Amylyx Pharmaceuticals Reports Third Quarter 2022 Financial Results
˗ RELYVRIO™ (sodium phenylbutyrate and taurursodiol) approved for the treatment of ALS in adults and now commercially available in the
˗ Commercial launch of ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) in
˗ Management to host conference call and webcast today at
“The third quarter has proven to be a transformative time for Amylyx and the ALS community, marked by the regulatory approval of our new oral therapy for the treatment of ALS in
Third Quarter 2022 and Recent Business Highlights:
- Announced FDA approval of RELYVRIO™ (sodium phenylbutyrate and taurursodiol) for the treatment of adults with amyotrophic lateral sclerosis (ALS) on
September 29. This decision represents Amylyx’ first regulatory approval in the U.S.and second worldwide. Shipments of RELYVRIO, previously known as AMX0035, commenced on October 24.
- Announced availability of ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) in
Canadafor the treatment of ALS. Commercial launch of ALBRIOZA, previously known as AMX0035, in Canadacommenced on July 29. This announcement marked the first commercial availability of AMX0035 worldwide.
- Marketing Authorisation Application (MAA) for AMX0035 for the treatment of ALS under review with European Medicines Agency’s (EMA)
Committee for Medicinal Productsfor Human Use (CHMP). The Company has received the Rapporteurs Day 150 Joint Assessment Report, which is provided to applicants as a reference as the CHMP collects comments to responses made to the Day 120 List of Questions. The Company has resolved certain major objections from the Day 120 List of Questions and will continue to work to address those remaining as part of the MAA review process. The Company currently expects a decision from the EMA in the first half of 2023. Preparations are underway for commercialization of AMX0035 in the European Unionif remaining objections are resolved and approval is received.
- Announced publication of preclinical data showing the combined potential synergistic effect of sodium phenylbutyrate and taurursodiol, compared to the individual compounds, in the peer-reviewed medical journal Annals of Clinical and Translational Neurology. These data on the transcriptomic and metabolomic profiles of primary skin fibroblasts from adults with sporadic ALS and adults without ALS showed that combined sodium phenylbutyrate and taurursodiol had a greater and more distinct effect on genes and metabolites involved in ALS-relevant pathways compared to either sodium phenylbutyrate or taurursodiol (also known as ursodoxicoltaurine) alone.
- Presented preclinical data at the
Northeast Amyotrophic Lateral Sclerosis Consortium(NEALS) Annual Meeting on AMX0114, a new, internally developed compound targeting Calpain-2 (CAPN2), a critical effector of axonal degeneration. AMX0114 is in Investigational New Drug (IND)-enabling studies.
- Completed an upsized public offering. In October, the Company raised
$230.8 millionin net proceeds after deducting underwriting discounts, commissions, and offering expenses in a public offering of common stock.
Financial Results for the Third Quarter Ended
For the quarter ended
Research and development expenses were
Selling, general and administrative expenses were
Net loss for the quarter ended
Cash, cash equivalents and short-term investments were
Investor Conference Call Information
Amylyx’ management team will host a conference call and webcast today,
We periodically provide other information for investors on our corporate website, amylyx.com, and our investor relations website, investors.amylyx.com. This includes press releases and other information about financial performance, information on corporate governance, and details related to our annual meeting of stockholders. We intend to use our website as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor our website, in addition to following the Company's press releases,
RELYVRIO™ (sodium phenylbutyrate and taurursodiol) is an oral, fixed-dose medication approved to treat amyotrophic lateral sclerosis (ALS) in adults in the
INDICATION AND IMPORTANT SAFETY INFORMATION FOR RELYVRIO (sodium phenylbutyrate and taurursodiol), for oral suspension
RELYVRIO is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.
IMPORTANT SAFETY INFORMATION
Before you receive RELYVRIO, tell your doctor about all of your medical conditions, including if you:
- Have pancreas, liver, or intestinal problems
- Have heart failure, including congestive heart failure
- Have high blood pressure
- Have kidney problems
- Are pregnant or plan to become pregnant. It is not known if RELYVRIO will harm your unborn baby
- Are breastfeeding or plan to breastfeed. It is not known if RELYVRIO passes into your breast milk. You and your doctor should decide the best way to feed your baby
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements and any taurursodiol products, such as tauroursodeoxycholic acid (TUDCA).
RELYVRIO may affect the way other medicines work, and other medicines may affect how RELYVRIO works.
What are the possible side effects of RELYVRIO?
RELYVRIO may cause serious side effects, including:
- Changes in bile acid levels. RELYVRIO may increase bile acid levels and cause worsening diarrhea if you already have problems with your liver, bile ducts, or pancreas. Your doctor should monitor you for these side effects. Some disorders of the pancreas, bile ducts, or intestines may also make it harder to absorb RELYVRIO
- Salt (sodium) retention. RELYVRIO contains a high amount of salt. For people who are sensitive to salt intake, such as people with heart failure, high blood pressure, or kidney problems, limit the amount of salt you eat and drink. Talk to your doctor about the total amount of daily salt that is right for you. Your doctor will monitor you for signs and symptoms of salt retention during your treatment with RELYVRIO
The most common side effects of RELYVRIO include diarrhea, abdominal pain, nausea, and upper respiratory tract infection.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of RELYVRIO. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088.
Statements contained in this press release and related comments in our earnings conference call regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential approval of sodium phenylbutyrate and taurursodiol for the treatment of ALS in countries other than
CONDENSED CONSOLIDATED BALANCE SHEETS
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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Weighted-average shares used in computing net loss per share attributable to common stockholders—basic and diluted