transition ventures; the success of our development plans for our wholly owned subsidiary, Matrix Design Group, LLC, and our investments in emerging infrastructure and technology companies; dependence on significant customer contracts, including renewing existing contracts upon expiration; adjustments made in price, volume, or terms to existing coal supply agreements; the effects of and changes in trade, monetary and fiscal policies and laws, central bank policy actions including interest rates, bank failures and associated liquidity risks; the effects of and changes in taxes or tariffs and other trade measures adopted by the United States and foreign governments; legislation, regulations, and court decisions and interpretations thereof, both domestic and foreign, including those relating to the environment and the release of greenhouse gases, such as the Environmental Protection Agency’s recently promulgated emissions regulations for coal-fired power plants, mining, miner health and safety, hydraulic fracturing, and health care; deregulation of the electric utility industry or the effects of any adverse change in the coal industry, electric utility industry, or general economic conditions; investors’ and other stakeholders’ increasing attention to environmental, social, and governance matters; liquidity constraints, including those resulting from any future unavailability of financing; customer bankruptcies, cancellations or breaches to existing contracts, or other failures to perform; customer delays, failure to take coal under contracts or defaults in making payments; our productivity levels and margins earned on our coal sales; disruptions to oil & gas exploration and production operations at the properties in which we hold mineral interests; changes in equipment, raw material, service or labor costs or availability, including due to inflationary pressures; changes in our ability to recruit, hire and maintain labor; our ability to maintain satisfactory relations with our employees; increases in labor costs including costs of health insurance and taxes resulting from the Affordable Care Act, adverse changes in work rules, or cash payments or projections associated with workers’ compensation claims; increases in transportation costs and risk of transportation delays or interruptions; operational interruptions due to geologic, permitting, labor, weather, supply chain shortage of equipment or mine supplies, or other factors; risks associated with major mine-related accidents, mine fires, mine floods or other interruptions; results of litigation, including claims not yet asserted; foreign currency fluctuations that could adversely affect the competitiveness of our coal abroad; difficulty maintaining our surety bonds for mine reclamation as well as workers’ compensation and black lung benefits; difficulty in making accurate assumptions and projections regarding post-mine reclamation as well as pension, black lung benefits, and other post-retirement benefit liabilities; uncertainties in estimating and replacing our coal mineral reserves and resources; uncertainties in estimating and replacing our oil & gas reserves; uncertainties in the amount of oil & gas production due to the level of drilling and completion activity by the operators of our oil & gas properties; uncertainties in the future of the electric vehicle industry and the market for EV charging stations; the impact of current and potential changes to federal or state tax rules and regulations, including a loss or reduction of benefits from certain tax deductions and credits; difficulty obtaining commercial property insurance, and risks associated with our participation in the commercial insurance property program; evolving cybersecurity risks, such as those involving unauthorized access, denial-of-service attacks, malicious software, data privacy breaches by employees, insiders or others with authorized access, cyber or phishing attacks, ransomware, malware, social engineering, physical breaches, or other actions; and difficulty in making accurate assumptions and projections regarding future revenues and costs associated with equity investments in companies we do not control.
Additional information concerning these, and other factors can be found in ARLP’s public periodic filings with the SEC, including ARLP’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on February 23, 2024,and ARLP’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed on May 9, 2024. Except as required by applicable securities laws, ARLP does not intend to update its forward-looking statements.
This data supports the potential of plasma ASC levels as a biomarker for early stages of cognitive decline, based on elevated ASC levels in older adults (>60 years) who were cognitively normal at baseline but demonstrated cognitive decline one year later (NI) compared to ASC levels in those who:
Were cognitively normal at both baseline and 1 year later (NN), and
Were cognitively impaired at both baseline and one year later (II)
Inflammasome-induced neuroinflammation has been associated with early stages of cognitive decline in dementia associated with Alzheimer’s and Parkinson’s diseases.
Excessive inflammasome activation leads to cell death (pyroptosis) and systemic release of cell contents, including ASC that can be measured in the plasma.
WESTON, Fla., July 29, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that leading inflammasome researchers from the University of Miami Miller School of Medicine and inventors of Inflammasome ASC Inhibitor IC 100 have published a scientific paper in the peer-reviewed International Journal of Molecular Sciences demonstrating that plasma levels of inflammasome ASC show promise as a biomarker of early cognitive decline in older adults.
