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Mark Cuban just posted this on Linkedin: "no one believed we could impact the drug industry. We did. Now we are adding ONE THOUSAND MORE MEDS, bringing our total to more than 2,200
please check out costplusdrugs.com to see if we can save you money and thank you to everyone who has supported us !"
It's a win-win for everyone that participates in their costplus program. Good for Progressive Care too.
https://www.linkedin.com/posts/mark-cuban-06a0755b_on-january-19th-2022-cost-plus-drugs-activity-7140757831183405056-AFe0?utm_source=share&utm_medium=member_desktop
They announced this webcast on Tuesday last week and didn’t release any other news after that. It surely sounds like some major updates will be announced today.
In this October's conference call, the company was asked the possibility of getting FDA approval right after Phase 2b results.
Q: Amylyx ($AMLX) received FDA approval for their combination therapy after a single phase two study (for ALS). So do you believe you'll be able to do the same for Prime C?
A: It's really entirely based on the readout of the phase 2B study. We're going to be in close connection with regulators and if the results are compelling we'll discuss this pathway forward with them (FDA), but ultimately it will be dependent on the readout.
Q: Can you predict how how early could Prime C be on the market?
A: Due to the dynamic regulatory environment and based on these decisions by the FDA for Amylyx and Biogen's therapies over the last 12 months, if we have outstanding data from the phase 2B study, it could be after we have data from this study we could move forward and have Regulators approve Prime C.
Watch the video starting at 18'43"
NeuroSense to Report Phase 2b ALS Topline Primary Safety and Tolerability & Secondary Clinical Efficacy Endpoints on December 5, 2023
PR Newswire
Data to be announced in a premarket press release followed by a conference call at 8:30 am ET
"In early December, we look forward to reporting topline clinical results from our Phase 2b ALS study. We believe that positive results would offer substantial hope to people living with ALS and would put PrimeC well on its path to a pivotal Phase 3 for regulatory approval," stated NeuroSense's CEO, Alon Ben-Noon. In November 2023, NeuroSense completed the 6-month double-blind segment of PARADIGM, a placebo-controlled, multi-center Phase 2b clinical trial using a unique upgraded formulation of PrimeC, 96% of participants who completed the double-blind segment of the trial chose to continue in the study and be treated with PrimeC through a 12-month open-label extension. All participants who have completed the 18-month trial to date requested to continue treatment with PrimeC.
https://neurosense.investorroom.com/2023-11-28-NeuroSense-Announces-Third-Quarter-2023-Financial-Results-and-Provides-Business-Update
This part is huge: "All participants who have completed the 18-month trial to date requested to continue treatment with PrimeC." They could convince FDA to go directly for approval.
NeuroSense Announces Third Quarter 2023 Financial Results and Provides Business Update
https://neurosense.investorroom.com/2023-11-28-NeuroSense-Announces-Third-Quarter-2023-Financial-Results-and-Provides-Business-Update
Topline clinical secondary efficacy results and primary safety endpoints from Phase 2b ALS trial (PARADIGM) expected in early December 2023
Patients who completed the 18-month PARADIGM trial, including the 6-month double-blind study plus the 12-month open label extension, have requested to continue treatment with PrimeC
First patient in Phase 2 Alzheimer's disease study expected to be enrolled December 2023
Cash runway beyond topline clinical study readouts, into Q2 2024
CAMBRIDGE, Mass., Nov. 28, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today reported its financial results for the nine months ended September 30, 2023 and provided a business update.
"In early December, we look forward to reporting topline clinical results from our Phase 2b ALS study. Additional data, including the biomarker results from our collaboration with Biogen and primary biomarker endpoints are expected within the first half of 2024. We believe that positive results would offer substantial hope to people living with ALS and would put PrimeC well on its path to a pivotal Phase 3 for regulatory approval," stated NeuroSense's CEO, Alon Ben-Noon. "With a cash runway extending towards the end of Q2 2024, we believe we are well positioned, upon a positive read out from the study, to advance our discussions with potential strategic partners."
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Business Update
Phase 2b Amyotrophic Lateral Sclerosis (ALS) PARADIGM Trial Completed Double-Blind Segment
In November 2023, NeuroSense completed the 6-month double-blind segment of PARADIGM, a placebo-controlled, multi-center Phase 2b clinical trial using a unique upgraded formulation of PrimeC, which is designed to maximize the synergistic effect between the compounds in its combination drug. 96% of participants who completed the double-blind segment of the trial chose to continue in the study and be treated with PrimeC through a 12-month open-label extension. All participants who have completed the 18-month trial to date requested to continue treatment with PrimeC. NeuroSense supplies the drug to the participants through an Investigator Initiated Trial (IIT) and will continue to provide PrimeC to any participant who completes the trial and requests to stay on the Company's investigational ALS medication.
PARADIGM's secondary clinical endpoints which are expected to be reported in December 2023 include: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), Slow Vital Capacity (SVC), and overall survival to demonstrate an attenuation in disease progression. NeuroSense also expects to report primary safety and tolerability results from the double-blind segment of the trial in December 2023.
U.S. FDA Confirmed CMC Strategy for PrimeC Ahead of Pivotal Phase 3 for Commercial Readiness
NeuroSense recently concluded a successful Type D meeting with the U.S. Food and Drug Administration (FDA) for PrimeC in the treatment of ALS. FDA Type D meetings are focused on a narrow set of issues at key decision points to provide timely feedback critical to move a drug development program forward. The purpose of NeuroSense's meeting with the FDA was to discuss PrimeC's chemistry, manufacturing, and controls (CMC) development plans in advance of an expected Phase 3 pivotal study and potential subsequent marketing approval. The FDA agreed with NeuroSense's proposed CMC development plan, setting the stage for a smooth progression with the production PrimeC for a Phase 3 and subsequent commercialization.
Non-Sponsored Study Demonstrated PrimeC's Outstanding Effect on ALS Survival
At the Ichida Stem Cell Lab at University of Southern California, PrimeC was shown to significantly increase the survival rate of induced motor neurons in an in vitro study utilizing induced pluripotent stem cells (iPSCs) generated from people living with ALS. In another independent study carried out by Dr. Ichida in an innovative iPSC model, PrimeC performed among the best in improving motor neuron survival when compared to two FDA approved ALS drugs as well as several other ALS drugs in development. Together, these results reinforce previous findings on PrimeC's efficacy and mechanism of action.
Phase 2 Alzheimer's Disease (AD) Trial Under Preparation, First Patient Enrolled Expected in Q4 2023
NeuroSense published data from a biomarker study which revealed elevated levels of novel biomarker TDP-43 in AD as compared to healthy controls in the first quarter of 2023. These results demonstrate the therapeutic potential of NeuroSense's combination drug platform for AD. Currently, NeuroSense is preparing a Phase 2 double-blind proof-of-concept clinical study in AD. Regulatory submissions and site readiness have been ongoing during Q3 2023 and the first patient enrolled is expected in December 2023.
Patents Granted in Europe, Japan, and Israel for PrimeC Valid Through 2038
Patents have been granted in Europe, Japan, and Israel for a key patent relating to "Compositions comprising an anti-inflammatory drug and a dicer activator for use in treatment of neuronal diseases." These patents address NeuroSense's unique fixed-dose combination of ciprofloxacin and celecoxib, two FDA approved drugs that are the active ingredients in PrimeC.
SME Status Received from European Medicines Agency & NeuroSense Opens EU Office
The European Medicines Agency's (EMA) Small and Medium-Sized Enterprise (SME) status offers NeuroSense regulatory guidance and engagement in dialogue with the EMA. The Company plans to enroll patients at multiple sites across Europe in its planned Phase 3 pivotal ALS study of PrimeC. As Europe is a key market, in addition to the U.S., NeuroSense opened an office in Ulm, Germany to lead its regulatory dialogue with the EMA and clinical operations during the planned Phase 3 study.
