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29-05-2025
- Business
- Yahoo
Vivani Medical Announces Filing of Form 10 Registration Statement for Planned Spin-Off of Cortigent Neurostimulation Business to Vivani Shareholders
Transaction is anticipated to be completed in third quarter 2025 Planned Cortigent Nasdaq listing intended to drive value for Vivani and Cortigent stockholders Cortigent is developing the Orion® Visual Cortical Prosthesis System to provide meaningful visual perception to people who are blind Cortigent is developing the Stroke Recovery System to improve the recovery of arm and hand movement in people who have suffered paralysis due to stroke Spin-off will allow Vivani to focus on its continued development of miniature, ultra long-acting GLP-1 implants for chronic weight management and type 2 diabetes with annual or bi-annual dosing ALAMEDA, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (NASDAQ: VANI) ('Vivani' or the 'Company'), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, today announced that Cortigent, Inc. ('Cortigent'), a wholly owned subsidiary of the Company that develops brain implant devices to help patients recover critical body functions, has filed a Form 10 registration statement with the U.S. Securities and Exchange Commission ('SEC') to spin off Cortigent as an independent, publicly traded Nasdaq company in third quarter 2025. The strategic goal of this transaction is to create two focused companies dedicated to driving current and future value in their respective therapeutic areas of expertise. 'Filing the Form 10 registration statement is an important milestone in our journey to establish Cortigent as an independent, publicly traded company dedicated to advancing its pioneering neurostimulation technology,' said Vivani Chief Executive Officer Adam Mendelsohn, Ph.D. 'Elon Musk's Neuralink Corp. has brought renewed excitement to the brain implant field, having commenced a six-year Early Feasibility Study of its brain computer interface device in paralyzed patients last year, which study is expected to be complete in 2031. The Orion Visual Cortical Prosthesis System has a U.S. Food and Drug Administration ('FDA') Breakthrough Device designation and completed a six-year Early Feasibility Study in March 2025, with promising safety and efficacy results. Cortigent's proven technology platform also achieved the first and only FDA authorization (under a Humanitarian Device Exemption) for an artificial vision device. This remarkable device, called the Argus II®, was marketed for a rare form of blindness and implanted in hundreds of patients. Establishing Cortigent as an independent public company on Nasdaq will allow Vivani to be fully focused on leveraging our proprietary NanoPortal™ drug implant technology and advance the development of our portfolio of miniature, subdermal GLP-1 implants with annual or bi-annual dosing for chronic weight management, type 2 diabetes, and other chronic diseases.' 'Our plan for Cortigent to trade as an independent public company on Nasdaq will best position Cortigent to accelerate development of the Orion Visual Cortical Prosthesis System and the Stroke Recovery System,' said Cortigent Chief Executive Officer Jonathan Adams, MBA. 'After successfully completing an Early Feasibility Study of Orion in 2025, which is our latest brain implant device for artificial vision, Cortigent is preparing for a pivotal trial of this breakthrough technology. We will advance clinical evaluation of Orion for commercialization and study applying our precision neurostimulation technology to a device for the recovery of arm and hand movement after paralysis due to stroke. We are confident that the important proprietary technology that underpins our platform will also allow us to address other critical unmet medical needs.' Adams has served as Cortigent's CEO since 2023, and prior to joining Cortigent, he founded and was CEO of BioVie Inc., a Nasdaq-listed biopharmaceutical company. He has 35 years of experience in the biopharmaceutical field and with medical devices including technology commercialization, financial management, operations, marketing and sales, and has assisted in the launch of dozens of new drugs and medical devices. Cortigent will continue to be headquartered in the Los Angeles area. Vivani previously announced the submission of a Form S-1 registration statement to support an Initial Public Offering of Cortigent and revised its strategy to file a Form 10 registration statement with the SEC, enabling the spin-off of Cortigent into a separate, publicly traded Nasdaq company subject to listing and regulatory requirements. This approach will allow Vivani stockholders to directly participate in Cortigent's future and enable Vivani to focus exclusively on the development of NanoPortal drug implants. Vivani believes the spin-off of Cortigent will result in two distinct companies that will: focus on and pursue strategic priorities specific to their core commercial therapies and pipeline assets; benefit from separate capital structures and capital allocation strategies; achieve additional operating efficiencies consistent with their respective long-term strategic objectives; and respond more quickly to the rapidly changing developments and global opportunities in their respective patient markets. The spin-off of Cortigent is expected to provide investors with greater visibility into the financial and operational structures of Vivani and Cortigent and a clearer understanding of their respective strategies and risks. Vivani believes creating two stand-alone companies, with dedicated and talented management teams, will provide the necessary foundation for long term value creation for each business. Vivani's board of directors has authorized management to proceed with a plan to spin off its Cortigent neuromodulation business. The spin-off is planned to be completed during third quarter 2025 or otherwise in 2025, subject to the satisfaction of certain conditions, including, among others, final approval of Vivani's board of directors, receipt of a favorable opinion that the transaction will qualify for non-recognition of gain or loss, as a result of receipt of Cortigent shares, for U.S. Federal Income Tax purposes, and SEC and Nasdaq approval. The spin-off is expected to be accomplished by distributing the requisite number of shares of Cortigent to Vivani stockholders. ThinkEquity is acting as the exclusive financial advisor to Cortigent, Inc. with respect to the spin-off transaction. For more information, please visit: About Cortigent, Inc. Cortigent, Inc., formerly Second Sight Medical Products and a wholly owned subsidiary of Vivani, is developing brain implant devices to help people recover critical body functions. Cortigent is a global leader in precision neurostimulation technology that provides meaningful visual perception ('artificial vision') for blind people. Cortigent previously marketed the Argus II, the first and only artificial vision device approved by the FDA, to treat a rare form of blindness. The Argus II has helped hundreds of profoundly blind people to achieve meaningful visual perception. Cortigent's next generation investigational system, the Orion Visual Cortical Prosthesis System, has been designed to treat blindness due to glaucoma, diabetic retinopathy, and other common causes. Orion has an FDA Breakthrough Device designation and completed a six-year Early Feasibility Study in 2025 with encouraging safety and efficacy results. Cortigent's platform technology combines advanced neuroscience with proprietary microelectronics, software, and data processing capabilities to create medical devices for alleviating serious medical conditions that cannot be treated with drugs. It is protected by an extensive intellectual property estate. Cortigent is also applying its core precision neurostimulation technology to the recovery of arm and hand motion in paralysis due to stroke by its Stroke Recovery System. For more information and patient videos, please visit: About Vivani Medical, Inc. Leveraging its proprietary NanoPortal platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve patient tolerance to their medication. Vivani's lead program, NPM-115, is a six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in obese or overweight individuals. Vivani's emerging pipeline includes NPM-139 (semaglutide implant), which is also under development for chronic weight management. The semaglutide implant has the added potential benefit of once-yearly administration. NPM-119 refers to the Company's six-month, subdermal, GLP-1 (exenatide) implant under development for the treatment of type 2 diabetes. These NanoPortal implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of orals and injectables. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. Medication non-adherence, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason obese or overweight patients, and patients taking type 2 diabetes or other chronic disease treatments, face significant challenges in achieving positive real-world effectiveness. While the current GLP-1 landscape includes over 50 new molecular entities under clinical stage development, Vivani is confident that its highly differentiated portfolio of miniature long-acting GLP-1 implants have the potential to provide an attractive therapeutic option for patients, prescribers and payers. For more information, please visit: Forward-Looking Statements This press release contains certain 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'target,' 'believe,' 'expect,' 'will,' 'may,' 'anticipate,' 'estimate,' 'would,' 'planned,' 'positioned,' 'potential,' 'future,' 'allow,' 'intended' and other similar expressions that are in this press release, including statements regarding Vivani's business, products in development, including the therapeutic potential thereof, the planned development therefor, the completion of the LIBERATE-1™ trial and reporting of trial results, Vivani's development plans for Vivani's products, including NPM-115, NPM-139, NPM-119 or Vivani's plans with respect to Cortigent and its proposed spin-off, technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani's current beliefs, expectations, and assumptions. