Q3 2019 Earnings Call

My name is Krish and I'll be your conference operator today.

Operator: And that will be your conference operator today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics 3rd Quarter 2019 Financial Results Conference Call. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Mr. Ian Karp, Karyopharm's Vice President, Investor Relations.

Tom I would like to welcome everyone to the Karyopharm Therapeutics third quarter two dozen the 19 financial results conference call.

There will be a question answer session to follow please be advised that this call is being recorded at the company's request.

I would now like to turn the call over to Mr. in car care, you forms Vice President Investor and public relations.

Thank you Chris. Thank you all for joining us on today's conference call to discuss Cartiform third quarter 2019 financial results and business update. This is the in carbon I'm joined today by Dr., Michael Kaufman, Our Chief Executive Officer, Dr., Sharon Shacham, President Chief Scientific Officer, Mr., Mike Mason, Chief Financial Officer, Mr., Christopher Miano, Chief business Officer.

Ian Karp: Thank you, Chris, and thank you all for joining us on today's conference call to discuss Karyopharm's third quarter 2019 financial results and business update. This is Ian Karp, and I'm joined today by Dr. Michael Kaufman, our Chief Executive Officer; Dr. Sharon Shacham, President and Chief Scientific Officer; Mr. Mike Mason, Chief Financial Officer; Mr. Chris Permiano, Chief Business Officer and General Counsel; Mr. Perry Monaco, Senior Vice President of Sales; and Dr. Jaden Shaw, Chief Medical Officer.

In General Counsel disrepair, everybody go senior Vice President of sale and Dr., Jay Shah Chief Medical Officer.

Ian Karp: On the call today, Dr. Coffman will provide an overview of key recent corporate developments, Kary will give an update on the initial commercial launch of Expovio, and Mike will highlight the third quarter 2019 financial results. We'll conclude with a Q&A portion of the call. Earlier this morning, we issued a press release detailing Karyopharm's results for the third quarter of 2019. This release, as well as an accompanying slide presentation, are available on our website at karyopharm.com.

On the call today nonrecourse will provide an overview of key recent corporate developments.

I'll give an update on the initial commercial launch of exposure.

I will highlight this third quarter 2019 financial results.

We will conclude with extremely portion of the call.

Well or this morning, we issued a press release detailing carrier forms results for the third quarter 2019.

This release as well as an accompanying slide presentation are available on our website Karyopharm dot com.

Ian Karp: Before we begin our formal comments, for those following along in the slide presentation, please turn to slide three, and I'll remind you that the various remarks we will make today constitute forward-looking statements for purposes of the State of Harvard provisions under the Private Securities Litigation Reform Act of 1995. These include statements about future expectations, clinical developments, regulatory matters and timelines, the potential success of our products and product candidates, including our expectations relating to the commercialization of Expovio, financial projections, and our plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our most recent quarterly report on Form 10-Q, which is on file with the SEC, and in other filings that we may make with the SEC in the future.

Before we get our formal comments for those following along in the slide presentation. Please turn to slide three and I'll remind you that various remarks, we will make today constitute forward looking statements for purposes of the safe Harbor provisions under the private Securities Litigation Reform Act of 1995.

Statements about future expectations clinical development and regulatory matters and timelines.

Interest expense for products and product candidates, including our expectations relating to the commercialization of extra reveal financial projections and our plans and prospects.

Actual results may differ materially from those indicated by these forward looking statements as there's all the various important factors, including those discussed in the risk factor section or most recently quarterly report on Form 10-Q , which is on.

And in other filings that we may make what gets you the future any forward looking statements represent our views as today only when we may elect to update these forward looking statements at some point of the future. We specifically disclaim any obligation to do so even if our future. Therefore, you should not why are these forward looking statements as representing our views as if any date subsequent today.

