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Edited Transcript of ATRS earnings conference call or presentation 3-Mar-20 1:30pm GMT

Q4 2019 Antares Pharma Inc Earnings Call

EWING Mar 22, 2020 (Thomson StreetEvents) -- Edited Transcript of Antares Pharma Inc earnings conference call or presentation Tuesday, March 3, 2020 at 1:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Fred M. Powell

Antares Pharma, Inc. - Executive VP & CFO

* John J. Howarth

Antares Pharma, Inc. - VP of Corporate Affairs

* Robert F. Apple

Antares Pharma, Inc. - CEO, President & Director

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Conference Call Participants

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* Anthony Charles Petrone

Jefferies LLC, Research Division - Healthcare Analyst

* David A. Amsellem

Piper Sandler & Co., Research Division - MD & Senior Research Analyst

* Elliot Henry Wilbur

Raymond James & Associates, Inc., Research Division - Senior Research Analyst

* Matthew Lee Kaplan

Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research

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Presentation

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Operator [1]

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Ladies and gentlemen, welcome to the Antares Pharma Fourth Quarter and Full Year 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.

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John J. Howarth, Antares Pharma, Inc. - VP of Corporate Affairs [2]

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Thank you, Shelby, and good morning, everyone. Earlier today, we announced our fourth quarter and full year 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 our expectations regarding our 2020 financial guidance and catalysts, future revenue growth, prescription volumes and market share for our products, new product approvals and launches, FDA actions and other regulatory activities, results of ongoing and future clinical trials and other product development activities and business 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, in the 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 fourth quarter and full year financial results and review our 2019 highlights. Fred will go through the detailed financials, and then Bob will conclude with some closing comments before opening up the lines for questions.

I'll now turn the call over to our CEO, Bob Apple. Bob?

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Robert F. Apple, Antares Pharma, Inc. - CEO, President & Director [3]

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Thanks, Jack, and good morning, everyone. 2019 was an exceptional year for the company, highlighted by the successful commercial launches of 2 products and the addition of a new chemical entity to our development pipeline. Our evolution as a pharmaceutical technology company continued as we delivered record revenue and the company's first full year of operating income. Our primary focus in 2019 was to accelerate and expand our commercial footprint in both our proprietary and partnered products. I'm proud to say that our team has delivered on that goal. This morning, we reported another record quarter and full year of financial progress driven in large part by sales of our flagship product, XYOSTED, as well as continued strong demand and growth for Teva's generic EpiPen.

On Slide #4, you will see that throughout 2019, we made steady financial and commercial progress, posting 4 consecutive quarters of total revenue growth, and we ended the back half of the year with 2 consecutive quarters of profitability for the first time in the company's history. I'd like to briefly touch on a few high-level financial highlights before Fred presents a more detailed review later on the call. Today, we reported fourth quarter revenue of $37.8 million, a 101% increase versus the $18.8 million we reported in the fourth quarter of last year, truly an exceptional quarter by any measure. This very impressive growth was driven by our key proprietary product, XYOSTED, and Teva's generic EpiPen. The continued commercial success we achieved throughout 2019 allowed us to raise our original full year guidance twice during the year. And as you saw this morning, we ultimately exceeded the upper end of the $120 million guidance range as we reported full year total revenue of $124 million. Let's take a closer look at what drove the dramatic increase in revenue for 2019.

Please turn to Slide #5. XYOSTED has been on the market for a little over 1 year now and last year generated approximately $21 million in revenue, exceeding street expectations of $17 million. We believe that is a significant achievement for a new product in a mature market such as testosterone, with payer dynamics creating significant roadblocks on product uptake. Further highlighting the success of the XYOSTED launch is that the same sales team was also growing OTREXUP, our legacy RA product.

XYOSTED fourth quarter total prescriptions continued its steep upward slope, according to data from Symphony Health Solutions. As important, new patient starts are increasing and refills continue to grow, a great sign of patient persistence. Since launch, XYOSTED has recorded quarterly double-digit prescription growth with fourth quarter prescriptions increasing 42% versus the third quarter. In the fourth quarter alone, Symphony reported that approximately 28,000 XYOSTED prescriptions were filled.

Through December of 2019, approximately 62,000 XYOSTED prescriptions have been filled since the beginning of the year. We believe much of this growth is due to innovative product attributes, solid messaging, strong rep performance, and the work we have done to obtain excellent coverage for potential XYOSTED patients. From an insurance coverage standpoint, it bears repeating that a significant milestone was reached in the fourth quarter of 2019 when we contracted with another large pharmacy benefits manager, increasing our managed care coverage to approximately 72% of all commercial lives.

