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Edited Transcript of ARRY earnings conference call or presentation 7-May-19 1:00pm GMT

Q3 2019 Array Biopharma Inc Earnings Call

BOULDER May 16, 2019 (Thomson StreetEvents) -- Edited Transcript of Array Biopharma Inc earnings conference call or presentation Tuesday, May 7, 2019 at 1:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Andrea N. Flynn

Array BioPharma Inc. - Senior Director of IR & Corporate Communications

* Andrew R. Robbins

Array BioPharma Inc. - COO

* Jason Haddock

Array BioPharma Inc. - CFO

* Ron Squarer

Array BioPharma Inc. - CEO & Director

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Conference Call Participants

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* Anupam Rama

JP Morgan Chase & Co, Research Division - VP and Analyst

* Chris Shibutani

Cowen and Company, LLC, Research Division - MD & Senior Research Analyst

* James William Birchenough

Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst

* Kyung Yang

Jefferies LLC, Research Division - MD & Senior Equity Research Analyst

* Michael Werner Schmidt

Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD

* Peter Richard Lawson

SunTrust Robinson Humphrey, Inc., Research Division - Director

* Stephen Douglas Willey

Stifel, Nicolaus & Company, Incorporated, Research Division - Director

* Thomas Jonathan Smith

SVB Leerink LLC, Research Division - Associate

* Varun Kumar

Cantor Fitzgerald & Co., Research Division

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Presentation

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Operator [1]

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Good day, ladies and gentlemen. Welcome to the Fiscal Third Quarter 2019 Array BioPharma Inc. Earnings Conference Call. (Operator Instructions) As a reminder, this call will be recorded.

I would now like to introduce your host for today's conference, Andrea Flynn. Please go ahead.

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Andrea N. Flynn, Array BioPharma Inc. - Senior Director of IR & Corporate Communications [2]

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Good morning. This is Andrea Flynn, Senior Director of Investor Relations and Corporate Communications. Welcome to Array BioPharma's conference call to discuss our financial results for the third quarter of fiscal 2019. You can join this conference call on Array's website at arraybiopharma.com. We are using slides to accompany our remarks today, which can be downloaded from the Investor Relations section of our website. A replay of the conference call will also be available on our website following today's presentation.

I'd like to introduce Array's Chief Executive Officer, Ron Squarer; our Chief Operating Officer, Andy Robbins; and our Chief Financial Officer, Jason Haddock, who will provide remarks today. Dr. Victor Sandor, our Chief Medical Officer, will also be available to answer questions as needed.

Before I turn the call over to Ron, I'll remind you of the following safe harbor statement. The matters we are discussing today include projections or other forward-looking statements about the future results, research and development goals of Array and its collaborators, and future financial performance of Array. These statements are estimates based on management's current expectations and involve risks and uncertainties that could cause them to differ materially from actual results. We refer you to risk factors discussed in our filings with the SEC, including our annual report filed on Form 10-K for the year ended June 30, 2018, and in other filings Array makes with the SEC. These filings identify important risk factors that could cause actual results to differ materially from those in our projections or forward-looking statements.

Today, we're discussing results related to BRAFTOVI and MEKTOVI and BRAF-mutant melanoma. For reference, the important safety information is provided in the appendix at the slide deck.

I'll now turn the call over to Array's CEO, Ron Squarer

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Ron Squarer, Array BioPharma Inc. - CEO & Director [3]

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Thanks, Andrea. Good morning to everyone and thank you for joining us today.

We're pleased to announce yet another strong quarter in which we achieved significant milestones for both our commercial and clinical operations, and made progress towards important additional upcoming value drivers in the remainder of 2019.

I'm starting on Slide 3. BRAFTOVI + MEKTOVI continue to receive a positive reception from the U.S. healthcare providers treating BRAF-mutant melanoma patients with over $35 million in net product sales in our third commercial quarter. We continue to see strong demand for BRAFTOVI and MEKTOVI with nearly 3,500 total prescriptions during the quarter and approximately 7,500 total prescriptions to date. We believe the continued market penetration in melanoma reflects the strength of the data from the COLUMBUS trial. Just to put our performance to date in context, we have seen substantial market penetration in a relatively short period of time, therefore, as expected with any successful launch, we do not expect the early quarterly growth in melanoma sales to continue at the same level.

And by way of background, there are approximately 5,000 new addressable BRAF-mutant metastatic melanoma patients each year in the U.S., which at the time of our launch, we estimated, represented a target market worth over $400 million in annual net sales in the U.S. and over $1 billion globally.

Now moving to BRAF-driven colorectal. To be clear, we do not have the top line BEACON CRC Phase III interim results today, but remain on track to deliver them this quarter. We remain confident given historic benchmarks that even with regression relative to the safety lead-in data, the BEACON study should deliver positive, clinically meaningful results. Patients with BRAF V600E-mutant metastatic CRC have a mortality risk more than double that of metastatic CRC patients without the mutation. And currently, there are no therapies specifically approved for this high unmet need population. We believe a positive outcome for BEACON would put us in a strong position to provide a potential new treatment option for patients. We were gratified to learn that BRAFTOVI, in combination with MEKTOVI and cetuximab or panitumumab, was added to the NCCN guidelines as a Category 2a treatment option for BRAF-mutant CRC patients in March.

Moving on to additional BRAFTOVI + MEKTOVI life cycle trials, the ANCHOR CRC trial is designed to assess the efficacy and safety of the combination of BRAFTOVI and MEKTOVI and cetuximab in patients with BRAF V600E-mutant metastatic CRC in the first-line setting, end trial is advancing. We also have 3 nonexclusive immuno-oncology clinical trial collaborations with BMS, Merck and Pfizer. Additional new trials in BRAF V600E-mutant melanoma brain metastasis and BRAF V600E mutant non-small cell lung cancer have been active since April. And we're pleased to be bringing benefit to patients with BRAF-mutant melanoma and hope to be able to bring benefit to additional patients with these trials.

