$MDVN earnings conference call or presentation

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Edited Transcript of MDVN earnings conference call or presentation 6-Aug-15 8:30pm GMT

Q2 2015 Medivation Inc Earnings Call

(Thomson StreetEvents) — Edited Transcript of Medivation Inc earnings conference call or presentation Thursday, August 6, 2015 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Anne Bowdidge

Medivation, Inc. – Senior Director IR

* David Hung

Medivation, Inc. – President, CEO

* Rick Bierly

Medivation, Inc. – CFO

* Lynn Seely

Medivation, Inc. – Chief Medical Officer

* Joe Lobacki

Medivation, Inc. – Chief Commercial Officer

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Conference Call Participants

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* Matt Roden

UBS – Analyst

* Jonathan Aschoff

Brean Capital, LLC – Analyst

* John Newman

Canaccord Genuity – Analyst

* Geoffrey Porges

Bernstein – Analyst

* Carter Copeland

Barclays Capital – Analyst

* Katherine Xu

William Blair & Company – Analyst

* Biren Amin

Jefferies LLC – Analyst

* Simos Simeonidis

RBC Capital Markets – Analyst

* Bryan Czyzewski

JMP Securities – Analyst

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Presentation

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Operator [1]

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Good afternoon, everyone, and welcome to Medivation’s second-quarter 2015 financial results conference call. This call is being recorded. At the end of the Company’s prepared remarks, we will open the call for questions and we will provide specific instructions at that point.

I now would like to turn the call over to Anne Bowdidge, Senior Director of Investor Relations. Please go ahead.

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Anne Bowdidge, Medivation, Inc. – Senior Director IR [2]

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Thank you for joining us. On the call today from Medivation are Dr. David Hung, President and CEO; Rick Bierly, Chief Financial Officer; Joe Lobacki, Chief Commercial Officer; and Dr. Lynn Seely, Chief Medical Officer.

We issued a press release today that you can find on our website at www.medivation.com.

Before we begin, I would like to remind you that various remarks that we make on this call contain forward-looking statements that are made under the Safe Harbor provisions of the securities laws. Forward-looking statements involve risks and uncertainties that could cause Medivation’s actual results to differ significantly from those projected or included in Medivation’s guidance, including, without limitation, risks related to the timing, progress, and results of Medivation’s clinical trials, including the risk that adverse clinical-trial results could alone or together with other factors result in a delay or discontinuation of the commercialization of XTANDI or some or all of Medivation’s product development activities, including, with respect to MDV9300, Medivation’s dependence on the efforts of and funding by Astellas for the development, manufacturing, and commercialization of XTANDI; the risks that the unanticipated expenditures or liabilities and other risks detailed in Medivation’s filings with the SEC, including our quarterly report on Form 10-Q for the quarter ended June 30, 2015, which is going to be filed today.

In addition to our prepared remarks, we may make forward-looking statements in response to questions, including, for example, statements regarding our current and potential future collaborations, potential in-licensing opportunities, and our future financial position and results.

Any statements made in this call that are not statements of historical facts may be deemed to be forward-looking statements. All forward-looking statements made during this call are based on information available to us as of today and we assume no obligation to update these statements as a result of future events or otherwise.

This call is the property of Medivation and any replay of this conference call cannot be made without Medivation’s expressed written permission.

We will also be using non-GAAP financial measures to help you understand underlying business performance. The non-GAAP to GAAP reconciliations are provided in our press release and will be posted on our website.

With that, I will turn the call over to Dr. David Hung, President and CEO of Medivation. David?

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David Hung, Medivation, Inc. – President, CEO [3]

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Thanks, Anne. Thank you all for joining us today.

XTANDI’s commercial performance in both the US and outside the US demonstrates continued traction towards becoming a foundation of therapy for the treatment of metastatic castration-resistant prostate cancer. Based on sales reported in the second quarter, XTANDI sales worldwide were at a nearly $2 billion annualized (technical difficulty), and after three full quarters with our expanded metastatic CRPC label, XTANDI has attained leadership status among novel hormonal therapies in the US.

We are proud of these accomplishments, especially considering that among those therapies XTANDI was second to market.

We believe there lies a significant opportunity ahead for XTANDI. Although the majority of prescriptions currently being written for XTANDI come from oncologists, we have seen substantial growth in prescriptions written by both oncologists and urologists following the chemo-naive metastatic CRPC launch. Over this past quarter, we saw urology sales grow to represent an estimated 20% of our business.

Looking ahead, a substantial opportunity for XTANDI is in the mCRPC market currently served by bicalutamide. Bicalutamide is the most commonly used anti-androgen in urology. We believe we are well positioned for future development in this area with the recent data from STRIVE and TERRAIN demonstrating head-to-head superiority against bicalutamide.

In addition, Medivation and Astellas have also launched the TRUMPET registry, which is a prospective observational patient registry designed to better understand the unique needs and treatment patterns for patients with CRPC. The registry will enroll and evaluate 2,000 patients diagnosed with CRPC from urology and oncology sites across the US.

The insights we gain from TRUMPET can directly impact our research and increase our understanding of important treatment considerations to help us provide the most effective therapy for patients and their caregivers.

I’m also very pleased to announce the recent US FDA approval of our label update for XTANDI noting significantly prolonged median overall survival in chemo-naive men with metastatic CRPC, based on the updated survival analysis from PREVAIL.

We do not intend to stand still. We will continue to generate clinical data that support the scientific and medical rationale for treating patients across the prostate cancer continuum, as well as in additional cancer patient areas of unmet need, which I will speak to later in the call.

With that introduction, I will turn the call over to Rick to discuss our financial results for the second quarter of 2015 and then I will update you on our clinical and research programs. Rick?

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Rick Bierly, Medivation, Inc. – CFO [4]

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Thank you, David, and good afternoon, everyone.

I will begin with XTANDI net sales worldwide at the level reported by Astellas, which were approximately $487 million in the second quarter, more than double the $229 million reported in the second quarter of last year and an increase of 36% over $357 million reported in the 2015 first quarter.

In the US, XTANDI net sales at the Astellas level were approximately $298 million in the second quarter, more than double the level of the year-ago second quarter. US net sales increased 33% over first-quarter 2015 net sales of $224 million.

