Q1 2020 Earnings Call

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Unknown Speaker: BF-WATCH TV 2021

Good morning, My name is Patrice and I'll be your conference operator today at this time I like to welcome everyone to the Karyopharm Therapeutics first quarter 2020 financial results conference call, you'll be a question and that's recession. So Paulo. Please be advised that this call is being recorded at the company's request I would now like to turn.

Patrice: Good morning, my name is Patrice, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics First Quarter 2020 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 and Public Relations.

The call over to Mr., even cart Karyopharm, Vice President Investor and public relations.

Ian Karp: Thank you, Patrice, and thank you all for joining us on today's conference call to discuss Karyopharm's First Quarter 2020 Financial Results and Business Update. This is Ian Karp, and I'm joined today by Dr. Michael Kaufman, Chief Executive Officer, Dr. Sharone Shackham, President and Chief Scientific Officer, Mr. Mike Mason, Chief Financial Officer, Mr. John Demery, Chief Commercial Officer, Mr. Christopher Permiano, Chief Business Officer and General Counsel, Dr. Jayden Shaw, Chief Medical Officer, and Mr. Perry Monaco, Senior Vice President of Sales. On the call today, Dr. Kaufman and John will provide an overview of key recent corporate developments and an update on our commercial progress. Mike Mason will then highlight the first quarter 2020 financial results, and we'll conclude with the Q&A portion of the call. Earlier this morning, we issued a press release detailing Karyopharm's results for the first quarter of 2020. This release, along with a slide presentation that we plan to reference, is available on our website at karyopharm.com.

Thank you for treatment. Thank you all for joining us on todays call. It looks cool disgust Karyopharm first quarter 2020 financial results and business update this would be incurred and I'm joined today by Dr., Michael Kaufman, Chief Executive Officer, Dr., Sharon Shacham, President and Chief Scientific Officer, Mr., Mike Mason, Chief Financial Officer, Mr., John Demeritt.

Commercial officer Mr., Christopher for me Ono, Chief Business Officer in General Counsel Dr. Jay Shah our.

Chief Medical Officer, Mr. Paramount to go senior Vice President of sales.

I would call today, Dr. coughing and John will provide an overview of key recent corporate developments and an update on our commercial progress.

Mike Basin will then highlight the first quarter 2020 financial results. They will conclude with the Q when a portion of the call.

Earlier. This morning, we issued a press release detailing carrier farms results for the first quarter of 2020. This release along with a slide presentation that we plan to reference are available on our website at Karyopharm dotcom.

Ian Karp: Before we begin our formal comments, 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. These include statements about our future expectations, clinical developments, regulatory matters, and timelines, the potential success of our products and product candidates, including our expectations related 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 disclosed in the risk factors section of our most recent annual report on Form 10-K, which is on file with the SEC, and in other filings that we may make in the future.

Once again, our formal comments I'll remind you that various remarks, you'll make today constitute forward looking statements for purposes of the safe Harbor provisions under the private Securities Litigation Reform Act of 1995. These include statements about our future expectations clinical developments and regulatory matters and timelines the potential success for our products and product candidates, including our exit.

Stations related to the commercialization of exposure, you financial projections, and our plans and prospects.

Actual results may differ materially promote indicated by these forward looking statements as result of various important factors, including those disclosed in the risk factor section of our most recent annual report on form 10-K, which is on file with the FCC and another filings that we may make in the future.

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 subsequent to today. 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 specified. I'll now turn the call over to Dr. Michael Kaufman.

Any forward looking statements represent our views as of today only what 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 changed therefore, you should not rely on these forward looking statements as representing our views as of any date subsequent to today.

In addition, please note that any references we make the clinical trial data during today's discussion refer interim unaudited site data unless otherwise specified.

I'll now turn the call over to Dr. Michael Kaufman.

Michael P. Mason: Thank you, Ian, and good morning, everyone. Despite these challenging times, I just want to say that I'm extremely proud to be part of this organization. It has been a remarkable several months now. Keep in mind that we are actively in dialogue with FDA on our supplementary NDA paracetal study in patients with relapsed or refractory diffuse heartbeat cell lymphoma, and we've been working extremely hard to deliver the highest quality supplementary NDA for the Boston trial for patients who have previously been treated with multiple myeloma. We're very pleased to report that this NDA will be submitted before the end of this month. And in the meantime, and following some extremely strong scientific preclinical and clinical observations, we've developed an internal virology program focused on SARS coronavirus 2, which causes COVID-19. In less than six weeks from conception internally, along with several independent external scientific reports, we've initiated a randomized phase two study in patients with severe COVID-19. What's even more remarkable about this program is the strength of the scientific foundation on which it's built.

Thank you and good morning, everyone.

Despite these challenging times I just want to have a couple of words that that robot extremely proud to be part of this organization. It has been a remarkable several months now.

Keep in mind that we are actively in dialogue with FDA supplementary India for our sales study in patients with relapsed or refractory diffuse large b cell lymphoma, and we've been working extremely hard to deliver a quality the highest quality supplementary and da.

For the Boston trial for patients with who have previously created multiple myeloma. We're very pleased to report that this end da will be submitted before the end of this month.

And in the meantime, and following some extremely strong scientific preclinical and clinical observations, we've developed an internal virology program.

