Halozyme Therapeutics, Inc. (HALO) Q3 2019 Earnings Report, Transcript and Summary

Please standby. Ladies and gentlemen, welcome to Antares Pharma's Third Quarter 2019 Operating and Financial Results Conference Call. [Operator Instructions] I will now hand the conference call over to Jack Howarth, Antares' Vice President of Corporate Affairs. Please go ahead, sir.

Thank you, Matt, and good morning, everyone. Earlier today, we announced our third quarter 2019 financial results and operating achievements. A copy of the press release and slide presentation for today’s conference call are available on the Investors section of the Antares website. 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. Examples of forward-looking statements include those related to our future financial and operating results including 2019 financial guidance and catalysts, future growth and market share, new product approvals and launches, sales and prescription volumes, FDA actions, and other regulatory activities. The results of ongoing and future clinical trials and other product development activities and corporate development efforts. These forward-looking statements are subject to certain risks and uncertainties, and actual results could differ materially. They are identified and described in today’s press release and in accompanying slide presentation and from time to time in the company's filings with the SEC on Form 10-K and is updated in Antares' recent periodic filings on Form 10-Q and Form 8-K. 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 3. Bob will begin with a high-level review of our outstanding third quarter results and provide an update on our commercial business. Fred will go through the detailed financials, and then Bob will open the lines up for your questions. I'll now turn the call over to our CEO, Bob Apple. Bob?

