CHATHAM, N.J., Feb. 03, 2025 (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 that it will effect a 1-for-100 reverse stock split of its outstanding common stock. The reverse stock split will be effective for trading purposes as of the commencement of trading on February 5, 2025.
The reverse stock split is intended to increase the per share trading price of Tonix’s common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market (Rule 5550(a)(1)). Tonix’s common stock will continue to trade on the NASDAQ Capital Market under the symbol “TNXP” and under a new CUSIP number, 890260839. As a result of the reverse stock split, every one hundred pre-split shares of common stock outstanding will become one share of common stock. The reverse split will also apply to common stock issuable upon the exercise of Tonix’s outstanding warrants and stock options. The reverse stock split will not proportionately reduce the number of shares of authorized common stock, as permitted under Nevada law, as shareholder approval for the reverse stock split was obtained on October 30, 2024.
Tonix’s transfer agent, VStock Transfer LLC, which is also acting as the exchange agent for the reverse split, will provide instructions to shareholders regarding the process for exchanging share certificates. Any fractional shares of common stock resulting from the reverse stock split will be rounded up to the nearest whole post-split share and no shareholders will receive cash in lieu of fractional shares.
Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has previously granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified 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 infectious disease, including a vaccine for mpox, TNX-801. In July 2024, Tonix announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. 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.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established 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.
Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert. Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only). Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider. This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633. You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Full year 2024 total revenue of $2.4 billion, net income of $360.9 million, and Adjusted EBITDA of $714.2 million
Record full year 2024 oil & gas royalty volumes of 3.4 million BOE, up 9.6% year-over-year
Fourth quarter 2024 total revenue of $590.1 million, net income of $16.3 million, and Adjusted EBITDA of $124.0 million
Completed $9.6 million in oil & gas mineral interest acquisitions during fourth quarter
In January 2025, 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 quarter and full year ended December 31, 2024 (the “2024 Quarter” and “2024 Full Year”). This release includes comparisons of results to the quarter and year ended December 31, 2023 (the “2023 Quarter” and “2023 Full Year”, respectively), as well as the quarter ended September 30, 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 Adjusted EBITDA and related reconciliation to its comparable GAAP financial measure, please see the end of this release.
Total revenues in the 2024 Quarter decreased 5.6% to $590.1 million compared to $625.4 million for the 2023 Quarter primarily as a result of reduced coal sales volumes, which declined 2.3%, and lower transportation revenues. Net income for the 2024 Quarter was $16.3 million, or $0.12 per basic and diluted limited partner unit, compared to $115.4 million, or $0.88 per basic and diluted limited partner unit, for the 2023 Quarter as a result of lower revenues, higher per ton operating expenses, which include $13.1 million of non-cash accruals for certain long-term liabilities, and $31.1 million of non-cash impairment charges in the 2024 Quarter due to market uncertainty at our MC Mining operation, partially offset by a $14.0 million increase in the fair value of our digital assets. Adjusted EBITDA for the 2024 Quarter was $124.0 million compared to $185.4 million in the 2023 Quarter.
Total revenues in the 2024 Quarter decreased 3.8% compared to $613.6 million in the Sequential Quarter primarily as a result of reduced coal sales prices, which declined 5.7% due in part to lower export price realizations. Net income for the 2024 Quarter decreased by 81.1% compared to the Sequential Quarter as a result of lower revenues and higher non-cash accruals relating to certain long-term liabilities and impairment charges in the 2024 Quarter, partially offset by an increase in the fair value of our digital assets. Adjusted EBITDA for the 2024 Quarter decreased 27.2% compared to the Sequential Quarter, as a result of higher non-cash accruals for certain long-term liabilities in the Illinois Basin, higher expenses related to the continuation of challenging geological conditions at our Tunnel Ridge and MC Mining operations in Appalachia, and lower revenue per ton for spot coal sold and per BOE in the Royalties segment.
