Ligand Pharmaceuticals Inc (LGND) 2012 Q2 法說會逐字稿

Greetings, and welcome to the Ligand second quarter 2012 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.

It is now my pleasure to introduce your host, Erika from Investor Relations.

Thank you, miss, you may begin.

Thanks, Dan.

Welcome to Ligand's second quarter financial results and 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 Chief Financial Officer.

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 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 the press release and this conference call.

Additional information concerning risk factors and other matters concerning Ligand can be found in Ligand's public periodic filing with the SEC, which are available at www.sec.gov.

The information on this conference call related to projections or other forward-looking statements represent the company's best judgment based on information available and reviewed by it as of today, August 8, 2012, and do not necessarily represent the views of GSK, Onyx, or any of our other partners are licensees.

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 call over to John.

Erika, thank you.

Thank you for joining us, welcome to our call.

This last quarter Ligand saw a major drug approval, two new NDA filings, numerous positive partner and clinical events, and solid financial performance.

We feel great about the recent developments in the company we have built, and are even more excited for what the future holds.

If you're on this call, you know the significance the Kyprolis approval holds for Ligand.

Kyprolis is Onyx's drug for Multiple Myeloma.

Given the excellent data and the well managed development work developed by Onyx, we had confidence the drug would eventually be approved and had optimism it might be approved this year.

To actually see that come to fruition is a major event for Ligand as it will significantly accelerate our royalty revenue growth by 1 to 2 years.

Now, Kyprolis a depends on Captisol for its formulation.

And, now with the product approved and launched, Ligand will earn tiered royalty between 1.5% and 3% on annual sales.

For illustration, on $1 billion in annual sales, Ligand will earn a 2.25% royalty.

Some analysts believe Kyprolis can achieve $3 billion in peak annual sales.

At that level, we will earn an average royalty of 2.75%.

In addition to the royalty, we will also enjoy revenue from the sale of Captisol for any Captisol that we supply to Onyx for clinical and commercial use.

Now, following the Kyprolis approval, some investors asked if we will raise guidance for 2012 since the approval came early.

We have not changed guidance, however we feel great about the business.

First half revenue and expenses are in line with plan, and the second half revenue outlook is strong as we've indicated in our press release.

John Sharp will also elaborate more on our second half outlook.

As for 2012 revenue impact of Kyprolis, I just want to clarify we book royalties on a one quarter lag basis, and the product just lunched.

So, we anticipate we'll have just a small stub of royalties booked in Q4 2012 for that product.

Now, in terms of material sales, obviously Onyx had prepared for a potential approval, and had already stockpiled some commercial supply for the near term.

The real growth and opportunity for Kyprolis will be in 2013 and beyond.

To put the Ligand model in perspective, Kyprolis is only 1 of over 30 partnered programs that rely on Captisol.

Of those more than 30 programs, 6 are in, or entering, Phase III trials, 10 programs are in Phase II, and over 15 are in Phase I development.

In all of these partnerships, Captisol addresses a common need.

Drug solubility or stability issues while also conferring additional patent protection and a strong safety database.

Now, our cost to run the Captisol business are low.

Yet, I want to be clear, on the other hand the upside in opportunity with Kyprolis and all of these other partnered programs is quite significant.

And, the business keeps growing.

When I say that we have 30 other Captisol licensees, I'm talking about the later stage programs.

Every quarter, we sign up new research collaborators which may lead to new license deals downstream.

And, shortly Matt will elaborate on that in a moment.

The other major development this quarter is the continued commercial and development success of Promacta.

This is our drug program partnered with GSK for the treatment of Thrombocytopenia, or the case of low platelet count.

On the commercial side, GSK continues to enjoy strong sales growth and market expansion.

For Q2, GSK reported $47 million in sales.

That is up 67% from last year's second quarter, and 9% from the prior quarter this year.

In addition to continued revenue growth with Promacta for ITP, GSK also filed Promacta for the treatment of Thrombocytopenia in HCV patients.

We see this market opportunity as many times larger than the existing label indication of ITP.

GSK just announced two weeks ago that they had secured priority review for supplemental applications in the US.

