Leonard Mazur: Founder and CEO of Citius Pharma

Leonard Mazur, founder and CEO of Citius Pharmaceuticals, shares his thoughts with BioBoss host John Simboli about leadership in biopharma and how Citius is working to unlock the potential of first-in-class critical care therapeutics, with a pipeline of anti-infectives in oncology, adjunct cancer care and stem cell therapy.

Transcript

John Simboli: 0:12

Today I'm speaking with Leonard Mazur, co-founder and CEO of Citius Pharma, headquartered in Cranford, New Jersey. Welcome to BioBoss. Leonard.

Leonard Mazur: 0:51

Hey, John, it's a pleasure to be here and thank you for having me on your program.

John Simboli: 0:56

What led to your role as co-founder and CEO of Citius Pharnma?

Leonard Mazur: 1:00

I started out in the pharma business with a company called Cooper Laboratories. That company was really my foundation, the company made 150 acquisitions, if you can imagine this, and what happened was, I started out in field sales and within a two year period I was promoted to being a market research analyst. And then, ultimately, product planning or product management and then was suddenly promoted to strategic planning and acquisitions, as well as managing one of the company's business units. So what happened there is the company made so many acquisitions that that they ultimately rationalized them by creating medical specialty silos. So I did the very first one, I wrote the whole strategic plan for it and everything. And it was in ophthalmology, and it was a company that became known as Cooper Vision. And we took that from about a $10 million dollar revenue base to $600-$700 million, in about a six-seven year timeframe. The company became one of the most successful vision care companies in the business. Today, it's part of the Cooper companies headquartered on the West Coast. I then also formed a dermatology unit called Cooper Derm. And Cooper Derm, had Aveeno as its cornerstone brand, which was interesting in those days when I contrast that to where Aveeno is today. It was a great place to be, had a great CEO. I learned a lot from that CEO. His name was Parker G. Montgomery. And he was incredible, probably one of the best dealmakers I've ever seen. So, from there, I went to BASF to their U.S. pharma group as a director of marketing, I launched a little brand called Vicodin, as well as a calcium channel blocker, which was one of the very first calcium channel blockers introduced into the U.S. market at that time. I spent four years there then went out to the west coast as the Vice President of Sales and Marketing For ICN Pharmaceuticals. And I launched Ribavirin, which initially was approved for respiratory syncytial virus, which is in the news these days, much more than it was then. And ultimately, that became a mainstay in the treatment of hepatitis C. And, as I always like to tell everyone, my wife did not like paradise, living in beautiful Orange County, California. I had to move back to beautiful New Jersey which was really interesting for me to do that. But nevertheless, at that point, after a brief stint with a small biotech company on the West Coast, I became the Executive VP of a pure startup company called Medicis. And Medicis was in dermatology. We had zero revenue, and we raised all of $8 million net on a giant IPO through D.H. Blair. I used to call them the underwriter to the stars. And ultimately, what happened was I in-licensed a bunch of prescription drugs and then out of whole cloth, more or less, I created a branded generic. I went to a generic manufacturer of Tretinoin, which is retina, and had them brand it up for us. Everybody predicted failure. It became hugely successful because if dermatologists believe in a company, believe in a product, and really they wrote scripts, and it took off, and ultimately, Medicis sold out to Valiant. And I went on my own, I became an entrepreneur. So I decided, after working for mostly all entrepreneurs except for my brief stint at BASF, I had a chance to really learn from each of the entrepreneurs that I worked for. That probably implanted in me an extreme desire to go off on my own. Which I did. And at the wrong time, by the way, from an age perspective. I did it when I was 50 years old. And I started a dermatology platform company, myself, no venture capital backing, nothing. Hocked everything I had, at various points in time, signed over my house several times. And that really helped formulate, and kind of provided me with more or less a platform of what an entrepreneur should be all about. I happen to have a philosophy that an entrepreneur should be all in. And that if you're asking investors to take a risk, you should take a risk alongside him as well. So I'm not one of those that does it for the stock options, which is very prevalent, very common. So I'm a lot different, in that respect. I learned that along the way, because as I was developing, but my derm platform company, was called Genesis Pharmaceutical, I had to go in, I had to basically sign over my house. And ultimately what happened was, I did manage, I sold a company to Pierre Fabre ofFrance, one of France's largest pharma companies. And then, after several years as their CEO here, I decided to go off on my own, this time with a partner. We would pick up older brands that were off patent from the big guys, and then repurpose them, relaunch them and then sell them off to somebody. So we did that several times, successfully. And ultimately, that led to the creation of Citius. We formed a company it was a private company, myself and Myron Holubiak, who was the former President of Roche laboratories. I'd known Myron for a long, long time. And we did it to in-license a drug from MD Anderson, an antibiotic lock solution for treating infected catheters, sterilizing them, actually. We had the company as a private company, we funded just about all the phase II-B work. And at one point decided that we really had to have a public entity in order to raise more capital to complete the research. So we merged in with Citius, which was public, and got a NASDAQ listing. That was like 2017. We started the company in 2014. And from there expanded to research for that antibody lock solution into a phase III trial. Along the way, we we raised capital numerous times, but we also invested, co-invested along with those raises. So at this point, I have$22.5 million of my own money in the company. And Myron has about$4 million of his own money directly invested in the company. Not in stock options, not anything like that, but direct investment. We believe in having skin in the game. And we believe that if you're an entrepreneur, if you're asking people for money, you better put your own funds in there if you can.

