Cell Therapeutics CEO Discusses Q1 2014 Results - Earnings Call Transcript

Apr.29.14 | About: CTI BioPharma (CTIC)

Cell Therapeutics, Inc. (NASDAQ:CTIC)

Q1 2014 Results Earnings Conference Call

April 29, 2014; 04:30 p.m. ET


Jim Bianco - President & Chief Executive Officer

Matt Plunkett - Executive VP of Corporate Development

Lou Bianco - Executive VP of Finance

Monique Greer - Senior Vice President of Corporate Communications & Investor Relations


Ren Benjamin - H.C. Wainwright & Co.

Kim Lee - Janney Capital


Good day ladies and gentlemen and thank you for standing by. Welcome to the Cell Therapeutics, first quarter 2014 financial results.

At this time all participants are in a listen-only mode. Later we’ll be conducting a question-and-answer session and instructions will be given at that time. (Operator Instructions).

I’d now like to turn the conference over to our host Ms. Monique Greer, Senior Vice President of Corporate Communications and Investor Relations. Please go ahead.

Monique Greer

Thank you so much. Good afternoon everyone and thank you for joining us today for our first quarter, 2014, financial results conference call. Following formal remarks by management, the conference call will be open for questions.

With me today is Jim Bianco, President and Chief Executive Officer; Matt Plunkett, Executive VP of Corporate Development; and Lou Bianco, Executive VP of Finance will be available during the question-and-answer period.

A press release was issued after market closed today, a copy of which can be found on the homepage and in the Investors section of our website at celltherapeutics.com.

Before we begin, please note that during the course of the call, we’ll be making forward-looking statements based on current expectations. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from these anticipated by the forward-looking statements.

Additional information concerning these risks and uncertainties is contained in the Risk Factors section of our Annual Report on Form 10-K for the year-ended December 31, 2013, and in the company's other periodic reports and filings with the Securities and Exchange Commission.

I will now turn the call over to Jim.

Jim Bianco

Thank you, M and good afternoon everyone. As most of you know CTI is a biopharmaceutical company with one marketed oncology drug and an exciting late-stage pipeline. Our focus is to become a leader in the development and commercialization of new treatment for blood-related cancers.

I’d like to start by providing an update on our commercial efforts in the EU with PIXUVRI. PIXUVRI is a first in class anthracenedione that has unique structural and physiochemical properties. Recent preclinical studies from the Fox Chase Cancer Center demonstrates that PIXUVRI, unlike the class in anthracycline related drugs is truly unique in its mechanism for inducing tumor cell death being a potent DNA Alkylator and inducing mitotic instability, supporting the thesis that this is the first approved drug in a new class of anti-cancer agents.

Based on the efficacy and the safety profile and its pivotal trial and the clear unmet medical need and aggressive B-cell non-Hodgkin lymphoma, PIXUVRI was the first therapy approved in the EU for the treatment for these patients. Prior PIXUVRI patients with aggressive B-cell lymphoma who had failed two or more prior lines of therapy had no approved treatment options, specifically for that stage of their disease.

During 2013 we initiated our European commercial operations on a country-by-country basis and as of today PIXUVRI is available in 10 European countries. We spent the better part of 2013 working with the regulatory agencies in the four large markets being Germany, France, Italy and the UK, to insure a successful outcome for getting PIXUVRI reimbursed.

During the first quarter of this year, as you know NICE, National Institute for Clinical Health and Excellence in the UK published its final guidelines in the Journal Lancet Oncology, recommending the prescription of PIXUVRI in England and Wales for patients with aggressive B-cell non-Hodgkin lymphoma, who have failed two to three prior lines of therapy.

NICE’s determination that PIXUVRI is cost effect and the treatment of patients with relapsed aggressive B-cell lymphoma has had an impact across the EU, where many European countries look to the rigorous process conducted by NICE as an endorsement for reimbursement in their own country.

So early today we announced the official launch of PIXUVRI in the UK and our medical affairs team organized a Symposium at the British Society for Haematology meeting in Birmingham that was well attended by leading Hematologists across the UK.

Its really gratifying to see the interest in PIXUVRI amongst treating physicians and to know that the estimated 1,600 to 1,800 people in the United Kingdome who are diagnosed with aggressive B-cell non-Hodgkin lymphoma each year now have an option other than just palliative care.

