Amylyx Pharmaceuticals Reports Second Quarter 2023 Financial Results
- Amylyx Pharmaceuticals reported strong financial results for Q2 2023, with product revenue of $98.2 million and net income of $22.1 million.
- The commercial launches of RELYVRIO in the U.S. and ALBRIOZA in Canada continued to progress.
- Five Canadian provinces announced public reimbursement for ALBRIOZA, and the coverage is expected to be in place for the vast majority of publicly insured lives in Canada by the end of August.
- Amylyx plans to initiate a global Phase 3 trial of AMX0035 for the treatment of progressive supranuclear palsy later this year.
- The Marketing Authorisation Application for AMX0035 for the treatment of ALS is under review with the European Medicines Agency's Committee for Medicinal Products for Human Use.
- None.
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Second quarter 2023 product revenue of
; demand and insurance coverage for RELYVRIO® in$98.2 million U.S. and ALBRIOZA™ inCanada continued to grow
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Strong financial position supported by
of net income during the second quarter of 2023 and cash, cash equivalents and short-term investments of$22.1 million at June 30, 2023$357.3 million
- Management to host conference call and webcast today at 4:30 p.m. Eastern Time
“We made strong and steady progress on our commercial launches in the second quarter, supporting people living with ALS with increased access to RELYVRIO/ALBRIOZA in the
Second Quarter 2023 and Recent Business Highlights:
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Commercial launches of RELYVRIO® in the
U.S. and ALBRIOZA™ inCanada , also known as AMX0035, continued to progress. Net product revenue for the three months ended June 30, 2023 was , compared to net product revenue of$98.2 million for the three months ended March 31, 2023.$71.4 million
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Five Canadian provinces announced public reimbursement of ALBRIOZA. Following the completion of the Company’s negotiation process with the pan-Canadian Pharmaceutical Alliance, the Company entered into a Product Listing Agreement with
Ontario for the public reimbursement of ALBRIOZA through the Ontario Drug Benefit Program, effective June 22, 2023. Since June, the provinces ofQuebec ,British Columbia ,New Brunswick , andAlberta committed to offering public coverage for ALBRIOZA by listing the therapy on their drug benefit formularies. Amylyx expects ALBRIOZA coverage to be in place for the vast majority of publicly insured lives inCanada by the end of August. By the end of 2023, the Company expects to finalize and sign product listing agreements with the remaining federal, provincial, and territorial public drug plans that have yet to include ALBRIOZA on their formulary.
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Plans underway to initiate a global, pivotal Phase 3 trial of AMX0035 for the treatment of progressive supranuclear palsy (PSP). PSP is a rare, progressive neurological disorder that affects body movements, walking and balance, and eye movement and is typically fatal within 6 to 8 years. There are currently no approved disease-modifying therapies for the treatment of PSP, and the disease affects seven in 100,000 people worldwide. PSP is characterized by widespread neurodegeneration associated with tau protein deposition in subcortical regions of the brain. Based on biomarker analyses from the Phase 2 PEGASUS trial of AMX0035 in Alzheimer’s disease and preclinical data, AMX0035 was shown to significantly lower levels of tau and other markers of neurodegeneration. The Company plans to initiate the pivotal Phase 3 ORION trial by year-end and intends to enroll approximately 600 adult participants across the
U.S. ,Canada ,Europe , andJapan .
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In July, the Company hosted a virtual webcast with Prof. Dr. Günter Höglinger to discuss the treatment landscape for people living with PSP, the scientific rationale for studying AMX0035 in PSP, and the Company’s clinical development plans. Prof. Dr. Höglinger, a leading expert in PSP, serves as the Director of the Department of Neurology at LMU Hospital, Ludwig-Maximilians-University in
Munich, Germany and is the primary investigator for the Phase 3 ORION trial. A replay is available at https://investors.amylyx.com.
- Marketing Authorisation Application (MAA) for AMX0035 for the treatment of ALS under review with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Amylyx received a negative opinion from the CHMP in June and requested a formal re-examination of the MAA in July. CHMP is re-examining its initial opinion on the current application for conditional marketing authorisation of AMX0035. The re-examination procedure is an approximately four-month process, which includes the appointment of a different rapporteur and co-rapporteur from the initial evaluation. At the end of the re-examination, the CHMP will adopt a final opinion, which is expected in fall 2023.
Financial Results for the Second Quarter Ended June 30, 2023
For the three months ended June 30, 2023, net product revenue was
Research and development expenses were
Selling, general and administrative expenses were
Net income for the three months ended June 30, 2023 was
Cash, cash equivalents, and short-term investments were
Investor Conference Call Information
Amylyx’ management team will host a conference call and webcast today, August 10, 2023, at 4:30 p.m. ET to discuss financial results and provide an update on the business. To access the conference call, please dial (833) 816-1395 (
Available Information
We periodically provide other information for investors on our corporate website, https://amylyx.com, and our investor relations website, https://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, SEC filings, and public conference calls and webcasts.
About RELYVRIO®/ALBRIOZA™ /AMX0035
RELYVRIO® (also known as AMX0035), an oral, fixed-dose combination of sodium phenylbutyrate and taurursodiol (known as ursodoxicoltaurine outside of the
RELYVRIO® (sodium phenylbutyrate and taurursodiol) Safety Information for
WARNINGS AND PRECAUTIONS
Risk in Patients with Enterohepatic Circulation Disorders, Pancreatic Disorders, or Intestinal Disorders
RELYVRIO contains taurursodiol, which is a bile acid. In patients with disorders that interfere with bile acid circulation, there may be an increased risk for worsening diarrhea, and patients should be monitored appropriately for this adverse reaction. Pancreatic insufficiency, intestinal malabsorption, or intestinal diseases that may alter the concentration of bile acids may also lead to decreased absorption of either of the components of RELYVRIO. Because different enterohepatic circulation, pancreatic, and intestinal disorders have varying degrees of severity, consider consulting with a specialist. Patients with disorders of enterohepatic circulation (e.g., biliary infection, active cholecystitis), severe pancreatic disorders (e.g., pancreatitis), and intestinal disorders that may alter concentrations of bile acids (e.g., ileal resection, regional ileitis) were excluded from the study; therefore, there is no clinical experience in these conditions.
