Earnings Labs

Halozyme Therapeutics, Inc. (HALO)

Q2 2014 Earnings Call· Fri, Aug 8, 2014

$63.70

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Transcript

John Howarth

Management

Thank you, Joe, and good morning, everyone. Thank you for joining us on today's call. We announced second 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 in 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 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 and Robert Apple, Chief Financial Officer and President of the Parenteral Products Group. After the presentation, we will open the lines for Q&A. I'll now turn the call over to Eamonn Hobbs. Eamonn?

Eamonn Hobbs

Management

Thanks Jack and good morning, everyone. Thanks for joining us on today's call. I am very excited to have joined Antares in June as President and Chief Executive Officer. My background in marketing and operations at companies developing and selling combination drug device products appears to be a perfect fit for Antares at this point in the company's evolution. Having served on the Antares Board of Directors since 2009, I truly believe in the company's potential to develop and successfully commercialize self administered parenteral medicines to really 505(b)(2) regulatory pathway that can optimize clinical benefits and produce enhanced cost effective health outcomes. We've shown what we can do that with the development and recent commercial introduction of OTREXUP and we believe that the QuickShot testosterone program may offer patients clinical benefits similar to OTREXUP's. And as we indicated in our last conference call, we are working on additional programs to our pipeline. Now before Bob provides an update on the launch of OTREXUP and the second quarter financial results, I would like to review the company's second quarter achievements. In April, the Annals of the Rheumatic Diseases published results in open label head to head randomized study comparing the relative bioavailability, safety and tolerability of OTREXUP methotrexate for injection to oral methotrexate in adult patients with rheumatoid arthritis of RA. In this multicenter cross-over study, adult patients with RA undergoing treatment with methotrexate were assigned to receive one or four dose levels of OTREXUP weekly in a random sequence of three treatments; oral methotrexate OTREXUP in five and OTREXUP in abdomen. For 24 hours after the administration of each treatment, blood samples were collected to measure drug levels and injection sites were assessed. 47 patients completed the study and the results show that the systemic availability of methotrexate following oral…

Robert Apple

Management

Thanks Eamonn. Before I go through the second quarter results I would like to make some brief comments about the metrics we are using to evaluate the OTREXUP launch. Like many of you buy prescription data from Symphony Health Solutions or IMS, we analyze your OTREXUP prescription data on a weekly and a four-week rolling total basis. Looking back over to six months since launch in February, OTREXUP scripts have grown every week except holiday weeks and the recent week of our National Plan of Action Meeting. The rolling four-week totals have shown growth every week and that includes refills, which are continuing to increase as new prescriptions increase. Looking at other leading data such as prescriber data, again we believe there is strong evidence of a successful launch. June 2014 data, which is the most recently available data showed an increase of prescribing writing OTREXUP. According to Symphony Health unique prescribers increased from approximately 500 in May to over 600 prescribers in June. We believe that continued education of healthcare providers and new initiatives such as 0 co-pay program for patients should continue the growth curve. Further analysis have shown that when we overlay the script growth of OTREXUP for the first six months compared to recent launches of other RA products the trends are very similar. It takes time and effort to change the prescribing habits of rheumatologist even if the product such as OTREXUP has a compelling medical and value proposition. Demand for samples remains high and insurance coverage continues to be strong. Script data through June 2014, shows that 10% of all scripts have been prescribed for dermatology. Our partner for the dermatology indication LEO Pharma has recently developed and launched the [psoriasis] (ph) for its 70-plus sales representatives, which should have a positive impact on…

Eamonn Hobbs

Management

Thanks Bob. Earlier on today's call, I talked about continued progress on both the commercial and development sides of the business. We believe that we are prepared for the entry of a potential competitor to OTREXUP and to the market whenever that might occur. We also intend to continue vigorously defend our intellectual property as it relates to OTREXUP and all of our developmental products. While we believe the 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 plan to constantly evaluate data to determine where we can improvements in our performance. As Bob said we are still in the process of evaluating the 2014 sales rep for OTREXUP given the potential for a new entrant to the market. On the patient side we've done some additional analysis on the first five months of prescribing data and have decided to enhance our co-pay assistance program to $0 co-pay at the pharmacy to be similar to a co-pay for biologic. We believe that this program will help reduce confusion at the pharmacy and will also help patients that have either co-pay amounts or co-insurance. These changes to our patient assistance program should enable more patients to access the benefits of OTREXUP. This is just one example of a change in tactics we’ve employed as a result of staying on top of the early stage of our launch. Thank you for attention. Operator, could you now open the lines for a Q&A session.

