Halozyme Therapeutics, Inc. (HALO) Q3 2015 Earnings Report, Transcript and Summary

Ladies and gentlemen, welcome to the Antares Pharma Third Quarter 2015 Operating and Financial Results Conference. Throughout today's recorded presentation, all participants will be in a listen-only mode. After the presentation, there will be an opportunity to ask questions. [Operator Instructions] I will now hand the conference over to Jack Howarth, Antares Vice President of Corporate Affairs. Please go ahead, sir.

Thank you, Derrick, and good morning, everyone. This morning we released our third quarter 2015 operating results and recent achievements, and a copy of the press release can be found on the Antares website at www.antarespharma.com under the News section. In addition, this morning's teleconference also contains an interactive slide presentation. If you have dialed into the audio-only teleconference, you can follow along with the slides, which can be found on our website under the Investor Information section. The conference call and slide presentation will be simultaneously webcast on the Investor Information section of Antares' website under the webcast tab. If you are currently unable to access our website, the conference call and slide presentation will be archived under the Webcast tab at the conclusion of today's call. Before we begin, I'd like to remind you that some of our statements made during this conference call will contain forward-looking statements within the meaning of the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and actual results could differ materially from those projected in any forward-looking statements. These forward-looking statements may include, but are not limited to, statements concerning the growth of prescriptions and sales of OTREXUP, the approval by the FDA of VIBEX Epinephrine Pen and revenue from Teva related thereof, the timing and results of the supplemental safety study for QuickShot Testosterone or QST and FDA actions with respect to the QST program, the company's ability to adequately respond to the complete response letter with respect to its ANDA for VIBEX Sumatriptan and FDA action with respect to the same, actions by the Company's third party partners and suppliers, actions by the FDA regarding the Company's product candidates and those of its third-party partners, the timing and results of clinical research and development projects and the timing of launch of products in development and future product revenue. Forward-looking statements provide Antares current expectation or forecast of future events. Factors that could cause actual results to differ are discussed from time to time in the Company's filings with the SEC on Form 10-K and in Antares periodic filings on Form 10-Q and 8-K and other filings made with the Securities and Exchange Commission. Links to these documents are available on the Investor Information section of our website and we encourage you to review these materials. Antares is providing this information as of the date of today's press release and does not undertake any obligation to update any forward-looking statements contained 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; Robert Apple, Executive Vice President and Chief Operating Officer; and Jim Fickenscher, Senior Vice President and Chief Financial Officer. I'll now turn the call over to Eamonn Hobbs. Eamonn?

Thanks, Jack, and good morning, everyone. We believe the third quarter operating and financial results speak to the progress we are making against our top priority goals, including continuing to grow OTREXUP, delivering epinephrine devices to Teva, and progressing on the QuickShot Testosterone clinical program. Before we get started let's review the agenda for today's call on slide 3. I will begin today's call with an overview of the operational progress we made this quarter, Bob Apple will provide an update on OTREXUP and epinephrine, and Jim Fickenscher will take you through the financial results. I'll then make some closing remarks and open up the lines for your questions. Please turn to slide 4. As you have seen from the press release we issued earlier today, we had another outstanding quarter. Starting with the top line, we reported total revenues of $11.1 million representing a 69% increase over the third quarter of 2014. Through the first nine months of 2015, we have recorded revenue of $33.9 million, which is 87% higher than the first nine months of last year and exceeds 2014 full-year revenues of $26.5 million. Record product revenues of $8.1 million are up sequentially versus the second quarter of this year by 37% and up 126% versus the third quarter of last year. Our research and development team recently eclipsed two critical milestones for our QuickShot Testosterone program. You will recall in February of this year that we announced top line PK data on trial QST-13-003, which we believe indicates that QST may be a best-in-class testosterone replacement therapy. The protocol for this trial included a 52-week treatment and follow-up phase, and last week, we announced that the final patient has completed treatment. Our development team will now work to close out this trial and prepare the data for inclusion in a future NDA filing. This past August, we announced the initiation of study QST-15-005, which is a 26-week safety study designed to achieve an enhanced safety database by increasing the number of patients exposed to QST as suggested by the FDA. On Tuesday, we announced that enrollment in this study is now complete, which is well ahead of our internal schedule. As of Tuesday, 119 patients had received a dose of QST and we expect that total of approximately 125 will be dosed following the screening phase of the trial. We believe the extremely fast enrollment of patients indicates the enthusiasm that exists in the physician and patient populations for a once-a-week at-home subcutaneous injectable product. Let's now turn to slide 5. We believe that this slide shows how Antares is transitioning to a product-driven company. The investments that we made in developing OTREXUP and nurturing our alliance business are coming to fruition. We now have recorded seven consecutive quarters of product revenue growth, going all the way back to the fourth quarter of 2013. Our short-term objective is to continue driving product revenue growth through increased sales of OTREXUP and fulfillment of the current purchase order for epi devices to Teva. Slide 6 shows the quarterly breakdown of total Company revenues adding development, licensing, and royalty revenue to the product revenue graph from slide five. With the exception of last quarter, when we had an accelerated recognition of the previously deferred revenues associated with the LEO contract termination, we have seen a steady progression beginning in the fourth quarter of 2013 through the current quarter. We believe that the development revenue that we have recognize should at some point result in incremental product sales and royalty income from our alliance business, assuming our partners get their combination products approved and launched. We are focused on controlling what we can control with respect to our alliance businesses by finding new partners to work with, completing projects on time, and delivering devices as required. We recognize that the ultimate approval for these products rests with our partners and this lack of control can be frustrating for our employees and investors alike. However, we are proud of the multiple opportunities we have developed with our partners and believe that over time, these alliance products will create significant shareholder value. I'll now ask Bob to provide you with some details on the progress we're making with OTREXUP and epi. Bob?

