John Timberlake Presents Berkshire Biomedical at LSI USA '23

Transcription

John Timberlake  0:05  

Good morning. So thank you for the introduction, you've pretty much covered by mission statements. So I may make some forward looking statements. But as, as he said, in more simple terms as we're developing technology to make sure we deliver medication to the right person, in the right amount, and at the right time. And so we're trying to leverage both compliance, adherence, but also security, making sure only that patient who is supposed to get the medication gets the medication. So I hit the wrong button. So I think everybody in this room unless you live under a rock noted, we have a serious opioid crisis in this country. And I'm not going to go through a lot of this data. It's an epidemic, and it's getting worse. And I'm not here to fix the epidemic. I'm here to try to help the patients who are already addicted to opioids. In just the last three years, you see the number of deaths from opioids have gone from 48,000 to over 80 to over 100,000. And I think we all know we hear a lot about the news is that over prescribe and use a pain medications and prescription products in 1990s, initiated this, then we had the drugs coming over the border. And now what you see with fentanyl and the semi synthetic opioids, it's an explosion, it's going to make the over prescription look like nothing compared to what's going on right now. So there's a huge unmet need to help patients already addicted to opioids. In fact, by the time I'm done with this talk to more people will have overdosed and died. And that happens every five minutes right now in this country. So how can we help those people who have opioid use disorder, I think, first of all, to recognize that opioid use disorder is actually a medical condition recognized by the AMA. And it's basically a condition where there's a long term treatable condition where the brain the brain basically takes over and even though the person knows it's wrong, they can't prevent it. 2.7 million people have this opioid use disorder. The most effective treatment, there are many treatments, and most effective is really going to an Opioid Treatment Program, and OTP. These are programs that are licensed by the federal state governments, there's about 2000 them in this country. And they use what's called medication assisted treatment, or medication for opioid use disorder. It's a combination of counseling and training and in work, but also using medication, actually using a very controlled drug called methadone, to actually block the receptors to reduce the craving for for drugs, very effective long term use, and people can live a normal life if they continue to have treatment. So these people who are treated with methadone at these clinics actually have a 76% chance less likeliness to have an overdose due to an opioid. In addition, they have 1/3 of the rate of ending up in an ER room due to an opioid. And the cost savings to the society is enormous just on those two facts alone, not to mention people dying for five minutes. So the death rate is actually if you're on methadone and being treated about 1/4 rate as if you're not being treated. So a very huge medical need to treat these people who are addicted to the opioids. So how, what's the standard of care today, so the patients who have an opioid use disorder in go to a clinic and OTP clinic, there are about 600,000, about right now is about five or 20,000 patients, and it's growing four to 6% a year, it's going to explode due to fentanyl. But initially, every patient must go to a physical location and have counseling initially, but have medication under supervision every single day. And that happens for at least 30 days. And then they might have the ability and earn the right and privilege to take some medication home. But the vast majority still have to go to a clinic every day. So think about that. These are people who want to do something about their treatment, they want to get better, they want to have a life, they want to take care of their family and have a job. Now they have to go to a physical location, pay for transportation costs public or otherwise, go to that clinic to have someone watch you take medicine, and then you go home. So it's a huge burden on them. It's also a huge deterrent of why there's only 500,000 being treated versus the 2.7 because it's a big deterrent, trying to ask someone to go to that clinic every day. So right now 20% of people have that at home during COVID. They loosen the guidelines. We did qualitative research last year, and we had clinics having 80 90% of our patients take a week's medication home, an average is 4050. So it can go much higher. You can have a much better quality of life for those people. So again, as I mentioned on peak thing about medication is it doesn't work if you don't take it. And from a from a health care provider. They don't know what the right patients taking the right amount at the right time. And is even the right person taking it. These people who are going home with methadone, maybe have six bottles for a week. They could take all six in one day and no one would know that or it could be diverted, misused overdosed. So what we have done What is our COPPA device which is our computerized oral prescription administration system? mouthful. So we say COPPA. And basically you see it here. It's a handheld automated, personalized medication dispensing system