Earnings Labs

Nektar Therapeutics (NKTR)

Q4 2013 Earnings Call· Wed, Feb 26, 2014

$83.74

-0.22%

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Nektar Therapeutics’ Q4 2013 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). As a reminder this conference call may be recorded. I would now like to introduce your host for today’s conference, Jennifer Ruddock, Vice President of Investor Relations. Ma’am, you may begin.

Jennifer Ruddock

President

Thank you, Samuel. 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 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 quarterly report on Form 10-Q filed with the SEC on November 7 2013. 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 Investor Relations page at Nektar’s website at nektar.com. With that I would now like to hand the call over to Howard. Howard?

Howard Robin

President and CEO

Thank you, Jennifer and thanks to everyone for joining us this afternoon. 2014 will be a very important year for Nektar with several key milestones ahead of us for the late stage programs in our pipeline. I’d like to spend today focusing on these programs and outlining our key priorities for this coming year. We ended 2013 in a strong cash position with $262 million in cash and investments which does not include $117 million in net proceeds from our recent financing. Later in the call, John will provide you with our specific financial guidance for this year. As you know, Nektar has five highly valuable late stage programs 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 these partnered programs are significant for Nektar and these programs will provide us with a steady stream of catalysts in 2014 and beyond. As I mentioned earlier, we anticipate several key milestones over the coming year for these late stage pipeline products. First, potential approval and commercial launch of Naloxegol for opioid-induced constipation in the US, EU and Canada which will trigger milestone payments to Nektar of up to $175 million. Second, we expect both phase 3 data and the planned BLA filing in the US for BAX 855 and hemophilia A by our partner Baxter. And third, phase 3 data from the NKTR-102 pivotal study in women with advanced breast cancer is expected by early 2015. In addition, we're finalizing our plans to start the phase 3 program for NKTR 181 around the middle of this year. We believe NKTR 181 can be a transformational product in both the treatment of pain and addressing the current health epidemic of…

John Nicholson

Chief Financial Officer

Thank you, Howard and good afternoon everyone. I will start with a review of Nektar’s 2013 financial results and will then discuss 2014 financial guidance. At the end of 2013, cash and investments were $262 million. Our yearend cash balance includes a $25 million milestone from AstraZeneca for filing Naloxegol in Europe and a $70 million milestone from AstraZeneca for filing of Naloxegol in the US. Our yearend cash balance does not include the $117.2 million in net proceeds from our recent financing. Total revenue in the fourth quarter 2013 was $31.1 million compared to $21.1 million in the fourth quarter of 2012. 2013 total revenue increased to $148.9 million versus 2012 revenue of $81.2 million. In addition to higher product sales in 2013, increased revenue was related to recognition of a number of collaboration milestones. These milestones were a $25 million milestone from AstraZeneca for filing of Naloxegol in EU, a $10 million milestone for the start of phase 3 study for amikacin inhale and an $8 million milestone from a pay collaboration partner. We plan to recognize a $7 million milestone for the US Naloxegol filing in 2014. Total operating costs and expenses in Q4 2013 were $67 million versus $64.5 million in the same quarter a year ago. For the full-year 2013 total operating costs and expenses were $269.1 million as compared to $222.4 million in 2012. The increased total operating costs and expenses was primarily a result of higher R&D expense. For the full year 2013 R&D expense was $190 million as compared to $148.7 million in 2012. Our R&D expense of 2013 increased primarily as a result of the advancement in the clinic of our proprietary pipeline candidates, NKTR 102 and NKTR 181, as well as production of amikacin inhale devices for the start of…

Operator

Operator

(Operator Instructions) Our first question comes from Jonathan Aschoff of Brean Capital. Jonathan Aschoff – Brean Murray, Carret : Howard, I was wondering to what extent if you could describe better for us the FDA [buy-in] [ph] was for everything that went into the design of the 181 study?

Howard Robin

President and CEO

Well, we haven't had our end of phase 2 meeting yet. So that will have to take place. But we did have discussions under Fast-Track status with the Agency, and we wanted to talk to them about some of the observations that we noticed during the Phase 2 study, specifically how we measured drug efficacy, the method of patient pain reporting, whether the FDA would be receptive to changing the methodology going to the WOMAC method, whether we could do a purely one-to-one parallel arm design where we look at placebo and drug from the onset. And those were the types of things we asked them and we worked through with them and they were very receptive to it. My sense is that they recognize the importance of new molecule like a NKTR 181 which clearly addresses a major healthcare crisis in the US. And I think they're very interested in working with us to see this become a success. But we have to have our end of phase 2 meeting and that's where we’ll lock in the actual design of phase 3. Jonathan Aschoff – Brean Murray, Carret : And even though the FDA had said that this panel was coming and I’ll quote “in the near future”. I mean are you given any reason to think that it would be something that could impact your PDUFA date?