Initially many physicians were skeptical about patient monotherapy treatment for aggressive lymphoma since many of them resort to in-hospital, much more toxic multi-agent regimens. Despite using those multi-agent regimens, achieving a complete response is rare and the overall response rates that they have seen are low, learning that 28% of the patients achieved a complete response, with 40% having an objective response to single agent PIXUVRI. In the pivotal trial many physicians have become interested in using PIX as treatment options for their patients.

As more physicians gain experience with PIXUVRI and they share those results with each other at society meetings such as BSH, key lymphoma congresses and educational seminars throughout the EU, we have been witnessing growing excitement, particularly amongst a transplant community around PIXUVRI’s ability to overcome chemo-insensitive disease and put third line patients back into remission.

For a transplant physician to be able to offer their patients with aggressive B-cell lymphoma another chance at a potentially life savings, second stem cell transplant has been truly remarkable. And for patients who are not transplant eligible, the ability to allow them the opportunity for a durable reemission in almost half of those patients treated with PIXUVRI and not just symptom palliation. It seems to have addressed a significant gap in the management of those patients across the EU.

As we ramp-up our medical education programs and filed activity, one of our stated business priorities is to generate sufficient sales to achieve a net positive contribution margin for PIXUVRI by the fourth quarter of this year. If we’re able to achieve that goal, then the PIX commercial effort will be profitable going forward in 2015 and beyond.

Now that we’ve secured reimbursement, we are seeing renewed interest in potential partners for PIXUVRI in markets where CTI does not have plans to have a commercial presence and as such, one of our corporate goals stated for this year is a secure part to help expand the product reach and the commercial potential of PIXUVRI in territories outside of the US.

Now we did not provide 2013 sales guidance given the uncertainty surrounding the secure reimbursement, which for the most part didn’t occur until late in the fourth quarter of last year and early this year. With that in mind, now we have largely overcome some of the reimbursement barriers and we are starting to see greater adoption and more consistent use of PIXUVRI by healthcare providers, particularly in Germany, in the UK, now growing in the Nordic regions as well. For example, the unit demand growth for PIX doubled over the fourth quarter of 2013, exceeding our internal Q1 projections.

So in summary, with regards to PIXUVRI we’re really pleased with the traction we are seeing in the firs quarter of this year and now stemming into April and we believe that PIXUVRI will become the second-line salvage treatment of choice for patients with aggressive B-cell non-Hodgkin lymphoma.

Now let me update you on our lead development drug candidate for Pacritinib, which as you know is an oral JAK2/FLT3 inhibitor that we acquired in 2012 from S*BIO, which is currently being evaluated in two Phase III clinical trials.

As I mentioned, Pacritinib inhibits, two important activating mutations JAK2 and FLT3, activating mutations of JAK2 are implicated in certain blood related cancers such as myeloproliferative neoplasms so called MPNs, leukemia and certain solid tumors.

FLT3 is gene commonly found mutated in patients with Acute Myeloid Leukemia or (AML). Well, Pacritinib not only inhibits the internal tandem duplication in FLT3, but also the A35Y point mutation that is commonly associated with resistance to Type2 FLT3 inhibitors.

Based on Pacritinib efficacy and tolerability profile demonstrated today, the current pivotal trial program for Pacritinib includes two randomized Phase III trials know as PERSIST-1 and PERSIST-2 for patients with intermediate one, two or high risk myelofibrosis, which as you know is a chronic malignant bone marrow disorder.

PERSIST-1 is currently enrolling patients with MF without limitations on platelet counts. This trial is comparing the efficacy and safety of pacritinib with that of best available therapy, which is any physician selected treatment, other than JAK2 inhibitors.

Unlike other trials in myelofibrosis there are no exclusion criteria for patients with low platelet counts. The primary end point of PERSIST-1 is the percentage of patients achieving a 35% or greater reduction in spleen volume from baseline to week-24 as measured by MRI or CT.

The secondary end point is the proportion of patients achieving a 50% or greater reduction in the total symptom score from baseline to 24 weeks as measured by tracking specific symptoms on a myelofibrosis symptoms assessment form. We expect to complete enrolment of the 320, 322 patients this quarter and if so, report top-line date from this trial late this year. We’ve been very pleased with the progress that we’ve seen with the PERSIST-1 one enrolment to-date.

