Spectrum Pharmaceuticals Inc (SPPI) 2014 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Spectrum Pharmaceuticals second-quarter 2014 financial results conference call.

(Operator Instructions)

As a reminder, this call will be recorded.

I would now like to introduce your host for today's conference, Mr. Shiv Kapoor, Vice President of Strategic Planning and Investor Relations. Please go ahead.

Thanks, Catherine. Good afternoon, and thank you for joining us today for Spectrum's second-quarter 2014 financial results conference call.

I am Shiv Kapoor, Vice President of Strategic Planning and Investor Relations for Spectrum Pharmaceutics. With me today are Dr. Raj Shrotriya, Chairman and CEO; Joe Turgeon, President and Chief Operating Officer; Kurt Gustafson, Chief Financial Officer; 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 Lee will review the pipeline. We will then open up the call for questions.

Before I pass the call to Dr. Shrotriya, I would like to remind everyone that during this call we will be making forward-looking statements regarding future events of Spectrum Pharmaceutics, including statements about the product sales, profits and losses, safety, efficacy, development, timelines and clinical results of our drug products and drug candidates, that involve risks and uncertainties that could cause the actual results to differ materially. These risks are further described in our reports filed with the Securities and Exchange Commission.

These forward-looking statements represent the Company's judgement as of the date of this conference call, August 7, 2014; 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 the 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 would now like to hand the call over to Dr. Shrotriya.

Thank you, Shiv, and thank you, everyone, for joining us this afternoon. We have been very busy at Spectrum, and I am pleased about the progress we have made. Let me cover some of our team's recent accomplishments.

Number one: First, we have been successful in getting FDA approval for Beleodaq on July 3, more than a month before the PDUFA date. A team was prepared for the early approval, and we made the drug available for relapsed or refractory PTCL patients within two weeks of approval. As you know, we had acquired the rights for Beleodaq while in development at TopoTarget just about four years ago.

Second, we are making good progress in preparing the NDA submission for our second drug, Captisol-enabled melphalan. With the Captisol-enabled melphalan technology, melphalan is now a stable 4 to 8 times longer using this technology. This type fits well with our existing medical and commercial infrastructure.

As you might remember, we had acquired the rights to CE melphalan in March of last year from Ligand. And as you may know by now, several drugs using this formation technology have been approved by the FDA.

Thirdly, we have now completely enrolled all patients in this important Phase 2 trial for SPI-2012, our novel, long-acting GCSF. And we will be making a Phase 3 go/no-go decision later this year. We have acquired the rights to our long-acting GCSF from Hanmi in 2012. We believe SPI-2012 has the potential to be a blockbuster drug in our latest-stage portfolio.

Also, we are also pleased with the developments in our ongoing Fusilev litigation. Last month, the second of two courts also ruled in Spectrum's favor in a (technical difficulty) decision. The 829 patent on Fusilev currently extends to March 7, 2022. We will continue to vigorously defend our intellectual property rights, and we remain confident about our intellectual property position.

I am delighted to see solid double-digit growth in our core business. It is clear to us that the efforts we have made on the commercial front are starting to bear fruit. Joe will cover this in more detail shortly.

Overall, I'm very pleased with the direction of the Company. Spectrum can now leverage five hematology/oncology FDA-approved products, many of which are targeted for patients who have very limited options. I am proud that our team has maintained fiscal discipline.

As a diversified Company, we have to make some important decisions continuously to prioritize our products. Joe Turgeon, who was recently promoted as President and Chief Operating Officer of the Company, has taken some important initiatives that I'm excited about, and he will talk more about it. We have created a solid foundation for future growth at Spectrum, and we are excited about the future of the Company.

Over the next 15 minutes or so, Kurt, Joe and Lee will provide an update on various aspects of our Business. Kurt?

Thank you, Raj, and good afternoon to everyone on the call today. The press release covers all the important figures; so, in my remarks, I will touch on a few of the highlights of the quarter that I believe are particularly important.

First, on sales: We had $46.9 million in total product sales in the second quarter compared to $32.2 million in the same quarter last year, a growth rate of 45%. On a sequential quarter basis, sales were up 17% from $40.1 million in the first quarter.

Fusilev sales were at $26.6 million in the second quarter, a 106% increase versus the same quarter last year, and a 20% increase over the first quarter of 2014. We continue to see strong Fusilev-to-end-user demand. As I had mentioned last quarter, we had seen a slight uptick in the underlying demand, which continued into the second quarter. Wholesaler inventory levels remained relatively stable from the prior quarter.