Focused on the Sars Corona virus to which causes cobot 90.

Less than six weeks from conception internally along with several independent external scientific reports, we've initiated a randomized phase two study in patients with severe cobot 90.

What's even more remarkable about this program is the strength of the scientific foundation on which it built and this foundation has supported the rapid regulatory approvals and excited a large number of hospitals across the world to join the study in short order.

Ian Karp: And this foundation has supported the rapid regulatory approvals and excited a large number of hospitals across the world to join the study in short order. Now, of course, it's still too early to know if low-dose felinexin will prove effective against SARS coronavirus 2. But we remain cautiously optimistic, and I frankly could not be prouder of our employees and partners around the globe who have worked with remarkable urgency to initiate this study and help us make a difference during these unprecedented times. Now, in the setting of these specific challenges created by the COVID-19 pandemic, we've still been extremely productive on the commercial, clinical, and corporate development fronts. And we expect this to be yet another transformational year for our company. For those following along with the slide presentation, please now turn to slide four.

Now of course, it's still too early to know if lodo selinexor will prove effective again, sorry as part of ours too.

But we remain cautiously optimistic and frankly could not be proud of our employees and partners around the globe, who work with remarkable urgencies two and get initiate this study.

And help us make a difference during these unprecedented times.

Now in the setting of these specific challenges created by the Cobot 19, Pandemics, we've still been extremely productive on the commercial clinical and corporate development fronts, and we expect us to be yet another transformational year for our company for those following along with slide presentation.

Please now turn to slide four.

Michael P. Mason: First quarter Expovio sales were $16.1 million, with total revenues reaching $18.1 million. We did experience a 9% decrease in Expovio sales compared to the fourth quarter of 2019, but the decline was primarily due to minimal channel inventory built in the first quarter as compared to the previous two quarters, as well as market effects from the COVID-19 pandemic, which primarily impacted the volume of new patient starts in the quarter.

First quarter exposure sales were $16.1 million with total revenues, reaching 18.1 million, we get experienced a 9% decrease in its folio sales compared to the fourth quarter of 29 team, but the decline was primarily due to minimal channel inventory built in the first quarter as compared to the previous two quarters as well as market affectionately focus.

19, pandemic, which primarily impacted the volume of new patient starts in the quarter Importantly, we did see more than 150, new physician accounts prescribing spoke here for the first time in the quarter and we saw demand for exposure will accelerate in April.

Michael P. Mason: More importantly, we did see more than 150 new physician accounts prescribe Expovio for the first time in the quarter, and we saw demand for Expovio accelerate in April. The most significant event in the quarter was the positive top-line results from the Phase 3 Boston study, a randomized trial of once-weekly selinexer, mortezomib, and dexamethasone against standard twice-weekly mortezomib and de The trial met its primary endpoint with a statistically significant increase in progression-free survival. This is now the first randomized phase 3 trial to demonstrate clinically significant activity of once-weekly exfovio in combination with once-weekly gortezomib over a current standard of care anti-myeloma treatment in patients who had previously received one to three prior therapies. We believe these results represent a significant advance with a highly convenient once-weekly regimen, our so-called Boston SVD regimen, for patients with previously treated myeloma.

The most significant event in the quarter was a positive topline results from the phase three Boston study.

A randomized trial once weekly Selinexor Bortezomib and dexamethasone against standard twice weekly for Testament of index amount. The zone. The trial met its primary endpoint with a statistically significant increase in progression free survival.

This is now the first randomized phase three trial to demonstrate clinically significant activity once weekly Expo in combination with once weekly bortezomib over a current standard of Ferranti myeloma treatment in patients who had previously received one to three prior therapies.

We believe these results represent a significant events with a highly convenient once weekly regimen, our so called Boston SPD regimen.

For patients with previously treated Milo.

Michael P. Mason: The study results will be disclosed in an oral presentation at the upcoming ASCO 2020 Virtual Scientific Program at the end of May. And, as mentioned, we expect to submit a supplemental new drug application to the US FDA by the end of this month, a bit earlier than originally planned. In addition, our SMDA for exspobia on patients with relapsed or refractory GLBCL, after at least two prior lines of therapy, received priority review from the FDA, and our application remains on track with an assigned fiduciary action date of June 23, 2020.

The study results will be disclosed in an oral presentation at the upcoming ASCO 2020 virtual scientific program at the end of May.

And as mentioned, we expect to submit a supplemental new drug application to the us at the by the end of this month a bit earlier than originally planned.

In addition, our SMB acreage bovie on patients with relapsed or refractory DLP CEO. After at least two prior lines of therapy received priority review from the FDA and our application remains on track with assigned to this action date of June 20, Threerd 2020.

Michael P. Mason: On the corporate development front, we have improved our strategic position to enable future access of Expovio to markets outside of the U.S. Specifically, we amended our agreement with Antigen, our partner in China, to expand their exclusive rights to develop and commercialize Selenixer and Elpenixer in all human oncology indications in Australia, South Korea, and additional Asian Pacific markets, excluding Japan. Under the terms of the amended agreement, we will receive an upfront payment of $12 million in the second quarter of 2020 and are eligible for additional future milestone payments and royalties. Additionally, certain countries included in the expanded Antigen territory became available at no cost to Karyopharm following our reacquisition of the exclusive development and commercial rights to monopharmaceuticals last month. Importantly, in addition to the U.S. and Europe, we now retain the full rights to Selenixer and Elpenixer in Japan, following our reacquisition of these rights from Mono, again, at no cost to Karyopharm. Please now turn to slide 5, where I will ask John Devery, our newly appointed Chief Commercial Officer, to provide some additional details on Expovio's sales performance during the quarter. John?

