Spectrum Pharmaceuticals, Inc.
Q2 2015 Earnings Call Transcript

Published: 6 Aug 2015

[Operator:]

Good day, ladies and gentlemen, thank you for standing by, and welcome to the Spectrum Pharmaceuticals, Inc. Second Quarter 2015 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference maybe recorded. It’s now my pleasure to turn the conference over to Shiv Kapoor, Vice President of Strategic Planning and Investor Relations. Please begin.

[Shiv Kapoor:]

Thanks. Good afternoon and thank you for joining us today for Spectrum’s second quarter 2015 financial results conference call. I’m Shiv Kapoor, Vice President of Strategic Planning and Investor Relations for Spectrum Pharmaceuticals. With me today are Dr. Raj Shrotriya, Chairman and CEO; Joe Turgeon, President and Chief Operating Officer; Kurt Gustafson, Chief Financial Officer; Dr. Lee Allen, Chief Medical Officer; Tom Riga, Chief Commercial Officer; and other senior members of Spectrum’s management team. Here’s an outline of today’s call. First, Dr. Shrotriya will provide you with the highlights of the second quarter and discuss our overall direction and strategy. Kurt will then provide a summary of our second quarter financial performance. Following this, Joe will review the company’s operations, and Dr. Allen will review the pipeline. We will then open up the call to questions. Before I pass the call to Dr. Shrotriya, I’d like to remind everyone that during this call we will be making forward-looking statements regarding future events of Spectrum Pharmaceuticals, including statements about product sales, profits and losses, the safety, efficacy, development, timeline and clinical results of our drug products and drug candidates that involve risks and uncertainties that could cause actual results to differ materially. These risks are described in further detail in our reports filed with the Securities and Exchange Commission. These forward-looking statements represent the company’s judgment as of the date of this conference call, August 6, 2015, and the company disclaims any intent or obligation to update these forward-looking statements. However, we may choose to update them, and if we do so, we will disseminate updates to the investing public. For copies of today’s press release, historical press releases, 10-Ks, 10-Qs, 8-Ks and other SEC filings and other important information, please visit our website at www.sppirx.com. I now would like to hand the call over to Dr. Shrotriya.

[Rajesh Shrotriya:]

Thank you, Shiv, and thank you everyone for joining us this afternoon. I’m very pleased with our performance this quarter. We have maintained a strong fiscal discipline, while advancing our pipeline. We have four exciting events coming to fruition within next several months. With two potential blockbuster drugs under development making progress, one in Phase 3, a registrational trial, and other entering Phase 2 study in the United States, one drug pending an FDA approval decision and with yet another drug the filing on an NDA, we believe that the second half of this year promises to be full of exciting events. In my further brief remarks, I’ll focus on these four top priorities. First, SPI-2012, a novel long-acting GCSF or granulocyte colony-stimulating factor, this drug has shown strong efficacy in Phase 2 clinical studies conducted in about 148 patients. It targets a blockbuster market of nearly $6 billion. It has the potential to change the face of our company and remains our highest priority. We’re taking several steps that will ensure the success of this drug. To ensure alignment with the FDA, we’re pursuing a special protocol assessment, or SPA; we plan to initiate a Phase 3 non-inferiority study; after reviewing our Phase 2 data and after discussion with several key opinion leaders, we have proposed following this study at 80% to show superiority compared to pegfilgrastim. Second, I’m very excited about EVOMELA’s potential approval later this year. The discussions with the FDA are proceeding well and if approved, EVOMELA will become our sixth commercial drug that will be launched with our existing sales force. Let me now talk about our second potential blockbuster drug Poziotinib. Based on our assessment of the market opportunity and the strong clinical data that we have seen in breast cancer, we are developing a Phase 2 program in consultation with US key opinion leaders. In addition, our partner, Hanmi, is conducting several Phase 2 trials in various tumor types. Based on early clinical data, we believe that Poziotinib has best in class potential among pan-HER inhibitors. Lastly, we’re on track to file an NDA by the end of this year on Apaziquone, a novel drug for non-muscle-invasive bladder cancer. In addition, a confirmatory trial with Apaziquone is being pursued with the FDA through another special protocol assessment. We’re continuing to work hard to control expenses and it’s evident this quarter. I’m pleased with our continued commitment to fiscal discipline. We’re expecting to end this year with a stronger cash position than our prior expectations. Joe will talk more about our operations; Kurt will then provide you more details about our financials; and Dr. Allen will go in some depth with our clinical update. Now, let me hand over the call to our Chief Financial Officer, Mr. Kurt Gustafson. Kurt?

