LOS ALTOS, Calif., March 04, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. UNI-494 is a cytoprotective agent that elicits an ischemic preconditioning effect by activating KATP channels in mitochondria to restore mitochondrial function.
“We are pleased to announce that the FDA has granted orphan drug designation to UNI-494 for the prevention of delayed graft function after kidney transplantation, an unmet medical need for which there are no FDA-approved drugs,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Obtaining ODD is an important milestone in the development of UNI-494 that may provide certain tax credits for qualified clinical trials, exemption of user fees, and the potential for seven years of market exclusivity after approval. DGF is one of the most serious complications resulting from kidney transplantation, and we believe that the mechanism of action of UNI-494 is ideally suited for the prevention of this orphan condition.”
The FDA, through its Office of Orphan Products Development (OOPD), grants orphan drug designation to agents that have the potential to offer a safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 individuals in the United States.
As previously announced, on March 12, 2024, Unicycive will present data on the efficacy of UNI-494 in animal models of DGF and a poster describing the ongoing Phase 1 clinical trial design for UNI-494 in healthy volunteers at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024.
About Delayed Graft Function
Delayed Graft Function (DGF) refers to the acute kidney injury (AKI) that occurs in the first week after kidney transplantation, which necessitates dialysis intervention. As the name indicates, DGF can result in sub-optimal or impaired graft function and is one of the most common and serious complications of kidney transplantation. Poor kidney function in the first week of graft life is detrimental to the longevity of the allograft. DGF is also associated with higher rates of tissue rejection and decreased patient survival. Currently, there are no FDA approved drugs for the treatment of DGF.
Ischemia/reperfusion injury (IRI) is known to be a major causative factor for the AKI that results in DGF during kidney transplantation. Ischemic preconditioning, that works by activating KATP channels in mitochondria, is a natural endogenous mechanism which protects cells from IRI in the heart, kidney, liver, and other organs. UNI-494 is a pharmacological approach that emulates and enhances this natural phenomenon of ischemic preconditioning.
About UNI-494
UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive is currently conducting a Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom that is expected to complete in 2H of 2024. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.
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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Progress across the pipeline in multiple clinical trials, including
Phase 2 program of GEO-CM04S1, next-generation Covid-19 vaccine, and
multicenter Phase 1/2 study of Gedeptin®, targeting advanced head and neck cancer
Catalyst-rich 2024 with data readouts planned throughout the year
Company to host conference call and webcast today at 4:30 p.m. ET
ATLANTA, GA, February 29, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31, 2023.
“2023 marked another year of advancement of our ongoing clinical programs for GEO-CM04S1, our next-generation Covid-19 vaccine, and for Gedeptin® in cancer therapy,” stated David Dodd, GeoVax’s Chairman and CEO. “This past year, we completed enrollment for the Phase 2 clinical trial assessing GEO-CM04S1 as a universal booster for the mRNA Covid vaccines, while expanding to multiple sites for our Phase 2 trial among immunocompromised/stem cell transplant patients, evaluating GEO-CM04S1 as a primary vaccine, in direct comparison to mRNA vaccines. In addition, the third Phase 2 trial of GEO-CM04S1 was initiated, evaluating our vaccine among immunocompromised/Chronic Lymphocytic Leukemia patients as a booster for such patients having initially received a mRNA vaccine, also in a direct comparison to a mRNA vaccine.
“Results released during 2023 demonstrated the safety and efficacy of GEO-CM04S1 and emphasize the role it will play in protecting immunocompromised patients from greater risk of severe disease, hospitalization and death from SARS-CoV-2 infection,” Dodd continued. “Perhaps of most importance, the results to date have demonstrated potential protective immunity of GEO-CM04S1 against multiple strains of SARS-CoV-2, from the ancestral Wuhan strain through Delta and the highly virulent Omicron XBB.1.5, without the need for vaccine reconfiguration. This critically important potential feature appears unique to our Covid-19 vaccine.”
Dodd concluded, “Relative to our oncology progress, GeoVax completed enrollment for the Phase 1/2 clinical trial of Gedeptin among advanced head and neck cancer patients. Results to date have demonstrated safety of this therapy and consistent reduction in treated tumors. During first half 2024, we anticipate reporting additional results from the Gedeptin Phase 1/2 clinical trial, as well as our plans for an expanded Phase 2 clinical trial. Overall, these achievements can be attributed to the successful execution of our long-term strategy, with an end goal to bring unique, patented products to market, addressing unmet medical needs. We look forward to reporting further progress in these studies and are encouraged to be entering into a data-rich 2024.”
2023 Clinical Trial Progress and Operational Developments
GEO-CM04S1
Enrollment completed for the Phase 2 clinicaltrial assessing GEO-CM04S1 as a potential universal booster for patients previously vaccinated with Pfizer or Moderna vaccines. The data presented during this period showcased promising results, indicating the potential of GEO-CM04S1 as a versatile Covid-19 vaccine capable of providing immunity against various strains, including the Wuhan, Delta, and Omicron variants. The trial involves 63 healthy adults who previously received mRNA vaccines as their primary vaccine. The data showed no serious adverse events and significant increases in neutralizing antibody, as well as cellular immune responses against multiple SARS-CoV-2 variants. Final results from this trial are anticipated during the fourth quarter of 2024.
Initiation of a Phase 2 booster trial targeting immunocompromised patients with chronic lymphocytic leukemia (CLL), who typically have reduced immune responses to mRNA vaccines due to their medical condition. This investigator-initiated trial expects to enroll 80 patients and directly compare GEO-CM04S1 with the Pfizer/BioNTech Bivalent vaccine. Results from an interim analysis are anticipated during the first half of 2024.
Data presentations from the immunocompromised/stem cell transplant patient Phase 2 trial of GEO-CM04S1 at the World Vaccine Congress, as well as initial results published in the peer-reviewed journal, Vaccines. The findings demonstrated robust immunogenicity, illustrating the vaccine’s ability to induce both antibody and T cell responses, essential for conferring protection, particularly in immunocompromised individuals. The article also highlighted the unique feature of GEO-CM04S1 providing protective immune levels from the ancestral Wuhan strain through Delta and the highly virulent Omicron XBB.1.5 variant. This study has been expanded to a multi-site trial, with further results anticipated throughout 2024.
Gedeptin®
Completion of patient enrollment for the Phase 1/2 clinical trial of Gedeptin among advanced head and neck cancer patients. The data presented at the AACR-AHNS Head and Neck Cancer Conference emphasized the safety and feasibility of Gedeptin therapy, providing insights into its potential as a treatment option for patients with limited therapeutic alternatives. The initial Phase 1/2 trial aims to guide future studies, potentially expanding the application of Gedeptin in other solid tumor areas and in combination with immune checkpoint inhibitors. During 2024, we expect to announce plans relative to an expanded Phase 2 study among advanced head and cancer patients, following discussions with regulatory authorities. In addition, we plan to outline plans for further Gedeptin clinical development, both in additional monotherapy and in combination-therapy (e.g., Gedeptin + immune-checkpoint inhibitor) indications.
Advanced Vaccine Manufacturing Process
Significant advancements made in MVA manufacturing capabilities focused on implementing a transformative manufacturing process in support of MVA-based vaccines and immunotherapies. The multi-product license with ProBioGen involving the AGE1.CR.PIX® suspension cell line enhances GeoVax’s capacity to produce MVA-based vaccines and immunotherapies at an unprecedented scale. Additionally, the agreement with Advanced Bioscience Laboratories, Inc. (ABL) secures cGMP production capabilities in support of GeoVax transitioning to worldwide commercialization capability. These developments signify GeoVax’s commitment to improving vaccine accessibility through cost-effective and scalable manufacturing processes. Our intent is to successfully develop our products for worldwide commercialization and distribution, in conjunction with partnering and collaborative relationships.
