Halozyme Therapeutics, Inc.

Halozyme Therapeutics, Inc.

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Biotechnology

Halozyme Therapeutics, Inc. (HALO) Q3 2014 Earnings Call Transcript

Published at 2014-11-09 02:42:04
Executives
Jack Howarth - VP, Corporate Affairs Eamonn Hobbs - President & CEO Robert Apple - EVP & COO
Analysts
Matt Kaplan - Ladenburg Thalmann Akiva Felt - Oppenheimer Oren Livnat - JMP Securities
Operator
Welcome to the Antares Pharma Third Quarter 2014 Operating and Financial Results Conference Call. (Operator Instructions). I will now hand the conference over to Jack Howarth, Antares' Vice President of Corporate Affairs. Please go ahead, sir.
Jack Howarth
Thank you, Taylor. Good morning, everyone. Thank you for joining us on today's call. We announced third quarter 2014 operating results and recent achievements earlier this morning and the press release can be found on the Antares website at www.antarespharma.com under the Investor Information tab. Before we begin, please be advised that during the course of this call, we may make forward-looking statements concerning the company that are not historical facts. These forward-looking statements may include but are not limited to statements concerning the potential benefits of OTREXUP and products in development, clinical trial design and outcomes, time of launch of products in development, growth of product sales and timing thereof and future collaborations in our device platform. Forward-looking statements provide Antares' current expectation or forecast of future events. Actual results could differ materially from those reflected in these forward-looking statements due to decisions of regulatory authorities and Antares' ability to execute on its development plans, capital needs and general financial, economic, regulatory and political conditions affecting the pharmaceutical industry generally. Additional information concerning these risks and uncertainties are contained in the Risk Factors section of Antares' annual report on Form 10-K and in Antares' periodic filings and other filings made with the Securities and Exchange Commission. Antares is providing this information as of the date of this release and does not undertake any obligation to update any forward-looking statements made in this earnings call as a result of new information, future events or circumstances after the date hereof, except as required by law or otherwise. The company cautions investors not to place undue reliance on these forward-looking statements. Joining me on the call today are Eamonn Hobbs, President and Chief Executive Officer and Robert Apple, Executive Vice President and Chief Operating Officer. After the presentation, we will open the lines for Q&A. I'll now turn the call over to Eamonn Hobbs.
Eamonn Hobbs
Thanks, Jack and good morning, everyone. Thanks for joining us on today's call. This morning, I would like to first update you on our QuickShot testosterone program and share some thoughts on the U.S. Food and Drug Administration's September Advisory Committee meeting on testosterone products. We'll also provide some comments regarding the OTREXUP launch. I'll then turn the call over to Bob and he'll give you a brief update on our pipeline programs before going into the third quarter operating and financial results. At the end of our remarks, we'll open the call for a question-and-answer session. So as you already know, we announced earlier this week that our Phase 3 QuickShot testosterone study had fully enrolled in just three months. We had originally expected that I would take six months to enroll, but we believe the level of interest and potential value proposition of a subcutaneous once weekly auto-injector of testosterone accelerated the enrolment. The study is designed to evaluate the efficacy and safety of QuickShot testosterone or QST administered subcutaneously once each week to adult males with testosterone deficiency. Patients that were enrolled in this study had a documented diagnosis of testosterone deficiency. The study includes a screening phase, a treatment titration and efficacy phase and an extended treatment phase for the evaluation of safety and tolerability including laboratory assessments, adverse events and injection site monitoring. Approximately 150 patients have been enrolled to ensure an adequate number will complete the full duration of the study. Patients meeting all eligibility criteria will receive QST once weekly for six weeks. Adjustments to dose may be made at week 7 based on the week 6 predose blood level. The efficacy of QST will be evaluated after 12 weeks of treatment. Upon completion of this phase, patients may remain on their optimized QST dose and will be put for an additional 40 weeks. Approximately 100 patients will complete collection of 26 weeks of safety data and approximately 50 patients will complete collection of 52 weeks of safety data. We plan to work closely with the FDA on the filing of the application and we still expect to launch this product in 2017. You will remember that on our last call we mentioned that in mid-September the FDA had scheduled a joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, to discuss the efficacy and safety of testosterone products, as well as the current treatment indications and potential cardiovascular risks, if any, associated with testosterone therapy. The objective of this meeting was to help the FDA identify the appropriate indicated population for testosterone replacement therapy and to determine whether there