Now, a priority review is a designation given only to drugs that, if approved, offer major advances in treatment or provide a treatment where no adequate therapy exists.

The FDA's goal for completing a priority review is six months.

Given that the submission was in late May, that puts a targeted action date into late November time frame.

A little over three months away.

GSK has acknowledged publicly that this is, and I quote, a very good signal.

And, of course, we agree with that in light of the priority review designation.

GSK has also noted that this is perhaps the quote, leading edge of expansion opportunity for Promacta.

We look forward to seeing what the rest of year holds for Promacta and the possible second approval for a major Ligand partnership this year.

Now, before I hand the call over to Matt, I believe the Ligand portfolio and business model is among the most compelling investments in all of biotech at this time.

We have an economic interest in a vast array of potential biotech and pharmaceutical products.

Clearly, other people are taking note as well as we now have five analyst covering Ligand today, up from one just last summer.

Ligand has an easy to understand business model and investment thesis.

Our revenues have the potential to grow significantly without any additional investment.

Our company expenses are modest, we have a lean share base with fewer than 20 million shares outstanding.

And, of course, we have a strong research and business development engine to drive future growth.

Our ultimate goal at Ligand is to generate substantial profits and cash flow per share.

And, given recent events, we're well on the path to making that a reality.

I'll now turn it over to Matt.

Thanks, John.

First, I wanted to expand on a couple elements specifically as they relate to Kyprolis and Captisol.

Kyprolis is the sixth FDA approved Captisol enabled product on the market.

And, that's important to note the product was approved and launched just five years after we did the initial licensing deal.

So, a fairly short period of time.

Importantly, Captisol continues to feed the future of the Ligand asset portfolio.

And, we see it becoming the platform for growth that we thought it would when we purchased CyDex last year.

In Q2, we entered into over 30 early stage research and pre-clinical Captisol use agreements.

So, these are early agreements, and I mention them because we see these as continued validation of an important technology that's meeting a critical industry need.

And, we're pleased that our partner base remains balanced in size, ranging from small start-ups all the way to well established big pharma players, and in therapeutic area focus.

In addition to these early stage research and pre-clinical use agreements I just mentioned, that we don't reflect in our shots on goal, we also entered into a new clinical stage license agreement with Vertex Pharmaceuticals in Q2.

The target for that is undisclosed, but it's in a promising field of research.

And, we look forward to talking more about this newest shot on goal in the future.

In relation to Promacta, I would like to expand a bit on John's comments and share a bit more color on other areas of growth potential beyond ITP and HCV.

As GSK continues to invest heavily in the future of Promacta with a focus on heme oncology related Thrombocytopenia, or HORT, or what we call HORT.

They are currently running Phase II trials in MVS and AML and recently presented data at ASCO utilizing Promacta to treat Thrombocytopenia resulting from a solid tumor regimen.

Additionally, a very interesting clinical study of Promacta in patients with Refractory Aplastic Anemia came out the first week of July in the New England Journal of Medicine.

And, represents yet another indication that could be a potential expansion opportunity for Promacta.

We also note that these represent new areas where Promacta may have significant competitive advantages and where GSK may be able to further leverage the already global footprint for the drug.

We commend GSK for their continued commitment and focus on Promacta.

And, appreciate their ongoing partnership.

I'm going to switch gears for a moment and talk a little bit about Pfizer.

In Q2, Pfizer announced that European Medicines Agency has accepted their regulatory submission for Bazedoxifene conjugated estrogens, or Aprella, for the treatment of symptoms associated with menopause and osteoporosis.

And, an expected action date for that asset is in 2013.

Additionally, internally here at Ligand we continue to progress our pipeline of currently unpartnered programs.

This quarter we announced positive pre-clinical data on LGD-6972, at the American Diabetes Association meeting.

6972 is our potent, orally available, small molecule glucagon receptor antagonist.

for the treatment of Type 2 diabetes.

We remain pleased with our R&D team's progress on this program as Type 2 diabetes is the most common form of diabetes.

And, is a major and quickly growing global health concern that currently affects over 200 million people worldwide.

And, we feel that 6972 is extremely promising and differentiated novel agent with a significant market potential in a strong intellectual property position.

Glucagon receptor antagonists are a clinically validated new class of molecules.

