Gerald Proehl - Director, President and Chief Executive Officer
Greg Fraser - Bank of America/Merrill Lynch
Santarus, Inc. (SNTS) Bank of America/Merrill Lynch Health Care Conference Call May 16, 2013 2:20 PM ET
Greg Fraser - Bank of America/Merrill Lynch
Good morning, everyone. Welcome to the tail end of the third day of our conference. Thanks everyone for sticking around this long. My name is Greg Fraser. I help cover specialty pharmaceutical at the BofA/Merrill Lynch on are Greg Gilbert's team.
It's my pleasure to introduce our next presenting company, Santarus. And presenting for Santarus is President and CEO, Jerry Proehl. And without further a due, I'll turn it over to Jerry.
Thanks, Greg. I appreciate everybody coming to the presentation. The money you're saving not been at the tables, you can invest in Santarus. I will be making some forward-looking statements, so I will refer you to our SEC fillings.
Santarus is a biospecialty pharmaceutical company. We call ourselves biospecialty pharmaceutical, because we have a combination for small molecule and biologic products. I'll talk a little bit more about that.
We currently have five products that are on the market and three that are in development. Two are late-stage products. One is, BLA is already filed. The other one we've completed one Phase III study. And then we have an earlier stage biologic product that's ready to move into Phase II.
Here, recently in January, we did get approval for Uceris for a treatment of ulcerative colitis. And last year in September, we actually won an appellate court decision with Zegerid, our first product we launched. That product is now selling both on authorized generic and brand product, and the generic company Par has stopped shipping their product. And I'll talk a little bit more about all of those.
And then the last thing, with regards to one of our other product, Cycloset, which is for Type 2 diabetes, we did get a new patent issued that actually gives us 20 years from the time we filed, which was 2012, so it goes until 2032. It gives us a lot more opportunities to do some other things with Cycloset.
Last year, we had revenues of $218 million, nice growth over the previous year and we expect to continue to see that growth. In the end of our first quarter call, we provided guidance from $330 million to $340 million in revenues. So we expect to see continue growth both on the topline and the bottomline.
This is our portfolio, you can see on the left are the marketed products. We've estimated peak sales for our five products between $650 million and $750 million. We do think there is a significant growth potential, particularly with Uceris and Glumetza, big markets and big opportunity to see continued growth.
With our late-stage products both Ruconest and Rifamycin, we've estimated peak sales of about $200 million. With one caveat on Ruconest that's really for acute treatment of hereditary angioedema. We do plan on looking at two other indications. We're going to look at prophylactic treatment of HAE, which we think could provide much bigger upside potential.
And we also plan on looking at Ruconest in acute pancreatitis, which has no approved product is a big disease area. And if we can demonstrate efficacy there, we think it has really huge upside potential. And then our early-stage program is anti-VLA-1 antibody program that was licensed out of Biogen, we call it SAN-300.
We completed the Phase I program both within IV and a subcu dosage formulation. And we plan on taking the subcu dosage formulation into a Phase IIa study in RA. We also plan on doing some additional work both in preclinical talks and the next year in inflammatory bowel disease.
If you think about the company and strategically what we're trying to do, and we began this a number of years ago. When we launched Zegerid, while it's a GI product and it is prescribed by gastroenterologist, it's also prescribed by most primary care doctors. And so we found ourselves with 300 reps competing against companies like AstraZeneca, J&J, Wyeth that had 2,000 or 3,000 reps, and it's very difficult to be really competitive in that type of market.
So strategically what we said is, as we look to bring in additional product, we're really going to look to bring in products that are much more targeted to a specialty audience. And try to slowly evolve out of a primary care company to more of a specialty company. And that's what we've tried to do, with when we brought in Uceris and Rifamycin, really specifically focused on the gastroenterologist.
We brought in Ruconest, initially focused on a subset of allergist, about a 1,000 allergists and even with the acute pancreatitis, the primary treatment for that disease are the gastroenterologist. And then with SAN-300, it will be specifically rheumatologist and then also the gastroenterologist, so really trying to focus our efforts.