Based on information provided by Astellas, we estimate underlying unit demand grew at a low to mid-teens percentage rate compared with first-quarter unit demand, accounting for just under half of the $74 million sequential-quarter growth. In the US, we estimate there were between 35,500 and 36,500 prescriptions written for XTANDI during the June quarter, compared with 31,000 to 32,000 in the March quarter. We continue to be pleased with the sequential-quarter growth we have seen since the PREVAIL approval in September of last year.

And since the US launch of XTANDI in September 2012, prescriptions have been written by more than 9,500 individual prescribers in the US. Since XTANDI’s PREVAIL label update, we have experienced substantial growth in new patient starts and total demand.

While most XTANDI prescriptions are written by oncologists, in the second quarter we saw continued growth in both the number of urologists writing XTANDI, as well as the total XTANDI volume in urology. Approximately 20% of prescriptions are now in urology.

Our market research suggests that XTANDI is now the preferred treatment modality among novel hormonal agents and it is an increasingly important therapeutic choice for urologists in mCRPC. XTANDI enjoys broad coverage in metastatic CRPC in virtually all US Medicare and commercial payer prescription plans.

I would like to briefly address gross to net, which, as you know, is managed by Astellas. For US net sales of XTANDI, you will see us reference two components of gross to net on sales reported at the Astellas level in any given period. The primary component is the gross to net accrual rate provided by Astellas related to current-period gross sales, and the second component is the adjustment Astellas may make from time to time to gross to net accruals related to previous-period gross sales.

The gross to net accrual rate related to current-period gross sales in the second quarter was a low double-digit percent of gross sales, compared with a high-teen percent seen in the first quarter. The difference in the accrual rates of gross to net used in the second quarter, compared with the first quarter, contributed approximately $20 million to the quarter-over-quarter growth in net sales.

As we have said, when we look at the four quarters of the calendar year, the first-quarter gross to net accrual rate utilized by Astellas is typically the highest rate of the year because of the annual calendar-year reset of the so-called donut hole associated with Medicare Part D coverage. And we expect the full-year weighted average gross to net rate utilized by Astellas before adjustments to be a mid-teens percentage rate in 2015.

Accordingly, we would expect third- and fourth-quarter gross to net accrual rates to be below the full-year mid-teens average rate before adjustments.

Turning now to the gross to net second component, net sales in the US at the Astellas level in the June 30 quarter also included a $2.8 million favorable gross to net adjustment related to changes to gross to net estimates from prior periods.

You may recall this was just over $5 million in the first quarter.

Specialty pharmacy and wholesale channel partner inventories increased in dollar terms single-digit millions during the second quarter, compared with the first. This increase, measured in units, is in line with XTANDI’s quarter-over-quarter unit demand growth, such that the number of weeks of supply at the end of the quarter within the channel is within a normal range of approximately two to three weeks.

Ex-US net sales of XTANDI, reported by Astellas, were approximately $188 million in the June quarter, 42% higher than the ex-US sales of approximately $133 million for the March quarter. Strong sales results were seen in Japan, Germany, and France following recent approvals and launches in those markets associated with PREVAIL.

US dollar equivalent sales for the June quarter were adversely affected by a strengthening US dollar versus other currencies by approximately $3 million, or 2%, compared with the ex-US sales for the March quarter.

Turning now to Medivation’s income statement, total non-GAAP collaboration revenue was $174.8 million in the second-quarter 2015, compared with $81.9 million for the same period in 2014. This is 114% growth over the prior year.

For the second quarter, collaboration revenue related to US net sales was $149.2 million, compared with $71.9 million in the year-ago quarter. These amounts, as you know, are equal to one-half of the net sales reported by Astellas in those respective periods.

Outside the US, our collaboration revenue related to ex-US XTANDI net sales was a royalty of $25.6 million, compared with $10 million in the year-ago quarter. Upfront and milestone payments are excluded from non-GAAP collaboration revenue. On a GAAP basis, such revenue was $0.8 million in the second quarter of 2015, compared with $66.2 million in the year-ago quarter, which included $62 million of development milestone payments earned from Astellas.

Second-quarter non-GAAP operating expense was $98.8 million, compared with $73.3 million for the same period in 2014. Non-GAAP SG&A expense for the second quarter of 2015 was $57.5 million, compared with $43.6 million for the same period in 2014. The increase in non-GAAP SG&A expense primarily relates to higher selling, marketing, medical affairs, and administrative expense. This includes higher personnel-related costs associated with expansion done in the past year, but it excludes stock-based compensation.

Non-GAAP R&D expense for the second quarter of 2015 was $41.3 million, compared with $29.6 million for the same period in 2014. The increase in non-GAAP R&D expense primarily relates to MDV9300, certain preclinical expense for other programs, and facilities, technology, and personnel related costs, but again it excludes stock-based compensation.

Medivation reported non-GAAP net income of $48.7 million or $0.58 per diluted share for the second-quarter 2015, compared with non-GAAP net income of $4.4 million or $0.05 per diluted share in the year-ago second quarter.

At June 30, we had cash, cash equivalents, and short-term investments of just under $500 million, down slightly from the level on hand at December 2014. This is primarily due to the cash used to settle over $90 million of the convertible notes during the second quarter. In late July, we completed the redemption of all of the remaining convertible notes with the issuance of 1.77 million shares of common stock and payment of $168 million in cash.

Moving now to guidance, we are revising upward our full-year 2015 XTANDI US net sales and non-GAAP collaboration revenue guidance. Looking first at the US, we now estimate 2015 XTANDI net sales at the Astellas level to be at a range of $1.14 billion to $1.18 billion, up from $1.05 billion to $1.125 billion.

The midpoint of this new range is an approximate 71% increase over 2014 US net sales of $680 million.

Medivation’s total non-GAAP collaboration revenue in 2015 is now expected to range between $670 million and $700 million, up from $600 million to $650 million. The midpoint of non-GAAP collaboration revenue guidance for 2015 represents a 76% increase over $389 million in 2014. This revenue measure includes our 50% share of collaboration revenue related to US net sales of XTANDI now expected to range from $570 million to $590 million, and it also includes our collaboration revenue related to ex-US net sales in the form of a royalty earned from Astellas now expected to range from $100 million to $110 million at current exchange rates.

