Earnings Labs

Nektar Therapeutics (NKTR)

Q1 2012 Earnings Call· Wed, May 2, 2012

$83.74

-0.22%

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the Nektar Therapeutic First Quarter 2012 Financial Results Conference Call. My name is Jeremy and I will be your operator for today. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] I would now like to turn the conference over to your host for today, Ms. Jennifer Ruddock, Vice President of Investor Relations. Please proceed.

Jennifer Ruddock

Analyst

Thank you, Jeremy. Good afternoon everyone 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 the call today, we expect to make forward looking statements regarding our business including, but not limited, the clinical development plans, the timing of future clinical results and regulatory filings, the economic potential of our collaboration partnership including potential milestone payments and royalties, 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. Important risks and uncertainties are set forth in our annual report on Form 10-K filed with the SEC on February 29th, 2012 and on Form 8-K filed today, each of which are available at SEC.gov. We undertake no obligations to update any forward looking statements 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 nectar.com. With that, I would like to hand the call over to Howard Robin. Howard?

Howard Robin

Analyst · Brean & Murray

Thank you, Jennifer. Thanks to everyone for joining us this afternoon. Today I will focus on the significant progress we made in the first quarter with our partnered programs and our priority pipeline. Following that, John will provide a quick review of financials. Nektar had a lot of momentum in the first quarter of 2012. We strengthened our balance sheet with a royalty sale that raised $124 million. We advanced our two lead clinical pain candidates, NKTR-181 for chronic pain and NKTR-192 for acute pain, and finally, the FDA approved the 8th product enabled by Nektar Technology, Affymax's OMONTYS. By the end of 2012, we anticipate 4 late stage Nektar drug candidates will either be in or poised to enter Phase III clinical trials. Three of these programs, Naloxegol and Opioid-Induced Constipation, BAX 855 in Hemophilia and Amikacin Inhale and Pneumonia are being developed and funded by our strategic pharmaceutical partners with a potential for significant partnership economics to Nektar. The fourth Phase III program, NKTR-102 in metastatic breast cancer is proprietary to Nektar. And as I just mentioned, Nektar is also rapidly advancing 2 new proprietary opioid molecules through the clinic. I'll talk more about the progress made in Q1 with these new opioid candidates in a moment. First, an update on Naloxegol with AstraZeneca. As you know, we are excited about the scope of AstraZeneca's global Phase III program from Naloxegol which is under investigation for the treatment of opioid induced constipation. The two pivotal registration studies will each include an estimated 630 patients with non-cancer pain and opioid induced constipation and will evaluate the safety and efficacy of Naloxegol in chronic pain patients. The primary endpoint for both studies is based on a 12 week treatment period. In addition there is a 52 week open label safety…

John Nicholson

Analyst · Brean & Murray

Thank you, Howard, and good afternoon, everyone. I will start with reiterating our financial guidance for 2012 which remains unchanged from our 2011 year-end call. For 2012 we expect our cash use and 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, where approximately 90 million of this is non-cash expenses such as stock based compensation and depreciation. 2012 G&A is still anticipated to be between $44 million to $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 Q1 2012 was $17.9 million versus $11.3 million in the first quarter of 2011. Revenue increased in Q1 compared to the same quarter of last year as a result of high product shipments to our collaboration partners. Totally operating cost and expenses in the first quarter of 2012 were $55.9 million versus $45.2 million in the same quarter a year ago. The increase was primarily driven by higher cost of goods sold and higher research and development expenses. The increase to cost of goods sold of $5.4 million in Q1 2012 compared to the same quarter of 2011 is attributable to the increase in product sales. For Q1 2012 our research and development expenses were $35.1 million, an increase of approximately $5 million as compared to $30.2 million in Q1 2011. R&D expense for the quarter included expenses related to our NKTR-102 BEACON Phase III trial, the production of Phase III devices for Amikacin Inhale, the Phase I tablet study for NKTR-181 and the initiation of Phase I clinical study of NKRT-192. Research and development expenses included $4.2 million of non-cash stock based compensation and depreciation expense. For the first quarter of 2012, G&A expenses decreased to $10.4 million as compared to $11.7 million in the first quarter of 2011. In the first quarter of 2012, $2.5 million of G&A expenses were non-cash. Cash, cash equivalents and short term investments at March 31, 2012 were $498.8 million as compared to $414.9 million at December 31, 2011. In February 2012, we received a $124 million in proceeds related to the sale of future CIMZIA and MIRCERA royalties. In relation to this transaction you may notice on our balance sheet the new line item entitled "liability related to the sale of future royalties". Based on GAAP reporting requirements, we have to cancel this transaction with a number of non-cash items which include this new line item. We will amortize this non-cash liability over the estimated life of royalty term which will result in non-cash royalty revenue and non-cash interest expense passing through our income statement. With that I will now open the call to questions. Operator?

