Earnings Labs

Lexicon Pharmaceuticals, Inc. (LXRX)

Q4 2010 Earnings Call· Thu, Feb 24, 2011

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Transcript

Operator

Operator

Thank you for holding. Welcome to the Lexicon Pharmaceuticals fourth quarter and year end 2010 conference call. At this time, all participants are in a listen-only mode. There will be a question and answer session to follow. Please be advised that this call is being taped at Lexicon’s request. At this time, I would like to introduce your host for today’s call, Wade Walke, Senior Director of Communications and Investor Relations. Please go ahead, Dr. Walke.

D. Wade Walke

Management

Good morning and welcome to the Lexicon Pharmaceuticals fourth quarter and year end 2010 conference call. I am Wade Walke and with me today are Dr. Arthur Sands, Lexicon’s President and Chief Executive Officer; Dr. Brian Zambrowicz, Lexicon’s Executive Vice President and Chief Scientific Officer; and Jeff Wade, Lexicon’s Executive Vice President and Corporate Development and Chief Financial Officer. We expect that you have seen a copy of our earnings Press Release that was distributed this morning. During this call, we will review the information provided in the release, provide an update on our clinical programs then use the remainder of our time to answer your questions. The call will begin with Dr. Sands who will discuss our key accomplishment for 2010. Dr. Zambrowicz will then discuss the status of our drug development programs and Mr. Wade will review our financial results for the fourth quarter and full year 2010 and discuss our financial guidance for 2011. We will then open the call to your questions. If you’d like to view the slide for today’s call, please access the Lexicon website at www.lexpharma.com. You will see a link on the Home page for today’s webcast. Before we begin, I would like state that we will be making forward-looking statements, including statements relating to Lexicon’s research and development of LX1031, LX1032, LX1033, LX2931, and LX4211 and the potential therapeutic and commercial potential of those drug candidates. This call may also contain forward-looking statements relating to Lexicon’s future operating results, financing arrangements, cash and investments, discovery and development of products, strategic alliances, and intellectual property. Various risks may cause Lexicon’s actual results to differ materially from those expressed or implied in such forward-looking statements, including uncertainties relating to the timing and results of clinical trials and preclinical studies of our drug candidates depended upon strategic alliances and ability to enter into additional collaboration and license agreements, the success on productivity of our drug discovery efforts, our ability to obtain patent protection for our discoveries, limitations imposed by patents owned or controlled by third parties and the requirements of substantial funding to conduct our drug discovery and development activities. For a list and a description of the risks and uncertainties that we face, please see the reports we have filed with the Securities and Exchange Commission. I will now turn the call over to Dr. Sands.

Arthur T. Sands

Management

Thank you, Wade, and thank you everyone for joining us this morning to discuss 2010 and also really focus on 2011 and some of the key goals we have for ourselves. We’ll be referring to slides, if you have access of those throughout the talk and I am going to start on our first pipeline slide that pictures our four programs in Phase 2 development. And really our accomplishment for 2010 all centered on achieving proof-of-concept around these four programs. And that is of course the key step in the progression of our new drug candidates that operates through novel mechanisms of action. And I think in each one of these programs we have accomplished significant steps forward in improving these mechanisms. I think overall 2010 was clearly dominated by the results in our diabetes program LX4211, which really have I think throughout the year as we learn more and more about the drug candidate exceeded our expectations with regard to its mechanism of action and its effects in patients. And so I’d like to spend most of this call discussing that program as we go into the body of the call. On the next slide I do want to highlight for each of the programs our 2011 objectives that are based on what we accomplished in 2010 and our logical steps forward for each of these. So the 2011 pipeline objective slide starting with LX4211, a key goal is to initiate the Phase 2b study in Q2 for this program. This will be approximately 300 patients trial in type II diabetes. And our goal is through the year to have enrollment be on track such that in the first half of 2012 we will be able to complete that study and have the result. So in addition to this,…