2015 non-GAAP collaboration revenue excludes $2.8 million related to amortization of the upfront and milestone payments that we fully expect to fully recognize on a GAAP basis in 2015. It also excludes the two remaining sales milestones. With the updated sales guidance that we are providing today, we now expect to earn the remaining $245 million of GAAP basis sales milestones from Astellas in 2015, as would occur at the low end of the revised guidance range.

As a reminder, this amount is related to attaining both of the $1.2 billion and $1.6 billion thresholds in worldwide XTANDI net sales in the 2015 calendar year, giving rise to $70 million and $175 million of sales milestones earned, respectively.

Regarding other guidance items, I provide the following for your models. We are maintaining our previously issued non-GAAP operating expense guidance of $410 million to $450 million. We currently anticipate the back half of 2015 non-GAAP R&D spend will reflect higher manufacturing, clinical, and personnel costs related to MDV9300 and XTANDI compared with that seen in the first half.

We are changing our previously issued non-GAAP interest expense guidance of $5 million to non-GAAP other expense of approximately $2 million for 2015. The non-GAAP other expense will exclude non-cash interest expense, as well as any loss on extinguishment of the convertible notes. Such loss on extinguishment was about $8 million in the second quarter and is expected to be another $13 million in the third quarter.

For taxes, I suggest to use 36% to 37% for the 2015 non-GAAP effective tax rate, which excludes any benefit from the R&D credit that expired at the end of 2014.

All guidance information is included in our press release filed today and non-GAAP information may also be found at our website at medivation.com.

With that, I will hand the call back over to David.

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David Hung, Medivation, Inc. – President, CEO [5]

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Thanks, Rick.

I would now like to update you on our progress to develop enzalutamide in earlier stages of prostate cancer, breast cancer, and in other indications where it may provide meaningful benefit.

I will start with our initiatives in prostate cancer. As I previously mentioned, earlier this year we announced positive topline results from both STRIVE and TERRAIN, two trials in which enzalutamide was compared head to head against bicalutamide and which collectively enrolled nearly 800 subjects. Both trials met all of their primary and secondary endpoints with robust statistical significance, showing substantial increases in medium PFS in the enzalutamide group versus the bicalutamide group.

Median PSF in STRIVE was 19.4 months in the enzalutamide group, compared with 5.7 months in the bicalutamide group.

The safety profile of the enzalutamide-treated patients in TERRAIN and STRIVE was consistent with the known safety profile of enzalutamide.

We look forward to publishing these results, as we believe they provide an important data point for physicians and patients.

Our first patient was enrolled in our EMBARK study just seven months ago. EMBARK is our global Phase III registrational trial evaluating approximately 1,860 patients with high-risk, hormone-sensitive nonmetastatic prostate cancer that has biochemically recurred, as defined by a rise in PSA following surgery and/or radiation.

The primary endpoint of the trial is metastasis-free survival. The purpose of the trial is to determine if enzalutamide can delay the development of metastatic prostate cancer in high-risk men with a rapidly rising PSA. The trial will have three arms, including enzalutamide in combination with leuprolide, enzalutamide alone, and leuprolide alone. This is the first trial that includes a head-to-head comparison arm of enzalutamide against the most widely used androgen deprivation therapy, leuprolide.

Our Phase III PROSPER trial has been enrolling since November 2013. As a reminder, PROSPER is enrolling a high-risk subgroup of approximately 1,560 pre-chemo nonmetastatic CRPC patients whose disease is progressing despite androgen deprivation therapy and are asymptomatic. The primary endpoint of this study is metastasis-free survival.

I will now take a moment to provide an update on our trials evaluating enzalutamide in three major subsets of breast cancer. In June at ASCO, Dr. Tiffany Traina from Memorial Sloan-Kettering presented data from our Phase II trial evaluating enzalutamide as a single agent for the treatment of advanced androgen receptor positive triple negative breast cancer, or TNBC.

TNBC is a type of breast cancer that does not express any of the three most commonly targeted receptors in breast cancer — the estrogen receptor, progesterone receptor, and HER2. It is estimated that approximately 20% of women with metastatic breast cancer are triple negative. TNBC is a particularly challenging subtype of the disease for which the only available treatment option is chemotherapy.

As we have previously announced in a press release and as we have described in detail in our most recent Form 10-Q, the study met its primary endpoint, achieving a clinical benefit rate at 16 weeks of 35%. We encourage you to read the 10-Q to achieve a comprehensive understanding of the design, conduct, and results of this study.

However, during this conference call, I would like to highlight just a subset of our TNBC data as pertains to our continuing development of a novel genomic signature diagnostic test. We presented at ASCO a poster describing the identification of a novel genomic signature that, on the basis of exploratory data derived from our TNBC study, we believe may improve our ability to predict response to enzalutamide therapy.

This diagnostic genomic assay identified approximately 50% of the intent-to-treat TNBC population as diagnostic positive. And patients were categorized as either diagnostic positive or diagnostic negative.

In women who are diagnostic positive in our TNBC study, 39% achieved a clinical benefit rate at 16 weeks and 36% achieved a clinical benefit rate at 24 weeks. In women who are diagnostic negative in our TNBC study, only 11% achieved the clinical benefit rate at 16 weeks and only 6% achieved a clinical benefit rate at 24 weeks.

Median PFS in the diagnostic positive group was 16.1 weeks, compared with 8.1 weeks in the diagnostic negative group. In the subset of diagnostic positive patients treated with enzalutamide as their first- or second-line therapy, the median progression-free survival was 40.4 weeks. In the diagnostic negative patients, it was 8.9 weeks.

This same diagnostic test also generated encouraging findings in an exploratory analysis of study data conducted to determine overall survival in this TNBC study, as overall survival was an exploratory endpoint in the trial. Whereas the median overall survival in diagnostic negative TNBC patients treated with enzalutamide was 32.1 weeks, the median overall survival in diagnostic positive TNBC patients treated with enzalutamide had not at the time of the analysis been reached, and in fact, the lower bound of the confidence interval of diagnostic positive TNBC patients treated with enzalutamide was 55 weeks, more than 23 weeks longer than the median overall survival in diagnostic negative patients.

