Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced
preliminary U.S. net product revenues of approximately $138 million
for the fourth quarter and approximately $366 million for the full
year 2023 for SYFOVRE® (pegcetacoplan injection) for geographic
atrophy (GA) secondary to age-related macular degeneration and for
EMPAVELI® (pegcetacoplan) for adults with paroxysmal nocturnal
hemoglobinuria (PNH).
Strong SYFOVRE launch continues:
- Approximately $114 million and $275 million expected in
preliminary U.S. net product revenues in the fourth quarter and
full year 2023, respectively.i
- Approximately 62,000 doses (commercial and sample vials)
distributed to physician practices in the fourth quarter;
approximately 160,000 total doses have been distributed in
2023.
- Approximately 95% of treated GA patients are estimated to be
using SYFOVRE.ii
Continued momentum with EMPAVELI:
- Approximately $24 million and $91 million expected in
preliminary U.S. net product revenues in the fourth quarter and
full year 2023, respectively.i
- High patient compliance rate of 97%.iii
- More than 50% of existing patients and more than 90% of new
patients now use the EMPAVELI Injector, an on-body device designed
to streamline self-administration, since the October Injector
approval.iii
“SYFOVRE is the market-leading treatment for GA, with
approximately 160,000 doses distributed since launch. More patients
than ever are benefiting from SYFOVRE, including the increasing
treatment effects over time and flexible dosing, and we look
forward to building on the momentum this year,” said Cedric
Francois, M.D., Ph.D., co-founder and chief executive officer,
Apellis. “Additionally, the high compliance observed with EMPAVELI
speaks to the important impact of this medicine on patients’ lives.
In addition to advancing our pipeline, we believe the tremendous
commercial progress made in the past year has positioned us for an
even stronger 2024.”
J.P. Morgan Healthcare Conference Presentation and
WebcastDr. Francois will discuss these updates in a
corporate presentation at the 42nd Annual J.P. Morgan Healthcare
Conference today, Monday, January 8, 2024, at 9:45 a.m. PT. The
event will be available via a live webcast from the “Events and
Presentations” page of the “Investors and Media” section of the
company’s website. A replay of the webcast will be available for
approximately 30 days following the event.
About
SYFOVRE® (pegcetacoplan
injection)SYFOVRE® (pegcetacoplan injection) is the
first and only approved therapy for geographic atrophy (GA). By
targeting C3, SYFOVRE is designed to provide comprehensive control
of the complement cascade, part of the body’s immune system.
SYFOVRE is approved in the United States for the treatment of GA
secondary to age-related macular degeneration.
About
EMPAVELI®/Aspaveli® (pegcetacoplan)EMPAVELI®/Aspaveli® (pegcetacoplan)
is a targeted C3 therapy designed to regulate excessive activation
of the complement cascade, part of the body’s immune system, which
can lead to the onset and progression of many serious diseases. It
is approved for the treatment of paroxysmal nocturnal
hemoglobinuria (PNH) in the United States, European Union, and
other countries globally. The therapy is also under investigation
for several other rare diseases across hematology and
nephrology.
U.S. Important Safety Information for
SYFOVRE® (pegcetacoplan
injection) CONTRAINDICATIONS
- SYFOVRE is contraindicated in patients with ocular or
periocular infections, and in patients with active intraocular
inflammation
WARNINGS AND PRECAUTIONS
- Endophthalmitis and Retinal Detachments
- Intravitreal injections, including
those with SYFOVRE, may be associated with endophthalmitis and
retinal detachments. Proper aseptic injection technique must always
be used when administering SYFOVRE to minimize the risk of
endophthalmitis. Patients should be instructed to report any
symptoms suggestive of endophthalmitis or retinal detachment
without delay and should be managed appropriately.
- Retinal Vasculitis and/or Retinal
Vascular Occlusion
- Retinal vasculitis and/or retinal
vascular occlusion, typically in the presence of intraocular
inflammation, have been reported with the use of SYFOVRE. Cases may
occur with the first dose of SYFOVRE and may result in severe
vision loss. Discontinue treatment with SYFOVRE in patients who
develop these events. Patients should be instructed to report any
change in vision without delay.