And, I note that Lilly announced positive Phase II data at the ADA meeting.

And, while our program is earlier staged than Lilly's, we believe our molecule has some significant advantages in potency as well as other attributes.

Because of this, we see 6972 as one of our most promising unpartnered pre-clinical assets.

And, we're continuing targeted and thoughtful investment into this program to ready it for an IND in 2013.

We also plan to start a pivotal clinical trial for our Captisol-enabled Melphalan program in the second half of this year.

And, are readying our pivotal clinical trial materials right now.

Conditioning treatment with high doses of Melphalan plays an important role in stem cell transplantation for Multiple Myeloma.

And, we believe that Captisol-enabled Melphalan could have distinct advantages over the current forms that are on the market.

We look forward to sharing continued progress on our pipeline as the data becomes available.

And, with that, I'll turn it over to John Sharp, who will review the Q2 numbers in detail.

Thanks, Matt.

As you have heard from both John and Matt, we have had several very exciting news events recently that we believe will drive significant revenue growth beginning next year.

And, while these events may only have a minimal impact this year, 2012 is shaping up to be a solid year.

And, the business continues to perform in line with our expectations.

Now, for some highlights from the second quarter.

First, as John Higgins mentioned, we are pleased to see that Promacta sales continue to show consistent strong growth on a quarter-over-quarter basis.

And, as a result, our second quarter 2012 overall royalty revenue was $3 million, compared to $2.2 million for the same quarter last year.

Revenue from material sales is lower than the same period a year ago.

But, that is simply due to the timing of orders.

We have a large Captisol customer base.

And, as you have heard many times from me in the past, Captisol shipments can be very lumpy with large orders coming in timed with clinical developments or product launches.

And, as you will see with our full year guidance, we expect to have a strong second half for Captisol shipments.

Finally, in terms of license and milestone revenues, this quarter we recorded $1.1 million, down slightly compared to last year's $2.3 million.

However, 2011 revenues included $1.3 million of non-cash deferred revenues, so on a cash basis, these revenues are slightly up.

Now, taking a look at our operating expenses, our combined R&D and G&A expenses for the quarter were $6.8 million, down slightly from $7.1 million for the same quarter last year.

And, in line with our overall goal of running the business with annual combined R&D and G&A expenses of approximately $25 million as we do expect to see expenses taper off in the second half of the year.

I also wanted to point out that we recorded a non-cash charge of $1.2 million in other expenses during the current quarter as a result of an increase in our liability for contingent value rights.

Which related to the milestone we owed CyDex shareholders for the approval of Onyx Kyprolis.

As a result of the approval the CyDex shareholders were entitled to a $3.5 million milestone payment.

In July, we paid out the cash milestone but given the positive regulatory developments in June for Kyprolis most of the charge was taken in the second quarter.

As far as our cash position, we finished the quarter in line with our expectations.

Over the past few weeks, we have sold 150,000 shares of Ligand stock through our at the market equity program.

We've raised total net proceeds of $2.6 million at a weighted average price of $18.19 per share.

In light of the Kyprolis milestone due to CyDex and the positive impact on our stock post approval, we had an opportunity to raise some equity proceeds in small stock sales.

The stock sales occurred after the end of the quarter, so they are not reflected in our cash balance.

Also of note, we paid down the remaining $1.5 million on our revolving line of credit facility in July.

To wrap things up, we are reiterating our previous financial guidance for the full year revenues of approximately $30 million.

With this outlook, we forecast revenues accelerating in the second half, with third quarter revenue of approximately $8 million and fourth quarter revenue of approximately $11 million.

As far as expenses, we continue to expect cost of goods sold for the full year to be between 30% and 35% of material sales.

And, we continue to expect combined R&D and G&A expenses of approximately $25 million for the year, including approximately $6 million of non-cash expenses.

And, as we have said consistently, we do expect the continuing operating business to be profitable and cash flow positive for the full year.

With that, I will turn the call back to John.

John, thank you.

Operator, if there are any questions, we can field some questions now.

Ladies and gentlemen at this point we'll be conduct a question-and-answer session.

(Operator Instructions)

Van Brady, Presidio Management.

