Earnings Labs

Halozyme Therapeutics, Inc. (HALO)

Q1 2013 Earnings Call· Wed, May 8, 2013

$63.42

-0.70%

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Transcript

Operator

Operator

Good morning, ladies and gentlemen, and welcome to the Antares First Quarter 2013 Operating and Financial Results Conference Call. [Operator Instructions] I would now like to turn the call over to Jack Howarth, Antares Vice President of Corporate Affairs. Please go ahead, sir.

John J. Howarth

Analyst

Thank you, Craig, and good morning, everyone. Thank you for joining us on today's call. We announced first quarter 2013 financial and operating results earlier this morning, and a 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. Antares' 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 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 of Pharmaceutical Sales and Marketing. After the presentation, we'll open the lines for Q&A. I'll now turn the call over to Paul Wotton. Paul?

Paul K. Wotton

Analyst

Thanks, Jack. Good morning, everyone. By now, I'm sure you've all had a chance to review this morning's release, so I'd like to briefly highlight some of the first quarter accomplishments. And one of the most important goals that I set for the company and for our shareholders got one step closer last quarter when the New Drug Application for OTREXUP was accepted by -- as filed by the FDA. By submitting the application in December of last year, we met the criteria for 10-month review with a target decision date of October 14, 2013. And while October still seems to be months away, we recently just completed our OTREXUP NDA mid-cycle review with FDA. Our product development group has been working closer with the FDA during the review of the application and has also been working on another important project, which I'd get to shortly. The potential FDA approval and launch of OTREXUP will be a major milestone for our company. So our next goal would then be the successful commercialization of OTREXUP, and this you can see from today's results, the increased investment in sales and marketing expense, an increase of over $0.75 million versus the first quarter of last year is part of the ramp-up necessary for successful commercial launch. We have built a marketing and trade team that is highly experienced in successfully commercializing rheumatology products. Every member of this team has worked on one or more of the current biological agents used to treat rheumatoid arthritis and all share the excitement of the opportunity that is OTREXUP. In addition to filling out the marketing and trade team, we have identified our target markets for early visible success, begun strategic third-party reimbursement discussions, initiated a publication strategy and identified all the necessary third-party vendors that will…

Robert F. Apple

Analyst

Thanks, Paul. Good morning, everyone. Before I get into the details of the first quarter results, I'd like to expand on Paul's thoughts regarding our revenue mix. I'd also like to remind everyone, as I said in previous calls, that we continue to derive revenues from multiple sources and each one of those sources can fluctuate quarter-to-quarter. We believe that moving away from a top line royalty-driven business model to a product revenue business model with OTREXUP and quick-shot testosterone as prime examples of potential product revenue not only will we grow our top line revenue, but we may also drive[ph] more consistent and sustainable top line growth in the future. So although this quarter's total revenue was lower than the first quarter of 2012, much of that can be attributable to certain onetime and nonrecurring events in 2012, which I will get into shortly. We still anticipate product revenue will grow between 20% to 40% this year without the benefit of any new product launches and total revenue growth of 10% to 20% depending on the level of business development and licensing revenue we generate this year. And as you can also see from today's results, the ramp-up in sales and marketing expenses has begun, and we will make the appropriate investments in OTREXUP to ensure its successful product launch. Total revenues were $4.5 million and $6.9 million for the 3 months ended March 31, 2013, and 2012 respectively. In the 3 months ended March 31, 2012, the company recognized revenue of approximately $3 million in connection with onetime milestone payments for our 3% oxybutynin gel from Actavis and Daewoong Pharma. Product sales were $2.5 million for both the 3 months ended March 31, 2013, and 2012. Product sales in the first quarter of 2013 includes $600,000 of initial…

Paul K. Wotton

Analyst

Okay. Thanks, Bob. So there's 3 words that best described the strategic process we have undertaken at Antares over the past 4.5 years: fixed, focus and growth. We stated that our goal was to reposition the technology company dependent on royalty streams and partnerships into a revenue-generating specialty pharmaceutical company that will enjoy the bulk of the revenues resulting from a growing product pipeline with control of its own commercial destiny. Four years ago, I envisioned that strategic investments and innovation were required in order to build a pipeline of novel products that would deliver the best long-term value for our shareholders. We're now on the verge of realizing that goal and I'm extremely pleased that the vision is becoming reality. We're a marketing-led company and data-driven. When I became CEO, we commissioned extensive primary market research. This showed us that the injectable market was about to grow rapidly and that Antares had a comprehensive technology platform that could play a role in the exciting growth of this segment. In the U.S. alone the value of generic injectable drugs amounts to approximately $6 billion, and segments such as rheumatoid arthritis are valued at over $17 billion where the bulk of the value is attributed to injectable medications such as Enbrel and Humira. The recent flurry of M&A activity in the injectable space is confirmed, that the outcome of our market research-driven strategy is correct as others now seek to capture value in this segment, and in fact, copy our strategic approach. Studies have shown that our VIBEX system can enable patients to self-administer a subcutaneous parenteral drug in the nighttime setting with a high level of convenience and confidence as taking a tablet and enhanced safety over intramuscular injections administered with a needle and syringe. Our technology has created product…

Operator

Operator

[Operator Instructions] And our first question does come from the line of Louise Chen with Guggenheim.