I'll also note that over the last few years, we have refocused our efforts to develop new, wholly-owned oncology INDs for Array, and we continue to look forward to a new IND this year as well as additional oncology INDs moving forward as we progress a growing portfolio of preclinical assets towards the clinic.

So now, moving to Slide 4. We have in place strong excellent partnerships to maximize the potential of BRAFTOVI + MEKTOVI around the world. Pierre Fabre, our European partner, is dedicated to oncology, has over 1,000 employees engaged in this therapeutic area, including commercial, research and development capabilities. They have made BRAFTOVI and MEKTOVI a top priority for their team.

Ono, a Japanese market leader in immuno-oncology obtained approval for BRAFTOVI + MEKTOVI in Japan in January. They subsequently launched the combination in Japan at the end of February. And based on their experience, we look forward to their success in introducing our products to patients.

Based on the agreements with these 2 partners, Pierre Fabre and Ono, we're also able to receive nearly $540 million in potential milestone payments. Additionally, more than half of future development costs could be cofounded by contributions from our partners. In Europe and other territories, PF will deliver royalties on annual combined net sales of BRAFTOVI and MEKTOVI with rates starting at 20% and rising to 35% when sales exceed only EUR 100 million. In Japan and South Korea, Ono will deliver royalties on an annual combined net sales of both products, with rates starting at 22% and rising to 25% when sales exceed only JPY 10 billion, which is approximately USD 90 million.

So with that introduction, I'll turn the call over to Andy for a commercial update.

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Andrew R. Robbins, Array BioPharma Inc. - COO [4]

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Thanks, Ron. Moving to Slide 6, we remain encouraged by the third full-quarter performance of BRAFTOVI + MEKTOVI for advanced BRAF-mutant melanoma with net product sales of $35.1 million. As Ron mentioned, demand for BRAFTOVI + MEKTOVI was nearly 3,500 total prescriptions during the third quarter and approximately 7,500 total prescriptions to date. Again, as a reminder, BRAFTOVI and MEKTOVI are written as separate prescriptions. So each time the combination is prescribed, it's counted as 1 prescription for BRAFTOVI and 1 prescription for MEKTOVI. The vast majority of prescription fills we've seen to date have been for the combination.

We believe the strong demand we have seen is driven by data from our COLUMBUS trial which show BRAFTOVI + MEKTOVI offers the longest observed median progression-free survival and overall survival of any BRAF + MEK inhibitor. Further, we believe the COLUMBUS trial demonstrated our combination offers attractive tolerability, and the safety profile continues to resonate with melanoma prescribers.

We continue to identify new prescribers and increase our customer base. As expected, clinical uptake has been strongest in academic centers, which is where the majority of metastatic melanoma patients receive care in the United States. We are pleased with how physicians in these centers have embraced our combination therapy, and that they are increasingly adding the combination to their practice.

As we mentioned in previous quarters, physicians began switching many patients on to BRAFTOVI + MEKTOVI, who were initially receiving treatment with other targeted therapy combinations. This switch tendency was certainly encouraging and drove strong first and second quarter performances. We expect this early uptake will help provide experience for prescribers, but caution that it is unlikely that this will represent a sustained pattern in use, particularly as BRAFTOVI and MEKTOVI begin to be used more often as the initial targeted therapy for patients.

I will echo Ron's statements that we are very pleased with our performance thus far, but we expect quarterly growth rates to slow compared to the early launch quarters, which is expected in any successful launch.

As a reminder, because some of the data we have on historical treatment for BRAFTOVI + MEKTOVI patients are empiric and incomplete, we are currently unable to predict the split between de novo patients and switch patients, and it will likely take some additional time before we can address duration of therapy. We continue to believe that BRAFTOVI + MEKTOVI offers the best targeted therapy choice for patients with metastatic or unresectable BRAF-mutant melanoma based on interactions with KOLs, treating physicians and third-party audits, and I'd like to recognize the tenacity, enthusiasm, and creativity of our sales marketing, medical and manufacturing teams and their dedication to patients.

We are pleased with how commercial payers have covered BRAFTOVI + MEKTOVI prescriptions 3 quarters into launch and see no significant barriers to reimbursement for the combination in BRAF-mutant metastatic melanoma. Payers are well-versed in the space and understand the value proposition for BRAF-MEK combination therapy in this patient population, in addition to the benefits of our OS and PFS results in our attractive tolerability profile. We believe that BRAFTOVI + MEKTOVI offers the best option for patients with BRAF-mutant metastatic melanoma and remain dedicated to providing access to all patients regardless of their insurance or income status.

Moving now to Slide 7, as Ron mentioned, in advance of a potential filing and approval of BRAFTOVI + MEKTOVI and cetuximab for BRAF V600E-mutant metastatic colorectal cancer, we were pleased to launch our Disease Education Campaign at ASCO GI in January. The goal of our newly introduced campaign is to educate physicians on the increased risks associated with BRAF-mutant colorectal cancer, and to encourage them to test their patients for the BRAF mutation, consistent with the current recommendation in the NCCN CRC guidelines. More information can be found on our disease education website at brafmcrc.com.

With that, I'll hand it back to Ron.

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Ron Squarer, Array BioPharma Inc. - CEO & Director [5]

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Thank you, Andy. Now moving on to Slide 9, and continuing on the topic of BRAF colorectal cancer, where we were delighted that the National Comprehensive Cancer Network, or NCCN, updated their clinical practice guidelines in Oncology for colon and rectal cancer in March to recommend BRAFTOVI in combination with MEKTOVI and cetuximab or panitumumab as Category 2A treatment option for patients with BRAF-mutant CRC after 1 or 2 prior lines of therapy for metastatic disease, although our U.S. sales force cannot and will not promote use in CRC until approved by the FDA.