Folotyn net sales were $12.6 million. This was flat compared to last year, and a 25% increase over the first quarter of this year.

The majority of the growth is due to an increase in underlying demand. And to a lesser extent, sales were also positively impacted by the fact that Folotyn is now being sold under a more typical specialty distribution model, which resulted in approximately $1 million of additional sales as a one-time fill of the channel. We continue to see the underlying demand of Folotyn tracking in the $10 million to $12 million range.

Zevalin sales were $6.3 million, and Marqibo sales were $1.4 million.

Let me move on to cover operating expenses on a GAAP basis. Total research and development expenses for the second quarter were $11.3 million, as compared to $10.5 million in the same period of 2013.

SG&A expenses for the second quarter of 2014 were $25.4 million as compared to $22.6 million in the same period of 2013. We remain fiscally disciplined in our approach to funding programs. Joe will talk to you about some of the work we've been doing in portfolio management to ensure that we are making investments in programs that will drive future value.

The increase in SG&A costs was driven by two factors. First, we had higher legal costs, as we defend our intellectual property; and second, there was an increase in sales and marketing costs. However, I am proud of the fact that we are now marketing two additional products relative to 2013, and have done this with minimal increase in costs, as we realize the leverage of our focus in oncology.

On a GAAP basis, the net loss for the quarter was $3.6 million, or $0.06 per basic and per diluted share, compared to a net loss of $9.7 million, or $0.16 per basic and diluted share in the second quarter of 2013. On a non-GAAP basis, net income was $6.8 million, or $0.11 per basic and $0.09 per diluted share, compared to a net loss of $5.3 million, or $0.09 per basic and diluted share for the same period in 2013. We continue to have a strong balance sheet, operating cash flow is strong, and we ended the quarter with $136 million in cash.

Now, let me hand the call over to Joe to provide an operational update.

Thank you, Kurt. Thank you, Dr. Raj. And most importantly, thank you to everybody on the call who is interested in Spectrum.

Since taking the role of President and Chief Operating Officer just about three months ago, I've taken a hard look at our clinical development program to ensure we maximize the commercial opportunities. Our pipeline is an important asset, second only to our people. Our goal is to invest in the key areas that enhance the care of cancer patients, while increasing shareholder value.

Prior to speaking on the enhancements that we made to our clinical development program, let me first provide you my perspective on our core business, which now includes five drugs. A good indicator of our commercial strength is the quarterly performance of our products. This is the fourth consecutive quarter we've reported sales over $40 million; and in the second quarter, we realized double-digit growth over the first.

Fusilev sales grew 20% quarter over quarter, driven by solid end-user demand. The inflection in end-user demand is specifically in the community oncology segment where 90% of our Business now resides. Lastly, wholesaler inventories remained within the pre-determined guard rails.

Overall, I'm very pleased with our performance for Fusilev, and believe we are gaining a deeper understanding of what this product will consistently deliver. Our strategy is sound, and the disciplined execution being demonstrated by our people is solid. I continue to have confidence about the strength about that core business.

Spectrum is the leader -- in a leadership position with our PTCL franchise, having two unique products now indicated for the treatment of these patients. As you know, peripheral T-cell lymphoma is a fatal disease. It's really difficult to treat, with the most effective drugs in the setting providing over -- only a 25% to 30% overall response rate. Those patients who initially respond usually fail treatment, and progress within a year. Therefore, patients routinely cycle through several lines of therapy.

Folotyn, an anti-folate, was the first drug approved for PTCL patients in 2009. Folotyn demonstrated strong quarter-over-quarter double-digit growth, primarily driven by increased end-user demand.

I'm excited that we just launched Beleodaq, a novel HDAC inhibitor. We are very pleased that Beleodaq received priority review by the FDA, despite the prior approval of three other drugs for this indication. Beleodaq was also approved five weeks ahead of its scheduled PDUFA date, a rather uncommon occurrence. We were prepared for the early approval, patients are already being treated, and early feedback from thought leaders is very positive.

We believe that Beleodaq has a unique safety profile, and has demonstrated efficacy across the various PTCL subtypes. As Beleodaq fits perfectly into our existing commercial organization, we are now driving end-user demand so that the promise of this product for patients may be realized.

For Marqibo, sales in the second quarter were $1.4 million. The current indication is adult Philadelphia negative relapse refractory ALL, a niche indication with approximately 1,600 adult patients a year in the US. We believe the potential of Marqibo could be significant, beyond the current indication.

