Questcor Pharmaceuticals, Inc. (QCOR) Q2 2012 Earnings Conference Call July 24, 2012 4:30 PM ET
Ladies and gentlemen, thank you for standing by and welcome to the Questcor Pharmaceuticals Second Quarter 2012 Financial Results Conference Earnings Call. During today’s presentation, all participants will be in a listen-only mode. Following the presentation, the conference will be opened for your questions. (Operator Instructions) Today’s conference is being recorded, July 24, 2012.
I would now like to turn the conference over to Doug Sherk of EVC Group. Please go ahead.
Doug Sherk – EVC Group
Thank you, operator and good afternoon everyone. Thank you for joining us today for the Questcor Pharmaceuticals conference call to discuss the second quarter of 2012 financial results. This afternoon after the market close, Questcor issued its second quarter earnings release, which is posted on the company’s website at www.questcor.com. Today’s call is also being webcast and a slide presentation will accompany management’s remarks. To access both the webcast and the presentation slides go to Questcor’s website at www.questcor.com, click the Inventor Relations link, and then click on Events and Presentations.
If you are listening via telephone today to review the accompanying presentation slides, navigate to the live webcast at www.questcor.com, then choose the audio/slides only option to review the slides in conjunction with the live conference call. There will be a taped replay of this call, which will be available approximately one hour after the call’s conclusion and will remain available for seven days. The operator will provide the replay instructions at the end of today’s call.
Before we get started, I’d like to remind you that during the course of this conference call, management will make projections and forward-looking statements regarding future events. We encourage you to review the company’s past and future filings with the SEC, including without limitation the company’s Forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors include Questcor’s reliance on Acthar for substantially all of its net sales and profits and risks associated with Questcor’s strategy to further develop other on-label therapeutic uses for Acthar.
Finally, a couple of housekeeping items. Given management’s schedule today, we have allocated one hour for this call. In addition, during the question-and-answer session, please keep your questions to two and then re-queue if you have any additional questions. We will take as many questions as time allows. In advance, we thank you for our cooperation.
Now, I’d like to turn the call over to Don Bailey, President and Chief Executive Officer of Questcor Pharmaceuticals.
Don Bailey – President and Chief Executive Officer
Thanks, Doug. Good afternoon everyone. With me today are several other members of our management team, including Steve Cartt, our Chief Operating Officer; Dr. David Young, Chief Scientific Officer; and Mike Mulroy, Chief Financial Officer. They will each be making prepared remarks.
We made significant progress with our business in the last three months. Financial performance again improved. We almost doubled the number of shipped vials in the quarter more than doubled net sales and tripled earnings from the year ago quarter. Paid scripts increased for both nephrotic syndrome and MS. We expanded two sales forces and starting building a third sales force in rheumatology using the same formula that works out well with MS and nephrotic syndrome. And we also made good progress in both our science and compliance programs.
Questcor’s financial results were driven by the increasing acceptance of Acthar among nephrologist and neurologist as evidenced by the continued growth in nephrotic syndrome and MS paid prescriptions. These two uses of Acthar now each have annualized sales of approximately $200 million. The strong increase in paid prescriptions for a nephrotic syndrome, a serious kidney ailment was the main factor for the increasing sales in the quarter. We entered this new market last year and this portion of our business has grown quickly probably due to the therapeutic usefulness of Acthar and the lack of other approved therapeutics for nephrotic syndrome.
Nephrotic syndrome patients are typically treated for a six-month period with Acthar compared to a much shorter Acthar treatment duration for MS flares or infantile spasms. As a result of the growth in nephrotic syndrome prescriptions as well as the longer treatment period, we estimate that net sales from nephrotic syndrome prescriptions now slightly exceed in net sales from MS prescriptions. We have just completed the doubling of the nephrotic syndrome sales team, so the sales in nephrotic syndrome has the potential to grow in the future, although not necessarily in every month or quarter.
In addition we’ve started to hear anecdotally from investors who are surveying nephrologists that physicians are in some cases keeping patients on Acthar past six months. Previously the average number of vials per nephrotic syndrome script was about seven, but that number appears to have increased to about eight vials on average. In MS we grew paid prescriptions 48% in the second quarter to 1,110 from the year ago quarter with the same number of representatives as we had a year ago. This growth reflects the increased productivity of our sales representatives. Shortly, Steve will talk about the further expansion of the MS sales force which is well underway at this point.
During the quarter we presented our plan to pursue the rheumatology market, our next vertical market opportunity. Our pilot commercial effort in the treatment of the on label rheumatology related indications was initiated in mid-July. Acthar has the potential to help rheumatology patients who have one of the serious difficult to treat auto immune and inflammatory disorders already on the Acthar label. We have been told by rheumatologists that there is an unmet need for certain patients in these disorders. In a few minutes Steve will provide more details on our rheumatology commercial plans.
We believe three factors enable Questcor to continue to grow sales. First, Acthar apparently provides benefits to many difficult to treat patients who do not respond to other treatments. Second, despite the rapid sales growth market penetration is still relatively modest. Third, we have assembled and are expanding an excellent and experienced commercial team. We remain committed to helping patients with serious difficult to treat medical conditions. It is this core focus that drives us to further build our understanding of the potential immune modulating and anti inflammatory properties of Acthar and study other inflammatory and auto immune diseases that are on the Acthar label. David Young will provide a summary of our approximately 60 pre-clinical and clinical studies in various stages of progress in a few moments.
Now I’d like to turn the call over the Steve Cartt, our Chief Operating Officer who will provide more details on our operating highlights and an update on the expansion of the commercial team during the second quarter.
Steve Cartt – Chief Operating Officer
Thanks Don and good afternoon everyone. I’ll first focus on quarterly paid prescriptions for the three key markets that we currently serve. The chart now on the screen shows nephrotic syndrome prescription growth for Acthar on a quarterly basis over the last two years. As you may recall, we initiated the nephrology pilot selling effort with five representatives late in the first quarter of 2011 and further expanded this sales force to 28 reps at the end of the third quarter of last year. Our nephrology sales force has performed extremely well generating 146 and 238 Acthar prescriptions during the fourth quarter of 2011 and the first quarter of this year respectively. Because of faster than expected Acthar prescription growth in nephrology, we announced in February our plan to expand the nephrology sales force to 58 reps.