[Kurt Gustafson:]

Thank you, Raj, and good afternoon to everyone on the call today. I just want to highlight a few items in our financial results. First, we continue to fund our highest priority projects, but I think you can see from our second quarter results that we have made progress with reducing our operating expenses both year over year and versus the previous quarter to address the declining FUSILEV sales. Our goal is to further identify operating efficiencies which will lead to additional reductions in SG&A expenses. We will also continue to drive our R&D infrastructure cost lower. However, our overall R&D expenses are expected to increase with the ramp in clinical trial activity. Also, let me make one comment on sales, the second quarter product sales of $35.1 million exclude the $7 million in FUSILEV sales that we deferred in Q1. We still expect to recognize that $7 million in the third quarter. Also in the second quarter, we recognized $9.7 million in licensing revenues associated with the CASI Pharmaceuticals transaction we signed last year, where we out-licensed the Chinese rights to three of our products. You’ll recall that we received a 19.9% stake in CASI, along with a $1.5 million promissory note. The revenue recognition for this deal had been deferred until we signed supply agreements. These supply agreements were signed in the second quarter, which allowed us to recognize the revenue. I also want to make a few comments about cash. The recent generic competition has created additional volatility in working capital quarter over quarter. While net cash flow was particularly strong in the second quarter, we expect this to reverse in the second half of the year. A better way to think about our cash burn is on a full year basis. We started the year with $133 million and based on our recent operating results we now expect our year ending cash balance to be greater than $110 million, up from our previous guidance of $100 million. This guidance does not include any cash flows from any new business development deals. Before I hand the call over to Joe, I want to emphasize that we remain very active on the business development front. While we continue to look at in-licensing opportunities, we’re more focused in the near term on out-licensing, particularly in geographies outside of the United States. With that, let me hand the call over to Joe to provide an operational update.

[Joseph Turgeon:]

Thank you, Kurt; thank you, Dr. Raj; thank you, Shiv; most of all, thank you for everybody on the phone for your interest in Spectrum. We continue to focus on developing Spectrum’s promising pipeline. We’re in a unique position to be able to advance these exciting programs, while maintaining a strong commercial organization in the hematology and oncology marketplace. First, I’d like to provide you with an update on our commercial business. Our PTCL franchise demonstrated double digit growth year on year of 11% and quarter over quarter growth of 16%. Our team remains focused and disciplined on execution and increasing the breadth of our customer base. ZEVALIN second quarter revenues were $4.8 million compared to $4.2 million in Q1, a 14% quarter over quarter growth. In Q2, MARQIBO sales had double-digit growth both year over year and quarter over quarter. While the relative sales are small in this limited indication, our performance is of strategic value because these are the same centers that will be targeting for the potential launch of EVOMELA. In regard to FUSILEV, our generic entrant launched in the second quarter, this had a negative impact of reported sales and average selling price. As we said in the past, we expect our future revenues will be significantly impacted due to the competitive at-risk launch. Uncertainty and price erosion are the direct result of the competitive entrants and will continue to put downward pressures on this market. We await our appeal in the legal system with this at-risk competitive launch. As you know, our base business is just a stepping stone for us. The cash flows from our base business help us develop our pipeline and our pipeline has never been stronger. First, let’s talk about EVOMELA. If approved in October, EVOMELA will be our sixth product in the market in the hematology/oncology space. EVOMELA has a stability advantage of 4 to 6 hours versus the current version that is only stable for 1 hour. This represents an important point of differentiation as the current administration process is cumbersome and disruptive for caregivers when treating patients. Our product is propylene-glycol free and the peak in systemic exposure is about 10% higher. The efficacy and safety were consistent with what we already know for high-dose melphalan followed by transplant for multiple myeloma. The melphalan market is around $100 million and is concentrated in just 100 transplant centers across the US. The top 20 centers represent over 50% of the business. This market is very concentrated and has excellent synergy with our existing infrastructure. We look forward to October 23 and bringing this drug to market with our existing sales force. Also, we plan to file another NDA by the end of the year for Apaziquone, a potent, tumor-activated pro-drug for bladder cancer. This will be our third NDA in three years. In consultation with the FDA, we are pursuing a special protocol assessment for confirmatory clinical trial. Bladder cancer is an area of significant unmet medical need with no new products approved in the last 40 years. The second quarter was a busy one for our highest priority in the company, SPI-2012, our novel long-acting GCSF. Our Phase 3 program is getting ready to begin and I’m excited about the proposed trial design that we are finalizing with the FDA, a Phase 3 program in breast cancer that is over 90% powered to detect non-inferiority and 80% powered to detect superiority will address some very important clinical questions. We are also keeping a close eye on ongoing marketplace events with regards to biologics. You may have been following the first approved biosimilar in the US through the 351(k) pathway as it navigates both the FDA and the judicial system. We are closely watching the approval, potential launch and evolving legislation on how these products will be reimbursed. We have modeled multiple scenarios based on the latest legislation. Because ours is a novel agent, we believe we’ll be in a favorable position of having untethered reimbursement. Bottom line, we know this marketplace inside out; we are both confident and looking forward to successfully competing in this $6 billion market. Finally, we’re excited to be advancing Poziotinib in the US based Phase 2 program in breast cancer. If the Phase 1 data replicated, this asset has a potential to be best in class competing in a multi-billion dollar market. As this asset advances through the development process, our strategy is to have two potential blockbuster products geared towards solid tumors, specifically breast cancer. Our sales team could be in a unique position of promoting both a best in class oncology therapeutic for breast cancer and a novel GCSF with potential superiority data. That will be game changing for patients, customers and shareholders. Again, I thank you for your time and interest in Spectrum. I will now turn the call over to Dr. Allen who is going to provide a more detailed information on our development advances. Dr. Allen?

