Ladies and gentlemen, welcome to the Antares Pharma First Quarter 2021 Financial and Operating Results Conference Call. [Operator Instructions]. I will now hand the conference over to Tram Bui, Antares Vice President of Corporate Communications and Investor Relations. Please go ahead.

Thank you, operator, and good morning, everyone. Earlier today, we announced our first quarter 2021 financial results and operating achievements. A copy of the press release and slide presentation for today's conference call are available in the Investor Relations section of the Antares Pharma corporate website. Before we begin, I'd like to remind listeners that some of the 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 the impacts of the ongoing COVID-19 pandemic and mitigation measures implemented in response to the outbreak on our overall business, operating results and financial condition, our ability to achieve the 2021 revenue guidance, future revenue growth, prescription volumes and market share for our products and our partnered products, including XYOSTED, OTREXUP, NOCDURNA and Teva's generic EpiPen, FDA actions and other regulatory activities, including actions with respect to Makena and approval of Teva's pending ANDAs for generic Forteo and Byetta, timing and results of ongoing and future development programs, and clinical trials including ATRS-1901 and 1902 as well as programs with Pfizer and Idorsia, and other product development activities and business development efforts. These forward-looking statements are subject to certain risk and uncertainties, and actual results could differ materially. They are identified and described in today's press release in the accompanying slide presentation on Slide 2 and in the company's filings with the SEC on Form 10-K and as updated in Antares' recent periodic filings on Form 10-Q and 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 replace 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 review of our overall business, including our commercial achievements and strategy for our proprietary portfolio as well as provide an update on our partner business. Fred will then go through the detailed financials and Bob will conclude with closing comments before opening up the line for your questions. Please turn to Slide 4 and I will hand the call over to Bob Apple. Bob?

Thanks, Tram, and good morning, everyone. Thank you for your interest in our first quarter results and operations update. We are pleased to have started the year with strong financial results with record first quarter revenue increasing 27% to $42 million with a reported net income of $3.8 million or $0.02 per share. In the first quarter, we continued to increase the adoption of XYOSTED that drove the 48% revenue increase in our proprietary products to almost $19 million. As we look ahead, we expect increasing momentum throughout the year for XYOSTED and NOCDURNA as our sales representatives enhance our targeting strategy and garner more in-office physician visits as the pandemic slows with increased vaccinations. These same vaccinations increases have also provided a temporary boost in demand for Teva's generic EpiPen with total prescriptions increasing 48% year-over-year. With a 53% share of the generic EpiPen market in the first quarter, their growth was the main driver of the almost 90% increase in our royalty revenue. As we continue to anticipate the U.S. approval and launch of Teva's generic Forteo alongside the growth opportunities of our commercial portfolio and partner business, we are reaffirming our full year 2021 revenue guidance. Let's first focus on our proprietary portfolio on Slide 5, which collectively represents our highest margin business and remains a significant growth driver of the company. The strong demand for XYOSTED drove the 60% increase in revenue for our flagship asset to more than $14 million in the first quarter compared to last year, despite seasonality that is typical across the industry. Q1 is always the most challenging quarter as the industry manages through the traditional dynamics of planned changes, payer coverage and patient deductible resets. All the while, we continued to implement all -- across all of our access and…

Thanks, Bob, and good morning, everyone. I believe that our strong first quarter results that we announced earlier today are indicative of the solid foundation we have built across our diversified business. We believe our first quarter total revenue of $42.1 million sets us on a good path to achieve our 2021 revenue guidance of $175 million to $200 million. With strong contributions again this quarter from our flagship product XYOSTED and Teva's generic EpiPen which is our primary partner product, we are pleased to be able to report net income of $3.8 million or $0.02 per share. So now let me provide a more detailed review of the financial results for the first quarter ended March 31, 2021, which brings us to Slides 8 and 9. Total revenue generated from product sales, license and development activities and royalties was $42.1 million for the 3 months ended March 31, 2021, representing a 27% increase compared to $33.1 million in the same period in 2020. Total proprietary revenue for the quarter of $18.7 million accounted for 45% of our total revenue, while our partner revenue was $23.4 million and made up 55% of our revenue for the first quarter. We expect, during the year, our proprietary revenue will continue to make up an increasing percentage of our total revenue. Sales of our proprietary products XYOSTED, OTREXUP and NOCDURNA generated revenue of $18.7 million for the 3 months ended March 31, 2021, compared to $12.6 million for the same period in 2020. The 49% increase in proprietary product sales were mainly attributable to continued growth in sales of XYOSTED, which increased 60% year-over-year to $14.4 million. Product sales, development revenue and royalties for our product -- partnered products increased 14% and totaled $23.4 million for the 3 months ended March 31, 2021,…

