Spectrum Pharmaceuticals, Inc.
Q2 2014 Earnings Call Transcript

Published: 8 Aug 2014

[Operator:]

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.

[Shiv Kapoor:]

Thanks, Catherine. Good afternoon, and thank you for joining us today for Spectrum's Second Quarter 2014 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; Lee Allen, Chief Medical Officer; Tom Riga, Chief Commercial Officer; and other senior members of Spectrum's management team. Here is an outline of today's call. First, Dr. Shrotriya will provide you with 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 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 in Spectrum Pharmaceuticals, including statements about the 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 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 judgment 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, the 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'd now like to hand the call over to Dr. Shrotriya.

[Rajesh C. Shrotriya:]

Thank you, Shiv, and thank you, everyone, for joining us this afternoon. We have been very busy at Spectrum, and I'm 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 1 month before the PDUFA date. A team was prepared for the early approval, and we make the drug available for relapsed or refractory PTCL patients within 2 weeks of approval. As you know, we had acquired the rights for Beleodaq while in development at TopoTarget just about 4 years ago. Second, we are making good progress in preparing the NDA submission for our second drug, Captisol-enabled melphalan. The Captisol-enabled melphalan technology -- melphalan is now stable 4 to 8x longer using this technology. This drug fits well with our existing medical and commercial infrastructure. And 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 formulation technology have been approved by the FDA. Thirdly, we have now completely enrolled all patients in this important Phase II trial for SPI-2012 of our novel long-acting GCSF, and we will be making a Phase III Go/No-Go decision later this year. We had acquired the rights to our long-acting GCSF from Hanmi in May 2012. We believe SPI-2012 has the potential to be a blockbuster drug in our late-stage portfolio. Fourthly, we are also pleased with the developments in our ongoing FUSILEV litigation. Last month, the second of 2 courts also ruled in Spectrum's favor in its final [ph] department decision. The 829 patent of FUSILEV currently extends to March 7, 2022. We will continue to vigorously defend our intellectual property rights. We remain confident about our intellectual property position. I'm 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 fruits. Joe will cover this in more detail shortly. Overall, I'm very pleased with the direction of the company. Spectrum can now leverage 5 hematology-oncology FDA-approved products, many of which are targeted for patients who have very limited options. I'm 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?

[Kurt A. Gustafson:]

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 $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 end-user demand. As I mentioned last quarter, we have 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 onetime fill of the channel. We continue to see the underlying demand of FOLOTYN tracking in $10 million to $12 million range. ZEVALIN sales were $6.3 million and Marqibo sales were $1.4 million. So let me move on to cover our 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 same period in 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 cost was driven by 2 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'm proud of the fact that we are now marketing 2 additional products relative to 2013 and have done this with minimal increase in cost, 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 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 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.

[Joseph W. Turgeon:]

Thank you, Kurt. Thank you, Dr. Raj, and most importantly, thank you to everybody on the call who's interested in Spectrum. Since taking the role of President and Chief Operating Officer just about 3 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 5 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 remain within the predetermined guardrails. Overall, I'm very pleased with our performance of FUSILEV, and believe we're 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 a leader -- in a leadership position with our PTCL franchise, having 2 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 1 year. Therefore patients routinely cycle through several lines of therapy. FOLOTYN, an end-type 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 3 other drugs for this indication. Beleodaq was also approved 5 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're 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 relapsed/refractory ALL, a niche indication with approximately 1,600 adult patients a year in the U.S. We believe that potential of Marqibo could be significant beyond the current indication. Marqibo is a liposomal 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'm pleased with the changes we made within the commercial organization, and expect our progress to continue. As I mentioned earlier, we have made some strategic enhancements to our clinical development program, I'd 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 a potential to change the growth trajectory of our company. As Dr. Raj mentioned, this is a high-priority program for Spectrum. The Phase II study is fully enrolled, and we expect all patients to be fully dosed by the end of this month. We are in a good position to evaluate the results for the Phase II study, discuss these with the FDA and make a Phase III Go/No-Go decision this year. As I mentioned before, SPI-2012 will give us a real chance to compete in a blockbuster market. We're taking a hard look into our medical programs that led to 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. The ZEST 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've discontinued the study. At the same time, we've 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 resources are being used wisely. We are focusing our spend on products and indications that will have higher probability of success, satisfy significant unmet medical need, add 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 we have recently made, coupled with the velocity of our core business, gives me great confidence that we'll 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.