PERSIST-2 was recently initiated and is evaluating the safety and efficacy of Pacritinib in patients with low platelet counts, who have what’s called moderate to severe thrombocytopenia, meaning patients with the platelet counts are less than or equal to a 100,000 per microliter.

This trial will evaluate Pacritinib as compared to best available therapy, but unlike PERSIST-1 this trial includes approved JAK2 inhibitors that are dosed according to the product label for myelofibrosis patients with thrombocytopenia. This trial is expected to enroll up to 300 patients in North America, Europe, Australia and New Zealand within 12 to 14 months and sufficed to say, there is a significant level of interest in site participation for this trial as well.

The PERSIST-2 trial as you may recall is being conducted under a special protocol assessment agreement, which is an agreement which we reached with the FDA on the plan design endpoints and analysis approach for the trial in support of the potential NDA submission. We expect that data from PERSIST-1 and PERSIST-2 if positive will form the basis for both an NDA submission at the end of 2015 and in early 2016 via MAA submission.

As you may know, as many of you know, in the fourth quarter of last year we entered into a worldwide license agreement with Baxter International for developing commercialized Pacritinib. This was a significant achievement towards our goal of bringing this novel promising agent to patients as quickly as possible, particularly to those who are under served by the current approved treatment options for myelofibrosis.

The Baxter collaboration is expected to help us accelerate our global development timeline and maximize the commercial opportunities for Pacritinib in myelofibrosis, as well as in other indications.

Like the underscore, the importance of Pacritinib program to the company. In addition to myelofibrosis, we have encouraging clinical data clinical data in lymphoma and preclinical data in FLT3 resistant AML. Pacritinib is currently being evaluated in AML through an ongoing investigator sponsored trial underway in the UK. We’re excited about the interest we have received from investigators and cooperative groups to study Pacritinib in other blood cancers and enhancers in the future, in addition to in certain select solid tumor applications.

We are confident that our collaboration with Baxter will allow us to more rapidly advance the development availability of Pacritinib for patients, not only with myelofibrosis, but AML and other cancers around the world.

Another compound that has begun to garner greater attention as a result of data presented at ASH last December is our oral selective first in class aminopeptidase inhibitor known as tosedostat. Unlike normal cells, transformed cells are very dependent on their ability to recycle intracellular proteins to make new proteins and survive. Scientific interest in tumor or top Veg-E (ph) has grown over the last decade following the clinical success observed with interrupting protein recycle at the level of the proteasome complex with agents such as proteasomal and others.

Attention has now turned to pathways downstream to the proteasome complex that are responsible for removing and recycling essential amino acids off of peptides. One novel target for intervention are aminopeptidases, into a family of metalloenzymes that clip and free up amino acids off of peptides and polypeptides, allowing them to be the building blocks for new proteins, essential tumor cell survival.

At the recent ASH meetings we reported positive interim results from an investigator initiated Phase II trial, tosedostat, in combination with either intermediate does cytarabine or decitabine, a hypomethylating agent in newly diagnosed older patients with AML or high risk Myelodysplastic syndromes, also called MDSs.

We see that combination of therapy was both well tolerated, predominately administered as an outpatient therapy and resulted in complete response rates in 54% of the patients. There is several ongoing Phase II cooperative groups sponsored trials and ISPs evaluating the activity of tosedostat in combination with standard agents and AML or MDS and data from those, what we call signal finding trials may help you form the appropriate design for a Phase III trial in the future.

Let me move on to the financials. For the first quarter March 31, 2014 we reported revenue of $1.4 million compared to $1.1 million for the same period in 2013. The revenues in the first quarter this year will predominantly or primarily attributable to net product sales of PIXUVRI.

The non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the first quarter of 2014 was $19.8 million, compared to $16.1 million for the same period in 2013.

The GAAP operating loss was $27.7 million for Q1 ‘14, compared to $18.5 million for the same period last year. The increase in GAAP operating loss primarily was related to the ongoing PERSIST-1 and PERSIST-2 Phase 3 clinical trials of pacritinib and as I mentioned, included the $7.8 million non-cash share-based compensation expense for the quarter.

