Questcor Pharmaceuticals, Inc. (QCOR) Q2 2010 Earnings Call July 28, 2010 4:30 AM ET
Good day, ladies and gentlemen and thank you for standing by. Welcome to the Questcor Second Quarter 2010 Financial Results Conference Call. During today's presentation all participants will be in a listen-only mode. Following the presentation, the conference will be opened for questions. (Operator Instructions). This conference is being recorded today, Wednesday, July 28, of 2010.
At this time, I'd like to turn the conference over to Mr. Doug Sherk with EVC Group. Please go ahead sir.
Thank you for joining us today on the Questcor Pharmaceuticals second quarter 2010 earnings conference call. This afternoon at market close, Questcor issued its second quarter earnings release. The release is posted on the company's website at www.questcor.com.
In addition, we have arranged for 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 the call. The call is being broadcast live and an archived replay will also be available. To access the webcast, go to Questcor's website at www.questcor.com.
Before we get started, I'd like to remind you that during the course of this conference call, the company 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.
With that, let me turn the call over to Don Bailey, President and Chief Executive Officer of Questcor Pharmaceuticals.
With me today are Steve Cartt, Executive Vice President and Chief Business Officer; Dave Medeiros, Senior Vice President of Pharmaceutical Operations; Gary Sawka, our CFO; Eldon Mayer, Vice President of Commercial Operations; and Dr. David Young, our Chief Scientific Officer. This afternoon, we will review Questcor's highlights for the second quarter of 2010 and discuss recent business developments. Then, we'll open up the call for your questions.
Questcor generated solid financial and operating results during the second quarter of 2010. Net sales were quarterly record of $28.3 million, up 12% from last year's second quarter. MS sales are now half of Questcor sales and are at an annual run rate of over $50 million a year. MS sales were up 145% year-over-year and 32% sequentially.
The strong sales growth and opportunities to build further sales in IS and Nephrotic Syndrome led to our decision to double our sales force in the third quarter of 2010. Steve will cover what's driving our strong MS sales growth and more about the sales force expansion in a few minutes.
Turning to IS sales, our second quarter results were within our historic levels. Back in early May, the Peripheral and Central Nervous System Drugs Advisory Committee to the FDA held a panel meeting to discuss approval for using Acthar in infantile spasm. As we have reported to you then, the meeting went exceptionally well. The panel's purpose was to advise the FDA on their opinion of whether or not Acthar should be approved by the FDA for this condition. The vote by panel members was overwhelmingly in favor of an approval for Acthar.
Since the panel meeting, the original PDUFA date of June 11 was extended to September 11. The FDA is reviewing information regarding labeling, REMS and a potential post-approval commitment that they solicited from Questcor. The process continues to move forward. If we do earn FDA approval to add IS to the Acthar label on schedule in September, we expect to launch Acthar in the treatment of IS during the Child Neurology Society Annual Meeting in October.
Moving on to Nephrotic Syndrome. During the second quarter, we have learned that several Acthar related abstracts were submitted for presentation at the American Society of Nephrology Annual Meeting in Denver in November of 2010, and one paper has been submitted to a major nephrology journal for publication early next year.
We believe that these initial reports on Acthar and its potential role in Nephrotic Syndrome will help the nation's 7,000 nephrologists better understand how Acthar might help their patients battling this difficult to treat disease.
For the second quarter of 2010, Questcor reported net income of $0.14 per share or $9.2 million. We continued to improve our balance sheet as cash has recently exceeded the $100 million mark.
During the second quarter, we decided to focus our business development efforts on identifying new uses for Acthar; new labeling, new label indications and enhancing our position as the drug's only manufacturer and marketer. We will keep you posted on how our progress goes with these initiatives.
Finally, as a result of our progress during the past year, we have revised our mission statement for Questcor. It now is, Questcor Pharmaceuticals is a biopharmaceutical company whose products help patients with serious difficult to treat medical conditions. We believe this mission statement captures all of the key elements that are important to Questcor's unique business model and provides a clear message of our direction to our investors, the industry and most importantly, our employees.
