John Simboli
That’s the voice of John Temperato, President and Chief Executive Officer of 9 Meters Biopharma, headquartered in Raleigh, North Carolina. Listen in now to hear John’s thoughts about leadership, and how 9 Meters Biopharma is advancing drug candidates for patients with rare and unmet gastrointestinal disorders including short bowel syndrome and celiac disease.
I’m John Simboli.
You’re listening to BioBoss.
John Simboli
Today I'm speaking with John Temperato, President and CEO of 9 Meters Biopharma headquartered in Raleigh, North Carolina. Welcome to BioBoss, John.
John Temperato
John, thanks for the opportunity. I appreciate the invitation and look forward to having a chat with you.
John Simboli
What led you to the role of President and Chief Executive Officer at 9 Meters Biopharma?
John Temperato
John, I've been in the biotech/pharmaceutical world about 30 years and at the beginning of my career I really didn't have an aspiration or say to myself, I'm going to be a CEO, or I wanted to be a CEO. I always thought about my career, as is the current job, and first of all you had to execute in your current job, is something that's going to lead me to a job I would be more interested in doing and more exciting for me. So that's sort of always the way I thought about my career. And the nice thing about biotech and pharmaceuticals, if you can't get inspired doing this type of job, or this being in this type of business, I don't know what can inspire you because at the end of the path, you're making a meaningful difference in patients lives.
John Temperato
So that's part of it. And I think the exciting thing about 9 Meters is it's a therapeutic category I know exceedingly well. Gastrointestinal disease is a therapeutic area I've been in for probably a third to half of my career, and it's a nice community. It's about 10,000 gastroenterologists, another couple 1000 hepatologists, so it's manageable. It's a tight community. And I'm excited to have the ability to spend a lot of my career in that therapeutic area.
John Simboli
And having had that experience of working for a long period of time in the biopharma industry and having lots of different experiences, what was that process like to decide, OK, now's the time I want to be the CEO, or now's the right time for me to be a new CEO?
John Simboli
I think becoming a CEO is about opportunity and putting yourself in the right place at the right time. And making sure that you put yourself in a position where you're able to succeed. So, do you have a board that's supportive? Do you have a board that understands? Your alignment and support is really, really critical. So I think it's a combination of sort of a long and winding road and then just once you have the opportunity, Is it the right fit for you? And are you putting yourself in a supportive situation and an aligned situation?
John Simboli
When you had the picture of what it would be like to be leading a biopharma company and then you stepped into that role and you began to do it, how was what you thought coming in compared to what it turned out to be?
John Simboli
I think the difference in leading a company versus leading a function is when you lead a function, you have to be that content level, expert, right? So if you're a CFO, you want to be that content level expert, if you're a chief medical officer, you want to be that content level expert, same thing, Chief Commercial Officer. When you're the CEO of a company, it's more like, I don't know if there's a content level expertise for a CEO per se. But I tried to describe this to my daughter the other day, it's almost like being a for lack of better word of puzzle master. So you want to make sure that pieces are in the right place, the right people are on the bus, you have the right processes in, you have the right strategy. So you know, I don't know more than my CFO about finance. I don't know more than my CMO about drug development. But I think I'm pretty good at communicating a vision and getting people to understand how we're going to get there, and why we're going to get there. Most importantly, why.
John Simboli
What were you hoping that you could achieve at 9 Meters Biopharma and maybe not at another company?
John Simboli
In bringing 9 Meters public, and then now that we've been in existence for about seven months—and by the way, 9 Meters is the approximate length of the GI tract and speaks to our dedication to the area. But I even wanted to have a clearer and more unwavering commitment. And what I mean by that, I didn't want to be the 10th bowel prep or the 20th product for mild to moderate UC in adults, we wanted to be more selective. So that really was the vision is really to focus on rare and unmet needs in GI and being very selective. I think, you know, being the 10th or the 5th product in a therapeutic category had its time and place but I think those days are long gone, where you're gonna be the 20th and antihistamine and shows a slight slight reduction in sedation rate versus the next one that's marginal, at best. So I think the key is being very selective and trying to make a real difference.