For the first quarter total operating expenses were $29.1 million compared to $19.6 million for the same period last year. The increase again was primary related to the clinical development cost related to PERSIST-1 and PERSIST-2 Phase 3 trials.

Net loss for the period ended March 31, 2014 was $20.9 million or $0.20 a share compared to $19.4 million or $0.18 a share in 2013. We ended the quarter in 2014 with cash and cash equivalents of $50.6 million. We like to reaffirm our expense guidance for 2014 and our loss from operations is expected to be approximately $45 million to $50 million, excluding any non-cash share based compensation expense, which as you know is a non-GAAP measure.

The projected 2014 net loss from operations is expected to primarily relate to a positive net product margin contribution from PIXUVRI commercial operations by year-end and with the intent to operate the commercial business with a net positive P&L in 2015.

License and contract revenue associated with the achievement of the clinical development milestones for Pacritinib, specifically related to the completion of enrollment in PERSIST-1 in 2014 and PERSIST-2 in early 2015.

Obviously management of our SG&A expenses, including management of sales and marketing expenses will drive sales of PIXUVRI, as well as medical affair expense and support of educational programs. R&D expenses including management of costs for ongoing and planned clinical trials involving Pacritinib and multiple investigative sponsored studies involving tosedostat.

So our key business priorities in 2014 on the development front for Pacritinib are complete patient accrual in PERSIST-1 Phase III trial of Pacritinib and report top line results lately this year; enrolled the majority of the patients in the second PERSIST-2 Phase III study, initiate a series of investigator sponsored trials evaluating Pacritinib in additional indications outside myelofibrosis; and as I mentioned with regard to PIXUVRI, we intend to grow EU sales and its primary indication in the EU with a net positive product margin contribution by the end of this year.

Now we are going pursue potential partner for commercializing PIX in addition markets within the EU and other markets outside of the EU and the US. We’ve been, say at least off to a very productive start in 2014 and we look forward to what is shaping up again to be another very busy and very exciting year for the company.

So before opening the call for questions, I want to thank our current shareholders for your support; our employees and our partners at Baxter for their collective passion and dedication to improving the lives of patients with blood related cancers.

And on that note we’d be happy to take any questions from the listeners today. Well operator.

Question-and-Answer Session


(Operator Instructions) And our first question comes from the line of Ren Benjamin. Please go ahead.

Ren Benjamin - H.C. Wainwright & Co.

Hey, good afternoon guys and congratulations on the progress. A couple of questions; can you give us a sense as to how many European countries maybe online and reimbursing PIXUVRI by the end of 2014.

Jim Bianco

Why, I would say that the 10 countries that we are currently marketing with are reimbursing the drug. As you know, Italy and France are a little bit different. We have market access, we’re in the process of expanding that in Italy. In France it’s really a tendering process to determine pricing amongst the buying groups. But now that you have market access, if physicians use it, it will be reimbursed.

Specifically in – for example, it was a major hurdle that went away at the end of last year in Germany and so I think its fair to say that the drug is doing very well in Germany with the NICE approval even ahead of the 90 day run-in period for the health trust to essentially list it in their funding.

We’ve seen a very nice sharp pick up in interest in the UK as well. So we’re pleased with the response we’ve seen to the reimbursement decisions and today we just got notice that it’s now included in the [hold on] (ph) guidelines for the treatment of this patient population. There are a very prestigious Northern, Dutch Group that really determine a lot of the treatment practices in the Nordic countries.

Ren Benjamin - H.C. Wainwright & Co.

Okay. When I think about the fact that you already have 10 European countries onboard, when I think about sort of the remainder that you would like to come on, because I thought once you’ve got an EU approval, there are about 20 or so countries that come onboard. Maybe I have that number wrong. Can you just remind me, once you have the launch at sort of full bore speed, how many countries should be on board.

Jim Bianco

Right, the free market access countries in theory had access to it last year. Once you have reimbursement decisions certainly from NICE in particular, the Nordic countries will draft off of that, the Eastern European countries will draft off of that. Germany, Italy and France kind of held their own process, but quite frankly the Italian authorities were taken aback that NICE found it cost effective, because I don’t know how many cancer drugs you can count last year that were being cost effective by NICE, but it wasn’t many, certainly less than one hand.