Thanks Jack. Good morning everyone on today's conference call and webcast. Today we reported a strong quarter of financial progress driven in large part by sales of our flagship product, XYOSTED as well as strong demand and growth for Teva's Generic EpiPen. Our diverse mix of proprietary and partnered products contributed to significant year-over-year revenue growth for Antares. Today, I'm also happy to report that the rapid growth in our top line has produced the company's first quarterly income from operations, as well as overall net income. The strong execution by our commercial team selling both XYOSTED and OTREXUP, coupled with the same strong execution by our operations team supplying our partners with devices and products has us outperforming street expectations in all aspects of our 2019 business forecast. As a result, we are once again raising our full year 2019 revenue guidance. So let's talk about some of the highlights from the quarter and how our achievements over the past nine months have helped pave the way for why we believe 2019 is a transformational year for the company. Please turn to Slide number 4. This morning, we reported $34.3 million in total revenue, almost double the $17.9 million reported in the third quarter of last year. Total revenue grew 21% sequentially from the second quarter. Product revenue grew 113% versus the same period last year and importantly, grew 20% sequentially from the second quarter. This is very impressive growth which was driven by our key proprietary and partnered products such as XYOSTED, OTREXUP, and the Generic EpiPen. Importantly, as a direct result of the increase in revenue reported from our partnered products, royalty revenue grew 126% compared to last year and sequentially grew to 51% over the recent second quarter. I'd like to now briefly review the two recently launched products, which drove record growth in the third quarter before turning the call over to Fred. XYOSTED, our once-weekly subcutaneous autoinjector of testosterone enanthate for men with testosterone deficiency was launched in January of 2019 by the Antares specialty sales force of approximately 80 sales representatives. Over the first nine months, our launch metrics have exceeded street expectations. We believe that is a significant accomplishment as new product launches historically are difficult with payer and physician dynamics creating significant challenges on product uptake. Further highlighting the success of the launch is that our sales team is also detailing OTREXUP, our legacy RA product to a totally different audience of rheumatologist, not only have they maintained the OTREXUP core plan, they've actually grown OTREXUP revenue while driving strong growth of XYOSTED. As you can see on Slide number 5, XYOSTED total prescriptions are growing nicely. More importantly, new patient starts are increasing and refills are growing, a great sign of patient persistence. Strong therapy persistence means good rates of refill, which we believe will lead to continued revenue growth. Since launch, XYOSTED has recorded double-digit month-over-month sequential percentage growth in both new and total prescriptions. In the third quarter alone, Symphony Health Solutions reported that approximately 20,000 XYOSTED prescriptions were filled which was a 73% sequential increase over the second quarter of 2019. Through September, approximately 35,000 XYOSTED prescriptions had been filled since the beginning of the year, and that number does not account for multiple month refills, it is important to note that sales of XYOSTED to the wholesale distributors continues to be higher than the number of prescriptions reported by IQVIA and Symphony. We believe much of this growth can be attributed to strong rep performance, solid messaging and the work we have done to obtain additional coverage for potential XYOSTED patients. From a coverage standpoint, a significant milestone was reached on October 1, when we contracted with another large pharmacy benefits manager, increasing our managed care coverage to approximately 70% of all commercial lives. Our aggressive goal for 2019 was to achieve two-thirds of all commercial lives covered in the first year of launch and we have exceeded this goal. We continue to target all large writers of testosterone products, 3,500 different physicians have written prescriptions to more than 12,000 patients since launch. Neurologists and endocrinologists are writing approximately half of all prescriptions, while general practitioners, nurse practitioners, and all others are writing the balance. It's a good diverse blend of prescribers and we believe it forms a solid foundation on which to expand. The most recent IQVIA data shows that our prescriptions are being written for a variety of patients who are either new to testosterone therapy or patients who are switching from a gel or generic injectable. We believe the trends we are seeing in both the number and type of prescriber, and the kind of patients using the product means that the XYOSTED product features and messaging are resonating with our target audience. Please turn to Slide number 6. On our last quarterly call, we disclosed plans for a new branded social media campaign, which was designed to educate patients and encourage them to ask their doctors if XYOSTED is right for them. I'm pleased to report that since the launch of this digital patient campaign, we have seen new non-targeted healthcare professionals prescribe XYOSTED. These were healthcare professionals they were not on our original call plan. We believe that our digital campaign is having a direct impact on driving patients to their doctors to ask for XYOSTED which is a key performance indicator for judging the success on the social media campaign. And while this campaign has continued to ramp-up, we want to make sure we stay in touch with the physicians who write XYOSTED. So we have a number of marketing initiatives planned, including a full slate of clinical congresses to attend. In fact, we just returned from the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America, where we hosted a session with key opinion leaders, who discussed physician and patient experiences using XYOSTED to treat testosterone deficiency. I personally heard from physicians that XYOSTED was having a meaningful and positive impact on their patients' lives and they were impressed how pain-free and easy it is to administer XYOSTED. This ongoing mini-activity and outreach underscores how important we believe it is to stay active in educating patients and healthcare professionals on the benefits of treating testosterone deficiency with XYOSTED. In summary, we remain very pleased with the progress made thus far and we are off to a great start. XYOSTED remains the fastest growing branded product in the testosterone replacement market. Please turn to Slide number 7. Shifting now to generic EpiPen, which remains the fastest-growing of our partnered products. Teva launched the adult version of generic EpiPen late last year and just this past August, launched the EpiPen Jr. When you look at the overall epinephrine and EpiPen market trends for the third quarter of this year, you can see a dramatic increase in prescriptions filled, and an increased market share for Teva's generic EpiPen. Almost 237,000 prescriptions were filled with Teva's generic EpiPen in the third quarter for a 27% share in the EpiPen market. The timing of the EpiPen Jr. launch in August was important, as a third quarter is back to school and allergy season, which happens to be the strongest quarter for the epinephrine market. With Teva now in full commercial launch mode, they have filled almost 400,000 prescriptions of two packs year-to-date with just under two-thirds of those prescriptions filled in the third quarter alone. We continue to track Teva's rapid progress towards our stated goal of a 30% share of the EpiPen market with the most recent monthly Symphony prescription data reporting them honing a 31% market share. Through the first nine months of this year, with the first six months being a limited commercial launch, combined product and royalty revenue from the sales of the generic EpiPen by Teva resulted in $23.4 million in revenue for us. We believe our partnership with Teva on the generic EpiPen continues to progress in a very positive direction. On Slide number 8, you can see that this has been another breakthrough quarter for Antares. And when you look at our revised revenue guidance of $115 million to $120 million for this year, we had a potential for almost 90% growth in our top line versus last year. We believe that Antares Pharma is one of the most compelling growth stories in our sector as a result of posting substantial increases in revenue, reductions in operating losses and the company's first quarterly income from operations and net income. Most importantly, we believe we have set a course for additional growth in future quarters. Now I'm going to turn the call over to Fred for the details on our outstanding third quarter. Fred?

