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 |
|---|
| What we know, Auryxia is a great product, [Indiscernible] is a great product |
| And in my past, I've seen significant organic growth from the more mature product when you have the opportunity to improve your access to the people who write the prescriptions, and I think that will be an important point of leverage |
| We believe our efforts will help create sustained value for our shareholders while continue towards our purpose to better the lives of people impacted by kidney disease |
| Our priority continues to be focused on strengthening our balance sheet as we enter a potential launch year, marched this quarter by a favorable loan amendment, which strengthened our cash position for 2024 |
| I feel very strongly about that, and that's the kind of conversation we're looking forward to having with the agency |
| As I mentioned earlier, we will have a strong tailwind from our CSL Vifor relationship, which will provide Akebia with potential access to up to 60% of the dialysis market through CSL Vifor's collaboration with Fresenius Kidney Care and several small to midsized providers with whom they contract |
| For our part, we're confident in our path forward and continue to believe in the benefit vadadustat can deliver to patients |
| It's important to highlight that we are already well prepared for a potential launch and have identified important tailwinds, we believe will contribute to our success |
| And the idea that patients who have an average phosphorus of six can get to five or four and a half would be a fantastic thing for patient outcomes |
| I had the pleasure of having many conversations with key medical experts, and I can say unequivocally that these physicians are very excited about the role vadadustat and HIF can play in the treatment of patients with CKD |
| Importantly, we'll also benefit from our partnership with CSL Vifor ,which enables potential access to 60% of the treatment centers through its collaboration with Fresenius Medical Care and other small and medium-sized providers |
| The favorable modification to payment terms enables us to strategically invest in the vadadustat launch activities, while also continuing to maximize Auryxia revenue for the remainder of the year and into 2024 |
| And so managing patients more aggressively, if you will, to a lower phosphorus level is a benefit to patients |
| While Auryxia is now a mature brand nearing loss of exclusivity in March of 2025, we expect relatively stable volume next year while benefiting from higher pricing due to exiting certain payer contracts over the next year |
| We expect Auryxia revenue to grow in 2024 as we exit unfavorable payer contracts, incrementally expand our commercial and medical footprint and gain broader access to providers from their interest in learning about vadadustat, if it's approved |
| So, the way we think about tenapanor, honestly, as persons working in this space for 30 years as a patient advocate, it's exciting to see a product -- a new technology come in |
| We'll advance our pipeline and grow our revenue in the years ahead |
| We're extremely happy with where we landed on our Pharmacon amendment and giving us the opportunity to invest incrementally costs to support the vadadustat launch, and we believe we have sufficient cash to fund operations well through 2024 |
| Lastly, we were able to delay the cash payments associated with our Pharmacon debt service until October of 2024, which provides us with additional flexibility to invest in the launch of vadadustat as well as other growth opportunities for the company |
| Now, we're also fortunate to be supported through this launch by the robust cash flows from Auryxia |
| I was excited to see how much innovation is happening for patients with kidney disease, including multiple products introduced since the meeting last year |
| The entire leadership team remains energized and focused on delivering an alternative oral treatment to patients if approved by the FDA |
| So, we're going to continue to lobby on the hill and with CMS to have those dollars follow the patients, and that's a real opportunity for us |
| But we'll do that quickly, and Auryxia will benefit from that as much as vadadustat will |
| For those who have been following our story over the past couple of years and have witnessed all of our team's efforts, you know it gives me great pleasure to talk to you about Akebia's future today with an extremely important and hard fought catalyst in our sites |
| Revenue from Auryxia continues to provide cash for operations, and we are excited that we have a PDUFA date of March 27th, 2024 |
| Julian Harrison Excellent |
| So, that certainly helps inform us as we think about our pricing for the vadadustat launch |
| We're now nearly through 2023, I just want to reiterate how well-positioned we believe Akebia is to close the year |
| We have a very experienced sales organization |
| Statement |
|---|
| The decrease is primarily due to a reduction in volume and the impact of shifting payer mix partially caused by contracting dynamics and a decline in the phosphate binder market |
| So, the MA area is a little more challenging since their individual contracts, each provider has a different contract, and they are a little hit and mistrial trying to understand and help ensure that there is this separate payment available for those MA patients |
| So, prior to TDAPA, it's actually -- I mean it's frustrating, obviously, to have to wait six months for CMS to provide that that TDAPA designation, and you'll see that come in, I think it's around July |
| So, for a product that has very limited use in a very small number of patients, that's really challenging, right? It doesn't really provide the dialysis providers the cash, if they have one or two patients that are getting a drug |
| You've seen that with the phosphate binder market that it hasn't quite started to recover, it's starting to, but not quite there |
| We've always talked about kind of understanding the market, and the market -- the price in the market for ESAs has gone down pretty substantively over the last few years |
| We don't have any indication that it's going to be significantly lower than that number |
| The decrease was primarily due to a reduction in spending on vadadustat development, including clinical trial costs and curtailment of outsourced contract services |
| Net loss was $14.5 million for the third quarter of 2023 compared to a net loss of $54.1 million for the third quarter of 2022 |
| We continue to find ways of operating more efficiently, placing an increased scrutiny on all areas of our operating expenses |
| So, we won't see -- and again, some dialysis providers may choose to do small experience trials to develop those protocols, and so you may see some revenue |
| And sorry I missed past weekend in Philadelphia |
Please consider a small donation if you think this website provides you with relevant information