Halozyme Therapeutics, Inc. (HALO) Q1 2018 Earnings Call Transcript
Published at 2018-05-08 14:08:04
Jack Howarth - VP, Corporate Affairs Robert Apple - President and Chief Executive Officer Fred Powell - Executive Vice President and Chief Financial Officer
Oren Livnat - H.C. Wainwright Matt Kaplan - Ladenburg Thalmann Anthony Petrone - Jefferies John Vandermosten - Zacks Small Capital Research
Ladies and gentlemen, welcome to the Antares Pharma First Quarter 2018 operating and financial results conference call. 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. I would now hand to conference call over to Jack Howarth, Antares' Vice President of Corporate Affairs. Please go ahead, sir.
Thank you, Ebenie and good morning everyone. This morning, we released our first quarter 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 have dialed in to the audio-only teleconference, you could 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 Webcasts tab. If you are currently unable to access our website, the conference call and slide presentation will be archived under the Webcasts 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, statements about new product approvals and FDA action, the company's ability to resolve the deficiencies identified by the FDA in the complete response letter for XYOSTED and FDA approval of the company’s NDA for XYOSTED and future market acceptance and revenue from XYOSTED. Future revenue including revenue from Makena, Sumatriptan, and OTREXUP, growth opportunities, the timing and results of research, development, clinical trials and financial performance and other factors which are also identified in today's presentation and from time-to-time in the Company's filings with the SEC on Form 10-K and as updated in Antares' recent periodic filings on Form 10-Q and 8-K and other filings made with the Securities and Exchange Commission. Links to these documents are available on the Investor Information section of our website and we encourage you to review these materials. Antares is providing this information as of the date of today's conference call and does not undertake any obligation to update any forward-looking statements contained in this conference 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 Bob Apple, President and Chief Executive Officer; and Fred Powell, Executive Vice President and Chief Financial Officer. Let's review the agenda for today's call on Slide number 3. Bob will begin with a review of the first quarter and recent highlights, Fred will present the first quarter financial results, and then Bob will give you commercial business update and review our catalysts. After our presentation, we will open the lines for your questions. Please turn to slide number 4. I'll now turn the call over to Bob Apple. Bob?
Thanks, Jack and good morning, to everyone joining us on today's call. I hope you had a chance to review this morning's operating and financial results press release, which highlighted several of our first quarter achievements. On the financial front, we reported first quarter revenue of $12.7 million versus $12 million in the comparable period last year. The growth was driven by a 9% increase in sales of our proprietary products and product devices sold through our partners. OTREXUP, our product for rheumatoid arthritis continue to grow both in scrips and net sales. Our Sumatriptan auto injector for migraine headaches sold by Teva continued its steady climb in market share growth. The recently approved Makena subcutaneous auto injector, our partner’s product for the prevention of preterm birth had a positive impact on first quarter product sales. Operating expenses were up approximately 6%, mostly attributable to increased investment in research and development and we ended the quarter with cash and short-term investments of $28.1 million. Fred will take you through the detailed financial results in just a few minutes. Please turn to Slide number 5. On the development front, we received notification from our partner AMAG in the first quarter that their application for subcutaneous injection or Makena using our QuickShot device have been improved by the U.S. FDA. This approval was a significant achievement for both companies. We believe the first pass approval of the Makena auto injector was validation of our QuickShot device technology and proves that we know how to work with our partners to get combination products approved at the FDA. AMAG launched the product during the last week in March and while it’s still early in the launch, they have indicated that they are very pleased with the progress thus far. AMAG’s commercial team is emphasizing the ease of use when speaking with physicians, nurses and other healthcare providers. The launch has been underway for just over a month and according to AMAG, anecdotal feedback from physicians and nurses who are already using the auto injector has been positive. The patient providers have indicated that the QuickShot auto injector is much easy to use and the patient experience is much less invasive than the IM injection products. On their earnings call last week, AMAG disclosed their four weeks after launching the auto injector 47% of new Makena patient enrollments through