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Nektar Therapeutics (NKTR) Q2 2012 Earnings Report, Transcript and Summary

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Nektar Therapeutics (NKTR)

Q2 2012 Earnings Call· Thu, Aug 9, 2012

$59.38

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Nektar Therapeutics Q2 2012 Earnings Call Key Takeaways

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Nektar Therapeutics Q2 2012 Earnings Call Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Nektar Therapeutics Second Quarter 2012 Financial Results Conference Call. My name is Erin, and I’ll be your coordinator for today. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session toward the end of today’s conference. [Operator Instructions] As a reminder, this conference is being recorded for replay purposes. I would now turn the presentation over to your host for today’s call, Ms. Jennifer Ruddock. Please proceed, ma’am.

Jennifer Ruddock

Analyst

Good afternoon and thank you for joining us. With us today are Howard Robin, our President and CEO, John Nicholson, our Chief Financial Officer, Dr. Robert Medve, our Chief Medical Officer and Dr. Steve Doberstein, our Chief Scientific Officer. On this call, we expect to make forward looking statements regarding our business including but not limited to clinical development plans, the timing of future clinical results and regulatory filings, the economic potential of our collaboration partnerships including potential milestone payments, the therapeutic and market potential of our drug candidates and those of our partners, our financial guidance for 2012, and certain other statements regarding the future of our business. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes that are difficult to predict and many of which are outside of our control. You should refer to important risks and uncertainties are set forth in our Annual Report on Form 10-K filed in February and our Form 8-k filed today, available at www.sec.gov. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise. A webcast of this conference call will be available for replay on the Investor Relations page at Nektar’s website at www.nektar.com. Now, I would like to hand the call over to Howard Robin.

