Earnings Labs

Nektar Therapeutics (NKTR)

Q1 2010 Earnings Call· Thu, May 6, 2010

$83.74

-0.22%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-1.37%

1 Week

+1.98%

1 Month

-14.32%

vs S&P

-8.72%

Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the first quarter 2010 Nektar Therapeutics financial results conference call. My name is Dianna and I will be your operator for today. At this time all participants are in a listen only mode but later we will conduct a question and answer session. (Operator Instructions) As a reminder, this conference is being recorded for replay purposes. I would now like to turn the conference over to your host for today, Ms. Jennifer Ruddock, Vice-president, Investor Relations. Please proceed.

Jennifer Ruddock

Management

Thank you, Dianna. Good afternoon everyone and thank you for joining us for Nektar Therapeutics' first quarter 2010 financial results conference call. With us today are Howard Robin, our President and CEO; John Nicholson, our Chief Financial Officer; Bharatt Chowrira, our Chief Operating Officer; Dr. Lorianne Masuoka our Chief Medical Officer and Stephen Doberstein, our Chief Scientific Officer. Before we get started, please note that the following presentation contains forward looking statements that reflect our current views as to the Company's business strategies, the value and potential of our technology platform, the progress and potential for our proprietary drug candidates, the future economic potential under certain of our partnership agreements, the potential market size for certain of our drug candidates and those of our partners, our financial guidance for 2010 and other future events and opportunities related to the Company. These forward looking statements involve significant risks and uncertainties that are detailed in Nektar's reports and other filings with the SEC, including our Form 10-K annual report filed with the SEC on March 3rd, 2010, our report on Form 8-K filed today and our Form 10-Q quarterly report to be filed following this call. Actual events could differ materially from these forward looking statements. We assume no obligation to update any forward looking statements as a result of new information, future events or developments. A webcast of this call will be available for replay on the Investor Relations page at Nektar's website at www.nektar.com. With that, I would now like to hand the call over to Howard Robin, our President and CEO. Howard?

Howard Robin

President and CEO

Thank you, Jennifer and thanks to everyone for joining us. Nektar continues to make great progress advancing our clinical pipelines of drug candidates that we created using validated polymer conjugate technology platform. Today I'm going to update your on our achievements in the first quarter of 2010 and also highlight a number of milestones and objectives for our R&D programs. I'd like to start first with a focus on our two clinical stage oncology candidates, NKTR-102 and NKTR-105. Both investigational compounds utilize our advanced polymer conjugate technology to potentially greatly enhance widely used chemotherapies. Irinotecan [ph] in the case of NKTR-102 and built a tax hole for NKTR-105. Most drugs that are used in the treatment of cancer are given every two to four weeks, despite the fact that their half-life ranges from only a few hours to a few days. This means that for most of the length of cancer treatment cycle, the tumor is not exposed to drugs. Using our proprietary technology, we have engineered NKTR-102 and NKTR-105 to have reduced peak plasma concentrations, longer half-lives and continuous exposure profiles with the twin goals of prolonging tumor exposure to the drug, while at the same time reducing toxicities associated with these agents. We believe that our technology offers the opportunity to design a cancer treatment with superior efficacy, an improved safety profile and potentially broader activity against a variety of tumor types. NKTR-102 is our most advanced anti-cancer compound. We're evaluating it in three Phase 2 clinical studies in ovarian, breast and colorectal cancers. With NKTR-102, we are demonstrating how our polymer conjugate technology successfully alters the PK profile of the parent molecule to allow for sustained exposure of drugs to tumor. The half-life of the active metabolite of irinotecan is about 48 hours. In a typical irinotecan…

