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Edited Transcript of SPPI earnings conference call or presentation 8-Nov-18 9:30pm GMT

Q3 2018 Spectrum Pharmaceuticals Inc Earnings Call

IRVINE Dec 6, 2018 (Thomson StreetEvents) -- Edited Transcript of Spectrum Pharmaceuticals Inc earnings conference call or presentation Thursday, November 8, 2018 at 9:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Francois Lebel

Spectrum Pharmaceuticals, Inc. - Chief Medical Officer

* Joseph W. Turgeon

Spectrum Pharmaceuticals, Inc. - President, CEO & Director

* Kurt A. Gustafson

Spectrum Pharmaceuticals, Inc. - Executive VP & CFO

* Shivpreet Kapoor

Spectrum Pharmaceuticals, Inc. - VP of Strategic Planning & IR

* Thomas J. Riga

Spectrum Pharmaceuticals, Inc. - Executive VP, COO & Chief Commercial Officer

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Conference Call Participants

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* Adnan Shaukat Butt

Guggenheim Securities, LLC, Research Division - Senior Analyst

* David George Buck

B. Riley FBR, Inc., Research Division - Analyst

* Edward Patrick White

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

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Presentation

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Operator [1]

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Good day, ladies and gentlemen, and welcome to the Spectrum Pharmaceuticals Third Quarter 2018 Earnings 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.

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Shivpreet Kapoor, Spectrum Pharmaceuticals, Inc. - VP of Strategic Planning & IR [2]

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Thanks. Good afternoon to everyone on the call today. Thank you for joining us today for Spectrum's Third Quarter 2018 Financial Results Conference Call. Our press release is available on our website at www.sppirx.com.

Joe Turgeon, our CEO and President, will start the call today and provide an overview; followed by Dr. Francois Lebel, our new CMO; a financial update from our CFO, Kurt Gustafson; and a discussion of our operations by our COO, Tom Riga.

These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.

With that, let me hand the call over to Joe.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [3]

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Thank you, Shiv. Hello, everyone, and thank you for joining us today. I appreciate you being on the call, and I appreciate your interest in Spectrum. This certainly was a data-rich quarter for our lead pipeline candidate, poziotinib. At the World Lung Conference in September, Dr. John Heymach of MD Anderson led an oral presentation that highlighted poziotinib interim data, which demonstrated impressive anti-tumor activity in a hard-to-treat mutation. As I talked to investigators who are treating the patients in the MD Anderson trial, I'm proud to see the impact that poziotinib is already having on the lives of these patients. Non-small-cell lung cancer is devastating alone, and these patients are at an even more complex situation. They have a rare and insidious mutation, for which current therapies have demonstrated limited effectiveness. For many of them, poziotinib has given them more time to live their lives.

We are very encouraged by these data, and in fact, we've submitted an application for breakthrough therapy designation status with the FDA. With their 60-day response window, we expect to hear back from the agency by the end of the year. We've expanded the clinical program to explore the full potential of poziotinib in broader patient populations. Tom Riga will provide you an update on the expansion later on this call. In short, our confidence in poziotinib is high, and we're accelerating its development on multiple fronts.

Now let me shift to ROLONTIS. We have an important limestones for ROLONTIS taking place at the end of this year. These include data being presented in a poster session at the San Antonio Breast Cancer Symposium in December and the filing of the ROLONTIS BLA. As we close out the year, the end of 2018 looks very promising with 2 big milestones: The FDA's response on breakthrough therapy designation for poziotinib and our ROLONTIS BLA submission.

Before we move on to financials, I wanted to introduce you all to our new CMO, Dr. Francois Lebel. We're pleased to have him on board. He is a veteran in drug development and in deepening Spectrum's leadership team. He has phenomenal experience in both the U.S. and in global markets. Before joining Spectrum, he was the CMO and Head of R&D at ZIOPHARM Oncology. And he has held clinical leadership roles at Baxter International and at MedImmune. He has led NDAs and BLA processes for multiple products, and his broad experience is exactly what we need.

