Spectrum Pharmaceuticals Inc (SPPI) 2017 Q3 法說會逐字稿

Good day, ladies and gentlemen and thank you for standing by. Welcome to Spectrum Pharmaceuticals' Q3 2017 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. And now I'd like to introduce your host for today's conference, Shiv Kapoor, Vice President of Strategic Planning and Investor Relations. You may begin.

Thanks, good afternoon, and thank you for joining us for today's -- for Spectrum's third quarter 2017 financial results conference call. I hope you've all had a chance to review the press release we've issued earlier today. If not, it's available on our website at www.sppirx.com.

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 product sales, profits and losses, the safety, efficacy, development, timeline and clinical results of our drug products and drug candidates that involve risks and uncertainties that could cause 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 day of this conference call, November 2, 2017, and the company disclaims any intent or obligation to update these forward-looking statements. However, we may choose to update them, and if we do so, we will disseminate the updates to the investing public. For copies of today's press release, historical press releases, 10-Ks, 10-Qs, 8-Ks and other SEC filings and other important information, please visit our website.

Dr. Raj Shrotriya, our CEO, will start the call today and provide you with the highlights of the third quarter and overall strategy.

I'd now like to hand the call to Dr. Shrotriya.

Thank you, Shiv, and thank you, everyone, for joining us this afternoon. We have been focused on developing our late-stage pipeline and I'm proud of our progress. I would like to start by highlighting our key priorities for the year. First, let me say a few words about poziotinib. A significant event in the third quarter as preliminary data from a Phase II study at MD Anderson Cancer Center was presented 2 weeks ago at the World Conference on Lung Cancer in Japan by Dr. John Heymach, of the MD Anderson Cancer Center. Poziotinib is being developed for patients with non-small cell lung cancer with a genetic mutation involving exon 20 insertion. These patients are generally younger, non-smokers, females and have a progression-free survival of about 2 months.

Current treatments for these patients are unsatisfactory. Promising preliminary data was presented in Japan 2 weeks ago, with overall response rates seen in 73% of patients. Following guidance from the FDA, we have initiated a Phase II study. This study is currently enrolling patients. Many of the premier cancer institutions in the country are expected to participate in this study. We are committed to working with the FDA, to find the fastest regulatory pathway for the approval of poziotinib.

Our second drug, ROLONTIS, our novel GCSF, we plan to announce top line data in first quarter 2018 from over 400 patients, that we'll study in the United States in a study called ADVANCE trial. Enrollment is also well underway in a second trial, which is an international study with sites mainly in U.S., Europe, and Canada, is called RECOVER study, which is similar to the ADVANCE study, but will enroll approximately 218 patients. We remain on track to file a BLA or biological license application, in the fourth quarter of next year.

Lastly, a novel tumor-activating cancer drug QAPZOLA, our registration study is now enrolling patients. This study has been designed, taking into account learnings from previous studies and is being conducted under a Special Protocol Assessment from the FDA.

In summary, I believe we are at a very exciting inflection point at Spectrum. Poziotinib has shown encouraging data in patients with exon 20 insertion mutation. This is a type of a genetic disorder in patients with non-small cell lung cancer, who have very limited options. We have initiated multicenter Phase II trial, which will involve top -- or many leading cancer centers throughout the country. I'm extremely proud to be working on a drug, which can have an impact that can change the lives of patients, who may have had only a few months to live.

In my 40 years in medicine, those are very few times when you come across a drug that can really impact patients' lives in such a meaningful way, and I'm very proud and very happy that we have potentially a drug like that. Joe Turgeon will soon provide you more details about our operations later in the call, but before that, let me hand over the call to our Chief Financial Officer, Mr. Kurt Gustafson to talk about our financials. Kurt?

