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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Amylyx Pharmaceuticals Inc | NASDAQ:AMLX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.78 | 1.77 | 1.84 | 1.84 | 1.70 | 1.79 | 5,218,046 | 00:58:31 |
˗ RELYVRIO™ (sodium phenylbutyrate and taurursodiol) approved for the treatment of ALS in adults and now commercially available in the U.S., representing second product launch for Amylyx worldwide
˗ Commercial launch of ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) in Canada continues to progress
˗ Management to host conference call and webcast today at 4:30 p.m. Eastern Time
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the quarter ended September 30, 2022.
“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 the United States and commercial availability of our first product in Canada,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx. “We are thrilled that RELYVRIO and ALBRIOZA are now available to people living with ALS in the U.S. and Canada, and we are encouraged by the early trajectory of enrollment in our Amylyx Care Team (ACT) Support Program as well as the rate of new prescriptions for this important new therapeutic option. We continue to work expeditiously during the early stages of our commercial launch to ensure every eligible person living with ALS will gain access as quickly and efficiently as possible.”
Third Quarter 2022 and Recent Business Highlights:
Financial Results for the Third Quarter Ended September 30, 2022
For the quarter ended September 30, 2022, net product revenue was $0.3 million and cost of sales were $0.2 million. Both net product revenue and cost of sales during the period were attributable to sales of ALBRIOZA in Canada. There were no product revenues or cost of sales for the comparable period in 2021.
Research and development expenses were $24.9 million for the quarter ended September 30, 2022, compared to $12.9 million for the quarter ended September 30, 2021. The increase was mainly driven by higher product manufacturing and development expenses in support of the global Phase 3 PHOENIX clinical trial and launch preparation activities for commercialization, as well as additional personnel-related expenses due to new headcount to support research and development efforts.
Selling, general and administrative expenses were $29.9 million for the quarter ended September 30, 2022, compared to $10.4 million for the quarter ended September 30, 2021. The increase was mainly driven by higher personnel-related expenses to support launch preparation initiatives as well as increased expenses for commercial readiness activities and operations as a public company.
Net loss for the quarter ended September 30, 2022, was $53.8 million, or $0.92 per share, compared to a net loss of $23.1 million, or $3.42 per share, for the same period in 2021.
Cash, cash equivalents and short-term investments were $162.6 million at September 30, 2022, compared to $206.7 million at June 30, 2022. The September 30, 2022 balance excludes aggregate net proceeds from Amylyx’ upsized public offering of common stock of $230.8 million after deducting underwriting discounts and commissions and offering expenses, which closed on October 11, 2022.
Investor Conference Call Information Amylyx’ management team will host a conference call and webcast today, November 10, 2022, at 4:30 p.m. Eastern Time to discuss financial results and provide an update on the business. To access the conference call, please dial (877) 870-4263 (local) or (412) 317-0790 (international) at least 10 minutes prior to the start time and ask to be joined into the Amylyx Pharmaceuticals call. A live audio webcast of the call will be available under “Events and Presentations” in the Investor section of the Company’s website, investors.amylyx.com/news-events/events. The webcast will be archived and available for replay for 90 days following the event.
Available Information 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, SEC filings, and public conference calls and webcasts.
About RELYVRIO™/ALBRIOZA™
RELYVRIO™ (sodium phenylbutyrate and taurursodiol) is an oral, fixed-dose medication approved to treat amyotrophic lateral sclerosis (ALS) in adults in the U.S. and approved with conditions as ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) for the treatment of ALS in Canada. Additionally, the European Medicines Agency (EMA) is reviewing the Company’s Marketing Authorisation Application for AMX0035 for the treatment of ALS in Europe. AMX0035 is being explored for the potential treatment of other neurodegenerative diseases.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR RELYVRIO (sodium phenylbutyrate and taurursodiol), for oral suspension
INDICATION 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:
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:
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.
For more information about RELYVRIO, please see the full Prescribing Information and Medication Guide.
