Edited Transcript of SPPI earnings conference call or presentation 7-May-20 8:30pm GMT

IRVINE May 9, 2020 (Thomson StreetEvents) — Edited Transcript of Spectrum Pharmaceuticals Inc earnings conference call or presentation Thursday, May 7, 2020 at 8:30:00pm GMT

Spectrum Pharmaceuticals, Inc. – EVP & Chief Medical Officer

* Joseph W. Turgeon

Spectrum Pharmaceuticals, Inc. – President, CEO & Director

* Kurt A. Gustafson

Spectrum Pharmaceuticals, Inc. – Executive VP & CFO

* Thomas J. Riga

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

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

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

* Robert H. Uhl

Good afternoon. My name is Rich, and I will be your conference operator today. At this time, I would like to welcome everyone to the Spectrum Pharmaceuticals First Quarter 2020 Earnings Call. (Operator Instructions)

Let me now hand the call over to Robert Uhl from Westwicke ICR. Robert, you may begin your conference.

Robert H. Uhl, Westwicke Partners, LLC – MD [2]

Thank you, Rich, and good afternoon, everyone. Thank you for joining us today for Spectrum Pharmaceuticals’ First Quarter 2020 Financial Results Conference Call. Our first quarter financial results press release was sent out earlier this afternoon and is available on our website at www.sppirx.com. Joining me on the call today from Spectrum Pharmaceuticals will be Joe Turgeon, President and CEO; Kurt Gustafson, Chief Financial Officer; and Dr. François Lebel, Chief Medical Officer.

Before we get started, I would like to reference the notice regarding forward-looking statements included in today’s press release. This notice emphasizes the major uncertainties and risks inherent in the forward-looking statements that we will make this afternoon. 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 Turgeon, CEO of Spectrum.

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

Thank you, Robert, and good afternoon, and thank you for joining the call today. Before I begin, I’d like to thank all of the health care workers across America for their hard work, their dedication and bravery in battling this pandemic head-on. They’re truly acting like heroes and these are really unprecedented times. The COVID-19 pandemic has put the entire biotech industry into unknown and unpredictable territory. Spectrum is no different. But having said that, we’ve made changes to our business processes to adapt to this new situation and have made significant progress thus far in 2020. The progress we’ll discuss today really speaks to the innovative and small company spirit that our employees embrace and take extreme pride in. It also speaks to the strong investigator interest in our pipeline as we aspire to bring new solutions to cancer patients.

Now we’ve partnered with our clinical trial sites as they navigate this pandemic and have advanced our pipeline. We continue to enroll patients in studies, as evidenced by the completion of the enrollment of cohort 3 in the ZENITH20 clinical trial. This cohort is studying the front line patients with exon 20 insertion mutations in lung cancer. Additionally, we’ve been able to dose the first patient in the same-day dosing study for ROLONTIS. If successful, this study may provide important insight regarding the timing of drug administration in a long-acting G-CSF therapeutic category. Bottom line, we’re not immune to the effects of the pandemic but we’re finding creative and innovative ways to continue to move our company and our programs forward.

So now let me turn to some brief updates on these programs. ROLONTIS is our late-stage drug product candidate that’s currently under active review at the FDA for the treatment of chemotherapy-induced neutropenia with a PDUFA date of October 24, 2020. If approved, ROLONTIS could be the first novel granulocyte colony-stimulating factor available to health care providers in over 15 years. Our launch preparations for ROLONTIS are actively underway. As the PDUFA date approaches, we have already put key leadership personnel in place and will accelerate our commercial build out as we approach the launch date. We’re planning to launch with a lean and effective commercial infrastructure to maximize the impact of ROLONTIS. We’re closely monitoring the evolving market dynamics and believe that launching this novel asset will benefit patients, our customers and our shareholders. We’re looking forward to its potential approval and to competing in this multibillion-dollar growth factor market.