is an increased risk of major adverse cardiovascular events with testosterone use. The advisory panel was asked to focus on the entire testosterone class including testosterone treatments under development, not one specific drug. By way of background, testosterone is currently indicated for replacement therapy in men for conditions associated with low serum testosterone and the need for testosterone is clearly necessary in men with low testosterone due to a specific underlying disease or condition. What is not clear to the agency is whether there is a benefit of testosterone therapy in men diagnosed with low testosterone due to old age. With respect to cardiovascular risk, there is confounding data. Some studies have reported a potential for increased cardiovascular risk with testosterone use and other studies speak to the cardio-protective benefits of testosterone therapy. The FDA began an assessment of the risk in 2010 and found that the data was inconclusive. More recently-published studies and media attention have prompted the FDA to begin again to assess the cardiovascular impact of testosterone use. Utilizing the IMS National Sales Perspective Database and the Symphony Health Solutions Database, the FDA was able to ascertain that there were increasing trends in testosterone replacement therapy sales and use and the majority of sales and use were in topical formulations although injectable testosterone use has been increasing as well and has increased at a faster rate than gels over the past five years. The data showed that the majority of users were men between the ages of 40 and 64 years of age. Average use was six months and large proportions of testosterone users were also taking at least one cardiovascular medication. The agency also found that 21% of men on testosterone therapy were not properly screened before or after their first prescription. The agency also presented an analysis on existing published studies to try to determine if there was a link between testosterone replacement therapy and increased cardiovascular risk and came to the conclusion that overall cardiovascular risks and/or benefits still remain unclear. Finally, an outside research firm analyzed and presented research from five years of data collected from the FDA's adverse event reporting system and concluded that, in general, the data supports current labeling with safety signals for recognized adverse events and there was no apparent safety signal for ischemic cardiovascular disease, stroke or death from any cause. We came away from these panel meetings understanding the types of questions and concerns the panel members had and we believe that that has been extremely valuable to us as we progress in our Phase 3 QuickShot testosterone study. I think it's important to note that we have not made any changes to the study as a result of what we learned at the meeting and the FDA has not asked us to make any changes to the study. Therefore, based on the advisory panel member's comments and recommendations that were made over the two-day meeting, we believe the FDA is likely to push for further compliance on pre-screening for a low testosterone prior to prescribing. The FDA indicated at the September meeting that any safety study potentially contemplated would be for the class of drugs and not specific to any particular product on the market or under development. Overall, we believe that our once weekly subcutaneous QuickShot testosterone product eliminates transference issues commonly associated with gels and may eliminate painful intra-muscular injections and the peaks and troughs associated with bi-weekly injections, could potentially improve compliance and may reduce costly in-office procedures. We're excited about the potential for the QuickShot product and based on this week's announcement, we expect to see topline pharmacokinetic data in the first half of next year and still expect to file a new drug application in 2016. Moving on to the OTREXUP launch, we now have eight months of data through September and we continue to see steady progress in the launch. To-date, based on monthly prescription data from Symphony Health Solutions, approximately 9,000 prescriptions have been written by almost 1,000 different prescribers and that number is up from the 600 unique prescribers we talked about on our last conference call in August. Our third quarter meeting with the sales force held late in July and on the six-month anniversary of the launch included very important enhancements to our messaging and a new co-pay assistance program. We believe that both initiatives have had a positive impact on increasing prescriptions during the first full month of implementation. Leo Pharma also had their first full month of detailing with their new promotional materials in August and although only accounted for approximately 10% of OTREXUP prescriptions to-date, we believe that OTREXUP will continue to gain traction in the psoriasis market given the number of patients with this condition. An additional metric we use in our launch analysis is prescriptions generated per sales representative compared to the same data for two recent rheumatology product launches, XELGANZ and RAYOS, to-date OTREXUP prescriptions per sales rep are feeding those for both XELGANZ and RAYOS at the same stage of their launches. Overall, we're happy with the progress to-date and the team continues to evaluate all aspects of the launch on an ongoing basis in order to make adjustments when necessary. I'll now turn the call over to Bob.
