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Ligand Pharmaceuticals Inc. (NASDAQ:LGND)

Q3 2012 Earnings Call

November 5, 2012 4:30 PM ET

Executives

Jennifer Capuzelo – IR

John Higgins – President and CEO

John Sharp – VP, Finance and CFO

Matt Foehr – EVP and COO

Analysts

Joe Pantginis – ROTH Capital Partners

Irina Rivkind – Cantor Fitzgerald

Carol Werther – Summer Street Research

Keith Markey – Griffin Securities

Ed Arce – MLV & Company

Operator: Greetings, and welcome to the Ligand Third Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded.

And it’s now my pleasure to introduce your host, Jennifer of Investor Relations for Ligand. Thank you. You may begin.

Jennifer Capuzelo

Thank you. And welcome to Ligand’s business update conference call. Speaking today for Ligand are John Higgins, President and CEO; Matt Foehr, Executive Vice President and COO; and John Sharp, Vice President of Finance and CFO.

As a reminder, 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 partner programs including Promacta and Kyprolis, and its management. These statements involve risks and uncertainties and actual events or results may differ materially from the projections described in today’s preliminary third quarter 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 based on information available and reviewed by it as of today November 5, 2012, and do not necessarily represent the views of GSK, Onyx, or any of our other partners.

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’ll turn the conference call over to John Higgins. John?

John Higgins

Jennifer, thank you. Welcome to our third quarter call. We’re pleased to have everyone joined us this afternoon. Ligand is doing great and we’re excited to be rounding out a strong finish to 2012.

Over the past several months, we enjoyed numerous major events that we believe will set us up for significant financial growth over the coming years and more late-stage pipeline developments as well. I like to hit a few of these high points. Notably, as I’m sure many of you are aware, Kyprolis Onyx’s drug for relapsed and refractory multiple myeloma was approved and launched in the third quarter. The product did $18.6 million in its first partial quarter of sales in just about eight weeks time and the revenue far exceeded the analysts’ initial expectations.

Now Ligand received royalties on Kyprolis, and we will book them as with our other royalties on a one quarter lag basis. Now to put in perspective, this initial quarterly sales level will yield Q4 Kyprolis royalties to Ligand of about $279,000. It has a 100% gross margin and that will generate in excess of $0.01 in earnings per share in the fourth quarter 2012 alone.

Now in addition to royalties, we anticipate we will continue to enjoy revenue from the sale of Captisol for the product for commercial and clinical use, and of note, Onyx has three Kyprolis global Phase III trials ongoing at this time.

On their earnings call last week, Onyx said, they are beginning to “unlock the significant potential for Kyprolis.” We certainly agree and commend them for their commitment and excellent management of the program so far to serve the significant unmet need in multiple myeloma.

Now to switch topics, Promacta, another major asset of ours, continues to advance very nicely commercially and clinically. GSK just reported Q3 sales of $55 million, that’s up sharp 59% over the same period last year on sales of $34 million in the third quarter of 2011. Plus, GSK remains on track to receive word from the FDA regarding the approval status of Promacta for the treatment of thrombocytopenia in HCV by the end of November. We are about three weeks away from that PDUFA date for this important indication. If that indication is approved, we expect continued expansion of the product revenue in our underlying royalty.

Merck has commenced a late-stage trial for dinaciclib for the treatment various cancers, we announced this couple of weeks ago. The milestone earned us a $2 million payment, which we just received. Obviously, we’re very pleased with Merck’s continued progress with this late-stage cancer program.

Other Ligand partners have advanced their programs as well. Curis started clinical trial for a cancer program and Meridian announced they are advancing a Ligand Partnered Program toward the clinic as well very recently. Also this past quarter Rib-X presented positive data on their delafloxacin program. We entered a new Captisol license with MEI Pharma, as well as an option agreement for an early-stage diabetes program.

Overall, I’ll say, the Ligand business has never been stronger with our revenue growth prospects of high quality royalty assets coming sharply into focus at this time. Promacta is generating significant revenue and growth for Ligand, and Kyprolis is just entering our financial outlook with royalties right now about 18 months to 24 months sooner than some analysts expected just earlier this year. These are both potential major financial assets and they are overlaid on to a company with a lean cost structure, a vast portfolio of other fully funded partner assets and a substantial base of tax assets. We had built this company to generate meaningful profits and cash flow per share and the management and board believe we are well on a way to achieving that.

As we announced last week, we are hosting the Analyst Day in New York City on December 4. At that meeting, we will showcase our business model, financial assets and dig deeper into our pipeline and assets. I truly hope that you can make it in person or join us live on the webcast.

With that, I’ll turn it over to John Sharp, our CFO.