The hazard ratio for these overall survival results was 0.38 with a nominal p-value of 0.0011, indicating a 62% reduction in the risk of death for diagnostic positive patients compared to diagnostic negative patients.

We will continue to monitor patients in an ongoing follow-up phase to establish the median overall survival estimate in the diagnostic positive patients.

It is premature to draw conclusions from these data since this trial did not control for factors that may influence outcomes. However, we believe that these exploratory results indicate that a diagnostic — a genomic diagnostic test could identify women who might realize a survival benefit from enzalutamide treatment. It is our intention to continue to develop a diagnostic and to test this hypothesis in the clinical setting.

Enzalutamide is not currently approved as a treatment for TNBC and the FDA would not consider it to be approvable as a treatment for TNBC on the basis of the exploratory data summarized above. An adequate, well-controlled Phase III trial demonstrating acceptable safety and efficacy of enzalutamide in women with diagnostic TNBC, as well as the clinical performance of the companion diagnostic, would be required in order to seek approval for enzalutamide in this indication.

I would now like to take a moment to discuss our ongoing trials evaluating XTANDI in other populations of breast cancer. Five months ago, we completed enrollment in our Phase II trial evaluating enzalutamide in combination with exemestane versus exemestane alone in women with advanced breast cancer as ER+ and/or PR+ positive and HER2 normal.

The trial enrolled 247 women. The primary endpoint is progression-free survival in all patients and in the subset of patients whose tumor expresses the androgen receptor. Enrollment is continuing in our Phase II trial evaluating enzalutamide in patients who are HER2 amplified and AR+, which Astellas began in August 2014.

The goal of the study is to determine whether adding enzalutamide to trastuzumab, otherwise known as Herceptin, will provide any incremental benefit for women who have progressed on trastuzumab.

We’re also evaluating other potential uses for enzalutamide. Recently, Astellas has begun startup activities for a Phase II trial evaluating enzalutamide in patients with advanced hepatocellular carcinoma, which is believed to be the most common hepatobiliary malignancy, representing more than 80% of all liver cancer cases.

Our research and development teams are also advancing innovative programs focused on new technologies with the potential to address the unmet needs of patients across several disease indications. In the future, we look to drive additional value through our internal proprietary research and development programs, as well as through external opportunities, to make a meaningful impact on the quality of life of patients with serious diseases.

Immuno-oncology is an important area of emphasis for Medivation. In December, we licensed the worldwide rights to the monoclonal antibody pidilizumab, which we will continue to develop as MDV9300. We anticipate initiating a Phase III clinical trial in at least one hematologic malignancy as early as 2015 and we are also considering evaluating MDV9300 in other indications, including, but not limited to, breast and prostate cancer.

We expect to announce another completely new development program in 2015 and will continue to actively pursue other external opportunities.

And finally, in our 8-K we filed on July 31 we announced a 2-for-1 stock split. Medivation’s common stock will begin trading on a split-adjusted basis on September 16, 2015.

In closing, we are pleased by our progress in the second quarter, including the strong commercial performance of XTANDI; execution on important trials evaluating enzalutamide earlier in the prostate cancer disease continuum, breast cancer, and other indications; as well as our continued development of our pipeline, all of which we believe support our short- and long-term growth strategies.

With that, we thank you for your continued support and look forward to updating you on our progress. I will now turn the call over to the conference coordinator to open the call up for Q&A.

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Questions and Answers

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Operator [1]

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(Operator Instructions). Matt Roden, UBS.

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Matt Roden, UBS – Analyst [2]

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Thanks very much for taking the questions. Congrats on the progress. The first question would be, can we go back to blocking the IMS prescription data? It seems to have caused a lot of confusion.

Seriously, though, Rick, thanks for the incremental detail on the components of the quarter-on-quarter growth. Just wanted to clarify, on the contribution of the two components of gross to net, as well as on the inventory contribution, these are not items that you would have to, quote, give back, so to speak, in the future periods? Is that correct?

In fact, it seems to me that at least in a prior period, the component of the gross to net and the inventory, you should be able to continue to contribute on a quarter-on-quarter growth going forward. Is that correct?

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Rick Bierly, Medivation, Inc. – CFO [3]

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Yes, thanks, Matt. Yes, I think you are right. Certainly with respect to the gross to net, we are looking at the second half of the year being, as I said, lower than the mid-teens rate, so let’s say more in line with what we saw in Q2 than what we saw in the first quarter, probably somewhere in between.

The inventory, there is a little bit of build in terms of dollars, but the units, I think, are consistent with the demand growth, so I would also agree there shouldn’t be too much of a giveback there. There might be a tiny bit.

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Matt Roden, UBS – Analyst [4]

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Okay, and then also, Rick, when you think about the assumptions underlying your guidance, obviously if you were to take it from here, it looks like your guidance range suggests about a 3% to 6% sequential growth for the rest of the year. Can you just maybe talk about the assumptions as it pertains to demand growth both in a oncology and urology setting to get to that guidance?

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Rick Bierly, Medivation, Inc. – CFO [5]

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Yes, sure. So I think, as you know, the way we have tended to look at this in the past is that we frankly prefer to be chasing this a little bit as opposed to be backing off, but I think if you were to take the $298 million at Q2, probably pull that favorable gross to net adjustment out of there and allow something for inventory, although I don’t think it’s much, and then build double-digit growth quarter to quarter off that, my thinking is you would probably get to the upper end of the range.

So that’s, as I said, probably consistent with where we have been on that.

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Matt Roden, UBS – Analyst [6]

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Okay, great. And then just lastly, Lynn, congrats on the updated breast cancer data here, but can you say whether or not you have submitted an abstract to San Antonio for the XTANDI and the hormone receptor breast cancer study? And if so, what do you need to see in that study to warrant advancement? And lastly, if it’s positive, how would you consider slotting in around [eye brands] in that setting? Thanks very much.

