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 |
|---|
| There is a very strong health economic argument that justifies spending on preventive treatment |
| And what's -- again, what's really, really exciting is that despite the J-Code issue, we've been able to put patients on drug and those patients have been reimbursable, right, which is really important |
| We also did an outstanding job with not just getting this product approved but also setting it up for success in Europe, and that's largely to Adrian's efforts that were underway since he joined us in August |
| We're pleased with our execution against strategic plans and our momentum in '23 which sets the stage for further success in '24 and beyond |
| We continue to be very encouraged with the progress we've made and we're even prouder of the work that is underway to sustain this momentum throughout '24 and beyond |
| I cannot be more pleased to see a very strong and capable player take on PEDMARQSI and really get access for it in these territories |
| The increase in net sales reflects strong growth in new patient starts and accounts |
| PEDMARK also continues to have broad and favorable payer coverage, as evidenced by payer-approved US prescription claims with commercial insurance plans and Medicare Part D plans |
| So in closing, I'm very pleased with the progress we are making and I'd like to thank the commercial and medical affairs teams for the tremendous effort they've made over the last few months, and I look forward to seeing the acceleration in revenue |
| It's really exciting because their passionate and commitment is right up there with ours |
| And so it's actually -- very, very proud of what the team has been able to accomplish |
| From a deal perspective, the terms provide us with many important benefits, including an upfront payment, further solidifying our balance sheet, attractive economic terms, providing meaningful participation in the ex-US success of PEDMARQSI and an experienced partner to successfully launch PEDMARQSI in the license territory |
| But again, based on the numbers, we're highly encouraged that that will be well received |
| It was an exciting year for Fennec given the strong performance with PEDMARK in the full full fiscal year following its US commercial launch |
| We're also continuing to build upon our commercial momentum to expanding the prescriber base to the community, increasing the utilization of the recent endorsement from the NCCN or PEDMARK in the adolescent and young adult AYA patient population |
| And now with the FDA communication on the safety risks, we're encouraged by that and our sales force as well as our medical team is out there educating |
| And this is something very, very attractive to, as you could imagine, many, many parties, especially when there is a specific need and market for a very, very unique product |
| We’re essentially just a couple of months into what is in effect a new launch for PEDMARK, but we're encouraged by the reception we received, patients have already been treated and reimbursed by payers |
| Testicular cancer has very high cure rates, 90% and beyond |
| And stay tuned, I think, there's more good news coming there |
| We've always been a very, very good stewards of capital historically |
| We have been very encouraged by the community's response to PEDMARK |
| We are pleased with the FDA reminder to providers of this issue, which supports our educational efforts in establishing PEDMARK as the necessary complement agent when prescribing a cisplatin based therapy for appropriate patients with a localized nonmetastatic solid tumors |
| And as you're correct in saying that it was a competitive process and a number of the potential suitors all came to that conclusion, it became clear to us that the suitors were very excited about the potential of the product, were prepared to commit significantly more resources than we would have been able to do given our other priorities in the US |
| I'm absolutely delighted with the partnership with Norgine, they're completely bought into the concept, we're completely aligned on our pricing assumptions |
| As you may recall, we announced preliminary unaudited fourth quarter and full year 2023 net revenues at the end of February and we're pleased to report that PEDMARK delivered fourth quarter revenues of approximately $9 million |
| They see this, as you said, Chase, as highly synergistic to their growing portfolio in pediatric oncology |
| With regards to our evaluation of the best commercial path in Europe, we were pleased to announce on Monday that Fennec has entered into an exclusive licensing agreement with Norgine, a leading European specialist pharmaceutical company, under which Norgine will commercialize PEDMARQSI in Europe, Australia and New Zealand |
| In closing, I want to reiterate that the focus of our commercial strategy remains on executing the following: establishing PEDMARK as necessary complement agent when prescribing the cisplatin based therapy for appropriate patients with localized non-metastatic solid tumors; minimizing the barriers to access and ensuring rapid responses to product questions and inquiries; and establishing Fennec as the premier partner of choice in the oncology, in-patient and community setting |
| I hope that to continue going forward |
| Statement |
|---|
| As Rosty mentioned, on January 8th, the FDA issued an e-mail reminder that PEDMARK cannot be substituted with other formulations of STS due to significant safety concerns |
| In terms of the value proposition that PEDMARQSI and PEDMARK offers, as you know, it's very difficult to get a product approved |
| We had overall, I would say, a limited success in some of those accounts |
| As a consequence, there has been some confusion and impact to the adoption of PEDMARK |
| So we have seen some increased use but it is not like switching a light on, it's slow |
| The FDA stated such substitutions post potential health risks, including potassium chloride, which at high doses can lead to increased risk of acute cardiac events and other serious adverse reactions; potassium chloride is not present in PEDMARK; overexposure to boric acid can cause health risks, including headache, hypothermia, restlessness, weariness, renal injury, dermatitis, alopecia and anorexia and indigestion; although PEDMARK also contains boric acid, it is at a lower concentration than other STS products; overexposure to sodium nitrate, which can lead to health risks, including methemoglobinemia; sodium nitrate is co-packaged with sodium thiosulfate as a separate vial in some products is not present in PEDMARK |
| Taking testicular cancer as an example, there are approximately 3,800 patients and the majority of these are likely to receive high doses cisplatin putting them at a very high risk of hearing loss |
| Further, Q4 2023 and the first six months of 2024 have additional expenses associated with the internal preparation for the EU launch, which with the announced partnership of Norgine, we anticipate these EU expenses to tail off significantly in the second half of 2024 |
Please consider a small donation if you think this website provides you with relevant information