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04/08/20 17:48
Ha respondido al tema Farmas USA
Staatnews, los compañeros del Bastardo. ¡Qué sorpresa! Edito: lo que he visto mirando por encima que no me ha gustado es que es hasta 59 años. No sé si lo sabíais de antes o no...NVAX
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04/08/20 11:55
Ha respondido al tema Farmas USA
KPTIDiapositivas de la rueda de prensahttps://seekingalpha.com/article/4364108-karyopharm-therapeutics-inc-2020-q2-results-earnings-call-presentation?source=intbrokers_regularY transcripciónGood morning. My name is Debbie, and I will be your conference operator today. I will -- at this time, I would like to welcome everyone to Karyopharm Therapeutics Second Quarter 2020 Financial Results Conference Call. (Operator Instructions) 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 Senior Vice President Investor and Public Relations. Please go ahead. -------------------------------------------------------------------------------- Ian Karp, Karyopharm Therapeutics Inc. - VP of Investor & Public Relations [2] -------------------------------------------------------------------------------- Thank you, Debbie, and thank you all for joining us on today's conference call to discuss Karyopharm's second quarter 2020 financial results and business update. This is Ian Karp, and I'm joined today by Dr. Michael Kauffman, Chief Executive Officer; Dr. Sharon Shacham, President and Chief Scientific Officer; Mr. Mike Mason, Chief Financial Officer; Mr. John Demery, Chief Commercial Officer; and Mr. Christopher Primiano, Chief Business Officer and General Counsel. On the call today, Michael and John will provide an overview of key recent corporate developments and an update on our commercial progress, and Mike Mason will highlight the second quarter 2020 financial results. We will conclude with the Q&A portion of the call. Earlier this morning, we issued a press release detailing Karyopharm's results for the second quarter of 2020. This release, along with a slide presentation that we plan to reference are available on our website at Karyopharm.com. 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 and regulatory [median] time lines, the potential success of our products and product candidates, including our expectations relating to the commercialization of XPOVIO, 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. Any forward-looking statements represent our views as of today only. But we may not like 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 Kauffman, Chief Executive Officer. -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [3] -------------------------------------------------------------------------------- Thank you, Ian, and good morning, everyone. Before I specifically review Karyopharm's performance in the second quarter, I'd like to put into some context where Karyopharm is on its journey to becoming a leading global oncology-focused pharmaceutical company. For those following along in the presentation, please turn to Slide 4. When Dr. Sharon Shacham and I founded the company over 12 years ago, we had a vision of one day, we would create medicines that approved the lives of patients suffering from cancer and other serious diseases. We spent the first 5 or so years building the organization and growing the body of scientific and clinical evidence around XPO1 inhibition, leading to the approval of the first-in-class oral compound, XPOVIO. And in July of last year, we officially transitioned to a commercial company with the initial FDA approval and launch of XPOVIO in relapsed or refractory multiple myeloma. This year, we achieved an additional important milestone on our journey as XPOVIO received its second FDA approval at the end of June and became the first branded therapy to be approved in both myeloma and DLBCL. And as we look out towards next year and beyond, we expect to expand our commercial reach and advance our robust clinical development pipeline, including into solid tumor indications, all in support of the patients and families in need of new treatment options for devastating cancers. Please now turn to Slide 5. In the second quarter, we achieved record quarterly XPOVIO sales of $18.6 million, the strongest quarter since our July 2019 launch. Total revenue for the quarter reached $33.5 million which included most of the payment from 1 of our international partners, Antegene, in the quarter for our expanded territory agreement, which we announced earlier this year. The 16% increase in XPOVIO net sales compared to the first quarter of 2020 was driven by increased demand from both academic and community-based physicians. Importantly, we saw more than 170 new physician accounts prescribe XPOVIO for the first time in the quarter, even as in-person activities were limited due to regional restrictions related to the ongoing COVID pandemic. This represents more new accounts added in Q2 than in Q1 despite the ongoing pandemic. The second quarter was also marked by the FDA granting accelerated approval of XPOVIO for the treatment of patients with diffuse large B-cell lymphoma, or DLBCL, including DLBCL arising from follicular lymphoma after at least 2 lines of systemic therapy. This represents the second approved indication for XPOVIO. We were able to launch immediately by leveraging our existing commercial infrastructure, given the overlap between oncologists treating myeloma and DLBCL, particularly in the community setting. At the annual ASCO Meeting in May, we presented the detailed results from the highly successful Phase III BOSTON study in patients with previously treated myeloma. BOSTON is our randomized trial of once-weekly selinexor with once-weekly Velcade, along with dexamethasone compared to standard twice-weekly Velcade and dexamethasone. The trial met its prespecified primary endpoint, and based on these results, we quickly submitted a supplemental New Drug Application, or sNDA, to the FDA for XPOVIO for the treatment of myeloma after at least 1 prior line of therapy. FDA has filed the application and assigned an action date of March 19, 2021, under the Prescription Drug User Fee Act or PDUFA. I'm also pleased to announce that we have now completed enrollment in our Phase III study of selinexor in patients with heavily pretreated dedifferentiated liposarcoma and expect top line data in the second half of this year. If these data are positive, we believe this will be a very important step towards our goal of bringing XPOVIO to patients battling solid tumors in addition to those with hematologic malignancies. We also made important progress in our clinical pipeline outside of cancer and today, we are providing an update on our placebo-controlled Phase II trial of low-dose selinexor for patients with severe COVID-19. That is, patients who are hospitalized, hypoxic and require supplemental oxygen. This program was prioritized at Karyopharm and rapidly advanced into the clinic in a matter of weeks due to the encouraging antiviral and anti-inflammatory activity of XPOVIO inhibition with selinexor. Recall that in addition to its roles in cancer, XPO1 also be an important target in viral infections by facilitating the transport of several key viral proteins from the nucleus of the host cell to the cytoplasm. At the planned interim analysis of the randomized Phase II study with approximately 120 patients, the results indicated that selinexor is unlikely to demonstrate a statistically significant efficacy benefit across the entire population of patients hospitalized with severe COVID-19 who were studied. However, selinexor does appear to confer clinical benefit in a subpopulation of patients that represents about 3/4 of the whole severe COVID-19 population. Based on these results, we have discontinued the current study and expect the future clinical development