Poziotinib, our second late-stage clinical asset, targets hard-to-treat genetic mutations in lung cancer. We’re conducting the ZENITH20 clinical trial in this patient population, which currently has no approved therapy. Following the presentation of our cohort 1 results at the virtual AACR meeting last week, we outlined our strategy for the program. This strategy is simple. We need to determine if optimization of dosing allows patients to stay on drug longer without interruption and increase responses. Our strategy incorporates an efficient study design that will enable us to quickly determine if the adjustment we are making will have a positive impact on patient outcomes. Dr. François will go into the — more details on this in just a few minutes.

We continue to drive the development of our 2 late-stage assets and the pursuit of new business development opportunities that will complement our pipeline and our capabilities. As I look ahead, I believe we are well positioned to execute on our goals. We’ve got a resilient team that continues to drive our business forward, a strong financial position and an exciting pipeline.

And with that, I’d like to turn the call over to Kurt to review the financials. Kurt?

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Kurt A. Gustafson, Spectrum Pharmaceuticals, Inc. – Executive VP & CFO [4]

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Thanks, Joe. Our SG&A expense for the first quarter of 2020 was $14.8 million versus $16 million in the previous year. R&D expense was $16 million versus $21.9 million. The decrease in R&D expense relates primarily to purchases of ROLONTIS drug substance in the prior year period, which did not repeat in this quarter. Other income expense was a loss of $9.8 million versus a loss of $10.2 million in the prior year quarter. The loss in both periods was primarily related to changes in the market value of our CASI securities. Our net loss for the quarter from continuing operations was $40.6 million versus $39.8 million in the comparable period in 2019. On a non-GAAP basis, which primarily backs out stock compensation costs, our loss for the quarter was $25 million versus $29.2 million in the prior year period.

We ended the quarter with $178 million in cash plus marketable securities. The overall change in cash was $46 million. However, $11 million of this change was a result of a decrease in the value of our CASI holdings, which declined to $20 million compared to $31 million at the beginning of the quarter due to the increased market volatility we’ve seen. Operating cash burn, which is a better measure of our actual cash outflow, was $33 million for the first quarter. This is consistent with where we have been the last few quarters.

Joe mentions our strategy for poziotinib. We have taken a hard look at our spend for this program and as we’ve said, the focus of this approach is to determine whether the new dosing for cohort 5 can increase tolerability and thus improve efficacy. We have rationalized spending on this program to make sure any expenditure serves the goal of achieving a timely decision on this program.

With that, let me now hand the call over to François to cover updates on our clinical programs.

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Francois Lebel, Spectrum Pharmaceuticals, Inc. – EVP & Chief Medical Officer [5]

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Thanks, Kurt. Hello, everyone. I’m going to start by providing a brief update regarding our late stage asset, ROLONTIS, which is under active review by the FDA. ROLONTIS is a novel, long-acting, granulocyte colony-stimulating factor and we are seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive cancer chemotherapy. We’re having a typical interaction with the FDA as they review our file, and our PDUFA date remains October 24 of this year.

The BLA is based on robust clinical data from 2 large pivotal randomized controlled trials. In both studies, ROLONTIS met the prespecified endpoint of noninferiority in duration of severe neutropenia and met all of the secondary endpoints. The safety profile was similar to pegfilgrastim. Our clinical investigation of ROLONTIS is continuing. Last week, we announced dosing of the first patient in a clinical trial to evaluate ROLONTIS when administered on the same day as chemotherapy. The trial looked at the duration of severe neutropenia when ROLONTIS is administered at 3 different time points following standard chemotherapy in patients with early-stage breast cancer. Approximately 45 patients will be enrolled in this Phase I open-label trial, with equal randomization to the 3 dosing time points.

The novel structure as well as positive preclinical data provide us an opportunity to further explore the pharmacodynamic properties of ROLONTIS administered the same day as chemotherapy in cancer patients. This study will allow us to scientifically reexamine the way neutropenia is managed in patients who receive myelosuppressive chemotherapy. Same-day dosing could enhance compliance and minimize a patient treatment burden by simplifying logistics. We will be presenting an abstract highlighting our preclinical data on same-day dosing in a [rodent] model at the AACR Virtual Annual Meeting next month. We will update you on the logistics of the presentation as we get closer to the date.