Thank you, Raj, and good afternoon to everyone on the call today. I'm going to cover a few important financial highlights from the quarter, and let's start with revenue. Total revenues for the third quarter were $36.4 million, and of this, product sales were $31.2 million. In addition to product sales, w recorded a one-time $5 million milestone in license fee revenue, based on the approval of FOLOTYN in Japan and the first commercial sale.

Moving on to expenses, SG&A expenses were $18.9 million this quarter. While this may look like an increase from the previous quarter, it is actually the result of a change in the line items in which we report this expense. As I pointed out in last quarter's call, our collaboration with Eagle Pharmaceuticals ended on June 30th. As a result, we are no longer reporting a portion of our sales and marketing expenses as cost of service revenue for the promotion of Eagle products, but rather all sales and marketing expense is now back to being recorded in the SG&A line. As compared to the second quarter, SG&A expenses actually declined due to lower staff-related costs. R&D expenses were $13.9 million for the quarter.

During the third quarter, we raised $114 million through the sale of 12.6 million shares, utilizing our at-the-market security offering program. We ended the quarter with $248 million in cash and cash equivalents versus $139 million at June 30.

Subsequent to the end of the quarter, we issued 1 million shares for net proceeds of approximately $14 million off of our ATM. Also subsequent to the end of the quarter, we entered into agreements with a few of our convertible bondholders, and exchanged approximately $69.5 million in aggregate principal of bonds for approximately 5.4 million newly issued shares of stock plus $26.7 million in cash. Following these, and other exchanges, we have reduced our debt from $120 million, down to approximately $40.5 million. Financially, the company is well equipped to fund our 3 advanced-stage programs.

And to hear more about these, let me turn the call over to Joe.

Thank you, Kurt, thank you, Dr. Raj, and thank you Shiv and thank you to everybody on the call. These are really exciting times at Spectrum. First let me talk about poziotinib, our oral irreversible tyrosine kinase inhibitor, which has shown potential in lung cancer patients with exon 20 insertion mutations, and also in breast cancer patients.

As Dr. Raj mentioned, just 2 weeks ago, we announced encouraging preliminary data from a current, ongoing trial at MD Anderson Cancer Center, studying poziotinib, in non-small cell lung cancer patients with exon 20 insertion mutations in EGFR and HER2. Patients with such tumors are generally non-smokers, younger, and have very few options for treatment. The prognosis for these patients is poor, with a median progression-free survival of about 2 months, and current therapies are unsatisfactory. There is a significant unmet need for this population.

Poziotinib has shown evidence of significant antitumor activity in non-small cell lung cancer in patients with EGFR exon 20 insertion mutations. Dr. John Heymach reported that all 11 patients who received the daily poziotinib showed tumor shrinkage. The objective response rate using RECIST criteria was 73%. There was also evidence of central nervous system activity in a patient with central nervous system metastases and another with leptomeningeal disease. This is especially exciting news because these patients are generally resistant to available treatments.

We just announced Monday that we have initiated and are currently enrolling patients in our own multicenter Phase II trial of poziotinib. This trial has been designed with input from leading KOLs as well as the FDA. The goal of this Phase II trial is to evaluate both the efficacy and safety of poziotinib in patients with non-small cell lung cancer that is locally advanced or metastatic, and have an exon 20 insertion mutation in either EGFR or HER2. The trial is to enroll up to 87 patients with EGFR exon 20 insertion mutations, and up to 87 patients with HER2 exon 20 insertion mutations.

In addition to lung cancer, poziotinib is also being studied as a single agent in a Phase II trial in the third-line setting with breast cancer patients, who have failed other HER2 directed therapies, and we've seen encouraging responses. We continue to enroll our breast cancer trial and will keep you updated on the progress.

Data from Hanmi's Phase II study of breast cancer was reported in September at ESMO. In patients that were heavily pretreated, including 4 prior anticancer therapies and a median of 2 prior HER2 directed therapies, the disease control rate was 74.7%, and confirmed ORR was 21.1%. This trial used a 12-milligram dose of poziotinib versus 16 milligrams in our ongoing study and also had 2 weeks on and 1 weeks off dosing compared to our continuous dose. So while the exposure of drug was much lower than the exposure in our ongoing breast cancer trial, we are encouraged by these data.

