Ligand Pharmaceuticals Inc (LGND) 2019 Q1 法說會逐字稿

Hello and welcome to the Ligand Pharmaceuticals Q1, 2019 Earnings Call.

My name is Ian and I'll be your web event specialist today.

During the presentation, we'll have a question-and-answer session.

(Operator Instructions) It is now my pleasure to turn the webcast over to Todd Pettingill.

Todd, the floor is yours.

Welcome to Ligand's first quarter of 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 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 program.

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 Ligand's earnings press release and public periodic filings with the Securities and Exchange Commission, which are available at www.sec.gov.

The information in this conference call related to projections or other forward-looking statements represents the Company's best judgment based on information available and reviewed by the Company as of today, May 2 2019 and do not necessarily represent the views of any other party.

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 Higgins.

Todd, thank you.

Good afternoon and thanks for joining our call.

Ligand is well positioned for the short, the mid and the long term.

Considering our updates at our Analyst Day last quarter and development since then, we believe we are in a promising period of growth and expansion for the Company.

Now as investors evaluate the business they should consider the breadth and diversity of our asset base, the quality of our technologies and our outlook for financial growth.

In terms of diversity, we have the most partnered assets or shots on goal under license with the most companies ever.

Over 200 shots and over 110 partners.

We have programs targeting a broad array of human disease, we have 3 streams of revenues; royalties, material sales and contract payment with a balanced mix of payments coming in across all three of the categories.

We have 4 main technology platforms available for license and that is up from just 1 about 5 years ago.

As for these main technologies they are all best in class, they are all very high quality, that's OmniAb, Captisol, VDP and LTP.

There is good IP, there's good data, evidence of technical success with each of the offerings and they continue to drive new deal flow at little or no cost to Ligand.

The new deal further expand our portfolio and create potential upside.

Finally, in terms of our financial growth our outlook is for meaningful top line growth on a relatively flat cost structure.

The growth outlook is fueled by increased revenue from existing commercial products, new product launches and more milestone payments, as we expand the portfolio.

We believe the existing business will realize attractive revenue growth and increasing gross margins over the next few years.

With our technology-licensing model, we can keep costs down and that will drive EBITDA, operating margin up from 50%, now well past 60% and potentially up to 75%.

And with that, earnings for the Company will expand significantly.

Now we continue to focus investors on OmniAb, as we are very impressed with the developments and the information we are getting from that technology.

OmniAb and Ligand's best-in-class antibody discovery platform.

The antibody space generally is white hot and Ligand is an important player in serving the vital discovery efforts of virtually all of the major antibody companies.

Antibodies are the top selling medicines in the pharmaceutical industry with total annual revenues for antibodies continuing to increase.

Published data shows there is massive and growing investment in antibodies and nothing to suggest that will slow.

We have more OmniAb partners today and substantially more OmniAb programs in clinical studies than we estimated a couple of years ago.

And as of this past quarter, we now have our first partnered antibody in a Phase III trial.

The first Phase III trial start is years ahead of what we anticipated.

All positive developments for Ligand.

Now, we'll continue to invest our substantial amount of cash into new opportunities, we talked about this with investors in our Analyst Day.

We are looking at buying companies and investing in late stage R&D projects and providing start-up capital to well vetted companies that are positioned to serve the needs of the industry.

We have a strong record of making good disciplined investments with promising upside.

Lately, we said no to a few deals.

The targets were overvalued or the fit with Ligand was not right.

At the same time, we continue to see a lot of ideas and ways to deploy our capital.

And we believe Ligand is undervalued and we've made substantial repurchases of our stock over the past 6 months.

We've reduced our share count by about 9%, meaningfully increasing the profits and the cash flow for shareholders going forward.

I'll now turn over to Matt Foehr who will go deeper into some of our portfolio of programs.

Thanks, John.

Our portfolio of partnerships continues to expand the number and to increase in diversity.

We have some important updates today and we've noted a few new regulatory approvals recently.

In March, we saw the FDA approval of Sage Therapeutics' ZULRESSO, also known as brexanolone injection that uses our Captisol technology in its formulation.