[Lee F. Allen:]

Thank you, Joe. We remain very excited about our robust cancer pipeline, and continue to work diligently on building additional operational efficiencies. Today, I'll 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 the its data package, our team's successful strategy in preparing this for the FDA, and the FDA's commitment to providing new treatment options to address the unmet medical need for patience with relapsed or refractory PTCL. Our team is continuing to work diligently on our next FDA submission, which will be a 505(b)(2) 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 the positive preliminary data from the pivotal Phase III study, which met its primary endpoint. In addition, we have had a pre-NDA meeting with the 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 II dose-finding study is now completely enrolled, and we look forward to meeting with the FDA for end of Phase II 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.

[Rajesh C. Shrotriya:]

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 5 drugs on the market. We will be submitting another New Drug Application for Captisol-enabled melphalan soon and for Apaziquone 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.

[Shiv Kapoor:]

Catherine, can you open the call for questions?

[Operator:]

[Operator Instructions] Our first question comes from Adnan Butt from RBC Capital Markets.

[Adnan S. Butt:]

So a high-level question first on commercial side. At what stage should we become comfortable that the revenues being reflected can be used as sort of run rate going forward? Or do you expect some volatility? That's the first question. And then, second, there's a pipeline question on 2012. Which dose do you think 2012 might advance with? And is there a specific noninferiority metric that needs to be hit to decide on a Go/No-Go? And a number of companies have announced plans for their GCSF. So what kind of a program needs to be run? What's the commercial opportunity here?

[Rajesh C. Shrotriya:]

Thank you, Adnan. So with regard to your first question, you know that we have had 4 quarters of sequential growth in our revenue. So in terms of reflection of business, I think we have a -- we are making a slow and steady progress. We now have fifth drug that was approved just last month and launched. And we are now preparing for a sixth drug. So I'm hoping and expecting that our revenue trajectory will continue. On the second aspect of SPI-2012, the current Phase II trial is designed to have 4 components to it. One is the comparative drug and then 3 doses of SPI-2012. And once the data is completed, our expectation is that we will pick the best dose. And the FDA has already approved one drug in this area, and this is not a -- this is an area where there is a well laid-out path for development of a molecule. So clearly, our goal is that once we have Phase II 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. So we are hoping that before the end of the year, we would have a meeting with the FDA. And depending upon the input we get, we will design a Phase III trial that will start sometime in early next year.

[Lee F. Allen:]

Perhaps I'll add a little bit more to that. As you know, the LAPSCOVERY technology is different than the other molecules. So the currently approved molecule is a PEGylated formulation. That formulation attaches covalently polyethylene glycol, and what it does is actually coat the molecule. And while that decreases its degradation in renal clearance, it also reduces the activity of the molecule. So LAPSCOVERY technology is very different. It covalently links it to a carrier molecule. This carrier molecule keeps it in the bloodstream and allows it to have a longer duration of action. And also, it increases its uptake into cells. So there's good scientific rationale and mechanistic reasons to think there may be differences. But obviously, the data will tell.

[Adnan S. Butt:]

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

[Lee F. Allen:]

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

[Joseph W. Turgeon:]

Adnan, listen -- this is Joe, Adnan. I just got to add to that I just really look forward to competing in a multibillion dollar market.

[Rajesh C. Shrotriya:]

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

[Operator:]

Our next question comes from Difei Yang from R.F. Lafferty.