of low-dose selinexor for patients or COVID-19 will focus on the subpopulation where we saw the significant effects. I'll provide some additional details on these specific results later in today's presentation. On the corporate development front, we were excited to announce our entry into a Cooperative Research and Development Agreement, or CRADA, with the National Cancer Institute's Cancer Therapy Evaluation Program for the research of XPOVIO in various oncology indications, which we hope yields additional opportunities for us and patients in the future. Finally, on the financial front, we ended the quarter with a strong cash position of approximately $348 million that we expect will be sufficient to fund our planned operations into the middle of 2022. Please now turn to Slide 6, where I'll ask John Demaree, our Chief Commercial Officer, to provide some additional details on XPOVIO's sales performance during the second quarter. John? -------------------------------------------------------------------------------- John Demaree, Karyopharm Therapeutics Inc. - Chief Commercial Officer [4] -------------------------------------------------------------------------------- Thank you, Michael, and good morning, everyone. As Michael noted earlier, we were pleased with the commercial momentum seen during the quarter, despite being impacted by some of the challenges associated from the COVID-19 pandemic, including limited in-person sales visits to our customers. I commend the carrier for our commercial organization for driving our educational initiatives forward virtually during these challenging times in support of our community of patients, families and caregivers. Our virtual initiatives for both multiple myeloma and DLBCL include digital tools to facilitate continued sales force, nurse liaison and payer team engagement with customers, search engine marketing and media placement and virtual peer-to-peer programs. Additionally, we believe XPOVIO's product profile offers some distinct advantages for our patients during the pandemic, including oral administration and home delivery, which can limit the need to travel to hospitals or clinics as frequently as commonly used parenteral therapies. As of June 30, approximately 3,200 XPOVIO prescriptions have been filled in the U.S. since launch and approximately 950 prescriptions were filled in the second quarter. Prescription demand increased by 12% compared to the first quarter, and as Michael highlighted earlier, net sales increased by 16% in the quarter. The second quarter was the strongest quarter-to-date for both net sales and patient demand. This growth was particularly exciting as the overall demand in the U.S. for a number of other multiple myeloma drugs declined in the second quarter as a result of the ongoing pandemic, further underscoring the strong performance for XPOVIO. There was also some incremental added -- some incremental inventory added at our distribution partners in Q2, driven by initial stocking at the end of June of 3 new XPOVIO package sizes to support the commercial launch in patients with DLBCL. Turning to Slide 7. I will provide some additional color on patient metrics that we followed closely and believe further reinforce the positive experience many physicians and patients are having with XPOVIO treatment. The graph on the left side of this slide highlights the average treatment cycles or prescriptions per patient based on data from our participating specialty pharmacies. What you will notice is that this number has increased steadily each quarter since launch as we believe physicians are getting more comfortable treating patients with XPOVIO and effectively managing its potential side effects. As of the end of June, the average number of prescriptions per patient was 2.7 as compared to 2.0 at the end of 2019. On the right side of the slide, the graph shows the prescription refill rate over time for both the first and second prescription refills for those patients eligible. These numbers have also continued to improve significantly each quarter since launch. As an example, in September of 2019, which marked the end of the first quarter that XPOVIO became commercially available, roughly 42% of patients were going on to get a second prescription. At the end of June 2020, that number stood at 61%, an impressive improvement. These increasing refill rates, coupled with the increasing average number of treatment cycles, further reinforced the positive feedback we have received from patients and physicians regarding their experience in usage of XPOVIO. Moving forward, we plan to continue to engage with the medical community and reinforce the potential benefits of XPOVIO through virtual and in-person engagements where possible. We will continue to fully leverage the newly approved indication in DLBCL to access our key stakeholders, educate on this new indication and also generate increasing excitement in multiple myeloma to help more patients impacted by these diseases. 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 8. Michael? -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [5] -------------------------------------------------------------------------------- Thank you, John. A critical milestone for us in the second quarter included the formal presentation of the positive BOSTON study results. As a reminder, this was the first large Phase III study in previously treated myeloma to directly compare a once-weekly triplet regimen with standard twice-weekly Velcade. We were thrilled that the study met its primary endpoint of a statistically and clinically significant improvement in PFS with a 47% increase in the median progression-free survival on the SVd arm as compared to the VD arm, representing a 4.47 month improvement. The median progression-free survival in the SVd arm was 13.93 months compared to 9.46 months in the VD arm with a hazard ratio of 0.70. SVd was superior to VD across other key efficacy endpoints such as overall response rate, the rate of very good partial response or better and the duration of responses. The results were consistent across most of the subpopulations, including patients over the age of 65, patients who are frail, those with prior lenalidomide treatment and those with high-risk cytogenetics. Median overall survival on the SVd arm has not yet been reached, but it was 25 months on the VD arm. Moreover, there were numerically fewer deaths on the SVd arm than on the VD arm. We were also pleased to report the rate of peripheral neuropathy on the SVd arm was significantly lower than the rate in the VD control arm. Remember, the peripheral neuropathy is among the most common causes of treatment limitation and discontinuation of VD and combination VD regimens, and add significant differentiator for the Boston regimen, pending future regulatory approval. The data also showed no new safety signals in the SVd arm relative to previously reported adverse events from other selinexor myeloma trials. In summary, we are able to conclude from the BOSTON study that in patients with multiple myeloma who have received 1 to 3 prior therapies, including prior lenalidomide or proteasome inhibitor, once-weekly SVd offers patients an effective, convenient triplet regimen, requiring approximately 40% fewer clinic visits and a reduced rate of peripheral neuropathy, pending future regulatory approval, of course. On Slide 9, I'll provide a brief update on our key upcoming regulatory activities. Our BOSTON sNDA was accepted for filing in July with a decision expected by March 19, 2021. And in Europe, we plan to submit the final additional monitoring data requested by EMA from the STORM study in patients with advanced refractory myeloma in September. We then expect to submit the BOSTON data to the EMA in the fourth quarter of this year. The exact timing of potential regulatory decisions