Earnings Labs

Ligand Pharmaceuticals Incorporated (LGND)

Q4 2008 Earnings Call· Thu, Feb 12, 2009

$231.68

-4.18%

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

+0.00%

1 Week

-2.60%

1 Month

+9.67%

vs S&P

+16.22%

Transcript

Operator

Operator

Good afternoon. My name is Andrew and I will be your conference operator today. At this time I’d like to welcome everyone to the Ligand's fourth quarter and year-end results conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks there will be a question-and-answer session. (Operator Instructions). Thank you. It is now my pleasure to turn today's call over to Ms. Erika Luib, Investor Relations. Go ahead ma'am.

Erika Luib

Management

Thanks Andrew. Welcome everyone to Ligand's fourth quarter results and business update conference call. Joining me today are John Higgins, President and CEO of Ligand Pharmaceuticals; John Sharp, Vice President of Finance and CFO, and Dr. Martin Meglasson, Vice President of Discovery Research. Before we begin the call, just a reminder to everyone that today's call will contain forward-looking statements within the meaning of Federal Securities Laws. These may include but are not limited to statements regarding intent, belief or current expectations of the company, its internal and partnered programs, regulations affecting the company's business and its management. These statements involve risk and uncertainties and actual events or results may differ materially from the projections described in today's press release and this conference call. Additional information concerning risk factors and other matters concerning Ligand can be found in Ligand's public periodic filings with the Securities and Exchange Commission, which are available at www.sec.gov. The information in this conference call related to projections or other forward-looking statements represents the company’s best judgment as of today, February 12, 2009. Ligand undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. At this time, I will turn the conference call over to John Higgins. John?

John L. Higgins

Management

Erika, thank you. Thanks everybody for joining us this afternoon. This is our first call of 2009. And it comes at a time where just recently over the last few months, we have had several significant and positive events that are transforming our company. The equity markets are in rough shape, no doubt, but Ligand is doing well. In addition to updating you on our financials it's a great time to talk about the business. After my remarks, John Sharp will provide information on our financials and then Mark will provide some highlights from some of our partnered and internal research programs. As investors and analysts evaluate Ligand, I want to focus people on what excites us about the business. First, we have a dynamite royalty asset in partnership with GSK for PROMACTA and other TPO molecules. PROMACTA was just approved. We think it's targeting a big potential market and GSK has done an excellent job advancing the program. Second, we have a long list of fully funded drug development collaborations with big pharma. Now, when I say fully funded, I mean the partners are paying all the development costs and commercial costs for drugs that are at various stages of development, without any further investment or use of our cash, we will enjoy the benefit of potential future revenues from milestone payments and royalties. Third, we have a great discovery platform that has a very strong incredible track record. Not only have we shown we can discover drugs, but in many cases our drug discoveries have made it all the way to product approval or to late-stage development. This can be the engine for new deal making. And finally, we believe we have the right thinking about how to run a biotech company. Stick to what you are good…

John P. Sharp

Management

Thank you, John. Jumping right into the numbers, our total revenues for the fourth quarter of 2008 were $12.4 million, compared with $5.8 million for the fourth quarter of 2007. Fourth quarter 2008 revenues consist of $5.4 million of royalty income from AVINZA sales, a $5 million license payment from GSK for LGD-4665, and a $2 million milestone payment from GSK related to the approval of PROMACTA. Fourth quarter 2007 revenues consisted of AVINZA royalties, as well as a $1 million milestone from GSK. Research and development expenses in the fourth quarter of 2008 were $11.1 million, compared with $10.4 million in the fourth quarter of 2007. Fourth quarter 2008 expenses includes $6 million related to the settlement agreement with Rockefeller University that was just announced. Excluding this settlement expense, the decrease in R&D expenses is primarily due to headcount-related expenses, as a result of our restructuring back in the fourth quarter of 2007. As well as lower outside research cost related to our internal programs. General and administrative expenses in the fourth quarter were $3.2 million, compared with $3.9 million in the fourth quarter of 2007. The decrease in expenses is again primarily due to lower headcount related costs. As a result of our acquisition of Pharmacopeia in December, we also expect to record a write-off of acquired in-process research and development of approximately $72 million. This amount is management's best estimate based on available information and is subject to change. The final amount will be recorded in our 2008 annual report on Form 10-K. The remaining allocable purchase price of approximately $6 million for any adjustments to acquire in-process research and development will be recorded on our balance sheet as an intangible asset to either be amortized over a period or reviewed for impairments on an annual basis.…