By doing that, what we think we can do is, over a period of years, you're going to see our SG&A as a percentage of revenue continue to go down. That allows us then to fund R&D and continue to develop our pipeline, but at the same time drive overall profitability. And that's strategically what we're trying to do.
We want to grow our topline. We want to continue to grow bottomline. But also we want to develop our pipeline, so we have nice long growth. The growth strategies we have are, number one, maximize our current portfolio, and I mentioned we have lots of different indications. I'll talk about each of those in a little bit.
But we think all of our products, Uceris, Rifamycin, Ruconest, SAN-300 that we can study in two, three different indications and really maximize the product. Once you get a certain amount of safety data on the products, we might as well go ahead and try to look at a number of different indications to really maximize sales of a product.
The second thing we're looking to do is, bring in late-stage products. We've been very transparent with folks that in 2016 we lose Glumetza and Zegerid. So we know we have a revenue gap. Our focus right now is develop our current pipeline to help fill that gap, but also looks to bring in some late-stage products.
Mainly focus on products that are either in Phase III or ready to move in the Phase III or beyond, in some cases it could even be products around the market. But that's our focus right now, and focus predominantly in gastroenterology and endocrinology. We will look at other products and other therapy to carry us, but it needs to be very focused, small target audience.
And then the last thing we're looking to do is bring on a senior executive, mainly in strategic planning and acquisitions to help us really start to think about how do we evolve and grow the company. As you start to get to a certain revenue base, obviously, bringing in one-off products, moving the needle as far as moving revenue gets more and more difficult.
And so you start to look at strategically other companies out there that make sense to acquire, and they have assets or they have technologies that would be complimentary to what we're doing. Maybe have a platform technology, where you could get three or four products out of it. So that's what we're going to start to really accelerate.
The other thing we'll look at is how do we move forward from a tax planning standpoint. We do have some NOLs still. We expect we'll those up mostly this year, maybe a little bit next year. But then we'll become a full taxpayer, and so we'll look at some strategies there also.
As it relates to our sales force, we have 235 reps, you can see here, who we cover. And we call in about 7,500 gastroenterologists, they sell Uceris and Zegerid. We call in endocrinologist, about 2,500 endocrinologists and we're selling Glumetza, Cycloset and Fenoglide. And then we call about 10,000 primary care docs we sell Glumetza, Cycloset and then either Fenoglide or Zegerid depending on the market potential.
Let me talk just briefly about Uceris. It's a locally acting steroid. We get about 10% absorption of the budesonide. We've estimated peak sales of $300 million for this product. And you'll see some data later that gives you some relativity of why we think we can do at least $300 million in sales.
We launched the product in mid-February and in the first quarter we reported $6.6 million of net sales. The market is about 600,000 for mild-to-moderated patients. So it's about 85% of the total UC marketplace. And we do have a Phase IIIb study ongoing, where we're using Uceris on top of our 5-ASA. That study should complete enrollment about mid-year, read out of the clinical data in the fourth quarter and the patent's going until 2020.
Typically, when a patient presents with ulcerative colitis, the doctor most of the time are going to start him on a 5-ASA. They are very comfortable with 5-ASAs. Typically they ask the doctor about the time to induce remission with the 5-ASA. It's going to take six to eight weeks to induce remission. The advantage of a steroid is, they induce remission fast.
The advantage of Uceris is it induces remission fast without some of the systemic side-effects you get with steroids. So you don't get the moon face. You don't get the acne, problem sleeping. The doctor has nothing to worry about steroid dependency or problems with bone mineral density down the way. So that's why they're using Uceris in place of systemic steroids.
This is the market, you can see here in the left are prescriptions, growth and on the right is dollar growth. I will focus in on Entocort EC and the generic to Entocort. Entocort is budesonide in a delivery to small intestine for Crohn's disease. There is similar number of Crohn's patients as you see patients. So the markets are very similar.