Now we're also very pleased with the updated results from the BEACON CRC safety lead-in announced at ASCO GI in January. Following consultations with the FDA and European Medicines Agency, we previously amended the BEACON CRC protocol to allow for an interim analysis of trial endpoints. Should the planned analysis based primarily on confirmed overall response rate and durability response in roughly half the enrolled patient population be supportive, we do plan to seek accelerated approval in the U.S. The interim analysis may also support regulatory submissions in other regions, and we anticipate top line results from the analysis this quarter. This timing allows for the subset of patients required for the interim analysis of ORR to achieve a response and for the durability of responses to be appropriately evaluated.

So now on Slide 10, we provide the details of the global BEACON Phase III clinical trial just for reference. As a reminder, we announced that we completed enrollment in January.

On Slide 11, while currently, there are no FDA approved therapies specifically indicated for this high unmet need population, the median OS demonstrated by EGFR and chemotherapy-containing regimens for this population is around 4 to 6 months, while recent experimental BRAF inhibitor containing triplet regimens reported median OS of 9.1 and 9.6 months. Now we reported mature, median overall survival of 15.3 months from the BEACON CRC safety lead-in at ASCO GI in January and recently published the BEACON CRC safety lead-in results in the journal of clinical oncology in March. The related ORR benchmarks in this patient population range between 4% and 8%, with the experimental BRAF containing triplet regimens demonstrating ORR rates of 16% to 21%. Now we reported a 48% confirmed ORR with a triplet combination from the BEACON safety lead-in, which was similar to the 41% ORR-reported by blinded independent reviews. So the earlier number was by local review.

Now related median PFS benchmarks in this patient population fall between 2 and 3 months, with a recent experimental BRAF-containing triplet regimens demonstrating around 4 months median PFS. And we reported a median PFS of 8 months with our triple combination from the BEACON CRC safety lead-in. As I mentioned earlier, we do not currently have the results from the randomized portion of the BEACON CRC trial, but we remain confident given these historic benchmarks that I've just discussed, that even with regression relative to the safety lead-in data, the BEACON study could deliver positive clinically meaningful results. I'll note that Array has not conducted head-to-head studies comparing encorafenib plus binimetinib against other BRAF met combination therapies, and these data come from separate Phase III and Phase II studies. I'll also issue a standard caution about making cross-trial comparisons. These trials were conducted under varying conditions, and results may not be directly comparable.

So next on Slide 12 at ASCO GI, we also shared the Kaplan-Meier curve depicting 15.3 months of median overall survival from the safety lead-in of the BEACON CRC trial. Median duration of follow-up was 18.2 months.

On Slide 13, we also provided updated detailed response rates results by local assessment, which were consistent with the central assessment of 41% response -- overall response rate, and with prior analysis of the safety lead-in patients.

On Slide 14, safety lead-in data presented at the meeting shows that almost all patients that have some degree of tumor regression as their best response in contrast to the inset graph that depicts tumor response by patients in the irinotecan and cetuximab treatment arm of the recent SWOG data set, which is similar to the control arm of the randomized portion of BEACON CRC where the majority of patients had significant tumor progression as their best response.

Now moving to Slide 15, we show the number of months each safety lead-in patient had been on therapy, with 6 patients on treatment for 18 months or longer and several approaching 2 years. The majority of responses were observed early at the first or second tumor assessment at 6 or 12 weeks, and the median time on treatment is about 8 months.

On Slide 16, we show key safety data for the BEACON CRC safety lead-in, including the most common grade 3/4 adverse events. As depicted, the triplet combination was generally well-tolerated with no unexpected toxicity. The rate of grade 3 or 4 skin toxicities continue to be lower than generally observed with cetuximab in the treatment of metastatic colorectal cancer.

On Slide 17, we show the colorectal cancer market globally. On the left side, we see that over 220 individuals succumb to colorectal cancer each year across U.S., Europe and Japan. As you can see on the right, it's estimated that approximately 10% to 15% of advanced colorectal cancer patients have tumors with BRAF mutations. I'll also point out that the BRAF CRC addressable population are maybe even larger than the size of the population of patients with BRAF melanoma, which I -- as I mentioned earlier, we estimated at over $400 million in annual net sales in the U.S. and over $1 billion globally at the time of our launch.

Now on Slide 19, we detail the design of our BRAFTOVI, MEKTOVI life cycle trials. ANCHOR CRC continues to advance. It's a Phase II single-arm international trial. Approximately 90 patients designed to assess the efficacy and safety of the combination of encorafenib, binimetinib and cetuximab in patients with BRAF V600E-metastatic CRC in the first-line setting. This trial is similar to the triplet arm in the BEACON CRC trial but in patients with metastatic BRAF-mutant CRC in the first-line therapy setting. The 2 additional new trials, POLARIS and PHAROS, have been active since last month. POLARIS is a multicenter, randomized open-label Phase II trial designed to assess the efficacy, safety and pharmacokinetics of 2 dosing regimens for BRAFTOVI and MEKTOVI in patients with BRAF V600-mutant melanoma brain metastases. Approximately 100 patients will be enrolled, including 9 patients in the safety lead-in of the high-dose treatment arm. The trial's primary endpoint is brain metastases overall response rate; and secondary endpoints are the global response rate, disease control rate, duration of response, progression-free survival, overall survival, safety, tolerability and pharmacokinetics.

The PHAROS trial is a multicenter, open-label single-arm Phase II trial to determine the efficacy, safety and tolerability of BRAFTOVI + MEKTOVI in patients with BRAF V600E-mutant metastatic non-small cell lung cancer. The trial's primary endpoint is overall response rate. Secondary endpoints include duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability. We're working hard to demonstrate the value of our combination in a series of clinical trial in multiple settings.

And next on Slide 20, I'll briefly review our additional strategic immuno-oncology partnerships. We have 3 nonexclusive clinical trial collaborations: one with BMS, one with Merck, and one with Pfizer, to investigate the safety and efficacy of our MEK inhibitor, MEKTOVI, with either anti-PD-1 or PD-L1 therapy in several solid tumor populations, including metastatic colorectal patients with microsatellite stable tumors.

