Earnings Labs

Nektar Therapeutics (NKTR)

Q1 2014 Earnings Call· Wed, May 7, 2014

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Nektar Therapeutics’ First Quarter 2014 Financial Results Conference Call. At this time all participants are in a listen-only mode. Later, we’ll conduct a question-and-answer session and instructions will follow at that time. (Operator instructions) I would now turn the call over to your host, Jennifer Ruddock, Vice President-Investor Relations. Please go ahead.

Jennifer Ruddock

President

Thank you, Stephanie. 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 clinical development plans, the timing of future clinical results, potential regulatory filings and commercial launch timing, the economic potential of our collaboration partnerships, the therapeutic and market potential of our drug candidates and those of our partners, our financial guidance for 2014 which includes potential milestone payments, 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. Important risks and uncertainties are set forth in our Annual Report on form 10-K, which was filed with the SEC on February 27, 2014. 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 call will be available for replay on the IR page at Nektar’s website at nektar.com. With that, I would like to hand the call over to Howard. Howard?

Howard W. Robin

Management

Thank you, Jennifer, and thanks to everyone for joining us this afternoon for our first quarter 2014 conference call. I would like to first focus on our late stage drug candidates Naloxegol, BAX 855 and NKTR-102 each of which is poised to achieve significant milestones in the near-term. I will also spend sometime discussing our plans for NKTR-181, which is being prepared for Phase 3. Finally, I will briefly discuss our earlier stage portfolio, we recently completed the first Phase 1 clinical study for NKTR-171, our new molecule to treat neuropathic pain and we are also developing several additional drug candidates in the area of pain management, as well as a highly promising cancer immunotherapy program. We ended the first quarter of 2014 in a strong cash position with $309 million in cash and investments. Later in the call, John will update you with our specific financial guidance for this year. As you know, Nektar has five highly valuable late stage program spanning multiple therapeutic areas that are either filed or in Phase 3 clinical testing, four of which are being developed by our pharmaceutical partners, AstraZeneca, Baxter, and Bayer. The economics of our late stage programs are significant for Nektar, and so we are excited that three of these programs, Naloxegol, BAX 855 and NKTR-102 have data and regulatory milestones over the coming months. First, we are anticipating approval and commercial launch of Naloxegol for opioid-induced constipation in the U.S., EU, and Canada, which will trigger milestone payments to Nektar of up to $175 million. Second, in the third quarter, our partner Baxter plans to announce Phase 3 data for BAX 855 and hemophilia A and plans to file a BLA in the U.S. by year end. And third, Phase 3 data from the NKTR-102 pivotal study in women…

John Nicholson

Chief Financial Officer

Thank you, Howard, and good afternoon, everyone. I will start with reiterating our financial guidance for 2014, which remains unchanged from our 2013 year-end call. For 2014, we still plan to end the year with approximately $225 million in cash and investments, representing a net use of cash of approximately $155 million. We anticipate in the launch of naloxegol in the first quarter of 2015, which would trigger launch milestones to Nektar of $100 million for the U.S. and $40 million for Europe. As a result, for 2014, year-end cash balance does not include these launch milestones. Revenue for full year 2014 is still expected to be between $190 million, $195 million. This guidance includes the anticipated recognition of two significant milestones in the third quarter of 2014, pursuant to the agreement with AstraZeneca signed with Roche. The $17 million milestone payment that we already received from AstraZeneca in Q4 2013 and a potential new $35 million milestone payment from AstraZeneca, both of which are related to FDA confirmation that a significant pre-approval cardiovascular safety study for naloxegol will not be required. In addition in the fourth quarter, we expect to recognize additional milestones related to other collaboration, new math of approximately $12 million to $17 million, remain of our revenue for the year-over-year approximately evenly split between the last three quarters of the year including $20 million of non-cash royalty revenue from UCB’s CIMZIA, and Roche’s MIRCERA. Our R&D expense guidance is still between $165 million and $175 million would approximately $16 million of this is non-cash items such as stock-based compensation and depreciation expense. 2014 G&A is still anticipated to be between $40 million to $42 million, which includes $10 million of non-cash expense. Total revenue of Q1 2014 was $19.8 million versus $23 million in the first…

Operator

Operator

Thank you. (Operator Instructions) Our first question comes from Jonathan Aschoff of Brean Capital. Your line is open. Jonathan M. Aschoff – Brean Capital LLC: Thank you. I was wondering what are your thoughts on Pfizer becoming the new owner of naloxegol potentially, and what are your plans for NKTR-102 in glioma and then have a couple others?

Howard W. Robin

Management

Okay, hi, Jonathan. Look, clearly, there is a chance that Pfizer acquires AstraZeneca, and then our contract for naloxegol clearly covers that, and it would become the ownership of Pfizer and they would be obligated to all the provisions under the contract. Quite frankly, I think it actually fits very well with Pfizer’s portfolio. If you look at what Pfizer is doing in the area of primary care, if you look at what Pfizer is doing in the area of pain management. I think actually in the lot of it fits very well there. So, I think they are accompanied that has excellent marketing skills. I think you; we’ve done a tremendous job in shaping that company. And quite frankly, I’d be totally fine with naloxegol being marketed by Pfizer, just as I would be very fine with naloxegol being marketed by AstraZeneca. Jonathan M. Aschoff – Brean Capital LLC: Thanks. And the NKTR-102 in glioma?

