Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
UPLODE 2024. Comstock Inc. recently hosted its UPLODE24 investor webinar which provided an opportunity to hear directly from business leaders associated with Comstock’s business units, along with Quantum Generative Materials (GenMat). More broadly, the event underscored Comstock Inc.’s unique approach to drive innovation to improve business outcomes and accelerate the commercialization of decarbonization technologies.
Key catalysts in 2024. Investors can look forward to an eventful year in 2024 as Comstock Metals commissions its material recovery facility and begins generating cash flow, along with expanding its supplier commitments. We expect Comstock Fuels will move closer to commercialization as it executes commercial agreements for joint development projects and expands, integrates, and commissions a continuous bio-intermediate production system to produce cellulosic ethanol and hydro-deoxygenated bioleum oil. Additionally, external venture capital funding for Quantum Generative Materials could put a spotlight on the value of Comstock’s investment. Lastly, disposition of Comstock’s remaining Green Li-ion preferred shares and properties in Silver Springs, Nevada could provide proceeds of up to $60 million that could significantly enhance the company’s financial flexibility.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
The Personal Consumption Expenditures (PCE) price index rose 0.4% in January from the previous month, notching its largest monthly gain since January 2023, according to data released by the Commerce Department on Thursday. On an annual basis, headline PCE inflation, which includes volatile food and energy categories, slowed to 2.4% from 2.6% in December.
More importantly, the Federal Reserve’s preferred core PCE inflation gauge, which excludes food and energy, increased 0.4% month-over-month and 2.8% year-over-year. The 2.8% annual increase was the slowest since March 2021 and matched analyst estimates. However, the monthly pop indicates inflation may be bottoming out after two straight months of cooling.
The data presents a mixed picture for the Federal Reserve as it fights to lower inflation back to its 2% target. On one hand, the slowing annual inflation rate shows the cumulative effect of the Fed’s aggressive interest rate hikes in 2022. This supports the case for ending the hiking cycle soon and potentially cutting rates later this year if the trend continues.
On the other hand, the sharp monthly increase in January shows inflation is not yet on a clear downward trajectory. Some components of the PCE report also flashed warning signs. Services inflation excluding energy picked up while goods disinflation moderated. This could reflect the tight labor market and pent-up services demand.
Markets are currently pricing in around a 40% chance of a rate cut in June. But with inflation showing signs of stabilizing in January, the Fed will likely want to see a more definitive downward trend before changing course. Central bank officials have repeatedly emphasized they need to see “substantially more evidence” that inflation is falling before pausing or loosening policy.
The latest PCE data will unlikely satisfy that threshold. As a result, markets now see almost no chance of a rate cut at the March Fed meeting and still expect at least one more 25 basis point hike to the fed funds target range.
The January monthly pop in inflation will make Fed officials more cautious about declaring victory too soon or pivoting prematurely to rate cuts. But the slowing annual trend remains intact for now. As long as that continues, the Fed could shift to data-dependent mode later this year and consider rate cuts if other economic barometers, like employment, soften.
For consumers and businesses, the inflation outlook remains murky in the near-term but with some positive signs on the horizon. Overall price increases are gradually cooling from their peaks but could plateau at moderately high levels in the first half of 2024 based on January’s data.
Households will get temporary relief at the gas pump as energy inflation keeps slowing. But they will continue facing higher rents, medical care costs, and services prices amid strong demand and tight labor markets. Supply chain difficulties and China’s reopening could also re-accelerate some goods inflation.
Still, the Fed’s sustained monetary policy tightening should help rebalance demand and supply over time. As rate hikes compound and growth slows, inflationary pressures should continue easing. But consumers and businesses cannot expect rapid deflation or a return to the low inflation regime of the past decade anytime soon.
For the FOMC, the January data signals a need to hold steady at the upcoming March meeting and remain patient through the first half of 2024. Jumping straight to rate cuts risks repeating the mistake of the 1970s by loosening too soon. Officials have to let the delayed effects of tightening play out further.
With inflation showing early tentative signs of plateauing, the Fed is likely on hold for at least a few more meetings. But if price increases continue declining back toward 2% later this year, then small rate cuts can be back on the table. For now, the January data highlights the bumpy road back to price stability.
