Seeking Alpha
We cover over 5K calls/quarter
Profile| Send Message|
( followers)  

Antares Pharma (NASDAQ:ATRS)

Q1 2014 Earnings Call

May 09, 2014 8:30 am ET

Executives

John J. Howarth - Vice President of Corporate Affairs

Paul K. Wotton - Chief Executive Officer, President and Director

Leroux Jooste - Senior Vice President of Pharmaceutical Sales and Marketing

Robert F. Apple - Chief Financial Officer, Chief Accounting Officer, President of the Parenteral Products Division, Executive Vice President and Secretary

Analysts

Louise Alesandra Chen - Guggenheim Securities, LLC, Research Division

Matthew L. Kaplan - Ladenburg Thalmann & Co. Inc., Research Division

Akiva Y. Felt - Oppenheimer & Co. Inc., Research Division

Operator

Ladies and gentlemen, welcome to the Antares Pharma First Quarter 2014 Operating and Financial Results Conference Call. [Operator Instructions] I would now like to hand the conference over to Jack Howarth, Antares Vice President of Corporate Affairs. Please go ahead, sir.

John J. Howarth

Thank you, Damien, and good morning, everyone. Thank you for joining us on today's call. We announced first 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 Relations 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 timing of product sales, market estimates, market potential and growth prospects, technology platforms and working capital needs. 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 the 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 Dr. Paul Wotton, President and Chief Executive Officer; Robert Apple, Chief Financial Officer and President of the Parenteral Products Group; and Leroux Jooste, Senior Vice President and General Manager, Pharmaceuticals. After the presentation, we will open the lines for question-and-answer.

I'll now turn the call over to Paul Wotton. Paul?

Paul K. Wotton

Thanks, Jack, and good morning, everyone. We've made significant progress on a number of fronts during the first quarter, and I'd like to review some of our accomplishments before I then turn the call over to Leroux to talk about the progress we made in the early stages of the OTREXUP launch. After witch, Bob will discuss the financials.

On a personal note regarding the launch, I've made a number of visits to rheumatologists in the New Jersey and Washington, D.C. areas due to this initial launch phase, and I'm delighted with the positive feedback that I've heard about OTREXUP. Today, our total prescriptions grew by 22% compared to the prior week, and we are starting to see repeat prescriptions coming in with significant numbers. We had our training for a 40-person commercial team in late January of this year, and our reps started detailing rheumatologists in February. We've had success gaining access to our physician offices, and our OTREXUP message is resonating with physicians. They understand the value of OTREXUP and seeing it being a considerable part of their RA treatment regimen in the future.

As an additional part of the initial launch phase of OTREXUP, our sales and marketing partner, LEO, started marketing OTREXUP in March to dermatologist for the psoriasis indication. We also announced the receipt of a second $5 million milestone payment from LEO in conjunction with reaching a certain percentage of lives covered by commercial insurance plans. The OTREXUP psoriasis indication has strong possibilities for us. There are approximately 7 million psoriasis patients in the U.S., and up to 10% of these may have severe recalcitrant, or debilitating, psoriasis, which is our current label.

LEO Pharma has a large data base, some 50,000 psoriasis patients, and as we've previously disclosed, we'll be using 85 sales reps to target approximately 7,000 dermatologists. We ultimately chose to partner with LEO, because of their competence and expertise in psoriasis, and their expert, established relationships with dermatologists and patients.

I anticipate that the launch of OTREXUP to dermatologists by LEO will soon begin to drive additional revenues for our company.

I will now hand it over to Leroux for more detailed overview of the OTREXUP launch. Leroux?

Leroux Jooste

Thank you, Paul, and good morning, everybody. Now before I comment on the launch of OTREXUP, I'd like to talk about the unique nature of this product, and why we believe it fits perfectly into the treatment regimen for rheumatoid arthritis and psoriasis. The value proposition and the positioning of OTREXUP is to extend the use of methotrexate beyond oral therapy, providing both patients and doctors another treatment option before adding or switching patients to more expensive options like biologics. The goal of OTREXUP is to create a new category of treatment between oral methotrexate and biologics. As this disease progresses, so should the treatment. And a tailored individualized approach is necessary to control this disease, and this can take several weeks as rheumatologists and dermatologists determine the specific treatment plan for each patient.