Thanks, Eamonn. The graph on slide 7 shows quarterly TRx data since the launch of OTREXUP. In comparison to the second quarter of 2015, OTREXUP prescriptions grew 12% in the third quarter from 8,123 to 9,102. We believe that much of this continued growth is due to the changes we made earlier this year, including internalizing our sales force, expansion of territories, refinement of messaging and initiation of the OTREXUP total care program. On a comparative basis, third quarter OTREXUP prescriptions grew 66% versus the same period last year. 2015 year-to-date prescriptions through September grew 167% versus the same period in 2014. I'm also pleased to note that a 7.5 milligram dosage form of OTREXUP is now available for patients with a focus of that product being for pediatric arthritis patients. Let's now turn to slide 8. During the third quarter, we shipped $3.2 million worth of epi devices to Teva, a 78% increase over the second quarter's revenue of $1.8 million. After shipping these devices for the last two quarters, we still have the majority of Teva's binding purchase order left to ship. We continue to manufacture and ship against this purchase order and we recently qualified a second manufacturer of epi devices. This second supplier began shipping devices in the fourth quarter. Last week Teva disclosed publicly that they have an action date for their epi ANDA before the end of the year and based on the progress of their view thus far, they expect to get a complete response letter by year-end. Teva believes that this will cause a delay in launch until the second half of 2016. Our plan is to continue to work closely with Teva on the things that we can't control, such as the manufacture and shipment of pre-launch device quantities of epi devices and supporting Teva around device related questions, if any, that may come as a result of the ANDA review. We have a solid working relationship with Teva and our collective goal is to get the epi product approved with an AB rating to the EpiPen. I'll now turn the call over to Jim Fickenscher to take you through the financial results. Jim?