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation, risks that the spin-off will not be completed in a timely manner or at all; risks of failure to satisfy any conditions to the spin-off; risks of failure of the spin-off to qualify for non-recognition of gain or loss for U.S. federal income tax purposes; uncertainty of whether the anticipated benefits of the spin-off can be achieved; risks of unexpected costs or delays; and risks and uncertainties associated with the development and commercialization of products and product candidates that may impact or alter anticipated business plans, strategies and objectives. Because forward-looking statements relate to the future, they are subject to additional inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Vivani's control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of Vivani's products, including NPM-115, NPM-139, NPM-119; delays and changes in the development of Vivani's products, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct Vivani's development activities; risks related to the initiation, enrollment and conduct of Vivani's planned clinical trials and the results therefrom; Vivani's history of losses and Vivani's ability to access additional capital or otherwise fund Vivani's business; market conditions and the ability of Cortigent to complete its spin-off, Cortigent's history of losses and Cortigent's ability to access additional capital or otherwise fund Cortigent's business and advance its product candidates and pre-clinical programs. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. There may be additional risks that the Company and Cortigent consider immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company's most recent Annual Report on Form 10-K filed with SEC on March 31, 2025, as updated by the Company's subsequent Quarterly Reports on Form 10-Q and in other reports that the Company has filed with the SEC. Any forward-looking statements made by Vivani or Cortigent in this press release are based only on information currently available to the Company and Cortigent and assumptions that Vivani and Cortigent believe to be reasonable. Any forward-looking statement speaks only as of the date on which it is made. Neither the Company nor Cortigent undertake any obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time-to-time, whether as a result of added information, future developments or otherwise, except as required by law. Company Contact:Donald DwyerChief Business Officerinfo@ 506-8462 Investor Relations Contact:Jami TaylorInvestor Relations Advisorinvestors@ 506-8462 Media Contact:Sean LeousICR 866-4012Error in retrieving data Sign in to access your portfolio Error in retrieving data
Yahoo
15-05-2025
- Business
- Yahoo
Q1 2025 PDS Biotechnology Corp Earnings Call
Mike Moyer; Managing Director; LifeSci Advisors, LLC Frank Bedu-Addo; President, Chief Executive Officer, Director; PDS Biotechnology Corp Lars Boesgaard; Chief Financial Officer, Principal Accounting Officer and Principal Financial Officer; PDS Biotechnology Corp Kirk Shepard; Chief Medical Officer; PDS Biotechnology Corp Mayank Mamtani; Analyst; B. Riley Securities Joe Pantginis; Analyst; H. C. Wainwright & Co James Molloy; Analyst; Alliance Global Partners Operator Greetings and welcome to the PDS Biotech first quarter in 2025 earnings conference call. (operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Moyer, lifestyle you, sir. You may begin. Mike Moyer Thank you, operator. Good morning, everyone, and welcome to PDS Biotech's first quarter 2025 results and clinical programs update call. I'm joined on the call today by the following members of the company's management team. Dr. Frank Bedu-Addo, Chief Executive Officer, Dr. Kirk Shepard, Chief Medical Officer, and Lars Boesgaard, Chief Financial Officer. Dr. Bedu-Addo will begin with an overview of the company's recent progress in its clinical development program. Mr. Boesgaard will review the financial results for the quarter ended March 31, 2025, and Dr. Shepard will then join the call to help address questions from our covering analysts. As a reminder, during this call, we will be making forward-looking. Statements which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in our filings with the SEC, including our quarterly reports on Form 10 and annual report on Form 10k, and cautionary statements made during this call. We assume no obligation to update any of these forward-looking statements or information. Now I'd like to turn the call over to Dr. Bedu-Addo. Frank Bedu-Addo Thank you, Mike, and good morning, our pleasure to speak with you again and to provide this brief update on our progress in advancing our clinical first quarter of 2025 in recent weeks have been a productive period for PDS Biotech, led by the initiation of our versatile 003 phase 3 clinical trial of Versamune HPV plus HPV plus pembrolizumab is a potential treatment for first line recurrence and or metastatic HPV 16 positive head and neck squamous cell carcinoma or head and neck with recurrent or metastatic HPV 16 passive head and neck cancer are difficult to treat and represent a large fast-growing population in need of targeted therapies to treat the underlying cause of the is projected that by the mid-2030s, HPV 16 positive head and neck cancer will become the most prevalent type of head and neck cancer in the United States and Europe. Considering the strength and durability of the clinical responses observed in our versatile 002 phase 2 are excited to get the versatile 003 registrational trial underway and are confident in the potential of the combination of Versamune HPV and pembrolizumab to significantly improve outcomes for patients with recurrent and or metastatic HPV 16 positive head and neck are pleased to announce that new sites, including Mayo Clinic sites were recently added to the trial, and we continue the process of activating additional clinical sites. We look forward to the continued progression of this we announced previously, the versatile 003 trial design includes approximately 350 patients. The two-arm registrational trial design has been given the go-ahead by the US Food and Drug Administration or two arms of the trial include a treatment arm of the Versamune HPV and pembrolizumab combination versus the control arm of pembrolizumab are enrolled in a two to one randomization. Median overall survival is the primary endpoint. The trial design is informed by the observed durability of the clinical responses in our versatile 002 clinical trial seen over the last year and a half with the most recent data presented at the European Society for Medical Oncology. ASCO Congress in encouraging patient survival and clinical responses coupled with promising tolerability as seen in the versatile 002 clinical trial will be the subject of a poster presentation of the 2025 American Society of Clinical Oncology annual Meeting, or data underscore our belief in the potential of the combination to be the first HPV-16 targeted therapy for head and neck cancer and a significant advancement in the treatment of the growing population of patients with HPV 16 positive head and neck versatile 003 trial in progress is the first phase 003 trial in the high-risk HPV 16 population and has also been accepted for presentation at the 2025 ASCO annual Mayo Clinic will present the results of the MC20-O-seven 10 study investigating Versamune HPV alone or with pembrolizumab prior to surgery or radiation therapy for locally advanced HPV 16 positive oropharyngeal three presentations will be held on Monday, June 2, 2025, from 9 A.M. to 12 P.M. Central Daylight Time during the head and neck cancer poster in our pipeline last week we announced that at the American Association of Immunologists Immunology 2025 annual meeting, pre-clinical efficacy and immune response data in mice and ferrets with a novel infect immune-based universal flu vaccine were featured in two presentations on universal influenza vaccines, including an oral studies were funded by and performed by investigators at the National Institute of Allergy and Infectious Diseases NIA Center for Influenza Vaccine Research for high-risk collaborative approach between NIA and PDS Biotech allows PDS Biotech to focus our resources on our versatile 003 clinical March, we were pleased to announce FDA clearance of our investigational new drug IND application for the combination of Versamune M1 and our IL-12 fused antibody drug conjugate PDS01ADC to treat metastatic colorectal cancer. Several highly prevalent solid tumors are Mach one positive, including non-small cell lung cancer, ovarian cancer, breast cancer, liver cancer, and are pleased to continue our strong relationship with the National Cancer Institute; MCI and this phase 1 and phase 2 clinical trial is scheduled to be run under our collaborative research and development agreement with the MCI. PDS Biotech will continue to focus our efforts on progressing the versatile 003 phase 3 clinical I will turn it over to Lars for a review of our results for [2025], Lars. Lars Boesgaard Thanks, Frank. And good morning, for the first quarter of 2025, we reported a net loss of approximately $8.5 million or about $0.21 per basic and diluted share for the three months ended March 31. That compares to $10.6 million or $0.30 per basic and diluted share for the three months ended March 31, 2024. This decrease is due to increased benefit from income taxes as well as lower operating and development expenses were $5.8 million for the first quarter compared to $6.7 million for the prior year quarter. This decrease was primarily due to lower clinical trial expenses. General administrative expenses were $3.3 million for the first quarter compared to $3.4 million for the prior year total operating expenses were $9.1 million for the first quarter compared to approximately $10.1 million for the prior year quarter. Net interest expenses were $0.6 million for the first quarter, which compared to approximately $0.5 million for the prior year cash balance as of March 31, 2025, was $40 million compared to $41.7 million as of December 31, 2024. You'll recall that on February 27 this year, we announced that we had entered into a securities purchase agreement with new and existing healthcare focused institutional investors, as well as participation for certain directors of the company. And under that arrangement, we raised approximately $11 million upon the closing. And with an additional $11 million that may be funded upon full cash exercise of the warrants that were included in the more recently, at the end of April, we completed a refinancing of our debt with new lenders, resulting in the extension of the term to 36 months, with the first four months being interest that operator we can open the call to questions. Operator (Operator Instructions)Mayank Mamtani, B. Riley Securities. Mayank Mamtani Yes. Good morning team. Thanks for taking your questions and Congrats on getting the versatile 003 phase 3 lamping up. So, first on, the Keytruda head and neck, new achievement data we saw at ACR, could you comment on how such a standard of care, changing data set impacts enrollment expectations of your phase 3, and did we sort of learn anything. If anything, on the HPV positive, tumor set and how maybe checkpoint inhibitors, monotherapy responses, response rate looks like in SPV 16 positive, and then I have a follow up. Frank Bedu-Addo Mike you're referring to the KEYNOTE-689 trial. Mayank Mamtani That's right. Frank Bedu-Addo Okay. Kirk, I'll hand over to you to