“Elevations in plasma ASC in early cognitive decline reinforce the role of inflammasome-induced inflammation in the development of neurodegenerative conditions such as Alzheimer’s and Parkinson’s diseases,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes and their associated ASC specks that trigger damaging inflammation pathogenic in neurological and other inflammatory diseases, such as obesity and its metabolic complications, our lead indication.”
Plasma ASC levels were elevated in older adults (>60 years) who were cognitively normal at baseline but demonstrated cognitive decline one year later (NI) compared to ASC levels in those who remained cognitively normal one-year post-baseline assessment (NN). The increase in ASC levels was even higher in people who were 70 years or older.
Likewise, plasma ASC levels in the NI group were elevated compared to ASC levels in older adults who demonstrated cognitive impairment at both baseline and one year later (II), indicating that plasma ASC levels are increased in the early stages of cognitive decline. Again, the increase in ASC levels was even higher in people who were 70 years or older.
In the group over 70 years old, area under the curve (AUC) for plasma levels of ASC in group NI versus group NN was 0.81, indicating excellent ability to differentiate between people with cognitive decline at one year versus those who were cognitively normal both at baseline and at one year. AUC is used to determine the diagnostic power of a biomarker.
“Dementia affects 57 million people worldwide, and the incidence is expected to double by 2040. There is an unmet need to develop minimally invasive, reliable biomarkers to diagnose early brain impairments so that emerging interventions can be applied before brain degeneration,” said Dr. Juan Pablo de Rivero Vaccari, Associate Professor of Neurological Surgery and The Miami Project to Cure Paralysis and Distinguished Faculty of the Center for Cognitive Neuroscience and Aging at the University of Miami Miller School of Medicine. “Our data indicate that plasma levels of ASC are a strong early indicator of the eventual development of cognitive impairment, especially in persons older than 70 years.”
About Inflammasome ASC Inhibitor IC 100
IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response. The lead indication for IC 100 is obesity and its associated metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.
About ZyVersa Therapeutics, Inc.
ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced proprietary technologies to develop first-in-class drugs for patients with inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux MediatorTM VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. For more information, please visit www.zyversa.com.
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.
Corporate, Media, and IR Contact: Karen Cashmere Chief Commercial Officer [email protected] 786-251-9641
MALVERN, Pa., July 29, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s second quarter 2024 financial results and provide a business update at 8:30 a.m. ET on Thursday, August 8, 2024.
Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 7453742 Webcast: Available on the events section of the Ocugen investor site
A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Second quarter 2024 total revenue of $593.4 million, net income of $100.2 million, and EBITDA of $177.7 million
Coal sales price realizations of $65.30 per ton sold, up 3.8% year-over-year
Increased oil & gas royalty volumes to 817 MBOE, up 6.8% year-over-year
In June 2024, issued $400 million in 8.625% Senior Notes due 2029 and redeemed outstanding balance of Senior Notes due 2025
Extended revolving credit facility maturity to March 2028
Enhanced liquidity position to $666.0 million, which included $203.7 million in cash and $462.3 million of borrowings available under credit facilities
In July 2024, declared quarterly cash distribution of $0.70 per unit, or $2.80 per unit annualized
TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) (“ARLP” or the “Partnership”) today reported financial and operating results for the three and six months ended June 30, 2024 (the “2024 Quarter” and “2024 Period,” respectively). This release includes comparisons of results to the three and six months ended June 30, 2023 (the “2023 Quarter” and “2023 Period,” respectively) and to the quarter ended March 31, 2024 (the “Sequential Quarter”). All references in the text of this release to “net income” refer to “net income attributable to ARLP.” For a definition of EBITDA and related reconciliation to its comparable GAAP financial measure, please see the end of this release.
Total revenues in the 2024 Quarter decreased 7.6% to $593.4 million compared to $641.8 million for the 2023 Quarter primarily as a result of reduced coal sales volumes, which declined 11.8% primarily due to transportation delays, partially offset by increased coal sales price realizations, which rose 3.8% to $65.30 per ton sold in the 2024 Quarter compared to $62.93 per ton sold in the 2023 Quarter. Net income for the 2024 Quarter was $100.2 million, or $0.77 per basic and diluted limited partner unit, compared to $169.8 million, or $1.30 per basic and diluted limited partner unit, for the 2023 Quarter as a result of lower revenues and increased total operating expenses. EBITDA for the 2024 Quarter was $177.7 million compared to $249.2 million in the 2023 Quarter.