ZULRESSO is the first and only treatment specifically indicated for postpartum depression or PPD and its approval was based on results from 3 pivotal clinical trials, showing that treatment provided significant and rapid reduction of depressive symptoms within days.

Postpartum depression is the most common medical complication of childbirth and is estimated to affect approximately 400,000 women annually in the U.S. This is a license that dates back to 2011, which we struck shortly after our acquisition of the Captisol technology.

Our partners at Sage expect to launch ZULRESSO late this month, early next month, excuse me.

And we look forward to seeing it on the market.

CASI Pharmaceuticals announced it received approval to market Captisol-enabled EVOMELA in China.

Because of Ligand's investment in clinical stage R&D for the program years back, we earn a 20% royalty on global sales for EVOMELA.

We're impressed with the management team at CASI, and their focus on the asset.

CASI has stated publicly that they see revenue potential for EVOMELA in China of more than $35 million annually.

Daiichi Sankyo received approval in Japan for esaxerenone now referred to by the trade name MINNEBRO for hypertension, and announced last week that they launched the product this month.

In addition to the hypertension indication, we note that they're now running a pivotal Phase III study of MINNEBRO in patients with diabetic nephropathy, also known as diabetic kidney disease.

Many of our other partners are also progressing towards data readouts or have recently announced or plan to announce clinical data at major medical meetings.

A few weeks back our partners at Viking Therapeutics presented new data from their Phase II study of VK-2809 in patients with non-alcoholic fatty liver disease and elevated LDL cholesterol at the late-breaker session at the International Liver Congress or EASL meeting.

Patients receiving 5 milligram daily doses of VK-2809 demonstrated statistically significant median relative reduction in liver fat content of more than 53%.

Importantly, 88% of patients receiving VK-2809 experienced a greater than 30% reduction in liver fat content at 12 weeks, including all patients receiving 5 milligram daily doses.

And VK-2809 was safe and well tolerated at all doses studied with no FAEs reported in any cohort.

The results reported at 5 milligram are similar to those obtained at higher doses and support our general enthusiasm for VK-2809's promise, and as a potential therapy for patients with NASH.

Viking has stated that the totality of the data suggests a differentiated therapeutic profile with the potential to improve liver health and provide global benefits on systemic lipids, such as LDL-C and arthrogenic proteins.

We're encouraged by VK-2809's safety and tolerability profile, and in particular, that no FAEs have been observed in any of Viking studies.

Experts seeing the data at EASL have commented that the clinical research suggest that reducing liver fat by 30% or more increases the likelihood of a potential histological response in NASH patients.

Since more than 2/3 of patients receiving VK-2809, demonstrated at least a 50% reduction in liver fat, there is an expectation for a higher likelihood of improved liver histology, and that the robust improvements in liver fat content combined with the reduction in plasma lipids, such as LDL-C suggest a potential for cardio protective benefit of VK-2809 in these patients, which would represent a promising and novel profile.

Viking plans to initiate a Phase II-b trial in patients with biopsy confirmed NASH later this year.

Our partner Palvella's work on the (inaudible) Phase II-III study of PTX-022 remain on track with significant clinical operations resources dedicated to patient enrollment and successful study execution.

And patient recruitment is now underway at multiple academic and commercial sites.

PTX-022 is addressing an orphan disease called pachyonychia congenita or PC.

PC is a rare chronically debilitating and lifelong myogenic disease in which mutations of genes responsible for keratin production lead to dysregulated keratinocyte proliferation, increasing skin fragility and impaired skin barrier function on the bottoms of the feet.

As a result, affected individuals experience difficulty with walking, which frequently necessitates use of either ambulatory aids or alternative forms of mobility such as crawling.

We're pleased to see Palvella's focus and progress on the trial.

I'll also update on the status of RVT-1502, the glucagon receptor antagonist, that's partnered with Metavant.

I'd mentioned on our last call that we expect the start of a clinical proof of concept trial this year for RVT-1502 in Type 1 diabetes.