John Simboli: 8:48

What made you ready to make the leap into being an entrepreneur? What was the draw?

Leonard Mazur: 8:53

I always like to say I had that itch and I had to scratch it. What it really was, it was the fact that it was working for people like Parker Montgomery at Cooper, Milan Panić at ICN, watching what they had done, what they had accomplished, and building a company made me think that, you know, I can do that. And I thought to myself, if I didn't take the plunge, I would regret it forever. I had to take that plunge, I had to do that. So there was something inside of me that was really, truly motivating me to do that. I don't come from a business family or anything like that. My parents, I was born in Germany. I came as an immigrant, actually, from Germany. My parents were from Ukraine. And so I always said the two best things that happened to me were coming here as an immigrant, and the second part was I grew up in a row house neighborhood in Philadelphia, With that type of a background, you know, especially when you come as an immigrant, you see lots of things, and you get motivated in a lot of ways to succeed. And I think there's a drive inside of you. I can't even begin to describe it. But there's a drive to take a risk. And I'll admit, I'm a risk taker. One of my favorite sayings is, if you're not sitting on the edge, you're taking up too much space,

John Simboli: 10:32

Once you made that decision that you were going to land both feet into the entrepreneurial world, and you began to experience it, do you remember how it was compared to your picture of what it was going to be like? What was the image ahead of time, what was the reality of being an entrepreneur?

Leonard Mazur: 10:51

I thought I would get there, I would have success pretty quickly. But the opposite was true. And it was a very painful process initially, Where I think I was fortunate is that

John Simboli: 11:06

What was it about the Citius possibilities that I was able to use utilize the relationships I had with various folks in the industry to really enable me to really lift the company up and get it going. So the way I got started initially is I had no research , , ,, I'm not a chemist or anything like that. I'd invented nothing. And what I did is there was a small company, a dermatology company outside of Detroit, Michigan, that I knew the the owner of it for a number of years. He was very skilled, he inherited the company from his father. And it was a family owned business. They had hardly any sales and marketing, hardly any sales at all. So I finally worked out a deal with him, where I agreed to put together a small sales force calling on dermatologists. He had a product line that you could actually sell into doctors offices. So it was a dispensing businesses, as they were known. So I managed to work out an agreement with him to to sell his product line to put together a salesforce. I would earn a percentage of the sale. And ultimately, as that progressed, I worked out a second agreement with him that I could buy out his business at a certain price after a certain period of time, which which worked out and I managed to put the funding together for that. It had its own little manufacturing facilities, everything in Hazel Park, Michigan. Instead of using my own sales force at that time, I contracted with, I had a special deal with a few . . . I don't know if you remember MMD, Medical Marketing, Distaff. It was one of the very first contract sales organizations in the business, I managed to work out a deal that was pretty favorable. It allowed me to go in there and start all that up with minimal expenses. So they worked with me until I could get enough cash flow coming into the company. So that's how I got started. And again, it was it was on a relationship basis, all the way. made you think that's what I want to develop?