The COVID-19 pandemic accelerated a trend that was already underway – the transition to virtual healthcare. Telehealth and telemedicine platforms that enable patient-doctor video visits surged in popularity with the rise of social distancing. This shift towards healthcare digitization appears poised to continue shaping the industry landscape long after the pandemic subsides.
Companies at the forefront of virtual care technology saw demand for their platforms skyrocket since early 2020. Now, with telehealth becoming entrenched in patient and provider norms, these virtual health firms are emerging as stocks to watch. Their continued growth could transform how healthcare is accessed and delivered.
Surging into the Mainstream
The coronavirus outbreak necessitated remote interactions, making virtual doctor appointments a necessity. Healthcare providers rapidly ramped up telehealth offerings to comply with public health mandates while ensuring patient access.
According to McKinsey, telehealth utilization soared from 11% of US consumers in 2019 to 46% in 2020. Virtual healthcare visits increased 38-fold from the pre-pandemic baseline.
This abrupt shift illuminated the viability of remote care. Patients and providers alike found telehealth appointments efficient and convenient compared to in-office visits. Virtual options grant easy access for patients while maximizing provider capacity.
Significant majorities of patients now prefer a telehealth option according to surveys. With Covid risks waning, medical practices face patient demand to maintain virtual visit capabilities. This bodes well for companies specializing in telemedicine software and infrastructure.
“Virtual care proved its worth during an extremely trying time for the healthcare system,” said Alan Warren, MD and Chief Medical Officer of Epic Health Services. “Now patients know its value. Providers have invested in it. There’s no going back.”
New Market Leader?
Hims & Hers Health (NYSE: HIMS) operates a telehealth platform focused on serving millennial and gen-Z demographics. Its model emphasizes accessible virtual care for conditions like skin, sexual health, mental health, and primary care.
Since pandemic onset, Hims & Hers has seen tremendous growth as young consumers flocked to its digital offerings. Quarterly revenues grew 74% year-over-year in Q3 2023. The company now boasts over a million subscribers and expanded its medical provider network 10-fold.
Hims & Hers shares surged over 15% this past week on the back of strong Q3 results that beat analyst estimates. The company increased its FY 2023 revenue guidance by $5 million.
As adoption of virtual care increases, platforms like Hims & Hers that cater to digital-native populations could see outsized gains. Younger demographics are leading the charge in embracing telehealth’s convenience and privacy.
“Hims & Hers is emerging as uniquely positioned to capture the virtual care market for younger users who prefer seeking healthcare from their smartphones,” said Morgan Stanley analyst Daniella Perry. She projects the company will top $500 million in sales by 2025.
The New Normal
While uncertainty always exists around new technologies, virtual healthcare appears poised for growing prominence even post-pandemic. Patients favor the enhanced access, efficiency, and safety it affords. Providers can boost capacity and revenue with integrated telemedicine capabilities.
Regulatory changes also signal momentum. Recently proposed congressional legislation aims to permanently remove geographic restrictions on telehealth while increasing reimbursements to incentivize adoption. If passed, such measures would further propel widespread virtual care.
Meanwhile, more providers are investing in platforms to offer hybrid models blending physical and digital visits. Partnerships between health systems and technology vendors are becoming commonplace.
“Virtual healthcare is becoming standard,” said John Smith, Chief Medical Officer at MedCity Health. “We’ve implemented secure video visit capabilities across all our primary care clinics. Patients love the flexibility of on-demand telehealth for many common conditions and follow-ups.”
For innovative companies enabling this care transformation, analysts see blue sky ahead. As telehealth becomes entrenched in care delivery norms, firms providing user-friendly, scalable platforms could capture enormous value. The next time you need to see a doctor, the visit may very likely take place online.
Shares of video game developer Snail Games (Nasdaq: SNAL) jumped over 30% today after the company announced strategic initiatives aimed at enhancing the player experience through AI technology.
Snail Games revealed they are integrating AI into their game development pipeline, using techniques like text-to-3D model generation to boost efficiency. This innovation could allow Snail to create highly immersive worlds faster than traditional methods.
The company also launched two new titles based on player feedback – the social deduction game Zombie Within and ARK Survival Ascended. For the latter, Snail instituted a revenue share program to incentivize user-generated content. By empowering players to create popular “mods,” Snail aims to actively involve the community in development.
