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| Statement |
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| The Amylyx team has made great strides in redefining how people with ALS are treated and in developing innovative therapeutic candidates for the treatment of neurodegenerative diseases more broadly |
| We're in a unique and exciting position as we enter 2024 |
| So we're quite excited about that program |
| Yesterday, there was this public discussion on the biomarkers in the rare disease space, where Peter Marks, I think was very positive about using biomarkers for accelerated approval pathway |
| So it's early, but I think the learnings from Canada, the initiatives now that we're advancing the US, we've had very positive feedback |
| Our work this year led to a strong bottom line with $49.3 million in net income for the full year |
| And second, I think they're very, very excited at the opportunity to see this sort of transformation |
| So I would say that I think the reception has been excellent |
| We believe we have significant growth opportunities ahead of us as we work to bring our treatment to many more thousands of people |
| In closing, we are proud of the achievements we made in 2023 |
| We delivered a strong launch for people living with ALS and we've become a profitable business |
| This would be an achievement never before seen in ALS, and we are enthusiastic about what supportive data from PHOENIX might mean for people living with this disease |
| And I would highlight as well that I think PHOENIX is a really great opportunity in both of those segments, both to increase confidence for the specialists in the potential benefits of RELYVRIO for their patients, as well as the opportunity to increase awareness more generally in the medical community |
| And we think our access is actually really excellent in the US |
| We also made great progress on our global expansion, built a pipeline of potential medicines for neurodegenerative disease, and transformed into a profitable company |
| We had a strong start to our launch of RELYVRIO and have reached many thousands of people living with ALS |
| We are proud that one year into our launch, thousands of people with ALS in the US and Canada are being treated with our therapy |
| We're proud that RELYVRIO has already been prescribed to thousands of people with ALS in the United States and Canada, and our therapy is having a transformative effect on the way people with ALS are treated |
| So I would say, as I was saying in the previous remarks, I think with the initiatives we've seen, I think great reception from the community and maybe break things out, as I did in the opening remarks, again into sort of two broad categories |
| So I think it's a really nice foundation to have and then we can broaden out from there |
| So I think some of our initiatives that we've just started kicking off, and we're very excited to have Dan lead as well are to boost general awareness in the broader medical community |
| We have a substantial opportunity ahead of us, both with our commercial launch in the US and globally and with our pipeline |
| We are excited to have Dan leading our US commercial organization and believe his leadership, approach and experience will help us with the goal of bringing the benefits of RELYVRIO to many more people |
| This represents our first full year of profitability and is a testament to the demand that we see both near and long-term for an efficacious treatment at ALS |
| Supported by our operating profits, we ended the year with a strong balance sheet, we had $371.4 million in cash and short-term investments and zero debt |
| Camille brings nearly 30 years of leadership in developing successful medicines for people living with rare diseases and facilitating global access to them |
| The PHOENIX trial will provide additional efficacy and safety data and a larger population of people living with ALS and build on the robust and positive results observed in the CENTAUR trial |
| So I think we view that generally as positive for patients |
| We are excited to welcome her to our team |
| While the vast majority of people taking RELYVRIO are in the US and Canada, we have leveraged early access pathways in Europe and Israel in 2023, helping people gain access and generating revenue |
| Statement |
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| Again, in the past, if one has not had to manage side effects, then those things can be uncertain |
| They lose the ability to eat, to hug a loved one, and to walk |
| ALS is a disease of being locked in a body relentlessly losing its ability to function independently, while also being conscious of what is going on |
| ALS is a disease that unfortunately strikes people equally in all regions of the world |
| So, for example, saying that this is not a cure, but it may slow down your ALS and keep you alive longer |
| Many doctors consider ALS one of the worst diagnoses possible to give a person |
| Many people with ALS are misdiagnosed initially and see several specialists before they are accurately diagnosed with ALS, valuable time that could be spent on a therapy that slows neuronal death |
| Knowing that the next loss is just around the corner, people living with ALS and their families live in a perpetual state of uncertainty and loss |
| Her experience will be invaluable as we advance our mission |
| Actual events and results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties and other factors, including those set forth in our most recent filings with the SEC and any other future filings that we may make with the SEC |
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