Total revenues decreased 4.6% to $2.45 billion for the 2024 Full Year compared to $2.57 billion for the 2023 Full Year primarily due to lower coal sales volume, partially offset by higher other revenues. Net income for the 2024 Full Year was $360.9 million, or $2.77 per basic and diluted limited partner unit, compared to $630.1 million, or $4.81 per basic and diluted limited partner unit, for the 2023 Full Year as a result of lower revenues, increased operating expenses and non-cash impairment charges, partially offset by a $22.4 million increase in the fair value of our digital assets. Adjusted EBITDA for the 2024 Full Year was $714.2 million compared to $933.1 million in the 2023 Full Year.
CEO Commentary
“Due to the continued strength of our coal contracts, our average coal sales price per ton for the 2024 Full Year of $63.38 came close to the record level achieved in the 2023 Full Year of $64.17. However, lower sales volumes, higher operating costs and several non-cash accruals caused 2024 Full Year financial results to fall short of last year’s record revenues and net income,” said Joseph W. Craft III, Chairman, President and CEO. “The cold winter weather at the start of this year has driven higher natural gas prices and increased coal consumption in the eastern United States, helping reduce inventories. We are seeing customer solicitations for both near-term and long-term supply contracts, and if the colder weather continues to be above normal, we are hopeful we can reach our goal to ship 30 million tons to the domestic market in 2025.”
Mr. Craft continued, “Having substantially completed major infrastructure projects at Tunnel Ridge, Hamilton, Warrior, and River View in 2024, we expect to see improved costs and productivity along with reduced capital spending this year. Additionally, the combination of cold winter weather and new LNG export terminal capacity should support strong domestic natural gas prices in 2025, benefiting both our Coal and Royalties segments.”
Mr. Craft concluded, “The increase in forecasted electricity demand, particularly from data centers and growth in AI, is highlighting the inadequacy of current resource plans without extended use of fossil fuel plants. These market realities, coupled with what we expect to be a more favorable regulatory environment, are laying the foundation for Alliance to continue serving as a cornerstone of the country’s reliable electricity infrastructure for years to come. We look forward to what we can achieve in 2025.”
Coal Operations
Total coal sales volumes for the 2024 Quarter decreased 2.3% compared to the 2023 Quarter while remaining relatively consistent compared to the Sequential Quarter. In Appalachia, tons sold decreased by 17.1% and 24.6% in the 2024 Quarter compared to the 2023 Quarter and Sequential Quarter, respectively, primarily as a result of lower production levels which reduced domestic sales volumes from our Tunnel Ridge operation. Partially offsetting these decreases, tons sold increased by 2.8% and 10.5% in the Illinois Basin compared to the 2023 Quarter and Sequential Quarter, respectively, due to improved sales performance from our River View, Hamilton, and Gibson South mines. Coal sales price per ton increased by 4.4% in Appalachia compared to the 2023 Quarter as a result of higher domestic price realizations at our Tunnel Ridge mine. In the Illinois Basin, coal sales prices decreased by 3.9% in the 2024 Quarter compared to the Sequential Quarter primarily due to reduced domestic price realizations from our Hamilton operation. ARLP ended the 2024 Quarter with total coal inventory of 0.6 million tons, representing decreases of 0.7 million tons and 1.4 million tons compared to the end of the 2023 Quarter and Sequential Quarter, respectively.
Segment Adjusted EBITDA Expense per ton for the 2024 Quarter increased by 12.8% and 5.2% in the Illinois Basin compared to the 2023 Quarter and Sequential Quarter, respectively, due primarily to reduced production, higher labor costs and lower recoveries at several mines in the region as well as an $11.0 million non-cash deferred purchase price adjustment recorded in the 2024 Quarter related to the 2015 acquisition of our Hamilton mine. In Appalachia, Segment Adjusted EBITDA Expense per ton for the 2024 Quarter increased by 20.9% and 17.4% compared to the 2023 Quarter and Sequential Quarter, respectively, due to lower recoveries across the region as well as challenging mining conditions which reduced production and led to higher materials and supplies and maintenance costs at our Tunnel Ridge operation.
