Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), today announced
its fourth quarter and full year 2023 financial results and
business highlights.
“I am extremely proud of our team, their accomplishments and
resilience in a year faced with many highs and some unexpected
challenges. The SYFOVRE launch exceeded even our own expectations,
with demand growth continuing into the first quarter of 2024, and
we remain encouraged by the uptake and high compliance rates for
EMPAVELI in PNH,” said Cedric Francois, M.D., Ph.D., co-founder and
chief executive officer of Apellis. “We are well-positioned to
continue our strong execution in 2024, with a focus on bringing
SYFOVRE to even more patients in the U.S. and globally, maximizing
EMPAVELI in PNH and C3G/IC-MPGN, advancing our earlier-stage
pipeline, and delivering on our mission for patients now and in the
future.”
Fourth Quarter 2023 and Recent Business
Highlights:
Ophthalmology Highlights
- SYFOVRE for the treatment of geographic
atrophy (GA) secondary to age-related macular degeneration (AMD):
- Recorded $114.3 million and $275.2
million in SYFOVRE U.S. net product revenue for the fourth quarter
and full year 2023, respectively.
- Delivered approximately 62,000
SYFOVRE doses to physician practices in the fourth quarter,
including 55,000 commercial vials and 6,400 samples. More than
160,000 doses have been delivered to physician practices since
launch in March through December 31, 2023.
- Permanent and product-specific
J-code for SYFOVRE became effective on October 1, 2023, helping to
simplify and streamline the billing and reimbursement of
SYFOVRE.
- Significant presence at multiple medical meetings, including an
oral presentation at the American Academy of Ophthalmology (AAO)
meeting on data from the GALE extension study showing continued
increasing treatment effects and consistent safety data over three
years of continuous SYFOVRE use.
- Data also showed that SYFOVRE
reduced nonsubfoveal GA lesion growth by 42% (monthly) in Year 3
compared to projected sham.
- Initiating a re-examination of the marketing authorization
application of SYFOVRE with the European Medicines Agency (EMA)
following a negative opinion from the Committee for Medicinal
Products for Human Use (CHMP) received in January 2024.
- Expect a final opinion to be issued
by the CHMP in the second quarter of 2024.
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Highlights
- EMPAVELI for the treatment of PNH:
- Recorded $24.4 million and $91.0
million in EMPAVELI U.S. net product revenue for the fourth quarter
and full year 2023, respectively.
- Continued high patient compliance
rates of 97%.
- Following approval in October 2023,
the EMPAVELI Injector is now used by approximately 60% of existing
EMPAVELI patients and greater than 90% of new EMPAVELI
patients.
- Presented post hoc data integrated
from the Phase 3 PEGASUS and PRINCE studies and the long-term
extension study reinforcing the safety and efficacy profile of
EMPAVELI in PNH for up to three years at the American Society of
Hematology (ASH) Annual Meeting.
R&D Highlights
- C3 glomerulopathy (C3G) and immune
complex glomerulonephritis (IC-MPGN): Completed enrollment in the
Phase 3 VALIANT study of systemic pegcetacoplan, with topline data
expected in mid-2024.
- Presented topline data from the Phase 2
NOBLE study investigating pegcetacoplan for the treatment of
post-transplant recurrence of C3G and IC-MPGN at the American
Society of Nephrology (ASN) Kidney Week Annual Meeting. Data
demonstrated reduced disease activity as measured by C3c staining
in as early as 12 weeks, as well as improvements across key
clinical measures.
- Cold agglutinin disease (CAD): As
previously reported by Sobi, the Companies discontinued the Phase 3
CASCADE study of systemic pegcetacoplan for CAD due to a
realignment of Sobi and Apellis’ development activities as there is
a decreased medical need in CAD and therefore a limited number of
patients eligible for the study.
- There were no safety concerns in
this study, and efficacy was not evaluated due to the blinded study
design.
- Sobi is working with
investigators on how to best support patients and their physicians
in finding an appropriate treatment option going forward.
- Hematopoietic stem cell
transplantation-associated thrombotic microangiopathy (HSCT-TMA):
Sobi continues to enroll patients in its Phase 2 study evaluating
the efficacy and safety of systemic pegcetacoplan in patients with
HSCT-TMA.
- APL-3007 (small
interfering RNA silencing C3): Currently in a Phase 1 dose
escalation study with topline data expected in 2024.