Dr. Martin D. Meglasson

Management

Thanks, John. I would like to provide some background on the three Phase II clinical development programs that were added to our pipeline in the Pharmacopeia transaction and an update on our SARM program. Schering-Plough is developing a CXCR2 chemokine receptor antagonist,. SCH527123. That was co-invented by Pharmacopeia and Schering-Plough. The CXCR2 receptor plays an important role in respiratory diseases involving neutrophilic inflammation, and mucous overproduction. Schering-Plough has recently completed data collection in a 12-week double blind placebo controlled Phase II study of SCH527123 in smokers with COPD. Schering-Plough is currently conducting two Phase II clinical trials in asthma patients that are estimated to be completed in the first half of 2009. In another collaboration, Bristol-Myers Squibb is developing a p38 MAP kinase inhibitor, BMS582949 that was discovered in a research collaboration between BMS and Pharmacopeia. p38 kinase is a convergence point for multiple signaling pathways involved in inflammation. Because of p38 kinase essential role inhibitors of the enzyme have long been sort as potential drugs for a variety of inflammatory diseases. Early attempts by other companies to develop p38 Kinase inhibitors have flaunted in Phase I to deliver function abnormalities. At the 2008 American College of Rheumatology Annual Meeting, BMS scientists reported results from three Phase I clinical trials in healthy men and up to 600 milligrams of BMS582949 once daily for 28 days. The compound was well tolerated with no serious adverse events observed. The most common adverse events were dizziness, rash, and headache. Most adverse events were mild to moderate in intensity, not dose related also observed in placebo subjects and results by steady discharge. Most laboratory abnormalities for Grade I or II and were comparable between BMS582949 and placebo groups. BMS has completed a positive Phase I exploratory medicine study of discompound in patients with stable…

John L. Higgins

Management

Yeah Martin. Thank you. Well that ends our prepared remarks. We would like to turn it over to the operator for questions.

Operator

Operator

(Operator Instructions). Your first question comes from Joe Pantginis from Merriman Curhan & Ford. Go ahead sir. Joe Pantginis – Merriman Curhan Ford & Co.: Hi, good afternoon fellows. Thanks for hosing the call and thanks for taking my question. Congratulations on the progress. Can you hear me, okay?

John L. Higgins

Management

Yeah you bet Joe. Thank you. Joe Pantginis – Merriman Curhan Ford & Co.: Great. Two quick questions, one on DARA and then one on Pfizer-Wyeth. Now that you have come out with the data, I know you are focusing on partnering DARA I’m just curious if you could give any visibility on the type of partnership you would be looking for now that you have this Phase IIb data in hand?

John L. Higgins

Management

Yeah, sure you bet Joe. Thanks for the question. So, we have the data, we are encouraged by the data, we really do believe this appears to be a good medical treatment. Obviously, since we acquired Pharmacopeia, we are really going back and looking at the conversations they had prior to the acquisition. They had reached out to dozens of companies, and many of the parties were interested in the program, but were keen to see the final Phase IIb data. So, we are going back, we are reviewing the key context, where the dialog was left off. Our objective as Martin indicated, we finished the study. We are preparing a full abstract, we will have some medical publications later this spring maybe May or June. In the meantime, we will prepare our package and really reach out and reinitiate the dialogue. As far as, what sort of partnership, I think it's too early to really talk structure or expectations. One thing we are clear is that we think we have got a very robust and compelling data package. We don't plan to do any more development ourselves. We want to get out there, see if we can partner this, find a good home for it and transfer the cost and future development to a third party. Joe Pantginis – Merriman Curhan Ford & Co.: Great. And if I could just follow-up real quick on Pfizer-Wyeth. Obviously I'm not asking you to put yourself in the minds of Pfizer and Wyeth, but post-merger of those two companies, they could have potentially two drugs on the market for osteoporosis and, how do you see that sort of playing out with regard to royalties toward Ligand, because obviously, one could potentially compete against the other?

John L. Higgins

Management

Yeah. sure. So, maybe two questions there, one is the prospect, just from a regulatory perspective, approvals, et cetera. Obviously, we can't predict the relative regulatory timelines and approvals. We are encouraged by the data, what we are seeing, what's been published there appears to be very good efficacy, attractive safety profile, and it is our sense that the medical community is looking for more SARMs or other osteoporosis treatments, they want more options. Having said that, we know both drugs have had a very difficult regulatory path. So, we really can't make a call as to whether one or both will be approved in any certain timeframe, as far as the merger, presuming it does go through, we do think these will be competitive drugs. We are waiting for clarity, whether one will be required to be divested. We don't know if that will be the case, we are trying to get that information. And just as soon as we do, we will give, we will translate that to investors. Joe Pantginis – Merriman Curhan Ford & Co.: Great. Thanks a lot John.