Operator

Operator

(Operator Instructions) We will take our first question from Louise Chen with Guggenheim Securities.

Unidentified Analyst

Analyst

Hi, it’s actually [Ben] (ph) on for Louise. We’re just wondering if you could give us some feedback you’ve had from physicians regarding OTREXUP and the possibility of taking any price increases there. Thanks very much.

Eamonn Hobbs

Management

Well, overall the response we've had to the OTREXUP product from physicians has been extremely positive. The value proposition is as we expected. The benefits of continuing patients on methotrexate when they are longer receiving benefit from oral from oral dose methotrexate resonates with the rheumatologists and the launch results so far have validated our original thesis that OTREXUP has a very bright future. The second part of your question?

Robert Apple

Management

Price increases.

Unidentified Analyst

Analyst

Yeah.

Eamonn Hobbs

Management

At this point in time, we aren’t anticipating any price increases.

Unidentified Analyst

Analyst

Okay, thanks and then just how many sales reps do you have detailing OTREXUP at the moment?

Eamonn Hobbs

Management

Currently we have 25 sales territories in the United States.

Robert Apple

Management

We also have six MSLs that talk to the physicians from a medical standpoint.

Unidentified Analyst

Analyst

Okay, great and then on the Vibex QST, what is the market opportunity you are looking at today?

Eamonn Hobbs

Management

Well, it’s -- clearly the current testosterone market is vibrant and growing. We have not offered guidance as to our anticipated penetration with our QST platform but one of the things to consider in the potential of a subcutaneous testosterone is that the fastest growing segment of the current testosterone market is the intramuscular injection segment. So the benefits of subcutaneous over intramuscular injection are many and including much lower pain, ability to inject at home and potentially less peaks and trough excursions. So we're very excited about the prospects of our product.

Unidentified Analyst

Analyst

Okay, thanks and then just one last one, on the generic EpiPen application, do you expect this to be AB-rated?

Robert Apple

Management

This is Bob. Our expectation is that it will be AB-rated. It's filed as an ANDA and we are obviously all of our labeling is done with a side-by-side basis of the -- for the listed drug and so we anticipate that the FDA will give us an AB rating.

Unidentified Analyst

Analyst

Good. Thanks so much.

Operator

Operator

We will move along to our next question from Matt Kaplan with Ladenburg Thalmann.

Matt Kaplan - Ladenburg Thalmann

Analyst · Ladenburg Thalmann.

Hi, good morning guys.

Eamonn Hobbs

Management

Good morning, Matt.

Matt Kaplan - Ladenburg Thalmann

Analyst · Ladenburg Thalmann.

Can you give us a little bit of detail in terms of OTREXUP with respect to where you are with payers and payer coverage, with that and then also in terms of how are physicians thinking about this in terms of their treatment strategy for patients, how does it fit into that [indiscernible] of different products that they have at their disposal especially for RA and for psoriasis as well.

Eamonn Hobbs

Management

Well, starting with the second part of your question, how we see subcutaneous methotrexate fitting into the treatment paradigm for RA patients is that virtually all RA patients start out on an oral dose methotrexate therapy with the majority getting benefit from that therapy, but due to various limitations of that therapy the benefits of that therapy wane and the current standard of the care is to progress the patient to a biologic. We all know that biologics are extremely costly and have a duration of treatment, so what we’re trying to create is a step between oral methotrexate and biologics where patients can continue to derive the benefits of methotrexate before they have to progress to the more costly and time limited biologics. The bioavailability that we demonstrated and secured in our labeling shows that one of the advantages of subcutaneous administration with OTREXUP is that we can provide a higher bioavailability then what we can obtained or via oral methotrexate and for patients that are benefiting from oral methotrexate have shown a benefit. It stands to reason that continuing that benefit and postponing need to progress to a biologic can provide some significant benefits. With regard to payer coverage, currently we have secured 90% coverage and are continuing to work to expand that.

