Earnings Labs

Nektar Therapeutics (NKTR)

Q3 2014 Earnings Call· Thu, Nov 6, 2014

$83.02

-0.80%

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Nektar Therapeutics Third Quarter 2014 Financial Results Conference Call. At this time all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. (Operator instructions). As a reminder, this conference may be recorded. 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. Ivan Gergel, 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 regulatory events and product launch timings. The availability of future clinical trial results, clinical development plans, 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, 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 August 14, 2014, which is available at www.sec.gov. We undertake no obligation to update any forward-looking statements, 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 nektar.com. With that, I would like to hand the call over to Howard Robin. Howard?

Howard Robin

President and CEO

Thank you, Jennifer, thanks to everyone for joining us this afternoon for our third quarter financial results call. During the third quarter, we achieved two transformational events as a company, the FDA approval of MOVANTIK for OIC and the positive Phase 3 data for BAX 855 in hemophilia A. The success of these two partnered programs could position Nektar to become cash flow positive which as you’ve heard me say in the past is a very important goal for our company. I will talk more about the economics from these programs in a moment, but first, I’d like to start by talking about another potentially transformative upcoming milestone for our company, which is the eagerly anticipated top-line data for the Phase 3 BEACON study of NKTR-102, which we expect in the first quarter of 2015. As our first wholly owned late stage drug candidate, NKTR-102 has the potential to transform our company. If the BEACON study is successful, NKTR-102 could emerge as an important new therapeutic option for patients with advanced breast cancer particularly for those women with HER2-negative disease. NKTR-102 would be a highly valuable asset and it would provide us with the opportunity to launch and market our own cancer drug in the United States. The BEACON study compares single-agent NKTR-102 to a single agent of physician’s choice in patients with metastatic breast cancer who have failed anthracycline, taxane and capecitabine therapies. The primary end-point of the trial is median overall survival and it is powered to show survival superiority over the physician’s choice arm. 90% of the patients enrolled in the BEACON study have HER2-negative breast cancer. This is important because while there has been tremendous progress in treatments for breast cancer patients with HER2-positive disease, the fact remains that 75% of all patients diagnosed with breast…

John Nicholson

Chief Financial Officer

Thank you, Howard and good afternoon everyone. I will start with updating our financial guidance for 2014. For 2014, we are increasing our guidance for our end-of-year cash balance by $20 million. And as a result we now expect the end-of-year with a total of $245 million to $250 million in cash and investments. This represents a net use of cash for 2014 of between $130 million to $135 million. As Howard said, we anticipate the launch of MOVANTIK in late Q1 2015 or early Q2 2015, which would trigger launch milestones to Nektar of $100 million in the U.S. and $40 million in Europe. As a result, our 2014 year-end cash balance projection of between $2450 million to $250 million does not include these $140 million in milestones. Revenue for the full-year 2014 is still expected to be between $190 million and $195 million, including approximately $20 million of non-cash royalty revenue from UCB’s CIMZIA, and Roche’s MIRCERA. As Howard mentioned, this guidance includes two significant milestones recognized this quarter pursuant to the agreement with AstraZeneca signed in August 2013, the $70 million milestone payment that we received from AstraZeneca in 2013 and the $35 million milestone from AstraZeneca, which we received in October this year. Through September 30, 2014, we recognized $70 million of additional milestones related to other collaborations. We now expect our R&D expense to be between $140 million and $145 million with approximately $60 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 Q3 2014 was $132.9 million versus $60.9 million in the third quarter of 2013. Revenue for Q3 2014 includes recognition of $105 million in…

Operator

Operator

(Operator Instructions). Our first question comes from Bert Hazlett with Ladenburg. Your line is open. Bert Hazlett – Ladenburg: Yes, hi, I’ve got one or two questions. First on NKTR-102 thank you for the color with your participation with regard to the Pediatric Committee that you’d be participating in, could you describe the circumstance is bit more about that participation? How were you selected and why – what your participation will be in terms of the indications being discussed? And then I have two on MOBANTIK.

Howard Robin

President and CEO

Okay. I’ll let Ivan take the first question.

Ivan Gergel

Analyst · Ladenburg

So, we believe that the FDA was interested in, sorry, this is Ivan Gergel. And thanks for the question Bert, that we believe that FDA was interested in some of the data coming out of the Stanford investigator initiated study that was reported a few months back on Glioblastoma. And we think the FDA – we believe the FDA sees that as potentially relevant for us, for our pediatric community. Bert Hazlett – Ladenburg: And your participation will be what at the meeting?

Ivan Gergel

Analyst · Ladenburg

Yes, we will essentially be presenting some of the data on sort of the mechanism of 102 and some of the prior data that we presented to date. It’s essentially information that’s in the public domain at this point.