Thanks, Fred. In the first quarter, we reported strong top line and bottom-line growth, driven by contributions from both our proprietary and partner business. We believe the strong first quarter results highlight the strength of our company as well as our value proposition with the significant opportunities we still have across the business. We have 2 significant commercial products, XYOSTED and Epi which are both in the early stage of their product life cycle and we believe have tremendous upside potential. We have also recently relaunched NOCDURNA that aligns well with our XYOSTED call universe and has a potential in a large therapeutic market. As you can see on Slide 10, our product development pipeline has multiple approval opportunities over the next 5 years. I believe it will be difficult to find a peer company in our sector with a more robust pipeline with potential FDA approval opportunities year-after-year for the next 5 years. As we look ahead, we look forward to the potential for continued growth of XYOSTED and the successful relaunch of NOCDURNA, the U.S. approval and launch of generic teriparatide by Teva, the IND submissions for ATRS-1901 and 1902 this year, Pfizer's NDA submission this year for a potential FDA approval in 2022, Idorsia's initiation of their Phase 3 trial for the selatogrel heart attack rescue pen, as well as new business alliance and business development opportunities. Again, thank you for your interest, and operator, can you now open the call up for questions?

[Operator Instructions]. Our first question comes from Anthony Petrone with Jefferies.

This is Briana on for Anthony. Congratulations on a great quarter and thank you for taking our questions. My first question is on the full launch -- on the full relaunch of NOCDURNA. So now that that full launch -- the full relaunch is under way, have you seen any additional interest in XYOSTED beyond the existing call points or pull-through for that product?

So as far as how NOCDURNA is doing relative to XYOSTED in bringing us new opportunities, I mean clearly as we -- there may have been a physician's offices who aren't using XYOSTED, but are interested in hearing about NOCDURNA and we obviously get into those offices and can then detail both products. And so it has provided us an opportunity to get in and talk about both when maybe they were like reluctant to talk about XYOSTED before. So we clearly have seen that happening in the field and we believe that trend will continue, especially as we get more and more access to the physicians' offices. Trying to launch a product during the pandemic is probably the most challenging thing anybody could do, but I think our team has done a great job of getting the message out there on NOCDURNA as well as XYOSTED during these difficult times.

And then I have two additional questions. Can you walk through expectations for seasonal peak orders flow for EpiPen? And then regarding the Pfizer NDA and the potential launch in 2022, how should we expect auto injectors to ramp in the anticipation of that launch?

So on your first question on EpiPen as far as what we expect going forward, we believe we're going to have a strong second quarter due to the pandemic because there is a large number of EpiPens that are being maintained at different mega centers and actually really any offsite location where vaccines are being provided to patients, there -- you need to have EpiPens there in cases of anaphylactic shock. And so we see that continuing at a minimum through to second quarter. Depending on how the vaccine rollout or how long it takes to finish, we believe that it could go beyond in the second quarter. Then into the third quarter, we expect a normal back-to-school market, which historically has been the best market for EpiPens. The third quarter when students are going back, parents are buying their EpiPens for both the school, making sure that their child has it for when they go to school as well as at home. We believe that seasonality will come back particularly with the multiple announcements that schools are reopening and it seems to be a mandate of the current administration to make sure that all schools are open come the fall. So we expect Q3 to be very strong and Q4 should be traditional, a little bit weaker just because you roll into the winter, you have less demand for Epi because like bee stings, things like that. So we believe overall the year for Epi, for both us and Teva, are going to be very strong. We delivered millions of devices today and we continue to do that and we expect that kind of volume to continue. With regards to your other question, if you could remind me what that was.

Yes, just on the potential launch of the Pfizer's product, how should we expect auto injectors to ramp in the anticipation of that launch?

Yes. So obviously, the expectation is that we will provide commercial devices as we start to ramp up or as we get closer to the approval in 2022. We are responsible for fully packaged product and so we won't recognize any revenue until we start shipping the devices to Pfizer, and that's likely going to happen sometime next year, not this year. Because obviously you don't want to put in drugs that has normally like a 2-year life way ahead of potential approval and launch. So it will likely be a more of an impact going into 2022.