Marqibo is a lysosomal form of vincristine, which is a well-established treatment in multiple hematologic and solid tumor types. The long-term growth potential for this product will be driven by our research efforts to study the possible expansion of the current indications into the broader ALL and NHL settings. Based on our progress in Q2, I am pleased with the changes we've made within the commercial organization, and expect our progress to continue.

As I mentioned earlier, we have made some strategic enhancement to our clinical development program. I would like to share with you a few of the highlights. As I mentioned earlier, at the top of the list is SPI-2012. This is an opportunity that has the potential to change the growth trajectory of our Company.

As Dr. Raj mentioned, this is a high-priority program for Spectrum. The Phase 2 study is fully enrolled, and we expect all patients to be fully dosed by the end of this month. We're in a good position to evaluate the results for this Phase 2 study, discuss these with the FDA, and make a Phase 3 go/no go decision this year. As a mentioned before, SPI-2012 could give us a real chance to compete in a blockbuster market.

We're taking a hard look into our medical programs through the lens of commercial viability, enhanced patient care, and shareholder value. We'll be doing this for all products in the future, but we've made some decisions regarding Zevalin that I want to share with you.

We've made an important strategic decision regarding the ZEST trial. This trial is enrolling very slowly, requiring a significant capital investment over time, and would not have yielded results leading to an indication expansion in a timely fashion. Therefore, we have discontinued the study. At the same time, we have made the decision to invest in new smaller Zevalin studies that target unmet medical need and could bolster our commercial trajectory.

We are evaluating every drug and every clinical trial to ensure our researchers are being used wisely. We are focusing our spend on products and indications that will have higher probabilities of success, satisfy significant unmet medical need, have meaningful market potential, and have rapid and a defined path to the market.

At Spectrum, we're in a strong position to execute our mission to redefine cancer care. The changes that we have recently made, coupled with the velocity of our core business, gives me great confidence that we will be able to realize the promise of our pipeline and deliver shareholder value.

I'd like to pass the call over now to Dr. Lee Allen, our Chief Medical Officer.

Thank you, Joe. We remain very excited about our robust cancer pipeline, and continue to work diligently on building additional operational efficiencies. Today I will provide you with a brief update on our clinical development programs for Beleodaq, Captisol-enabled melphalan, and SPI-2012, our long acting GCSF compound.

As Joe mentioned previously, the major development in July was the early FDA approval of Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. We believe this decision reflects the activity of Beleodaq, the strength of its beta package, our team's successful strategy in preparing its dossier, and the FDA's commitment to providing new treatment options to address the unmet medical need for patients with relapsed or refractory PTCL.

Our team is continuing to work diligently on our next FDA submission, which will be a 505 B2 filing for Captisol-enabled melphalan. As we have discussed, Captisol is a unique modified cyclodextrin that was rationally designed, and has already been successfully used to improve drug solubility, stability, bioavailability, and the dosing for several other FDA-approved drugs.

For melphalan, its use has enabled the elimination of the need for propylene glycol, which has been associated with significant toxicities. And it has also improved melphalan's stability, allowing for longer infusion times, and potentially the administration of higher dose intensities. We have already announced its positive preliminary data from the pivotal Phase 2 study, which met its primary endpoint. In addition, we have had a pre-NDA meeting with FDA, and are making good progress on preparing the Captisol-enabled melphalan NDA submission.

For SPI-2012, our novel, long-acting granulocyte stimulating factor, the Phase 2 dose-finding study is now completely enrolled, and we look forward to meeting with the FDA for an end of Phase 2 meeting before the end of this year. By linking GCSF to a specifically engineered protein carrier through the novel Lapscovery technology, the half-life of this novel GCSF molecule was increased, meaning it could potentially circulate in the bloodstream longer. This formulation also leads to greater bone marrow penetration.

In summary, we have a very robust pipeline with a lot of promise that we are aggressively advancing. We plan to meet or exceed each of our project milestones, and consistently drive the development of high-quality products that positively impact the lives of cancer patients.

I will now turn the call back to Dr. Raj.

Thank you, Dr. Lee. As you just heard, this is an exciting time for Spectrum, and the foundation is in place to continue to leverage our growth. We continue to develop and grow into a much more diversified Company. We now have five drugs on the market. We will be submitting another new drug application for Captisol-enabled melphalan soon, and for our (inaudible) thereafter. We will make a very important decision on one of our highest priorities in our pipeline, SPI-2012, and continue to prioritize our programs.