Our goal for last year was to achieve 2/3 of all commercial lives covered in the first full year of launch, and we exceeded that goal. Our sales reps are continuing to focus on large prescribers of testosterone products. We have grown our prescriber base to approximately 4,700 unique prescribers of XYOSTED, an increase of over 1,300 physicians versus the third quarter metrics. These prescribers have written prescriptions for more than 15,000 patients since launch. In summary, we believe we made great progress in our first year on the market. And the early trends in 2020 are very positive with strong shipments in the first 2 months of this year. According to Symphony prescription data, XYOSTED is the fastest-growing branded testosterone on the market.

Turning now to Teva's generic EpiPen on Slide 6. Teva's fully launched the audit -- the adult version of generic EpiPen in July of '19, and then launched the EpiPen Jr. in August. When you look at the EpiPen prescription trends for the third and fourth quarters of this year, you can see an increase in market share for Teva's generic EpiPen in both quarters. According to Symphony prescription data, almost 237,000 prescriptions were filled with Teva's generic EpiPen in the third quarter, representing a 27% share in the EpiPen market. And 183,000 prescriptions were filled in the fourth quarter for a 36% market share. While the overall EpiPen market declined in the fourth quarter due to seasonality, Teva's market share increased 9%.

According to the January prescription data, Teva's generic EpiPen market share was 42%. Teva's best weekly market share since launch was 45%, very close to our stated goal of 50% share in 2020. In 2019, even with the first 6 months of the year held back by limited commercial launch, combined product and royalty revenue for the year from sales of the generic EpiPen by Teva resulted in more than $34 million in revenue for us. We are very pleased with the progress Teva's made in 2019. I would now like to talk about one of our most exciting and perhaps underappreciated achievement of 2019.

Please turn to Slide #7. Last November, we entered into a significant new development agreement with Idorsia Pharmaceuticals to develop a drug device rescue pen combining selatogrel, a new chemical entity with our QuickShot auto injector. Selatogrel is a fast acting and highly selective P2Y12 receptor antagonist for the treatment of suspected acute myocardial infarction, commonly referred to as a heart attack or MI, for adult patients who have a history of heart attacks. This is a very exciting and potentially large opportunity for both companies, given the size of the patient population.

To put things in perspective, approximately 7.6 million Americans have survived the heart attack and are potentially at risk for another MI. Every year, around 550,000 patients have their first heart attack and another 200,000 have a recurrent MI. The product concept is very simple. Patients who have had a previous MI would carry the selatogrel rescue pen with them just like an EpiPen. If they experience the symptoms of a heart attack, they would self-inject selatogrel and then seek immediate medical attention. Unlike a patient taking an oral medication, selatogrel injection is intended to work quickly to stop platelets from aggregating or sticking together and may prevent a platelet plug from blocking circulation through the coronary artery. Thus, potentially preventing or minimizing the extent of a recurrent heart attack.

Selatogrel was tested in 2 Phase II studies, which, according to Idorsia, demonstrated a rapid platelet inhibition effect in patients experience an acute MI as well as patients with stable coronary artery disease. According to the authors of the study, the product was also well tolerated. This is potentially a breakthrough rescue drug to treat acute MI and would be used in addition to current chronic oral P2Y12 therapies such as Plavix or Brilinta. Idorsia is currently preparing for a clinical bridging study of a formulation followed by a global Phase III study for the prehospital treatment of a suspected recurrent heart attack.

On the terms of our license agreement, Idorsia will pay for the development of the combination product and take responsibility for obtaining global regulatory approvals. Antares and Idorsia intend to enter into a separate license and commercial supply agreement, under which Antares will supply fully assembled and labelled product to Idorsia at a cost plus margin. And Idorsia will be responsible for global commercialization of the product, pending FDA or foreign approval. Antares will receive an already negotiated royalty on net sales of the commercialized product in all territories.

It is important to note that Idorsia has obtained global patent protection for selatogrel with the U.S. patent expiring in 2034. We're extremely pleased and excited to be working with Idorsia on this potentially life-saving new chemical entity. Assuming a positive outcome from their clinical bridging study, we would anticipate beginning to supply devices later this year for their Phase III trial as Idorsia has guided to a potential 2021 initiation of the study.

Continuing on to our pipeline accelerating in some near-term catalysts. Teva's generic Forteo ANDA filing could be approved in late 2020. As a reminder, Teva believes the generic Forteo pen will be fully substitutable and still maintains first-to-file status. According to Lilly's 2019 10-K, Forteo achieved $1.4 billion in global sales, with the U.S. making up $646 million of the total. Our agreement with Teva provides for us to sell the devices at cost plus margin and then receive escalating royalties from high single-digit to mid-teen percentages. If approved, we believe the product represents a significant opportunity for both Teva and us.

And finally, our development of a nondisclosed rescue pen with Pfizer continues to progress well as evidenced by the development revenue earned in 2019. As a reminder, subject to FDA approval, we will supply Pfizer with fully packaged commercial-ready product at cost plus margin and then receive escalating royalties from mid-single-digit to double-digit percentages on end sales of the product. We will provide estimates on the development time line once we receive more clarity from Pfizer.

