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.

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.

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…

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…

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 Instructions). And we will take our first from Louise Chen with 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.

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.

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.

We will go next to Matt Kaplan with 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.

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.

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?

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.

And then can you talk a little bit about reimbursement and where you are on tiers and formularies?

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.

And what percentage is Medicare Part D for this product? Or do you have Medicare Part D coverage?

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.

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.

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?

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.

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?

No changes whatsoever.

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.

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.

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.

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?

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.

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?

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.

Do you expect multiple generics in that marketplace?

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.

We will go next to Akiva Felt with 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.

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.

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?

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 Instructions). We will go next to Oren Livnat with 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.

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.

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?

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.

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.

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.

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.

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.

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.

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.

This concludes today's conference. Thank you for your participation.