Compared to the Sequential Quarter, total revenues in the 2024 Quarter decreased 9.0% primarily as a result of lower tons sold. Lower revenues and a $3.7 million reduction in the fair value of our digital assets, partially offset by reduced operating expenses, reduced net income and EBITDA by 36.6% and 24.4%, respectively, compared to the Sequential Quarter.
Total revenues decreased 4.6% to $1.25 billion for the 2024 Period compared to $1.30 billion for the 2023 Period primarily due to lower coal sales, partially offset by higher oil & gas royalties and other revenues. Net income for the 2024 Period was $258.2 million, or $1.98 per basic and diluted limited partner unit, compared to $361.0 million, or $2.75 per basic and diluted limited partner unit, for the 2023 Period as a result of lower revenues and increased total operating expenses. EBITDA for the 2024 Period was $412.7 million compared to $520.1 million in the 2023 Period.
CEO Commentary
“During the 2024 Quarter we enhanced our liquidity position,” highlighted Joseph W. Craft III, Chairman, President, and Chief Executive Officer. “The successful completion of our Senior Notes offering further strengthened our balance sheet and represents a vote of confidence from the capital markets for our business strategy and plans for execution. As we have said time and again, reliable, affordable, baseload energy is a cornerstone of our nation’s economy, and our strong financial position means we are well-positioned to provide strategic energy supply from our well-capitalized and strategically located coal mines and growing minerals acreage portfolio for many years to come.”
“Coal sales volumes during the 2024 Quarter were impacted by flooding on the Ohio River delaying barge deliveries. Rail and port logistics were disrupted by the Baltimore bridge incident, which as time progressed impacted shipments from our Appalachia rail operations. These delays, combined with lower export sales, lifted our inventories higher by 0.8 million tons compared to the Sequential Quarter,” commented Mr. Craft. “Our well-contracted order book continued to provide stability for our business, delivering improvements in coal sales pricing per ton compared to both the 2023 Quarter and the Sequential Quarter. Additionally, our Oil & Gas Royalties segment reported a 6.8% increase in BOE volumes year-over-year during the 2024 Quarter as our Permian-weighted minerals portfolio continues to realize production growth from recently drilled and completed wells.”
Balance Sheet and Liquidity
As of June 30, 2024, total debt and finance leases outstanding were $503.9 million, including $400 million in newly issued Senior Notes due 2029. The Partnership’s total and net leverage ratios were 0.61 times and 0.36 times debt to trailing twelve months Adjusted EBITDA, respectively, as of June 30, 2024. ARLP ended the 2024 Quarter with total liquidity of $666.0 million, which included $203.7 million of cash and cash equivalents and $462.3 million of borrowings available under its revolving credit and accounts receivable securitization facilities.
During the 2024 Quarter, the Partnership issued $400 million in 8.625% Senior Notes due 2029 and redeemed the outstanding balance of $284.6 million in ARLP’s 7.5% Senior Notes due 2025. The Partnership also amended its revolving credit facility to extend the maturity date to March 9, 2028.
Distributions
On July 26, 2024, we announced that the Board of Directors of ARLP’s general partner (the “Board”) approved a cash distribution to unitholders for the 2024 Quarter of $0.70 per unit (an annualized rate of $2.80 per unit), payable on August 14, 2024, to all unitholders of record as of the close of trading on August 7, 2024. The announced distribution is consistent with the cash distributions for the 2023 Quarter and Sequential Quarter.
Outlook
“For the first half of 2024, utility coal burn has been essentially flat with 2023,” commented Mr. Craft. “Since the start of this summer, cooling demand has been strong across many parts of the country driven by recent record-breaking temperatures and accelerating coal-based power generation. This is encouraging considering the very mild 2024 winter and persistently low natural gas prices. At the same time, while demand is holding up, U.S. thermal coal production has slowed significantly (Eastern U.S. production down 11% year-over-year) as utilities are relying on consuming coal from their elevated inventories to meet this demand. Weather forecasts suggest this heat wave will continue through August and an industry publication is projecting demand will exceed supply by close to 20 million tons in the second half of 2024.”