Robert Apple
Thanks, Eamonn. Before I go through the results, I would like to make some brief comments about third quarter progress in our pipeline. As Eamonn mentioned earlier, the Phase 3 QuickShot testosterone study is fully-enrolled and we expect the topline readers' data during the first half of next year. We were pleasantly surprised with the fast rate of enrolment and look forward to a successful conclusion to the study. Vibex Epi Program is progressing well. As they had stated publicly, they will file the final amendment to their application in December. We're prepared to manufacturer substantial device quantities and anticipate that we will begin shipping the devices to TEVA early next year. We believe that TEVA is on track for a 2015 FDA approval and an AB rating to the Epi pen. Next our Vibex Sumatriptan auto-injector abbreviated new drug application is currently under review by the FDA and we expect an action on that filing in the near future. We currently have two other pen programs under development with TEVA. The TEVA Pen 1 program is still progressing and under development in Europe and we anticipate a 2016 filing. We were recently informed that the TEVA Pen 2 program ANDA has been accepted by the FDA. After the reference-listed drug company has been notified by TEVA of the ANDA filing, we will update our pipeline chart with the name of the product. You will recall in the past that we had identified the reference-listed drug as a product generating several hundred million dollars in branded sales. So an AB-rated generic product, if approved, could generate substantial sales. Antares will receive from TEVA revenue from device sales and a high significant royalty on product sales which could potentially increase with increased market penetration. Overall, this could be another high value product within our TEVA portfolio. The TevTropin 10 milligram amendment is still being reviewed by the FDA and we anticipate that TEVA will receive an approval in the near future. The branded OTC gel product deal with Pfizer continues to progress and we look forward to providing status updates when Pfizer hits certain development milestones. Finally, I'm very pleased to tell you that in September 2014 we entered into a new development and license agreement with an undisclosed pharmaceutical partner to develop and supply an auto-injector for an already-approved and marketed product. Our partner was looking for a life-cycle management program for their current injectable product. The agreement calls for upfront milestone payments and royalties on the partner's product sales, as well the purchase price for each device sold. We will continue to look to enter in these types of agreements as they have the potential to be attractive revenue-generators for the company and validate the importance of our auto-injector technology, for not only us, but other alliance partners as well. Since the approval of OTREXUP and the validation of our auto-injector technology, we have had tremendous inbound interest on the development project from potential strategic partners and it will continue to be a key strategic focus for Antares. In addition to the recent progress we made on our pipeline, we're continuing to invest time and resources in OTREXUP growth and branding. As Eamonn mentioned earlier on the call, we continue to see positive growth in our prescription trends with last week's weekly prescription numbers being the highest to-date. Our 25 territories have performed well and our sales representatives' performance compared to other RA product benchmarks are in the top decile. Looking in 2015, we will be expanding our region frequency of doctor calls with measured growth in the number of sales representatives and territories to maximize OTREXUP revenue. On the marketing end of OTREXUP, we continue to provide useful tools for prescribing physicians and their staff and patients, to better understand the value of OTREXUP and make it easier for both the patient and physicians to get a prescription for OTREXUP filled at the pharmacy. OTREXUP's brand recognition continues to grow and to that end we will be well represented at the Annual American College of Rheumatology Meeting which will be held in Boston this year. Our team will be on hand to talk to rheumatologists about OTREXUP and the benefits of subcutaneous administration of methotrexate and demonstrate the ease of use of our advice. This annual event gives us an opportunity to re-engage physicians outside of their offices and to speak with them on a one-to-one about the brand and to review scientific abstracts and posters regarding subcutaneous methotrexate. The annual meeting begins Saturday, November 15 and will run through Tuesday, November 18. Now for the third quarter results, total revenues were $6.6 million and $5.5 million for the three months ended September 30, 2014 and 2013, an increase of 19%. For the nine months ended September 30, 2014, the company's total revenue was $18.1 million compared to $15.9 million in the first nine months of 2013, an increase of 14%. Product sales were $3.6 million in the third quarter of 2014 compared to $3 million in the third quarter of 2013. For the nine months ended September 30, 2014, product sales were $8.7 million compared to $10.1 million in the first nine months of the prior year. In the three and nine months ended September 30, 2014, the company recognized net product sales of $2.6 million and $4.5 million from sales of OTREXUP based off of patient prescriptions. OTREXUP revenue recognized is net of estimated wholesaler discounts, prompt pay discounts, rebates and patient discount programs. In the first nine months of 2014, the company shipped $6.4 million of OTREXUP to wholesalers and deferred the difference between distributor sales and prescription sales. Based on currently weekly prescription trends, we have approximately six weeks of inventory at the distributors which is down from approximately eight