First, John, I'd like congratulate you and the team for developments on Promacta and Kyprolis this year.

It looks very favorable.

And, I did have a question about the royalty schedule for Kyprolis.

I wasn't able to cap it -- to copy it down fast enough.

There was 1. -- for some, some volume there was 1.5% to what?

It's 1.5% to 3%.

And, Van, in our Q that will be filed by 2.30 today, there will be an exact schedule of the royalty in there.

Yes.

And Van, just to give a little more color, certainly, thanks for the question, and I appreciate your remark about the recent developments.

We're also very excited about the last couple of months.

The royalty, it starts at 1.5% on the first $250 million in annual sales.

And then, it goes to 2% on the next $250 million, so from $250 million to $500 million.

And then, to 2.5% on the next $250 million.

And then, it caps off at a 3% rate on sales north of $750 million annually.

So, it's a simple royalty tier that escalates essentially at every quarter of $ billion revenue mark.

I see.

So, if Rachel McMinn's estimate of Kyprolis sales next year, I think it was about $250 million, that would be at 1.5% royalties.

Is that correct?

That's correct.

That first royalty tier starts at 1.5%.

If her guess of Kyprolis sales is correct, what would the accompanying Captisol sales be for that size of drug product?

Van, roughly $200 million.

We don't break out what the exact Captisol revenue would be on a per product basis.

Partly because it does relate to pricing and we have different pricing schemes with our various contracts.

But, at that level, we'd enjoy a nice slug of royalties and have, potentially, $200 million of material sales that would be related with that level of sales volume.

That would be great.

Looks pretty good.

Thank you Van.

Thank you, again, for the answers.

Joe Pantginis, Roth Capital Partners.

Hi, guys, good afternoon and congratulations on your progress.

Couple quick questions if you don't mind.

First, since you really have such broad programs for Captisol and you keep signing more and more, maybe you can just touch upon, to the level of extent you can, regarding your manufacturing capacity?

And, your ability to provide enough Captisol for all of these collaborations that you've been signing as well as for the approved products?

Yes, Joe, this is Matt.

Thanks for the question.

We have a 50-metric ton capacity for Captisol.

So, we've got plenty of capacity.

We work very closely with our supplier, Hovione.

And, have multiple sites that we're working with within the Hovione network to make sure we have some level of redundancy built in and safety stock built into the system.

But, we've got plenty of capacity.

So, we're pleased with that.

And, to put it in perspective, that 50-metric tons, currently we are producing -- what we're supplying right now is a small proportion, maybe 20%, 25% --.

Yes, a little less than 20% correct.

Of that target.

So, again, just a way to say there's a lot of head room, and we have a great manufacturing relationship with Hovione.

Also, while they're a, quote, sole supplier, the fact is we're operating out of multiple sites which is a real benefit for us as well.

Sure.

No, that's really helpful, thank you.

And then, maybe just with regarding to the broad aspects of Promacta, you did mention a couple indications just any further color or body language from Glaxo about what they're also really excited about bringing to pivotal studies.

And then, also the same question for you guys.

Internally, obviously you're putting some resources behind the pivotal Melphalan program.

You mentioned the 6972 program, also wanted to get a sense of what also are you really excited about, about throwing some resources behind?

Thanks, a lot.

Yes.

Okay, Joe, thanks.

I'll make a quick remark about Promacta and then invite Matt to add some more color too.

Promacta, it is, it's a tremendous asset.

And, obviously investors are warming up to it more and more given the financial success and the regulatory filings and the new data that's coming out.

But, I want to be clear for the investors listening to this call or those who might read the transcript, Promacta is a -- an A plus program.

It is absolute top quality, top flight.

And, any investor involved in biotech or the pharmaceutical space should seriously spend time learning more about this medicine and its potential.

GSK is doing a brilliant job, in our opinion, advancing it.

And, obviously it's a tremendous investment, it's a lot of work, a huge staff.

But, they have a great molecule with tremendous promise.

Obviously, we know what it's done in ITP, we're monitoring the sales.

The potential to enable Hepatitis C patients to treat -- to seek treatment, we think is revolutionary for the sickest of the sickest Hep C patients.