start if you have any comments on that. Kirk Shepard Sure, can you hear me okay. Frank Bedu-Addo Yes, we can hear you. Kirk Shepard Great. The KEYNOTE-689 trial, should not affect our versatile 003. The reason is 689 was a study of mainly HPV negative patients. That's because the eligibility criteria of the to be that the patients were eligible for surgery and most patients who are HPV positive at this stage are not eligible for surgery. So that resulted in only 3% to 4% of the patients of this study being HPV positive. So, the study was focused mainly on HPV negative patients and not positive. Frank Bedu-Addo Kirk, thanks a lot. So, that's very important because even if this does become standard of care, there is going to be very little impact on the HPV positive it may actually speed up the HPV 16 population becoming the predominant recurrent metastatic head and neck cancer population. And this is something that we actually had our steering committee evaluate and give us advice on. And their feedback to PDS was Even if this new adjapan treatment is approved, since very few HPV positive patients are actually eligible for surgery at this stage, there should be negligible impact on the HPV 16 recurrent metastatic head and neck cancer population. And that's exactly what we saw as Kirk mentioned, only about 3% of the patients were actually HPV positive. Mayank that answered your question. Mayank Mamtani Yes, it you, both. And then, second on this, ask poster presentation coming up, could you talk to what we should be looking to learn on durability, incremental from what you've shown before, and maybe if you could comment on, just your durability, how might that be tracking relative to, also the emerging data from the next generation EGFR targeted therapies. Thanks again for taking your questions. Frank Bedu-Addo Thanks, my I'm not going to speak much about the EGFR inhibitors. I think they will make their presentations at ASCO. We will learn more. At this point, we can't say any more than they have currently presented to the markets. We have no additional information on how their programs are performing. But with regards to PDS Biotech, and our versatile 002 trial, as one of the key characteristics of this technology and the product is the On our corporate deck, one of the slides that shows how these patients react long term. I think one of the key things with oncology today with the current cytotoxic drugs, including cetuximab, is you get pretty good responses upfront, a good objective response rates. But what we have not seen to date in head and neck cancer, and many other cancers is once you are able to achieve these clinical you maintain these responses long term. That is the challenge, and that is exactly what we see with our adverse immune HPV plus KEYTRUDA formulation, where the patients who have clinical responses, including stable disease, partial responses, and complete responses, the majority of these patients appear to be maintaining those clinical responses long term and that has translated also to survival, which is very important. And so, as our last presentation at ASCO, as you recall, we presented a 30-month median overall survival, right. The standard today is approximately 12 months. So, really just putting that into perspective, right. Today, with the standard of care, if a patient had gone on to the standard of care, which have been KEYTRUDA or KEYTRUDA chemo. The probability of living 12 months was about 50%. You had a 50% probability of living for 12 months. However, if that patient had gone on to our versatile 002 trial, They had a 50% probability of living for 30 months or more. Right, that's the kind of durability we've seen in this HPV 16 population, which by the way, in some studies that have been public, have shown that in head and neck cancer, they found that in HPV 16 patients had the worst prognosis for survival once the disease becomes an advanced recurrent metastatic disease, to HPV negative and other types of HPV, the HPV 16 positive patients had by far the worst survival prognosis. So this is for us is an extremely encouraging result. And what we tend to do is to give an additional update on a more recent data cut on that durability and survival of these patients in the versatile 002 trial. Mayank Mamtani Thank you, Frank. Frank Bedu-Addo You're welcome. Operator Joe Pantginis, H. C. Wainwright & Co. Joe Pantginis Hi guys, good morning. Thanks for taking the question. So, I want to ask two nuanced questions regarding your two lead programs, and part of it you've already started to discuss. So first with KEYNOTE-689, when you're comparing it again, it's apples and oranges, even though I think from a perception standpoint. There are some, I guess, investor, comparing apples to oranges here, at least from a perception standpoint, so I'm just curious, how do you view the learning curve here and does it apply at all and I don't think it does, to physicians, impact and being able to want to participate in versatile 003 and then I have a follow up. Frank Bedu-Addo So, no to date and I'll ask Kirk to give his opinions on that. But to date, we have seen very strong enthusiasm from the investigators and the key opinion leaders in actually participating in the versatile 002 trial. I'll actually hand over to Kirk to give any comments before I get back to continuing my answer. Kirk, any comments on interest in the trial based on KEYNOTE-689. Kirk Shepard Yes, no, the response was very brisk and all the same from our steering committee, which are the experts in head and neck cancer, that 689 does not apply to HPV positive patients. And this is even before they saw the data broken down, which we saw at the AACR. And sure enough, when we saw the data, as Frank had mentioned, I mentioned earlier too, only 3% of the patients were HPV positive because it's not appropriate to treat these patients with surgery upfront. So, it's been discussed a lot with our investigators and especially our steering committee that this should not affect our patient accrual at all. And we're very fortunate that we have a number of versatile 002 investigators with us now who have experience with this drug and are very excited for versatile 003 to get started. Frank Bedu-Addo Thanks a lot, Joe, so along those lines, I think very importantly, I think that the oncologist and the key opinion leaders in the space really understand that this there are very few people who are going to be HPV positive who will be eligible for that new Apan treatment. And one of the things you can see in relation to that is that even at Mayo Clinic, one of the studies that we will be presenting at ASCO has to do with utilizing our Versamune HPV plus KEYTRUDA in that new adjuvan setting for HPV 16 positive patients. And one of the key things that the KOLs mentioned on our last AOL call was that their very strong recommendation for this combination based upon the tolerability that we've seen in the patients today would be to rapidly move it into that earlier stage setting, which would be locally advanced head and neck cancer. we have, we've already seen the experts in the field, based upon the promising results that we've seen in versatile 002, take that. Combination to start evaluating it in this patient population who will not be really impacted, who may not get any benefit from the KEYNOTE-689 since the HPV positive, can we take our combination and apply it now to those patients who may not be eligible for surgery, but can go on this new adjuvant/adjuvant treatment with our we see a significant opportunity for this combination there too. Joe Pantginis Great, I appreciate that added color, Frank and Kirk. So, my second nuanced question is your newly or IND approved, MUC1 program, so I wanted to do a little bit of historical perspective to where we are today and especially your program. I want to focus on the antigen itself; this has been a key target. I mean, MUC1 for immunotherapy and or cancer vaccines for more than two decades now, and there have been some, pretty high-profile failures with this target. So, I wanted to just get a little more sense again from you guys, why are you differentiated here, and I guess can you describe interest, from sites to participate knowing this history. Thanks a lot. Frank Bedu-Addo Really great question, Joe. Well, I'll start by saying that very similarly in HPV 16 positive head and neck cancer, cervical cancer over the last 20 years, there have also been some very high-profile failures. Right. However, with our technology, we now see that for the first time, we have a technology and product that has now has really strong data, very durable responses in moving into a pivotal registrational trial for the first time, right. There have been many failures in HPV 16, positive cancer over the last 20 years. the reason I'm giving you this analogy is it's important to recognize two things, not only the antigen. But the technology that is able to now perform the immunological function that the previous technologies have not been able to perform. That's very important in being able to activate the right immunological signaling pathways and also more effectively present those antigens into the right presentation pathways. So having a strong antigen doesn't get you very far. If it can't be effectively presented. And the right immunological pathways also activated both have to go hand in hand, now, moving from where we've demonstrated that this technology can do this effectively in head and neck cancer with the HPV antigens, we're now moving on to the Mach one after this proof of con solid proof of concept that we've generated the Mach one, these are novel antigens, agonist, what we call agonist epitopes that have been designed by the National Cancer Institute. And what they have, what they, these antigens have been designed to do is to be much more immunologically potent than the native MUC1 antigens. Therefore, having a much stronger ability to activate the immune system to recognize MUC1 as a foreign agent. And what we have now done is now taken our verse immune it with those novel or more potent antigens to facilitate their presentation to the immune system and to facilitate the training of the immune system to recognize them as foreign agents and then also activate those trained T cells to now be a lot more potent in attacking and killing the MUC1 positive And so, really, we have to look at it in the entirety of what's really happening here. The antigen alone does not do much to guarantee you or to generate an effective anti-tumor response. And what we're also doing in the study is combining it with our IL-12 anti-used antibody drug conjugate, right. And so, with the IL-12, we have demonstrated also with our HPV programs that by targeting the tumors and really driving the IL-12 away from the circulating blood, but into the tumors, which is the tumors are the required