On the corporate development front, we've improved our strategic position to enable future access of exposure you have to markets outside the U.S, specifically, we amended our agreement with Entergy our partner in China to expand their exclusive rights to develop and commercialize selinexor and Elton exar in all human oncology indications.

Australia, South Korea in addition to Asian Pacific markets, Excluding Japan.

Under the terms of the amended agreement, we will receive an upfront payment of $12 million in the second quarter 2020 and are eligible for additional future milestone payments and royalties certain countries included in the expanded answer gene territory became available at no cost of Karyopharm. Following our re acquisition of the exclusive development in commercial rights Mono Pharmaceuticals last.

Hello.

Importantly in addition to the US in Europe, we now retain a full rights to Selinexor and out for next or in Japan. Following our re acquisition of these rights for mono again at no cost to Karyopharm.

Please now turn to slide five will where I will ask John Demeritt, our newly appointed Chief commercial officer to provide some additional details on expose sales performance during the quarter John.

John Demery: Thank you, Michael. And let me first begin by saying how excited I am to be leading the Karyopharm commercial organization on behalf of the patients who may benefit from our medicines now and in the future, and the healthcare providers who care for them. These are truly exciting times for Karyopharm.

Thank you Michael and let me first began by saying how excited I am to be leading the karyopharm commercial organization on behalf of the patients who may benefit from our medicines now and into future and healthcare providers, who care for them. These are truly exciting times for Karyopharm and I'm thrilled to have joined the team.

John Demery: are truly exciting.

John Demery: The launch today for Expovio has been strong. As of March 31st, more than 2,200 Expovio prescriptions have been filled in the U.S. since launch, which highlights the unmet medical need that Expovio is addressing. When looking at sales for the first quarter, there are three important components to consider: inventory, new patient starts, and how existing patients are doing in terms of refills and duration of therapy. First, as Michael mentioned, the inventory build was negligible in Q1 as compared to Q4. As we launched, it took a couple of quarters for our distributors to build inventory levels to meet the ongoing needs of their customers. And, as expected, these levels did not grow meaningfully in the first quarter of 2020.

The launch to date for exposure has been strong as of March 30, Onest more than 2200 exposure prescriptions have been built in the U.S. since launch, which highlights the unmet medical need that exposed addressing.

When looking at the sales for the first quarter. There are three important components to consider inventory new patient starts and how existing patients are doing in terms of refills and duration of therapy.

First as Michael mentioned, the inventory build with negligible in Q1 as compared to Q4 as we launched it took a couple of quarters for our distributors to build inventory levels to meet the ongoing needs of their customers and as expected. These levels did not grow meaningfully in the first quarter 2020.

John Demery: Second, despite the impact of COVID-19, we were able to maintain approximately flat demand in Q1, with 845 prescriptions, although new patient starts on Expovio were fewer than anticipated, with fewer new patient visits to oncologists and fewer patients starting on new therapies. Third, importantly, we continue to see strong prescription refill rates for existing patients and an increasing average number of cycles per patient. Finally, we did see a good increase in exposure prescription demand in April, which is encouraging as we continue to assess the ongoing impact of the COVID-19 pandemic. Slide six provides more detail on how existing patients are doing.

Second despite the impact of Koby 19, we were able to maintain approximately flat demand in Q1 with 845 prescriptions, although new patient starts unexposed, we're fewer than anticipated with fewer new patient visits to oncologists and pure patient starting on new therapies.

Third importantly, we continue to see strong prescription refill rates for existing patients and an increase in average number of cycles per patient.

Finally, we did see a good increase and expose the o. prescription demand in April which is encouraging as we continue to assess the ongoing impacted because endemic.

Slide six provide more detail and how existing patients are doing I'm pleased to report that the exposure real world patient experience continues to be strong.

John Demery: I'm pleased to report that the Expovio real world patient experience continues to be strong, often exceeding what was seen in the pivotal storm trial. On the right side of this slide, we've highlighted several important metrics from our network of specialty pharmacy providers, which give us confidence that patients are having a positive experience with Expovio. First, we are pleased that more than 97% of prescriptions are being approved by insurance carriers. This approval rate underscores the terrific work that our market access team has been doing since launch to ensure broad and unencumbered access.

And exceeding what was seen in the pivotal storm trial.

On the right side of this slide we've highlighted several important metrics from our network of specialty pharmacy providers, which give us confidence that patients are having a positive experience unexposed vo.

First we are pleased that more than 97% of prescriptions are being approved by insurance carriers. This approval rate underscores the terrific work that our market access team has been doing since launch to ensure abroad and unencumbered access.