I'm now going to turn the call over to Fred for details on our outstanding fourth quarter. Fred?

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Fred M. Powell, Antares Pharma, Inc. - Executive VP & CFO [4]

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Thanks, Bob. Please turn to Slide #8. As Bob mentioned earlier on today's call, 2019 was a tremendous year for Antares and our 2019 revenues reflect this success. Full year revenue was approximately $124 million, which exceeded the upper end of our guidance range of $115 million to $120 million, and it represented a 95% increase over 2018 full year revenue. In addition, we recorded our first quarterly income from ongoing operations as well as overall net income.

So let me start my financial overview by providing a detailed breakdown of our revenues and operating expenses for the fourth quarter and full year of 2019. Total revenue was $37.8 million for the 3 months ended December 31, 2019, compared to $18.8 million at 2018, a 101% increase. For the year ended December 31, 2019, total revenue was $123.9 million, a 95% increase over the $63.6 million reported in 2018.

Total product sales were $28.5 million for the fourth quarter compared to $14.2 million in the fourth quarter of 2018, a 100% increase. Importantly, product revenue as a percentage of total revenue continues to grow and accounted for 75% of total fourth quarter revenue. For the 12 months ended December 31, 2019, product sales were $92.1 million as compared to $47.9 million in 2018, a 92% increase.

Sales of our proprietary commercial products, XYOSTED and OTREXUP, totaled $14 million for the 3 months ended December 31, 2019, compared to $5.7 million in the same period 2018. The launch of XYOSTED continued to go as planned, as fourth quarter revenue totaled $8.4 million, which reflected a 20% sequential growth versus the third quarter. Our other proprietary commercial product, OTREXUP, grew 10% in the fourth quarter of 2019 versus the fourth quarter of 2018. For the full year of 2019, XYOSTED and OTREXUP revenue totaled $39.2 million versus $17.5 million in 2018, a 124% increase.

Licensing and development revenue for the fourth quarter was $3.2 million as compared to $1.1 million for the same period in 2018. And for the full year 2019, it was $7.5 million versus $6.8 million for 2018. The increases for the 3- and 12-month periods were primarily from the Pfizer rescue pen and Teva pen development programs.

Looking ahead to 2020. We believe we will continue to see growth in development revenue with the Pfizer rescue pen entering the next phase of development as well as an increase in activities around the Idorsia rescue pen. Royalty revenue was $6.2 million for the fourth quarter compared to $3.5 million for the same period 2018, a 78% increase. For the full year 2019, royalty revenue was $24.2 million compared to $8.9 million for 2018, a 171% increase. The significant increases in royalty revenue for the 3- and 12-month periods were primarily attributable to royalties recognized from Teva on their net sales of their generic EpiPen and from AMAG on their net sales of the Makena subcutaneous auto injector.

Gross profit was $73.4 million for the year ended December 31, 2019, as compared to $32.5 million for 2018. Gross profit, as a percentage of total revenue, increased to 59% at December 31, 2019, up from 51% reported in 2018.

Operating expenses were $18.2 million for the fourth quarter of 2019 compared to $14.9 million in 2018. For the year ended December 31, 2019, operating expenses were $72.4 million as compared to $49.1 million for 2018. The increase in operating expenses for the 3- and 12-month period of 2019 was primarily attributable to additional sales and marketing expenses associated with the launch of XYOSTED.

For the second consecutive quarter, we generated quarterly operating income. For the quarter ended December 31, 2019, our operating income was $5.6 million, which compares very favorably to the operating loss of $5.7 million for the same period of 2018, excluding the $12.5 million gain from the sale of the needle free business. Total operating profit for the 12 months ended December 31, 2019, was $1 million as compared to total operating loss of $16.6 million for 2018, excluding the $12.5 million gain from the sale of the needle free business.

Net income was $4.7 million for the fourth quarter of 2019 compared to a net income of $6.1 million in 2018. For the full year of 2019, we recorded a net loss of $2 million as compared to $6.5 million loss recorded in 2018. Net earnings per share was $0.03 for the fourth quarter as compared to net income per share of $0.04 for the quarter ended December 31, 2018. For the 12-month period ended December 31, 2019, we reported a net loss per share of $0.01 versus a net loss per share of $0.04 for 2018. Important to note that the results of the 3- and 12-month periods of 2018 reflected the $12.5 million gain from the sale of our needle free product line to Ferring Pharmaceuticals.

At the end of the fourth quarter, cash and short-term investments were $45.7 million compared to $27.9 million at December 31, 2018. During the fourth quarter of 2019, we generated $3.8 million of cash. In 2019, we restructured our term loan with Hercules Capital, adding an additional $15 million in debt to our balance sheet, bringing the total outstanding debt to $40 million. This nondilutive financing gave us the means necessary to appropriately invest from the launch of XYOSTED.