Fourth Quarter and Full Year 2023 Financial
Results:
Cash. As of December 31, 2023, Apellis had $351.2 million in
cash and cash equivalents, compared to $551.8 million in cash and
cash equivalents as of December 31, 2022. Apellis anticipates its
cash balance, combined with cash anticipated to be generated from
the unwind of the capped call transactions and from the sales of
EMPAVELI and SYFOVRE, will be sufficient to fund its projected
operating expenses and capital expenditures for the foreseeable
future.
Total Revenue.
- Total revenue was $146.4 million for
the fourth quarter of 2023, which consisted of $114.3 million in
U.S. net product revenue of SYFOVRE, $24.4 million in U.S. net
product revenue of EMPAVELI and $7.7 million in licensing and other
revenue associated with the Sobi collaboration. Total revenue was
$22.7 million for the fourth quarter of 2022, which consisted of
$19.7 million in U.S. net product revenue of EMPAVELI and $3.0
million in licensing and other revenue associated with the Sobi
collaboration.
- For the full year
2023, total revenue was $396.6 million, which consisted of $275.2
million in U.S. net product revenue of SYFOVRE, $91.0 million in
U.S. net product revenue of EMPAVELI and $30.3 million in licensing
and other revenue associated with the Sobi collaboration. For the
full year 2022, total revenue was $75.4 million, which consisted of
$65.1 million in U.S. net product revenue of EMPAVELI and $10.3
million in licensing and other revenue associated with the Sobi
collaboration.
Cost of Sales.
- Cost of sales was $19.9 million for the fourth quarter of 2023,
compared to $2.9 million for the fourth quarter of 2022,
respectively. For the full year 2023, cost of sales was $58.5
million as compared to $5.6 million for the full year 2022.
- Cost of sales consists primarily of
costs associated with the manufacturing of SYFOVRE and EMPAVELI,
royalties owed to our licensor for such sales, costs associated
with Sobi revenue, and certain period costs.
- Prior to receiving FDA approval for EMPAVELI in May 2021 and
SYFOVRE in February 2023, costs associated with the manufacturing
of EMPAVELI and SYFOVRE inventory were expensed as research and
development (R&D) expense. This resulted in inventory being
sold during the 2022 and 2023 periods, for which a portion of the
costs had been previously expensed prior to FDA approval.
R&D Expenses.
- R&D expenses were $69.3 million
for the fourth quarter of 2023, compared to $99.4 million for the
fourth quarter of 2023. For the full year 2023, R&D expenses
were $354.4 million compared to $387.2 million for the full year
2022.
- The decrease in R&D expenses for
the full year 2023 was primarily attributable to a decrease in
program specific external costs, including the discontinuation of
the MERIDIAN study for ALS and the approval of SYFOVRE, and a
decrease in non-program specific external costs. These decreases
were partially offset by an increase in compensation and related
personnel costs.
General and Administrative (G&A) Expenses.
- G&A expenses were $141.7 million
for the fourth quarter of 2023, compared to $84.4 million for the
fourth quarter of 2022. For the full year 2023, G&A expenses
were $500.8 million compared to $277.2 million for the full year
2022.
- The increase in G&A expenses for
the full year 2023 was primarily attributable to an increase in
employee related costs related to hiring activities to support the
launch of SYFOVRE, an increase in commercialization related
activity, an increase in professional and consulting fees, an
increase in travel related expenses and higher office costs.
Net Loss (Income). Apellis reported a net loss of $88.5 million
and $528.6 million for the fourth quarter and full year 2023,
respectively, compared to a net loss of $166.0 million and $652.2
million for the same periods in 2022.
Convertible Notes.
- Apellis entered into agreements to unwind approximately 80% of
the capped call transactions that it entered into in connection
with the issuance of the Company’s 3.500% Senior Convertible Notes
due 2026 (the Notes).
- The unwind agreements will apply to the portion of the capped
call transactions in a notional amount corresponding to the $426.1
million of Notes that are held by Apellis in treasury as of
December 31, 2023, or have been previously converted.
- The unwind transactions will be settled based on a 7-day
averaging period beginning on and including February 27, 2024.
- Apellis anticipates that it will receive aggregate net cash
proceeds of approximately $100 million in connection with this
portion of the capped call transactions, although the final amount
of net cash proceeds will be determined after the expiration of the
7-day averaging period.
- In connection with the unwind, the counterparties may sell
shares of Apellis’ common stock in secondary market transactions,
and/or unwind various derivative transactions with respect to
Apellis’ common stock.
- As of December 31, 2023, the aggregate principal balance of the
Notes due 2026, net of unamortized debt issuance costs, was $93.0
million.