Financial Summary
Research and development expenses for the nine months ended September 30, 2023 increased to $5.6 million compared to $4.9 million for the nine months ended September 30, 2022. This increase was primarily attributable to an increase in expenses to subcontractors and consultants as well as salaries and social benefits as a result of the commencement of a Phase 2b ALS clinical study in the second quarter of 2022, which were partially offset by a decrease in share-based compensation expenses. NeuroSense expects research and development expenses will remain steady through 2023.
General and administrative expenses for the nine months ended September 30, 2023 decreased to $4.4 million compared to $5.3 million for the nine months ended September 30, 2022. This decrease was primarily attributable to a decrease in directors and officers insurance expenses and share-based compensation, which were partially offset primarily by an increase in payroll and related expenses. NeuroSense expects that general and administrative expenses will remain steady through 2023.
Operating expenses for the nine months ended September 30, 2023 were $10.02 million compared to $10.17 million for the nine months ended September 30, 2022 due to the reasons described above.
As of September 30, 2023, NeuroSense had cash of approximately $4.8 million.
In October 2023, the Company terminated its previously established "at-the-market" ("ATM") equity offering program.
A summary of NeuroSense's unaudited consolidated financial results is included in the tables below.
At 13 minutes in the webinar, the CEO said: the results obtained from our phase 2b study will dictate our regulatory strategy as there is a chance we could file directly based on these results"! WOW! if the results can be this good, $NRSN will run past $10 overnight! This is huge. Great confidence from the CEO.
NeuroSense Webinar with Emerging Growth Conference - October 4, 2023
As the CEO and Co-Founder of NeuroSense Therapeutics, I lead this unique Biotech startup that is dedicated to finding a cure for ALS and other neurodegenerative diseases.
I am privileged to work with a team of experts and pioneers in ALS research, who have developed an innovative and revolutionary drug candidate that has shown promising results in preclinical and clinical trials. Our mission is to accelerate the delivery of this therapy to the people who suffer from this devastating condition, and to explore its potential for other CNS disorders. I am passionate about making a positive impact in the world through science and innovation.
Alon Ben-Noon
"We’re trying to do the right thing," Cost Plus Drugs CEO says.
https://finance.yahoo.com/video/prescription-access-trying-thing-cost-155855252.html
Cost Plus Drugs CEO Alex Oshmyansky joins Yahoo Finance Live to discuss partnering with independent pharmacies, expanding membership offerings, competing with big pharmacy chains, and the outlook for Cost Plus Drugs.
Video Transcript
[AUDIO LOGO]
- Jeff Bezos isn't the only billionaire breaking into the pharmacy business. Mark Cuban is challenging pharmacy benefits managers with his Dallas-based company Cost Plus Drugs. His company is now looking to increase access by partnering with independent pharmacies to expand its membership offerings and compete with the big pharmacy chains as they shut down in rural and low-volume areas. Here to discuss is Cost Plus Drugs CEO Alex Oshmyansky, joined by Yahoo Finance's Anjalee Khemlani. A big thank you to you both.
So obviously, you're not new to this. The company is not new to this, but it's continuing to expand here. So how do you plan on differentiating yourself, especially as you get some of these other tech companies now also coming into the health space?
ALEX OSHMYANSKY: Yeah, Mark is very fond of saying our product isn't pharmaceuticals. Our product is trust. So yeah, I think we differentiate ourselves by taking transparency to its logical end, trying to build that foundation of trust with our patients and the providers that partner with us as well, that we're trying to do the right thing. We're trying to cut out the bad-acting middlemen in the supply chain and get patients access to their medication and make business more sustainable for the pharmacists and other clinicians that partner in our ecosystem.
- Alex, great to see you. Anjalee here. Talk to me about this push into the rural areas, and independent pharmacies in particular, because they have been struggling for some time and often get ignored compared to those retail chains. We saw that especially during the pandemic with vaccine distribution. So how does this help, and what is the goal here?
ALEX OSHMYANSKY: Yeah, so my background-- I'm a clinician myself. I'm a physician, a diagnostic radiologist. So yeah, I know on a very personal level how important it is to have a clinician in your area that knows you and can provide the care you need. And it's always been in our plan to try to support the local pharmacists who are really in their community, who know their patients, who are really doing the good work there but are being taken advantage of by bad actors that control the payments.
I think it's somewhat crazy, just from an anti-competitive perspective, that CVS Caremark oftentimes gets to set the rates that independent pharmacists are paid. That's kind of crazy if you think about it. And it's in their interest to try to drive these small pharmacies completely out of business. So our perspective is by cutting out the bad-acting middlemen, we can decrease the price to patients while making independent pharmacy, which is so important in these small communities, more sustainable as a business in the long term.
- Absolutely, because you help with the volume there. Talk to me about the competition though with other PBMs. Because just today, Cigna announced through Express Scripts that they too are focusing on independent pharmacies and are looking to increase the reimbursement to these pharmacies. How does that compare, or does it compete in any way with what you're doing?
ALEX OSHMYANSKY: Yeah, funny timing, that. But no, I think that these companies have taken advantage of small independent pharmacies for so long, it's hard to envision anything transformative in that regard where they will actually start supporting these communities. So no, I think-- just look at the history. Has it gone well in the past? It's hard to envision it turning around at this point.
But yeah, from our perspective, our goal is to try to improve patient access, patient health care, the ability of clinicians to do their work. So if part of what we're doing is just to drive change in the industry as a whole, that's a win. If it incentivizes others to act in positive ways, we've done our job.
- And we know that the Biden administration has been looking at the cost of prescription drugs and really trying to crack down on some of these excess costs and that you recently launched the Team Cuban Card in Austin. Talk about the competitive edge that really gets passed on to customers versus some of the existing big players in the space.
ALEX OSHMYANSKY: Yeah, absolutely, and it's all about transparency. Oh, I see on the screen here imatinib. That's our extreme edge case example of bad price dynamics in the marketplace. So you see the retail price there is $2,500. For that dose of imatinib, what we see is the actual adjudicated price.
So the price if you have a high-deductible plan that you'll be asked to pay at the counter before you can get that medication is $800. In the meanwhile, our price is $12. And we are, if anything, paying more for that drug from the manufacturer then large chains that are able to negotiate prices with volume as compared to us.
So where is that delta of, essentially, $800 going? It's not going to the pharmacy. It's not going to the manufacturer. So it's just going to all these intermediaries in the supply chain. And the startling thing is we launched imatinib at this price over a year ago, and the adjudicated price at the counter hasn't changed.
I think these big entities are just addicted to these absurd profit margins from these ultra-high-cost generic products and are unwilling to bring them down. So I think our competitive edge is we're small. We're nimble. We're able to move forward with these products at the price that they should cost, and we're not addicted to those margins that have been there for sometimes decades.
- Does that play a role, Alex, in what Mark Cuban tweeted about when he announced this, that the big pharmacy chains don't like you? So is that part of it where they are also taking a part of this, especially as we know many of them belong to larger entities now or are very diversified in what their business lines are? Does that play a role in all this where the money is going? And how do you differentiate that way?
ALEX OSHMYANSKY: Yeah, absolutely. So all of these entities, the big pharmacy chains are vertically integrated up and down the supply chain. CVS Caremark is in-- it's in its name. It's vertically integrated as a [AUDIO OUT] as a pharmacy chain, as a PBM. It has its relationship through Red Oak, its sourcing program with Cardinal.
And it has underneath-- I hope I don't get the name of this right-- Zinc, its rebate aggregator which is a subsidiary corporation based in Switzerland that takes a cut of pharmaceutical price dollars, so-called rebate dollars, where it can never be audited before those dollars are sent back to the parent corporation in the US. It's just this mess of entities and subsidiaries. Who knows how many? We heard one starting in the Caribbean recently, specifically around generic drugs. I'm not sure if that moved forward.