Finally, earlier this year, we issued 2020 full year net revenue guidance, providing a range of $135 million to $155 million, which includes a range potential revenue scenarios for AMAG's Makena. We believe the lower end of the guidance range can be achieved without any 2020 revenue from AMAG's Makena. Of course, we will continue to supply the Makena auto injector at AMAG for their distribution to physicians and patients while they work on the resolution, if any, with the FDA and continuing to provide access to the product.

From a quarterly perspective, similar to 2019 and the pharmaceutical industry in general, we expect first quarter XYOSTED revenue will be the lowest for the year as high deductible plans always reset in the beginning of every year. But we also believe XYOSTED revenue will increase in each successive quarter of 2020. The midpoint of the guidance range for 2020 represents a 17% growth over 2019 revenue.

I'll now turn the call back to Bob. Bob?

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Robert F. Apple, Antares Pharma, Inc. - CEO, President & Director [5]

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Thanks, Fred. And if you haven't noticed, both Fred and I are both suffering from really bad cold and the flu is going through our organization. So I apologize for the coughing and the challenging voice here.

But as you can see on Slide 9, this has been a very exciting time for Antares and for our shareholders. We had an outstanding year, and we believe that our financial results and commercial successes continue to reflect the progress we made in growing our business. We announced revenue guidance for double-digit growth in 2020, despite uncertainties around revenue from one of our partner products.

With our 2020 revenue guidance range of $135 million to $155 million, we are poised to deliver a 4-year average revenue growth rate of 29% at the midpoint of that range. We remain focused on driving commercial success, and we are committed to advancing our product pipeline. We believe our pipeline will translate into future product revenue and royalties for our company over time. It's probably worth mentioning that our auto injector devices are manufactured in 3 locations in the U.S. and the prefilled syringes for our proprietary products are not sourced from China. Overall, 2019 was an incredibly successful year for Antares. And as a result, we believe we have put in place a solid foundation for future growth in 2020 and beyond. This concludes my prepared remarks for today.

Operator, could you please open the line for a question-and-answer session? Thank you.

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Questions and Answers

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Operator [1]

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(Operator Instructions) We'll take our first question from Anthony Petrone with Jefferies.

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Anthony Charles Petrone, Jefferies LLC, Research Division - Healthcare Analyst [2]

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Great. And congratulations on a great year for the company and good luck into 2020. I hope everyone is feeling well there as well. Maybe just to start on XYOSTED and selatogrel. Just on XYOSTED, maybe when we look at just actual patients being prescribed, so the 15,000 put up exiting the year versus the refill rate. I'm just wondering on the actual new patient starts when considering that we're at 4,700 physicians, just where you think that number can go through 2020? And what are the expectations maybe sort of for peak penetration within the TRT market? And then the follow-up on selatogrel will be, when we look into the back half of the year, we're heading into 2021, when that Phase III study begins, how large do you think that study will be? And how substantial do you think the auto injector sort of uptick within the study specifically can be once that begins?

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Robert F. Apple, Antares Pharma, Inc. - CEO, President & Director [3]

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Thanks, Anthony. So on your first question around -- on XYOSTED. Obviously, new patient starts are a critical part for the growth of XYOSTED. And fortunately, for us, we've seen a very positive continuing trend of NRxs on a weekly basis, monthly basis is really what you need to look at. We expect to see continued growth in that area. We clearly haven't even scratched the surface of the number of patients that are on testosterone therapy today. What we're focusing on is getting those doctors who are writing to write for more patients. And I think that what's happened is the initial year, we definitely had success in getting those patients who were unhappy on their IM injection or they were new to therapy, so the doctors wanted to put them on test -- on XYOSTED because they felt that they were -- XYOSTED is the best product on the market, we believe.

But I think that when we look at continuing to grow the product, we need to get those doctors to now start switching patients who are on IM, who aren't complaining. It doesn't mean they're not unhappy, it just means that they're not complaining. And so part of the messaging is really focusing on those patients. I can't give you specifics as to how many new patients we think we'll achieve over the next year. It's kind of hard for me to even know that number at this point. But all I can say is, again, it's a big focus of ours, and we have had a lot of success in getting new patients every week, and we expect to see that trend continue.

So things are going well with XYOSTED. And again, I think the only thing that is worth mentioning for XYOSTED is that now that we're at about 72% of all lives covered, from a commercial insurance standpoint, which really didn't happen until September, October last year. It's starting to get quite a bit easier to get patients on the product. And I've always maintained that. When a doctor writes a prescription, if 2 out of 4 don't get filled, they tend to get frustrated. But once you get into that 3 out of 4, it starts to become a much easier product for them to adopt. And so we're at that -- almost at that 75% rate. So I feel that we'll see continued growth just based on the fact that we have really good coverage. So that's -- I think, for XYOSTED, that answers your question.