Now let me shift gear to poziotinib. We are conducting the ZENITH20 clinical trial to investigate poziotinib for the treatment of exon 20 insertion mutation in non-small cell lung cancer. Exon 20 mutations are among the most difficult to treat and the patients and their physician are in search of effective treatment options as there are no approved therapies for this indication. ZENITH20 is a multicenter, multi-cohort trial evaluating lung cancer patient with the specific mutation. Last week, we presented results from cohort 1 at the AACR Virtual Annual Meeting. Following that meeting, we announced some changes to our strategy on ZENITH20 study. These changes are the result of our further understanding of pozi’s data from cohort 1. As stated before, when you look at the waterfall plot showing responses, there is undeniable activity, even though we did not reach our primary endpoint.

We now believe that the 16-milligram once-daily dose might have been too wide to administer all at once and led to frequent dose interruptions and dose reductions. 88% of patients had some sort of dose interruption from therapy, which we believe prevented the drug from demonstrating its full potential. Half-life of — the half-life of poziotinib is approximately 8 hours as we described in our discussion last week. Typically, when you have a half-life of less than 12 hours, the drug is generally administered 2 to 3 times per day. As a result, we have amended the ZENITH20 protocol to include various new dosing schedule. This amendment will impact cohorts 4 through 7. As a reminder, cohorts 1 through 3 are fully enrolled. For cohorts 4, 6 and 7, new patients coming into the study will receive 8-milligram BID dosing. In cohort 5, new patients entering the trial will be randomized to 10-milligram once-a-day or to 6 or 8-milligram BID.

An additional learning from our analysis of cohort 1 was that some sites supported their patient more successfully with earlier use of steroids, and we have implemented this change into the amended protocol. One of the concerns about using a lower dose is loss of efficacy. Let me remind you that at 8-milligram BID, we’re actually using the same daily dose. However, our pharmacokinetic modeling suggests that [DISTO’s paradigm] will deliver a better PK profile. BID dosing should allow us to achieve both of our goals, reducing treatment-related adverse events that are frequently a function of Cmax while not losing anti-tumor pressure at trough level by staying above the critical IC50 value. We are planning to release the results for cohort 2 midyear, with results for cohort 3 during the second half of the year. Rapid enrollment in our BID cohorts is a key priority for the company. The challenges of the current pandemic make it difficult for me to give you an exact time line for cohort 5 data readout. However, our investigators are motivated and the team is focused to act with urgency despite the challenge of COVID-19 pandemic.

Finally, we have recently completed additional analysis of cohort 1 data. We will have an oral poster presentation at the upcoming Virtual ASCO Meeting in late May. The presentation will cover activity and durability of responses in various subgroups of cohort 1, in previously treated EGFR exon 20 non-small cell lung cancer patients.

Now I’ll turn it back to Joe.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. – President, CEO & Director [6]

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Thank you, Dr. Francois and thank you, Kurt. I think you can see from Dr. Francois’s remarks that spectrum continues to make progress on our pipeline. I’d like to thank our team for their hard work and dedication in these very difficult times.

With that, operator, let’s open the line for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Okay. So I’m seeing Maury Raycroft.

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Kevin Strang, [2]

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This is Kevin Strang for Maury. I just wanted to ask for the recently initiated trial looking at same-day administration with chemotherapy. Can you elaborate on what — on when you might get results? And what expectations you might have around the data? And then also, could you see that data getting added to the marketing label at the time of approval?

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

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Yes. First, let me describe what it is, just as the case, Kevin. And I’ll have Dr. François talk to the clinical aspects around it, what it means. But first of all, what this means on same-day dosing to make sure everyone understands is that currently, today, when you get your myelosuppressive chemotherapy, you get your chemo, you actually have to go home and come back the next day to get your GCSF to get your protection. Or you have to have a device put on you which some people like, a lot of people don’t like and for many, many reasons. So that’s the current situation. And in the past, the innovative product did try a trial that failed to try and do this, because doctors, nurses, who actually use the product with the patients and also the patients would really benefit if right after the chemo, within an hour or two, you could give that shot, it would be fantastic. It would really — will really, really change the way — what you could do with these patients.

