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Spectrum Pharmaceuticals (NASDAQ:SPPI)

Q4 2013 Earnings Call

March 06, 2014 4:30 pm ET

Executives

Shiv Kapoor - Vice President of Strategic Planning & Investor Relations

Rajesh C. Shrotriya - Chairman, Chief Executive Officer, President, Chairman of Placement Committee and Chairman of Product Acquisition Committee

Kurt A. Gustafson - Chief Financial Officer, Principal Accounting Officer and Executive Vice President

Joseph Kenneth Keller - Chief Operating Officer and Executive Vice President

Joseph Turgeon - Chief Commercial Officer and Senior Vice President

Analysts

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

Reni J. Benjamin - H.C. Wainwright & Co, LLC, Research Division

Jason Kantor - Crédit Suisse AG, Research Division

Operator

Good day, ladies and gentlemen, and welcome to the Spectrum Pharmaceuticals Fourth Quarter and Fiscal Year 2013 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to turn the call over to Spectrum Pharmaceuticals' Vice President of Strategic Planning and Investor Relations, Shiv Kapoor. Mr. Kapoor, you may begin.

Shiv Kapoor

Thanks. Good afternoon, and thank you for joining us today for Spectrum's Fourth Quarter 2013 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, CEO and President; Ken Keller, Chief Operating Officer; Kurt Gustafson, Chief Financial Officer; Joe Turgeon, 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 the highlights of the fourth quarter and discuss our overall direction and strategy. Kurt will then provide a summary of our fourth quarter financial performance. Following this, Ken will review the pipeline and commercial progress of the company. And then we will open up the call to 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 Pharmaceuticals, including statements about the products' sales, profits and losses, the safety, efficacy development time lines 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, March 6, 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 releases, 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 C. Shrotriya

Thank you, Shiv, and thank you, everyone for joining us this afternoon. I'm very pleased to share with you the progress we have made during the fourth quarter and the critical corporate objectives that we have achieved throughout 2013. Looking back at last year, we achieved several milestones in multiple areas of our business. Let me summarize a few of them. Number one, on acquisition front, I'm pleased to report that we completed 2 strategic acquisitions. We acquired an FDA-approved, patented proprietary oncology drug Marqibo through the acquisition of a NASDAQ-listed company, Talon Therapeutics. In addition, we licensed in a later-stage oncology drug Captisol-enabled melphalan from Ligand Pharmaceuticals.

On commercial front, we executed the launch of Marqibo in less than 7 weeks after its acquisition and have continued to focus on the growth of our marketed drugs. On medical front, we filed the New Drug Application for Beleodaq, for which FDA has now granted a priority review and has established an action date of August 9 of this year. That is within about 5 months from today. We completed the enrollment in the pivotal study for Captisol-enabled melphalan. We also initiated a Phase II study with SPI-2012, a long-acting GCSF, and I will shortly talk more about this.

On corporate front, we strengthened our management team with the addition of a new Chief Financial Officer and Chief Medical Officer.

On financial front, we have exercised utmost fiscal discipline and, on a non-GAAP basis, have turned slightly profitable in the second half of 2013. In spite of a significant drop in revenue due to market conditions. We ended the year with over $150 million in cash. We believe, with the significant cash reserve and a strong pipeline, 2014 promises to be an exciting year for Spectrum.

Today, I'll focus on mainly 3 growth drivers that I believe are most important for Spectrum. First, let me talk about SPI-2012, a long-acting granulocyte colony-stimulating factor or GCSF, which could be one of the only new branded drugs to be approved in a market that is over $5 billion. We're especially excited about this pipeline project as the launch would be led by a Spectrum team that already has extensive experience in this market. This year, we believe we will make a go-no-go decision on the Phase III study. I also believe that this is one of the most exciting projects in our pipeline that could enter Phase III program before the year end. Exciting because unlike many other drugs in our portfolio that require an endpoint of PFS or an overall survival that could take years to reach for certain drugs, for this drug, the endpoint is the measure of the absolute neutrophil count, or ANC, which is achieved rather quickly. Also, from value perspective, long-acting GCSF market, which is currently at about $5 billion. Even a 20% penetration into this market could result in revenue for the Spectrum approaching $1 billion in annual sales.

