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| Statement |
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| As we look to the future of multiple myeloma franchise, we believe that as a profitable business, generating a 2:1 ROI, it will continue to provide a steady inflow of cash to fill our pipeline and continue to drive confidence an experience in our product at a lower dose as we prepare for future launches, including the potential approval of the all-oral SPd regimen, which could unlock further growth |
| These trials will potentially enhance and create new standards of care for patients and provide significant value creation opportunities in the near term |
| Let's review some key accomplishments from our core programs in 2023, which strengthen our confidence in our ongoing Phase 3 trials |
| In myelofibrosis, we are very encouraged by the comprehensive profile including tolerability, spleen volume reduction, symptom improvement as measured by TSS50 and a long-term durability that we saw in our Phase 1 data of selinexor plus ruxolitinib in JAKi-naive patients presented at ASH |
| We are doing this by concentrating our investments into these pivotal programs and leveraging our existing multiple myeloma franchise, anchored on our commercial drug XPOVIO, which is approved in over 40 countries, generating brand profitability and growing experience with physicians |
| Through ongoing disciplined expense management, we have an expected cash runway into late 2025, providing us with a financial strength to deliver on key data readouts from our three Phase three studies |
| Finally, our commercial organization is well established and has developed deep relationships in the community, which represents a key overlapping customer base in both myelofibrosis and endometrial cancer to enable rapid launches in these areas |
| Importantly, our existing commercial infrastructure is profitable to date and provides us with the capability to support their rapid and smooth commercial launch of selinexor in new indications |
| As I mentioned at the start of the call, we believe the largest opportunities for selinexor are yet to come with data expected from these three Phase 3 trials next year is going to be an incredibly exciting time for our organization |
| The data we are seeing in myelofibrosis and endometrial cancer are highly encouraging and we believe, the largest opportunities for selinexor are yet to come |
| And I think as I mentioned before, we're very excited about our innovation and growth strategy |
| In endometrial cancer, we are excited by the substantial improvement in median progression-free survival for patients who are TP53 wild-type as reported to the ASCO Plenary Series |
| We're very encouraged and we're very confident that when we look at symptoms in our Phase 3 it is going to show meaningful benefit compared to selinexor alone |
| So we'll update on Q1, but we're progressing in Q1 here we feel very good about being able to deliver our full year guidance |
| As you know I think we've had some really positive evolution with regards to our IP position |
| These robust subgroup data demonstrate the potential to provide substantial benefit to a unique and sizable population defined by P53 status which directly ties to selinexor as a mechanism of action given that XPO1 inhibition retains P53 within the nucleus thus enhancing cell kill |
| John Mascarenhas noted that the combination is tolerable and that the spleen and symptom data observed to-date from the Phase 1 study may significantly improve these outcomes in first-line myelofibrosis |
| On slide 18, prominent myelofibrosis leaders in the field are impressed with the profile this unique selinexor combination may provide to JAK naive myelofibrosis patients |
| As the body of data grow and positively evolve, we maintain a high level of confidence in the ongoing Phase 3 study shown on slide 19, which is evaluating the combination of selinexor 60 milligrams with ruxolitinib versus ruxolitinib alone in 360 JAK naive myelofibrosis patients |
| These efficacy data coupled with a generally manageable side effect profile suggests that oral selinexor is uniquely positioned as an optimal maintenance therapy or convenience, tolerability and meaningful efficacy are the hallmarks of the maintenance option |
| In Q4 2023, XPOVIO new patient share was approaching 70% in the second to fourth line representing double-digit growth year-over-year |
| Our story in multiple myeloma has been one of resilience and said fasteners in a highly competitive and rapidly evolving environment, whether the disease remains incurable and XPOVIO continues to be an effective option for many patients |
| As you can see on slide 32, we are excited about our innovation and growth strategy with our Phase 3 clinical trials in multiple myeloma, endometrial cancer and myelofibrosis, each of which would be transformative for patients and our organization |
| So I think that's a strong validation of the value and the unmet need in myelofibrosis |
| As we are seeing positively evolving data with longer median PFS observed with selinexor 40 milligrams in combination with pomalidomide and dexamethasone, a beneficial outcome for these patients, top line data are now expected in the first half of 2025 |
| This highlights the opportunity we may have to deliver unprecedented outcomes for a large and unique population of patients |
| This is strengthened by our new data and elevation of selinexor in the NCCN guidelines |
| During 2023, we achieved total demand growth in the community setting and shifted patient mix into earlier lines, consistent with our strategy |
| In summary, we have near-term late-stage opportunities supported by compelling data in our rapidly advancing pipeline that will potentially benefit multiple cancer patient populations of high unmet need building on our approved indications |
| Any one of these programs, if approved, represents an incredibly meaningful growth opportunity for our company with endometrial cancer and myelofibrosis, representing the largest opportunities |
| Statement |
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| So last year we were really in the eye of the storm especially in the second half of the year where we saw downward demand pressure as a result of the uptake of the bispecific class, two of the three bispecifics launched in the second half of last year |
| So the bispecifics as I touched on, it really posed a significant competitive threat in the academic setting particularly in the second half of last year, as I mentioned two of the three launched in the second half |
| We faced some considerable headwinds in 2023, including increased competition from new entrants in the bispecific class in the later lines, which adversely impacted demand in the academic setting in the second half of 2023 |
| Additionally, higher gross to net, driven by increased 340B discounts and Medicaid rebates due to the inflation reduction at and a significant increase in the free drug of patient assistance program utilization due to closures of multiple myeloma foundations adversely impacted our revenue |
| Thanks Steve and I will just add a high-level data that looking at the numbers in detail is very difficult and it's more directional |
| But in the academic setting, we definitely saw an impact |
| I apologize |
| Actual results may differ materially from those indicated by these FLS as a result of various important factors, including those discussed in the Risk Factors section of our most recent Form 10-Q or 10-K which are on file with the SEC and in other filings that we may make with the SEC in the future |
| This range reflects the highly competitive nature of the multiple myeloma market, with important new entrants in the second half of 2023 and more anticipated this year, which we are mindful of, especially when setting expectations for our financial performance this year |
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