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Edited Transcript of LGND earnings conference call or presentation 5-Nov-19 9:30pm GMT

Q3 2019 Ligand Pharmaceuticals Inc Earnings Call

LA JOLLA Nov 19, 2019 (Thomson StreetEvents) -- Edited Transcript of Ligand Pharmaceuticals Inc earnings conference call or presentation Tuesday, November 5, 2019 at 9:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* John L. Higgins

Ligand Pharmaceuticals Incorporated - CEO & Executive Director

* Matthew Korenberg

Ligand Pharmaceuticals Incorporated - Executive VP of Finance & CFO

* Matthew W. Foehr

Ligand Pharmaceuticals Incorporated - President & COO

* Patrick O'Brien

Ligand Pharmaceuticals Incorporated - SVP of IR

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Conference Call Participants

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* Emanuela Branchetti;H.C. Wainwright & Co.;Analyst

* Lucas Grant Baranowski

Craig-Hallum Capital Group LLC, Research Division - Research Analyst

* Peter Kirk Lukas

CJS Securities, Inc. - Analyst

* Scott Robert Henry

Roth Capital Partners, LLC, Research Division - MD, Senior Research Analyst & Head of Pharmaceuticals Research

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Presentation

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Operator [1]

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Hello, and welcome to today's webcast, Ligand Pharmaceuticals Third Quarter 2019 Earnings Call. My name is Li Wei and I'll be your event specialist today. (Operator Instructions) Today's webcast is being recorded. (Operator Instructions) It is now my pleasure to turn today's program over to your SVP of Investor Relations, Patrick O’Brien, the floor is yours.

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Patrick O'Brien, Ligand Pharmaceuticals Incorporated - SVP of IR [2]

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Thank you, and welcome, everybody, to Ligand's Third Quarter 2019 Financial results and Business Update Conference Call. Speaking today for Ligand are John Higgins, CEO; Matt Foehr, COO; and Matt Korenberg, CFO. As a reminder, today's call will contain forward-looking statements within the meaning of the federal securities laws. These may include, but are not limited to, statements regarding intent, belief or current expectations of the company and its management regarding its internal and partnered programs. These statements involve risks and uncertainties, and actual events or results may differ materially from the projections described in today's press release in this conference call.

Additional information concerning risk factors and other matters concerning Ligand can be found in our Ligand's earnings press release and the public periodic filings with the SEC. 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 the company as of today, November 5, 2019, and do not necessarily represent the views of any other party.

Ligand undertakes no obligations to revise or update any statements to reflect events or circumstances after the date of this conference call.

At this time, I'd like to turn it over to John Higgins.

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [3]

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Welcome to our call. And I'd like to welcome to Ligand, and introduce to all of you Patrick O'Brien. Patrick just joined Ligand yesterday as our Senior Vice President of Investor Relations. Pat, welcome.

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Patrick O'Brien, Ligand Pharmaceuticals Incorporated - SVP of IR [4]

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Thank you, John. It's a pleasure to be here and nice to work with you again.

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [5]

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Yes, yes. Absolutely. What -- Since you're on our call, Pat, how about you share a little bit about your background.

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Patrick O'Brien, Ligand Pharmaceuticals Incorporated - SVP of IR [6]

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Well, really focusing on -- post investment banking in the late 1990s, started in Investor Relations at Allergan in 2001. And really, the bulk of my experience came from my tenure at Gilead, which was from 2007 to 2016.

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [7]

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Yes. Fantastic. Well, it's great having Patrick on board. His first day was yesterday and if you saw the earnings release, his name is now posted in the upper left corner.

The business is growing and doing well and as we work with investors, a top priority is quality, proactive communications with investors. And so we're thrilled to have someone with Patrick's experience running IR for Ligand. I want to acknowledge the outstanding work that Todd Pettingill has done in IR the last 2 years. I know most of you on the call today have worked closely with Todd, and Todd will keep working with Matt Korenberg, focusing now entirely on Corporate Development. Todd is in the room here, we're going to give him a little pat on the back. Thank you.

Really appreciate your excellent work. Now speaking of new additions, we just added Sarah Boyce to our Board of Directors. Sarah, she's a great new addition, bringing extensive biopharma management experience from companies such as Novartis, MedImmune and Akcea which is a spinout from Ionis. Ionis has a business model that is similar to Ligand's. She is now CEO of Avidity, a drug-discovery company based in San Diego. Sarah's great experience in business development, strategic planning, commercialization and communications. We're very pleased to expand our Board to include her.

Now on the Board topic, we've had strong interest from people to join the Ligand Board, with many names coming forward as potential candidates.

Our focus at Ligand is to have top-tier directors on our Board, managing the oversight, governance and strategic planning. Our Board is composed of very talented, highly experienced professionals. We have former heads of research from Merck and Pfizer, past research analysts, large fund investors and business operators. Diversity in the Boardroom is also very important, and we are pleased to expand the number of women directors on our Board, and to have a Board with diverse ethnicity. We have a team of outstanding leaders that are highly engaged and working hard for investors. Sarah will fit in well.