I'm going to turn over now the call to Dr. Lebel to say a few words.

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Francois Lebel, Spectrum Pharmaceuticals, Inc. - Chief Medical Officer [4]

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Thank you, Joe. I'm just honored to join Spectrum. As I was getting to know the company, it became very apparent that Spectrum was the right place for me. I have watched the evolution of the company under its new leadership and have been impressed with the focus and rigor to aggressively develop targeted and novel products in oncology, including poziotinib, an intriguing therapy in development for lung cancer. Exon 20 mutation in non-small cell lung cancer are notoriously aggressive and hard to treat, unlike the more well-known mutations that have -- that we have all become accustomed to in lung cancer like ROS1, ALK and acquired mutation like the T790M. Treatment of exon 20 mutation has been elusive, and frankly, inadequate. Case in point, at ESMO just a few weeks ago, data for osimertinib at the label 80-milligram dose in exon 20 insertion mutation showed response rate of only 5.6%. Let me remind you how effective osimertinib is for acquired mutation. These results really speak to the challenges that exon 20 mutations present for patients and investigators. The unique characteristic of the binding pocket and structural features of these mutations have proven to be very difficult to overcome.

This brings me to poziotinib. I was very impressed with the data coming out of the MD Anderson trial, and it was, in fact, a key driver in my final decision to join Spectrum. I was in Toronto at the World Lung Cancer meeting for Dr. Heymach's presentation on poziotinib trial and saw the data first hand. I found poziotinib to be a compelling asset with impressive interim data. The overall response rate is strong with significant duration of response. This product may provide a hope to patients with very limited options. I look forward to working with the team on an aggressive development program as we seek to address this high unmet medical need.

At Spectrum, we have a passionate and talented group of scientists, who are simultaneously preparing the ROLONTIS BLA filing for the fourth quarter, while making major progress on poziotinib. I am thrilled to be part of the team.

Now I'll turn it over to Kurt for a financial update.

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Kurt A. Gustafson, Spectrum Pharmaceuticals, Inc. - Executive VP & CFO [5]

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Thank you, Francois, and it's great to have you on the team. Starting with the top line, our total revenues for the third quarter were $25.3 million, of which $24.6 million were product sales.

With regards to cash, we ended the quarter with $167 million in cash and $54 million in marketable securities for a total of $221 million of available liquidity. Cash burned in the quarter was $8 million.

We are refining our total revenue guidance to be between $100 million to $110 million for the year versus our previous guidance of $95 million to a $115 million. Our cash guidance also remains unchanged as we expect our cash balance is sufficient to fund operations into 2020.

With that, let me now hand the call over to Tom to cover our operations.

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Thomas J. Riga, Spectrum Pharmaceuticals, Inc. - Executive VP, COO & Chief Commercial Officer [6]

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Thanks, Kurt. Last quarter, I provided you with an overview of the full poziotinib clinical program in our 4 key development areas. The first area of development is in the use of poziotinib in previously treated non-small cell lung cancer patients. We also laid out 3 additional areas of clinical development, including the use in treatment naïve non-small cell lung cancer patients, the treatment of other solid tumors and the use in combination regimens. I'll provide you an update on all 4 areas.

First, let me talk about the heavily pretreated patients. We have made significant progress on this front with the presentation of updated interim data from the MD Anderson Phase II trial. This data was in a heavily pretreated population with 68% of the patients having failed at least 2 prior therapies. The headline from the interim data is that poziotinib demonstrated high antitumor activity in both EGFR and HER2 exon 20 mutations.

Let me provide some highlights from the data that Dr. Heymach presented at the conference. In the EGFR cohort, there was a 43% confirmed objective response rate in the evaluable population. This compares favorably to an overall response rate of less than 10% with available TKIs and a rate of less than 20% with the current standard of care second-line agents. 19 EGFR or over 40% of the patients remained on treatment at the data cut-off, 6 of which have been on the drug longer than a year. The median PFS was 5.5 months.