But there are all these complicated price dynamics manipulations that the big actors in this space go through to get additional margin on pharmaceutical products at the cost of largely two groups. Individual patients and the most vulnerable and indigent patients or indigent people in society are being taken advantage of by these sophisticated price manipulations as well as large employers. Going back to that imatinib example, for the most part, that $800 is being billed back to employers as basically a hidden tax on our entire economy. It's basically rent-seeking behavior. And those resources could be better used elsewhere.
So our Team Cuban Card, it's a benefits card, not just a discount card. So by default, patients get our transparent cash price, the same one that they would get through our website at their local pharmacy. But we can also bill that back to their employer as well, which multiple independent studies at this point-- academic groups from Harvard, Vanderbilt, multiple independent consultancies-- have all found the same numbers, that our pricing model saves 50% to 60% on drug spend as compared to traditional PBM pricing models. So we're hopeful that we'll not just improve the lives of individual patients but save the economy significant amounts of money as a whole.
- That transparency is key, especially when you think of how much medical debt people end up getting into just trying to get some of the basic care that they need. We do appreciate you joining us this morning, Alex Oshmyansky, Cost Plus Drugs CEO, and Yahoo Finance's own Anjalee Khemlani. A big thank you to you both.
"Mark Cuban Cost Plus Drug Company might be a major game changer in the independent pharmacy industry."
https://info.rxsafe.com/blog/quick-recap-the-business-of-pharmacy-transpharmation
This new drug manufacturer/distributor is working towards drug price transparency and affordability. In a recent webinar hosted by RxSafe and the Pharmacy Podcast Network, the panel discusses the new business model expected to disrupt the independent pharmacy industry with the goal of improving drug affordability.
How are they reaching this goal?
The new company promises to reveal the cost of each drug, and only add a 15% markup to remain profitable. “We will disclose publicly what our input costs are, or what our machinery costs are, what our distribution costs are, what our salaries are, and then put a flat 15% margin on all of the drugs we produce,” says Dr. Alex Oshmyansky, MD, PhD, CEO and Founder at Mark Cuban Cost Plus Drug.
Keeping Prices Low
The mission of Cost Plus Drug is to ensure that all patients are able to afford their medications. Dr. Oshmyansky is passionate about improving affordability to get more medications out to patients who need them. “Our goal is to introduce transparency and help patients, while saving independent pharmacies money along the way,” says Dr. Oshmyansky.
The current drug supply chain model involves several layers of payors and middlemen, which have consistently changed drug prices and even implemented gag clauses, preventing independent pharmacy owners from providing affordable medications to patients.
“Actual generic manufacturers are working on razor thin margins, barely profitable if at all, but the PBMs and wholesalers are all Fortune 20 companies, and that's even before they all merged together,” says Dr. Oshmyansky.
“Clearly there's something wrong with the system when patients can't afford their medicines and pharmaceutical companies can't break even,” says Dr. Oshmyansky.
By removing the middlemen and selling medications directly to pharmacies, Mark Cuban Cost Plus Drug promises to ensure profitability and viability - for all parties.
The Impact on Independent Pharmacy
Today, Cost Plus Drug only offers Albendazole, a medicine designed to treat parasitic infections, but the company is planning on adding more medications to its drug base.
“We're planning to make low-cost versions of high-cost drugs, and hope to drive business to independent pharmacies from there,” says Dr. Oshmyansky.
Independent pharmacies will have the opportunity to purchase medications directly from the company, removing the middlemen. "Working directly with drug manufacturers will help decrease the price for patients and for independent pharmacies struggling to stay profitable," Dr. Oshmyansky says.
"Why independent pharmacies, with the help of the likes of Mark Cuban, are on the rise"
https://finance.yahoo.com/news/why-indie-pharmacies-with-the-help-of-the-likes-of-mark-cuban-are-on-the-rise-193953230.html
Independent pharmacies have lost a lot of market share over time. But that trend has recently reversed slightly, making them attractive prospects for large pharmacy benefit managers like Cigna's (CI) Express Scripts, as well as startup discount platforms like Mark Cuban's Cost Plus Drugs.
The number of independents has gradually grown by 8% over the past 10 years, even though for decades they lost market share to big retail outfits. Between 2022 and 2023, so far, 99 new independent pharmacies have opened, which translates to 0.4% growth, according to the Pharmaceutical Care Management Association.
That gradual change in landscape is attracting the attention of both Express Scripts and Cost Plus. In addition, indie pharmacies can help fill the coverage hole left by big retail chains.
Cuban's Cost Plus, a discount platform that partners with PBMs, is capitalizing on growth in the niche market with new benefit cards that will be accepted by more than three dozen independent pharmacies in Indiana, Texas and New Jersey, with a growing list daily, it says.
In a tweet announcing the move, Cuban said the new benefit card will not be available for big retail pharmacies because "they don't like us. We will be working with indie pharmacies, groceries and others."
Unlike other discount cards, the benefit card is a membership tied to individual patients. And unlike discount cards, which charge pharmacies a fee for filling the prescription using their discount, Cost Plus will pay the pharmacies $8 — equivalent to the charge of labor of shipping if a patient orders from its website, according to the company.
CEO Alex Oshmyansky said the goal is to cut out the middlemen and their fees by directly negotiating with manufacturers and passing on the savings. By doing so, "We can decrease the cost to patients while making independent pharmacies....more sustainable as a business in the long term," he told Yahoo Finance in a recent interview.
"It's always been in our plan to try and support the local pharmacists who are really in their community, who know their patients," Oshmyansky said. He added that big pharmacy managers, which set the drug prices, are often owned by the drug store chains like CVS. Thus, they have squeezed profits for independent pharmacies.
"I think these entities are just addicted to these absurd profit margins, from these ultra-high-cost generic products, and are unwilling to bring them down," Oshmyansky said.
Cost Plus is largely playing in the generics market, where other discounters like Walmart (WMT) and GoodRx (GDRX) have been for some time—and where there is significant competition for lower prices. Online pharmacies or mail-order platforms are also increasingly competitive for generics, including with Amazon (AMZN) now in the mix.
All of this has added to the competition that independent pharmacies have faced in recent years.
Meanwhile, Cigna's PBM, Express Scripts, announced a strategy that would increase reimbursements to independent pharmacies that fill prescriptions for its members, plus a longer-term strategy to increase the importance of these pharmacies in the communities they serve.
One for Express Scripts, according to president Adam Kautzner, is to ensure that underserved populations in both rural and urban areas finally get the attention they've been missing.
Lack of access
Underserved populations vary from rural areas to pockets that lack access in urban areas.
The access gap has been amplified in recent years: Large retail chains like CVS, Walgreens (WBA) and Rite Aid (RAD) have announced that they have, or will be, closing locations. This year, CVS said it would shutter 900 outlets, but didn't specify where. (Rite Aid said it would open mini locations to serve rural areas.)
A University of Southern California study shows that "as of 2020, pharmacies in Black and Latino neighborhoods were more likely to close and less likely to offer immunizations, 24-hour, and drive-through services than pharmacies in other neighborhoods," according to the study's authors.
The Cost Plus focus on these vulnerable populations can help independent pharmacies in these markets. The company recently announced a partnership with Zócalo Health, a telehealth platform that provides care for cash for underinsured and uninsured individuals in the LatinX market community, according to CEO Erik Cardenas. The National Hispanic Medical Association has told Congress that Latinos are more likely to be uninsured.
It's why Zócalo teamed up with Cost Plus. The care providers at Zócalo can help ensure and track the fulfillment of prescription needs of patients, and answer questions about medications as needed.