I would now like to open the call for questions.

Catherine, can you open the line for questions?

(Operator Instructions)

Adnan Butt, RBC Capital Markets

Hey, everyone, congrats on the great execution. High-level question first on commercial side. At what stage should we become comfortable that the revenues being reflected can be used as a run rate going forward? Or do you expect some volatility? That's the first question. And then second, if there's a pipeline question on 2012, which dose do you think 2012 might advance with, and is there a specific non-maturity metric that needs to be hit to decide on a Go/No go? And a number of companies have announced time for their GCSFs, what kind of a program needs to be run? What's the commercial opportunity here? Thanks.

Thank you, Adnan. With regard to your first question, you know that we have had four quarters of sequential growth in our revenue. In terms of reflection of business, I think we have a -- we are making slow and steady progress. We now has a fifth drug that was approved just last month and launched, and we're now preparing a six drugs. I'm hoping and expecting that our revenue trajectory will continue. On the second aspect SPI-2012, the current Phase 2 trial is designed to have four components to it. One is the competitive drug and then three doses of SPI-2012. Once the data is completed, our expectation is that we will pick the best dose

And you know the FDA has already approved one drug in this area, this is not a -- this is an area where there is a well laid out path for development of a molecule. Clearly, our goal is that once we have Phase 2 data, we plan to meet with the FDA. In fact, we're planning to request a meeting with the FDA soon. And within 60 days usually, FDA takes about 60 days to grant this meeting. We are hoping that before the end of the year, we will have a meeting with the FDA. And depending upon the input we get, we will design a Phase 3 trial that will start sometime in early next year

Perhaps to add a little bit more to that. As you know, the last recovery technology is different than the other molecule. Currently approved molecule is the pegylated formulation. That formation attaches (inaudible) polyethylene glycol, and what it does is actually coat the molecule. While that decreases its degradation and renal clearance, it also reduces the activity of the molecule. The Lapscovery technology is very different. It fills out links it to a carrier molecule. This carrier molecule keeps in the bloodstream and allows it to have a longer duration of action. and also, it increases its uptake into cells. There is good scientific rationale and [many specific] reasons to think there may be differences, but obviously the data will tell.

Just a follow-up on 2012, in terms of the competitive space, is it truly competitive, or is 2012 differentiated?

Again, the majority of the molecules that are in development are still short-acting molecules, so there is only one that we're aware, lead molecule that's long acting. And again, I think the data itself will tell you whether there will be differentiation or not. We think that we have some advantages that -- from the marketing perspective that may be important.

This is Joe, Adnan, how are you doing? I've just got to add that I really look forward to competing in the multi billion dollar market.

And I think, Adnan, you might remember that Joe was responsible for launching the only other long-acting GCSF that is on the market right now, which is bringing about $6 billion in worldwide sales. In fact, that was launched under the tutelage Joe Turgeon. We are very proud to have the team that actually launched a very successful drug into the space.

Thank you.

Difei Yang, R.F. Lafferty.

Hi, good afternoon, everyone. Thanks for taking my question. Just a few quick ones. With regards to Fusilev, it looks like Q2, you had a great quarter Q2. I'm wondering if you could give us a little bit more color of what might be driving the revenue.

Let me ask our chief commercial officer, Tom Riga, to talk about this first.

Yes, Difei, I'll give some additional color around that number. When we look at our performance, it's driven by solid end-user demand that is largely within the committee oncology segment. And 90% of our business is there. I would also look to that result and look at the decisions we've made structurally within our commercial organization that we're truly benefiting from. We've designed a sales team that is focusing specifically on the market and we have a fantastic leadership team that's executing very well and the strength of our people in the space is bearing fruit.

And so is there any inventory adjustment that's included in the revenue?

Let me have Kurt drop part of this.

There is no real inventory adjustment at the wholesaler level. The wholesaler inventories remain relatively stable and have been stable for the last few quarters.

Thank you. And then moving onto the next product, Marqibo. If we look at the launch trajectory, it's somewhat flat right now. And would you give is a little bit more color with regards to the -- your expectation of the product uptake and how is it likely to be adopted by the patients and doctors?

Difei, let me first remind you what Marqibo is. Marqibo is a novel liposomal formulation of vincristine, and vincristine is a well-established anticancer drug that is effective in a dozen oncology settings, both hematological and solid tumors. In fact, it is the core for treating (inaudible) used commonly as CHOP or CDP. The vincristine or oncovin is really Marqibo. What we have demonstrated -- the number one problem, that's the number one issue that we should realize, that Marqibo is vincristine in a novel formulation.

