˗ 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:
- 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 Canada for the treatment of ALS.
Commercial launch of ALBRIOZA, previously known as AMX0035, in
Canada commenced 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 Products for 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 Union if 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 million in net proceeds after deducting
underwriting discounts, commissions, and offering expenses in a
public offering of common stock.
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:
- Have pancreas, liver, or intestinal problems
- Have heart failure, including congestive heart failure
- 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.
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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