Royalties
Segment Adjusted EBITDA for the Oil & Gas Royalties segment decreased to $25.6 million in the 2024 Quarter compared to $31.0 million and $28.7 million in the 2023 Quarter and Sequential Quarter, respectively, due primarily to lower average sales price per BOE, which decreased 17.2% and 7.3%, respectively, partially offset by decreased expenses. A reduction in oil & gas volumes compared to the Sequential Quarter also contributed to the sequential decrease.
Segment Adjusted EBITDA for the Coal Royalties segment increased 3.6% to $10.5 million for the 2024 Quarter compared to $10.2 million for the 2023 Quarter as a result of higher royalty tons sold, which increased 9.4%, partially offset by increased selling expenses and lower average royalty rates per ton received from the Partnership’s mining subsidiaries. Compared to the Sequential Quarter, Segment Adjusted EBITDA decreased 4.8% due to higher selling expenses, partially offset by increased sales volumes.
Balance Sheet and Liquidity
As of December 31, 2024, total debt and finance leases outstanding were $490.8 million, including $400 million in recently issued Senior Notes due 2029. The Partnership’s total and net leverage ratios were 0.69 times and 0.50 times debt to trailing twelve months Adjusted EBITDA, respectively, as of December 31, 2024. ARLP ended the 2024 Quarter with total liquidity of $593.9 million, which included $137.0 million of cash and cash equivalents and $456.9 million of borrowings available under its revolving credit and accounts receivable securitization facilities. ARLP also held 482 bitcoins valued at $45.0 million as of December 31, 2024.
Distributions
On January 28, 2025, 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 February 14, 2025, to all unitholders of record as of the close of trading on February 7, 2025. The announced distribution is consistent with the cash distributions for the 2023 Quarter and Sequential Quarter.
Outlook
“For 2025, we expect improved coal production costs to counterbalance lower market prices, keeping Coal segment margins near 2024 Full Year levels,” commented Mr. Craft. “In the Oil & Gas Royalty business, we achieved record production volumes for the 2024 Full Year despite only making modest additions to our overall acreage position. We continue to favor the cash flow generation profile and ability to self-fund growth in the Oil & Gas Royalties segment, and therefore, will actively pursue growth in this segment in 2025.”
Mr. Craft concluded, “Looking forward, we anticipate a more supportive regulatory environment from the new administration that will help address the growing need for affordable, reliable baseload power without prematurely retiring critical generation sources. As the realities of physics meet the needs of the grid, we believe previously announced retirements will be delayed and our products will remain a cornerstone of energy security in some of the strongest industrial growth areas of the country for years to come.”
ARLP is providing the following guidance for the full year ending December 31, 2025 (the “2025 Full Year”):
Conference Call
A conference call regarding ARLP’s 2024 Quarter and Full Year 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 13750955.
About Alliance Resource Partners, L.P.
ARLP is a diversified energy company that is currently the second 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 investorrelations@arlp.com.
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 or maintain 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, including the timing of such investments coming online; 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, and the results of 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, and state legislation seeking to impose liability on a wide range of energy companies under greenhouse gas “superfund” laws, 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, 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 Reports on Form 10-Q for the quarters ended March 31, 2024, June 30, 2024 and September 30, 2024, filed on May 9, 2024, August 7, 2024 and November 7, 2024, respectively. Except as required by applicable securities laws, ARLP does not intend to update its forward-looking statements.
Reconciliation of Non-GAAP Financial Measures (Unaudited)
Reconciliation of GAAP “net income attributable to ARLP” to non-GAAP “EBITDA,” “Adjusted EBITDA,” “Distribution Coverage Ratio” and “Distributable Cash Flow” (in thousands).