Operator

Operator

[Operator Instructions]. Our first question comes from Jonathan Aschoff with Brean & Murray.

Jonathan Aschoff

Analyst · Brean & Murray

I was wondering which preclinical candidate do you think you might be able to use a little help on to be your next IND. I mean it seems to be that inhibiting or slowing central assess is something you guys have done really well, so I mean 171 sounds like a great one to me.

Howard Robin

Analyst · Brean & Murray

It's a good question. NKTR-171 is clearly a very important program in that it becomes a peripheral neuropathic pain drug and I think that’s very, very exciting and we know mechanistically our polymer conjugation can enable a drug like that. So yes, that is very exciting. But I am also very excited about NKTR-214 because I think to produce a immunostimulatory cytokine for cancer that is highly, highly effective and that it activates the IL-2 pathway and one where you have very, very greatly diminished the negative side effects associated with IL-2 therapy for me is also a very, very important program. So I think one of the wonderful things about Nektar is we have a number of great programs, including NKTR-125 and including a number of other things that we talked about at R&D Day. So I am pretty happy with all of these choices, but you're right, NKTR-171, NKTR-214, very important programs that could move quickly.

Jonathan Aschoff

Analyst · Brean & Murray

I was wondering when might we see the absolute last data from the ovarian phase II -- I mean it's in more like a I.V. drip kind of coming out and when might be that last bit that will make up, kind of, a Phase III go, no-go decision.

Howard Robin

Analyst · Brean & Murray

I am going to turn that over to Rob to see if you can give you a little more insight into that.

Robert Medve

Analyst · Brean & Murray

Certainly. Hi, Jonathan, it’s Rob. We still have patients, as Howard noted, we still have 17 patients in this study who are on drug. So the study is very much ongoing although closed to enrollment. We are going to anticipate in the second half of this year we would reach a data, and then as we have said at R&D Day and previously, will then be taking that data for discussion with FDA and EMA about next steps in development. So we we'll make that very much a data drive decision.

Jonathan Aschoff

Analyst · Brean & Murray

Okay, and John, just that COGS bump, as in years past, it's just sort of very inconsistent thing right?

John Nicholson

Analyst · Brean & Murray

Yes, Jonathan. As you know we really don’t have a control over when our partners are going to order product from us. And so the main difference between this year and last year was in the first quarter last year there were less product sales and that’s the reason for the bump.

Operator

Operator

Our next question comes from Matt Lowe with JPMorgan.

Matt Lowe

Analyst · JPMorgan

Hi, there. It's Matt Lowe in for Cory Kasimov today. Just for 102, just wondering how long after you receive the final Phase II ovarian data could you potentially meet with the FDA on that program? And I guess, given the recent deal between Endocet and Merck does this change your plans or how does it play into your thinking with 102 in ovarian cancer? Thanks.

Howard Robin

Analyst · JPMorgan

Thank you. I will let Rob answer the first part of your question but let me take the second part of your question first. I don’t think the program, Endocet's program, really concerns us. I think it's potentially a very good drug. I think there hasn’t been a useful drug approved for ovarian cancer since, I believe, 1999 when Doxil was approved. So anything for ovarian cancer patients is important, but these are patients that are going to need multiple treatment options. You are not going to cure the disease at that stage and these are completely different mechanisms, so I think for the patients' benefit a drug like Endocet's drug has great potential for these patients and NKTR-102 will as well. So I don’t think they are competing with each other. I think you have a patient population that needs all the different treatment options it can possibly get. With that I will turn over to Rob and give you some insight into timing.

Robert Medve

Analyst · JPMorgan

Thank you, Howard. Once we finalize the data, and again, we have lots of patients still on drug and even more than that in follow-up on the trial so we need to mature the database to get to those progression free survival and overall survival numbers. We'll then, when we have that, request the meeting and, of course, the timing of meetings with the regulatory agencies is out of our control. But as soon as we reach a point where we are able to put together a pre-meeting package that is substantive and unlikely to change, we will make that request.