They are selling currently about $400 million for Crohn's disease. And so we really believe that the opportunity of $300 million is very reasonable. Entocort does have a maintenance indication, so they are getting certainly some use on maintenance, ours is for induction only, right now.
This is the ad we use, a professional ad with physicians. It's, Power Your Patients Can Handle. It tests very well with doctors. They get the idea of the power of a steroid with the ability to handle it from the safety and side-effect perspective. And then we have a patient ad, you see a woman stuck in traffic. I see someone, who doesn't have to worry about getting there.
The concept is that these patients that are actively flaring typically are experiencing 15 to 20 bowel movements a day. It really it affects their ability to socialize and do the normal things that every one of us would typically do. And so they are worried about where is the bathroom, how quickly can I get to a bathroom.
What we're hearing from physicians is that they are putting their patients on Uceris. And within one or two weeks, these patients are seeing significant improvements in their bowel movements. They are moving from 15 or 20 bowel movements a day to four or five bowel movements a day. That's really significant for the patient.
It's very positive from our perspective, because when a patient goes from 20 bowel movements a day to five, the first thing they do is they pick up the phone, they call the doctor, and the rave about how much better they feel. And that's a good positive feedback loop to the doctor to say it's working great and it's working fast. So they are more likely then for newly diagnosed patients, not only to use a 5-ASA, but also to use Uceris and try to get the remission going faster.
You can see here the prescription trend, just a little under 900 prescriptions per week. I always caution people on the weekly numbers, you're going to see some bouncing up and down. When IMS does their projection from pharmacies, they don't use prescriptions from every pharmacy, they survey pharmacies and then they project out to the universe.
So if they miss pharmacies, occasionally you're going to see little ups and down. But look at the overall trend, you're going to see a good trend. You do see total prescriptions start to break for new prescriptions. It's a good indication that patients are refilling. This is for eight weeks of therapy, so they typically would have one refill to treat their patients.
As far as prescribers, you can see we have about 425 doctors writing in any one week. About 1,700 doctors have written at least one prescription of Uceris. We call on 7,500 doctors, so there is still lots of opportunity for growth here.
With regards to our second product Zegerid, I won't spend a lot of time on Zegerid. It's an immediate release proton-pump inhibitor. We went for two years as a generic. We weren't promoting the product. We saw a significant reduction in the total prescriptions of the total molecule. And our goal right now is to stop the decline, and as we move in the second half of the year, start to see some growth.
We're starting to see a little bit of that with new prescriptions on the brand side. So I think as we move forward, we'll start to look at not only total, but new prescriptions in and how we're able to grow the brand. This is a high-margin product for us that will have another about three years. So it's a nice product for us to have. And again, we reported just under $25 million in the first quarter.
Glumetza is our largest product by sales. It's extended-release metformin product, typically used after doctor tries generic metformin either immediate-extended release generic metformin. Patients go on this product, because they have GI side-effects on generic metformin and the doctor can't titrate the dose up.
The real advantage here is that the doctor can keep titrating Glumetza all the way up to 2,000 milligrams without the GI side-effects. And that's a real advantage both from a complexity of treating a patient. They don't have to add a second or third product. And from the patient perspective, they only have one co-pay.
We do offer an eVoucher program with Glumetza, that's a $10 co-pay. So similar to what they'll pay for a generic, but they are actually able to continue to titrate the dose up to 2,000 milligrams. So the market is substantial in treating these patients. These are just our doctors that we call on. Those particular doctors prescribed about 3,000 Glumetza prescriptions, previous 12 months. They prescribed $8.3 million metformin prescriptions. We don't have to get much of the metformin market, we just have to get even a 0.5% would be a huge growth potential for us, so lots of upside for Glumetza.
Cycloset is our second product for Type 2 diabetes, typically chose anywhere from the second to fourth line. It's centrally acting, the first centrally acting dopamine agonist for Type 2 diabetes. The unique thing about Cycloset is its cardiovascular safety profile. So Cycloset was the first product approved under the new guidelines from FDA where we head into a large cardiovascular safety study.