Now in terms of some business highlights. Ligand is doing great here in 2019. It's a very balanced business, with great execution, strong dealmaking, good data events driving the portfolio, and a robust business calendar that is building for some major events in 2020 and 2021.

I want to give just quick a couple of highlight comments on Kyprolis. This is, today, our largest royalty asset. Kyprolis posted $280 million combined worldwide sales for third quarter. That's the highest quarterly sales ever, equal to last quarter.

Importantly, we enjoy a higher royalty tier as revenue increases through the year for Kyprolis, so our revenue is even higher this quarter than last. Our last year total sales were just over $1 billion for the product and this year, full year sales are on track to exceed that by a good margin. We don't market it, the drug, Amgen and Ono do, but we book our royalty on worldwide sales.

Now as we study sales trends over the past few years, Q3 sales are somewhat flat compared to Q2. In some cases, they're actually down. But Q4, what we've looked at, what we've noticed, Q4 has shown a nice bump as the year closes out. That trend, we hope, continues here in the fourth quarter of 2019.

There have been 2 important developments for Kyprolis the past 6 weeks that we believe set the product up for continued growth in the years ahead. The first was Amgen's announcement of positive top line Phase III data for its CANDOR trial, testing Kyprolis in combination with DARZALEX. Very encouraging efficacy data that could potentially support expanded use of the drug in the future.

And just last week, Amgen announced a commercial partnership with BeiGene for commercialization in China. Now our assessment is China has not been a major focus for commercial forecasting for analysts. So this deal could provide a nice expansion to worldwide revenue long-term once that market is opened up.

Now I want to turn to OmniAb. This is our largest, most valuable platform, and we've been posting significant positive financial and licensing updates from that platform over the past couple of years. We've highlighted this, of course, at our Analyst Day and we've been on the road with investors, Matt and I -- Matt Foehr and I, we get out and we've had really some good meetings with a lot of focused questions about that business. But Matt, maybe you want to give a couple of highlights, some developments of the last few months around the OmniAb platform?

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Matthew W. Foehr, Ligand Pharmaceuticals Incorporated - President & COO [8]

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Yes. Often we get asked the question, how is OmniAb doing? In a word, I'll say OmniAb has been doing fantastic. We're seeing -- the partners are increasingly turning to the OmniAb platform for their novel antibody discovery needs. And we're confident in our view that OmniAb truly is a best-in-class technology and our partners are continuing to help illustrate that with the progress they're making.

Three things I'll point out: New deals, the recent Ab Initio acquisition and program clinical progression and new program starts, specifically around OmniChicken.

On the new deals, we've entered into 5 new OmniAb partnerships recently with Takeda, GigaGen, Talem Therapeutics, Kira Pharma and AbVivo. And our signing on of new partners continues to be very strong. And we have a number of other potential new OmniAb licenses that are in various stages of finalization that we hope to execute in the coming months.

On the Ab Initio antigen technology acquisition, while it was a small deal, it's really a game changer from a technical perspective, and we're already seeing the benefits of it. Antigens generate specific immune responses in animals and partners have been and are attracted to the OmniAb platform, both by the quality and the performance of our multiple species of animals and now, with the Ab Initio antigen piece, once the program's underway, its chance of technical success can be greatly improved if driven initially by a high-quality antigen.

And then on the general progression of OmniAb programs, the number of clinical trials evaluating OmniAb-derived antibodies continues to increase in breadth and number. And the patient numbers and the volume of clinical trials are continuing to grow.

We're looking forward to data readouts for OmniAb-derived antibodies this year and next from CStone, from Immunovant, from J&J, Symphogen and others. So that's on the clinical side. And on the discovery side -- and for OmniChicken in particular, we work very closely with our partners performing some of their earliest stages of work. We see them leveraging OmniChicken for drug targets that are generally considered difficult targets. And in the last few months, we've had the most new OmniChicken program starts for partners that we've had in any period in our history. And we actually see that accelerating significantly in the coming months based on current planning dialogues with our existing partners.

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [9]

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Right. Yes, no doubt, a big portfolio. You know, Matt, a lot of news flow out of OmniAb. As the year's winding down, we're getting questions about what are some leading partnered assets that investors should be focusing on and I know we've had a couple of big news events and some calendar events are coming up next year, so maybe highlight a couple of key programs for investors?

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Matthew W. Foehr, Ligand Pharmaceuticals Incorporated - President & COO [10]

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Yes, there are 2 in particular that I'd call out, Retrophin sparsentan and then also Viking's TR Beta programs. Regarding sparsentan, last week, Retrophin confirmed that enrollment is on track in pivotal Phase III trials to support registration of sparsentan for patients with FSGS and IgA nephropathy. They have what's called the DUPLEX study, running in FSGS and the PROTECT study running in IgA nephropathy, top line data are expected in the first half of 2021 for DUPLEX and the first half of 2022 for PROTECT. And importantly, Retrophin also mentioned last week that they'll be presenting new data on sparsentan at the American Society of Nephrology's Kidney Week meeting that's happening this week in Washington, D.C. They've got new data from the Phase II DUET study, examining the important impact of sparsentan on quality of life in patients with FSGS and have preclinical data -- new preclinical data exploring the potential effect of sparsentan on Alport Syndrome.