So the long-winded answer is it is reimbursable in 27 countries in the EU today. The feet on ground answer is the place where we’re seeing use in traction, where we have a physical presence, where we do medical ad boards for ad society meetings, very promotionally sensitive product and now its positioned, the KOLs are getting hands-on use and having their so called case studies that they get up and they present quite dramatic results in patients who are chemo insensitive and they get them back in to CR and then they offer them something that they are weren’t going to offer him, which is a second transplant. Those resonate very well across the countries that we physically have a presence in.

For that to resonate in the other 18 countries or 17 countries in the European Union, that is charged to our corporate development group this year. There’s been a lot of interest amongst more than a handful of good-sized companies coming at us and saying, hey, we can expend that reach. We know what to do in Eastern Europe.

We at CPI have absolutely no aspirations of being an Eastern European block, etcetera or in Latin or in other parts of the geographies. We’re wanting to retain kind of the upside option in the U.S. and if we can bring on a partner to really cut our expenses and when we talk about getting the operating unit to be breakeven by year end, that’s without the consideration of the partner sharing some of those expenses.

That’s organically on our own and so when I think, that will be the news for us coming into the second half of the year. We’ll now make it available through a partner outside of the countries that we’re currently in. Depending on the partner, we may even find a cohabitation within the countries we’re in if the economics are attractive enough to us. But the long and the short of it is, I think PIX will be a story going forward in the second half of this year and certainly in 2015 for this company.

Ren Benjamin - H.C. Wainwright & Co.

Got it. Okay, thank you. That clarified it quite a bit. Would you be able to provide the unit specifics? You had mentioned that the units doubled from the previous quarter. I don’t access to the IMS data. Would you be able to provide the specifics there?

Jim Bianco

Not yet. We’re on a really good track line. Let us get to where we have three quarters and we’ll come in to the fourth quarter and we’ll tell you what it will take for us to breakeven, because we should be running at that rate.

Ren Benjamin - H.C. Wainwright & Co.

Got it, okay. Just switching gears to pacritinib, can you talk a little bit or maybe just how your thoughts are evolving regarding the competitive landscape, given how things are changing. Anything that you may have learned from Sanofi pulling out of the market and maybe some of the competitors that are currently on the market evaluating their drugs.

Jim Bianco

Yes, just before I get to that Ren, I just want to back up and just you know – I’m not trying to skirt the unit sales forecast. There’s lessons to be learned from Seattle companies that have put out numbers before they knew whether or not they are going to be able to achieve those numbers, so we want to be conservative on that front.

With regards to what we learnt from Sanofi pulling out, I can say that there is a very significant segment of the MPN community that were disappointed by having the inability to have a FLT3 antagonist with a JAK2 inhibitor, and that – forget about the JAK2 story with fedratinib. The fact that it was a FLT3 JAK2 combination unit is what was very exciting for them, so that’s the first component.

So while we maybe second to market in the MF space, we will be first to market in a combined JAK2 FLT3 very differentiating feature, with respects to other liquid tumors, specifically AML in particular. We didn’t talk about this here, but there will be some data coming out at ASH etcetera.

The kinome profile of pacritinib is uniquely differentiateable from what’s been published or the other JAK2, JAK 1 inhibitors and more importantly are now very exciting targets in and of themselves in diseases like myelodysplasia, MDS in particular. And people start talking about the micro environment and tumor stromal environment, the polykinase profile of pacritinib will be very exciting in the application, in combination with other drugs in tumors outside of myelofibrosis or AML and you’ll see more of that elucidated at the society meetings at the end of the year.

Ren Benjamin - H.C. Wainwright & Co.

Okay, okay. When we look at PERSIST-2, can you just give us a sense as to how many sites are up and running right now?

Jim Bianco

We have site initiation visits in a number of sites. When I say number I’d say certainly the majority of the total number of sites, but let me put into context that as you know you have to evaluate the sites, then you have to initiate the sites and then you have to get contracts, IRBs, protocol committees.

So all that’s in process, so when we look at, as you know, these forecasts could have started out slow, a couple of patients more and more and then all of a sudden it just takes off, just like we saw with PERSIST-1. So we feel based up on the demand that we’re confident with the projection that we gave, 12 to 14 months for enrollment.