In the HER2 cohort, MD Anderson reported a 42% confirmed response rate in the evaluable patients with a median PFS of 5.1 months. EGFR-related toxicities were manageable and consistent with the class. Discontinuation due to poor tolerance was rare and seen in 3% of patients. Overall, the time in Toronto at World Lung was extremely productive. We conducted steering committee and advisory board meetings, and I was energized by the investigators' early experience with poziotinib. There was clear alignment that there is significant unmet medical need and poziotinib has the potential to uniquely address it.

Regarding the approval pathway, we remain confident in our belief that poziotinib meets the criteria for a breakthrough therapy designation. We've submitted our application for BTD with the FDA and anticipate that we will receive a response by the end of the year. This breakthrough therapy request is specific for previously treated non-small cell lung cancer patients with EGFR exon 20 mutations, and the MD Anderson data is the backbone of this submission. There is a clear unmet medical need in this disease, and we believe that poziotinib demonstrates substantial improvement over existing therapies.

Let me shift to our ZENITH20 study. It is well underway. We currently have more than 40 sites and have initiated our first European sites with patient enrollment anticipated in Europe by the end of the year. Overall, we're pleased with the enrollment in our trial, and we expect that the EGFR cohort will be fully enrolled by the first quarter of 2019.

The second poziotinib development area is the use in treatment-naïve patients. In the third quarter, we initiated 2 first-line cohorts in our ZENITH20 trial. We now have first-line EGFR and HER2 cohorts that are enrolling in parallel at our sites along with the previously treated cohorts. Each of the 4 cohorts will be independently analyzed with prespecified statistical hypothesis and power. This expanded patient population could derive significant benefit from early intervention with a targeted therapy that is specific to their mutation.

The third area of poziotinib clinical development is in the treatment of other solid tumors with EGFR and HER2 mutations. This strategy is grounded in the prevalence data initially unveiled at AACR in the second quarter and further validated in Toronto at World Lung. The data presented included 390,000 patients from 15 different databases. Foundation Health, Guardant, MD Anderson and multiple others were combined to make the single largest database for these mutated cancers. These data demonstrated that HER2 and EGFR exon 20 mutations are prevalent across multiple solid tumors. Both Spectrum and MD Anderson will soon be initiating a pan-tumor basket study to explore poziotinib's use in this setting.

The fourth poziotinib clinical development area is in use with combinations with other treatments. We will study poziotinib in combination with other drugs to further improve outcomes. The focus is to identify synergistic mechanisms with nonoverlapping toxicities. We engaged KOLs at World Lung to further develop this strategy and are actively pursuing combination studies. We will provide updates along the way.

Our clinical development plan for poziotinib is in robust and in full swing. We have a responsibility to act with urgency and remain steadfast in our belief that poziotinib may significantly advance the treatment of cancer patients with exon 20 mutations.

I will talk about ROLONTIS. In the third quarter, we had a positive pre-BLA meeting with the FDA. Based on that meeting, our team has been diligently working on the BLA submission for ROLONTIS, and we expect to file by the end of the year. In December, data from the Phase III RECOVER study will be presented at the San Antonio Breast Cancer Symposium. We previously announced that the RECOVER study met its primary endpoint and we'll have more detailed data at the conference. RECOVER is the second Phase III ROLONTIS study to have met its primary endpoint. The data has demonstrated that ROLONTIS has strong efficacy and a comparable safety profile to pegfilgrastim. If approved, we have the experience to effectively compete in this multibillion dollar market. As we close the year, we are focused on advancing the poziotinib development program and filing ROLONTIS BLA. We look forward to keeping you updated on our progress. And I'll now turn the call back over to Joe.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [7]

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Thank you, Tom, and thank you, everyone, else. And with that, I would like now to open up the call to questions. Operator, could you please open up the call to the questions?

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from Ed White with H.C. Wainwright.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [2]

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So just a few on pozi, but I wanted to start with the levoleucovorin, the new formulation and name. Just wanted to discuss any sales expectations there or what your idea is there for launching that product, if you do intend to launch in 2019?

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [3]

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Yes, Tom, do you want to...