Second thing you should know is that vincristine, while as a good anticancer drug as it is up until Marqibo, could not be given in the dosage that are effective. For the first time, when you give Marqibo, you are actually giving vincristine in a dosage without being afraid of the neuropathy. FDA put a warning that you cannot increase the dose of more than 2 milligrams as we described for vincristine. For the first time, there is no upper limit on how much Marqibo can be given. So, keep in mind.

Third thing is that the current indication for which Marqibo has been approved is a Philadelphia negative ALL. A very small indication of that total in the United States, 1,600 patients that are treated in about 200 centers, about 200 doctors. It's a very small market that we're launching this drug. When we acquired the rights to this drug and we launched, we were fully aware that the current indication is for a very small market. However, we also aware of the potential of this drug.

Wherever CHOP is used, in fact, we now have a trial comparing head-to-head CHOP with [chen]. In other words, in the CHOP setting, they are replacing oncovin or vincristine with Marqibo. So, all of those things are going to happen. In order to appreciate the full potential of this drug, you have to wait for some or data coming in and more uses taking place. In current approved indications, the sales will remain low.

Thank you for the explanation. That is very helpful. My last question is with regard to the Beleodaq, the new product the just received approval. Where are we with regards to reimbursement on that product?

Joe, you want to take that question?

Sure. First of all, this -- in the peripheral T-cell lymphoma market, virtually all drugs are paid for because this is a very small market in the big picture. It's a fatal disease, patients go through several drugs through their therapy. The Beleodaq, we just started selling it, as you know. I'm not worried about reimbursement for this product, just like all of the products in this space.

Can there be processing you need to go through, or we can just assume the patient demand will automatically be translated into revenue?

I'll take that one. The process for the [jayco] will launch with a miscellaneous [jayco], not atypical of any other Part B launch within the oncology market. And as it relates to driving demand, that is absolutely what we intend to do with our field force. Being a leader in this space, having two products, 50% of the approved drugs for this disease will give us added time with our physicians because their are unique mechanism of action it will allow us to maintain and grow our anti-folate business with Folotyn and accelerate and compete assertively in the HDAC space as we have a novel HDAC inhibitor. We're excited about the opportunity and look forward to serving our leadership.

Difei, let me remind you that in 2009, Folotyn was the first drug ever approved by the FDA for treatment of PTCL. We knew -- we know this market like the back of our hand. And out of the three drugs that actually have a full label PTCL, we own 75% of the market with Folotyn and now Beleodaq. The third from Seattle Genetics also has a subtype of PTCL in their package insert; however, out of the three approved drugs, the full PTCL label, we expect to own 75% of the market and we therefore know this space extremely well. And we are very excited about it, because it is two drugs that we now have that have different mechanisms of action. One is a folate analog, Folotyn, and one is an HDAC inhibitor in Beleodaq. And in oncology, as you know, drugs that have different mechanisms of action and different toxicities are often combined for better effect. And in fact, we are right now exploring some pre-intel studies to see whether the two drugs could be combined to achieve a better response rate.

Yes, thank you. That's very helpful.

Reni Benjamin, H.C. Wainwright.

Good afternoon, guys, and congratulations on a great quarter. Just a couple of questions, a couple regarding Zevalin. What trials are remaining that the Company is sponsoring, and can you talk -- do any of them have survivals as an endpoint? Could you talk a little bit about the other smaller trial indications that you will be exploring? What kind of indications and will they be more IST type trials or ones that are corporate sponsored?

Ben, let me ask Dr. Lee to respond to this question. But before he does that, let me put to you, we have no trials where survival is the endpoint at this time. They are doing trials in an area where some abstracts have been published, some work has been done that shows that Zevalin has an added advantage for the patients' benefit. So, maybe, Dr. Lee, you could comment upon the --

Sure, just start with a brief introduction and address the question specifically. As you know, radioimmunotherapy is almost like a lost art at this point in time. Bexxar came off the market, we're the only player in town at this point in time. There are a lot of physicians that really believe that this is an important mechanism. I think what we've learned is that, our opportunity here is to generate some data that provides education and reeducate physicians. Our understanding that this modality of treatment is not even taught in residency programs anymore. And so again, we think that small short-term trials will be able to put us in the forum for discussions around that.

