Halozyme Therapeutics, Inc. Q1 FY2021 Earnings Call

Ladies and gentlemen, welcome to the Antares Pharma First Quarter 2021 Financial and Operating Results Conference Call. 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 risks 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 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 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 vaccination 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 access and affordability programs to help patients get their XYOSTED prescriptions filled, particularly in this first quarter. Notwithstanding, according to IQVIA data, total prescriptions for XYOSTED increased 50% year-over-year, with March representing our highest month to date, and we expect continued growth throughout the year. We remain enthusiastic about the opportunity to compete in a growing testosterone market with XYOSTED, particularly given the evolving industry dynamics due to the pandemic. As our sales reps continue to execute a hybrid detailing model of approximately 60% in-person and 40% virtual detailing this quarter, we believe the advantages of XYOSTED with an easy-to-use once-weekly virtually painless at-home testosterone replacement therapy will continue to garner brand recognition and adoption by physicians. We believe that the pandemic will continue to shift societal norms to seek good at-home therapies, which are at the core of our platform technology and development portfolio. During the first quarter, our hybrid detailing model continued to prove effective, driving strong brand awareness and profile acceptance by our target audience, supporting a growing prescriber base and year-over-year prescription growth. We believe these accomplishments, when paired with an enhanced targeting strategy and new digital and social media promotional campaign that was recently introduced, have the brand poised for continued growth. And as the year progresses, we also expect our sales force to increase their productivity as they garner more in-office visits with a slowdown of the pandemic. We believe that the success that we have achieved thus far with XYOSTED can be leveraged for the relaunch of NOCDURNA. Total prescriptions for NOCDURNA remain consistent with our expectations in year one of this relaunch. We believe this product is uniquely positioned to help patients suffering from nocturia due to nocturnal polyuria. Our learnings from the soft launch at the end of last year have translated into a new comprehensive marketing campaign illustrated on Slide 6 that we believe will increase awareness, trial and adoption of NOCDURNA with our targeted physicians. We anticipate continuing to call on existing XYOSTED targets, but also have the potential to prescribe NOCDURNA to assure we reallocate the appropriate selling time to reestablish NOCDURNA while also remaining focused on XYOSTED. Furthermore, we also have a select group of new high-potential NOCDURNA targets through our sales force that will be able to reach with minimal distraction to XYOSTED. With that overview of our commercial portfolio, I'd like to take this opportunity to welcome Joe Renda to the company as our new Senior Vice President of Commercial. Joe brings considerable commercial experience from large and mid-sized pharma companies, where he has led commercial organizations with significant revenue. He's also proved successful across therapeutic areas and we look forward to his contributions to our sales, marketing, and data analytics that we believe will enhance our strong growth trajectory. His broad therapeutic experience also aligns with our initiatives to continue to expand our commercial portfolio through business development. On that same note, we're also very pleased to have Dr. Peter Richardson join our leadership team as Executive Vice President, Research and Development and Chief Medical Officer. Peter joined us at a very exciting juncture of our internal development with a proven track record of success in managing development programs and clinical trials that have resulted in multiple product approvals. We look forward to being able to leverage his extensive research and development background as we advance ATRS-1901 and 1902 and look to continue to expand our internal development pipeline. Looking at our current internal development programs, we remain on track and expect to file an IND with the FDA for endocrinology rescue pen 1902 in the first half of this year, and 1901, a weekly formulation of an auto-injector administered product in urology in the second half of the year based on positive feedback from the FDA on both potential products at our pre-IND meetings with them last year. And as we previously noted, once we file the IND and they're accepted by the agency, we'll be able to provide more detail around the asset and opportunity. It is important to remember that we are pursuing a 505(b)(2) pathway for both assets, helping to potentially provide an abbreviated development timeline. With the commercial footprint that aligns with where we are today, we believe these assets will only enhance our future growth. And while we believe that we have a robust proprietary business and development pipeline, we are equally pleased with our partner business, which brings me to Slide 7 and Teva's generic EpiPen. The success of Teva's generic EpiPen in the first quarter allowed us to garner attractive royalties and strong demand for our devices. While Teva captured 53% market share of the EpiPen market this quarter, we do expect the growth to continue throughout the year, partially driven by an atypical and temporary boost in demand for EpiPens due to the low risk of an allergic reaction to COVID vaccines by some patients as well as an expectation for a more normal back-to-school season compared to last year. We continue to value our partnership with Teva and remain excited for the potential U.S. approval and launch of their generic Forteo and Byetta. Although everyone is clearly disappointed with the lack of action by the FDA on the Forteo ANDA, Teva believes that the FDA remains committed to the advancement of complex generics, including Forteo. We, along with Teva, look forward to the large market opportunity that generic Forteo represents. And now to Pfizer. Again, we obviously want to be able to disclose the asset to our investor base, but it remains important for Pfizer to keep it confidential for competitive reasons at this time. Nevertheless, after successfully completing clinical trials for this rescue pen last year, Pfizer expects to file the NDA this year. We believe its potential approval in 2022 will contribute to our continued growth. We are excited to be able to offer our rescue pen technology and supply chain expertise to support this important market opportunity. And before handing the call over to Fred to discuss the financials, I'll also briefly comment on Idorsia's development of the selatogrel rescue pen. We know that Idorsia continues to be hard at work to initiate their large global Phase 3 trial in the first half of this year and we look forward to supplying them with product for the trial. Their fast-track designation by the FDA highlights the potential importance of this product and we believe that their success will prove transformational for both companies as well as physicians and patients. With that, I'll turn the call over to Fred.