Given a very recent update from our partners at Metavant, we no longer expect to see that clinical trial start this year.

Metavant has had discussions with the FDA, who have requested additional non-clinical studies specifically for chronic use settings.

Metavant is evaluating its plans for the program, and we expect them to provide a program update.

They have an expert project team working on this and we continue to be impressed with the overall scope and the experience base of the team at Metavant and we look forward to their update.

The ASCO 2019 Annual Meeting in Chicago will start at the very end of this month and we've noted a number of presentations from our partners.

We view the presentations as a representation of the diversity of our partner base, the drug targets they're pursuing and the underlying technologies from Ligand's portfolio.

These include an oral presentation of Cantex Pharmaceuticals CX-01 Phase IIb data in AML.

CX-01 is a polysaccharide derived from the class of compounds known as heparinoids, which have long been known to possess biologic and potential therapeutic properties separate from their well known use as anticoagulant.

In addition to the results of the Phase IIb AML trial, encouraging top line results from a Phase II in refractory MDL -- MDS were reported at ASCO last year.

Cantex has indicated publicly that it plans to advance development of CX-01, and start a Phase III trial in AML.

And CX-01 has received orphan drug and fast-track designations from the FDA for AML.

The license associated with this program dates back to 2009 when Ligand licensed patent for [desulfanated] heparin technology to ParinGenix, which is now known as Cantex.

Also at ASCO, there are multiple presentation for Kyprolis, in newly diagnosed and relapsed-refractory multiple myeloma, as well as one in small cell lung cancer.

Additionally, we note Merck KGaA's presentation of Captisol-enabled M6620 in combination with the PARP inhibitor Talazoparib in solid tumors.

And MEI Pharma is presenting new data related to Captisol-enabled ME-344 in breast cancer and Sermonix will also present data related to lasofoxifene use as a treatment for ER-positive metastatic breast cancer.

Lilly will also be presenting new clinical data on Captisol-enabled prexasertib, which we note they disclosed -- they have removed from development in their earnings call earlier this week.

For the first time at ASCO, we also note 2 presentations from OmniAb partners, one from Arcus Biosciences on their Phase I study with their OmniAb-derived anti-PD-1 monoclonal antibody AB122 and another from CStone from a recently completed Phase I study in advanced solid tumors with their anti-PDL1, CS1001, which is their lead compound that is now in Phase III.

Switching now to our technology platforms and starting with OmniAb.

Our OmniAb antibody discovery platform has continued to grow, and rapidly drive the expansion of our portfolio of partnerships.

We see OmniAb as our most valuable technology platform.

We track the progress of our partners in a variety of ways, including tracking patent filings, clinical trial starts, and data events like the ones I just highlighted.

We now see 24 published patent applications filed by our partners that claim an OmniAb-derived antibody, and see 9 Phase I trials in progress, 5 Phase II trials and now for the first time a Phase III trial, which is, CStone's CS1001.

The Phase III is known as the GEMSTONE-303 trial and its assessing CS1001 in combination with chemotherapy for the treatment of gastric adenocarcinoma, or gastro-esophageal junction adenocarcinoma.

We continue to add new partners, and many of our partners are expanding species use and adding programs that leverage our OmniChicken technology.

We continue to innovate and maintain OmniAb's place as a best-in-class technology.

At the PEGS meeting in Boston, in April, our scientists presented data on and officially launched our newest transgenic chicken platform known as OmniClic, which is designed to generate antibodies with what's described as a common light chain to facilitate the development of bispecific antibodies.

The data presented at PEGS showed that OmniClic antibodies were highly diversified in their heavy chains, resulted in high affinity and high specificity antibodies despite there being little to no variation in their light change.

A subtle change in the transgene design enabled this dramatic shift relative to the standard OmniChicken where light chains are highly diversified and further demonstrates our teams world-leading technical command over genetic engineering.

OmniClic received substantial attention at PEGS, and is already being utilized in partner programs.

Turning now to the Vernalis Design Platform or VDP.