Thanks, Bob. Please turn to Slide number 9. As Bob said, this was another tremendous quarter for Antares with significant sequential and year-over-year revenue growth in the company's first quarterly income from operations, as well as overall net income. The third quarter was an important quarter for the company with our employees focused on the commercial success of our proprietary product XYOSTED and OTREXUP, which on a combined basis grew 180% versus the third quarter of last year. In addition, our partnered products with Teva grew sequentially 38% during the third quarter compared to the second quarter of 2019, while our revenue from AMAG's Makena grew 27% during the same period. As many of you know, our partner AMAG recently appeared before an FDA advisory committee to discuss the findings from a post-approval confirmatory trial from Makena called the prolonged study, which failed to meet its co-primary endpoint. While the committee discussed multiple questions, on the key question, seven committee members voted to leave the product on the market under accelerated approval and require new confirmatory trial, and nine members voted to recommend that the FDA pursue withdrawal of approval for Makena. It's important to remember that the advisory committee's vote is not binding, but the FDA will consider it in making their decision. AMAG recently stated their belief in the safety and efficacy of Makena, and has indicated that they are committed to exploring options on how to gather additional data that will be most informative to physicians and the FDA, and at the same time work to ensure that eligible patients continue to have access to Makena. The timing and the outcome of the FDA's decision regarding the ongoing availability of Makena is uncertain. During the FDA's decision period, we will continue to supply Makena auto injector to AMAG for the distribution to physicians and patients. Let me start my financial overview by providing a detailed breakdown of our revenues and operating expenses for the third quarter of 2019. Total revenue was $34.3 million for the three months ended September 30, 2019, compared to $17.9 million in 2018, a 92% increase. The launch of XYOSTED continues to go as planned as revenue from the product grew 52% sequentially versus the second quarter while our second commercial product OTREXUP grew 8% in the third quarter over the third quarter of 2018. Total revenue from Teva's generic EpiPen was approximately $11.5 million representing over 33% of our total revenue. The combined revenue from XYOSTED and Epi, while still in their respective launches contributed $18.5 million or more than half of the total third quarter revenue. Product sales were $24.7 million for the third quarter compared to $11.6 million in the third quarter of 2018, a 113% increase. Importantly, product revenue as a percentage of total revenue continues to grow and accounted for 72% of total third quarter revenue. Sales of our proprietary commercial products XYOSTED and OTREXUP totaled $11.5 million for three months ended September 30, 2019, compared to $4.1 million in 2018. Partnered product sales totaled $13.2 million in the third quarter of 2019 as compared to $7.5 million in 2018. The increase in total product revenue was primarily driven by sales of Epi devices to Teva. Licensing and development revenue for the third quarter was $1.2 million as compared to $2.6 million the same period 2018, and was primarily driven from the Teva's teriparatide pen and Pfizer rescue pen development programs. Royalty revenue was $8.4 million for the third quarter compared to $3.7 million for the same period in 2018, a 126% increase. With the entire generic EpiPen franchise now available in pharmacies following the August launch of the generic version of the EpiPen Jr., royalty revenue grew sequentially from the second quarter by 51%. Operating expenses were $19.2 million for the third quarter of 2019, compared to $11.9 million in 2018. The increase in operating expenses in 2019 was primarily attributable to additional sales and marketing expenses associated with the launch of XYOSTED. For the first time in the Company's history, we generated quarterly operating income, which totaled $2 million, which compares favorably to the operating loss of $1.4 million for the same period in 2018. Net income was $1 million for the third quarter of 2019 compared to a net loss of $1.9 million in 2018. Net earnings per share was $0.01 for the third quarter as compared to a net loss per share of $0.01 for the quarter ended September 30, 2018. At the end of the third quarter, cash and cash equivalents were $41.9 million compared to $27.9 million at December 31, 2018, and increased $1.7 million from the $40.2 million reported at the end of the second quarter of 2019. During the third quarter, we generated $1.7 million in cash from operations as compared to a cash burn from operations of $80,000 to the same period in 2018. In October, we received the final payment of $2.5 million from Ferring in connection with the sale of the needle-free product line. We previously recorded a gain on the sale of the needle-free product line in the fourth quarter of 2018. The sale of this legacy product brought $15 million in cash over the past two years, which was used in growing our commercial business. That concludes my prepared remarks. I'll now turn the call back to Bob. Bob?

Thanks, Fred. Wrapping up on Slide 10. This is obviously an exciting time for Antares, and for our shareholders. We had an outstanding quarter. And we believe that our third quarter and year-to-date results continue to show the progress we've made in focusing our future growth on increasing the diverse mix of our total revenue. We are outperforming Street expectations and once again revised upward our 2019 revenue guidance to what could be a potential increase of almost 90% over 2018 full year revenue. And while we are laser-focused on driving commercial success, we also remain committed to advancing our internal pipeline and helping our partners complete development programs which we believe will translate into future product revenue for our Company over time. Operationally, we are investing in expanded office, laboratory, manufacturing warehouse base, in order to support our rapidly growing business and set the stage for long-term growth. To date 2019 has been a transformational year for Antares, and we are proud of the extraordinary efforts and results from our employees. We should provide an exciting future for our Company and shareholders. This concludes my prepared remarks for today. Operator, could you please open the lines for the question-and-answer session?

Yes. Thank you. [Operator Instructions] Your first question will come from Elliot Wilbur with Raymond James.