Second thing that I want to say a few words about is Captisol-enabled melphalan. We acquired this drug about a year ago at this time in March 2013. I'm very pleased with the progress we have made. We have already completed full enrollment in the pivotal study. We expect final data in the second quarter and an NDA filing soon thereafter. Captisol-enabled melphalan is designed to meet the need for a formulation of melphalan that is free of propylene glycol, which has been associated with renal and cardiac side effects. Further, the Captisol technology may allow for more optimal dosing of melphalan. If approved in 2015, we believe that our drug could capture major share of the $130 million market.

Thirdly, let me say a few words about Beleodaq. Based on a positive pivotal trial conducted under the SPA, or Special Protocol Assessment, we filed a New Drug Application for accelerated approval with the FDA. The FDA granted it a priority review designation with a decision date of August 9 this year, which is barely 5 months from today. Beleodaq is an HDAC inhibitor with a unique pattern of inhibiting the various HDAC isoenzymes, and Beleodaq has totally different mechanism of action and a different safety profile as compared to FOLOTYN, our currently approved PTCL drug. Our drug seems to have activity in PTCL subtypes where other HDACs don’t. If approved, Beleodaq would be indicated for use in relapsed and refractory patient population. However, because these patients fail multiple treatments in the course of their therapy, we expect PTCL patients will cycle through Beleodaq as well as FOLOTYN. Because of FOLOTYN experience, we know this market well. We will therefore be able to strongly leverage, our existing clinical and sales infrastructure to support the launch of this drug. There are several growth opportunities and catalysts beyond the ones that I have just mentioned. Our base business remains strong. We have 4 commercialized drugs that are helping us develop our pipeline and build significant shareholder value.

This is our first full quarter of reporting sales from Marqibo, and we're excited about its future. We remain focused on other potential growth drivers like Marqibo's potential additional indications such as in aggressive non-Hodgkin's lymphoma and adult ALL; apaziquone for superficial bladder cancer; and ZEVALIN for the treatment of diffuse large B-cell lymphoma.

Ken will cover these in more detail in just a few minutes. As we look into 2014 and beyond, we're energized about the opportunities for Spectrum. If Beleodaq is approved in August, we will have 5 drugs on the market. And if melphalan is approved in 2015, we could have 6 drugs on the market, bringing revenue -- and within the next 1 to 2 years, we could have multiple drugs like SPI-2012 and SPI-1620 in Phase III trials.

I will now hand over the call to Kurt to discuss financials. Following Kurt, Ken will give you an overview of our commercial and research progress in more detail. Kurt?

Kurt A. Gustafson

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

First on revenue. We had $41.5 million in total revenue in the fourth quarter. This compared to $42.4 million in the previous quarter. FUSILEV sales were $20.6 million in the fourth quarter, which is consistent with the underlying demand for the product, which remained stable between $20 million and $25 million per quarter. FOLOTYN net sales were $11.3 million. For the past few quarters, we've seen stable demand for FOLOTYN in the $10 million to $12 million range. ZEVALIN net sales were $7.3 million, and for the past few quarters, we have seen stable demand for ZEVALIN in the $7 million to $8 million range. This is the first time we are reporting a full quarter sales from Marqibo, and net sales were $1.3 million, and Marqibo launch trajectory is consistent with our expectations. Talon is now fully incorporated into our business, and I'm proud of its quick and seamless integration within Spectrum.

In the fourth quarter, we took a valuation reserves against our deferred tax assets. This was the result of the company entering into a 3-year cumulative loss position, which is calculated by using book income for the years 2012, '13 and '14. As the company turns the corner and shows sustainable profits, this reserve will reverse similar to what happened in the first quarter of 2012, and you would see a corresponding onetime benefit in our provision for taxes.

