We are rightfully excited by the potential of AE a
Post# of 36537
This long summary of the CC is for my benefit because I understand things better when I write them down. I figured I might as well share. No guarantee that everything is spot-on accurate, but I hope it helps. (hoops)
(What is an MSO in healthcare?
A management services organization (MSO) is a healthcare specific administrative and management engine that provides a host of administrative and management functions necessary to be successful in the ever changing healthcare environment.. That's the business model.
" The Company's strategy of an end-to-end patient centric solution offers access to diagnostic testing and laboratories, therapeutic drugs, medical devices and additional health-related services that greatly improve the patient experience in receiving care.
Our corporate mission at Generex is to provide physicians, hospitals and all healthcare providers with an end-to-end solution to patient centric care from rapid diagnostics through delivery of personalized therapies, streamlining care and processes, minimizing expenses and delivering transparency for payers. Today, I am happy to share a number of significant transactions that we have planned or have recently completed to build revenues profits and long term value for Generex and our shareholders."
The key acquisition for achieving Generex' mission statement is Veneto Group (NuGenerex Distribution Solutions). The $35M debt obligation has been restructured through an agreement that is non-dilutive to shareholders. This has been made possible primarily by the donation of the 12/3/2018 dividend shares awarded to Joe Moscato, CEO, Larry Salvo, board member, partner Steve Berkman, from whom HDS was acquired (HDS escapes me for now), and an unnamed investment fund.
"ll proceeds from that pool go to the benefit of Generex and its shareholders. These shares are available to the Company for non-dilutive financing and acquisitions and we have used the pool to advance Veneto transactions as well as additional acquisitions that I will now review."
The is the composition of the MSO:
A letter of intent has been signed to acquire Fuse Medical.
Regentys and Olaragen have been acquired. Ownership by Generex of Olaragen is now 60.2%. Olaregen ownd FDA approved Excellagen .
"We are excited about the prospects of Olaregen as we planned the commercial launch in April 2019 of the Excellagen wound conforming gel that is cleared by FDA for 17 wound care indications including post-surgical wounds, diabetic wound ulcers and other hard to manage wounds."
There is an agreement to acquire Pantheon Medical Foot and Ankle.
"Pantheon Medical Foot & Ankle manufacturer of specialty orthopedic surgery products and tools. Under the terms of the deal, Generex will acquire all the assets of Pantheon Medical including business operations, accounts receivable, inventory, contracts and an FDA letter to balance places on a debt-free basis, for $1.4 million worth of Generex stock from the pool shares, plus an additional cash to stock consideration upon achieving certain sales of profit goals over the next two years."
Under the terms of the Pantheon deal Generex will acquire MediSourse.
"Under the terms of the deal, Generex will acquire all the assets of MediSource including business operations, accounts receivable, inventory and contracts on a debt-free basis for $1 million worth of Generex stock, plus additional cash and stock consideration for achieving certain sales and profit projections over the next two years. MediSource partners is a 10-year-old private company currently contracted with all the 25 vendors including Pantheon Medical for a nationwide distribution of implants and devices for spine, hips, knees, foot and ankle, hand and wrist surgeries."
"Both Pantheon and MediSource partners [indiscernible] an extensive line of surgical and biological products to our MSO partners and hospital systems, integrating our management services to not only integrate purchasing and billing, but to also offer better pricing and access to new innovative products, especially in the field of biologics and regenerative medicine. We're excited that through the acquisitions of Pantheon and MediSource together with Fuse Medical, NuGenerex Distribution Solutions will provide access to a whole new line of products that not only enhances our current MSO network currently operating in 5 states and eventually expanding it to 27."
Due diligence is currently being completed in order to close the deals with Fuse, Pantheon, and MediSource.
The pharmacy network will be integrated into NuGenerex Distribution Solutions.
"To round on our discussion on Generex Distribution Solutions, I want to update you on our plan to acquire a direct-to-patient pharmacy network and IT systems, which the Company had previously announced in the letter of intent and 8-K filings.
After a year of work Generex expects to receive the final audit report on the target company. The audit report will enable Generex to finalize the terms and price of the acquisition, thereby providing a path towards integration of the pharmacy network into NuGenerex Distribution Solutions in the near future. We're excited about the opportunity to expand our pharmacy network that ultimately will enhance our distribution and direct-to-patient capabilities. We look forward to integrate the pharmacy's cutting edge database systems, operational capabilities to grow our Distribution Solutions business by introducing a number of innovative pharmacy programs."
Antigen Express will be spun off from Generex and shareholders will receive 1 share of AE for every four shares of Generex they own. 1000 shares of Generex=250 shares of AE. Later in the call Joe states that you will get the shares as long as they are purchased by Feb. 22nd, 2019, the last trading day before the distribution on Feb., 25th 2019.