Matt Kaplan - Ladenburg Thalmann

Analyst · Ladenburg Thalmann.

Just shifting gears a little bit to the QST program, can you give us a sense in terms of timing, can you give us a sense in terms of timing of the Phase III and when we should expect a potential read-out from that?

Eamonn Hobbs

Management

Yeah, our expectation is that we’ll have the efficacy portion of the study the PK is really what it is, in mid 2015 and then the safety will continue on and our expectation is that this study will take up a little bit over a year obviously with it being a total of 52 weeks. Enrolment's going extremely well, and we anticipate that that’s going to continue to enroll quickly and fully enrolled and we feel really positive about that program.

Matt Kaplan - Ladenburg Thalmann

Analyst · Ladenburg Thalmann.

All right, and then in terms of that program and the upcoming -- any comments on the upcoming FDA ATCOM meeting on testosterones.

Eamonn Hobbs

Management

We’ve been watching what the FDA doing there in and at this point it doesn’t seem very robust and so we’re just going to be active listeners and see where they go with it. We don’t see any major event happening out of that and we’ll be watching with everybody else. I think that the safety of testosterone is establishes over years of use and each product is looked at on an individual basis and that’s will continue on a going forward basis. I think that the rejection of the citizen’s petition on a wholesale basis from the FDA indicates where the FDA’s position is but as you know again generally the FDA looks at it product by product basis and I think that’s what potentially will be the outcome of this committee meeting.

Matt Kaplan - Ladenburg Thalmann

Analyst · Ladenburg Thalmann.

And there’s a couple of more questions to that. The EpiPen program. When should we expect FDA approval on that of the NDA?

Eamonn Hobbs

Management

That’s a question that Teva can answer. They are working with the FDA on that filling. It’s their ANDA and obviously we hope that the approval comes shortly and we will keep an eye on that. But that’s Teva’s responsibility and not ours.

Matt Kaplan - Ladenburg Thalmann

Analyst · Ladenburg Thalmann.

Okay. Fair enough. And then just final question, in terms of the products that you already -- that you have on the market, so to speak already, hGH, Gelnique and Elestrin, can you give us a sense in terms of -- a little bit of guidance how do you think about those as from royalty prospective in going forward. Obviously there is a dip this quarter, you’ve mentioned based on some of the recalls of the Teva Tev-Tropin, but can you help us understand that?

Eamonn Hobbs

Management

Yeah, I think that if you look back historically last year, you are going to see that those levels continuing for an indefinite amount of time barring the issue that we had with Teva with their Tev-Tropin and when that comes back in to play and we do believe Teva will start shipping hGH in the next quarter or so, but I think it’s a steady cash generating piece of our business that will see normal growth over the next few years, but it helps us put our money into new development program and our partners continue to detail all the products and there’s no -- there doesn’t seem to be any near-term issues with the longevity of those and so again I think that if you look at last year’s level with slight growth is typically what we’re going to see over the next few years.

Matt Kaplan - Ladenburg Thalmann

Analyst · Ladenburg Thalmann.

Great. Thank you for the detail and congrats on the products.

Eamonn Hobbs

Management

Thanks Matt.

Robert Apple

Management

Thank you Matt.

Operator

Operator

(Operator Instructions) We will take our next question from Akiva Felt with Oppenheimer.

Unidentified Analyst

Analyst · Oppenheimer.

Hi guys, this is actually [indiscernible] on for Akiva. Good morning.

Eamonn Hobbs

Management

Good morning.

Unidentified Analyst

Analyst · Oppenheimer.