Corporate and Intellectual Property Developments
Achieved notable milestones in intellectual property development, securing multiple patents covering a range of vaccine candidates. The expanded rights under the NIH Covid-19 license to include Mpox and smallpox further diversify GeoVax’s vaccine portfolio, potentially offering broader protection against infectious diseases. Additionally, the issuance of patents for Ebola, Marburg, Malaria, and HIV vaccines underscores GeoVax’s innovative approach to vaccine development and its dedication to advancing global health initiatives. As of February 2024, the following actions were taken by global patent offices, further strengthening the Company’s intellectual property assets:
The Japanese Patent Office issued a Decision of Grant notifying GeoVax of the allowance of the Company’s Patent Application No. 2022-153352 titled “Compositions and Methods for Generating an Immune Response to a Tumor Associated Antigen.” The allowed claims are directed to recombinant MVA viral vectors comprising specific MUC-1 nucleic sequences used in GeoVax’s MUC-1 tumor-associated antigen immunotherapy program. Pharmaceutical compositions for inducing immune responses, preventing or reducing neoplasm growth, or treating cancer are also covered by the granted claims.
The U.S. Patent and Trademark Office issued Patent No. 11,896,657 to GeoVax, pursuant to the Company’s patent application No. 17/584,231 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).” The allowed claims generally cover GeoVax’s vector platform for expressing Marburg virus antigens in virus-like particles (VLPs) utilizing an MVA viral vector.
The U.S. Patent and Trademark Office issued Patent No. 11,897,919 pursuant to the Company’s patent application No. 17/409,574 titled “Multivalent HIV Vaccine Boost Compositions and Methods of Use.” The allowed claims generally cover a priming vaccination with a DNA vector encoding multiple HIV antigens in virus-like particles (VLPs), followed by a boost vaccination with GeoVax’s vector platform for expressing HIV-1 antigens in VLPs utilizing an MVA viral vector.
Appointed J. Marc Pipas, M.D., as Executive Medical Director, Oncology. Dr. Pipas has extensive clinical, research, and leadership expertise in oncology, built on a long and successful academic career at Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center, an NCI Comprehensive Cancer Center. He brings a deep understanding of oncologic therapeutics and clinical trial management, as well as a network of research contacts and leadership skills honed by many years of experience.
2023 Full Year Financial Results
Net Loss: Net loss for the year ended December 31, 2023, was $26.0 million, as compared to $14.0 million for the year ended December 31, 2022.
R&D Expenses: Research and development expenses were $20.7 million for 2023, compared to $9.1 million in 2022, with the increase primarily due to the costs of conducting clinical trials for GEO-CM04S1 and Gedeptin, costs of manufacturing materials for use in our clinical trials, technology license fees, personnel costs, costs of preclinical research activities and higher travel costs.
G&A Expenses: General and administrative expenses were $6.0 million for 2023, compared to $5.0 million in 2022, with the increase primarily attributable to higher personnel costs, investor relations consulting costs, legal fees, patent costs and travel expenses.
Cash Position: GeoVax reported cash balances of $6.5 million on December 31, 2023, as compared to $27.6 on December 31, 2022.
Summarized financial information is attached. Further information is included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission.
Conference Call Details
Management will host a conference call scheduled to begin at 4:30 p.m. ET today, February 29, 2024, to review financial results and provide an update on corporate developments. A question-and-answer session will follow management’s formal remarks.
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 therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation Covid-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as 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, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable Covid-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, 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.
HOUSTON, Feb. 29, 2024 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange142, LLC (“Orange142”), today announced that the Company will report financial results for the fourth quarter and fiscal year 2023 ended December 31, 2023 on Thursday, March 21, 2024 after the U.S. stock market closes.
Management will host a conference call and webcast on the same day at 5:00 PM ET to discuss the results. The live webcast and replay can be accessed at https://ir.directdigitalholdings.com/.
About Direct Digital Holdings Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 125,000 clients monthly, generating over 300 billion impressions per month across display, CTV, in-app and other media channels.
ZyVersa is developing Inflammasome ASC Inhibitor IC 100, which is designed to inhibit formation of multiple types of inflammasomes, including NLRP3, and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation associated with obesity and numerous other conditions.
WESTON, Fla., Feb. 29, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of inflammatory and renal diseases with high unmet medical needs, announces that on February 26, 2024, the company generated approximately $2.7 Million from existing investors’ exercise of previously issued warrants. This was following excitement around news issued by NodThera on February 19, 2024, that their NLRP3 inflammasome inhibitors have potential to treat obesity with weight loss efficacy similar to the GLP-1 receptor agonist, Wegovy, but with added cardiovascular benefits. This news became viral among financial reporters, driving high volume trading and increased stock prices for companies developing inflammasome inhibitors, including ZyVersa.
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, NLRP3, and AIM2, to address inflammatory diseases in which multiple inflammasome pathways are activated. 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 spread and 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. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.
About ZyVersa Therapeutics, Inc.
ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and peripheral inflammatory diseases. 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 kcashmere@zyversa.com 786-251-9641
Total revenue was €46.9 mm in Q4 2023, while net gaming revenue1 was €50.1 mm in the period, 32% and 33% above those from Q4 2022, respectively.
Mexico revenue was €22.6 mm in Q4 2023, while net gaming revenue1 was €25.1 mm in the period, 54% above Q4 2022.
Spain revenue (and net gaming revenue) reached €20.8 mm in Q4 2023, 17% above Q4 2022.
Net loss was €1.0 mm in Q4 2023 versus a net loss of €17.4 mm in Q4 2022.
Total cash position of €41 mm as of December 31, 2023.
Providing full year 2024 net gaming revenue outlook of €185-200 mm and expect to generate positive Adjusted. EBITDA and cash flow.
Madrid, Spain and Tel Aviv, Israel, February 29, 2024 – (GLOBE NEWSWIRE) Codere Online (Nasdaq: CDRO / CDROW, the “Company”), a leading online gaming operator in Spain and Latin America, has released its preliminary unaudited2 financial results for the fourth quarter and year ended December 31, 2023.
Below are the main financial and operating metrics of the period.
Quarter ended December 31
Year ended December 31
2022
2023
Chg. %
2022
2023
Chg. %
Net Gaming Revenue (EUR mm)1
Spain
17.8
20.8
17%
60.0
75.7
26%
Mexico
16.3
25.1
54%
51.1
81.7
60%
Colombia
2.3
2.3
–
7.9
8.5
8%
Other
1.3
1.8
38%
3.9
6.0
54%
Total
37.7
50.1
33%
122.9
171.9
40%
Avg. Monthly Active Players (000s)3
Spain
41.3
47.4
15%
38.1
42.3
11%
Mexico
50.8
59.1
16%
38.5
52.5
37%
Colombia
38.5
23.0
(40%)
28.7
24.3
(15%)
Other
11.2
9.6
(14%)
7.9
9.2
17%
Total
141.8
139.2
(2%)
113.1
128.3
13%
Aviv Sher, CEO of Codere Online, stated, “In Q4 2023 we delivered an impressive 33% growth in net gaming revenue to €50 million, our highest ever quarterly figure, despite a tough comp with the World Cup in the prior year period. Our strategic focus on Mexico and Spain, where we are seeing a strong return on marketing investment, has proven successful, with significant increases in both our active customer base and spend per customer. Casino continued to exceed our expectations with a second consecutive quarter contributing 58% of total net gaming revenue in the period.”
Mr. Sher further added, “Our net gaming revenue in Mexico grew by 54% in the fourth quarter, reaching more than €25 million, whereas net gaming revenue in Spain, grew by 17%, to nearly €21 million. We were able to grow our active customer base by more than 15% in both markets in the quarter which we believe is impressive considering the similar level of marketing investment in these countries in 2023 versus the prior year.”