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 was 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 partnered products increased 14% and totaled $23.4 million for the 3 months ended March 31, 2021, as compared to $20.5 million for the same period in 2020. During the first quarter of 2021, Teva's EpiPen saw tremendous growth of the EpiPen market share as well as the stocking of Epi devices required in mass vaccination sites. Results of these two factors allowed us to record total revenue related to Epi of $17.4 million, an increase of $6.1 million over 2020. The most significant component of Epi revenue growth was royalties, which grew $3.6 million. Offsetting the increased Epi revenue was the overall revenue reduction from AMAG's Makena. Our total revenue for the first quarter of 2021 from Makena was $2.3 million, a reduction of $2.8 million from 2020. Our gross profit was $25.7 million, representing a gross margin of 61% for the first quarter of 2021 as compared to $18.1 million or 55% gross margin the same period in 2020. The increase in gross profit and margin was primarily attributable to the increases in XYOSTED sales and Epi royalty. Selling, general and administrative expenses were $17.6 million for the 3 months ended March 31, 2021, compared to $16.4 million for the comparable period in 2020. The increase in SG&A expenses was primarily due to an increase in sales and marketing costs for our proprietary portfolio and increases in compensation and professional expenses. As a result of our strong operational results, net income was $3.8 million or $0.02 per basic and diluted share for the first quarter 2021 compared to a net loss of $2.4 million or $0.01 per basic and diluted share in the same period in 2020. Finally, our cash balance increased $2.1 million from December 31, 2020, to $55.7 million as of March 31, 2021. I'll now turn the call back to Bob for closing remarks.

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 two 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 potential in the 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 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?

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 relaunch of NOCDURNA. So now that that full relaunch is underway, have you seen any additional interest in XYOSTED beyond the existing call points or pull-through for that product?

As for how NOCDURNA is performing compared to XYOSTED in creating opportunities, it is evident that there are physician offices that are not currently using XYOSTED but are interested in learning about NOCDURNA. This allows us to enter those offices and promote both products. It has enabled us to engage in discussions about both products when they might have previously been hesitant to consider XYOSTED. We have clearly observed this in the field and believe this trend will persist, especially as we gain more access to physicians' offices. Launching a product during the pandemic is likely one of the most challenging tasks, but our team has done an excellent job of communicating the benefits of both NOCDURNA and XYOSTED during these tough 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?

Regarding your first question about EpiPen and our expectations moving forward, we anticipate a strong second quarter due to the pandemic. There are many EpiPens being kept at various vaccination sites and offsite locations to address potential anaphylactic shock. We expect this trend to continue at least through the second quarter, and possibly longer depending on the vaccine rollout. In the third quarter, we expect a typical back-to-school market, which has historically been the strongest period for EpiPens. As students return to school, parents usually purchase EpiPens for their children to have both at school and at home. We anticipate seasonality returning, especially with announcements of schools reopening, supported by the current administration's push to ensure all schools are open in the fall. Therefore, we expect the third quarter to be very strong, while the fourth quarter may see a slight decline in demand as winter approaches, leading to less need for EpiPens due to fewer incidents like bee stings. Overall, we foresee a robust year for EpiPen for both us and Teva. We have delivered millions of devices and anticipate maintaining that volume. Could you remind me of your other question?

Yes, just on the potential launch of the Pfizer's product, how should we expect auto injectors to ramp in 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 have normally like a 2-year shelf life way ahead of potential approval and launch. So it will likely be more of an impact going into 2022.