Thanks. Good morning and congratulations to the team for crossing both the profitability and operating cash flow thresholds. In terms of reaching positive territory, I know that's something you guys have been striving toward for a long time. So good job. Specifically, a couple of questions for yourself Bob around XYOSTED, not surprisingly. I guess just there kind of upfront as the fixation on sort of the weekly Rx trends probably is only going to increase going forward and Symphony in IQVIA seem to show a similar trend in pattern, but one of them services is quite a bit higher than the other. Just wondering if you could maybe provide a little bit of color, commentary, and sort of how you guys look at those metrics internally, specifically thinking about points of distribution or sales channels that you know, the product is moving through that just aren't simply captured by either of those services? And whether or not the difference between those two based on at least what you see may just be sampling area or one picks up perhaps part of the channel that the other doesn't? But just anything you could shed light on, with respect to sort of how to more accurately gauge kind of the weekly numbers would be helpful?

Yes. Thanks. Thanks for all your comments earlier – too early. As far as the Symphony and IQVIA weekly numbers, we really use those for a trending. What's important to us is what gets shipped out of our distributor to our distribution partners such as ABC, Cardinal, McKesson and so forth. And, so what we're seeing are positive trends, like I mentioned in my prepared remarks, our shipments are exceeding both of those services as far as weakly numbers. And I think it's a combination of we do sell direct to some large practices. We also obviously have some business that goes through the DoD, the Department of Defense, as well as the Medicare and Medicaid business, which typically doesn't get picked up well by prescription trends. And I think also, it's still in the early part of a launch and in both IQVIA and Symphony tend to take a bit more time to get the trends right as the doctor base continues to change and on smaller products vis-a-vis the launch here, I think they have a little bit harder time tracking down exactly where all the scripts are coming from. All that being said, we use them for trending. The trends are very positive, both from a prescription standpoint as well as shipments. And then it will be a good day for us when everyone stops looking at weekly numbers, because quite honestly, they're not very accurate. But again they are trending in the right direction. And I think you can see that based on where our revenue is for the quarter for XYOSTED is far exceeding Street expectations because the trends are better than what the script data is showing.

Okay. I just wanted to ask a ○follow-up question regarding the current call pattern, detailing and source of prescriptions for XYOSTED, it looks like about 50% of Rx is coming from endocrinologists and urologists, I guess, what we would expect with kind of a specialty product like this. I assume though that you're fairly active in terms of detail in a lot of the high prescribing GPs. And I'm just wondering, would it be reasonable to assume that eventually this product kind of moves to more of a sort of a class pattern where you've got 60% to 70% of prescriptions coming from GPs and only 30% to 40% from the specialist? Or is it more likely that we're kind of continue to see relatively high proportion from those two specialties? Just trying to figure out basically if those are leading indicators for what we may see eventually in GPs? Or if this is just going to be a product where we see a higher concentration of Rx as among the specialists?

Yes. So from our call plan standpoint, we call on the high prescribing testosterone writers, whether they're endocrinologists, urologists or primary care docs, we call them all the top docile [ph] 7s through 10s essentially. I think what we're seeing is the adoption early on is, from the key opinion leaders. The urologists who really are the leaders in this area, they tend to write first. They're very comfortable with the product and moving forward with it. Also, I think what surprising is, we are seeing a lot of endocrinologists writing, which is a disproportionate share relative to the class. And I think that's really a function of, and again, it's my opinion, it’s a function of that, the levels that we achieved in the clinical studies are translating into the field is from what we're hearing from physicians. And I think they like – the endocrinologists really like that steady-state. And so do urologists, but I think endocrinologists focus heavily on hitting certain levels and targets. So we're seeing a really strong uptake more so than any other product in this space from endocrinologists. And I – that could continue. I think going forward, we'll see the mix start to follow the marketplace. The big primary care writers will start to follow the key opinion leaders is what they're writing. And I think overall, we'll see the trend becoming more traditional with the general practitioners being a large piece of the writing. And again, we don't call on a lot of those general practitioners because they're in the lower deciles, but they will eventually right potentially based on what they're seeing in the marketplace and so forth. So early on, it's a little bit different than the classic product in the testosterone space, but I think it will eventually gravitate toward being a heavier primary care, general practitioner, sexual medicine type doctor writing. But again, that remains to be seen.

Fair. Last question. With respect to the pipeline, I think there is some belief out there that there is quite a bit of value accruing the pipeline that you're not being credited for and a lot of it is probably based on the fact that name rank and serial number, a lot of the programs aren't really known. So as we think about 2020, any chance that we're going to get detail in terms of specific molecules with respect to either 1701, the urology product, or the Pfizer – undisclosed Pfizer product rescue agent? And then a quick sub part to that question. Is that program partnered with the Meridian platform? There was some disclosure in some recent filings that Mylan is negotiating to acquire that business. And just wanted to get some clarity on whether that asset is tied to another area within Pfizer or if in fact it is tied to the Meridian platform? Thanks, Bob.