Oscar Iglesias, CFO of Codere Online, stated, “Our fourth quarter results have allowed us to reach nearly €172 million of net gaming revenue for the full year, 19% above the midpoint of the initial €140-150 mm outlook we provided early last year. This outperformance, combined with the overall lower level of marketing investment, also allowed us to deliver a better than expected negative €12mm in Adjusted EBITDA versus the initial outlook of negative €20-30mm.”
Mr. Iglesias further added, “We are very encouraged by our performance in 2023 which further supports our expectation that we will generate positive Adjusted EBITDA and cash flow for the full year in 2024, a year in which we expect net gaming revenue of €185-200 mm. In short, we expect to deliver upon our original commitment to investors to be a profitable company in the third year after de-SPAC and are more committed than ever to creating meaningful value for our shareholders.”
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, February 29, 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.
Reconciliation of Revenue (IFRS) to Net Gaming Revenue (non-IFRS)
Quarter ended December 31
Year ended December 31
Figures in EUR mm
2022
2023
Chg. %
2022
2023
Chg. %
Total
Revenue
35.6
46.9
32%
115.7
162.6
41%
(+) Accounting Adjustments4
2.1
3.1
48%
7.2
9.2
28%
Net Gaming Revenue
37.7
50.1
33%
122.9
171.9
40%
Spain
Revenue
17.8
20.8
17%
60.0
75.7
26%
(+) Accounting Adjustments4
–
–
n.m.
–
–
n.m.
Net Gaming Revenue
17.8
20.8
17%
60.0
75.7
26%
Mexico
Revenue
14.5
22.6
56%
45.5
73.3
61%
(+) Accounting Adjustments4
1.8
2.5
39%
5.6
8.4
50%
Net Gaming Revenue
16.3
25.1
54%
51.1
81.7
60%
Colombia
Revenue
2.4
2.8
17%
7.0
9.3
33%
(+) Accounting Adjustments4
(0.1)
(0.5)
n.m.
0.9
(0.8)
n.m.
Net Gaming Revenue
2.3
2.3
–
7.9
8.5
8%
Other
Revenue
0.9
0.7
(22%)
3.2
4.4
38%
(+) Accounting Adjustments4
0.4
1.1
n.m.
0.7
1.6
129%
Net Gaming Revenue
1.3
1.8
38%
3.9
6.0
54%
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 the City of Buenos Aires (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 Guillermo.Lancha@codere.com (+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 See “Preliminary Information” below. 3 Average Monthly Active Players include real money (i.e. exclude free bets) sports betting and casino actives. 4 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.
Program recognizes innovative and impactful sourcing industry partnerships
SYDNEY–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, has announced the winners of the 2024 ISG Paragon Awards™ ANZ, which celebrate the ongoing transformation of sourcing industry partnerships with new solutions and technologies.
A total of 50 nominations were submitted for the annual ANZ program. Winners in each category were selected by an experienced independent expert and announced at a gala awards dinner on Wednesday, February 28, 2024, at the Fullerton Hotel Sydney.
The winners of the 2024 awards are:
Excellence: Outstanding delivery by a service provider
Gold: PWC Australia with Levande
Silver: Tech Mahindra with One New Zealand
Innovation: Imagination and entrepreneurial spirit in helping organizations future-proof their businesses and better serve clients
Gold: AC3 with Southern Cross Austereo
Silver: Tech Mahindra with Dnata
Silver: Tata Consultancy Services, Ltd. with NSW Government
Transformation: The successful transformation of an organization or key business function
Gold: Infosys with Team Global Express
Silver: Capgemini with Cochlear
High-Performing Partnerships: Successful partners that demonstrate seamless collaboration, leverage each other’s strengths and adapt together to achieve shared objectives
Gold: Ramco with a leading New Zealand telecommunications provider
Infosys and Westpac won the Excellence in Diversity award and Transurban and Blue Connections Pty Ltd. received the People’s Choice Award for an outstanding relationship identified by a client.
“Technology and business services providers make critical contributions to enterprise success,” said Michael Gale, partner and regional leader, ISG Asia Pacific. “We are honored to recognize the winners of the 2024 ISG Paragon Awards ANZ for finding powerful new ways to support their clients’ IT goals and achieve outstanding results.”
The 2024 ISG ANZ Paragon Awards celebrate the evolution of the sourcing industry through the application of new sourcing approaches, automation and digital technology. Full details are available here.
About ISG
ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,600 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.
SANTA MONICA, Calif.–(BUSINESS WIRE)– Entravision (NYSE: EVC), a leading global advertising solutions, media and technology company, announced that it will release its fourth quarter and full year 2023 financial results after market close on Tuesday, March 5, 2024. The Company will host a conference call that day at 5:00 p.m. Eastern Time to discuss the fourth quarter and full year 2023 results.
To access the conference call, please dial (844) 836-8739 (U.S.) or (412) 317-5440 (International) ten minutes prior to the start time. The call will also be available via live webcast on the investor relations portion of the Company’s website located at www.entravision.com.
If you cannot listen to the conference call at its scheduled time, there will be a replay available through Tuesday, March 19, 2024 which can be accessed by dialing (844) 512-2921 (U.S.) or (412) 317-6671 (International) and entering the passcode 10186277. The webcast will also be archived on the Company’s website.
About Entravision
Entravision (NYSE: EVC) is a global advertising solutions, media and technology company. Over the past three decades, we have strategically evolved into a digital powerhouse, expertly connecting brands to consumers in the U.S., Latin America, Europe, Asia and Africa. Our digital segment, the company’s largest by revenue, offers a full suite of end-to-end advertising services. We have commercial partnerships with Meta, X Corp. (formerly known as Twitter), TikTok, and Spotify, and marketers can use our Smadex and other platforms to deliver targeted advertising to audiences around the globe. In the U.S., we maintain a diversified portfolio of television and radio stations that target Hispanic audiences and complement our global digital services. Entravision remains the largest affiliate group of the Univision and UniMás television networks. Shares of Entravision Class A Common Stock trade on the NYSE under ticker: EVC. Learn more about our offerings at entravision.com or connect with us on LinkedIn and Facebook.
Integration Between Holding Group’s Colossus SSP and FreeWheel to Provide Enhanced Connections to Demand to Increase Ability for Advertisers to Reach Audiences at Scale on CTV
HOUSTON and NEW YORK, Feb. 28, 2024 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”), Huddled Masses LLC (“Huddled Masses”) and Orange 142, LLC (“Orange 142”), announced a new partnership with FreeWheel, a global technology platform for the television advertising industry.
The agreement builds on Direct Digital Holdings’ buy- and sell-side relationship with Beeswax, FreeWheel’s programmatic buying platform.
This new deal will allow the holding group’s Colossus SSP to directly connect to FreeWheel’s premium CTV inventory and server technology. Colossus SSP provides brands with access to a truly inclusive audience, tapping into a range of multicultural/diverse publishers and general market media – and this partnership will open pathways to top-tier CTV inventory for both. The partnership will bring together expertise, resources, cutting-edge technology, and robust content to drive demand from top advertisers.
“This agreement will significantly grow the high-quality CTV inventory available through Colossus SSP,” said Mark D. Walker, Co-Founder, CEO, and Chairman at Direct Digital Holdings. “FreeWheel is able to unify all demand channels into one optimal ad decision to maximize the end-viewer experience. Their capabilities complement the performance, efficiencies and transparency that brands and media buyers have come to value at Colossus SSP.”
“Today’s TV ad marketplace is very fragmented and complex, and so, one of our key focus areas is to continually find new ways to simplify and streamline the ad buying process,” said Katy Loria, Chief Revenue Officer, FreeWheel. “We recognize today’s consumers increasingly gravitate towards CTV and our audiences are becoming more diverse. It is our hope that, by teaming up with Colossus SSP, we can help connect publishers to multicultural audiences – at scale – on premium content.”