"NuGenerex Immuno-Oncology will operate as independent company with a new board of directors that will be assembling a management team around Dr. Eric von Hofe, President. Additionally, we are in active discussions with academic institutions and development companies in the fields of the immuno-oncology that predictive analytics to expand the breadth and depth of our immuno-oncology intellectual property and product portfolio.
"NuGenerex Immuno-Oncology will operate as independent company with a new board of directors that will be assembling a management team around Dr. Eric von Hofe, President. Additionally, we are in active discussions with academic institutions and development companies in the fields of the immuno-oncology that predictive analytics to expand the breadth and depth of our immuno-oncology intellectual property and product portfolio."
Additional info obtained through stakeholder questions:
As best as I can ascertain, most of the questioners were from this board, and all of us are overwhelmingly grateful to Joe for bringing our investment back form near bankruptcy. He accomplished this through donation of his and his partners shares and funds.
Veneto acquisition was completed on 1/16/2019.
Oral-yn is on the back burner. "Dr. Anderson is an instrumental team member."
O-L has been reformulated, and the reformulation is much better than the old one. It is also much more cost-effective. However, Type II diabetes is too expensive to take on at this time.
Generex has a "major license" to use the Rapid Mist delivery system with cannabis. There should be an update in the "upcoming" months. There have been discussion regarding the use of RM is other "treatment paradigms", but they are only in early stages.
Shenzhen:
Dr. Eric von Hofe
"Sure, sure. Yes, hi Steve. So, Shenzhen is in the process now of as Joe mentioned, getting filings ready for China, but also doing the study in the EU. So, the Phase 1 was done at EU and that's where it's easier to setup the Phase 2 from that, but at the same time getting the application to China which of course is where they have rights. We do not yet have an exact start date for the trial, but they're in the process of getting that lined up. So we hope to have an update in the next probably month or so or just around when that trial is going to be started."
Discussions are being held with investment banks regarding a rights offering for Nugenerex Immune-Oncology (formerly AE).
The spin-off of AE will require fewer than 10% of the shares to be distributed to shareholders. (Sounds like a much lower float than we expected. Apparently 6.5M shares, according to Joe.)
Olaragen and Regentys never received any stock through their transactions with Generex. Here's the quote, but I'm not certain as to what it means.
Olaragen and Regentys "never received any stock. There is no stock. There is no stock involved with Olaregen and or Regentys. That now we have for Olaregen we have obligatory commercialization payments throughout the year that we need to make to them. We already own 51%. We're contracted right now. We get a little over 60% taking out some of their shareholders and exchanging their shares for Generex shares at the 250 share price. But we -- out of that pool, we will raise the money that we need to make those obligatory payments as well as Regentys to get through the clinic to get an FDA approval, hopefully FDA approval, we're highly confident they will and then talk to that commercialization.
So, these are all the money that we have to pay both companies, are either for commercialization or to getting their products approved. So, it's not for the cost of acquisition, it's the cost of furthering science or to commercializing and having a viable product that which we can sell either through our MSO or through our distribution channels."
There is no definitive date or venue for the annual shareholders meeting, but Joe would like to hold it within "the next few months".
Joe reiterates that shareholders will be entitled to the AE spin-off shares until the pay date of Feb. 25th, 2019.
Consideration is being given to merging NuGenerex Immuno-Oncology(NI-O) with another company to assist with the uplisting to NYSE or NASDAQ.
"But yes, our intention would be is to all the rights offering and hopefully that investment bank that we would pick would be able to bring in the necessary money to make an uplift to curve, have enough capital for the clinical work as well as maintaining a NASDAQ or a New York Stock Exchange listing."
Unclear, but it sounds as if the goal is uplist both NI-O and GNBT to national exchanges.
A formulation has been developed for NuGenerex Health Water.
"Joe Moscato
Well, it's in combination. We came up with a formulation that we were pretty happy with, with our NuGenerex Health Water. So, right now, we’re almost done with the labeling and the artwork for a branding of the product. Our formulation is significantly a little bit higher than most of the other CBD what is out there as high up one were. So, we believe 1 million bottles of water is really not a lot at all. We have our pharmacy network potentially going to sell a lot of water through that pharmacy network as well as other distribution channels that have already shown significant interest in carrying the product as well as the other distribution channels. So you know CBD is hot right now. And for us, it really was being able to put it out into our own pharmacy networks to sell the product. It's a great product thereby wants it is the high demand. And since we own pharmacies, we thought it was a great idea to get the business."
Team members, including Joe, met with the CEO of Puration and the meeting went well. The contract and partnership are also going well.