And the benefit goes both ways. The more independent pharmacies do business, the more drug manufacturers and insurers will too. Which is also why the additional screening and testing services, which could create more prescription volume, is part of the strategy.
"By continuing to have accessibility to independent pharmacies, to keep them strong and to be able to continue to grow their own businesses, patients will be able to and get new prescriptions, refill their prescriptions, and stay adherent (to current prescriptions)," Express Scripts' Kautzner said.
More than drugs
"I'm a pharmacist from rural America. So this area is also top of mind to me, of the role independent pharmacists play," Kautzner said.
That's why he's spearheading the effort that will provide greater reimbursements for prescriptions for rural pharmacies that are within a 10-mile radius of an Express Scripts member.
Express Scripts will also help boost the services such as common medical screenings and vaccinations.
The company, meanwhile, is also convening a new advisory committee focused on independent pharmacies. That committee will also be instrumental in coordinating with state and federal government bodies to ensure these independent pharmacists are able to succeed.
Kautzner said that in rural areas, which serve about 20% of the U.S. population, pharmacists sometimes are the only medical professional a person has access to as physicians are in short supply. "So this is a way for them to expand the level of services that they can provide."
Kautzner said Express Scripts decided to launch the strategy after studying the independent pharmacy space last year and coming to the conclusion that there are more pharmacies opening up in some areas. He added: "That's definitely encouraging, post-pandemic, that we are starting to see some of them continue to thrive and expand."
Higher profit margin is a huge win for Progressive Care using Mark Cuban Cost Plus. This is a big deal to improve the company’s bottom line.
No PBM fees with Mark Cuban Cost Plus plan. This is a huge win for Progressive. Their profit margin will be much higher than traditional plans using those big chain PBMs.
On the company's site, Cost Plus calls itself "unPBM" because there are "no rebates or off-shore entities to be found here."
Traditional PBMs act like middlemen: They work between payers and pharmaceutical companies to negotiate drug prices. Their opaque business practices have raised concerns for years, and in June, the Federal Trade Commission opened an investigation into the six largest PBMs that nearly cover the whole PBM market.
PrimeC boosts survival of motor neurons derived from ALS patients
Potential oral therapy in Phase 2b clinical trial with results likely this year
https://alsnewstoday.com/news/primec-boosts-survival-als-patient-derived-motor-neurons/#:~:text=PrimeC%20combines%20the%20antibiotic%20ciprofloxacin,NEALS)%20annual%20meeting%20in%20Florida.
PrimeC, NeuroSense Therapeutics‘ investigational, fixed-dose combination therapy for amyotrophic lateral sclerosis (ALS), significantly boosted the survival of patient-derived motor neurons to levels similar to healthy controls in a lab study.
The independent study was led by Justin Ichida, PhD, a professor of stem cell biology and regenerative medicine at the University of Southern California (USC).
“Dr. Ichida has been described as being beyond the cutting edge in his field and we are honored that he and his lab chose to evaluate PrimeC in this non-sponsored study,” Alon Ben Noon, founder and CEO of NeuroSense, said in a company press release.
PrimeC combines the antibiotic ciprofloxacin with anti-inflammatory celecoxib
Findings were presented by Shiran Zimri, PhD, NeuroSense’s vice-president of research and development, at the recent Northeast Amyotrophic Lateral Sclerosis (NEALS) annual meeting in Florida.
“These results further bolster our confidence that PrimeC may offer a much-needed therapy for this debilitating disease,” Noon said.
PrimeC is an oral, fixed-dose combination of two approved compounds with well-established safety profiles: the antibiotic ciprofloxacin and the anti-inflammatory celecoxib.
Together, the medications are expected to prevent ALS progression by targeting inflammation and other mechanisms that damage motor neurons, the nerve cells in the brain and spinal cord that coordinate movement by sending commands to muscle cells.
Ichida and his team at USC’s Eli and Edythe Broad CIRM Center for Regenerative Medicine and Stem Cell Research examined the efficacy of PrimeC in patient-derived motor neurons.
These cells were generated from blood cells using a kind of cellular programming. First, the scientists collected blood cells from ALS patients and healthy people. Then, through a series of biochemical manipulations, the blood cells were reprogrammed into induced pluripotent stem cells, or iPSCs, which are lab-made stem cells able to grow into other types of cells.
Because the iPSCs retain the genetic code of the person that the blood cells were collected from, they enable the creation of nerve cells that recapitulate the same features of diseased motor neurons. iPCS also provide an almost unlimited source of patient-derived motor neurons, which can be used for large screenings of potential therapies.
“At our lab, we screen thousands of compounds in search of one that may be effective in ALS, and we were very impressed by the data resulting from our iPCS in vitro study of PrimeC,” Ichida said. “We chose to evaluate PrimeC based on the growing body of clinical, pre-clinical, and biomarker data on its efficacy in ALS.”
PrimeC protected motor neurons more effectively than its components alone
In a previous study, Ichida found PrimeC to be among the best at improving motor neuron survival in a list that included multiple approved and experimental ALS therapies, NeuroSense reported, adding that PrimeC outperformed Relyvrio (sodium phenylbutyrate and taurursodiol) and Radicava (edaravone) in that study’s model.
In the current study, researchers compared survival rates of ALS motor neurons with PrimeC versus each of its components. They also tested each of those treatments against motor neurons derived from healthy individuals.
Data showed that, while both ciprofloxacin and celecoxib led to significantly better survival rates than no treatment, the combination therapy was better than either drug alone at improving cell survival.
Notably, ALS motor neurons treated with PrimeC had survival rates similar to those seen in healthy motor neurons, NeuroSense reported.
“These findings present a new opportunity to potentially screen super responder patients using iPSCs, a non-invasive method which only requires a blood draw from the patient. Using this screening model may result in higher efficacy in people living with ALS who are most likely to benefit from PrimeC,” Zimri said.
In a Phase 2a clinical trial (NCT04165850) that concluded in 2021, an early formulation of PrimeC showed a potential to safely slow overall disease progression and lung function decline compared with an historical group of patients.
A new, extended-release formulation of PrimeC is being investigated in a Phase 2b clinical trial, called PARADIGM (NCT05357950). There, 69 adults were randomly assigned to the experimental medicine or a placebo, given twice daily for six months alongside standard ALS medications. Top-line trial findings are expected in the coming months.
The "Digitalizing Healthcare" link on NextPlat's homepage is now directly linked to Progressive Care's homepage. It's the first link in the center on that homepage. The merger of the two is coming.
https://www.nextplat.com/
Great things are coming. There’s no doubt about this with $35M cash on hand. Charles is not playing a kid game here.
Progressive Care is on the right track expanding business continuously with tons of cash on hand. Between RXMD and NXPL, they have $35M cash. It’s easy to see what their plans will be. More investment internally and potentially more M&A. Selling a few shares down here will not scare anyone. The future is bright.
NeuroSense’s CMC earn FDA OK ahead of PrimeC Phase 3 trial Results from Phase 2b PARADIGM trial expected next month
Patricia Inácio, PhD avatar
by Patricia Inácio, PhD | November 16, 2023
https://alsnewstoday.com/news/fda-oks-neurosenses-cmc-primec-ahead-phase-3-trial/
The U.S. Food and Drug Administration (FDA) has signed off on the chemistry, manufacturing, and controls (CMC) clinical development plan for NeuroSense Therapeutics‘ lead candidate for amyotrophic lateral sclerosis (ALS) ahead of a planned Phase 3 study.
The Phase 3 trial of PrimeC is due to start in 2024 pending positive results from the company’s ongoing PARADIGM Phase 2b clinical trial (NCT05357950), whose results are expected in December. CMC refers to the manufacturing practices and product specifications that must be followed and met to ensure product safety and consistency between batches.