Brian P. Zambrowicz

Management

Thank you, Arthur. I’ll be giving an update on LX4211. This is the first in class dual inhibitor of two sodium-dependent glucose transporters, SGLT1 and SGLT2. It’s a once day oral drug candidate for type 2 diabetes, and in our Phase 2a clinical trials we saw large and rapid improvements in glycemic control that read out as a strong decrease in hemoglobin A1c over only four weeks of dose time. In addition, we saw some favorable decreases in triglycerides, blood pressure and body weight. We do believe this compound has a potential for best in class or to be first in class, and that’s illustrated on the next slide, and the reason it’s unique is because of its dual inhibition of both SGLT1 and SGLT2. SGLT1 is the major glucose/galactose transporter in the gastrointestinal tract. It’s the key transporter for uptake of these nutrients from the diet and as I’ll describe later inhibiting this target triggers secondary benefits that are really helping us in our in treatment of type 2 diabetics. SGLT2 is better known, its major transporter for re-uptake of glucose in the kidney that would otherwise be lost in the urine. The uniqueness of our compound is further illustrated in the table on next slide, what we’ve done here is we’ve shown the SGLT inhibitor landscape, these are SGLT inhibitors in different phases of clinical development, and what I’d like you to focus on is the columns that show SGLT1 and SGLT2 in addition. What you can see is most of the agents in development are selective SGLT2 inhibitors. Our compound is unique in that it’s a dual inhibitor of SGLT1 and SGLT2. What also stands out is that a compound at the bottom of the table, the GSK compound, which is quite unique in being a selective…

Jeffrey L. Wade

Management

I will provide a brief financial review. As indicated in our press release today, we have revenues for the 2010 fourth quarter of $1.3 million, which was a decrease of 11% from $1.4 million in the prior year period. For the year, revenues decreased 54% to $4.9 million from $10.7 million in 2009. Our research and development expenses for the 2010 fourth quarter decreased 3% to $18.3 million from $18.8 million in the prior year period. And for the year our R&D expenses decreased 3% to $78.5 million from $81.2 million in 2009. In connection with our acquisition of Symphony Icon, we made an initial estimate of the fair value of our liability, toward the base and contingent payments. Changes in that liability, which are based on the development of the programs and the time until the payments are expected to be made, are recorded in our consolidated statement of operations. The associated increase in fair value of Symphony Icon purchase liability was $1.6 million in the 2010 fourth quarter and $2.7 million for the year. Our general and administrative expenses for the 2010 fourth quarter were $3.9 million, which is a decrease of 13% from $4.4 million in the prior year period. And that decrease was primarily attributable to lower patent fees. For the year our G&A expenses were $19.4 million, which was consistent with the prior year period. Our net loss for the 2010 fourth quarter was $23 million or $0.07 per share compared to a net loss of $22 million or $0.13 per share in the prior year period. Our net loss for the year was $101.8 million or $0.34 per share, compared to a net loss of $82.8 million or $0.57 per share in 2009. For the 2010 fourth quarter, our net loss included non-cash stock-based…

Arthur T. Sands

Operator

Thank you, Jeff. So we can now open the call for questions.

Question-and-Answer Section

Analyst

Operator

Operator

(Operator Instructions) Your first question comes from the line of Cory Kasimov of JPMorgan. Cory Kasimov – JPMorgan: Hey good morning guys, thank you for taking the questions. I have a few of them for you. First one to start off with 4211. At this point what are the gating factors to starting that Phase 2b trial in the second quarter? Is it just a metformin interaction study? And then in terms of the design of the 2b, are you also – is the plan still to include an active control arm in addition to placebo?

Brian P. Zambrowicz

Management

Hi, Cory, it’s Brian. Yes the only gating factor at this point for the 2b is a drug-drug interaction study. And whether or not to have an active comparator, we continue to discuss that with (inaudible). We have met with many. One of the issues in the Phase 2b study, the only thing you can obtain is non-inferiority. So it may not be the best setting in which to really compare two different drugs. But local drugs have been tested on behalf of metformin. Cory Kasimov – JPMorgan: Okay. And then staying on 4211, Arthur, can you talk a little bit more – can you update us with your latest thinking regarding the potential partnering strategy for this? Is it something you’re interested in now before Phase 2b, after Phase 2b, et cetera?

Arthur T. Sands

Operator

Yes, and I’ll invite Jeff to join in this discussion. We have a lot of parties, very interested in the program. It is – so we have ongoing conversations. It ends up being a question of value and what kind of value we can generate from the next study versus doing a partnership early. So I think our default view is to go forward and complete the next study. We believe we’ll build significant value. However, if there are partners that may intervene in that process in a productive way, we’ll entertain it. Jeff, do you want to comment as well?

Jeffrey L. Wade

Management

I think that pretty much sums it up. But I think we are pretty confident in this program. And we believe that there is significant value here and we are continuing to talk to you people as we lead up to the Phase 2b study. But we’re proceeding with the Phase 2b study on our – as sort of a baseline expectation. Cory Kasimov – JPMorgan: Is it possible for you guys to broadly characterize how interest in this asset may or may not have changed since you came out with the additional data regarding GLP-1 and PYY?