I'm going to turn the call over to Jason at this time to review our financial highlights.

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Jason Haddock, Array BioPharma Inc. - CFO [6]

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Thank you, Ron, and good morning, everyone. Slide 22 outlines our select financial performance for the third quarter of fiscal 2019, and I encourage you to read our full consolidated financial statements and MD&A contained in our 10-Q, which was filed with the SEC this morning.

We reported revenue of $64.7 million for the quarter, of which $35.1 million was from BRAFTOVI and MEKTOVI sales in the third quarter. Net revenue from product sales is recorded net of estimated rebates, chargebacks, discounts, fees and vouchers. These gross-to-net adjustments represented 16.1% of gross product sales for the third quarter.

Our collaboration revenue for the quarter was $19.5 million, which is down from last quarter by just over $30 million, driven by the Vitrakvi milestone we received in Q2. We also received royalties of nearly $1 million related to the global sale of BRAFTOVI and MEKTOVI. Note these royalties were offset -- or were subject to an offset, up 50% for cumulative costs related to the marketing authorization application in Europe. We've exhausted the majority of currently identified expenses and do not anticipate that offset to materially affect future royalties. We do expect that royalties will become even more meaningful in the coming quarters.

Finally, our Novartis reimbursement revenue was $9.2 million for Q3. As we move to our operating expenses, our research and development costs were $65.5 million for Q3, which is up $3.4 million from last quarter. The increase in R&D expense was primarily driven by proprietary trial activities related to the BEACON CRC trial as well as POLARIS and PHAROS, our BRAFTOVI and MEKTOVI life cycle trials.

SG&A for the third quarter was $35.5 million, which was $5.1 million higher than last quarter, primarily driven by BRAFTOVI and MEKTOVI commercialization activities as well as general corporate expenses. This brings our reported loss from operations for the third quarter of fiscal 2019 to $37.5 million compared to $10.8 million in the previous quarter primarily driven due to the recognition of Vitrakvi milestones in the prior quarter and slightly higher expenses. Net loss for Q3 was $37.5 million or $0.17 per share compared to a loss of $11.4 million or $0.05 per share for Q2.

Finally, we closed the quarter with the balance of $479 million in cash, cash equivalents and marketable securities. Excluding nonrecurring items, our net burn rate for Q3 remains consistent with prior quarters and was in the mid-$40 million range.

Now I'd like to turn the call back to Ron.

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Ron Squarer, Array BioPharma Inc. - CEO & Director [7]

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Great. Thank you, Jason. So to conclude the presentation, I'll review our top priorities and value drivers on Slide 24.

We remain focused on the commercialization of BRAFTOVI and MEKTOVI in BRAF-mutant melanoma, and are encouraged by the results from our third commercial quarter with over $35 million in net product sales. The regulatory process continues to advance outside the U.S. with the recent BRAFTOVI and MEKTOVI approvals in Europe in late 2018, and in Japan in early 2019. Furthermore, we're thrilled -- we were thrilled to announce the NCCN guidelines now recommend BRAFTOVI in combination with MEKTOVI and cetuximab or panitumumab as a Category 2a treatment option for BRAF-mutant CRC patients. And following consultation with the FDA and EMA, we have planned an interim analysis based primarily on confirmed overall response rates and durability of response, which we believe could support an S&DA submission with positive results. This interim analysis may also support regulatory submissions in other regions, and we do anticipate top line results this quarter.

Further, the ANCHOR trial in first-line BRAF-metastatic CRC setting continues to advance, and we're pleased to further expand our life cycle investment with the initiation of POLARIS and PHAROS and in BRAF-mutant melanoma brain metastases as well as BRAF-mutant metastatic non-small cell lung cancer respectively. We're excited about our continued commercial and clinical progress, and look forward to providing additional updates on our key value drivers and our growing research portfolio throughout the remainder of 2019.

Now with that, I'll now open up the call to Q&A.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Chris Shibutani with Cowen.

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Chris Shibutani, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [2]

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Congratulation on such a strong continued launch. I did want to post some questions regarding the colon opportunity. Two, if I may. With the NCCN guidelines, can you comment on what you're actually seeing, share any observations, and help perhaps frame expectations for how you think that this, in combination with the interim readout, could impact what we're seeing as far as actual commercial impact in physician awareness? And secondly, in the first-line opportunity where you have the ANCHOR trial that's ongoing. How is enrollment progressing? Any impact relative to news, for instance, the NCCN, et cetera? And then help us with what you think is a reasonable timeline for when we could expect a potential readout? And is there something in the way of an interim for ANCHOR that could also come to play?

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Ron Squarer, Array BioPharma Inc. - CEO & Director [3]

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Great, Chris. So let's start with CRCs. The reason we are pleased with the NCCN guidelines addition is about essentially endorsement or validation of the concept of using RAF inhibitors in treatment of BRAF colorectal cancer. Also, anything that helps to progress awareness about the need for BRAF testing, as far as we're concerned, is helpful to patients and, ultimately, to the franchise. So that's why we mentioned it. There is -- and we've said this in previous quarters, there are -- there is some use of our products in BRAF colorectal. It remains a relatively small part of the business, and what would happen with a positive supportive readout from the BEACON CRC Phase III interim is yet to be determined. But ultimately, we can't promote and won't promote in CRC until we have full FDA approval. But still, the sort of, let's call it momentum, that NCCN is essentially starting in terms of awareness of this condition and how to treat it over time, I think, will be very, very helpful. So that's what we mentioned NCCN as more of an endorsement of the concept.

Regarding ANCHOR. So I do think -- look, the study is opening. We are using -- not exclusive, but we are using some of the sites that recruit the BEACON trial. We haven't given, at this point, any specifics on when we'll have that readout available, but we'll give updates over time. We would like to see the results of the primarily second-line BEACON CRC trial to begin to anticipate what we might see in a first-line setting. So there'll be more news about that. But ultimately, over time, we would love to be able to see more line-agnostic approach to treating this disease, and we'll give color as we can. Thanks for those questions, Chris.