“We have worked collaboratively with both Colossus SSP and FreeWheel, and we’re excited to tap into their new partnership as they continue to diversify and scale their collective offerings,” said Michael Piner, EVP, Advanced Advertising, Mediahub. “High-quality CTV inventory is a top priority for our clients, and this partnership will deliver that while expanding our ability to reach robust, diverse audiences through a diverse-owned partner.”
Forward-Looking Statements This press release may contain forward-looking statements within the meaning of federal securities laws, including the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are subject to certain risks, trends and uncertainties.
As used below, “we,” “us,” and “our” refer to Direct Digital Holdings. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All statements contained in this release that do not relate to matters of historical fact should be considered forward-looking statements.
All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Our forward-looking statements are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. Although we believe that these forward-looking statements are based on reasonable assumptions, many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements, including, but not limited to: our dependence on the overall demand for advertising, which could be influenced by economic downturns; any slow-down or unanticipated development in the market for programmatic advertising campaigns; the effects of health epidemics, such as the ongoing global COVID-19 pandemic; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; any unavailability or non-performance of the non-proprietary technology, software, products and services that we use; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; any inability to compete in our intensely competitive market; any significant fluctuations caused by our high customer concentration; any violation of legal and regulatory requirements or any misconduct by our employees, subcontractors, agents or business partners; any strain on our resources, diversion of our management’s attention or impact on our ability to attract and retain qualified board members as a result of being a public company; our dependence, as a holding company, of receiving distributions from Direct Digital Holdings, LLC to pay our taxes, expenses and dividends; and other factors and assumptions discussed in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and other sections of our filings with the SEC that we make from time to time. Should one or more of these risks or uncertainties materialize or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
About FreeWheel FreeWheel empowers all segments of The New TV Ecosystem. We are structured to provide the full breadth of solutions the advertising industry needs to achieve their goals. We provide the technology, data enablement and convergent marketplaces required to ensure buyers and sellers can transact across all screens, across all data types, and all sales channels, in order to ensure the ultimate goal – results for marketers. With offices in New York, San Francisco, Chicago, London, Paris, Beijing, and across the globe, FreeWheel, A Comcast Company, stands to advocate for the entire industry through the FreeWheel Council for Premium Video. For more information, please visit freewheel.com, and follow us on X and LinkedIn.
About Direct Digital Holdings Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage on average over 125,000 clients monthly, generating over 300 billion impressions per month across display, CTV, in-app and other media channels.
Topline results expected in the third quarter of 2024; planning a Phase 2 Trial for prevention of kidney transplant rejection
Anti-CD40L has multiple possible indications in addition to solid organ and bone marrow transplantation including autoimmune diseases: potential pipeline in a product
Sanofi recently published results on their Fc-modified humanized anti-CD40L mAb, frexalimab, for multiple sclerosis in the New England Journal of Medicine1
CHATHAM, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical stage of its Phase 1, single ascending dose escalation trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy volunteers. TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplant and for the treatment of autoimmune disorders.
“Despite advancements in the field of solid organ transplantation, there remains a significant need for new treatments with improved activity and tolerability,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Anti-CD40L modulates T cell function and has the potential to promote tolerance of transplanted organs. We are excited to have completed the clinical stage of this Phase 1 trial of TNX-1500, a third-generation Fc-modified anti-CD40L mAb that has been designed by protein engineering to eliminate the risk of thrombosis associated with first-generation anti-CD40L mAbs. Preclinical studies in non-human primates did not result in any thrombotic complications, suggesting that the protein engineering of TNX-1500’s Fc region has achieved its design goals.”
Dr. Lederman continued, “Recently, positive clinical data with other CD40L blockers have been reported by Sanofi, with its Fc-modified humanized anti-CD40L mAb frexalimab in treating relapsing multiple sclerosis.2 Eledon Pharmaceuticals is developing tegoprubart, a non-covalent dimer antibody with no heavy-light or heavy-heavy interchain disulfide bridges for the prevention of rejection of kidney transplants3.”
Dr. Lederman concluded, “We believe TNX-1500 has the potential to prevent organ transplant rejection and improve graft survival with reduced long-term toxicity burden of current immunosuppressive regimens. In addition, TNX-1500 has the potential to address multiple other indications, including several autoimmune diseases. We look forward to the results of this Phase 1 trial, which are expected in the third quarter of this year, and to continuing the development of TNX-1500 as a promising candidate in an important therapeutic space.”
About TNX-1500
TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. The first-in-human Phase 1 trial of TNX-1500 was initiated in the third quarter of 2023. The primary objective of the Phase 1 trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous (i.v.) TNX-1500. Eligible participants enrolled in the Phase 1 trial were distributed across three dosing cohorts (3 mg/kg, 10 mg/kg, and 30 mg/kg, respectively) and evaluated regularly over a 120-day period after dosing. This first-in-human trial is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients. Two published articles in the American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in non-human primate renal and heart allografts.4,5
About anti-CD40L Therapeutics in Development
No anti-CD40L mAb has been approved in any jurisdiction. In addition to TNX-1500, frexalimab and tegoprubart, tn03 fusion protein dazodalibep is being developed by Amgen (formerly Horizon Therapeutics Public Limited Company) for the treatment of Sjögren’s Syndrome .6,7 Dapirolizumab pegol, an anti-CD40L pegylated Fab, is being developed by UCB for the treatment of systemic lupus erythematosus.8
*TNX-1500 is an investigational new biologic and is not approved for any indication
Tonix is a 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 Tonmya1, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with 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.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has 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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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.
Obesity, which affects over 1.9 billion people worldwide, is a state of low-grade chronic inflammation that causes an array of different metabolic disorders, including insulin resistance, type 2 Diabetes, hypertension, cardiovascular disease, dyslipidemia, and even cancer.
The article summarizes data demonstrating that inflammasome activation in fat tissue triggers cell death, known as pyroptosis. Pyroptosis results in systemic release of inflammatory cytokines, IL-1β and IL-18, and ASC specks, which perpetuates and spreads inflammation to other tissues leading to the metabolic disturbances associated with obesity.
ZyVersa is developing Inflammasome ASC Inhibitor IC 100, designed to inhibit formation of multiple types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation.
WESTON, Fla., Feb. 28, 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, highlights data published in Nature reinforcing IC 100’s rationale for inhibiting ASC and ASC Specks to attenuate damaging inflammation associated with various conditions, including obesity and its complications.
Studies dating back to 2011 have implicated a pathogenic role for inflammasome activation in initiation of obesity and its metabolic complications. Authors of the review paper published in Nature titled, “Cell death and inflammation during obesity: Know my methods, WAT(son),” reviewed 111 papers, which demonstrated that the state of low-grade chronic inflammation in obesity combined with activated macrophages in adipose tissue result in a vicious cycle of inflammation, cell death, and metabolic dysbalance that together cause metabolic syndromes. This also promotes a pro-tumorigenic microenvironment that induces or supports tumor growth in cancers linked to obesity such as breast, liver, and colon carcinomas.
The authors concluded, “There is no question that macrophage-inflammasome activation triggers systemic inflammation during obesity and it is one of the main culprits of metabolic syndromes.” To read the article, Click Here.