weeks at the end of last quarter. Now to our reusable needle-free injector devices and disposable components primarily to Ferring and TEVA in the third quarters of 2014 and 2013 were $700,000 and $1 million and in the first nine months of 2014 and 2013, were $3.6 million and $2.8 million. Product sales in the third quarter in the first nine months of 2013 included $2.1 million and $6.2 million respectively of initial sales to TEVA of our Vibex auto-injector for TEVA's generic epinephrine auto-injector product. We expect to start shipping additional generic Epi auto-injectors to TEVA early next year. Product sales in the first nine months of 2014 and 2013 also included $600,000 and $300,000 of sales of pre-commercial pen injector devices to TEVA. Development revenues were $1.7 million in the three-month period ended September 30, 2014, compared to $1.3 million in the prior year period. For the nine-months ended September 30, 2014, the company's development revenue was $5 million compared to $2.7 million in the first nine months of 2013. The development revenue in each year was primarily due to auto-injector and pen-injector development work for TEVA. Licensing revenues were $900,000 and $100,000 in the three-month period ended September 30, 2014 and 2013. For the nine months of 2014, licensing revenues were $2.8 million compared to $200,000 in the first nine months of 2013. The licensing revenue in the first nine months of 2014 was primarily due to revenue recognized in connection with our license and promotion agreement with Leo Pharma executed in November of 2013. The licensing revenue in the third quarter and first nine months of 2013 was primarily due to the recognition of revenue under agreements with Ferring. Royalty revenues were $300,000 in the three-month period ended September 30, 2014 compared to $1.1 million in the same period of the prior year. For the nine month period ended September 30, 2014 and 2013, royalty revenues were $1.6 million and $2.9 million. We received royalties from TEVA and from Ferring related to the needle-free injected device sales and our HGH sales, from Actavis on sales of Gelnique and from Meda Pharma on sales of Elestrin. The royalty revenue decreases were primarily the result of receiving no royalties from TEVA in the second and third quarters of 2014 due to TEVA's recall of their HGH drug product, TevTropin. We expect TEVA to start shipping HGH drug product towards the end of 2014. Total gross profit was $4.1 million and $2.5 million in the third quarters of 2013 and 2014 and was approximately $12.3 million for the first nine months of 2014, compared to $7.4 million for the first nine months of 2013. The increases were primarily the result of the increases in development and licensing revenues. Total operating expenses were $11.2 million and $8.9 million for the three months ended September 30, 2014 and 2013 and were $37.4 million and $22.3 million for the nine months ended September 30, 2014 and 2013. The increases were primarily due to increased sales and marketing costs in connection with the launch of OTREXUP, along with an increase in legal fees in connection with litigation. Net loss per share was $0.05 in each of the third quarters of 2014 and 2013 and was $0.19 and $0.12 for the nine month periods ended September 30, 2014 and 2013. At September 30, 2014, Antares had approximately $48.1 million in cash and investments compared to approximately $69.1 million at December 31, 2013. With that I'll turn the call back to Eamonn.
Eamonn Hobbs
While we continue to believe that our OTREXUP launch has gotten off to a good start and are pleased with the additional growth over the past several weeks in both new and repeat prescriptions, we're still evaluating data to determine where we can make improvements to the launch. I've talked to our sales representatives and visited with physicians and the feedback continues to be very positive. We also continue to make progress in our pipeline. The QuickShot testosterone study is fully enrolled and on track. Additionally our partner, TEVA, is making excellent progress toward filing applications on several of our collaboration projects which may result in additional cash flow from product sales and royalty payments. Overall, we are very pleased with our progress to-date and the team remains focused on our goals aimed at building long term shareholder value. Thank you for your attention. Operator, could you now open the lines for the Q&A session?
Operator
(Operator Instructions). And we will take our first from Louise Chen with Guggenheim Securities. Brendon Mason - Guggenheim Securities: It's Brendan on for Louise. Just a high-level question, just curious if you could give us an update on new management vision for Antares and how this will be different from former management. And then just secondly, I know you said the feedback from physicians has been positive. Just perhaps a little, on OTREXUP, just perhaps a little bit more color there and then detail -- the sales force detailing OTREXUP and any potential for price increases. Thanks.
Eamonn Hobbs
I'll start out with the vision and then hand it over to Bob on the OTREXUP detail. As you're probably well aware, I had the good fortune of being a board member for five years prior to joining as CEO. So I think what investors should expect out of the new CEO is a lot of respect for the plan that Antares was on as I was a participant from the Board level in the creation and implementation of that plan. So I wouldn't anticipate too many changes. What I think we see as a management team is an execution story. Antares is at a point where it has many different irons in the fire if you will with regard to potential material revenue growth and executing on delivering those revenue growth is really where we're focusing our attention. So I'm very pleased to be here. I'm very pleased to join a very strong management team and with that I'll hand it over to Bob to talk about OTREXUP.