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Operator [4]

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Our next question comes from Anupam Rama with JP Morgan.

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Anupam Rama, JP Morgan Chase & Co, Research Division - VP and Analyst [5]

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You've given some color here on script trends for melanoma for BRAFTOVI and MEKTOVI. Wondering if you could give us some details on what you're seeing in the market place about new prescriber trends as well as repeat prescriber trends?

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Ron Squarer, Array BioPharma Inc. - CEO & Director [6]

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Yes. So as we mentioned in the past, the way the products are distributed, we have only partial visibility to who is a new patient or a repeat patient. It's only a segment of our channel that would be able to provide that information. And so unfortunately, our data is not strong regarding that. And so we haven't really called out trends in prescriptions beyond to describe the TRxs that we're seeing and, of course, the related revenue as well as anecdotal information. So perhaps over time, we'll have more to say about that, but at this point, we're focused on what we've said today.

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Operator [7]

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Our next question comes from Stephen Willey with Stifel.

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Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division - Director [8]

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Ron, I was just maybe wondering if you can provide us with a little bit more color just with respect to kind of where we are with respect to timing? I know that the BEACON trial-initiated enrollment -- I think it was October of '16. I know you said that you completed enrollment in January. I'm just trying to think about enrollment kinetics as a function of having a minimal amount of follow up in all patients at this point to provide a sufficient evaluation or duration of response. It would seem to me that you're kind of well into the follow-up period for the number of patients that are required to trigger the interim. So maybe you can just help us kind of better understand why it -- at least in my opinion, kind of seems to be taking a bit longer than expected to get to this interim response assessment.

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Ron Squarer, Array BioPharma Inc. - CEO & Director [9]

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Sure, Steve. Thanks for the question. So look, I'll start by saying that the reason for that drives the timing is that, of course, first, we had to recruit the patients needed for the interim analysis. As we've suggested, about half the patients. We do anticipate it takes a couple of cycles to see a response. And then we're waiting a predefined period of time to allow sufficient time for those responses to be deemed durable. Then there's a traditional sort of cleaning process related to any clinical trial, and we've certainly, I would say, been very diligent in optimizing the amount of time that, that's taken. And so from the first day I think we announced timing, we said it would be the first half, and we believe it will be the first half. I know we're coming sort of close to the end of the first half. But we remain, in our minds, on track with that plan. And so there's nothing -- we can't point out anything that has occurred that is sort of out of scope. So it's just a matter of following the plan and producing the data in the not-too-distant future. So I hope that helps, Steve..

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Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division - Director [10]

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That's helpful. And then just a couple of questions on the newly posted Phase 2 trials. I know these are open-label. How are you guys thinking about communicating data from these? Will we see incremental updates along the way? Or should we expect to see a final read? And then I guess on the lung cancer trial, I guess kind of curious as to why 40 patients. I know Novartis ran a Phase 2 trial in the setting of, I believe, around kind of 90 to 100, which proved to be sufficient for a full approval. So maybe you can just kind of help us understand why you're looking at about half of those patients in the Phase 2 lung study?

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Ron Squarer, Array BioPharma Inc. - CEO & Director [11]

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Sure. Thanks for those questions. I'll start with ANCHOR, and I'll simply say that what we've said consistently and continue to believe is that depending on the results, we may view this as an opportunity to approach regulators and update our label. And so we have to see how that goes. We haven't been specific about when and how we'll be presenting that data, but that's the ultimate sort of goal. Regarding lung cancer, the current set of design is listed here, or in clinicaltrials.gov, does indicate the number you stated. But I'm sure you're aware that there are opportunities to expand trials based on a number of factors over time, and doing so later in the progress to study can offer more flexibility. We haven't been specific about our plans. It's the same message, which is we're going to look at the data, see what we have, and then decide how to progress, whether it means adjusting study design or publishing or reaching out to regulatory authorities over time. And I would say same is true for brain metastases, which is a really -- we get a lot of feedback on brain metastases. Unfortunately, if it is often the cause of patients succumbing to their disease. A lot of interest in this. We're really looking forward to collecting the data and, ultimately, sharing it, especially looking at sort of variable doses. So these are -- when you do a list of high-impact, reasonable-timeframe studies, this is what we're doing. We've mentioned in the past that adjuvant, in general, is a topic that interests us. We're considering certainly a path in BRAF colorectal looking beyond our second -- primarily second-line current approach. Our first-line trials is running with ANCHOR. Thinking about even moving upstream. Thinking about is there a reasonable path in melanoma. So -- but these are the, what I'd call sort of reasonable-timeframe, high-impact studies that we've initiated now. I hope that helps, Steve.

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Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division - Director [12]

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Yes, that's helpful. And then just one quick housekeeping question if I might -- or if I may. Gross to net on the quarter? Just curious just given the historical seasonality that tends to inflate this number.

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Jason Haddock, Array BioPharma Inc. - CFO [13]

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Yes. You can actually see that we went down a bit in Q1. And you're exactly right, there is some seasonality as we get to the beginning of the year. That portion of the business is relatively small in total. But we expect to stay in that -- the range that we've been in the last few quarters for the upcoming. So no demonstrative change in our gross to net for subsequent quarters.

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Operator [14]

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Our next question comes from Peter Lawson, SunTrust.

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [15]

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Ron, just on the quarterly revenues, just wonder if you could add some more color just around where we are for the switching patients. And kind of any sense of where we are for the duration of therapy, either if -- even if it's kind of directionality? And then anything around the academic versus community testing use? That'd be great.