Howard Robin

Analyst · Brean, Murray

Thank you Jennifer, and thanks to everyone for joining us this afternoon. Nektar continues to make significant progress this year advancing our clinical and preclinical programs and greatly strengthening our financial position. I would like to give you a business update and then hand the call over to John for a review of the financials. Last month, we completed a $125 million private placement of Senior Secured Notes that strengthens our balance sheet without any dilution to our shareholders. These Notes, which have no equity or warrants associated with them, are due in July of 2017 and callable by Nektar beginning in July of 2015. Importantly, the notes have no financial performance targets and we retain the freedom to operate our business as we have in the past, including, for example, our ability to enter into collaborative transactions or monetize royalties. We are very pleased with this transaction which we believe reflects the strength of Nektar’s proven technology and our late-stage pipeline. The placement of these secured notes builds on the $124 million sale of nonstrategic royalties that we completed in the first quarter of this year. Funds from these 2 transactions will be used to repay the remaining balance on our convertible debt which is due in September of this year. This will eliminate the significant dilution associated with convertible debt for Nektar. After repayment of the convertible debt, we now expect to end 2012 with approximately $300 million in cash and investments which should give us multiple years of working capital and bring us through many important potential product milestones. Now I’d like to review the significant progress we’ve made with our clinical pipeline in the past quarter. Let me start first with an update on naloxegol, a peripherally-acting mu-opioid receptor antagonist being developed by AstraZeneca as a once-daily oral tablet for the chronic treatment of opioid induced constipation or OIC. In 2011, AstraZeneca initiated a global and comprehensive Phase 3 clinical program for naloxegol. The planned registration package will include 2 pivotal studies to evaluate the efficacy and safety of naloxegol in patients with chronic non-cancer pain, a 6-month extension study, and a long-term safety study. The 2 pivotal placebo-controlled studies each include an estimated 650 patients with OIC with a primary endpoint based on a 12-week treatment period. In addition, one of the pivotal studies has a 6-month double-blind extension. Finally, the 52-week long-term safety study is a randomized, open label study design. This comprehensive Phase 3 program is the only one of its scope and size for the treatment of opioid induced constipation. We are very pleased to report today that AstraZeneca and Nektar anticipate announcing high-level results from the 2 pivotal studies and the extension study in the fourth quarter of this year. AstraZeneca is also planning a full presentation of the efficacy results at a scientific meeting in 2013. Results from the 1,135 patient long-term open label safety study are anticipated in the first quarter of 2013. Importantly, AstraZeneca remains on track for mid-2013 global regulatory filings for naloxegol. There are an estimated 100 million chronic pain patients worldwide that are treated with opioids and up to 50% of these long-term pain patients develop constipation. AstraZeneca estimates that there are 5 key markets that account for over 90% of patients taking opioids for chronic pain. These are the U.S., Canada, France, Germany and the UK. Primary care practitioners and pain management specialists make up the majority of prescribers in these key markets. AstraZeneca, with its global presence, is an ideal development and commercial partner for naloxegol. Under our agreement with AstraZeneca, Nektar is entitled to receive $95 million upon acceptance of regulatory filings in the US and EU. We will receive an additional $140 million in regulatory and launch milestone payments when naloxegol is approved and launched in the US and EU. Nektar is also entitled to significant escalating double-digit royalties on product sales of naloxegol and up to $375 million in additional sales milestones at certain commercial sales levels. As a reminder, AstraZeneca is responsible for all costs of development and commercialization of naloxegol. We are very excited about the advancement of this program and look forward to the studies completing this year. I’d now like to update you on the significant progress we’ve made with NKTR-181, our novel mu-opioid agonist molecule, the first opioid analgesic of its kind. As a new molecule, NKTR-181 has been specifically engineered with a number of important properties inherent to the molecule. First, NKTR-181 has been designed to enter the CNS slowly, thereby avoiding the dopamine rush of traditional opioids that is associated with euphoria and can lead to abuse and addiction. This slower rate of entry should also reduce other serious CNSmediated side effects seen with traditional opioids, such as sedation and respiratory depression. The abuse and diversion of opioids is a serious public health issue and solutions to this problem are desperately needed. In May, we received Fast Track designation from the FDA for the NKTR-181 development program for the treatment of moderate to severe chronic pain. This designation underscores the unique potential that NKTR-181 has to address the urgent medical need for pain therapies with less abuse potential and fewer side effects. As an NCE, NKTR-181’s potentially differentiating properties are inherent to its new molecular structure and are not a result of a physical barrier or formulation. The Phase 2 trial of NKTR-181 for the treatment of chronic pain is now underway. The study utilizes a placebo-controlled design to assess the efficacy, safety and tolerability of NKTR-181 in 200 opioid-naïve patients with moderate to severe chronic pain from osteoarthritis of the knee. This Phase 2 study utilizes an enriched enrollment study design that is a standard design used in the development of opioid compounds. We will also be conducting a human abuse liability study, which will compare the likeability of NKTR-181 to commonly abused opioids in approximately 20 recreational drug users. We expect to complete the Phase 2 development program for NKTR-181 by the middle of next year. Our next novel opioid molecule, NKTR-192, has a distinct profile from NKTR-181. It is also designed to have reduced abuse liability and fewer CNSmediated side effects but is short-acting and designed for the treatment of acute pain. We have successfully completed our first Phase 1 single ascending dose pharmacokinetic study for NKTR-192, which confirmed that the PK profile of NKTR-192 is well-suited for the treatment of acute pain. Next month, we will start a second Phase 1 study to evaluate single ascending doses of NKTR-192 on both PK and pharmacodynamic endpoints. The second study should be complete by the end of the year. With NKTR-181 and