On a non-GAAP basis, Spectrum was slightly profitable in the fourth quarter. We reported a non-GAAP profit of $0.05 per share. We continue to be committed to fiscal responsibility while making prudent investment decisions on our pipeline and our infrastructure.

So now let me talk a little bit about the business going forward. The reported revenue gives a good you indication of the health of our base business. We are confident that we can grow our base business from here, and our revenue growth will be further enhanced with the help of additional drugs from our pipeline over the next 2 to 3 years.

A few specific comments about the rest of the 2014 P&L. First, the partner revenue seen in the past 4 years is primarily due to the amortization of an up-front payment from Allergan. This up-front payment is now fully amortized. So unless there is additional out-licensing activity, you will not see significant license or contract revenue in 2014. Second, we have the commercial infrastructure that we need. So you should expect that our SG&A cost would remain relatively stable. However, we do expect our clinical development activity to increase as we pursue label expansions and aggressively advance the products in our portfolio. And thus, we would anticipate that our R&D costs would go up in 2014. I would also note that we expect to record the milestones paid to TopoTarget for the Beleodaq filing, both the $10 million in cash as well as the 1 million shares as R&D expense in the first quarter this year. So you'll see a onetime increase in R&D expenses for that.

Now let me hand the call over to Ken, and he will provide an operational update.

Joseph Kenneth Keller

Thank you, Kurt. Today, I'll begin my comments with an update on our pipeline. As Dr. Raj mentioned, we filed Beleodaq's NDA in December, and the FDA granted it a priority review with a decision date of August 9. We are seeking FDA approval of Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. PTCL is a difficult disease to treat. The most effective drugs in the setting provide a 25% to 30% overall response rate, and those patients who initially respond usually progress within a year. Therefore, patients routinely cycle through several lines of therapy. The need for a new drug in this setting is high, and that is reflected in the FDA granting Beleodaq a priority review. Based on feedback from key opinion leaders, we believe Beleodaq will be a welcome new treatment option for these patients.

Physicians feedback highlights the safety and the tolerability profile that Beleodaq offers, which we believe differentiates it from existing treatment options. Beleodaq also fits perfectly into our existing commercial organization. Our team currently works with a majority of key opinion leaders who treat PTCL with FOLOTYN, which is the market leader in this category. Therefore, we expect to successfully launch Beleodaq within our existing team.

The second pipeline priority in 2013 was to reach full enrollment of the Captisol-enabled melphalan trial. In October, we successfully fully enrolled this study where the drug is being tested as a conditioning agent for stem cell transplant of patients with multiple myeloma. Captisol-enabled melphalan is designed to overcome the limitations of the existing melphalan formulations. Current formulations contain propylene glycol, which has been associated with renal and cardiac side effects, as well as poor solubility and a short stability profile of only 60 minutes. The Captisol technology eliminates propylene glycol from the formulation and provides for a significantly longer stability profile. This may allow physicians to administer Captisol-enabled melphalan for longer durations and at slower infusion rates, enabling higher dose intensity for pretransplant chemotherapy. We expect the final data Captisol-enabled melphalan trial in the second quarter of this year and to file the NDA shortly thereafter. Captisol-enabled melphalan is being studied as a conditioning agent for stem cell transplant in multiple myeloma and has been granted Orphan Drug designation by the FDA for this indication. The target audience for this indication will be transplant physicians and institutions. There are less than 200 centers where the majority of transplants in the U.S. are performed. Many of these physicians are currently called on by our existing sales team as these physicians routinely transplant both multiple myeloma patients and lymphoma patients. We estimate the market size to be approximately $130 million.

