Berkshire Biomedical | John Timberlake, President & CEO

(Transcription)

John Timberlake  0:03  

So Berkshire biomedical we are a medical device company. And our lead compound or lead product, as you can see in front of you is we call it the computerized oral prescription administration system. That's a mouthful, so we call it COPPA. So what COPPA is, it's a handheld, automated personalized medication delivery system that is designed to deliver very accurate and precise doses of both controlled and non controlled medications. And it's doing that through the use of authenticated only upon an authenticated user identification using biometrics, in addition to the delivery of the medication, and incorporates remote monitoring, it does not require the patient to have an input into that, and advanced analytics, so that we can truly improve medication adherence. But very importantly, we can also really enable the physician to make more informed decisions or better informed decisions. So I think everybody who's been in this space knows that one of the biggest challenges all chronic diseases and chronic medications, is medication adherence, and I'm not going to read all this stuff, because it's a big problem. And it's no matter what the disease category is, it cost us a lot of money in the healthcare system. And it results in poor health care. The heart of the issue is really, the answers to a couple of simple questions that we just don't know, is is the medication that's prescribed? Is it really used by the patient in the right amount? Is it used at the right time? And very importantly, for some drugs? Is it used by the right person? So once a physician prescribes medication? And does that hard work to diagnose it and prescribe the medication? Once the patient leaves the clinic, the Commission's office, it really introduces Boyd, there really is no true knowledge. What happens after that? Does the patient even pick up the prescription? Do they use it at the right time, the right amount? What did they go on and off the product to somebody else use the product. And what that leads to is essentially, our physicians, you know, basically practicing medicine blind in the senses, they have to rely on the patient telling them they used it. And what happens is so many times the drugs is either the dose has changed, the medication has changed, procedures are ordered. It's just a big waste, and the patient loses in the end as well. So we looked at a bunch of therapeutic areas that have a need to improve adherence, as well as what's important to make sure that the patient who's prescribed medication gets it. And we are focused on this top right corner, there is a huge need to address the issue of using opioids for patients, especially with chronic pain, as well as patients who are using opioids to actually address opioid use disorder or addiction. So you need both adherence, compliance as well as control and security. So that's what we're going to focus on initially. Despite the significant opioid crisis, we are all have gone through over the last 10 years. Probably longer than that, there still remains a real clinical need to treat patients who suffer from pain. And with proper products, because what's happening is a lot of them are now seeking illicit drugs. And we see the consequences of that in this marketplace. While we need to also reduce that improper non medical use. So if you look this 2018 in Iraq, about 75 million people in 2018, were using opioids prescribed opioids, I'm going to drill down, there's 15 million of them who are using it chronically. For things like chronic pain, I want to go down even deeper than that, there's 20% of them have been identified as part of the system before you put a patient on opioids anymore or keep them you have to assess their risk for abuse, and 20% of them are considered at high risk. And that's 3 million patients that really cost a lot of burden and in an effort to try to control those patients, so they don't abuse the product. And back in 2016, the CDC issued guidelines, and we really issued a lot of constraints on opioid use, try to prevent and detect improper use of them. Now, a lot of these things are very burdensome, they're expensive, and in the end, they just are not as effective. And the main reason they are not is because nothing to date really gives us the assurance to understand whether the patient who took the product, actually ingested the product actually took the product. We can use machines to make sure they're the ones who took the pill out of the machine, but we don't know whether they ingested it. So now if you look at the nearly 2 million people who are trying to overcome their addiction with opioids and licit drugs, but half of them and this number is going to skyrocket, if you look what's gonna happen during the last few years and COVID If you look at the 500,000 patients who are actually utilizing an opioid to get over their opioid use disorder, such as methadone here, they the big challenge errs, they have to go to a clinic, the vast majority of them every single day, wait in line and take this methadone, this opioid under supervision because they are not trustworthy. The in their system do not allow us to trust them to take medicine home. So this has a huge cost and burden to the system. And again, these are people who want to get over their addiction. So they're trying to hold down a job and trying to get back on their feet, but they are stuck having to wait in line and sometimes in rural areas drive hours to get this medication. So if we can truly have a tool that allows more patients to take medicine home for one to three weeks at a time, and then come back for counseling, you can dramatically increase the throughput of these systems and actually help these patients maintain their jobs and get back into society. So we believe COPPA is the solution because COPPA really on the left side just focuses on very accurate precise delivery down to like a point to five millimeter accuracy. It's also has great compliance and automated controls, sell their controls, great analytics to make decision making. And then the security I talked about the device will only work with that patient that it's been set up with based on your biometrics fingerprint in a my mouth bite or denotation. So this is the COPPA, you can see a picture of the Coppa is essentially it's a handheld, private sizeable water bottle. And it does basically it allows you to see the fingerprint scanner there, which is really a thumbprint scanner, and then the mouthpiece that the patient would basically softly bite on, and that would actually capture their indentation. And everybody has a very unique denotation. So only when those two are used simultaneously, will they with a product live or a drug. So here's a quick little video on the product. So the product basically can be used there one or one or two rounds. And for bottles from the pharmacy. Once the pharmacist fills it, they would basically put this cap on the top, the cap cannot be removed. So smart cap and is tamper proof, they device or text message will tell them when it's ready to deliver the dose, they will then put their thumb onto the reader, once it recognizes that thumb, they will tell them put your mouth in the mouthpiece. Immediately when the device recognizes their teeth, it will deliver drug the liquid drug directly into the mouth onto the tongue. And then the device tells them when the drug is delivered, it stopped. So if that patient had to take it out of the mouth before it was done, it stops delivering it, they can't start it and divert it into a cup or something else. And so really were designed around making sure only that authenticated patient is the one who gets the drug. So if I look at the potential for this product, and just these first two initial therapeutic areas, again, I started to 75 million patients, I drill down to 15 long term users and then I drill down to only 3 million. So I'm really at a very finite or very defined town here. In base, you have 3 million patients high risk, high risk of abuse. If we were to capture, say 14% of them, that'd be about $1.6 billion turnover. We did market research with high prescribers of opioids. And with this product, they would move their patients using orals, or liquids about 30% of their high risk patients over. So again, we have more work to do that was based on your initial review of the product. We also look at the other indication, which is again delivering methadone, which is an opioid to help control controlled opioid use disorder or addiction therapy. As I mentioned, roughly 20% of patients have the privilege to take some product home periodically versus every day. So if we could increase that to 40% or 50%, we could dramatically not only drive revenue for us, but very importantly, these clinics could actually treat to three times more patients than they're treating today. And we think this is going to balloon based on our research. More patients would be would be more willing to go through this treatment if they didn't have to go to clinic every single day. So I think we have a strong team we put together cross discipline people drug medical device, very importantly, cybersecurity experts, regulatory manufacturing, so a very strong team. And so in conclusion, I think we are really, truly going to create something that's going to change the way drugs can be delivered. Patients can be monitored interacted with and really drive compliance for very important products. In addition to the opioids we know that we could use this for products like Alzheimer's, epilepsy, ADHD, bipolar, so there's just a lot of potential for this product. We're working closely with the FDA. They've been very cooperative with us. We've had multiple precepts. They want us to have a very successful de novo filing, which we will be doing this year. And we have strong patents in the US issued as well as in major markets. So with that, I thank you very much for your time.