The OTREXUP bioavailability data presented at last year's American College of Rheumatology meeting showed for the first time that absorption of methotrexate following oral dosing had a plateau effect at doses of 15 milligrams or greater. The greater bioavailability of OTREXUP could extend the benefit of methotrexate in patients who have had inadequate response to oral methotrexate due to efficacy or tolerability. As this important finding has now been published in the prestigious Annals of Rheumatic Disease. So while still early in the launch, rheumatologists have viewed the OTREXUP value position and proposition favorably, and we've had a good start with strong momentum gained in the first 3 months. We estimate that in February, 85 patients started treatment, and that by the end of March, 369 patients were treated with OTREXUP. We estimate that almost 1,000 patients have been treated through the end of April with OTREXUP.

The market research soon after the launch and the data from Symphony Health Solutions has confirmed that rheumatologists have a high level of awareness and an intent to prescribe OTREXUP. This favorable perception is also reflected by the sales force experience and feedback in the first 12 weeks after launch. Through the first 3 months of the launch, we have made more than 8,500 calls on rheumatologists and it reached 76% of our targeted customers and this excludes LEO. More importantly, we have reached 93% of the high methotrexate prescribing rheumatologists with the greatest potential for driving OTREXUP utilization, and we'd had orders for more than 6,000 samples. The weekly prescriptions continue to grow and has regained momentum over the past 2 weeks following the short holiday week a few weeks ago.

Prescription drug coverage for OTREXUP, as reported by MMIT, a formulary coverage service provider for more than 4,000 plans, commercial plans, shows that 90% of commercial lives have some form of coverage and 48% either have referred, preferred or good access, just requiring a prior authorization to oral methotrexate.

Our 40-person commercial team has been very successful in generating launch momentum with actual prescriptions written in the first 2 months, which has more than doubled the number of the actual dispensed prescriptions. And there's absolutely no doubt that we can increase the number of dispensed prescriptions by making sure that the prior authorization requirements for some plans are met and that the patient out-of-pocket expense is acceptable when our copay assistant program is used. Our sales force continues to increase the emphasis and focus on educating rheumatologists, on identifying the right patients medically and financially, and the sales force is also making it a high priority for rheumatology nurses and office managers to use our free insurance verification and benefits investigation service to confirm that patients will be able to initiate treatment with OTREXUP without any prior authorization or copay surprises. We continue to work with major health insurance plans where we seek to obtain a favorable formulary status for OTREXUP, and have made good progress in discussing the cost offset to the expensive biologics. And last, but not least, we've engaged 22 key opinion leaders in a nationwide speaker bureau program to educate rheumatologists, physician assistants, nurses and pharmacists on the value of OTREXUP. All these speakers have had expressed in using OTREXUP and will be sharing this with their colleagues. Lastly, LEO launched OTREXUP, as Paul mentioned, to dermatologists in March, and early feedback indicates that OTREXUP is also recognized as an option for many patients to consider before a biologic is prescribed. We look forward to continued progress with LEO and our partner in the dermatology segment.

And I'll now turn it back to Paul.

Paul K. Wotton

Okay. Thanks, Leroux. So on the development area, this past February, we announced positive results from a multi-center phase IIb clinical study, which evaluated the clinical pharmacokinetic profile of testosterone administered once weekly by subcutaneous injection at doses of 50 milligrams and 100 milligrams using the VIBEX QuickShot auto-injector. 29 adult males with low testosterone and testosterone blood levels less than 300 nanograms per deciliter were randomized into 2 groups. The first group received 50 milligrams of testosterone administered subcutaneously with QuickShot device, and the second group received 100 milligrams. Both groups received once weekly injections for 6 weeks, and the study patients were then followed for another 4 weeks after last dose. Results of this study showed rapid restoration and consistent maintenance of normal testosterone levels and dose proportionality of both dosage strengths. We are very optimistic about potential for self-administered at-home once-weekly subcutaneous dose of testosterone based on the outcome of this study. It's clear to us that the administration of testosterone using our proprietary QuickShot device showed that normal testosterone levels can be rapidly restored, and reliably maintain with reduced peak to trough ratios relative to those associated with intramuscular injections, which are also studied as part of this trial.

We believe that the injectable testosterone market will continue to grow due to the current underpenetration, a growing awareness of the benefits for treating testosterone deficiency, and the FDA's willingness to continue to look for and approve new therapies of treatment, such as the most recent product, Aveed. It's worth reminding everyone here that the injectable space has grown over the past 5 years so the compound annual prescription growth rate of around 40%, outstripping Joe prescription growth of 14% in the same period.

