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| Statement |
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| We are excited by the tremendous progress that we have made across our US and international businesses |
| I'd add on in PSC, really exciting opportunity here where volixibat is positioned to be the first and only therapy for PSC by using pruritus as an endpoint really gives an outcome to use for bringing a new therapy to these patients |
| I think the March data reinforced the strong value proposition that LIVMARLI offers to our various stakeholder groups and I think that will certainly help us |
| We are placed for another great year in 2024 with three growing commercial products and with several clinical and regulatory catalysts as we strive to make continued advances for rare disease patients around the world |
| It has been a strong year for Mirum, finishing with the biggest ever revenue quarter for LIVMARLI and the Bile Acid portfolio |
| Our increasing revenue base places us in an exceptional position to grow the business through clinical development and continued expansion of our global commercial presence over the coming years |
| We have now built a growing self-sustaining leading rare disease business that is positioned for a great 2024 and beyond |
| The last year has shown the value creation potential of our strategy to drive growth in our commercial medicines, unlock the potential of upcoming label expansion opportunities, leverage our expertise in cholestasis in adult settings and continue to grow the pipeline |
| We remain well funded with a strong and self-sustaining business |
| We also have multiple regulatory and clinical catalysts this year to advance our pipeline |
| We're excited for the opportunity to bring the strong results of the March PFIC Phase III study to patients with a potential label expansion |
| This experienced team has accomplished so much in such a short period of time and I'm excited to continue the momentum and progress in the treatment of rare diseases |
| In summary, 2023 was a fantastic year for our team as we expanded our portfolio to three commercial products and grew our presence both in the US and worldwide |
| The fourth quarter was the first full quarter with these two medicines under Mirum's leadership, and I'm very happy with how quickly we have been able to transition these medicines into our business |
| I'm proud of all of our progress in 2023 and the potential ahead for Mirum |
| I'm proud of the Mirum team's focus on patients while simultaneously driving the seamless integration of CHOLBAM and CHENODAL and this is evident in the $69.6 million of total net product sales we achieved in the fourth quarter of 2023, which reflected growth across all three commercial medicines |
| We are already seeing the benefits of our newly expanded pediatric hepatology franchise and enhanced offering amongst the patients and prescriber community |
| We're really excited about the potential approval for LIVMARLI and PFIC |
| And we also made great progress with the VISTAS and VANTAGE studies for volixibat in PSC and PBC |
| So, quite excited about the positioning there |
| So we're pretty confident that this study, the way it's designed actually addresses an important unmet medical need at this point |
| Regarding CHENODAL and CTX we're making good progress here as well |
| Other than that, we're making great progress getting LIVMARLI really rolled out as standard of care in Alagille across all markets |
| Over the year, we transformed our business with a broadened reach to patients in the US and internationally achieving $179 million in net product sales and 142% year-over-year growth in total revenue |
| We are thrilled to have Joanne and her extensive leadership and scientific expertise helping to drive the value creation we see ahead from Mirum |
| On the regulatory front where we expect to be so excited about the PDUFA date coming up |
| This was driven by continued strong growth for LIVMARLI and the expansion of our commercial portfolio with the acquisition and integration of CHENODAL and CHOLBAM |
| So we feel pretty confident in terms of the design being robust and this being kind of well set up to a productive registration study for us |
| This represents over 70% growth from 2023 with increased contribution from all commercially available medicines |
| So, pretty unique positioning that we see for PBC |
| Statement |
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| For the year ended December 31st 2023, net loss was $160.9 million or $3.94 per share |
| So as you know Pruritus is a big issue in both of these diseases |
| In the fourth quarter COGS also reflected a reserve in excess of $5 million for inventory, primarily related to the Bile Acid acquisition |
| And as you know, it is a big issue in this particular patient population so there's really no particular therapies |
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