Howard W. Robin

Management

Well, we said that we will be presenting at ASCO on May 31, based on the results of the work that Dr. Reck and Dr. Paul did at Stanford. I have no further comments that I can make a response to would you like that to say something else about it perhaps.

Howard W. Robin

Management

No, look I think it’s really exciting what we’ve seen so far in that program. And clearly, it’s a devastating disease and very poor prognosis. I think that our current investigators on that study, I think are excited in discussing what to do next. We have to take a look at the data from ASCO, I think that’s going to be great, we’ve got a lot of preclinical data that supports these effective one or two in various brain captures as well as metastasis to the brain from Mongrain cancers. So I think it’s an exciting path forward. We’re looking forward now to the outcome of the BEACON trial and I think that’s where our real attention is focused that we’ll be able to talk more about glioma later in the year I would expect. Jonathan M. Aschoff – Brean Capital LLC: When do you guys expect to see the Federal register populated with everything for this panel coming up, to get some comfort that it won’t be a second delayed panel?

Howard W. Robin

Management

Well, we don’t have the exact date. but I would say it’s either later this month very early June it’s hard to be precise, I mean the date that have been schedule tentatively and I said tentatively in the discussion earlier, I think those will be the final dates, but we have to wait and see when that publishes. I would say it’s in the very near future. Jonathan Aschoff – Brean Murray, Carret & Co.: Okay. And what product sales would decrease 1Q 2013 to 1Q 2014, what were those exactly?

John Nicholson

Chief Financial Officer

Yes, Jonathan, basically why we’re having a decrease is, as you know, we started couple of years ago that our purpose in life was not to be a CMO for major pharmaceutical companies, it was basically to develop our own drugs. And so, at this point in time, one of the things that our partners have been doing is taking on manufacture of PEG reagent themselves. So in all reality with the shortfall is, is that basically, it’s been more than just one product, but it’s basically partners picking up manufacturing of their own PEG reagent and that’s concentrating on us specifically our own reagents. Jonathan Aschoff – Brean Murray, Carret & Co.: Okay, thanks.

Howard W. Robin

Management

Jonathan, let me add to that. I mean, I think like John said, we are not a contract manufacturer. And we use our manufacturing facility principally to make at this point forward to make our own products. But of course, we have contractual obligations with other companies and we always want to fill the plan as best we can to absorb the overhead. So that will fluctuate at a point in time, sometimes we’re manufacturing for others, we absorb all overheads, sometimes we maybe making product for ourselves in which phase I can’t absorb all the overhead into revenues. So, it’s going to vary. I think you have to recognize that one of the strongest assets Nektar has is that, we do have our own in-house CMC programs and manufacturing capability for our own programs. And I think that sets us apart in many ways. But I think you will see fluctuations there, because, we are not setting up a strategy to be a contract manufacturer. To the extent that we bring in additional business, but still the unused capacity will always try to absorb overhead that way. But in many times, you will see that we are manufacturing for ourselves as opposed to others. Jonathan Aschoff – Brean Murray, Carret & Co.: Okay. Thanks a lot, guys.

Operator

Operator

Our next question comes from Cory Kasimov with JPMorgan. Your line is open. Cory W. Kasimov – JPMorgan Securities LLC: Hey, good afternoon, guys. Thanks for taking the question. I really just wanted to ask about your expectations for next month’s advisory committee meeting, assuming that it doesn’t take place next month. I guess I’m curious in your expectations for how it may be set up, and maybe the types of questions the FDA would be asking the panel, given that there are multiple parties involved. Do you anticipate that there are perhaps voting questions related to individual products, or is it more overall class related?

Howard W. Robin

Management

Well. Look, it’s a very good question, and is the question that we really can’t answer yet, because we don’t have the FDA briefing package yet. So how that meeting, what questions they are going to ask? We don’t know at this point. I can’t tell you that clearly there are number of companies there. I think the questions will – each company will have its own time to discuss its own product. There are significant differences between these drugs, of course, but mechanistically they are very different. They are all going after the new opioid receptor, but they are approaching the mu-opioid receptor in very different ways. So it isn’t really a class in that sense, but these drugs are all distinct, and I think it will be interesting to see how this unveils itself. The FDA has to make certain decisions. The advisory panel certainly has to make certain decisions. I believe that AstraZeneca and Nektar have done a great job in pulling together a briefing book and a set of data that clearly supports the safety of Naloxegol from a cardiovascular point of view. But it is not common that the FDA closing advisory panel with multiple companies like this. So it’s hard to predict how to go. I do know that each company has its own individual time to be asked questions and to respond. And that’s at this point I don’t know what questions that FDA will ask. Cory W. Kasimov – JPMorgan Securities LLC: Okay. And have you found all of the activity taking place between Pfizer and AstraZeneca to be a distraction for AstraZeneca, in terms of their preparation work ahead of the panel?