the Makena Care Connection program are for the auto injector. These new enrollments give AMAG a good early read on the percentage of new patients starting therapy with the Makena auto injector and our leading indicator of potential future sales as enrollments per seat treatment by approximately two weeks. AMAG believes sales in Makena auto injector will continue to grow in the second quarter and we believe the launch is off to a good start based on their enrollment data. The more time AMAG has to convert patients from the current IM administration to the subcutaneous auto injector helps with the finder position in this market and potentially preserves a greater portion on the Makena franchise. According to AMAG, a potential generic entry to IM Makena could occur in mid-year. Moving now to Slide number 6. During the first quarter, we participated in a face-to-face Type A meeting with the FDA to discuss the CRL we received for XYOSTED. After the Type A meeting, our clinical and regulatory team began to assemble a resubmission package based upon our understanding on the discussions held that day. Once the official minutes were received from the FDA, and analyzed, we filed our resubmission. Our response to CRL included a reanalysis of existing data, as well as draft labeling of potential post-approval risk mitigation strategies. On April 5, we announced that the FDA had acknowledged the receipt of our submission and considered at a complete Class 2 response assigning a September 29, 2018 PDUFA goal date. The planning will proceed with the FDA toward a potential XYOSTED approval later this year. Now kindly turn to Slide number 7. In October of last year, we announced the sale of the worldwide rights for the ZOMAJET needle-free auto injector device at Ferring Pharmaceuticals for $14.5 million. The purchase price will be paid in four installments, of which the first two totaling $4.75 billion have already been received including a $2.75 million payment received in the first quarter of this year. The final two installments totaling $9.75 million will be paid upon the completion of contractual milestones and customary closing conditions. We anticipate this transaction will be completed this year and the remaining two payments received prior to the end of 2018. I would now like to turn the call over to Fred who will discuss our first quarter financial results. Fred?
Thanks, Bob. Let’s begin by looking at the revenue details for the first quarter on Slide number 8. Total revenue was $12.7 million for the three months ended March 31, 2018, compared to $12 million in the first quarter of last year, a 6% increase. Product sales were $10.9 million for the first quarter of 2018, compared to $10 million for the comparable period in 2017, a 9% increase. Product sales represents sales of our proprietary products and devices or device components to our partners. The improvement in product sales in the first quarter of 2018 versus the same period last year was primarily driven by Makena auto injector sales of $2.4 million. OTREXUP revenue decreased to $4 million for the first quarter as compared to $4.6 million in the same period of 2017. The primary reason for the decrease was due to the recognition of an additional $1.3 million of revenue in the first quarter of 2017 as a result of an accounting change in estimation and recognition for OTREXUP revenue that was previously deferred. Excluding the effects of this one-time change in revenue recognition, OTREXUP revenues for the first quarter of 2018 increased versus the comparable period last year driven by 15% increase in the unit sales to distributors. Development revenue was $1.3 million for the three months ended March 31, 2018, compared to $1.6 million in the first quarter of 2017. The decrease in development revenues for the first quarter of this year compared to 2017 was primarily a result of a reduction in development activities with AMAG for the Makena auto injector product. Typically, development revenues decreased as potential products moved towards commercialization. Turning now to Slide number 9. Operating expenses were approximately $11.1 million for the first quarter as compared to $10.6 million in the comparable period of last year. The increase in operating expenses was primarily due to additional research and development spending associated with potential pipeline products, increased regulatory expenses associated with XYOSTED and an increase in compensation and benefits expense. Net loss per share was $0.04 for the first quarter of 2018, as compared to $0.03 in the first quarter 2017. The net loss for the quarter excludes the $2.75 million receipt from Ferring Pharmaceuticals which was recorded as a deferred gain on the balance sheet. The $2.75 million installment and any future installments received this year will be recognized as a gain once it is considered probable that a significant reversal of the gain will not occur. This will likely happen in the fourth quarter of this year based on the anticipated closing timeline. As of March 31, 2018, cash, cash equivalents and short-term investments totaled $28.1 million, compared to $31.6 million at year-end 2017, a $3.5 million burn. I’ll now turn the call back to Bob. Bob?