Leonard Mazur: 14:00

I took a whole different approach with Citius because up until that point in time, I had worked strictly with revenue producing drugs, strictly. I was all about top line. And so, at one point, my business partner and I, we owned brands, like Inderal, we had a giant manufacturing facility, a million square foot that we acquired at one point. I mean, we had to several drugs like that, but everything was always about the top line. I'd never really gone into a situation where it was about the constant raising of capital to fund your research and engage in the long game of an approval process. That was about as far away from me at that time. When we started the company, myself and Myron, we had several different possibilities that we looked at, then we settled on that one for that drug from MD Anderson. And so, it was the start, that was a 505b2 kind of project. So we were really much more of a pharma company, but engaged in a research effort to get a drug through the process. What happened here is, as we went along, we had a great relationship with our bankers, and we raised a considerable sum of money from them. At one point, right at the height of the pandemic, it was like unbelievable, and as a result, what happened was, the opportunity to go into biotech suddenly came up. There was a drug for cutaneous T cell lymphoma, that had a history to it. It had been originally developed by Ligand. And then Eisai, the big Japanese pharma company, acquired it from Ligand. It was on the market for about three years. One of the conditions for approval, they had a phase IV requirement to reformulate the drug. They had to take out some unfolded proteins. And they did and when they went back to the FDA after they had completed . . . what happened was, they took the drug off the market while they were doing a reformulation work. It was an inventory issue, they either devoted inventory to revenue or devoted inventory to the project. So they decided to do it to the project. When they completed it, the FDA told them that they had a brand new drug, and they had to start all over again, they had to do a phase III study. And the way this went, it was kind of interesting. They got started with that phase III study in 2014. Somewhere around probably 2016, somewhere in there, they out-licensed the drug, to Dr. Reddys of India, the big Indian generic company, Because Dr. Reddys was on an expansion program at that time, to expand into the branded side of the market. They were heavy into dermatology. But this drug is really an oncology drug. So somewhere in 2020-21, somewhere in there, they decided to suddenly divest all their branded holdings. And we were contacted by a banker to see if we were interested in bidding for this asset, which by then, they were down to their last patient on a trial that had taken them seven years. So we bid on it, and we won the auction. We took a risk. And it was sizable, we put $40 million down. For us, that was a big, big risk, but we did it. And within three months of closing the deal, the last patient was completed. A couple months later, top line data came in, and we filed for a BLA several months after that. The BLA gets accepted and along with that, we still have our our antibiotic lock solution. We also have a third drug. That is again, not a biotech drug at all. But it's just so far afield from where we've been. It's a hemorrhoid drug. The reason we have it is because when we merged in with Citius, they had it their portfolio. We weren't going to keep it. But we took a good look and realized that we had an opportunity to monetize this for our shareholders. And the reason being is because believe it or not in the 21st century, there is not a single FDA-approved prescription drug for the treatment of hemorrhoids. You have the over the counter side of the market, which has Preparation H and products like that, but they're not prescription. And it's a giant market opportunity because there are literally millions of patient visits to physicians offices for hemorrhoids.

John Simboli: 19:46

It sounds like you've made a series of decisions to try new things which a lot of us don't do. When you made that decision to move from the revenue side of those kinds of charts you're describing towards something that was R&D based, did you say to yourself, What am I doing? Or did you say to yourself? Yeah, I'm ready for this, I need a new challenge?

Leonard Mazur: 20:13

That's a combination. I can't say it was black and white either way. Some days, of course, I would say to myself, Why did I do this? I would say that, but I was, and I remain confident that we will succeed. It's about creating value for the shareholders of the company because I think that's an important driver for me. I always like to emphasize the fact that my interests and the shareholders interests are totally aligned. Totally. They have to be; they are. So as a result, I'm going to do what's best for the shareholders of this company.

John Simboli: 20:59

I have this picture right now, of someone who hasn't seen you for a while, or a better example, maybe someone that you've been introduced to for the first time, maybe it's through a family connection. But anyway, someone who doesn't know your work life. And they say, What do you do for a living? Leonard? They know that you're a CEO. Do you think they picture you in a lab coat? And what do you think they think you're doing? And what do you do each day?

Leonard Mazur: 21:25

I think a lot of people that I meet like that, do think that, that I come from a technical background, etc., which is the furthest thing from the truth. I'm a business person, and who happens to be in the biotech pharma industry. And as a result, I have to become very familiar with what the business is all about, including the technical side, as well. So I always looked at it this way, that whatever the product was, that I was involved with, I ultimately would become a real expert in that product or that drug. I think a number of us that are in the pharma business that don't have technical backgrounds are like that, for the most part. You have to be because you've got to be able to communicate with different people along the way where most of the communications and most of the dialogue is on a technical level, even more so at this point. Because when you're on the research side, you've got to then all of a sudden, now you're looking at discussing much different things than just revenue. So it's about the data, it's about the mechanism of action, it's about potential side effects. It's about what the possible indications are, where this drug could really work. How does it compare to others in the market segment that you're in. So you better get yourself well versed, or as well versed as you can be, in terms of that.

