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| Statement |
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| We have been very pleased with the strong and positive payer response to the value proposition associated with ROCTAVIAN and how this has translated into published payer policies and lives covered |
| In the fourth quarter of 2023, BioMarin generated strong total revenue of $646 million, representing 20% year-over-year growth, including KUVAN, and 26% growth, excluding KUVAN |
| As expected, the strength of our enzyme products generated more than $1.7 billion of net product revenues for the full year 2023, an increase of 4% year-over-year |
| This is a very strong performance |
| We're making good progress |
| Furthermore, we continue to be confident with the clinical profile of the product, which is evidenced by the warranty agreement which has been equally well received in the marketplace |
| These 2023 results along with our growth expectations, as implied by our full 2024 financial guidance provided today, solidifies our position as a financially self-sustaining business that can grow revenue, expand operating margins and accelerate earnings per share |
| And we see more of that at ACMG, demonstrating these long-term positive effects on growth, importantly, also on improvements beyond height |
| Specifically from the United States, which is one of our largest and highest value markets, we're really encouraged by both the continued uptake in the older children, those ages five and up from the original approval and also the new demand from the younger patients |
| What we've said is that we've seen very nice signals of patient demand, for example, in the United States, much of last year, we talked about the buildup of a patient funnel in the strategic market and priority market of Germany where we had gotten good uptake of CDx testing |
| And so, we're really focused on us building our leadership position in the genetic statural conditions where we see an incredible potential for VOXZOGO, again, to normalize growth to sustain that normalization of growth through the entire growing period and having the greatest possible impact in patients' lives |
| The US and EU approvals last quarter, allowing treatment from infancy sets VOXZOGO up to be a major multiyear growth driver |
| Beyond having an expanded age label, VOXZOGO's profile benefits from more than 1,000 patient years of long-term safety and efficacy data beyond just height |
| We are encouraged to see an increase in the 12 month annualized growth velocity of 1.81 centimeters in VOXZOGO-treated children treated with hypochondroplasia, and a safety and sustained durability profile observed in achondroplasia at 6 months and 12 months |
| As a result of the growing global demand for VOXZOGO treatment and the scope of our extensive long-term clinical data, we're seeing an increase in the breadth of our prescriber base |
| Our world - our work to build prescribing confidence and relationships with pediatric endocrinologists in the United States has been extremely well received |
| And as I just referenced, the accumulating data on height gain is really quite positive and informative |
| We've been talking about it for a while, and it is - we're pleased to be able to actually deliver upon that |
| So I think we've had some good returns on our commercial investments to-date |
| But it's an important signal, and I think it's a good one, good and encouraging looking forward |
| And so with those higher bars, we can also see that subsequent events have a higher probability of success and also contribute to improving the cost effectiveness of programs |
| We also recognize that we've got operating model and cost efficiency opportunities |
| We have also continued to make good progress, activate in the global marketplace, including the recent publishing of the Italian ROCTAVIAN price |
| But one of the things that's really exciting about the update that we can report is that every so often we look at ongoing studies to assess the durability of VOXZOGO's effect, and we continue to be reassured that VOXZOGO, unlike other growth-promoting types of drugs has this - been a remarkable benefit of sustaining its effect |
| So I think we're pretty confident that we've got an opportunity for increased uptake there going forward |
| As I said in January and reiterate today, the opportunity at BioMarin to positively impact patients' lives through transformative therapies, while delivering value creating revenue growth and profitability to shareholders has never been more evident |
| I've been impressed by the level of innovation and expertise in developing transformational therapies |
| So again, we are pleased to be able to report and deliver over the last few years kind of year-on-year operating margin improvement |
| The SORC is proceeding extremely well |
| Gene therapy is offered obviously significant potential benefits for patients, transformative benefits |
| Statement |
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| First, on the financial side, you mentioned 4Q revenue, I think you're seeing sort of broadly 4Q revenue reflected modest incremental revenue that would impact 1Q growth |
| We've previously discussed the supply constraint on VOXZOGO revenue in 2023 |
| Please note, we had a number of unique expenses during the fourth quarter of 2023, including impairment charges related to the discontinuation of our first-generation VOXZOGO |
| So now that tax, since the beginning of '23 is in our non-GAAP income to the extent those benefits, don't recur, that would be a headwind, if you will, to 2024 non-GAAP |
| GAAP net income for the fourth quarter was also impacted by the recognition of a loss on an impairment recorded in the other income and expense line |
| So the concept of basketing has already been in front of the FDA and has already gained a little bit of acceptance |
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