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Lynn Seely, Medivation, Inc. – Chief Medical Officer [7]

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So, certainly we are continuing to collect data from our breast cancer program and, as you know, we will consistently place abstracts as we are able and submit the data to upcoming meetings. And so I think that as we typically do, you can expect to see (technical difficulty) hopefully if they are accepted at ESMO and at San Antonio Breast. And I think we are continuing to discuss the best way to move this program forward with our partner Astellas and hopefully we will be able to update you in the future.

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Matt Roden, UBS – Analyst [8]

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Okay, great. Thanks very much and congrats on the progress.

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Operator [9]

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Jonathan Aschoff, Brean Capital.

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Jonathan Aschoff, Brean Capital, LLC – Analyst [10]

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I was wondering, perhaps David or Lynn, if you could please give us your view of AR-V7 targeted drugs as a competitive threat. And given that XTANDI promotes those changes, at least in part, as a means of resistance, what are you doing to develop or acquire one of your own?

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David Hung, Medivation, Inc. – President, CEO [11]

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Yes, so the data on it — so AR-V7 is one of the splice variants that has created some controversy over the past year. AR-V7 is known to be increased with any androgen deprivation therapy, so it actually occurs as early as getting bicalutamide or Lupron or XTANDI or Zytiga or any therapy that decreases androgen signaling.

There has really been no evidence yet that AR-V7 really correlates with a changed clinical outcome. In fact, there was a publication presented at ASCO-GU this past year by an Australian group showing that it did not seem to correlate at all with subsequent therapy — in response to subsequent therapies.

It is believed that AR-V7 becomes more prevalent the farther you fall in prostate cancer treatment, so the farther — the more advanced your disease is, it is believed that AR-V7 expression increases, and to that end there was a study presented by Bruce Montgomery at ASCO a little while ago looking at patients who failed abiraterone. So clearly after you fail a drug like abiraterone, you’re going to be more advanced than average.

And so, those patients would be expected to have a fair amount of AR-V7 expression. And if you look at that study, where Tokai [one] galeterone was studied, the PSA response rates in those [abby] failures was about 13%, whereas the PSA response of enzalutamide in that same study was 46%. So that would certainly suggest that if indeed AR-V7 is increased, there does not appear, at least in that study, to be an advantage of galeterone over XTANDI, and you may recall from publication in PNAS a couple years ago by Charles Sawyers, Charles Sawyers actually showed that XTANDI does appear to have a inhibit AR-V7, because AR-V7 appears to dimerize with full-length AR and because XTANDI hits the [lag and bind] to full-length AR, Charles Sawyers showed that it did inhibit AR-V7 in his publication.

But all that said, I think there is really no compelling evidence today that AR-V7 really predicts clinical outcomes, so I don’t really know. I think the most compelling data we can cite is just the head-to-head study in the Montgomery poster of galeterone against XTANDI, and as I said, the PSA response rate of XTANDI was about 3 times greater than galeterone. So, those of the data are out there.

I think one other thing to think about is that if you look at the Antonarakis paper, AR-V7 is measured in circulating tumor cells. So if you have high CTCs, you’re going to have — that’s the way you look for AR-V7. And in the Antonarakis paper, when he mentioned that patients were AR-V7 positive, clearly you had to have CTCs to find AR-V7. But what was not mentioned in that paper was whether or not [case 2] or AR-V7 negative had the control for a denominator of CTCs.

It is conceivable that those patients didn’t have CTCs, and if that indeed is the case, then what you might be looking at is patients who are CTC positive versus CTC negative. We know from multiple published studies that anybody who has a high CTC count is going to do worse than patients who don’t have a high CTC count.

So, I think the totality of the data suggests to us that — we think that XTANDI will be highly competitive. In the only known head-to-head study against galeterone, we think XTANDI looks pretty good. We think that the activity we have seen in post-chemo and now pre-chemo metastatic CRPC suggests to us that the drug has robust survival benefits. And if you now look at the data we have recently published on STRIVE and TERRAIN showing head-to-head comparisons against the gold standard of care, Casodex, again I can say that those data give us great confidence, given the fact that we have now — we are the only agent to have demonstrated a benefit over the gold standard, Casodex, in a well-controlled trial.

So I think — we believe that we are pretty well positioned and I think that we are seeing increased urology adoption and we think that the profile of XTANDI has a lot to do with that.

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Jonathan Aschoff, Brean Capital, LLC – Analyst [12]

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Thanks, David. That was really helpful.

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Operator [13]

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John Newman, Canaccord.

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John Newman, Canaccord Genuity – Analyst [14]

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Thank you for taking the question. So the question I have is, David, can you remind us — and I apologize if you mentioned this in the script, can you remind us the percentage of patients that you believe may test as positive with your diagnostic tests in breast cancer for XTANDI?

And then, I wonder if you could give us any descriptive color around what you are observing in terms of the urology share quarter over quarter and maybe going back into last year, and just also any comments that you’re hearing from the urologists following the data presentations earlier this year.

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David Hung, Medivation, Inc. – President, CEO [15]

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I will take the first question and I will pass it to Joe for the second and third. So in our TNBC study, about 50% of our patients were diagnostic test positive, and so you look at — TNBC is about 20% of all metastatic breast cancer and clearly that is what is important because all the deaths in breast cancer really require metastasis to happen. So 20% of a metastatic population is a pretty sizable population and it appears to us in our study of TNBC patients about half of those were diagnostic test positive.

Joe, you want to answer the second?

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Joe Lobacki, Medivation, Inc. – Chief Commercial Officer [16]

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Sure, so thanks. This is Joe Lobacki. Looking at our shares, we continue to grow in the urology segment, and I think as mentioned by Rick and David we saw it growing from 15% to 20% of our business in urology.

We continue to gain in urology riders, so we build on that each quarter. And the riders from the first quarter, the good thing was they continue to ride to the second quarter, and again, we added new ones in the second quarter as well.

So we continue to grow in that space, and actually if you look at how we are growing, we surpassed sales of Zytiga this year — this quarter, so I think that’s a nice indication of how we are growing in urology and oncology.

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John Newman, Canaccord Genuity – Analyst [17]

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Great, and then if I could sneak in one last quick question for David, David, we have heard a lot of companies talking about the idea of running dual combination drugs in terms of two investigational drugs at once. I wonder if that is something you are considering with your PD-1 and XTANDI. Thanks.