- Neovascular AMD
- In clinical trials, use of SYFOVRE was
associated with increased rates of neovascular (wet) AMD or
choroidal neovascularization (12% when administered monthly, 7%
when administered every other month and 3% in the control group) by
Month 24. Patients receiving SYFOVRE should be monitored for signs
of neovascular AMD. In case anti-Vascular Endothelial Growth Factor
(anti-VEGF) is required, it should be given separately from SYFOVRE
administration.
- Intraocular Inflammation
- In clinical trials, use of SYFOVRE was
associated with episodes of intraocular inflammation including:
vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber
cells, iritis, and anterior chamber flare. After inflammation
resolves, patients may resume treatment with SYFOVRE.
- Increased Intraocular Pressure
- Acute increase in IOP may occur within minutes of any
intravitreal injection, including with SYFOVRE. Perfusion of the
optic nerve head should be monitored following the injection and
managed as needed.
ADVERSE REACTIONS
- Most common adverse reactions (incidence ≥5%) are ocular
discomfort, neovascular age-related macular degeneration, vitreous
floaters, conjunctival hemorrhage.
Please see accompanying full Prescribing Information for more
information.
U.S. Important Safety Information for
EMPAVELI®
(pegcetacoplan)
BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED
BACTERIA
-
Meningococcal infections may occur in patients treated with
EMPAVELI and may become rapidly life-threatening or fatal if not
recognized and treated early. Use of EMPAVELI may predispose
individuals to serious infections, especially those caused by
encapsulated bacteria, such as Streptococcus
pneumoniae, Neisseria
meningitidis types A, C, W, Y, and B,
and Haemophilus
influenzae type B.
- Comply with
the most current Advisory Committee on Immunization Practices
(ACIP) recommendations for vaccinations against encapsulated
bacteria.
- Vaccinate
patients at least 2 weeks prior to administering the first
dose of EMPAVELI unless the risks of delaying therapy with EMPAVELI
outweigh the risk of developing a serious infection.
- Vaccination
reduces, but does not eliminate, the risk of serious infections.
Monitor patients for early signs of serious infections and evaluate
immediately if infection is suspected.
- EMPAVELI is
available only through a restricted program under a Risk Evaluation
and Mitigation Strategy (REMS). Under the EMPAVELI REMS,
prescribers must enroll in the program.
CONTRAINDICATIONS
- Hypersensitivity to
pegcetacoplan or to any of the excipients
- Not currently
vaccinated against certain encapsulated bacteria, unless the risks
of delaying EMPAVELI treatment outweigh the risks of developing a
bacterial infection with an encapsulated organism
- Unresolved serious
infection caused by encapsulated bacteria
including Streptococcus pneumoniae, Neisseria
meningitidis, and Haemophilus influenzae
WARNINGS AND PRECAUTIONS
Serious Infections Caused by Encapsulated
BacteriaThe use of EMPAVELI may predispose individuals to
serious, life-threatening, or fatal infections caused by
encapsulated bacteria, including Streptococcus
pneumoniae, Neisseria meningitidis types A, C, W, Y, and
B, and Haemophilus influenzae type B (Hib). To reduce the
risk of infection, all patients must be vaccinated against these
bacteria according to the most current ACIP recommendations for
patients with altered immunocompetence associated with complement
deficiencies. Revaccinate patients in accordance with ACIP
recommendations considering the duration of therapy with
EMPAVELI.
For patients without known history of vaccination, administer
required vaccines at least 2 weeks prior to receiving the first
dose of EMPAVELI. If immediate therapy with EMPAVELI is indicated,
administer required vaccine as soon as possible and provide
patients with 2 weeks of antibacterial drug prophylaxis.
Closely monitor patients for early signs and symptoms of serious
infection and evaluate patients immediately if an infection is
suspected. Promptly treat known infections. Serious infection may
become rapidly life-threatening or fatal if not recognized and
treated early. Consider discontinuation of EMPAVELI in patients who
are undergoing treatment for serious infections.
EMPAVELI REMSBecause of the risk of serious
infections, EMPAVELI is available only through a restricted program
under a REMS. Under the EMPAVELI REMS, prescribers must enroll in
the program and must counsel patients about the risk of serious
infection, provide the patients with the REMS educational
materials, and ensure patients are vaccinated against encapsulated
bacteria. Enrollment and additional information are available by
telephone: 1-888-343-7073 or at www.empavelirems.com.