Use in Patients Sensitive to High Sodium Intake
RELYVRIO has a high salt content. Each initial daily dosage of 1 packet contains 464 mg of sodium; each maintenance dosage of 2 packets daily contains 928 mg of sodium. In patients sensitive to salt intake (e.g., those with heart failure, hypertension, or renal impairment), consider the amount of daily sodium intake in each dose of RELYVRIO and monitor appropriately.
ADVERSE REACTIONS
The most common adverse reactions (at least
Please click here for RELYVRIO Full
About Amylyx Pharmaceuticals
Amylyx Pharmaceuticals, Inc. is committed to supporting and creating more moments for the neurodegenerative community through the discovery and development of innovative new treatments. Amylyx is headquartered in
Forward-Looking Statements
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 timing of review of its initial opinion and an anticipated final recommendation from the CHMP regarding whether to approve AMX0035 for the treatment of ALS in
AMYLYX PHARMACEUTICALS, INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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UNAUDITED |
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(in thousands) |
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|
||||||
|
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June 30, 2023 |
|
December 31, 2022 |
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Assets |
|
|
|
|
||
Cash, cash equivalents and short-term investments |
|
$ |
357,276 |
|
$ |
346,945 |
Accounts receivable, net |
|
|
33,473 |
|
|
15,306 |
Inventories |
|
|
42,587 |
|
|
9,769 |
Prepaid expenses and other current assets |
|
|
11,787 |
|
|
10,113 |
Other assets |
|
|
8,465 |
|
|
9,320 |
Total assets |
|
$ |
453,588 |
|
$ |
391,453 |
Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity |
|
|
|
|
||
Accounts payable and accrued expenses |
|
$ |
61,936 |
|
$ |
44,569 |
Other liabilities |
|
|
5,287 |
|
|
6,277 |
Total liabilities |
|
|
67,223 |
|
|
50,846 |
Stockholders’ equity |
|
|
386,365 |
|
|
340,607 |
Total liabilities, redeemable convertible preferred stock and stockholders' equity |
|
$ |
453,588 |
|
$ |
391,453 |
AMYLYX PHARMACEUTICALS, INC. |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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UNAUDITED |
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(in thousands, except share and per share data) |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Product revenue, net |
|
$ |
98,216 |
|
$ |
— |
|
|
$ |
169,644 |
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
||||||
Cost of sales |
|
|
5,580 |
|
|
— |
|
|
|
10,863 |
|
|
— |
|
Research and development |
|
|
29,044 |
|
|
24,259 |
|
|
|
53,236 |
|
|
45,723 |
|
Selling, general and administrative |
|
|
43,391 |
|
|
29,994 |
|
|
|
87,397 |
|
|
56,344 |
|
Total operating expenses |
|
|
78,015 |
|
|
54,253 |
|
|
|
151,496 |
|
|
102,067 |
|
Income (loss) from operations |
|
|
20,201 |
|
|
(54,253 |
) |
|
|
18,148 |
|
|
(102,067 |
) |
Other income, net |
|
|
3,806 |
|
|
360 |
|
|
|
7,262 |
|
|
472 |
|
Income (loss) before income taxes |
|
|
24,007 |
|
|
(53,893 |
) |
|
|
25,410 |
|
|
(101,595 |
) |
Provision for income taxes |
|
|
1,933 |
|
|
174 |
|
|
|
1,763 |
|
|
320 |
|
Net income (loss) |
|
$ |
22,074 |
|
$ |
(54,067 |
) |
|
$ |
23,647 |
|
$ |
(101,915 |
) |
|
|
|
|
|
|
|
|
|
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Net income (loss) per share attributable to common stockholders |
|
|
|
|
|
|
|
|
||||||
Basic |
|
$ |
0.33 |
|
$ |
(0.93 |
) |
|
$ |
0.35 |
|
$ |
(1.85 |
) |
Diluted |
|
$ |
0.31 |
|
$ |
(0.93 |
) |
|
$ |
0.34 |
|
$ |
(1.85 |
) |
Weighted-average shares used in computing net income (loss) per share attributable to common stockholders |
|
|
|
|
|
|
|
|
||||||
Basic |
|
|
67,233,617 |
|
|
58,275,903 |
|
|
|
66,976,871 |
|
|
54,958,537 |
|
Diluted |
|
|
70,132,040 |
|
|
58,275,903 |
|
|
|
70,471,821 |
|
|
54,958,537 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20230810561102/en/
Media
Amylyx Media Team
+1 (857) 799-7274
amylyxmediateam@amylyx.com
Investors
Lindsey Allen
Amylyx Pharmaceuticals, Inc.
+1 (857) 320-6244
Investors@amylyx.com
Source: Amylyx Pharmaceuticals, Inc.
FAQ
What were Amylyx Pharmaceuticals' financial results for the second quarter of 2023?
What progress has Amylyx made with the commercial launches of RELYVRIO and ALBRIOZA?
Which Canadian provinces announced public reimbursement for ALBRIOZA?
What is the expected coverage for ALBRIOZA in Canada?
What trial does Amylyx plan to initiate for the treatment of progressive supranuclear palsy?