John L. Higgins

Management

You bet. Hey Joe. Thank you. Appreciate your support.

Operator

Operator

(Operator Instructions) Your next question comes from the line of Christopher James from Rodman & Renshaw. Go ahead sir. Christopher James – Rodman & Renshaw: Taking my question and congratulations on an excellent fourth quarter. Can you help us understand the size of the chronic ITP market a little bit better in the U.S. I mean is this is a $200 million or $500 million opportunity split between you, GSK and Amgen. And maybe potential sort of size of other indications?

John L. Higgins

Management

Sure, Chris. Thanks for the question. The market the way we look at it is there are roughly as many as 100,000 to 200,000 patients characterized as having ITP, but I think the more severe patients who would be qualified to go on these medicines, there is probably more in the 50,000 to 60,000 patient level. So, that's the target market. Now, with any market, you aren't going to get full penetration, and I really defer to the analyst to think through whether it's a fourth or half of that market of patients that actually go on therapy. So, we're talking somewhere in, somewhere below the 50,000 to 60,000 numbers of patients within the U.S. Drug pricing is another factor. As we understand, and we looked at the weekly treatment cost, the cost for PROMACTA could range in the $40,000 to $60,000 a year. That's a full year of treatment that is significantly below in plate. We think not only the dosing convenience, the efficacy, but also the pricing advantage creates a nice profile for PROMACTA, but I think when you are thinking about dollar size, we would look at patients probably total market below $50,000 patients, shared with Amgen. A treatment that is probably on average, while the full year is $40,000 to $60,000. The full year per patient cost since this could be treated intermittently will be less than that. I think when you roll it up for this market alone in the U.S., we think it could be several hundreds of millions of dollars that’s the target market. We are eager to see how the landscape plays out the next several quarters, knowing that there are now two competitive products approved for the same indication. But we do think it is an important initial market. We believe that there are comparably sized markets elsewhere in the world, and again, this is what we hope will be just the first indication of many that the drug can be approved for. Christopher James – Rodman & Renshaw: Great. Thanks. I guess could you give us a little bit of insight into what we should expect from PROMACTA sales in 2009, it looks like in-plate is doing up pretty well it looks like it could easily up to a $100 million, 2009 alone.

John L. Higgins

Management

Well, yeah we've talked with analysts and obviously are eagerly getting input from many third-party sources possible. Generally, we aren't going comment on our expectations for PROMACTA sales. We really want to look at what GSK does in the first quarter or two. They are our partners. They are running all the commercial plans. I think we really want to look to see what guidance they give, or a direction they help investors with. Our perspective realistically is that this is an important medicine it will be used I think early on the sales will probably be low. But the potential for the drug, we really do believe is significant. So, I think from a guidance perspective, we have given our revenue range we are comfortable with that, its comprised of several factors. I think we don't want to get ahead of ourselves in terms of PROMACTA royalty guidance, at least into the short-term. We really need more information before we start getting a sense of what the trend lines are going to be. Christopher James – Rodman & Renshaw: Great. Thanks John and thanks for taking my question.

John L. Higgins

Management

You bet, Chris. Thank you.

Operator

Operator

(Operator Instructions). Your next question comes from the line of Kevin DeGeeter from Oppenheimer. Go ahead sir. Kevin DeGeeter – Oppenheimer & Co.: Hi good afternoon, guys.

John L. Higgins

Management

Kevin, I'm glad to hear you made on the call. Kevin DeGeeter – Oppenheimer & Co.: Made it other words. You know, I appreciate the help all around. Yes. So, I apologize if you covered some of this earlier, but, John, could you just give us what you know today on Pfizer and Wyeth and just the antitrust dynamic with regard to their concerns. I mean, when might we have a little bit more clarity, whether both of those will survive the merger into one entity or one main, ultimately need to be divested?