John Demery: Next, approximately 60% of eligible patients since launch have received a refill for their second prescription, and the number of prescriptions per patient average continues to increase each quarter. One of the key factors that we believe is contributing to these refill rates has been our ability to educate health care providers regarding which patients are appropriate for Expovio. Also, only 13% of patients who have discontinued expovio indicated the reason was due to side effects. We believe our education efforts here on appropriate mitigation of side effects are improving the patient experience. This is particularly encouraging as we saw 27% of patients in the STORM study discontinued therapy due to side effects. Finally, across all prescription refills, we're seeing patients refill their prescriptions in about 34 days on average.

Next approximately 60%, but eligible patients since launch have received to rebuild for their second prescription and the per patient average number of prescriptions continues to increase each quarter.

One of the key factors that we believe is contributing to these refill rates has been our ability to educate healthcare providers regarding which patients are appropriate for expo.

Also only 13% of patient to have discontinued Expo have indicated the reason was due to side effects. We believe our education efforts here on appropriate mitigation of side effects are improving the patient experience.

Particularly encouraging as we saw 27% of patients in the storms study discontinue therapy due to side effects.

Finally across all prescription refills, we're seeing patients rebuild their prescriptions in about 34 days on average.

John Demery: This indicates that the Explovio package and dose sizes available are appropriate, and patients are not extending monthly dose packs much beyond 30 days. Moving to slide seven, there are several COVID-19 dynamics that will impact sales in the first quarter, as well as potential advantages of Expovio to patients in the context of the ongoing pandemic. The COVID-19 pandemic has, unfortunately, negatively impacted patient care, with many physician practices, including oncologists, reporting fewer visits for patients without COVID-19. This reduction in visits had a particularly notable impact on the volume of new patient starts on Expovio in March. Additionally, just like other biopharmaceutical companies, our field sales force has been unable to make in-person calls to health care providers and has been working from home since the beginning of March.

This indicates that the extreme package in dose sizes available are appropriate and patients are not extending monthly dose packs much beyond 30 days.

In practices Gooding oncologist reporting fewer visits for patients without Kobe 19.

Reduction in that it had a particularly notable impact on the volume of me patient starts annex Bolio in March.

Additionally, just like other by a pharmaceutical companies are fields sales force has been unable to make in person calls to health care providers and had been working from home since the beginning of March because newly launch products in general require greater physician education deployed there probably adopted as compared to more established their fees and brands we believe.

John Demery: Because newly launched products, in general, require greater physician education before they are broadly adopted as compared to more established therapies and brands, we believe new patient starts are further impacted. In these current market conditions, Expovio's product profile offers some distinct advantages for myeloma patients, including oral administration and home delivery, which may limit the need to travel to hospitals or clinics that are commonly used for parenteral therapies. Supportive care resources are also available over the phone via our Carry Forward patient support program.

New patient starts we're further impacted.

In these current market conditions <unk> product profile offer some distinct advantages for my own the patience, including oral administration and home delivery, which may limit the need to travel to hospitals and clinics as frequently as commonly used parental therapies.

Care resources are also available over the phone <unk> carry forward patient support programs.

John Demery: Finally, our commercial organization has made tremendous progress over the past few months to mitigate some of these pressures just highlighted and leverage the competitive advantages of Expovio. These are highlighted on slide eight and include rapidly launching multiple digital tools to facilitate continued salesforce engagement with customers. And according to a leading industry market insights provider, our salesforce engagement remains the best among our peer group. We've also transitioned our peer-to-peer programs to virtual channels in order to expand our commercial reach. We're increasing non-personal promotion via electronic medical record information at the point of diagnosis, search engine marketing, and media placement. And finally, we're actively preparing for a virtual omni-channel launch for Expovio and diffuse large B cell lymphoma pending FDA approval. Now, I'd like to turn the call back over to Michael to discuss our key clinical development activities and priorities, which begin on slide nine.

Finally, our commercial organization has made tremendous progress over the past few months to mitigate some of these pressures just highlighted and leverage the competitive advantages of expose yeah. These are highlighted on Friday.

And include rapidly watching multiple digital tools to facilitate continued salesforce engagement with customers and according to a leading industry market insights provider. Our sales force engagement remained the best among our peer group.

We've also transition peer to peer programs to virtual channels in order to expand our commercial reach we're increasing non personal promotion yeah electronic medical record information at the point of diagnosis search engine marketing and media placement and finally, we're actively preparing for a virtual on the channel launch for exposure.

Oh, and diffuse large be selling thumma pending F.D.A. approval.

Now I'd like to turn the call back over to Michael to discuss or keep clinical development activities and priorities, which began on slide nine Michael.

Michael P. Mason: Michael? Thank you, John. On slide nine, you can see the top-line results from the phase three Boston study. The study met its primary endpoint of a statistically significant improvement in PFS with a 47% increase in median PFS on the SBD arm as compared to the VD arm, representing a 4.47 month improvement. The median PFS in the SBD arm was 13.93 months versus 9.46 months in the VD arm, and the hazard ratio was 0.70.

Huge on one side nine you can see the top line results from the Phase three Boston study. The study met its primary endpoint of a statistically significant improvement in P.F.S., but the 47% increase in medium if asked when the S.B.D. arm as compared to the V.D. arm, representing a 4.47 month improvement the median P.F.S. in the F.B.D. arm was 30.