For selatogrel -- thank you. For selatogrel, the -- Idorsia is responsible for the regulatory and clinical program. They've been communicating with the FDA vis-à-vis pre -- end of Phase II meetings, things like that. I would say that we don't know the final number, but we're estimating that the study will be about 15,000 patients globally. But obviously, it's being run out of the U.S. and dealt with through the FDA. And that's a number based on the fact that once a patient is on selatogrel and when they're enroll in the study, they're going to look for an outcome where a patient has a heart attack. And that doesn't happen, obviously, to every patient who's already had a heart attack. So I think that the number of patients of around 15,000 would anticipate some percentage of those patients needing to use selatogrel. And so right now, it's an early estimate, but we'll see where it goes with the FDA and with Idorsia and give updates as the Phase III starts.

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Operator [4]

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We'll take our next question from Elliot Wilbur with Raymond James.

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Elliot Henry Wilbur, Raymond James & Associates, Inc., Research Division - Senior Research Analyst [5]

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Bob, you touched on this in your prior response to some extent, but just maybe any additional detail you could share with us in terms of how the XYOSTED marketing plan may evolve over the course of 2020, specifically thinking about changes in the number of targeted doc's frequency. And then I know previously, you've talked about potentially altering some of the copay support programs and maybe to get past kind of the initial depressive effects of some of the high deductible plans and the impact that they have in the first quarter. And anything you could share with respect to just to DTC or social media, just maybe a little bit more color in terms of changes to the overall marketing game plan for 2020.

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Robert F. Apple, Antares Pharma, Inc. - CEO, President & Director [6]

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Okay. Great. So first, I'd like to say that the marketing messaging has been pretty much spot on as far as a physician standpoint and as a patient standpoint. So there isn't going to be many changes in the message. The steady levels of XYOSTED are driving the business. The level -- the lack of those peaks and valleys that patients are seeing in real life are driving the demand. And in the fact that it's easy to use, it's painless, it's once a week. All of those attributes are still the biggest component of selling XYOSTED for us with physicians and with patients.

Now with that said, like you mentioned, Elliot, is that in the beginning of every year, you have patients who -- their copays reset. And also importantly, about 30% of all people in the country are on high deductible plans. And so they typically have to burn through an average deductible of $1,000 to $1,500 per year before they start getting coverage for any drug. What we've done to help compensate for that is we've increased our copay support for a short period of time, probably about 3 months where we've doubled that support to help those patients get through that high copay or high deductible plan. And we've seen great persistence with that program.

The one thing we didn't want to have happen, were people that were on the drug. We're very happy with it. We're happy with XYOSTED. And then they go to the pharmacy and they have to spend $300 for a copay or worse sometimes. We didn't want to lose those patients even for just a few months. And so we've accelerated or increased our copay support, which has so far has shown really good results in persistence. I think we have a very high persistence rate of about 70%, I think, in the first 2 months of this year. So we're very happy with that.

Beyond that, from a messaging standpoint or social media, we have definitely stepped up our social media campaign, utilizing Facebook, LinkedIn and other services where, if you are online searching about testosterone, you will likely receive a banner ad for XYOSTED, for our product. And so we're focusing on where we're spending. Obviously, in the first year, you see what worked, what didn't work, and we're pushing those resources to where we think we're getting the most ROI for those programs. So social media is a big aspect in the copay support. The other thing that we've increased to is just generally adjudication service is just helping the doctors continue to deal with the prior authorizations, helping them where we have our in-house, I guess, adjudication reps, if you want to call them, handling when a script gets written, if there needs to have certain things done where there's a prior authorization or a signature from the office. They chase it down instead of our reps. It gives our reps more time to spend detailing the field. And to your point earlier, Elliot, detailing the more doctors. And I think what we're going to do in 2020 is expand our reach into more prescribers, so we can get the continued growth that we're seeing right now.

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Elliot Henry Wilbur, Raymond James & Associates, Inc., Research Division - Senior Research Analyst [7]

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Okay. And I want to ask a follow-up question around pipeline activity during the course of 2020. Any movement on some of the undisclosed programs such that might trigger disclosure in terms of advancement in the clinical trials or some sort of IP filing or something like that might give a little bit more visibility into the identity of some of the molecules?

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Robert F. Apple, Antares Pharma, Inc. - CEO, President & Director [8]

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Yes. So I mean, I think, you're referencing the Pfizer program, which is really our undisclosed program, and there's quite a bit of scoping going on with our investors. And so I think that, clearly, the program is moving forward. Clearly, we'll be conducting all the studies this year with Pfizer. And so whether it's in clin trials or whether it's in some other filings, we're not sure when or how it's going to emerge as to what product it is. But clearly, we're talking to Pfizer on a regular basis. We have JSC meetings, joint steering committee meetings, and we're looking for that right time where they're ready to publicly disclose what the product is. We're really excited about the asset. We want it out there. But obviously, Pfizer, it's their product that we're working with them on and we want to respect what their wishes are. And so -- but I think that there's a lot of activity that's happening that will probably make it more evident as to what the product is. And hopefully, once we get a green light from Pfizer, we'll be able to announce it, what the program is based on. Sorry, I can't…

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Elliot Henry Wilbur, Raymond James & Associates, Inc., Research Division - Senior Research Analyst [9]

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Any -- no, understood. Any decision points on methotrexate asset and ectopic pregnancy that may be reached during 2020?