NKTR-192 in our pipeline, Nektar can address both the chronic and acute pain markets. In the US alone, there are over 148 million opioid prescriptions written annually for patients with chronic pain, and over 100 million prescriptions written annually for acute pain conditions. We are extremely excited about the advancement of these important new pain candidates and we look forward to sharing more on NKTR-181 and NKTR-192 as they move through clinical development. Now let’s talk about etirinotecan pegol, or NKTR-102, our targeted topoisomerase inhibitor being developed as a single agent in several tumor settings. Recruiting is going very well in Nektar’s ongoing Phase 3 BEACON study of etirinotecan pegol in patients with metastatic breast cancer. BEACON is an open label, randomized head-to-head trial, which will enroll approximately 840 patients comparing single-agent NKTR-102 to an agent of physician’s choice with a primary endpoint of overall survival. To date, we have initiated over 80 clinical sites in the U.S., Canada, and Europe. We are planning approximately 160 sites worldwide. Enrollment in the BEACON study is expected to be completed in 2013 with data expected in 2014. We believe etirinotecan pegol could provide physicians and patients with an important and much needed new therapeutic weapon in fighting breast cancer. Cross-resistance is a key problem with existing therapies. As the only targeted topo I inhibitor being developed in breast cancer, etirinotecan pegol offers a different mechanism of action from microtubule inhibitors, which are the most commonly used drugs to treat these patients. If the BEACON study is successful, NKTR-102 will have the opportunity to become a worldwide standard of care in advanced breast cancer. In platinum-resistant ovarian cancer, our Phase 2 expansion study is ongoing. We expect that the study will conclude towards the end of 2012. Following its conclusion, we will analyze the final data and meet with the FDA and the EMA to discuss our regulatory options and possible next steps for the development of NKTR-102 in ovarian cancer. This week, we announced our first investigator-sponsored study with NKTR-102 in patients with avastin-resistant high-grade glioma. The Phase 2 single-arm study is being conducted by Dr. Lawrence Recht at Stanford Cancer Institute and will enroll up to 20 patients with glioma. Dr. Recht is Professor of Neurology and Neuroscience at Stanford and is a world-renowned specialist in cancers of the brain. We are excited about Dr. Recht’s interest in our technology, and NKTR-102’s potential to help a patient population that currently has little to no treatment options. In addition to the small molecules we just discussed, a key element of Nektar’s success in building our pipeline is our ability to enable protein and peptide therapeutics, such as BAX 855 and OMONTYS. BAX 855 is a PEGylated long-acting form of ADVATE that is partnered globally with Baxter for the treatment of hemophilia A. BAX 855 is currently in a Phase 1/2 clinical study which is expected to complete this year. Baxter is targeting the start of Phase 3 by the end of 2012. We are very excited about this program. Baxter is a world leader in the treatment of hemophilia, and ADVATE, their Factor VIII molecule is approved in 53 countries with sales in excess of $2 billion annually. In preclinical studies, BAX-855 achieved a profile that supports its potential to be dosed less frequently than ADVATE. Analysts estimate an annual market potential of $3-4 billion for long-acting Factor VIII products. Under our agreement with Baxter, Nektar will receive significant royalties on net sales of BAX 855. We are very pleased to be partnered with Baxter on this important development program for their ADVATE franchise. OMONTYS, marketed by Affymax and Takeda, is another successful example of the application of Nektar’s technology platform. In fact, OMONTYS is the 8th product approved that was enabled by Nektar polymer conjugate technology. Affymax and Takeda launched Omontys in April and they recently announced 2 supply agreements. One with Fresenius, one of the world's leading dialysis providers and another with U.S. Renal Care, representing one of the top 10 providers in the U.S.. Analyst estimates for OMONTYS range as high as $700 million in the US dialysis market alone. Our agreement with Affymax includes mid-single digit royalties on global sales of OMONTYS, as well as manufacturing revenues. Now moving on to another important partnered program, Amikacin Inhale, which is being developed to treat gram negative pneumonias in patients on ventilators in the ICU. Devices for the Phase 3 study of Amikacin Inhale have been manufactured and are undergoing final stability studies. Bayer has selected its CRO and has started Phase 3 activities. They expect to initiate dosing in early 2013. The Phase 3 program for Amikacin inhale will be conducted under an SPA, which will enroll approximately 1,200 patients with a primary endpoint of clinical test of cure. Amikacin inhale represents considerable potential economic value for Nektar. Gram negative bacteria make up 70% of all ICU pneumonias and are associated with very high rates of morbidity and mortality. Current IV standard of care therapies are limited by their inability to reach effective concentrations in infected lungs. By targeting the lungs directly with antibiotic, Amikacin Inhale could emerge as a very important treatment for these deadly pneumonias. Upon commercialization, Nektar will receive a flat 30% royalty in the US and an average ex-US royalty of approximately 20% on all product sales. Finally, before I hand the call to John, let me remind you that in addition to our clinical programs, we have several preclinical candidates in late-stage research, including NKTR-171 for neuropathic pain and NKTR-214 for cancer immunotherapy. We plan to announce our next IND candidate by the end of this year. Nektar is in an enviable position scientifically, clinically, and financially. We have built an incredibly diverse pipeline over the last 5 years. We have 2 programs in Phase 3, naloxegol and NKTR-102. 2 programs preparing for Phase 3, BAX 855 and amikacin inhale, and 2 pain programs, NKTR-181 and NKTR-192 in Phase 2 and Phase 1, respectively. These programs capitalize on different aspects of our technology platform across multiple therapeutic areas, spreading development risk and clearly demonstrating the breadth and depth of opportunities available to us with both large and small molecules. Further, our scientific strategy, to address proven human disease targets with well-understood mechanisms of action, should increase probability of success while still allowing us to address significant unmet needs. There are very few technologies in the pharmaceutical industry that are capable of generating such a diverse, innovative, and valuable pipeline. I am exceptionally proud of the team at Nektar and I’m exceptionally proud of the company we are building. With that, I will now turn the call over to John. John?