based on both the STORM and BOSTON data will be determined following feedback from EMA. As we turn to Slide 10, I will highlight our recent accelerated approval for XPOVIO for the treatment of adult patients with relapsed or refractory DLBCL. In the SADAL study, which served as a basis for approval, XPOVIO demonstrated an overall response rate of 29%, including a complete response rate of 13%. Responses were seen in all subgroups regardless of age, gender, prior therapy, GCB or ABC subtype or prior stem cell transplant therapy. Importantly, responses were associated with longer survival, underscoring the potential of oral XPO1 inhibition as a simple nontherapeutic option for patients with recurrent DLBCL. While we have just kicked off our commercial launch in this indication, we believe XPOVIO's product profile addresses several key treatment considerations for this difficult-to-treat disease, as displayed on Slide 11. Physicians commonly examine patient history and disease subtype, previous therapies used and treatment efficacy and durability when deciding on an appropriate treatment pathway. The simple administration, single agent and novel mechanism of action of XPOVIO provides additional advantages for use with a manageable safety profile. Next, please turn to Slide 12, where I review the updates from our COVID-19 study. Based on anti-SARS corona viral activity in-vitro and antiinflammatory activity in-vitro and in-vivo, Karyopharm began enrollment in a placebo-controlled randomized Phase II study to evaluate low-dose oral selinexor in hospitalized patients with severe COVID-19 in April of this year. These patients require supplemental oxygen and are at high-risk for clinical worsening. Many of them had already received remdesivir, steroids, combos and plasma and other agents used to treat COVID-19. As mentioned previously, the data safety monitoring board for the study concluded that the trial is unlikely to demonstrate a statistically significant efficacy benefit across the entire population of severe patients who were enrolled. However, they also concluded that the trial was likely to show a benefit in the subpopulation of patients who are less than 75 years old and have a COVID-GRAM non high-risk score which represented approximately 75% of the entire population enrolled in the study. Preliminary results from the unaudited site data indicate that in this specific sub population, on the primary endpoint for the entire study, which was a 2-point improvement in ordinal score at day 14, statistically significant results were obtained. In addition, on day 28, improvement in ordinal score by 2 points also reached statistical significance with P is less than or equal to 0.05. And very importantly, the rate of hospital discharge by day 14 was significantly higher with selinexor as compared with placebo. In other words, patients treated with selinexor stopped requiring supplemental oxygen more rapidly than those on placebo and could leave the hospital sooner. Finally, while all patients entering the study were required to have positive SARS-CoV-2 PCR results, conversion to SARS-CoV-2 PCR negative status was significantly higher on the sell-in arm as compared with the placebo arm across the entire population. Fatalities were similar in the subpopulation mentioned above. While the rate of fatalities in the study were imbalanced in the patients 75 years or older or with the COVID-GRAM high-risk score, the DSMB considered at all deaths on the study were due to severe COVID-19 disease and/or underlying comorbidities without a clear contribution of selinexor. Moving forward, and based on these data, we are following the DSMB recommendation to discontinue the current trial and plan to analyze the data to further characterize the specific subpopulation that will likely benefit from selinexor. We plan to work with the FDA and other regulatory bodies to identify a path forward for future clinical development given these initial positive findings. Furthermore, we plan to engage with potential partners to seek external funding to advance future clinical development in COVID-19. Before turning the call over to Mike Mason, I do want to take a moment to sincerely thank all of the patients and investigators who participated in this study in support of our collective efforts to make a positive difference in the ongoing pandemic. With that, I'll now turn the call over to Mike for a review of the financials. Mike? -------------------------------------------------------------------------------- Michael P. Mason, Karyopharm Therapeutics Inc. - Senior VP, CFO & Treasurer [6] -------------------------------------------------------------------------------- Thank you, Michael. Since we issued a press release earlier today with the full financial results, I will just focus on the highlights, which begin on Slide 14. Net product revenue for the second quarter of 2020 was $18.6 million and total revenue was $33.5 million. As previously mentioned, second quarter sales were driven by patient demand from academic and community-based positions with minimal channels inventory build in the second quarter related to our DLBCL launch in late June. The estimated gross to net discount for XPOVIO in the second quarter was approximately 16%. We continue to expect the gross to net discount to fall between 15% and 20% throughout the remainder of this year. Research and development expense for the second quarter of 2020 was $42.6 million compared to $26.5 million for the second quarter of 2019. The increase in R&D expenses compared to the second quarter of 2019 was mainly due to the rapid initiation and enrollment in our COVID-19 study, which, as discussed, will now be discontinued, and we expect R&D costs to be relatively consistent for the remainder of 2020 on a quarterly basis. For the second quarter of 2020, SG&A expense was $30.8 million compared to $24.7 million for the second 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 XPOVIO and preparations for the launch of XPOVIO as a treatment for patients with relapsed or refractory DLBCL. Cash, cash equivalents, restricted cash and investments as of June 30, 2020, total of $340.2 million compared to $265.8 million as of December 31, 2019. Based on our current operating plans, we expect our non-GAAP R&D and SG&A expenses, which excludes stock-based compensation expense, for the full year 2020, to be in the previously projected range of to $260 million. In addition, as shown on Slide 15, we currently expect that our existing cash, cash equivalents and investments and the revenue we expect to generate from XPOVIO 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. Michael? -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [7] -------------------------------------------------------------------------------- Thank you, Mike. Before moving to the Q&A, let me highlight some of the key clinical and regulatory milestones that we expect for the remainder of 2020, shown on Slide 16. As you can see, we have done a terrific job so far in 2020, achieving many of the goals we set forth at the start of the year, but we have some important goals still to accomplish. First, we plan to submit additional STORM data and the full BOSTON data to EMA in the coming months. We hope to have greater clarity on the timing of future EMA regulatory decisions following feedback from the agency. Next, we expect to share top line Phase III data from the SEAL study, evaluating selinexor in liposarcoma. Assuming positive results on the primary endpoint of PFS, we plan to file subsequent regulatory submissions. And finally, we anticipate initiating a confirmatory Phase III study of XPOVIO and DLBCL in support of our recent accelerated approval. And of course, we will work diligently through the remainder of the year to support our sNDA based on the BOSTON study as well as explore potential next steps for selinexor development in patients with severe COVID-19. As we look forward to the next several years, we will increasingly expand our activities in solid tumors, both as a single agent and in combination. These include uterine cancer with the ongoing Phase III SIENDO study, glioblastoma multiforme, both alone and in combination, colon cancer and lung cancer. We appreciate your ongoing support and look forward to keeping you updated on our 2020 progress. I'll now turn the call over to the operator for questions. Operator? ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- We will now begin the question-and-answer session. (Operator Instructions) The first question comes from Maury Raycroft with Jefferies. -------------------------------------------------------------------------------- Maurice Thomas Raycroft, Jefferies LLC, Research Division - Equity Analyst [2] -------------------------------------------------------------------------------- Congrats on the progress. I had a question about the COVID-19 study. So for the less than 75-year old patients that are GRAM non high-risk patients where you saw this benefit, can you go into more details on what you know so far about how other medications or treatments could have impacted results? And then it seems like this is the larger population of COVID-19 patients. Do you expect additional funding and support to come from an external pharma partner? Or would it be from governments? -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [3] -------------------------------------------------------------------------------- Yes, the second part is we're in ongoing and expect additional discussions for all options in terms of next steps, given all the things on our own plate in oncology, we believe the strong proof-of-concept results will lead to some kind of a partnership to make sure this moves along. But we don't -- we will not be able to fund that. In terms of the risk factors for response -- or, if you will, or better prognosis with selinexor. So far, we've not found that prior therapy really impacts the outcomes in this population where there was a significant benefit. In fact, what was, I think, more surprising was many of the patients we received, including in that particular group, had already gone through and were worsening on the available therapy. So we kind of got a relapsed or refractory population. But so far, there's no specific prior therapies that mattered, and that's somewhat consistent with the novel mechanism of selinexor in this disease. -------------------------------------------------------------------------------- Maurice Thomas Raycroft, Jefferies LLC, Research Division - Equity Analyst [4] -------------------------------------------------------------------------------- Got it. And maybe one quick question on the commercial update. So you mentioned the new package sizes. Can you just go into any more specifics on how the DLBCL package size could impact multiple myeloma? And then for inventory, if you can provide any more specifics on what you saw in inventory this quarter? . -------------------------------------------------------------------------------- John Demaree, Karyopharm Therapeutics Inc. - Chief Commercial Officer [5] -------------------------------------------------------------------------------- Sure. Let me take that, Michael. -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [6] -------------------------------------------------------------------------------- Yes. -------------------------------------------------------------------------------- John Demaree, Karyopharm Therapeutics Inc. - Chief Commercial Officer [7] -------------------------------------------------------------------------------- Yes. We introduced 3 new package sizes at the end of this quarter to match the label dosing requirements for patients with DLBCL. So we introduced a 60-milligram twice a week, a 40-milligram twice a week and a 40-milligram once per week to address the patient dosing within the context of the package insert. Of course, these package sizes could also be used if a doctor chose to use them in the context of multiple myeloma also. But those 3 package sizes were specifically introduced to address the need in DLBCL. And I'll turn it over to Mike to address the inventory. -------------------------------------------------------------------------------- Michael P. Mason, Karyopharm Therapeutics Inc. - Senior VP, CFO & Treasurer [8] -------------------------------------------------------------------------------- Sure. So we said, we reported $18.6 million in sales for the quarter. About 5% of that was inventory build related to the DLBCL launch because it got approved so late in June and 95% was driven by patient demand. -------------------------------------------------------------------------------- Operator [9] -------------------------------------------------------------------------------- The next question comes from Mike Ulz with Baird. -------------------------------------------------------------------------------- Michael Eric Ulz, Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst [10] -------------------------------------------------------------------------------- Congrats on the progress as well. Just a question on XPOVIO, I guess, just post presentation, the BOSTON data at ASCO, maybe you can provide some color on the types of feedback you've gotten from physicians there? And then separately, have you noticed any increase in off-label use post the ASCO presentation? -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [11] -------------------------------------------------------------------------------- Yes. Thanks, Mike. Look, the feedback has really been uniformly very positive. I'd say there's sort of the several camps out there that were -- the people that always believed and were early adopters that were very gratified to see the results. And so they were not surprised. There were the people that are somewhat on the fence and using the drug more cautiously. We're quite excited and actually impressed with the drug. And then a group of people that were really skeptical and perhaps not using the drug yet, all sort of nodded and said, "It's time to learn how to use this drug." And you can easily see some tweets for some folks that have sort of converted and they are using the drug. It's very difficult to tell how the drug is being adopted immediately. We suspect that there may be increased Houston combination but in general, the use is in the patients who've already gone through the available therapies and are indeed of something new. The good news is that the once-weekly combination therapy does seem to be well tolerated, and we do believe there's some increased use of that. But again, it's in advanced refractory population. We have submitted to NCCN guidelines and we're awaiting responses from the NCCN, and hopefully, we'll be able to see adoption of BOSTON regimen in earlier lines of therapy, and of course, the PDUFA date early next year. -------------------------------------------------------------------------------- Operator [12] -------------------------------------------------------------------------------- The next question comes from Peter Lawson with Barclays. -------------------------------------------------------------------------------- Peter Richard Lawson, Barclays Bank PLC, Research Division - Research Analyst [13] -------------------------------------------------------------------------------- Just maybe around kind of the impact of COVID and any of the dynamics you could talk through around new script growth, patient growth and level of discounting, would be much appreciated around the quarter. P -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [14] -------------------------------------------------------------------------------- John, do