site of T cell activation, right. So, by being able to get both our T cells. And the IL-12 into the patient's tumors. We've also demonstrated significantly enhanced survival and anti-tumor responses. So, the goal is to apply this combination again to this program is being performed as part of our collaboration, collaborative research involvement agreement with the National Cancer Institute. So, this is a program where the first trial is going to be a single-site study and that's going to be done by the NCI. And this collaboration also allows us to focus our resources and efforts on running our versatile 003 program. Joe Pantginis Frank, really appreciate that detailed explanation and looking forward to see initial data thanks a lot. Frank Bedu-Addo You're welcome. Operator James Molloy, Alliance Global Partners. James Molloy Hi Frank, good you for taking my question. Just a quick, follow up on, 003. Has the first patient, have you guys announced the enrollment of the first patient yet. I, did I miss that, or what's the expectation on that. And then any anecdotal comments, from the docs on how they on enrollment and how sort of that's proceeding or how the conversations are going with the potential enrollees. Frank Bedu-Addo No, we have not made it public in how enrollment is going. So, as James, once the sites are activated, we act the sites actually have a number of internal processes they will undergo followed by screening of patients. So, the patients have to be screened that's part of the process of getting all these patients into the trial. This process is occurring as we continue to activate more sites, and the goal is to hopefully eventually get to a steady recruitment as the larger sites such as Mayo Clinic take longer to activate and get going. So our goal here is to update the markets when we have a much better idea of how enrollment is going and when we are able to approximately estimate when we're going to get to that interim data readout point. So, we will provide more updates when we have much better insight into when we, how the, what the recruitment rates should be and when we'll get to those data readout points. James Molloy That makes sense. Just starting the trial literally to try to guess that yet, I guess, and then maybe, on a mechanistic looking at the print for the OpEx for the quarter. Is this sort of the level we should anticipate going forward or expect that to kind of ramp up going through '25 or '26. Frank Bedu-Addo Lars, I'll hand over to you for that. Lars Boesgaard Yes, hi Jim. This is Las here. Yes, so we don't currently provide financial guidance, but I think it's fair to say that that we're happy the trial is, has been started well, the way it has, and as you probably are aware, right, we do tend to see a bit of a higher spend in the first couple of quarters, like we get the year up and running. So, I think without giving you any specific numbers, I think we see a relatively stable in terms of the trial spends going forward. James Molloy Okay great thank you very much for taking the questions. Operator There are no further questions at this time. I would now like to turn the floor back over to Dr. Frank do for closing comments. Frank Bedu-Addo Thank you, closing, we are very pleased to have initiated the versatile 002 registration trial this quarter. This study is the first phase 3 clinical trial specifically in the growing population of HPV 16 positive head and neck are excited based on the strong Versatile 002 results and our fast-track designation about the potential for Versamune HPV in head and neck cancer. We expect to provide updated results from our ongoing phase 2 versatile 002 study at ASCO in a couple of weeks. Our engagement with investors and clinical investigators has validated our approach and the long-term opportunity that we believe the H targeted immunotherapy presents in the HPV 16 positive head and neck cancer look forward to keeping you updated on our progress. And thank you very much again for your time and support. Thanks a lot. Operator This includes today's teleconference. You may disconnect your lines at this you for your participation. Sign in to access your portfolio
Yahoo
14-05-2025
- Business
- Yahoo
DuPont Unveils Brand Identity for Qnity, Future Electronics Spin-Off
Qnity™ Branding Symbolizes the Power of Innovation and Partnership WILMINGTON, Del., May 14, 2025 /PRNewswire/ -- DuPont (NYSE: DD) today unveiled the branding of Qnity, the planned independent Electronics public company that will be created through the intended spin-off of its Electronics business*. As a pure-play electronics materials company, Qnity will be one of the largest and broadest solutions providers to the semiconductor and electronics industries enabling advanced computing, smart technologies and connectivity. Qnity (pronounced cue-ni-tee) is inspired by 'Q', the symbol for electrical charge, and 'unity'. "Qnity's logo and graphic identity reinforces the innovation and partnership that our global team harnesses to make tomorrow's technologies possible," said Meg Miller, head of communications for DuPont's Electronics business. "The distinctive Q is evocative of the power icon on electronic devices, while the logo mark, designed as a flexible network radiating from a central chip‑like core, captures how we bring together people, companies and technologies to enable advanced computing and advanced connectivity." "For more than 50 years we've worked closely with industry leaders to power amazing advances in the electronics field," said Jon Kemp, DuPont Electronics business President and CEO-Elect of Qnity. "Next generation technology requires next generation solutions, and with our bold new identity we are primed to deliver the next leap forward." Qnity will be powered by over 10,000 employees serving advanced electronics customers in more than 80 countries. A microsite with further information on the Qnity brand can be found at About DuPontDuPont (NYSE: DD) is a global innovation leader with technology-based materials and solutions that help transform industries and everyday life. Our employees apply diverse science and expertise to help customers advance their best ideas and deliver essential innovations in key markets, including electronics, transportation, construction, water, healthcare, and worker safety. More information about the company, its businesses, and solutions can be found at Investors can access information included on the Investor Relations section of the website at DuPont™, the DuPont Oval Logo, Qnity and all trademarks and service marks denoted with ™, ℠ or ® are owned by affiliates of DuPont de Nemours, Inc. unless otherwise noted. *On January 15, 2025, DuPont announced it is targeting November 1, 2025, for the completion of the intended separation of the Electronics business (the "Intended Electronics Separation"). The Intended Electronics Separation will not require a shareholder vote and is subject to satisfaction of customary conditions, including final approval by DuPont's Board of Directors, receipt of tax opinion from counsel, the completion and effectiveness of the Form 10 registration statement filed with the U.S. Securities and Exchange Commission, applicable regulatory approvals and satisfactory completion of financing. Cautionary Statement about Forward-Looking StatementsThis communication contains "forward-looking statements" within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In this context, forward-looking statements often address expected future business and financial performance and financial condition, and often contain words such as "expect," "anticipate," "intend," "plan," "believe," "seek," "see," "will," "would," "target," "stabilization," "confident," "preliminary," "initial," "drive," "innovate" and similar expressions and variations or negatives of these words. Forward-looking statements address matters that are, to varying degrees, uncertain and subject to risks, uncertainties, and assumptions, many of which that are beyond DuPont's control, that could cause actual results to differ materially from those expressed in any forward-looking statements. Forward-looking statements are not representations or warranties or guarantees of future results. Some of the important factors that could cause DuPont's actual results to differ materially from those projected in any such forward-looking statements include, but are not limited to: (i) the ability of DuPont to effect the Intended Electronics Separation and to meet the conditions related thereto; (ii) the possibility that the Intended Electronics Separation will not be completed within the anticipated time period or at all; (iii) the possibility that the Intended Electronics Separation will not achieve its intended benefits; (iv) the impact of Intended Electronics Separation on DuPont's businesses and the risk that the separation may be more difficult, time-consuming or costly than expected, including the impact on DuPont's resources, systems, procedures and controls, diversion of management's attention and the impact and possible disruption of existing relationships with customers, suppliers, employees and other business counterparties; (v) the possibility of disruption, including disputes, litigation or unanticipated costs, in connection with the Intended Electronics Separation; (vi) the uncertainty of the expected financial performance of DuPont or the separated company following completion of the Intended Electronics Separation; (vii) negative effects of the announcement or pendency of the Intended Electronics Separation on the market price of DuPont's securities and/or on the financial performance of DuPont; (viii) the ability to achieve anticipated capital structures in connection with Intended Electronics Separation, including the future availability of credit and factors that may affect such availability; (ix) the ability to achieve anticipated credit ratings in connection with the Intended Electronics Separation; (x) the ability to achieve anticipated tax treatments in connection with the Intended Electronics Separation and completed and future, if any, divestitures, mergers, acquisitions and other portfolio changes and the impact of changes in relevant tax and other laws; (xi) risks and costs related to each of the parties respective performance under and the impact of the arrangement to share future eligible PFAS costs by and among DuPont, Corteva and Chemours, including the outcome of any pending or future litigation related to PFAS or PFOA, including personal injury claims and natural resource damages claims; the extent and cost of ongoing remediation obligations and potential future remediation obligations; and changes in laws and regulations applicable to PFAS chemicals; (xii) indemnification of certain legacy liabilities; (xiii) the failure to realize expected benefits and effectively manage and achieve anticipated synergies and operational efficiencies in connection with the Intended Electronics Separation and completed and future, if any, divestitures, mergers, acquisitions, and other portfolio management, productivity and infrastructure actions; (xiv) the risks and uncertainties, including increased costs and the ability to obtain raw materials and meet customer needs from, among other events, pandemics and responsive actions; (xv) adverse changes in worldwide economic, political, regulatory, international trade, geopolitical, capital markets and other external conditions; and other factors beyond DuPont's control, including inflation, recession, military conflicts, natural and other disasters or weather-related events, that impact the operations of DuPont, its customers and/or its suppliers; (xvi) the ability to offset increases in cost of inputs, including raw materials, energy and logistics; (xvii) the risks associated with continuing or expanding trade disputes or restrictions, new or increased tariffs or export controls including on exports to China of U.S.