“Obesity, a well-established risk factor for array of different metabolic disorders, including insulin resistance, type 2 Diabetes, hypertension, cardiovascular disease, and cancer, has reached pandemic proportions, and may affect up to two-thirds of the adult population in developed countries,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “The research published in Nature demonstrates that inflammasome activation in fat tissue triggers cell death. Cell death results in systemic release of inflammatory cytokines, IL-1β and IL-18, and ASC specks, which can perpetuate and spread inflammation to other tissues leading to the metabolic disturbances associated with obesity. This provides support for Inflammasome ASC Inhibitor IC 100 as a potential therapeutic option. By inhibiting ASC, IC 100 blocks formation of NLRP3 and other types of inflammasomes to block initiation of the inflammatory cascade. Likewise, IC 100 uniquely inhibits ASC specks to attenuate spread and perpetuation of damaging inflammation.” To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.
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, 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.
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 renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. 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, IR, and Media Contact: Karen Cashmere Chief Commercial Officer kcashmere@zyversa.com 786-251-9641
Low-Cost Business Model and Disciplined Capital Allocation Drive Solid Operating Performance and Strong Adjusted EPS Growth in 2023
Repurchased 6 Million Shares for $298 Million in Full Year 2023
Announces “Project Core”: Enterprise-Wide Program Focused on Streamlining Operations and Enhancing Focus on Core Business
Approves New $1 Billion Share Repurchase Authorization
Provides 2024 Guidance
BOCA RATON, Fla.–(BUSINESS WIRE)–Feb. 28, 2024– The ODP Corporation (“ODP,” or the “Company”) (NASDAQ:ODP), a leading provider of products, services, and technology solutions to businesses and consumers, today announced results for the fourth quarter and full year ended December 30, 2023.
Consolidated (in millions, except per share amounts)
4Q23
4Q22
FY23
FY22
Selected GAAP and Non-GAAP measures:
Sales
$1,806
$2,106
$7,831
$8,491
Sales change from prior year period
(14)%
(8)%
Operating income (loss)
$(31)
$55
$201
$243
Adjusted operating income (1)
$43
$58
$290
$296
Net income (loss) from continuing operations
$(37)
$36
$139
$178
Diluted earnings (loss) per share from continuing operations
$(0.99)
$0.76
$3.50
$3.61
Adjusted net income from continuing operations (1)
$35
$40
$223
$216
Adjusted earnings per share from continuing operations (fully diluted) (1)
$0.92
$0.85
$5.60
$4.40
Adjusted EBITDA (1)
$73
$89
$417
$437
Operating Cash Flow from continuing operations
$70
$158
$331
$237
Free Cash Flow (2)
$41
$127
$224
$138
Adjusted Free Cash Flow (3)
$43
$147
$235
$201
Fourth Quarter 2023 Summary(1)(2)(3)
Total reported sales of $1.8 billion, down 14% versus the prior year on a reported basis, or down 9% when eliminating the $128 million favorable impact related to the 53rd week included in the fourth quarter of 2022. The decrease in reported sales is largely related to lower sales in its Office Depot consumer division, primarily due to 64 fewer retail locations in service compared to the previous year, as well as reduced retail and online consumer traffic and transactions
GAAP operating loss includes non-cash asset impairment charges of $68 million related to goodwill at Varis, which led to a GAAP operating loss of $31 million and net loss from continuing operations of $37 million, or $(0.99) per diluted share. This result compares to GAAP operating income of $55 million and net income from continuing operations of $36 million, or $0.76 per diluted share, in the prior year. GAAP operating income results in the prior year period included the favorable impact related to the 53rd week of $20 million
Adjusted operating income of $43 million, compared to $58 million in the fourth quarter of 2022; adjusted EBITDA of $73 million, compared to $89 million in the fourth quarter of 2022
Adjusted net income from continuing operations of $35 million, or adjusted diluted earnings per share from continuing operations of $0.92, versus $40 million or $0.85, respectively, in the prior year period
Operating cash flow from continuing operations of $70 million and adjusted free cash flow of $43 million, versus $158 million and $147 million, respectively, in the prior year period
Repurchased 672 thousand shares at a cost of $32 million in the fourth quarter of 2023
$1.1 billion of total available liquidity including $392 million in cash and cash equivalents at quarter end
Full Year 2023 Summary
Total reported sales of $7.8 billion, versus $8.5 billion in the prior year. Consolidated sales results in the prior year included the favorable impact related to the 53rd week in 2022 of $128 million
GAAP operating income of $201 million and net income from continuing operations of $139 million, or $3.50 per diluted share, versus $243 million and net income from continuing operations of $178 million, or $3.61 per diluted share, respectively, in the prior year. Operating income results in the prior year include the favorable impact related to the 53rd week in 2022 of $20 million
Adjusted operating income of $290 million, compared to $296 million in 2022; adjusted EBITDA of $417 million, compared to $437 million in 2022
Adjusted net income from continuing operations of $223 million, or adjusted diluted earnings per share from continuing operations of $5.60, versus $216 million or $4.40, respectively, in the prior year
Operating cash flow from continuing operations of $331 million and adjusted free cash flow of $235 million, versus $237 million and $201 million, respectively in the prior year
Repurchased 6 million shares for $298 million in 2023
“In the first year of operating under our new structure, we delivered strong adjusted EBITDA and adjusted earnings per share results throughout an ongoing challenging macroeconomic environment, underscoring our commitment to our low-cost business model and capital allocation strategy,” said Gerry Smith, chief executive officer of The ODP Corporation. “We expanded margins at ODP Business Solutions, drove strong external EBITDA growth at Veyer, expanded our product and service offerings at Office Depot, and began our strategic review of Varis in late Q4. In addition, our operational excellence helped drive free cash flow above our forecasted guidance, supporting our return to shareholders of nearly $300 million through our share repurchase program during 2023.”
“As we continue to evolve and consistent with our low-cost model approach, we are announcing today “Project Core” — a comprehensive initiative aimed at streamlining operations, sharpening our focus on our core business, and increasing shareholder returns through an expanded new $1 billion share repurchase program,” Smith continued. “We expect this broad-based plan to generate annualized savings in the range of $50 million to $60 million when fully implemented, achieved through cost efficiency measures across the entire enterprise including all routes to market, including Varis, as well as corporate support functions, leading to further optimization of our organization and supporting future profitable growth. During this effort, we are working to complete a strategic review of Varis and we expect to provide a full update of that review by our first quarter earnings call in early May 2024,” Smith added.
“We’re excited about the future and confident in our position of strength, as we focus on continuing to drive our low-cost business model, leveraging our multiple routes to market, and remaining disciplined with our capital allocation plan,” Smith concluded.
Consolidated Results
Reported (GAAP) Results
Total reported sales for the fourth quarter of 2023 were $1.8 billion, a decrease of 14% compared with the same period last year, or down 9% when eliminating the $128 million favorable impact related to the 53rd week included in the fourth quarter of 2022. This result was driven primarily by lower sales in its consumer division, Office Depot, primarily due to 64 fewer stores in service compared to last year related to planned store closures, as well as lower retail and online consumer traffic and transactions. Sales at ODP Business Solutions Division were down slightly compared to last year when eliminating the favorable impact to sales from the 53rd week included in the fourth quarter of last year, largely driven by weaker economic activity and lower sales of personal protective equipment (PPE) and technology products. Meanwhile, Veyer provided strong logistics support for the ODP Business Solutions and Office Depot Divisions and continued to capture additional sales for its supply chain and procurement solutions among other third-party customers.
The Company reported a GAAP operating loss of $31 million in the fourth quarter of 2023, down compared to GAAP operating income of $55 million in the prior year period. Operating results in the fourth quarter of 2023 included $74 million of charges, primarily related to a $68 million non-cash impairment of goodwill in its Varis business unit. Net loss from continuing operations was $37 million, or $(0.99) per diluted share in the fourth quarter of 2023, down compared to net income from continuing operations of $36 million, or $0.76 per diluted share in the fourth quarter of 2022.
Adjusted (non-GAAP) Results(1)
Adjusted results for the fourth quarter of 2023 exclude charges and credits totaling $74 million as described above and the associated tax impacts.