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Robert F. Apple, Antares Pharma, Inc. - CEO, President & Director [10]

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Yes. I think that we're looking at that asset. We believe it's a really good asset. We think it's a very viable out-license opportunity. It's not in the area that we focus on. We're trying to really drive our product portfolio into the areas where we are -- where we commercially have a footprint, endocrinology, urology, even some general prac -- GP products just because we're in those offices.

And so I think that ectopic, we're going to continue to look for a potential partner for that product. We think it's got a great opportunity for any companies that are in women's health, maternity, and we'll focus our efforts in that area at least initially, and if -- we'll see where, if there's interest there.

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Elliot Henry Wilbur, Raymond James & Associates, Inc., Research Division - Senior Research Analyst [11]

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Okay. One last question for Fred. Maybe just give us some insight to the extent possible into GTN trends over the course of 2020. And also, specifically, any color or commentary you could share on the strength in OTREXUP sales in the quarter, whether that was GTN adjustment effect or actually the increase in sales had showed a pretty strong correlation with units.

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Fred M. Powell, Antares Pharma, Inc. - Executive VP & CFO [12]

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Sure. And I’ll answer the first one. The OTREXUP question first, and that was really no reserve adjustments during the quarter. We continue to see growth take place in OTREXUP. We're looking for growth to continue into 2020. Certainly not the same dramatic growth that we would expect in XYOSTED. But still, we would expect to see steady volume growth as we go into all of 2020. When we take a look at the gross to net calculations that we have for this year, I think it's going to remain fairly stable from where we were at the end of 2019.

And I say that because of the individual components. As you remember, when we first launched the product, we had a significant amount of first fill free because we wanted to make sure that doctors that were actually writing XYOSTED for their patients actually had those prescriptions filled, as Bob was mentioning, we didn't want doctors to prescribe and then their patients not receive XYOSTED. And so that has a total percentage in the gross to net calculation has come down as now we have over 70% coverage.

What the opposite side of that is rebates. And during the year, our rebates were relatively low as a percentage of the gross to net calculation. Going to the over 70% in the fourth quarter, pushed our rebate amount much higher than we had then during the full year. Other than the copay support for the beginning of the year, as Bob mentioned, doubling for high deductible plans, we would expect the copay support percentage remain fairly flat for the entire year. So overall, I don't see much of a change taking place from the end of 2019 to 2020. Individual components may change. But overall, I expect it to be about the same in the mid-50s percent that we would see dropping to the net revenue line.

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Operator [13]

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We'll take our next question from David Amsellem with Piper Sandler.

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David A. Amsellem, Piper Sandler & Co., Research Division - MD & Senior Research Analyst [14]

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So just a couple. So first, you provided in the past some nice metrics on the usage mix for XYOSTED in terms of patients who were testosterone naive versus those who are on IM injection versus those who were switching from the gels. Can you just talk about the mix as we sit here today and how you expect that to evolve as 2020 progresses? And then secondly, given that you have sales infrastructure in place, calling on basically men's health prescribers, broadly speaking. How active are you in looking for assets to bring in where you can better leverage that sales infrastructure?

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Robert F. Apple, Antares Pharma, Inc. - CEO, President & Director [15]

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Thanks, David. So on your first question, I believe that in the later part of last year, our metrics for XYOSTED were -- over half our patients were new patient therapy starts. And again, I mentioned that earlier, that was clearly where the doctors were going in the beginning as they were comfortable writing XYOSTED for new patients. We saw a very high percentage of our patients being new to therapy, which was a great sign because, obviously, in men that doctors were very comfortable with XYOSTED being first-line therapy. That still continues as far as I'm being very comfortable at first-line therapy. We have seen a shifting of the trend where towards the latter part of the -- the latter part of last year and this year, we're seeing more of our prescriptions are switches from the IM, which make sense. It's a great product from an injectable standpoint. It's easy to use once a week. It's painless. It's subcutaneous versus IM. And so we're seeing about 60%, I believe, of our patients are switches from IM.

And then about 30% or 40% are new patient therapies. And then we still -- it's interesting, we still are not seeing a big penetration on the gels. And I think that's generally because when the men choose the gel is because they're needle phobic. And so -- and they still -- the new patients will still say, "Hey, if I'm given a choice of an injection versus a non-injection, I'll try the gel." When they try the gel, fortunately for us, within 3 months or so, they're very unhappy with it, so they tend to be switches later on. But early in the treatment paradigm, we still see patients go into some of the gels. Clearly, still a smaller percentage overall, but still that's the first inkling sometimes with the patients. So we're seeing, again, just to wrap it up on that aspect, more of our sales are coming from IM switches, which is good because the IM piece of the market is around 70% of all prescriptions. So it's a very large part of the market that we can attack.