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David Hung, Medivation, Inc. – President, CEO [18]

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We have said that we are going to talk a little bit more about our pidilizumab as we get into Phase III, so I think right now we are probably not going to talk a lot about that program.

I think that strategy has real merit. I think that we believe that may be an attractive thing to do not only with our pidilizumab agent, but potentially other agents. So we think that it is a very interesting way to create value. As you know, when you do combo drugs, your clinical trial becomes somewhat more complex because of the number of arms you have to show the combined superiority of.

But I think that, yes, it’s a strategy that we think about. We think about probably most strategies that we can to create value, so that would be one of them. But we will talk a little bit more about pidilizumab when we get into Phase III, which should be this year.

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John Newman, Canaccord Genuity – Analyst [19]

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Great, thank you.

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Operator [20]

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Geoffrey Porges, Sanford Bernstein.

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Geoffrey Porges, Bernstein – Analyst [21]

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Thanks very much for taking the questions. I wanted to push on this question of the urologists. Could you give us a sense, first of all, how far into what you foresee to be the addressable opportunity in the urology segment you are, just approximately? Is this still early days or are you halfway there to where you might get or are you most of the way there? I think we are all struggling to understand what incrementally is the opportunity in the urology segment.

And then, could you talk a little bit about what you are seeing in terms of the realized duration as you move into the urology segment? Are they keeping patients on — is it fair to use the TERRAIN and STRIVE duration of therapy as a proxy or are you heading more towards PREVAIL or could it be even longer than that? Thanks.

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Joe Lobacki, Medivation, Inc. – Chief Commercial Officer [22]

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Thanks. We continue to see some great growth in the urology segment, so we’re picking up new riders and maintaining the riders that we have. I think we are just really starting to get into this market. As David mentioned, there are some large agents in this market. There is a lot growing in mCRPC.

So we are making great strides and I think we have more to go, so we’ve got a great opportunity in the urology segment.

In terms of duration, we don’t talk about duration a lot, but I think you can look at it to say as we get to those earlier lines of therapy, you’re going to start seeing the duration increase. That just, I think, makes sense as you get into the area of lines of therapy. So we expect that to happen with urology and that’s why that segment is so important to us, so it’s a big focus.

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David Hung, Medivation, Inc. – President, CEO [23]

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And in fact, we have seen increases in uptake and duration, so it is a changing target, because clearly the more upstream patients you get, the more duration changes, so it is moving. It may not stabilize for some time, but we are seeing growth in sales and we believe that’s being contributed to by both increase in uptake and increase in duration.

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Geoffrey Porges, Bernstein – Analyst [24]

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Thanks very much.

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Operator [25]

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Geoff Meacham, Barclays.

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Carter Copeland, Barclays Capital – Analyst [26]

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It is Carter on for Geoff. Congrats on the strong quarter and thanks for taking our questions. So, first, can you offer some greater clarity on the timing of the publication of the STRIVE and TERRAIN results? Is that something we should still expect this year?

And second, I know you’re not going to give color on your pricing strategy, but does the improved guidance assume anything about a subsequent price increase in the second half of the year? Thank you.

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Lynn Seely, Medivation, Inc. – Chief Medical Officer [27]

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This is Lynn. I can answer with respect to the STRIVE and TERRAIN publications. We are, of course, very anxious to get those data published as soon as we can.

We want to, obviously, go to a high-quality peer-reviewed journal, and so that is a process, but I’m very optimistic about the ability to get these very important data published quickly.

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Rick Bierly, Medivation, Inc. – CFO [28]

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Yes, I will take the second question, Carter, on the pricing. This is Rick. As I think we have said before, we don’t talk about pricing strategy, but if I can cite facts and cite the history, I think we have been on a nine-month cycle here the last couple of times, but I would encourage you not to think that we are automatically on a nine-month cycle.

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Carter Copeland, Barclays Capital – Analyst [29]

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Thank you.

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Operator [30]

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Katherine Xu, William Blair.

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Katherine Xu, William Blair & Company – Analyst [31]

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I am just curious on the urologist side, of course you’re promoting on label mCRPC. What kind of responses do you get from urologists? Do you get any pushback on the pricing and all that?

And also, because STRIVE also has some metastatic patients there in that study, I’m just wondering whether XTANDI is being used in non-metastatic patients as well.

And also with the current annual scripts of 600,000 for Casodex, do you have a sense of breakdown of that in metastatic versus nonmetastatic? So that’s part one of my question, if you don’t mind.

And then, part two is on the Phase III TNBC — let’s say TNBC. Do you plan to go into a Phase III on the diagnostic assay or do you need another Phase II study to bridge or you think the current data is already strong enough for you to power into a Phase III?

And on the diagnostic assay, because it is a microarray analysis of 500 [aught] genes, is this difficult to develop? Is it going to be a reference lab thing or is it going to be a commercial type of diagnostic assay? Thank you.

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Joe Lobacki, Medivation, Inc. – Chief Commercial Officer [32]

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Thanks. This is Joe Lobacki. I will take a couple of the first questions there.

So in urology, you are correct. We do not — we promote in mCRPC and that’s our focus, so we promote to the PREVAIL label. And the urologists have seen the product very favorably, so it fits very nicely into their practice.

There are a lot of benefits for the patients in terms of it is easy to take. They don’t have to worry about food. There are no liver enzyme testing. So a lot of benefits for the urology office and the patients, so it has been very well received in mCRPC.

As we look at pricing, we do work with the offices on pricing. We haven’t had major pushback on that at all. We have, between our sales reps and the XTANDI support solutions, groups that help walk the urologists through accessing XTANDI for their patients. So, again, it has been well received in the urology setting.

In terms of annual prescriptions, it is hard to tell how things would break out, but we do see a lot of men who are being diagnosed or not being diagnosed as mCRPC, so that may be on bicalutamide, so we think those are our patient populations, so we are focused on that in trying to look at men who may not be properly diagnosed in mCRPC. But again, we promote to our label.

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David Hung, Medivation, Inc. – President, CEO [33]

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And then, Katherine, you asked about feedback from urologists. I think the feedback we have gotten is pretty consistent with what we have said we expected.