[Lee Allen:]

Thanks, Joe and my greetings to everyone on this call. We are very excited about Spectrum’s robust portfolio and are working to aggressively advance our high priority projects of registration with a true sense of urgency remembering that patients are waiting for a new and effective treatment. Today I’ll provide an update on four of our top pipeline priorities. First, I’ll talk about SPI-2012, our novel long-acting GCSF. As Joe mentioned, SPI-2012 is a new biologic that is more potent than pegfilgrastim and consists of a novel recombinant GCSF conjugated using the proprietary long-acting protein discovery technology that enhances the half life of this therapeutic protein. SPI-2012 has also been shown having acceptable safety profile, with no significant dose-related or unexpected toxicities and adverse event incidences that were comparable to pegfilgrastim. Our specifically engineered GCSF is promising because of its high potency, its long half life, and targeted delivery to the bone marrow which is its key site of action. SPI-2012 has several important potential advantages over PEGylated formulation that is currently approved in the US. You may recall from the Phase 2 breast cancer study data that we shared with you on the Investor Day in March that at the mid dose tested, SPI-2012 was shown to be non-inferior to the recommended pegfilgrastim dose and importantly that at the high dose, SPI-2012 was statistically superior to pegfilgrastim. With SPI-2012 as our top development priority, we have been working aggressively to finalize the Phase 3 study protocol with FDA. Because of the importance of this program, we have submitted a special protocol assessment request to FDA on the design, clinical endpoints and statistical analysis plan for this Phase 3 registrational trial in breast cancer patients that we plan to start by the end of the year. The proposed study has a short-term primary endpoint of the duration of severe neutropenia, with over 90% power to demonstrate non-inferiority and 80% power to demonstrate superiority to pegfilgrastim. It is important to highlight that this study does not have a primary survival endpoint and is focused on neutrophil recovery post chemotherapy. Currently, our team has qualified over 70 US study sites and is actively following up with an additional 50 interested sites, so that we can get this study off to a very rapid start. Our goal is to rapidly enroll this important study, quickly analyze the data and then expeditiously file a [BLA]. To achieve this, we will be very proactive and aggressively monitor the data on an ongoing basis and initiate BLA preparations well in advance of completing this registrational trial. Let me now talk about another of our exciting assets Poziotinib. Because of its great potential, we are prioritizing the start of a US-based Phase 2 program in breast cancer for this novel pan-HER inhibitor, in addition to the Phase 2 studies ongoing in multiple tumor types in Korea. As you know, the human epidermal growth factor receptor has been shown to be over expressed or mutated in a variety of cancers and that these patients are frequently resisted to conventional chemotherapies. While clearly a very competitive area with multiple approved products and compounds in development, we believe the strong Phase 1 clinical data for Poziotinib in breast cancer patients were demonstrated in overall response rate of 60% gives our pan-HER inhibitor the potential to truly be best in class. Poziotinib has also shown activity in several other tumor types, including non-small cell lung cancer and gastric cancer, but given its promising efficacy data in breast cancer, we’re concentrating our development efforts for Poziotinib on this indication. Our focus remains on a fast to market development strategy, capitalizing on the activity already demonstrated in breast cancer patients who had failed previous HER-directed therapies. We believe the robust preliminary data with Poziotinib predicts a high probability of success for this important development program. For EVOMELA, our novel propylene-glycol free formulation of melphalan, we remain on track for an NDA decision by FDA on October 23. We have been quick to respond to the FDA information requests and are happy to report that the review is progressing well and we are now only two and a half months from our PDUFA date. In addition to the currently approved indication for melphalan, which is for the palliative treatment of multiple myeloma patients who cannot take oral medication, we have specifically developed EVOMELA [indiscernible] with FDA for its use as a high dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma. As a reminder, ENOMELA has been branded orphan drug designation by FDA for this transplant positioning indication. It’s also important to remember that there is currently no drug approved by FDA for use as a high dose conditioning agent for these patients with multiple myeloma. Our novel, even though a formulation, uses Captisol to improve solubility and stability of melphalan and has eliminated the need for propylene-glycol containing solvents. Importantly, this allows for longer use in infusion times, which simplifies its clinical use and administration logistics. Our medical team has been actively working to support the successful launch of EVOMELA, if approved later this year. Finally, I’ll talk about Apaziquone, our tumor-activated pro-drug for the treatment of non-muscle-invasive bladder cancer. As we discussed with you in our March Investor Day meeting, this remains an area with a large unmet medical need. Our analysis of the integrated data from the two large completed randomized Phase 3 settings with Apaziquone demonstrated a statistically significant decrease in two-year recurrence rates in patients with early bladder cancer. We have discussed these data with the FDA and are well on our way to complete the Apaziquone NDA that will be submitted in the fourth quarter of this year. This will be the third NDA Spectrum has submitted to the Agency over the past three years. The Apaziquone submission will be made following initiation of an additional Phase 3 study that is being discussed with FDA under the special protocol assessment process. Given the lack of new therapies for these patients, Apaziquone has the potential to be the first new drug approved to treat non-muscle-invasive bladder cancer in more than 40 years. We continue to be focused on our key priorities in our development program and I’m very confident in our team’s ability to execute on our goal and successfully deliver on the value of Spectrum’s promising pipeline. With that, I’ll now turn the call back to Dr. Shrotriya.