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Ron Squarer, Array BioPharma Inc. - CEO & Director [16]

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Thanks, Peter, for the question. So just as a reminder, you may recall, we saw unexpectedly high demand and revenue right out of the gate, and that continued for some time, which we -- although we don't have great data. Meaning even if we, in some parts of our channel, can see if a patient is new or repeat, we don't get to know what they had prior. And so switching dynamics are mostly anecdotal, but we do feel confident they occurred. And the reason we talk so much about that is twofold. One, we saw -- we were able to tap into a large pool of existing MEK/RAF-treated patients, and we suggested this dynamic was not necessarily sustainable over time. So we wanted folks to understand that over time it would weigh in. And we believe that it has come down as a percentage of total treated patients.

Now the other dynamic might be, and we don't have this information, is that the duration on a patient who has switched could be different from, let's call it a treatment-naive or MEK/RAF-naive patient. Unfortunately, we don't have that data yet, and we don't expect to have it until there's been sufficient time for a reasonable pool of patients to have received the medications both on a naive basis and a switch basis over a longer period of time. So we're not able to comment about that now and probably won't for some time. And even then, we're going to have to work with organizations that are treating patients to try and get a good look at what's actually happening. With all of that said, we do still believe that the promise of this offering, Peter, is that given our tolerability profile, there is the potential that patients may be able to stay on longer and even relative to other treatment options, at higher doses, which could in fact grow the market. It's just that we don't have the evidence to determine if that's occurring or not. And so we sort of stick to mentions or benchmarks to what the market looked like when we launched because we can't say if -- at this point, we don't know if the profile that we presented is actually contributing to growth in metastatic melanoma, BRAF melanoma, just by virtue of patients being able to take more drug for longer. So I hope that helps, Peter.

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Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [17]

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And then just on -- I apologize if I missed this, but on the next IND, any color around what you'll be targeting, whether it's mutations of genes, et cetera?

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Ron Squarer, Array BioPharma Inc. - CEO & Director [18]

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It'll definitely be cancer. I can say that. We haven't been more specific. We -- we're building not just our first IND, which we expect to announce this year, but really, a portfolio. And we know that folks are very interested in learning more about it, especially given our very recent, I think, remarkable achievements with the RET inhibitor and TRK inhibitors that are now at Lilly and Bayer. The KRAS inhibitor at Mirati. There's a great recency to those achievements. And so I'm sure folks believe that the Array team can build exquisite molecules to important targets, and they want to know more about it. But of course, we want to be sure that we know exactly what we're going to have and when we're going to have it before we announce it, and so there'll be more information over time. We have said that we're looking at sort of emerging, let's call it in a colloquial way, hot new targets. But we're also looking to see if our know-how and technology can actually improve existing approaches if we believe we can address the mechanisms of resistance and escape through what we do well. So there'll be a combination of those approaches over time, and we look forward to talking to them, but we haven't provided any more detail at this time. So thanks, Peter.

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Operator [19]

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Our next question comes from Michael Schmidt with Guggenheim.

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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [20]

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Ron, I appreciate your comments around BEACON CRC. Just curious if you could provide us with a little bit more color on how the actual disclosure of the results may happen. We noticed you do have an oral ASCO presentation slide, and just curious if we should look for press release at some point or actually wait until the ASH disclosure at that point?

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Ron Squarer, Array BioPharma Inc. - CEO & Director [21]

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Right. So typically, given how important this result is to our company, we would share top line results as soon as practical, after receiving them. We've had a practice of working to ensure that any material information that emerge from the analysis is also disclosed or at least characterized in that announcement. So that's typically how we approach that. And then, of course, our goal would be to present the full dataset, or whatever we have at that point, at a major scientific conference. There are certainly a couple of coming up -- there are certainly a couple coming up. But as I said, as of today, we don't have the results, so we'll see how that timing works out. But I think that's what you can expect. And so that's more than just the primary analysis or the primary focus of the analysis. If -- when we look at it, and we haven't seen it yet, but when we look at it, we think -- see things which we think are important to evaluating how the study went, and we'll share those in a press release. Beyond that, we haven't decided what other interactions we would have. But often, we do at least engage analysts to answer any follow-up questions they may have. So I hope that helps, Michael.

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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [22]

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Yes, perfect. And then a question on BRAF melanoma. There are a couple of Phase 3 trials looking at combinations of MEK, BRAF and PD-1 inhibitors expected to read out later this year from competitors. Just wondering how you think about the potential impact of that on market dynamics in melanoma.

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Ron Squarer, Array BioPharma Inc. - CEO & Director [23]

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We've been pretty consistent about this. We'll have to see how it emerges over time. Our view is that MEK/RAF is a powerful intervention of BRAF melanoma, as is I/O separately. There's a lot of activity in each. So the question is, when you put them together, are you going to see a noticeable improvement that justifies using essentially all available therapy upfront, and that's where things get a little more complicated. There may be and will be physicians around the world, typically academic physicians, that might engage in that. But I think the average treating physician might not, unless, again, there's some blow-it-out-of-the-water kind of result. Now we're very invested in this topic ourselves, and we are conducting a trial now to answer that question for us. There has been a lot of news, I think, out of Novartis. They talked a lot about their triple, that they're very enthusiastic and excited about it. I don't know, but I suspect that it's partly because it is their path to getting their checkpoint inhibitor approved. And so the relative importance of that study to them is, of course, greater than whether a triple will be commonly used in BRAF melanoma. But the important message is if it becomes an important paradigm, we will -- we expect to have data at some point to support use of our drugs. We still are very proud of the profile we present with the MEK and the RAF, and so we're seeing that would carry through to a triple going forward. So that's our current view. Probably not going to be a new standard, but could be important and we're generating data.

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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division - Senior Analyst & Senior MD [24]

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Makes sense. And then one last question just regarding ANCHOR CRC. I know you didn't want to provide guidance just yet on enrollment and data disclosure. But could you just help us maybe contextualize what sort of benchmarks are in frontline BRAF CRC, and how you're thinking about next steps there should you be able to exceed that in that study?

