- Second quarter 2023 product revenue of $98.2 million; demand
and insurance coverage for RELYVRIO® in U.S. and ALBRIOZA™ in
Canada continued to grow
- Strong financial position supported by $22.1 million of net
income during the second quarter of 2023 and cash, cash equivalents
and short-term investments of $357.3 million at June 30, 2023
- 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 second quarter
ended June 30, 2023.
“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 U.S. and Canada,” said
Joshua Cohen and Justin Klee, co-CEOs of Amylyx. “We continued to
execute on our long-term R&D strategy, which includes exploring
the full potential of our therapy in other neurodegenerative
diseases. We are on track to initiate our global Phase 3 ORION
trial of AMX0035 for the treatment of progressive supranuclear
palsy later this year. Our Phase 2 HELIOS study of AMX0035 for the
treatment of Wolfram syndrome is enrolling participants, and we
continue to expect topline results next year.”
Second Quarter 2023 and Recent Business Highlights:
- Commercial launches of RELYVRIO® in the U.S. and ALBRIOZA™
in Canada, also known as AMX0035, continued to progress. Net
product revenue for the three months ended June 30, 2023 was $98.2
million, compared to net product revenue of $71.4 million for the
three months ended March 31, 2023.
- 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 of
Quebec, British Columbia, New Brunswick, and Alberta 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 in
Canada 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.
- 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, and Japan.
- In July, the Company hosted a virtual webcast with Prof. Dr.
Günter H�glinger 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.
H�glinger, 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 $98.2 million, and cost of sales were $5.6 million. Both net
product revenue and cost of sales during the period were primarily
attributable to sales of RELYVRIO in the U.S. and ALBRIOZA in
Canada. There were no product revenues or cost of sales for the
comparable period in 2022.
Research and development expenses were $29.0 million for the
three months ended June 30, 2023, compared to $24.3 million for the
same period in 2022. The increase was primarily driven by an
increase in personnel-related expenses due to added headcount to
support research and development efforts and an increase in
spending on AMX0035 for the treatment of PSP to support the
initiation of the Phase 3 ORION trial.
Selling, general and administrative expenses were $43.4 million
for the three months ended June 30, 2023, compared to $30.0 million
for the same period in 2022. The increase was primarily driven by
higher personnel-related expenses due to added headcount to support
our launch, commercialization initiatives, and operations as a
public company.
Net income for the three months ended June 30, 2023 was $22.1
million, or $0.31 on a fully diluted per share basis, compared to a
net loss of $54.1 million, or $0.93 on a fully diluted per share
basis for the same period in 2022.
Cash, cash equivalents, and short-term investments were $357.3
million at June 30, 2023, compared to $345.7 million at March 31,
2023.
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 (U.S.) or +1 (412)
317-0488 (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,
https://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, 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 U.S.), is approved to treat
amyotrophic lateral sclerosis (ALS) in adults in the U.S. and
approved with conditions as ALBRIOZA™ for the treatment of ALS in
Canada. The Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA) is re-examining its initial
opinion on the current application for conditional marketing
authorisation of AMX0035, under the trade name ALBRIOZA®, for the
treatment of ALS in the European Union. AMX0035 is being explored
for the potential treatment of other neurodegenerative diseases.
The formulation of RELYVRIO, ALBRIOZA, and AMX0035 are
identical.
RELYVRIO® (sodium phenylbutyrate and taurursodiol) Safety
Information for United States
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 15% and at least 5%
greater than placebo) with RELYVRIO were diarrhea, abdominal pain,
nausea, and upper respiratory tract infection.
Gastrointestinal-related adverse reactions occurred throughout the
study but were more frequent during the first 3 weeks of
treatment.
Please click here for RELYVRIO Full U.S.
Prescribing Information.
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 X, formerly known as 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 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 Europe; the potential of
AMX0035 (sodium phenylbutyrate and taurursodiol) as a treatment for
ALS and other neurodegenerative diseases including Wolfram syndrome
and PSP; the Company’s beliefs regarding the benefits of AMX0035 in
ALS and other neurodegenerative diseases, the potential of AMX0035
to be a foundational therapy for ALS and a potential, future cure;
the ongoing commercialization of RELYVRIO and ALBRIOZA;
expectations regarding the timing of initiation of the Company’s
Phase 3 ORION trial of AMX0035 for the treatment of PSP and of the
results of the Company’s Phase 2 HELIOS trial of AMX0035 for the
treatment of Wolfram syndrome; statements regarding coverage by
insurance plans for ALBRIOZA and the timing of, and the Company’s
ability to, finalize and sign product listing agreements with the
remaining public drug plans for ALBRIOZA in Canada; the potential
continued market acceptance and market opportunity for RELYVRIO and
ALBRIOZA and opportunities for growth; expectations regarding the
speed of access to RELYVRIO; the potential for new pipeline
programs and clinical indications for AMX0035; statements regarding
regulatory developments; the Company’s expectations with respect to
its progress through IND enabling studies of AMX0114 and other
advancements in its pipeline; the Company’s expectations regarding
its financial performance; and expectations regarding the Company’s
longer-term strategy. Any forward-looking statements in this press
release and related comments in the Company's earnings conference
call 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 commercialize RELYVRIO in the United States and
ALBRIOZA in Canada, Amylyx’ ability to execute on its commercial
and regulatory strategy, regulatory developments, expectations
regarding the timing of a decision from the EMA regarding AMX0035
for the treatment of ALS, Amylyx’ ability to fund operations, and
the impact that global macroeconomic uncertainty, geopolitical
instability and public health events, such as COVID-19, 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 March 31, 2023, and subsequent filings with the
SEC. All forward-looking statements contained in this press release
and related comments in our earnings conference call 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)
June 30, 2023
December 31, 2022
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.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
UNAUDITED
(in thousands, except share
and per share data)
Three Months Ended June
30,
Six Months Ended June
30,
2023
2022
2023
2022
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
)
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
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