Okay, hi, good morning everybody. This is Kristen Kluska, I'm one of the biotech analysts at Cantor. Very happy to be hosting Jack Khattar of Supernus Pharmaceuticals. How are you doing today?
Good, thank you. Thanks for having me.
Yeah, thank you so much for being here. Lots to talk about, a big year for you, big commercial steps, but maybe to start, do you mind just providing an overview of the company?
Yeah, sure, and good morning everyone. Just to remind everyone, I'll be making forward-looking statements, so please check our SEC filings for all the risk factors. For those of you who may not be familiar with us, we're a CNS-focused biopharmaceutical company. We do have a portfolio of about eight to nine products on the market. We are profitable. We have a very clean balance sheet. Just consumed an acquisition, Sage acquisition, which we are in the middle of integrating at this point. We started our journey actually back in 2005 and our first two products in 2013 that have gone a full cycle. We just managed through the loss of exclusivity on these two legacy products.
We are now just turned the page on that, pretty much completed that transition, and we are now in a re-accelerated growth phase of the company, behind some of our key growth drivers: Qelbree, which is a novel non-stimulant, GOCOVRI in the Parkinson’s space, ONAPGO, which we just launched in April, and of course ZURZUVAE with the acquisition of Sage. Very exciting time for the company, re-accelerating growth moving forward.
Okay, I wish we had a couple of hours because there are several assets there, but just for the sake of today's conversation, I want to touch on Qelbree for ADHD, ONAPGO for Parkinson's, and ZURZUVAE for postpartum depression. Is that okay?
Yeah, that's fine.
Okay, on the ADHD space, you've had a front-end view for a couple of decades now. How has it evolved over time, and what have been the main treatment goals for patients?
Yeah, we've been in this space for, you know, three decades. We used to be a Shire Pharmaceuticals, part of Shire, and we've developed four products in this space, more than anybody in the industry. For so many, you know, so much such a long time, we had only two stimulants, amphetamines and methylphenidates, that are the mainstay, you know, therapeutic regimen that everybody goes to initially. We had a couple non-stimulants that unfortunately didn't work that well. We saw a major need for a non-stimulant, put it very simply, that works and works for a lot of folks, in hyperactivity, in attention. As important, it works fast. The existing older non-stimulants, like Strattera, for example, atomoxetine, sometimes would take four, five, six, or even eight weeks into the school year, and you still, as a parent, don't know whether the drug is going to work or not.
For me as a parent, that's like eternity. You know, dealing with suspension letters, bad reports, issues in the classroom, and so forth. That's why a lot of parents end up resorting to stimulants, and that's why 90% of the market is stimulants. With the introduction of Qelbree, which is very differentiated versus the Strattera molecule, the atomoxetine drug, this is a product that works as early as week one. We can sample it, you know, people can get a two-week sample so they can see whether it's really working for their child or even as an adult as well, because now it's indicated for both pediatric and adult. The reaction has been really phenomenal. We're now into year five into the launch. We're always in the mindset, we're still launching, because the growth potential of this product is, is, is really huge.
It's a huge market, 100 million prescriptions a year, in both pediatric and adult, and we're just scratching the surface.
You mentioned part of developing this product was knowing that the market needed better options for non-stimulants. What do you think triggered a lot of patients in general to want to make the switch to go to a non-stimulant? Why is it that with Qelbree, you think that could potentially improve even further?
While stimulants work, they don't work for everybody. A lot of people forget about, you know, 15%- 20% or even higher. Sometimes you see numbers like 30% don't really respond well to stimulants. Stimulants are not like the magic bullet. However, that's been the treatment guidelines for a long time. Physicians go to stimulant one, stimulant two, maybe stimulant number three, and then they consider non-stimulants. They're recycling with the same molecules, amphetamine and methylphenidate, and they've been doing this for decades. Parents don't like to give their kids controlled substances, for the obvious reason. I mean, these are scheduled substances like heroin and cocaine. I can't believe, you know, we're giving them as a first-line treatment for children. They can be used in the appropriate environment with the right, you know, cautionary manner.
Adults don't like how they feel a lot of times with the stimulants because of a lot of the side effects. Stimulants also are contraindicated with comorbidities, especially in mood disorders, which tends to be the case in a lot of ADHD cases. You have comorbidities, anxiety, depression, and so forth. Stimulants are contraindicated because they exacerbate these mood disorders and make them worse. Therefore, we need very good non-stimulants that can really work for a lot of these patients.
Okay, something we really like doing at Cantor is looking at patient stories and anecdotes because I think that tells you a lot about how a drug is doing. I was wondering if you have any that you could share, what you hear about Qelbree.
Yeah, I mean, the biggest, pleasant surprise for a lot of folks, especially like in the adult space, because adults, they don't like to give up their stimulants. A lot of them like to still even take the immediate release. They supplement the extended release or the immediate release later in the day, but they are struggling with the side effects and so forth. When they want to switch to a non-stimulant, they try to do it very gradually so the physician doesn't take them off the stimulant abruptly and suddenly because there are withdrawal issues. There are a lot of issues with it. They add Qelbree over time. They titrate Qelbree up and then they titrate down or taper off the stimulant.