EBITDA is defined as net income attributable to ARLP before net interest expense, income taxes and depreciation, depletion and amortization and Adjusted EBITDA is EBITDA adjusted for certain items that we characterize as unrepresentative of our ongoing operations. Distributable cash flow (“DCF”) is defined as Adjusted EBITDA excluding equity method investment earnings, interest expense (before capitalized interest), interest income, income taxes and estimated maintenance capital expenditures and adding distributions from equity method investments and litigation expense accrual. Distribution coverage ratio (“DCR”) is defined as DCF divided by distributions paid to partners.
Management believes that the presentation of such additional financial measures provides useful information to investors regarding our performance and results of operations because these measures, when used in conjunction with related GAAP financial measures, (i) provide additional information about our core operating performance and ability to generate and distribute cash flow, (ii) provide investors with the financial analytical framework upon which management bases financial, operational, compensation and planning decisions and (iii) present measurements that investors, rating agencies and debt holders have indicated are useful in assessing us and our results of operations.
EBITDA, Adjusted EBITDA, DCF and DCR should not be considered as alternatives to net income attributable to ARLP, net income, income from operations, cash flows from operating activities or any other measure of financial performance presented in accordance with GAAP. EBITDA and DCF are not intended to represent cash flow and do not represent the measure of cash available for distribution. Our method of computing EBITDA, Adjusted EBITDA, DCF and DCR may not be the same method used to compute similar measures reported by other companies, or EBITDA, Adjusted EBITDA, DCF and DCR may be computed differently by us in different contexts (i.e., public reporting versus computation under financing agreements).
Investor Relations Contact Cary P. Marshall Senior Vice President and Chief Financial Officer 918-295-7673 investorrelations@arlp.com
MALVERN, Pa., Feb. 03, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the European Commission has provided a positive opinion from the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) for OCU400 Advanced Therapy Medicinal Product (ATMP) classification. OCU400 is the first gene therapy to enter Phase 3 with a broad retinitis pigmentosa (RP) indication.
“Receiving ATMP classification is another significant milestone toward bringing OCU400 to the market in Europe,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This designation makes it possible to stay on track with our clinical and commercial strategy and potentially provide this novel modifier gene therapy candidate to all RP patients in the United States (U.S.) and Europe by 2027.”
ATMP classification is granted to medicines that can offer groundbreaking opportunities for the treatment of disease and accelerates the regulatory review timeline of this potential one-time gene therapy for life. Additionally, this classification allows Ocugen to interact with EMA more frequently for scientific advice and protocol assistance as the Company pursues Marketing Authorization Application (MAA) filing in 2026.
Underscoring the vital need for gene-agnostic treatments for diseases with multiple mutations such as RP, both the U.S. Food and Drug Administration (FDA) and EMA have acknowledged that the ongoing single, pivotal Phase 3 trial of OCU400 can suffice for Biologics License Application (BLA)/MAA submissions. Ocugen intends to file simultaneously in the U.S. and Europe upon completion of the Phase 3 trial.
The Phase 3 OCU400 liMeliGhT clinical trial is currently enrolling. The study has a sample size of 150 participants—one arm of 75 participants with RHO gene mutations and the other arm with 75 participants that are gene agnostic. In each arm, participants will be randomized 2:1 to the treatment group (2.5 x 1010 vg/eye of OCU400) and untreated control group, respectively. Patients eight years of age and older, with early through late-stage advancement of RP, are being recruited to participate in the liMeliGhT study.
“We are encouraged by the EMA’s recognition of OCU400 as the Phase 3 liMeliGhT clinical trial advances,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “I look forward to working collaboratively with the EMA to address the unmet medical need that remains for nearly 98% of the RP patient population.”
RP affects nearly 310,000 patients in the U.S., EU, and Canada. Currently, RP is associated with mutations in more than 100 genes and there are no approved treatment options that slow or stop the progression of multiple forms of RP.