With regards to your second question on our men's health. Obviously, we have a very strong sales force of about 85 representatives calling on urologists and endocrinologists as well as some sexual medicines/general practitioners who write for testosterone products. And so that is a big asset for us as a organizations. So we have been very focused on looking at already approved assets that are on the market where companies may not be focused on that asset or they might be looking to get outside of that therapeutic area. And so we have an extensive BD engagement or search for those type of assets. And so what we want to make sure is that if we do acquire or license in another asset that it doesn't hurt the growth of XYOSTED. And so getting the right asset is the challenge. But rest assured that we are clearly looking at putting more products in the bag of our sales force in 2020.

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David A. Amsellem, Piper Sandler & Co., Research Division - MD & Senior Research Analyst [16]

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And just to follow-up on those comments, it sounds to me that you don't have an appetite to bring in an asset where you're going to take on significant R&D risk. Is that a fair characterization?

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Robert F. Apple, Antares Pharma, Inc. - CEO, President & Director [17]

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Well, I mean, I think that it's really -- I mean we clearly are looking at even assets that maybe have already passed through Phase II, where you have reduced the risk of clinical failure at least as much as you can. No, I mean, we clearly look at even Phase III assets. It's definitely more -- our focus right now is more on commercialized assets. But that doesn't mean that, if the right development asset comes along that we wouldn't look to license it. Again, it would be -- we want to make sure that we don't drive our profitability down based on what we're seeing on our upward trend. And so it's really a balance of what asset make sense for us. But it doesn't -- we are looking at all assets that kind of continue to build that pipeline we have.

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Operator [18]

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We'll take our next question from Matt Kaplan with Ladenburg Thalmann.

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research [19]

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So just want to dig in a little bit more to kind of your kind of 2020 revenue guidance, $135 million to $155 million. It appears as though there's kind of no new products adding to that equation there in terms of your product mix and royalty stream. Talk about -- I guess, with respect to that, talk about the pipeline and potential new products coming in, in 2020 or 2021 with respect to PTH, exenatide, internal programs. And then I guess, lastly, kind of the time line for selatogrel to the market?

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Fred M. Powell, Antares Pharma, Inc. - Executive VP & CFO [20]

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I'll handle the first part of it with the guidance that we issued and where that was built upon. And you're exactly right, Matt. When we took a look at our guidance for 2020, we certainly do expect that XYOSTED is going to continue to grow this year, really be the most dynamic part of the growth that we see in our guidance. At the same time, if you remember, with Epi really being fully launched in the middle of 2019, we only had the back half of the year for the full launch there. So we would expect that to be a significant driver of our revenue. Taking a look at the -- where some of the potential risk would be is Makena, and as I mentioned, in our lower end of our guidance, we can hit that without having any revenue coming in from Makena. That, obviously, we're already through the second month of the year. So we will have some revenue. But that's really why you see the lower end where it's at.

When it comes to other products for 2020, we do not -- we have not built in anything for Forteo. Teva has made the announcement that there could be an approval by the end of 2020, we did not model that into our upper end of our guidance, and that would be an upside to our guidance. We certainly would expect that, that would come -- we certainly would hope that it would come into 2021. And as I mentioned a little bit earlier, with OTREXUP, again, we would expect some continued growth taking place with that product. Development is going to be strong again, and we'd expect that the royalty that we will get from Epi will increase year-over-year. So overall, that's how we built the guidance. With the other products, I'll turn it over to Bob.

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Robert F. Apple, Antares Pharma, Inc. - CEO, President & Director [21]

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So first, a couple of clarifications. On Makena, there's no indication that, that product is coming off the market anytime soon. We just don't know. And AMAG had recently announced that they're working with the FDA to keep the product on the market. So our guidance shouldn't reflect any belief that we have, whether the market -- the product is going to stay in the market for the whole year, less than the whole year or not. We believe Makena is a great product and has a lot of value for patients and physicians, and we hope that AMAG can come to an agreement with the FDA to keep the product on the market.

Secondly, on the Forteo, same thing, our guidance should not reflect our belief. Our guidance, we do not put unapproved assets in our guidance. And that's why it's not in there. It's not that we don't believe it can be approved and launched. It's just the fact that we found that it's most prudent to not put unapproved assets or unapproved products in our guidance until they become approved. We feel very confident about PTH. We think it's a great asset. And I know it's a very important asset for Teva. The product is still doing really well for Lilly, and we believe, if approved, being a fully substitutable first priority -- no, I mean, first to market generic would be a very big asset for both of us. So I just wanted to clarify those 2 things.

