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| Statement |
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| And it's been very encouraging as well there |
| We entered 2023 in arbitration with JNJ and prevailed in that matter decisively, which reinstated significant cash flows due to us, strengthened our balance sheet and enabled us to raise our financial expectations |
| ARISTADA net sales in the fourth quarter grew 5% year-over-year to $83.4 million, driven primarily by demand growth of approximately 5% on a months-of-therapy basis |
| We do see a nice recovery of that into Q4, which led to 11% TRx growth |
| And third, an efficient operating structure that positions the business for sustained profitability and significant cash generation |
| In terms of DTC, again, we feel really good about the overall program that we have |
| First, if we just look at Q4, we just finished this quarter, overall TRx demand was 11%, which was really encouraging |
| Alcohol dependence is an important growth opportunity and our team remains energized about driving awareness and uptake in that under-served disease area |
| With the moving pieces I mentioned now behind us, we have clarified and strengthened the financial profile of the business and we believe we are well positioned to execute on our strategy as a pure-play neuroscience company |
| The 2024 guidance reflects really nice cost control on operating expenses |
| So 2023 was an eventful and productive year at Alkermes one in which we repositioned the company and established a strong foundation for growth |
| Our 2023 financial results reflect strong performance of our core neuroscience business |
| So it wasn't particularly surprising, and we were actually encouraged to see that they had strong results in the NT1 cohort sort of reaffirming the pharmacology that we're all seeking to exploit in this therapeutic class that's emerging |
| I am pleased to share that we achieved strong year-over-year growth of 18% across our proprietary commercial portfolio in 2023, as we executed our commercial strategy for each of our three proprietary products and continued to demonstrate the operating leverage we are able to capture with our commercial infrastructure |
| In 2023, VIVITROL net sales grew 6% year-over-year to $400.4 million, driven primarily by unit growth |
| So demand grew over 100% year-over-year, which we're really encouraged with |
| We think that's a good thing |
| With a proprietary product topline that is expected to exceed $1 billion this year, a sharpened strategic focus, and an operating structure that we have carefully calibrated to support the needs of the business going forward, we believe we have positioned the company for significant growth and profitability |
| In terms of VIVITROL right now, we're seeing really strong growth with our alcohol dependence strategy |
| And we're really pleased so far with just the overall response to the program from HCPs, but also from patients |
| And we actually think that's a good thing for LYBALVI |
| And we also met our goal of continuing to drive our top line revenue from proprietary products, including the continued strong launch of LYBALVI |
| While this work was underway, we continued our focus on operational efficiency and generated strong profitability and cash flows with GAAP net income from continuing operations of $519.2 million, non-GAAP net income from continuing operations of $396.5 million and EBITDA from continuing operations of $486.3 million |
| Net sales of the ARISTADA product family increased 8% to $327.7 million in 2023, driven by unit growth; and LYBALVI net sales increased 100% year-over-year to $191.9 million |
| Second, proven development capabilities with an advancing neuroscience pipeline |
| 2024 is set to be an exciting and important year, enabled by the significant work over the last several years to reposition the company |
| Blair, anything you want add? Blair Jackson The only thing I'd add, Paul, is that we also, as you mentioned, we have a very clean balance sheet, and that provides us optionality as we move forward and we can be opportunistic as need be |
| It tested very well in market research, and we're starting to see the benefits of -- to new patient starts |
| And we are focused on executing across the portfolio and are optimistic about the opportunities ahead |
| In 2023, we successfully executed our strategy to position the business for sustained profitability and growth |
| Statement |
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| We could be too low, we could be too high |
| So I think it's important to recognize as you compare '23 to '24, that it becomes difficult because '23 was such a complicated year for us, a year where we had a number of activities that were ongoing |
| You might remember, in Q3, we saw a little bit of softness overall due to some inventory draw down and also some seasonality with patient visits |
| We could have unacceptable tolerability |
| We did see some headwinds in Q4 for opioid dependence, but that's really a subnational phenomenon |
| First principles are that we saw some evidence of visual disturbances in healthy volunteers at doses above 15 milligrams |
| My understanding is that they capped the dose due to some concerns about LiverTox |
| The reason why we do that is we know that once you start increasing gross to net, it's very difficult to pull that back |
| We reported these visual disturbances in the healthy volunteers |
| Please see slide 2 of the accompanying presentation, our press release issued this morning, and our most recent annual and quarterly reports filed with the SEC, for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements |
| So our view is to the extent that one saw visual disturbances that we saw in healthies, i.e., mild, transient self-limiting that would not be limiting for the drug |
| And in fact, as I said earlier, given the limitation of their dosing or fear of the liver toxicity, and we weren't surprised to see that outcome |
| So a patient might -- and what we meant specifically by visual disturbances was blurriness of vision or photosensitivity or photophobia, which categorized differently other people have reported hallucinations and things like that |
| Two questions from us |
| Our financial results for 2023 reflect a number of one-time factors, such as back payments and reinstatement of the long-acting INVEGA royalties, one-time legal expenses associated with the Janssen arbitration and the settlement of the VIVITROL patent matter, and most notably the separation of the oncology business, which had operational financial and tax consequences |
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