designed that delivers very precise and accurate liquid oral medications. And again, we're finding that both controlled and non controlled drugs. But on first indication will be going after the opioid use disorder, we use a cloud based database encrypted HIPPA compliant. And really, what you're doing is you're making sure that only the patient can get the drug at the right amount at the right time. So I have a short video that kind of demonstrates the product, I'll kind of talk over it. But this is the product here. Again, it's handheld, it has an amber bottle that's filled up by you the pharmacy or the clinic. In this case, we have a smart cap on it, which reads the device only can be used by that device for that patient device tells the patient when the dose is ready tells them to use their thumbprint to recognize that patient. And once it recognizes the thumbprint, and then loads the dose that has on the system, the patient will put their mouth on it you recognize is there a unique bite. And once it does, it automatically delivers the liquid drug right into their tongue. And then the device tells them it's done both visually and audibly, and also tells them when the next doses, so they can't take a dose outside the window that's prescribed they can't overdose account under dose, it's all pre predetermined by the prescription in the device. So where can this really help. So these 2000 OTP clinics out there, their biggest cost are brick and mortar in nursing time, they use primary use nurses to dispense drugs every day to these patients. So again, if the average was 20%, pre COVID, if they could double that, like they did during COVID. Or even get higher, they can either reduce the number of labor they need, they can reduce brick and mortar and more importantly, they can treat more patients. So with the same resources, so you basically have a lot more throughput, a lot more resources, a lot more profitability, the way these things are reimbursed today, it's primarily Medicaid and Medicare, and they pay the same price whether that patient gets the drug in the clinic every day, or they take it at home. So again, if you're a clinic, and you can get the same amount of money, and you have twice as many patients not coming to clinic, what's the bottom line, it's automatic improvement to the bottom line, why you're helping patients, again, with this device, they know when the patient takes it, they can't take it outside the window, if they skip a dose, they know it immediately with real time monitoring. So a very powerful tool for the OTP clinics. So with this, again, we believe and worth work, we've been doing some of the clinics that we can dramatically increase the number of patients to at least the COVID level if not higher, using take home therapy. Some patients who might have only had a week privileges because the clinic wants to see them more just to make sure I can have two weeks, three weeks or four weeks depending on the state. So again, you're basically reducing the burden all these resources, so you can treat more patients and treat them more appropriately. And then you can do more counseling, which they can get reimbursed separately for. And as I mentioned, only about 500,000 Patients are seeking treatment, because this is a huge turn to have to come to a clinic every single day and have someone watch you take a medicine, make sure you swallow and open your mouth show me you swapped it. I mean, just think about the cost and the just the quality of life for that person who's trying to hold down a job. So with that, we think we can dramatically increase the number of patients who are actually being treated, and help reduce these emergency visits and these healthcare costs. So what's the potential for the product? Again, this is our first indication, it's against for, for opioid use disorder, with 2.7 million patients and this growing over time. It really depends. I've just showed you some examples of what percentage of patients who have take home can use this. And depending on that growth, I think it's a 500,000 plus or minus market. And we can the beauty of this market. From a company point of view, it takes a small commercial footprint to actually support this in the market. It's not a huge Salesforce, it's not a huge infrastructure, it really is a relatively small amount of capital to commercialize this product. We have a very, as I mentioned, this is our first indication, which is basically that little green dot down there. And that's the 500 million plus the other indications anything for a child or a senior person that you want to make sure they get the medication, you know, they get the medication adherence is important, and making sure the right patient, so a lot of potential that we look for partners and strategics to help us with that. strong team. Everybody on here has operational experience. This is no but every single person has launched drugs and devices in the real world over 15 to 30 years. And in closing, again, we're using biometrics to secure the delivery. And we're focused on opioid use first, but there's many, many indications, very strong IP, we did get a $2 million dollar grant from NIH and the National Institute of Drug Abuse exclusively focused on increasing take home therapy. Like I mentioned, strong IP so we're really excited and we're on schedule after having about four pre sub meetings. To submit our de novo application this year and the next six months so thank you