During the second quarter we completed this expansion with all the new reps trained and in the field selling by June 1. This sales team generated 340 new paid Acthar prescriptions in the quarter. The majority of which were generated by our existing sales reps. As our new nephrology sales reps gained some experience and comfort selling Acthar and begin to become fully productive over the next couple of quarters, we expect to continue and even potentially accelerate our sales momentum. Of note, we estimate that net sales from nephrotic syndrome in the quarter exceeded $50 million. This of course represents $200 million annualized run rate in the second quarter, which is only the third full quarter of nephrology selling activity since our commercial efforts commenced in this market with 28 reps in the fourth quarter of 2011. Thus, while we are having solid early success, it is important to remember that our efforts in this market are still very, very early.
Looking forward, we expect our newly expanded nephrology sales force of 58 reps will continue to build on this momentum and we expect to see the benefit from the expanded sales effort beginning in the third quarter of 2012. Previously having only 28 reps, there are many nephrologists that we have not yet called on and this recent expansion to 58 reps will allow us to significantly increase the number of doctors we can reach and the frequency with which we are able to call on them.
Insurance reimbursement continues to be very good for Acthar in nephrotic syndrome, with about 90% of prescriptions covered by insurance. We attribute this continued strong coverage to the severity of the health outcome if nephrotic syndrome is not adequately treated, coupled with the fact that Acthar has indicated and approved in this condition.
Very importantly, we often hear anecdotally that Acthar treatment is producing positive results for patients. This is not always the case, of course, not everyone responds, but clearly, many patients are benefiting significantly from this drug and there are few other treatment options available. All these factors are contributing to the rapid increase in Acthar usage in nephrotic syndrome. Balance turned to our efforts in the multiple sclerosis relapse market. The chart now on the screen shows quarterly MS relapse prescription growth for Acthar.
During the second quarter, MS prescriptions grew 48% to 1110 from second quarter 2011 with the same number of representatives as we had a year ago. We calculate net sales during the quarter due to MS prescriptions to be slightly less than sales for nephrotic syndrome, but still to be about $50 million or also about $200 million annualized run-rate. Our year-over-year growth in MS paid scripts is due to positive patient outcomes, increasing awareness about how Acthar can help patients who are not fully benefiting from other therapies, continued excellent Acthar insurance coverage for MS relapse, and the increasing productivity of our MS commercial team.
Our next chart shows the same MS paid prescription data on a monthly basis. It’s evidenced that our approach in the MS relapse market continues to work with the trend showing steady growth despite some month-to-month volatility. We have had solid sustained growth over the last few years of the MS market that we continue to believe there remains significant opportunity to further penetrate this market and we believe we still have a lot of room to grow. There maybe as many as 200,000 MS relapses annually in the U.S.
IV steroids are clearly and appropriately the primary first line treatment for MS relapses, yet extensive survey data indicate that many patients are not fully satisfied with first line steroid treatment for relapses. We believe our expanding neurology sales force will continue growing Acthar usage by enabling us to further broaden physician awareness of the appropriate role for Acthar as with additional treatment option in MS relapse management in patients for whom steroids maybe problematic.
The expansion of our neurology sales force to 107 from 77 reps is progressing very well. Many of the new reps have recently been hired and trained and we expect the expansion will be completed in August. As part of this expansion, we will increase our efforts directed to key academic centers and major MS clinics around the country. Importantly, as part of the continued evolution of the company, we are also investing in our support infrastructure with new hires in marketing, medial affairs, reimbursement, and compliance.
Turning briefly to infantile spasms, there were a total of 96 paid prescriptions for Acthar in the second quarter and IS sales were within our normal quarterly sales range. It is important to remind everyone that we have significant quarter-to-quarter variability in paid IS prescriptions due to fluctuations in the incidence of this very rare disorder.
Now, let’s turn to rheumatology, an intriguing new market for Acthar, which we are currently exploring. There are number of important indications related to rheumatology already on the Acthar label including indications associated with lupus, Psoriatic arthritis, Rheumatoid arthritis and other disorders.
Acthar is also proved for indications related to rare neuromuscular disorders dermatomyositis and polymyositis, which I’ll refer to as DM/PM. There are patients suffering from all of these conditions that are in need of new treatment options. They can be difficult to treat and if not treated successfully such patients can become debilitated. And in some cases these conditions can even become light threatening. In each of these indications we believe Acthar has a potential to be an appropriate treatment option for patients who do not respond adequately to or experienced problematic side effects from current treatment. Within each of these rheumatology related disorders lies a significant patient population where Acthar could be an appropriate treatment alternative. We believe the entire rheumatology opportunity for Acthar represents a multi billion dollar opportunity.
As many of you know we’ve recently hired 12 high calibers sales reps with significant rheumatology experience to begin to explore this new Acthar market much like we did in nephrology in the first half of last year. About half of these new reps have been trained and are in the field now and the remaining reps will be actively selling within the next couple of weeks. This dedicated team will educate rheumatologists about Acthar and initially focus their discussions with doctors on the appropriate role for Acthar in DM/PM. Again like the pilot effort in nephrology last year, this pilot in rheumatology is designed to confirm the need for Acthar in select DM/PM patients and to fine tune our messaging and commercial plans in this new market. So, far our efforts are off to encouraging start. Our first group of rheumatology reps have very recently just began to successfully generate the first several DM/PM prescriptions. And what we hope to be a key market for Questcor in the future.
We are now just working this first handful of Acthar referrals through the reimbursement process. So, please keep in mind that our July numbers may not completely reflect this early positive development. Where we are just starting our efforts with DM/PM calls in rheumatology, we expect that this is only the beginning. As new data emerges over the next 24 months regarding Acthar’s utility in lupus, RA and Psoriatic arthritis, we anticipate layering on selling activity by our rheumatology reps for these indications as well.