-regulated products and technology; (xviii) the risks, including ability to achieve, and costs associated with DuPont's sustainability strategy, including the actual conduct of DuPont's activities and results thereof, and the development, implementation, achievement or continuation of any goal, program, policy or initiative discussed or expected; (xix) other risks to DuPont's business and operations, including the risk of impairment; and (xx) other risk factors discussed in DuPont's most recent annual report and subsequent current and periodic reports filed with the U.S. Securities and Exchange Commission. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Consequences of material differences in results as compared with those anticipated in the forward-looking statements could include, among other things, business or supply chain disruption, operational problems, financial loss, legal liability to third parties and similar risks, any of which could have a material adverse effect on DuPont's consolidated financial condition, results of operations, credit rating or liquidity. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. DuPont assumes no obligation to publicly provide revisions or updates to any forward-looking statements whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by securities and other applicable laws. 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Yahoo
13-05-2025
- Business
- Yahoo
Q1 2025 Assertio Holdings Inc Earnings Call
Matt Kreps; Investor Relations; Assertio Holdings Inc Brendan O'Grady; Chief Executive Officer; Assertio Holdings Inc Ajay Patel; Executive Vice President & Chief Financial Officer; Assertio Holdings Inc Thomas Flaten; Analyst; Lake Street Naz Rahman; Analyst; Maxim Group Ram Selvaraju; Analyst; H.C. Wainwright Scott Henry; Analyst; AGP Capital Markets James Sidoti; Analyst; Sidoti & Company Operator Please stand by. Well, good day, ladies and gentlemen. Welcome to the Social Holdings first quarter 2025 results conference call. Just a reminder that today's call is being recorded. I would now like to hand things over to Mr. Matt Kretz. Please go ahead, sir. Matt Kreps Thank you and good afternoon. Thank you all for joining us today to discuss the Assertio's first quarter of 2025 financials. The news release covering our results for this period is now available on the investor page of our website at investor. I would encourage you to review the release and tables in conjunction with today's discussion. With me today are Brendan O'Grady, the Chief Executive Officer, and Ajay Patel, Chief Financial Officer. Brendan will open the remarks and provide an overview of the business, including an update on Assergio's long-term business strategy. After Brendan AJ will cover our financial results and guidance. Brendan will then provide some closing comments before we take questions from our covering research analysts. Please note that during this call, management will make projections and other forward-looking statements regarding our future performance. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in today's in this afternoon's press release, as well as the Sergio's filings with the FCC. These and other risk factors are more fully described in the risk factors section and other sections of our annual report on Form 10K and in our Form 10 filings. The actual results may differ materially from those projected in the forward-looking statements. Sarcio specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. With that, I will now turn the call over to Brendan. Please go ahead. Brendan O'Grady Thank you, Matt, and thank you to everyone who has joined today's call. I'll begin today with a quick overview of our first quarter financial results which are in line with the full year 2025 net product sales and adjusted EBITDA expectations that were set forth during the March earnings call. In the first quarter, net product sales came in slightly ahead. Of plan at 26 million and we are tracking to our full year net product sales and adjusted to Outlook. As I signaled in March, Rove on results in the first quarter were impacted by sell through 1/4 quarter initial stocking activity that supported customer and volume expansion, which we expect to benefit us from Q2 onward. In addition, we are continuing to add new customers and have strengthened our payer coverage that started in February with Cigna and expect to further expand our payer coverage going into the second half of this year. Overall Rodon demand remains strong and combined with our focused execution, we foresee net sales to continue increasing throughout the year. In addition, our revised Simpazan promotional strategy is proving effective, with total Simposan prescriptions in the first quarter up 6.5% year over year. This is a very positive-trend that we expect will continue building in the quarters ahead. Lastly, Indison remained stable in the first quarter, achieving our expectation for net sales and contribution. These results, along with expected performance throughout 2025, are influenced by the substantial progress Ossergio has achieved to date, implementing the long-term business strategy that I put into place last year. As I approach my one year anniversary with Osserio, I think it's important to recognize the team's progress and address our expectations moving forward. As previously stated, our strategy includes 3 phases characterized as stabilization, transformation, and growth. Stabilization was successfully completed in 2024 and it has adapted our organization to the changing operating environment. We strengthened our balance sheet, repositioned our portfolio to focus on Rovedon and Simpizan as core growth drivers, and rebalanced our talent and promotional resources. These significant achievements pave the way for us to begin implementing our current phase transformation. This phase is occurring throughout 2025 as we implement actions intended to catalyze a shift in future growth potential. I will cover this in more detail in just a minute. Finally, the growth phase of our strategy is expected to start in 2026, during which time we intend to become a leading commercially focused specialty pharma company that creates top tier value over the long term. Now coming back to the transformation phase of our strategy, we set forth the following priorities for 2025. First, reduce legal exposure. Second, simplify our corporate structure and processes. Third, prioritize investment and growth assets. 4th, divest non-core assets, and 5th, use the strength of our balance sheet to close a strategic transaction. These 5 transformation priorities are well underway with the goal of completing each by the end of this year, and I'm encouraged by our progress in just the 1st 4 months. I'll address several notable achievements and we'll start with reducing our legal exposure. Assergio has settled multiple prior legal matters, including the previously disclosed 2017 Department of Justice False Claims Act Q-tam lawsuit, the last remaininglumea antitrust action, and Spectrum's legacy Luau Securities class action. It is important to note that we admit to no wrongdoing in any of these cases, but decided to settle rather than continue to litigate and incurring the cost to defend as well as the distraction to our business. In addition, we obtained a dismissal of the company's Edwards Securities class action pending court approval. Our overall progress in reducing our legal exposure improves our ability to optimize operating expenses. By reducing legal costs and refocusing those resources back to the business. As noted in our earnings release, we have also begun simplifying our corporate holding structure by transferring all of our assets in our Sergio Therapeutic subsidiary to ATIH Industries LLC. At the closing of this transaction, Asserio Therapeutics held approximately $8.2 million in cash, a single digit royalty in Anderson, and certain legal liabilities, including those related to opioid litigation, which ATIH has assumed responsibility for managing and defending. As a result of this transaction, neither Seria Holdings nor any of its current subsidiaries remain named defendants in any opioid-related litigation. As we move throughout the year, we will also progress our strategy to invest some non-core assets which will further improve our ability to reallocate corporate resources to focus on growth and bolster our balance sheet to acquire or in license new growth assets. Already we have added new marketing support for Rodon and rebalanced promotional efforts for Simpizan by augmenting our omnichannel activities with select in-person support for the largest markets and key high decile prescribers. As a result, we are seeing improved efficiency and sales performance as previously mentioned. The actions I have just touched on allow us Sergio to optimize operating expenses so that we can better invest in the future and advance our strategic activities as we move through the transformation and into the growth phase. I want to conclude my remarks by stating that Ossertio's underlying business is strong and will be most successful by pivoting to a more sustained operating model driven by not only cash flow assets but by growth assets. To be clear, our strategy is to focus on specialty pharma assets with the potential to grow over a sustained period of time. Within a commercially focused operating model, that is why we are implementing a long term business strategy that we are confident can create sustained near term growth and increase long term value. I look forward to providing you with continued updates on our progress as we head through 2025. I will now hand over to our CFO Ajay Patel, who will walk us through the details of our first quarter performance. Ajay Patel Thanks, Brendan. Today I'll walk through our financial results