Now, I would like to turn the call over to Steve Cartt, who will discuss our commercial activities in more depth. Steve?
The strong growth in prescriptions that we're seeing for the treatment of MS exacerbations is a direct result of our strategy to build increased awareness of Acthar's benefits to MS patients.
Acthar prescription activity in MS during the second quarter grew 145% over the same period in 2009. In addition to rapid growth, we have recently identified other positive trends in our MS business.
While the data is still preliminary and we'll be working to refine it in coming months, it appears that we have a steadily growing number of both repeat prescribers and repeat patients.
This is particularly encouraging, because it indicates we are beginning to develop a loyal customer base among MS physicians and their patients. We hope to provide greater detail on these developing trends on future calls.
The principal driver of growth at our MS business was our 2009 sales force expansion. In early 2009, we expanded from 15 to 30 sales reps and then again to 38 late in the third quarter of 2009.
This increase in our sales organization led to strong MS prescription growth during the last half of 2009 and the first half of 2010. The sustained MS growth coupled with the possible launch of the new indication for Acthar late this year led to our recent decision to double the size of our sales force.
I'll now provide some detail on the thinking behind our expansion decision, as well as a brief update on the progress of the expansion. The 2009 expansion resulted in a modest sales force capability for Acthar and we are still only able to deliver sales calls on fewer than 2,000 MS treating neurologist.
With only 38 reps, covering the entire country, our sales territories have been quite large geographically and as a result we have not been able to visit many of these neurologists with optimal frequency and we had not been able to deliver any sales calls at all on many other neurologists, who treat MS patients.
Often our reps have had to spend more time driving or flying around the territories and actually making sales calls. Clearly, this is less than optimal. To effectively change prescribing behavior, it is important to make calls and target physicians on a much more regular basis, ideally once or twice per month or more for an extended period.
With the sales expansion that is currently underway, we will roughly double the number of sales reps to 77, thereby increasing the total number of neurologists we can call on and allowing us to structure much smaller and more efficient territories.
Each of the individual rep will consequently spend less time driving and flying and will be able to deliver more frequent calls on those neurologists that they are responsible for.
Once our expanded sales force is fully hired, trained in making calls in the fourth quarter of 2010, we expect this will begin to have a positive impact on MS prescription trend. On last month's call, we mentioned that so far there have been less than 400 Acthar prescribers at more than 8,000 neurologists in the U.S.
The goal of the current expansion is to increase our call activity to include over 4,000 neurologists, with a highest prescription potential in MS. And as a result, we expect the number of Acthar prescribers to grow significantly overtime.
Now I'll provide a brief progress report on the expansion. Most of our sales manager positions are now filled. We promoted three of our top sales people who are ready to move at the manager position. We've also been able to recruit four very experienced sales managers from outside the company and most have extensive experience, selling in the MS market.
Recruiting for the 43 sales rep positions is also well underway and we expect to have most if not all sales positions filled by late September. Overall, we are very pleased with the caliber of personnel we have been able to attract.
Turning to infantile spasms, we filled the total of 95 paid non-Medicaid commercial prescriptions for Acthar in IS during the second quarter. This is fairly consistent with previous quarters, despite the expansion of Medicaid rebates resulting from the healthcare reform legislation earlier in the year.
In fact, this is the highest number of paid IS prescriptions we have filled since the first quarter of 2009. Though we feel pretty good about where this base line IS business currently stands, we think there are also more children with IS, who could be helped with Acthar.
As Don mentioned, the PDUFA date for our sNDA is currently September 11th of this year, assuming FDA approval comes through as expected, which of course can never be guaranteed, we're actively planning for commercial introduction of the IS indication for Acthar at the Child Neurology Society Annual Meeting in Providence, Rhode Island during the week of October 4th.
This would of course be the first time that we would be able to promote Acthar for the treatment in infantile spasms. With an approved indication, we can also initiate targeted public education efforts regarding the importance of early diagnosis and effective treatment of IS.