John Nicholson

Chief Financial Officer

Thank you, Howard, and good afternoon, everyone. We ended the first quarter with $362 million in cash. Revenue in the first quarter increased to $33 .2 million, versus $9.7 million in the first quarter of 2009. Research and development expenses were $23.3 million in Q1, as compared to $23.4 million in Q1 2009. G&A expenses declined to $9 million in the first quarter of 2010, from $11 million in the first quarter of 2009. Total operating costs and expenses decreased by approximately 9% in the first quarter of 2010, as compared to the first quarter of 2009. Our financial guidance for 2010 remains unchanged. Revenue for 2010 is expected to be between $155 million and $165 million. As a reminder, the revenue projection for 2010 includes amortization of approximately $100 million from the upfront payment of $125 million you see from AstraZeneca from 2009. R&D expense for 2010 is anticipated to be between $110 million and $115 million, as compared to $95 million in 2009. Our development expenses for 2010 include a continued investment into our Phase 1 clinical study of NKTR-105 and Phase 2 studies of NKTR-102 in ovarian, breast and colorectal cancers as well as preparing NKTR-102 for Phase 3 in ovarian cancer. In addition, our research expenses include preclinical studies for new pain and oncology compounds, and other clinical areas, as well as activities at our facilities in Huntsville, Alabama and Hyderabad, India to bring NKTR-181 to an IND stage later this year. G&A expense for 2010 is anticipated to be approximately $41 million, essentially consistent with 2009 levels. Included in this amount is approximately $8 million of non cash items, consisting mainly of depreciation and stock compensation expense. Capital expenses were ongoing operations expect to be $10 million for 2010. Ten improvements are proceeding on budget and according to schedule for Nektar's new mission bay research and development center in San Francisco. As I said last quarter these ten improvements will be approximately $25 million. We anticipate moving into the facility by the end of this year. As a reminder under the terms of lease we will not pay any rent for this facility until August 2014. We expect to end this year with $265 million and $275 million in cash and investments. This anticipated year end cash balance does not include any payments related to a potential NKTR-102 partnership. With that I will now open the call to questions. Operator?

Operator

Operator

(Operator Instructions) And the first question will come from the line of Cory Kasimov, JPMorgan. Cory Kasimov – JPMorgan: Hi, good afternoon. Actually this is Mona here on behalf of behalf of Corey. I have two questions, one regarding NKTR-102, I was wondering if you can speak about what is new in the data, but we will see it the data from the full 71 patients and are there still patients on drug at this point? And then just related to that, I understand it's early but would love to hear your preliminary thoughts on what the Phase III, 102 and ovarian would look like and if that is something you would consider initiating only once you have a partner, or is that independent? Thanks.

Howard Robin

President and CEO

Sure, well, we will be presenting the full 71 patients at ASCO in the oral session and I'm hopeful that you will attend. I think it will be an interesting presentation. With regard to your question about preparing for Phase III or at least moving forward in Phase III, we're certainly preparing for Phase III, but as I said earlier in the discussion that we are talking to a number of companies, they are highly interested in a collaboration in NKTR-102 and while we are preparing for Phase III in the sensitive CMC and production and everything that has to move forward to get ready for a Phase III study in ovarian cancer, I think it is too soon to discuss whether that will happen with or without a partner. At this point I strongly believe that we will have a collaboration for NKTR-102 and I think the different flavors of that collaboration may lead us to slightly different paths. So, I think we'll have to wait and see as to what that collaboration looks like. Cory Kasimov – JPMorgan: Okay. And then I have a another question, just wondering if you could provide an update on the negotiations with Amgen regarding in your agreement.

Howard Robin

President and CEO

Well look as we have said in prior meetings. We're having discussions with Amgen. I can't tell right now how they will progress. Assuming that the economics makes sense to both companies and then perhaps we can reach an agreement. If they don't, as we've already said, we believe that our obligation to manufacture under the terms of the contract expires this year. So let's see how that progresses. Cory Kasimov – JPMorgan: Okay. Thanks.

Operator

Operator

And your next question will come from the line Bert Hazlett of BMO Capital Markets. Bert Hazlett – BMO Capital Markets: Yes. Thank you. I have actually two separate questions. Howard if you would be so kind us to, you've discussed the potential for several different partnership structures. Could you give us a sense of what may be on the table and what maybe off the table in terms of those partnership structures? And, then secondly, in terms of how you think about the opportunities that are earlier-stage in the pipeline going forward, how are you contemplating the choices between oncology and those efforts there, and the pain platform and those effort there? What should we focus on as investors trying to evaluate and value those efforts?