Operator

Operator

Our next question comes from Bert Hazlett with Roth Capital.

Robert Hazlett

Analyst · Roth Capital

My question is more in general on oncology and the relative emphasis on oncology. It seems as if you have had number of compounds in the pipeline a while back and you've obviously progressed with 102 and had some erosion but just thinking about the effort that’s required in later stage clinical studies with oncology, is that an area that Nektar might be thinking is more right for partnering as programs advance or is it something an area where you intend to maybe keep those programs in house or just how do you think about the relative waiting as programs advance through the clinic of the oncology assets in particular?

Howard Robin

Analyst · Roth Capital

Well look, I think that’s a very good question. As you can see Nektar is putting an awful lot of its effort into the pain programs and if you look at NKTR-181 and 192 and 171, these programs for me are somewhat easier to develop than oncology classes. That said, I think we're being fairly careful on what we develop in oncology. Nektar has partnering discussions ongoing with lots of programs, with lots of companies. We're always talking to all the major pharmaceutical companies about where collaboration may make sense for them and for us, but if you look at what we are doing in NKTR-102 very selectively in Metastatic Breast Cancer, that’s a very, very defined population and a very, very well designed study which will answer the question as to the potential for NKTR-102. If you look at the program that we just recently talked about at R&D Day and I talked about again today, NKTR-214, I mean, NKTR-214 is a large molecule. It's the application of our technology back to large molecules which we know works very, very well and here we have designed something unique in which we can block receptor binding and if we can make a very potent immunostimulatory cytokine that has few side effects, I think that has historically at least been demonstrated as curative in number of cancers. I think that’s very, very exciting for us. But I think in general we are going to be very selective on where we work on oncology drug and I think while NKTR-102 is in the clinic and we've greatly enhanced the pharmacokinetic and the pharmacodynamics profile of NKTR-102, I think if you look at something like NKTR-214, that’s a completely different application of polymer conjugate technology. So I think oncology is an important place to be but we have to do it very, very selectively. In the pain area, it's very different. In there, as I said, we have NKTR-181 which has made great progress and going into Phase II this year, NKRT-192 which is just finishing Phase I and NKTR-171 which maybe -- is on our short list of programs that are moving towards IND stage. So -- and I think if you look at the incredible advancements we've made with these new opioid molecules, I mean, let’s be realistic. If these drugs work as we'd like them to, if they meet their target profile, they change the pain market. So we're very excited about those and I think overall we have a pretty impressive pipeline. I wouldn’t narrow it down to oncology and I wouldn’t start to hypothesize where we might partner, where we may keep it because everything has a different driver.

Operator

Operator

Our next question comes from Steve Byrne with Bank of America.

Steve Byrne

Analyst · Bank of America

Couple of questions about the pain drugs, just starting with 181. From the perspective of, say, the prescribers, how do you view the market opportunity for 181? Is it more that it's less diversion or do you think the value is in being less addictive?

Howard Robin

Analyst · Bank of America

Well, I think it's in -- it's a very good question, it's an excellent question and we went through a lot of time thinking about that before we even started the programs. I think it encompasses a lot of features. First of all, from a pure diversion point of view, as I said, it's a molecule. It's not a formulation. We have not been able to do anything to free up the opioids without breaking that molecule. So, this is a molecule and I think this would be the first anti-diversion, if you will, type of molecule or opioid simply because of its inherent structure. That said, that’s an important reason for society to embrace something that can provide patients with, and the world with, a drug that can’t be readily diverted. That said, I think the lack of sedation is very important and the lack of creating euphoria which causes patients to be addicted, honest patients who aren’t looking to abuse the drug in the first place. And if you talk to pain physicians, one of the things they are greatly worried about, and this goes to your point about payers and reimbursers, I mean, one of the things that people are very, very worried about especially physicians who are prescribing opioids for patients who have severe pain, they don’t want them to be become addicted. And if you can provide a drug that works excellently as algesic and doesn’t cause euphoria, and therefore your patient is unlikely to become addicted to it, I think that is a major healthcare benefit. And I think it will also cause physicians to want to prescribe that drug, because right now they are nervous about prescribing opioids to patients in pain because they think they are going to make drug addicts out of them.