I'll now provide an update on our progress with SPI-2012, our long-acting granulocyte colony-stimulating factor. We are conducting a Phase II dose finding study in the setting of chemotherapy-induced neutropenia. This study is enrolling well, and our goal is to complete this trial and start the Phase III program by the end of 2014. Our Phase III program will consist of 2 pivotal studies running parallel. The trial designs will be finalized based on Phase II results. Chemotherapy-induced neutropenia is a large well-established market. Total sales of neutrophil-stimulating proteins exceed $5 billion worldwide. Today, the long-acting version in this market consists of one drug, pegfilgrastim. Based on discussions with key physicians and physician groups here in the United States, we are confident the oncology community would welcome additional options. Regarding our other advance-stage drug apaziquone, we plan to start another Phase III study and file a New Drug Application in 2014.

I'll now provide an update on our progress with Marqibo. We launched Marqibo on September 3, using our existing sales force. We were happy with the progress and continue to see Marqibo being well received by providers. There is a high interest in academic centers, supported by both orders and continued request for visits from a medical science liaison team. The target population is approximately 1,600 patients a year in the U.S. Long-term growth will be driven by the 2 ongoing Phase III studies that, if positive, can lead to expansion of Marqibo's labeled indications. As a reminder, we have the HALLMARQ study, which is a global clinical program studying Marqibo as treatment for patients 60 years or older with newly diagnosed ALL. The second Phase III trial is the OPTIMAL study, which is being conducted by the German High-grade Lymphoma Group in untreated adults with aggressive non-Hodgkin's lymphoma. The size of these populations is significantly larger than the current indication.

Before handing the call back to Dr. Raj, I'm going to share with you the goals we have set for our organization. We expect 2014 to be an active and productive year, marked by a number of key value-creating milestones. Number one, final pivotal data for Captisol-enabled melphalan will be available in quarter 2 with a filing thereafter. Number two, we will fully enroll the Phase II study of SPI-2012, our novel long-acting granulocyte colony-stimulating factor, and make a go-no-go decision for Phase III. Number three, we await the FDA's decision on approval of Beleodaq on August 9. Number four, we plan -- our plan is to file the New Drug Application for apaziquone and start another Phase III based on the learnings from previous studies. And number five, we will continue to enroll patients in 3 Phase III programs: the optimal trial of Marqibo into diffuse large B-cell lymphoma; the HALLMARQ trial of Marqibo in frontline acute lymphoblastic leukemia; and the Phase III ZEST study evaluating ZEVALIN into diffuse large B-cell lymphoma consolidation. All 3 of the studies focus on areas of great unmet need and they target large patient populations.

I'll now turn the call back to Dr. Raj.

Rajesh C. Shrotriya

Thank you, Ken. Let me conclude by acknowledging that 2013 presented challenges for Spectrum. Because of market dynamics, our revenues in the year came down by nearly $100 million to about $155 million. I'm really proud of the fact that, in the face of these challenges, we continued to invest in our business. For instance, we bought in 2 key drugs through in-licensing and acquisitions. We continue to advance our drugs in pipeline and file New Drug Application. We further strengthened our management this year. At the same time, we continued to be physically disciplined and were profitable in the second half of the year on a non-GAAP basis. This year's challenges have made a stronger company. So in a nutshell today, we have an exciting pipeline, robust cash position and a strong management team, and we are very well-positioned to grow meaningfully going forward.

At this time, I would like to open the call for questions.

Question-and-Answer Session

Operator

[Operator Instructions] And our first question comes from Adnan Butt with Capital Market.

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

It's Adnan from RBC. First question, higher-level question. What are the company's thoughts in terms of giving guidance for 2014, either high-level or product-specific guidance?

Rajesh C. Shrotriya

So Adnan, the reported revenue gives you a good indication of the health of our base business. We are confident that we can grow our base business from here with the help of additional drugs from our pipeline in the next 2 to 3 years.

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

Okay. I won't push the point, but maybe, you can discuss Marqibo a bit more since it's the newest launch. As you have seen the trends for a full quarter, what's demand like or the push for the drug-like in the first quarter this year?

Rajesh C. Shrotriya

So I would like Ken and Joe, maybe, to give some more color on Marqibo.