Our next question comes from Gregory Eurinoff [ph] with Cowen and Company.

So, I guess, first maybe on NOCDURNA, as you're familiarizing yourself with the product, where do you think your commercial team can improve on the prior launch. And I guess what is your sense of the initial patient demand? In addition to that as well what is the -- do you have -- do you expect that there will be a lot of commission education as you promote the product? And, I guess, just all related to that same question, what are the most crucial aspects or I guess long hanging fruits to growing NOCDURNA?

Great. I'll take that question, very long question. But, yes, with NOCDURNA we essentially launched it in February. We did a soft launch last year, which basically meant that we had our reps calling on just XYOSTED prescribers basically through February, talking about early on. And now, since our national sales meeting in late February, we now are going out to not only our current XYOSTED riders, but also doctors who would be the right targets for NOCDURNA, patients who are suffering from night time nocturnal polyuria. So it's really just started. We're starting to see new patients come on, new riders for sure and it's going well. So I think that our expectation is that it will ramp over time. This is not a XYOSTED type of call. XYOSTED is a product that doctors understand right away. They understand what testosterone does and they understand the mechanism of action. NOCDURNA is a bit different. It's a newer product. It's completely novel to the physician. So it's going to take more cycles to get those physicians understanding what the product does, how it works and why it benefits patients. And so, the reps are out there making those calls and it's going to take a number of calls like a normal new product would take to get lift. And so we expect to that a big component of the success of this product where very unlikely didn't have any success with it, is really around the education component to both the physicians and the patients. So clearly on the physician side, we're going to be doing meetings and conferences. We're going to be detailing them directly as well as at scientific advisory boards and so forth or speaker bureaus. With the patients, we're going to be doing just like we do with XYOSTED. We're going to be using social media to try to educate the patient on social media about what nocturia is and what nocturnal polyuria is, this excessive nighttime urination, and why is it happening and how's it happening, and drive those patients to the doctors to ask about it. And so that all takes a little bit of time and we believe that long term this is a large market opportunity. It fits really nicely with our universe of doctors in urology and also some endocrinologists who treat patients for this. And so we believe it's a large product opportunity that will take some time, but it will grow and we believe it will be successful.

I understand. Very helpful. And just a quick one on EpiPen, do you have any sense of, I guess, what percentage of demand is coming from the COVID vaccinations?

No, we don't have an exact number because when you look at the prescription and their market share of about 53% and just recently it's been as high as 57% market share, that's prescriptions that patients are going to get for the normal refills of their EpiPens. What happens with the EpiPens that go to the mega sites and the different vaccines centers, they're not even picked up as prescriptions. And so that's why our growth is so tremendous relative to what even the prescription market show because they're are sales that are happening outside of that IQVIA universe. And so we know what we ship to Teva, we know what Teva ship to the distributors. We don't know what percentage of those actually went to those centers. We get a sense that it's a large percentage of what we shipped relative to the prescriptions. So -- but I would eventually guess it's at least 25% of where we were from a prescription standpoint.

Got it. No, that's very helpful. Congratulations on all the progress.

[Operator Instructions]. Our next question comes from Elliot Wilbur with Raymond James.

This is Lucas Lee on for Elliott. So you've indicated that the commercial organization implemented and enhanced targeting strategy around XYOSTED and NOCDURNA. Could you provide some more color around this targeted strategy? And I have a couple more follow-ups.

Sure. So on the XYOSTED component of it, what we have found is we continued to increase in number of prescribers. I think we're over 7,800 doctors or more than have written XYOSTED since launch. So we call in around 12,000 physicians. So we have really high penetration rate of who we call and that a large percentage of those are writing. What we have found is that those writers, it still represents a relatively small percentage of their overall testosterone business. And so what we want to do with the new targeting strategy is really to go to those doctors more often and go deeper, try to get more and more of their business that they're writing for the IM injections or other products. And we believe that once the doctor sees the benefits of XYOSTED, they see how easy it is to use, particularly during the pandemic, it's an easier sell to them to get them to switch patients. Patients are -- doctors are always reluctant to switch patients on a drug that they may have been on for a number of -- for a long period of time if they think it's working for them. It's easier for us to get a doctor to get a new patient on therapy to try because they know it works, they know they like the way XYOSTED gets the patient in the right testosterone levels as the steady PK, all those elements are all important. It's easier for a doctor to switch somebody who's never been on or to put a patient who has ever been on testosterone versus switching someone. So for us the new targeting strategy is to get to those docs who were already writing it but only let's say a 20% of their business or 10% of their business or whatnot and try to get them to write it in the majority of their patients. And so it's going after those doctors more often and letting the ones who have less opportunity calling on them less. So that's the new enhanced targeting strategy that we're focusing on. With regards to NOCDURNA, the new strategy is -- before we were just go into XYOSTED targets, now we have a new complement of over 1,000 doctors beyond the XYOSTED ones that write specifically NOCDURNA-type products and we're going to call on them pretty heavily. So that's the new targets that the reps have across their business for NOCDURNA as well as the way we want to kind of hone them in on XYOSTED writers to get more of their business as opposed to more and more doctors writing.