Now, let me comment on a second pilot effort we are beginning in neurology. DM and PM are rare neuromuscular diseases that both neurologists and rheumatologists treat. As such we are in the process of initiating a small pilot selling effort in neurology using a dozen of our existing neurology reps. These reps will speak to neurologists about the potential role for Acthar in treating DM/PM, as they are engaged in their daily MS selling activity. We look forward to providing further updates on this pilot neurology selling effort for DM/PM as well as our pilot selling effort in rheumatology for DM/PM in the coming months. But at this very early stage the pilot efforts I can say that we are already becoming quite encouraged by the respond we’re hearing from doctors.
The overall growth in Acthar prescriptions has led to consistent growth in vials shipped. And as Don mentioned as nephrologists gain experience with Acthar and then some are seeing certain patients respond somewhat late in the treatment period and are wondering to continue treatment beyond six months. We are actually seeing the average number of vials per prescription increase in MS. This has been a bit of a positive surprise. In the second quarter Questcor shipped 4710 vials of Acthar representing a record quarter for vial shipments. This of course has in turn driven our significant growth in sales and earnings.
I'll now turn the call over to Dr. David Young, our Chief Scientific Officer to bring you up-to-date on our comprehensive research and development efforts. David?
Dr. David Young – Chief Scientific Officer
Thanks, Steve. Good afternoon everyone. As you can see by our operating results reported in today’s press release we’ve been increasing our investment in research and development to better understand the unique immunomodulator and anti-inflammatory properties of Acthar Gel. Our subjects are objective that produce additional supporting data for the commercial team for on-label indications and to expand our Acthar Gel used through FDA beyond the current on-label indications.
Surprisingly, previous owners of Acthar Gel in the pharmaceutical industry in general have not invested in ACTH-based research. Therefore, there are many research areas that still need to be assessed by our R&D group in order to better understand ACTH and the clinical roles of Acthar Gel. We have begun or completed more than 25 non-clinical studies to better understand the basic chemistry and the pharmacology of Acthar Gel as well as the biological activity in neurology, nephrology, and rheumatology.
We also currently expect to have about a half a dozen clinical studies up and running by the end of the year in nephrology, rheumatology, and clinical oncology. In addition to the company-sponsored research, we have approximately 30 outside investigator-initiated studies underway in a number of on-label and off-label areas. For example, last month, we reported to investors on the promising results for Acthar Gel treatment for the on-label indications of polymyositis and dermatomyositis, which Steve just discussed. This was based on a report by Dr. Todd Levine, Co-Director in the Neurophysiology Department at Banner Good Samaritan Medical Center and Assistant Professor at the University of Arizona in Neurology.
Given our expanding effort and company-sponsored and investigator-initiated research, we anticipate that there will be a number of other reports than medical meetings and a number of publications coming out over the next 12 months to come out at Acthar Gel. Before I turn the call over to Mike to discuss the financials, I want to touch some of the questions we’ve been getting on respect to a competition of Acthar.
At a recent investor conference, I addressed the question whether old ACTH applications or NDA and ANDA might be revived without doing any additional research, based on our understanding of the drug products, our in-depth understanding of FDA requirements and our experience with both the offices of new drugs and the office of generic drugs at the FDA. It is our belief that the NDA and ANDA cannot be reinstated without the significant amount of work. All of the old NDAs have been discontinued. It is our understanding that any company attempting to reintroduce them to the public will be required to submit either a brand new product application following the manufacturing efficacy and safety standards today or they could request reinstatement after first meeting moderate FDA manufacturing and efficacy and safety standards.
We believe that either approach would require FDA approved manufacturing facilities and processes, toxicology programs, and clinical efficacy and safety data for each desired indication. Essentially, this would be a program not unlike when required for new chemical entity, we are not aware of any effort to reinstate these old NDAs. It is our estimate that such a program would carry significant risk and require many years to prepare an FDA submission. To compete with Acthar Gel, the product may also have to be compared head-to-head with our Acthar Gel in trial this would impact the chances of success in the clinical trial.
We have also been asked a number of questions about the generic, the purchase of Watson Generic. The Watson Generic is not a generic of Questcor’s HP Acthar Gel nor any modified release form of ACTH. There are no generics of Acthar Gel that exists to our knowledge. Therefore, there should be a little, where no threat of a substitutable generic product from these previously approved discontinued products. Many of the old products including the Watson Generic appear to have used an immediate release powder version of pituitary extract, not Questcor’s long-acting Acthar Gel. The immediate release powder for a very short-acting and is metabolized within minutes, which is conducive to diagnostic use, but would likely not be the sort of the therapeutic drug. Even if an immediate release powder form of Acthar will be reproduced following today’s manufacturing standards, which we do believe would be very challenging.
Manufacturing Acthar Gel involves several complex process and steps versus just mixing gels in with the porcine pituitary extract that is done with the Watson product. The competitive hurdles are highest for potential AB rated generic version of the Acthar. We continue to believe that any potential generic competitor will have multiple challenges.
First, a generic without difficulty characterizing all of the active peptides in Acthar Gel, given the final product in a gel made of peptide and the final peptide profile is very dependent on the manufacturing steps, including the pituitary extraction. Their characterization of active peptides is a requirement for generic. Two, the manufacturing process is not public information. Three, our pituitary extracted Acthar is now available to any of the source. Four, based on our understanding of the FDA generic guidance, the generic drug will be required to demonstrate chemical equivalents and bioequivalent, Acthar Gel in order to ensure the same safety and efficacy profile. Given the challenges one, two, three that I mentioned above, developing a product can be shown to the both chemical equivalent and bioequivalent is very challenging.
From a regulatory perspective, Acthar Gel appears to be very similar to Premarin, which is a hormone replacement therapy derived from the urine of pregnant mares and contains many different estrogens. Premarin was approved by the FDA in 1942 and then has never been a generic approved. Like Acthar Gel, the precise knowledge of the composition of Premarin and as each of the various estrogens contributes to the drug’s overall effectiveness has never been definitively determined.