Robert Apple
So on your one question about the physician feedback on OTREXUP I mean, what we're seeing in the field and what we're hearing back from the physicians, is number one, is that the patients find it extremely easy to use and the auto-injector and the product itself is performing extremely well. They are looking at it in all different areas of their practice as far as before they go on a biologic or in other areas where they want to maximize or improve the fact that they're having with their oral methotrexate and so we're seeing it used in all different ways at the physician level within RA and we expect to see that growth continue. As you would expect, in a normal product launch, the doctors are trying it in one or two patients and they're seeing good results. And I think that we're going to see an increase in the number of patients that each doctor is using. As we mentioned in our script, we had over 1000 doctors that prescribed the product which was up from 600 only in August. So I think the message is resonating and once its physicians get comfortable that the product gives benefits to patients, I think we'll see obviously increased utilization. Your second question was on the size of the sales force. Currently, we’ve 25 territories and they're performing like a traditional sales force, a traditional bell curve and we're looking at ways to improve certain territories and really trying to look at why certain territories have been performing extremely well and try to apply that to the other territories that are not. Going forward, I think we're going to have -- because we're seeing a really positive impact on a per rep, per script basis, we're going to increase our sales force over time in 2015. I don't think we're going to see a dramatic increase, but we're going to do a measured look at it and see every time that we add people, make sure that we're getting additional value for those territories. And so that will be an ongoing process, but clearly we see the potential of OTREXUP and we want to put more resources to the sales force in that area. And then I think your last question was is there going to be a price increase or is there a potential for a price increase? Well, we've been only on the market for about eight months. Our intention is not to increase the price right now, but obviously, as we get into 2015, we'll look at the market conditions and see what we think is appropriate.
Operator
We will go next to Matt Kaplan with Ladenburg Thalmann. Matt Kaplan - Ladenburg Thalmann: Two questions, I wanted just to follow-up, I think, stay on the OTREXUP front first and questions there. In terms of, what are you seeing in the field, in terms of competition from RASUVO out there and how are you detailing against that? That's the first question. There is a few others on OTREXUP as well.
Robert Apple
Sure. As you know, RASUVO launched about a month or so ago and they seem to have about the same number representatives and I think that they are messaging their use of injectable methotrexate like we're and at the end of the day. Their traction in the beginning is less than ours, but I think, generally, there's plenty of room for both people in the marketplace and we think that the message of using injectable methotrexate increased in the (indiscernible) of methotrexate is good for our brand. And so right now we haven't seen an impact and we're going to keep selling OTREXUP and focusing on our product. Matt Kaplan - Ladenburg Thalmann: Right. And then in terms of the use of OTREXUP, can you help us understand the breakdown in the use of RA and psoriasis and how it's ramping up in the two different areas?
Robert Apple
Yes, I mean, 90% of our scripts for rheumatoid arthritis and then 10% are for dermatology. The derm piece has grown from about 8% a few months ago, so it's a slow steady growth for Leo. The dermatology area isn't -- methotrexate is not the gold standard within dermatology, so it's more of a messaging, more of a getting the dermatologists comfortable that methotrexate is a valuable tool in their treatment of psoriasis and we have a really great partner in Leo and were hoping that they continue to do strong messaging and get those prescriptions up, but the majority of our prescriptions are for rheumatology. Matt Kaplan - Ladenburg Thalmann: And then can you talk a little bit about reimbursement and where you are on tiers and formularies?
Robert Apple
Sure. Yes reimbursement is key, as everyone knows; any new product launch faces reimbursement issues for at least a year. You have plans that will NDC block every launched product for the first six months and we went through that as well. And where we have been and where we continue to be is we're typically in tier 3. We're in preferred tiers for some plans. But generally, the patients are seeing a $40 co-pay, up to an $80 co-pay and then some have co-insurance which can be 25% of the cost of the drug. And so what we did to help that alleviate or eliminate any issues with where we're in the third party payer tier is we put out a co-pay assistance card for patients where they pay zero and we cover up to $125 which I guess covers us around anyone who has up to a 25% co-insurance which we think is an appropriate level of support. And that has had an impact and we know from both the patients and the physicians, it's been well received and we'll continue that program until we start to potentially see getting onto the formularies by giving a rebate at this point. We don't have any rebates with any third party payers, but obviously if you get on there and you start to see a better tier, you'll reduce your co-pay support but you'll be giving out rebates to the third party payers, but we're not there yet. But right now I would say, generally our coverage is good. Matt Kaplan - Ladenburg Thalmann: And what percentage is Medicare Part D for this product? Or do you have Medicare Part D coverage?