That's very helpful. And I think you've mentioned last -- during last call that in-person calls to docs were about 50% of targeted levels and I think you said it's around 60% this quarter. How strongly do you believe these in-person calls are correlated with the new patient starts?

I mean, I think that there will always be a hybrid going forward. We will always use a virtual component for the harder-to-reach docs, the ones who maybe are on autopilot and so forth. You don't have to go to them in-person all the time. But clearly, we believe that an in-person call is more effective. I mean, I think that the virtual calls are more efficient, but the in-person are more effective. And so as the doctors -- as we get more and more towards the 80% in-person and more importantly, probably the patients coming back where they're still down -- most practices are down 25% still at least, when those new patients come back, I think that's going to continue to spurt a growth that we've seen with XYOSTED. When we look at what XYOSTED has been able to do with the switches during the pandemic, our -- most of our business had been coming from switches from IM during the pandemic. During pre-pandemic, we were probably doing around 400 new patients to XYOSTED, new to brand per week that were new to therapy. They went down quite a bit. Now we're getting back up to those pre-pandemic levels. We're probably around 350 to 375. At the worst part of the pandemic, we were below 200. So we believe those patients coming back to the doctor's office is going to what's going to accelerate the growth in the second half of this year. And so, the in-person is important to get those new patients that are going to start to come back on the XYOSTED, be their first choice and get that growth in new patients because obviously a new patient brings multiple refills, which is important.

And for my last question, what would be the levels of patient flows or visits target at prescribers' offices and how much are they still down compared to pre-pandemic levels?

Well, I can't answer that across the board as far as every physician's office, right, because it's different. But I would say that we're still down -- from new patients coming into the office, we're still down about 20%, 25% from pre-pandemic levels. It goes up and down every week. It really is a function of if a particular state is having a spike -- we saw spikes in Texas, we saw spikes in Florida that impacted the business. We saw California getting shut down a few weeks ago. That all impacts the patient flow and the accessibility of the offices. But we do see it kind of lightening up right now and we expect that to continue as more and more states drop their COVID restrictions. But overall, it's hard to answer that question other than it's still down, but we expect it to normalize in next couple of months.

Our next question comes from David Amsellem with Piper Sandler.

So I got disconnected earlier, so I apologize if you addressed these items earlier. So high level question in terms of the business. You are obviously seeing more migration of the total top line towards proprietary products versus partner products. So I guess with that in mind, how aggressive do you want to be in terms of adding new assets where you can leverage the infrastructure you have in place, maybe another NOCDURNA or even something transformational? Do you have something -- do you have appetite for that? Just help us understand your latest thinking. And then secondly on the testosterone market, any commentary on the oral forms of testosterone or testosterone enanthate [ph] and how that might change market dynamics? Do you look at it as just creating more buzz around Teva placement or do you look at it from a -- as a competitive threat in anyway?