John Nicholson

Analyst · Brean, Murray

Thank you, Howard, and good afternoon, everyone. At the end of the second quarter, cash and investments were $477.1 million. Following the end of Q2, in July, we completed the placement of $125 million of senior secured notes. This transaction, along with the $124 million monetization of non-strategic royalties completed in Q1, will be used towards the repayment of the remaining convertible debt in September of this year. We expect to end 2012 with approximately $300 million in cash and investments. Our financial guidance for 2012 remains unchanged. We expect our cash used in operations, including capital expenditures, to be between $130 million and $140 million. Revenue for 2012 is expected to be between $75 million and $85 million. Our R&D expense guidance is still between $152 million and $157 million, with approximately $19 million of this as non-cash expenses, such as stock-based compensation and depreciation. 2012 G&A is still anticipated to be between $44 million and $46 million. Included in our 2012 G&A expense are $11 million of non-cash items, such as amortized free rent on our San Francisco facility, stock-based compensation expense, and depreciation. Total revenue in Q2 2012 was $23.7 million versus $17.3 million in the second quarter of 2011. Total revenue was $41.6 million in the first half of 2012 compared to $28.6 million in the first half of 2011. Revenue increased as a result of higher product sales, royalties, and collaboration revenue. Total operating costs and expenses in the second quarter of 2012 were $50.7 million versus $51.6 million in the same quarter a year ago. For the first half of 2012, total operating costs and expenses were $106.6 million as compared to $96.8 million for the same period in 2011. Total operating costs and expenses increased primarily because of increased cost of goods related to higher product sales as well as higher development expenses. R&D expenses in the second quarter of 2012 were $33.2 million as compared to $32.3 million in the second quarter of 2011. In Q2 2012, research and development expenses included $4 million of non-cash expense, primarily stock-based compensation and depreciation. R&D expenses for the first half of 2012 were $68.3 million as compared to $62.4 million in the first half of 2011. R&D expenses in the first half of 2012 included the ongoing costs of the NKTR-102 BEACON Phase 3 study, the production of devices for the Phase 3 study of Amikacin Inhale, the Phase 1 study for NKTR-181, preparations for the Phase 2 study for NKTR-181 and the Phase 1 study for NKTR-192. For the second quarter of 2012, G&A expense was $10.3 million compared to $11.2 million in the same period of 2011. In Q2 2012, G&A expense included $2.3 million of non-cash expenses, primarily stock based compensation, depreciation, and amortized free rent. G&A expense was $20.7 million for the first half of 2012 compared to $22.9 million for the first half of 2011. Interest expense for the first half of 2012 was $12.3 million and included $7.3 million of non-cash interest expense related to the monetization of the nonstrategic UCB Cimzia and Roche Mircera royalties. We expect interest expense for the rest of 2012 to be approximately $11 million in the third quarter and $10 million in the fourth quarter, which includes $5.5 million of non-cash interest expense in the third and fourth quarter related to the royalty monetization. Let me remind you again that we plan to end the year with approximately $300 million in cash and investments. With that, I will now open the call to questions. Operator?