John Simboli
When someone who doesn't know you and doesn't know your profession, just you meet them socially, perhaps, and they say, John, what do you do for a living? How do you answer?
John Simboli
We want the company to be elite without being elitist. So I would never say to somebody, I'm the CEO and President. That's just not how I'm wired. I would say to somebody, I work for a biotech company that's focused in the GI therapeutic area and we truly are focused on rare and unmet needs. And I will try to talk to them about, we have two co-lead assets, one celiac, and pretty much everybody knows what celiac is, you can't go to a supermarket without seeing a gluten-free diet aisle, right. And then then I try to educate them about what short bowel syndrome is, and what the heck that is, and why it's a horrible disease. It really is debilitating for patients that suffer from it.
John Temperato
Everybody who runs into somebody in our industry should feel first and foremost like we're trying to improve the lives of patients. That's why 505B2s aren't interesting to me and, you know, the 7th or 20th product in a therapeutic category, I just think the industry is better when self-polices, and truly innovates for the betterment of providers, payers, and most importantly, patients.
John Simboli
I spoke once with a CEO who said, you know, I'm a chief executive officer, yeah, I have to make the decisions. But I'm also a Chief Education Officer. I spend a lot of my time trying to educate people about the process that accompanies the therapeutic condition. Do you spend much of your time in that realm as well?
John Simboli
I think as much as you're an educator, you also have to be a listener. I learned a long time ago, and I don't know if controlling your conversation is the right way to put it, but you do a lot more to impact the conversation by listening than you do by talking. So you know, I try to be a really good listener. I try to make sure that everybody is heard; it doesn't mean that I'm going to agree with everybody, or that we're going to go down that path. But everybody should have the right to be heard. A long time ago, somebody told me that you should treat feedback, like pearls of wisdom, and what you do with those pearls is up to you. So I tried to do that.
John Temperato
I think early in your career, you spend a lot of time as—I don't know whether it's a youth thing or an inexperience thing or what it is—but I think early on, especially when you're in your first management job or leadership role, you spend a lot of time on the "what's." "You need to do this. You know, here's the timeline, I have to have this." I think the more experience you get, hopefully, and this is definitely something I've learned and, hopefully, I did it relatively sooner in my career than later is, the "why's" are the most important thing. So you have to spend a lot of time and everybody should know just not the "what's" But the "why's." Because if people know the "why's", then it becomes not motivational—inspirational. And you'd always rather inspire somebody than motivate them.
John Simboli
When you were of age to be thinking about, you know, what interested you, I don't know, eight, nine, 10, whatever it might be, can you remember that far back, you remember what it was you thought, maybe, your parents thought you should do or what you thought you should do in life?
John Simboli
Well, there's two things. I played a lawyer in a second-grade play. And my mother, from that day, thought I should be a lawyer. I have no interest in ever being a lawyer. But that was funny. But I remember going to work, my dad was an executive with Colgate Palmolive. And I remember, Colgate's offices, if you don't know, are right on Park Avenue, literally right across from the Waldorf Astoria. So I remember going to work with my dad as a kid, I think was probably maybe fifth, sixth, seventh grade, some somewhere in there. And I got to hang out with the advertising department. This is probably after sort of the "madmen" generation, but I thought, Wow, it would be really cool going into advertising for a large consumer products company. And just to create an ad where people are buying your products because you gave them a reason to do so. So I thought that'd be cool. So for a lot of years, I've thought I'm just simply going to go into advertising for a large consumer products company.
John Simboli
And then something happened and you fell in love with something else. Can you tell me about that?