I'll answer the testosterone question first, the oral testosterones. First of all, there is over 7.5 million prescriptions for testosterone every year in the U.S., dominated by the IM injections around 70% in the market. Obviously, XYOSTED is a subcutaneous injection and we continue to gain market share as we grow. The other -- the balance of the market are gels that you have to apply daily and then obviously there is one oral testosterone product on the market right now that is trying -- is slowly building a little bit of momentum. I think that what's going to happen -- first of all, there is plenty of room in the market for an oral product or multiple oral products or whatever. There is -- we're still just scratching the surface of what we're able to do with XYOSTED just because the IM injections have been entrenched in this market for so long. Doctors have been writing them for 20 years and it's -- they're on auto pilot a lot of times when they write the IM injections. So getting them to change is always a challenge for any new product and has been a challenge for XYOSTED, but we've done extremely well with our product. With regards to the orals, I think that they will likely replace the gels. I think the gels are -- they keep going down in market share dramatically over the last few years. And the reason is it's cumbersome, it's a daily application, it's messy and so forth. But when a man is first presented with that he had low testosterone or testosterone deficiency and the doctor likely gives them a choice and they're told about a gel that they can rub on their arm, they think it's going to be pretty easy until they try it. I think they're going -- that's going to be potentially where some of the patients go for the orals. "Oh, I don't -- I'd rather try an oral than try an injection." Obviously, XYOSTED, we believe we've overcome those objections. It's a painless injection, it's once a week. The orals are twice a day. And so they're not a panacea. And so I think that there is going to be -- there is a large enough amount of market for everyone to do well in the marketplace. And so I think orals have a place and I think that XYOSTED clearly is still the best product in the market, but we will continue to grow the market even with orals on the marketplace. So that's the testosterone question.

Taking our new products or --

All right, thanks. So your second question about would we be looking at another NOCDURNA and/or transformational type products, we are looking at both. And we have a very heavy focus on corporate development for both. Marketed products that may be available to us in our space in the endocrinology, urology or some other niche area we believe we can effectively approach with our sales team. We want to leverage what we -- those relationships that we have. We have an 80 person sales force, approximately 10 district managers doing extremely well, and we want to put more products in the bag for them. And so that is a key component for us. On the transformational side, we absolutely look at companies and other products where it doesn't even have to be a combination product or injectable. As long as it makes sense for us from a commercial footprint standpoint, where we're going -- we have a lot of rescue pens that we're working on, we have products that are going to be orphan like products. It gives us a lot of different opportunities to look in areas that could be transformational for us if we look and find the right company. They are obviously challenging. We have a really strong growing business and we want to make sure that anything that we bring on is accretive. And so it's a full time job for a number of people in our organization and we're committed to both looking for new assets as well as any kind of type of transformational acquisitions of companies and/or mergers.

Our final question comes from Matt Kaplan with Ladenburg Thalmann.

Saving the best for last. So just wanted to focus on your proprietary pipeline and then your pipeline in general. Maybe first start out with kind of visibility to teriparatide potential launch in the U.S. this year and what your thoughts are on that? And then really focusing on your near-term INDs, your programs 1901 and 1902, and thinking kind of how those fit in your portfolio and potential for those products and potentially other products beyond 01 and 02 as well.

Sure. As far as Forteo, like I mentioned in the script, both Teva and Antares are very disappointed with the lack of action by the FDA and that's the only way I can describe it is the lack of action. They are in dialog with the FDA to get it across the goal line. There is nothing outstanding. And so it's just a matter of the agency dealing with a complex generic and they need to do internally to make sure that they're content with how this product is going to get approved and so forth. So our expectation is going to happen at any time and same with Teva. And so as far as what that means is we expect it to launch this year. And if it does, it's a significant product for both us and Teva. To remind everybody, we get a -- we sell the devices at a nice margin and then we get a high single-digit royalty mid-teens on this. And so it's a much more lucrative product for us, because it's a very expensive product on a per unit basis. And so we really look forward to that happening and again we're disappointed as everybody else is as far as the FDA's timeline on this. So that's Forteo. On our 1901 and 1902, first and foremost, it's a little bit the other way around. But 1902 is the first one that we believe we're going to file the IND and we think it fits perfectly within our portfolio, in our potential bag. It's a -- it's going to be a rescue pen in endocrinology. It's an orphan indication that we believe we maybe will get protection on and/or released in minimum, be able to support that area for patients. We think it's a large…

Great. And any other program percolating in the background?

Yes, we are always looking at new opportunities. We're hoping to put another product -- combination product, likely a rescue pen, in our portfolio or our pipeline the -- towards the back end of this year. And right now, we're working on a formulation on a particular product. If the formulation works out, then that's what -- that's the one we're going forward. And then, of course, we're always looking at new products on a regular basis. We have a product steering committee internally that comprises commercial, regulatory, clinical, all the elements that you need to make sure that the product has -- not only that you -- that it has the opportunity to get across the goal line from a regulatory and FDA standpoint, but also that has a commercial opportunity. And so we'll continue to look internally as well as externally for those pipeline enhancements.

Thank you, ladies and gentlemen. This concludes today's presentation. You may now disconnect.

Thank you. Have a great day.