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Thomas J. Riga, Spectrum Pharmaceuticals, Inc. - Executive VP, COO & Chief Commercial Officer [4]

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It's Tom. KHAPZORY is the name of that product. We expect to launch that product in January of 2019. That was filed in October of last year, largely as a life cycle management strategy for FUSILEV. And we will be bringing that to market. It's a 505(b)(2) pathway. There's plenty of generic competition in that space. But right now, we're working with the group purchasing organizations and distribution to make sure that we're running that launch in January.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [5]

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Okay. Anyhow, this is something new for you guys to go for -- to take the 505(b)(2) pathway. But you do have a lot of experience, as you said, with FUSILEV. I'm just wondering is this still -- you still think, this is a niche product for you, just to fit in with the legal -- the current sales force and selling FUSILEV right now?

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Thomas J. Riga, Spectrum Pharmaceuticals, Inc. - Executive VP, COO & Chief Commercial Officer [6]

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Yes. We have a lot of experience with 505(b)(2)s as you know, and I think our expectations on this one will be, it will fit into the sales force that we currently have in the sales line. Our expectations are low being that it's a highly competitive space.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [7]

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Okay. And then just moving on to pozi and the ZENITH20. So the first-line cohorts were initiated in the third quarter and you said enrollment in the EGFR previously treated cohort is expected to be completed by the first quarter of '19. Can you give us any timing as to the first-line cohorts? When do you expect them to be fully enrolled and when we can see some data?

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Thomas J. Riga, Spectrum Pharmaceuticals, Inc. - Executive VP, COO & Chief Commercial Officer [8]

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Yes. We were thrilled that the enrollment trajectory in the previously treated population, to have that enrollment finished in the first quarter of '19. I think it's early at this point to be making projections on the front-line cohort, but we do have 40 sites up and running in the U.S. The initiation of the sites in Europe has happened, and we're going full steam ahead with our sites, and we'll provide updates when they progress.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [9]

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Okay. And then just the last question. With pozi and the rash, I think Dr. Heymach went into great detail at World Lung to explain the experience with rash. I just wanted to get your thoughts on the rash side effect. And are doctors -- in the training that you're going to go into with the docs to keep patients on drug, perhaps lowering dose, but keeping them on drug, so that they can maintain their responses?

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [10]

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Yes, Ed, I'll -- let me answer your question. And Tom, you could add in if you like. First of all, what was -- you're right, Dr. Heymach did go into great detail, I think, at World Lung. And what you saw was clearly that it was -- while the rash was, as I believe, that's 34%, it was manageable. It's what we heard from the site. It's not that different than other TKIs. You are correct. In our trial, we have a rash kit that we've added to ours. And we fully trained the sites, whether be the site nurses, the physicians, et cetera, on the rash. It's usually what we've seen, it happens early when it happens. It usually -- it could be a precursor to a response. And then, it seems to dissipate over cycles. But the bottom line is it's a fact with TKIs. I think most sites know how to deal with it. And I do want to point out to another great fact that we did see. Despite the rash and other AEs that you see, that only 3%, as Tom pointed out, of the patients actually discontinued due to AE. And that's extremely low, lower than other TKIs that you see in other trials. So Tom, I don't know if you want to add anything.

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Thomas J. Riga, Spectrum Pharmaceuticals, Inc. - Executive VP, COO & Chief Commercial Officer [11]

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No, the key here is, is the drug effective? And potency really matters with this elusive mutation. And I think the data from World Lung clearly answers that question as yes. And then the management of very TKI-like side effects is something that the sites are equipped to do.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [12]

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Okay. And just one last thing. I'm not sure if you saw the kind of paper, it's an in vitro study. It was positive for pozi versus the competitors. But it did mention e8058 was identified as a mechanism underlying acquired resistance to pozi. And I'm just wondering if you saw that and you think that maybe that's an opportunity there to identify patients who would respond better to pozi? That's all I have.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [13]

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Thanks, Ed. Regarding resistance mutations, we'll get back to you on that. I think MD Anderson is obviously looking at that closely as were we, and we'll get back to you.