for the first quarter of 2025. My commentary will resume the use of year over year comparisons as we have now completed the stabilization phase that Brendan discussed regarding the 2023 spectrum acquisition and Indison's generic competition, which made year over year comparisons difficult in 2024. Q1 2025 product sales came in at $26 million compared to $31.9 million in the prior year quarter. Odon sales were $13.1 million a decrease from $14.5 million in the prior year first quarter, driven by lower pricing, partially offset by higher volume. As Brendan mentioned, the current year first quarter was impacted by fourth quarter stocking. Indi and net product sales were $5.5 million down from $8.7 million in the prior year quarter due to the impacts of generic competition. The prior year first quarter was still in the early stages of the generic impact. Symphozan sales were $2.2 million compared to $2.6 million in the prior year period, impacted slightly by pricing and volume. Reported gross margin increased to 70% from 65% a year ago. The prior year reported gross margin included Rovedon inventory step up amortization, excluding the impact of the inventory step up, prior year gross margin was 78%. The year over year gross margin decline was driven by the impact of higher rovedon volumes on cost of sales. Turning to operating expenses, reported SG&A expense was $22 million up from $18.5 million in the prior year quarter, primarily driven by higher legal charges, including a net settlement charge of $2.8 million for the Luau shareholder matter. R&D expense was $0.4 million down from $0.7 million a year ago due to the completion of the same day dosing trial at the end of 2024. Adjusted operating expenses, which exclude stock compensation, DNA, and non-reoccurring restructuring and legal settlement charges, were $18.5 million compared to $17.3 million in the prior year period due to higher external litigation costs. GAAP net income for the first quarter was a loss of $13.5 million compared to a loss of $4.5 million in the prior year. In addition to the impacts just discussed, GAAP net income was affected by higher intangible amortization expense due to a change in useful life at the end of 2024. Adjusted IIDA for the first quarter was $0.2 million compared to $7.4 million in the prior year quarter, primarily reflecting the impact of lower net sales and gross margin as discussed. Turning to our balance sheet and cash flow statements, as of March 31, 2025, cash and investments totaled $87.3 million compared to $100.1 million as of December 31, 2024. Cash flow from operations during the first quarter was impacted by the timing of approximately $12 million of accounts receivable collected in early April. At the end of April 2025, cash and investments stood at approximately $96.7 million. Debt at March 31, 2025 remains unchanged at $40 million comprised of the company's 6.5% convertible notes with no maturities until September 2027. With that, I will turn the call back to Brendan. Brendan O'Grady Thanks. In the first quarter, the Ossertio team delivered strong financial performance on track to the expectations that we set for 2025. We also demonstrated outstanding execution on the transformation phase of our business strategy with notable achievements that keep us on a path to realizing our goal of creating sustainable near-term growth and increased long-term value. I am confident that the strengths of our underlying financials, ongoing business performance, and business strategy will enable our success. With that, let's go ahead and open the call for questions from our analysts. Operator Thank you, sir. (Operator Instructions) Thomas Slayton, Lake Street. Thomas Flaten Hey, good afternoon, guys. Thanks for taking the questions. Brendan, congrats on offloading the opioid litigation matters. Were there, just out of curiosity on that, was there value in in either direction on that? Did you guys pay them to take it? Did they pay you to accept it? Was there any. Brendan O'Grady Value movement there? Yeah, just nominal value they paid us, Thomas. Thomas Flaten And a quick one for AJ. AJ, you guys, have some. Relative to the beginning of last year, your accrued rebates, returns, accrued liabilities are up. How do we think about you guys using cash to bring those balances back down again? Will that occur pretty evenly over the course of the year or how should we think about that? Ajay Patel Yeah, Thomas, thanks for the question. Yeah, I would think about that relatively evenly. As the primary factor of that is Rover down with its ASP-based pricing. So as the rebates increase for that, the payments typically occur in the subsequent quarter. Thomas Flaten Got it, understood. And just a final one for me if I might, any more thoughts on same day dosing, progress with the NCCN, any update on that? Brendan O'Grady Yeah, Thomas, so as we've discussed or said before, we, it's kind of a 12 month strategy as far as the NCCN. So we've presented the results of the same day dosing trial twice, once in December, once in, I think March. We've approached a peer reviewed journal for a publication that we hope will be midsummer. And once that's done, then we will approach NCCN about inclusion of the guidelines for 2026. So, everything's moving according to plan. Ultimately we don't control whether we get in the NCCN for the guidelines or not, but we are executing the plan to get there. Thomas Flaten Excellent. I'll hop back in the queue. Thank you. Operator Naz Rahman, Maxim Group. Naz Rahman Hi, thanks for taking my questions and gras on progress. Just two questions on Wennon, I believe you first spoke about expanding into the hospital setting away from the community setting. Could you kind of provide some comments and details about how that's progressing thus far in 2025 and sort of where you start or wherever you would expect to see an inflection point there. Brendan O'Grady Yeah, hi, Naz. Thanks for the question. I think if you think about Rollon today, most of our business is in the community oncology Medicare Part B space. To be successful in the hospital space, we really need to grow our commercial payer side that will unlock a couple of things for us. It will unlock more of the commercial channel for us. And then it'll unlock hospitals as well. So the next step in the strategy is really to build our payer coverage, which we've done with Cigna, as I mentioned in my opening comments, and hope to expand in the second half of this year and then further expand in 2026. As we do that, we'll be able to get more of the commercial clinics based business as well as that will enable us to impact or penetrate hospitals to a greater degree. Naz Rahman Got it, thank you. And my last question is just on guidance. So based on you on the adjusted bit of guidance of 10 million to 19 million, why not adjust the band down or do you still think it's possible and what leverage could you, do you think we'll get you towards that 19 million? Why not adjust that band down from 10 to something else do the 12 results. Brendan O'Grady I think that there's still too many things going on that that wouldn't make sense for us to adjust it down. We'll see how 2nd quarter pans out and we'll talk about it again in August. But at this point, I think the guidance ranges we put out there for both EEA and net sales, I think we're tracking to within those guidance ranges, and we'll see how things go, but we'll update it again in August if necessary. Operator Ram Selvaraju, HC Wainwright. Ram Selvaraju Thanks very much for taking my questions just in furtherance of. Additional context regarding the Roaddon situation. Can you give us a sense of what additional promotional or marketing strategies you expect to implement over the course of the remainder of this year to TRY to accelerate growth and roll it on sales? Brendan O'Grady Sure, hi Ram. Thanks for the question. A couple of things. I mean, first of all, there's still more market share we can get in our primary space, which is the Medicare Part B clinics. There's still some large groups out there that that we hope to attract additional volume with and additional shares. So that's one. Second, I mentioned the payer piece. We've just begun to start starting to pull that business through on the commercial side. So that's 2. We hope to expand that coverage in the second half of the year, which would be the 3rd, and again that will enable us to get some penetrations in the hospital. So if you see that it's kind of building throughout the year, we expect Rodon to continue to grow in net sales and volume as we go through this year. Ram Selvaraju Can you talk about how you expect the overall genericization picture to evolve over the course of the remainder of 2025 with respect to Edison? Are you expecting a substantial additional number of generic purveyors of Edison? Between now and the end of 2025, if so, approximately how many and what impact do you expect that to have, even if only on a qualitative basis regarding the remaining in the sin revenue stream. Brendan O'Grady Yeah, another good question. Thanks, Ram. I think our plan assumed two more generics for Indiin this year, one in the first half of the year, one in the second half of the year. There was an approval back in February. We have not got any confirmation of launch yet, so I think we're still relatively tracking to plan. But you can think about, if there's 3 on the market, you split the market by 3, if there's 4 on the market, you split it by 4. So each time you lose volume and you lose price, so it will decline with the with the entrance of more generics. But I think, I'm optimistic right now that that we're we're tracking to our plan. I think we've got a pretty good a pretty good handle on it. We'll optimize Anderson as much as we can as we go through the year. Ram Selvaraju And then lastly, you had mentioned on this and a couple of previous calls the interest of the company in doing something on the strategic front to broaden potentially the commercial portfolio. Can you give us some additional context on that if there's been any sort of evolution in your thinking, particularly if this pertains to the broader market environment changes that you're seeing within that, and also the possibility of identifying opportunities that are directly synergistic with your existing commercial assets. Brendan O'Grady Yeah, I mean, we have numerous ongoing conversations, all very positive conversations going in the right direction, and I'm very optimistic that we will get something done in 2025 that will certainly add to our business and position us for that growth phase in 2026. I obviously can't be more specific than that, but I'm very encouraged by the conversation that we currently have going on. Ram Selvaraju They're just for clarification purposes, as of right now, your forecast or outlook for 2025 is not contingent upon any such