Earnings Labs

Halozyme Therapeutics, Inc. (HALO)

Q4 2018 Earnings Call· Fri, Mar 1, 2019

$63.70

-1.23%

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Transcript

Operator

Operator

Ladies and gentlemen, welcome to the Antares Pharma Fourth Quarter and Full-Year 2018 Operating and Financial Results Conference. Throughout today's recorded presentation, all participants will be in a listen-only mode. After the presentation, there will be an opportunity to ask questions. [Operator Instructions] I would now like to turn the conference over to Jack Howarth, Antares' Vice President of Corporate Affairs. Sir, please go ahead.

Jack Howarth

Analyst

Thank you, Katie, and good morning, everyone. This morning, we announced our fourth quarter and full-year 2018 financial results and recent operating achievements, and a copy of the press release can be found on the Antares’ website at www.antarespharma.com under the For Investors section. In addition, this morning's teleconference also contains an interactive slide presentation. If you've dialed into the audio-only teleconference, you can follow along with the slides, which can be found on our website, under the Investor Information section. The conference call and slide presentation will be simultaneously webcast on the For Investors section of the Antares’ website, under the Webcast and Presentations tab. If you're currently unable to access our website, the slide presentation will be archived under the Webcast and Presentations tab at the conclusion of today's call. Before we begin, I'd like to remind you that some of our statements made during this conference call will contain forward-looking statements within the meaning of the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties, and actual results could differ materially from those projected in any forward-looking statements. Forward-looking statements provide Antares' current expectation or forecast of future events. Factors that could cause actual results to differ include, but are not limited to, market acceptance, adequate reimbursement, successful launch and future revenue from XYOSTED and Teva's generic EpiPen, market acceptance and future revenue from Makena, sumatriptan and OTREXUP, the timing and results of proprietary and partnered research, development and clinical trials, including ATRS-1701 and development projects with Teva and Pfizer, statements about new product approvals and FDA action, and the Company's financial performance, including achievement of the 2019 revenue guidance and other factors, which are also identified in today's presentation and from time-to-time in…

Bob Apple

Analyst

Thanks, Jack and good morning to everyone on today's conference call and webcast. This morning, we announced record revenue of $63.6 million, a 17% increase over last year and we also highlighted a significant number of operational goals achieved throughout the quarter. But first, let's get started with a summary review of the achievements in 2018 as we are proud of the progress we made last year. Two key potential drivers of value for Antares emerged. First, strong development and regulatory success of three total product approvals, one for our self and two for our partners; and second, the continuing and expanding diversified commercial growth of our business. Our year began with an announcement that our partner AMAG Pharmaceuticals had received FDA approval of their Makena subcutaneous auto injector product. The product was launched at the end of the first quarter and we recorded just over $18 million of revenue from finished product sales and royalties in 2018. The Makena subcutaneous auto injector product has been well received by healthcare professionals and patients, and AMAG believes the value proposition of the product could meaningfully extend the life of the Makena brand. I will cover more of this later in the call. In August, we were excited to hear that Teva had received FDA approval for the generic EpiPen. Late November, they announced the limited commercial availability of their fully substitutable generic product. Teva had indicated on their fourth quarter earnings call that they are continuing to manufacture drug and build supply, and they believe inventory will normalize by the end of the first quarter or the beginning of the second quarter of 2019. Teva also expects to launch a generic EpiPen Jr. late in the second quarter of this year. We've already received purchase orders for restocking auto injector devices…