Robert Apple
I don't know that specific metric. I think that when we look at Medicare, Medicaid, VA, DoD, that's about 20% of our prescriptions. How much is Medicare Part D? I don't know off the top of my head. So our government business is robust and actually for the VA and DoD and so forth, we're a preferred product with a very low co-pay.
Eamonn Hobbs
And just to add to that, the demographics of RA are such that over 80% of the patients are under the age of retirement. So it's a relatively young person's disease. Matt Kaplan - Ladenburg Thalmann: And I guess shifting gears again to the QST program, I guess topline data first half of '15, can you give us a little bit of detail now that you've completed enrolment in the study in terms of the type of patients that you enrolled in terms of just kind of their age and entry criteria?
Robert Apple
Obviously they had to have a testosterone level below 300 and we were able to meet that rather quickly. As far as an age, there is no age restriction on our enrolment, but I would say the average age is anywhere from 40 to 65 of our patient population and so far everything is moving well. Matt Kaplan - Ladenburg Thalmann: And in terms of the longer term data that you need to file for approval, any feedback or change in the guidance from the FDA at this point in terms of -- or is it just kind of ICH guidelines that you have to file?
Eamonn Hobbs
No changes whatsoever.
Robert Apple
Yes. It's just your typical safety readings that you have in every study and there's no specific cardiovascular review or anything like that. It hasn't changed from when we started the study and the majority of the readings for us were PK. Matt Kaplan - Ladenburg Thalmann: I guess just recently the European regulatory body instituted some labeling changes to testosterone. They seem to be pretty benign and relatively benign. I guess there are kind of three things that they kind of instituted there, any comments from your point of view in terms of when you expect FDA to institute their labeling changes and when we could see that? And I guess what changes you expect.
Eamonn Hobbs
As we mentioned in our script, we believe that the jury is still way out with regard to any labeling changes with regard to cardiovascular risk being increased. The data is conflicting. Some studies showing cardio-protective benefit, others showing increased cardiovascular risk. What came out of the panel with regard to labeling changes was along the lines of the agency wasn't especially convinced that there was an increase in cardiovascular risks. They were more focused on their concern associated with their database showing that over 20% of patients that were currently on a low testosterone therapy were never screened or there was no record of them being screened for demonstrated low testosterone levels. So we believe the agency to address that, may add some labeling that points clinicians towards the professional society guidelines for working patients up property prior to initiating therapy. In addition, we believe that the agency may add some language to the label that points out that there is no data to support the efficacy of low testosterone therapy in an age-related population. There is an NIH study and an over 65 year old population that is scheduled to produce results around the middle of next year and that may be the first indication of the potential efficacy in an age-related population. So it would surprise us if FDA put something stronger in there than a call-out with regard to a lack of data. Matt Kaplan - Ladenburg Thalmann: And I guess when was the last time you had the chance to interact with the agency in terms of the regulatory path or for QST?
Eamonn Hobbs
Well, our team is in close contact with the agency since we have an ongoing clinical trial that's progressing very swiftly. So the read we've got from the agency has been that -- and in fact they came out and actually stated at the meeting that if they were going to institute any changes with regard to testosterone it would be in the context of a post-approval commitment for the entire class. And I believe the direct quote was if we chose to do so and we haven't decided to do so, we would make sure that it was associated with a post-approval commitment for the entire class. We haven't gotten any feedback from the agency about any potential changes to our development program. So we were very pleased coming out of the outcome meetings. Matt Kaplan - Ladenburg Thalmann: And then a question associated with your pipeline of products. Specifically some of the products that are already approved and on the market, you saw a reduction in royalty the revenues. I guess it was because of the recall of the TevTropin, but can you comment on the Gelnique and also Elestrin potentials beyond that and then also the potential for additional TEVA products and TEVA collaboration in terms of approval there and what their potential is?