Ian Karp: Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date, especially when they are not. In addition, please note that any references we make to clinical trial data during today's discussion refer to interim, unaudited site data, unless otherwise. We will also be providing on this call a non-GAAP outlook for operating expense for 2019, which can only be provided on a non-GAAP basis without unreasonable effort. I'll now turn the call over to Dr. Michael Kuffman, Chief Executive Officer, and please now turn.

In addition, please note that any references we make the clinical trial data during today's discussion reported interim.

At that site data unless otherwise specified we'll also be providing on this call non-GAAP outlook for operating expense for 2019, which can only be provided on a non-GAAP basis without.

Unreasonable efforts.

I'll now turn the call Dr., Michael Kaufman, Chief Executive Officer, and please now turn to slide number four.

Michael P. Mason: Thank you, Anne. Thank you.

Thank you and and good morning, everyone before I provide details for third quarter performance I think it's important to set a bit of context in terms of where we are on our journey towards becoming a leading oncology focused pharmaceutical company.

Michael P. Mason: And good morning, everyone.

Michael P. Mason: Before I provide details of our third quarter performance, I think it's important to set a bit of context in terms of where we are on our journey towards becoming a leading oncology-focused pharmaceutical company. Karyopharm's mission is clear, to help improve the lives of patients with cancer and other serious diseases. Our ability to effectively fulfill this mission is predicated on three fundamental principles.

Our mission is clear to help improve the lives of patients cancer and other serious diseases, our ability to effectively propel. This mission is predicated on freight fundamental principles first our company was founded on and remains intensely committed to advancing innovative science. So in discovery development and commercialization medicine.

Michael P. Mason: First, our company was founded on and remains intensely committed to advancing innovative science and pursuing the discovery, development, and commercialization of medicines with novel mechanisms of action. Our core area of scientific focus, nuclear export dysregulation, is increasingly recognized as playing a fundamental role in oncogenesis, along with other conditions, and Expovio is now the first and only approved drug targeting the inhibition of XPO1 proteins, plays a critical role in many camps. This novel approach was recognized specifically in myeloma with the recent publication of the storm results in the New England Journal of Medicine.

With novel mechanisms of action.

Our core area of scientific focused nuclear export regulation is increasingly recognized as playing a fundamental role and also genesis along with other conditions annex folio and now the first and only approved drug targeting inhibition of SPL. One protein plays a critical role in many cancers. This novel.

Roche was recognized specifically in myeloma with the recent publication of the Star results in the New England Journal of Medicine.

Michael P. Mason: Secondly, we aim to meaningfully and urgently impact the treatment of patients with relapsed refractory multiple eloma. We were extremely pleased with the FDA's accelerated approval decision in July, and you'll hear more about Expovio's early commercial success in a few minutes from Paris. Additionally, we aim to expand Expovio's role in multiple myeloma treatment and eagerly await the top-line results from the Phase III Boston study in early 2020. Finally, we believe Expovio and our follow-on investigational medicines have the potential to impact patients with high-unmet medical needs beyond multiple myeloma. To that end, in the near term, we expect to submit an NDA requesting accelerated approval in DLV's deal before the end of this year. And we remain highly encouraged about the potential solid tumor indications for Expovio, the first in Leglo sarcoma, with phase three seal data expected mid-next year.

Secondly, we aim to meaningfully and urgently impact and treatment to patients with relapsed refractory multiple myeloma.

We were extremely pleased with the Afghan accelerated approval decision in July and you'll hear more about expose early commercial success in a few minutes from there.

Additionally, we aim to expand its phobias role in multiple myeloma treatment eagerly await the topline results from the phase three Boston studies in early 2020.

Finally, we believe its folio and our follow on investigational medicines has the potential to impact patients with high unmet medical need cancers beyond.

To that end in the near term, we expect to submit an ending a requesting accelerated approval in deal PCL before the end of this year.

And we remain highly encouraged about potential solid tumor indications for its phobia a person like lets start with.

Phase III deal data expected mid next year.