So this is new news for the program. It is another new potential indication for sparsentan, Alport Syndrome, just as background, is a genetic condition characterized by kidney disease, hearing loss and eye abnormalities and people with Alport Syndrome experience progressive loss of kidney function.

And then for Viking, they announced just this morning that they're quickly approaching the start of VK2809's Phase IIb trial in biopsy-confirmed NASH. So that's one that we're watching closely. NASH is obviously seen as a large market with a high unmet need. And Viking announced positive Phase II data last year for the program, achieving key primary and secondary endpoints and showing potent reductions in liver fat content and plasma lipids. Separately, they also announced this morning that clinical development of VK0214 for X-ALD is expected to begin in the first half of next year. So that was new news as of this morning as well

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [11]

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Yes. It was great to see that -- in their market reaction today. Clearly, investors seem to be focused on that. The stock looks like it was up almost 20% on very high volume.

What's interesting about those 2 programs you call out, both those came via acquisitions we did, boy, 7, 8 years ago, Pharmacopeia and Metabasis. Sparsentan was originally the DARA program out of Pharmacopeia and the TR Beta came from the Metabasis acquisition. So some great marquee assets. More recently, we've done a couple of other deals, a little bit different type of deals. We're still doing M&A, corporate M&A but also we're looking at what we call project finance where we are investing some of our cash to acquire royalty rights in late stage assets. And ideally, we're targeting Phase III stage assets. And there are 2 deals we did early this year, I know investors have been following this but Matt, both Palvella and Novan have had very good progress. Maybe you want to give some update on those 2 programs?

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Matthew W. Foehr, Ligand Pharmaceuticals Incorporated - President & COO [12]

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Yes, so Palvella, a private company, they've now started the Phase III pivotal portion of the Phase II/III VALO study of PTX-022 in pachyonychia congenita which is a significant milestone for the development program with the first subjects now randomized in the Phase III double-blind placebo-controlled portion just this past quarter.

And our interactions and technical dialogue with Palvella are very close. And they report that patient enrollment efforts continue to be strong with full study enrollment projected to be achieved in Q1. The Phase II portion of the clinical study will be complete in Q2 of next year with the full Phase III study readout expected to happen in the second half of 2020.

Palvella recently made the decision to implement an open label extension study for patients who participate in the VALO trial. And the primary purpose of the open-label extension study will be to generate additional safety data around long-term treatment with PTX-022.

They also have identified, and will be pursuing, a second high potential rare genetic indication called Gorlin syndrome. Gorlin syndrome is a genetically driven disease in which patients can develop hundreds to thousands of malignant skin cancers in the form of basal cell carcinomas over a lifetime.

And recent scientific work from leading cancer researchers has confirmed that the mTOR pathway has a key role in BCC tumorigenesis in Gorlin syndrome. So an estimated 10,000 patients are affected by Gorlin in the U.S. There are no FDA approved therapies indicated for Gorlin, and Palvella has said that they will commence a Phase II study in Gorlin syndrome in 2020. Similarly, Novan has been making great progress as well. They completed patient recruitment in the B SIMPLE Phase III pivotal trials with SB206 for the treatment of molluscum contagiosum. Novan affirmed that top line data from these trials are expected in the first quarter of 2020. And again, as you mentioned, both of these programs are new additions to the Ligand pipeline and both are now positioned for late stage data readouts next year.

I just make a comment more generally on the pipeline. I'll also mention that we look forward to the American Society of Hematology or ASH annual meeting this year, which is in early December. We expect a number of our partners may present data there, and we'll be monitoring the abstract releases that are happening tomorrow. ASH is traditionally an important meeting across the industry and we expect to see data again this year

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [13]

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Yes. Yes. Great. And again, both those programs did not exist in our portfolio just 10 months ago. And there are -- really have very high quality assets making good progress, and if they are successful, we believe they have a chance to contribute significant economics to Ligand.

Before we turn it over to Matt Korenberg to walk through the finances. Matt, maybe just a couple of quick highlights on some of our internal research projects?

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Matthew W. Foehr, Ligand Pharmaceuticals Incorporated - President & COO [14]

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Sure. Obviously, a key element of our business model is focused R&D investment with the goal of downstream partnering. In July, we announced positive top line results from our Phase I trial of Captisol-enabled iohexol demonstrating pharmacokinetic bioequivalence between CE-iohexol and reference products after IV administration.

CE-iohexol was safe and well tolerated and adverse events were in line with the known safety profile of GE's Omnipaque. The study was conducted in Canada under a CTA with Health Canada. Details and data from that Phase I trial will be presented at ASN's Kidney Week later this week in Washington, D.C. and also additional data will be presented next week at the Contrast Media Research Symposium in Italy along with a presentation on data from CE-iohexol in preclinical models of acute kidney injury.

There will also be a presentation on comparative cardiovascular assessment of CE-iohexol and iohexol in dogs at the AAPS PharmSci meeting in San Antonio later today. And I know that we have a significant presence at AAPS this year with our Captisol technology as well. I just returned from the conference last night and want to give credit to our Captisol team for their efforts leading up to and during the AAPS conference.