I just had a quick question with regards to the Medac product, Rasuvo. It was approved in early July. I was wondering, I am not 100% sure if its hit the market or not but I guess how are you expecting the dynamic of the I guess of this space to change given the fact that there’s another oral subcutaneous product on the market with similar dosing profile.

Eamonn Hobbs

Management

Well, to our knowledge, Rasuvo hasn’t been launched yet and we don’t have insights as to when it would be launched. Medac is a product company headquartered, parent company being in Germany. So that’s about the extent of our knowledge there. With regard to a competitor entering the market, we have to wait and see how Rasuvo is positioned but what we do expect to happen is that the overall market will benefit in size from the addition of a new competitor that’s working on creating this new space between oral methotrexate and biologics. So the feel for us that is associated with Rasuvo will be beating us the similar drum with regard to the benefits of subcutaneous methotrexate and we’ll expect the market to benefit from that.

Robert Apple

Management

Yeah I think too if you look at Rasuvo and OTREXUP, the products both have to be detailed and as Eamonn said, I think the more reps out there educating physicians on the use of injectable methotrexate is going to increase the market size. Rasuvo is not an ANDA. It’s not therapeutically equivalent and so therefore they’re going to have to -- Medac will have to go out and detail the physicians and basically encourage physicians to use injectable methotrexate just we’re doing and I think that it’s non usual to have competition in this pharmaceutical world and we’ll be prepared for it.

Unidentified Analyst

Analyst · Oppenheimer.

Great and I guess next question on methotrexate, as I spoke to the expansion of the unique prescriber base from 500 to over 600 in June, I was wondering do you have any numbers for July as of yet?

Eamonn Hobbs

Management

Yeah, the prescriber data is only provided from a monthly standpoint and the July data would be really available at the end of August and so our expectation is that it is going to continue to grow. I think that that’s a key statistics that over 600 prescribers have already prescribed OTREXUP and there are about 3000 to 3500 rheumatologists so I think that’s a very good penetration in a very short period of time and I think a lot of the physicians are looking at certain patients and seeing a lot of potential there and so once they get comfortable using it, we expect to see an increase in our script as well as the increase in the number of doctors using OTREXUP.

Unidentified Analyst

Analyst · Oppenheimer.

I am sorry Bob. Just to clarify, the 3,000 to 3,500, that’s the targeted rheumatologists base or that’s the total rheumatologist base.

Eamonn Hobbs

Management

That’s the total rheumatologist base. Right now we target around 1,500 and a little bit less as we look at -- every month we look at our targets and decide if we need to expand it or keep it the same and that’s normal and a new area in product launch is particularly in one way you’re trying to change the prescribing habit of the physician. So it’s just takes time and lot of calls to get that physician to remember about OTREXUP or of any injectable methotrexate and we believe we’re having success in that area and we’ll continue to have success.

Unidentified Analyst

Analyst · Oppenheimer.

Okay and I guess continuing on that line of, talking of about the breadth of the base, I guess, can we go into the depths as in how you’re seeing frequency of prescribers as in how many like if you could speak to how many doctors are predominantly ordering or just concentrating in one -- like a group of those 500 patients or if it’s spread out evenly I guess, pretty much…

Eamonn Hobbs

Management

Yeah, it’s spread out pretty evenly. Like I mentioned, they’ll try it with one patient or two patients or something. Our highest prescriber through that period has probably only wrote 50 prescriptions and so it’s a really nice distribution among physicians. So I think that educating them and then seeing the benefits is showing up and as they get comfortable really to potentially rank more than one or two patients and so I think we’re really happy with how the distribution is looking right now.

Unidentified Analyst

Analyst · Oppenheimer.

Okay. Great.

Eamonn Hobbs

Management

Yeah, last week’s scripts were very, very impressive so yeah, hoping that trajectory continues and best of luck. Thanks for answering the questions.

Eamonn Hobbs

Management

Hey, thank you.

Operator

Operator

And that concludes today’s question and answer session. I would like turn the call back over to Mr. Jack Howarth for any closing or additional remarks.

John Howarth

Management

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. Thank you.

Operator

Operator

That concludes today's conference call. We appreciate your participation.