The grade-3 diarrhea of 14% in this study also compares favorably with the comparable treatments at this stage of development.

We have worldwide rights to poziotinib except for South Korea and China. Our team is embarking upon an overall strategy for global clinical development and regulatory filings for poziotinib. We are in early discussions with key opinion leaders in Europe and Japan to discuss regulatory pathways to maximize the potential of poziotinib.

Next ROLONTIS, a long-acting granulocyte colony-stimulating factor or GCSF. ROLONTIS is a novel molecule that has been designed using a proprietary platform-based technology. In Phase II studies, ROLONTIS has shown encouraging safety and efficacy. We are building a strong regulatory package for this program. We have designed a comprehensive clinical program with 2 Phase III trials, to evaluate ROLONTIS. These registration trials are multicenter, randomized, and active controlled studies.

Enrolled patients receive chemotherapy every 21 days. ROLONTIS is administered subcutaneously as a fixed dose once per cycle. The primary study endpoint is a duration of severe neutropenia assessed through absolute neutrophil counts in cycle I of chemotherapy based on central lab assessments over the 21-day cycle. Secondary endpoints include the incidence of neutropenic complications, incidence of febrile neutropenia, relative dose intensity and safety.

The ADVANCE trial was completely enrolled ahead of schedule. We have randomized 406 patients in this trial, and expect to have top-line results in the first quarter of 2018. We are running a second trial for this program, called the RECOVER study, which is similar to the ADVANCE trial in design. The RECOVER study is an international study that will enroll around 218 patients from Europe, the U.S. and other selected countries. This study is enrolling well and should yield results next year in time for us to file a BLA for ROLONTIS in the fourth quarter of 2018. With ROLONTIS we'll have the opportunity to compete in a multibillion-dollar market with a novel agent. As a reminder, ROLONTIS is not a biosimilar, it's a novel agent. If successful, this drug could change the growth trajectory of our company.

Now let's move on to QAPZOLA, our tumor-activated drug for bladder cancer. We initiated the Phase III trial in August and are currently enrolling patients. We have used learnings from our previous research and recommendations from the FDA in designing our new Phase III trial. This trial is being conducted under an SPA from the FDA. The Phase III study is expected to enroll 425 evaluable patients, using a single dose of 8 milligrams. It has a 2:1 randomization in favor of QAPZOLA, and is evaluating time to recurrence as the primary endpoint. This is being studied in low and intermediate risk patients, and based on the SPA, we are required to complete only this one trial for an NDA submission.

At the upcoming ASH meeting, we'll present more than a dozen abstracts across our current portfolio. 2 of these are oral presentations involving FOLOTYN, including a Phase I dose escalation study of FOLOTYN in combination with CHOP in frontline patients with newly diagnosed PTCL. And a second, a report from the comprehension -- comprehensive measures for PTCL.

Thus far, 2017 has been a highly productive year at Spectrum. We have progressed our advanced-stage pipeline and have executed on our goals. We look forward to updating you on the progress as we work towards bringing more treatment options to cancer patients.

I really appreciate your interest in Spectrum, and now I'm going to turn the call back over to Dr. Raj.

Thank you, Joe. These are exciting times for the Spectrum. With that, let's open the call for questions. Operator, please.

(Operator Instructions) Our first question comes from the line of Adnan Butt of Guggenheim Securities.

Clearly impressive data for poziotinib. At this point, would you be able to tell us when the next update from the MD Anderson study could take place?

Well Adnan, as you know, the current study at MD Anderson is a investigative sponsored study. Although we are intimately involved in following and monitoring these patients. As for the update is concerned, I think it will be sometime in early -- I expect it some time to be early in next year, as we have been discussing about filing an abstract -- submitting an abstract or some paperwork for the ASCO presentation, which happens in February. So I would say something like in February, I'm expecting some update, but again, I don't control that. That has to come from MD Anderson, but my discussions reveal that the plan is to file an abstract for ASCO in February next year.