Robert Apple
Sure. As far as our current products that are on the market, Elestrin is now being -- well it's owned by Meda and it's being detailed by Mission Pharmacal and we're seeing growth there. Elestrin is a nice steady product that's going to bring in royalties for the near term, for the near future and I don't see tremendous growth in that, but it's consistent and it helps us use up money towards our other programs, that's probably doing around $15 million in sales a year. With Actavis and Gelnique, again, same thing we are not seeing a tremendous amount of growth in that product, but Actavis is committed to it. We talk to them on a quarterly basis and they think it's a key product for them and they're going to continue to detail that product. That is an OAB space, it has a lot of generic tablets. And ours is a gel, as you recall and it's a niche product that's going to continue to do what it's doing. And we don't expect a whole huge trend up on that, but I think generally, it's going to be a strong product for us from a royalty standpoint. The products with TEVA, as I mentioned, the Pen 2 which we call Pen 2 -- cleverly called Pen 2 -- that is an ANDA that was filed. The RLD has been -- I think they've been informed, but obviously it hasn't been stated publicly what the product is yet. That deal for us, is another nice deal like the Epi Program where we get a high single-digit royalty on the sales of the product and device sales to TEVA. And the product is like I said, several hundred million dollars and so a true AB-rated product of a complex generic is what we've kind of characterized this product as. That could be a significant product. Typical generic products can get up to 50% or more market share and that would be very successful for TEVA and for us. Matt Kaplan - Ladenburg Thalmann: Do you expect multiple generics in that marketplace?
Robert Apple
We're the first to file and we don't see anyone behind us, but at some point, there probably will be another generic competitor. But again, I think what's unique about our business and what makes it a really strong value proposition for us is that there are not that many competitors in this area. It's a difficult area both from a drug standpoint as well as a device. And then when you combine the two of them, it increases the complexity of an approval drastically. And so we think that these have long term value and if you hear the way TEVA talks about these complex generics, they believe the same thing that there's going to be less competition and so a higher value per product. And so I think that when we look out, I think these have long term value from a royalty standpoint as well as a device sales standpoint. And then the Epi-pen Program obviously, that's a significant potential product for us. It's over $1 billion branded product, we believe we're going to get AB rating on it. It would be the first AB-rated product in that space. There is no one behind us as far as we know. And again, we high single-digit royalties on end product sales, as well as device sales and that could be very substantial for both TEVA and for us assuming the approval happens next year.
Operator
We will go next to Akiva Felt with Oppenheimer. Akiva Felt - Oppenheimer: Bob, just a follow-up. You've been mentioning expectations to get AB rating for both Epi-pen and TEVA Pen 2 products. Is that based on sort of TEVA's feelings about it or do you have any kind of additional insight that you're confident that they will receive the AB rating and maybe the impact that would have on your end of revenues. Thanks.
Robert Apple
Sure. Well, both of the filings are TEVA's, but obviously we do all the device work and we know the functionality of the device relative to the RLD. And we're very confident based on user studies that we perform that the devices are very, very similar if you want to use a term. So we believe that is going to be AB-rated both on the Epi product, as well as this closed product. They were both accepted as ANDAs and the questions surrounding that you typically get back from the ANDA on the filings were very specific to the RLD. And so our expectation is that if we meet all those requirements of the FDA that we should get AB rating for both products. And so that's our position and it's really up to the FDA but we feel strongly that the products that we're filing are very similar to the RLD. Akiva Felt - Oppenheimer: Okay. And in terms of revenue recognition, how should we expect that prior to approval and post-approval and how the product shipments are recognized versus royalties?
Robert Apple
Right. And so we clearly will be shipping them devices before the approval even happens. You have to have a fully packaged product at launch and so we will be recognizing those device sales when we ship them. Just like we did last year, we had a substantial amount of device sales to TEVA or on Epi of over $6 million. And we think that obviously we'll be producing -- well, we're producing now, but we'll be shipping in 2015 a substantial amount of product for the Epi Program which will get recognized in those quarters. From a royalty standpoint, it's obviously a function of when they actually start selling the Epi product and then once that product is shipped into the trade is when we get paid and that -- we get a high single-digit royalty on the value of those products being shipped into the trade.
Operator
(Operator Instructions). We will go next to Oren Livnat with JMP Securities. Oren Livnat - JMP Securities: I apologize, I jumped on the call a little late so hopefully I don't ask anything redundant, but if you could talk big picture about the testosterone opportunity. I mean, obviously people were a little surprised by the methotrexate incursion of MEDAC which hadn't been on our radar and sort of shows, perhaps, I won't say easy, but how quickly and relatively inexpensively someone can approach these markets with a short program. And I'm just wondering, can you comment on testosterone how you think it's different from the methotrexate product and market such that we should think there's a higher barrier to entry, implied longer exclusivity that we're not going to get a MEDAC situation where three months behind you comes somebody else and somebody else and then I do have some other questions. Thanks.