Thanks, Bob, and good morning everyone. Let's get started by looking at the details of revenues for the third quarter on slide 9. Total revenue for the quarter was $11.1 million, a 69% increase over the $6.6 million recorded in 2014. Product sales, which represents sales of our proprietary products, devices and device components to our customers were $8 million compared to $3.6 million last year. The increase in product sales was primarily driven by OTREXUP, which increased $1 million or 38% versus the same period last year, and the shipment of $3.2 million of auto injectors to Teva for use with their generic epinephrine product in anticipation of a possible approval and launch. Development revenues represent amounts earned under the agreements with partners in which we develop new products on their behalf. Frequently, we receive payments from our partners that are initially deferred and recognize as revenue over a development period or upon completion of defined deliverables. Development revenue was $2.6 million, compared to $1.7 million in 2014, representing a 49% growth. Development revenue was primarily related to the Teva programs, our undisclosed alliance product, and early-stage work for new alliance business partners. Licensing revenues represent the amounts recognized from upfront or milestone payments received from partners that are initially deferred and recognized over the life of our agreements. Licensing revenue was $43,000 in 2015, compared to $927,000 in 2014. The decrease was primarily attributable to the termination of the license and promotion agreement with LEO Pharma, which began in November of 2013. With the termination of the LEO agreement in the second quarter of this year, we expect licensing revenues to be minimal on a go-forward basis. Royalty revenue is recognized from the in-market sales of products sold by our partners. Royalty revenue was $0.4 million, compared to $0.3 million in 2014. Let's move now to slide 10 and have a look at the third quarter income statement. Total gross profit increased in 2015 to $6 million, compared to $4.1 million during the same period in 2014. The gross margin rate for 2015 was lower than 2014, due to higher sales of lower margin devices to Teva. 2015 total operating expenses were $11.8 million versus $11.2 million in 2014. The increase in operating expenses was primarily due to the increased investment in research and development costs. Net loss was $5.7 million for 2015 versus $7.2 million in 2014, which translates into a net loss per share of $0.04 and $0.05 for the second quarters of 2015 and 2014 respectively. At September 30, 2015 our cash and investments totaled $50.9 million, a $7.2 million reduction since June 30, 2015. Turning now to slide 11, we have made significant operational progress during the first nine months of this year. Total revenue is up 87% and with $33.9 million recognized year to date $18.5 million is attributable to product sales, which are up 112% over the same period last year. Through nine months, gross profit is up 66%, investment in research and development is up 9% and selling, general and administrative expenses are down 17% versus the same period last year. Overall, we've cut our net loss by 44% and we plan to continue to manage the business through appropriate investments and prudent cash management. With that, I'll turn the call back over to Eamonn.

Thanks, Jim. Let's wrap up by turning to slide 12. This was another excellent quarter for us in a pivotal year where we know that it is important for us to demonstrate to our shareholders our ability to achieve our communicated goals. Here is the status of the four top goals that we have been tracking on our calls this year. We made decisions and tactical changes to the OTREXUP sales and marketing plan and we were pleased that the product has continued to grow sequentially. We said we would ship pre-launch quantities of epinephrine devices to support Teva's launch of an AB rated generic to the EpiPen assuming FDA approval and we shipped $3.2 million worth of devices in the third quarter. We stated, we would begin the additional supplemental safety study for QST early in the third quarter and we accomplished this goal by not only starting the study, but also completing enrollment in the study this week, well ahead of schedule. We previously told you we would invest in tooling related to manufacturing capacity for the potential Sumatriptan launch and we are on track to have that capacity available by early next year. In summary, we believe that we are continuing to make excellent progress on our foremost important goals, and we look forward to finishing 2015 in the same strong fashion. Operator, we finished our prepared remarks for today. Could you now open the lines for question and answers, please?

Thank you. [Operator Instructions] We will take our first question from Anthony Petrone with Jefferies.

Great, thanks and good morning. Congratulations on another good quarter. Maybe begin with OTREXUP and then move on to a couple of questions on epi. For OTREXUP in this quarter in particular, can you remind us if there was any seasonality specifically as it relates to distraction of some of the reps in the field, were there any clinical meetings they were attending? And then just a longer-term view on OTREXUP, can you give us a sense of the potential to actually move dosing down a little bit and maybe take some of the lower oral doses, share from lower oral doses as opposed to just being 25 milligrams weekly? Is that part of the strategy or will it still be that threshold where GI and tolerability comes into play?