Fred Powell

Analyst

Thanks, Bob. Please turn to Slide Number 6. As Bob mentioned earlier on today's call, 2018 was a tremendous year for Antares, and our 2018 revenues reflect the success. During 2018, we issued revenue guidance for the first time in Antares' history. And our net revenue of $63.6 million was within the upper end of the guidance range of $60 million to $65 million. Total revenues were $18.8 million for the three months ended December 31, 2018, compared to $14 million in the fourth quarter of 2017, an increase of 34%. Total revenue for the year ended December 31, 2018 grew to $63.6 million, as compared to $54.5 million for the year ended December 31, 2017, an increase of $9.1 million or 17% on a year-over-year basis. Product sales in the fourth quarter of 2018 increased by 30% to $14.2 million, compared to $11 million in the comparable period of 2017, and were $47.9 million for the full year of 2018, compared to $41.7 million in 2017, a 15% increase. For the fourth quarter and full year of 2018, product sales accounted for approximately 75% of total revenue. Product sales represent sales of our proprietary products and commercial product, or device components to our partners. The increase in product revenue for the three-month period was primarily attributable to OTREXUP, Makena, sumatriptan injection and XYOSTED – offset by a decrease in orders from Teva for epinephrine auto injectors, as we had supplied Teva with pre-launch quantities in 2017. The increase in product sales for the 12-month period was primarily driven by sales of Makena auto injectors to AMAG. Licensing and development revenue was $1.1 million and $2.2 million for the three months ended December 31, 2018 and 2017 respectively, and $6.8 million and $11.2 million for the years ended December 31,…

Bob Apple

Analyst

Thanks, Fred. Please turn to Slide 7 for a brief update on the XYOSTED launch. We launched XYOSTED in December 2018 and our reps have been detailing the product in the field for a little over two months. Our plan is to initially target high prescribers of testosterone products. With respect to managed care coverage we believe we are making steady progress towards our goal of having two-thirds of all insured lives covered for XYOSTED by the end of 2019. The comprehensive commercial launch strategy includes an initial XYOSTED trial where the patient receives his first injection in the physician's office via sample. So they're comfortable with XYOSTED, it's easy-to-use, an innovative auto injector. After treatment the patient leaves with a prescription and a co-pay assistance card. Our team has created a program to help the commercially insured patient get their first script filled even if it's not initially covered by insurance. We also initiated several pre-launch programs, including an unbranded social media campaign, which targets dissatisfied TRT patients. The information gathered from this engaging and unique consumer program will support our soon-to-be launched branded consumer program, which will aid in growing our brand awareness and reach. During 2019 we have plans to attend numerous scientific and medical conferences in order to engage urologists, endocrinologists and other physicians in a meaningful medical exchange. Turning now to Slide Number 8, according to the most recent testosterone prescription data, the market grew 6% in 2018 with approximately 7.2 million prescriptions filled. The injectable market grew 12% and now represents approximately 70% of all TRT prescriptions written monthly. The overall topical market is declining. We believe XYOSTED offers several compelling reasons to switch from existing therapies, and therefore, our sales representatives will be targeting both injectable and topical prescribers. Although very early in…

Operator

Operator

Thank you, sir. [Operator Instruction] Our first question will come from Bill Maughan with Cowen & Company.

Bill Maughan

Analyst

Good morning. Thanks. Congrats on all the progress. I was just wondering if you could give us some sense of how the net price on XYOSTED might progress throughout the year as payers sequentially come onboard and start covering the product? And then on generic Forteo, as you mentioned, it's factored in on a risk-adjusted basis. How have your discussions with the FDA progressed and what's your sense on, where the FDA stands in terms of what they want to see for a generic Forteo approval? Thanks.

Bob Apple

Analyst

Thanks, Bill. I'll take the second question first and then hand the other question over to Fred. So with Forteo, we are not the ANDA holder, it's Teva. So they're the ones who deal with the FDA on a regular basis and they're the ones who actually came up with the guidance that the launch was risk-adjusted in their models. From our standpoint, we are producing devices for the potential launch and we overall feel pretty good about where we are from a production standpoint and from a device standpoint. As far as the approval, all we can go by is what Teva said on their earnings call, which is they are potentially expecting a launch in the second half of 2019, which lines up with their settlement with Lilly. So other than that, we're doing everything we can to make sure we support the launch.