Fourth quarter of 2023 adjusted EBITDA was $73 million compared to $89 million in the prior year period. This included depreciation and amortization of $28 million and $31 million in the fourth quarters of 2023 and 2022, respectively
Fourth quarter of 2023 adjusted operating income was $43 million, down compared to $58 million in the fourth quarter of 2022
Fourth quarter of 2023 adjusted net income from continuing operations was $35 million, or $0.92 per diluted share, compared to $40 million, or $0.85 per diluted share, in the fourth quarter of 2022, an increase of 8% on a per share basis
Division Results
ODP Business Solutions Division
Leading B2B distribution solutions provider serving small, medium and enterprise level companies with an annual trailing-twelve-month revenue of nearly $4 billion.
Reported sales were $0.9 billion in the fourth quarter of 2023, down 10% compared to the same period last year, or down 4% when eliminating the $58 million favorable impact to sales related to the 53rd week included in the fourth quarter of 2022. The decrease in sales was related primarily to weaker macroeconomic conditions and lower sales of PPE and technology products
Total adjacency category sales, including cleaning and breakroom, furniture, technology, and copy and print, were 44% of total ODP Business Solutions’ sales
Continued strong pipeline and net new business customer additions
Operating income was $34 million in the fourth quarter of 2023, down 8% compared to the same period last year on a reported basis. When eliminating the $5 million favorable impact to operating income related to the 53rd week included in the fourth quarter of 2022, operating income was up approximately 6% over last year. As a percentage of sales, operating income margin was 4%, flat compared to last year
Office Depot Division
Leading provider of retail consumer and small business products and services distributed via Office Depot and OfficeMax retail locations and an award-winning eCommerce presence.
Reported sales were $0.9 billion in the fourth quarter of 2023, down 18% compared to the prior year on a reported basis, or down 13% when eliminating the favorable impact of $70 million in sales related to the 53rd week included in same period last year. Lower sales were partially driven by 64 fewer retail outlets in service associated with planned store closures, as well as lower demand relative to last year in certain product categories and lower online sales. The Company closed 22 retail stores in the quarter and had 916 stores at quarter end. Sales were down approximately 5% on a comparable store basis when eliminating the favorable impact of the 53rd week included in the prior year period
Stronger sales of copy and print services were more than offset by lower sales in supplies, technology, and other categories
Store and online traffic were lower year over year due to a greater percentage of customers having returned to the office post pandemic, as well as weaker macroeconomic activity
Operating income was $43 million in the fourth quarter of 2023, compared to operating income of $57 million during the same period last year, driven primarily by the flow through impact from lower sales. Operating income results in the prior year period included a $15 million favorable impact related to the 53rd week in in 2022. As a percentage of sales, operating income was 5%, flat compared to the same period last year
Veyer Division
Nationwide supply chain, distribution, procurement and global sourcing operation supporting Office Depot and ODP Business Solutions, as well as third-party customers. Veyer’s assets and capabilities include 8 million square feet of infrastructure through a network of distribution centers, cross-docks, and other facilities throughout the United States; a global sourcing presence in Asia; a large private fleet of vehicles; and next-day delivery to 98.5% of US population.
In the fourth quarter of 2023, Veyer provided strong support for its internal customers, ODP Business Solutions and Office Depot, as well as its third-party customers, generating sales of $1.2 billion
Operating income was $3 million in the fourth quarter of 2023, compared to $4 million in the prior year period driven by the flow through impact of lower sales to internal customers partially offset by higher sales of services to external third-party customers
For the full year 2023, sales and EBITDA generated from third party customers increased 25% and 120% respectively, resulting in sales of $35 million and EBITDA of $11 million
Varis Division
Tech-enabled B2B indirect procurement marketplace launched in the fourth quarter of 2022, which provides buyers and suppliers a seamless way to transact through the platform’s consumer-like buying experience and advanced spend management tools.
Continued work with new customers, incorporating feedback and adding new features and capabilities to the platform
Generated revenues in the fourth quarter of 2023 of $2 million, flat compared to the fourth quarter of 2022
Operating loss was $15 million in the fourth quarter of 2023, an improvement over the prior year
Share Repurchases in 2023
Throughout the year, the Company continued to execute under its previously announced $1 billion share repurchase authorization valid through year-end 2025. During the fourth quarter of 2023, the Company repurchased 672 thousand shares at a cost of $32 million, resulting in a total of 6 million shares for $298 million for the full year 2023. Since the inception of the authorization beginning in November 2022, the Company has repurchased 10 million shares for approximately $451 million.
“We’re encouraged by the opportunities within our business to generate value and enhance shareholder returns,” stated Anthony Scaglione, executive vice president and chief financial officer of The ODP Corporation. “Since the beginning of our previous authorization, we have repurchased 10 million shares, retiring over 20% of our outstanding shares since November 2022. Moving forward, we are thrilled to expand this initiative through Project Core, establishing a new $1 billion share buyback authorization valid over the next three years, creating additional value for shareholders while enhancing our core focus and driving our low-cost business model.”
Balance Sheet and Cash Flow
As of December 30, 2023, ODP had total available liquidity of approximately $1.1 billion, consisting of $392 million in cash and cash equivalents and $696 million of available credit under the Third Amended Credit Agreement. Total debt was $174 million. Subsequent to the end of the quarter, in January 2024, the Company retired $53 million of outstanding FILO Term Loan Facility loans, funded through available liquidity.
For the fourth quarter of 2023, cash generated by operating activities of continuing operations was $70 million, which included $2 million in restructuring and other spend, compared to cash provided by operating activities of continuing operations of $158 million in the fourth quarter of the prior year, which included $20 million in restructuring and other spend. The year-over-year change in operating cash flow is largely related to the timing of certain working capital items.
Capital expenditures in the fourth quarter of 2023 were $29 million versus $31 million in the prior year period, reflecting continued growth investments in the Company’s digital transformation, distribution network, and eCommerce capabilities. Adjusted Free Cash Flow(3) was $43 million in the fourth quarter of 2023, compared to $147 million in the prior year period.
“Our team’s strong commitment and dedication in managing inventory and working capital has resulted in strong cash flow generation,” said Scaglione. “As we move into the new year, we will maintain our disciplined approach, focusing on managing costs, maximizing cash flow, and executing our capital allocation plan,” he added.
Project Core and New $1 Billion Share Repurchase Authorization
Upon a year-end review across all of its business units and consistent with its low-cost business model approach, the Company announced “Project Core”, a plan designed to create further efficiencies in its business, focused on driving enhanced operating results and increasing shareholder returns through an expanded share repurchase program. This broad-based plan includes cost improvement actions across the entire enterprise, including all routes to market, Varis, procurement, IT and shared services, encompassing the entirety of ODP’s enterprise, optimizing its organizational structure to support future growth of the business. During this effort, the Company continues to review strategic options for it’s Varis business unit and expects to conclude this review and provide a full update by its first quarter earnings announcement call in early May 2024.
In connection with Project Core, the Company expects to realize annualized savings in the range of $50 million to $60 million when fully implemented. Restructuring and related charges associated with these actions are estimated to be in the range of $20 million to $30 million and are expected to be substantially incurred throughout 2024. The Company expects to begin reducing costs exiting the first quarter of 2024, with most of these actions expected to be completed over the following 12 months.
“Project Core aligns with our low-cost model mindset and builds upon our continued focus of driving strong operating results while enhancing value for shareholders through our new share repurchase authorization,” said Smith. “We’re taking what we’ve learned during our first year of operating under our new structure, and through Project Core, we’re driving further operational efficiencies in our business, enabling us to more effectively serve customers and pursue new avenues of long-term growth.”