Infusion-Related ReactionsSystemic
hypersensitivity reactions (e.g., facial swelling, rash, urticaria)
have occurred in patients treated with EMPAVELI. One patient (less
than 1% in clinical studies) experienced a serious allergic
reaction which resolved after treatment with antihistamines. If a
severe hypersensitivity reaction (including anaphylaxis) occurs,
discontinue EMPAVELI infusion immediately, institute appropriate
treatment, per standard of care, and monitor until signs and
symptoms are resolved.
Monitoring PNH Manifestations after Discontinuation of
EMPAVELIAfter discontinuing treatment with EMPAVELI,
closely monitor for signs and symptoms of hemolysis, identified by
elevated LDH levels along with sudden decrease in PNH clone size or
hemoglobin, or reappearance of symptoms such as fatigue,
hemoglobinuria, abdominal pain, dyspnea, major adverse vascular
events (including thrombosis), dysphagia, or erectile dysfunction.
Monitor any patient who discontinues EMPAVELI for at least 8 weeks
to detect hemolysis and other reactions. If hemolysis, including
elevated LDH, occurs after discontinuation of EMPAVELI, consider
restarting treatment with EMPAVELI.
Interference with Laboratory TestsThere may be
interference between silica reagents in coagulation panels and
EMPAVELI that results in artificially prolonged activated partial
thromboplastin time (aPTT); therefore, avoid the use of silica
reagents in coagulation panels.
ADVERSE REACTIONSMost common adverse reactions
in patients with PNH (incidence ≥10%) were injection-site
reactions, infections, diarrhea, abdominal pain, respiratory tract
infection, pain in extremity, hypokalemia, fatigue, viral
infection, cough, arthralgia, dizziness, headache, and rash.
USE IN SPECIFIC POPULATIONS
Females of Reproductive PotentialEMPAVELI may
cause embryo-fetal harm when administered to pregnant women.
Pregnancy testing is recommended for females of reproductive
potential prior to treatment with EMPAVELI. Advise female patients
of reproductive potential to use effective contraception during
treatment with EMPAVELI and for 40 days after the last dose.
Please see full Prescribing Information, including Boxed
WARNING regarding serious infections caused by encapsulated
bacteria, and Medication Guide.
About Apellis Apellis Pharmaceuticals,
Inc. is a global biopharmaceutical company that combines courageous
science and compassion to develop life-changing therapies for some
of the most challenging diseases patients face. We ushered in the
first new class of complement medicine in 15 years and now have two
approved medicines targeting C3. These include the first-ever
therapy for geographic atrophy, a leading cause of blindness around
the world. We believe we have only begun to unlock the potential of
targeting C3 across serious retinal, rare, and neurological
diseases. For more information, please visit
http://apellis.com or follow us
on Twitter and LinkedIn.
Apellis Forward-Looking
StatementStatements in this press release about
future expectations, plans and prospects, as well as any other
statements regarding matters that are not historical facts, may
constitute “forward-looking statements” within the meaning of The
Private Securities Litigation Reform Act of 1995. These statements
include, but are not limited to, statements regarding preliminary
financial information for the fourth quarter and full year ended
December 31, 2023. The words “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “will,”
“would” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, including
adjustments to Apellis’ preliminary revenue figures resulting from,
among other things, the completion of financial closing and review
procedures for the quarter and year ended December 31, 2023; and
other factors discussed in the “Risk Factors” section of Apellis’
Annual Report on Form 10-K with the Securities and Exchange
Commission on February 21, 2023 and Quarterly Report on Form 10-Q
filed on November 1, 2023 and the risks described in other filings
that Apellis may make with the Securities and Exchange Commission.
Any forward-looking statements contained in this press release
speak only as of the date hereof, and Apellis specifically
disclaims any obligation to update any forward-looking statement,
whether as a result of new information, future events or
otherwise.Media Contact: Lissa
Pavluk media@apellis.com 617.977.6764
Investor Contact: Meredith
Kaya meredith.kaya@apellis.com617.599.8178
i The revenue figures presented in this press release are
preliminary and based on management’s estimate as of the date of
this press release and are subject to completion of the Company’s
financial closing and review procedures.ii This is an estimation
based on ECP injection demand data on file as of December 31, 2023.
This dataset may not represent the entire patient population.iii As
of December 31, 2023.
Apellis Pharmaceuticals (NASDAQ:APLS)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Apellis Pharmaceuticals (NASDAQ:APLS)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024