“Turning to the export markets, net back pricing for high sulfur Illinois Basin coal has declined to a level that we have decided it is prudent to slow down production for the back half of the year. Therefore, we are adjusting 2024 full-year guidance for our coal operations. At the midpoint, we now expect to sell approximately 34.0 million tons in 2024, or 2.6% below the mid-point of our original guidance for the year. Due to the increased summer burn, we now expect more than half of our uncontracted tonnage position will be sold in the domestic market.”
Mr. Craft continued, “Looking at our Oil & Gas Royalties platform, year-to-date performance and continued strong activity across our Permian Basin acreage has set the tone for another robust year. As a result, we are pleased to increase volumetric guidance across all three commodity streams within our Oil & Gas Royalties segment.”
Mr. Craft concluded, “The increase in coal-fired generation and inventory drawdown is constructive for the U.S. thermal coal market and for ARLP as we look forward to next year and beyond. We remain confident in the core fundamentals expected to drive rapid growth in electricity demand for many years to come, including the increasing power requirements stemming from AI, data centers, and the onshoring of U.S. manufacturing.”
Conference Call
A conference call regarding ARLP’s 2024 Quarter financial results is scheduled for today at 10:00 a.m. Eastern. To participate in the conference call, dial (877) 407-0784 and request to be connected to the Alliance Resource Partners, L.P. earnings conference call. International callers should dial (201) 689-8560 and request to be connected to the same call. Investors may also listen to the call via the “Investors” section of ARLP’s website at www.arlp.com .
An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial U.S. Toll Free (844) 512-2921; International Toll (412) 317-6671 and request to be connected to replay using access code 13747640.
About Alliance Resource Partners, L.P.
ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.
News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com . For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at [email protected] .
The statements and projections used throughout this release are based on current expectations. These statements and projections are forward-looking, and actual results may differ materially. These projections do not include the potential impact of any mergers, acquisitions or other business combinations that may occur after the date of this release. We have included more information below regarding business risks that could affect our results.
FORWARD-LOOKING STATEMENTS: With the exception of historical matters, any matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from projected results. Those forward-looking statements include expectations with respect to our future financial performance, coal and oil & gas consumption and expected future prices, our ability to increase unitholder distributions in future quarters, business plans and potential growth with respect to our energy and infrastructure transition investments, optimizing cash flows, reducing operating and capital expenditures, infrastructure projects at our existing properties, growth in domestic electricity demand, preserving liquidity and maintaining financial flexibility, and our future repurchases of units and senior notes, among others. These risks to our ability to achieve these outcomes include, but are not limited to, the following: decline in the coal industry’s share of electricity generation, including as a result of environmental concerns related to coal mining and combustion, the cost and perceived benefits of other sources of electricity and fuels, such as oil & gas, nuclear energy, and renewable fuels and the planned retirement of coal-fired power plants in the U.S.; our ability to provide fuel for growth in domestic energy demand, should it materialize; changes in macroeconomic and market conditions and market volatility, and the impact of such changes and volatility on our financial position; changes in global economic and geo-political conditions or changes in industries in which our customers operate; changes in commodity prices, demand and availability which could affect our operating results and cash flows; the outcome or escalation of current hostilities in Ukraine and the Israel-Gaza conflict; the severity, magnitude and duration of any future pandemics and impacts of such pandemics and of businesses’ and governments’ responses to such pandemics on our operations and personnel, and on demand for coal, oil, and natural gas, the financial condition of our customers and suppliers and operators, available liquidity and capital sources and broader economic disruptions; actions of the major oil-producing countries with respect to oil production volumes and prices could have direct and indirect impacts over the near and long term on oil & gas exploration and production operations at the properties in which we hold mineral interests; changes in competition in domestic and international coal markets and our ability to respond to such changes; potential shut-ins of production by the operators of the properties in which we hold oil & gas mineral interests due to low commodity prices or the lack of downstream demand or storage capacity; risks associated with the expansion of and investments into the infrastructure of our operations and properties; our ability to identify and complete acquisitions and to successfully integrate such acquisitions into our business and achieve the anticipated benefits therefrom; our ability to identify and invest in new energy and infrastructure transition ventures; the success of our development plans for our wholly owned subsidiary, Matrix Design Group, LLC, and our investments