John Sharp

Thanks, John. As you heard from John, it is a very exciting time at Ligand as we see our business model working as designed with recent and near-term events for Kyprolis and Promacta. We look forward to the next few quarters when these assets begin to really drive our top line revenue growth.

Now for some highlights from the third quarter, we continue to see solid growth in our royalty revenue on the strength of Promacta sales. Promacta royalties for the third quarter were $2.2 million out of a total Q3 royalties of $3.2 million. This compared to Promacta royalties of $1.4 million for the third quarter last year out of a total royalties of $2.4 million. Revenue from material sales were up slightly to $1.8 million from $1.7 million last year. And as we mentioned in last quarter, we continue to expect a strong second half for Captisol shipments. And as you’ll hear from our financial guidance in a minute, we now expect those shipments to take place in the fourth quarter driven partly by new Captisol supply orders for Kyprolis.

Finally, our license and milestone revenues were $1.3 million for the quarter. Of note, we announced shortly after the third quarter end, we have now received a $2 million milestone payment from Merck for dinaciclib.

Looking at our operating expenses, our combined research and development and general administrative expenses for the quarter were $7 million, up slightly from $6.4 million last year. Our expenses are generally in line with our plan that will run slightly higher through year-end than originally expected due to various cost-related to our R&D projects, business development activities, and cost associated with tax planning in anticipation of the company turning profitable.

On the cash side, we finished the quarter with $8.4 million of cash, cash equivalents and restricted investments. And as we disclosed in our press releases today, we will be filing restated financials for recent periods. During our quarter close process, while reviewing the potential impact of future milestones, we discovered errors in the original calculation of the contingent liability for the CyDex acquisition in January 2011.

Specifically, the restatements relate to errors in the accounting for contingent liabilities that stem from our license agreement with The Medicines Company and the associated payments we might owe to Prism and the CyDex CVR holders. Essentially, we estimate the initial value of the liability was overstated by $1.6 million. By reducing that liability, there are related impacts to goodwill and other intangible assets, other income and expenses and our deferred tax assets and tax benefit.

I want to point out that the initial valuation and subsequent mark-to-market adjustments, our non-cash accounting estimates based on the probability of various future conditions being met. The restatement does not impact our revenue, operating costs or the outlook on the potential of our partnered programs. We have made good progress on finalizing the restatement works and are striving to get the restated documents and our third quarter 10-Q in as soon as possible.

To wrap things up, we are expecting a very strong fourth quarter with the fourth quarter revenues approximately double the revenue we just reported for the third quarter. And as a result, we are now expecting full-year revenues of approximately $30 million to $31 million compared to our previous guidance of $30 million.

And as I previously mentioned, we are expecting expenses to be a little higher than originally estimated and now expect combined R&D and G&A expenses of approximately $26 million compared to our previous guidance of $25 million, including approximately $6 million of non-cash expenses. And we continue to expect our cost of goods sold for the full-year to be approximately 35% of material sales.

With this outlook, we project that continuing operating business will be profitable and cash flow positive for the full-year and finish 2012 with a higher cash balance than we ended with the third quarter. And with that, I’ll turn the call back to John.

John Higgins

Yeah, John, thank you. Well, just in summary, again, we’re very pleased with the revenue performance with our operating performance and execution and are delighted with the recent developments in positive news flow from our partners. We’ll be on the road a bit the next several weeks, including at the Brean Murray conference; we’ll be participating in on Wednesday in New York City; and again, we look forward to our Analyst Day in about a month in New York City. Hopefully, you can make it in person or dial into the webcast.

With that, I’ll turn it over to the operator for any questions.

Question-and-Answer Session

Operator

(Operator Instruction) Our first question comes from the line of Joe Pantginis with ROTH Capital Partners. Please proceed with your question.

Joe Pantginis – ROTH Capital Partners

Hey, guys, good afternoon, and thanks for taking my question. A couple of quick questions if you don’t mind, John, obviously, you have a big catalysts coming up with Glaxo and Promacta for HCV, it’s a very large market. If we can hope we expect some positive news and I don’t want you to speak for Glaxo necessarily, but what do you believe Glaxo is most interested in since they have so many other studies ongoing for Promacta following HCV?

John Higgins

Yeah, Joe, I appreciate the question. Clearly, a label expansion for any products in any company is going to be the highest priority if it’s the near-term opportunity. And HCV, again, we’re about three weeks away from getting an update on the status of that. So that is clearly, our sense, GSK’s primary focus. And since the product is labeled, it’s priced, it’s on the market, we believe that GSK, upon approval, will be efficient at rolling out that expanded label if indeed it is approved.