That's good to hear, Dr. Raj. I think on the prior conference call, Dr. Heymach mentioned that there would be an update from the HER2 cohort as well. And do you expect it at the same update or could that be a separate update?

I'm not sure at this time, Adnan, I'll have to go back to Dr. Heymach and find out about it.

Okay. Let me just ask a question on your study then. It's good to see you start the Phase II. Could you tell us if there are any differences between the protocols that you've developed versus the MD Anderson protocol?

Well, I think those are very fine differences, Adnan, after this call, you and I can get over this, I can have our Chief Medical Officer, (inaudible) our Chief Project Officer and Dr. Zane Yang, our Senior VP Medical, go over the differences with you, but they are subtle, they are minor, they are all targeting non-small -- advanced metastatic non-small cell lung cancer with exon 20 insertion mutation. There are some fine points that we can talk about, about the -- for example, we have built in centralized reading of these scans, PET scans, CT scans.

Because our study is multicenter, we expect 20 to 50 sites participate in the trial. We want to make sure that all the scans are read centrally, that is something that we are insisting. Similarly we are collecting plasma from all these samples, all these patients, and trying to collect tissue from all these -- so there is some of the things that are unique to a multicenter trial, that are certainly different than from MD Anderson's cancer trial, but the fundamentals basically remain the same. Patients remain the same. Diagnostic criteria using NGS remains the same, and also the scans remain the same.

So last one for me, Dr. Raj. In terms of managing patients, either via the prophylaxis or a primary prophylaxis, are there any plans to do them -- to make them stay on the dose -- higher dose longer?

Yes. You are right. This is, as you know, in oncology, we try to use maximum tolerated dose or MTD, the goal is to give the highest dose possible. So as you know, that we started our breast cancer study with 24 milligrams and backed off, and here we found that 16 milligrams was the best dose in our assessment. So everybody starts with 16 milligrams and the goal is to keep everybody on 16.

But the reality is that some patients don't tolerate the highest dose. And therefore, we have to gradually reduce the dose. Dose reduction is only subject to what kind of side effects they have. Not everybody has the same severity of reaction, but certainly, we have seen rash, diarrhea, paronychia, mucositis, and it all depends how well the patients are tolerating. But clearly, our design -- the study is designed to keep the patients on as high a dose as possible for as long as possible.

Our next question comes from the line of Laura Engel with Stonegate Capital Partners.

I wonder if you had any update from Hanmi on the potential readout whether you thought we might hear something before year-end, or if it looked like it would be 2018 for that next readout?

So from Hanmi, any readout will be in 2018, I'm not aware of any readout in this year.

Okay. And then on the QAPZOLA, can you give us any idea of the number of patients or the number of active sites thus far? And then, if you've heard anything as far as the higher dosage that's being used in this trial design, if that's going still well with this second design?

Yes, so QAPZOLA trial -- we have a lot of experience in this area because we had done previous 2 trials in which involved almost 90 centers that participated in enrolling patients. We have gone back to several of those sites, at least 40, 50 sites I have been told have been on active right now. Patients are being actively recruited in -- both in U.S. and in Canada. And the number of patients that we need, evaluable patients, is 425.

There are 3 differences in this trial as compared to the previous trials -- 3 major differences. One of them is that we are using a double the dose of the previous study, it's 8 milligrams rather than 4 milligrams. We also have time to recurrence as the endpoint and also patients are randomized 2:1. In fact, for every 2 patients that get QAPZOLA, only there'll be 1 patient of placebo. And this trial design was blessed by the FDA.