So that’s what’s trying to be done and hasn’t worked in the past. We have a different novel molecule. So that’s what’s important — why this would be important. And Dr. François, why don’t you walk through the other parts of the question on the timing and the potential for label?

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Francois Lebel, Spectrum Pharmaceuticals, Inc. – EVP & Chief Medical Officer [4]

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Sure. So yes, I think the important aspect, Kevin, here is that this molecule, ROLONTIS is novel. So this is not a biosimilar. And when you actually look at the product characteristic with our — which are somewhat unique here, we have different potency. We have more bone marrow resident time. The half-life is different. So all of those characteristics and taken with some of the preclinical data that we’ve already generated and as I indicated in my remarks, we’re going to present some data in [rodent] at AACR, all of this makes us believe that the behavior of this molecule could be different and allow us this time to potentially provide the drug at the same time or just after the chemotherapy during the same medical visit.

As to your question as to the original label, the original label in the BLA currently will not have this particular characteristic included in the BLA, but we’re planning ahead, right? We are — we have restated that the PDUFA date does still stand and we’re preparing, if you want, for the next wave of things in development for ROLONTIS. I hope that answers your question.

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Kevin Strang, [5]

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Yes, that was great. And then for my last question, I was wondering for the ZENITH cohort 3, if you could provide any perspective into whether those naive healthier patients are staying on treatment longer and maybe getting fewer dose reductions at the standard 16-milligram dose than cohort 1?

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Francois Lebel, Spectrum Pharmaceuticals, Inc. – EVP & Chief Medical Officer [6]

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Yes. So it’s a good question. So I think you’re right on here, patients who are treatment naive, like we have in cohort 3 and 4, are — one would expect that they would be able to — they’re in much better condition. They have not — their bone marrow have not beaten up with rounds of chemotherapy or some other therapy like the checkpoint inhibitor, where they might have had pneumonitis or other complication. So one would expect that they would be more tolerant of adverse events, potentially. But we don’t know yet. And we are not guiding — we’re going to look at the data later and because we also want to have duration of response. And we have guided that for cohort 3, it will be in the second half of the year.

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Operator [7]

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And then we now have the second question. It’s from the line of Ed White.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division – MD of Equity Research & Senior Healthcare Analyst [8]

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So just a couple of questions. On cohort 5 with the new dosing strategy, has the first patient been enrolled yet?

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Francois Lebel, Spectrum Pharmaceuticals, Inc. – EVP & Chief Medical Officer [9]

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So we just opened, cohort 5 the amendment was accepted by the FDA and we’re deploying at various sites currently. So we have not made any announcement about the enrollment status at this point.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division – MD of Equity Research & Senior Healthcare Analyst [10]

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And then just on cohort 2, first of all, is there any reason to believe that cohort 2 would have a different outcome than what we saw on cohort 1? And then you’re talking about adding data in the middle of the year, I’m just wondering if that’s going to be just a press release or if you’re thinking of hosting a conference call for that data, if it is similar to cohort 1?

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Francois Lebel, Spectrum Pharmaceuticals, Inc. – EVP & Chief Medical Officer [11]

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So I’ll take that question, Joe?

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. – President, CEO & Director [12]

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Yes.

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Francois Lebel, Spectrum Pharmaceuticals, Inc. – EVP & Chief Medical Officer [13]

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So Ed, the — I don’t think we’ve finalized how we’re going to release the data. It will be high level data midyear. In terms of what to expect with the result, cohort 2 was also — patients were receiving a starting dose of 16-milligram in 1 sitting. So there could be issues of tolerance. But HER2 is a different patient population and it would not be totally surprising that we would see different response rate in that particular patient population. It’s hard to predict. They’re all powered independently. So we’re going to have to wait and wait for the result.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. – President, CEO & Director [14]

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Yes. Ed, the only thing I’ll add is we just don’t know like Dr. François says. It is a more homogeneous population in HER2. In other words, you don’t have the wide range of mutations like you do in EGFR but we don’t know if that will make a difference or not yet until we see the data.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division – MD of Equity Research & Senior Healthcare Analyst [15]

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Okay. And then just 2 questions on ROLONTIS. First, on the same-day trial, since it is open label, are we going to get an interim look at the data? Or will we be waiting for the trial to conclude before seeing something from that?