Fred Powell

Analyst

Hey Bill, this is Fred. Regarding your question with the gross to net and the progression that we should for XYOSTED in 2019, I think it's a fair assumption that we will see an improvement in the net price as we go throughout the year. At the beginning of the year, in our efforts to ensure that patients actually receive the product, we have a first-fill free program, which allows our patients actually get a first prescription free at the – it's not covered at the time. We expect that program will slow down and stop during 2019. At the same time, we would expect that we would get additional coverage and contracted PBMs in place that provide the coverage for those products. The combination of those products should see us improve our gross to net calculation, as we continue into the second quarter, into the third, and finally, through the end of the year. So yes, it should be an improvement as we see different programs take place during the year.

Bill Maughan

Analyst

And are there any specific dates where we might see sort of large chunks of covered lives coming onboard?

Bob Apple

Analyst

Yes. So I think that you know, right now, we are ahead of where we're expected to be as far as coverage. I think that the way that most plans or the larger plans follow is, there's usually a six-month review. So we anticipate that in the second half of 2019, we'll see an acceleration of the covered lives. I think that's – I'm not sure that's the way it works for all new products that are in the market. So I think we'll follow that course. I think what's been interesting and positive for us there is, there is a good level of support from the payer standpoint for this product. I think they see the value of the need for testosterone products and the value potentially what XYOSTED brings to the patients. And so, we'll continue to work on that and reach our target of two-thirds of all lives being covered by the end of the year.

Bill Maughan

Analyst

Thank you.

Operator

Operator

Thank you. Our next question comes from Anthony Petrone with Jefferies.

Anthony Petrone

Analyst · Jefferies.

Hi, good morning and congratulations on a great year. Maybe Fred, just for the guidance $95 million to $105 million, just kind of going through what Teva announced on their call, so the late 1Q launch of EpiPen, they announced EpiPen Jr. as well, and then also obviously as you discussed the risk-adjusted potential for generic Forteo, I'm just trying to get a sense of how much of that is actually baked into $95 million to $105 million, just given that, that was announced after you issued this guidance. And then I have a few follow-ups on XYOSTED.

Fred Powell

Analyst · Jefferies.

Sure. With our guidance of $95 million to $105 million, its first time beginning of the year, we've actually issued guidance. And being as large of an increase year-over-year, we've not broken it down by individual products. With the launch of XYOSTED taking place, as well as the full launch of Epi, we didn't think that would be prudent. However, I can tell you with the Epi becoming fully available and based upon [indiscernible] comments regarding how much of the market they expect to have we have built in epinephrine's revenue into our number for the $95 million to $105 million. –:

Anthony Petrone

Analyst · Jefferies.

–:

Fred Powell

Analyst · Jefferies.

That's right, that's right.

Bob Apple

Analyst · Jefferies.

–: –: –:

Anthony Petrone

Analyst · Jefferies.

Right. Helpful. Fair, fair. And then maybe just to shift over to XYOSTED. So obviously, there is some activity out there in the marketplace. Symphony and others are picking up some activity. So maybe just some feedback from physicians and patients what they're saying about XYOSTED. And just really the reps as well, so 55 reps, are they actually all out there at this point and fully trained in doing this thing, or is there still a little bit of a ramp phase for them as well?

Bob Apple

Analyst · Jefferies.

–: –: –: –: –: –: –:

Anthony Petrone

Analyst · Jefferies.

Last one from…Sure, go ahead.

Bob Apple

Analyst · Jefferies.

–:

Anthony Petrone

Analyst · Jefferies.

And Fred, just the spend level, was this what we should be modeling quarterly or any uptick should we be factoring in the next couple of quarters? Thanks again.

Fred Powell

Analyst · Jefferies.

Sure. I think – as we mentioned, I think on the last call, with the increase in sales and marketing, adding in the additional sales reps as well as the launch expenses, we saw a bit of that take place in the fourth quarter of 2018. We'll see more of that hit in 2019. So the sales reps did not come on until the second half of the quarter in mid-November. So assume that with the additional 50 plus sales reps, as well as sales and marketing guys, that indeed should be added in for the full year for the sales and marketing line.

Anthony Petrone

Analyst · Jefferies.

Thanks.