There was one major change because in the first trial, patients could get QAPZOLA right soon after surgery. And we found that some of the patients who might have bleeding, the bleeding deactivates or inactivates the drug. In the current protocol, we are allowing 30 minutes to pass before we consider giving QAPZOLA. And in fact if there is a [frank] bleeding then we wait even longer, we say, 1 hour plus/minus 30 minutes. So some patients could wait for 1.5 hour if need be. So these are the major 3 or 4 differences within the first trial. But clearly, we are very aggressively pursuing these trials and people in the -- our investigators are very excited about the potential that this drug could be in the hands of patients.

Laura, this is Joe. I'll just add to also that at San Antonio Breast, Hanmi will have a poster on the ESMO data that I referenced in the transcript, so there will be a poster San Antonio Breast.

Okay, great. And then just one more related to current sales, so just comparing ups and downs quarter-to-quarter, I expected a little bit of the continuing decrease in FUSILEV, strong increase for EVOMELA. I wondered if you could just comment looking forward, the largest actual change was in MARQIBO, I hope I'm saying that right, close to $1 million. So if you could comment on that. And then just as far as EVOMELA, still gaining traction going forward, how you feel about that, and its market share at this time?

So I'll have Tom Riga, our Chief Commercial Officer and Head of Business Development, answer this question.

Laura, let me start with MARQIBO, as a reminder this is indicated in a very limited population. There are about 1,600 patients in adult Philadelphia negative ALL. In the third quarter, we actually saw 2 competitive entrants come into this space with different mechanism of action that clearly had an impact on our business. Now we're going to monitor that going forward and keep you posted as we go. But your observation is correct, and those new products are likely the cause. When you look at it in an absolute patient basis, while you see the $1 million decrease, you're looking at less than 15 patients as we evaluate that but in a very small market, that presents itself as significant. So we'll keep an eye on that.

Regarding EVOMELA, we're thrilled with the performance, I think this is the highest quarter we've seen with the brand. We are the market leader. I think the market has spoken on the differentiation of the product. But that said, there are 4 generic competitors that we're constantly competing with, and price pressures are a reality of the game. We believe we're differentiated, we've been holding strong, but our team is working tirelessly to continue to earn new business as well as maintain a differentiated price schedule. But that's something we have to monitor on a very regular basis.

Our next question comes from Ed White with H.C. Wainwright.

So just wondered, I seldom ask about the commercial products, but I do want to come back to MARQIBO, but not on sales, on the -- if you can give any update on the protocol you submitted for the SPA for CHOP versus the CHMP?

Dr. Zane? Can you give us some...

So the MARVEL study. This is Zane. The MARVEL study is designed for the MARQIBO in non-Hodgkin's lymphoma patient population. And we have discussion with the FDA regarding for the study design and seeking for the SPA in order for the clear path for the registration. And the discussion and the design is still under discussion with the Agency.

Okay. So there's no real update yet on that one?

Not really, Ed. But that will be a Phase III registrational trial. If and when we get it. We're just trying to get it under an SPA.

Okay. Great. And then Joe, a question for you, maybe if you can talk about the changes that you're expecting in the GCSF market, in the U.S. either through the biosimilars or healthcare reform, what has changed since you started strategically planning the ROLONTIS launch? And how you're positioning in the market. We've talked about that before, but has anything changed that either makes you think that there is less of an opportunity or more of an opportunity now for ROLONTIS?

Yes, I think first of all, Ed, what hasn't changed, is exciting because what hasn't changed is we're a novel agent. The way reimbursement works still through today puts us in a good position to compete because we will be the novel agent. But I guess the only real change in the time we've been talking and watching it, Ed, is several biosimilars that we thought would be on the market already are not yet on the market. You've also seen that in Europe on some of the new ones. So right now it's, I don't know who will get to the market first as a long-acting biosimilar, but at this point, there are none on the market. So that's different than I thought. I thought there'd be at least 1 if not 2 on the market already. Tom, you want to add?