So for iohexol, we plan to submit an IND with the FDA and initiate a Phase II study in the U.S. in the second half of next year. The IND filing is a necessary step as the plan will be to run the next trials here in the U.S. We're highly confident that the data generated so far support further development and we'll explore potential commercial partnerships for the program as we prepare for the next phase of development.

And switching gears a bit, I also just quickly comment on the internal antibody programs that we have ongoing leveraging OmniChicken, we've been pleased with our team's progress on the internal OmniChicken programs. And we will be presenting data in December at the AETC meeting in San Diego on our B7H3 antibody program and our CD38 program, where we are seeing evidence of peak amolar affinities. I realized that's fairly technical but antibody affinity refers to the strength with which an antibody binds to a specific target. High affinity antibodies permit greater sensitivity in assays and often correlate with higher potency in vivo.

Once our work's complete on those programs, our goal will be to partner them. And so that's our general update on our internal programs. And with that, I'll turn the call over to Matt Korenberg to review the financials.

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Matthew Korenberg, Ligand Pharmaceuticals Incorporated - Executive VP of Finance & CFO [15]

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Thanks, Matt. I'll start today as I usually do with a review of the financials contained in our earnings release issued earlier this afternoon.

The total revenues for the quarter of -- were at $24.8 million and included $9.8 million of royalty revenue, $6.8 million of material sales and $8.2 million of milestone and license fee revenue. It was another strong quarter across all 3 lines of revenue.

With respect to royalties, we saw nearly 40% quarter-over-quarter organic growth driven by reaching the higher royalty rate tiers on Kyprolis and by the launch of EVOMELA in China by our partner CASI Pharmaceuticals.

Material sales considered -- continued their strong performance this year, with another strong quarter.

And on the milestone and license fee line, we again saw more than double the revenue we recorded a year ago from the normal course of contract in milestones.

Total revenues for Q3 of 2018 were $45.7 million, and included $27.8 million of nonrecurring royalty revenue from Promacta. And investors know we divested the Promacta asset to Royalty Pharma in March for $827 million. Accordingly, Ligand did not receive any Promacta royalties in the third quarter of 2019. So on an apples to apples basis, Q3 2019 total revenues of $24.8 million compared with Q3 2018 total revenues of $17.9 million, and represented an increase of about 39%.

Regarding gross margin, our Q3 gross margin for Captisol sales was lower versus the prior year. Our mix of commercial and clinical material sales shifts from quarter-to-quarter and from year to year, resulting in the changes in gross margin. Our material sales costs are still expected to translate to an overall corporate gross margin of over 90% for the 2019 fiscal year.

On the expense side, R&D in Q3 2019 was $13.7 million. Excluding stock comp and other noncash charges, R&D was $6.2 million. For G&A, our Q3 total was $9.5 million, and excluding stock comp and other noncash charges, G&A was $5.6 million. Taken together, the total cash operating expenses for the quarter were $11.8 million, which was right in line with our expectations.

During the third quarter, we processed a couple of tax provision items that are impacting our third quarter and full year net income and EPS. Two factors impacting our tax accruals are the divestiture of Promacta and the application of R&D tax credits, but primarily, it's the divestiture from Promacta. As the year has progressed, we now see the sale of Promacta had a higher net profit than we expected due to the lower tax rate.

That's good news for the business overall because it makes the sale of the asset even more profitable for Ligand. But the result is that the rest of the business post Promacta is taxed at a slightly higher rate as compared to our initial estimates.

In addition, we have a lower benefit from R&D tax credits this year compared to last. The impact of these 2 changes is that we anticipate more than $13 million of additional overall cash tax savings for Ligand, but given the way we broke out our guidance for investors earlier this year, excluding the Promacta transaction, we have about a $0.20 impact to our guidance.

Again, just to reiterate, we'll pay about $13 million less in taxes compared to our original estimates, but there's a nonoperating impact due to our adjusted earnings reporting methodology. And I'll discuss this more in a moment.

GAAP net loss for Q3 of 2019 was $15.3 million or $0.81 per share. In this quarter, the performance of Viking's share price and the amortization of the purchase price from our Palvella and Novan investments contributed to the loss. The unrealized loss related to the movement in Viking's stock price that's included in our GAAP earnings this quarter was $10.5 million. Just as evidence of the variable nature of that item, after Viking announced their Q3 earnings this morning and provided an update on their development plans, their stock is up about 19%, and based on our 7.5 million shares and warrants, if we were to book that number today, it would be a $10 million gain versus yesterday's price.

With respect to Palvella and Novan, any future product investment trends in any other future product investment transactions that we do, just a reminder that we're required to expense the upfront cash investment over the period in which the funds are spent by our partners. These acquisitions [are product] economics, therefore, result in ongoing noncash R&D expense during the life of the clinical trials. In Q3, these deals contributed $4.8 million of noncash R&D expense.

For the quarter, we reported adjusted net income of $9.5 million or $0.49 per diluted share. This compares with adjusted net income last year of $31.7 million or $1.32 per diluted share. And again, last year's Q3 numbers were higher due to the inclusion of the Promacta royalty revenue. And as I just mentioned, earlier for the -- for this year, the tax -- the change in tax assumptions for the core and non-continuing business will -- impacted these numbers.