OCU400 is the Company’s gene-agnostic modifier gene therapy product based on NHR gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its drive functionality, OCU400 resets altered/affected cellular gene networks and establishes homeostasis—a state of balance, which has the potential to improve retinal health and function in patients with inherited retinal diseases.
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
Thispressreleasecontainsforward-lookingstatementswithinthemeaningofThePrivateSecuritiesLitigationReformActof1995,including,butnot limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,whicharesubjecttorisksanduncertainties.Wemay,insomecases,usetermssuchas “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, including,butnotlimitedto,therisksthatpreliminary,interimandtop-lineclinicaltrialresultsmaynotbeindicativeof,andmaydifferfrom,finalclinical data;the ability of OCU400 to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data;thatunfavorablenewclinicaltrialdatamayemergeinongoingclinicaltrialsorthroughfurtheranalysesofexistingclinicaltrialdata;thatearlier non-clinicalandclinicaldataandtestingofmaynotbepredictiveoftheresultsorsuccessoflaterclinicaltrials;andthatthatclinicaltrialdataare subject to differing interpretations and assessments, including by regulatory authorities.Theseandotherrisksanduncertaintiesaremorefully describedinourperiodicfilingswiththeSecuritiesandExchangeCommission(SEC),includingtheriskfactorsdescribedinthesectionentitled“Risk Factors”inthequarterlyandannualreportsthatwefilewiththeSEC.Anyforward-lookingstatementsthatwemakeinthispressreleasespeakonlyas ofthedateofthispressrelease.Exceptasrequiredbylaw,weassumenoobligationtoupdateforward-lookingstatementscontainedinthispress release whether as a result of new information, future events, or otherwise, after the date of this press release.
Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Hans Baldau, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Agreement with SACL. Comstock Fuels executed definitive agreements with SACL Pte. Limited (SACL), a Singapore-based renewable fuel project developer with plans to develop renewable energy projects in Australia, New Zealand, Vietnam, Cambodia, and Malaysia. SACL has been granted a master non-exclusive license to Comstock Fuel’s intellectual property to develop, finance, build, and manage renewable fuel production facilities. The agreement provides exclusive rights to market projects subject to SACL’s satisfaction of certain milestones, including completion of engineering and financing for SACL’s first licensed facility in 2025 followed by commissioning and production in 2027.
Favorable terms. Comstock will contribute site-specific technology rights in exchange for a 20% equity stake in each refinery and provide engineering support in exchange for 3% of each facility’s capital and construction costs. This will increase to 6% for facilities with a capacity of 250,000 metric tons per year (MTPY) or more. Additionally, an upfront payment of $2.5 million will be required upon the execution of a site license agreement. Comstock Fuels will receive a royalty fee equal to 3% of the total sales from licensed products produced by each facility, which will rise to 6% for facilities with a capacity of 250,000 metric tons per year or greater.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Tariffs. Pursuant to the International Emergency Economic Powers Act, the Trump Administration is implementing a 25% additional tariff on imports from Canada and Mexico and a 10% additional tariff on imports from China. The tariffs are effective on February 4. Energy resources from Canada will have a lower 10% tariff. The action is intended to hold Mexico, Canada, and Mexico accountable for their promises of halting illegal immigration and preventing fentanyl and other drugs from entering the United States. The ad valorem duties do not appear to consider the origin of raw materials or to be subject to exemption.
Exposure. In 2021, FreightCar moved its manufacturing activities in the United States to a new state-of-the-art facility in Castanos, Mexico. It steadily grew production capacity to 5,000 rail cars per year with the addition of a fourth production line during the fourth quarter of 2023. Importantly, the company’s competitors, Greenbrier Companies (NYSE-GBX) and Trinity Industries (NYSE-TRN), also have significant manufacturing operations in Mexico that serve the U.S. market.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