“This confirmation from the FDA of our CMC strategy for a future pivotal Phase 3 clinical trial and commercial launch of PrimeC in the treatment of ALS marks a critical milestone in our drug development program,” Alon Ben-Noon, CEO of NeuroSense, said in a company press release. “It sets the stage for a smooth transition, particularly as we anticipate clinical efficacy top-line results (secondary endpoints) from our Phase 2b trial very soon.”
PrimeC is an oral, fixed-dose combination of ciprofloxacin, an antibiotic, and celecoxib, an anti-inflammatory. Both are approved in the U.S. for other indications. The compound’s combined action would block key mechanisms in ALS to slow disease progression.
RECOMMENDED READING
An illustration for
October 2, 2023 News by Andrea Lobo, PhD
PrimeC, potential ALS therapy, earns patents in Europe, Japan, Israel
What is PARADIGM trial assessing?
An initial formulation of PrimeC was deemed safe and well tolerated, in a Phase 2a clinical trial (NCT04165850) with 15 ALS patients. After treatment, patients saw a slower decline in their functional and respiratory abilities over a historical group of untreated patients. Key ALS blood biomarkers, particularly TDP-43, also were reduced.
PARADIGM is assessing the safety and effectiveness of a longer-acting formulation of PrimeC, which would release the medications over time, requiring less frequent dosing.
A total of 69 ALS patients from Canada, Italy, and Israel were randomly assigned to a placebo or PrimeC for six months, while continuing with their standard ALS treatments. PrimeC was given at a total daily dose of 1,496 mg, taken as two tablets twice daily.
The trial will also measure PrimeC’s impact on key ALS blood biomarkers, TDP-43 and prostaglandin J2. Changes in functional disability, assessed by the ALS Functional Rating Scale-Revised (ALSFRS-R), as well as lung health, quality of life, and survival will also be assessed.
After completing six months of treatment in the trial’s randomized part, most patients (96%) joined an open label extension, where they are receiving PrimeC for a year.
The company plans to announce safety results and data from the trial’s secondary measures in December. Biomarker analyses, including those conducted in collaboration with Roche, are due in the first half of 2024.
PrimeC has received orphan drug status in the U.S. and the European Union. The designation is meant to accelerate the development and regulatory review of rare disease therapies.
NeuroSense Therapeutics to Present at Upcoming U.S. and European ALS Conferences NeuroSense Therapeutics
09 Nov, 2023, 09:00 ET
https://www.prnewswire.com/news-releases/neurosense-therapeutics-to-present-at-upcoming-us-and-european-als-conferences-301983397.html
- Last patient completed the double-blind segment of PARADIGM, a Phase 2b ALS Trial
- Clinical efficacy top-line results from PARADIGM expected in December 2023
CAMBRIDGE, Mass., Nov. 9, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced scientific presentations at three upcoming conferences.
Neuroscience 2023
Mr. Nitai Kerem, NeuroSense's Scientific Project Manager, will present a poster on NeuroSense's latest biomarker data at Neuroscience 2023, the Society of Neuroscience's annual conference. This is the largest U.S. Neuroscience conference, bringing together scientists and physicians devoted to understanding the brain and the nervous system. The conference will be held in Washington D.C. on November 11th-15th, 2023.
ALS ONE's 6th Annual ALS Research Symposium
Dr. Shiran Zimri, VP of R&D at NeuroSense, will present the Company's latest clinical updates and findings in her talk titled "Shifting the Paradigm - A Biomarker Driven Approach for Studying Amyotrophic Lateral Sclerosis (ALS) Therapy Activity" at ALS ONE's 6th Annual ALS Research Symposium, to be held virtually on November 16th-17th, and 20th 2023. In addition to NeuroSense being a sponsor of this year's conference, this marks the fourth year NeuroSense will present at ALS ONE's symposium.
With a focus on the Company's Phase 2b PARADIGM PrimeC study, Dr. Zimri will present key elements of PrimeC's development program. The last patient has completed the double-blind segment of PARADIGM, with clinical efficacy results (secondary endpoints) expected in December 2023.
The 34th International Symposium on ALS/MND
Dr. Shiran Zimri and Dr. Ferenc Tracik, NeuroSense's Chief Medical Officer, will present a poster at the 34th International Symposium on ALS/MND, which brings together leading ALS and motor neuron disease (MND) experts, European patient advocacy groups, and ALS foundations, on December 6th-9th, 2023 in Basel, Switzerland.
"We believe NeuroSense's highly innovative approach of using biomarkers as a primary efficacy endpoint in our Phase 2b PARADIGM study will further elucidate the biological activity of PrimeC and help us to better understand the effect on people living with ALS," said Dr. Zimri. "We are excited to soon begin sharing the initial results of the double-blind segment of our Phase 2b trial to determine our drug's impact on efficacy."
About PARADIGM
NeuroSense's Phase 2b PARADIGM trial evaluating PrimeC's efficacy, as well as safety and tolerability, in people living with ALS. The study is randomized 69 people living with ALS in a 2:1 ratio to receive PrimeC or placebo, respectively. Primary endpoints of the study include assessment of ALS biomarkers, evaluation of clinical efficacy, improvement in quality of life, as well as safety and tolerability.
Alon Ben-Noon. CEO
Join us in spreading Hope for those affected by ALS!
In December, NeuroSense will unveil the clinical Top-line results of the Paradigm study, marking a major turning point in the fight against ALS. We're committed to sharing all results from this groundbreaking clinical trial with the ALS community.
Please help us reach as many as possible - share this message with your loved ones. Together, we can make a difference. 🩵 #ALS #HopeForACure
Cecile Munnik, the CFO, just shared this post by Datarails on LinkedIn.
https://www.linkedin.com/posts/datarails_celebrating-cfos-we-asked-for-nominations-activity-7132374549240680448-Y91V?utm_source=share&utm_medium=member_ios
Celebrating CFOs
We asked for nominations for unsung financial heroes.
Here are 3 transforming their companies.
3️⃣ Cecile Munnik, CPA, CA, CFO, PharmcoRx Pharmacy
You know finances are in good hands when x6 separate departments nominate their CFO.
Amanda Ferrio, VP of Accounting & Finance, Progressive Care: “Cecile is always willing to teach others financial leadership and skill to further their knowledge and career.”
Pamela Roberts, COO: “Cecile has exceptional leadership, strategic financial planning, effective cost management, and meticulous risk management skills that have contributed to our Company’s turn-around and success.”
Kenly Alberto, IT Specialist, PharmCo Rx added: “Cecile has helped my department establish itself with It controls and risk management.”
Carlos Rangel- Director of Marketing Operations: “Cecile has turned the company around and has brought structure and strategic vision to Progressive Care."
Lyz Dominguez, Regulatory Compliance Manager: “Cecile has exceptional leadership, strategic financial planning, day-to-day problem solving and diligent risk management skills. She is one of the prime reasons our company is headed in the right direction."
Michael Bacchiocchi Controller: "Cecile has navigated the company through tight spaces and has done it with ease and grace...and without drama. “
Congrats to all the CFOs👏 + swag on its way!
Progressive Care's PharmcoRx Enters into Agreement with NationsBenefits to Offer Enhanced OTC Benefits to Health Plan Members
https://www.otcmarkets.com/stock/RXMD/news/Progressive-Cares-PharmcoRx-Enters-into-Agreement-with-NationsBenefits-to-Offer-Enhanced-OTC-Benefits-to-Health-Plan-Mem?id=422036
PR Newswire
MIAMI, Nov. 20, 2023
Latest OTC Program Expands PharmcoRx Pharmacy's Ability to Provide Patients with Access to Additional Healthcare Benefits Covered by Medicare Advantage Plans
MIAMI, Nov. 20, 2023 /PRNewswire/ -- Progressive Care Inc. (OTCQB: RXMD) ("Progressive Care" or the "Company"), a personalized healthcare services and technology provider, today announced that its PharmcoRx ("PharmcoRx") pharmacies in Florida will expand their ability to provide customers with access to over-the-counter ("OTC") benefits through a new partnership with NationsBenefits LLC. ("NationsBenefits) for its NationsOTC program.