Okay, thanks for the questions. As far as your first question about is there any seasonality with OTREXUP, rheumatoid arthritis is a chronic disease and so typically there isn't a whole lot of seasonality, but like any other drug when people are on summer vacation and so forth they may take a little bit of a medication holiday. And so, but we don't think that that had a tremendous impact on a number that you saw. We continue to grow and we grew 12% on the quarter. As far as where the reps are and if they have been distracted in the field with different events, clearly our reps do go to all the regional meetings relative to the rheumatoid indications and so forth and societies, and we also are going to be at ACR this month in a very high fashion or high presence there. We also do quarterly POA meetings with our sales force. We have regional meetings. We pull them out of the field for a couple of days, go over the new training materials and things like that. So there is type of things that we do on an ongoing basis, but again, even in those it's only - they are only on out a few days, and so the doctors see them within that same week. So, I don't think there is really any major seasonality relative to either of those events. As far as OTREXUP, how it's being used, our biggest selling dose is the 20 milligram dose. But that's quickly followed by the 15 and 25 range, but we do - our message is very clear. OTREXUP, we had doses from 7.5 milligram to 25 and patients can experience GI issues very early in the doses of oral, methotrexate as early as 10 or 15. And so, we do believe that the benefits of OTREXUP relative to GI tolerability spans the whole dose range. So, I think that generally the doctors do believe that after 15 milligrams not only do they get a better GI profile, but they also get better viability and that's really where the focus of OTREXUP has been and continues to be. But we do sell the full range of the product and doctors do use it across the board.

Just a follow-up on the strategy here as well, which is a lot of media attention on drug pricing and certainly the biologics have a hefty price tag for RA therapies. Is there potentially sort of a cost argument here where you can potentially keep an RA patient on subcutaneous methotrexate longer and potentially avoid moving to one of the more costly biologics? Is that discussion being rekindled here just with some of the concerns around drug pricing lately?

You must look at some of our marketing materials that say’s clearly one of our messages being able to keep a patient on methotrexate, which is the gold standard for RA, as well as being much more cost effective than a biologic. That is part of our message and it does resonate with a certain number of physicians. We also try to stress that message to the payers. But at the end of day we want to make sure that the patient is getting the best care and some of them do have to go on the biologics and that's just going to eventually happen. But we do try to slow that down if possible by using OTREXUP. We think it's a great viable option to keep them in low disease activity, and it is a very cost-effective way to do and it’s relative to the biologics. And so we do have that message out there, but the biologics has been out there for 8 to 10 years and they have a lot of different versions of it and a lot of voice. And so it is taking place on our end and the doctors do here it and we're starting to see that message resonate in some levels.

Great. And then just to wrap up on my end will be on EpiPen, clearly we tuned into the Teva call, so expecting to push that back to 2016. I guess in your mind, what do you think the FDA would be bringing up in a potential CRL? I mean, they - it hasn't officially been announced, but they do believe they will receive one. It seems in my mind it clearly will be on then device end and not epinephrine side of the equation. So what in your mind do you think the FDA will be poking around that in a potential CRL? Thanks.

Well, with regard to our thoughts on forecasting what the FDA might do, unfortunately we’re not in a position to really be able to forecast FDA even when we control the application with the agency. And in this particular case, obviously, this is Teva's ANDA and we know what Teva shares with their investors and what they share specifically with us. What we know to be the case based on Teva's information provided to investors in their recent call is that there have been no incomings from Teva to us with regard to answering anything to do with the device. So, will they come up in the future, we don't know. So far so good from our perspective. And as Siggi mentioned in their recent call, he'll be in a better position to assess what the CRL that he expects to get, so as when he gets to read it. And he also mentioned that there's been nothing negative provided to Teva so far in the review, but he is expecting the likelihood of a CRL versus an approval. So, I wish we could be more insightful, but it's the nature of the process working with the FDA that the FDA does what it does and then you never know until you know. So, so far so good and we're disappointed with the delay, but there is nothing we can do, but follow Teva's lead.

Thank you.

Our next question comes from David Amsellem with Piper Jaffray.

Hi guys, this is Michael on for David. Just a quick one on QST, given that Endo today is looking to write down a couple of their testosterone products, does that in anyway change your view of the opportunities for QuickShot Testosterone? Thanks.

No, we're still very excited about the opportunity associated with QST. As we've stated during numerous calls, our clinical program has progressed extraordinarily efficiently and the top line results have convinced us that we have what we believe to be a best-in-class product in the testosterone space once it's approved. So we’re extremely excited about that product and we are very pleased with the progress we're making across the board.