0.93 months versus 9.46 months in the B.D. arm and the hazard ratio was 0.70. We believe these top line data represented very meaningful improvement appear fast in the treatment of patience with previously created my Loma.

Michael P. Mason: We believe these top-line data represent a very meaningful improvement in PFS in the treatment of patients with previously treated myeloma. And because patients in the SBD arm receive Velcade only once per week, while those in the VD arm receive Velcade on the standard twice weekly schedule, patients in the SBD arm received about 40% less Velcade and 25% less dexamethasone than in the VD arm and required about 37% fewer clinic visits over the course of treatment. The data also showed no new safety signals in the SVD arm relative to previously reported adverse events from our other selenex or myeloma trials. There was no imbalance in patient deaths across the treatment arms, and, in fact, there were numerically fewer deaths in the SVD arm. Finally, we are pleased to report that in the Boston study, the rate of peripheral neuropathy in the SVD arm was significantly lower than the rate in the VD control arm.

And because patients in the S.B.D. arm received though it only once per week, while those in the B.D. arm received located on the standard twice weekly schedule patients in E.S.P.D. arm received about 40% less velcade and 25% less back the methods zone than in the V.D. aren't and required about 37% fewer clinic visits over the course of treatment.

The data also showed no new safety signals in the S.B.D. on relative to previously reported adverse events from our other selinexor mind when the trials.

Knowing balance and patient deaths across the treatment arms and in fact, there were numerically fewer deaths in the S.B.D. on.

Finally, we also are pleased to report that in the Boston study <unk> on the S.B.D. arm was significantly lower than the rate in the B.D. control on remember that personal her off at these amongst the most common causes a treatment limitation and discontinuation of belt paid decks and combinations I'll tape decks residents.

Michael P. Mason: Remember that peripheral neuropathy is amongst the most common causes of treatment limitation and discontinuation of Velcadex and the combination Velcadex regimen. We have seen particularly high rates of peripheral neuropathy in other phase 3 trials, as noted on slide 10, and these that study VD as a control arm and often triplet VD regimens have even higher peripheral neuropathy rates than the standard backbone VD. Turning now to slide 11, we believe the commercial opportunity for Expovio in the second and third line settings, subject, of course, to future regulatory approvals, represents a significant opportunity for Karyopharm and, more importantly, would meaningfully advance the treatment options available to patients battling myeloma. Specifically, there are approximately 32,000 patients treated in the second and third lines, which is dramatically larger than the number of patients in the fourth and later lines where Expovio is currently being prescribed, based on its current FDA-approved indication.

We have seen particularly high rates of peripheral neuropathy in other face free trials as noted on slide 10, and these that study V.D. as a control arm and often triplet BB regiments have even higher for not neuropathy rates than the standard backbone the date.

Turning out of sight 11, we believe the commercial opportunity for it's probably on the second and third line settings subject of course to future regulatory approvals represent a significant opportunity for karyopharm and more importantly would meaningfully advanced the treatment options available to patients battling might lump specifically there are approximately 32000 patients treated in the.

Second and third lines, which if dramatically larger than number of patience and the fourth and later lines were exposed you know is currently being prescribed based on its current F.D.A. proved indication.

Michael P. Mason: In addition, we know that the average time patients with myeloma remain on any drug therapy, including Expovio, is much longer in earlier lines as compared to later lines of therapy. I'd now like to spend a few minutes discussing our new Selenexer clinical program in patients with severe COVID-19, which begins on slide 12. In addition to its roles in cancer, XPO1 may also be an important target in treating viral infections by facilitating the transport of several important viral proteins from the nucleus of the host cell to the cytoplasm.

<unk>, we know that the average time patience with my little remain on any drug therapy, including <unk> is much longer in earlier lines as compared to later lines of therapy.

I don't like to spend a few minutes discuss our new Selinexor clinical program and patience with severe carpet 19, which begins on side well.

In addition to withdraw from cancer X.P.O.. One may also be an important target in treating viral infection by facilitating the transport several important viral proteins from the nucleus of the hotel to the side of class.

Michael P. Mason: Encelonex has recently demonstrated potent anti-SARS coronavirus 2 activity in cell cultures, with 100 nanomolar encelonex inhibiting viral replication by 90%. This is particularly exciting given that for patients taking the low 20 milligram dose of Selenexer, serum levels of the drug are expected to be over 300 nanomolar, so that marked viral replication inhibition may be possible, in addition to its potential direct antiviral effect. Selenox R and other sign compounds have demonstrated potent anti-inflammatory activity through the inhibition of nuclear factor Kappa B. This is particularly relevant given that one of the most important aspects of COVID-19 is marked pulmonary inflammation with high levels of cytokines, such as IL-6, IL-1, interferon gamma, and others. Selenects and other signs have shown reductions in all of these cytokines in a variety of models, and this may be particularly beneficial to hospitalized patients with severe COVID-19.

Selinexor recently demonstrated potent anti Sars corona virus to activity in cell cultures, with 100, and animal or Selinexor inhibiting viral replication by 90 per cent.

This is particularly exciting given that for patients taking the low 20 milligram dose of Selinexor serum levels of the drugs are expected to be over 309, similar so that marked viral replication ambition maybe possible.