John L. Higgins

Management

Right. There was a question earlier, but I know you had some trouble getting on the call. So, the simple answer, we don't have a lot of information. What we are hearing from various public sources is that people believe the merger will happen, it will probably happen in the third quarter. So, we are looking out six to eight months or so. These are two clearly directly competitive drugs that are at the exact same stage of regulatory review. I think that's one part of this, will both drugs be approved and well realistic, they have had a difficult path so far, but we are encouraged by that product profiles. We are reaching out to these two companies in any other source we can to try to get a clarity, is there a divestment plan or will there be an FDC requirement to divest? We just don't know right now just as soon as we hear something, we will make sure that we communicate that to investors. Kevin DeGeeter – Oppenheimer & Co.: Okay. terrific. And, I guess sort of on a related point here, I mean, how are we able to think about the kind of more quarterly flow through of the integration for Pharmacopeia here? I mean, in terms of the expense has been once again, I apologize if you have covered this, but, yeah, I mean, how do I think about this expense guidance you provided for the year on a more quarterly basis? I mean is it sort of meaningfully higher in the first quarter here. And you can take some cost out or was all of that done prior to close?

John L. Higgins

Management

Yeah right, good. It hasn't been covered, John you want to give a little more detail on that.

John P. Sharp

Management

Yeah I think for the most part, you can expect the expenses to be fairly consistent throughout the quarters. Most of the transition costs were up front, you may see a little bit higher in the first quarter, but nothing to just speaking… Kevin DeGeeter – Oppenheimer & Co.: Okay. And just lastly on my side, and I appreciate all your help on this. Can, just give us a sense of how you think about the M&A landscape out there. Now. I mean, what type of assets are most interesting to you and have buyers in your view, really, or excuse me, sellers really come around to depreciation of, kind of the reevaluation of assets here, and kind of small cap biotech or, is it still difficult to find willing sellers out there?

John P. Sharp

Management

Yeah, right. Well, generally, we've got a reference point with Pharmacopeia. We are finding it's a, in a bit more equity environment, we all realize that. Many companies are out of options and they otherwise have good assets, development programs or partnerships. But they just don't have access to capital and that's something, at least in my career I really can't say I have ever seen before. And so out of necessity, we are seeing more and more companies and it has become very cute the last four or five months, really facing the realities that they just don't have funding or liquidity options. As and that is creating more opportunities. But also, I do believe that there is a perceptible changing in the way the Board is thinking about the realities of small cap biotech. Frankly, the costs are high, the regulatory timelines are being pushed out. We are finding that big pharma, you can strike a very attractive deals on earlier stage programs. So, that the realities are changing, so, I think as much of the investors make a bet and they know the reason for why they want to own something, it is tough to do deals, it's tough to get people to come around. But I think that we are seeing more companies interested in deal making and also more realistic about the realities of their responsibility to drive value for shareholders. So, it's a fascinating market. As to Ligand, we like our business and our platform. I think that we are looking to drive a business that is financially well-managed, very prudent spending discipline, and a business where if we would acquire other assets, they really have an eye toward potential positive cash flows and not businesses or assets that would be ultimately a cash drain on the combined business. Kevin DeGeeter – Oppenheimer & Co.: All right. So, I appreciate that so much. That's very insightful. Thank you.

John P. Sharp

Management

Thank you, Kevin.

Operator

Operator

(Operator Instructions) And you have a follow-up question from Christopher James from Rodman & Renshaw. Go ahead. Christopher James – Rodman and Renshaw: Follow-up. Can you give us a little bit more color on the revenue guidance? I guess, can you tell us what you are looking for in terms of milestones versus royalties?

John L. Higgins

Management

Yeah, John. He gave some general remarks, maybe John, if you want to elaborate, but we have in this mix, really four buckets and this is the way we see it going forward. I think the buckets will change. But royalty revenue from both AVINZA and PROMACTA, that's one bucket and the second are contract R&D payments. We have a got a couple of companies who every quarter are paying us money for research, we are helping them with. And then the third bucket, takes into account potential milestones that we might get from existing collaborations. And then the fourth bucket is non-cash deferred revenue. When we did some licensed deals in the past we hung up the revenue on our balance sheet and we spread it out by accounting rules overtime. So, those are the four buckets and that’s I think as the business evolves, those will remain in our picture as it turns out with this revenue guidance, each one of those buckets is roughly about the same amount, about a fourth of that total number. Christopher James – Rodman and Renshaw: Great, it's helpful.

John L. Higgins

Management

Okay. Well, thank you. Well we appreciate everybody's time on the call. I know it happened to be a very busy day for earnings calls for some reason, but I just want to, I guess conclude by saying that our management and the Board is very excited about our business. We have worked hard to get here. We've had ambitious goals for ’08. We thought last year was a successful year for us. We have great assets, great track record, and particularly given this tough economic environment, we believe we have the right mix of prudent spending discipline, and clarity on our business and strategy to drive value for shareholders. So, we appreciate your support from investors and analysts. And look forward to giving you updates throughout the year. Thank you.

Operator

Operator

This concludes today's presentation. You may now disconnect your lines.