Now, I'll take a moment to discuss our progress in nephrology. As a reminder, nephrotic syndrome is already an on-label indication for Acthar. You may recall that earlier in the year, we decided to run a very small pilot sales effort in nephrology in the second quarter. With five of our reps periodically calling on about 60 nephrologists out of a total audience of about 7,000, we have already learned some important things from this effort.
First, nephrologists readily acknowledged that they are in need of new treatment for nephrotic syndrome due to the significant shortcomings of current treatment and they are clearly interested in Acthar, but most nephrologists want to see Acthar-specific data from a reputable academic center before prescribing Acthar.
Second, insurance coverage has been good, hovering in a range from 80% to 90% coverage. Considering the complete lack of Acthar clinical data up to this point, this is quite good, and we believe we can improve coverage once Acthar clinical data becomes available.
Let's talk about the early results of the pilot efforts so far. Since the very small flow of prescriptions that resulted from our activities, the American Society of Nephrology meeting last October has largely tapered off at this point. Most of the prescriptions generated now are a result of our small pilot selling effort.
During the second quarter, we had five reps spend about 20% of their time each on nephrology calls. Point of fact, we had equivalent of about one full time rep calling on nephrologists during the quarter.
From this very limited effort, we are able to generate four commercially paid nephrology prescriptions during the initial quarter of activity and three more in July. On average, a paid nephrology prescription ultimately totals nine to 10 vials over the course of six months of Acthar treatment, which amounts to about $200,000 in net revenue.
So in summary, the equivalent of one sales rep full time without any Acthar clinical data generated in one quarter, which should ultimately amount to about $800,000 in sales. While it is very early and the prescription numbers here are admittedly very small, we believe this is an exciting early indication of what could be possible in this market once we have clinical data coupled with the nephrology trained sales force actively promoting Acthar.
So when will nephrology data for Acthar be available? We anticipate that at this year's American Society of Nephrology meeting in November, new clinical and preclinical data related to Acthar in the treatment of nephrotic syndrome will be presented.
We also expect the very first Acthar peer review publication in nephrology to be available sometime in the first quarter of 2011. Availability of such data sets could allow us to begin significantly increasing our commercial efforts in the nephrology market in 2011.
Let me summarize before turning the call over to Gary Sawka, our CFO to review the financial highlights. We've had a very strong quarter for Acthar and MS and we're seeing some encouraging repeat prescriber and repeat patient trends. Our sales force expansion is going very well and is on schedule.
The IS business remained stable and we hope to be able to launch a new indication for IS later this year. Nephrology efforts are progressing and we continue to get a small takeover prescription, most of which are now resulting from our very small selling effort rather than spontaneously coming in.
Finally, the first Acthar data related to the treatment of nephrotic syndrome is expected later in the year.
With that, let me turn the call over to Gary.
Thanks Steve. As Don mentioned, net sales were $28.3 million for the quarter. Gross profit was 93%. Operating expenses came in at $12 million and net income was 33% of sales, which is $9.3 million, or $0.14 per diluted common share.
As of this morning, July 28, 2010, I am pleased to report Questcor's cash, cash equivalents and short-term investments totaled just over the $100 million mark.
During the second quarter, because of the pending sNDA, we were not able to purchase any shares under our share repurchase program and have to-date used approximately $67 million to repurchase 14 million common and preferred shares during the last 2.5 years.
We continue to have 5.1 million shares authorized for repurchase under the revised common share purchase program. At June 30, 2010 we had approximately 62 million common shares outstanding.
With that, I'd like to turn it back to Don. Don?
Thanks Gary. Our goals for the remainder of 2010 remain unchanged. We aim to continue to drive increased year-over-year revenue growth for MS and we're well on our way to meeting that goal.
Second, our goal for Nephrotic Syndrome is to execute our pilot sales effort to educate the market about the use of Acthar in this condition and to work with key nephrologists to get data from studies to help our sales effort.
Third, we will continue to work with the FDA on our sNDA in an attempt to gain US market clearance for Acthar in the infantile spasm market.