The oncology-related thrombocytopenia, the other markets are very compelling. There is over 20 studies ongoing right now, a variety of indications and like the anemia-related drugs, Epogen and other drugs to treat anemia, there is not one specific cancer, but several cancers; there’s leukemia’s, MDS, chemotherapy-induced thrombocytopenia, a range of oncology-related thrombocytopenia’s that still will take a few years to develop and advance due to the market. But given the size of the commercial potential and the investment by GSK, we see that as a very exciting opportunity as well for the product.

Joe Pantginis – ROTH Capital Partners

That’s helpful. Thank you. And maybe just one quick follow-up, obviously, the Kyprolis launch was stronger than expected. I know you’ve been asked this question, a similar question in the past, but I just want to get the latest. Since you have such a strong launch with Kyprolis for Captisol and so many other Captisol deals in place, I just wanted to make sure you guys are well-equipped to supply as much Captisol as anyone could need.

John Higgins

Yeah. Joe, we are – certainly and I’ll invite Matt, for our Chief Operating Officer to comment, but we’re definitely prepared and certainly look forward to meeting even higher volumes if it arises. Matt?

Matt Foehr

Yeah, absolutely, Joe. We’ve got a lot of capacity beyond what we’re using right now. And so we feel very good about our capacity.

Joe Pantginis – ROTH Capital Partners

Great. Thanks a lot, guys.

John Higgins

Thank you, Joe.

Operator

Our next question comes from Irina Rivkind of Cantor Fitzgerald. Please proceed with your question.

Irina Rivkind – Cantor Fitzgerald

Hey, good afternoon. I just wanted to see if you can give us an update on the status of the Captisol-enabled Melphalan trial and whether it’s still on track to start in 4Q?

John Higgins

You bet, Irina. Matt, you want to comment on that?

Matt Foehr

Yeah, great. Irina, thanks for the question. So we plan to start the trial for Captisol-enabled Melphalan within the coming weeks. Right now we’re in the final stages of institutional approval at our two lead sites. So we’re looking forward to enrolling patients very soon. For those that don’t know, this is a product, it’s a conditioning treatment for high-dose Melphalan plays a central role in stem cell transplant conditioning for multiple myeloma. So we’re excited about getting the trial started. And as I said, we’re in the final stages of institutional approval right now.

Irina Rivkind – Cantor Fitzgerald

And then I had a question about gross margin. It looks like it took a little slight dip this quarter, is there any particular reason and is it sort of the gross margin that we should look to going forward?

John Higgins

Yeah, John.

John Sharp

Yeah. So it really fluctuates depending on what type of material, i.e. the commercial versus clinical. And it – the range is in the 30% to 35%; actually if you look at year-to-date, it’s closer to 30%, but we do expect more commercial in the fourth quarter. So we think that’s going to be up near, full-year about 35%.

Irina Rivkind – Cantor Fitzgerald

Okay. And then I just have one last one. And this relates to your SARM program. I saw news that GTx, who has a similar molecule in development, they had a Data Safety Monitoring Board that give the green light to their program. And just wondering, if you guys are keeping an eye on this and how you’re thinking about your own molecule with regard to potential negotiations with partners in light of this information?

John Higgins

Irina, thanks. Good question, and for the last year or so that’s been relatively below the radar for investors, but it’s a program we remain very excited about and proud of our achievements so far. You are right, the SARM CLD – our program is similar to what GTx has. GTx is further long in development. As a point of reference, we believe our molecule is certainly – it’s different, it’s next generation, if not a best-in-class for a variety of features by what we can tell. But we are monitoring.

The frailty in the muscle wasting space is a very important therapeutic category. I think for regulatory reasons it has been a challenging field to get partners to focus on doing licensing deals for, but no doubt, if GTx can break the ground and show excellent clinical data and a regulatory path forward, we think the commercial medical markets are definitely there. And our outlook is to a 2013 review of their data and we think that could help catalyze interest for them and us and others who might be active in the field as well, which can be dynamite for this significant medical need.

Irina Rivkind – Cantor Fitzgerald

Thanks very much.

John Higgins

Yeah. Irina, thank you.

Operator

Our next question comes from the line of Carol Werther with Summer Street Research. Please proceed with your question.

Carol Werther – Summer Street Research

Thanks for taking my question. So I’m just trying to get an idea of when do you think you might have more results with Promacta on some of these cancer indications?

John Higgins

Yeah, Carol, thanks. Matt, I know you’re close to the clinical status, why don’t you provide a little color on that?

Matt Foehr

Yeah, Carol, I’ll just comment quickly. Obviously, a few upcoming conferences I think are important and GSK obviously has continued to report out new data as it becomes available for Promacta, but there are number of posters and a couple of oral presentations, abstracts just went live today for ASH in December. So I think that would be the next point at which we start seeing more data, specifically around MDS and AML, as well as in some of the oncology indications.

Carol Werther – Summer Street Research

Okay. And are you still thinking about possibly licensing the Melphalan product?