[Rajesh Shrotriya:]

Thank you, Dr. Allen. We continue to execute our business strategy of acquiring, developing, and commercializing products for unmet medical needs of cancer patients. I believe the second part of this year will be a very exciting time at Spectrum. We remain energized and focused on the milestones ahead. We have the potential to have six drugs in the market by year-end and multiple blockbuster drugs in development and third NDA filing in three years. With that, let’s open the call for questions. Operator?

[Operator:]

[Operator Instructions] And it looks like our first question in the phone queue will come from Adnan Butt with RBC Capital Markets.

[Adnan Butt:]

So first a couple of 2012, how long will the FDA process take and if you can, could you clarify if the non-inferiority endpoint is the primary endpoint and superiority is the secondary endpoint and what are the statistics around the two? And then how do you demonstrate superiority, what kind of an endpoint is that, or is that what the agreement with the FDA is being sought?

[Rajesh Shrotriya:]

So let me give you a very straight, simple answer. As you know, this a biological where the endpoint is a blood test, neutrophil count. So these studies are powered – they are small studies relatively speaking, between 500, 600 patients. The endpoint we powered at about 90% to show non-inferiority, so the studies are designed to be non-inferiority trials. However, we have built in a superiority margin, showing the superiority at 80% power, to 80% to show the superiority. The endpoint, as you know, is DSN, the duration of severe neutropenia. And we have been working with the FDA for the last several months, we’ve gone through multiple iterations with the FDA and then we decided that since there is so much [writing] for Spectrum on this drug and multiple biosimilars on the market, multiple other things are happening, people are discounting. People think that Spectrum’s drug, they start wondering with the pegfilgrastim being – the marketplace will be – by the time we come to the market in 2018, the marketplace might be crowded. So we clearly based on the Phase 2 data, that was exciting, that we saw superiority in about 40 patients, 30 to 40 patients we saw superiority over pegfilgrastim at a certain dose. So we discussed with the FDA and we decided to pursue that line of thinking.