We conducted a 3,000 patient's study, 2,000 on drug 1,000 on placebo. We showed of 55% or 52% reduction in composite endpoint of MI stroke in cardiovascular death. So it has an excellent cardiovascular safety profile, just added to the ACE guidelines, and so we think we have a nice growth potential with this product. Again, it competes against large pharmaceutical companies, Eli Lilly, AstraZeneca and Takeda, so we don't expect this to be a huge product, but it's a nice complimentary product to Glumetza.
And then Fenoglide is our third product we sell to Endocrinologists and primary care docs. It's a fenofibrate product. It's a nice third product detail. I don't spend much time on it. We think it pays some bills, but it's never going to be a huge product for us.
And as far as our development pipeline, we talked a load about Uceris. We plan on initiating the study next year in pediatrics. And we're also been talking with some key opinion leaders about looking at another indication call microscopic colitis. And its inflammation in the colon typically occurs in older patients, no ulceration, no blood in the stool. So it's not as severe as ulcerative colitis. It affects about 300,000 patients in the U.S. And we think it's an attractive second indication to pursue.
I mentioned Ruconest with acute HAE. We are pursuing that. BLA has been filed. We expect to hear on the acceptance of the filing here coming up in mid-June. And then, we'll approach the FDA with study design for prophylactic treatment of HAE and acute pancreatitis.
With Rifamycin, we've just completed a Phase III study last year with positive results and our partner Dr. Falk Pharma is completing their Phase III study in India. And then our antibody program, we expect to start the RA study in fourth quarter.
So I won't spend much time, I've talked about most of these. With Ruconest since it's a biologic, the protein is producing the milk of transgenic rabbits. So we get at least 12-years of exclusivity. We think there could be even longer life with this particular product, because of the difficulty of the manufacturing process.
The data in Phase III was very good. It was under a SPA. You can see the P-value is 0.031. So we feel very good about this product moving through the FDA and ultimately getting approval. The way we compare to the competitive products is Berinert and Cinryze are also C1 esterase inhibitors, but they are from blood plasma. We think there is an inherent safety with a recumbent of product.
We have never seen any thromboembolic events, which is not the case with the plasma derived products. So we think we have some advantages. We deliver 50 units per kilogram of C1 esterase inhibitor. Berinert delivers 20 and Cinryze delivers about 13. So we're also delivering more C1 esterase inhibitor, which we think is important.
I mentioned the Rifamycin. You can see the clinical data. The P value in our first Phase III study was 0.0008. It sounds like John Belushi's GPA from animal house, if anybody is familiar with that. Anyways, very statistically significant results and we think this is a very effective product.
In many respect, similar to Xifaxan from Salix, the deliveries are different. Xifaxan typically releases in the stomach. Ours release at right at the beginning of the colon. So we concentrate our antibiotic effect late in the colon where we think the bacterial resides. And we have patents that go until 2025 on this product.
And then our antibody program, we think is really attractive program. This particular antibody affects circulating T-cells and monocytes. We have developed a very nice subcu formulation and as I mentioned, we will begin the RA program in the fourth quarter and then next year I look to move into inflammatory bowel disease, either you UC or Crohn's, probably UC as the first indication, also Biologic with 12 years of data exclusivity and the product was licensed actually out of Biogen Idec.
Our financials, you can see here and look, very good growth from 2012 to '13, $46 million to just under $80 million in revenue growth. If you look at our bottomline, net income went from $0.6 million to $18.7 million in the first three months of the year. And our non-GAAP adjusted earnings you can see just about $24 million.
We typically say that the non-GAAP adjusted earnings is probably little close to where we think our overall cash generation will be. And we had just under $100 million in cash. So we feel we're in very good shape. We are generating cash. We don't think we need to go out and raise capital to do anything with regards to operations. We might do something if we were going to acquire a substantial product or acquire a company, but beyond that we think we can operate the way we were operating with the current cash.