As a component of Project Core, the Company announced that its Board of Directors has approved a new $1 billion, 3-year, share repurchase authorization, replacing its prior authorization that was valid through 2025, which had approximately $530 million available at the end of February 2024, after the Company repurchased approximately $470 million since November 2022.
“Our new $1 billion share repurchase authorization highlights our management team and Board of Director’s continued focus on enhancing value for shareholders. Our disciplined capital plan, combined with our continued focus on driving operational excellence enhanced through Project Core, create a compelling value proposition for all of our stakeholders,” said Smith.
The number of shares to be repurchased under the authorization in the future and the timing of such transactions will depend on a variety of factors, including market conditions, regulatory requirements, and other corporate considerations. The new authorization could be suspended or discontinued at any time as determined by the Board of Directors.
2024 Guidance
“We’re enthusiastic about the numerous opportunities in our business to drive long term value and we remain focused on prudently deploying capital to the benefit of shareholders,” said Smith. “As we move forward into 2024, we remain cautiously optimistic regarding the macroeconomic environment, and we will remain focused on executing upon our three horizons strategy and continuing our commitment to our low-cost model approach through Project Core.”
“While macroeconomic conditions posed challenges throughout the year and we expect these conditions to persist in the near term, our team’s continued focus on driving our low-cost model, enhanced by Project Core, have positioned us to issue the following guidance for 2024,” Scaglione added.
The Company’s full year guidance for 2024 is as follows:
FY 2024 Guidance(1)
Sales
Decline of 2% – 5%
Adjusted EBITDA
$410 million – $430 million
Adjusted Operating Income(1)
$280 million – $300 million
Adjusted Earnings per Share(1)
$5.60 – $5.80 per share
Adjusted Free Cash Flow (3)(*)
Greater than $200 million
*Adjusted Free Cash Flow is defined as cash flows from operating activities less capital expenditures excluding cash charges associated with the Company’s Project Core Restructuring and related expenses
The Company’s full year guidance for 2024 includes non-GAAP measures, such as Adjusted EBITDA, Adjusted Operating Income, Adjusted Earnings per Share and Adjusted Free Cash Flow. These measures exclude charges or credits not indicative of core operations, which may include but not be limited to restructuring charges, capital expenditures, acquisition-related costs, executive transition costs, asset impairments and other significant items that currently cannot be predicted without unreasonable efforts. The exact amount of these charges or credits are not currently determinable but may be significant. Accordingly, the Company is unable to provide equivalent GAAP measures or reconciliations from GAAP to non-GAAP for these financial measures.
“Our revenue guidance assumes continued store footprint consolidation and improving trends in our eCommerce channel at Office Depot, organic and inorganic growth at ODP Business Solutions, continued expansion at Veyer and progress at Varis. Our adjusted EPS outlook assumes higher interest expense associated with projected intra-quarter ABL borrowings, and the impact from a higher level of share buyback activity associated with Project Core. While our guidance assumes incremental improvement in the overall macroeconomic environment throughout 2024, we remain cautious on the state of the overall US economy, primarily workforce employment and the consumer, as well as international trade policies and agreements that could further impact the level of consumer and business activity,” Scaglione added.
The ODP Corporation will webcast a call with financial analysts and investors on February 28, 2024, at 9:00 am Eastern Time, which will be accessible to the media and the general public. To listen to the conference call via webcast, please visit The ODP Corporation’s Investor Relations website at investor.theodpcorp.com. A replay of the webcast will be available approximately two hours following the event.
(1)
As presented throughout this release, adjusted results represent non-GAAP financial measures and exclude charges or credits not indicative of core operations and the tax effect of these items, which may include but not be limited to merger integration, restructuring, acquisition costs, and asset impairments. Reconciliations from GAAP to non-GAAP financial measures can be found in this release as well as on the Company’s Investor Relations website at investor.theodpcorp.com.
(2)
As used in this release, Free Cash Flow is defined as cash flows from operating activities less capital expenditures. Free Cash Flow is a non-GAAP financial measure and reconciliations from GAAP financial measures can be found in this release as well as on the Company’s Investor Relations website at investor.theodpcorp.com.
(3)
As used in this release, Adjusted Free Cash Flow is defined as Free Cash Flow excluding cash charges associated with the Company’s Project Core Restructuring, and related expenses Adjusted Free Cash Flow is a non-GAAP financial measure and reconciliations from GAAP financial measures can be found in this release as well as on the Company’s Investor Relations website at investor.theodpcorp.com.
About The ODP Corporation
The ODP Corporation (NASDAQ:ODP) is a leading provider of products, services, and technology solutions through an integrated business-to-business (B2B) distribution platform and omni-channel presence, which includes supply chain and distribution operations, dedicated sales professionals, a B2B digital procurement solution, online presence, and a network of Office Depot and OfficeMax retail stores. Through its operating companies ODP Business Solutions, LLC; Office Depot, LLC; Veyer, LLC; and Varis, Inc, The ODP Corporation empowers every business, professional, and consumer to achieve more every day. For more information, visit theodpcorp.com.
This communication may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements or disclosures may discuss goals, intentions and expectations as to future trends, plans, events, results of operations, cash flow or financial condition, the potential impacts on our business due to the unknown severity and duration of the COVID-19 pandemic, or state other information relating to, among other things, the Company, based on current beliefs and assumptions made by, and information currently available to, management. Forward-looking statements generally will be accompanied by words such as “anticipate,” “believe,” “plan,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “expectations”, “outlook,” “intend,” “may,” “possible,” “potential,” “predict,” “project,” “propose” or other similar words, phrases or expressions, or other variations of such words. These forward-looking statements are subject to various risks and uncertainties, many of which are outside of the Company’s control. There can be no assurances that the Company will realize these expectations or that these beliefs will prove correct, and therefore investors and stakeholders should not place undue reliance on such statements.
Factors that could cause actual results to differ materially from those in the forward-looking statements include, among other things, highly competitive office products market and failure to differentiate the Company from other office supply resellers or respond to decline in general office supplies sales or to shifting consumer demands; competitive pressures on the Company’s sales and pricing; the risk that the Company is unable to transform the business into a service-driven, B2B platform that such a strategy will not result in the benefits anticipated; the risk that the Company will not be able to achieve the expected benefits of its strategic plans, including the strategic review of Varis and benefits related to Project Core; the risk that the Company may not be able to realize the anticipated benefits of acquisitions due to unforeseen liabilities, future capital expenditures, expenses, indebtedness and the unanticipated loss of key customers or the inability to achieve expected revenues, synergies, cost savings or financial performance; the risk that the Company is unable to successfully maintain a relevant omni-channel experience for its customers; the risk that the Company is unable to execute the Maximize B2B Restructuring Plan successfully or that such plan will not result in the benefits anticipated; failure to effectively manage the Company’s real estate portfolio; loss of business with government entities, purchasing consortiums, and sole- or limited- source distribution arrangements; failure to attract and retain qualified personnel, including employees in stores, service centers, distribution centers, field and corporate offices and executive management, and the inability to keep supply of skills and resources in balance with customer demand; failure to execute effective advertising efforts and maintain the Company’s reputation and brand at a high level; disruptions in computer systems, including delivery of technology services; breach of information technology systems affecting reputation, business partner and customer relationships and operations and resulting in high costs and lost revenue; unanticipated downturns in business relationships with customers or terms with the suppliers, third-party vendors and business partners; disruption of global sourcing activities, evolving foreign trade policy (including tariffs imposed on certain foreign made goods); exclusive Office Depot branded products are subject to additional product, supply chain and legal risks; product safety and quality concerns of manufacturers’ branded products and services and Office Depot private branded products; covenants in the credit facility; general disruption in the credit markets; incurrence of significant impairment charges; retained responsibility for liabilities of acquired companies; fluctuation in quarterly operating results due to seasonality of the Company’s business; changes in tax laws in jurisdictions where the Company operates; increases in wage and benefit costs and changes in labor regulations; changes in the regulatory environment, legal compliance risks and violations of the U.S. Foreign Corrupt Practices Act and other worldwide anti-bribery laws; volatility in the Company’s common stock price; changes in or the elimination of the payment of cash dividends on Company common stock; macroeconomic conditions such as higher interest rates and future declines in business or consumer spending; increases in fuel and other commodity prices and the cost of material, energy and other production costs, or unexpected costs that cannot be recouped in product pricing; unexpected claims, charges, litigation, dispute resolutions or settlement expenses; catastrophic events, including the impact of weather events on the Company’s business; the discouragement of lawsuits by shareholders against the Company and its directors and officers as a result of the exclusive forum selection of the Court of Chancery, the federal district court for the District of Delaware or other Delaware state courts by the Company as the sole and exclusive forum for such lawsuits; and the impact of the COVID-19 pandemic on the Company’s business. The foregoing list of factors is not exhaustive. Investors and shareholders should carefully consider the foregoing factors and the other risks and uncertainties described in the Company’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. The Company does not assume any obligation to update or revise any forward-looking statements.