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

Could you share your thoughts on how your commercial team can enhance the launch of NOCDURNA? What do you anticipate regarding initial patient demand? Additionally, will there be significant education for the sales team as you promote this product? Lastly, what do you believe are the key areas or quick wins for expanding NOCDURNA?

Great. I'll take that question. A 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 nighttime nocturnal polyuria. So it's really just started. We're starting to see new patients come on, new writers 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 a big component of the success of this product where we very likely 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, excess 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 prescriptions and their market share of about 53%, which has recently risen to as high as 57%, those are prescriptions for the normal refills of EpiPens. The EpiPens sent to mega sites and various vaccine centers are not recorded as prescriptions. This is why our growth appears to be significantly stronger than what the prescription market indicates, as there are sales occurring beyond that IQVIA scope. We know what we ship to Teva and what Teva ships to distributors, but we don’t know the exact percentage that went to those centers. However, we sense that a large portion of what we shipped is relative to prescriptions. I would estimate it to be at least 25% of what we used to see from a prescription standpoint.

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

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 an 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. Regarding the XYOSTED component, we have continued to increase the number of prescribers, now exceeding 7,800 doctors who have prescribed XYOSTED since its launch. We are reaching out to approximately 12,000 physicians, resulting in a high penetration rate. However, the prescribers still represent a relatively small portion of their overall testosterone sales. Our new targeting strategy aims to engage these doctors more frequently and delve deeper into their practices to capture a larger share of their business related to intramuscular injections and other products. We believe that once doctors recognize the benefits of XYOSTED and its ease of use—especially during the pandemic—it will facilitate their willingness to switch patients. Doctors often hesitate to change a patient's medication if they feel it is working well. However, it is generally easier for us to introduce XYOSTED to new patients who have never been on testosterone. Thus, our enhanced targeting strategy focuses on the doctors already prescribing it, who are currently allocating only about 10% to 20% of their business to XYOSTED, with the goal of increasing that percentage. Furthermore, we are minimizing calls on those physicians with less potential. In relation to NOCDURNA, our new strategy expands beyond XYOSTED targets to include over 1,000 doctors who specifically write for NOCDURNA-type products, and we plan to reach out to them significantly. This approach is intended to focus our efforts on securing more business from existing XYOSTED writers while also tapping into the new targets for NOCDURNA.

That's very helpful. I believe you mentioned during the last call that in-person calls to doctors were about 50% of targeted levels, and now you're saying it's around 60% this quarter. How strongly do you think these in-person calls are linked to the new patient starts?

I believe that a hybrid approach will always be present moving forward. We will continue to use a virtual component for the harder-to-reach doctors, particularly those who may not be as engaged. It’s not always necessary to meet them in person. However, we strongly feel that in-person meetings are more effective. While virtual calls are certainly more efficient, the effectiveness of in-person interactions cannot be denied. As we strive to increase our in-person engagements to around 80%, and especially as more patients return—given that many practices are still seeing a 25% decline—the resurgence of new patients is likely to continue fueling growth for XYOSTED. During the pandemic, the majority of our business came from switching patients from intramuscular therapy. Before the pandemic, we were seeing approximately 400 new patients per week for XYOSTED. That number dropped significantly, but we are now nearing pre-pandemic levels, sitting around 350 to 375 new patients weekly compared to below 200 at the pandemic's peak. We believe that the return of patients to the doctor's office will significantly boost growth in the latter half of this year. In-person interactions are critical for attracting new patients to choose XYOSTED, which is essential for generating multiple refills from those new patients.

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?

I can't provide a general answer for every physician's office since it varies. However, I would estimate that we are still seeing about a 20% to 25% decrease in new patients compared to pre-pandemic levels. The numbers fluctuate weekly, largely depending on whether a state is experiencing a COVID spike. For example, we noticed spikes in Texas and Florida that affected our business, and California experienced shutdowns recently. These situations influence patient flow and office accessibility. Currently, we are noticing some improvement and expect it to continue as more states lift their COVID restrictions. Overall, it's difficult to give a precise answer, but we are still down, though we anticipate normalization in the next few months.

Our next question comes from David Amsellem with Piper Sandler.

I apologize for being disconnected earlier, so I might have missed some of your earlier points. I have a high-level question regarding the business. It's clear that the top line is increasingly shifting towards proprietary products rather than partner products. With this in mind, how aggressive are you considering being in adding new assets where you can utilize the existing infrastructure, perhaps something similar to NOCDURNA or even a more transformational opportunity? Do you have an appetite for that? Additionally, could you provide some insights on the testosterone market, particularly regarding oral forms of testosterone or testosterone enanthate? How do you think that might impact market dynamics? Do you view it as simply generating more interest around Teva placement, or do you see it as a competitive threat?