John Simboli
You graduate college, you look for a job. And then it's actually now my mother, going back to my mom, who said that I should think about biotech and pharmaceuticals. And you know, my first job out of college, I got a job with a pharmaceutical company, and I carried the bag. So I was a rep calling on physician offices. So I went from that to, basically. if you want to move up in a pharmaceutical company, you've sort of got to move out and around the country. And I don't know how many different roles I've had on the commercial organization and throughout our organization, but it's been many and I had a bunch of different promotions and been through a lot of M&As. But it was a journey and there was nothing I would look back and say I wish I would have done it differently. And probably the major reason I wouldn't do any of it differently is because the immense amount of friends that I've made on my journey along the way. You know, when you work with somebody 10-12 hours a day, it's very in emboldening and you just become lifelong friends. So, I wouldn't change anything. I loved the journey.
John Simboli
So in a sense, that early interest in advertising carries through in a way every time you have to tell the story to an investor or to somebody, prospective employee, whatever. Because you have to make it come alive for them, right?
John Simboli
You couldn't be more right. I actually like to present. Not that I like to be in front of people. I truly do like to stand up and watch the lights go on in people's eyes. That's one of the disadvantages with Zoom or whatever platform people are using. Some people don't have a video on so you really can't make a connection. And now everybody's wearing a mask, so you can't see anybody smile. So that sort of stinks. But we all should be wearing masks.
John Temperato
But you're right. When people truly buy-in, they got the narrative. So the narrative should have a beginning, you know, the middle, the contact, and then Okay, the WIIFT and what's in it for them? Or what's it mean to me? So it really does pay off and it goes back to the "why" because you're providing the "why" the entire way. So, yes, absolutely, couldn't be more, right. The best way to get somebody to do something that you would like them to do is to involve them in the story so they can understand the full breadth and depth of what you're trying to say.
John Simboli
What do you say when people ask who is 9 Meters Biopharma?
John Simboli
9 Meters. Biopharma is a company that is focused on rare and unmet needs in gastroenterology. So I mentioned earlier 9 meters is the approximate length of the GI tract and speaks to our dedication. When we built the company and brought it public and changed names, we basically merged three companies together and then named the combination of the three companies 9 Meters. We wanted to name it, and it was very important to me to name it so that, "A," it spoke to what we did. I didn't want to be Ajax Pharmaceuticals or Bright Pharmaceuticals, I don't know what that means. So I wanted somebody to see the name and say, Oh, I know exactly what they are. The other thing is I wanted somebody to understand the name, and never forget who we are. Because it goes back to the story, right? Physicians will get it right away, 9 Meters, especially our logo has the GI tract. But you get a lot of people that say, well, what is 9 Meters, and then as soon as you tell them, they'll never forget it. And I learned that lesson a long time ago, I was hiring a market research company, and they named the company was YTMBA and I said, Well, what does YTMBA stand for? And he said, it was the song that was playing when I met my wife— You took my breath away. Now honestly, I don't remember if I hired them and did any work. But I remembered the name of the company for the rest of my life. So that was important. But yes, rare unmet needs, GI, so that's the goal. That's the focus of the company.
John Simboli
What you just described to me, definitely says this is the space we're in, we're in the GI space. What is your vision for 9 Meters Biopharma being different from the other companies that are in the GI space?
John Simboli
Most new companies in biotech are binary; they're either binary to a single product, or a single platform. So it's very important for us to have that unrelenting, and unwavering commitment to the strategy. So rare and unmet, but also not to be binary. As a "newco," you're asking people to invest into your thesis, and they want a return on that thesis, All of us invest our own money into something but I guarantee you and I don't have 100% of our investment into one fund or one stock. So you try to build a company with that same thing. So that's why we have two co-lead assets. And we actually have a pipeline beyond that. So I think that's really differentiated from, especially, new companies. And then from the therapeutic space, as I said, rare and unmet, we are going to be unwavering. I don't want to be the 20th product for GERD.
John Simboli
John, what's new at 9 Meters Biopharma?