Joseph Kenneth Keller

It's Ken. When we look at Marqibo, we're really happy with what we're seeing so far. And we based that on a couple of things. Number one, we look at the number of new accounts that are purchasing this product for the first time. Very happy with that. We see that growing week after week. So I really like where that is. Second thing we look at is the initial feedback. Long-term aspects of the drug have a lot to do with what the doctors and patients experience in the first few uses. Right now, we're hearing doctors being very happy with the responses they're seeing. So that's a great, great sign. And the other one is, we continue to get requests, more and more all the time, for our medical science liaisons to visit accounts. So those are all 3. They're early markers, mind you, but all 3 very, very positive markers. When you look at the sales in Q4, it really is just the start. There is no inventory load with this product at all. There is no inventory build. People buy it as they use it. So based upon where we are, so far, no surprises, just right what we thought would happen. So we're pleased.

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

Ken, from a reimbursement standpoint, is that something one should expect to improve over the course of the year? Or you're satisfied from what you're seeing?

Joseph Kenneth Keller

Well, right now, all the reimbursement is positive. We haven't heard of a single example where it hasn't been. Mind you, I mean, these are acute lymphoblastic leukemia patients, only 1,600 patients. These are patients that have failed multiple lines of therapy. So I really would expect this not to be a reimbursement challenge, and so far, it hasn't.

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

Okay. Maybe I can -- I may ask a pipeline question as well. On SPI-2012, what is the company looking for in terms of deciding what it takes to move it to Phase III or not? And then what's the opportunity or the value proposition against what I expect to be a pretty entrenched competitor?

Joseph Kenneth Keller

Sure. So the Phase II study is a dose-finding study where you actually have 3 arms, 3 different doses of lapsed [ph] GCSF. Compare it to the other arm, which is pegfilgrastim, the monopoly market today, and what we'll be looking at is simply neutrophil recovery and the development of febrile neutropenia. We're going to pick a dose that is effective and safe. As Dr. Raj mentioned, this is nothing like progression-free survival or anything like that. So when that study is fully enrolled, we'll actually have the data when that last patient receives their second cycle of chemotherapy. So it's very quick. We would -- we expect to get that in the middle of the year. So that's what we'll be looking at. Based on that, what we'll do is we've got a very good model. We'll take a look at pegfilgrastim label and what their registration studies look like, and we'll have a study that will mirror that. The study will have 2 studies. We will select 2 different regiments of chemotherapy, and we will be looking at the duration of neutropenia and febrile neutropenia. In terms of the market, it's a $5 billion a year market worldwide right now. For the long-acting version of GCSF, that it's larger than that when you look at short-acting, I think -- note that it is important to not get lost here as there will be many drugs that are short-acting GCSFs, right? There's a few of them already available. But there is only a limited number of drugs that are in development right now that are long-acting versions of GCSF. So this will not be a crowded market, and our customers, based on what we're hearing, really look forward to having options.

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

Okay. And then in terms of the -- so has the company thought about how to make the announcement, which you announced that the data has been positive? Or would you just announce that there's a decision made to going to Phase III or not?

Joseph Kenneth Keller

Yes.

Rajesh C. Shrotriya

So when we...

Joseph Kenneth Keller

Well, go ahead. Go ahead, Raj.

Rajesh C. Shrotriya

Yes. Adnan, yes. We -- once we have analyzed the data and once we have -- we will definitely share the data with public at that time.

Operator

[Operator Instructions] Our next question is from Reni Benjamin with H.C. Wainwright.

Reni J. Benjamin - H.C. Wainwright & Co, LLC, Research Division

Just very quickly, I guess, just some added color on FUSILEV numbers. And I believe Kurt mentioned that we should be expecting the range to be $20 million and $25 million. Clearly, there is some lumpiness compared to the third quarter as the numbers come in, in the fourth quarter. Can you provide any sort of color to us regarding what's the breakdown right now between institutions and hospitals? Any sort of metrics regarding accounts -- account growth and potentially any sort of color regarding wholesalers and sort of the tight hold you may have on their inventory?