Generic companies that try to copy the Premarin production process were not successful. They also attempted to make synthetic generic versions of Premarin. But in 1997, the FDA decided not to approve those synthetic generic forms of Premarin because they were not shown to contain the exact same type of ingredients and therefore the therapeutic equivalents could not be proven through the generic drug approval process.
Similar to Premarin, Acthar Gel would be extremely difficult to copy. A generic Acthar Gel has never been approved by FDA and the development and approval of a generic Acthar Gel is extremely unlikely. We have long held and noted that creating a competitive ACTH product certainly a possibility. However, approval would required a new drug application, which would likely require a full toxicology program together with the four clinical program demonstrate efficacy and safety for each desired indication.
Our belief is that this will take a minimum of five years and we are not aware of any effort underway. If an asset grew underway in U.S, it would likely be registered on www.clinicaltrials.com. In addition, the label for Acthar notes that Acthar is reported to bind to melanocortin receptors plural receptors. This probably eliminates the possibility of these in cortisol as a surrogate for clinical end points of Acthar Gel efficacy since introduced to only one of the bioequivalent receptors.
Since different melanocortin receptors are known to act on different body systems, we believe applications – applicants would only receive approvals for the specific indication investigated in the clinical efficacy and safety settings of the regulatory filing. With respect to Synacthen, a synthetic peptide marketed by Novartis in Europe and Australia. We believe unlikely to be compared to Acthar. Synacthen is a fragment of ACTH called tetracosactide and is not an androgynous peptide of the body.
It has the different amino acid sequence and a different pharmacology profile from Acthar Gel. Synacthen contains benzyl alcohol, which is toxic to children, it can potentially cause gastric syndrome, it can be fatal.
Since Acthar Gel is widely used in children under two years of age for infantile spasm, Synacthen might face substantial safety and distribution issues in U.S. In addition, Synacthen will face the same regulatory and business issues discussed earlier for similar ACTH vials. All said the company plans to reinstate to old NDA for developing a similar ACTH product like Acthar, that company will have to weigh the time and cost for development, the regulatory hurdles and market value potential indication and likely sales promotion costs, the short three to five year exclusivity period unless (indiscernible) with lower penetration and then decide whether it’s worthwhile to develop a competing product to Acthar Gel.
And even if they decided to move forward, all this would result in a proven only one indication. Others have estimated that Acthar Gel markets for the single indication will need to be in the $800 million to $1 billion range in order to make the efforts financially viable option. Furthermore, we believe that ACTH product previously approved would not likely become competitors to Acthar Gel, anytime soon either because the lack of therapeutic usefulness and or regulations required compliance with modern manufacturing, safety, and efficacy patterns.
Finally, Synacthen by our analysis faces substantial approval hurdles as well. When compared to generic drug, we believe that in generic drug approval is unlikely due to this complexity involved, improving similarities to Acthar Gel.
In summary, I’d like to bring it back to my initial topic our R&D efforts. We have previously reported our R&D efforts have been -- has been and are continuing to focus on three areas. First, producing its additional supporting data for the commercial team for on-label indications, second, extending Acthar use -- Acthar Gel use beyond existing on-label indications in the following FDA processes and third, our greatest priority, better understanding the unique chemical, biological and clinical characteristics of Acthar Gel.
Our research results from this third area thus far suggest that development of generic drugs of Acthar Gel is very challenging. All three areas of research are intended to advance the science of Acthar Gel in order to improve to help patients with devastating autoimmune and inflammatory diseases.
Now, Mike Mulroy, our CFO will discuss our financial highlights. Mike?
Mike Mulroy – Chief Financial Officer
Thanks David. Net sales for the second quarter were $112.5 million on the doubling from the 46 million Questcor achieved in the second quarter of 2011 with growth driven by increased physician acceptance of Acthar to treat serious difficult-to-treat autoimmune and inflammatory disorders. The second quarter of 2012, the sales reserve rate was 14.6% of gross sales compared to 23.5% for the year ago period. In absolute dollar terms, the sales reserve in our balance sheet has grown from $27.1 million at June 30, 2011 to $38.7 million in the current period.
Medicaid continued to represent the lion’s share of sales reserves. As a reminder, we do not generate any net sales on Medicaid business due to our 100% rebate position. Our growth in net sales continued to outpace growth in operating expenses which were $45.1 million in the current quarter compared to $22.7 million for the second quarter of 2011. The increase in OpEx is primarily due to the growth of our sales force and our research and development program as well as an expanded commercial infrastructure to support the larger sales force.
Despite the increase in operating expenses, operating margin was 54.3% in the second quarter up from 44.4% in the year ago period. We continued to expect to see operating expenses increase by approximately $5 million in the third quarter over the second quarter.
Turning to the bottom line, GAAP earnings per share for the quarter were $0.65 diluted based on $64.1 million diluted shares outstanding, up from $0.21 in the second quarter of last year. Non-GAAP EPS were $0.69.
Second quarter ending channel inventory appeared to be lower than the higher than average level at the end of the first quarter of 2012 and in the range of channel inventory over the past several quarters. Of course as we have discussed in previous disclosures Questcor believes in investors to consider the company’s results over several quarters when analyzing its performance.
Operating cash flow during the second quarter was $43.2 million driven primarily by net income of $41.5 million for the second quarter ended June 30. Questcor used $156.1 million in cash to repurchase 3.7 million shares of its common stock in open market transactions and an average price of $41.85 per share during the second quarter. We have 4.7 million shares remaining under our current common stock repurchase program. Return on equity was 92% for the second quarter which compares favorably to our first quarter ROE of 68%. This increase was driven by both net income growth as well as our share repurchases during the second quarter which reduced shareholders’ equity.
Finally, I’d like to make a comment in my capacity as Questcor’s general counsel. From time to time, investors ask us questions about our trading window of stock repurchase black out policy, potential government investigations and acquisition increase. I’ll comment on these three items now, but in the future management will not respond to questions on these items. Of course we will make public regulation FD compliant disclosures regarding any such matters to be deemed appropriate or legally required to do so in the future.