Conference Call and WebcastApellis will host a
conference call and webcast to discuss its fourth quarter and year
end 2023 financial results and business highlights today, February
27, 2024, at 8:30 a.m. ET. To access the live call by phone, please
pre-register for the call here. A live audio webcast of the
event and accompanying slides may also be accessed through 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 30 days following the event.
About SYFOVRE® (pegcetacoplan
injection)SYFOVRE® (pegcetacoplan injection) is the
first-ever 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
EMPAVELI, a complement inhibitor, increases the risk of
serious infections, especially those caused by encapsulated
bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis,
and Haemophilus influenzae type B. Life-threatening and fatal
infections with encapsulated bacteria have occurred in patients
treated with complement inhibitors. These infections may become
rapidly life-threatening or fatal if not recognized and treated
early.
- Complete or update vaccination for encapsulated
bacteria at least 2 weeks prior to the first dose of EMPAVELI,
unless the risks of delaying therapy with EMPAVELI outweigh the
risks of developing a serious infection. Comply with the most
current Advisory Committee on Immunization Practices (ACIP)
recommendations for vaccinations against encapsulated bacteria in
patients receiving a complement inhibitor.
- Patients receiving EMPAVELI are at increased risk for
invasive disease caused by encapsulated bacteria, even if they
develop antibodies following vaccination. Monitor patients for
early signs and symptoms of serious infections and evaluate
immediately if infection is suspected.
Because of the risk of serious infections caused by
encapsulated bacteria, EMPAVELI is available only through a
restricted program under a Risk Evaluation and Mitigation Strategy
(REMS) called the EMPAVELI REMS.
CONTRAINDICATIONS
- Hypersensitivity to
pegcetacoplan or to any of the excipients
- For initiation in
patients with unresolved serious infection caused by encapsulated
bacteria including Streptococcus pneumoniae, Neisseria
meningitidis, and Haemophilus influenzae type B
WARNINGS AND PRECAUTIONS
Serious Infections Caused by Encapsulated
Bacteria
EMPAVELI, a complement inhibitor, increases a patient’s
susceptibility to serious, life-threatening, or fatal infections
caused by encapsulated bacteria including Streptococcus pneumoniae,
Neisseria meningitidis (caused by any serogroup, including
non-groupable strains), and Haemophilus influenzae type B.
Life-threatening and fatal infections with encapsulated bacteria
have occurred in both vaccinated and unvaccinated patients treated
with complement inhibitors. The initiation of EMPAVELI treatment is
contraindicated in patients with unresolved serious infection
caused by encapsulated bacteria.
Complete or update vaccination against encapsulated bacteria at
least 2 weeks prior to administration of the first dose of
EMPAVELI, according to the most current ACIP recommendations for
patients receiving a complement inhibitor. Revaccinate patients in
accordance with ACIP recommendations considering the duration of
therapy with EMPAVELI. Note that, ACIP recommends an administration
schedule in patients receiving complement inhibitors that differs
from the administration schedule in the vaccine prescribing
information. If urgent EMPAVELI therapy is indicated in a patient
who is not up to date with vaccines against encapsulated bacteria
according to ACIP recommendations, provide the patient with
antibacterial drug prophylaxis and administer these vaccines as
soon as possible. The benefits and risks of treatment with
EMPAVELI, as well as the benefits and risks of antibacterial drug
prophylaxis in unvaccinated or vaccinated patients, must be
considered against the known risks for serious infections caused by
encapsulated bacteria.
Vaccination does not eliminate the risk of serious encapsulated
bacterial infections, despite development of antibodies following
vaccination. Closely monitor patients for early signs and symptoms
of serious infection and evaluate patients immediately if an
infection is suspected. Inform patients of these signs and symptoms
and instruct patients to seek immediate medical care if these signs
and symptoms occur. Promptly treat known infections. Serious
infection may become rapidly life-threatening or fatal if not
recognized and treated early. Consider interruption of EMPAVELI in
patients who are undergoing treatment for serious infections.
EMPAVELI is available only through a restricted program under a
REMS.
EMPAVELI REMS
EMPAVELI is available only through a restricted program under a
REMS called EMPAVELI REMS, because of the risk of serious
infections caused by encapsulated bacteria. Notable requirements of
the EMPAVELI REMS include the following:
Under the EMPAVELI REMS, prescribers must enroll in the program.