What they find out is that actually they don't need to take an extended release stimulant and then supplement with an immediate release to get a 24-hour coverage because Qelbree gives you a true 24-hour all-day control. That's truly been a big surprise for a lot of adults that they can get rid of these stimulants and they can get on Qelbree just one, you know, capsule a day and that really works for them. It's been a great addition to the therapy. We have about 40% of our adult prescriptions are actually combination therapy, because of this dynamic in the marketplace.
One, I'll share one that stood out for me. It was a mother on social media saying that prior to Qelbree, their child got in a lot of trouble at school. They threw a chair and got detention. Fast forward to being on Qelbree, they became the student of the month.
It's incredible, the stories we hear, and that's what really, we always tell our employees, that's what really keeps us going every single day, you know? It's truly amazing.
You've been on the market for five years. I would love to hear how you think the next five years might look, both in terms of switches and combination.
We certainly continue to push on the adult segment. The adult segment is 67% of the market, so that's the biggest segment. We're making a big push there, a lot of consumer education, patient education. We have a couple of really great influencers who are working with us on the female side and the male side. We've had significant push in that segment and some really early successes behind it. We reported recently that we're up to 35% of our business in the adult segment. Clearly, five years moving forward, we continue to see the brand continue to grow. I mean, even the last four weeks, rolling four weeks, now we are into the back-to-school season. We're seeing growth in the 25%, 26%. The brand continues to be very healthy, growing 20%+ . As I said earlier, we're only scratching the surface. There is so much potential out there.
We're not even at a 1%- 2% market share, and easily we can be in the 4%, 5%, 6% potential from a peak perspective. We're very excited about Qelbree. Qelbree can be a very huge product for Supernus and a very successful ADHD product.
Yeah, the influencer side of things is great. I would imagine when you started your career in this space, there's probably still stigmas, and people didn't want to be as open about their diagnoses.
That's right. That's right. I mean, especially in the adult space. I mean, we forget it's not just about school. ADHD is not just about focus. It's about their social life. It's about a lot of being able to hold a job, being able to have a relationship, being able to do a lot of things that a lot of us take for granted. These patients really struggle through a lot of these things on a daily basis. It really helps to have folks like Busy Philipps and Jay Glazer talk about these things and their experiences, and what they go through.
Thank you for that. Parkinson's is another space you've been following quite closely. We've seen a lot of innovation, yet why do patients still experience these off episodes and why is it so disruptive for their lives?
The disease itself is a progressive disease. Over time, as patients progress through it after so many years in diagnosis, actually statistics are somewhere in the 90%-95% of patients end up getting off episodes. It is unfortunate because off episodes, we think it sounds like it's not a big deal, but again, for a lot of folks, when they get up in the morning, they're stiff, they're rigid, they can't move, they can't even get up and get dressed. Some of the basic things that we take for granted, they can't even do. They can't go down and have a breakfast or meet a friend or go to a wedding or whatever. It is very disruptive for their life, especially as they progress. That's why a lot of the products are steered towards the off episodes and the treatment of the off episodes.
There are a lot of other complications as you progress through the disease. You start getting dyskinesia triggered by a lot of the medications that you are taking. That's where, for example, GOCOVRI, which is one of our products, is very unique from that perspective because it's indicated for both off episodes and dyskinesia. Of course, we're very excited about ONAPGO, which is our most recent product that we just launched in April. This is the first time a new device, infusion, continuous infusion of apomorphine is ever introduced in the market in the U.S. We've been very excited about the launch and the initial response that we're getting from it.
Okay. Parkinson's is obviously quite common. What percent of patients are experiencing these episodes, and at what point do they go to their doctor and ask for help about it?
It is in the 90%+ if you have been diagnosed five years or more. Certainly, as you progress through it, it's a very high incidence of episodes. Typically, that's most of the focus of the discussion with your doctor. It is about the off time. It's all about how can I convert that into a good on time, on time meaning I can function. We also say it's a good on time because you want to be on, you want to be able to function, but without the dyskinesia. That's where a lot of the balance is. A lot of the discussion is around the off time.
Okay. You mentioned the two products that you have in the space. There are also other ones available, including (inaudible). How should we be thinking about these key differences, and which scenarios might one medication be more appropriate than another?
Yeah, so we have APOKYN, which is for acute injection for an acute episode, for example, and it works within minutes. It's a great, great product for as-needed type of therapy. Some patients take it once, probably one injection a day. They don't need more than that. Others that are more progressed, they might take up to four or five different injections a day of APOKYN. We also have ONAPGO, which we just launched, which is also apomorphine, but that's a continuous infusion device that you can wear all day or less than, depending on how your situation is. That's more for continuous dopaminergic activity. It really continuously gives you apomorphine, and that's a very unique device. The receptivity so far has been great. Two different positionings of these two products. GOCOVRI is our third product in this space, which is for off episodes and dyskinesia.