I will close with an update on sales in July thus far. Shipped paid prescriptions for MS are running slightly higher in July than the average for the second quarter, IS, is running slightly below last quarter, and Nephrotic Syndrome has had three paid referrals thus far in the quarter.
Operator, you may now open the call for questions.
Thank you, sir. Ladies and gentlemen at this time we will begin the question-and-answer session. (Operator Instructions) Our first question comes from the line of Yale Jen with Maxim Group.
Yale Jen - Maxim Group
Just a few questions, number one is that could you just give us a little bit of breakdown in terms of the revenue of the three indications -- three or four indications that -- of the quarter?
Well, we'll do our best. We don't see every prescription. So all we can do is provide an estimate and we estimate right now that MS is just about 50% of our sales, IS, is about 40% or just a little bit higher, Nephrotic Syndrome is about 5%, and then the remaining 5% is spread amongst some other indications.
Yale Jen - Maxim Group
Okay, great. And the second question is with the new hiring you anticipate in terms of the sales force up to 77 by fourth quarter. Should IS get approved and going forward and potentially you would – potentially also have the MS become – you begin actively marketing it, how would use your sort of expanded sales force all together and how do you see that going forward?
Okay. I am going to ask Eldon Mayer, our Vice President of Commercial Operations to answer that question.
Yes. So, we've thought that through and our approach for that is to use one sales force to cover all the different indications that they would be promoting. The audiences they would be calling on, the adult neurologists for multiple sclerosis and the child neurologists for infantile spasms are of course two distinct audiences. The child neurologists representing a much smaller audience, and we think that they we will be able to cover them quite efficiently.
As well as, what Steve said, minimize the amount of travel times they have and really become a true Acthar specialist, becoming familiar with the -- all the specifics about the drug whether they be efficacy or safety across the different indications. So we thought that approach made the most sense.
Yale Jen - Maxim Group
What about for Nephrotic Syndrome, for the nephrologists if that's become relevant and how would you allocate your sales force for that?
I'll tell you that we are currently studying the nephrology market and the audience in depth, learning some of course from a pilot effort that was mentioned, but we're evaluating -- we are certainly open to all approaches for that. We need to further understand that market before we really make a decision.
However, it's not unlikely that we would use a similar approach for that audience as well. Of course that would require further expansion most likely but that might be in fact the most efficient way. But as I said, we need to study and understand the size of the audience and how valuable those targets are, how many of them there are on the physician level before we decide what the structure of our sales force would be.
Yale Jen - Maxim Group
But would be that -- as during the same time you may still employ part of the part-time of some of the sales force and at least continue with that for during the interim?
We are going to split their time so maybe initially it will be like two-thirds MS, one-third IS, something along those lines. With MS we need a continued presence day after day with the neurologists. With the IS doctors we need an initial push with the IS doctors, but then we believe we can reduce that selling effort after some period of time, maybe three or six months with the child neurologist. We then will divert that activity either to MS -- reduced IS activity over to MS or to nephrology depending on what's going on in Q1 of 2011.
Yale Jen - Maxim Group
Okay. Last question is that the data to be presented in the ANS [ph], would that be the same one to be published in the peer-review journal, or those are different presentations or different studies?
Hey, Yale, this is Steve, good question. There is going to be some overlap between the two. There will be several different independent data sets presented at ASN. And part of -- one of those will be part of the peer-review publication in the first quarter. And we are cautiously optimistic but we think the publication will give us some ammunition to be able to go and start making a little bit more aggressive effort in the nephrology audience.
The next question comes from the line of Chris Holterhoff with Oppenheimer & Company.
Chris Holterhoff - Oppenheimer & Company
Can you just remind us how many current Acthar sales reps you have and if any of the new reps have been added in the second quarter, if you think the Acthar sales level was affected by any of the new reps that were added?
We have 38 sales reps in the second quarter and none were added during that time period. So these were mostly added around the September, October timeframe of last year. So selling expense would have been about the same in Q2 versus Q1.