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Francois Lebel, Spectrum Pharmaceuticals, Inc. – EVP & Chief Medical Officer [16]

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So we have internally set — I mean, it’s an open trial. You’re absolutely correct. So we will have access to the data as we progress. And we have an internal target as to the minimal amount of patients that we will need to see data on before making any kind of announcement as to the proof of concept. So I don’t think I can specify any date at this point. And the other thing, we’ll have to see how it goes. A Phase I study, especially during the pandemic here, I’m sure you’re aware that other companies are having a lot of difficulty IQVIA, Icon have made some statement about their serious inability to reach sites, et cetera, to monitor a trial. We have been reasonably in good shape so far. But we’ll have to see how it goes. We have entered the first patient, we’re thrilled about that, and we’ll have to see how it progresses, and then we’ll update you in a timely fashion.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division – MD of Equity Research & Senior Healthcare Analyst [17]

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Okay. And then my last question is just my second ROLONTIS question, is just how should we be thinking about the launch? And more importantly, how are you thinking about the launch? With what we’re seeing now, salespeople can’t go into the hospitals. They can’t go into the doctor’s offices. Are you planning for a virtual launch? Or since it’s not going to — the PDUFA is not until October, do you think — are you planning on more of a traditional launch of the drug?

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

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Yes, it’s Tom Riga. Hope you’re well. We are actually doing contingency planning. Given the timing of our PDUFA date and the launch timing, we very well may find ourselves in the more traditional launch camp. But I think it’s prudent to contingency plan because today, we don’t know. But independent of the launch vehicle, whether it’s virtual or live, we’re thrilled to launch into this multibillion-dollar market.

And how we think about this launch, Ed, I think it comes down to 3 things: volume, price and share. Right now, the volume in this market over the last 5 years in the U.S. has been consistent at about 1 million units dispensed a year. And even recently, NCCN has come out with updated guidelines to encourage additional growth factor use to ultimately keep people out of the ERs, given the pandemic. So from a unit perspective, this market has been consistent at 1 million units.

I think in pricing, we have seen the really rational pricing by the biosimilars. And I think that ultimately speaks to this market staying as a robust market. Today, it’s about $3 billion. And what’s happening is the ASPs are actually compressing between biosimilars as well as the innovator. And that ultimately creates a really competitive space, which is our sweet spot.

And then I think the third one is share, on what do you believe you can achieve. And we are just thrilled to get into this market, whether it be virtual or live at the point of launch. But we will be ready, and we’re thrilled to have an opportunity to compete.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division – MD of Equity Research & Senior Healthcare Analyst [19]

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And just one last question on that. Are you all set as far as supply goes, has the pandemic affected your supply at all?

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Thomas J. Riga, Spectrum Pharmaceuticals, Inc. – Executive VP, COO & Chief Commercial Officer [20]

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Yes. So that’s a great question. We manufacture the drug substance in Korea. That — the manufacturing today is ongoing. Korea is actually ahead of the United States. But as you heard in Kurt’s prepared remarks, we had purchased inventory. I wish I could tell you we had some crystal ball, but we didn’t. But fortuitously, we do have launch supply stateside, and we believe we’ll be ready to go pending that approval.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division – MD of Equity Research & Senior Healthcare Analyst [21]

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Great. Good luck with the launch. I’ll talk to you soon.

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Operator [22]

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And one last question from the line of Michael Schmidt.

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Yue-Wen Zhu, Guggenheim Securities, LLC, Research Division – Associate [23]

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This is Charles Zhu on for Michael Schmidt. Congrats on the quarter. I do have a question on the ROLONTIS commercialization and pricing contracting dynamics. Given that, like contracts in this marketplace tend to, I guess, the most value-add potentially in the commercially insured segments of this population. How do you think about the potential impact of COVID shifting the payer mix of these patients, potentially from commercial to Medicaid and how that fits into your assumptions and how you may approach the commercialization and launch?