Addition to its potential direct antiviral effects. So next on other sign compounds and demonstrated potent anti inflammatory activity to the inhibitions nuclear factor cap a beep.

Particularly relevant given at one of the most important aspects to cope with 19.

Pulmonary inflammation with high levels of side of time, such as I'll six iowan interferon gamma in others Selinexor and other signs have shown reductions in all of these side of time in a variety of models and this may be particularly beneficial to hospitalized patients with severe covert 19.

Michael P. Mason: Based on the strong scientific rationale in our highly motivated team, we were able to initiate and begin dosing patients in a global, randomized, multicenter placebo-controlled study in April. The primary endpoint of the study is time-to-clinical improvement based on an improvement on the ordinal scale consistent with COVID-19 trial recommendations. Additional secondary endpoints in the study include the overall death rate at day 28, as well as the rate of and time to mechanical ventilation.

Certainly strong scientific rationale highly motivated team, we're supposed to initiate and begin dosing patients in a global randomize multi center placebo controlled study in April the primary endpoint of the study is time 'cause clinical improvement based on an improvement on the ordinal scale consistent with covert 19 trial recommendations additional secondary endpoints and stuff.

Include the overall death rate it they 28 as well as the rate of and time to mechanical ventilation I.N.. So very proud of our team preventing these programs. So quickly and we look forward to providing an update as quickly as possible.

Michael P. Mason: I am so very proud of our team for advancing these programs so quickly, and we look forward to providing an update as quickly as possible. Finally, before I hand the call over to Mike Mason to highlight our financial results, I'd like to say a few words about our growing clinical development pipeline, which can be seen on slides 14 and 15. For our other ongoing clinical trials, we do expect some delays in patient enrollment due to clinical site closures and disruptions caused by the pandemic. We will continue to update the investment community as we learn more about potential COVID-19 impact timelines and remain committed to advancing our programs as expeditiously as possible. And with that, I'll now turn the call over to Mike Mason to review the financials.

Finally, before I had the call over to make basin to highlight effort into the results I'd like to say a few words about our growing clinical developed and pipeline, which can be seen on size 14 and 15.

For our other ongoing clinical trials, we do expect some delays and patient enrollment due to clinical psych closure them disruptions caused by the tandem.

We will continue to update the investment community as we learn more about central Coven 19 impact on England and remain committed to advancing our programs as expeditiously as possible and with that all now turned to call over to Mike based and to review the find it might.

Michael P. Mason: Thank you, Michael. Since we issued a press release earlier today with the full financial results, I will just focus on the highlights on slide 17. Net product revenue for the first quarter of 2020 was $16.1 million, and total revenue was $18.1 million. As previously mentioned, first quarter sales were driven almost entirely by patient demand with minimal channel inventory build in the quarter. As a reminder, our distribution partners typically keep about three weeks of channel inventory on hand and, in 2019, purchased approximately $4.5 million of Bellinextra at the recent level by the end of the year.

Thank you Michael since we should have Presley earlier today.

<unk> just focus on the highlights yeah.

Slide 17, not product revenue for the first quarter of 2020, what 16 million Untold rubber there was a white 1 million as previously mentioned first quarter sales recruitment almost entirely by patients man with minimal channel four to fill in the core as a reminder, or distribution partners typically typically keep about three weeks.

The channel and the story on hand, and it's 2019 first approximately four and a half million.

Reached its level.

Michael P. Mason: We would expect channel inventory levels to only increase in line with increases in patient demand. The estimated gross net discount for Expovio in the first quarter was approximately 15%, which is on the lower end of our annual expectation of 15 to 20%. Research and development expenses for the first quarter of 2020 were $34 million, compared to $38 million for the first quarter of 2019. The decrease in R&D expenses compared to the first quarter of 2019 is mainly due to a decrease in clinical trial costs. We expect our R&D expenses to remain relatively consistent quarter over quarter for the remainder of the year. For the first quarter of 2020, SG&A expense was $30.7 million compared to $27.1 million for the first quarter of 2019. The increase in SG&A expenses compared to the prior year was primarily due to activities to support the U.S. commercialization of Expovio and in preparation for the potential launch of additional indications. Cash equivalents for restricted cash investment as of March 31st, 2020 totaled $385.2 million compared to $265.8 million as of December 31st, 2009.

You know moving forward, we would expect sale unemployed levels only increased in line with increases in Asian Man.

<unk> gross discomforts over you on the first order it was approximately 50% which is on the lower end of our annual expectation 15% to 20%.

[noise] research and development and stuff for the first quarter of 2020 or 34 million compared to 38 for the first quarter of 28.

Increasing aren't expensive compared to the purse or 40, working as manager or decrease Oh Wow.

We expect our aren't expensive remain relatively consistent order over a quarter for the remainder.

Well the first quarter of 2020, S.T. inexpensive 13.7 million or just 27.1 million for the first quarter team the increase in S.P. names fences compared to the prior year was primarily due to activities with support from U.S. commercialization of <unk>.

And in preparation for the potential lots of additional education.

Cash <unk> strictly cash investment as of March 31st 2020, total 385.2 million compared to 265 20 a girl.

31st 2000.

Looking ahead, we expect exposure you in that product still to be slightly higher in a second quarter of 2020 or so the first quarter.