Overall, the full year, full company results will be more profitable with the inclusion of the new Promacta tax assumptions. However, our adjusted diluted EPS excludes the sale of Promacta and the benefits of that transaction.

To highlight this point, if the Promacta tax changes had not been run through the P&L in Q3, adjusted diluted EPS would've been $0.61 a share.

Turning to cash flow in Q3 2019, we generated [$18 million] of operating cash flow before tax payments. And on the balance sheet, we finished the quarter with $1.1 billion of cash and we spent approximately $181 million on share repurchase and $24 million on taxes, principally associated with the sale of Promacta.

With respect to share repurchased since the last update to investors in our quarterly filings, we repurchased 1.4 million shares of our stock for $139 million, and as we will disclose in our 10-Q when we file, we have about 17.6 million basic shares outstanding today, and at today's stock prices, that translates to about 18.4 million diluted shares outstanding.

We began actively purchasing our shares about 1 year ago in November of 2018. And over the past 12 months we've repurchased about 18% of our outstanding shares. We currently have a $500 million share repurchase authorization in place and have utilized about $91 million of that authorization so far.

Turning now to guidance. We're reiterating our full year 2019 revenue guidance and expense outlook and we're updating our adjusted diluted EPS guidance to allow for the changes in tax assumptions that I described.

For the year, we continue to expect total revenues approximately $118 million. In reaffirming this full year number, we're implying about $24.5 million of Q4 revenue.

And one -- taking one step deeper on our revenue guidance, our revenue mix has shifted slightly over the course of the year from our -- since we give our original guidance, but we still believe that we'll meet or perhaps exceed our $118 million target. And within the royalty revenue line, given the early stage launch process for ZULRESSO from Sage, we've included an immaterial amount of royalty revenue related to that product in our guidance for the remainder of the year.

Overall, the operating business is performing well and is coming in right in line with our expectations. Our outlook is consistent and expectations for revenue, cost of goods sold and operating expenses remain unchanged.

The one factor that's changing the -- changing, is the allocation of taxes between the large onetime sale of Promacta and the rest of the ongoing core business.

As mentioned, we updated our assumptions this quarter for the taxes related to the Promacta divestiture, and we realized the lower tax rate was applicable to Promacta, making the sale of that asset more profitable for Ligand.

As a result, the rest of the business is now being taxed slightly higher, and the $0.20 impact to our -- and resulting in the $0.20 impact to our previous EPS guidance.

As such, our new guidance for core adjusted diluted EPS for the year reflecting these tax changes is $3 per share instead of our previous guidance of $3.20 per share.

On the EPS line there's one other nonoperating item to mention. Our guidance at the start of the year reflected interest rates at the time, as investors know the interest rate environment has been challenging for holders of significant cash with the Federal Reserve rate cuts decreasing interest yields.

As a result, we've given up nearly $0.10 of EPS from lower interest income. However, the lower share count due to the share repurchase has made up for the lower interest income compared to what was originally assumed for guidance, and these changes are all factored into our updated guidance.

Finally, just as a reminder, our adjusted diluted EPS guidance excludes stock-based compensation expense, noncash debt-related costs, changes in contingent liabilities including our CVRs, transaction-related amortization expenses and onetime costs, unrealized gains or losses related to our holdings and public companies' stock, mark-to-market adjustments for amounts owed to licensers, excess tax benefits from share-based compensation, excess convert shares covered by our bond hedges, and certain other onetime nonrecurring items.

With that, we'll take your questions and I'll turn the call back over to the operator to open up for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question comes from the line of Matt Hewitt.

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Lucas Grant Baranowski, Craig-Hallum Capital Group LLC, Research Division - Research Analyst [2]

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Yes, this is this is Lucas on for Matt Hewitt here at Craig-Hallum. You touched briefly on the Omni -- internally developed OmniChicken programs. And I was just wondering if there is anything you can tell us about kind of the level of interest you're getting in those programs and if you're still planning to out-license them before the end of the year?

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Matthew W. Foehr, Ligand Pharmaceuticals Incorporated - President & COO [3]

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Yes, Lucas, thanks. This is Matt Foehr. We announced the programs in the first quarter of this year and actually once we announced them at our Analyst Day, we actually had some inbound interest right out of the gate. But we've obviously decided and we wanted to focus on generating data packages. The key in any internal R&D investment is to generate data that derisks the program or answers key questions, characterizes the program. And over the years, we've been very focused on what are the key things we need to do for the various programs in order to translate those into a partnership with better downstream economics.

So we have 5 programs running, we'll be presenting data at the AETC conference in San Diego in December for 2 of the programs, specifically the B7H3 antibody program and the CD38 antibody program, both with novel antibodies that are derived out of our OmniChicken. So we'll generally describe some technical data around that. And then from there, we'll assess the partnering landscape for the programs as we go into next year.

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Lucas Grant Baranowski, Craig-Hallum Capital Group LLC, Research Division - Research Analyst [4]

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Okay. Great. And then I guess on a similar topic, it's been a couple of quarters since you launched the OmniClic platform. Is that a platform that you see maybe spawning some internally developed programs as well?

