Xeris Fireside Chat

And this is used to build a commercial engine and really drive commercial process and sales and marketing, all that. It's very hard to do with just one product.

The other thing that we, you know, so we sit down once a year with our board of directors and we go through, where are we? Where do we want to be? And how are we going to get there? Um, and in January of last year, we S we came to the realization. Getting to critical mass and getting to profitability. We're at the absolute top of our strategic objectives.

Um, there's several ways you can do that. You can grow organically. We can bring more products through the pipeline, but they're very early stage. They're not going to contribute to critical mass and profitability anytime soon. So mergers and acquisitions, M and a became an important part of our strategy.

And then, you know, you look at what you could combine. That number one is in your space. So who's in endocrinology. Do they have products that could add to our portfolio and, or, um, maybe expand into other therapeutic areas that are related? Um, and can we do that while staying very focused in specialty pharmaceutical products or rare disease, um, and strong bridge biopharma was a perfect fit because they had a product for Cushing's disease that was in front of the.

Um, that we analyzed and figured had a high chance of getting approved, which it just did, um, December in December of last year, right at the end of the year. Um, and they had a product for periodic peripheral paralysis, which was doing quite well in the marketplace, um, ultra repair, um, highly targeted physician audience.

And so the combination of the two and they were, their sales level was pretty good. And there was a great deal that they were going to have to do. To launch their endocrinology product, that if you put the two companies together, you get tremendous synergies. So by putting the two companies together, we saved $50 million.

We will realize $50 million worth of synergy of money not spent. Um, we ended up with three marketed products. We ended up with, we finished the year with over a hundred million dollars in the bank. So we created a more substantial enterprise that has a. Pathway to critical mass and profitability. Um, we're not there yet.

There's still work to do there's other steps we have to take M and a is still part of the process. Organic growth is still part of the process and we're bringing some products through, uh, in the pipeline, so long winded answer, but how we got there is very important. Paul, what do you think is your secret sauce?

Um, how do you differentiate yourself from other specialty pharma companies? Yeah. So if you look at, if you look at the way, the biopharmaceutical marketplaces for public companies right now, nobody's got any secret last cause it's just, it's depressed, incredibly depressed. Um, but if you, if you just look at the fundamentals of this company, um, there are very few companies at our stage that have multiple, um, marketed products in multiple therapeutic areas.

Um, there are very few companies that have. Um, the technology to bring more products forward, but I would say the most important thing that differentiates our company and our ability to be successful with that is the team that we've assembled. Um, if you look at the team that is running this company, we've been together in one form or another in one company or another for over two decades.

Wow. Um, there are many people here who. Together back in the Searle days. Um, there are people here who worked at the first company that I built called med point. Um, a lot of people here that were at Durata, um, and there are a few people that have been at all three. So it is all for actually, uh, going back to Searle.

So really in this world, when you're trying to build a company from scratch, how you assemble the team. And what we've done is really differentiated versus most companies in the, in the space. Great. So I'm already getting questions. I'm going to have to deviate from my own questions just because we're already getting his barrage of audience questions, which is great.

We've got a great audience tonight. So, um, it's, everybody's cued in on this. So obviously we've got a lot of, um, academic institutions, not just Rosalind Franklin here, but other academic institutions. Is there as far as Cirrus biopharma, collaborating with academia in any way and any research or a clinical preclinical discovery activities, would you consider and if not, would you consider that kind of activity in the future?

So the answer is yes and no. Um, there, some of the clinical studies we do are highly specialized. Um, there are. Some of them are done in a single site. Um, some are done in the U S some are done out of the country because not everybody does what we do and the chemistry, the product we work with is, um, not compatible in, in every situation.

But we do collaborate with, um, those universities who were in and, um, institutions that are doing clinical stage research. Um, I don't, I don't recall off the top of mind. How many sites we had for the glucagon studies, but those that study was done in multiple sites around the country. Um, we do animal research.

Um, so we work with animal research group. We, we outsource everything. We don't, we don't have, you know, a library and we don't do our own animal research. Uh, we work with all the contract research organizations, um, and depending on the study, um, we go where the. The sites are. Right. Right. So from my superficial analysis of the company, it seems you have kind of two companies within one, a one, a therapeutics company where you're developing your own and marketing and selling your own, uh, therapeutics, particularly in the area of endocrinology, neurological disorders.

And the second is a drug delivery company where you've got several drug delivery technologies where you're actually trying to help other companies improve their, their allergies. Why that business model? Can you tell us a little bit about that? Um, well, the company started with technology and that technology allows us to develop drugs.