Yes. So I agree with everything you said that our pipeline is undervalued and I think a lot of it has to do with the fact that we don't disclose both proprietary and our partnered products. And it depends on the partnership. Obviously, with Teva, we have Forteo product under an annual review which is a substantial product. We're waiting for the FDA approval along with Teva. Teva drives that process. They drive, they hold the file. And so we're hoping that, that gets approved soon and we can launch a very big important product in the osteoporosis space. As far as the Pfizer program that will – from what we understand and from everything we're hearing from Pfizer, that is not part of the Meridian transaction or the Upjohn transaction. It is a product that is within Pfizer's branded division, and that is going to stay there. There is no indication whatsoever that that's going with the merger or a spin out. And so, as far as when we may see or when that may get disclosed again, it's really a function of Pfizer's timing and desire to disclose that product into the marketplace. It could become apparent when they start doing some work – as far as accelerated work with the FDA and so forth. But until then, Pfizer is a very large organization and may probably are in the middle of doing a 100 programs, so whether or not, it is, they determine to disclose that one is really up to them. And in our own internal program, our rescue pen in the neurology space, I fully expect that will become very apparent in 2020, as we move that product into clinical trials. We're doing a lot of really good work right now on the device as well as formulation, and we expect to move that into an IND typesetting in 2020. So that will become apparent. And again, on the other pipeline products that we're working on. As we progress toward an IND is really when we'll disclose what those products are. So we do have a great pipeline. We also have another product with Teva, exenatide, not a huge product, but still a meaningful one for people with diabetes and important one that we're hoping to have approved soon with the FDA, again as an ANDA. So that's our current pipeline, as well as we look to continue to bring in other lines – deals in the near term to continue to bolster that pipeline. So, hopefully, there'll be some additional news in that area in the future, and we'll be able to get the pipeline further bolstered.

And your next question will come from Anthony Petrone with Jefferies.

Anthony, you're probably on mute.

Hello?

Yes.

I apologize. I was on mute. Congratulations on the strong quarter. Maybe just two for me and I can hop back in queue. One on XYOSTED, just trying to get a sense of sort of penetration within physician accounts that are prescribing, how many patients are these physicians prescribing XYOSTED in lieu a topical or an intramuscular injections? So that will be the first question. And then anything you can provide just in terms of the AMAG, FDA panel that you mentioned in your prepared remarks. Just sort of how we should be thinking about that as it relates to auto injector purchases going forward? Thanks.

Sure. So thanks, Anthony. As far as your first question prescribing habits of our writers, obviously it's mixed. We have some big writers that have adopted XYOSTED and it's probably their first-line therapy for most patients. What we see is that, obviously, they're offering it to new patients, and we're seeing a really nice number of patients that are new to therapy. About 50% of our scripts are patients who've never been on another testosterone therapy. So that shows that the doctors viewed as a strong first-line therapy, as well as when the patients given the option between gels, IM injections, or XYOSTED, they are picking XYOSTED. So we're seeing a good mix of patients. And then other doctors are switching their IM patients. Again what we found is that most doctors will say, hey, if the patient doesn't complain, we're not going to offer it. But if they're complaining, they offer XYOSTED, and if they switch, they tend to be happy. But a lot of it has also do with coverage. We're really now at a nice percentage of lives covered for XYOSTED, but it took through October to get there. And with any product launch, it takes anywhere from six months to a year to get relatively good coverage, if you get it at all. And we got 70% of all lives covered. So I think we'll start to see the patient demographics really changing based on their coverage. If they weren't covered, it was an expensive proposition to change from a generic IM or generic gel to XYOSTED. So we're seeing all kinds of doctors, we call them internally like dabblers, adopters and something else, I can't recall exactly what it is, but it's – I think it's normal. In that, you have doctors who are aggressive in looking at new therapies and adopt them and it becomes a big part of their practice, and then others who take time, and they want to hear from other doctors, they want to hear from patients and so forth. So I can't say that we have one particular doctor – type of doctor that writes heavily and ones that don't. I think we're seeing a really nice mix of doctors like I said in my prepared script, 3,500 physicians have written XYOSTED, we call on about 12,000, and probably 10,000 on a regular basis. And so that's a pretty good mix in a very early – in a very short period of time to get that number of doctors writing, and then also the number of patients that are using XYOSTED. I think what's important is, as we continue to get new patients, the persistence has been really strong and so the refills become more and more important. And we're – and again, I think we're seeing better persistence than what you typically see in testosterone products. And if that trend continues, we think we'll continue to see a really nice growth with the product. Your second question...

Great.