John Simboli: 23:21

You've had that conversation you were just describing and the person understands . . . now you're not you're not in a lab coat, you're a business person. They also realize that you've got a team, you've built a team, and I'm sure everyone can understand that. But how do you explain to them what you do all day? In other words, do they picture you then reading through manual after manual, publication after publication? Becoming an expert as best you can about science? Which is part of it. Or is it communication with your team? Or is it talking to investors? How does how does your time go by each day?

Leonard Mazur: 23:54

I do spend a fair amount of time with the team members going over and reviewing different things. But then at the same time, I'm running a public company, and as a CEO of a public company, I have shareholders, I have other obligations, I've got to be thinking, all the time, also about the financial side, about, about fundraising, about how to maximize the company and its presence in the marketplace. You're judged many different ways when you're running a public company, including, the fact that your stock price, which you may or may not have anything to do with, but the reality of it is you do have something to do with it. Because

John Simboli: 24:42

When you were a young guy in, in Ukraine, or when you're a research based company, the only way you can be really effectively judged is by your results. And the results mean your data. So the more data you generate, hopefully, you'll be be rewarded accordingly, in terms of how the marketplace looks at you and values you So I've got to deal with that constituency all the time, as well as those that would be instrumental in helping us in terms of raising capital. So you have to have relationships, on on all sides. It is very much a relationship-driven position, especially when you're running a publicly traded company that's in biotech and pharma. maybe when you were in Philadelphia, and you had this self image of what do I want to be when I grow up? It probably had something to do with what you might have thought your parents wanted. Because that's, I think that's natural at that age. Can you remember what it was you pictured yourself doing? And it doesn't have anything to do with what you're doing professionally now?

Leonard Mazur: 25:59

I can recall certain things for sure. I'm from Germany. My parents were from Ukraine. Just to correct that for you. So I remember at one point, I was pretty young, I thought being a state policeman would be really the thing to be.. That was one,. Two, believe it or not, I was an altar boy. And the priest of my parish always insisted, whenever we had funerals, that the undertaker send a limousine to pick me up and bring me to the funeral home and to the church for the services. And at one point, I thought those undertaker's had a great lifestyle. It's really funny, isn't it? They were always dressed in these pinstripe suits. And they'd take big, long, black Cadillacs. The whole bit. When you're growing up in a row house neighborhood, there's some things that you can look up to. So it was either look up to the priest or look up to those guys. But you have different aspirations. I certainly had no aspiration for the pharma business, I had none. I had actually probably no idea about it until I graduated from undergraduate school. I didn't even know it existed, because I was a psychology major in liberal arts. What I call it is the random walk through life. Ultimately, you come across something that is going to be really appealing, and you gravitate towards it. And hopefully, it all works out. It's certainly worked out for me that way.

John Simboli: 28:19

You built a lot of partnerships, it sounds like over the years, and in the businesses, through the relationships you have with people. There's also the partners as in a big pharma partner or an academic institution partner. There's, lots of different ways a company can have a partner, but let me just ask it and take it a direction seems right. But what makes a good partner for Citius?

Leonard Mazur: 28:40

We have a great partnership with, for example, with MD Anderson, the Cancer Hospital in Houston. And, in particular, with the chief of infectious disease, Dr. Issam Raad, who invented Mino-Lok, that's the antibiotic lock solution that we have. They're a great partner to have, because they're very supportive. We have a great relationship. They know they can pick up the phone, call me or call anybody in the company, and vice versa. So from an academic side, I really value that relationship that we have with them. One of the things that you have to be able to engage in is your manufacturing sources because we don't do our own manufacturing. So those CDMOs are really important to the company. So we try to maintain as positive relationship as possible. And the one thing that I try to encourage our people, everybody in the company about is, that is the FDA. The FDA, in reality is our partner, because they're that important to us. Your future, and your whole existence as a company is dependent upon them. So why wouldn't you treat them as a partner?

John Simboli: 30:21

Thanks for speaking with me today, Leonard.

Leonard Mazur: 30:23

John, thank you for the time and the effort that you put into this. I really appreciate our dialogue.