Louise Alesandra Chen - Guggenheim Securities, LLC, Research Division

Analyst

I had a few. So the first one I had was on the OTREXUP product. And this is the question that we've gotten is you don't have a head-to-head trial per se, but why do you feel confident that doctors and payers will choose your product over other options? And what do you expect to be in your label on the trials that you have done? And then my second question is on the AB rating for EpiPen. Just wondering here how many people that buy the EpiPen actually use this product, so wondering how -- is the argument that it has to be exactly alike, how strong is that? And the last question is on the VIBEX 3 product, the QS M. Just wondering if you'd give more details on that and if you have a VIBEX 4 product also in development?

Paul K. Wotton

Analyst

Thanks, Louise. So we have 3 questions, 1 on OTREXUP, 1 on EpiPen and 1 on QS M. So with OTREXUP, actually, what I think the best thing to do is to hand that over to Leroux who can talk about the label. And with -- from the market research we've done, what we know is that there is a need out there for a subcutaneous methotrexate product. All of the work we've done, and in fact we just validated that with third-party research, has shown that physicians like the product concept that we have. So let me just hand over to Leroux to give some flavor on the marketing elements that we're proposing.

Leroux Jooste

Analyst

Good morning. Thank you, Louise. Great question and certainly a question that we have looked at in depth as you might imagine during all of our target product profile and market research as we talked with rheumatologists and payers. And clearly, the use of subcutaneous methotrexate is fairly well known. In fact, I think it's very well known and the data that exists -- publications that have already been published, as well as the data that we are looking at from a variety of different registries and databases that would make up our publication strategy would support the use of subcutaneous methotrexate in providing the benefits that we have talked about in the past, extending the time to the need to add or switch to the biologic; in other words, enhancing and expanding the optimal use of methotrexate. It's well recognized as a benefit that OTREXUP will provide. Your second part of that question related to the labeling, I will address some of that and perhaps Paul will add to that. Clearly, we have not yet had feedback from the FDA in terms of what they will accept in the label that we have submitted as part of the NDA. However, I think we are pretty confident that the studies that we did, the bioavailability pharmacokinetic data, the actual human use study, the human factor study, that all of those data would be included in the label. In addition, we included many references to this subcutaneous methotrexate providing the evidence in publications out there that would update the label as the existing methotrexate label is quite outdated and does not reflect subcutaneous use at all.

Paul K. Wotton

Analyst

Yes, thanks. And the other thing, Louise, which we'd -- there was a-head-to-head study in a sense, which would be availability of the injectable methotrexate using our device compared to all availability of doses between 10 and 25 milligram. And that data we actually have included in our draft label. It's available because it's on our website presentation. But when you are giving talks to investor groups, including physicians in the audience and they all get the value of the methotrexate given using our OTREXUP product, when you get to doses above and beyond 15 milligrams, they'd like the precision that patients get. They like the fact that physicians are giving patients a reproducible dose that gives you better systemic availability of the drug and avoid some of the gastrointestinal side effects that you see with high doses of oral where patients may be getting more drug, but they're not necessarily getting more drug to where it needs to be. So I think that what we have is a good package here. And all of the work we do in terms of the market research, and we continue to talk to people on this front, this is a sticky product and we believe it's going to work well. The next product we've had you mentioned was the EpiPen. And actually you asked a great question, which is how many people actually use an EpiPen. And from the work we've done actually, I believe that 99%, possibly higher, of all EpiPens are never used at all. And patients typically they obviously have to have more than one EpiPen in their home to provide a backup, but they also have EpiPen kits in their cars, at their office and now there's a movement to put the EpiPen into schools. With respect to AB substitutability, we believe that the device we have will be AB rated and all of the work and feedback we've received is indicated that will be the case and we've only ever had comments back from the FDA based on this being an ANDA-approvable product.

Robert F. Apple

Analyst

I think, too, Louise -- this is Bob. I think the FDA has been pretty open about the fact that the devices don't have to be identical. They have to operate in a similar manner. They entered that in a number of citizen petitions a few years ago and clearly we believe our device operates in the same exact manner as the epinephrine product in the market. So we feel pretty confident that our device is very similar in the way it works and that the FDA is going to continue to review of it as an ANDA.

Paul K. Wotton

Analyst

Yes. And Louise, I think the last question was on the QS M product, which we did announce is a new pipeline program for us this year. This is a program that will be actually in urology and we will announce that program once we have actually completed all of the work necessary to reinvent the intellectual property around the assets. So typically what we do with methotrexate and what we did with testosterone was start working on that, develop the data, file the patents. And once we've actually filed more than 1 patents around that, we would then announce what the product was and that's the same intent here with QS M. There's also going to be a -- we are looking at a fourth pipeline product to add to the pipeline. And this is important because this is a pipeline story. What we've discovered here is a very effective way -- cost-effective way, indeed, of generating an NDA to creating these combination product opportunities with our own technology platform. And a lot of the early intellectual property that we filed in the earlier part of this decade is going to give us good protection, we believe, for us to be able to dominate the subcutaneous injectable space using auto-injectors. So I think there's a nice pipeline opportunity here for this company. That's where the real value is of Antares today. And going forward, as we mentioned earlier, we'll be marketing OTREXUP ourselves and we intended to use the same type of model, focused field force into specialty segments where combination products can make a real difference to the patient.

Operator

Operator

[Operator Instructions] And at this time, I'm showing no further questions. I would like to turn the call back over to Jack Howarth for any closing comments.

John J. Howarth

Analyst

Thanks, Craig. Thanks again for listening today's conference call. If you have any follow-up questions, please give us a call at (609) 359-3016. That completes today's call.

Operator

Operator

Thank you very much. Ladies and gentlemen, that will conclude the conference for today. We do thank you for your participation on today's call. You may now disconnect your lines at this time.