As this could be viewed as a change in our disclosure practices, we feel it’s appropriate to start up with the clean slate. So, let me confirm that Questcor is currently in our regular quarterly black out trading period. Questcor is not aware of any pending or threatened state or federal investigation regarding Questcor, its employees or its products including Acthar and finally, Questcor is not currently in discussions with any company which would involve the acquisition or merger of Questcor.
Now, I’ll turn the call back to Don.
Don Bailey – President and Chief Executive Officer
Thanks Mike. So to summarize, we remain committed to helping more patients with unmet medical needs and we continue to deliver on our growth strategy. Our commitment and execution brought another record financial performance quarter for Questcor. We believe Acthar provides substantial benefits to many patients who would otherwise continue to suffer the effects of serious difficult-to-treat disorders. Our expanding commercial efforts in nephrology and neurology made for other sales growth. In addition we are seeing positive early results from our rheumatology pilot commercial effort and at the same time we’re committed to investing in research and development to learn about Acthar’s unique properties and the possible therapeutic applications to treat other inflammatory and immune diseases.
Operator, you may now open up the call for questions.
Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. (Operator Instructions) Our first question comes from the line of David Amsellem with Piper Jaffray. Please go ahead.
David Amsellem – Piper Jaffray
Thanks. Just a couple on the nephrotic syndrome setting, can you elaborate on how many nephrologists you’re now calling on with the expanded sales force and how many you were calling on before the expansion? And talk a little bit more about reimbursement in the MS setting and particularly interested in what kind of reimbursement you’re seeing in the Medicare Medicaid setting and just remind us what portion of the nephrotic syndrome setting are government payer based? Thanks.
Sure. So, I let Steve answer that question. I’ll take off the government part real quick. Medicaid and Medicare are both covering this drug. Of course Medicaid, we have a 100% rebate situation and Medicare represents about a quarter of our sales. Steve, you want to address the rest of those -- rest of this question?
Sure. So David before the expansion we are calling on about 1200 nephrologists with any kind of reasonable frequency. Post-expansion we expect to be in the 2500 plus range and expansion is very, very new and just recently completed it last month, so we want to see how that develops and we’re expecting at least 2500 docs that we’ll be calling on regularly, so that’s going to be a nice uptick for us there.
In terms of reimbursement in nephrotic syndrome is that remains very, very strong. The payers in fact are becoming more custom now as you would expect to see nephrotic syndrome prescriptions whereas you know several months ago there were a lot of the payers that are still new just seeing that first one or two or handful, but now they’re becoming more custom to seeing them and our coverage rates are remaining very strong. We’re up around 90% coverage. We see no indication of that’s changing at all and are monitoring it closely. You know we speak with payers literally on a daily basis as we work the prescriptions for our reimbursement hub and we’re seeing no indication there is any slowdown of coverage whatsoever there.
David Amsellem – Piper Jaffray
And just a quick follow-up on question, this is a rheumatology related question, maybe for Dr. Young, remind us again what the relevant clinical endpoints are in this setting? What's the most important to physicians in determining clinical success and I’m specifically asking about dermatomyositis and polymyositis? Thanks.
So, in – this is Don Bailey. So, in polymyositis, dermatomyositis, physicians are looking at muscle weakness as the primary endpoints that they’re trying to improve. We got some background noise. So, muscle weakness is something they can measure on a scale and they’re trying to improve that.
Thank you. Our next question comes from the line of Steve Byrne with Bank of America. Please go ahead.
Steve Byrne – Bank of America
Hi, Steve. Can you just talk a little bit more about the demographics of the NS patients that you are picking up perhaps geographically or the subtype of NS and by doubling the sales force are you targeting certain geographies or certain types of nephrologists?
Yeah, so it’s allowing us to spread out and cover more nephrologists in general and what we’ve seen in the last several months is primarily usage in membranous nephropathy, idiopathic membranous, but we’re beginning to see more usage in other types of nephrotic syndrome for example FSGS and IgA nephropathy is two examples, so while doctors are typically using it you know for the first time in membranous they’re then beginning to branch out a little bit and you know really as I mentioned calling on and we’ve only been calling on 1200 or so which is a very small number, so doubling the sales force is allowing us to branch out quite a bit from there. We’re calling on academic centers for nephrotic syndrome as well as community nephrologists. Of course community nephrologists are easier to get to see, easier to access, but now that you have a broader coverage geographically the reps are spending less time behind their windshields more time in the offices, so they will be able to put more of a concerted effort on the academic center, so we are seeing definitely increased usage in the academic centers at this point.
Steve Byrne – Bank of America
And if I could follow-up with one for you David just you talked about the characterization of Acthar and could you just comment a bit on the effects of the Gel on the characterization of the peptides how does that change the composition in the analysis of that mixture?
Actually right now we’re studying that. We’re trying to understand how the Gel might go through their extraction and we don’t know that answer right now, but that’s one of our big efforts going on in R&D area.
Thank you. Our next question comes from the line of Mario Corso with Caris & Company. Please go ahead.
Mario Corso – Caris & Company
Thanks. Good evening. Couple of things I wanted to ask about. In terms of the rheumatology effort I know it’s early, but either Don or Steve I’m wondering what you can say anecdotally you know what you’re hearing in the first couple of weeks in terms of physician interest, their patients’ scope. And on the early use you talked about you know should we be thinking about that in terms of -- you know is there a way to characterize it? Is it hence of Rxs or is each rep you know getting an Rx I’m just wondering how we could characterize that?
And then on the generic side, you know it was really helpful and insightful to hear David go through the barriers. I’m wondering in terms of IP is we think about and you talk about the mechanism of action over time and all the work you’re doing there. I know you may not want to talk about specifics, but are there active efforts ongoing to see what there can be patented in terms of the use of a you know specific mechanism in one of the diseases you’re targeting? Thanks very much.