Ren Benjamin - H.C. Wainwright & Co.

Okay. I guess just one other final question, a little bit on encompassing, but you mentioned that there is encouraging clinical data from AML and that you have a study going on in the UK. You have several IST’s to see this task.

Can you give us any sort of an update or a sense as to how these trials are progressing and probably more importantly, when we might see data from any and all of these trials and related to that, what sort of milestones, data milestones we can expect this year. For example, I know you mentioned a presentation at ASH with the pacritinib kinome profile, but is there anything else coming up maybe at ASCO or any other scientific meetings.

Jim Bianco

Not much of a presence at ASCO this year, at least not with the pacritinib [one on] (ph) tosedostat program. As you know that you do these IST’s and these signal finding studies to really determine what’s the best potential regulatory round for the drug. Our focus with the CD stat really is an MDS and there’s a lot of interest in the MDS community kind of looking at that; that’s what we’re doing with the IST’s abroad. But certainly the direction that we think makes more sense for that product.

The AML trial, well as you mentioned there will be several of them up and running this year and late in the second half of the year we’ll be looking at pacritinib in combination with other agents in solid tumors.

So to put them to timelines when your dealing with cooperative studies, it’s a little – how do you put it, sufficed to say, these for example, the MRC trial consortium, they treat several thousand AML patients a year. So to get a study done of 70 patients in a relatively quick period of time from that group, once they are up and geared, it should not be a long duration. We’ll have some data at ASH and we’ll take it from there.

Again, a lot of this stuff coming out of various laboratories, looking not at just at the kinome profile, but really the difference in kinome and in signally paradigms between JAK1, JAK2 and JAK2 FLT3, particularly pacritinib, really explains the underlying thesis of the lack of mile suppression within the lack of immunosuppression associated with pacritinib versus others.

Ren Benjamin - H.C. Wainwright & Co.

Excellent. Thank you very much and good luck.


Our next question comes from the line of Kim Lee with Janney Capital. Please go ahead.

Kim Lee - Janney Capital

Good afternoon. Thanks for taking the questions. As far as PIX’s resales go, so for the last question here, I know its hard to project, but based on what your seeing as far as unit data goes, do you expect any seasonality at all or should we expect this first quarter sales to come and be a good base to start the year on and then I have a follow up question.

Jim Bianco

The latter. I think it’s a good base for projecting where the year can go from quarter-to-quarter. I don’t see the seasonality. I can tell you that that number that was reported was demand number. So it was a real pull through. It wasn’t in the first launch and as you all know, you get some wholesaler or buy in our stocking and none of that was present in the Q1 sales.

Kim Lee - Janney Capital

Okay, great, thanks for that clarity. And also as far as expense line items also I know you did provide a guidance for 2014, but the SG&A expense, it seems to be a fairly sizable jump that’s from the end of last year. Can you provide us any guidance on how we should think about SG&A going forward this year?

Jim Bianco

I think I’ll have Lou jump in on that, because there is one major component to the SG&A change.

Lou Bianco

Yes, there is one major component to the SG&A and that’s the stock based compensation that you mentioned on the call. There’s over $7 million in the 2014 number for the quarter. So if you back that out, you’re pretty much in line with where it was in the first quarter of 2013.

Kim Lee - Janney Capital


Jim Bianco

That’s a non-cash expense, right.

Lou Bianco

Yes, its non-cash, share based.

Kim Lee - Janney Capital

Okay, great. Thanks a lot.


(Operator Instructions).

Jim Bianco

Okay, well I think we’ll just conclude the call. Having just been at the British Society Hematology meeting I can tell you once again, the interest for meeting that house maybe 400, 500 attendees, to have probably about 200 of those being in a room and listening to it, a presentation about PIXUVRI, again I think underscores the unmet need of backing and aggressive B-cell treatments. I mean it sits very clear.

So I thank everyone for joining us on the call today. As always, we appreciate your support and look forward to seeing many of you at our annual shareholders meeting, which we have conveniently arranged to take place in New York City on May 22, as well at a number of upcoming investor conferences later this quarter.

So have a good evening.


Ladies and gentlemen, that does conclude our conference for today. You may now disconnect.

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