On the other element, Idorsia, we believe, based on what Idorsia has taught us, and again, it's very early. They haven't even started their Phase III yet. But they're targeting like a 2024 type of approval, potential launch. It's not in a year or so. This is a very large study. It's 15,000 patients or so. And so we -- that's more of a longer-term pipeline asset for us. But the magnitude of it is so large. We just want to make sure that people understand, not only the value of the asset, but also just how impactful that product may be for people who have suffered a heart attack or may have coronary artery disease. So we're excited about that. And we'll see some significant development revenue during that period of time before a potential approval launch. But for us, it's really around the novel concept of a heart attack rescue pen that gets us really excited.

Pfizer, we haven't really given any guidance yet as to the timing. But clearly, we think it's in that '23 time frame, maybe a little sooner or later. It's really a function of when they get everything going. And then when they disclose it, I think a lot of it has to do with is the regulatory time line as to how fast the FDA will review the product. And so clearly, nothing in 2020 from a product standpoint for the Pfizer transaction or Idorsia.

And so I think as -- for 2020, besides PTH, there's obviously exenatide is still as a potential of approval. Not a large product, but still be a nice single for us. The product itself is doing around $100 million. It would be the first generic for diabetes. BYETTA still sells. People still use it. It's just one of the older products for diabetics. And so -- but Teva is still committed to getting that product across the goal line, and it's -- hopefully, they'll have an approval in 2020 for that as well.

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research [22]

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Great. And then just in terms of internal programs that you're focused on that could add to your endo, uro GP focused marketing effort. When should we have any more detail -- additional detail on your internal pipeline?

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Robert F. Apple, Antares Pharma, Inc. - CEO, President & Director [23]

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Yes. So I think in our 10-K, you'll see that we wrote that we're focusing -- we are working on 2 different assets right now, one for endocrinology and one as well in urology. And they're early stage. We would not announce what those products are until we have the IND filed. We're hoping to have our pre-IND meetings this year on those assets. We need -- we're doing some formulation work that obviously needs to be successful. As we look at our pipeline, we're looking at more challenging assets in order for them to have more value in the marketplace. And so with the challenging assets, obviously, there's more risk in the predevelopment stage, whether it's formulation or just generally the clinical design. And so our pipeline, we continue to focus on where our commercial footprint is. I think, again, we're looking to have a pre-IND meetings on 2 assets. And hopefully, if they evolve, we'll be able to announce what those assets are once we have an IND filed with the FDA.

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Research Division - MD & Head of Healthcare Equity Research [24]

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And I guess, on the internal programs, was there a program that you're working on in the neurology space previously and -- or am I mistaken?

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Robert F. Apple, Antares Pharma, Inc. - CEO, President & Director [25]

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No, there -- it was 1701, and we are -- because it's not really in our area of where we're focusing. We are looking to potentially out-license that asset. But again, that's early stages, and we'll give updates as we get more information to provide you guys.

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Operator [26]

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(Operator Instructions) We'll take our next question from Anthony Petrone with Jefferies.

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Anthony Charles Petrone, Jefferies LLC, Research Division - Healthcare Analyst [27]

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Just wanted a quick follow-up, and I think you referenced it earlier, just on Makena. I know it's baked in the 2020 guidance. But anything as we sit here in March, as it relates to Makena, just in terms of orders you've gotten in the fourth quarter and just the outlook relative to where the 2020 range is today, just an update on Makena.

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Robert F. Apple, Antares Pharma, Inc. - CEO, President & Director [28]

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Yes. I think that our shipments continue to AMAG. They gave guidance of, I believe, $80 million to $100 million, which obviously is substantially less than what they did last year. I think last year, they did about $120 million...

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Fred M. Powell, Antares Pharma, Inc. - Executive VP & CFO [29]

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To $130 million.

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Robert F. Apple, Antares Pharma, Inc. - CEO, President & Director [30]

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$120 million, $130 million. They haven't announced yet. But we're clearly seeing shipments supporting that range. And until AMAG gives more guidance, it's really not our place to say. But Makena continues to be a good asset for us and for AMAG. And again, we hope that they can come to an agreement with the FDA to keep that product on the market and keep it available for physicians and patients. But we'll clearly see revenue in Q1 related to Makena, and we expect to see, hopefully, the rest of the year.

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Fred M. Powell, Antares Pharma, Inc. - Executive VP & CFO [31]

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And just to expand just a little bit on that. As Bob said, we certainly expect to go through the rest of the year. We do have orders for the rest of the year. It's not as though they're cutting it off after the first quarter and saying no more orders. So we continue to see Makena orders for production throughout all of 2020.

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Operator [32]

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There are no more questions in the queue at this time. I'd like to turn the call back over to Jack Howarth for closing remarks.

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John J. Howarth, Antares Pharma, Inc. - VP of Corporate Affairs [33]

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Thanks, Shelby, 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.

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Operator [34]

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This concludes today's call. Thank you for your participation. You may now disconnect.