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Thomas J. Riga, Spectrum Pharmaceuticals, Inc. – Executive VP, COO & Chief Commercial Officer [24]

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Charles, thanks for the question. It’s Tom again. I think we’re going to keep a close eye on that. I think the segment of business and how it shifts is something that we will need to be prepared for. If I just give you a little bit of color on how the market is evolving today, there is a compression at the lens of ASP between the innovator and the biosimilars. And that ultimately is through CMS as the basis of the Medicare population. But I think what we are really enthusiastic about is having the ability to provide predictable contracting value to our customers, whether it be a third party payer, a community oncologist, the government or a hospital, as a novel entity, we will have that ability uniquely to do that. And if the dynamics of patients shift from one segment to the next, we will have a strategy to address each of those segments. And we will just keep a close eye on how that shifts and what ultimately we need to do as a go-forward plan when we launch.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. – President, CEO & Director [25]

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Charles, this is Joe. I’m going to add one thing and Tom’s spot on. When you think about COVID, first of all, many cancer centers are not in hospitals. Some are, but many are not, which is a good thing because they’re not treating COVID. But for those patients who watch and wait today, I think it will be even more important to doctors with COVID to say, listen, if I’m going to give you a myelosuppressive agent, the last place I want you is immunocompromised and going to a hospital with this going on. I think the white blood cell factors become even more important. So some of those patients who in the past maybe would watch and wait. So I thought I’d just throw that in there.

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Operator [26]

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All right. So we have now another question from [George Junis].

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Unidentified Shareholder, [27]

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I’ve invested in the company and as a businessman, I like to look at the competition. And we’re probably familiar with OncLive. Are you guys familiar with Dr. Ross Camidge? Hello?

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

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Yes. I don’t know Dr. Camidge. I don’t know if anybody else does.

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Unidentified Shareholder, [29]

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Okay. Well, the reason was on OncLive, he compared TAK-788, who just recently last week, received breakthrough designation, something unfortunately poziotinib didn’t receive. And he was comparing the 2. When he was — he was saying that poziotinib hits the wild-type of the exon 20 insertions as opposed to hitting the insertion itself. I’m probably not explaining that properly. I’m a layman. And he said that TAK-88 — sorry, TAC-788 does the reverse, therefore, will be more successful. And he said this about 6 months ago. Could you give us your point of view on that?

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. – President, CEO & Director [30]

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Dr. Francois, why don’t you give your opinion there?

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Francois Lebel, Spectrum Pharmaceuticals, Inc. – EVP & Chief Medical Officer [31]

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Sure. So you’re correct that TAK-788 is also a drug being developed for exon 20 mutations. So they both affect what’s called a wild-type EGFR. And there’s something we call selectivity, which is the ratio of how much of the inhibition that can — this drug can afford or do is wild-type versus the mutated EGFR.

So Takeda, as you have stated, has presented in the past in certain cell line, that they were showing that they might be a little more selective. However, when work done at MD Anderson and at Omni, our co-developer, we got different results. In other words, we don’t see as clearly that one drug is more selective than the other. So that’s in vitro with cell line.

What really matters, as I’m sure you can appreciate, is what are going to be the result in the clinic. And we have results for cohort 1, we demonstrated activity there, undeniable activity. However, it was not as high as we wanted. But we have other cohorts, as you well know. And the cohort 1 are not necessarily predictive of the outcome of cohorts 2, 3, 4 and for that matter, in 5, when we’re going to change the dosing and the — that 1 sitting versus BID. So there’s no question, Takeda looks like they have some interesting results. And we’ll have to see as the data comes in and we’ll see if it may end up that 2 drugs move forward here. It could happen.

And the other thing you got to remember is that poziotinib right now, we have dosed more than 1,000 patients, at different dose and schedule. Takeda is not as advanced that way. So over time here, we might uncover that there are different adverse events that are uncovered. And we’re pretty confident right now. We understand quite well the side effect profile of pozi. We understand and we believe on the basis of the data and modeling we’ve done that we could mitigate the amount of adverse events we see. And we’re anxious to see the result of cohort 5 when we give the drug BID. So I guess, the short answer is stay tuned. And we’ll see with more data, which drug is — will come to market first and which one is more promising.