So. We could either develop those drugs and sell them to other people or build a, build a commercial enterprise and market that market them ourselves, and the kind of drugs that we develop are improved versions of older drugs. Um, some of which are less attractive to the bigger pharmaceutical companies.

So it makes sense to try to build our own commercial engine and build our own enterprise. The second thing is the technologies themselves in terms of partnering them with other companies is, is early stage. So we have a number of partnerships that are in the demonstration stage that we're working with a lot of companies that have monoclonal antibodies, for example, that are delivered through an Ivy.

We have a technology, a delivery technology of pace, where we can suspend those products, those large molecules monoclonal. In our paste injected and get the same blood levels. Um, those are long-term projects. They take a lot of time, you've got to improve stability and then that company, so we announced recently a partnership with Merck.

Um, once we do our part and show that we can do what we're supposed to do with their drug, then they have to decide if they're going to take that drug into full development and commercial. So that piece of the business as tremendous potential, but it's, it's really earliest nascent to say the least, um, and not really a business yet.

Um, I really liked that the model, because if we prove and what we can do, and we can partner those consummate, those partnerships, then we'll have an engine that. Creating revenue through partnerships using our technology. The recognition of our technology will benefit the public perception of our company and our stock.

And that will allow us to put more time, energy, money, and resource into developing and launching our own products. That's a model that is been very seldom executed effectively in our business. Um, and I think we're in a good position to be able to do that. I'm going to take an audience question here. Uh, that's.

Commercializing a new product is tough and getting uptake in the market with generics is even harder. How does zeros approach this conundrum with its recent approval of and how well is its launch been accepted by the market? I'll take that in reverse order. It's like two weeks old. So who knows yet? Um, you know, we will see, um, yes, it's hard.

It's very. Um, and there are a lot of forces working against a small company launching a product, um, which is why we, we like the whole rare disease area, because it is, you can focus your resources with great intensity, um, it's public knowledge that we have, you know, 18 or 20 people who are calling on. So, number one, we were already calling on all the endocrinologists.

So a drug like correla, we were already calling on the people who would be the primary presenter. For our Jibo product, which is the rescue glucagon. So our ability to target was, um, exquisite. And we have a small team of 18 to 20 that are doing nothing but calling on aggregators of Cushing's patients, which are pituitary centers.

Um, and then we have another 60 or so that are calling on the community endocrinologists doing and record. And some that are in areas where we know there are no Cushing's patients, you know, we've done the analysis of those offices that are just doing voting. So our ability to target, um, for that rare disease, you figured the target population is for drug treated uncontrolled and Cushing's is about 3,200 people.

Not a lot. The drug treated controlled is about eight. So we think the opportunity is somewhere two 30, 208,000 patients, and there you can find them. Um, so, but it's not easy, you know, you've got payers, um, you know, so it's a process, but it's a process that we think is achievable. Yep. Paul you previously started two successful specialty pharma companies, both of which got acquired by larger companies.

What were some of the key learnings, good and bad experiences that helped you shape your ideas for Xirrus?

Um, interesting. So one of the things that we do here and anybody who's looked at the company or. No knowledge of the company culture is, is the be-all and end-all, um, we, we have a, a set of behaviors, one piece of paper with four quadrants that it's all about. If we build our company a certain way, and if we do our jobs a certain way, um, we will build a better company at the end of the day, and it will be more successful.

And we say routinely, every time we have. Um, how we do what we do is more important than the outcome at the end of the day, because that's how you're going to build a really good company. Um, and I think that's been a learning over time with multiple companies. And so this, and the other thing I would say is our focus is designed building a really good successful enterprise.

We're not building a company to get. Get sold, whatever we're building a really good enterprise and we're also building a company that people can be proud of and, and enjoy working for. So, one question from the audience is since the public may perceive your products as just old drugs with high prices, how do you make the value case there?

Yeah. So if you, if you think about it, so glucagon. It's an old drug it's been around. I think since FDR was president, I don't know, but long time. Um, but the, it was in a form factor that was unusable. You couldn't save lives because you couldn't mix the drug while you're having, uh, a hypoglycemic event.

And most caregivers couldn't execute it either in clinical work, people got it wrong, delivered the wrong dose, like 70% of the. Um, number one. So by building a liquid stable version is a tremendous advantage. And by putting it in a prefilled syringe or an auto-injector, it allows for self-administration, that's a huge change.