New Scientific Advisory Board member played instrumental role in FDA approval and commercialization of multiple blockbuster products
CHICAGO, IL, Feb. 27, 2024 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced the appointment of immuno-oncology leader Remus Vezan, M.D., Ph.D., to its Scientific Advisory Board (SAB).
With over 20 years of academic and biopharmaceutical industry experience, Dr. Vezan is a highly regarded leader in drug development of novel therapeutic modalities, including cell and gene therapies, and played a pivotal role in the development and approval of CAR-T cell products TECARTUS® and YESCARTA® (Gilead), and kinase inhibitor IMBRUVICA® (AbbVie). Dr. Vezan currently serves as Vice President, Global Clinical Development at BeiGene.
“Dr. Vezan holds vast experience in guiding oncology assets through all stages of development, from research to clinical strategies and registration. His extensive engagement with the regulatory agencies to maximize clinical and commercial opportunities has been instrumental in garnering multiple FDA and global approvals for novel therapies including biologics and CAR-T cell products,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “It is a pleasure to welcome Remus to the MAIA franchise, where he will provide valued guidance along our pathway to approval and commercialization of our lead candidate THIO.”
Previously, as executive director of clinical development at Kite Pharma (Gilead Sciences), Dr. Vezan was primarily responsible for managing and overseeing the clinical development of CART-cell products, including axi-cell/YESCARTA®, the first CART-cell therapy approved for relapsed/refractory B-cell lymphoma, and brexu-cell/TECARTUS®, the first CART-cell therapy approved for mantle cell lymphoma and adult acute lymphoblastic leukemia. Earlier, Remus served as Medical Director at Pharmacyclics, an AbbVie Company, where he was the clinical lead for IMBRUVICA® in lymphoplasmacytic lymphomas.
Dr. Vezan’s therapeutic expertise includes both hematology and oncology, with various treatment modalities including next generation small molecules and adaptive cellular therapies (CAR-T, NK, autologous, allogeneic).
Dr. Remus Vezan commented, “It is my pleasure and privilege to join MAIA as scientific advisor and support the efforts of the MAIA team in advancing the clinical development of its first-in-class telomere targeting agent. THIO is a next generation asset with the potential to provide meaningful clinical benefit to many patients with malignancies.”
Dr. Vezan completed his medical training (M.D. and Ph.D.) at the University of Medicine and Pharmacy Cluj, Romania, and University of Bern, Switzerland. He holds multiple medical and scientific affiliations including the American Society of Hematology (ASH), the European Hematology Association (EHA), and the American Society of Clinical Oncology (ASCO). His work has appeared in numerous scientific papers and publications.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
AdTheorent utilizes precise location data for visitation modeling, location-based targeting, and deterministic measurement
NEW YORK, Feb. 27, 2024 /PRNewswire/ — AdTheorent Holding Company, Inc. (Nasdaq: ADTH), a machine learning pioneer and industry leader using privacy-forward solutions to deliver measurable value for programmatic advertisers today announced the launch of Point™, a suite of proprietary machine learning-powered geo-intelligence solutions designed to drive real world visitation performance for advertisers. Point is fully integrated into the AdTheorent platform, offering advertisers a seamless way to activate, optimize, and measure the efficacy of their advertising campaigns.
Point delivers differentiated geo capabilities enabled by the industry’s most advanced machine learning foundation:
AdTheorent’s Point of Interest (POI) Capability: The AdTheorent platform enables advanced location targeting by points of interest locations. AdTheorent has access to more than 29 million consumer-focused points of interest that span across more than 17,000 business categories. POI categories include: shops, dining, recreation, sports, accommodation, education, retail banking, government entities, health and transportation. AdTheorent’s POI capability is fully integrated and embedded into the platform, giving users the ability to select and target a highly customized set of POIs (e.g., all Starbucks locations in New York City) within minutes.
Point’s Targeting Suite, Powered by Machine Learning: AdTheorent’s machine learning-powered geo-intelligence solutions allow advertisers to leverage precise location data in highly differentiated ways. Point’s targeting capabilities include:
Omnichannel Geo-Targeting: AdTheorent can target by country, state, city, DMA, or zip code and only serves ads to those within the specified geo that have the highest likelihood of converting, as measured by AdTheorent predictive models.
POI Location Targeting and Retargeting: can be leveraged to reach customers near a brand’s location, or customers who have visited a brand or competitive brand’s location within a customizable period of time.
AdTheorent Predictive Audiences: in addition to the multitude of custom inputs that can be incorporated into AdTheorent ID-independent audiences, proprietary visitation patterns can be used to inform advanced audience quality algorithms.
Custom Machine Learning KPI Models: all AdTheorent campaigns utilizing Point have performance models built upon visitation and location data, ensuring the attainment of important client KPIs, such as visits, cost per visit, and incremental lift.
Point’s Visitation Reporting: AdTheorent offers deterministic visitation reporting to quantify the impact of AdTheorent campaigns. Reporting metrics include: total visits, visitation rate, cost per visit, standard visitation lift and incremental lift. Unlike most solutions, AdTheorent can measure and report on visitation by individual POI location or nationally.
“AdTheorent’s Point is a differentiated and powerful suite of geo-intelligence solutions that provides advertisers with endless applications of location-based data – whether to drive incremental visits to a specific set of locations, or to use location data to build ID-independent customized Predictive Audiences,” said Jim Lawson, CEO of AdTheorent. “Most importantly, all of these applications are enabled by AdTheorent’s proprietary machine learning technology, which drives superior performance for advertisers.”
About AdTheorent AdTheorent (Nasdaq: ADTH) uses advanced machine learning technology and privacy-forward solutions to deliver impactful advertising campaigns for marketers. AdTheorent’s machine learning-powered media buying platform powers its predictive targeting, predictive audiences, geo-intelligence, audience extension solutions and in-house creative capability, Studio A\T. Leveraging only non-sensitive data and focused on the predictive value of machine learning models, AdTheorent’s product suite and flexible transaction models allow advertisers to identify the most qualified potential consumers coupled with the optimal creative experience to deliver superior results, measured by each advertiser’s real-world business goals.
AdTheorent is consistently recognized with numerous technology, product, growth and workplace awards. AdTheorent was named “Best Buy-Side Programmatic Platform” in the 2023 Digiday Technology Awards and was honored with an AI Breakthrough Award and “Most Innovative Product” (B.I.G. Innovation Awards) for five consecutive years. Additionally, AdTheorent is the only seven-time recipient of Frost & Sullivan’s “Digital Advertising Leadership Award.” AdTheorent is headquartered in New York, with fourteen locations across the United States and Canada. For more information, visit adtheorent.com.