Rajesh C. Shrotriya

Ken?

Joseph Kenneth Keller

Sure. So today, underlying demand has been very, very consistent for long period of time now between $20 million and $25 million. Now reported sales, as you cited correctly, they can and they will fluctuate based on the wholesale inventory levels at the end of the quarter. But what you see in this quarter, is really consistent with underlying demand. So we feel really good about that. In terms of where the business is, the majority of our business, the overwhelming majority of our business today, is in the clinics. And so the business that was at risk, the price-sensitive kind of place where the generics really focused on the hospitals, that business, for the most part, has gone away. That was last year. Today, the bulk of our business rests in the clinics. Joe is with me, and so Joe maybe want to add a few things.

Joseph Turgeon

Well, I think you're spot on. Reni, it's 80% of our business is in clinics, to answer your question, so the vast majority, and that's where we focus.

Reni J. Benjamin - H.C. Wainwright & Co, LLC, Research Division

Okay. And I guess, just going along those -- the same sort of questions. But for your new product line, Marqibo, it beat out our expectations for the fourth quarter. How much of that might be wholesaler stocking? Or is this the base run rate that we should be thinking about going forward? And I know, I think it was you Ken who mentioned that you're pretty happy with the number of accounts that are coming on. Can you give us a little bit more color as to maybe how many accounts came on? Or what are your -- what's the target number of accounts that you're going for?

Joseph Kenneth Keller

Sure. So let me answer the first one. In terms of Q4 sales, absolutely 0 of that is wholesaler inventory. We ship this directly to the accounts, and the accounts only ordered this on a patient-by-patient basis. It's one of those drugs. So you can be assured that the $1.3 million is all end-user demand that we saw in the fourth quarter, which makes us feel good about where we are. In terms of the number of accounts, we -- I'm not trying to give you the numbers that are coming aboard every single week. I can tell you, though, this week we got new accounts. Last week, we got new accounts, and we expected more new accounts next week. The other thing we look at, too, which is those accounts that come aboard, how much do they order and do they continue to order. And a really good sign is, we've gotten many, many second and even third orders from accounts. Those are all positive signs.

Rajesh C. Shrotriya

Then I would just further on Marqibo that it is our foot in the door with Marqibo. Keep in mind that we are looking for additional indications. We have 2 large studies underway. One in adult ALL and the other in aggressive non-Hodgkin's lymphoma, untreated. Both of these studies are running well, and we are very excited about the possibility to what Marqibo could be. We believe the sales of Marqibo could be in hundreds of millions of dollars each year, if approved for those indications.

Reni J. Benjamin - H.C. Wainwright & Co, LLC, Research Division

So that comment helps me transition to one of my questions. So thank you for that Raj. You mentioned that the trial is enrolling well. Can you just help us understand when you believe enrollment would be complete? And can you remind us what the target enrollment is for all 3 Phase III trials?

Rajesh C. Shrotriya

So I think these studies -- I would give you broader picture that these studies are being run in by an aggressive lymphoma group in Germany consortium of test for NHL and that enrollment is going well. And we expect this could take at least 2 to 3 years. It is not something that will happen tomorrow.

Reni J. Benjamin - H.C. Wainwright & Co, LLC, Research Division

Got it. Got it. And just 2 more questions, pipeline-based. Can you just remind us the melphalan -- if you could discuss the melphalan study details and what the primary endpoint is there. And what's the delta we're looking for?

Rajesh C. Shrotriya

Okay. So it's Ken.

Joseph Kenneth Keller

Okay. So the melphalan study, it's a multicenter open-label study, right? So it's an open-label study, so there won't be a competitor here. Patients out in this study actually receive Captisol-enabled melphalan at 100 milligrams per meter squared, and they receive it day minus 3 and day minus 2 to them at transplant. So transplant is day 0. And the end points that we're looking at -- and these are more transplant end points. So you look at safety and efficacy. We're looking at day 100 mortality. We're looking at day 100 engraftment, and that's really the key, day 100 engraftment and looking at the time that it takes for patients to actually get back to the target number of neutrophils and platelets. And the other important thing to look at is overall response rate. So that's the end points of the study, and that's why even though the study was fully enrolled a while ago, that day 100 is coming up in Q2, right? So that's when we'll have the data.