Progressive Care, Inc. logo (PRNewsfoto/Progressive Care, Inc.)
NationsBenefits is a leading provider of supplemental benefits, flex cards, and member engagement solutions for health plans. OTC benefits are provided by many State and Nationwide Medicare Advantage ("MA") plans such as those offered by Humana, Devoted, Wellcare, and United Health. The OTC benefits provide MA members with the ability to purchase a wide array of goods including over-the-counter medicines, food, and groceries. The Centers for Medicare & Medicaid Services (CMS) estimates that in 2024, MA enrollment will rise from 31.6 million individuals in 2023 to 33.8 million, accounting for about 50% of all Medicare eligible. According to Statista, revenue in the OTC pharmaceuticals sector of the market will reach $39.3 billion in 2023 and is expected to grow annually by 3.53% (CAGR 2023-2028). Through the NationsBenefits partnership, PharmcoRx will be included in a list of NationsOTC participating pharmacies for program participants thereby providing patients with seamless access to valuable OTC benefits fully paid for by their MA plans along with their prescription medications when they are delivered to their homes free of charge.
Dr. Pamela Roberts, Chief Operating Officer of Progressive Care Inc., said, "The expansion of our OTC benefit program will allow us to deliver added convenience and value to our customers when they have their prescriptions filled at our pharmacies, creating immediate new sales opportunities for the Company. Partnering with NationsBenefits enables us to provide new services that were only available at national retail chains, and we are excited to be part of this growing network as we continue to provide our communities with offerings that can contribute to their improved health and quality of life."
"We are pleased to welcome PharmcoRx pharmacies and its growing customer base to our NationsOTC program as we continue on our mission of delivering value to health plan members and to providers through innovative supplemental benefit solutions," commented Glenn M. Parker, M.D., Founder and CEO at NationsBenefits.
MA plan members in the NationsOTC program can immediately access their OTC benefits which can exceed $3,000 annually, at PharmcoRx pharmacies when they have their prescriptions filled. This means patients can now seamlessly fill their prescriptions and purchase their OTC medications such as pain relievers as well as hundreds of hair, skin and oral care products with no out of pocket costs simply by using their Medicare insurance benefits and have them delivered to their homes free of charge. PharmcoRx will actively market the availability of the program to its existing customer base as well as those in its network of providers, clinics, Management Services Organizations ("MSOs"), Accountable Care Organizations ("ACOs") and Long-Term Care facilities.
Exactly. He specifically mentioned $27M cash on hand with no debt. His vision is obvious on the table right there.
Although it takes longer to get RXMD listed on Nasdaq through this way than direct uplist or SPAC, it will be a much safer and more stable process for both NXPL and RXMD. Combined with NextPlat's partnership with Alibaba and potential more acquisitons as Charles said, the combined company (highly possible with the spinoff of Orbisat) will become profitable. The stock price will reflect that on Nasdaq.
They want to make sure the conversion will be smooth for the stock price. The most important stabilizing element during the transition process is revenue. Now the 10Q is out, the Street knows what's going on and will take it easy once the conversion starts. I think it will happen very soon.
As Charles said the two companies will see more savings through more and more consolidation. Now Progressive care is officially a subsidiary of NextPlat as we can see from the 10Q, the next step has to be converting RXMD shares into NXPL, which will save the company tons of money spent on SEC compliance.
Their partnership with Alibaba will have a dramatic rippling effect down the road once the "machine" (Charles's own words decribing NextPlat) starts rolling with all new partnerships and acquistions. This can be huge for the Street.
He also said their distribuiton, marketing and sourcing agreement is the first time that Alibaba ever signed with an american company.
Charles said "Florida Sunshine" is "our own brand" that will have a Flagship Store on Tmall Global. This brand is for the nutritional products that are made by One Innovation Labs, the company where Progressive Care's independent director, Anthony Armas, works as the CEO. It's interesting why he says "our own brand". 4'00" - 4'15" in the video.
He said in the interview the two companies (NXPL and RXMD) are operating as a unit now, and he sees cost savings that will happen through more and more consolidation (between the two) and will become profitable. 2'00" - 2':30" in the video
Charles Fernandez today's interview with Proactive Investors. Reposting the link because the youtube video is not showing on my phone.
Charles Fernandez today's interview with Proactive Investors:
Overall, this is a great quarter for Progressive Care. Business keeps growing at record pace. The net loss was mostly due to an increase of “push-down accounting method” and increase of franchise taxes. Now the two companies are formally combined and the one-time accounting cost will be removed in the future. NextPlat will invest more into Progressive Care as they said in the Q to grow the business even further, especially with the “rollout of new services provided by PharmocoRx in the fourth quarter (we are already in it, but not included in the 3rd Q).
https://www.otcmarkets.com/filing/html?id=17054447&guid=ckJ-kWUD04t3dth#ex_564024_htm
“Our continued growth across our business combined with the rollout of new consumer services at our PharmcoRx pharmacies later this year, gives our team confidence in the growth potential of Progressive Care. Supported by a solid financial foundation, we continue to execute on our strategic plan and look forward to further capitalizing on the value we can deliver to patients, providers, and our shareholders.”
As compared to the prior year period, the salaries and wages only increased by 0.2 million.
“The increase was primarily attributable to increases of approximately $0.6 million in the amortization (non-cash expense) of newly identifiable intangible assets because of the push-down accounting, approximately $0.3 million of increased franchise taxes, and approximately $0.2 million in salaries and wages, when compared to the prior year period.”
https://www.otcmarkets.com/filing/html?id=17054447&guid=ckJ-kWUD04t3dth#ex_564024_htm
“Our continued growth is supported by strong, debt-free balance sheets with sufficient cash to invest both internally and in acquisitions that can quickly add scale to our platform. It is through these investments that we intent to create greater synergies in our business as we seek to unlock valuable new benefits for our customers, partners, patients, and shareholders."
Progressive Care Inc. Announces Record Third Quarter 2023 Revenues of $12.4 Million, an Increase of 22%, as Gross Margins Improve to 31% Over Third Quarter 2022 Results
https://www.progressivecareus.com/post/progressive-care-inc-announces-record-third-quarter-2023-revenues-of-12-4-million-an-increase-of-22-as-gross-margins-improve-to-31-over-third-quarter-2022-results
NOVEMBER 14, 2023
Miami, FL – November 14, 2023 – Progressive Care Inc. (OTCQB: RXMD) (“Progressive Care” or the “Company”), a personalized healthcare services and technology provider, today announced financial results for its third quarter ended September 30, 2023. The Company reported record third quarter revenues of $12.4 million, a 22% increase in comparison to the prior year period, driven primarily by strong growth at its PharmcoRx pharmacies.
“We are thrilled with our third quarter results and the significant continued growth of Progressive Care, highlighted by strength in our pharmacy and 340B contract businesses. Our performance is a direct result of our commitment to improving outcomes for patients through medical adherence,” said Charles M. Fernandez, Chairman and CEO of Progressive Care Inc. “During a time when the broader pharmacy sector and the entire healthcare industry increasingly faces mounting pressures to improve care while reducing costs, our team continues to capitalize on the many growth opportunities in front of us including expanding our services for our existing patients and partnering with organizations that can provide us with the potential to reach large numbers of new customers.”
Third Quarter 2023 Financial Highlights:
? Total revenues increased by approximately $2.2 million, or 22%, to approximately $12.4 million during the three months ended September 30, 2023, compared to approximately $10.1 million in the prior year period. Sequentially, total revenues increased by approximately 7% over revenue reported for the second quarter of 2023.