John Temperato
For a company our size, we have a lot of news flow. And when you're putting together a company, one of the things that I've learned early on in trying to manage a company is that you want to have news flow, but you don't want to have news flow for news flow's sake. You want to have meaningful news flow. So we put the company together so it's not only important that we were focused in binary, but we had a set of key inflection points throughout the year, where people can say they are managing the timelines and they're executing against what they said they were going to do. So in a short period of time, although it seems like dog years to me, we have taken institutional ownership from nine to approximately 50%, or even north of that. We just did our second follow on financing and that closed in December. So we're very pleased with that because we brought in about 80-90% institutional investors and another lead investor, which we're very happy that we brought in; a very, very large hedge fund. So that's new. We've, over the last seven months, have had five analysts initiate, I started with zero, so just think about that. I merged into a public company, they had zero analysts. So we've had five people cover us. Our consensus is almost 10 to 12 to 15 times where the current stock price is now. So that's encouraging. We said we would initiate a IB/IIA trial and complete it. We did that, so that the results of that just came out. And we saw some very meaningful safety and tolerability results which that study was designed to do. And very directionally supportive efficacy results, and that for our short bowel program. So we'll be going to the FDA, shortly, on that. We also recently got orphan drug status for another product in our pipeline, for graft versus host disease.
John Simboli
What do people most frequently misunderstand, when they misunderstand? Then how do you help them to understand what it is that you're about?
John Simboli
There are two parts to that answer. The first part is the person who's presenting, so in this case, we're talking about me. Over the last seven months, I don't know how many investor presentations I've given, Zooms, hundreds, if not 1000. So the first thing you really have to focus on is message fatigue. Because I've said it 1000 times, you're hearing it for the first time. So that's the first thing, you've got to focus on yourself to make sure that you're not having message fatigue yourself, and just turning that switch or pulling that string like the GI Joes when we were little kids. And so making sure that you pause, you listen to the question. So that's the first thing.
John Temperato
And then the second is, our two co-lead programs. One is in phase III for celiac, and it's an adjunctive therapy. What adjunctive therapy means it's for those folks who have celiac, that are non-adherent to a gluten-free diet, either have cross-contamination or inadvertent exposure. So it doesn't mean that you can take this and go eat a pizza. That's not what this means. So it's a lot of education about that, and truly how you're differentiated, why you're differentiated. And we're also the first therapeutic or drug to make it to phase III. And not only we're the first to make it to phase III, the people that are behind us are years behind us, at least two years behind us. So it's really a lot of education. So everyone knows what celiac is, but what's our approach? Why is our approach? The other thing that's important with celiac, let's talk about that one for a second, is that most functional GI diseases are what you call differential diagnosis, functional GI diseases or differential diagnosis. And basically what a differential diagnosis is that you eliminate everything else and you end up with, let's say, IBS, D diarrhea-predominant, or C constipation-predominant. So celiac is a function of GI disease, but there's a genetic linker. So there's a definitive genetic test. So that's probably where a lot of that education goes.
John Temperato
And then for our short bowel syndrome program, the way that we're approaching it is different than the current standard of care. The current standard of care is a GLP-2 that grows the villus architecture of the lumen of the GI tract. So just take a step back, short bowel syndrome patients have approximately two meters or less of GI tract. So they have an inability to absorb nutrients. And if you have an inability to absorb nutrients, you're not long for the world, unfortunately, it's a horrible disease. And so they typically get a IV bag full of what's called parenteral nutrition and parenteral support. So this drug that was approved eight or nine years ago, is a GLP-2. Again, the approach is to build this thick shag carpet in the two meters of your remaining GI tract to snag nutrients as you digest. And then there's two other drugs in development that do a similar type of process, mechanistically.
John Temperato
Our approach is totally different. So when your approach is totally different, there's a lot of education that goes from a regulatory standpoint. Well, if there's no regulatory predicate, are you guys nervous? Are you going to have the same endpoint? Our mechanistic approach is different; why should we have the same endpoint? So our approach is simply slowing the transit time, the time in which you digest to excrete, which gives the ability of the body to naturally absorb nutrients. So that's, mechanistically, how we work.