Reni J. Benjamin - H.C. Wainwright & Co, LLC, Research Division

And are we supposed to compare it to the standard melphalan that's out there with? Was it all based off of historical results? Or how do we gauge these results?

Joseph Kenneth Keller

So for us and for the customers, we're talking about the customers, they'll look at it compared to historical controls with melphalan. And in bone marrow transplant, there are very well-done, very descriptive databases and actually registries. And so they'll be looking at that. And so you're looking for at least as good as, if not better, engraftment, mortality, those kind of things. But the idea is that at least as good as -- and then you've got all the advantages of increased stability, those kind of things. The safety aspects of not having propylene glycol that may show up in the study, and we'll be looking at those kind of things as well.

Rajesh C. Shrotriya

And Reni, remember that these studies were -- this study was designed with input from the FDA.

Operator

[Operator Instructions] Our next question is from Jason Kantor with Crédit Suisse.

Jason Kantor - Crédit Suisse AG, Research Division

I joined late so if any of my questions were asked and answered, I apologize. So in terms of FUSILEV, you speak about $20 million to $25 million in demand, and you came in at the low end of that. I guess, I'm just wondering, is demand decreasing over time or increasing over time? And where are you in terms of your inventory levels? In the past, you gave -- you specifically quantified inventory in terms of vials. I'm wondering if you can provide that level of detail or if you could speak to where you are within your new contractual ranges?

Joseph Kenneth Keller

Yes. So this is Ken. So Jason, the underlying demand is right between $20 million to $25 million, and that's been very, very consistent. So we look at IMS on a regular basis, and we see it now consistent for many, many months. So, that's number one. Can't say it's grown a lot, but it's absolutely consistent. It has not gone down for the last few months. So really consistent, we like that. Joe's team is out there working with a number of accounts, and we're getting lots of positive signs, but consistency is what we're looking for. And when you look at the quarter, since the demand was between $20 million and $25 million, and that's what we reported, that gives a good idea that inventory didn't move much in this quarter.

Jason Kantor - Crédit Suisse AG, Research Division

If you want to kind of deconstruct a little bit, sort of let's say what happened in 2013, it'd be pretty helpful. I mean, in March, you gave the guidance and maybe it was a little premature of $80 million to $90 million, and you came in, I think, closer to $70 million. So I'm just wondering, looking back at that, did inventory come down more? Did the net realized price come in lower throughout the year? Or was end-user demand lower than where you thought? Which piece of the puzzle fell short overall from where you guys thought it might for the year?

Joseph Kenneth Keller

So I think the -- there a bunch of factors played in, but the key one is the net realized price, when we gave the $80 million to $90 million, it ended up a little bit lower than we thought it would be, and that was the primary driver. The inventory came down a little bit more than we thought, but really, the primary driver was net realized price. And when you look at price now, our net realized price, as you'll notice, has come up quite a bit from the first part of the year, right? It was really low when you look at Q2. A little bit lower than we thought it would be, but it's come up, and now we're at where we should -- it should be consistent as we look forward. So that was the kind of thing that took us a little bit less than we thought it would be.

Operator

All right. I'm not showing any further questions at this time. Dr. Rajesh, you may proceed with any further comments.

Rajesh C. Shrotriya

In closing, we would like to thank you, again, for joining us on the call today and your interest in Spectrum. With our 4 marketed products, 1 product under FDA review, 2 near-term NDAs pending additional latest-stage clinical data, a robust R&D pipeline and a leading team of managers, we're excited about the positive direction of Spectrum and our potential for further growth. Please keep tuned. We believe the best is yet to come. Thank you.

Operator

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

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