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Operator [14]

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Our next question comes from Adnan Butt with Guggenheim Securities.

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Adnan Shaukat Butt, Guggenheim Securities, LLC, Research Division - Senior Analyst [15]

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First on the study that's almost enrolled. Could you tell us if you decided to enroll all 87 patients? Or how many patients have you enrolled?

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [16]

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Adnan, we haven't said how many patients exactly we've enrolled. You are correct. It is up to 87 patients, is what we agreed to with the agency. When we're talking about getting it fully enrolled, that would be up to the 87 patients by the first quarter. If there's anything less than that, then we would let you know that. The plan is 87 right now, up to 87, and we can get that done certainly by the first quarter.

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Adnan Shaukat Butt, Guggenheim Securities, LLC, Research Division - Senior Analyst [17]

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And Joe and team, based upon what you saw from the MD Anderson study and when this study will complete enrollment, are you prepared at this time to give some time lines as to when this one could read out?

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Thomas J. Riga, Spectrum Pharmaceuticals, Inc. - Executive VP, COO & Chief Commercial Officer [18]

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Adnan, it's Tom. Enrollment -- if enrollment finishes in the first quarter, there's 8-week confirmation. There's time for cleaning up the data. I would expect to see top line in the back half of '19, would be the way I'd be thinking about it.

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Adnan Shaukat Butt, Guggenheim Securities, LLC, Research Division - Senior Analyst [19]

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Great. And then on a related question. Maybe you can expand on this one a bit more. Do you expect responses in this particular arm to track those that we saw from the MD Anderson study? Or are there tweaks in the study that could lead to differences?

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [20]

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Well, I want to make sure you said track. I want to make sure I understand the question.

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Adnan Shaukat Butt, Guggenheim Securities, LLC, Research Division - Senior Analyst [21]

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Will that be similar to what we've seen already? Or can they be improved upon?

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Thomas J. Riga, Spectrum Pharmaceuticals, Inc. - Executive VP, COO & Chief Commercial Officer [22]

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Yes, so Adnan, I guess, we'll wait and see what the data reads out. But I think it's an -- it's important to just point out the differences in design of these studies. So if you remember, the MD Anderson study needed 16 weeks to confirm. So the first scan was at 8 weeks, second scan was 8 weeks later. Our confirmation will occur at 8 weeks. So there is a timing difference in confirmation. When you're dealing with a patient population with prior treatments that has -- PFS is 1.9 months, I think time is of the essence, and we think by having that interim scan at 4 weeks could prove to be beneficial, but we have to wait and see the data.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [23]

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And I'll add. Remember, Adnan, that there are dosing differences. Whereas in the MD Anderson study, it was 16 to 12 and down to 8, we're only going -- we've only 16, 14, 12 and only down to 10 with monitor approval. So that's a learning, and that's one of the changes we made in our trial. The appointed patients are not included in our trial whereas they were included in the MD Anderson trial.

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Adnan Shaukat Butt, Guggenheim Securities, LLC, Research Division - Senior Analyst [24]

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Just the last one from me. In terms of the breakthrough therapy designation, is that decision basically based upon the data that we've seen at World Lung? Or did you also submit any additional information, clinical data to the FDA?

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Francois Lebel, Spectrum Pharmaceuticals, Inc. - Chief Medical Officer [25]

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I'll take that, okay?

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [26]

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Yes.

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Francois Lebel, Spectrum Pharmaceuticals, Inc. - Chief Medical Officer [27]

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So Adnan, we've had several engagements with agency to understand what they were looking for. So what they were requesting was an identical scenario of the World Lung presentation, but it was a subset.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [28]

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We knew exactly, Adnan, what they wanted, and I think we gave them the data they asked for.

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Operator [29]

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Our next question comes from David Buck with B. Riley.

