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.
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| Statement |
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| We see all of these as positive indicators for productive reimbursement conversations following a potential approval and access to a final label |
| We believe this gives us a significant advantage when it comes to being the potential first to market mover in NASH |
| As we proceed through this critical year for Intercept, I'm pleased with the disciplined execution our team has taken to grow our leadership in PBC to work through the regulatory review process for OCA in NASH and prepare its potential commercial launch and to advance our pipeline |
| Given the robust body of evidence we've gathered through our OCA NASH clinical development program, we're confident in the improved benefit risk profile of OCA and believe it has the potential to become an impactful therapy for patients in urgent need of pharmacologic intervention |
| In summary, we believe that our balance sheet cash position and foundational PBC business provide us with the financial strength to grow our existing business and meet our strategic objectives, including preparation for a commercial launch in NASH should we gain approval by the FDA or a pivot to profitability if we are unable to achieve an approval in NASH |
| In summary, I'm proud of the progress we've made in the first quarter of the year and believe we're in a strong financial position as we manage our upcoming milestones, including our advisory committee meeting for OCA in NASH and planning for a potential launch |
| Paired with our commercial expertise in liver space and deep knowledge of our Hep, GI and ATT customers, we stand poised to successfully launch OCA in Nash later this year |
| This strong performance is evidence of the sustained growth of our foundational PBC business |
| Additionally, we are sharing research results that show our reps are highly regarded in gastro and hep offices, and our corporate reputation is equally strong in the NASH field |
| Looking ahead, we have strong conviction in the strength and long-term opportunity of our foundational PBC business for several reasons |
| The strategic actions we took in 2022 established a strong base for us to build on in '23 |
| In fact, over 95% of our business is driven by existing patients and our refill rate continues to be strong at approximately 90% |
| Importantly, reaching this substantial percentage of identified NASH targets can be achieved at launch using our current field footprint, which we view as a strength and differentiator |
| The role of FXR dysregulation in NASH and how OCA as an FXR agonist addresses that to help stop and reverse fibrosis and our compelling efficacy data |
| First, we are pleased with our strong sales performance this quarter, recording $68 million in net sales as compared to $59.2 million in net sales in the prior year quarter |
| So in multiple areas we are clearly very strongly in anti-fibrotic drugs |
| OCALIVA is the only second line therapy in PBC to demonstrate a positive impact on outcomes, driving greater awareness of the real world applications and benefits of OCALIVA in PBC is an important differentiator and part of our long-term strategy |
| Supporting our well established leadership position in the PBC market is strong IP protecting OCALIVA market exclusivity into the 2030s |
| And finally, our OCA and Bezafibrate fixed dose combination program, which Michelle will discuss in a moment, further adds to our long-term leadership in this space |
| In summary, I'm confident in the strength of OCALIVA's market position and the long-term opportunity with our foundational PBC business, as evidenced by double-digit sales growth for the third consecutive quarter and clinical development progress for the OCA-Bezafibrate fixed dose combination |
| Importantly, our strong financial position gives us the optionality to drive continued growth in PBC, execute on our upcoming milestones in NASH and develop innovative new medicines through our pipeline programs |
| So I think those the strength of that data has improved |
| But for advanced fibrosis, I think, we're positioned very, very well there with the strength of our data |
| In these analyses, OCA has demonstrated a strong and consistent anti-fibrotic effect, as was seen in the Phase 2 FLINT study, the first clinical study to show anti-fibrotic benefit |
| Additionally, our safety database, which is the largest in the NASH field with the longest duration of patient exposure, provides a well characterized safety and tolerability profile that supports the potential chronic administration of OCA |
| We believe that a fixed dose combination of OCA and Bezafibrate presents an opportunity to optimize the doses of each medicine and further improve the treatment of PBC with the potential to establish best-in-class clinical benefits |
| We're excited about the progress we're making |
| Based on the additional data we have generated, we believe that the benefit risk of OCA has improved since our initial regulatory submission |
| Now turning to PBC, our PBC business continued to perform well in the first quarter |
| Importantly, we also see improvement in fibrosis in nearly 40% of patients who had baseline and month 18 liver biopsies in REGENERATE |
| Statement |
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| To reiterate, weakened FXR signaling in NASH is associated with the disruption of multiple biologic processes which lead to the progression of liver fibrosis |
| Our study was not positive there |
| The impracticality of really performing biopsies on every patient who may or may not have NASH coming into the market space I think is a little bit prohibitive in and of itself |
| We reported a net loss from continuing operations of $31.9 million for the first quarter of 2023, a decrease compared to a net loss from continuing operations of $33.4 million in the first quarter of 2022 |
| Nonetheless, I think while that urgency is there |
| The issues around the CRL were about overall benefit risk |
| In a retrospective study comparing NASH patients with and without fibrosis survival among those with fibrosis was significantly reduced as their fibrosis progressed |
| As we mentioned, last quarter, we anticipated a heavier than normal cash burn to occur in the first quarter relative to the rest of the year |
| If we don't get regulatory approval, that would take a lot of our expense down right away |
| There's there would be a delay potentially in getting them et cetera, et cetera |
| However, I think it is important that we didn't see differential safety in that patient population with cirrhosis even though we didn't hit the primary regulatory endpoint |
| We experienced the typical revenue seasonality in Q1 as patients were impacted by the resetting of insurance plans and medicare coverage gaps |
| Notably, these patients are fundamentally at greater risk for mortality as their fibrosis progresses to cirrhosis |
| Research and development expenses decreased to $41.7 million in the first quarter of 2023 from $47.6 million in the prior year quarter |
| The fact that we cannot currently predict which patients are most likely to progress makes treating these at risk patients an urgent priority |
| The challenge in PBC is that the patients are spread across a very large number of these gastroenterologists |
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