Unknown Speaker: Unknown Speaker....

Michael P. Mason: We expect Expovio Net product sales to be slightly higher in the second quarter of 2020 as compared to the first quarter of 2020. In addition, we expect total revenues to be higher in the second quarter due to the recognition of the majority of the upfront payment we expect to receive from Antigen in the second quarter in connection with the amended agreements to expand Antigen's territory. We are not issuing full year 2020 Expovio revenue guidance at the current time, as we continue to monitor the ongoing commercial impact of the COVID-19 pandemic, as well as the timing of key expected regulatory actions for 2020. These regulatory events include the potential approval of Expovio for patients with relapsed or refractory DLDCL, as well as our planned SNDA submission and subsequent FDA review period requesting expansion of the approved indications for Finally, based on our current operating plans, including the reduction of some R&D costs as a result of trial delays due to the ongoing COVID-19 pandemic.

In addition, we expect toll revenues to be higher in the second quarter to the recognition of the majority of the upfront payment, we expect to receive from <unk> and the second quarter in connection with the amendment agreements to stand Nantucket's territory.

We're not issuing pull your <unk> rubbing regarding current time as we continue tomorrow or the ongoing commercial ones back from the cold and dark.

Well the timing it he expected regulatory action 2020.

Use regulatory events, including pretends will improve over the scroll wheel patients with relapse or factories deal. These yeah as long as are planned S.N.D.S.L.D.A. submission. Subsequent F.D.A. review period requesting expansion teams improved indications are exposed to second line patients collapse refractory local.

Yeah.

Filing.

Our current operating plants, who didn't you were the reduction of summer and be costs as a result trial delays due to the ongoing overnight.

And overall expense and we expect or non-GAAP, r., and D. and asking expenses, which excludes stock based compensation.

For the full year 2020 to be at the lower end previously projected rain 240 $260.

Michael P. Mason: and overall expense management. We expect our non-GAAP R&D and SG&E expenses, which includes stock-based compensation, for the full year 2020 to be at the lower end of the previously projected range of $240,000 to $260,000. This estimate includes the additional costs associated with our new Selenexor clinical trial in patients with COVID-19. In addition, we currently expect that our existing cash, debts, equivalents, and investments, and the revenue we expect to generate from Expovio product sales, will be sufficient to fund our planned operations into the middle of 2022, which puts us in a terrific position to further advance our strategic aspirations. I'll now turn the call back over to Michael for some concluding remarks. Thank you.

And that includes the additional costs associated with our new saw an expert clinical trial patients a cold at night.

In addition, we're <unk>. We currently expect that are just the cash that's what the ones in investments and the revenue we expect a giant from exposure wheel product sales will be sufficient to ponder plant operations into the middle 2022, which puts us in a terrific.

Answers teaser aspiration.

Well now trying to call back over to Michael person reading remarks, Michael.

Thank you might before moving to Q. and I, let me highlights some of the key milestones we expect the remainder this year.

Please see slide 19 first the Boston clinical data will be presented an oral session at the upcoming Jasko 2020, Birkel scientific program and we expect to submit an S.N.D.A. based on these data before the end of May.

We anticipate a regulatory decision in June regarding our exposing L.S.N.D.A. for patients with the L.D.C.L. After at least two months prior therapy and then the subsequent commercial launch if approved.

Michael P. Mason: Thank you, Mike. Before moving to Q&A, let me highlight some of the key milestones we expect for the remainder of this year. Please see slide 19. First, the Boston clinical data will be presented in an oral session at the upcoming ASCO 2020 Virtual Scientific Program, and we expect to submit an SNDA based on these data before the end of May. Next, we anticipate a regulatory decision in June regarding our Expovio SNDA for patients with DLBCL after at least two months of prior therapy and then the subsequent commercial launch if approved. We also expect to share the initial results from our Phase 2 study of low-dose cell and external patients with severe COVID-19, as well as the top-line Phase 3 data from the SEAL study in liposarcoma.

We also expect to share the initial results from our base to study of Lodo, Selinexor and patience with severe covert 19 as well if the top line based free data from the seal study in life sorry <unk>.

And finally should the F.D.A. prove are anticipated S.N.D.A. based on the Boston data before the end of the year, we expect the U.S. commercial launch in second line mile on either by the end of 2020 or early 2021, depending on the F.D.A.'s review time like you can clearly see we have a robust list of expected milestones across our commercial cynical stage port.

Folios, and we look forward and providing updates throughout the remainder of the year. We appreciate your ongoing support and look forward to keep you updated on our 2020 progress on now trying to call over to the operator for questions operator.

Michael P. Mason: And finally, should the FDA approve our anticipated SNDA based on the Boston data before the end of the year, we expect a U.S. commercial launch for second-line myeloma either by the end of 2020 or early 2021, depending on the FDA's review timeline. As you can clearly see, we have a robust list of expected milestones across our commercial and clinical stage portfolios, and we look forward to providing updates throughout the remainder of the year. We appreciate your ongoing support and look forward to keeping you updated on our progress in 2020. I'll now turn the call over to the operator for questions. Operator?

As I remind parents last question, even neat restaurant why not only your telephone with cars are question press, the pound or husky to standby why would <unk>.

Your first question comes from Mari, Frank Croft Capris.