Howard Robin

President and CEO

Yes. And I think the FDA is also interested there in the safety profile. Because as you know, by reengineering this molecule and making an NCE which has a very, very different half-life, very different PK profile, the side-effects are very much dialed down. No neuropathy, very little Neutropenia, I mean, NKTR-102 is a very clean drug. And I think they’re very interested in that. Bert Hazlett – Ladenburg: Terrific. Thank you. Well, congratulations on the participation. And then, just two on MOVANTIK, again, you’ve made terrific progress with that program. How long do you think the pricing negotiations will take in the EU? And then, could you just update us on any progress whatsoever with regard to any combinations with the AstraZeneca collaboration? Thanks.

Howard Robin

President and CEO

Yes. Look, I think the EU pricing process probably takes three or four months. Easy as said, they plan to launch in the U.S. and the EU late first quarter, very early second quarter. And it’s very difficult to predict, I mean, whether it’s three months, four months, five months. I think it’s a process that they understand very, very well as you can imagine. With regard to combination, you’re referring to NKTR-119, they’re looking at that. They haven’t started that program in the clinic yet. But I would imagine they’re getting much more comfortable. So I really can’t comment. I’d have to send you to them for specific comments on NKTR-119. Bert Hazlett – Ladenburg: Okay. Thank you. Congratulations again.

Operator

Operator

Our next question comes from Steve Byrne with Bank of America. Your line is open. Steve Byrne – Bank of America: I would like to continue with Bert’s question on 119. I guess a technical question for you would be whether there is, whether there are any formulation issues that you’ve seen so far combining that product with any of the commonly available opioids? And then from a more commercial perspective do you have a sense from AZ as to their interest level in taking something like that into the market?

Howard Robin

President and CEO

Well, look, the first part of your question is the technical challenge there really isn’t much of a technical challenge. We’ve actually already done it. And taking an opioid and putting it into the same tablet with naloxegol is not a big hurdle. And it’s been done it’s still a very small tablet. That’s not a problem at all. And you could actually, you could do it that way, you could actually make a blister pack with both tablets next to each other so you take one tablet of each as a combination dose, there are lots of ways to do it. But to put them into one tablet is also not a tremendously complicated thing to do. And like I said, we’ve already made that formulation. Now, in terms of their level of interest in it, they should be interested in it. I mean, there is, I can’t speak for them in that regard because they haven’t announced anything publicly yet and I won’t do that. But I can tell you, they should be interested in it. You can combine naloxegol with a number of different opioids. And as you know, the morphine equivalent units don’t really matter. In other words, regardless of what opioid you are taking, it’s still a fixed dose one-a-day MOVANTIK. So, it doesn’t matter which opioid you combine it with or what the dose of that opioid is, MOVANTIK is 25 mg once-a-day regardless. And I think that makes it fairly easy to combine. Steve Byrne – Bank of America: And if such a product, were developed and an abuser wanted, decided to crush and snort it, would the naloxegol enter the CNS, if it bypass the GI track that way?

Howard Robin

President and CEO

No, no, naloxegol is not going to get into the CNS, I mean, even by snorting it. So, I don’t yes, that wouldn’t happen, no. Steve Byrne – Bank of America: Okay. So, no anti-abuse functionality from something, like that?

Howard Robin

President and CEO

Steve, you want to. Not really, but Steve, let me let you comment.

Steve Doberstein

Analyst · AZ as to their interest level in taking something like that into the market

Yes, hi Steve, this is Steve Doberstein. The thing about snorting, the reason that people snort drugs of abuse is to get – is to bypass first medicine pass metabolism in the river. It’s actually not, it’s not scientifically correct that the drugs get into the brain faster. So, for example, just because you snort it, it doesn’t mean it goes directly into CNS that actually goes into the bloodstream first. So, all of the mechanics of naloxegol that’s specifically designed to restricted to the peripheral system, it would still be in place in that case. Steve Byrne – Bank of America: Okay. And then one kind of off the wall question for you Howard. With the near term commercialization of inhaled insulin from Mankind and Sanofi, just wondering whether any of your patented state is potentially infringed by that product?

Howard Robin

President and CEO

Well, I think we’ve looked at that, we continue to look at that. And I won’t comment specifically but I think had that drug been on the market two or three years ago, the answer might have been yes. In today’s world at this late date, there probably isn’t much there any longer. Steve Byrne – Bank of America: Okay, thank you.

Operator

Operator

(Operator Instructions). I am currently showing no further questions. I will now turn the call back over to Howard Robin for closing remarks.

Howard Robin

President and CEO

Well, I want to thank our employees for their dedicated and their hard work. The approval of our first drug MOVANTIK is a testament to their efforts. And I want to thank them from my heart. Thank you for joining us today and taking the time to be with us, and your continued support of Nektar. And we look forward to seeing many of you at the upcoming investment conferences over the next few months. So, thank you very much. Bye-bye.