John Temperato
The other big advantage for us is our onset of action. The current standard of care takes up to six months. Can you imagine being a patient, taking up to six months? And the current standard of care is $40,000 per patient, per month. So we put together a target product profile, we have a lot of reasons to believe, and I've been in the biotech industry a long time, and I know everybody shows you their reasons to believe and discounts everybody else's. So I get that, that's one of the things that we're very good with investors about. So the way that I like to talk to investors and say, OK, here's our four big reasons to believe; some of these are almost in-arguable; our onset of action—you can't sort of debate what we are versus what the standard is. You can't really debate our administration will be, at worst case, twice a month, and a fixed-dose. The current standard of care is daily and weight-based dosing. So it'd be almost impossible to argue that our potential profile for those two isn't better. Our safety profile—we're a combination of this long-acting linker and exenatide. Exenatide has been used in millions of patients and has a very good safety profile. The GLP-2 class has a neoplastic growth warning. So basically what that means, it grows polyps. So could you imagine having only two meters of GI tract left, and it grows polyps, not a good thing. So it'd be hard to argue that we don't have a safety advantage. And then efficacy will be proven through the rest of the development. The proof will be put in the pudding in the efficacy portion, but it'd be tough to argue the other three boxes,
John Simboli
What kind of partners are a good fit to 9 Meters Biopharma?
John Temperato
We are very active in business development in terms of looking for opportunities to bring in. That's always a balance between the opportunity and the cash burn associated with it, especially for a new company. So that's that part. And then for external partners, and I've been on both sides of the equation; I don't know, a better way to put this, it's almost like, you know, raising your kid and then giving your kid to somebody else to take them through the maturation process. So I heard Brent Saunders characterize drug development, because a lot of people talk about their drugs, and I'm sure, you know, Brent Saunders, ex CEO of Allergan. He said until it's approved, it's all signs. So could you imagine getting something all the way through an idea, and somebody said, phase I, phase II, phase III, manufacturing all that stuff, and then handing it off to somebody else? Well, you want to make damn sure that whoever you're handing it to, is going to maximize that return of the asset, and do what's right for providers, payers, and most importantly, patients.
John Temperato
So that's one, and then you have to have a really good set of communication. It's almost like when you start building a relationship with somebody, if there's questions right away, there's questions right away, it never gets better. It only gets worse. Right? And then I also think, as a management team, you have to make sure that you're not entrenched and you try to build value in an organization every single day. And so I think that's the most important thing, you just, every day at work, you just try to build value.
John Simboli
What kind of people thrive at 9 Meters, Biopharma?
John Temperato
The type of people that we really need, and I learned this a long time ago, too, if you're in a big company, big pharma company—name any of the top three to top five—everybody who works there, especially at some level, thinks that they're smarter than people that work for smaller companies. Everybody who's at a smaller company thinks they work exponentially harder than somebody in a bigger company. So it's almost comical; It's like a joke, right? I'm sure there's a whole cohort of people that work hard there. And there's a whole cohort of people that are smarter here. But I think to answer your question, really what you need is you can't have people that are silent. At a biotech company that's new in their age, you have to attract people that understand the interconnectivity, how everything's connected. You just have to. You can't have somebody that has no idea what other functions do, and how that impacts the bigger picture. You really have to understand the interconnectivity. I don't know at what point we'll change the phenotype of the people that we're attracting. I'll never want people that don't understand the bigger picture, but it's really important that you understand the interconnectivity of all the different functions and how they interrelate.
John Simboli
When you're in the day to day, deep world of details, of helping the company get to the next step, do you still find time to think about the premise like, you know, if I can do some good with this company, I can really help people? Or do you have to sort of put that aside and say, I know that that's there, and I'll come to it. But I can't be thinking about that right now.
John Temperato
That's why you do what you do. Like celiac disease, when somebody has a gluten sensitivity, and it's not controlled. You know, that's not like, high blood pressure that sort of is in the back, right, the silent killer or something like that. I mean your quality of life for GI diseases is horrible, horrible. You're tethered to a toilet. I mean, that's basically what it is. You're tethered to a toilet. So whether it's ulcerative colitis, or Crohn's disease, where you have bloody diarrhea 20 times a day, it's just all horrible, horrible quality of life.