Prescribers must counsel patients about the risks, signs, and
symptoms of serious infections caused by encapsulated bacteria,
provide patients with the REMS educational materials, ensure
patients are vaccinated against encapsulated bacteria at least 2
weeks prior to the first dose of EMPAVELI, prescribe antibacterial
drug prophylaxis if patients’ vaccine status is not up to date and
treatment must be started urgently, and provide instructions to
always carry the Patient Safety Card both during treatment, as well
as for 2 months following last dose of EMPAVELI. Pharmacies that
dispense EMPAVELI must be certified in the EMPAVELI REMS and must
verify prescribers are certified.
Further information is available at www.empavelirems.com or
1-888-343-7073.
Infusion-Related Reactions
Systemic 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
EMPAVELI
After 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 Tests
There 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 REACTIONS
Most 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 Potential
EMPAVELI 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 the expected timing of clinical data, the
re-examination of the marketing authorization application of
SYFOVRE and the expected proceeds from the unwind of the capped
call transactions. 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
whether the benefit/risk profile of SYFOVRE following the events of
retinal vasculitis will impact the Company’s commercialization
efforts; whether SYFOVRE will receive approval from foreign
regulatory agencies for GA when expected or at all, including the
impact of the reported events of retinal vasculitis on the
likelihood and timing of such approvals; whether the Company’s
clinical trials will be completed when anticipated; whether results
obtained in clinical trials will be indicative of results that will
be generated in future clinical trials; whether pegcetacoplan will
successfully advance through the clinical trial process on a timely
basis, or at all; whether the results of the Company’s clinical
trials will warrant regulatory submissions and whether systemic
pegcetacoplan will receive approval from the FDA or equivalent
foreign regulatory agencies for C3G and IC-MPGN or any other
indication when expected or at all; the period for which the the
Company believes that its cash resources will be sufficient to fund
its operations; ; 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 27, 2024 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
Pavlukmedia@apellis.com617.977.6764
Investor Contact:Meredith
Kayameredith.kaya@apellis.com617.599.8178
|
|
|
|
APELLIS
PHARMACEUTICALS, INC. |
CONDENSED
CONSOLIDATED BALANCE SHEETS |
(Amounts in
thousands, except per share amounts) |
|
|
|
December 31, |
|
December 31, |
|
|
|
2023 |
|
2022 |
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
351,185 |
|
|
$ |
551,801 |
|
|
Accounts receivable |
|
|
206,442 |
|
|
|
7,727 |
|
|
Inventory |
|
|
146,362 |
|
|
|
85,714 |
|
|
Prepaid assets |
|
|
38,820 |
|
|
|
36,350 |
|
|
Restricted cash |
|
|
1,114 |
|
|
|
1,273 |
|
|
Other current assets |
|
|
22,408 |
|
|
|
36,658 |
|
|
Total current assets |
|
|
766,331 |
|
|
|
719,523 |
|
|
Non-current
assets: |
|
|
|
|
|
Right-of-use assets |
|
|
16,745 |
|
|
|
18,747 |
|
|
Property and equipment, net |
|
|
4,345 |
|
|
|
6,148 |
|
|
Other assets |
|
|
1,309 |
|
|
|
15,799 |
|
|
Total
assets |
|
$ |
788,730 |
|
|
$ |
760,217 |
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
|
|
37,516 |
|
|
|
37,342 |
|
|
Accrued expenses |
|
|
127,806 |
|
|
|
95,139 |
|
|
Current portion of development liability |
|
|
75,830 |
|
|
|
29,504 |
|
|
Current portion of right of use liabilities |