Howard W. Robin

Management

No I don’t know, not at all, not at all actually. The team that has been actively working on the Adcom preparation is highly focused, I don’t see them distracted at all. And I also know that AstraZeneca has been very active in educational activities in OIC. So if you look at the type of booths they’re setting up in the educational materials, they’re providing NOIC just in May alone just the American Pain Society, Digestive Disease week, SMIs, Pain Therapeutics Meeting, I mean they have a major presence in educating about OIC. So I think they are very committed to it, I think the keenness working on the Adcom has not missed the beat regardless of what’s happening at the corporate level. So I’m pretty pleased with the work product. Cory W. Kasimov – JPMorgan Securities LLC: Okay. Thanks for taking the questions.

Operator

Operator

(Operator Instructions) Our next question comes from Steve Byrne with Bank of America. Your line is open. Steve Byrne – Bank of America Merrill Lynch: I was curious about that tag that you put on IL-2 for 214. How does this effect the distribution of that product throughout the body and particularly partitioning into tumors?

Howard W. Robin

Management

I’m going to let Steve answer that. One thing I’d like to point out is that what’s so exciting about it is that, we’ve been able to use our polymer conjugate technology platform in a different way with this molecule and that we are allowing it to be more active with certain receptors and less active with other receptors. And that is a very significant potential. I’ll let Steve address your question directly.

Stephen K. Doberstein

Analyst · Bank of America

Yes Steve thanks for the question I think one of the coolest things about the 214 concept is that fact that it doesn’t end up evenly distributed throughout the body, it takes advantage in the same kinds of effects that we see with NKTR-102, where we get a much higher tumor exposure to drug than exposure in normal tissues. Now if you couple that difference in exposure which can be quite high, to the receptors like Howard mentioned. I think you get a Cytokine now that has a completely different profile, than IL-2 does, which of course is what we’ve been looking for. So I think that bio-distribution is a really great part of this the concept here, and I think the receptors activity is the other really important part of the concept. And of course all of that together also allows us to dose much less frequently in the animal models we’ve been studying to put the molecule on more of an antibody type dosing schedule which I think is critical for being able to use it effectively in the clinic. Of course, Proleukin or IL-2 the way it’s currently used, is dosed in an ICU study several times a day, over a week. And this is a molecule we think of a much antibody like in pharmacokinetics. So this is, first three things all together really are what make the concept work. Steve Byrne – Bank of America Merrill Lynch: And what do you think about timing with respect to getting into human study is there any thoughts about the types of indications you might pursue with the combo, with the checkpoint inhibitors?

Stephen K. Doberstein

Analyst · Bank of America

Yes great question. So I think step one, of course is going to be single agent, as you would expect. We can get that as early as late next year I think maybe earlier the following year. One of the thing without Phase 1 for a molecule like this with that you go directly into patients and if one did that and say patients that had superficial tumors like melanoma patient, one might be able to look into tumor biopsies and find actual if we able to measure the difference was in immune cells and get sort of the proof-of-concept, mechanistic concept right away. Of course, there is a lot of work going on with the Checkpoint Inhibitors in all different types of solid tumors. And we will keep a close eye on those development, but I think of course we already know that the highly immunogenic tumors, like renal cell tumors and melanomas are great targets for immunotherapy, but I think we want to expand up beyond that. And there I think we will let the science guide us as we what the mechanism looks like in the first of man study. Steve Byrne – Bank of America Merrill Lynch: And then just lastly, your acute pain drug this NKTR 196, how does it differ from one that I think you had about a year ago NKTR 192 I believe it was. I thought it was also for acute pain. Is it functionally similar?

Howard W. Robin

Management

Yes, great, that’s a great question. So from 100,000 feet, the concept is similar the goal here was to have the drug for acute pain that would need to have a very rapid onset of action that’s critical aspect here. And it shares those characteristics with NKTR 192 now and were difference from NKTR 192, it’s based on a different molecular scaffold and it’s an entirely different MCE. The scaffold is more metabolically stable it’s been NKTR 192 molecule and I think that’s going to give a better properties clinically, but what we are seeing in the animal model so far is very rapid onset of action and very effective analgesia so far preclinically, so we’re excited about it. Steve Byrne – Bank of America Merrill Lynch: Thank you.

Operator

Operator

And I’m currently showing no further question. I will now turn the call back over to Howard Robin for closing remarks.

Howard W. Robin

Management

Well, clearly this year to be transformational one for Nektar with multiple product candidates advancing to Phase 3 data, regulatory filing and potential approval. So I want to thank our dedicated employees for their superb performance. And I want to thank everyone for their time today and continued support for Nektar. We look forward to seeing many of you at the UBS conference in few weeks. Thank you very much. Take care.

Operator

Operator

Thank you ladies and gentlemen that does conclude today’s conference. You may all disconnect and everyone have a great day.