Yes. Thanks. Your second question on AMAG. So I'm not really going to comment on AMAG's regulatory plan or process. What I can tell you is that it's November, so clearly in 2019, I don't think there'll be any impact whatsoever of the AdCom votes in talking to Bill Hayden. The doctors are still writing Makena, auto injector, our shipments are still strong. And so for 2019, I really don't see any impact. Beyond 2019, what we said in the prepared script, it's really – it's likely going to being extracted or an extended period of time at the FDA gathers all their information that they need. AMAG is working with them as they disclosed in their earnings, just last week, they are working with the FDA to try to come up with another study to conduct while the product stays in the market. But at the time that it takes and the outcome is really something I can't predict at this point. And we're going to continue to supply the Makena auto injector product to AMAG. And like I said, it will – on a go-forward basis, we’ll just keep doing what we've been doing in the past which is supplying them, and – I mean, very nice product that they've been distributing to their physicians and patients.

Thanks. I'll hop back in the queue.

Thanks, Anthony.

Next we will hear from Stacy Ku with Cowen and Company.

Hi, all. Congratulations on another great quarter and thank you for taking my questions. First, on XYOSTED, can you remind us of plans for co-pay support for XYOSTED going into the next year? Maybe help us understand what might be the pushes and pulls we could expect for volume dynamics and gross to nets in 2020? And I have two follow-up.

So, I'll let Fred answer the gross – I mean, gross to net. But on the co-pay support, right now our program is co-pay support of up to $125, I think for patients who have commercial insurance. And we get really good utilization with the co-pay support. About 65% of our patients utilize a co-pay support. And as our coverage continues to grow, our co-pay will sort of likely continue to grow. Looking into 2020, we're looking at various changes that could be made. Likely to support – it will stay the same, but we're looking at if there is anything we can do in Q1 where that the – with high deductible plans taking hold in Q1 for all products, is there a way that we can minimize the effect of those high deductible plans on the prescriptions in Q1. We haven't come to the conclusion on that, but clearly co-pay assistance is one of those areas that you can help a patient as they're going through that transition to cover their medications in that first couple of months where it's a lot of out-of-pocket cost for them as an individual. As far as the gross to net, I'll turn it over to Fred.

Sure. Thanks, Bob. Good morning, Stacy. Regarding the gross to net, that percentage has been improving during the year. At the beginning of the year, we have discussed our first-fill free program prior to us gaining the significant coverage that we have in the market now. And that actually brought down our gross-to-net percentage low where it is right now. When we take a look at the third quarter, we're in the mid-to-upper 50%. That remains in net, so therefore about little over between 40% and 45% the deductions that we have. And the biggest ones being the co-pay as well as the typical four distributors as well as we have kept the first-fill free program in place and then the rebates. We expect that percentage to stay steady, as well as a slightly increase as we go into the end of the year. And then, as Bob said, we're currently looking at the programs for the first quarter of next year, as well as all of next year as to the co-pay assistance programs. But as of now, we are looking in the mid-to-upper 50% that remains in net in the gross to net calculation.

That's really helpful. And also, so how should we think about the cadence of EpiPen related revenue, particularly how it might relate to tell us market share goals and potential inventory building? And then how has your recent quarterly performance changed, how you're looking at the end of 2019 and 2020 in terms of potential earnings guidance and potential continue to profitability?

Well, – I mean clearly, our increase in guidance, a big piece of that is around the EpiPen. I mean, we had an outstanding quarter in Q3, which is historically the best quarter in the epinephrine market because back-to-school analogies and so forth. So we see Teva's market share being in anywhere from 31% to 34% or higher depending on the week. We expect to see that trend continue to improve as they try to reach their stated goal of 50% market share of the overall EpiPen market. So I think going forward, we're being conservative in Q4, and because the Q3 is the strongest quarter for EpiPen, we don't know what's going to happen in Q4. It's unpredictable for us. We know our shipments are strong to Teva, but what's going out to the trade is really – we don't know until the end of the quarter. So we expect EpiPen to continue to grow. We expect it to be a meaningful part of our business going forward. And we've been very happy with how Teva has been producing or performing to have over I think I said 400,000 prescriptions filled since launch. Putting in perspective, remember, we sell – we make or in a package three autoinjectors, it's two with drug and one with one trainer. And so it's millions of pens that we produced and we're really proud of that, we continue to ship Teva. And we know that they're not building inventory and we know that they are supplying the market and that they are aggressively gaining market share and continue to sell almost everything that we ship. So we're really happy with that – where that program is going. In 2020, I really can't predict at this point. It's too early to determine how quickly or if they hit their 50% market share goal. It's a goal. And right now, the trends are strong and we're really happy with where Epi is going, and we see that's being a long-term meaningful product for both organizations.

Okay. Congratulations again.