Urologists are very familiar with AR inhibition as a mechanism of drug because they use Casodex, as we have said more than 100 times more commonly than they use ketoconazole, which inhibits CYP17. So we have gotten that feedback and I think their familiarity with XTANDI’s mechanism is something that has probably helped us.

They also love the fact that we don’t require steroids; we don’t have a food effect; we are a once-a-day pill; the fact that we don’t require monthly liver function tests monitoring. I think those are all things that we hear are helpful. And of course, the efficacy and safety profile of XTANDI, I think, is also very compelling. So that’s the feedback that we get from urologists. I think it is very consistent with what we expected.

On the TNBC issue, I’m going to let Lynn answer that.

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Lynn Seely, Medivation, Inc. – Chief Medical Officer [34]

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Sure. In terms of moving into the Phase III program, I think you are aware we ran a quite complex Phase II program to really get a lot of information out of a single study. I think we have shown you a lot of data to suggest that we believe we have a diagnostic that can enable us to select women to run a successful trial, and I think this is our hope that we could move straight into a Phase III program and that is something we are discussing with our partner (technical difficulty) and hopefully that will be the case.

And in the question about the diagnostic assay, we haven’t talked in detail about how that will work moving forward. But again, we are quite confident that we have an assay which will enable us to get into Phase III and that it will be appropriate for the marketplace down the road.

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Operator [35]

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Biren Amin, Jefferies.

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Biren Amin, Jefferies LLC – Analyst [36]

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Thanks for taking my questions, guys. Maybe I will just start off with the ER+ study. Should we expect a similar patient population as the Phase II Zytiga trial, where they enrolled about 65%, 70% of their patients had prior exposure to nonsteroidal aromatase inhibitors? And I guess to clarify on that trial, did you enroll for AR+ patients and did you utilize a gene signature diagnostic?

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Lynn Seely, Medivation, Inc. – Chief Medical Officer [37]

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So let me just answer the second part of that first. We did enroll AR any, so the vast majority of these women will express the antigen receptor, but in our analysis we will be looking both at all patients, as well as those who are AR driven by the diagnostic.

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Joe Lobacki, Medivation, Inc. – Chief Commercial Officer [38]

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Maybe another point of consideration in considering other data that exists out there in breast cancer, as you know Zytiga inhibits CYP17 as a target, and when you inhibit CYP17, you change the profile of multiple hormones and one of those hormones is progesterone.

And there is published literature showing that when you inhibit CYP17, you get an upregulation of progesterone by a very considerable amount. And so, clearly giving those breast cancers that may be PR+, which is not uncommon at all, that can greatly affect the results of — or the efficacy, I guess, of that agent in breast cancer.

Clearly, XTANDI operates by a completely different mechanism by inhibiting the androgen receptor, so you probably can’t extrapolate results from a CYP17 inhibitor to an AR antagonist in breast cancer.

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Biren Amin, Jefferies LLC – Analyst [39]

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Got it, and then maybe if I could get a question on PROSPER. What was the reason for the completion date being pushed out on clintrials.gov from 2017 to 2019? Should we read anything into that as far as how enrollment is going?

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Lynn Seely, Medivation, Inc. – Chief Medical Officer [40]

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No, I think we are very pleased with our progress in PROSPER and, in fact, it is really going very much on track. I think — as you know, this is a nonmetastatic patient population and we don’t expect it to enroll quite as quickly as we saw with PREVAIL and AFFIRM because as we screen some of these patients that doctors think are nonmetastatic, it turns out that they’re actually metastatic, and so we have to screen more patients to actually get enrollment. But we are moving along medically and are on track with our projection.

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Biren Amin, Jefferies LLC – Analyst [41]

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Got it, and then maybe just a commercial question. With the urology share, is that being driven by large centers or by community centers?

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David Hung, Medivation, Inc. – President, CEO [42]

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We see actually across the whole — of all [the]. Whether it is a local small urology practice, larger urology practice, or even in academia, it is being driven across all urology.

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Biren Amin, Jefferies LLC – Analyst [43]

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Great, thank you.

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Operator [44]

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Simos Simeonidis, RBC Capital Markets.

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Simos Simeonidis, RBC Capital Markets – Analyst [45]

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Thank you very much for taking the question. You mentioned the shift in improvement in urology market share to 20%. I was wondering if you can comment on what you believe the penetration or market share is versus Zytiga in the pre- and post-chemo settings.

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David Hung, Medivation, Inc. – President, CEO [46]

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I was just going to say we usually don’t talk about the kind of market, the split between pre- and post-chemo, but just on the market share, and I will let Rick respond as well, it wasn’t — we are looking at urology to be 20% of our total business, not a market share in that area.

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Rick Bierly, Medivation, Inc. – CFO [47]

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Yes, I was going to say the same thing, and clearly I think we know that XTANDI has had pretty good acceptance and we had the predecessor drugs with ketoconazole, as well as Casodex, in urology and we saw that similar sort of receptivity.

So we are not closely tracking the share here in urology. We feel pretty good about our prospects there.

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Simos Simeonidis, RBC Capital Markets – Analyst [48]

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But in terms of what percent of the addressable population you at this point have been able to penetrate?

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Rick Bierly, Medivation, Inc. – CFO [49]

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Yes, I think as Joe said early on, I think we’re in the early stages here, and as you know, we are also conducting trials earlier than mCRPC, so we think there is a good runway ahead of us.

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David Hung, Medivation, Inc. – President, CEO [50]

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I think that — as you know, we surpassed Zytiga this quarter in sales, but our real target is Casodex. I think we are very, very early in capturing the entire prostate cancer market, which is really dominated by Lupron and Casodex, and that’s what we are going after.

So the trials that we are conducting, that’s PROSPER and ultimately [CHAARTED] will hopefully move us farther and farther upstream, and I think that, given the profile of the drug, we feel pretty optimistic that we are going to be pretty attractive to urologists.

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Simos Simeonidis, RBC Capital Markets – Analyst [51]

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Okay, I was going to ask you whether you believe that the CHAARTED study that was presented last year, I guess, in 2014 at ASCO may have any sort of impact, positive or negative, on XTANDI.