[Adnan Butt:]

In terms of how the company have used the market, do you get impacted by whether the outcome is non-inferior versus superior?

[Rajesh Shrotriya:]

Joe, do you want to comment, Joe or Tom?

[Joseph Turgeon:]

I think first of all let’s say non-inferiority. Non-inferiority allows us to compete very well and go after a large, large piece of the marketplace. I think with any drug, if you have the potential to have the yes word superiority, it puts you in an even better position all the way around. Since the data in Phase 2 were so robust, we looked at that and said, why not at least power to 80% to potentially get superiority. But I’m very, very comfortable launching in the marketplace with non-inferiority, obviously I’m in a much, much better position even to have more fun and go after larger piece of the market with superiority if that was the case. And we think we have data that potentially shows us that.

[Adnan Butt:]

And then if I [indiscernible] number is a good number relatively, can you shed some light into what you’d expect in the third quarter, fourth quarter?

[Rajesh Shrotriya:]

Adnan, I don’t think you want to waste more time on FUSILEV at this time, because clearly as we have stated before, we have a generic competition introduced. We’re still selling lot of units. Still a lot of our units of FUSILEV are being sold, but every sales price for a drug has been decimated by the generic launch. And therefore, we’re not counting much on the revenue of FUSILEV going forward.

[Operator:]

Our next question in queue comes from the line of Chris Howerton with Jefferies.

[Chris Howerton:]

I just had a quick one on 2012, given that you’ve included the powering for the potential to demonstrate superiority, have you adjusted the dosing that you’ll include in these Phase 3 trials to include the highest dose that you evaluated in Phase 2?

[Rajesh Shrotriya:]

Chris, yes indeed. So we have done trials with three doses. The earlier trials were done where there was a low dose, medium dose and a high dose and we have chosen a dose that is closer to the high dose than to the middle dose.

[Chris Howerton:]

And then just another quick one on Apaziquone, in terms of the FDA’s review of your NDA that you plan to submit towards the end of this year, when will they review that once you have data in hand from the confirmatory trial or they start reviewing the data and potentially provide you with a PDUFA data after acceptance of that NDA?

[Rajesh Shrotriya:]

The FDA wants us to do a confirmatory trial. The understanding that we have is that if we’re able to submit the old two trials 611, 612, that you combine, as you remember, each study alone is not significant [indiscernible] submitted with those protocols. However, when you combine those two studies, then the data becomes highly significant. So those two studies combined are going to be treated as one study and FDA wanted us to start another trial for which FDA’s input has been sought and is being further solidified by this. The understanding is that the FDA – we can file the NDA now, but the FDA will not review it, FDA will send it to DAC, but will not send it until we have included enrolled majority of the patients in the new trial. And the understanding – the FDA said that if we approve your drug now, or review your drug application now, there is no way you can complete a placebo-controlled trial. Let me remind you the protocol that we’re now planning to do is a placebo-controlled study. And therefore to answer your question, until majority of the patients have been enrolled into this trial, the NDA will not be – the ODAC meeting will not be held, I’m sure at the end some review at the FDA will continue.

[Operator:]

[Operator Instructions] And it looks like our next question will come from RK with HC Wainwright.

[Swayampakula Ramakanth:]

A quick question on EVOMELA, could you please discuss with us how your conversations with FDA has been especially with just two months away from approval and what arrangements are you doing in terms of getting a good launch out of this product?

[Rajesh Shrotriya:]

I’ll let Dr. Lee and Tom both address this issue.

[Lee Allen:]

As far as the discussion with the FDA, again, they have submitted some information request for us, there has been nothing that’s been challenging or difficult to answer. We’ve been able to very quickly address their concerns or questions. And really there aren’t – no pending issues that we’re aware of and we expect to be in label negotiations.

[Rajesh Shrotriya:]

Packaging, labeling and cartons, those are the kind of things that are now expected to be finalized.

[Thomas Riga:]

And from a commercial standpoint, our launch efforts are well underway. You heard Joe talk about both the synergy and the concentration of this business. We have 100 centers that are making over 90% of the business and 20 of them make over 50%. So we’re spending time there now with our current portfolio of products and we have a lot of activity preparing to be ready to go when that approval comes, if that approval comes.