Okay, so let me pick up the last one real quick. We’re not going to -- you’re right. We’re not going to comment on the specifics of that, but of course we’re always looking for any IP we can get and the MOA certainly is an area that we’re looking at. The rheumatology groups have -- it was hiring 12 new rheumatology day sales people and we will be soon adding to that a dozen of our current MS reps to call on neurologists. So, literally six of these new rheumatology reps had been in the field for maybe 10 days. So, when you’re saying there is encouraging early results from six people working for 10 days. So, we’re talking about a handful of scripts, but let me let Steve tell you what we’re hearing from rheumatologists at this very, very early stage. Steve? And we’re also hearing this from investors by the way, who are calling on rheumatologists. Steve?
Yeah, Mario, so as you can imagine I mean I think it’s wild to even be able to even pronounce polymyositis and dermatomyositis. I mean this is a really neglected area of medicine and there had been nobody investing in research; there had been no industry support really of anything in this field and so when we are going into rheumatology offices and mentioning to doctors that we have a drug that’s approved for polymyositis and dermatomyositis, their eyes just light up.
I mean there is real surprise if there is something approved and they’re encouraged by the early data set that we have. These are patients who are typically on long term steroids. They have a significant problem to develop as a result of long term steroid use. Some patients no longer respond or never really did respond. There is also a fair amount of use of immune suppressive agents and so the docs don’t like to have patients on those for sustained periods of time. So, they’re looking for some new tool to help manage these DM/PM patients so there is a lot of interest to that. They clearly recognize very similarly to nephrotic syndrome. They immediately agree that there is a high unmet need in this particular area of medicine with these patients.
Again this is a rare disorder. These are considered orphan diseases. They’re only combined 65,000 to 70,000 in the US for both of them combined, so rare disorder highly neglected. There has been very little resourcing for patient support groups or patients or the doctors that treat them, so a lot of interest in what we’re talking about. And in terms of the number of patients per physician that we’re seeing, you know there is going to be a range. I mean we’ve had some doctors mention they have 20 or more. There are some clinics with you know up in excess of 100 large tertiary care clinics with the excess of 100 then we often see doctors who have two or three or four and they’re just -- they’re grasping it strong looking for new tools to help manage the patients.
So, we’re very encouraged as Don said it’s extremely early. The reps, very small number of reps have been out for a very short period, but the initial response is quite encouraging. It feels a lot like nephrotic syndrome did at the very beginning of that pilot effort. In fact you might argue it feels even a little bit more positive because of their lack of attention those areas had.
Thank you. Our next question comes from the line of Chris Holterhoff with Oppenheimer & Company. Please go ahead.
Chris Holterhoff – Oppenheimer & Company
Hi thanks. Just want to ask you question about all the work you’ve done you know showing those other active peptides in Acthar in addition to ACTH, specifically wondering if you sort of have any conversations with the FDA to try to get you know some of that work added to the label you know just to give yourself additional protection from here.
Sure Chris. I’ll let Dave – David elaborate just in a minute, but of course that’s something that’s not a consideration and if we get some results that we think would be helpful to the label I think we would. David do you want to elaborate just a little bit.
Dr. David Young
Yes. You know in order to make sure that the data is robust enough, it takes us a lot of experiment to go through and repeat and repeat and repeat, so even though our preliminary results look good we’re not quite ready to put this upfront to the FDA. We are ready to talk to them that you know to communicate with them, but the process of doing and how we’re going to do that and when we’re going to do that hasn’t been completely decided yet. And so we’re kind of strategizing that on that now.
Chris Holterhoff – Oppenheimer & Company
That’s helpful. Thanks. And just a follow-up on MS scripts, you know you look at after being flattish since the end of last year we see some good growth in May and June and just wondering if you think you know that’s a function of having more reps in the field or is there something else there that you think might be going on?
Well, I think there is multiple reasons that as we look at year-over-year this is a pretty fair comparison at this point, Q2 versus Q2 we’re up 48%. So that 48% is pretty much with the same number of reps. I think that’s reflective of the improvement in productivity and learning of these reps. We see reps who have been solid all along and other reps who are picking up and you know doing much better now than they were a year ago. It’s pretty much what you might expect from when you’re still in the early stages of a market. And even at a worst level and it was quote flat, we’re still growing at about 24% and 25% annualized rate, so I don’t think it was ever. I don’t think flat was ever quite the right word. It’s just flat by comparison, but you know 100% growth. Steve you want to elaborate a little bit on the sales force and how they’re doing?
Yeah. Chris we you know hired some of the reps in the expansion of the MS team we’re still in the process of hiring and we expect to have the full complement through going up to 107 completed in August to have them out selling, so we’re really pleased. We’re continuing to be attractive company for new reps in the MS area to come to and we’re competing with people as you might imagine people for competing with companies like you know the larger biotech companies and some of them are launching new drugs in MS maintenance, so there is a lot of attractive elements of selling products like that, but we’re continuing to attract very, very good people and we’re quite pleased with the caliber of folks we’ve got on board, but you know I’d say right now you know we’re encouraged. We had a quarter that was strong. As Don mentioned you know we’ve had periods over the last three to four years of sharp increases and then things have you know moderated a little. Then we had sharper increases you know few months down the road, so we just have -- we have these periods where growth is a little stronger than little softer than we’re stronger and I think that’s probably a pattern you will see over time.
Thank you. Our next question comes from the line of Marko Kozul with Leerink & Swann. Please go ahead.
Marko Kozul – Leerink Swann
Hi good afternoon. Thanks for taking the question. I wanted to ask about diabetic nephropathy if you could talk a little bit about the ongoing trial how it might be enrolling and if you could help us understand what a go, no-go decision might be when you do have results or progress into more advanced studies. Thanks.
David you want to take that question?
Dr. David Young
Yes. Right now we don’t have all the sites up. About half of them are up and running and so we’re doing a lot of screening. We have a few patients enrolled and there are you know we have somewhere between 10 and 20 patients screened and the screening process is quite long. It’s more than you know just one day screen, takes us a month so most of the patients are on the screening process. We do have some patients that actually have read about it again are dosing.