you want to take that? -------------------------------------------------------------------------------- John Demaree, Karyopharm Therapeutics Inc. - Chief Commercial Officer [15] -------------------------------------------------------------------------------- Sure. Two parts to that. First, I'll address the new patient growth. We continue to add new patients each quarter, which is one of the key drivers of our sales, especially when you consider that some patients will also come off XPOVIO therapy each quarter. We're encouraged by recent trends and new patient starts, but we don't break out our sales figures by the new patient starts compared to existing patients. What we did see in Q2 was increasing total demand, as mentioned earlier, up 12%, even in the context of the full -- even in the context of the pandemic. The increase was driven primarily by multiple myeloma as the new DLBCL indication was approved at the end of the quarter. In terms of the impact of the COVID-19 pandemic on our commercial efforts. We believe the COVID-19 impact is having multiple effects. As reported by many other companies as well in secondary data sources, patient visits to their doctors continue to be lower than pre pandemic levels. In the context of this environment, we were pleased to be able to grow demand for XPOVIO in the quarter. We've also seen as an impact, in-person visits by our sales force, nurse liaisons and payer teams to be extremely limited. Based on secondary data in our own experience, we estimate only about 15% of HCPs can be seen in-person visits. We've also seen, of course, ASCO was virtual this year, which limited the ability to have a number of engagements with academic and community-based oncologists. We are doing a number of things specifically to offset the impact of being virtual and continuing to grow XPOVIO. Back to the DLBCL launch we planned on and executed virtual launch. We've increased our level of nonpersonal promotion and digital content, including implementing virtual meeting technology for field force engagements, launching e-mail and mail campaigns, direct professional and through the field force, increasing search engine marketing spend for both HCP and patient audiences, increasing media placements, launching new websites and executing XPOVIO education at the point of diagnosis and EMR systems. So just some examples of things we're doing to offset the ongoing impact from the COVID-19 pandemic. -------------------------------------------------------------------------------- Peter Richard Lawson, Barclays Bank PLC, Research Division - Research Analyst [16] -------------------------------------------------------------------------------- Got it. And then do you get any sense of where XPOVIO is being used in DLBCL and multiple myeloma? What lines? -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [17] -------------------------------------------------------------------------------- John? -------------------------------------------------------------------------------- John Demaree, Karyopharm Therapeutics Inc. - Chief Commercial Officer [18] -------------------------------------------------------------------------------- So as Michael just mentioned before, we see the most use of XPOVIO in the context of the indicated lines. So in the context of multiple myeloma, most of the use is in that refractory setting where indicated. And while we just have limited data, given the early launch in DLBCL, we see it being used there in after 2 or more lines of therapy where it's indicated as well. -------------------------------------------------------------------------------- Operator [19] -------------------------------------------------------------------------------- The next question comes from Eric Joseph with JPMorgan. -------------------------------------------------------------------------------- Eric William Joseph, JPMorgan Chase & Co, Research Division - VP & Senior Analyst [20] -------------------------------------------------------------------------------- I really appreciate all the added commercial color on XPOVIO to date. I'm just wondering if you could comment on the latest trends in terms of discontinuation in the myeloma indication, how that's split between progression of disease versus tolerability? And whether you see much more headroom to expansion of time on therapy from the current duration here at 2.7 months. -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [21] -------------------------------------------------------------------------------- John will take that. -------------------------------------------------------------------------------- John Demaree, Karyopharm Therapeutics Inc. - Chief Commercial Officer [22] -------------------------------------------------------------------------------- Yes. Thanks for the question, Eric. The discontinuation rate due to adverse events remains 13%, the same number we reported last quarter since our launch. We attribute this in part due to the emphasis our commercial organization has had in discussing with physicians and their teams the proactive measures that can be taken to prevent and mitigate some of XPOVIO's potential side effects. Particularly the recommended supportive care guidelines and dose modifications included in the product label. We've also enhanced -- we also offer enhanced nurse service offerings through our specialty pharmacy partners to ensure patients have a positive experience with XPOVIO. And additionally, we're finding that physicians -- as physicians gain more personal experience with XPOVIO, they're becoming much more familiar with how to best support to keep their patients on therapy. In terms of the duration of therapy, we would expect that as a collective group of patients to continue to improve over time, as we would expect longer duration of therapy in the DLBCL patients, and then with the future indication pending FDA approval, longer duration of therapy in earlier stages of myeloma. -------------------------------------------------------------------------------- Eric William Joseph, JPMorgan Chase & Co, Research Division - VP & Senior Analyst [23] -------------------------------------------------------------------------------- Of course. Got it. Okay. And just a housekeeping question here regarding the provided cash guidance. Can you talk a little bit about what anticipates in terms of Expos sales in 2021? -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [24] -------------------------------------------------------------------------------- Yes, we're not going to give a specific number for 2020 on sales. But it obviously includes the currently approved indications. And then obviously, at some point, it goes at all BOSTON approval which we produced to date in March of 2021. -------------------------------------------------------------------------------- Operator [25] -------------------------------------------------------------------------------- The next question comes from Jonathan Chang with SVB Leerink. -------------------------------------------------------------------------------- Unidentified Analyst, [26] -------------------------------------------------------------------------------- First question, can you provide any color on what the outstanding questions and remonitoring data are from the European regulators? -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [27] -------------------------------------------------------------------------------- Yes. I mean they were just requested that all efficacy data be remonitored for all the responders, and it's not an unreasonable request. The problem we ran into was -- in something that would have normally taken 4 to 8 weeks, was impossible during the COVID problem because a lot of the sites were completely shut down with 0 access at all. So we're just providing all efficacy data