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Ron Squarer, Array BioPharma Inc. - CEO & Director [25]

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Yes, so unfortunately, there's not great sort of historic-source data. We kind of look at the tribe, and I think it's called the FIRE-3 trial as relative benchmarks. I think the best way to characterize it is you do see higher response rates in the first-line setting with existing therapies, then you see, in second and third-line settings, with existing therapies. And so the -- I think that in many ways, we have to wait and see the predominantly second line BEACON CRC result to understand what we might be able to see in a first-line setting, and then will that be good enough. But I think there's numbers splitting out there for response rates sort of north of 40% for that setting. But they're not great studies to call upon. Of course, we prefer it when there's many sources of data over time to call upon. So I think we just have to say it'll be a higher hurdle than in second line. And after we see the BEACON results, we can all sort of guess whether we think we'll be able to make those standards. All right?

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Operator [26]

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Our next question comes from Jim Birchenough with Wells Fargo.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [27]

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Congrats on the strong results. A few questions for me. I guess first, Ron, just in terms of setting expectations for BEACON. You mentioned potential for regression. Could you remind us what the lowered down confidence integral was around the central review response rate? And other than regression within the confidence intervals, any other reason you'd expect different results from what we saw on the lead-in?

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Ron Squarer, Array BioPharma Inc. - CEO & Director [28]

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Yes. Jim, thanks for the question. I think what we're trying to do here, because we don't have the results, is simply remind folks that when you move into a larger study population, numbers can shift. We're trying to avoid -- we don't know the results, but we're trying to avoid sort of, let's call it disappointment with a good result. What I mean is that the benchmark control and even historic results with experimental regimens, we think those benchmarks are so low that even if there is movement in the results from BEACON CRC versus safety lead-in, that there's a lot of, let's call it, daylight between the two., and that's really what our messaging is. When we talk to KOLs, not necessarily investigators, they expect numbers to change. But they've told us that even a substantial move in results would still be very meaningful as a new treatment option for these patients. So we're just -- and most investors and analysts are aware that numbers can change. We're just trying to remind folks that the benchmarks are low and there's a lot of room there. In terms of specific confidence intervals, we publish them. We can get them to you. But what we're talking about is more of a general concept. I hope that helps, Jim.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [29]

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That's helpful. And then, Ron, do you have a sense of what the diagnosis rates are for BRAF V600E in colorectal cancer? And have you seen any movement, either from your education programs or from the NCCN guideline recommendation, increasing those diagnosis rates?

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Ron Squarer, Array BioPharma Inc. - CEO & Director [30]

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Yes. I'm going to ask Andy to answer it. Remember though that there is not a really useful treatment intervention today. And so we do think that the introduction of a useful treatment intervention is going to really help with that.

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Andrew R. Robbins, Array BioPharma Inc. - COO [31]

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Jim, it's Andy. So there's sort of 2 ways to answer that question. One is what is the rate of testing? And then second, what is the rate a positive test in the patients who receive the diagnostic test. So we think today in the U.S., the rate of testing for the BRAF mutation within the CRC population is probably on the order of about 60% to maybe 70%, depending on the setting, definitely skewing much higher in the academic setting and a little bit lower in the community setting. As far as for patients in a population who are tested, we remain confident that the underlying prevalence of the BRAF mutation in the colorectal cancer population is in that range of between 8% and 15%. We believe that as testing becomes more prevalent, it is possible that, that hit rate, so to speak, goes up, and you actually find more patients in the population than you've seen historically in clinical trials. So we continue to maintain kind of in that 10% to 12% range, if you're going to try to midpoint it, is a good estimate.

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James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [32]

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And then maybe just one final question just on market dynamics. You're on a run rate right now of about to $140 million, so on a dollar sales basis, about 1/3 of the category sales in the U.S. What's -- what are the major barriers to getting to the other 2/3? Is that more community versus academic? Are docs treating patients with brain mets holding off, waiting to see more direct evidence on brain mets? What are the some of the things you can do to get into that -- the rest of the market?

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Andrew R. Robbins, Array BioPharma Inc. - COO [33]

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Yes. So you can hear that we are sort of letting folks know that we've really, I would say, tremendous penetration in a relatively short period of time. And so the sort of quarter-on-quarter growth that you've seen for the last -- well, for the first 2 quarters where we could do this analysis, is something that you would expect with any launch to begin to come down over time. And so we are reminding people of that natural dynamic. And now, in terms of why launches tend to have this dynamic, it's not that profound. We obviously target the largest, earliest adopting institutions first, and to get where we are, we've obviously done a good job there. Let's call that the low-hanging fruit. And then over time, you have to expand, sometimes to less concentrated areas of the market and to treaters that are, let's call have more inertia in the way they think and in which they approach treatment. And so that's how we see the dynamic emerging over time. But we are very pleased with how far we've come quickly. We're simply asking the analyst community to be thoughtful about how the growth looks going forward.

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Operator [34]

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Our next question comes from Eun Yang with Array (sic) [Jefferies].

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Kyung Yang, Jefferies LLC, Research Division - MD & Senior Equity Research Analyst [35]

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Also I have a question on interim BEACON trial data coming up. Is there any efficacy level where data is a positive, but it may not be supportive for accelerated approval process?

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Ron Squarer, Array BioPharma Inc. - CEO & Director [36]

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It's very difficult to judge, Eun. By the way, good morning, and thanks for the question. I think our message is that the differences we've seen with the safety lead-in and historic benchmarks is there's a lot of difference there, and so we think there's a lot of room for, let's call it, error, to use one term. If there is the kind of regression you typically see when you move into large populations. Speculating beyond that is a real challenge. Other than to say -- and I believe you've done some work on this yourself. I think you've had some primary interactions with treaters. The population is so desperate, meaning if you're diagnosed with BRAF mutation in your colorectal cancer, your treatment options are limited, the disease is very aggressive. We often hear that after progression on the first-line with available therapies, patients' prognosis is quite poor. So they have said that almost any treatment option would be exciting to them. They reacted with enthusiasm to the SWOG trial results where those results were quite low and quite toxic. And so we think that there's a lot of demand. But going beyond that, it's really hard to speculate. We'll have the results in the not-too-distant future, and then we can judge.