The only thing I would add is as early as last night, there was some news on PHS reform in the United States. We, as a company, believe that cancer care is best held with the community oncologist, and I think the reform to the PHS space really helps eliminate some of the issues that have plagued patients in that segment and puts the control of the care back into the community oncologists' hands, which I think is advantageous for the GCSF space as we've talked in the past. Today, greater than 70% of all GCSFs are treated by the community and that number is only looking to grow as we see the PHS reform come into vision.

Okay, Great. So maybe just one last ROLONTIS question, you expect the BLA submission in the fourth quarter of '18, is it safe to assume the European submission early 2019?

Yes, that's what we are planning. Yes.

Okay. And then just on -- just one pozi question. The -- in breast cancer, so Joe had just said that, you're in the -- running the single-agent second Phase II trial and third line. Can you give us any idea of how many patients are enrolled or when we could see data from that study?

Dr. Zane?

So this study has been conducted for more than a year. And initially this study design is for the patient with metastatic third line and HER2 positive for breast cancer with a single agent of pozi 24 milligram once a day, 2 weeks on, 1 week off regimen recommended by our partner from Hanmi Pharmaceuticals.

But based on our experience, we feel there is no scientifical rationale for having the drug holiday in this patient population, but also we do believe there is room to increase the patient therapeutically and without a compromise the patient's efficacy by justify the dose from 24 milligrams to 16 milligrams. Because of this observation we opened this discussion with the FDA and now we get Agency's agreement we move to amendment, now we have 2 cohorts currently in the study.

The first cohort, we have 32 patients, treated with 24 milligram once daily for 2 weeks on, 1 week off. That cohort is complete. And the data is under -- analyzed and hopefully we maybe share this information in the major public -- in a major scientific conference in the future. And more importantly, the second cohort will open, in the U.S. and it's the 16 milligram once daily continuous, and we do -- we are still have limited number of patients. So it's early to say, the observation of the data. But I just want to let you know, the second cohort is open and all this information is available at clinicaltrial.gov.

And I'll just remind you overall, it's 70 patients. Just to remind you.

Our next question comes from the line of Matthew Andrews with Jefferies.

Question on poziotinib. At what point do you go to the Agency to advance the discussion on potential for breakthrough designation? Is there a minimum amount of safety and efficacy data that you need to have to request such a meeting?

So, Matthew, this is good question. In fact, the data that we saw in Yokohama, it was really ahead of its time. In other words, when we started this trial, Dr. Heymach thought it would take 2 to 3 years to complete this trial in 30 patients. And now actually, we already have data that is present -- and we didn't expect the data to be available until December of this year. So we are quite heartened to see that the data is already available.

And we are, as we speak, we are preparing our submission to the FDA requesting a meeting to discuss a regulatory strategy, whether it involves breakthrough designation or it involves [exclusive] approval or it involves just -- we are planning to have a meeting with the FDA as soon as possible. We are just now preparing a document and we hope to send it very quickly to the FDA.

There is a lot of excitement in the lung cancer community, there's a lot of excitement in the patients. And I can tell you that our investigators are inundated with the number of patients that are phoning in about the use of poziotinib for them. So we are very excited and we hope to meet with the FDA as soon as FDA would allow us to.

So on the call, a few weeks ago, Dr. Heymach mentioned enrolling a cohort of front-line patients. What is the strategy for your multicenter study? Do you plan out of the 174 patients to have a proportion that are actually first-line or what are the thoughts around that? Is the MD Anderson data pace how you enroll for first-line? Anything you can add on that?

So Matt, the current protocol that was heavily discussed with the FDA, and with key opinion leaders, requires -- the FDA requires that the patient must have failed 1 treatment. Whether it's chemotherapy or targeted therapy, they must have failed 1 therapy. However, my -- at least the discussions with the carers as -- the thinking is the following: that because an exon 20 insertion mutation, the standard chemotherapy or targeted therapy is not effective, why waste time with these patients, giving them therapies that are not effective? And therefore, there is a pitch that we should treat some patients, first-line with poziotinib. That is the discussion that we plan to have with the FDA and we will let you know when the decision is made.