business development activity being successfully concluded, is that correct? Brendan O'Grady That is correct. Our outlook for 2025 includes only our current portfolio. Operator Scott Henry, Alliance Global Partners. Scott Henry Thank you and good afternoon. I guess first with regard to Rovean, you do mention pricing pressure. Could you talk about the pricing, how it is, kind of year over year and sequentially and your expectations going forward? Brendan O'Grady Yeah, hi Scott. I mean, it is a quarter to quarter type of strategy, so you know. ASP does erode over time, and some quarters is a bigger impact than others. It's a very competitive marketplace as we play in this this new lastA biosimilar long acting GCSF space. And there could be new entrants that enter as we go through this year that could also have an impact. So we're, I think we're doing a very good job of maintaining and managing our ASP. I think the way that we think about the business and the way we execute and contract the business is smart, which I think is why our ASP has. Been slower to erode maybe than others, and we continue to build volume and gain new customers and that's part of of the step down from Q4 to Q1 was we brought in some new customers in Q4 that were going to pull through in Q1, so we wanted that inventory there and we pulled that through in Q1, so you'll start to see that grow as we go into Q2 and beyond. Scott Henry Okay, thank you for that caller. And then with regards to SG&A, I believe you said that the base SGA is around $18.5 million quarterly. I guess the question is, did I hear that correct? And as well, what would you expect for the legal wind down, particularly, given that you've had this divestment, should that start to be declined materially in the coming quarters or or how long should some of that that other litigation take? Ajay Patel Yeah, no, thanks for the question, Scott. You're right. So the base, adjusted op back for the first quarter was 18.5 million. Now in the first quarter we were burdened, we typically have kind of two components of litigation exposure legacy matters and shareholder matters, as Brendan kind of alluded to in his comments, right, the legacy matters for the most part have been mitigated now with the divestment of Assertio therapeutics. We are expecting kind of on an annualized front that to benefit us, in the neighborhood of $2 million to $3 million annually. And then from a shareholder litigation as we continue to resolve, settle, and exit those cases, the ongoing burden does decrease over time. Scott Henry Okay, thank you. Final question, just for clarity, what is, what assets exactly did you divest into the AITH entity? And was there any material event impact from those assets? Brendan O'Grady There is just a a single digit royalty on Edison that we divested. Scott Henry With -- Brendan O'Grady The therapeutic divestiger and ATIH as well as some cash. Scott Henry Okay, all right, so none of the other products went with it, none of the small. Brendan O'Grady Nope. Scott Henry Okay, and if I may, and it's, I guess it's, I don't want to ask you a legal question, but I think I'm going to, if you divest. Some of your legal responsibilities to this asset, what is the risk that they could still come after the parent company that that you can't in fact, completely divest that liability? Brendan O'Grady Well, I mean, if you think about it, the way that we got the liability was through M&A and so this is no different. We transferred this. Legal entity to a third party that is going to maintain and run this business and manage and manage it accordingly. So while there's always a risk, I think the risk is very low. Operator (Operator Instructions) Jim, Sidoti & Company. James Sidoti Hi, good afternoon. Thanks for taking the questions. In addition to all the, internal changes there, you, you're dealing with some external changes as well. Can you comment on, what impact do you think there could be from either the tariffs or the executive order regarding drug pricing or the proposed changes to Medicaid. Brendan O'Grady Yeah, I mean, so the tariffs is who knows, right? That's a daily up and down. We've got a significant, I mean, probably a thing we would be most exposed on with tariffs would be drug substance on roodon, but we've got a significant inventory here in the US, so we don't expect any short-term impact, and by the time there is an impact, hopefully that situation will be worked out. With regards to drug pricing, we do not sell any products outside of the US with the exception of Cambia that we sell in Canada, and Cambia is probably more expensive in Canada, the fact that it's not generic and it's generic here. So we'll see. There needs to be a lot more details on drug pricing. It's going to take a while for the details to come out as to how that's actually going to play out, but at least right now we don't see any real risk on either one of those two things. James Sidoti Okay, and I just want to be clear, post the divestiture, are you maintaining your revenue guidance of 108 million to 123 million? Brendan O'Grady We are. Operator Yeah, And at this time there are no further questions. Everyone that does conclude today's Osserio Holdings first quarter conference, we would like to thank you all for your participation. You may now disconnect.
Yahoo
12-05-2025
- Business
- Yahoo
BioStem Technologies Reports Preliminary First Quarter 2025 Operating and Financial Results
Preliminary net revenue increased 73% to $72.5 million for Q1 2025, compared to $41.9 million in Q1 2024 Achieved preliminary GAAP net income of $4.5 million, or $0.27 per share Reported preliminary Q1 2025 Adjusted EBITDA of $7.8 million Quarter-end cash balance of $26.7 million, up from $22.8 million as of December 31, 2024 Financial results conference call and webcast to be held on May 12, 2025 at 4:30 pm ET POMPANO BEACH, Fla., May 12, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM) (the 'Company' or 'BioStem'), a leading MedTech company focused on the development, manufacture, and commercialization of placental-derived biologics, today reported preliminary financial results for the first quarter ended March 31, 2025. The Company will host a webcast and conference call today at 4:30 pm ET. These results are unaudited, have been prepared in accordance with current accounting policies, and remain subject to SEC review related to the Company's pending Form 10 filing in connection with its planned uplisting to Nasdaq. Jason Matuszewski, CEO of BioStem, commented: 'I am pleased to report the strongest first quarter in BioStem's history, with Q1 2025 revenue increasing 73% compared to the first quarter of 2024. With the launch of Vendaje AC® in Q4 2024, we have seen rapid adoption of that product through our commercial partnership with Venture Medical. Furthermore, we are encouraged by the LCD implementation date being extended from April 2025 to January 2026, as the uncertainty throughout this quarter had created temporary headwinds that impacted our operations and sequential growth trajectory.' Mr. Matuszewski added: 'As we progress through Q2 and the rest of the year, we remain focused on continued growth and further strengthening our position in the chronic wound care market. Strategically, we are prioritizing the transition of more customers to Vendaje AC to drive brand consistency within the Vendaje family, while also reducing SG&A by phasing out licensing fees associated with AmnioWrap2. On the capital markets front, we remain in active review with the SEC regarding our Form 10 registration and uplisting process, and we look forward to completing this milestone and becoming listed on Nasdaq. We want to thank our shareholders for their continued support.' First Quarter 2025 and Recent Corporate Highlights: In Q1 2025, BioStem announced key milestones that further solidify its leadership in placental-derived products for wound care. The Company has received Institutional Review Board (IRB) approval to initiate a new clinical trial evaluating BioREtain® Amnion Chorion (BR-AC) for the treatment of venous leg ulcers (VLUs). This study is BioStem's third prospective clinical trial and reflects its ongoing commitment to building a robust body of clinical evidence that demonstrates superior patient outcomes and supports wider adoption of its advanced wound care solutions. BioStem also launched its BR-AM-DFU clinical trial to evaluate Vendaje®, the Company's proprietary amniotic membrane product, in the treatment of non-healing diabetic foot ulcers. This trial will evaluate Vendaje against the current standard of care, offering an opportunity to further validate the clinical efficacy of the BioREtain technology platform and accelerate commercial growth in the diabetic wound care segment. Additionally, BioStem has expanded its intellectual property portfolio with the U.S. Patent and Trademark Office. With a total of 55 patents that have been issued and 52 pending patents, the Company continues to reinforce its innovation leadership and lay the groundwork for the development of next-generation products in regenerative medicine and wound care. Summary Financial Information1: The following table represents preliminary net revenue, gross margin, operating expenses, and other expenses for the fourth quarter and year-to-date periods ended March 31, 2025, and March 31, 2024, respectively: Three months ended, March 31, 2025 March 31, 2024 $ Change % Change Net revenue $ 72,528,112 $ 41,904,213 $ 30,623,899 73 % Gross profit $ 71,674,674 $ 39,679,509 $ 31,995,165 81 % Gross profit % 99 % 95 % 4 % Operating expenses $ 66,425,350 $ 35,071,396 $ 31,353,953 89 % Operating income (loss) $ 5,249,325 $ 4,608,114 $ 641,211 14 % Other expense, net $ (766,229 ) $ (1,350,200 ) $ 583,971 -43 % Net income (loss) $ 4,483,096 $ 3,257,914 $ 1,225,182 38 % ________________________ 1 As will be discussed in more detail on the BioStem conference call, BioStem is currently going through an SEC review process in connection with its planned uplist to Nasdaq. The ongoing discussions with the SEC relate to the accounting treatment of the Bona Fide Service Fees (BFSF) paid to Venture, and the related impact to reported revenue, gross margin and operating expenses. All of the financial information provided herein, including in this Summary Financial Information, are unaudited, has been prepared consistent with the Company's current accounting policies and is subject to resolution of all SEC comments and completion of all closing and audit procedures which may cause actual results to differ materially from those presented in this press release. Financial Results for the Three Months Ended March 31, 2025: Net revenue for Q1 2025 was $72.5 million, a 73% increase compared to Q1 2024. The increase was driven by strong performance across the Company's wound care portfolio, led by VendajeAC, supported by expanded