Analyst Conference Summary



conference date: May 4, 2023 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2023 (first quarter, Q1)

Forward-looking statements

Overview: Revenue continues to expand rapidly, but still deep in the red.

Basic data (GAAP):

Revenue was $319 million, down 5% sequentially from $335 million, and up 50% from $213 million year-earlier.

Net income was negative $174 million, up sequentially from negative $207 million, and up from negative $240 million year-earlier.

Diluted EPS was negative $1.40, up sequentially from negative $1.68, and up from negative $2.00 year-earlier.


For full year 2023, net product revenue of $1.2 to $1.285 billion. Collaboration and royalty revenue $100 to $175 million. Non-GAAP R&D expense $1.575 to $1.65 billion.

Conference Highlights:

Yvonne Greenstreet, CEO of Alnylam, said: "The first quarter of 2023 saw continued strong commercial execution, driven by the ongoing launch of Amvuttra, delivering robust 48% growth in total product sales compared with the first quarter 2022. We also made significant progress with our broad pipeline, delivering positive first-in-human results for an RNAi therapeutic in the CNS from an interim analysis of the Phase 1 study of ALN-APP in patients with early-onset Alzheimer’s disease. We believe this proof of concept is a significant catalyst for future potential growth for Alnylam with the expansion of our product engine to include tissues beyond the liver. We are also excited for other key upcoming milestones from our pipeline, including topline Phase 2 results from the KARDIA-1 study of zilebesiran, which are expected mid-year. With this continued execution, we believe we are tracking well toward our Alnylam P5x25 goals of becoming a top-tier biotech company delivering sustained innovation and exceptional financial results."

Onpattro (patisiran) Apollo-B Phase 3 study in patients with hereditary and wild-type ATTR amyloidosis with cardiomyopathy topline results were positive (Q3 2022) and sNDA filed. PDUFA date October 8, 2023.

Alnylam will not proceed with regulatory filings for biannual dosing of Amvuttra, instead advancing ALN-TTRsc04, which could work with annual dosing. Began dosing in the Phase 1 trial in Q1 2023.

In Q4 2022 Alnylam Completed enrollment in the KARDIA-1 Phase 2 monotherapy study of zilebesiran in patients with mild-to-moderate hypertension.

In Q1 2023, in collaboration with Regeneron, ALN-PNP began a Phase 1 study for NASH.

therapy ($ millions) Q1 2023 Q4 2022 Q1 2022 % y/y
Onpattro 102 122 137 -25%
Amvuttra 102 69 0 na%
Givlaari 48 47 35 36%
Oxlumo 24 24 15 66%
total net product 276 262 187 48%

Non-GAAP net income negative $132 million, up sequentially from negative $172 million, and up from negative $240 million year-earlier. EPS negative $1.06, up sequentially from negative $1.39, and up from negative $1.49 year-earlier.

Cash and equivalents balance at the end of the quarter was $ billion, down sequentially from $2.19 billion.

In Q3 2022 Alnylam filed a Clinical Trial Application for ALN-TTRsc04, the first clinical program from the IKARIA platform, aimed at achieving an annual dosing regimen with highly potent and reversible effects of TTR lowering.

ALN-APP Phase 1 topline results for early-onset Alzheimer's are expected in early 2023.

See also Alnylam pipeline.

Operating expenses of $469 million consisted of: $41 million for cost of goods sold; $231 million for research and development; and $184 million for general and administrative expense; $13 million cost of collaboration. Operating loss $150 million. Interest & other expense was $12 million. $2 million income tax.

Q&A Selective Summary:

not available at this time

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Disclaimer: My analyst call summaries are my personal notes that may include both our condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. This is investment journalism, not financial advice.

Copyright 2023 William P. Meyers