Operator

Operator

[Operator Instructions] Your first question comes from the line of Jonathan Aschoff from Brean, Murray.

Howard Robin

Analyst · Brean, Murray

Yes. I -- just for everybody in the call, we’ve just been informed that -- by the conference call provider that there was some technical fault, and we did notice some technical difficulty during the call. If you noticed at one point I had to stop because we are having some difficulty with the conference call procedure. So if right now we were trying a different system and we can hear you. So please, if you can stay on the call, everybody on the call please feel free to ask as many questions as you like, and we’ll try to clarify for you. So go ahead Jonathan, I can hear you now yes.

Jonathan Aschoff

Analyst · Brean, Murray

Okay. So regarding abuse resistant competitors, have abusers sound ways to better abuse that latest version OxyContin that was approved in 2010, and is that potential Pfizer competitors has immediate released only, is that just on unabusable in that non-oral route to administration is difficult?

John Nicholson

Analyst · Brean, Murray

Little bit, yes. All right, if you can hear me, I’m going to let Rob answer that question to you.

Robert Medve

Analyst · Brean, Murray

All right, Jonathan, it’s Rob. Thank you for the question. Two parts to the answer. One around the reformulated OxyContin. All of these things generally fall in this category where there are sort of physical barriers to accessing the active pharmaceutical or the API. The API itself is the issue of these compound, essentially immediately and they play in once they are in the blood and that’s why people try to manipulate it from and can get them in faster. So the answer is yes. Apparently [indiscernible] That immediate release of oxycodone and the formulation similarly [indiscernible] compound relatively quick as an immediate release.

Jonathan Aschoff

Analyst · Brean, Murray

Okay. And could you guys please highlight some key primary, secondly endpoints that may have been strongly encouraged by FDA for NKTR-118?

John Nicholson

Analyst · Brean, Murray

Yes. I’ll let Rob to comment on that specifically, but I think as I mentioned I hope you heard this during the call, that we put together what we believe is the most comprehensive program in depth and breadth that has been done for drugs such as NKTR-118 to treat opioid-induced constipation. And we believe that we have the most expensive program available. And I’d like to let Rob comment on your question regarding key endpoints.

Robert Medve

Analyst · Brean, Murray

I mean these are two very big development program that been through lots of up. The breadth and depth for in the loss of our Forex fees what have been done in support of [indiscernible]. The last of our program is robust, it’s proactive and it incorporates feedback from the FDA and the EMA on appropriate endpoints. Now there are many more differences than there are similarities between the programs, but the key differences are really around the end points and the dosing. Importantly, naloxegol incorporates 12 daily dosing in pivotal trials whereas the rest of the program was 4 weeks followed by (inaudible) so in terms of market differences in the primary endpoints relative [indiscernible] were full 12-week responder analysis. And it’s really important to note that the 12-week responder analysis was specifically recommended by the FDA as a necessary to support a chronic once-daily indication. Another important differences around the nature of the safety data being collective, the last program has randomizing control sleeping database [indiscernible] exposure. But as I mentioned, they are very, very different programs AstraZeneca put together a very robust program really seeks to proactively address potential issues. So we’re very pleased.

Jonathan Aschoff

Analyst · Brean, Murray

How about specific ways of monitoring opiate withdrawal?

John Nicholson

Analyst · Brean, Murray

Yes. There are very specific ways to measure that. We incorporate -- there are instruments that are specifically designed to capture potential opioid withdrawal symptom post objective symptoms withdrawal and objective symptoms withdrawal. So, when I mentioned the program being robust and proactive, I’m referencing they were proactively looking for things that one would presume to be potential issues and that includes issues around withdrawal.