and any updated data that are available for those patients who responded to the drug, and that will all be completed and submitted in September. -------------------------------------------------------------------------------- Unidentified Analyst, [28] -------------------------------------------------------------------------------- Got it. And second question, for the XPOVIO launch, do you have a sense of whether things were trending up in July versus June? Are there any metrics you can share with us today? -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [29] -------------------------------------------------------------------------------- Yes. I mean I think what we would say is, again, we tend not to project monthly data. But certainly, with the -- certainly, there's a lot of positive momentum and we're without doubt seeing prescriptions generated from the DLBCL indication. -------------------------------------------------------------------------------- John Demaree, Karyopharm Therapeutics Inc. - Chief Commercial Officer [30] -------------------------------------------------------------------------------- So certainly, we are seeing more patients coming into the system in July and June, certainly by the fact that we now have DLBCL patients being prescribed XPOVIO. But I would say, in general terms, we continue to be pleased with the momentum that we're seeing based on the approval in the DLBCL, the BOSTON data being presented and XPOVIO being added to NCCN guidelines, et cetera, et cetera. And we think that, that momentum will continue to build as we get out to the second half of this year and to early next year with the progression of publications, medical meetings as well as, hopefully, an approval by the first quarter of next year. -------------------------------------------------------------------------------- Operator [31] -------------------------------------------------------------------------------- The next question comes from Brian Abrahams with RBC Capital Markets. -------------------------------------------------------------------------------- Unidentified Company Representative, [32] -------------------------------------------------------------------------------- Congrats on all the progress. I was wondering if you could talk a little bit more about maybe how the FDA's views on XPOVIO's benefit risk profile may be evolving at all following the BOSTON presentation and submission now that randomized detailed safety and efficacy data are available. Do you expect we could see label expansion even sooner than the standard review PDUFA in March? And then I'm also curious about the potential time line and impact you might expect from getting on the NCCN guidelines? -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [33] -------------------------------------------------------------------------------- Sure. I mean look, we recognize -- we all recognize that the FDA is inundated, and they're under the same difficult working conditions that the rest of us are in. So they have a lot on their plate. Myeloma with 1 to 3 prior therapies has always been a standard review time. But we're hopeful that our rapid responsiveness to their information requests and their strong knowledge about XPOVIO in both myeloma and DLBCL will help facilitate the review. And of course, we're hopeful they can get it done sooner. But right now, we have to stick with the PDUFA date. Remember that for the original approval for STORM, they did look at the early data from BOSTON and those data, which we were not aware of, have clearly borne out. And I guess they're probably gratified that they followed the Phase III trends back then. And we think that they will -- they have now felt comfortable with their decision to get this drug not 1, but 2, accelerated approvals. In terms of the code -- the NCCN situation. Now we've submitted to the NCCN, and we're hopeful that we'll see action from the NCCN sooner. Interestingly, we submitted our DLBCL data at approximately the same time, and that immediately moved onto the NCCN guidelines. It really is, in myeloma, just dependent upon the myeloma group and NCCN getting together a rendering a decision. -------------------------------------------------------------------------------- Operator [34] -------------------------------------------------------------------------------- The next question comes from David Lebowitz with Morgan Stanley. -------------------------------------------------------------------------------- David Neil Lebowitz, Morgan Stanley, Research Division - VP [35] -------------------------------------------------------------------------------- Would you be able to give us any thoughts on cadence of XPOVIO sales going into the second half of the year? -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [36] -------------------------------------------------------------------------------- John? Mike? -------------------------------------------------------------------------------- Michael P. Mason, Karyopharm Therapeutics Inc. - Senior VP, CFO & Treasurer [37] -------------------------------------------------------------------------------- Yes. I mean I think what you saw in Q2 with the $18.6 million of revenue, about 95% of that, as we mentioned, was demand versus 5% was channel. And we expect the launch to continue strong and the MM sales in the second half of the year. But we're not going to give specific color as far as numerically on the call. -------------------------------------------------------------------------------- David Neil Lebowitz, Morgan Stanley, Research Division - VP [38] -------------------------------------------------------------------------------- And with respect to the upcoming liposarcoma data, could you tell us -- I guess, run us through what your expectation for that study is given what occurred in the Phase II part of the trial? And what your thoughts are on what that data might mean for the broader topic of solid tumors? -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [39] -------------------------------------------------------------------------------- Yes. I think importantly, this is a strategic -- it's not a shift, I would say, but it's definitely a focus area that we'll be focusing considerably more of our resources in solid tumors. And liposarcoma represents an extreme unmet medical need, relatively small population with dedifferentiated liposarcoma. But unfortunately, pretty much uniformly fatal and only chemo -- parenteral chemotherapies are available. There's no oral treatments there. So demonstrating activity in these very large tumors that are chemo refractory, we think, is an excellent precedent and an excellent first potential approval for XPOVIO into solid tumors. The Phase II study, as you may recall, showed a hazard ratio of just shy of 0.7, which is what the Phase III was powered to do, and we hope to see a similar kind of result. And if we do, then we will be filing that into both the U.S. and other regulatory bodies. And we think that this will be an important drug for liposarcoma and our -- and also, in general, showing that XPOVIO has activity, not only in hematological malignancies, but also in solid tumors, particularly chemo refractory tumors. Following that, we have our SIENDO study that should read out the end of next year in uterine cancer in the adjuvant setting. So that's after first line completion of chemotherapy and then to try to delay progression after chemotherapy in patients with advanced uterine cancer. And we have additional trials ongoing in glioblastoma multiforme, both now in the front line in combination with radiation plus or minus temozolamide and in the second line in combination with [Altela] therapy. We have additional studies that are also ongoing now, both investigator and company-sponsored in colorectal cancer and in lung cancer, and we