John Higgins

Carol, we are. We are fully committed to that strategy. When we acquired CyDex a year and half ago, we acquired principally partnered assets programs that we’re already partnered in the supply chain for Captisol. This was a development stage asset that given the niche focus in stem cell transplant and multiple myeloma, what we believe to be a relatively small and lower cost commercial investment and a very high margin and important category, we believe it’s a specialty product. This is a product that Ligand could advance to the market itself.

However, the execution of the clinical work in the trial started, complete everything is fairly straightforward, it’s fairly low cost. We believe that in the interim to be talking with oncology specialty companies is important. And whether we go it alone or whether we do it with a partner, our objective is to one, be successful in driving to the clinic and also maximize the return to Ligand. But this is a product we’re excited about exactly the path forward commercially or whether we partner it. We haven’t fully committed to, but we are seriously evaluating a partnership option as well.

Carol Werther – Summer Street Research

Thank you, and congratulations on a good quarter.

John Higgins

Carol, thank you.

Operator

Our next question comes from the line of Keith Markey with Griffin Securities. Please proceed with your question.

Keith Markey – Griffin Securities

Hi, John. Thank you for taking my call. Couple of questions. First, I was wondering if you could give us a sense as to the tax impact that was referenced, because you’re going to be turning profitable impact on the fourth quarter and perhaps if you could give us some guidance on 2013?

John Higgins

Sure. Keith, I appreciate the question. The guidance for next year, we’re going to hold off on for now. We obviously are the early stage of launches of Kyprolis and are eagerly awaiting word, the HCV label expansion. So a couple of developments that we want to process before we get out on 2013 guidance. I’ll defer to John Sharp though to comment about that tax impact potentially for turning profitable here in the fourth quarter.

John Sharp

Yeah, Keith, so in general, the way it works since Ligand does have a full valuation allowance against its deferred tax assets, while that remains and until we show consistent profitability, you will see a very low effective rates, it really just for AMT, which is less than 2%. At some point, when we do show that consistent profitability, we will – we anticipate releasing that valuation allowance. And so in that year, you would see a very large tax benefit go through the income statement. And then after that, it would – the effective rate would really – would look like the stated rates in the 40% range.

Keith Markey – Griffin Securities

Okay. Thank you. Then I was wondering if you might remind us of the clinical trials that are ongoing regarding Kyprolis?

John Higgins

Yeah, Matt, you want to comment on that or what’s publicly available?

Matt Foehr

Yeah. Thanks, Keith. There are three ongoing Phase III trials as well and there’s also been discussion around additional Phase III trials. But there are three global trials running currently, and then a number of smaller ones that are reported out as well. As I mentioned earlier, the ASH abstracts went live today and there are number of Kyprolis-related abstracts and presentations, posters, et cetera there.

Keith Markey – Griffin Securities

Okay. I’ll take a look at those. Thank you very much.

John Higgins

Keith, thank you.

Operator

Our next question comes from the line of Ed Arce with MLV & Company. Please proceed with your question.

Ed Arce – MLV & Company

Hi, guys. Thanks for taking my question. Most of the questions I have, been answered, but I did have one. And I apologize I’ve joined a bit late, I don’t know if this has been answered already. But you’re still expecting the PDUFA date for the sNDA to be towards the end of this month?

John Higgins

That is correct. We – what we know, this is for Promacta and the treatment of thrombocytopenia in HCV. As you know, GSK submitted the NDA earlier this year in May; later in the summer, they received accelerated review designation, which qualified them for a six-month review. And while GSK has not published the actual PDUFA date, our estimate is that it’s the end of November. We picked Monday the 27, again that is only our estimate, but essentially the last week in November is when we believe the PDUFA date will be for that drug.

And we don’t have any other information in terms of status of it, but given the fact that drug, it’s – obviously, it’s doing well commercially, but it’s enjoyed some changes to the safety disclosure and there’s been supplements to the long-term safety data and the like. Internally at Ligand, we’re optimistic that this drug or that the drug will enjoy a label expansion here soon.

Ed Arce – MLV & Company

Okay. Great. Thanks, John. I appreciate it.

John Higgins

You bet, Ed. Thank you.

John Higgins

Okay. Well, it sounds like that’s the last of our questions. So again, we appreciate everyone’s attendance and questions and interest. We have worked hard to build the business, not only assembling the portfolio of assets, but also to running a business for the lean cost structure and really doing our part to help facilitate our partners success in the development of other programs. From a biotech model perspective, we’re very excited by the research and the underlying programs that our partners are advancing and are equally excited about our financial outlook. We’re building an exciting company and look forward to updating investors in the ensuing quarters. Thank you very much.

Operator

Ladies and gentlemen, this concludes today’s teleconference. You may disconnect your lines at this time, and thank you for your participation.

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