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Unidentified Shareholder, [32]

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Great. I have one more quick question, if possible.

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

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Sure.

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Unidentified Shareholder, [34]

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Hello? Yes. Great. So regarding ROLONTIS. Again, as a layman, I don’t know much about Phase III trials. But it seems to me that all the research they’ve done that they’re pretty — they’re pretty good size, both of them. To give you the short question, what do you think the chances are of these 2 Phase III clinical trials being accepted by the FDA?

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

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Yes. First of all, for a layman, let me tell you, [George], I think it was, that you’re asking good questions. What I can tell you about…

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Unidentified Shareholder, [36]

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Well there’s a lot of money involved. Yes, I worked hard for it. I’m sure you appreciate that.

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

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Yes, I do. And I appreciate that, too. And that’s why a good question. Listen, the 2 trials we have, number one, there were over 600 patients, 643 patients, as I recall, 2 Phase IIIs. This is under an SPA, which is a special protocol assessment. And what that means, [George], is that we worked with the agency, the FDA, to develop the actual protocol, which they agreed, we were in tandem with them, and they agreed with the protocol. If you have seen the data on both separate Phase IIIs or in a presentation of combining the 2 trials together, the results were outstanding. We hit all our primary and secondary end points. You actually — it’s what’s called a noninferiority trial. In other words, all we had to demonstrate is we were non-inferior to the standard of care, which is the drug that’s on the market today. And we certainly did that. You can argue in the first cycle, we actually showed some superiority, although it’s a noninferiority trial.

So we feel really good about the data that we’ve submitted. All I can tell you, it’s under active review as we speak. The PDUFA date, which means the date of approval, is October 24. And that still stands despite the pandemic. The — we’re on active review and active work with the agency. So we’re hoping that we can get an approval this year.

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Unidentified Shareholder, [38]

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Great. I hope that’s the case for everybody involved. Just the — I know cancer, nothing simple, even the way it’s administered. Do you see any like difficulties, how it could be administered? Or hospitals not adopting it for any reason?

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

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Now, Tom, why don’t you take that? That’s right up your alley.

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Thomas J. Riga, Spectrum Pharmaceuticals, Inc. – Executive VP, COO & Chief Commercial Officer [40]

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[George], from administration, it’s actually — it’s a subcu injection. So all of the products in the space are administered the same way. I think nurses as Nurses Day was yesterday and Nursing Month, they are an invaluable part of the HCP team. And they largely do the administration. So I see no barrier with administration of ROLONTIS or any of the products in this category for that matter.

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Unidentified Shareholder, [41]

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Fantastic. I hope that’s the case. Yes.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. – President, CEO & Director [42]

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[George], I’ll add one other thing. I just want you to know the same gauge needle, which means the size of the needle is exactly the same as the existing product. The size of the vial or the amount of solution you’re actually injecting is the exact same. So there’s no differences there. Sometimes if you have a larger gauge needle or if you have more solution being pushed in, you can have more injection site reactions, patients and nurses and health care providers wouldn’t like it. But we have the same gauge needle and the same amount of solution going in, although it’s about only half the dose of the current product because it is a novel and different product.

So we’re excited to go compete there and get a crack at it.

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Unidentified Shareholder, [43]

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Listen, good luck. I know with pozi, things didn’t work out initially. But what I understand is this is your specialty. You launched Neulasta, so I think things are looking good.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. – President, CEO & Director [44]

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Well, yes. I had a lot of help, there are several of us here. And I know Tom Riga, there’s no one better than him to lead this parade and I’ll be involved myself. So we’re looking forward to it.

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Operator [45]

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(Operator Instructions) We now have a question from Mayank Mamtani.

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Sahil Kazmi, B. Riley FBR, Inc., Research Division – Analyst [46]

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This is Sahil Kazmi on for Mayank. Just a couple of questions from us. A quick follow-up on ROLONTIS. Maybe relative to the kind of Onpro at home administration, how do you think about the same-day dosing in the context of the post-COVID world? And then maybe a quick follow-up on pozi afterwards.