in emerging infrastructure and technology companies; dependence on significant customer contracts, including renewing existing contracts upon expiration; adjustments made in price, volume, or terms to existing coal supply agreements; the effects of and changes in trade, monetary and fiscal policies and laws, central bank policy actions including interest rates, bank failures and associated liquidity risks; the effects of and changes in taxes or tariffs and other trade measures adopted by the United States and foreign governments; legislation, regulations, and court decisions and interpretations thereof, both domestic and foreign, including those relating to the environment and the release of greenhouse gases, such as the Environmental Protection Agency’s recently promulgated emissions regulations for coal-fired power plants, mining, miner health and safety, hydraulic fracturing, and health care; deregulation of the electric utility industry or the effects of any adverse change in the coal industry, electric utility industry, or general economic conditions; investors’ and other stakeholders’ increasing attention to environmental, social, and governance matters; liquidity constraints, including those resulting from any future unavailability of financing; customer bankruptcies, cancellations or breaches to existing contracts, or other failures to perform; customer delays, failure to take coal under contracts or defaults in making payments; our productivity levels and margins earned on our coal sales; disruptions to oil & gas exploration and production operations at the properties in which we hold mineral interests; changes in equipment, raw material, service or labor costs or availability, including due to inflationary pressures; changes in our ability to recruit, hire and maintain labor; our ability to maintain satisfactory relations with our employees; increases in labor costs including costs of health insurance and taxes resulting from the Affordable Care Act, adverse changes in work rules, or cash payments or projections associated with workers’ compensation claims; increases in transportation costs and risk of transportation delays or interruptions; operational interruptions due to geologic, permitting, labor, weather, supply chain shortage of equipment or mine supplies, or other factors; risks associated with major mine-related accidents, mine fires, mine floods or other interruptions; results of litigation, including claims not yet asserted; foreign currency fluctuations that could adversely affect the competitiveness of our coal abroad; difficulty maintaining our surety bonds for mine reclamation as well as workers’ compensation and black lung benefits; difficulty in making accurate assumptions and projections regarding post-mine reclamation as well as pension, black lung benefits, and other post-retirement benefit liabilities; uncertainties in estimating and replacing our coal mineral reserves and resources; uncertainties in estimating and replacing our oil & gas reserves; uncertainties in the amount of oil & gas production due to the level of drilling and completion activity by the operators of our oil & gas properties; uncertainties in the future of the electric vehicle industry and the market for EV charging stations; the impact of current and potential changes to federal or state tax rules and regulations, including a loss or reduction of benefits from certain tax deductions and credits; difficulty obtaining commercial property insurance, and risks associated with our participation in the commercial insurance property program; evolving cybersecurity risks, such as those involving unauthorized access, denial-of-service attacks, malicious software, data privacy breaches by employees, insiders or others with authorized access, cyber or phishing attacks, ransomware, malware, social engineering, physical breaches, or other actions; and difficulty in making accurate assumptions and projections regarding future revenues and costs associated with equity investments in companies we do not control.
Additional information concerning these, and other factors can be found in ARLP’s public periodic filings with the SEC, including ARLP’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on February 23, 2024,and ARLP’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed on May 9, 2024. Except as required by applicable securities laws, ARLP does not intend to update its forward-looking statements.
TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) today announced that the Board of Directors of ARLP’s general partner (“Board of Directors”) approved a cash distribution to its unitholders for the quarter ended June 30, 2024 (the “2024 Quarter”).
ARLP unitholders of record as of the close of trading on August 7, 2024 will receive a cash distribution for the 2024 Quarter of $0.70 per unit (an annualized rate of $2.80 per unit), payable on August 14, 2024. The announced distribution is consistent with the cash distributions of $0.70 per unit for the quarters ended June 30, 2023 and March 31, 2024.
As previously announced, ARLP will report financial results for the 2024 Quarter before the market opens on Monday, July 29, 2024 and Alliance management will discuss these results during a conference call beginning at 10:00 a.m. Eastern that same day.
To participate in the conference call, dial (877) 407-0784 and request to be connected to the Alliance Resource Partners, L.P. earnings conference call. International callers should dial (201) 689-8560 and request to be connected to the same call. Investors may also listen to the call via the “Investors” section of ARLP’s website at www.arlp.com.
An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial U.S. Toll Free (844) 512-2921; International Toll (412) 317-6671 and request to be connected to replay using access code 13747640.