? Prescription revenue, net of PBM fees, increased by approximately $1.1 million, or 13%, to approximately $9.9 million during the third quarter of 2023, compared to approximately $8.8 million in the prior year period.
? 340B contract revenue was approximately $2.5 million during the third quarter of 2023, an increase of approximately $1.3 million, compared to approximately $1.2 million in the prior year period. The increase was attributable to an increase in our existing 340B contracts.
? Gross profit margin increased to approximately 31% from approximately 21% reported in the third quarter of 2022.
? Cash balance as of September 30, 2023 was approximately $7.0 million as compared to approximately $6.7 million as of December 31, 2022.
Organizational Highlights and Recent Business Developments:
? On June 30, 2023, NextPlat Corp (NASDAQ: NXPL, NXPLW) (“NextPlat”), Charles M. Fernandez, Chairman and Chief Executive Officer of the Company, and Rodney Barreto, Vice-Chairman of the Company, entered into a voting agreement whereby at any annual or special shareholders meeting of the Company’s stockholders Messrs. Fernandez and Barreto agreed to vote all of the common stock shares that they own in the same manner that NextPlat votes its Common Stock and equivalents. On July 1, 2023, NextPlat, Messrs. Fernandez and Barreto exercised common stock purchase warrants and were issued common stock shares by the Company. After the exercise of the common stock purchase warrants, NextPlat, Messrs. Fernandez and Barreto collectively owned 53% of the Company’s voting common stock. Collectively, the exercise of the common stock purchase warrants and the entry into the voting agreement constituted a change in control in Progressive Care.
Mr. Fernandez concluded, “Our continued growth across our business combined with the rollout of new consumer services at our PharmcoRx pharmacies later this year, gives our team confidence in the growth potential of Progressive Care. Supported by a solid financial foundation, we continue to execute on our strategic plan and look forward to further capitalizing on the value we can deliver to patients, providers, and our shareholders.”
Summary Financial Results for the Three Months Ended September 30, 2023 and 2022
Note on Financial Presentation
In connection with the change in control on July 1, 2023, the application of push-down accounting created a new basis of accounting for all assets and liabilities based on their fair value at the date of acquisition. As a result, our financial results of operations subsequent to the acquisition on July 1, 2023 have been segregated to indicate pre-acquisition and post-acquisition periods. The pre-acquisition period through June 30, 2023 is referred to as the “Predecessor”. The post-acquisition period, July 1, 2023 and forward, includes the impact of push-down accounting and is referred to as the “Successor”.
We recognized overall revenue from operations of approximately $12.4 million and $10.1 million during the three months ended September 30, 2023 and 2022, respectively, an overall increase of approximately $2.2 million, or 22%. The increase in revenue was primarily attributable to an increase in prescription revenue, net of PBM fees of approximately $1.1 million and an increase in 340B contract revenue of approximately $1.3 million, which was offset by a decrease in COVID-19 testing revenue of approximately $0.2 million, when compared to the prior year period.
Sequentially, overall revenue increased approximately $0.8 million, or 7%, during the three months ended September 30, 2023, when compared to the three months ended June 30, 2023. The sequential increase in revenue quarter-over-quarter was attributable to our continued growth of 340B contract revenue, an increase of approximately 18%, and prescription revenue, net of PBM fees, an increase of approximately 4%, when compared to the second quarter of 2023. The number of prescriptions filled increased by approximately 3% during the third quarter of 2023, when compared to the second quarter of 2023.
We filled approximately 122,000 and 117,000 prescriptions during the three months ended September 30, 2023 and 2022, respectively, an increase of 4% year-over-year.
Gross profit margins increased from 21% for the three months ended September 30, 2022, to 31% for the three months ended September 30, 2023. The increase in gross profit margins during the third quarter of 2023, compared to the same period in 2022, was primarily attributable to the increase in 340B contract revenue, which has higher margins than revenue generated from pharmacy operations.
Loss from operations decreased by approximately $0.5 million for the three months ended September 30, 2023, when compared to the three months ended September 30, 2022, as a result of the increase in gross profit of approximately $1.6 million, partially offset by the increase in operating expenses of approximately $1.1 million.
Our operating expenses increased by approximately $1.1 million, or 27%, for the three months ended September 30, 2023, as compared to the three months ended September 30, 2022. The increase was primarily attributable to increases of approximately $0.6 million in the amortization (non-cash expense) of newly identifiable intangible assets because of the push-down accounting, approximately $0.3 million of increased franchise taxes, and approximately $0.2 million in salaries and wages, when compared to the prior year period.
Other loss decreased by approximately $7.1 million for the three months ended September 30, 2023, as compared to the same period in 2022. Other loss of approximately $7.1 million in the prior year period was attributable to NextPlat transaction-related expenses and losses, including the changes in fair value of derivative liabilities, day one losses on issuance of units and debt modification, and abandoned offering costs, offset by gains on debt settlement and grant revenue.
We had a net loss of approximately $1.4 million and $9.0 million for the three months ended September 30, 2023 and 2022, respectively. The decrease in net loss was attributable to the decrease in other loss due to the NextPlat transaction-related expenses and losses recognized in the prior year period.
Quarterly Report on Form 10-Q Available
The Company’s Quarterly Report on Form 10-Q, available at www.sec.gov and on the Company’s website, contains a thorough review of its financial results for the three months ended September 30, 2023.
NextPlat Reports Consolidated Third Quarter 2023 Results with Increased Revenues of $15.3 Million, Margins Improve to 30% and $2.7 Million Net Income
https://www.prnewswire.com/news-releases/nextplat-reports-consolidated-third-quarter-2023-results-with-increased-revenues-of-15-3-million-margins-improve-to-30-and-2-7-million-net-income-301986948.html
"The third quarter of 2023 marks an inflection point for NextPlat as we report the consolidation of our global e-commerce and Progressive Care healthcare operations. As a unified business, our teams are focused on maximizing the value of each of its operations through the launch of new online storefronts for customers including OPKO Health into China's multi-billion dollar marketplace on Alibaba's Tmall Global, and the further expansion of Progressive Care's services for both patients and providers," said Charles M. Fernandez, Executive Chairman and CEO of NextPlat Corp. "The intersection of technology, global e-commerce, and healthcare, creates tremendous opportunities for NextPlat. Our continued growth is supported by strong, debt-free balance sheets with sufficient cash to invest both internally and in acquisitions that can quickly add scale to our platform. It is through these investments that we intent to create greater synergies in our business as we seek to unlock valuable new benefits for our customers, partners, patients, and shareholders."
Third Quarter 2023 Financial Highlights:
Consolidated revenues for the third quarter were approximately $15.3 million, an increase of over 481% versus revenue of approximately $2.6 million in the third quarter of 2022. Our third quarter 2022 revenues only reflect the results of the Company's e-commerce operations. e-Commerce revenues were approximately $2.9 million, reflecting growth of 11% when compared to its reported revenues in the third quarter of 2022. The contribution of the Company's healthcare operations were approximately $12.4 million for the third quarter of 2023 and is a result of the Progressive Care consolidation as of July 1, 2023.
Gross margins increased significantly to 30% for the quarter ended September 30, 2023, up from 26% reported for the quarter ended September 30, 2022, primarily attributable to the healthcare operations because of the Progressive Care consolidation. Gross profit margin attributable to our healthcare operations were approximately 31%. Our e-commerce profit margins improved to over 27% from under 26% reported in the third quarter of 2022.
Operating expenses for the quarter ended September 30, 2023, were approximately $8.1 million, an increase of approximately $5.2 million compared to approximately $2.8 million in the year-ago period. The increase was primarily driven by expenses including stock-based compensation of approximately $1.2 million (non-cash expense), salaries and wages of approximately $1.8 million, amortization expense of approximately $0.7 million, and net other operating expense of approximately $1.5 million.