This platform strengths are related to fragment and structure-based drug discovery, where protein structure determination, fragment screening and molecular modeling are closely integrated with medicinal chemistry to enable rapid and efficient discovery of novel drugs.

Our VDP partnerships continue to progress very well, as we collaborate on a variety of novel targets.

Data from our partnership with Servier was presented at the recent AACR meeting related to the Phase I stage MCL1 inhibitor for cancer that Servier has now partnered with Novartis.

The molecule was previously known as S64315 at Vernalis and Servier and now at Novartis is known as MIK665.

And now very briefly on Captisol.

Captisol continues to provide value to our partners, as we expand our active Captisol Drug Master Files in the U.S., Canada, Japan and China.

In addition to our DMS, the global footprint and the established quality profile are also significant value drivers for our partners.

I note that we entered into new Captisol clinical use or commercial license and supply agreements recently with Merck KGaA, reVision Therapeutics, Takeda, Bexson Biomedical and a startup named SQ Innovation.

And I'll wrap up with some brief updates on activities with our internal R&D pipeline, starting with Captisol-enabled Iohexol.

As we announced this morning, we've now completed enrollment of 24 healthy volunteers in a single-center, randomized, double-blind two-period crossover study to determine the relative bioavailability of CE-Iohexol and a reference product which is GE Healthcare's OMNIPAQUE.

The trial enrolled faster than we expected.

This first trial is also assessing safety and tolerability and we now expect to have unblinded top line data in Q3.

We plan to present the clinical data and some new preclinical data at relevant medical and scientific meetings in the second half of this year and to assess partnering opportunities as well as targeted investments in the program that will drive partnering.

We also now have 5 new internal antibody related programs that leverage the capability of our deeply experienced OmniAb team.

We initiated the programs in mid-2018 and rolled them out at our Analyst Day in mid-March.

We selected 5 immuno-oncology targets based on leveraging known biology with broad clinical and partner interest and where we could also leverage the benefits of OmniChicken in antibody discovery.

The 5 programs are B7-H3, CD38, ICOS, TIGIT and TIM-3.

Our team is generating partnering packages to include sets of novel, fully human antibodies, and we now have unique monoclonal antibodies for each target that our team is characterizing.

We plan to initiate partnering dialog for the programs in the second half of this year.

And I note that we've already received inbound interest in the programs very shortly after we unveiled them.

And I'll now turn the call over to Matt Korenberg to discuss the financials.

Thanks, Matt.

I'll begin today by diving right into a review of the financials contained in our earnings release issued earlier today.

Total revenues for the first quarter of 2019 were $43.5 million, as compared to $56.2 million in the year ago period.

Royalty revenue in Q1 2019 was $19.5 million, compared with royalty revenue of $20.8 million in Q1 2018.

We sold our Promacta asset and royalty to Royalty Pharma as of March 6. So included in these numbers is a partial quarter for Promacta in the 2019 quarter resulting in $14.2 million of royalty revenue and a full quarter of Promacta in the 2018 quarter resulting in $15.6 million of royalty revenue.

Milestone and license revenues were $15 million in Q1, 2019 versus $30.9 million for the year-ago period with 2018 including the $20 million upfront payment related to out-licensing our GRA program.

Captisol material sales were $9 million in Q1, 2019, compared to $4.4 million in Q1, 2018.

Timing of a couple of larger orders contributed to the higher than expected increase in sales.

Regarding gross margin, our Q1 gross margin for Captisol sales were lower than the previous year.

As you know, our mix of commercial and clinical material sales shifts from quarter to quarter and from year to year resulting in changes to gross margin.

Our material sales cost translated to an overall corporate gross margin of 91% for Q1 2019.

On the expense side, R&D in Q1 was $11.3 million, excluding stock comp and other non-cash charges, R&D was $7.1 million.

For G&A, our Q1 total was $11.1 million and excluding stock comp and other non-cash charges, G&A was $7.7 million.

Taken together, total cash operating expenses for the quarter were $14.8 million, which was in line with our expectation.