Chris Holterhoff - Oppenheimer & Company
Okay. Great. And can you just comment on the level of Acthar inventory currently in the channel that's at a stage day or --
Actually at the end of the quarter, we believe the Acthar inventory in the channel was down below normal levels. For example, we got an order on the first day of the -- sizable order on the first day of July, that kind of corrected that situation.
(Operator Instructions) Our next question comes from the line of Tim Chiang with CRT Capital.
Tim Chiang - CRT Capital
Hi, Don. I wanted to ask you about the deep business development front, also sort of, how do you sort of use your cash position? Do you think that more stock buybacks are going to continue to occur even at the current stock levels or do you think better use of cash might be to look at additional partnerships to bring in additional products? Thanks.
Sure, Tim. During the second quarter, we did take a look at one asset and determined that we didn't want to pursue that particular asset. And in the process we realized how much time and energy we diverted from Acthar in looking at that effort and decided that's really a poor use of our human resource. So we made the decision to just focus on Acthar. We believe Acthar is its own pipeline.
There are plenty of on-label and off-label indications for us to look at within Acthar and that there is a much higher risk adjusted rate of return in looking at Acthar. Acthar is a drug we understand really well. If we are going to buy an unknown drug we always have to wonder why is, it being sold. So, we've made the decision to focus on Acthar and put business development on the back burner. And as far as our cash, we'll continue the stock buyback program at a minimum and study other possible uses of cash.
Tim Chiang - CRT Capital
Just one follow-up, with Acthar, in the infantile spasm market, how much of the market you think you can capture with a formal indication? Do you think there is incremental growth that you can capture with more focused marketing than a formal label?
Tim, this is Steve. We do believe there is some incremental growth to be had in IS and we had many years of off-label usage. We've never been able to go out and actively promote with a label, with data in hand and we think there is some benefit to that. That's why many pharma companies have sales forces.
We do know there are doctors out there in child neurology, who are not familiar with how to dose Acthar, how to monitor properly and so subsequently are a little uneasy using the drug particularly in first line. So, we think there is an opportunity to get some of them converted to first line users and also there are doctors, who simply don't use it at all. We think there is an opportunity there.
So, it remains to be seen as to how big that opportunity is. We don't view IS as being a major growth driver for us in the future, but we should be able to see some incremental revenues from having an IS indication.
Maybe 20%, 30% something like that.
Tim Chiang - CRT Capital
I know you guys have talked a lot about the Nephrotic Syndrome market, are there other markets that you are already starting to take a look at, certainly at an early level, other disease states that Acthar might be applied for?
Yes. It's something we're very interested in and we have been looking at additional markets. Of course, we've already announced we're funding a couple of preclinical studies in ALS and traumatic brain injury. We'll have to wait over time to see how those initial studies go, but given our label and a number of possible off-label uses that we might want to pursue indications for. We have a wealth of opportunities and we are stepping through those and developing a better sense of what the market potential might be.
Acthar seems to have a role at a minimum in those diseases and conditions, where prednisone or other steroids are used and where the outcome can be devastating if the patient doesn't respond to those steroids. There is quite a few diseases and conditions, where that's the case.
The next question comes from the line of Jim (inaudible) with Manchester Management.
Hi guys great quarter. Sorry to give this to you, but could you just quickly repeat what you said about your color so far in MS this quarter with Acthar?
Yes, MS is running slightly higher in July. So if we take the average on a per day basis, for the second quarter and compare that on an average of per day basis through yesterday, for July, we were running slightly higher in July.
So we seem to be keeping with the pattern that you guys had over the last year and a half of up 30% to 40%, up 10%?
It's only a few weeks here, so there is nothing that steady. We see big variations over time. We see sometime two week time periods worth of sales go way up and then they go way down. I don't want to draw anything from that, but maybe Steve has a further comment.
Yes. One thing to keep in mind is that with the current expansion I wouldn't expect to see any impact in Q3. The reps will be hired. They will be trained. On Acthar, trained, where they don't have previous MS experience will be trained in MS. That's going to take pretty much the full quarter. So, I wouldn't expect to see anything in terms of an impact from this expansion in Q3.