Michael P. Mason: We remain truly excited about what the future has in store for Karyopharm and the patients we are serving. With this as a backdrop, let's now turn to the progress we made, specifically in the third quarter, which is highlighted on slide five. The past few months have been a remarkable period for Karyopharm, following the accelerated approval on July 3rd from the FDA, with the first shipments of Expovio taking place on July 9th. The Expovio launch is off to a very strong start, and we are pleased to report $12.8 million in net product sales for the third quarter. The demand for Expovia has been driven by a broad base of health care providers with over 300 unique positions.

We remain fully excited about what the future has in store for Karyopharm and the patients were serving.

With this as a backdrop, let's now turn to the progress we made specifically at third quarter, which is highlighted on slide five.

The past few months had been a remarkable carried for karyopharm. Following the accelerated approval on July 3rd on the FDIC with the first shipments of exposure we have taken place on July nine.

Phobia launch is off to a very strong start we're pleased to report $12.8 million in net product sales for the third quarter. The demand for exposure has been driven by a broad base of health care providers with over 300 unique positions our accounts, having prescribing Fabio and over 500 prescriptions filled in less than the are you all months.

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Michael P. Mason: [inaudible] We also continue to make additional important clinical and regulatory progress in the quarter. Most notably, the results of the Phase 2B Storm Study evaluating Expovio in patients with triple class refractory multiple myeloma were published in the New England Journal of Medicine in August. Additional supportive clinical data highlighting the activity of Expovio with dexamethasone and with other anti-myeloma agents were presented at the 17th International Myeloma Workshop in September. As we look ahead to some important milestones over the coming months, we remain on track to submit an NDA and DLVPL by the end of 2019. And importantly, we expect top-line data from the phase three Boston study to be reported in early 2020, with specific timing contingent on the occurrence of progression events, the primary endpoint of this study.

On the market.

We also continued to make additional important clinical and regulatory process progress in the quarter.

Most notably the results from phase to be storm study evaluating spone on patients the triple class refractory multiple myeloma are published in the knowing the journal of Medicine in August and additional support a clinical data highlighting the activity phobia index MSR and with other anti myeloma agents were presented at 17 International Myeloma workshop.

Temper.

As you look out for some important milestones over the coming months, we remain on track and submit an M.D.A. NGL bcl by the end of 2019.

And importantly, we expect topline data from the phase three Boston Studies reported in early 2020 specific timing contingent on the currency progression events. The primary endpoint of this study.

Michael P. Mason: Additionally, we continue to anticipate a decision from EMA on our marketing authorization application for Selenexor in patients with heavily pretreated multiple myeloma in early 2020. Finally, on the financial front, in the third quarter, we secured additional capital to support the ongoing commercialization and development of Expovio, along with our other products, specifically entering into royalty agreements with healthcare royalty partners for up to $150 million in capital. This additional capital contributed to Karyopharm ending the quarter with approximately $270 million in cash, cash equivalents, and investments, and extending our expected cash runways to fund planned operations into the middle of 2021. Now turning to slide 6, I'll take a moment to review the Expovio product profile and approved indicators, which Foveo has approved in combination with dexamethasone for the treatment of adult patients with relapsed...

Finally, we continue to anticipated decision for me I may on our marketing authorization application for Selinexor in patients with heavily pretreated myeloma in early twenties one.

Finally on the financial front in the third quarter, we secured additional capital support the ongoing commercialization and development Oh yeah.

Along with our other for other products specifically entering into a royalty agreement was held healthcare royalty partners for up to 150 million in capital.

This additional capital contributed to Karyopharm ending the quarter was approximately $270 million and cash cash equivalents and investment and extended our expected spending our expected cash runway to fund planned operations in the middle of 2021.

Now turning to slide six I'll take a moment to review the Fabio product profile and approved indication.

Well the I was approved in combination estimates so the treatment of adult patients with relapsed.