Net income for the quarter ended September 30, 2023, was approximately $2.6 million, or $0.17 diluted earnings per share compared to a net loss of approximately $5.7 million, or $0.60 diluted earnings per share reported for the quarter ended September 30, 2022. Net income in the third quarter of 2023 includes a one-time, gain on equity method investment of approximately $6.1 million (non-cash expense) related to the change in accounting method due to the Progressive Care consolidation as of July 1, 2023. The net loss in 2022 includes an equity in net loss of affiliate expense of approximately $3.4 million (non-cash expense) for its strategic investment in Progressive Care prior to the consolidation on July 1, 2023.
The Company ended the third quarter of 2023 with approximately $26.3 million in cash.
Organizational Highlights and Recent Business Developments:
Effective on July 1, 2023, NextPlat, together with its Executive Chairman and CEO, Charles M. Fernandez, and its Director, Rodney Barreto, acquired a controlling interest in Progressive Care, Inc. As such, Progressive Care is now a consolidated subsidiary of the Company for accounting purposes. The Company intends to support Progressive Care's continued rapid growth through a series of business development and expansion activities designed to boost the continued expansion of Progressive Care's healthcare offerings.
NextPlat announced its first customer for its Florida e-commerce development program, agreeing to exclusively launch the online sales of OPKO Healthcare ("OPKO") products in China on Alibaba's Tmall Global platform. OPKO is a global diversified diagnostic and pharmaceutical healthcare company with over 5,500 employees spanning nine countries. Through this new e-commerce agreement, NextPlat will develop and launch an OPKO-branded storefront on Tmall Global and offer select nutraceutical and veterinary products for sale to potentially millions of Chinese consumers starting in the first quarter of 2024.
The Company is also currently developing a full-line of premium-grade vitamins and dietary supplements under the Florida Sunshine brand name which it can sell to domestic and international markets, including China via the Tmall Global platform.
David Phipps, President of NextPlat and CEO of Global Operations, added, "Supported by the reach of our global platform and network of key partners, we see an increasing number of opportunities to leverage our capabilities to assist businesses across multiple high-growth domestic and international markets, to grow their online presence and e-commerce revenue. Our unique expertise and access into large markets such as China through Alibaba's Tmall Global, positions us well to penetrate several additional consumer and commercial sectors with a broad array of products and high-value services starting in 2024."
The financial information included in this press release should be read in conjunction with the Company's Form 10-Q report for the quarter ended September 30, 2023, as filed with the Securities and Exchange Commission.
For more information regarding the financial results of Progressive Care Inc. for the quarter ended September 30, 2023, investors should refer to its Form 10-Q as filed with the Securities and Exchange Commission.
NextPlat Reports Consolidated Third Quarter 2023 Results with Increased Revenues of $15.3 Million, Margins Improve to 30% and $2.7 Million Net Income
https://www.prnewswire.com/news-releases/nextplat-reports-consolidated-third-quarter-2023-results-with-increased-revenues-of-15-3-million-margins-improve-to-30-and-2-7-million-net-income-301986948.html
"The third quarter of 2023 marks an inflection point for NextPlat as we report the consolidation of our global e-commerce and Progressive Care healthcare operations. As a unified business, our teams are focused on maximizing the value of each of its operations through the launch of new online storefronts for customers including OPKO Health into China's multi-billion dollar marketplace on Alibaba's Tmall Global, and the further expansion of Progressive Care's services for both patients and providers," said Charles M. Fernandez, Executive Chairman and CEO of NextPlat Corp. "The intersection of technology, global e-commerce, and healthcare, creates tremendous opportunities for NextPlat. Our continued growth is supported by strong, debt-free balance sheets with sufficient cash to invest both internally and in acquisitions that can quickly add scale to our platform. It is through these investments that we intent to create greater synergies in our business as we seek to unlock valuable new benefits for our customers, partners, patients, and shareholders."
Third Quarter 2023 Financial Highlights:
Consolidated revenues for the third quarter were approximately $15.3 million, an increase of over 481% versus revenue of approximately $2.6 million in the third quarter of 2022. Our third quarter 2022 revenues only reflect the results of the Company's e-commerce operations. e-Commerce revenues were approximately $2.9 million, reflecting growth of 11% when compared to its reported revenues in the third quarter of 2022. The contribution of the Company's healthcare operations were approximately $12.4 million for the third quarter of 2023 and is a result of the Progressive Care consolidation as of July 1, 2023.
Gross margins increased significantly to 30% for the quarter ended September 30, 2023, up from 26% reported for the quarter ended September 30, 2022, primarily attributable to the healthcare operations because of the Progressive Care consolidation. Gross profit margin attributable to our healthcare operations were approximately 31%. Our e-commerce profit margins improved to over 27% from under 26% reported in the third quarter of 2022.
Operating expenses for the quarter ended September 30, 2023, were approximately $8.1 million, an increase of approximately $5.2 million compared to approximately $2.8 million in the year-ago period. The increase was primarily driven by expenses including stock-based compensation of approximately $1.2 million (non-cash expense), salaries and wages of approximately $1.8 million, amortization expense of approximately $0.7 million, and net other operating expense of approximately $1.5 million.
Net income for the quarter ended September 30, 2023, was approximately $2.6 million, or $0.17 diluted earnings per share compared to a net loss of approximately $5.7 million, or $0.60 diluted earnings per share reported for the quarter ended September 30, 2022. Net income in the third quarter of 2023 includes a one-time, gain on equity method investment of approximately $6.1 million (non-cash expense) related to the change in accounting method due to the Progressive Care consolidation as of July 1, 2023. The net loss in 2022 includes an equity in net loss of affiliate expense of approximately $3.4 million (non-cash expense) for its strategic investment in Progressive Care prior to the consolidation on July 1, 2023.
The Company ended the third quarter of 2023 with approximately $26.3 million in cash.
Organizational Highlights and Recent Business Developments:
Effective on July 1, 2023, NextPlat, together with its Executive Chairman and CEO, Charles M. Fernandez, and its Director, Rodney Barreto, acquired a controlling interest in Progressive Care, Inc. As such, Progressive Care is now a consolidated subsidiary of the Company for accounting purposes. The Company intends to support Progressive Care's continued rapid growth through a series of business development and expansion activities designed to boost the continued expansion of Progressive Care's healthcare offerings.
NextPlat announced its first customer for its Florida e-commerce development program, agreeing to exclusively launch the online sales of OPKO Healthcare ("OPKO") products in China on Alibaba's Tmall Global platform. OPKO is a global diversified diagnostic and pharmaceutical healthcare company with over 5,500 employees spanning nine countries. Through this new e-commerce agreement, NextPlat will develop and launch an OPKO-branded storefront on Tmall Global and offer select nutraceutical and veterinary products for sale to potentially millions of Chinese consumers starting in the first quarter of 2024.
The Company is also currently developing a full-line of premium-grade vitamins and dietary supplements under the Florida Sunshine brand name which it can sell to domestic and international markets, including China via the Tmall Global platform.
David Phipps, President of NextPlat and CEO of Global Operations, added, "Supported by the reach of our global platform and network of key partners, we see an increasing number of opportunities to leverage our capabilities to assist businesses across multiple high-growth domestic and international markets, to grow their online presence and e-commerce revenue. Our unique expertise and access into large markets such as China through Alibaba's Tmall Global, positions us well to penetrate several additional consumer and commercial sectors with a broad array of products and high-value services starting in 2024."
The financial information included in this press release should be read in conjunction with the Company's Form 10-Q report for the quarter ended September 30, 2023, as filed with the Securities and Exchange Commission.
For more information regarding the financial results of Progressive Care Inc. for the quarter ended September 30, 2023, investors should refer to its Form 10-Q as filed with the Securities and Exchange Commission.