[Difei Yang:]

Just few quick ones. With regard to FUSILEV, it looks like Q2 you had a great quarter, Q2. So I'm wondering if you could give us a little bit more color of what might be driving the revenue.

[Rajesh C. Shrotriya:]

So let me ask our Chief Commercial Officer, Tom Riga, to talk about this first.

[Thomas J. Riga:]

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 community oncology segment, 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's focusing specifically on the market and we have a fantastic leadership team that's executing very well, and the strength of our people in that space is bearing fruit.

[Difei Yang:]

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

[Rajesh C. Shrotriya:]

So let me have Kurt to talk about this.

[Kurt A. Gustafson:]

Yes, there's no real inventory adjustment at the wholesaler level. The wholesale inventories remain relatively stable, and have been stable for the last few quarters.

[Difei Yang:]

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

[Rajesh C. Shrotriya:]

So, 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 all lymphomas, used commonly as CHOP or CBP. The vinCRIStine or Oncovin is really Marqibo. So what we have demonstrated -- and then the number one problem, the number one issue that you should realize, that Marqibo is vinCRIStine in a novel formation. Second thing you should know is that vinCRIStine, while as good an anticancer drug as it is, up until Marqibo it could not be given in the dosage that are effective. So for the first time -- when you give Marqibo, you're actually giving vinCRIStine in a dosage without being afraid of the neuropathy. FDA had put a warning that you cannot increase the dose of more than 2 milligrams what we prescribe 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 that total in the United States, 1,600 patients. They're treated in about 200 centers by 200 doctors. So it's a very small market that we are 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 have the potential of this drug. Wherever CHOP is used, in fact, we now have a trial comparing head-to-head CHOP with CHMP. So in other words, in the job setting they're replacing Oncovin -- vinCRIStine with Marqibo. So all those things are going to happen. So in order to appreciate the full potential of this drug, you have to wait for some more data coming in and more usage taking place. In current approved indications, the sales will remain low.

[Difei Yang:]

That's very helpful. So my last question is with regards to Beleodaq, the new product that just received approval. So where are we with regards to reimbursement on the product?

[Rajesh C. Shrotriya:]

So, Joe, you want to take this question?

[Joseph W. Turgeon:]

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

[Difei Yang:]

And would there be a process you need to go through? Or we can just assume the patient demand will automatically be translated into revenue?

[Thomas J. Riga:]

Yes, I'll take that one. So the process for the J-Code, we'll launch with a miscellaneous J-Code, 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 2 products, 50% of the approved drugs for this disease, will give as added time with our physicians. Because of their unique mechanism of action, it will allow us to maintain and grow our antifolate business with FOLOTYN, and accelerate and compete assertively in the HDAC space, as we have a novel HDAC inhibitor. So we're excited about the opportunity and look forward to asserting our leadership.

[Rajesh C. Shrotriya:]

So Difei, let me remind you that in 2009, FOLOTYN was the first drug ever approved by the FDA for treatment of PTCL. So actually, we know this market like the back of our hand. And out of the 3 drugs that actually have a full label PTCL, we own 75% of the market with FOLOTYN, and now Beleodaq. The third drug, from Seattle Genetics, also has some type of PTCL in the packaged insert. However, out of the 3 approved drugs, with full PTCL-enabled, we -- Spectrum owns 75% of the market. And we therefore know this space extremely well. And we are very excited about it because it's 2 drugs that we now have -- have different mechanism of action. One is a folate analogue, FOLOTYN, and one is an HDAC inhibitor in Beleodaq. And in oncology, as you know, drugs that have different mechanism of action and different toxicities are often combined for better effect. And in fact, we are right now exploring some preclinical studies to see whether the 2 drugs can be combined to achieve better response rates.

[Operator:]

Our next question comes from Reni Benjamin from H.C. Wainwright.

[Reni J. Benjamin:]

Just a couple of questions or a couple regarding ZEVALIN. What trials are remaining that the company is sponsoring? And can you talk -- and do any of them have survival as an endpoint? And can 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?