Um, it's going to take time to get the, get the market growing and get physicians to recognize that and actually do something about it. Um, and oh, by the way, we priced it identical to the 40 year old. Hmm. So it isn't an old drug at a high price. Wow. Um, wow. So, and, you know, record love is, is a totally different version of ketoconazole it's half of ketoconazole and it's the part of ketoconazole carries all the efficacy with fewer side effects and a better safety profile.

So highly differentiable, and that drug will not be priced like the generic. There's no question. Um, but it will be. Pretty much at parody to the other branded drugs. Um, so, you know, in that instance we've taken a drug that was never studied for cushions. Cushing's not indicated for Cushing's, um, has all kinds of warnings against using it in Cushing's and as being used to totally off label, um, with the liability issues for physicians being very high, he took the positive ice, an Adam, or I use the right term.

Built a better drug and priced it to the market last. So I think that's in the benefit of people, you know, in our, our, our drugs are life-changing and life-saving so another question, if I may, um, the focus of zeros today seems to be the U S market you had in your prior life, extensive work overseas. Um, I'm curious, um, two questions in this one is from all your work overseas, working in Asia, Pacific, Latin America, Canada.

What lessons learned from the international business? Do you draw into you building your Xirrus business and are you planning international activities or do you have international relationships with other companies around the globe? Yeah. The number one thing you learn when you're an international and you're working with.

Um, small enterprises and all these countries is you learn, you really learn how to operate in a small company because every single country is its own little bitty company. Um, regardless of whether you're a part of a multinational or not, every country is different. Okay. So you, you really do learn the ins and outs of the business an awful lot better, in my opinion, as opposed to being in a big us pharmaceutical company where you learn a function, functional expertise.

Um, the second thing you learn is the pricing structure for drugs everywhere, everywhere else, except maybe Japan is such that you, unless you're established, unless you've got an infrastructure and you are operating in multiple times, Like a Merck or Pfizer or whatever, you can't launch drugs overseas and make money.

You just can't. So we're not going to establish XUS, at least in the form, at least at the side and who we are today. We're not going to do anything outside the country. We're going to out-licensing our products to other companies. So for example, the rescue glucagon, we licensed to a company called Tetris in the UK.

They just launched it in the UK. The other thing too, is we made a commitment that we were not going to launch our drug outside the U S at the traditional 10% of the U S price. Um, and you know, the company that we contracted with or licensed to made a commitment to pursue really, I mean, better pricing.

Um, and they actually in the UK got pricing, which is about a third of the U S. Which is a tremendous achievement. Um, and so throughout, and now they have the, the ability to go and, um, launch in the rest of Europe and they're pursuing, you know, regular pricing. So it's not the us paying for the rest of the world to get drugs.

Um, and you know, those, those areas, those places where, um, you, we would otherwise be forced to sell at bargain basement prices. We're not going to launch the drug. We won't launch the drug in Mexico for. Right. Okay. Your audience question. Um, you obviously, with the acquisition of strong Briggs, you brings you an additional portfolio of products, uh, for your pipeline.

Um, are you to further expand your pipeline in the future? Will you go earlier in development or will be MNA be the strategy to. Or products, or would you anticipate going a little bit earlier pre-clinically to find technologies that might be either in universities or earlier stage biotech companies? So most of the above, not all of the above we're we're not going to go earlier and, and pursue more technologies.

In the short term, we may end up with more technologies through M and a, um, So, you know, there's always the possibility that we could do additional M and a with companies that have products and technologies, but to go add technologies in a preclinical stage, it's just not affordable for a company, our size.

Um, that being said, our current technologies, we have drugs that are preclinical, um, preclinical, and first in man, um, we have, uh, So interesting that two to one of the earlier questions that you take old drugs, you make them better. There's an old drug called levothyroxine, which is one of the largest prescribed drugs in the world.

Um, it's an oral once a day, oral or daily oral. And you would think that turning that into a, an injectable would be kind of, it doesn't make sense until you look at it and you see that a large percentage, maybe 25 or 30% of patients on levothyroxine. Um, absorption issues and, um, can't tolerate the oral dose.

So we're currently in phase one with a once weekly subcutaneous injection, if that works and we get a once weekly subcutaneous injection for 30% of the legal thyroxine population that has the potential to be a very big. Yep. So we're, we're, we're, we're doing early stage with the technologies that we have.