To the types of trials, there will be both sponsored initiated studies that we will sponsor ourselves. We're currently in discussions with thought leaders around those. Those will be unlabeled target indications and will hopefully be able to get to a decision point within the next several months on the design of those. In addition to those specific trials, we are also sponsoring investigator-initiated research.

There's a couple of different ones that we're considering or have moved on, including the use of that product with condition regimens for aggressive lymphomas. Diffuse, large B-cell lymphoma [ZB] in combination, for which there is already preliminary data out there. We're' approaching this from several different aspects, both investigator-initiated studies, sponsor-initiated studies, and also really looking to reeducate the clinical community about the utility of this modality of treatment.

Thank you. Joe, do you want to comment?

Yes, Ren, one other thing. This is Joe. I - the only other thing I want to comment, one of the things you clearly see what you talk to thought leaders and doctors around is we want to provide some, what I will call the newest, modern data. Most of the data around here is 12 years old, and we want to give them some fresh, new data that they can use quickly. And again, we can take action quickly commercially with that.

Got it. Switching gears to CE Melphalan, I know that -- correct me if I'm wrong, but I think that it's going to undergo the 505B2 pathway. Can you talk to us a little bit about, I believe you're going to submit the application this third quarter. Can you talk to us a little bit about how long you expect the review period to be, when do you think the drug could be launched?

As you know, the 505B2 does not give you any priority. It's normal review which normally can run from 10 to 12 months time period. But what I can tell you is that we had a meeting with the FDA, what's called pre-NDA meeting or end of Phase 2 meeting. And it was a very positive, very productive meeting. And we came back and we started working on the final as we speak. We expect decision, once we file is application, expect about 12 months.

Are we still on track to file third quarter?

I was just going to add a little bit about -- a little more color on the FDA dialog. Obviously, we don't usually talk about FDA communication. But in this case, really, they were very encouraging. Although, again, it will be subject to a standard review because that's what the 505B2s will get. We've already seen in our own case, an example where sometimes decisions are made earlier than that. We're very optimistic about the timeline for review and we will be submitting that application in the next several months.

Got it. Switching gears to Fusilev, I know Kurt in the last conference call mentioned that he had seen an uptick and clearly, it translated into the revenues this quarter. Anything that you're seeing going into the third quarter, uptick, downtick, relatively stable?

We don't want me to talk about third quarter in second quarter, do you?

No, that's true. But how is it going forward for the rest of the year?

I would say that we're very excited with the results that we're seeing in the marketplace.

How many salespeople in total employees are at the firm now, and do you think that that will expand by the end of the year? Or do think that you've got the optimal force?

We are very frugal when it comes to hiring people. When we have need for five people, we hire one person. Our people work very hard, they are very competent, they all[answer]. Owners of the Company, every single employee in the Company including receptionist is an owner of the Company. They all have -- their interests are aligned with all shareholders. I would say our number right now, it's a little over 200 people in the Company. I don't know what else your question was.

I will tell you this, Ren. I think from a commercial side, what Tom has done is I think take what we have and redeploy it. Remember, in the last call we said we were redeploying our sales forces. I think that's part of the execution you're seeing. I'll always let them have -- right size us. My question is, at the end -- whether it be the end of this year, next year, whenever, we will do the math and what I want to be is right size to get the job done. That would be my answer.

How may salespeople are on board right now?

We have 100 people in our commercial operations. Commercial operation the largest block of people under the leadership of Tom Riga, and we have about 100 people in the commercial operation.

Got it. And one final question regarding data, presentations and milestones for the rest of the year. Anything that we should be focusing on? Obviously, besides 2012, which will get by the end of the year. But at ASH or at the AACR triple meeting or anything that we -- that's not on our radar screen right now?

Dr. Lee?

Yes, I'll comment briefly. For this year, I think there will be a few abstracts that are being submitted for ASH around Beleodeq, the data around the GCSF product in Captisol-enabled melphalan. We will be submitting abstracts for the appropriate meetings early next year.

Excellent. Thank you, guys, very much, and congratulations.

Thank you.

I'm showing no further questions at this time. I would now like to turn it back to Dr. Raj for any closing remarks.

In closing, we would like to thank you again for joining us on this call this afternoon and your continuing interest in Spectrum. Today we have an exciting pipeline, robust cash position, and a strong management team, and we're very well-positioned to grow meaningfully going forward. We are looking forward to a great future for Spectrum and continuing our mission to meet the needs of cancer patients. Thank you.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program, you may all disconnect. Everyone have a great day.