Howard Robin

President and CEO

Okay. Well, two good questions. To your first question, look, there are lots of possibilities for what a collaboration could look like. It would be totally inappropriate for me to define what's on the table and you can imagine there are lots and lots of flavors here. So, as I've said, we will put together a deal or transaction, collaboration that really works in the best interests of our shareholders, and that could have many different possibilities, and there are many companies that are, as you can imagine, highly interested in NKTR-102. So, I think well have to wait and see what that looks like. Probably not appropriate to be discussing it in at level of detail at this time. With regard to your second question, I think the focus is pretty clear for us. Look, there is no doubt that we can apply our technology to chemotherapeutics and greatly enhance their efficacy and safety. Some people think chemotherapeutics are old market, last decade's technology, etcetera. I hear that once in a while. The fact is, there are over $12 billion in annual sales of chemotherapies in the U.S., and I don't think they're last decade's technology. And the fact is there could be even greater sales of chemo therapeutics if you could engineer them to have a better safety and efficacy profile which is exactly what we are doing. NKTR-102, NKTR-105 are examples of that kind of progress. So, I think you will see INDs filed for other chemotherapeutic agents. I'm not prepared to tell you which ones they are today but clearly in our research activities we have other chemotherapeutics that are moving forward in our preclinical pipeline. Now that said, we have also had tremendous success as you know with NKTR-118 in keeping the bloods from transitioning…

Operator

Operator

(Operator Instructions) The next question will come from the line of Shiv Kapoor, Morgan Joseph. Please proceed. Shiv Kapoor – Morgan Joseph: Thanks, I actually have most of my questions answered, on the call, but I want to ask a couple of general questions. First, beyond 118 and 102 and 061, I think are the most exciting drugs in the pipeline that you are working on in early stage, and why? And, second, Howard, what are the risks that you worry about at night?

Howard Robin

President and CEO

Well, I assume you mean the business risks? Shiv Kapoor – Morgan Joseph: Yes.

Howard Robin

President and CEO

Look, I think, if you look at the preclinical pipeline, as I just said, 181 for me is a very, very exciting compound. I mean, to have at least the potential to become a dominant opioid therapy, as I said, the market in the U.S. for opioid therapies alone is $10 billion a year U.S. So, if you have an opioid that doesn't cause respiratory or causes less or doesn't cause respiratory depression, has less abuse potential and, by the way, it inherently in that drug is the ability or the design, which limits the ability to tamper with the drug. So, we're not even talking about tamper-resistance, which is already inherent in the molecule in that you can't separate the peg from the opioid, so that is inherently in this drug. We're talking about tamper resistance, we're talking about less abuse liability and we're talking about safety. That could become the opioid of choice. So it's a very, very exciting program, also NKTR-194, if you can develop an opioid which, as you know, if you keep it out of the CNS has very few side effects to replace NSAIDs, COX-2 inhibitor another potentially enormous market. So, I think what we are doing in the area of pain is exciting. I think if you look at what we have available to us although NKTR-105 is the only other chemotherapy that we talk about because it is in Phase I, there are many chemotherapy agents that we're looking at in preclinical and we'll be discussing some of them later this year. That's also very exciting, so what keeps me up late at night sometimes is where do you pick from? How do you prioritize at Nektar? There are so many opportunities for this company to apply our small molecule polymer conjugate technology platform. The challenges is finding the right 10 things, the right 20 things. There are probably hundreds of opportunities, and I think what keeps me up at night if you really want to know, is how do we prioritize properly and how do we advance the company as rapidly as we possibly can. And I think so far we have been doing a pretty good job with it. Shiv Kapoor – Morgan Joseph: Thank you so much.

Operator

Operator

And there are no more questions in the queue at this time. I would like to turn the call back to Howard Robin for closing remarks.

Howard Robin

Operator

Well, look, I think Nektar has a powerful and proven technology platform that really is now validated for large and small molecules, and with our diversified pipeline of, I think, highly promising therapies, and therapeutics, a strong financial position, and a talented team executing on our goals, we are steadily demonstrating what makes Nektar exceptional. I look forward to seeing many of you at Nektar's dinner event at ASCO in Chicago. The event will be held on Sunday, June 6 at the Fairmont Hotel, beginning at 6:30 PM and it will conclude a presentation by the Dr. Dr. Vergote on the results from NKTR-102 as well as the Q&A session. So, I look forward to seeing many of you there. Thank you for attending, good afternoon and please stay tuned to Nektar. Thanks a lot, bye-bye.

Operator

Operator

Ladies and gentlemen, this concludes today's conference. Thank you for your participation. You may now disconnect and have a great day.