Injectable testosterone currently accounts for more than 1/3 of total testosterone prescriptions written annually. Given the current force of injectable testosterone, we believe that a once weekly, convenient, precise quick-to-administer subcutaneous dose of testosterone will become the choice route of administration.

Earlier this week, we announced that the meeting was held to the FDA to discuss the proposed Phase III registration study that will include approximately 150 testosterone deficient males, and we plan to begin recruitment in the third quarter this year. This study is designed to show that once-weekly self-administration of testosterone with the QuickShot auto-injector can safely achieve normal blood levels of testosterone and hypogonadal in men with an injection that's only going to take about 5 minutes -- 5 seconds to administer.

In April, we announced the issuance of new patents, RE44846 and RE44847. The significance of these reissued patents traces back to Antares' inventions made in the late 1990s, and these patents capture innovations in the field of auto-injectors, but originally established Antares Pharma position as a leader and innovator in medical injection device technology. More importantly, these patents add protection to OTREXUP, as well as our other pipeline products.

Antares is already taking steps to supplement the current Orange Book listings related to OTREXUP. We continue to believe that our overall patent portfolio coverage exemplifies the company's intellectual property strategy of obtaining patents that are directed towards devices, combination products including drugs, and methods for delivering injectable drugs, which the company has earned on its filed invention. We are very confident about the intellectual property portfolio covering the OTREXUP asset, and is extremely comprehensive. We intend to assert it in defense of our products to the fullest extent possible.

Finally, we announced at the Annals of Rheumatic Diseases, the published results from an open label head-to-head randomized crossover study comparing the relative bioavailability, safety and tolerability of OTREXUP to oral methotrexate and adult patients with rheumatoid arthritis. This peer reviewed publication reported results from previously conducted multi-center three-way crossover study in patients greater than or equal to 18 years old, with adults already undergoing treatment with MTX for 3 months or more. 47 patients completed the study, and the results show that the systemic availability of methotrexate following oral dosing plateaus at 15 milligrams and greater.

Following administration of OTREXUP, the systemic availability increased proportionately at every dose, which extended the range of exposure compared to patients receiving oral medication. No unexpected adverse events were noted for either formulation in the short-term study, and high systemic methotrexate exposure was not associated with any increase in adverse events.

I'd like to turn the call over now to Bob to talk about the financial results. Bob?

Paul K. Wotton

Thanks, Paul. Our first quarter financial and operating results were as follows: Total revenues were $5.2 million and $4.5 million for the 3 months ended March 31, 2014 and 2013, an increase of 15%. Product sales were $1.8 million and $2.5 million for the 3 months ended March 31, 2014 and 2013. In the first quarters of 2014 and 2013, sales of our reusable needle-free injectable devices and disposable components were $1.2 million and $1.1 million, and were generated primarily from sales to Ferring and Teva.

Products sales in the first quarter of 2014 also included $300,000 in sales of pre-commercial pen injector devices to Teva. Additionally, in the 3 months ended March 31, 2014, the company shipped $2.7 million of OTREXUP to wholesalers and recognized net product sales of $200,000 from sales of OTREXUP based on prescriptions dispensed.

The OTREXUP revenue recognized is net of estimated wholesaler discounts, prompt pay discounts, and patient discount programs. We are 12 weeks into the launch of OTREXUP and the prescription data for our new product such as OTREXUP is not always consistent with respect to the length of each prescription written in the refill data.

Data suggest that some rheumatologists are writing a prescription for 1 month with no refills, and then asking the patient about their experience before writing the next perception. The next prescription could either be for the same dose with a refill or the rheumatologists may choose to titrate off to the next dose with no refills. Either way, this would count as a new prescription and not as a refill. So based on what we've seen to date with new patient starts, it's still too early to project refills based on current prescribing trends. What I can tell you is that the average length of new prescriptions has progressed beyond 28 days, suggesting rheumatologists are writing multiple month prescriptions. We now have the first 8 weeks of data, and we are analyzing not only high prescribers, but prescribing trends as well. Another point to note is that not all OTREXUP sales will be captured by a prescription. OTREXUP has been dispensed by specialty pharmacies, NVA, which do not typically show up as a script. Currently, basing on our OTREXUP product revenue and prescription is likely underreporting our revenue until we start to book revenues based on sales to distributors. This will likely happen when the shipments to distributors is more aligned with the level of prescription sales value, which I estimate will be towards the end of 2014.