Operator

Operator

Thank you. Our next question comes from Elliot Wilbur with Raymond James.

Unidentified Analyst

Analyst · Raymond James.

Hi, good morning. This is Lucas Lee in for Elliot.

Bob Apple

Analyst · Raymond James.

Hi, Lucas.

Unidentified Analyst

Analyst · Raymond James.

Hey, how are you? Few questions though. When do you think we can expect an update on progress points related to the Pfizer partner's product?

Bob Apple

Analyst · Raymond James.

–: –: –: –:

Unidentified Analyst

Analyst · Raymond James.

–:

Bob Apple

Analyst · Raymond James.

Yes, I think that our target is about 10,000 to 12,000 physicians. Each territory has in excess of a 100 key targets, about 120 I think, which is pretty standard for the industry. And obviously, with the higher decile docs, like I mentioned, we are trying to get to them on a much more frequent basis. What you find in testosterone is at the decile eight to ten or a seven to ten write a substantial piece of the business. They write a lot of testosterone and they are the ones we really want to focus on an ongoing basis. –:

Unidentified Analyst

Analyst · Raymond James.

Got it. Moving on to 2019 revenue guidance, is there any additional color that you guys could provide in terms of product breakdown within that guidance range? Thank you.

Fred Powell

Analyst · Raymond James.

No, this is Fred, sorry about that, but we are not able to provide that. Obviously, we have our own internal targets and goals for the various line items. But this time, we're just providing the topline total number of $95 million to $105 million for revenues.

Bob Apple

Analyst · Raymond James.

–: –: –: –: –: –:

Unidentified Analyst

Analyst · Raymond James.

Got it. And lastly on Teva's generic EpiPen, they recently indicated that they're targeting peak share of the epinephrine market by 50%. Is there any supply limitations on your side that would limit Teva's ability to achieve their share? That will be it. Thank you.

Bob Apple

Analyst · Raymond James.

–: Again, that's not our guidance, that's their guidance and go knock it out of the park. Please, that would be great for us and them.

Unidentified Analyst

Analyst · Raymond James.

Thank you.

Operator

Operator

Thank you. [Operator Instructions] Our next question comes from David Amsellem with Piper Jaffray.

Unidentified Analyst

Analyst · Piper Jaffray.

Hi, good morning. This is Mickey Ingerman on for David. Thanks for taking the questions. Just a couple of quick ones. First, can you guys remind us on the economics with Teva on your Forteo product? And then secondly, I know it's still early in the launch, but can you guys discuss early patient access results that aside from demonstrating prior use of other testosterone treatments are there any other mitigating factors to patients getting access to the drug?

Bob Apple

Analyst · Piper Jaffray.

–:

Unidentified Analyst

Analyst · Piper Jaffray.

Yes, basically just on patient access, I mean aside from demonstrating prior use of other testosterone therapy, are there any other mitigating factors for patients getting access to the drug?

Bob Apple

Analyst · Piper Jaffray.

–: –: –: –: –: –: The second question...

Unidentified Analyst

Analyst · Piper Jaffray.

PTH economics.

Bob Apple

Analyst · Piper Jaffray.

–: –: –: –: –:

Unidentified Analyst

Analyst · Piper Jaffray.

Got it. That's helpful. And then one last one and I apologize if I missed it in the prepared remarks, but on your proprietary neurologic rescue pen, when should I see this will enter the clinic and what's the best-case scenario for eventual commercialization? Thanks.

Bob Apple

Analyst · Piper Jaffray.

–: –: –:

Unidentified Analyst

Analyst · Piper Jaffray.

Great, thanks again.

Operator

Operator

Thank you. At this time, I would now like to turn the call back over to Jack Howarth for closing remarks.

Jack Howarth

Analyst

Thanks, Katie. Thanks again for joining us on today's conference call webcast. If you have any follow-up questions, you can call Investor Relations at 609-359-3016. That concludes today's call.

Operator

Operator

Thank you, ladies and gentlemen, this concludes today's teleconference. You may now disconnect.