Howard Robin

President and CEO

Well, now you’re talking about NKTR 118 -– so I think - look, the FDA has said to everyone that they are rescheduling – they rescheduled the panel because of scheduling conflicts. I don't see it affecting the PDUFA date; we don't know when they're going to reschedule it. We like to believe it's is in the near future but they haven't told us yet. As soon as we get a date, we will certainly let everybody know. But their point to AstraZeneca was, and to Nektar was that this is a function of scheduling of the people that they would like to attend the panel discussion. Jonathan Aschoff – Brean Murray, Carret : And I was wondering if you could please comment on the recent Bayer announcement on its Long-acting factor VIII, specifically, what are the differences here between their product 855 and are they ahead of you in filing?

Howard Robin

President and CEO

Well, I am going to let Steve answer some of the technical issues. I think we expect that Baxter will file first because Baxter plans to file in the US this year. So Steve, I would like to let you comment a little further on the differences between the drug?

Steve Doberstein

Analyst · Brean Capital

Sure. Good question. So of course BAX 855 is a full-length version of factor VIII that is based on ADVATE, comes right off the ADVATE manufacturing line and then is conjugated with the PEG that gives it the extended half-life. The Bayer molecule is a truncated version of factor VIII, it’s called B-domain deletion. It also has an amino acid change that was made, it's engineered protein sequence, to allow a site-specific PEGylation to the engineered protein. So it’s quite a different molecule from a protein engineering standpoint. When we look at the results of their release this week, I think that while they were just topline results and I don't want to read too much into them, certainly look very similar to the [inaudible] results that we've seen earlier with the longer periods of administration leading to higher bleed rates. And then as Howard pointed out, when we think about time to NDA filing, of course Baxter is planning to file by the end of this year and Bayer reiterated I believe in their press release that they are going to file in the second half of next year simultaneously in the US and EU and they made some comments about manufacturing stuff that they're doing in anticipation of that filing. So I think we still anticipate that Baxter’s NDA filing – BLA filing that is -– will happen in advance of Bayer’s. Jonathan Aschoff – Brean Murray, Carret : Thanks for that. And I was wondering just briefly what exactly is next for 102 in glioma?

Howard Robin

President and CEO

Well look, we are going to be publishing data to major medical conference this year. And there is a lot of -– there are certainly a lot of interest from the medical community as well as commercial community in terms of the effectiveness of NKTR 102 in high grade glioma and that results we’ve seen so far are fairly compelling. So there's really not much for me to report now prior to us releasing data to major medical conference. But I think what we've seen in late stage Avastin resistant glioma is very impressive and says a lot about -– it really defines what everyone has said about topoisomerase 1 inhibitors. If you can make a topoisomerase one inhibitor that has a great pharmacokinetic profile and avoid these severe, severe toxicities that are associated with that class of compounds, you probably have a very, very important anticancer drug. And that’s what’s I think we have here.

Operator

Operator

Thank you. Our next question comes from Bert Hazlett of Roth Capital. Robert Hazlett – Roth Capital Partners: Just first on the economics of the 70 million amortization or 70 million from AstraZeneca that you got, will that be amortized over 2014 or is there a specific triggering event that will occur? Could you just clarify that a bit?

John Nicholson

Chief Financial Officer

This is John, Bert. Thank you for the question. To answer your question, we would recognize it immediately, basically what it comes down to is that the drug would have to be approved in the US without any pre-cardiovascular studies being done. And AstraZeneca would have to move forward the drug. So we expect to do that this year. Robert Hazlett – Roth Capital Partners: And then another housekeeping item, I know you said the Baxter milestones for development and sales are $70 million. Have you clarified what the development component of that is for 855?

Howard Robin

President and CEO

I don't believe we've said that publicly yet. So we have to check on that for you. And we can look into that but at this point I don't think we’ve defined the breakout yet. I have to look at what we are allowed to communicate regarding that, sorry. Robert Hazlett – Roth Capital Partners: And then just a pipeline question on NKTR 214, I think you’ve said previously that the IND for that was still on track, maybe Steve could comment on that program and whether the enthusiasm is still high for that immunologic program, that’d be great?

