Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
Please consider a small donation if you think this website provides you with relevant information
| Statement |
|---|
| So overall, we're very pleased with the performance, not only on the top line growth for PDT, but also on its profitability |
| The strong data and remaining unmet need in the U.S |
| Importantly, we continue to track well towards our management guidance for performance at a constant exchange rate |
| Our largest product, ENTYVIO, continues to perform well, with growth of 6%, but remains a little behind where our expectations had been |
| So the -- now we become the only product really that has both subcu and IV options, a really excellent pen, along with all the other benefits of ENTYVIO |
| Our first semester performance underscores the strength of our core business, and our ability to deliver life transforming treatment to patients and communities |
| And with approval last month of the subcutaneous device, and ongoing investment in both marketing and life cycle management, we remain fully confident in the continued growth outlook for the product |
| In rare diseases, TAKHZYRO continues its strong momentum with growth of 13% having successfully launched in 50 countries and with sustained demand in the U.S |
| We also see continued launch successful LIVTENCITY up for83% with strong market penetration in the U.S |
| Combined with the launch of the ENTYVIO Pen, combined with the growth of ENTYVIO actually also outside of the U.S., we are very much confident about our peak estimate of between $7.5 million and $9 billion |
| And so the subcutaneous pen is another opportunity for us to demonstrate the value of ENTYVIO in IBD, and we're very excited about that |
| PDT Immunology continues to deliver outstanding growth of 17%, including 19% growth of immunoglobulin and 11% growth of albumin |
| And the safety profile looks very good |
| Both our IG and albumin products continue to see strong demand |
| Together with initiatives to improve efficiency across the PDT value chain, this has enabled us to improve PDT margins year-on-year for the first time since the pandemic |
| And we had a very large team at the Sleep conference this week and are very excited about the Orexin franchise that we have at Takeda |
| Our newest growth in launch product, which is seeing strong initial demand in both endemic and travel markets |
| And with the launch of the subcutaneous formulation ENTYVIO Pen, we're quite confident in our ability to continue to support ENTYVIO growth in the U.S |
| We have confidence in our portfolio and pipeline to deliver a return to growth in the near-term, and we will continue to allocate capital with discipline as we focus on delivering sustainable growth and competitive shareholder returns |
| Also in September, we announced positive top line result from our Phase 2b trial of TAK-279 for active psoriatic arthritis |
| We are seeing strong initial demand in private market in endemic countries as well as strong launches in travel market led by the EU |
| And so we expect a very significant positive impact on the overall brand |
| On the PBT margin, what's improving, it's gross profit margin is improving, as well as core operating profit is improving |
| But on the core operating profit margin, we're seeing significant improvements overall, driven by a really efficient end-to-end process, whether it's leveraging data digital technology throughout the PDT daily chain or manufacturing capacity |
| Volume growth remains strong in the in the EU in Europe |
| Outperforming the overall IBD advanced therapy market despite pricing headwinds |
| So we're seeing the gross profit margin improving mainly because of product mix within the portfolio |
| We continue to believe in the benefits demonstrated by ALOFISEL and ADMIRE I, as well as in other trials such as the positive Japanese pivotal study and the INSPIRE registry, an 800 patient European real world body of evidence |
| So we feel quite good about the overall safety and tolerability profile at this point |
| Nevertheless, the majority of moderate to severe patients remain untreated or on an conventional therapy, so we continue to see significant opportunities and our commercial organization is working very hard to expand our leadership in this area |
| Statement |
|---|
| The results are disappointing, particularly given the robust benefits previously demonstrated in the ADMIRE I Phase 3 study, which served as the basis for approval in Europe and Japan |
| All these items combined led to the reported operating profit decline of 53.2% |
| On a reported basis, we are lowering fully a profit forecast due to the impact of the non-core item booked in the second quarter |
| Finally, the other segment is declining in H1 mainly due to lower revenue from COVID-19 vaccines in Japan |
| One, as you highlighted already, the product mix, so we saw loss of exclusivity of high margin products, such as DEXILANT, VELCADE, AZILVA, coupled with lower COVID vaccine revenue versus last Q2 fiscal year 2022 |
| IBD market, and we are also being impacted by pricing headwinds in Europe |
| Reported net profit and reported EPS declined approximately 75% |
| The market growth in volume has been quite lower than what we expected |
| So that put pressure on our margin for quarter two, our gross profit margin |
| Core operating profit was JPY588.8 billion, a decline of 5.8% on an actual FX basis or 9.5% at constant exchange rate |
| EXKIVITY, negative progress and ALUNBRIG, strong competition and growth and new share products are struggling in this background |
| These are reflected in our reported operating profit result of a JPY119.2 billion a year-on-year decline of 53% |
| But we also faced some headwinds |
| Core operating profit was JPY588.8 billion or $3.9 billion with a decline versus prior year of 9.5% |
| In addition to these major updates, we also faced a couple of headwinds this past quarter |
| Low-single-digit percentage decline in revenue low 10 percentage decline in core operating profit and low-20s percentage decline in core EPS or on a constant exchange rate basis |
| Core net profit and core EPS is impacted by a slight -- a slightly higher core tax rate compared to last year, with core EPS for the first-half of JPY261, down 14.4% versus prior year at constant exchange rate |
| All these factors combined resulted in a first-half core operating profit decline of 9.5% on a constant exchange rate basis or 5.8% decline when factoring the FX |
| There was also a core gross margin impact from the setbacks to EXKIVITY and ALOFISEL, due to inventory write off and impairment of manufacturing facility |
| Here, you can see the sizable increase in impairment of intangible assets, which totaled JPY115.8 billion in the first-half, mainly due to the negative Phase 3 study readout of ALOFISEL and the voluntary global withdrawal of EXKIVITY |
Please consider a small donation if you think this website provides you with relevant information