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Kyung Yang, Jefferies LLC, Research Division - MD & Senior Equity Research Analyst [37]

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Okay. And then although you have not guided at all, is there a possibility that you may hit the overall survival primary endpoint at interim?

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Ron Squarer, Array BioPharma Inc. - CEO & Director [38]

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Yes. Look, we've said that the analysis is focused on response rates that have been given sufficient time to be deemed durable. We have stated that other endpoints will be analyzed, but we have not commented beyond that. So we're going to have to just wait for the analysis and see what comes up.

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Kyung Yang, Jefferies LLC, Research Division - MD & Senior Equity Research Analyst [39]

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Okay. And the last question is on melanoma. And I understand that the $400 million targeted therapy market in the U.S., that could potentially expand over the longer duration of therapy for BRAFTOVI and MEKTOVI. But at the same time, aside from taking market share from other BRAF and MEK inhibitors, have you seen you are taking market share away from checkpoint -- immune checkpoint inhibitor, meaning that patients who would like to try targeted therapies, perhaps to the MEKTOVI, prior to anti-PD-1, anti-PD-L1 treatment?

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Ron Squarer, Array BioPharma Inc. - CEO & Director [40]

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Yes. So look, it's possible. We're not focused on that right now. What I mean is our attitude is if you want to start with I/O, start with I/O. If you want to start with MEK/RAF, we've got a great offer in our MEK and RAF combination. And if you want to use this in second life, that's perfectly fine. So we're not engaging right now in really the debate of whether you should use I/O or targeted agents in the first line or second line. We may over time, but now is not the time for that. We still feel that it's roughly half-half, although we don't have great data for that, but different in the settings, so academic settings. You're going to see more first-line I/O use in the community, less in the first-line. But your question is very relevant. That's -- let's call it a challenge or an opportunity for the future once we've established ourselves as a great MEK/RAF choice. So I appreciate the question. But right now, that's not our focus.

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Operator [41]

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Our next question comes with Thomas Smith with SVB Leerink.

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Thomas Jonathan Smith, SVB Leerink LLC, Research Division - Associate [42]

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Congrats on the strong quarter. I just have two questions on BRAFTOVI-MEKTOVI commercialization in melanoma. First, apologies if I missed this, but can you give us a sense of, I guess, any inventory trends during the quarter? And then secondly, in the first quarter, you've reported royalties for ex U.S. sales of the combo. And Jason, you called out the offset related to the MAA filing. But I was wondering if you can just give us a sense of the early demand trends that your partners are seeing outside the U.S. and how this compares to the uptake you've seen in the early launch?

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Ron Squarer, Array BioPharma Inc. - CEO & Director [43]

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Yes, great. Tom, I'll answer this quickly to see if we can get a couple more questions in today. Look, with regards to inventory, there's nothing sort of special going on in that regard. So it's not been -- I don't think it's in the area to focus on. Second, in terms of the channel, and from what I understand, channel's pretty efficient. They don't like to stock much of these drugs unless they have some consideration for that. So that's the standard across all oral molecules. Then with regards to demand ex U.S., what we'll say is, it's early days in Europe. You know that in Europe, pricing -- the challenges in regulatory approval is pricing approval. We've already mentioned that our European partner has been selling in the sort of pre-priced market. Germany, that's by far their most important early market. They are selling in other markets as well. The feedbacks we've received is very positive, similar dynamics to what we're seeing in the U.S., interestingly enough, in terms of some switch activity there. So we're pleased with what we're saying, it's just that they're only really able to capture a small percentage of the total European market, which over time, we think is going to be very important. This was exacerbated, as Jason mentioned, by this sort of small offset we had, which is mostly exhausted at this point, which made the early [losses] look even smaller. But it's going to become more relevant in the future. With Japan, we have to be clear. Melanoma is quite rare in Asia. It's not going to be about melanoma. We hope it will be about colorectal, assuming that the results are positive. So thanks for that question. I think we have time for at least one more.

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Operator [44]

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And our next question comes from Varun Kumar with Cantor Fitzgerald.

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Varun Kumar, Cantor Fitzgerald & Co., Research Division [45]

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Just one quick one on colorectal cancer. Now given colorectal cancer patients are mostly in community setting, and given now MEKTOVI and BRAFTOVI is already in the market, my question is how the launch dynamic in colorectal cancer, if approved, may differ versus melanoma, just given the impressive ramp we are seeing in melanoma market?

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Ron Squarer, Array BioPharma Inc. - CEO & Director [46]

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Yes, Varun. Thanks for the question. And I think we will have time as we approach the top of the hour just for one last question after this. So you got it right. Melanoma is primarily -- or is not primarily, but is more treated in the academic setting than in community; and the BRAF colorectal is going to be the reverse. And so you can expect us to have expansion in our customer-facing resources across sales, market access, and also separately, medical affairs, to really have to reach more of a community setting. We think that at the highest level, strategic level, that kind of expansion, that kind of activity, will put more of our folks in touch with the community melanoma prescribers when we're approved and can talk about it, assuming that we get there. And so we see it as a different marketing approach, but one that helps us perhaps to expand our melanoma effort beyond the -- beyond a focus in the academic setting. Not to mention that there's a -- I think there'll be a halo effect if our results are positive in BEACON that these products are really special and good. So I hope that helps, and maybe we'll take one last question today.

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Operator [47]

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I'm showing no further questions at this time.

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Ron Squarer, Array BioPharma Inc. - CEO & Director [48]

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Okay. Well thank you so much, everyone. I really appreciate it. We're certainly pleased with our results to date, and we'd like to thank our employees here at Array for their creativity, commitment and strong sense of urgency that continues to fuel our success. I also want to thank our patients, partners and shareholders for their continued confidence and support. We'll now close the call.

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Operator [49]

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