Thanks, Fred. Please turn to Slide number 10 that I will provide a further update on our commercial business and read some potential catalysts. OTREXUP continued its steady growth in the first quarter. As Fred mentioned earlier in the first quarter of 2017, we reported OTREXUP sales included a one-time increase in revenues due to an accounting change involving revenue recognition. Excluding the effects of this one-time change, OTREXUP revenue for the first quarter increased 21%, as compared to the same period in 2017. This was driven by an increase in units sold, and a price increase to distributors offset by an increase in estimated sales allowances. As you can see on Slide number 10, OTREXUP’s first quarter 2018 prescription numbers reflect impressive double-digit growth over the same period last year and the year before. Much of the success can be attributed to the enhanced data analytics our sales reps are using to target auto injector adopters and areas where we have strong insurance coverage. Our sales and marketing team continues to refine the product messaging, as well as improved perception around access and affordability. We continue to believe OTREXUP will be a solid contributor to our top-line growth. Turning now to Sumatriptan injection on Slide 11. First quarter 2018 Sumatriptan revenue was $2.8 million. As discussed in previous quarters, our Sumatriptan revenue is mostly dependent upon Teva’s device forecast and the arrival of prefilled syringes that we received from Teva and therefore it’s highly variable on a quarter-to-quarter basis. According to Symphony Health Solutions, Teva’s distribution of Sumatriptan has achieved a 32% quarterly TRX share, for the Sumatriptan auto injector market, up sequentially from 30% reported in the fourth quarter of 2017. We are very pleased with Teva’s strong commercial presence in major pharmacy teams and all of this level of market penetration can translate into future successes with the other Teva projects. Let me turn now to some potential catalysts on Slide number 12. We believe we made significant progress towards resolving the two deficiencies outlined in XYOSTED complete response letter through constructive dialogue and our resubmission to the FDA. The current PDUFA goal date is September 29 and we are tentatively targeting a late 2018 launch pending FDA approval. The XYOSTED commercial team has resumed launch planning activities. Moving now to our most recent partner success. The FDA approval of the auto – Makena auto injector, the first patient was injected on March 28 and AMAG has seen a steady weekly increase in new patient enrollments. They have indicated that insurance coverage remains strong for the new product due to price parity with the existing, single-dose IM via vial product. We will do our part in continuing to fill vouch for them as they are received. As a reminder, we sell AMAG the fully packaged product with margin and receive high single-digit to low-double-digit royalties on the end-sales of the Makena auto injector product. ZOMAJET sale of a non-core legacy asset was strategic in nature and we will continue to ship products to our ZOMAJET partners and receive royalties on those sales until the completion of the transaction. Moving to the ongoing pipeline of projects with Teva, Teva is still anticipating a 2018 launch of an AB rated generic EpiPen and we stand ready to start supplying them with additional devices when needed. Teva continues to pursue the Teriparatide approval in the U.S. going the ANDA pathway and is already been approved in 17 countries in Europe and is awaiting patent clearance before launching. Lilly reported 2017 worldwide sales of Forteo of $1.75 billion. So this could be a great opportunity for Teva as well as for us. Lilly and Teva settled the litigation late last year and did not disclose the settlement terms. Lilly however it has disclosed that it do not expect to have any competitive products to enter the market earlier than the second half of 2019. Finally, - Exenatide is following the same ANDA pathway for approval as Teriparatide. We will continue to support Teva as needed on all three of these ANDAs. From a commercial standpoint, we will sell Teva the devices with a margin and receive royalties on the end-sale of their generic product. Turning now to our own development projects, we have been reviewing a number of potential product opportunities to add to our pipeline and have conducted significant pre-clinical work on one of these compounds. We continue to expect to add a lead candidate to our pipeline in the second half of this year. Overall, I believe we made excellent progress on the commercial business and our pipeline, since our last quarterly update two months ago. We are excited about the many potential catalysts and are pleased to have numerous product candidates currently at the FDA. Thank you for your attention. I look forward to providing commercial and operational updates and our investors throughout 2018. That concludes our prepared remarks for today. Operator, could you now open the lines for the question and answer session.