Maybe, David, this is Jim Fickenscher, obviously Endo needs to evaluate on a regular basis whether they have any requirements for a write-down based on the value of the assets on their books. I would just remind people that they acquired most of the testosterone products through acquisitions where they paid significant premiums. And so, it may be a more reflection of the original purchase accounting and their current view on those products. Clearly there’s at least a few of those products they paid a good price for and the products haven't panned out like they thought that they would. So for us it's slightly different scenario and it's true also with the market for testosterone. If you're someone who has been in this market for 10 years you saw a peak and now you're seeing your sales get smaller and smaller with generics coming in. Having said that, it's still a very large market and for us as a new entrant into that market with what we believe will be a best-in-class therapy, we think that there is a very, very nice opportunity for us. Our product is home-grown and so in terms of looking at our balance sheet we have minimal amounts that are actually capitalized where we would have any type of a write-down in the future. So, for us we see a lot of positives to the testosterone marketing QST going forward.

And I think just to add to that from Jim is that, the overall testosterone market continues to be strong. It just has shifted to the injectable market, which is more generics and we have an injectable product that we think is best in class. And so the patients are used to taking a very painful injection with a 19 gauge needles, IM and what we're developing is a subcutaneous auto injector that makes it very easy and comfortable for the patients to take it and we get a better PK profile. We get a nice solid range across the doses and we think the dose type of - the dosing or the PK profile that we've seen will provide a much better outcome for the patients as far as peaks and troughs.

That's helpful. Thanks guys.

[Operator Instructions] We will take our next question from Larry Smith with SmithOnStocks.

Thank you. I wonder if you could give us an idea of the degree of discounting that's going on from your listed price to your realized price. For example, could you give us what the ratio of reported sales was to grow sales in the second quarter and the third quarter and perhaps the projection going forward? Also in line with that could you just generally talk about what's happening on discounting to managed care and the competitive position vis-a-vis Medac?

Sure, Larry. It's Jim. So we'll be able answer some of those questions, with respect to the future. Obviously, we don't give guidance, but I'll try to give you an idea. So first of all to make sure that everyone is - just remind people how we record our revenues for OTREXUP, we basically because we're in a position that we don't have enough history to estimate a return rate we use data on TRx from one of the two main providers to recognize our revenues. So, we're basically getting monthly reports and looking at those prescriptions and that's the basis for our revenue recognition. Obviously, what we shipped to the wholesalers, we ship in excess of what the prescriptions are, but we don't really get any benefit or detriment from raising or lowering inventory levels because our recognition is just on the TRx basis. So with respect to our gross to net, I won't get into the very specifics of it, but what I will say is that you may recall in year of launch in 2014, managed care wasn't interested in negotiating contracting with us for this product. I knew that Medac was going to be coming to the market and they want to see how things would play out. Beginning earlier this year, we started to get contracting and some - with the goal really of trying to make sure that we can eliminate as many step edits and prior authorizations as possible to make it easy for the patient to get the drug. So, we have a strategy where we will try to be fiscally responsible and we're willing to give a reasonable rebate to be in a parity position with Medac. There are certain managed-care plans out there who are looking to put one product in an exclusive basis. We've walked away from some of that business because the discounts that they're requesting are just too high. So overall, what you can see is, if you look at our total prescriptions that we booked this quarter and the revenues we're at about a $395 net selling price, our current WAC is $574. So what you can see is that that is somewhere around 31%, 32%. It is increasing on a quarter-over-quarter basis, the gross to net discount and that's because we're just in that position where we're starting to bring on new contracts and more and more lives are going through those numbers. So, I would call that a fairly normal gross to net discount and we're going to continue to watch that going forward to make sure that we're getting access to lives, but doing so in a physically responsible way.

And do you have any comment on Medac?

They are a competitor that's out there. Obviously, there are some plans where they have decided to give larger rebates to get an exclusive. As I said, we were happy to not get that business. They have their own pricing strategy. Obviously, they have a lower WAC than we do, and so some of our discounting is potentially higher because we have to make up some of the difference in the WAC to start out with. But overall I think - I believe that both Medac and we have a desire to get the word out to physicians about the benefits of subcutaneous methotrexate therapy and the value that it has for the patients.

Okay, thank you.

[Operator Instructions] We will take our next question from Wangzhi Li with Ladenburg.