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Matthew W. Foehr, Ligand Pharmaceuticals Incorporated - President & COO [5]

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I guess, the short answer is, yes, it certainly could. We do have -- the OmniClic, just as background for investors, is a specialized version of OmniChicken that produces antibodies with a common light chain. And those are generally used for development or pursuing bispecific antibodies that can go after a couple of targets at the same time. That's a growing area of interest and need in the industry. So we launched that earlier this year. We actually already have partnered programs that are producing OmniClic-derived antibodies. But, yes, it certainly could be one that we leverage for internal programs but our focus right now is on spreading that and expanding that with our partner programs.

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Lucas Grant Baranowski, Craig-Hallum Capital Group LLC, Research Division - Research Analyst [6]

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Okay. Great. And then maybe I can just squeeze one more in. You kind of highlighted the opportunity that exists with Palvella. I guess, how are you thinking about the addressable market for that product? And assuming everything kind of reads out when it's supposed to, do you think we could see sales from that late in 2020?

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Matthew W. Foehr, Ligand Pharmaceuticals Incorporated - President & COO [7]

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Yes. The data readouts is -- I'll generally describe kind of the clinical plan and then Matt Korenberg can talk a little bit about the market and the business deal itself. It just switched over to the Phase III pivotal portion of the trial. So the -- just as a background, it's a Phase II/III trial called the VALO study. They just started the Phase III pivotal portion and have patients now randomized into the double-blind placebo-controlled portion, which just happened this past quarter.

So the Phase II portion will read out in Q2 of next year and then the full Phase III readout is expected to happen in the second half of next year. This is a drug, obviously, with orphan designation. There is -- it also has fast-track designation and real high unmet need for the program. We've been really pleased with not only the team at Palvella, just their focus and commitment to progressing the trial quickly and with a target of getting this product out to the market for patients in need.

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Matthew Korenberg, Ligand Pharmaceuticals Incorporated - Executive VP of Finance & CFO [8]

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Yes. And on the market size, with any rare disease drug like this, it ultimately comes down to pricing. Obviously, in this case, the expected impact on patients' lives is significant and we could imagine pricing would be relatively attractive. And with about 8,000 or 9,000 patients likely in the U.S. market, we could see that translate into several hundred million dollars of end-user sales. So a real nice market for the drug.

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Operator [9]

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Your next question come from the line of Joseph Pantginis.

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Emanuela Branchetti;H.C. Wainwright & Co.;Analyst, [10]

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This is Emanuela for Joe Pantginis. I was wondering if you can give a little bit more color on these novel license agreements you mentioned. Maybe in regards to how you look at partners when you are -- how you look at this license agreement and the choice you make in terms of the companies. And also, if we should expect news flow coming soon from all of them or some of them.

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Matthew W. Foehr, Ligand Pharmaceuticals Incorporated - President & COO [11]

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Yes. This is Matt Foehr. Thanks for the question. We entered into -- I think you're referring to the 5 OmniAb platform license agreements we entered into the last quarter here. An agreement with Takeda, obviously, a large multinational global player, GigaGen, Talem Therapeutics, Kira Pharma and AbVivo. In all of those instances, they are partners who are looking to access our OmniAb technology to discover fully human antibodies that they want to take into development. So I think it's further validation of the platform and we continue to see nice momentum and new dealmaking.

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [12]

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Generally, these are similar transactions to deals we've done in the past. The cadence of deals is very consistent and it's a mix of private and public companies, some smaller, some much larger, but a common interest to access what we think is a best-in-class antibody discovery platform.

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Emanuela Branchetti;H.C. Wainwright & Co.;Analyst, [13]

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Okay. And I also saw in your past release you mentioned some data coming out from Verona Pharma Phase IIb data. I was wondering if you have any thoughts on how our view on Verona's RPL554 should change based on the recent approval of Trikafta In cystic fibrosis. If you have any.

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Matthew W. Foehr, Ligand Pharmaceuticals Incorporated - President & COO [14]

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Yes. I'll just speak generally. This is the -- the Verona Pharma asset is an asset that came to us through our Vernalis acquisition last year. They reported positive Phase II data. They're working on a number of forms of presentation, which is not uncommon in the respiratory space. And they reported positive Phase II data with their dry powder inhaler formulation recently. And that they also announced that they completed enrollment in their Phase IIb study with a nebulized form of ensifentrine as an add-on to long-acting bronchodilator. Obviously, they're going after a big indication, COPD, which is the third-largest -- third-leading cause of death. And their plan is to enter Phase III trials in COPD sometime in 2020. That's been their communication. So, yes, that's kind of the summary of the status of the program, that's one we are continuing to watch and obviously cheering them on.

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Operator [15]

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Your next question comes from the line of Scott Henry.

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Scott Robert Henry, Roth Capital Partners, LLC, Research Division - MD, Senior Research Analyst & Head of Pharmaceuticals Research [16]

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Just a couple of questions. Unfortunately, I'm going to ask about the tax changes and that impact. I certainly have -- I don't think fully understand all of the moving parts. But the question is, should these changes impact only 2019 or will this also impact the tax rate in 2020 and going forward? And how should we think about that magnitude going forward if it does impact that?