And then you can see here what the overall trend looks like from 2010 through 2013 guidance. And we expect as we move into the '13, and then '14 and '15, you are going to see continued nice growth on the topline and even more accelerated growth on the bottomline. So in closing and then we can open up the questions. Really focused on executing on the Uceris launch, moving through and get ready to launch Ruconest next year and then doing the clinical work to broaden the indications of our development pipeline.
Lastly, we've been asked the question many times, are you going to spend a whole bunch of money in R&D and what are you going to do with earnings? We are very focused on not only driving revenue, but driving earnings. We think that's important for our company to do that. We are going to invest in R&D, but we do it in a very measured fashion. We want to continue to that over the next few years, I think that's what you are going to see with Santarus. Thank you very much and Greg, will open up the questions.
Greg Fraser - Bank of America/Merrill Lynch
Thanks Gerry. We have got eight to nine minutes for some questions. So if anybody has any questions in the audience, please raise your hand, we'll get the microphone over to you. I'll get it started, actually a question I find here first.
If I remember correctly Zegerid is basically Prilosec plus baking soda. Is that correct?
That's right. Let me explain kind of differences. So a PPI is acid labile, so you have to put an enteric coating around the PPI to protect it stomach acid and get it into the small intestine and then enteric coating will dissolve off, the particle will be observed. It typically is going to take anywhere from two to four hours for that to actually occur.
Once that occurs then it moves through the bloodstream, crosses over this into the wall of stomach where the parietal cells are located. It inserts into the proton pumps, irreversibly binds and shuts off acid production. The difference with our product is we use sodium bicarb to protect PPI. The sodium bicarb is very rapid in increasing the PH, so you're going to get a PH of six or seven within a matter of a minute. That gives you relief if you have heartburn right now, it will give you immediate relief.
But we also get rapid absorption of our PPI. We get peak blood levels in about 30 minutes. If you just took sodium bicarb, baking soda by itself, you'd get this huge increase in PH and then your proton pumps will turn on, and it will start pumping out acid to bring the PH back down and you'd get this up and down rebound effect.
But the positive thing is you want active proton pumps when the PPI is sitting there, because that's when they bind to the proton pumps when they are active. So it actually works together, to get very quick neutralization of stomach acid, but then the PPI then shuts off acid production and so we get the duration effect, you get with the PPI. It's just happens a lot sooner than you do with an enteric coated PPI.
Really, my question was Prilosec is not only generic, it's over-the-counter also. So how do you manage to compete with them and be price competitive?
First off, over-the-counter products are not inexpensive. In many cases, you can get our product, because we have a brand and we have an authorized generic. So the authorized generic typically will have $10 co-pay. So you can get a 30 day supply of our authorized generic, which is our brand product under different label for $10. You can't get 30 days of Prilosec for $10 OTC, because it's a 20 milligram dose. You have to double the dose that means 40 milligrams and so on. So it's actually less expensive on the Rx side.
One more question, Cycloset. How long can a patient stay on this drug, before they have to move up to GLP-1 or insulin or whatever?
We don't have any data that indicates that they need to move on to another product. That being said, we don't have any long term data. We have a year long data from a clinical perspective. Typically what happens is that the patient starts on 0.8 milligrams. Every week they titrate them up by 0.8 milligrams and typically they can go as high as 4.8 milligrams.
The average is about four pills, so 3.2 milligram dose. And they will maintain them on that for some period of time and then they will measure their A1C. And it's really a matter of how is the disease progressing. If they see their A1C stays down, they don't need to add anything else. If it starts to go up, that's when they start to add other product.
So will that life of this product comparable to let's say metformin?
Yes, I think you can stay on the product for a long time once you are on it, as you would with metformin. Typically, what doctors are going to do is just start to add things on right there. So with metformin, they might add a DPP-4. Then they might add Cycloset, then they might add a GLP-1 and then they have to go to insulin.
Greg Fraser - Bank of America/Merrill Lynch
I know you don't break down revenue guidance by product, but perhaps maybe you can comment on the key drivers underlying your 2013 revenue. Uceris isn't launched, so obviously that's big and important factor. Zegerid on year-over-year basis is important, given Par is not in the market anymore. So just maybe comment on how you think about qualitatively the important drivers in 2013?