Absolutely. [Operator Instructions] And we will take our first question from Oren Livnat with H.C. Wainwright. Please go ahead.
Hi guys. Thanks for taking the questions. On XYOSTED, now that you’ve resubmitted to the NDA and given how fast you do turn that thing around, I think it’s about a week after you got the minutes, are you prepared to give us a little more color on what safety data may or may not have been in that package, obviously, specifically, everybody wants to know if there was an ambulatory blood pressure study in there? And I do have a follow-up. Thanks.
Yes, I mean, as far as the response piece, thanks for the current comment that it was a quick turnaround. We have been working on it for quite some time since we got the CRL. But, as we said in our press release, it contain mostly reanalysis of data. We had performed an ABPM study during the Phase 3 program. It was just part of the protocol that we had submitted in to the FDA and so we felt pretty comfortable that there wasn’t any additional need for more data. And really I think I believe that the back and forth between the FDA will be around labeling and any kind of post-marketing medication strategies.
So, just a couple follow-ups on that. So, can you clarify if that ABPM was in your original Phase 3 or is that a part of the supplemental safety study you guys had to do?
Yes, it was part of the supplemental safety study.
All right. And, yes, go ahead.
When we met with the FDA, they wanted us to add more patients and one of the elements was to get some of those patients on an ABPM.
Perfect. And, I guess, about that REMS that you mentioned, is that differ meaningfully from perhaps your original commercial plans and expectations around a potential label? Can you talk about how all in REMS that might be, would it just be about information communication or something more restrictive potentially?
Well, I mean, I think that’s - we don’t know the answer to that, because we don’t if there is any going to be REMS. That vision is really made by the FDA going back and forth again between the safety group with the FDA as well as the division and then those types of topics have not been covered to this state. But clearly, other Testosterone products have REMS programs attached to them and they vary in degree of difficulty. All the junks have REMS around the transference and then the weed has REMS around anaphylactic shocks. Our issue was really around potentially an increase in blood pressure which we see hypertension in every label of Testosterone products. So we don’t know how the FDA is going to handle that from a REMS standpoint.
All right. Thanks so much. Appreciated.
Our next question will come from Matt Kaplan with Ladenburg Thalmann. Please go ahead.
Matt, are you on mute? Ebenie, maybe we can go to the next question and Matt can requeue.
All right. Here we go. Go ahead, Matt. Your line is open.
Hi, thank you. Thanks for taking my question. Just focus on XYOSTED a little bit more, what are you doing to prepare for the launch of XYOSTED at this point given the rapid turnaround that you had with the FDA?
So, we still have a number of our district managers for the XYOSTED, in the interim they’ve been helping with OTREXUP. But accordingly, they are starting to relook at candidates for reps. Obviously, our marketing team is relooking at all of the detail agents and so forth, they developed to this point and training trying to reflect changes that may or may not happen in the label. And from a sales standpoint, our lead sales person is managing and he is getting all of the training materials refreshed as well as really looking at targeting and see if that’s changed at all since last year as far as the top docs and things like that.
And you are planning to launch if this year if you get approval late September?
That being kind of, yes. If we – the PDUFA date September 29 and we believe that we could do a soft launch with most of our reps before the end of the year.
And then, a question shifting to Makena. How was QuickShot Makena performing so far in the marketplace?