Product sales in the first quarter of 2013 include a $600,000 of initial sales of Teva over VIBEX auto-injector for Teva's generic epinephrine auto-injector product, and included $500,000 of sales to our top -- for our topical oxybutynin gel 3% product to Actavis in connection with their marketing of Gelnique 3%.

Development revenues were $1.4 million and $800,000 for the 3 months ended March 31, 2014 and 2013. The development revenue in the first quarter each year was primarily related to auto injector and pen injector development work for Teva.

As you can see based on the increase in development revenue year-over-year, the Teva programs continue to progress. We are now in the commercial stools -- commercial tooling stage for all 3 development programs. We have successfully made pre-commercial devices for the epi program, and are now gearing up for the pre-commercial phase of the 2 undisclosed pen programs.

On a different front, our partner, Pfizer, has informed us that the first of 2 Phase III studies on the undisclosed OCC product has completed enrollment and should finish in Q3. And the second Phase III study is expected to be done by late Q4 2014 or early Q1 2015.

Licensing revenue was $900,000 and $100,000 for the 3 months ended March 31, 2014 and 2013. The licensing revenue in the first quarter of 2014 were primarily due to revenue recognized in connection with our license and promotion agreement with LEO pharma executed in November 2013.

Revenue from royalties was $1 million and $1.2 million for the 3 months ended March 31, 2014 and 2013. We received royalties from Teva and Ferring related to our needle-free injected device sales and/or hGH sales, from Meda Pharma on sales of Elestrin and from Actavis on sales of Gelnique 3%.

Total gross profit increased in the first quarter of 2014 to $4 million from $2.5 million in 2013, an increase of 61%. The increase in the quarter was primarily related to license revenue recognized under the license and promotion agreement with LEO pharma and development revenue from Teva.

Total operating expenses were $12.8 million and $5.9 million for the first quarters of 2014 and 2013. The increases was primarily due to the increased investment in sales and marketing activities of $5.5 million in connection with the launch of OTREXUP, along with an increase in expenses related to the completed Phase II study of our VIBEX QS T for testosterone replacement therapy of approximately $1.3 million.

Net loss was approximately $8.8 million and $3.4 million for the first quarters of 2014 and 2013, respectively, and net loss per share was $0.07 and $0.03 in the first quarters of '14 and '13.

At March 31, 2014, Antares had approximately $63.1 million in cash and investments compared to approximately $69.1 million at December 31, 2013.

And then finally, as I mentioned in our year-end earnings call, until we can establish prescription trends and correlate shipments from distribution centers to pharmacies, and how they much up with prescription data, we will be booking quarterly revenues based on prescription data that we receive on a monthly basis. And as you can see from today's press release, the $200,000 we recorded in sales based on prescriptions dispensed is much less than the $2.7 million of OTREXUP we shipped to wholesalers. As we said in the past, we hope that the June, July time frame will start to give us a meaningful prescription trend so that we will be able to give you some guidance on what the 2014 revenue potential for OTREXUP might be on our second quarter results call in August.

And with that, I'll turn the call back to Paul.

Paul K. Wotton

Thanks, Bob. Well, we believe here that the OTREXUP launch has gotten off to a good start and have not changed our views on peak sales potential for the product. As Leroux said, it is very early in the launch, and we are following the metrics closely. In addition, formulary coverage is getting better all the time, and is actually very good given the limited period we have had of active marketing of OTREXUP. Our dermatology partner, LEO, has had some good reception in the physicians' office and has started to make progress on all of their core plans. Overall, we are very pleased with the progress of the launch thus far. And as I mentioned earlier, my visit to rheumatologists' office during April have confirmed that doctors and patients like the product.

On the pipeline front, we've already completed the market research on 7 product candidates, and we'll be adding 3 to the pipeline before the year is out. The revised pipeline will be heavily weighted to the CNS area, and I expect that this therapeutic area will become a key strategic focus as we continue to evolve as a specialty pharmaceutical company.

Before we go into Q&A, I'd like to make one quick comment on the Medac litigation. We have been advised by an outside counsel not to comment on, or speculate on the outcome or timing of this litigation. I can, however, tell you that we believe that our strategy is sound and we have every intention of protecting all of our pipeline assets based on our IP on behalf of shareholders.