commercial coverage and sales force expansion. Gross profit was $71.7 million, or 99% of net revenue, compared to $39.7 million or 95% of net revenue in Q1 2024. The improvement reflects product mix benefits, scale efficiencies, and increased contributions from Vendaje AC, which does not incur licensing fees. Operating expenses totaled $66.4 million, up from $35.1 million in Q1 2024, primarily driven by increased sales and marketing costs associated with the Venture Medical distribution agreement. Adjusted EBITDA for the first quarter was $7.8 million, compared to $7.9 million in Q1 2024. The slight decline reflects higher gross profit being offset by increased operating expenses, including sales and marketing costs—primarily Bona Fide Service Fees tied to elevated sales volume—along with higher research and development expenses related to three active clinical trials, and increased general and administrative costs driven by expanded headcount as the company scales. GAAP net income was $4.5 million or $0.27 per share, compared to $3.3 million or $0.20 per share in Q1 2024. This marks BioStem's fifth consecutive quarter with positive GAAP net income. Quarter-end cash balance of $26.7 million, up from $22.8 million as of December 31, 2024. Conference Call & Webcast Information: Conference ID: 9695874 North America Toll-Free: (800) 715-9871 International Toll: +1 (646) 307-1963 Webcast Link: The live and archived webcast will be available on the BioStem Technologies website under the Investor Relations section, HERE. Join BioStem's Distribution List & Social Media: To follow the latest developments at BioStem, sign-up to the Company's email distribution list HERE, and follow us on X and LinkedIn. About BioStem Technologies, Inc. (OTC: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain ® processing method. BioREtain ® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies' quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks ('AATB'). These systems and procedures are established per current Good Tissue Practices ('cGTP') and current Good Manufacturing Processes ('cGMP'). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE ® , VENDAJE AC ® , and VENDAJE OPTIC ® . Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida. For more information visit and follow us on X and LinkedIn. Preliminary Results: BioStem's financial results for the first quarter 2024 and 2025 included in this press release are preliminary, unaudited and subject to finalization of BioStem's audited financial statements for the year ended December 31, 2024 and resolution of all SEC comments on the Form 10 registration statement BioStem filed with the SEC in connection with its planned uplist to Nasdaq. These financial results should not be viewed as a substitute for final reviewed results prepared in accordance with U.S. generally accepted accounting principles ('GAAP'). The preliminary financial results represent management estimates that constitute forward-looking statements subject to risks and uncertainties. As a result, the preliminary financial results and other information provided herein may materially differ from the actual results that will be reflected in the consolidated audited financial statements for the year ended December 31, 2024 and unaudited financial statements for the first quarter ended March 31, 2025 and 2024 when they are completed and publicly disclosed. BioStem undertakes no obligation to update or supplement the information provided herein until it reports its final audited financial results for the year ended December 31, 2024. Forward-Looking Statements: Certain statements in this press release may be considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to expectations or forecasts of future events. Forward-looking statements may be identified using words such as 'forecast,' 'intend,' 'seek,' 'target,' 'anticipate,' 'believe,' 'expect,' 'estimate', 'plan,' 'outlook,' and 'project' and other similar expressions that predict or indicate future events or trends or that are not statements of historical fact. Forward-looking statements in this release include, among other things, statements regarding: the preliminary financial results for the first quarter 2025; the anticipated timing of current and planned clinical trials; the expectation that such trials will demonstrate the clinical superiority of the Company's products; the Company's expectations regarding its ability to uplist to Nasdaq; the Company's ability to resolve the SEC's comments to the Company's Form 10 registration statement; the Company's strategic initiatives; second quarter and full year 2025 projections; continued financial growth; and the market penetration of the Company's core products. Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: the impact of any changes to the reimbursement levels for the Company's products; significant and continuing competition, which could adversely affect the Company's business, results of operations and financial condition; rapid technological change, which could cause the Company's products to become outdated or obsolete, harming the Company's ability to effectively compete; the Company's ability to convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; the Company's ability to obtain financing to expand its business; the Company has incurred significant losses since inception and may incur losses in the future; changes in applicable laws or regulations; the Company's ability to maintain production of its products in sufficient quantities to meet demand; and the effects of global and regional economic, political, social and health crises;. There may be additional risks about which the Company is presently unaware or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company undertakes no duty to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. BioStem Technologies, Inc.:Phone: 954-380-8342Website: info@ @BSEM_TechFacebook: BioStemTechnologies Investor Relations:Adam HoldsworthE-Mail: adam@ Phone: 917-497-9287BioStem Technologies, Inc. and Subsidiaries Consolidated Balance Sheets March 31, 2025 (Unaudited) December 31, 2024 (Unaudited) Current Assets Cash and cash equivalents $ 26,673,455 $ 22,832,706 Accounts receivable, net 109,657,309 104,980,085 Inventory 1,972,637 1,824,001 Short-term loan receivable 1,250,000 1,250,000 Prepaid expenses and other assets 2,479,457 2,874,317 Total current assets 142,032,858 133,761,109 Long-Term Assets Property and equipment, net 1,488,128 1,504,578 Construction-in-process 348,503 190,422 Right-of-use asset, net 247,104 271,214 Intangible assets, net 193,270 224,137 Goodwill 244,635 244,635 Deferred tax assets 4,759,016 4,179,632 Total assets $ 149,313,514 $ 140,375,727 Current Liabilities Accounts payable and accrued expenses $ 4,048,467 $ 5,289,787 License fees payable 443,850 2,359,575 Bona fide services fee payable 85,525,228 81,873,058 Income tax payable 4,285,551 2,908,730 Accrued interest 2,029,677 1,962,983 Operating lease liabilities 110,653 106,722 Notes payable, net of discount 3,894,122 3,957,744 Other current liabilities 1,155,591 711,361 Total current liabilities 101,493,139 99,169,960 Long-Term Liabilities Operating lease liabilities, less current portion 151,280 180,235 Notes payable, less current portion 150,000 150,000 Total long-term liabilities 301,280 330,235 Total liabilities 101,794,420 99,500,195 Commitments and contingencies (Note 8) Stockholders' Equity (Deficit) Series A-1 convertible preferred stock, $0.001 par value authorized, 300 shares; issued and outstanding, 300 shares as of December 31, 2024 and December 31, 2023. - - Series B-1 convertible preferred stock, $0.001 par value authorized, 500,000 shares; issued and outstanding 5 shares as of December 31, 2024 and December 31, 2023. - - Common stock, $0.001 par value authorized, 975,000,000 shares issued and outstanding 16,661,482 and 16,214,390 shares as of December 31, 2024 and December 31, 2023, respectively. 16,602 16,662 Additional paid-in capital 56,803,063 54,642,012 Treasury stock, 18,000 shares at cost (43,346 ) (43,346 ) Accumulated deficit (9,257,226 ) (13,739,796 ) Total stockholders' equity (deficit) 47,519,094 40,875,532 Total liabilities and stockholders' equity $ 149,313,514 $ 140,375,727 BioStem Technologies, Inc. and Subsidiaries Consolidated Statements of Operations Three-months ended, March 31, 2025 March 31, 2024 Revenue, net $ 72,528,112 $ 41,904,213 Cost of goods sold 853,438 2,224,704 Gross profit 71,674,674 39,679,509 Gross Margin % 98.8 % 94.7 % Operating Expenses Sales and marketing expenses 57,684,468 30,547,721 General and administrative expenses 6,994,004 4,399,262 Research and development expenses 1,690,154 70,748 Depreciation and amortization expense 56,723 53,665 Total operating expenses 66,425,350 35,071,396 Income (loss) from operations 5,249,325 4,608,114 Other income (expense): Interest expense, net 31,617 (163,942 ) Other expense (409 ) 1,571 Other income (expense), net 31,208 (165,513 ) Total Income (loss) from operations before income taxes 5,280,533 4,442,601 Income tax expense (797,437 ) (1,184,687 ) Net Income (loss) $ 4,483,096 $ 3,257,914 Basic net income (loss) per share attributable to common stockholders $ 0.27 $ 0.20 Diluted net income (loss) per share attributable to common stockholders $ 0.17 $ 0.15 Basic weighted average common shares outstanding 16,673,875 16,316,178 Diluted weighted average common shares outstanding 26,257,562 22,383,275 Non-GAAP Financial Measures Our management uses financial measures that are not in accordance with generally accepted accounting principles in the United States, or GAAP, in addition to financial measures in accordance with GAAP to evaluate our operating results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. Our management uses Adjusted EBITDA, which we calculate as net income less interest, taxes, depreciation and amortization and share-based compensation expense, to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA helps identify underlying trends in our business that could otherwise be masked by the effect of the items that we exclude. Accordingly, we believe that Adjusted EBITDA provides useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by our management in its financial and operational decision-making. The following is a reconciliation of GAAP net income (loss) to non-GAAP EBITDA and non-GAAP Adjusted EBITDA for each of the periods presented: Three months ended, March 31, 2025 March 31, 2024 $ Change % Change Net income $ 4,483,096 $ 3,257,914 $ 1,225,182 38 % Interest expense (31,617 ) 163,942 195,559 -119 % Depreciation and amortization 56,723 53,665 3,058 6 % Income Taxes 797,437 1,184,687 (387,250 ) -33 % EBITDA 5,305,639 4,660,208 645,431 14 % Share-based compensation 2,536,933 3,279,117 (742,184 ) -23 % Adjusted EBITDA $ 7,842,572 $ 7,939,325 $ (96,753 ) -1 % Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