Howard Robin

Analyst · Brean, Murray

Jon, this is Howard. I think, look it’s very difficult to understand what the current status of [indiscernible] is there is not a lot of information for forthcoming and what the FDA’s concerns are. But I would say this, I looked at them last call. I wouldn’t look at the last call [indiscernible] clinical development for -- I mean, really short clinical development brought them in the same way at all, very, very different programs, very different endpoints and we took a lot of advice from the FDA. So, we leave at that.

Jonathan Aschoff

Analyst · Brean, Murray

Okay. And then lastly, simply yes or no I guess. Is Astra speaking any other slower at inversion of 118 that predominantly seek to foster daily rather than any kind of PRMUs ?

John Nicholson

Analyst · Brean, Murray

Well, the NKTR-118 is being developed as daily chronic therapy and not PRM, I’m not sure I followed your question.

Jonathan Aschoff

Analyst · Brean, Murray

Okay. So like nothing that works even slower than that is in your plan, is that true, like a slower onset?

John Nicholson

Analyst · Brean, Murray

No. We’re developing naloxegol as a once-daily oral formulation. And I can’t speak for AstraZeneca’s plan for potential follow-on on life essential products.

Operator

Operator

And your next question comes from the line of Bob Hazlett from Roth Capital.

Robert Hazlett

Analyst · Bob Hazlett from Roth Capital

I too am having serious difficulties hearing you folks. So if I ask something that’s been touched on, my apologies. Really 2 separate things, just one more on the -- on the 118 program. I believe, Rob, you mentioned the differences between Relistor and the 118 program, really the time to VEN analysis versus your 12-week responder analysis, I think I got that. We talked about the opioid withdrawals. What other differences can you specifically point out between the 2 -- the programs that would influence FDA? And again, my apologies if I’ve asked this again, but again the breakup in the phone line is very difficult to manage.

Robert Medve

Analyst · Bob Hazlett from Roth Capital

No. We apologize for the technical difficulty. So, the programs are very, very different in scope, as you might imagine. The program for naloxegol is built in support of full NDA filing, it’s not an S&DI state filling obviously. So there is a lot more data being generated around that. We’re following pain data, opioid use, all sort of things. And the secondary end points are actually listed on the clinicaltrials.gov for the pivotal and the safety trial. So you can certainly find a comprehensive listing of them there. But we believe this program is very proactive in addressing, what may -- what one would think of as the typical piece of the information you would really want to know around, are opioid use patterns changing during the trail, are pain scores changing during the trail, or the safety data. So everything is working. That’s why it’s every important to have a controlled safety database, not just everybody on drug and not knowing how to interpret anything that you might absorb. So there is -- as I mentioned there is many more differences than there are similarities between the programs and strategically the naloxegol program that is designed to be a full global regulatory filing and not just a trial in support of an SNDA.

Robert Hazlett

Analyst · Bob Hazlett from Roth Capital

That’s helpful. And the reception seems to be a bit clear now. So thank you for that as well. Just 2 more quick ones. In terms of the Bayer program in the single-used device, have you set down specifically that have enough product or enough devices -- single-use devices to initiate Phase 3? And when should we expect milestones from that program? I think there are some still upcoming if I’m not mistaken in terms of development?

Howard Robin

Analyst · Bob Hazlett from Roth Capital

Yes. Well, we do have enough devices manufactured. They are in final stability testing. And as I said, you may not have heard it during the call, Bayer has now hired a CRO, and it’s planning and starting up Phase 3 activities in terms site recruitment, et cetera. So we do have sufficient quantities. I think there is a $10 million milestone on the start of Phase 3. And we do expect that to start early in 2013, but the important answer is yes, we do have the devices manufactured. They are on final stability testing and Bayer has hired a CRO and he is starting up Phase 3 activities.

Robert Hazlett

Analyst · Bob Hazlett from Roth Capital

And again that’s clear. And just one more quick one, in terms of the potential next in the clinical, I am seeing a lot of focus on NKTR-171 in terms of the additional pain programs, is that a likely candidate for the next in the clinic, and peripherally-restricted sodium channel blocker?