I mean, I can really tell you from what I hear from Bill Heiden the CEO of AMAG as well as what they publicly disclosed on the earnings call last week. But, so far the – I think the adoption of the auto injector is above or beyond our expectations at this point. 47% of all new patients are starting on the auto injector that was as of last week of 2018 and higher this week. I think they’ve done a great job of getting the market ready for the auto injector and I think they were really wise in keeping the price the same as the IM injection. Therefore not really giving any reason for a doctor not to switch we are really not giving any reason for the payers to block it. And so, so far, I would say, the launch is going great as far as anecdotal evidence, Bill believes that they are best advocates of the product right now or the doctors and the nurses, they like the product. They like how convenient is for the patient. It’s a 15 second injection versus a minute. But more importantly, it’s in the back of the arm as opposed to the booties and so the patient doesn’t have to disrobe and so there is a lot of convenient aspects that I think are key. But importantly, the product was being the quite one to the IM injection and it’s being converted rapidly. So we feel really strongly and positive about the launch so far.
Great. Thanks for taking the questions and congrats on the progress during the quarter.
We will now take a follow-up question from Oren Livnat with H.C. Wainwright. Please go ahead.
So, thanks. Fast turnaround. Just a follow-up on Makena. Obviously, you can’t speak for your partner, but based on your interactions with them and maybe your own speculation, obviously that 47% share of all new patients, the Makena care is great. On the other hand, I could imagine that would be something closer to a 100% if they are coming through their specialty channel and there is no hurdle to converting from it to a better formulation. So I am just wondering, do you think that’s being manually, or intentionally staged and limited that switchover, so that they can soak up maybe existing inventory in the channel of the vials? Or do you think that they are trying their best to switch everybody and for some reason half the patients still aren’t converting yet for other reasons?
In my conversations with Bill Heiden, clearly, their goal is to get every patient on as quick as possible. But I don’t think there is any kind of holding back on the switches just to deplete their IM inventory. One of the things that I am aware of and again in discussions with Bill is that, the average REMS gets through our whole territory in 12 weeks. And so, there are a number of doctors and nurses that haven’t been detailed the auto injector just by virtue of the size of the sales force and the routing that happened. And so, we are only four weeks into it. So, in theory, two-thirds of the docs having been heard about Makena auto injector at least directly from the rep and so, I think the amount of conversion that they got just in a few weeks is actually pretty high.
Okay. Actually, it goes back to the question, which I actually asked you last quarter and I don’t think you answered that and maybe do now. Do you know if a doctor needs to specifically write for an auto injector for it to then become an auto injector sell at Makena cares or are they just writing for Makena ex strength and it’s up to the back-end to just get them, what we want to get them?
Well, I mean, the only thing – I mean, I don’t know the answer directly other than not maybe rated like generic. So, it doesn’t get automatically switched at the pharmacy so my bet or my guess is that, it may have the right Makena auto injector. And I think that, if they don’t, when it comes to Makena cares connection, maybe they call them back to and make sure that they want the auto injector. I am assuming that level of detail having, but I don’t know for sure. But it’s definitely not automatically switched if they write Makena.
[Operator Instructions] And we will move next to Anthony Petrone with Jefferies. Please go ahead.
Thanks. So, maybe, Bob just to stay on Makena for a second there, do you – are you aware of any direct-to-consumer advertising on the part of AMAG for the subcue injector? And then secondly, on that, there is still obviously a concern about a generic entrant. Are there any sort of preliminary thoughts on how pricing for the subcue injector may or may not shift with the generic entrant into that space? And then I have one follow-up. Thanks.
Yes, as far as any direct-to-consumer detailing or advertising, I think that’s a question for AMAG. I don’t know, I am sure they are going through some of the patients type of media – not media, but patient re-detailing through ads and so forth on your iPhones, things like that, possibly, some of that. But I don’t know for sure, and as far as the generic entrants, we can only go by what the AMAG has probably stated that they believe there is a chance that one happens mid-year this year. Non-half surface and longer, they go without a generic into the market, obviously the longer or the better we are as well as AMAG is switching the patients to the auto injector. As far as pricing is concerned, I do not know AMAG’s strategy around the pricing if a generic shows up and I think that if you look at a market such as this, it really is a function also of how many generics show up. And again, we have no clarity into when, if and how many are going to show up. I am sure AMAG really doesn’t have much in front of them either other than some tell us they may occur that so much coming out of the generics. But other than that, it’s not like a filing is obvious because there is no P4 filing is required with this product.