In addition to the cash distribution for the 2024 Quarter, ARLP is announcing that John H. Robinson will retire from the Board of Directors at the end of the year.
“John has been an invaluable asset of Alliance since 1999,” said Mr. Joseph W. Craft III, Chairman, President and CEO of ARLP’s general partner. “John’s service on the Board of Directors has been instrumental to ARLP’s success since its inception and we are grateful for his thoughtful guidance over the years and wish him the best in retirement.”
Mr. Robinson has stepped down as Chairman of the Compensation Committee, but he will remain a member of the Audit, Compensation and Conflicts Committee until his retirement at the end of the year. Board of Director member Nick Carter, who is a member of the Compensation Committee, has been appointed as Chairman of such committee. In addition, Wilson M. Torrence, who is the Chairman of the Audit Committee, has been appointed as a member of the Conflicts Committee.
ARLP is also announcing that on July 24, 2024, Paul H. Vining has been elected to the Board of Directors and will serve as the board’s lead director. In such capacity, Mr. Vining will assist the Board of Directors and ARLP’s management team on planning and other initiatives as directed from time to time by the Board of Directors or Mr. Craft.
“I am pleased to welcome Paul to the ARLP team,” Mr. Craft said. “Paul’s extensive background and leadership in the natural resources mining industry brings a unique level of knowledge and experience of global energy markets to the Board of Directors. We look forward to working with Paul as lead director to continue positioning ARLP as a reliable energy provider now and into the future.”
Mr. Vining has served as Chairman of the Board of Directors of Westmoreland Mining, LLC, a privately held coal producer, since October 2019, and as Chairman of the Board of Directors of The Frazier Quarry Inc. since July 2023. From May through July 2022, Mr. Vining served as Chairman of the Board of Directors of Allegiance Coal Limited (ASX: AHQ) and from 2016 to 2019 served as a member of the Board of Directors of the general partner of then NYSE-listed Foresight Energy LP. Mr. Vining began his career in 1979 as a mineral engineer and has held a variety of senior executive positions over the years with several companies, including as Chief Executive Officer of Minerals Refining Company throughout 2022, Executive Vice President Global Investment and Development for Xcoal Energy and Resources LLC from 2019 to 2021, and Chief Executive Officer of The Cline Group, LLC from 2015 to 2019. Prior to that, Mr. Vining held senior executive positions in several major companies including as Chief Operating Officer and then President of Alpha Natural Resources, Inc., President and Chief Operating Officer of Patriot Coal Company, Chief Executive Officer of Magnum Coal Company, Chief Commercial Officer of Arch Coal Inc. and Chief Commercial Officer of Peabody Energy, Corporation. Earlier in his career, Mr. Vining held various commercial and marketing positions at Massey Energy Company, Occidental Petroleum Corp., and ENI S.p.A. Mr. Vining holds a Bachelor and a Master of Science degree in Mining and Minerals Engineering from Columbia University and a Bachelor of Science degree in Chemistry from the College of William and Mary.
In addition to news regarding the Board of Directors, ARLP is announcing that Mark A. Watson has been promoted to the role of Senior Vice President – Operations and Technology of the Partnership’s general partner.
“Please join me in congratulating Mark on his promotion to Senior Vice President,” commented Mr. Craft. “Mark has been with Alliance since starting as an intern in 1994, holds a Bachelor of Science degree and a Master of Science degree in Electrical Engineering from the University of Kentucky, and has contributed significantly to the operations side as well as the technology development side of ARLP’s business over many years. Mark’s strong leadership and expertise at our Matrix Design Group (“Matrix”) has seen Matrix expand its products and services beyond the domestic underground mining industry into the international mining and industrial markets positioning Matrix to accelerate innovation and growth at ARLP. In Mark’s expanded role he will continue to lead Matrix as well as advance other technology growth opportunities in different markets for ARLP.”
Concurrent with this announcement we are providing qualified notice to brokers and nominees that hold ARLP units on behalf of non-U.S. investors under Treasury Regulation Section 1.1446-4(b) and (d) and Treasury Regulation Section 1.1446(f)-4(c)(2)(iii). Brokers and nominees should treat one hundred percent (100%) of ARLP’s distributions to non-U.S. investors as being attributable to income that is effectively connected with a United States trade or business. In addition, brokers and nominees should treat one hundred percent (100%) of the distribution as being in excess of cumulative net income for purposes of determining the amount to withhold. Accordingly, ARLP’s distributions to non-U.S. investors are subject to federal income tax withholding at a rate equal to the highest applicable effective tax rate plus ten percent (10%). Nominees, and not ARLP, are treated as the withholding agents responsible for withholding on the distributions received by them on behalf of non-U.S. investors.