[Rajesh C. Shrotriya:]

So, Ren, 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 to the patient's benefit. So maybe, Dr. Lee, you can comment upon the...

[Lee F. Allen:]

Sure. I'll just start with a brief introduction and address the question specifically. I mean, as you know radio immunotherapy 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 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 to provide education and reeducate physicians. Our understanding is that this modality of treatment is not even thought 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 that will be both sponsored, initiated studies that we will sponsor ourselves, we're currently in discussions with thought leaders around those. Those will be on unlabeled, target indications and we'll 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. And 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 lymphoma. So diffuse large B-cell lymphoma, a Z-BEAM combination for which there is already preliminary data out there. So we're sort of approaching this from several different aspects, both investigator-initiated studies, sponsor-initiated studies, and then also really looking to reeducate the clinical community about the utility of this modality of treatment.

[Rajesh C. Shrotriya:]

Thank you. Joe, you want to make a comment?

[Joseph W. Turgeon:]

Yes, Reni, one other thing. This is Joe. The only other thing I want to comment, one of the things you clearly see when you talk to thought leaders and doctors around is we want to provide some, what I'll call, in other words, 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.

[Reni J. Benjamin:]

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 505(b)(2) 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?

[Rajesh C. Shrotriya:]

So as you know, the 505(b)(2) does not give you any priority. It's a 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 II meeting. And it was a very positive, very productive meeting. And we came back and we have started working on its filing as we speak. So we expect a decision, once we file this application, expect about 12 months.

[Reni J. Benjamin:]

We're still on track to file in the third...

[Rajesh C. Shrotriya:]

So, Dr. Lee...

[Lee F. Allen:]

I was just going to add a little bit about -- a little more color on the FDA dialogue. Obviously, we don't usually talk about FDA communications. But this case, really, I mean, they were very encouraging. So although, again, it will be subject to a standard review, because that's what the 505(b)(2)s will get. We've already seen, our own case as an example, where sometimes decisions are made earlier than that. So we're very optimistic about the timeline for review. And we will be submitting that application in next several months.

[Reni J. Benjamin:]

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?

[Rajesh C. Shrotriya:]

You don't want me to talk about third quarter in the second quarter do you?

[Reni J. Benjamin:]

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

[Rajesh C. Shrotriya:]

. I would just say that we are very excited with the result that we are seeing in the marketplace. [indiscernible], yes.

[Reni J. Benjamin:]

Okay. How many salespeople and total employees are at the front now? And do you think that, that will expand by the end of the year? Do you think that you've got the optimal force?

[Rajesh C. Shrotriya:]

Well, we are very frugal when it comes to hiring people. When we have need for 5 people, we hire 1 person. So our people work very hard, they're very committed. They also are the owners of the company. Every single employee in the company, including the receptionist, is the owner of the company. They all have -- their interests are aligned with all the shareholders. So I would say our number right now is little over 200 people in the company. And I don't know what else your question was.

[Joseph W. Turgeon:]

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

[Reni J. Benjamin:]

And how many salespeople are on board right now?

[Rajesh C. Shrotriya:]

So we have about 100 people in our commercial operations. Our commercial operations is the largest block of people under the leadership of Tom Riga. And we have about 100 people in the commercial operations.

[Reni J. Benjamin:]

Got it. And just one final question regarding data, presentations and milestones for the rest of the year, anything that we should be focusing on? I mean, obviously, besides 2012, which we'll 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?

[Rajesh C. Shrotriya:]

So Dr. Lee...

[Lee F. Allen:]

Yes, maybe I'll comment briefly. So for this year, I think there'll be a few abstracts that are being submitted for ASH around Beleodaq. The data around the GCSF product and Captisol-enabled melphalan, we will be submitting abstracts for the appropriate meetings early next year.

[Operator:]

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

[Rajesh C. Shrotriya:]

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

[Operator:]

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.