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Matthew Korenberg, Ligand Pharmaceuticals Incorporated - Executive VP of Finance & CFO [17]

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Yes, Scott, it's Matt Korenberg. Thanks for the question. And don't apologize, we're not upset about this at all, really. It's pretty simple at a high level. When we announced the transaction, we had an estimated tax rate for Promacta. And today, as we kind of get through filing the taxes and paying the taxes, we're realizing that the tax rate is going to be lower than we had estimated. It might help investors if I remind folks that before we excluded Promacta from what we were going to call our adjusted EPS this year, the gain, we gave guidance of $32.25 for the total company. Today, we are still reporting on that number, largely as a result of the change in the tax estimate and partially as a result of the share repurchase that we've done. That $32.25 today would be over $35 a share in earnings. So EPS has actually increased significantly since the time we gave the original EPS guidance. What we did at the time, after $32.25 guidance came out, the next call we said let's give investors an estimate of what the actual business is doing. And we estimated the amount of tax that will be associated with Promacta, we deducted then the after-tax gain from that $32.25 and got to the $3.20 that we were talking about.

Flash forward to today, we're starting with a higher number of $35. The gain is significantly higher than we expected, the after-tax gain is significantly higher than we expected. So when we're reducing that $35, you reduce it down and it gets down to $3 a share. So in -- a big picture overall company perspective, as I mentioned, cash flow is higher but the split between the 2 buckets is just a little different and so we end up with slightly lower EPS attributable to the non-Promacta part of the business.

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [18]

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And then, Matt, just Scott was also asking about the tax rate going forward. Should we anticipate an increase in the rate in next year?

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Matthew Korenberg, Ligand Pharmaceuticals Incorporated - Executive VP of Finance & CFO [19]

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Yes. Thanks for the reminder, John. No. Tax rate for the core business is still 21% federal and a little bit of state. So as we say on most calls, 21% to 23% is our estimate. Transparently, when we give the Promacta guidance, we estimated that, that number would be closer to 23% on the Promacta gain. It's turning out to be closer to the 21% level. And so that's really the bulk of the difference.

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Scott Robert Henry, Roth Capital Partners, LLC, Research Division - MD, Senior Research Analyst & Head of Pharmaceuticals Research [20]

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Okay. That's helpful. And then just another question. On the royalty line, we're starting to get some other products filtering into that line. Are any of them material? And would you expect any of them to be -- I think you said, certainly, I think it was one of them was not material yet, ZULRESSO, I believe, but any of the other ones, Carnexiv or any -- Baxdela, when would we expect those to be material?

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [21]

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Yes. Scott, it's John. The -- a couple of new entrants, Baxdela, you mentioned that was -- is now about a year ago, that's been a very small product and we've talked about this. Frankly, the revenues for that product had been considerably lower than the Street's expectations and, frankly, even our internal expectations. That's not new news. That's really has been the story the last 3 or 4 quarters. ZULRESSO just launched. First quarter, there's really no script data. There's no trend or other information for us to go off of. So consistent with other modeling, we're -- until we have information really, assuming a very negligible amount. Carnexiv, you mentioned, is a product we expect to launch early part of 2020. It's a good royalty but we believe that will be a relatively small product just in terms of its market category.

So what's interesting is that you got a couple of these products that admittedly are small or unknowable right now. One other entrant though is CASI, this is the China partner marketing EVOMELA in China. And it's a brand new market. Right? The product launched just a couple of months ago. But China is a big market, multiple myeloma is an important segment in the China market. And we have been told by our partner that they expect to get pretty good pricing. So all of those assumptions are included in our revenue but next year and the year beyond, as those forecasts come together, there may be some upside potential there.

There are some other products that are coming into focus, we mentioned sparsentan and TR Beta, the Novan and Palvella assets. Those are still a couple of years out but those are much more substantial products in royalty rate and market size. And we believe will create a very different revenue narrative than some of these other small products we're just talking about right now.

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Scott Robert Henry, Roth Capital Partners, LLC, Research Division - MD, Senior Research Analyst & Head of Pharmaceuticals Research [22]

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Okay. I know you haven't put out the 10-Q yet but obviously, we know what Kyprolis is and I can factor that in and it still looks like there's some upside to the royalty line. I mean could that be inferred that, that would be EVOMELA in -- would there be any stocking in China we should factor in?

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Matthew Korenberg, Ligand Pharmaceuticals Incorporated - Executive VP of Finance & CFO [23]

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Yes. And so good question, obviously, we have to make estimates of what our partners have done. And CASI will report later this week or early next week. I'm not sure exactly their date of report, but when you see that, you'll get more color specifically on what that is. But I think, Scott, it's a fair way to assess it that at a 20% royalty rate, the only thing that could really move the needle significantly enough to make the difference you're probably seeing is on the EVOMELA line.

In terms of stocking in China, I think it's like any pharmaceutical market, there's probably a bit of stocking at the beginning of a launch. But you know, we understand that they're seeing good procedure flow and procedure volumes in China, which is generating real underlying demand.