Joe is relying on Tony Dolisi to improve commercialization of Excellagen. Joe doesn't know why it hasn't previously been well-commercialized. Excellagen has been reformulated from a gel to an injectable with 3 different dosages. (From what I read the appropriate dosage will be determined by the size of the wound.)
Richard Purcell, executive Vice President of Research and Drug Development for Generex on commercialization of Excellagen:
"Richard Purcell
Yes, sure. Hi this is Richard Purcell the Executive Vice President of Research and Drug Development for Generex. And just to comment on a question regarding Excellagen and previous we failed commercialization. The original company was a bunch of scientists, they weren't commercial people. And they didn't have the pieces and parts together to get it to a commercial stage. And they also didn't have a patent that was fully approved yet. Just recently when Tony came on board and took over the Company they were able to get the patent. So they had an FDA approval without a patent, so they weren't able to raise the capital without a standing patent. Now that we have a patent it changes the game. And that's one of the reasons I think we're going to be successful here with Excellagen patented product. It's always been a good product. Was it packaged right, it wasn't put it into a commercial team properly. It was a scientist team. And now we're in position now to move forward. So that's all I wanted to say. Thanks."
Tennessee is one of the 27 states targeted for expansion of the MSO.
Shreya is dead.
NI-O will have its own ticker symbol, but Generex will hold the majority of shares.
Chris Reed, CEO, Fuse Medical on being included on the Deloitte list of fastest growing companies.
"Chris Reed
Yes. Thanks, Joe, and thanks Rich for the question. Fuse Medical, we have maybe a little similar history in fact that we were trying to build our enterprise being over-the-counter and eventually make a major exchange. So we've been in the distribution and manufacturing business for 10 years as a privately held -- closely privately entity. So we've developed our supply chain and our network and our products. And two years ago then reversed into the Fuse Medical shell. So it was an existing entity that was already -- was Fuse Medical in the same business space but we just reversed into that entity. That $26 million revenue that we popped in there was what put us on a Deloitte Fast 500 growing list in North America for publicly traded companies."
Joe anticipates a network of 13 hospitals to come on board to the MSO. He describes negotiation as "deep discussions".
Travis Bird, CEO of Pantheon and MediSource:
"t really was a synergistic viewpoint of what we all were trying to accomplish. And that's where -- sitting down with Joe on the executive seat, where they were going with their view of healthcare really matched to where we wanted to be with our view as Medisource being an all-in, where we could be a full service provider for hospitals. And for physicians to be able to not only distribute products, but also manufacture own unique ideas that our physicians came to us as well too."
"So it's been a great relationship thus far. We're excited to close this as soon as possible. And really see where the year is going to go for 2019. We're all excited and we're really excited to hear from the investors as well too of the buzz that's going out there. So I thank you guys for giving me the time to talk a little bit about Pantheon and Medisource Partners."
Joe didn't mention a number of companies owned by Generex.
Dr. Eric von Hofe on combo study with Merck's Keytruda:
"Sure. So we're going to be enrolling 29 patients for this combination study. It's not a controlled randomized study like the previous Phase II. So the way we work this out and this was in collaboration with Merck and NSABP was to do a non-blinded study. The idea is, if we see a response rate greater than what we expect from KEYTRUDA alone, that would want a larger controlled randomized study. But currently we're anticipating rolling 29 patients for that combination study."
Dr. von Hofe is hoping for a greater partnership role by Merck.
"That's certainly the hope and I think it’s also the expectation. I don't think they would have entered into this agreement, if they see the potential for moving forward. So yes, that, that would be the hope."
I am skipping "cost basis" discussion.
Joe Moscato on market cap and uplisting.
"I would say the biggest one is market cap, you have to have a market cap of over $75 million, or to get to a bigger one $110 million. So our market cap now is in the range of where we need to be to respond any one of the -- either anyone of these exchanges. So I'm confident that in the next 30 to 45 days, we can -- hopefully and potentially if all goes the way we've been planning to get that application timing."
(There are a number of variables that impact uplisting. We need to stay on top of this development. Not only is it crucial to gaining reliability with the market, but it will also help with monitoring trading and fund raising. IMO, it may be difficult to accomplish if it is not prioritized by mgmt.)
Dr. Eric von Hofe on breast cancer trial:
"Dr. Eric von Hofe
Sure. Yes. So the trial is scheduled to be enrolled within one year. So by the end of 2019, we anticipate having the entire trial enrolled. Follow-up for efficacy is going to be one year. So by the end of 2020, we’ll get the results for that trial and should be in a position to move forward at that time.
Unidentified Analyst
Okay, so we're talking about a time span of about two years from now, right?
Dr. Eric von Hofe
Yes."