Thanks.

Your next question will come from David Amsellem with Piper Jaffray.

Thanks. So I had a few first on XYOSTED, and I apologize if I missed this, but I wanted to get a sense of the patient mix between those who have been on topicals versus those who have been on intramuscular injections versus those who are testosterone naive, and how you're seeing that evolving? That's number one. Number two is, I know you've commented on the gross-to-net. But I wanted to get a sense from you as to where you think that's going to head in 2020 or even longer-term. And then lastly, I had a question on capital deployment. I mean you are profitable and you're building your cash position. So I wanted to get a sense from you as to how you're thinking about the addition of assets where you can leverage your commercial infrastructure? Thanks.

Sure. So David, on your first question about the mix of XYOSTED patients, about 50% or more of our patients are new to therapy, which I think again is an impressive percentage of our patients being naive to testosterone replacement therapy. It shows that the doctors are comfortable with XYOSTED being a first-line therapy. So 50% are new. On the other side of it, I would say the vast majority the balance is from IM injections. It's hard for me to determine whether, how much it was gel versus IM, but clearly I think the vast majority of our IM injection in patients who want a better injection, want to get rid of those – potentially get rid of those peaks and valleys that they see with IM injections. And so that's the second biggest component of our patient base and then some on gels. I think longer-term we'll see more growth in the IM side of the business, because I think as doctors move away from that – well, if the patient is not complaining, I'm not going to offer anything to. If they see that XYOSTED is really working well for the other patients that may – potentially they'll start to offer it to their patients that are on IM and start to get them more switches – get more switches going. But again, our focus really is just giving – having XYOSTED as a choice for patients. And so far it's been a pretty good mix of patients choosing to go with XYOSTED versus the generics options that are out there. So overall, we're happy with the patient reaction to XYOSTED. As far as the gross-to-net, I'll turn that over to Fred, again.

Sure. Thanks, Bob. Yes. With the gross-to-net as I was just mentioning, we were looking at the improvement of the percentage during the year third quarter and we believe the fourth quarter, we should be in the mid-to-upper 50% remaining on the net, so looking at a gross to net discount in the 40% to 45%. We see that fairly stable in the third and fourth quarter. Going forward, we would like to boost that number up as we get into 2020 and beyond. But it's yet to be determined what programs we're going to be putting in place for the co-pay assistance, as well as the impact of total rebates for all of 2020. But I'd say right now, we're comfortable in the mid 50% to – 55% to 60% remaining on the net line or 40% to 45% deduction.

As far as the deployment of capital, I mean, it's a bit early to be discussing capital deployment, while it’s our first quarter of generating cash. But I would say that generally because we have a very productive sales team of approximately 100 people overall when you look at 80 some reps plus 10 district managers and so forth. We are looking at other products to potentially acquire. But there is – there are not many out there, but we are looking at assets because that's one area where we would definitely deploy our capital to bolster our revenue with what we think is a very effective resource with our sales force. They've done a really great job of XYOSTED and OTREXUP, and we want to potentially give them another product. And so that's where – that's the area that we're really looking at from our capital standpoint. Everything else is really being funded by operations. Our internal R&D is being funded by operations, our external R&D with our partners is being funded by them, which brings in additional revenue and profit for us. And so our cash growth hopefully going forward will be used to bring in other assets.

Okay. That's helpful. Thanks.

Thanks, David.

[Operator Instructions] Next we will go to Matt Kaplan with Ladenburg Thalmann.

Hi. Good morning, guys.

Hey, Matt.

Congrats on the quarter as well. Just wanted to dig in a little bit more into the XYOSTED, a couple of things. It seems to me your persistence rate should be pretty high given the level of NRx and refills comparatively. Can you talk a little bit about what you're persistence rate is? I guess historically – given historically persistence on TRT therapies has been pretty low past six months. And what's your – or 12 months, especially, what's your, sense now given I guess although it's early in the launch?

Yes. I mean I think that's – it's clearly still early. The vast majority of our patients really start – didn't start coming on to therapy until like March-April, when we started to see the trends moving up. But I will say that persistence looks pretty darn good at this point. We're seeing persistence, six, seven months of the patients who started. The only ones that may not – some of the patients that we're not seeing persistence is they do first-fill free, and they don't have insurance coverage, and some of them don't obviously pay for it out of pocket and so that's the one area where we see less persistence because of financial decision not because the drug decision for the most part. So overall, I think we're ahead of where we thought we will be from a persistent standpoint. Clearly, like you mentioned earlier, this therapy is one generally that's right with the low persistence, but we seem to be bucking that trend early on, but again, it's very early. But right now, things are looking pretty strong in that area.