Hi, Good morning, everyone in bad things for taking my questions. First question is just based on their 60% number opera patients not choosing to get the second prescription and then you mentioned that 13% less patient stopped because the side effects I guess one of the reasons for the other 27% and can you.

Operator: As a reminder, to ask a question, you will need to press Star 1 on your telephone. To withdraw your question, press the pound or hash key. Please stand by while we compile the Q&A roster. Your first question comes from Maurice Raycroft, Jeffries.

Prove upon the 13% in 27% numbers and one of the plans to do that.

Yeah, let's John.

Maurice Thomas Raycroft: Hi, good morning, everyone. And thanks for taking my questions. The first question is just based on the 60% number for patients not choosing to get the second prescription. Then you mentioned that 13% of those patients stopped because of side effects. I guess what are the reasons for the other 27%? And can you improve upon the 13% and 27% numbers? And what are the plans to do that?

Actually 60% of patients are getting a refill not 60% alright hitting.

Gretchen, which is this job number.

After that 13% discontinuation rate that with about half of what we saw in the storm trial, which suggests the education efforts are working in positions are getting comfortable mitigating potential side effects with expel the out to provide patients abettor experience other drivers discontinuation the top three drivers.

Unknown Speaker: Yeah, well, that's John's involvement.

Include as expected prescriber decision, a patient deceased or patient decision.

John Demery: Yeah, so it's actually 60% of patients are getting a refill, not 60% are getting a second prescription, which is a strong number. Relative to the 13% discontinuation rate, that was about half of what we saw in the STORM trial, which suggests the education efforts are working, and physicians are getting comfortable mitigating potential side effects with Expovio to provide patients a better experience. Other drivers of discontinuation, the top three drivers would include, as expected, prescriber decision, a patient's death, or patient decision.

<unk> that's helpful and and then for the 60% 40% numbers can you provide any perspective into what line of treatment. Those patients are on I guess can you provide any more details on that.

The most of the patients that we're seeing today are in the indicated patient population fill in the pen to refractories settings. So these are heavily pretreated relapse refracted patients in multiple myeloma.

John Demery: That's helpful. And then for the 60%, 40% numbers, can you provide any perspective into what line of treatment those patients are on? I guess, can you provide any more details on that?

Okay and then last question just on the increasing demand in April that you're seeing I'm. Just wondering what the driver is for that I guess is that coming from states that are reopening because of Kobe, it or is or something else fundamental that's driving that.

John Demery: Most of the patients that we're seeing today are in the indicated patient population, so in the pentarefractory setting. So these are heavily pre-treated, relapsed, and refractory patients with multiple myeloma.

I'll, let John handle that.

I think there could be a a combination of factors there we fell on a national drop off in March as the market started to react to the dynamics around coded 19, the market started to adjust to that and we did see a rebound and demand with demand being higher for patient prescription in April than in March and I'll ask.

Maurice Thomas Raycroft: Got it. Okay. And then last question, just on the increase in demand in April that you're seeing, I'm just wondering what the driver is for that. Is it coming from states that are reopening because of COVID? Or is there something else fundamental that's driving it.

Unknown Speaker: I'll let John

John Demery: So I think there could be a combination of factors there. We saw an initial drop in March as the market started to react to the dynamics around COVID-19. The market started to adjust to that, and we did see a rebound in demand, with demand being higher for patient prescriptions in April than in March. And I'll ask, Perry, do you have anything to add to that?

Do you have anything to add to that.

No I I think you'd coverage on other than I would say that in terms of you know our refill rates have been strong and I think a lot of that increased volume that we saw in April was due to the strong refills.

After accounts got kinda used to the coven environment and the increase in Tele medicine.

Perry Monaco: No, I think you covered it, John, other than I would say that, in terms of, you know, our refill rates have been strong, and I think a lot of that increased volume that we saw in April was due to those strong refills after accounts got kind of used to the COVID environment and the increase in telemedicine.

Oh yeah.

Oh, Yeah, just assets that I think there's there's more and more of the cancer societies are recommending oral treatments for patients. So they can minimize their time at the clinic.

Selinexor really unique drug in that regard with with potent activity in late line setting.

Michael P. Mason: Yeah, just to add this: I think more and more cancer societies are recommending oral treatments for patients so they can minimize their time at the clinic. Solanix is really a unique drug in that regard with potent activity in the late setting. And obviously, oral action and many of the monitoring activities can be done easily at a typical laboratory. There's nothing very special about complete blood counts and so on.

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Action and many of the Ah monitoring activities can be done easily at a typical laboratory, there's nothing very special about.

Blood counts and so on.

Got it thanks for taking my questions that I have backpacking gear.

Your next question comes from Brian Ingraham, R.P.C. capital markets.

Maurice Thomas Raycroft: Got it. Thanks for taking my questions, and I'll hop back in the queue.

Hey, guys. Thanks, very much for taking my questions I'm wondering drove down <unk> <unk>.

Operator: Your next question comes from Brian Abrahams, RBC Capital Markets.

Brian Corey Abrahams: Hey guys, thanks very much for taking my questions. I wanted to drill down a little bit.

More too.

Mm.

Unknown Speaker: More are two.

Unknown Speaker: You know who would be on it?

Who would be on.