In terms of that long term you know what we would look for I can’t really answer that now. It really depends on what results look like and also the input from our KOLs about the things that I referred for those of the product and an indication. So, right now it’s a little early for me to comment on what the criteria would be for us to go forward beyond the study.
Marko Kozul – Leerink Swann
Thank you. Our next question comes from the line of Tim Chiang with CRT Capital. Please go ahead.
Tim Chiang – CRT Capital
Hi thanks. Don I have a question. You talked about relatively low penetration rates with Acthar. Even with the increased sales force that you have fully expanded by August, you know how many or what percent of the physicians are prescribing for these different disease states and you’re actually able to detail too now by August in MS, NS, and DM/PM?
Steve you want to take that question, I’ll hand it off.
Yeah. Tim so on DM/PM it’s going to be a very small number where we’re going to have a dozen of our neurology reps selling their alongside of what they’re already doing in MS. And then in rheumatology there is you know we have a dozen selling in rheumatology as well, but I want Eldon comment on our selling activity in MS. Eldon Mayer is our Senior VP of Commercial Ops. He is on the line as well.
Sure. I would estimate that I will take these -- is the question Tim just to clarify you’re looking at the various disease states MS and nephrotic syndrome as well?
Tim Chiang – CRT Capital
That’s right. That’s right.
Tim Chiang – CRT Capital
Seems like that, yeah.
Yeah, so looking at MS you know we intend to detail with the expansion probably about 3500 or so doctors and somewhere in that range. We estimate there are probably somewhere between 6,000 and 7,000 total targets that we begin to -- we’ll understand our audience better and better. So that would be roughly 40% to 50% somewhere in that range that we can detail. So, we’re looking at nephrotic syndrome. Again this is a market that as you know we haven’t been calling on very long and this is essential. And during the time we have with not that many sales folks so we will understand the audience better and better over time, but I would estimated this still relatively early stage that there are as Steve mentioned roughly about 2500 doctors will be calling on with the 58 sales folks, but we estimate there are, at least 5000 to 6000 total targets maybe even more, so that would be at least around 50% maybe less of that market that we can be calling on. As you know, we have a small number of doctors who are writing, so significant upside for growth there as you call on more doctors.
Tim Chiang – CRT Capital
Okay, that’s helpful. Don, I just had one follow -up for you. I know you mentioned you are starting to see more vials on a per pay prescription, potentially seeing the strength in nephrotic syndrome, I mean is that what you are seeing in your monthly data?
Yes, we are seeing at their monthly data. MS and IS are stable at about 1.5 and 4 vials and nephrology has moved up from 7 to 8.
Tim Chiang – CRT Capital
Okay, great. Thanks very much.
Thank you. Our next question comes from the line of Biren Amin with Jefferies & Company. Please go ahead.
Biren Amin – Jefferies & Company
Yeah, thanks guys for taking my questions. I wanted to ask on the preliminary data identifying other peptides and Acthar Gel that David referred to earlier in the call. When can we expect the company to publish these data in medical journals?
Well, we’ll publish that information if we want it published when it’s ready. So, I don’t think we can give you an exact timeframe even if we had it. I think that will be information we would keep pretty closer to that.
Biren Amin – Jefferies & Company
Okay. And then question on the chart Phase IV trial in nephrotic syndrome, could we get an update on that?
Sure. David, you want to give a quick update on the IMN trial?
Dr. David Young
Sure. This trial as you know has gone a little slower than we expected, but it appears to be because many of our patients are opting to not receive the placebo, but whether actually preferred to receive Acthar itself for many of our potential patients in the study. And so it has gone slower. We have modified the inclusion/exclusion slightly in order to ramp it up a little bit more. We’ve got some sites. We are being proactive like we were in the beginning, but we are looking at some other options in terms of enrolling it a little bit faster. Other than that, these are not much to say. We hope that the changes that we have made will improve our recruitment, but we won’t recruit the fact that patients with now they have the drug of the people, that’s something that we are not going to be able to alter very much as we have a lot of patients like that.
Thank you. Our next question comes from the line of Jim Molloy with ThinkEquity. Please go ahead.
Jim Molloy – ThinkEquity
Hi guys. Thanks for taking my question. Have some more on Mario’s question from earlier regarding the DM/PM. Can you talk about sort of any pushback or the selling cycle to neurologist and given that the fact that anecdotal rose, then your modern trial obviously, you have the approval? Can you talk a little bit about that selling cycle?
Sure. So, I think that we are frankly just too early to give you a real clear answer. And to be clear here, we are just calling on rheumatologists with the rheumatology pilot group to neurologist calls haven’t started yet. And as Steve said, the rheumatologists are viewing this with some surprise and are very anxious to hear about this drug and what it might do for their patients. So, I think that’s where are in the cycle and since we’ve only had leveling two weeks here out in the field, it’s really hard to say what the whole selling cycle is going to be. I think that it’s logical, like in nephrotic syndrome these patients make take a little while to get through the process while they are in some distress. They are really going to depend on the level of the stress that the patient is in. If the patient is in a lot of the stress it will move a little quicker, but that’s logic, we don’t have any experience to really answer your question.
Jim Molloy – ThinkEquity
Fair enough. Then my follow-up question any thoughts, I mean, we need to expand any production at all given the sort of the new indications in labels?
Well, we have Dave, are you on the line, I don’t know?
Dr. David Young
Yes, I am.
Maybe you could answer the question?
Dr. David Young
Sure. We have been increasing our production as sales have been increased over the last couple of years. And we’re in good shape as far as been able to increase for the best price and frequency when we do lot so into the future there is no issue there.
Jim Molloy – ThinkEquity
Thank you. Our next question comes from the line of Yale Jen with Roth Capital. Please go ahead.
Yale Jen – Roth Capital
Thanks for taking the questions. Just the first one is Don, could you give us a little bit breakdown in terms of the revenue from each indications I believe you mentioned that roughly 50 million from what about gross, what about the other major expense?
I’ll ask Mike to answer that question.