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David Hung, Medivation, Inc. – President, CEO [52]

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Let me talk about that. So the CHAARTED, for those of you who are less familiar, was a study where chemotherapy docetaxel was given to men who had high-volume metastatic disease who were hormone insensitive. That is actually a very small number of patients. We think that is a patient number probably in the range of 1,500 to maybe a little bit more than that, but a very small number because very few men just suddenly out of the blue present with metastatic high-burden disease who are hormone insensitive.

Most of prostate cancer, as you know, tends to progress slowly and over time, and it starts with a rising PSA after an extended therapy and then presents over time with metastases.

But we know that there are many, many year windows where patients have rising PSAs, develop metastases, don’t have — don’t really present with explosive disease.

So number one, CHAARTED represents a relatively small number of patients. Number two, if you look at the adverse events from chemotherapy between the STAMPEDE and CHAARTED studies, you can see that the grade 3 to 5 toxicities, 5 being death and 4 including life-threatening adverse events, is in the range of 50% to 52%, so that’s pretty tough. If you are early on in the disease spectrum, most of those men are just not going to take a therapy which has — where more than one in two of them is going to have to face a life-threatening or even serious adverse event.

So we think that given the tolerability profile of XTANDI, we think it is going to be a very welcome choice in those patients.

Also, I want to remind you of our PREVAIL data. So even in PREVAIL where we are talking about metastatic disease, but in patients are farther along, so they are castration resistant, as opposed to hormone sensitive, I might remind you that XTANDI still had a 59% overall response rate shrinking tumors, so this would be comprised of both complete responses and partial responses, and the complete response rate of XTANDI in metastatic castration-resistant pre-chemo disease was still 20%, so one in five patients had complete response of their tumor in a later-stage disease population.

So we think those data are very compelling. We think XTANDI is a highly active agent with an excellent safety/tolerability profile and we think that CHAARTED really represents a very small fraction of the prostate cancer market. So, we think we’re going to do just fine and we’re moving farther and farther upstream in every one of our development programs

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Simos Simeonidis, RBC Capital Markets – Analyst [53]

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Great, thank you. That’s very helpful. Final question for Lynn, in breast cancer. Lynn, the recent data out of the Genentech PD-L1 compound, I was wondering what your view is of XTANDI’s position in triple negative in light of this changing environment in the space? Could you potentially see XTANDI be a partner to a PD-L1 antibody, for example? Is there biologic rationale for such a combination?

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Lynn Seely, Medivation, Inc. – Chief Medical Officer [54]

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I guess I would say, first and foremost, our monotherapy data as alone are quite impressive, particularly in terms of the progression-free survival interval that we are seeing. So they have some response rate, but the duration of responses is actually not that impressive.

And so I think as monotherapy, our data looks quite good, but absolutely I think there is rationale to combine these drugs with immunotherapy, and as we said with our MDV9300 pidilizumab program, that is an opportunity for us.

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David Hung, Medivation, Inc. – President, CEO [55]

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And I would echo those comments by Lynn because, as you know in prostate cancer there was a recent publication by Jennifer Bishop showing that although most prostate cancers don’t express a lot of PD-L1, that when they fail XTANDI, when they are more advanced, you actually get a significant upregulation of PD-L1, which means that you can expect PD-1 inhibitors probably to have a greater effect.

So, the possibility of combining XTANDI with an agent like PD-1 is something that at least has a mechanistic rationale.

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Simos Simeonidis, RBC Capital Markets – Analyst [56]

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All right, thank you very much for taking the questions.

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Operator [57]

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Bryan Czyzewski, JMP Securities.

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Bryan Czyzewski, JMP Securities – Analyst [58]

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Thanks for taking the question. Most of my questions have already been answered, but I’m curious if you can give us some guidance on understanding how to think about the PREDICT AR positive population out there, especially as maybe how it compares to typical stratification methods out there, like IHC. Thanks.

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Lynn Seely, Medivation, Inc. – Chief Medical Officer [59]

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Yes, and when we actually started this Phase II program, you may or may not be aware, we actually thought a lot about IHC. In fact, we looked at a couple of different antibodies and we thought that maybe IHC might be a diagnostic of choice.

But what we found was it really wasn’t good enough and there is so much variability in immunohistochemistry, particularly when you roll it out and try and do it in a commercial setting, that we were actually really intent on finding something that might be a little bit better for us. And so, we were able to come up with a genomic signature which really helps us select women who we believe are more likely to respond to our drug and to enable us to enrich a Phase III trial which could be done successfully.

So, we believe we’re actually in a stronger position with this genomic test than with immunohistochemistry.

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David Hung, Medivation, Inc. – President, CEO [60]

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And as you know, IHC is a pretty laborious test and it is slow turnaround and requires a fair amount of labor, and so genomic testing also has other advantages that we think are very attractive and a quick turnaround and scalability.

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Bryan Czyzewski, JMP Securities – Analyst [61]

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Great, thanks a lot.

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Operator [62]

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Anupam Rama, JPMorgan.

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Unidentified Participant [63]

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This is [Eric] in for Anupam. Maybe just a follow-up question on potential publication of STRIVE interim data. Just wondering maybe you have plans to submit the data, as well, to NCCN and AUA, and is it possible or reasonable to expect potential guideline amendments around the time of publication? Thanks.

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Lynn Seely, Medivation, Inc. – Chief Medical Officer [64]

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Certainly. As you know, once they are presented and then certainly when they’re published that they can — they are considered by the guidelines committee, and we work very actively to make sure that groups like the NCCN are kept up to date with the data that we have.

And so, one would hope that actually (technical difficulty) will act upon that, but that will be up to them and we will have to wait and see. But that is, again, one of the reasons we are so intently looking to publish as quickly as we can.

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Joe Lobacki, Medivation, Inc. – Chief Commercial Officer [65]

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And just — this is Joe, I’ll just add on to that, the data will help out, but just be aware that the NCCN guidelines already place us in a very strong position for mCRPC patients, so, and ahead of some other agents. So, we’re in a good position right now.

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Unidentified Participant [66]

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Okay, thanks for taking the question.

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Operator [67]

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I am showing no further questions at this time. Ladies and gentlemen, this concludes today’s conference. Thank you for your participation and have a wonderful day. You may all disconnect.

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