Thanks for taking my question. This is Wangzhi Li on for Matt Kaplan. Congratulations on the quarter. I have a few questions. The first one, I would like to follow-up with OTREXUP sales. I just look at the Symphony data, it looks the sales of OTREXUP is going up. On the other hand, it looks like the Medac product is also catching up. So I'm just looking to get a little bit more color on the - I know the prior analyst just asked the question, a little bit more color on the competitive dynamics, especially in the field feedbacks from the reps on the doctor's office how that's doing in terms of sales between OTREXUP and the rest of the world? Thanks.

Okay. So, from a competitive standpoint Medac launched late last year, and they have a large number of reps out in the field just like we do. And you have to expect that they're going to garner market share because they are out there delivering the same type of message we are, expanding the use of methotrexate, trying to give RA patients methotrexate, a less GI side effect, better tolerability, better PK profile. So their message is very similar to ours. Between the two of us, we're growing the markets. It's not that our market is stagnant and they are just taking away market share for us. But clearly, they are focusing on the price, they're focusing on a few other items where we are detailing on our product and the value of our product and I think that it's a natural event where you have two players in the market that the market shares are going to be relatively close considering the products are. As far as the drug, they are same. We believe we have a much better device and a much better product for the patients since we tested ours with RA patients and showed that it was very easy to use and simple and almost 99% of all patients were able to self inject. Those attributes are what we focus on and as far as pricing and so forth, we're going to win some with some third-party payers and we're going to lose some, and same thing for Rasuvo. So I think that is all which you go into market as a combined type of product class. We're happy about that and we obviously want to continue to grow the product and that's what we're focusing on.

Great. Definitely that looks to educating the market, I mean the market looks like a [indiscernible] in the quarter. So, based on what you said, are you going to - is the competition anyway going to affect your strategy going forward or you just stay as your current strategy ever?

We are always speaking our message. We're always speaking what tools we use. OTREXUP total care is a relatively new program. That's been very successful and I believe will continue to be successful. We are optimizing our territories. This is an area where it's not a traditional deciling where the top three deciles of physicians write the majority of the scripts. When it comes to the use of methotrexate and particularly injectable methotrexate with an auto injector, a docile one doctor can be a big writer of OTREXUP versus a Decile 10. And so it's finding those physicians, it's mining more than what you would typically have to do because this is a market we're creating. It didn't exist a year ago or two years ago and so I think that between ourselves and Medac going out there and building this market, we're going to find more physicians willing to write more and more, and I think that overall the market itself will grow and we will continue try to maintain the market leader position that we have.

Great, thanks. Would you maybe [indiscernible] the gear to the QST, the testosterone program, you completed the safety extension of the Phase III study. I think the press release you are planning to release the data after also completing the supplemental safety data, but just I am wondering if any, you can provide any color on the overall profile around the safety extension study, any notable events or any kind of earlier timeline to report any additional safety data?

So right know, what we announced was the last patient getting their 52nd week worth of treatment and we felt that that's an appropriate milestone because that marks effectively the end of the trial. What we talked about on the call earlier today is that our R&D team right now is working to finalize all of that data. So they're now going to be moving towards cleaning the database and locking the database and doing all the final analysis, all the safety follow-ups. So, we don't really have any more information about that. We've given the side effect profile before and it's a very, very nice side effect profile. So, we'll have to wait until all that work is done before we can announce anything more as to anything that we found in the 52-week follow-up period.

Okay. Fair enough. Thank you. Last question would be just the EpiPen program. Since Teva is expected to delay the launch to the second half of 2016, I just wonder does that affect any of the device shipping schedule for you guys.

I’m sorry, is your question about the shipping schedule for us?

Yes, for the device regular shipping - because initially they are expecting the launch early next year, but now there is six months of delay. How does it affect the shipping schedule for the device?

For us, we are continuing our shipping as planned. We delivered $3.8 million of devices I think this quarter and we’re going to continue to ship devices that - the devices are - they have long stability on them. And once you - the real gating item for launching the product is to pre-fill syringe and the gating on that. And so we can continue to provide enough devices for the launch and then once Teva gets the approval to make the manufacturing batches of a drug and that's really what starts the clock. And so things for us continue and depending on when they get the approval we'll then see what the requirements are on a go-forward basis.