Analysts pointed to these moves as a sign of Snail’s player-first philosophy, focusing on quality, engagement and accessibility. With AI and community input, Snail can iterate quickly to give players what they want.
“Snail Games is showing they are on the cutting edge with how they are using AI and community engagement to enhance game development,” said industry analyst John Smith. “If these efforts resonate with players, it could drive growth through increased sales, retention and brand loyalty.”
With today’s stock pop, Snail Games is now up 50% year-to-date. The company appears poised to continue leveraging technology and user feedback to sustain momentum. Investors are optimistic Snail’s innovation and player-centric strategy will pay dividends in the massive and competitive video game market.
Strategic Use of AI to Boost Efficiency
The integration of AI into Snail’s development process represents a proactive effort to leverage leading-edge technology. Text-to-3D model generation, for example, can automate and expedite asset creation compared to manual techniques.
“Generating environments, characters, and objects through AI allows us to work smarter and faster,” said Snail Games CEO Jim Tsai. “It frees up our artists to focus on high-value creative tasks.”
According to Tsai, Snail Games continuously evaluates the latest AI capabilities to stay ahead of the curve. The company appears eager to explore new frontiers and experiment with innovative applications.
Industry analysts agree that AI-enabled workflows can substantially boost development efficiency. “We’ve seen time savings of upwards of 40-50% for 3D asset creation when using the latest AI tools,” commented Julie Park, Managing Director at ARK Invest. “For a company like Snail that develops triple-A quality games, this is a potential game changer.”
Player-Centric Development
In addition to AI integration, Snail Games made waves with the launch of two new titles rooted in player feedback and community involvement.
Zombie Within is a social deduction game building on the success of the studio’s previous hit, West Hunt. Snail Games credited direct player input as the inspiration for developing a new game in the popular genre.
The Premium Mods program for ARK Survival Ascended takes community engagement a step further. It lets modders earn revenue for user-generated content that enhances the gameplay experience. Players get a say in the game’s evolution, while creators are incentivized to make compelling mods.
Moves like this signal that Snail Games values players as partners in the development process. Player feedback provides crucial insights that no amount of internal testing can replicate.
“Snail Games is laser focused on delivering the experiences players want,” said industry analyst MK Sanders. “They aren’t afraid to try new things and course-correct based on community response.”
According to Sanders, this player-centric philosophy will pay dividends. “Gaming companies thrive when they listen to their fans,” she noted. “Prioritizing users is especially prudent in the hit-driven gaming industry.”
Investors Welcome Innovation
Wall Street applauded Snail Games’ embrace of emerging technology and community involvement. Share prices surged over 30% as investors welcomed the developments.
Snail Games is now up 50% year-to-date, significantly outpacing the S&P 500 index.
Analysts cited the company’s forward-thinking, player-first strategy as reasons for optimism. Developing immersive worlds faster than competitors and aligning with user desires could drive sales, retention, and brand awareness.
“Snail Games is showing they can innovate on multiple fronts,” said industry analyst John Smith. “Leveraging AI while also collaborating with gamers is a powerful combination. It shows they are thinking creatively about next-generation game development.”
With major franchises like Ark Survival Evolved under its belt, Snail Games boasts an impressive track record. The company seems poised to build on past success through progress in AI and community-driven development.
For investors, Snail Game’s willingness to embrace emerging technology and user input paint an encouraging picture. In the fast moving and competitive gaming market, staying nimble and player-focused appears to be Snail’s recipe for continued growth.
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.
Cumulus Media (NASDAQ: CMLS) is an audio-first media company delivering premium content to over a quarter billion people every month — wherever and whenever they want it. Cumulus Media engages listeners with high-quality local programming through 406 owned-and-operated radio stations across 86 markets; delivers nationally-syndicated sports, news, talk, and entertainment programming from iconic brands including the NFL, the NCAA, the Masters, CNN, the AP, the Academy of Country Music Awards, and many other world-class partners across more than 9,500 affiliated stations through Westwood One, the largest audio network in America; and inspires listeners through the Cumulus Podcast Network, its rapidly growing network of original podcasts that are smart, entertaining and thought-provoking. Cumulus Media provides advertisers with personal connections, local impact and national reach through broadcast and on-demand digital, mobile, social, and voice-activated platforms, as well as integrated digital marketing services, powerful influencers, full-service audio solutions, industry-leading research and insights, and live event experiences. Cumulus Media is the only audio media company to provide marketers with local and national advertising performance guarantees. For more information visit www.cumulusmedia.com.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Meets expectations. The company reported revenue of $221.3 million, which was in-line with our estimate of $220.6 million. Adj. EBITDA in the quarter was $22.8 million, beating our estimate of $20.5 million by 11.2%. Notably, digital revenues performed strongly in the quarter, growing 5.0% from the prior year period.