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David George Buck, B. Riley FBR, Inc., Research Division - Analyst [30]

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It's David Buck of B. Riley FBR. Just a follow-up on poziotinib. Can you talk about just breakthrough therapy, the expectation, if you do receive that, will that automatically include the priority review with that? And for Joe, can you talk a little bit about ROLONTIS with the BLA filing by year-end. What type of marketplace changes should we be looking for in terms of reimbursement and competitor activity? What are you anticipating? Or what are you sort of worried about, perhaps, if the marketplace changes before approval? And maybe another one for Joe. Anything in terms of activity on -- financial decision on Europe, whether to go alone or out-license poziotinib? And any update on QAPZOLA, where things stand with that program and keeping it in-house?

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [31]

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Tom, you want to do the BTD? I'll take the rest.

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Thomas J. Riga, Spectrum Pharmaceuticals, Inc. - Executive VP, COO & Chief Commercial Officer [32]

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Sure, sure. David, we're thrilled to have submitted the application for BTD, and we remain very steadfast in our belief that there is an unmet need, and poziotinib is showing indications of being substantially better than currently available treatments. That's ultimately the criteria. Now the FDA will decide ultimately and where that goes, but there are multiple regulatory pathways besides BTD, like you had mentioned in the fast track setting and others that exist, but we are thrilled to have applied for that application and believe that the drug qualifies.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [33]

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Yes, I agree 100%. David, thanks for the ROLONTIS question because we are excited about this. We're filing the BLA this quarter. That's been set. You and I've been talking about this a long time, so here it comes, right?

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David George Buck, B. Riley FBR, Inc., Research Division - Analyst [34]

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Yes.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [35]

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Rest about the marketplace changes. Listen, obviously, health care has changed a lot. We watch the landscape, and we will morph into whatever we have to do. But let me just say this, right now, reimbursement remains the same as it has been. And we're in a unique position because we are a novel. And no matter what happens, David, we're the only new novel product that will be available, and so we'll be in a position to compete no matter what happens. So I'm excited to go compete with this thing. And the next step is to get the drug approved and certainly do that by filing your BLA. So that's -- it's been a long time coming, I'm glad to do this. And you also asked about activity on the financial decisions around -- what was the -- on which one was it? I want to make sure I answer all your questions.

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David George Buck, B. Riley FBR, Inc., Research Division - Analyst [36]

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Yes, so it was whether or not to go it alone with poziotinib in Europe? And then also whether you keep QAPZOLA or look to out-license and what projections are there?

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [37]

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Yes, great question. I wouldn't say no to a partner in Europe for ROLONTIS. However, I'm looking across the room and some have a lot of international experience and Dr. Lebel. We have -- now we're opening sites there with pozi. So we'll go alone if we have to. I'd be open to discussing a partnership in Europe for ROLONTIS with a right partner and team, but we'll cross the bridge when we go through it. Right now, if we have to do it ourselves, we certainly are capable of doing that. But I do want to say that our plan would be some time in 2019 would be the time we start focusing on the EMA and filing an EMA for ROLONTIS. So we are excited about that. Remember, David, that's the reason, in our second trial, we got 20 sites in Europe because when you file an EMA, you like -- they like to have European patients in the trial, and that's exactly why we did that. And I will remind you again in not-too-distant future, just in a matter of weeks, you're going to see more data at San Antonio Breast beyond the top line data on our second trial, so we're excited about that also. You mentioned QAPZOLA. Now that's something that I even had a question for a long time. This file remains. There are patients still enrolling in that trial. However, I will tell you this, it's something I want to evaluate it. I'm looking strategically. I may look for a partner with that because there's other competition there now, there's other drugs that are being used. And secondly, that -- even though it's an oncolytic, I'll remind you, it's used in urology offices. So -- and I am sure in the long term, that fits us. So I'd be willing to look at and outsourcing that also. So nothing has changed with the trial at this point.

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Operator [38]

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I'm showing no further questions at this time. I would like to turn the call back to Mr. Joe Turgeon for any closing remarks.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. - President, CEO & Director [39]

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Thank you, Katherine, and thank you to everybody, again, on the call. I really appreciate your interest, and I look forward to speaking with you next quarter. And in between, have a great day for the rest of the day, and we appreciate your interest.

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Operator [40]

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