But, beyond that, again, the investment and the opportunity, it's not only a great commercial assets it is a fascinating medical asset.

So, with that set up, I just would like Matt to add a little more color on other areas that GSK is working in.

Yes, thanks, John.

Obviously, I think everyone is well familiar with the commercial success in ITP and obviously the Hep C is obviously a big indication GSK has done a lot of great work on.

We applaud them for that.

Following the literature and also just following where GSK has been spending time developmentally, MDS and AML represent really interesting new fields.

Also, there have been some publications in leukemia.

I mentioned the New England Journal of Medicine publication in Aplastic Anemia.

Very interesting that raise some fundamental biology, I guess, observations around Promacta as it compares to endplate.

And, basically, I think at a basic level endplate binds to a receptor like endogenous TPO does.

Whereas Promacta binds in a trans-membrane domain.

There's a lot of biology there, but it's starting to become an important sub-story as to why Promacta may have an advantage and may be applicable in a number of other diseases.

So, we're certainly following it closely and are very excited about it and see it having a lot of potential in the future.

And then, on top of that there are other indications like thrombopheresis or other areas where Promacta is an obviously fit and could expand into as well.

And then, just the related question regarding internal programs beyond what you mentioned.

What are you most excited about looking to throw some of your resources behind?

Yes.

Joe, as I said in the prepared remarks, obviously 6972 is an exciting program.

We disclosed some data this past quarter.

We continuing a thoughtful investment there to ready it for an IND next year.

That area, the Glucagon Receptor Antagonist area, is one where that we really feel like the science is ripening in.

And, we've got -- we feel like we've a better molecule that can be differentiated.

So, we're excited about that.

And, we continue to be excited about Captisol-enabled Melphalan.

We're just gearing up now to start the pivotal trial.

It's a 60 patient focused trial, a really good development path that was defined really in the CyDex days originally.

But, we obviously completed the Phase IIA last year and announced that data.

But, it's a very focused development path.

A 505(b)(2) route also with an orphan drug designation.

So, a very rare combination.

And, meeting a key need in the stem cell conditioning area.

So, we -- we're excited about that program.

We're looking forward to getting the clinical trial started in the second half of the year.

Great guys, thanks a lot.

Thank you, Joe.

Carol Werther, Summer Street.

Thanks, for taking my question.

So, the first is how many shares do you have outstanding following the ATM?

So, it's just under $20 million, it's $19.9 million.

Okay.

Thanks.

And then, on the Melphalan program, how long do you think it will take to run the pivotal trial and receive the results?

Carol, we estimate -- obviously there's a -- once we get the trial running, we'll get multiple sites up and running, we estimate about a year.

Okay.

That's helpful.

And then, can you give us any update on where the Medicines company is with their program?

Yes, for those who may not know, we, last year, licensed an IV Clopidogrel or IV Plavix, the active ingredient Plavix, to the Medicine's company.

They're progressing that product through development now.

They announced most recently in their earnings call that they're planning to get a clinical trial started in the second half of the year.

So, they continue to be a great partner and we're cheering them on.

And, think they'll -- they've got a great global platform for the product.

Okay.

And then, when I look at -- maybe you could help me with some of the other milestones that we might see this year.

I think we were expecting to see some data from HepDirect?

Are we still expecting to see that?

Yes, Carol, we are still doing some R&D work on HepDirect.

It's a technology we acquired through the Metabasis acquisition a couple years ago.

And, we're looking forward to presenting some additional pre-clinical data on HepDirect at scientific meetings in the second half of this year.

Yes, you will start to see some data in the second half of the year.

So, perhaps an SLD?

Yes, yes.

Okay.

That's helpful.

And, I think we were all -- I thought Pfizer had a separate program than the one mentioned in the press release that there was work going on.

But, I might be wrong about that.

I get a little confused with how many programs you have.

So, Pfizer, there are two drugs.

There's a single agent synthetic estrogen, or a SERM, Selective Estrogen Receptor Modulator, Conbriza, which they are marketing in Europe and Japan.

So, that's approved and we enjoy a small royalty off of that.

This other drug, Aprela, now is filed in Europe and accepted.

And, we still anticipate that the US filing will also go in this year as well.