So with that, I'd like to thank everyone for listening. And operator, could you now open the lines for the Q&A session please?

Question-and-Answer Session

Operator

[Operator Instructions] Our first question is from the line of Louise Chen with Guggenheim Securities.

Louise Alesandra Chen - Guggenheim Securities, LLC, Research Division

I had a few. So first on OTREXUP, I was curious how we should think about the launch trajectory and the Rx progression given some of the factors that you mentioned? So do you expect the sort of an acceleration in the second half of the year? And to be somewhat slower now, as the doctors kind of titrate patients up? And then I'm also curious, in terms of the IMS data, will the LEO scripts be captured under Antares or under LEO? And then on VIBEX QS T, I was wondering, so you're starting the Phase III trials in 3Q, and when you expect data and for those to be completed? And maybe more details on the trial design. And then, lastly, just on formulary coverage for OTREXUP, where do you stand currently, and where is upside from there as we progress throughout the year?

Paul K. Wotton

Okay. Thanks Louise. This is Paul here. Yes, the -- I can ask Leroux to comment on more details, but with respect to the launch of OTREXUP projections and progression which you asked, yes, we are titrating patients into the product right now. We do expect an acceleration of sales in the second half of the year. Patients typically see their physicians on a quarterly basis, and we think we have to go through 2 cycles of that. Bearing in mind, we launched in February. We're looking at the July/August timeframe when we expect to see the acceleration. With respect to LEO and the IMS prescriptions, Antares will be recording all of the revenues from sales of OTREXUP, whether it's in psoriasis or in rheumatology. And so all of the revenues for the product will be ours. We will be able to identify by specialty later on in the year under our arrangement with LEO in order to make sure we provide LEO with the correct compensation for the work that they're doing. I'll ask Leroux to comment on the formulary first, and then I'll come back on the QS T in a moment.

Leroux Jooste

Could you just repeat the specifics of the formulary question? I want to be sure I answer your question correctly.

Louise Alesandra Chen - Guggenheim Securities, LLC, Research Division

Yes, so basically, what is your coverage today for OTREXUP? And where do you think it'll be by the end of the year?

Leroux Jooste

So as I've mentioned, we get access to the MMIT database to inform us on formulary status. And the commercial plans that they monitor and track includes over 4,000 commercial plans. And on their latest report, we show that of the covered lives, commercially covered lives, 7% have a preferred status, about 41% have what they call a restricted status with usually a Tier 3 category. These are branded products, so then have a prior authorization or a step added, all those in place. And then there's about 42% of plans that are either covered or not yet listed, but it is available, they are still in the process of reviewing and determining the status. But as of the end of April, only 10% of commercially covered lives do not have access, and this is, as you know, mostly due to plans, some plans, rather big plans that have an exclude at launch policy. And so these plans usually take 6 to 8 months before they determine whether or not they will review the products and included in the form. Did that answer your question?

Louise Alesandra Chen - Guggenheim Securities, LLC, Research Division

Yes.

Paul K. Wotton

Okay. So going back to QS T, Louise, we had a really good meeting with the agency about 10 days ago. We have received guidance on the program going forward including the Phase III trial, which, as I mentioned earlier, is going to involve 150 patients with low T. It's a clinical pharmacokinetic study. I anticipate that the top line data from this study will be available in Q1 of next year. A lot of the timing on this, of course, depends on our ability to enroll patients. And we're being prudent of this, but typically testosterone trials do enroll quite quickly. And so we're anticipating completing that program and finding the NDA with a view to being on the market source the very back in 2016, early part of 2017. And that's I think a really exciting program. I have to say that the discussions we have with the agency were extremely positive indeed. The opportunity that we provide here is for patients to self-inject with testosterone at home once a week. It gives you a better blood level profile than you would receive with an every 2, every 4 weeks injection of testosterone, which usually has to be given under medical supervision. This has been intramuscular injections, so you avoid this high peaks and low troughs. What we have is a blood level profile which gives you similar blood level profiles to the gels. But, of course, we don't have the transference issues with the gels, which are quite significant. So I think what we have here is the right product in the right place at the right time. And I was also delighted to see that the agency -- they were very clear that we have a good program here. And I have to say I think that they've been very helpful to us in designing our pathway going forward.

Operator

Our next question is from the line of Matt Kaplan with Ladenburg Thalmann.