|
|
6,441 |
|
|
|
5,625 |
|
|
Total current liabilities |
|
|
247,593 |
|
|
|
167,610 |
|
|
Long-term
liabilities: |
|
|
|
|
|
Long-term development liability |
|
|
239,817 |
|
|
|
315,647 |
|
|
Convertible senior notes |
|
|
93,033 |
|
|
|
92,736 |
|
|
Right-of-use liabilities |
|
|
11,454 |
|
|
|
14,352 |
|
|
Other
liabilities |
|
|
2,312 |
|
|
|
— |
|
|
Total
liabilities |
|
|
594,209 |
|
|
|
590,345 |
|
|
Stockholders' equity: |
|
|
|
|
|
Preferred stock, $0.0001 par value; 10,000 shares authorized and
zero shares issued and outstanding at December 31, 2023 and
2022 |
|
|
— |
|
|
|
— |
|
|
Common stock, $0.0001 par value; 200,000 shares authorized at
December 31, 2023 and 2021; 119,556 and 110,772 shares issued and
outstanding at December 31, 2023 and 2022 |
|
|
12 |
|
|
|
11 |
|
|
Additional paid-in capital |
|
|
3,035,539 |
|
|
|
2,479,596 |
|
|
Accumulated other comprehensive loss |
|
|
(3,542 |
) |
|
|
(875 |
) |
|
Accumulated deficit |
|
|
(2,837,488 |
) |
|
|
(2,308,860 |
) |
|
Total stockholders' equity |
|
|
194,521 |
|
|
|
169,872 |
|
|
Total
liabilities and stockholders' equity |
|
$ |
788,730 |
|
|
$ |
760,217 |
|
|
|
|
|
|
|
|
APELLIS
PHARMACEUTICALS, INC. |
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(Amounts in
thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
138,655 |
|
|
$ |
19,653 |
|
|
$ |
366,281 |
|
|
$ |
65,092 |
|
|
Licensing and other revenue |
|
7,722 |
|
|
|
3,010 |
|
|
|
30,310 |
|
|
|
10,330 |
|
|
Total revenue: |
|
146,377 |
|
|
|
22,663 |
|
|
|
396,591 |
|
|
|
75,422 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Cost of sales |
|
19,912 |
|
|
|
2,925 |
|
|
|
58,510 |
|
|
|
5,636 |
|
|
Research and development |
|
69,282 |
|
|
|
99,423 |
|
|
|
354,387 |
|
|
|
387,236 |
|
|
General and administrative |
|
141,701 |
|
|
|
84,368 |
|
|
|
500,815 |
|
|
|
277,163 |
|
|
Operating
expenses: |
|
230,895 |
|
|
|
186,716 |
|
|
|
913,712 |
|
|
|
670,035 |
|
|
Net
operating loss |
|
(84,518 |
) |
|
|
(164,053 |
) |
|
|
(517,121 |
) |
|
|
(594,613 |
) |
|
Loss on conversion of debt |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(32,890 |
) |
|
Interest income |
|
4,548 |
|
|
|
4,575 |
|
|
|
20,933 |
|
|
|
8,914 |
|
|
Interest expense |
|
(7,402 |
) |
|
|
(7,738 |
) |
|
|
(29,581 |
) |
|
|
(32,626 |
) |
|
Other (expense)/income, net |
|
219 |
|
|
|
(246 |
) |
|
|
(727 |
) |
|
|
(288 |
) |
|
Net loss before taxes |
|
(87,153 |
) |
|
|
(167,462 |
) |
|
|
(526,496 |
) |
|
|
(651,503 |
) |
|
Income tax expense |
|
1,423 |
|
|
|
(1,471 |
) |
|
|
2,132 |
|
|
|
669 |
|
|
Net
income/(loss) |
$ |
(88,576 |
) |
|
$ |
(165,991 |
) |
|
$ |
(528,628 |
) |
|
$ |
(652,172 |
) |
|
Other
comprehensive (loss)/gain: |
|
|
|
|
|
|
|
|
Unrealized (loss)/gain on marketable
securities |
|
— |
|
|
|
382 |
|
|
|
— |
|
|
|
(1 |
) |
|
Unrealized (loss)/gain on pension plans |
|
(2,618 |
) |
|
|
1,646 |
|
|
|
(2,618 |
) |
|
|
1,646 |
|
|
Foreign currency gain/(loss) |
|
141 |
|
|
|
124 |
|
|
|
(49 |
) |
|
|
(430 |
) |
|
Total other
comprehensive income/(loss) |
|
(2,477 |
) |
|
|
2,152 |
|
|
|
(2,667 |
) |
|
|
1,215 |
|
|
Comprehensive loss, net of tax |
$ |
(91,053 |
) |
|
$ |
(163,839 |
) |
|
$ |
(531,295 |
) |
|
$ |
(650,957 |
) |
|
Net loss per
common share, basic and diluted |
$ |
(0.73 |
) |
|
$ |
(1.50 |
) |
|
$ |
(4.45 |
) |
|
$ |
(6.15 |
) |
|
Weighted-average number of common shares used in net loss per
common share, basic and diluted |
|
121,232 |
|
|
|
110,629 |
|
|
|
118,678 |
|
|
|
106,114 |
|
|
|
|
|
|
|
|
|
|
|
Apellis Pharmaceuticals (NASDAQ:APLS)
Historical Stock Chart
From Apr 2024 to May 2024
Apellis Pharmaceuticals (NASDAQ:APLS)
Historical Stock Chart
From May 2023 to May 2024