So I think if you look at each of the products, maybe we'll start with Uceris. Obviously, we're just launching that product. We expect that to continue on a very nice growth curve. The nice thing about Uceris as we mentioned this before is, we pay Cosmo 22% combine cost of goods and royalty. When we get to about 50 million of Uceris sales, its starts to become highly profitable for us, probably end up dropping about $0.75 of every dollar to the bottomline.
And so that's an important kind of marker to see when do we get to $50 million, because we start see our profits really look good. As far as percentage growth that's going to be our biggest growth driver. We still think there is nice growth potential in Glumetza. It's our largest revenue product, so even a little growth there will be nice for us.
Zegerid, we mentioned more kind of a flat we expect as we move into second half of year maybe we'll start to see a little bit growth. And then as we move in the '14, we hope to see prescription grow from there. Cycloset, we think we'll see growth in Cycloset as we move into second half of the year. Fenoglide, probably more flat to maybe some slight increase.
Greg Fraser - Bank of America/Merrill Lynch
Does your agreement on AG for Zegerid last until patent expiry or could that market go back to just to your brand at some point?
So we made the decision when we won the appeal to keep to keep an authorized generic on the market, primarily one reason is retail pharmacists make more money of generic on the spread than they do of a brand. And our concern was that if Par pulled their product from the market stop shipping and we start shipping our authorized generic, than many other pharmacists would try to move patients from the generic Zegerid to generic omeprazole, even though it's not AB-rated.
And so we chose the path of going back to Prasco, who does our authorized generic. We negotiated the agreement, which essentially we sell them our authorized generic at a higher price, which required them to increase their price. And we renegotiated the spilt so we get the vast majority of the economics. So it's much better for us and there is a high probability we wouldn't lose those prescriptions going forward.
Greg Fraser - Bank of America/Merrill Lynch
Any questions out in the audience?
I'm (Evan). You mentioned on the 1Q call that stocking for Uceris in the wholesalers and retail channels, was intentionally limited. I'm just curious to hear your thinking behind that strategy and sort of how you prevent a patient for getting a prescription and going to the pharmacy and not being able to fill it and then getting switch to the something else?
Uceris is about a little over $1,200 for a month supply. At that kind of price, pharmacists just aren't going to put bottles on the shelf. So we actually went out and surveyed. We went to change. We went to some independence and we said here is the profile, here is the product, if we gave you a stocking incentive would you put a bottle on the shelf, most of them said no. So that wasn't a real reason for us to try to push into retail pharmacy.
So what we did is we put together a two-day sample pack for physicians. And so when our reps going in call in physicians they tell them, listen, the retail pharmacy likely if you haven't written a prescription before, won't have the product, they'll be able to get it within one usually the same day or next day. And so give them samples and then have them call in to the pharmacy and have them order the bottle. And so we haven't really heard of much problem with that, from actually filling the prescription.
Greg Fraser - Bank of America/Merrill Lynch
We'll squeeze in one last question. We have a little another couple of minutes. Just on IP, you mentioned a 2020 patent, just maybe discuss the protectability of Uceris?
Well, if anybody follows this marketplace, and particularly as it relates to anything colonic deliveries of 5-ASAs is a good example. There has been no 5-ASA generic at this point. Pentasa has been off patent for over 10 years. The hurdle rate is pretty high and with 5-ASAs you get about 20% absorption of mesalamine.
With Uceris you get about 10% absorption of the budesonide. We have filed the Citizen Petition with the FDA asking them to require more than just a traditional dissolution and PK study looking at AUC and Cmax, because you have to deliver the products throughout colon for they to be effective. So we think there is a higher hurdle than a typical systemically absorbed product, because this really is a product that works locally. And so it's not just the patent protection, it's a technology protection we think is important.
Greg Fraser - Bank of America Merrill Lynch
With that we'll wrap it up. Thanks, everyone for attending. And thanks Santarus for being here.
Great. Thanks, Greg.
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