Eamonn Hobbs
Well to be very clear, we believe we're not going to see a near term competitor to QST like we saw with OTREXUP and the reason is easy to understand from a couple of perspectives. Unlike OTREXUP, there is no subcutaneous testosterone product on the market anywhere in the world where we're at. There are intra-muscular prefilled syringe products that are available in some countries. But those have very large needles and those very large needles are required for hand injection from a practical perspective because the viscosity of the testosterone is quite high compared to for instance, methotrexate and OTREXUP. So an auto-injector really plays a pivotal role in being able to quickly inject a high viscosity fluid like testosterone. So that leads us to the second aspect of it, if a competitor was looking to create their own testosterone auto-injector product they would have to go through the engineering challenges of being able to inject a very high viscosity fluid like testosterone. We don't see any devices under development for testosterone and therefore we expect to have a significant head start in the marketplace with our QST product. The other aspect of differences between testosterone and methotrexate are in some ways the recent controversies associated with the testosterone market that were in many ways addressed by the recent outcome panel I think have given a number of potential entry companies pause as to whether they would want to develop an auto-injector for testosterone. Having come through that process with our own program that's well along in its pivotal trial, I think we're very pleased that we did because the dust is settling, the smoke clearing and we believe that the testosterone market is going to be as robust as we originally anticipated and that our product is going to have really excellent positioning. So anyone starting now is going to have quite a ways to catch up. Oren Livnat - JMP Securities: And on Epi Pen, can you comment on how you think -- and I know this is not your filing -- but how any potential mile-end quote-unquote next generation device might impact the market, if at all how that might change your opportunity?
Robert Apple
First of all, I don't know of any device or anything that they're working on, so I couldn't even comment on the attributes that they would be changing or anything, but obviously if the market was well served with the Epi pen currently out there at $1 billion. We think that market will remain in place when we come out with a product in the near term. So I really can't comment on something that isn't happening or that I know of and so that's really all I can say about that. Oren Livnat - JMP Securities: The only thing I would ask, when -- I guess they have suggested in the past that they have another device, just based on what you're seeing in terms of the hurdle, what you and TEVA are seeing with regards to sort of how equivalent do you think you have to be, does that make you think that you couldn't just swap out another device anyways. Like Mylan, if they came out with some change that's material, that they couldn't just pull a switch on the market, a fourth switch, for example because that in fact would be a different enough device that they would be bumping up against the same issues that any non-AB rated product does.
Robert Apple
Yes, I think that their own product wouldn't be substitutable unless it was very similar and so I think that they would have to be a totally different type of product and then they would have to re-establish that marketplace completely. And so I think there will always be a market with the current Epi pen and potentially our generic to that. And like I said, I can't comment on what I don't know, so I don't what type of device -- if they say they're doing a different device. But I think that you can't get a drug-device combination approved in like a short period of time. It's a very complex process and so I would think that even if they are working on one, it will take some time. Oren Livnat - JMP Securities: And just a nitpicky one at the end, and maybe you mentioned this. OTREXUP value per script, whether I use Symphony which is higher or IMS which seems more understated, either way I come out to significantly above a $400 value per script. So I'm just wondering, what are you seeing out there in practice and should we expect any major shifts in the value? Perhaps you maybe do some additional formulary contracting.
Robert Apple
Right now, we're in that $450 to $480 range per script. It depends on when we do our net sales, it's based off of an estimate based -- we reduce it based on the discounts out there for the VA and Medicare and Medicaid and so forth. And like I said earlier in the call, we don't have any rebates in place right now with third party payers and so we get a very high value based off of WAC and where we're today. We do expect probably to enter into some rebate arrangements with third party payers, and that clearly would bring the net price per script down. But I don't think it's going to be dramatic in the near term and we believe that value proposition is still there for OTREXUP and with the support we give to the patients, it seems to be resonating well and we're seeing growth. So right now I think that the value is pretty stable, but as we get into contracts, we will see a decrease just like every other product. When you start to contract we will see a decrease off of WAC.
Operator
And there are no further questions at this time. I would like to turn it back to Jack Howarth for any additional or closing remarks.
Jack Howarth
Thanks, Taylor and thanks again for joining us on today's conference call. Our conference call provider has made us aware of the fact that the web link was not functioning properly earlier in today's call and we apologize for that. So if you missed anything on today's call as a result of this, the replay numbers are as follows. Domestic toll-free 888-203-1112 or international toll-free 719-457-0820 and the Conference ID is 8566591. And if you have any further follow-up questions you can reach me at 609-359-3016. That completes today's call.
Operator
This concludes today's conference. Thank you for your participation.