John Nicholson

Analyst · Bob Hazlett from Roth Capital

Well look I’ve said that NKTR-171 for peripheral pain as you properly describe and a NKTR-214 which is cancer therapy, are the 2 next programs that are vying for the next IND filing, which we said we would have by the end of year. And I can’t comment on which one of those 2 it will be, but clearly NKTR-171 is very-very important and I would expect that we put a lot of emphasis on it.

Operator

Operator

And your next question comes from the line of Rashie Jain from JPMorgan.

Rashie Jain

Analyst · Rashie Jain from JPMorgan

This is Rashie on behalf of Cory Kasimov from JPMorgan. Thanks for taking my questions. I have two. First, how much data will be top-lined with the Phase 3 results later this year, if you could provide us more granularity in terms of what end points and measurements we can expect? And second, with respect to filings, I wanted to -- in ovarian cancer, are you proposing similar regulatory options in U.S. and EU? Thanks a lot.

Howard Robin

Analyst · Rashie Jain from JPMorgan

Okay. Let me do the first question and I’ll have Rob answer in more details. But as we’ve said and I heard you -- I hope you heard this during the call that Nektar and AstraZeneca plan to provide top line results from the NKTR-118 Phase 3 pivotal programs in the fourth quarter of this year. So, I’ll let Rob comment on what’s that top line results should look like in terms of data.

Robert Medve

Analyst · Rashie Jain from JPMorgan

Yes. And I didn’t completely hear your questions. So I hope I’m answering the right question. Let me say, the total high-level data generally we’re talking about top line around primary and key secondary end points. There’ll be 2 pivotal trials as noted and also the 6 month extension, which is primarily a safety trial. So, we’ll have safety and efficacy data as what we are expecting. And could you read -- we were a little -- had a little difficult hearing you as well. What was the answer to your second question, what was your second question?

Rashie Jain

Analyst · Rashie Jain from JPMorgan

Yes. Sure. With respect to filings for 102 ovarian cancer, so are you proposing similar regulatory options in the U.S. and EU both?

John Nicholson

Analyst · Rashie Jain from JPMorgan

Yes. We are absolutely looking at what we - where we can go with NKTR-102 in ovarian cancer in the EU as well and we think there is a number of good options.

Operator

Operator

[Operator Instructions] Your next question comes from the line of Biren Amin from Jefferies.

Biren Amin

Analyst · Biren Amin from Jefferies

Thanks for taking my question. I have one question on naloxegol. Given the dropout would be considered non-responders in the primary efficacy responders analysis, what measures if any are being utilized to minimize dropouts in both Phase 3 trials? And are your assumptions for dropouts in the Phase 3 program similar to the discontinuation rates that have been observed in the Phase 2 trial? Thanks.

Howard Robin

Analyst · Biren Amin from Jefferies

Well, much of that I can’t speak to and those are AstraZeneca questions. We do, in these trials, typically handle dropouts the way we do in clinical trials. So people can dropout for like of efficacy. They can also dropout for adverse events. Both are relevant to interest, relevant and interesting endpoints of course. The way we deal those is in line with what’s typically done in a statistical analysis plan. So, I’m not sure I’m directly answering your question, so it’s not a specific measure to try to encourage patients to continue dosing that could potentially muddy your results if you try to do something like that. Am I getting to your question Birin?

Operator

Operator

And I would now like to turn the call over to Howard Robin for closing remarks.

Howard Robin

Analyst · Brean, Murray

Well, thank you. I’m I glad you were able to bear with you today. And I am sorry about this technological problem. We’re going to make sure that the webcast replay has a full audio check and that’s its crystal clear, and the transcript is accurate. So please go to our website if you want to listen to this again. We’ll make sure it’s crystal clear for you. And feel free if there are any other questions, do contact Jennifer Ruddock, we’ll make sure that we set up the appropriate meetings. And I again I apologize for the bad audio. But I’m very, very happy with the progress the company is making and I think we’re in excellent position both scientifically, clinically and financially. And it’s turning out to be so far very, very good year for Nektar. So thanks for sticking with us. I appreciate it. We will see you all at the UBS Conference in New York. Thanks a lot. Bye-bye.

Operator

Operator

Thank you for your participation in today’s conference. This concludes the presentation. You may now disconnect. Have a good day.