It's the only product in the Parkinson's space which is indicated for dyskinesia. We have three very distinct products with three distinct positionings.
Okay. I think you surprised a lot of us on your last earnings release because the metrics looked really impressive out of the gate. Can you help us understand how we should be thinking about the peak market opportunity and how that cadence might take place? I mean, you quite literally just launched it.
A big factor in determining whether this product is going to be $500 million or $1 billion, and I know people throw different numbers around. We've said $200 million- $300 million, and maybe that is conservative, but it remains to be seen because we're really trying to get our arms around what is the patient profile. Now, if you go literally per the label, the label is for advanced, progressed patients. However, we've seen in Europe, because this device has been available in Europe for many years, the treatment kind of migrates and a lot of KOLs start using it for earlier stage patients, more moderate or even mild earlier in their, you know, life cycle. If that does happen, that means the opportunity is going to be open, you know, more wider and a much bigger potential versus if it only gets restricted to very advanced patients.
That's where the big difference between some of the estimates or some of the thinking that you see around the product. Until we have a good feel, and we're still early, we just launched in April, until we have a good feel as to what that patient profile is and how are the KOLs using it, then we can update, you know, our estimate for peak potential. Certainly, the early uptake has been very encouraging, and we're very excited about it. I mean, the product really works, works very well and gives, you know, patients on an average around two, two and a half hours a day of good on time, which could mean the world for a lot of these patients. It's just a great product.
Okay. ZURZUVAE was the first oral medication approved for postpartum depression, something that affects one out of every seven people. Unfortunately, we all know somebody that was impacted. Considering how massive this is, why did it take so long for somebody to get it right?
Yeah, it's, and we're learning more about this. Obviously, we're new to the space, but it looks like the disease awareness education hasn't been a lot, you know, over the years. Actually, about 500,000 women, you know, related to the one out of eight, as you said, you know, they experience these symptoms. Diagnosis has been only around the 40% or even lower over the years. There's a lot to be done to educate physicians on how to screen, how to look for these, you know, for the symptoms. A lot of times, the symptoms are mixed up and confused with, you know, typical fatigue, lack of sleep that typically a mother experiences, you know, after birth, and they don't make too much out of it. It's also the extra, you know, workload that you have.
Now you have a newborn, you know, there's a lot of work and you're not used to it. It's a great change time for family, which should be the happiest time. Unfortunately, a lot of mothers go through a lot of these symptoms, which can be on the extreme side, could lead to suicide or really behaviors that could harm the baby or the mother. With education, I think the awareness around the disease itself, the importance of screening, the importance of diagnosis, whether you're an OB/GYN or you're a psychiatrist, whatever is the touchpoint when the mother comes back for, you know, the well-being visits of the child and so forth, the check-ins. I think it's very important.
I think, you know, Sage and Biogen have done a great job since they launched the product about a year and a half ago in starting with that market education, you know, really doing a lot of the training, helping OB/GYNs to be attentive to these issues during these visits to help them screen for these situations.
Is it your understanding that women are now going to their doctors and explaining their symptoms and wanting to seek help? You had mentioned part of it was they may not even realize they're going through it because of all the other emotions and duties that come with being a new parent.
No, that's exactly what it is. I mean, a lot of times it is the, they're not, even women who are diagnosed with PPD, 50% of them say, what is that? T hey don't even know what is that. That really tells you a lot of lack of awareness and education that has to occur for that discussion to happen. Also, in a lot of these visits as well, a lot of the attention is on the newborn. You know, how's the baby doing? How's the, you know, versus the mother? Unfortunately, I mean, it has to be both. That has to change over time, and it is changing. You know, there is more and more attention to it.
I even learned from one of our colleagues who just had a child that even pediatricians are screening for PPD these days, which I was, you know, surprised to see that when a mother walks in with a child to the pediatrician, the first thing they give her is a screening survey looking for signals or anything that could lead to, you know, the PPD diagnosis. I think there is more awareness now, and it's coming, you know.
That's great to hear. I didn't know that either. How are you working with OB/GYNs? This is a new space for you as well to help with the screening and potentially seeing if someone's a good candidate.
We have a lot of programs that focus on education, the training of the physicians from a healthcare provider perspective, as well as efforts to educate patients and the public about these issues. You really need both. You can't just do it from one side. You need to encourage mothers to be attentive also to what they're going through and encourage them. That's something that a lot of folks go through. That's okay to talk about it. It's nothing to be ashamed about, something that does happen, and there is a treatment for it. Please open up and discuss it with your doctor and look at these for alternatives. A lot of these efforts are built into the marketing programs, of course, and the way we push the education for the product itself. What we see, which is very encouraging, is once an OB/GYN or a physician.