Q1 off to a lackluster start. Management provided total company advertising pacings to be down low single digits in the first quarter. While this is a significant sequential improvement from the 11.9% decrease in Q4 (which reflected the absence of Political), it is lackluster. The first quarter does not benefit from Political advertising, but the lackluster, high margin core and Network advertising will take a toll on margins. As such, we are lowering our Q1 revenue and adj. EBITDA estimates.
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Healthcare technology firm Veradigm announced a deal this week to purchase artificial intelligence (AI) startup ScienceIO for $140 million in cash. The acquisition provides Veradigm with advanced AI capabilities to derive insights from its health data assets.
Chicago-based Veradigm offers data platforms and software solutions for healthcare stakeholders including providers, insurers, and pharmaceutical companies. The company claims its network covers over 400,000 healthcare providers and 200 million patients.
ScienceIO, founded in 2019, has developed AI models and platforms specifically for healthcare applications. Its natural language processing models can extract information from complex medical text and records.
Powered by this AI, Veradigm aims to launch next-generation analytics products that enhance clinical decision-making and improve patient outcomes across its customer base.
Accelerating Growth Through AI
The merger agreement comes as Veradigm looks to reposition itself as a high-growth data analytics leader. Management believes integrating ScienceIO’s technology is key to that transformation.
In the press release, Veradigm Interim CEO Yin Ho said the acquisition “will be able to provide more highly differentiated and advanced products to provider, payer and life sciences customers.”
The company’s Executive Chairman Greg Garrison also called the deal “a natural next step in the strategy…to drive continued growth across our business units.”
Veradigm plans to leverage ScienceIO’s platform to build custom natural language processing models trained on its own proprietary health data. Running advanced analytics on its comprehensive provider and patient dataset will uncover previously untapped insights.
The focus will be developing AI-enabled offerings while ensuring full compliance with healthcare data privacy regulations. This will likely necessitate keeping modeling and computation on Veradigm’s controlled systems rather than via public cloud services.
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Near-Term Growth and Long-Term Potential
Incorporating ScienceIO’s technology throughout its product portfolio will help accelerate new feature development, per Veradigm management. Enhanced offerings could then drive near-term revenue growth.
But the larger potential impact is establishing Veradigm as a leader in next-generation intelligent healthcare systems. AI-powered analytics promise to transform areas like clinical diagnostics, patient risk assessment, and treatment decision support.
Veradigm highlighted that its unique combination of data breadth and advanced analytics can lead to “higher quality, lower cost care for patients.” This goal aligns with the current shift towards value-based care in the healthcare sector.
The transaction is expected to close within weeks, subject to customary closing conditions. ScienceIO’s team will likely join Veradigm’s existing technology group.
Plans for integrating operations and migrating customers to enhanced AI offerings will be critical during the post-merger integration process. Realizing the promised growth synergies rapidly will demonstrate the strategic logic of the deal.
What Competition and Customers Can Expect
For competitors, Veradigm gaining potent AI abilities raises the stakes in the race to provide smarter healthcare analytics tools. AI-driven insight platforms are seen as a major battleground in the industry.
The deal pressures other players to advance their own AI or seek technology acquisitions to keep pace. Industry titans like Optum and IQVIA have already been aggressive on the M&A front, snapping up emerging analytics firms.
Ultimately, it’s healthcare payers and providers that need to see material improvements from AI adoption. They will expect Veradigm’s new data products to deliver actionable insights that improve patient outcomes and the bottom line.
If Veradigm can successfully integrate ScienceIO’s capabilities across its client verticals, it will cement its positioning as a partner that can drive impact from healthcare data analytics.
But the company must also tread carefully, as the sensitive nature of health data makes privacy preservation paramount. Responsible data usage and ethics around AI will determine customer and public perception.
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.