That’s helpful. Maybe just to shift gears over to XYOSTED. Maybe just a question on how the patterns of payer discussion shifted with the CRL late last year and then the resubmission, it sounded like there was some ongoing discussions. Did those shifts post-CRL, are they still ongoing? What are your thoughts around those early next year? And I’ll get back in queue. Thanks.
Sorry, Anthony. Could you ask that again? Are you asking about the payers’ reaction? Is that what?
No, no, just your – the company’s discussion with payers around XYOSTED. I know that they were ongoing at some point last year, but then of course, we have the CRL. So was there any update in terms of the discussions with payers, should the product come to market later this year?
Yes, I mean, we clearly are still talking to the majors in the payer landscape, the large PBMs, the large national health plans. And so far nothing has changed in their understanding of where they would put the products, what type of rebate if any will be requiring. And again, we are targeting in a Tier-3 coverage, which the only thing that typically covers that carries a Tier-2 would be something like an AndroGel which is the market-leader. We believe that, Tier-3 coverage with a relatively low co-pay that we can assist with will get us probably the best possible outcome and we say at lunch time. The one thing we do know is that, products don’t get on formularies right away. They have to go through a formulary review. And so, we are looking at ways to get on a formulary at launch and that typically requires some form of a rebate in order to accelerate that review at the PBM level or the clinical review team with the health plans. And so, nothing has changed. The market is still continuing to be in a 6 million prescription range. It goes up and down every month based on the number of days and based on this new starts and things like that. So the market is still fully intact. The amount of percentage of the market of the IM continues to grow. Obviously, I think that’s a function of the fact that the patients do like the feeling that you get when they are on an IM product because it’s more available or well available. But also, I think it’s too is that, the gels really start to lose voice in the marketplace. The only branded gel in the market right now is AbbVie’s AndroGel. And Lilly went generic. Lilly’s Axiron went generic late last year. And so, I think that’s also why you are seeing a change in the amount of patients that are on IM versus the gels.
If that answer your question? There was no sound. We will move next to John Vandermosten with Zacks Small Capital Research. Please go ahead.
I’ve missed some of the questions. Jumping on a couple calls this morning. So, but I won’t ask anything that that’s already been covered. But one of the things I wanted to address was just the FDA’s concerns with pressure and depression and you know, kind of what the response was from you that you think will satisfy them?
Well, I think that, what we said in all of our announcements since we had the CRL is that, we believe this will be a labeling discussion with the FDA around those two issues. What you may not have heard with that, we had to conduct an ABPM study as part of our safety study in our Phase 3. And there is really nothing else we could do that would give us any more information than we already have. And so, I think that, the agency will be looking at where we – how we highlight the increase in blood pressure, where we highlighted and how do we mitigate any risk if there any in that area. As far as depressions, the same thing, it’s – depression in the class, you see that typically been with hypogonadism or depressed and it’s a co-morbidity. And so, again, I believe we’ll be held in labeling because our clinical data from a PK standpoint was very strong and there was no concern around that. It was around those two safety issues if the FDA raise some concern.
Okay. And just the second question is just on, the FDA today is supposed to give their opinion on Lipozene’s product in similar area as XYOSTED and what kind of takeaway will you take from either a positive or a negative response here?
Actually, I don’t think it really bears much on our file at all. It’s a Lipozene has an oral Testosterone product which are very different than our injectable product. I am not - read to their NDA. So I don’t know what their issues are. They did get in front of the Nadcom and I – obviously I was there listening to both theirs and Clarus’ Nadcom. But they were both oral Testosterone. So I don’t really seen any correlations of whatever action the FDA takes on them today if it’s today versus our product. I think that it’s a very different type of delivery, different PK, and I hope them the best. But I don’t think it has any bearing on us at all.
[Operator Instructions] It does appear that there are no further telephone questions at this time. I’d like to turn the conference back over to Jack Howarth for any additional or closing remarks.
Thanks, Ebenie 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.
Thank you for your participation. You may now disconnect.