Yep. Very cool. Very cool. Uh, we have a number of bio entrepreneurs in the audience that are trying to build new companies. Um, what are some of the hard lessons that you've learned that you can impart to them in their own frustrations and trying to build a new company on. Uh, it's, it's hard. Um, and it's, it gets harder every day.

Um, you know, the, the, the most important thing, I mean, I think not most important, but one of the important things that I've learned over the years with multiple companies is who you build it with, um, and where you get your funding and the degree to which you're all, you all have the same motivations and the same desired outcomes.

Um, Yeah. You know, we had a company a while back, um, that the investor set we're always on the same page. Um, and that makes it, that makes it very, very hard. Um, so, you know, it's not just getting the money, but it's getting from the. I think people who have the same vision at the end of the day for what it is you're trying to build.

Um, the second, the other thing I would say is, you know, reality being realistic about how hard it's going to be, how long it's going to take, um, and what you have to do to get there. Um, and putting the right people, the right place. You know, I have together know there's mathematicians and they're scientists, and I have none of the above.

Um, what I've learned to do over time is to surround myself with people who know that.

So great. Another audience question. Um, tell us what you, without again, going into a forward-looking statement, uh, w how do you seize your as a farmer three years from now? What do you envision it to be? Yeah. Um, so I've been very public about the fact that, that we're trying to build a, um, fully capable pharmaceutical enterprise.

When I say fully capable, it's the ability to preclinical all the way through commercialization, um, formulation, chemistry, which is before preclinical all the way through commercialization. We don't want to be in the manufacturing business. We don't want to be in the clinical trial business. We don't want to be in the, you know, the animal research business.

We want to contract all of that, but we're, we're here to build a substantial pharmaceutical enterprise. With multiple products in multiple therapeutic areas that has a, a commensurate market value. Now I'm not going to say what that is. I'm not going to say what our vision is, because that would be a forward looking statement.

And all of the investors in alias will hold me to it. Um, but you know, we're, we're growing our business and, you know, our goal is to be, um, a substantial. Great. So, um, we're, we're getting down to, it's hard to believe how this time has gone by so quickly. Uh, uh, another question perhaps one of the final questions, but there, uh, if there are other audience questions quickly, please send them in, um, you know, a key topic.

Today's diversity of diversity within the company, but diversity within health care. The whole concept of healthcare inequities. Uh, we've seen obviously with COVID play out these, all these healthcare inequities, how does Xirrus look at diversity a was as part of your company culture within the company.

And, and then how do you look at it? Diversity as part of your strategy in terms of healthcare, diversity, different populations you're looking at, um, et cetera. Yeah. In healthcare diversity, the populations are the populations there's, you know, with our kinds of, um, drugs. So anybody who's on insulin is part of the audience we want to talk to for our rescue glucagon product.

So, um, it's, we don't have to differentiate between populations because if you're on insulin, you're at risk for a severe hypo, and that could be very dangerous. In Cushing's for example, it's 80% of the people with Cushings are women. Uh, so they, the therapeutic areas sort of dictate how we approach that.

Um, clinical trial wise, you always have a diverse population in clinical trials because that's part of the FDA process culturally. Um, it's very important to us, the diversity of thinking and diversity of ideas and, um, diversity of culture. And. Um, how you view the world at the end of the day makes us a better company if we embrace those things.

So, you know, we, we talk about that a lot. We have a diversity equity and inclusion process. Um, you know, so, and if you look at me like our board, for example, everybody's saying, you know, you've got to have a diverse board. Our board was more diverse than just about anybody that any you'd look at in our sector.

Very early on. Uh, so that's the important part. And that I think Paul, um, I would love to go on, we could probably go on, uh, unfortunately we're getting near the top of the hour here and we want to be respectful of your time and the audience's time. So I would, first of all, like to thank you and personally give you kudos for these insights into, uh, zero biopharma, but also into yourself and your.

Um, and we thank you for elevating our whole Chicago biomedical biopharma industry with your leadership. And, uh, thank you so much for, for sharing your thoughts with us tonight. Thank you. I appreciate it. I mean, I love talking about our company and I love talking about, you know, what we're trying to do.

Um, and I love doing it in Chicago and, you know, that's, that's an important part of why we're here because we want to help build the Chicago. Um, biopharmaceutical sector. Great. Thank you again, Paul, Tom, back to you. All right. Thank you, Paul. Thank you very much. Incredible. Um, by the way, this is probably one of the most, maybe the most engaged crowd we've had at least in recent memory.

Um,

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