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Thomas J. Riga, Spectrum Pharmaceuticals, Inc. – Executive VP, COO & Chief Commercial Officer [47]

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Yes, I’ll take that one. I think first of all, for the PDUFA date in October, that label will be a non-inferiority label and we are thrilled to be able to compete in that space. Same-day, next day, that will be next day at launch, and we are bullish on our ability to take meaningful share of that market and be very competitive. So that, I think, first and foremost.

I think the fact that this is an innovative novel asset really enables us to explore the full development. And if same-day dosing pans out to be successful, I think it will be very relevant commercially. I think the benefits of Onpro, you see it in the share. It still maintains a relatively high share in that space. But I think there’s also complexities that go with that to get to the true stickiness of the concept of a device. I think if you could eliminate that with a real development program that uniquely allows you to differentiate it would be valuable, but that’s down the road. Our focus today for October 24 will be to be competitive in a noninferiority, next day, traditional, long-acting GCSF market.

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Sahil Kazmi, B. Riley FBR, Inc., Research Division – Analyst [48]

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Great. Yes, that’s helpful. And maybe a brief follow-up for Dr. François. Could you clarify what the development path is there beyond the Phase I trial that’s ongoing right now?

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Francois Lebel, Spectrum Pharmaceuticals, Inc. – EVP & Chief Medical Officer [49]

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On ROLONTIS or pozi you’re talking?

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Sahil Kazmi, B. Riley FBR, Inc., Research Division – Analyst [50]

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On ROLONTIS relative to the same-day dosing.

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Francois Lebel, Spectrum Pharmaceuticals, Inc. – EVP & Chief Medical Officer [51]

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I see. So well, as you know, the — look, the most important thing right now in late-stage is the active review of the BLA with the FDA. The Phase I, it’s obviously early, and we — there’s a concept here that if we could successfully give it because of the unique characteristic of the product, on the first — on the same-day as the chemotherapy that potentially could be a game changer. So we’re very interested in that. We’ll have to see whether or not what the data we’ve seen on the basis of modeling, pharmacokinetic, pharmacodynamic as well as the [rodent] model and then you’ll — so it’s hard for us to predict until we see the data what the path would be after in terms of how do we go forward. So we’re focused on the BLA approval at this point.

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Sahil Kazmi, B. Riley FBR, Inc., Research Division – Analyst [52]

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Great. No, that makes sense. And then just a brief one on pozi. Could you discuss maybe how you plan to monitor the hypothesis of whether BID dosing is having the effect that you’re seeing in sort of pharmacokinetic studies? And kind of are there interim analyses along the way in each cohort that’s going to enroll new patients?

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Francois Lebel, Spectrum Pharmaceuticals, Inc. – EVP & Chief Medical Officer [53]

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Yes. So the cohort 5 is an open trial. So there will be — and it does have central imaging, though. So there will be regular looking at the data if you want, once we get back from our central imaging lab, the result of the data. The monitoring of safety is on an ongoing basis. So we will decide and obviously, we’ll guide the street over time. As to — if we see what we want to see in terms of the number of drug interruption and potentially post reduction over time. And — but we still need to — we can’t just conclude at the first sign of anything. We need to understand as well if we’re getting response, the durability of response and does it modify the course of the [patient]. So we’ll — obviously, we’ll update you, but we don’t have to necessarily fully enroll cohort 5. We will be able to get some insight, gain insight before we fully enroll.

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Operator [54]

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And there are no further questions at this time. Joe, you may proceed.

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Joseph W. Turgeon, Spectrum Pharmaceuticals, Inc. – President, CEO & Director [55]

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I’d like to thank everybody on the call today for your interest in Spectrum Pharmaceuticals. I will tell you that we will be participating in the upcoming Jefferies Virtual Health Care Conference in early June. In the meantime, if you have further questions or need any additional information, feel free to contact us at any time. And I’d like to thank everybody again for their interest in Spectrum. Stay safe. And we appreciate your being on the call. Thank you, operator.

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Operator [56]

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Thank you so much, and this concludes today’s conference. Thank you all for your participation. You may now disconnect.

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