Great, thanks. We mentioned that the nephrotic syndrome was slightly greater than MS but there are pretty close. So you could call each about 50 million in net sales. You could roughly 10 million to IS in the stock we just be kind of remainder for some rounding there but other…
We do get a few prescriptions for handful of other indications. And then on MS that we talked about this in the past well its roughly just ahead of MS in the quarter it doesn’t give that kind of benefit to MS that we’ll see from its tail given the longer treatment regiment for each MS script.
Yale Jen – Roth Capital
And the follow up question I have is that for handful a number of clinical studies ongoing or some are maybe going to finish should we - what meeting we should anticipate say over the next 12 months to come out, you guys have the schedule on any of those yet?.
Well, we have a series of studies that are at the stage where there will be publications coming out many of these our investigator-initiated studies and as far as (indiscernible) I maybe let Steve, can you ask a question was there which meetings they may show of that?
Sure. I think we’ll have less data is ASN this year there maybe a little bit at the ACR meetings which is a rheumatology meeting and I don’t know if you took note of the publication last month in the American Journal of Nephrology which was out of Colombia on Acthar that actually represented the very first perspective trial of Acthar in the product syndrome that was published. So that, we want to take a look at as well you haven’t seen that. So, Don said this, very small perspective trials that Acthar in nephrotic syndrome in particular will be rolling out over time, but we’ll definitely have some data at ASN and a little bit at the ACR meeting.
Thank you. Our next question comes from the line of Frank Pinkerton with SunTrust. Please go ahead.
Frank Pinkerton – SunTrust
Hey thank you for taking the question. Don you’ve got a unique property in the drug and you’ve spoken a lot on both that your last conference presentation and today about R&D. can you take a step back not on any single trial but just what is the risk reward opportunity for spending increasing spend on research and development and how does the company ultimately look at as the spend goes forward what that does to maybe expand in the some markets maybe exclude from other markets with the drug? Thanks.
Thanks. That’s a really excellent question. The Acthar first of all you have to ask the question why is Acthar seem to be effective and such desperate conditions as a form of epilepsy with babies very difficult to treat kidney condition and these exacerbation from NS as well as some of these other rheumatology condition. And of course the answer we think is in the immune system and what Acthar is doing to help the immune system moderate or modulate. And so that’s why we want to spend a lot of our R&D effort in that area and understand the various mechanisms of action and exactly what elements of Acthar are doing what inside both with the port receptors. And frankly maybe with some other receptors probably the answer to that R&D effort may unleash opportunities in other indications that currently in line on our radar screen we have an ongoing effort to identify research that will help us with the on label conditions but we also have a pretty significantly effort underway to identify those other immune conditions we think have the best probability – the best probability of Acthar working in helping those patients, and where there is also an unmet need and commercial liability. So, we think there is a lot of reward here and very little risk, because Acthar has been around for a long time. The safety record is pretty well-known and we are taking that rather conservatively as far as any trials we design and do.
Frank Pinkerton – SunTrust
Okay, great. And then just as my second question and I know you historically haven’t given this information, but can you either give some detail or would you consider giving detail on the quarter on number of doctors and repeat prescribers, excuse me, number of prescribers per repeat prescribers for the drug? Thank you.
Sure. Steve, you want to take a shot of that question?
Sure. I don’t think we’ll give out too many specifics, I think. Suffice to say over the last year or so, we had about 1000 prescribers on the MS side and about 500 prescribers on the nephrotic syndrome side, so a pretty good healthy number of prescribers for each, but it still speaks to the very low penetration rate that we still have in those markets and there is a lot of upside there. I think in terms of the distribution of prescriptions over the prescriber base, it’s pretty typical. It follows a typical curve that we have seen many times in our creators for products. And there is really nothing out of the ordinary, it’s pretty normal as far as distribution of scripts to docs.
Yeah, we see good distribution across docs, good distribution across reps, good distribution geographically. We’re averaging about 1.5 scripts per nephrotic or nephrologist at this point, but it’s very, very early and about 4 per MS doctor. So, pretty low numbers and a good chance to probably increase those in the future, Frank.
Thank you. Our next question comes from the line of Juan Sanchez with Ladenburg. Please go ahead.
Juan Sanchez – Ladenburg
Hi guys. Couple of questions. The first one is on you have any updates on expenses for the second half of the year, are they as high as you expected or could not greater given the recent development? And the second question is on, when you modernized your label five years ago, can you just refresh your memory on how was the back and forth with the FDA in terms of shrinking the number of claims from 52 or 50 of close for 2019, and if the FDA gave you any specific reason why they are okay with not new clinical data?
Mike, you want to answer the expenses question?
Yeah. Just on expenses, first on Q2, they came in about where we had guided maybe a little north of that, though there is some shifting in sales and marketing came in, but it pick up a little bit more of the increase than R&D and that was really the function of acceleration in our growth in the sales force. I mentioned earlier, we continue to expect see about another $5 million in bump up in OpEx in Q3. Q4, we haven’t really called yet, but we wouldn’t expect a big leap from the Q3 level. So, Juan, I’ll take a quick shot at your second question if I understand it. So, in October 2010, the Acthar label went through a full monetization at the FDA. And in that process, we ended up with 19 indications. The review of the indication is on the label followed the FDA rules for modernizing and active – active label and so the 19 indications met the qualification that the FDA has. Operator?
Thank you. And I am showing no further questions in the queue at this time. I’d like to turn the conference back to management for any final remarks.
Don Bailey – President and Chief Executive Officer
Thanks everybody for joining us a rather long call, but sure had a lot of information to provide you. We look forward to speaking to you in the future. Bye-bye.
Ladies and gentlemen, this does conclude our conference for today. If you’d like to listen to a replay of today’s conference, you may do so by dialing 1-800-406-7325 or 303-590-3030 and entering the access code of 4550797 followed by the pound sign. Thank you for your participation. You may now disconnect.
Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.
THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.
If you have any additional questions about our online transcripts, please contact us at: firstname.lastname@example.org. Thank you!