About Alliance Resource Partners, L.P.
ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.
News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at [email protected].
Investor Relations Contact
Cary P. Marshall Senior Vice President and Chief Financial Officer 918-295-7673 [email protected]
The 2024 designation is the third consecutive year Conduent was named a best place to work. Conduent earned top scores for the United States, India and the Philippines.
The Disability Equality Index is the world’s most comprehensive benchmarking tool for Fortune 1000 companies to measure disability workplace inclusion inside their organization and to assess performance across industry sectors.
“On the 10th anniversary of the Disability Equality Index, we’re extremely proud of the 542 national and international companies that are taking a proactive role in leading progress towards disability inclusion, setting a benchmark for others to follow. Their dedication to fostering inclusive workplaces not only attracts top talent but also drives innovation and creates sustainable performance in today’s global market,” said Jill Houghton, President and CEO of Disability:IN.
“It is an honor to receive top scores on the Disability Equality Index in recognition of Conduent’s commitment to disability inclusion. We will continue our efforts to create a welcoming, supportive, and accessible workplace for our associates of all abilities – one where everyone feels empowered to thrive. Through programs such as our Employee Impact Groups, accessibility awareness and education, mental health sessions, and flexible work, we continue to build a culture where everyone is valued, has a sense of belonging and can bring their authentic selves to work,” said Rob Houser, Global Head of Strategy and Executive Sponsor of Conduent’s Employee DisAbility Impact Group.
The 2024 Index measured: Culture & Leadership; Enterprise-Wide Access; Employment Practices (Benefits; Recruitment; Employment, Education, Retention & Advancement, Accommodations); Community Engagement; Supplier Diversity; and Responsible Procurement (Non-Weighted).
About Conduent
Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The Company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 59,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $100 billion in government payments annually, enabling 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing nearly 13 million tolling transactions every day. Learn more at www.conduent.com.
About the Disability Equality Index®
The Disability Equality Index has become the leading independent, third-party resource for the annual benchmarking of corporate disability inclusion policies and programs and is now trusted by more than 70% of the United States Fortune 100 and nearly half of the Fortune 500. Such companies must increasingly consider how emerging global reporting directives and stakeholder expectations surrounding social and corporate governance factors impact their operational, cultural, reputational and financial performance.
The Disability Equality Index is an objective, reflective, forward-thinking, and confidential disability rating tool designed to assist business in advancing inclusion practices. It is a comprehensive benchmark that helps companies build a roadmap of measurable, tangible actions across five scored categories: Culture & Leadership, Enterprise-Wide Access, Employment Practices, Community Engagement, and Supplier Diversity. Participating companies receive a score, on a scale of zero (0) to 100, with those scoring 80 or higher earning the distinction of “Best Places to Work for Disability Inclusion” for the benchmark year.
Findings from a two-year Global Disability Equality Index pilot informed the launch of a scored benchmark that opened in 2024 to seven new countries in addition to the United States. These include: Brazil, Canada, Germany, India, Japan, the Philippines, and the United Kingdom. Now in its 10th year, the Disability Equality Index has grown nearly 7x since 2015, expanding from 80 companies in its first year to 542 in 2024. Collectively, the 2024 edition received 753 submissions spanning the eight benchmarked countries.
About the American Association of People with Disabilities (AAPD)
AAPD is a convener, connector, and catalyst for change, increasing the political and economic power for people with disabilities. As a national cross-disability rights organization AAPD advocates for full civil rights for the 60+ million Americans with disabilities. Learn more at: www.aapd.com
About Disability:IN®
Disability:IN is a global organization driving disability inclusion and equality in business. More than 500 corporations partner with Disability:IN to create long-term business and social impact through the world’s most comprehensive disability inclusion benchmarking and reporting tool, the Disability Equality Index; best-in-class conferences and programs; expert counsel and engagement; and public policy leadership. Join us at disabilityin.org/AreYouIN #AreYouIN.
Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.