Matthew L. Kaplan - Ladenburg Thalmann & Co. Inc., Research Division

I have several questions. I want to start out first with QS T and then move on to the OTREXUP. Based on your conversations, your discussions with the FDA, are there any specific cardiovascular safety requirements to your Phase III program that you have to execute before filing your NDA? This is obviously around the question that is based around the current cardiovascular questions that are out there.

Paul K. Wotton

Yes, Matt, that's a good point. And the answer to your question is no.

Matthew L. Kaplan - Ladenburg Thalmann & Co. Inc., Research Division

Great. That was easy. In terms of -- and then moving on to OTREXUP. Several questions there. What's the net sales price right now after the discounts and things like that? And then in terms of where you need to get to be -- sales levels you need to get to, to break even on the product? And then talk about some of the gross margin metrics as well. And then, do you see it being necessary to increase your sales expenses to reach your goals later this year? And I guess in particular, talk about where you are now, and where you hope to be by year end in terms of growth of scrips? And then, talk a little bit about -- also the breakdown of scrips where you are now in terms of derm versus rheumatologists? And where you hope to be at year end as well. Several questions there. I hope I didn't confuse you. I can repeat them if you like as we have the discussion.

Paul K. Wotton

Well, you might have to. As I get older, I forgot more and more.

Matthew L. Kaplan - Ladenburg Thalmann & Co. Inc., Research Division

I've forgotten them already. Don't worry.

Paul K. Wotton

Obviously, I'll need to be taking testosterone. The question around the metrics on the net sales price, I'm going to hand over to Bob. And then we'll follow up with Leroux on the projections going forward. Specifically, I think, we have to all be clear about one thing, which is we're very early in this launch phase. And to date, we don't have a breakdown of the scrips between rheumatologists and dermatologists. So I really can't answer that phase of the questions that you asked, but I'll hand over to Bob now with respect to the financial details on OTREXUP.

Robert F. Apple

Sure. On OTREXUP, our wholesale acquisition cost that we basically charge to the distributors is $548. We haven't given any discounts to anybody other than your traditional Medicare/Medicaid, VA type of pricing, that's negotiated. We do pay distributors for the distribution services for the majors, and that's part of that. That does reduce our net sales by about 7% or so. And then after that, we haven't entered into any contracts specifically, with any third party payers yet. And so the net price is typically the $548 less the 2% you give for QuickPay and then the distribution fees. So I think it's very traditional at this point. I do foresee that we will enter into some contracts with third party payers for the ones that don't allow access. The Kaizers of the world, the Blue Crosses of Massachusetts, and so forth because they're very tight programs or third party payers that really don't allow access unless you contract with them. And then we'll see where the balance of the plans are as far as any contracting, and so forth with their coverage. That's pretty much where we are with the pricing. One thing I will say about the terms and the RA scrips, because we did just get the March data and there is a delineation between the 2, and it is very heavily skewed right now towards RA. I mean, a very small percent with derm, because they just started detailing it in mid-March, I think there was like 15 scrips for derm. So we're going to expect to see that change over time. But again, we believe that for us, both areas are very potentially valuable for Antares both in the derm space and the RA space.

Matthew L. Kaplan - Ladenburg Thalmann & Co. Inc., Research Division

And then just to follow through on that on a question in terms of where you think it could be in terms of the balance at year end as your several more months into the launch, and LEO has some time to get some traction as well?

Robert F. Apple

That's a tough question to answer is only because the derm doctors, they use methotrexate, but it is not as prevalent as the RA doctors. I mean, for RA, methotrexate is a gold standards, kind of cornerstone. They use it all the time. But it's a difficult question, but I think we're going to probably be at the 30% to 70%. 70% being RA.

Matthew L. Kaplan - Ladenburg Thalmann & Co. Inc., Research Division

Okay, great. And then, just going back to I guess, the other metric in terms of where you think you need to be in terms of breaking even on the product? And if your gross margins right now, it sounds like they are basically close to 90%?

Robert F. Apple

Yes, that's correct. We have your traditional pharmaceutical margins on the branded product. And last quarter, we spent $5.5 million in sales and marketing. It's going to be about average at this point as to what we spend on a quarterly basis going forward based on our current plans. So you can figure it out, we would probably need to be in the $23 million to $25 million range to have a breakeven for OTREXUP, which again in the launch here, I think is amazingly good. And we are obviously hoping that the trends continue, and we see those results at the end of the year.