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 Cambridge, Massachusetts and has operations in Canada and EMEA. For more information, visit amylyx.com and follow us on LinkedIn and Twitter. For investors, please visit investors.amylyx.com.
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 potential approval of sodium phenylbutyrate and taurursodiol for the treatment of ALS in countries other than the United States and Canada; the timing of an anticipated decision from the EMA regarding whether to approve AMX0035 for the treatment of ALS and our ability to resolve remaining major objections as part of the MAA process; the potential of sodium phenylbutyrate and taurursodiol as a treatment for ALS and the Company’s plans to explore the use of sodium phenylbutyrate and taurursodiol for other neurodegenerative diseases; the potential market acceptance and market opportunity for RELYVRIO and ALBRIOZA; the initial demand for RELYVRIO and our expectations around the timing of receipt of revenue from RELYVRIO; the anticipated timing of coverage and policy decisions by insurance plans related to RELYVRIO and whether those decisions will be favorable; the Company’s ability to maintain commercial availability of RELYVRIO in the United States and ALBRIOZA in Canada, as well as access to and coverage for RELYVRIO; our expectations with respect to recruitment and completion of our ongoing PHOENIX trial; the anticipated ramp in our selling, general and administrative expenses; and expectations regarding the Company’s longer-term strategy. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx’ program development activities, Amylyx’ ability to successfully launch RELYVRIO in the United States, Amylyx’ ability to execute on its commercial and regulatory strategy, regulatory developments, expectations regarding the timing of EMA review of AMX0035 for the treatment of ALS, Amylyx’ ability to fund operations, and the impact that the ongoing COVID-19 pandemic, global macroeconomic uncertainty and geopolitical instability will have on Amylyx’ operations, as well as the risks and uncertainties set forth in Amylyx’ United States Securities and Exchange Commission (SEC) filings, including Amylyx’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
AMYLYX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
September 30, 2022
December 31, 2021
Assets
Cash, cash equivalents and short-term investments
$
162,593
$
96,118
Prepaid expenses and other current assets
8,336
5,392
Accounts receivable, net
137
—
Inventories
563
—
Deferred offering costs
570
3,441
Other assets
9,244
663
Total assets
$
181,443
$
105,614
Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Accounts payable and accrued expenses
$
30,657
$
17,396
Other liabilities
6,758
35
Total liabilities
37,415
17,431
Redeemable convertible preferred stock
—
239,351
Stockholders’ equity (deficit)
144,028
(151,168
)
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)
$
181,443
$
105,614
AMYLYX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED
(in thousands, except share and per share data)
Three Months Ended September 30,
Nine Months Ended September 30,
2022
2021
2022
2021
Revenues:
Product revenue, net
$
345
$
—
$
345
$
—
Grant revenue
—
285
—
285
Total revenues
345
285
345
285
Operating expenses:
Cost of sales
172
—
172
—
Research and development
24,914
12,853
70,637
30,646
Selling, general and administrative
29,940
10,350
86,284
24,012
Total operating expenses
55,026
23,203
157,093
54,658
Loss from operations
(54,681
)
(22,918
)
(156,748
)
(54,373
)
Other income (expense), net
800
(224
)
1,272
(5,214
)
Loss before income taxes
(53,881
)
(23,142
)
(155,476
)
(59,587
)
(Benefit) provision for income taxes
(125
)
—
195
—
Net loss
$
(53,756
)
$
(23,142
)
$
(155,671
)
$
(59,587
)
Net loss per share attributable to common stockholders —basic and diluted
$
(0.92
)
$
(3.42
)
$
(2.77
)
$
(9.20
)
Weighted-average shares used in computing net loss per share attributable to common stockholders—basic and diluted
58,533,226
6,757,152
56,163,194
6,477,140
View source version on businesswire.com: https://www.businesswire.com/news/home/20221110006026/en/
Media Becky Gohsler Finn Partners (646) 307-6307 amylyxmediateam@amylyx.com Investors Lindsey Allen Amylyx Pharmaceuticals, Inc. (857) 320-6244 Investors@amylyx.com
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