Turning to net income, GAAP net income for Q1 2019 was $666.3 million or $31.32 per share.

In this quarter, the significant non-cash items impacting net income included an after-tax gain on the sale of Promacta of just over $640 million and a gain related to the performance of Viking share price of $17.3 million.

As we mentioned in previous quarters, under ASU 2016-01, beginning last year we account for the value of our ownership in common stock and public companies by marking the value of our shares to current market prices, with the resulting unrealized gain or loss running through the P&L each quarter rather than at the time of selling the stock.

Prior to the new accounting standard, the changes in value would impact the balance sheet, but not the P&L.

These fluctuations in common stock value whether positive or negative are not reflective of our core operating business.

As such, we exclude these gains or losses from our adjusted earnings calculation.

This Viking gain that we just covered was non-cash, but obviously the Promacta sale was a cash item and netted $640 million.

For the quarter, we reported adjusted net income of $24.8 million or $1.16 per diluted share related to the core operations of the business.

This compares with adjusted net income of $35.7 million or $1.55 per diluted share for the same period last year.

The Q1, 2019 adjusted EPS excludes $30.09 of the gain related to Promacta.

In Q1, we generated $45.3 million in operating cash flow.

And with respect to taxes, we've now utilized substantially all of our federal NOLs and tax assets as a result of the sale of Promacta.

Our earnings and adjusted earnings were already being reported as if we were fully taxed, and we will continue to do so.

Our expected cash tax rate going forward is 21% to 23%.

On the balance sheet, we finished the quarter with $1.4 billion of cash, cash equivalents and short-term investments.

As investors are aware we've been actively buying back stock under a $350 million share repurchase authorization.

As of today, we spent $234 million to acquire 1.8 million shares.

We began actively purchasing shares in November and in the past 6 months, we repurchased 8.5% of our outstanding stock.

We continue to believe our stock is undervalued at these prices and plan to continue our repurchases.

These repurchases increased the per share cash flow and earnings for all investors going forward.

Turning now to financial guidance.

We are reiterating our full year 2019 guidance.

On revenue for the year, we expect about $48 million of royalty revenue, about $27 million of Captisol sales and about $43 million of milestones and license fees.

These components translate to expected full year 2019 total revenues of $118 million with potential upside from milestones and license fees.

On EPS at $118 million of revenue, we're reaffirming our adjusted diluted EPS guidance of $3.20 for the core operations of the business.

For the total business, our previous guidance of $32.25 included the gain on Promacta of $29.05.

As mentioned, the final Promacta gain figure was $30.09 and the total EPS for the year including the gain will be -- therefore be approximately $33.29.

On our longer-term outlook, we continue to see sustained revenue growth coupled with a relatively fixed cost base leading to improved operating margin and strong earnings and cash flow growth.

Finally, a reminder that our adjusted diluted EPS guidance exclude stock-based compensation expense, non-cash debt related costs, changes in contingent liabilities including our CVRs, transaction related amortization expenses and one-time costs, unrealized gains and losses related to the holdings and public company stock, mark-to-market adjustments for amounts owed to licensers, the excess converted shares covered by the bond hedge and certain one-time non-recurring items.

With that, I'll now turn the call back over to the operator and open the line up for questions.

(Operator Instructions) We have a question from Larry Solow from CJS Securities.

It's couple on your commercial and a couple on the pipeline.

Just on Kyprolis, I think sales grew 10% in the quarter and that seems like that's about consensus for the year.

Can you maybe just discuss when we might see some new data for earlier stage multiple myeloma.

Obviously, I think in combination with DARZALEX.

So you look at -- I don't know if there's anything coming up at ASCO where we might see some of that new data?

Yes, Larry.

Thanks.

This is Matt Foehr.

Yes, Amgen reported just yesterday, strong unit growth year-over-year driven primarily by growth in what they described as the key markets including the U.S. and specifically the U.S. at 12% growth.

One of the things they're highlighting is increased adoption of the once weekly dosing that they invested significantly in over the last couple of years.