I'll start by addressing the question about oral testosterone. In the U.S., there are more than 7.5 million testosterone prescriptions annually, with intramuscular injections making up about 70% of that market. XYOSTED is a subcutaneous injection, and we are steadily increasing our market share. The remainder of the market consists of gels that require daily application, and there is currently one oral testosterone product that is gradually gaining some traction. There's definitely room for additional oral products in the market. We're just beginning to explore what we can achieve with XYOSTED since intramuscular injections have been prevalent for so long. Physicians have been prescribing them for two decades, and many are habitually comfortable with this method. Therefore, persuading them to shift to a new product can be challenging, but we have seen considerable success with XYOSTED. Regarding oral testosterone, I believe they may eventually replace gels, which have been losing market share significantly in recent years due to their cumbersome daily use and messy application. Initially, when men are diagnosed with low testosterone, they might prefer the convenience of a gel, thinking it will be easy, but often find it less appealing in practice. This may lead some patients to consider oral options instead of injections. We believe XYOSTED addresses these concerns effectively. It's a painless, once-a-week injection compared to the oral products that are taken twice a day. While the oral forms aren't a perfect solution, I believe there is a large enough market for everyone to thrive. Oral testosterone certainly has its place, but XYOSTED remains the leading product, and we will continue to expand our market presence even with oral options available.

Taking our new products

Thank you for the question. In response to your inquiry about whether we are considering additional products similar to NOCDURNA or other transformational options, I can confirm that we are exploring both avenues. We are particularly focused on corporate development for marketed products that may be available in the endocrinology and urology sectors, or other niche markets where we believe we can effectively engage our sales team. We aim to utilize our existing relationships and have a dedicated sales force of about 80 people, along with approximately 10 district managers who are performing exceptionally well. Our goal is to add more products to our portfolio for them. On the transformational front, we are definitely examining companies and products, which do not necessarily need to involve combination products or injectables, as long as they align with our commercial strategy. We are currently working on several rescue pens and orphan-like products that provide us various opportunities for transformation, provided we identify the right company. While these opportunities can be challenging, we have a strong and growing business, and we want to ensure that any acquisitions we consider will be accretive. Thus, a number of our team members are focused full-time on seeking new assets and pursuing potential transformational acquisitions 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. Regarding Forteo, both Teva and Antares are quite disappointed with the FDA's lack of action. They are currently in discussions with the FDA to move the process forward. There are no outstanding issues, and it ultimately hinges on the agency's internal considerations regarding this complex generic. We anticipate it will be approved soon, and Teva shares the same expectation. If it launches this year, it will be a significant product for both us and Teva. We have a solid profit margin on the devices we sell, along with a high single-digit royalty in the mid-teens range. We are eager for this development, though we, like everyone else, are frustrated by the FDA's timeline. As for our 1901 and 1902 programs, 1902 is the one we plan to file the IND for first. We believe it fits seamlessly into our portfolio as a rescue pen in endocrinology for an orphan indication. We expect to provide protection for the product and support patients in a sizeable market. Current offerings face several limitations, and we believe ours can address many patient needs, representing a significant opportunity for Antares. We aim to file the IND in the first half of this year with an approval anticipated next year, reflecting a relatively quick turnaround. We've already held a pre-IND meeting with the agency, which is aligned with our development timeline. The focus now is on obtaining clinical supplies and conducting a streamlined study before filing. Regarding 1901, we also expect to file the IND in the second half of this year. This asset, which focuses on uro-oncology, encompasses a large market and will be a once-weekly auto-injector designed to enhance availability and patient compliance. Based on our pre-IND meeting with the agency, we feel confident in our clinical program, and this is likely to commence earnestly next year. Although this program is more complex and targets a '24 or '25 approval timeline, it remains a strong fit with our current and future objectives. Thus, we see promising opportunities with both 1901 and 1902.

Great. And any other program percolating in the background?

Yes, we are continuously searching for new opportunities. We aim to add another product, likely a rescue pen, to our portfolio or pipeline by the end of this year. Currently, we are developing a formulation for a specific product, and if it proves successful, that will be our focus moving forward. Additionally, we routinely explore new products. We have an internal product steering committee that includes members from commercial, regulatory, and clinical teams to ensure that the product has a viable path to meet regulatory and FDA requirements, as well as strong commercial potential. Therefore, we will keep looking for enhancements to our pipeline both internally and externally.

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

Thank you. Have a great day.