John Simboli
How did you come to the decision to place your headquarters in Raleigh, North Carolina?
John Temperato
GSK was down here we had Research Triangle Park. So during the period in which we were building Salix, it became very clear, it was a phenomenal and is a phenomenal place to recruit to. It's a horrible place to recruit from because nobody wants to leave. So when I'm building 9 Meters, I knew because Salix was headquartered here and I knew the quality of people that understand the GI therapeutic space, and how easy it was to recruit people to come to Raleigh, should you want them to come to Raleigh, it was a no brainer.
John Simboli
How about on the investor side, there are people who believe you need to be in the Bay Area, or you need to be in Cambridge or wherever it's easy for someone to hop off the plane or hop off the train. What's been your experience with that, being in the Research Triangle,
John Temperato
Not an issue at all. As I said, there's a ton of biotech companies down here, s ton of big companies in terms of GSK, and others that are down here. We're in an hour flight to New York and an hour and change to Chicago; directs to London, directs to Paris, directs San Francisco, directs to LA. So no it's very, very easy. Being in Raleigh has done nothing but been additive to the equation.
John Simboli
Is there a part of thought leadership that you're especially plugged into now?
John Temperato
I think probably one of the things that I harp on a lot, I've had market access report up into me, for the last 25 years in any organization that I've been with, that's one of the functions that's always reported up into me. I try to be very pragmatic in my approach to everything, very common sense. Other than very acute diseases, acute rhinitis, there's a lot of diseases that are prevalent over multiple years. I'm a big fan of employer-based insurance, I think that is the right way to go because I think it just puts a competitive marketplace in place. And the more competitive something is, the more evolution and appropriate improvement will be.
John Temperato
The crazy aspect of it is they contract for it year to year; how insane is that? Every single year an employer renegotiates their contract. That's insanity when you think about it. You know, there's a whole industry, it's not even a cottage industry, that is involved with connecting insurers with employers and going through this yearly RFP process. I think it's Switzerland that has this model where you sign up for three to five years. It just makes more sense, because what's happening is, let's say you have an obese patient. The patient qualifies for bariatric surgery, it's the right thing to do. And most employers and payers say, well, you know, it's going to be somebody else's patient next year. There's no long-term incentive. So we have to create long-term aligned incentives between insurers and employers. And I just think it would benefit everybody. The average employee stays with, I forget what the stat is, but it's probably three to five years. I don't know what COVID's done to that, but I think it used to be like three to five years. So Shouldn't we align insurance to align with employers for that same sort of length of time? I mean, how often you change car insurance companies or homeowners insurance, right? I don't remember the last time I changed my homeowner's insurance or the car insurance but damned health insurance, seems like every other year, every year, we're changing it.
John Simboli
Thanks for making time to speak with me today, John.
John Temperato
Well, John, I definitely appreciate the opportunity to go through my background and my leadership traits, and some of the background on the company. And hopefully, you understand that we truly do want to make a meaningful difference in the lives of patients suffering from debilitating GI diseases. And I can't thank you enough for the opportunity.
John Simboli
Thanks, john.
John Simboli
Near the beginning of my conversation with John Temperato, he told me the subject matter experts in his company know a lot more about their areas than he does. But, as John said “I think I'm pretty good at communicating a vision and getting people to understand how we're going to get there, and why we're going to get there. Most importantly, why. If people know the "why's," then it becomes not motivational, but inspirational.
I don’t know about you, but when I get the feeling a leader is trying hard to be motivational, I can’t help but ask “What’s in it for them?” But when a leader involves me in a story of "Why?" I feel invited to connect with something in my own life—and that can become inspirational.
Most of us who work in the field would agree with John when he says, “If you can’t get inspired doing this type of job, I don’t know what can inspire you. Because at the end of the path, you’re making a meaningful difference in patients’ lives.”
I’m John Simboli.
You’re listening to BioBoss.