Okay. And just lastly following up on Adnan's question. As it relates to minimizing rash and other toxicities, it sounds like you're committed to starting with 16 milligrams, is that right? Or would you consider starting at a lower-dose 12 milligrams?

So, as I told you, I know oncology right, left and center. And in oncology, you give the best dose that has the best chance of success. Remember, our first patient that we started in November of last year, under compassionate ground was started at 16 milligrams daily dose, this patient had metastatic lesions, and pain, and difficulty breathing, and cough, and within first week, she -- a clinical benefit was seen within first week. And later a total response was seen in 4 weeks with 16 milligrams daily.

Clearly, I as a physician, would not want -- I would want every patient to benefit from this quick and early effect we saw in first patient. So we have no plans to start at this time, with a lower than 16. Once patients start with 16 and then if they develop intolerance that we can certainly decrease the dose. That is standard practice in oncology and that is what we plan to continue at this time.

16 milligrams dose has been found to be safer and effective dose in these patient populations so far with the limited experience that we have. But mind you, let me just give you an idea. With poziotinib has already been given to over 300 patients. While the lung cancer patients are limited, the total exposure to breast cancer patients and other patients is over 300. So we feel pretty comfortable giving 16 milligram as a starting dose.

And we have a follow-up question from Adnan Butt with Guggenheim Securities.

Just a quick one here. Could you tell us how commonplace screening is for these mutations in lung cancer and other cancers? And then maybe, have you had a chance to do some work on how commonplace these mutations are at least in the major markets?

So the -- I have seen numbers all over the place. This is -- you start looking at the non-small cell lung cancer indication -- about 200,000 patients a year are diagnosed in the United States. And the number of patients that could have exon 20 insertion mutation, I've seen numbers anywhere from 4,000 to 8,000 patients, but that is just in the U.S. But you just start going to Europe and Japan, the number of patients expands to as much as 15,000 to 20,000 patients. So that number is, I can't tell you, that how accurate this number is, but certainly, there is a range that seems believable to me.

And I will tell you, when we were in Yokohama, we did meet experts in Japan, and they were all very, very interested. We had the Chairman of the Department of Lung Cancer -- Thoracic Cancer in Tokyo, and in several other places in Japan, Osaka, Nagoya, and we certainly plan to -- Japan has the highest incidence of exon 20 insertion mutation. There's a lot of interest in these people and we certainly plan to have some program going forward in Japan.

Okay. And then, would you know how -- is it standard screening for these mutations?

It is becoming increased. You should realize that until 2004, nobody knew about these mutations. This is all is relatively new, thanks to Human Genome Project and now every day, increasingly people are being tested routinely with the genetic mutations because lung cancer is #1 killer for cancer deaths in both men and women, and the reason for that is we were treating blindly these cancers. Give them chemotherapy, give them platinum therapy, not knowing that there is certain genetic mutation that prevents for these chemotherapies to act.

So now therefore, more and more physicians, even in practice -- community practice, they are resolving to these, what's called, liquid biopsies or blood, they take plasma and they run it through what's called, next-generation sequencing or Foundation tests or Oncomine test. So they are able to do quickly the genetic screening of these patients. And therefore, our target therapies are becoming more common, tests are becoming more common, but it's still its infancy. I think as this grows, number of patients diagnosed will be far greater than what it is today.

Thank you, I would now like to turn the call back over to Dr. Rajesh Shrotriya for any further remarks.

Well I would like to thank all the participants today in this conference. I want to thank you for your interest in Spectrum. And we look forward to updating you in the near future on our continuing progress. Stay tuned. I believe, best is yet to come. Thank you.

Ladies and gentlemen, thank you for your participation in today's conference. That does conclude the program. You may all disconnect. Everyone have a wonderful day.