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| Statement |
|---|
| So, IPX203 coverage, the initial discussions, which is going back to last year, has been very positive |
| First, Amneal has one of the best service levels in the industry, with quality at the center of everything we do |
| We raised our guidance twice during the year and delivered on it, driven by strong execution and the robust performance across our diversified business |
| We believe 2024 will be even better as we continue to grow, expand our reach, and impact more patients than even before |
| Finally, we continue to make solid progress on our fourth pillar of value creation, deleveraging |
| Next, we are very excited about the future of biosimilars and pleased with the commercial success of our first three products |
| In our affordable medicines business, which is our Generics segment, we have been building our leadership position since Amneal's inception |
| The strong cost generation reflects higher EBITDA, typical accounts receivable collection patterns, and higher interest expense |
| And on endocrinology, we have our K-114, which we're very excited if we can get through the regulatory hurdles |
| Looking forward, we believe 2024 will be even better as our future is so bright |
| We have a new leader in that market and just continues to drive high single-digit prescription growth |
| It's a strong uptake and shouldn't take - it's not a new molecule that should take a longer time for going to the peak sales |
| In addition, we're optimistic on the potential FDA approval of Naloxone, which could add over $30 million in 2024 |
| Our 2023 performance was well ahead of our expectations, and benefited from strong collections in December |
| And the purpose of IPX203, having a great market access team, MSL teams, the sales team, which have relationship over last seven to eight years, we're very excited |
| That performance exceeded our revenue expectations in 2023, driven by an exceptional commercial execution in that first year |
| IPX203, that's good news |
| So, that is a fantastic market for a company like us who is completely focused on affordable medicines as we lead the retail segments, pretty soon to be leading injectable segments |
| IPX203, we're also ready to launch, and as you know, that's completely differentiated product, then Rytary and obviously much better than the IR with the 1.55 hours of good on-time per dose, which is significant |
| Next, we are so excited about the potential approval and launch of IPX203 this year, which we believe meaningfully advances the standard of care for all Parkinson's patients |
| And by learning a little bit from the dynamics that we'd seen in the past and putting forward a solution that we felt addressed those, we were able to create what is a fairly stable pricing dynamic and fairly stable uplift that looks like it improves Q-over-Q |
| In short, we are starting 2024 with remarkable momentum |
| We believe our durable broad-based top and bottom-line growth profile is sustainable and accelerating |
| So, very excited on the complex product launches |
| We feel good |
| Amneal is on an upward trajectory and we are so excited for what's ahead |
| Two, on guidance, again, 2024 strong EBITDA guidance |
| Our growth was driven by strong operating leverage, favorable R&D spend, and growth in our commercial expenses |
| As Chirag mentioned, we are executing well on our strategy to be an innovative global pharmaceuticals company capable of driving sustainable growth in the key areas of medicine |
| So, we're very positive on the coverage, which we're under initial discussions and we should be - it should be coming online upon approval as well as a few months after that |
| Statement |
|---|
| As you know, the US pharmaceutical market is plagued by chronic drug shortages, including critical oncology therapies |
| Generics net revenue was $363 million, down 9% due to year-end timing of orders |
| So, FDA is really worried |
| Chirag Patel And just to add, Nathan, our injectable plants are underutilized as we are launching new products |
| And I'm afraid that if consumer starts knowing that the pill they're taking is being made or sold for one penny, it may have a very negative placebo impact |
| This is a real problem |
| As we look at Avastin and our oncology/biosimilar franchise as a whole, what we recognize is that the marketplace is challenged by pricing dynamics that are not consistent with the expectations |
| Nobody can even invest, and it'll cause quality issues and shortages |
| Full-year 2023 adjusted EPS of $0.64 declined 6% as higher interest expense offset adjusted EBITDA growth |
| There are several contributing factors, including market price being generally too low for some products to be produced, and contract commitment being too short term in the retail market |
| The next wave of affordable medicines is biosimilars, which has an estimated $141 billion in branded products facing loss of exclusivity between 2023 and 2027 |
| With a global aging population and ongoing supply challenges and shortages, our capabilities have never been more important and more in need |
| So, just talk about what you think are going to be the challenges here regarding access |
| Q4 EPS of $0.14 compares to $0.23 in the prior year quarter, mostly driven by higher interest costs |
| If we - it has to get better |
| Six years of massive price erosion, nobody can invest in quality |
| Net leverage has come down remarkably from 7.4x in 2019 to 4.8x at the end of 2023 |
| From an operating cashflow perspective, in the fourth quarter of 2023, we generated $136 million compared to negative $23 million in the prior year quarter |
| And since having multiple launches, that should not be any problem |
| We expect to see more of those failures in the coming months, and I think the market is ripe for solutions like those that we provide |
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