hope to be sharing some additional data in other solid tumors towards the end of this year. So long story that the company will be focusing, to a large extent, on solid tumors while continuing to move expeditiously in both myeloma and DLBCL. -------------------------------------------------------------------------------- Operator [40] -------------------------------------------------------------------------------- The next question comes from Ed White with H.C. Wainwright. -------------------------------------------------------------------------------- Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [41] -------------------------------------------------------------------------------- So maybe just staying on solid tumors, Michael. If you can just give us a little update on the glioblastoma trial. You had the first patient enrolled in June, can you give us any further enrollment update or timing to the Phase I data? And then also on the colorectal cancer and lung cancer studies in Israel, just -- are they progressing? Has there been any impact on any of these studies for -- with the COVID pandemic? -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [42] -------------------------------------------------------------------------------- I'll turn that to Sharon. -------------------------------------------------------------------------------- Sharon Shacham, Karyopharm Therapeutics Inc. - Co-Founder, President, Chief Scientific Officer & Co-Chairman of Scientific Advisory Board [43] -------------------------------------------------------------------------------- So the study is progressing nicely on all 3 arms that Michael just mentioned in the in the newly diagnosed first-line as well as in patients that have can and we hope to be able to present the results on this study scientific meeting next year. . -------------------------------------------------------------------------------- Operator [44] -------------------------------------------------------------------------------- (Operator Instructions) The next question comes from Arlinda Lee with Canaccord. . -------------------------------------------------------------------------------- Unidentified Company Representative, [45] -------------------------------------------------------------------------------- It's Ben Shim calling in for Arlinda. Congrats on the strength of XPOVIO sales. And we really appreciate all the details that you guys provide on the sales metrics. . Just 2 questions. Have you rethought or are you thinking about your EU commercialization strategy in oncology (inaudible) partner? And I'll ask my follow-up after that. -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [46] -------------------------------------------------------------------------------- Christopher Primiano will take that. -------------------------------------------------------------------------------- Christopher Brett Primiano, Karyopharm Therapeutics Inc. - Executive VP, Chief Business Officer, General Counsel & Secretary [47] -------------------------------------------------------------------------------- Sure. Ben, it can be hard to give satisfying incremental updates when it comes to these types of things. But as you know, we continue to assess numerous options for potential commercialization in Europe. Now that we've regained the development in commercial rights in Japan, we think those potential options for us have increased. One option and it's probably the most likely one, that could involve a partnership. In this scenario, we look for a partner and a partnership that is mutually beneficial for both parties, maximizing the potential of selinexor in the European market. We've said often that we're looking for a partner who aligns with our philosophy regarding our long-term development and commercialization plans for selinexor and has the expertise in marketing hematologic malignancy drugs in the EU and then obviously, building towards a solid tumor presence as well. The second option could be to potentially launch selinexor on our own in select European countries, where reimbursement negotiations and decisions typically occur more quickly and at accessible levels. But in either scenario, our belief is that the value of selinexor will build over time, particularly as we progress through the regulatory process in myeloma. And just as an aside, in myeloma, obviously, the most significant opportunity in Europe will come following a potential approval based on the data from the BOSTON study. And I just also know that there are opportunities to leverage approvals in the U.S. for paid name patient programs in certain territories where we wouldn't anticipate any impact to reference pricing. So we may also avail ourselves of these opportunities as well, subject, of course, to the always evolving global pricing and reimbursement landscape. -------------------------------------------------------------------------------- Unidentified Analyst, [48] -------------------------------------------------------------------------------- Right. Great. That's very helpful. Switching gears to COVID-19, and I guess some of this may touch upon potential partner in oncology. Will you be pursuing emergency use authorization here? And I kind of wonder what the implications will be for pricing, both in a pandemic and a post pandemic world. -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [49] -------------------------------------------------------------------------------- Yes. I think both of those questions in parts are a little premature. I mean our intention is to demonstrate prospectively that we have this -- what appears to be a significant benefit now in the specific subpopulation, is an important large subpopulation. And once we get there, we'll work with all of the different constituents to do the right thing, and this is not a time to start playing around. People are suffering greatly, and we'll do the right thing. But we've got to demonstrate prospectively that this is correct and replicate the results, and then we'll move ahead. And we don't believe this is a low dose of selinexor. It's 20 milligrams given 3 times a week. We don't believe this will have implications to the oncology franchise. -------------------------------------------------------------------------------- Operator [50] -------------------------------------------------------------------------------- This concludes our question-and-answer session. I would like to turn the conference back over to CEO, Michael Kauffman, for any closing remarks. -------------------------------------------------------------------------------- Michael G. Kauffman, Karyopharm Therapeutics Inc. - Co-Founder, CEO & Director [51] -------------------------------------------------------------------------------- Thanks very much, and thank you all for joining today's call. We look forward to updating you on our progress in the future. Best. -------------------------------------------------------------------------------- Operator [52] -------------------------------------------------------------------------------- The conference has now concluded
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04/08/20 10:02
Ha respondido al tema Farmas USA
KPTICovid solo con minado de datos,aunque minando parecen buenos. Dicen que buscarán partner
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04/08/20 09:27
Ha respondido al tema Farmas USA
KPTITops revenue by 4.6M. Misses estimated EPS by 6c.Karyopharm Therapeutics (KPTI) came out with a quarterly loss of $0.63 per share versus the Zacks Consensus Estimate of a loss of $0.57. This compares to loss of $0.71 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -10.53%. A quarter ago, it was expected that this pharmaceutical company would post a loss of $0.70 per share when it actually produced a loss of $0.78, delivering a surprise of -11.43%.