Arthur T. Sands

Operator

Yeah, broadly stated it has increased, I’d say, significantly and I think it’s because there is another following of – now for the compound, of companies that have been seeking oral GLP-1 secretagogues as a potential competitor for the injectables. And so I think that that’s why as we go forward to 2011, we’re also – we intend to conduct additional mechanistic study to really accentuate that differentiating feature. So that could actually open up potentially a difference sort of competitive landscape for us and new partners that we have not talked to previously in this regard. So that’s why I think it really does behoove us to go forward through the year with the study, and we’ll have more for you, Cory, on the actual study design, I think at the time of the next call, because by that point, we will have completed all of the logistical studies required to initiate and we’ll have the design nailed down. Cory Kasimov – JPMorgan: Okay, sounds good. Thanks for taking my questions.

Arthur T. Sands

Operator

Thanks.

Operator

Operator

And your next question comes from the line of Phil Nadeau of Cowen and Company. Philip Nadeau – Cowen and Company: Good morning and thanks for taking my question as well. First, a couple on 1032, in the slides it mentioned that you – in the European study, you have 16 patient planned enrollment and you’ve dosed four patients to date. So is it really possible that that study completes next quarter? It seems like you kind of got into a big hockey stick in patients being dosed?

Arthur T. Sands

Operator

I think we were referring to the U.S. study when we talked about completion in Q2, and not the European study.

Brian P. Zambrowicz

Management

Our goal for the European study is to finish it by year end. Philip Nadeau – Cowen and Company: Okay. And do you need the data from the EU study to sit down with the regulators to plan the next trial, is it possible that that based just on the U.S. study that you could design a pivotal study?

Arthur T. Sands

Operator

I think it’s possible just on the U.S. study. I mean that’s our current view. Philip Nadeau – Cowen and Company: Okay, and can you remind us, in the U.S. trial and the EU trial, have the patients failed prior therapy before entering, can you remind us what line of therapy this is?

Arthur T. Sands

Operator

Well, that’s the way it’s written up is U.S. trials only contemplate patients that have failed on octreotide or a somatostatin analog. In the European trial, we do allow patients that are naïve to somatostatin analog. But I think in general, both type of patients are rare. Philip Nadeau – Cowen and Company: Okay, great. Thanks for taking my questions.

Arthur T. Sands

Operator

Thank you.

Operator

Operator

And your next question comes from the line David Friedman from Morgan Stanley. David Friedman – Morgan Stanley: Hi, thanks. Sorry about that echo. I was wondering if you could just talk a little bit about the inflammatory bowel disease program. Where you – if you could just discuss a little bit where your confidence comes from in starting that program. And maybe a little bit about just the mechanism that would allow the drug to have a meaningful benefit in that disease?

Brian P. Zambrowicz

Management

Sure. There’s a couple of reasons. One, there was a publication from an external lab where they induced the IBD model in rodents that were either wild-type for our target TPH1 or knockouts for our target TPH1. And the knockouts were resistant to the IBD challenge. That gives genetic support for the concept that it could be a useful mechanism in this indication. Secondly, they went on and did a pharmacology experiment where they treated wild-type animals, that where they’d induced the IBD model and then treated with either placebo or PCPA, which is an inhibitor of our target TPH1, and showed that with the PCPA, the TPH inhibitor, they reduced the inflammatory response in that model. So both genetic and pharmacology evidence supporting that. And then we went on and both internally as well as with an external expert lab in this area, we’ve both (inaudible) data that fit very well with that published data and support utility of 1032 in the indication. And we’ve run models that are thought to more closely relate to ulcerative colitis, and we’ve run models that are thought to be more closely related to Crohn’s disease, and want you to – looks to reduce the inflammatory response in both models. The other thing I’d say is as we have used a positive control, which is still developing, at its maximum tolerated dose in mice. And 1032 looks clearly superior to that agent, which is currently used to treat IBD patients. David Friedman – Morgan Stanley: Okay. Thank you.

Arthur T. Sands

Operator

Thank you.

Operator

Operator

(Operator Instructions) And there are no additional questions at this time.

Arthur T. Sands

Operator

All right. Well, listen, thank you for participating. If you turn to the last slide, obviously from this discussion, you can surmise that Lexicon continues with advancing our entire pipeline. We have four programs active in Phase 2. I think as we go forward in the year, we’ll be sharing more with you on our next wave of small molecule programs that are in IND-enabling studies, as well as updating you on the multiple clinical milestones that we expect throughout the year. Thank you for your participation. Bye-bye.

Operator

Operator

Ladies and gentlemen, this does conclude today’s conference. Thank you for your participation. You may now disconnect.