And they now see that approaching 20% of the share for Kyprolis in the U.S. As I said in the prepared remarks, we do see more data coming at ASCO, just kind of continuing to add to the dataset around Kyprolis, but Amgen's highlighted additional data that will come later this year in combination studies as well as in broader treatment settings, that's earlier line or in other treatment settings.

So we're continuing to keep an eye out for that and continue to see really impeccable and just top-notch clinical work done on the part of Amgen.

And Larry, Matt Korenberg, I'll just add it.

Folks should always keep in mind that Amgen reported already Ono who also collect royalties on doesn't record for another week or so.

So we'll make sure to combine those 2 numbers as we think.

It's a pretty small minority piece right of the total?

Yes.

It's usually relatively small, I think last quarter was about $12 million, but on that order of magnitude.

All right.

And just on the Metavant, you mentioned the Roivant, the RVT-1502.

So this is a -- was a, I guess, sort of Phase II -- early Phase II, Phase IIa I guess proof of concept type study that, that they were planning on.

And they're also in Type 2 Diabetes, just remind me where it -- or it was just the one pathway that it was seeking right now.

Yes, the trial that we were referring to earlier and that I mentioned in the prepared remarks was a Type 1 Diabetes trial.

So they're going into -- they had plan to go into Type 1 Diabetes patients.

You'll recall Ligand had obviously done some Phase II work in Type 2 Diabetes earlier.

What we can say, essentially the FDA came back to Metavant requesting more studies.

The study they've requested are non-clinical in nature, which is not uncommon in drug development, but it's clearly a development for the program, and we wanted to be sure to update investors to say that, that trial that we had originally saw at starting this year will not be.

So that's -- the extent we know now, we expect Metavant will provide a further update and we'll be keeping an eye out for that.

And they haven't advanced any other -- that they haven't done any other trial or are they seeking to start other trials in Phase II, you know, more at Phase II, I mean, Type 2 Diabetics or this is the...

Yes, their initial plan was to do -- to go into the clinic in a Type 1 Diabetes setting.

That was their initial plan.

And so that's kind of where they are now (inaudible).

Okay, got you.

All right, just on the -- just quickly on the capital for that, I guess, the cost of goods.

Matt, you kind of touched on it little bit, but seemed unusually high, but I guess, like you said, I guess was -- must have been related to a larger order and somehow -- I don't know, make the mix shift obviously makes it changed, but it seemed pretty dramatic even though it's a small number I get.

Yes, good question.

I think we do see this from time-to-time when the mix shift in a way that causes a higher cost of goods and a lot of it that will happen in one quarter or another.

Our outlook for the year is still the same margin wise for Captisol.

This order we planned at some point during the year and it just happened to come in Q1.

Okay.

And just lastly on the Iohexol.

Would your plan -- maybe you don't know your plan yet, but after you do this study, the small study, would you go -- you're able to go right into sort of a later stage Phase II or even a pivotal trial or is that not known yet?

Yes, Larry, we'll have data from the trial that we just announced enrollment completion on in Q3.

That trial enrolled faster than we expected.

Right.

And after we have that data, generally, our model is to partner early, but there are -- any time there are questions, we think we're well positioned to invest in answers too.

And that can translate into better downstream economics.

We generally think about doing that, and you know that could be the case here as well, we may decide we want to answer or do a little more clinical work around it.

But in the meantime, we'll get the data in Q3, we'll assess the data and announce it at top line data and then at medical meetings and go from there.

Got it.

Okay.

Great, thanks.

Okay.

Well, thank you.

Really appreciate the turnout and questions here on the call.

I want to give a preview, we have a couple of conference events coming up.

We'll see investors on the road at Craig-Hallum in Minneapolis is having their annual investor confab May 29.

And then we will be in New York area for the CJS conference on July 9. So those are two investor events coming up.

Really appreciate your time and attention and we'll keep you updated as the business rolls forward.

Thank you.

Thanks to all participants for joining us today.

We hope you found this webcast presentation informative.

This concludes our webcast.

You may now disconnect.

Have a good day.