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04/08/20 07:52
Ha respondido al tema Farmas USA
AMRNPlans to maximize "Blockbuster potential" of Vascepa in EuropeAmarin to Build Dedicated Organization to Retain Substantial Value of One of the Most Anticipated Cardiovascular Drug Products in Decades Veteran Cardiovascular Commercial Executive Hired to Lead Focused LaunchDUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN),today announced the company's plans to undertake its own focused commercial launch of VASCEPA® (icosapent ethyl) in Europe. Amarin's plan is subject to review and approval of its Marketing Authorization Application (MAA) by the European Medicines Agency and the European Commission, respectively. The application is in the late stages of review for the reduction of cardiovascular (CV) risk in high-risk patients based on the REDUCE-IT® cardiovascular outcomes study."With more than 80 million people in Europe with cardiovascular disease1, there is a significant and untapped market opportunity for a safe and effective treatment beyond conventional therapies for cardiovascular risk reduction for appropriate patients based on the REDUCE-IT study," said John Thero, president and chief executive officer, Amarin. "In anticipation of approval, we conducted an extensive evaluation of the commercial options for VASCEPA in Europe. Based on that analysis, we determined that a commercialization team within Amarin and dedicated to VASCEPA is the best choice to maximize the blockbuster potential of the drug in Europe. Amarin's plan will allow the company to retain substantially all of the economic benefits of this sizeable market opportunity in key regions within Europe and is expected to result in select partnering transactions in certain smaller countries. Amarin has the passion, commitment and in-depth understanding of the product and its unique cardiovascular benefits necessary for a commercial launch. We look forward to advancing VASCEPA through the regulatory process and maximizing the blockbuster potential of VASCEPA in Europe to help millions of patients in need."Ten to eleven years of market protection is anticipated from regulatory exclusivity in connection with VASCEPA approval based on REDUCE-IT in Europe. Amarin has filed for additional patent protection, which has the potential to extend exclusivity into 2039.Over the past year, Amarin has made considerable progress laying the foundation for a successful commercial launch in Europe. While not yet approved for sale in Europe, VASCEPA is already included in the medical treatment guidelines of the European Society of Cardiology (ESC) and the European Atherosclerosis Society. Amarin is also looking forward to supporting a series of robust clinical data presentations highlighting the role of VASCEPA in CV risk reduction at the ESC annual meeting later this month. In addition, Amarin has been conducting market analysis and payor access research in order to size the market opportunity and prepare for the reimbursement negotiations in the various countries.To enable Amarin to deliver on its vision in Europe, the company announces its recent hiring of Karim Mikhail as senior vice president, commercial head Europe. Mr. Mikhail joins Amarin from THEODON, a global commercial strategy consultancy that he founded in 2018 and where he served as chief executive officer. Prior to that, he was with Merck for 22 years, in a career spanning seven different countries across three continents. His most recent role was global commercial leader for Merck's $4 billion lipid franchise, where he led the global launch of ezetimibe with the IMPROVE-IT study indication. Prior to that Mr. Mikhail was also chief marketing officer for Europe, Middle East and Africa and chief operating officer for emerging markets. While at Merck, Mr. Mikhail led the successful commercial launch of dozens of products, including ezetimibe and various molecules in diabetes, hypertension, immunology, and oncology.At Amarin, Karim plans on selecting a team of highly talented professionals to fill key positions while leveraging third-party relationships to focus further on product reimbursement and launch plans. Reimbursement, which needs to be sought for VASCEPA on a country-by-country basis, should be supported by the drug' s demonstrated effectiveness and support from leaders in the medical community.Based on its current plans and expectations, Amarin believes that its current capital resources are sufficient to achieve sustained positive cash flows from VASCEPA, including commercial launch of VASCEPA in Europe. Physician targets to be educated about VASCEPA in Europe tend to be more concentrated than in the United States. In addition, the efficiency of launching a product and educating physicians in Europe should be aided by innovations in digital communication and other forms of education and promotion."We are delighted to welcome Karim to the Amarin team," continued Mr. Thero. "He is an accomplished professional with a successful track record in building organizations and commercializing numerous products in Europe and internationally. Karim brings to Amarin extensive European regulatory experience, market access expertise and the commercial innovation needed to successfully launch VASCEPA in Europe. Importantly, Karim shares our vision and excitement for VASCEPA and its potential multi-billion-dollar market opportunity in Europe.""Assuming market authorization is granted in early 2021, we look forward to the successful launch of VASCEPA as the first and only non-LDL lowering agent approved in Europe with a cardiovascular disease risk reduction indication as an adjunct to statin therapy in dyslipidemic patients," concluded Mr. Thero.
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04/08/20 06:18
Ha respondido al tema Farmas USA
AMRNAmarin (NASDAQ:AMRN): Q2 Non-GAAP EPS of $0.04 beats by $0.11; GAAP EPS of $0.01 beats by $0.09.Revenue of $135.32M (+34.3% Y/Y) misses by $14.16M.Normalized prescriptions for VASCEPA increased by ~44% in Q2 compared to 47% in Q2 2019, based on data from Symphony Health and IQVIA, respectivelyTotal Revenue Increased 34% in Second Quarter 2020 Compared to Second Quarter 2019 Despite COVID-19 HeadwindsMultiple Upcoming Milestones Regarding VASCEPA® Opportunity in United States and Internationallyhttps://seekingalpha.com/pr/17957060-amarin-reports-second-quarter-2020-financial-results-and-provides-update-on-operations10-Qhttps://seekingalpha.com/filing/5106393?utm_medium=email&utm_source=seeking_alpha&mail_subject=amrn-amarin-corporation-plc-sec-filing-quarterly-report-10-q-august-04-2020&utm_campaign=rta-stock-filings&utm_content=link-1
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03/08/20 04:13
Ha respondido al tema Farmas USA
EVFMFuera 3,25 en leve rojo desde 3,31. Mañana resultados. Y es un cagarro al que no volveré.
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