That, as Matt indicated, is a combination drug with both the SERM, Bazedoxifene, and Premarin.

And, this is non-Captisol, correct?

Correct.

Okay.

And, can you talk about which product Vertex is developing?

Not at this point.

We're not at liberty to share the target just yet.

Okay.

But, we hope to sometime in the future.

All right.

Well, thanks, so much.

It looks like very nice quarter.

Carol, thank you.

Keith Markey, Griffin Securities.

Hi, thank you for taking my questions.

First of all, I just wondered if you could reiterate what number of more advanced Captisol products are under development?

I didn't quite get that.

Right, Keith, in my remarks I commented that there were over 30.

As you know, in our investor presentation we site that we have over 60 fully funded partnered programs, which is the case.

And, the number, in fact, has gone up a bit recently.

But, in the Captisol business, and I was tying the remark to the Kyprolis commentary, in the Captisol business we have over 30 partnered licensees.

And, in the breakdown on the stage is 6 programs are in or entering Phase III.

And, we're excited.

I mean, as exciting as Kyprolis is, clearly we have got a very high quality, late stage roster of other Captisol programs that are moving nicely through development.

And then, we have another 10 that are in Phase II, and over 15 are in Phase I.

Great, thank you.

And then, I was wondering, do you have a sense as to whether Promacta sales are benefiting much yet from the Hepatitis C indication?

Keith, our sense is they are not.

And, this is very anecdotal.

But, we have -- we're interested in how much of the revenue growth, or levels, is at all driven by Hepatitis.

We don't have a direct handle on the commercialization of the product.

But, anecdotally, the sense that we're getting from anybody in the marketplace we've been able to talk to, is that this really, to date, really is used for the labeled indication of ITP.

Is there any reimbursement limitation that might be holding it back?

Because I would think that some of the patients might be, or physicians would want to be able to have access to drug -- the drug for that particular purpose already?

Yes.

A fair point.

I think that's a very logical conclusion.

I'm not aware of anything in particular.

Obviously, physicians are permitted to prescribe off label when they deem appropriate.

But, I think circumstantially it may be partly a timing issue, I mean, the data it's fairly new.

But, also it may be a policy issue.

I think that GSK and those who follow the company know their recent history.

I think they are very conservative on promotion of product.

And, frankly, it's responsible.

I think they really do care about the regulatory status and making sure that they get a labeled approval before they put any resource behind it.

So, I think it's largely circumstantial.

We don't read into that at all.

Our own view of the data is that it's a very, very robust and compelling dataset.

These patients are the sickest of the sick.

As excited as the whole pharma space is about the new HCV drugs, the reality is those drugs are targeting mild to moderate patients.

Important patients, but they ostensibly are not sick right now.

Promacta is targeting the sickest patients who have a severely damaged liver.

They run the course of dying or contracting liver cancer within just a few years.

So, given the nature of the medicine, how it works, and what it means for these patients, personally myself, and I know all of my colleagues here at Ligand and our Board are very excited about what GSK is doing with this program.

Right, yes.

Thanks.

It would seem then that we should expect a nice pick up in revenue from Promacta next year?

That is our outlook as well.

I mean, we obviously need to see an approval, the label, we need to understand better the timing of launch.

But,, what's dynamite about the Ligand business is that we're right on track with our research investment.

I think we're getting quality results out of our investment.

We're managing a very tight ship financially.

And, at the same time, in the last two, three months we have seen some absolutely block buster news developments with our portfolio.

These are very high quality assets.

That now are pending approval, or are launching, that have the potential to generate significant revenue growth in the very near term.

So, we're excited for what we've seen.

But, candidly we're even more excited about what the next several quarters hold for Ligand.

Right, sure.

And, just one more question if I could.

Can you tell us if there are anymore approvals that might be coming in 2013 aside from the Hepatitis C indications for Promacta and approval of Aprela?

Sure, well, okay.

Actually, you mentioned Aprela.

So, I think that's one that Pfizer is talking about with the filings this bi-calendar.

And, I think their expectation, they are hopeful that we're looking at a 2013 approval.

Matt, can comment on --.

Yes.

We Spoke a little bit where briefly about the Medicine's company and the IV Clopidogrel.