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Matthew W. Foehr, Ligand Pharmaceuticals Incorporated - President & COO [24]

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Yes, Scott, it's Matt Foehr. I'll just make one other comment on EVOMELA and China. Unlike the U.S., where there is competition in that melphalan market, EVOMELA is actually the first approved melphalan in China in that form. So that obviously plays a role as well.

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [25]

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So that wraps up -- looks like -- okay, yes, operator, please. Looks like we have one more question.

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Operator [26]

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Your next your question comes from the line of Larry Solow.

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Peter Kirk Lukas, CJS Securities, Inc. - Analyst [27]

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It's Pete Lukas for Larry. I'll make it quick. I think you touched on it quickly, just on Kyprolis. Do you anticipate the positive CANDOR trial results in combo with DARZALEX moving the needle in any significant way? I think you touched on -- I think you said no. And can you remind us where Kyprolis stands in the first multiple melanoma (sic) [myeloma] treatment and when we'd see data from that?

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Matthew W. Foehr, Ligand Pharmaceuticals Incorporated - President & COO [28]

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Yes, this is Matt Foehr. I'll comment on the CANDOR data. So Amgen announced in mid-September positive Phase III data. That was the CANDOR trial combining Kyprolis with DARZALEX and it met its primary end point of progression-free survival in what was a large Phase III trial. They saw a 37% reduction in risk of progression or death in patients with relapsed refractory multiple myeloma. So a pretty substantial increase and very positive data. We -- based on Amgen's public reporting, we imagine they'll present the full data set at an upcoming medical meeting and then we'll pursue getting that in the label. It's tough to say exactly when that would happen, but I think generally folks, maybe estimating it would be sometime next year. And that's usually when you start to see the impact of what this is, which is obviously a [substantial] data, yes, addition and label expansion.

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [29]

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Yes. In our view, we internally at Ligand are actually bullish about the prospects of that label expansion. To be clear, we do not manage the regulatory, the clinical work, we do not market the drug. So it's really not our business to get ahead of ourselves in terms of projections. We look at Street estimates. There are about 15 or 16 analysts who cover Amgen and we really look at consensus to help guide our forecasting. But fundamentally, it is a great drug, it's been on the market for now 5, 6 years or so. And the data set, safety and efficacy continues to build and get more robust. We know Amgen has invested considerably. It's our sense, that they believe that the big time of that asset and the potential for it to treat a broader group of patients. So on balance, the CANDOR data is a good news event. And frankly, the market received it as such. We saw a variety of articles, not just analysts' reports, but medical articles or commentators that were remarking on the robustness of that data. So we're excited about that. I mentioned the BeiGene commercial partnership, that as well we see as a very interesting development. That was not on our radar. Obviously, we knew China was open potentially for partnering but that is something that was really new news for us. China is a big market for multiple myeloma, and it's hard to tease out exactly market segmentation. But we think, generally, China has not been included in those long-term sales forecast. So that could be some upside in royalties if that market launches in the next couple of years.

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Peter Kirk Lukas, CJS Securities, Inc. - Analyst [30]

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And just the last one for me. Your thoughts going forward on Baxdela? I mean it seems like -- you touched on results so far, but seems like it has potential, just needs a marketing partner with deep product -- with deep pockets. Do you wait it out with Melinta? Or kind of how are you looking at the opportunity there going forward?

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [31]

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Yes. That's actually a good summary. We'll wait it out. We care about our partner. They obviously have a license. They've had some challenges with their -- in their commercial business in general operations. But aside from that, it is a good drug. It's a captisol-based asset. There has been very good data, new indications, a recent approval for an expanded label. So it's -- on one hand, in the superpotent antibiotics space, it's a very attractive asset. It's been underperforming. It hasn't had a really a big impact in our business in terms of our forecasting. But the prospect is still there that they are able to solve their financial issues and find a quality larger marketing partner. So that's some upside. I'll say there's no overhead -- overhang or risk to our financial performance given the way we're looking at that asset now but that is potential upside if they do find a larger partner.

Thank you. All right. Well, that looks like that wraps up the questions. So I really appreciate the turn out today. Again, it's great to have Patrick on board. Patrick, I know it's just couple of days on the job, but you're going to have a busy fall coming up on -- any [travel dates] or conferences?

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Patrick O'Brien, Ligand Pharmaceuticals Incorporated - SVP of IR [32]

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Yes. At this point, John, we've got the Stephens conference set up for November 13, so looking forward to being out there.

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [33]

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And that's where?

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Patrick O'Brien, Ligand Pharmaceuticals Incorporated - SVP of IR [34]

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In Nashville. Matt Korenberg will be representing Ligand at that conference.

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [35]

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Fantastic. And you'll be out there and you'll probably be on the road as well, meeting analysts and investors and so on?

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Patrick O'Brien, Ligand Pharmaceuticals Incorporated - SVP of IR [36]

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I hope so.

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John L. Higgins, Ligand Pharmaceuticals Incorporated - CEO & Executive Director [37]

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Yes, fantastic. All right. Look, really appreciate the turnout. And we'll be in touch to keep you posted as the business advances. Thank you.

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Operator [38]

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Thank you, presenters, and thanks to all our participants for joining us today. We hope you found this webcast presentation informative. And this concludes our webcast. You may now disconnect. Have a good day.