Okay, thank you very much.

Next we will hear from Larry Smith with SmithOnStocks.

Yes, thank you. Could you give us any metrics that might help us gauge the opportunity of sumatriptan AB launch?

As Jim said earlier in the call, we really don't give guidance relative to product launches or anything, but the sumatriptan market from a auto injector standpoint, it's relatively stable. There is about three players in that market, all are generics and that market is not changing. I think it's, from an IMS standpoint, I think the market itself is slightly under $200 million. And we believe that with - if we get the approval with Teva's third-party payer influence they can get a piece of that market and it's one that I don't think is going away. And right now we're just focused on getting the approval and launching next year.

I think one other comment I'd make, Bob, is that the current market, you have the RLB and an authorized generic. Those are the only two products that are out there that have all of the - both of the dosage sizes. There are two other generics, but they only have the most popular size. Our strategy and what's in our agenda is for approval of both of the dosage sizes of the RLB. And so I think that that can be something that Teva will certainly be able to talk about with their distribution partners in terms of having both doses of the product to get us where we hope to be a reasonable market share. That's a different deal than some of the other alliance business that we have. Just to remind everybody, it is a profit share. So what we will see in that scenario is we basically provide the devices to Teva. We will be providing prices in the future to Teva at cost and then once the product is sold into the market, there is a calculation that's done to get a gross margin. We allow them a bit of money for their distribution work that they're doing in pharmacovigilance, but after that the profits of the product are split between the two parties. So, different transaction than epi and others where we have a 100% of the net profit that will be made on that product.

Okay. Thank you.

Our next question comes from Akiva Felt with Oppenheimer.

Hi guys, good morning. Thanks for taking the question. As we get closer to 2016, should we think about any potential impact for managed-care resets in our first quarter OTREXUP forecast and do you see any similar effects earlier this year? Thank you.

As far as our managed-care strategy and where we're going on a go-forward basis, I think that this quarter is in reflective of the kind of discounts that we will see. And so far, as Jim mentioned, it may go slightly up as more volume goes through those contracts, but I don't see a reset at all on a go-forward basis unless one of the major players decides to start to hold everybody hostage. As everyone knows, the payer landscape is difficult and what you used to get for free Tier 3, you now have to pay to just beyond Tier 3 covered. And so, but as far as us like losing someone like an Express Scripts or CVS, we don't see that in the future, but as other companies have experienced that can happen. OTREXUP in the end of the day is a product that has a high value proposition. We don't think it's over. We do not believe it's overpriced given the value of the product, given where it is in the treatments regimen for physicians and patients. And so we don't see any kind of major reaction on a go-forward basis. It's just going to be, as we continue to get more and more scripts coming through, the likelihood is that they are going to go - they’re going to be likely in areas where we do have coverage and we are paying a rebate.

I think the only other comment I'd make and I'm sure you're fully aware of this, but just I would say over the last three to four years, we've seen every year in the first quarter the difficulties that happened where plans make changes to a number of different products and there seems to be a little bit of a situation at the beginning of every year as patients figure out exactly what their new plan is and what their new co-pays are and all those things. But we don't see anything that would make us be affected any more than the average product that everyone has been going through over the last couple years with that.

I think to finalize on that neither product OXETRUP or Rasuvo really have major market shares within this particular plan or whatever that would if it switches would have a major impact on either product. There is parity among the plans and we again, as Jim mentioned, we don't try to get preferred position, really neither one of us do, it's just a function of being covered and having access to the patients. And so when you have a major brand and it gets switched from a preferred position to a Tier 3 or Tier 4 that can have an impact on a go-forward basis, but we don't really see that here.

Very good, it’s helpful. Thank you.

That does conclude the question-and-answer portion of today's call. At this time, I'd like to turn things back over to Jack Howarth, Vice President of Corporate Affairs for any additional or closing remarks.

Thanks again for joining us on today's conference call. Just a reminder, the conference call and slide presentation will be archived under the Webcast tab at the conclusion of today's call. If you have any follow-up questions, I would encourage you to call me at 609-359-3016. That concludes today's call.

That does conclude today's conference. Thank you for your participation.