They're intent is to file next year.

So, we should see another filing from that.

We also have some other late stage Captisol programs that are undisclosed currently that are in that time frame.

The other one that has a Phase III reading out late this year, or early next year, is Lundbeck for an IV Carbamazepine for seizures.

So, a number of programs, some of which we've talked about in detail.

And, ones that we'll see filings coming out in the next year.

Terrific.

Thank you, very much.

Thank you, Keith.

Ed Arce, MLV and Company.

Hi, guys, thanks for take my questions.

And, congrats on a great, great progress in the quarter.

I just, I guess, I wanted to start with Promacta with ITP continuing to climb in sales for that indication.

And, likely approval by the end of this year in ACV.

I know that you started to look, along with GSK, towards some of the later stage follow on indications.

And, I was curious if you could help us understand a little bit more about HORT and others that GSK is considering?

Yes, Ed, I'm happy to take that.

And, the HORT is an acronym for, for heme and oncology related Thrombocytopenia.

There are multiple legs to that.

One is Thrombocytopenia as a result -- created as a result of chemo therapy treatment.

Also, diseases themselves, MDS and AML for which GSK is running trials right now.

So, that is progressing and we're certainly seeing evidence of commitment there.

I mentioned a little bit earlier that some of the data that's coming out in the high profile journals, specifically the Aplastic Anemia publication in the New England Journal of Medicine, I think opens up some interesting doors potentially for Promacta in other indications.

And then, of course, there are things like thrombopheresis, or platelet infusions where you could see Promacta playing an important role as well.

So, we continue to be very pleased with GSK's commitment to the asset and investment.

They've got a very capable team spending a significant amount of time and effort in looking at ways to expand the indications for Promacta.

So, we're obviously cheering them and are pleased with their progress.

Okay.

I believe this, the acronym that was used previously to describe this program was ORT.

So, does that mean that hematological cancers are something that has recently been added as a potential in this program?

Well, there's certainly a lot of ripening biology out there.

I mentioned some of the publications, earlier stage publications, in anemia and other fields.

But it -- there's a lot of subgroups to the HORT area.

But, no -- yes, so, you obviously know the literature and what's out there, so.

Great.

Okay.

And then, going over the milestones left in the year, I think you might have mentioned this already just briefly, but I'm just wondering what do you know, the latest the Lundbeck program for Carbamazepine?

Yes.

So, the latest -- obviously, they have updates and have [quintrials.gov] disclosures.

But, the latest we see is a potential readout at the end of this year.

Okay.

So, that remains on track then?

From what we know, yes.

Great.

And then, one last question.

You mentioned the $3.5 million milestone payment to the former CyDex shareholders.

Would there be any other milestone payments to those former shareholders with potential future approvals?

And, which programs might those be?

Yes.

So, Ed, that was the last milestone payment.

What is still left on the table is our revenue sharing payments that are possible.

And, that's anything over $15 million, we pay 20% to the former CyDex shareholders.

And then, there's another over $30 million.

And, just to clarify the sale threshold it's Captisol revenue only.

And, it's through 2016.

The milestone, the $3.5 million was specifically tied to the Kyprolis approval and that's the last milestone.

Right, okay.

So then, just to be clear, these thresholds and the 20% and 30%, these are for Captisol material sales?

So, these are relatively small amounts?

Well, it's Captisol related revenue.

So, it could include licenses as well.

But, it's of note, it does reset every year as well.

Okay.

All right.

Thanks, for taking my questions.

Great.

Ed thank you.

(Operator Instructions)

Okay.

Well, thank you.

It looks like we don't have any other questions.

So, I appreciate the attendance and turn out today.

That concludes the earnings call.

I've already said this, but I am personally excited about the story on behalf of the team and our board.

I believe we're running a good business with an exciting future.

I want to acknowledge the new sell siders who have initiated coverage.

Certainly appreciate the support.

We've had more coverage and interest the last several months than we've had in quite a while.

We're going to be active on the road this fall.

And, it is a great time to be looking at Ligand.

So, we hope to meet with you or speak with you if you have interest.

Thank you.

This concludes today's teleconference.

You may now disconnect your lines at this time.

And, thank you for your participation.