Good. And in terms of your current peer coverage, you said you're 70% ahead of schedule with respect to coverage. Where do you think you could drive that? Is that where you kind of plateau now, or do you see that continuing to grow going forward?

Yes. I think that we're at a very nice level. I think the 70% for any branded product is a pretty strong coverage percentage. So we're going to have the ins and outs. And then we're going to have some plans that decide not to cover. Others that will add on, based on what their customers are saying. And so, I would say that I don't see a significant increase from this point on. But we'll see ins and outs. And hopefully, we'll get a little bit more regional coverage. A lot of the PBMs were on their national formulary. But when you peel that onion back, there is some plans that are in there they don't cover that we may win over time that will increase that number. And again, there'll be plans, let's say, hey, I'm just not covering any testosterone products and they drop out of the universe. But overall, I think that it's a pretty successful high number as far as coverage is concerned. And we'll continue to work on improving that. But I wouldn't expect a large increase of coverage from this point on.

Okay, that's helpful. And then in terms of EpiPen, you talked a little bit about the seasonality, which is obviously expected kind of back-to-school in the third quarter. Can you give us a little bit more detail in terms of the level of that seasonality versus second quarter and first quarter?

Yes. I don't have those numbers in front of me. And again with it's really been a launch year for us and Teva, and more so for Teva. I can't predict what Q4 will be relative to their market penetration at this point. We know that the weekly trends have been good. But if you look at the overall market in Q4, it's been down relative to Q3, and not dramatically, but it's been down. And Teva could bluff that trend a little bit by just getting more market share. But I think overall, the market is going to be a Q4 market which is historically lower than Q3. I don't know the exact numbers, off the top of my head as far as what percentage of how many scripts are written in Q1 through Q4 overall. But clearly, we do look at Q3, and it is the strongest quarter for the epinephrine market. And hopefully, Teva will continue to grow their market share and we'll see continued growth with the EpiPen product.

Okay, good. And then last question kind of a little bit of a follow-up to Elliot's in terms of your pipeline. You don't disclose what the products are, but maybe one thing that could be helpful for us is if you could help us understand the different products in the current market sizes that you're going after, and I guess specifically, for your internal product for Pfizer? And then more specifically, we know about teriparatide, but help us understand what the teriparatide opportunities for Antares, specifically?

Well, so it's a really tough question to answer, so a lot of different products, and so we're not prepared at this point to give you a market estimation on the overall – all the other products, especially Pfizer when it's an undisclosed product. I think you'd narrowed down pretty quickly as to what the product is, and that would be kind of the purpose of what Pfizer is trying to do, same thing with our other internal program. Again I said earlier, that will be probably disclosed in that product in 2020 as we move into an IND in the clinical trials. So it's not like we're asking – we're – it's not going to be that much longer before it's disclosed on a couple of the programs. On the one that is disclosed Forteo – I mean Forteo, I think last year, Lilly's product did about $750 million in the U.S., about the equivalent amount globally. So for Teva, it's a large market opportunity. It's obviously bigger than epinephrine. And hopefully when they get the approval, the product substitutable, and if it's substitutable, I think we could see potentially same substitution rate that we're seeing with EpiPen. So it's a meaningful product because we get – we sell in devices. It's clearly not the volume of devices like epinephrine to much lower volume product, but a much higher dollar value. I think – don't quote me on this, but I think the Forteo pens about $3,500 of pen. And so the dollar value is very high and we get a royalty on that dollar value. We get a high royalty relative to Epi, because of that kind of change or mix – the change in dynamics between price and volume. So we get a – we start out at a high single-digit royalty to a mid-teen royalty on Forteo, which obviously could be very meaningful for us as an organization, depending on the penetration that Teva gets. And so again I think and globally, the rest of the market, we get the same economics for Teva with Forteo on the rest of the world. But the rest of world pricing is much lower than in the U.S., but overall, it's still a meaningful amount of potential opportunity for Teva and for us. So I would say, that's the only other one I could characterize exenatide, which is also disclosed at the smaller products. I think overall the brand is doing around $100 million. It's not a big opportunity. But for us and Teva, it's important because it will be one of the first generic products available for people with diabetes. And so, it's still a viable and important product for both of us. So hopefully that will get approved. And that's exact same economics from our standpoint as Forteo, high-single-digit royalties to mid-teens, and we sell the devices again and not a ton of devices being sold in that market, so it's more on the dollar value.

Thanks, Bob for that detail.

Thanks, Matt.

And ladies and gentlemen, that does conclude the question-and-answer session for today. I would now like to turn the call back over to Jack Howarth for any additional or closing remarks.

Thanks, Matt, 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 concludes today's call.

Once again, that does conclude the call for today. Thank you for your participation. You may now disconnect.