[Rajesh Shrotriya:]

In fact, next week we will be addressing a group of KOLs in this area. So we’re very actively pursuing this in anticipation of approval, we’re working very hard.

[Swayampakula Ramakanth:]

A quick question on BELEODAQ, were you surprised that the sales number – compared to what we saw in the first quarter, it is a much lower number, is there anything that we need to understand regarding the dynamics of this drag in the market?

[Rajesh Shrotriya:]

RK, I’ll have either Joe or Tom comment on it, but I can tell you, think about this, PTCL is a very small number of patients and now there are multiple drugs in the market. And keep in mind that Spectrum has the largest share of this franchise between FOLOTYN and BELEODAQ. So with this intro, I would have Joe or Tom talk about this.

[Joseph Turgeon:]

I’ll take that one. I think if I look at our PTCL franchise overall, I’m thrilled to see double digit growth both quarter on quarter and year on year, but if I look at the product performance, the team is not satisfied with it. We expect it to be better. But you also have to take into consideration that this is a 6000-patient market that we anticipate some variability in demand quarter to quarter because it is a rare disease. But like I said, when I see double digit growth, that I like at the product level, something we’re taking a deep look at and expect to be better.

[Operator:]

And it looks like we do have a follow-up question from Adnan Butt with RBC Capital Markets.

[Adnan Butt:]

I wanted to ask on Poziotinib, you mentioned the Phase 2 study, when could it start and what types of breast cancer patients would you enroll, would it be a similar population to the prior study? And then on EVOMELA, how quickly could you launch assuming approval, post-approval?

[Rajesh Shrotriya:]

Let me talk about EVOMELA, as soon as the approval comes, we plan to launch this drug as soon as possible, it may take a couple of months, but I would think that we should be able to launch quickly after approval. The market is already preparing. As I said, they are having already meetings with the – they’re identifying the markets where the growth is, we’re meeting all the people who treat transplantations and whatnot. About Poziotinib, it’s a little bit early in the sense that we are right now in discussion with key opinion leaders who have been involved in pan-HER inhibitors, others like neratinib and whatnot. So even right from the time of ASCO, where we had meetings, we have planned several meetings at this time. So let me remind you that Poziotinib was developed by our partner called Hanmi in Korea and they had found activity in variety of tumor types, in colorectal cancer, in lung cancer, in breast cancer and in gastric cancer. However, based on the 60% response that we saw in breast cancer, we have decided to pursue only breast cancer in the United States at this time. And since then, we have been focusing on breast cancer patients. Adnan, the kind of details you’re asking, I think it’ll be premature for us to share with you what the design would be, what kind of cancer patients we’d go after, but clearly you can imagine that we have lot of expertise, Dr. Allen in fact has been working with pan-HER inhibitors for a long time. And we have now assembled with Dr. Allen Yang who will be – who is heading the development group. We have assembled both inside the company and outside the company expertise in this field. And you will be getting more about it as time progresses.

[Adnan Butt:]

But based upon other drugs being in the same space, you think you could find a similar approach or differentiated approach or is that to be determined?

[Rajesh Shrotriya:]

I would say to be determined. Having said that, I’ll share my experience with you in not only in oncology, but in drug development, when [status were] developed, we’re selling billion dollars each. Pfizer came back with Lipitor with $12 billion in sales. Until that time, there were many drugs [indiscernible] AstraZeneca, Squibb, they were selling billion dollars each and people thought why would Pfizer come back with a fifth Lipitor statin. And the fifth statin came and became number one selling – any drug ever in the world, $12.5 billion in revenue. So in oncology, the increments, the improvements with drug treatment becomes the small steps. And based on the data that we’re seeing and our experts are seeing, we think that our compound has a chance of being the best in class. And therefore, we’re very excited about it and we want to take our time to design the right study, both with the blessing from the FDA, the European authorities and experts in both sides of the pond.

[Operator:]

And presenters, at this time, I’m showing no additional questions in the queue. I’d like to turn the call back over to management for any additional remarks.

[Rajesh Shrotriya:]

At this time, we would like to thank you again for joining us on the call today and your interest in Spectrum. Our passion is to deliver better treatment options for patients suffering from cancer and we believe with the team in place and our robust pipeline, we are well positioned for future growth. Thank you.

[Operator:]

Thank you presenters and thank you to all attendees for joining us today. Thank you for your participation. This does conclude our call. You may now disconnect and have a wonderful day.