Steve Byrne

Analyst · Bank of America

Does that -- to be able to demonstrate less addiction, is that really more of a theoretical concept but in reality difficult to demonstrate?

Howard Robin

Analyst · Bank of America

Let me turn that over to Rob for a moment.

Robert Medve

Analyst · Bank of America

Hi, Steve. Interesting question. There has been a lot of news recently around the rate of entry of substances into the brain and how that relates to the attractiveness of any drug, not just limited to opioids. But if you think about things like cocaine and heroin and nicotine, all these drugs that are very attractive as agents of abuse, go very quickly into the brain. That’s a fundamental difference that we're looking at with 181 here. You might have heard at R&D Day, some of KLO was talking about the fact that the API or the active agent here is not a known drug that once it's in plasma it's immediately into the brain. This is somehow -- this is a fundamentally different approach to this. So what does that do on the prescriber side? Well, this is about managing patients appropriately with a level of comfort for both the patient and the prescriber that this is a better way to treat patients who require an opioid. This is a better and safer way that’s going to decrease the ability for patients to not only misuse the drug but we believe also, from everything we have seen so far, has a wider therapeutic index. So if that can -- meaning the distance, the separation between an effective analgesic dose and the dose that gets people into trouble with side effects including things like respiratory [ph] depression is actually wider than we see with other traditional opioids. So there is a lot going on with this compound. It's a very interesting compound and we're very excited to be carrying this forward to Phase II starting mid-year.

Howard Robin

Analyst · Bank of America

And to your point about how you would measure this, I mean as I said earlier, I mean the Phase II study for NKTR-181 will clearly look at efficacy as well as a number of secondary end points, such as euphoria, such as sedation, et cetera. But we will also be conducting a likeability study. So you will basically be giving this drug to 25 or so recreational drug users and seeing if they like it and in theory they shouldn’t like it. They shouldn't get high off this drug. They shouldn't like taking NKTR-181. It shouldn’t provide them with any euphoria and that’s one of the ways you demonstrate that your drug is not doing that. We know we saw in the Phase I study that out of 40 patients or so, only one patient experienced mild euphoria, the rest did not. And we also measured, via pupillometry, the rate of entry into the CNS which we determined to be relatively slow. So the unique components of NKTR-181 is it's not just a slow release into plasma and then -- because there is a number of ways to get slow release into plasma, once it's in plasma though, it's in the CNS. With NKTR-181 you get slow release into plasma and then from plasma across the blood brain barrier you also have a slowing of the rate because of the structure of the molecule. So it's slow release into plasma, slow release into CNS. That’s a very important distinction here.

Steve Byrne

Analyst · Bank of America

And that’s a segue into my next one, and that is in the 192, how is it that it is slow entry into CNS but yet rapid acting? Is there a mechanism there that you could clarify for us?

Robert Medve

Analyst · Bank of America

Sure, this is Rob again. This is, again, it's a new agonist opioid and this profile is what we observe in the animals. It's very interesting data with this compound in the animal models and, of course, we're just in the first human studies of this now. But what we see in animals is onset -- in multiple different animal models, onset of analgesic very quickly at the first time point we measure, often as early as five minutes. But then, what we don’t see is when we use the animal models that represent the addiction potential or abuse liability of a drug, the animals just don’t identify it as an opioid. So it has a very -- so animals who are trained to recognize an opioid don’t recognize 192 as opioid. Yet it has this rapid onset of analgesic effect. So it's a very interesting profile that we're seeing preclinically and we'll see how this maps to humans, but generally speaking, with no susceptive pain conditions it tends to map fairly well. So we're, again, very intrigued by what we're seeing and that’s just -- that’s the profile we see, rapid onset but not identified as an opioid.

Operator

Operator

At this time there are no questions queued.

Howard Robin

Analyst · Brean & Murray

Okay. Well, thank you for joining us on today’s call and I am think we are very, very pleased with the progress we made in the first quarter. And we are highly focused on executing our plans and advancing our programs. So I am exceptionally proud of the accomplishment of the entire Nektar team. We appreciate your support as shareholders of the company and we look forward to seeing many of you over the next several months at the Deutsche Bank, Bank of America and Jefferies conferences. So, thank you very much and good afternoon.

Operator

Operator

Ladies and gentlemen, that concludes today’s conference. Thank you for your participation. You may now disconnect. Have a great day.