Matthew L. Kaplan - Ladenburg Thalmann & Co. Inc., Research Division

And then in terms of inventory levels at your distributors right now, do you see those -- are those growing? What do you see?

Robert F. Apple

No, I mean, I think that the inventory levels have been pretty consistent. We're seeing buying since -- you've seen buying from the distributors in April and May. And is basically replacing the inventory that they've been selling, and so we're very happy with the allocation that we have based on where -- throughout the country and where the products are being moved. So we don't see an inventory build. We actually see it being replenished on a regular basis.

Matthew L. Kaplan - Ladenburg Thalmann & Co. Inc., Research Division

And then one final question on OTREXUP. Any new initiatives or changes you're planning to make in terms of your marketing efforts? Any co-pay assistant programs or anything like that, that you're contemplating at this point?

Paul K. Wotton

Actually, Matt, we already have a co-pay assistance program in place. We have a good plan and we're sticking with that plan. And as you can see from the data, we had a growth in prescriptions again last week. This plan is working, so we continue to learn as we go through the process, and I'm very happy with the progress we've made to date and I expect it will continue.

Matthew L. Kaplan - Ladenburg Thalmann & Co. Inc., Research Division

In terms of the litigation with Medac, can you comment where you are in terms of that process? I'm not asking timing questions, seems like you can't answer those. But where you are, and will things -- frequently things move to settlement or is this something that goes to trial?

Paul K. Wotton

Matt, I was deposed last week and I really can't comment legally, but I will say that I believe personally that our intellectual property is very, very good indeed. My name is on one of the patents. And we intend to use the full intellectual property estate that we have around OTREXUP to make sure that we defend it to the fullest extent possible, as I said in my comments. For me to go beyond the comment like that will just be foolish. And I'm under advice not to say anything else as well, but suffice to say that we believe we have a very strong position here.

Matthew L. Kaplan - Ladenburg Thalmann & Co. Inc., Research Division

Okay, fair enough. Great. And then in terms of pipeline update, in terms of partner programs, Pfizer and Teva, can you give us any more color and detail on where those are, and what's happening with the products that you have partnered?

Paul K. Wotton

Well, the Teva programs continues to make good progress. You'll see from the numbers that we're getting a lot of development revenue from Teva right now. And the Pfizer program, Bob actually talked about in his commentary that wrapped up one of the Phase III trials on the product. Another one's coming to closure fairly soon. So that one looks like it's on track to hit the market in 2016 assuming a 12-month review cycle by the agency.

Operator

[Operator Instructions] Our next question is from the line of Akiva Felt with Oppenheimer.

Akiva Y. Felt - Oppenheimer & Co. Inc., Research Division

Just a quick follow-up to one of Louise's questions earlier. The trial design for the QuickShot testosterone, how close to the final design with the -- what you proposed to the FDA?

Paul K. Wotton

Yes, that's a good question. It was very close to what we proposed to the FDA. It is a pharmacokinetic trial. The only change I would say, that we were notified about was that we've gone to the agency with a proposal to run the study in 250 patients, and the number of patients we're actually going to be asked to look at is in fact 150 patients. So with that guidance from the agency, obviously, we're very happy. Helps us get through the trial a bit quicker than we would normally have been able to do. And like I said earlier, Akiva, I think that the agency were really helpful to us during those discussions. They're very cordial discussion and we've laid out our plan pretty much from now until the NDA filing, including over CMC worth, which is essential for our product like this to get approved.

Operator

Mr. Howard, I show there are no further questions at this time. Please continue with any closing remarks.

John J. Howarth

Thanks, Damien, and thanks again for joining us on today's conference call. If you have any follow-up questions you can reach me at (609) 359-3016. That completes today's call.

Operator

Ladies and gentlemen, if you like to listen to a replay on today's conference call, you may dial 1 (800) 406-7325 or (303) 590-3030 and enter the access code 4681721 followed by the pound key -- sign. This concludes the Antares Pharma First Quarter 2014 Operating and Financial Results Conference Call. Thank you for your participation. You may now disconnect.

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.

If you have any additional questions about our online transcripts, please contact us at: transcripts@seekingalpha.com. Thank you!

Source: Antares Pharma's (ATRS) CEO Paul Wotton on Q1 2014 Results - Earnings Call Transcript
This Transcript
All Transcripts