Further more there is always a disruption, when we make a big change in the sales force that happened last time because each rep is giving up some of their territory and the hand-off that starts to take place between the existing rep and the new rep, et cetera.
What should we be budgeting in our models for additional expense for these reps this quarter if you hire?
It should run approximately a total of $300,000 a rep and that includes the management. So if we rounded it to 40 reps that's $12 million or $3 million a quarter and have a full quarter's worth of expenses in Q3, but we would in Q4, maybe a couple of million in Q3 and $3 million in Q4.
So we should assume that it maybe $2 million this quarter with no offsetting revenue impacts and something like $3 million next quarter with some revenue impact?
The next question comes from the line of [Jason Aria with Java Equities].
Jason Aria - Java Equities
Hey Don. I want to first of all commend you for your business development decision. We got a little concerned that few quarters ago, when you talked about potentially in-licensing something and I think you have consistently made the prudent business decisions for Questcor and I commend you for that. It is the pipeline Acthar within itself and that's what you should really try to exploit.
I wanted to ask about Sabril, do you think that the IS, the lack of growth in IS that you are experiencing is that a result of Sabril? What is the competitive pressure you are seeing there and how do you think that might be affected by in Acthar IS label approval from the FDA?
Yes, Jason, this is Steve, I'll take that one. Without being able to be actively promoting in IS, it's really hard to grow usage of the drug there. So it's been pretty stable overall for the last several years in terms of prescription volume.
We really are not seeing much impact at all from Sabril. We haven't seen any downtick in prescription activity. That drug seems to be used in cases of tuberous sclerosis and that's not an area, where Acthar is used very frequently. So, it seems to be niche where as we are used for all the other types of infantile spasms. So, we really are not seeing much, if really of any impact from Sabril. It has been 10 months after from their launch. I doubt we are going to see any.
Furthermore once we're out promoting assuming we had approval, that trend should even continue more in that direction. The economics for Sabril in IS, really don't warrant much of a selling effort. If you look at the price of the drug and what the expected market could be, it will be hard to justify much of a sales force for one back there.
Jason Aria - Java Equities
That was going to be my next question. Are you gaining some visibility into Lundbeck's commitment to Sabril and in IS particularly?
No, we really are not, I mean, we hear anecdotally some things, but I wouldn't want to try to comment on that. We just look at the size of the market from a dollar perspective for Sabril, it's pretty small. The IS market is probably only worth $15 million for Sabril. So, why would you spend a whole lot of time marketing, when your expectation is you have 20%, 25% penetration of that $15 million, that sum is $3 million to 5 million, you can't really afford too much in a way of a selling effort.
Jason Aria - Java Equities
Well, congratulations on a good quarter and again excellent decision to keep the company focused.
Well, thanks Jason. It's good to hear from you.
(Operator Instructions) Our next question is a follow-up question from the line of Yale Jen from Maxim Group.
Yale Jen - Maxim Group
I just wanted the housekeeping things in terms of Doral sales, is that approximately 0.2 million as previous few quarters was?
Yes. It's that sounds about right.
We don't even know, I hate to tell you.
Yale Jen - Maxim Group
Okay. That would be fine.
That's our focus for on Acthar. We are all looking at each other like anyway in the number.
Yale Jen - Maxim Group
It's one of a type.
However, we'd have to say it's immaterial.
Yale Jen - Maxim Group
Okay. That's fine, that's one of the [charge] I just want to know. That's all. Thanks a lot for that.
I'm showing no further questions in queue. I'll turn it back over to management for closing comments.
Thank you operator and thanks to all investors for participating. The operator will now provide some replay instructions.
Ladies and gentlemen if you would like to listen to replay of today's conference please dial 303-590-3030 or 1800-406-7325 enter the pass code 4330467. Once again those numbers are 303-590-3030, 1800-406-7325, enter the pass code 4330467. That does conclude today's Questcor second quarter 2010 financial results conference call. Thank you for your participation. You may now disconnect.
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