Steve Doberstein

Analyst · Roth Capital

Yeah, you bet, Bert. We remain really bullish on 214. I have to say that the preclinical data as we continue to expand into different models and use different combinations of other immunotherapies in those models, it really looks quite revolutionary to us. So we just couldn’t be more excited, it continues to hold up to its potential in the preclinical analysis that we’re doing. We’re continuing to work on the CMC aspects of the molecule of course. It’s our first home-grown biologic and we’re quite proud of that, and we want to make sure we get that right. So we are on track. I think you could see that drug hit the market – I am sorry, hit the clinic in 2015. Of course you have to remember that we've got 3 or 4 different small molecule pain related programs that also are advancing towards the clinic. And so that could change the timing one way or the other on 214 but we remain really, really excited about it and of course I think the whole world is excited about cancer immunotherapy as really the emerging way to treat tumors. So we’re excited about it.

Operator

Operator

Thank you. Our next question comes from Cory Kasimov of JP Morgan. Cory Kasimov – JP Morgan: First one is on the significance of the NKTR 102 interim analysis. Could the data monitoring committee have stopped this for futility with its interim look and because they've also recommended for you to upsize the study which I know they didn’t do, but was that an option?

Howard Robin

President and CEO

Yes, the answer to both of those questions was yes. They could have done both of those things. So we don't have access to the data. I mean it’s blinded to us but they certainly could have stopped it for futility and there was no recommendation to change the number of - the timing of events and number of events. So that -– now you know as much as we do. Cory Kasimov – JP Morgan: And then on 181, if you were to start the phase 3 around midyear based on your enrollment assumptions and such how long do you think it would be before you reach the interim look at 200 patients?

Howard Robin

President and CEO

I think we said we would be at those 200 patients by second quarter 2015. I believe that's about right.

Operator

Operator

(Operator Instructions) Our next question comes from Simos Simeonidis of Cowen and Company. Simos Simeonidis – Cowen and Company: Could you talk about the potential commercial effort behind Naloxegol from AstraZeneca? And also Howard, you said that they are thinking or they are planning for first half of ‘15 or early ’15 launch, if you have an approval in early September they probably wouldn’t be able to launch earlier than 2015?

Howard Robin

President and CEO

Look I think they are doing a great job in getting ready and getting ready to launch the product and they are assembling all the necessary forces to do that. And one of the reasons we selected AstraZeneca for this program and why we wanted to collaborate with them and take them as a partner is because -– remember this is not a G.I. drug, it’s a primary care drug. You have to recognize that patients who take opioids and receive opioids from their primary care physician for osteoarthritis or back pain etc. if they become constipated which many, many of them do as you know, they don't go to a G.I. physician for that constipation, they go back to their primary care physician. So the G.I. market for a drug for an opioid induced constipation drug is extremely small. This is a primary care physician market and that's what I think is one of the great strengths of AstraZeneca and one of the reasons we selected them as a partner. In terms of timing, they are planning for an early 2015 launch. I can't comment -– I can't comment as to the exact timing and how they want to move that forward at this point. I think it's very safe to say that the launch – and they plan to launch it in early 2015 and I'm sure if they can accelerate it, they will. Simos Simeonidis – Cowen and Company: Again and then in terms of what type of commercial effort do you think they might be putting behind the drug?

Howard Robin

President and CEO

Well I don't – yeah, I don't -– I can't tell you how many sales reps and how much money they're allocating to a launch program and a launch campaign. I know it's a very important drug for them. I know they take it very, very seriously. We have a very effective joint company steering committee and we have discussions with AstraZeneca regularly. I can't comment on the specifics of what they plan to do. But I can tell you that they are an excellent partner and I can tell you that they take this drug very, very seriously. I'm sure they are going to put significant muscle behind it.

Operator

Operator

Thank you. And at this time, I am not showing any further questions. I would like to turn the call back to Howard Robin for closing remarks.

Howard Robin

President and CEO

Well, thank you everyone for joining us today. And I want to thank all the employees of Nektar for doing such a great job in getting us to this stage. And we will see many of you at the Cowen, Needham and Roth conferences over the next month. So have a great afternoon or evening everyone. Thank you. Bye, bye.

Operator

Operator

Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program. You may all disconnect. Everyone have a wonderful day.