Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a
commercial-stage biopharmaceutical company with a pipeline of
immune-modulating assets designed to target a spectrum of
cardiovascular and autoimmune diseases, today reported fourth
quarter and full-year 2023 financial results and recent portfolio
execution.
“Kiniksa meaningfully advanced its business in 2023, primarily
through robust ARCALYST net product revenue and collaboration
profit growth. Significant growth remains with ARCALYST in
recurrent pericarditis, and we expect to help an increasing number
of patients in the years ahead. Importantly, we anticipate our
robust commercial performance to contribute to our strong financial
position and ability to drive growth across our business,” said
Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa.
“Additionally, abiprubart recently showed clinical effect in the
first three cohorts of the Phase 2 trial in rheumatoid arthritis.
We now expect to advance the asset into a Phase 2b trial in a new
indication, funding for which is included in our current cash
runway guidance. Data from the fourth cohort of the abiprubart
Phase 2 trial are intended to inform trial design and are expected
in April.”
Portfolio and Collaboration
ExecutionARCALYST (IL-1α and IL-1β cytokine
trap)
- ARCALYST net product revenue was $71.2 million and $233.2
million for the fourth quarter and full-year 2023,
respectively.
- Since launch in April 2021, more than 1,700 prescribers have
written ARCALYST prescriptions for recurrent pericarditis.
- As of the end of the fourth quarter of 2023, average total
duration of ARCALYST therapy in recurrent pericarditis had
increased to approximately 23 months.
- As of the end of the fourth quarter of 2023, approximately 9%
of the target 14,000 multiple-recurrence patients were actively on
ARCALYST treatment.
- A poster entitled Rilonacept Utilization in a Steroid-Sparing
Paradigm for Recurrent Pericarditis: Real-World Evidence
Demonstrating Increased Adoption is planned to be presented at the
upcoming American College of Cardiology Scientific Session (ACC.24)
in April 2024.
Abiprubart (anti-CD40 monoclonal antibody inhibitor of
CD40-CD154 interaction)
- Kiniksa previously announced topline data from the Phase 2
clinical trial of abiprubart in rheumatoid arthritis, showing that
the trial met its primary efficacy endpoint: change from baseline
in Disease Activity Score of 28 Joints Using C-reactive Protein
(DAS28-CRP) versus placebo.
- In Cohorts 1 and 2 (pharmacokinetic lead-in), multiple doses of
abiprubart were well-tolerated.
- In Cohort 3, the abiprubart 5 mg/kg subcutaneous (SC) weekly
dose level achieved statistical significance. The 5 mg/kg SC
biweekly dose level did not achieve statistical significance.
Across both dose levels abiprubart reduced Rheumatoid Factor, a
clinical marker of disease activity and an autoantibody
pharmacodynamic marker of CD40 target engagement. Abiprubart was
well-tolerated, with no dose-related adverse experiences
observed.
- Kiniksa expects data from the fourth cohort (Cohort 4) of the
Phase 2 clinical trial in April 2024. Cohort 4 will evaluate a
fixed dose level administered as a single subcutaneous injection
once monthly.
Mavrilimumab (monoclonal antibody inhibitor targeting
GM-CSFRα)
- Kiniksa is evaluating potential partnership opportunities to
advance development of mavrilimumab, which has generated positive
data in mid-stage clinical trials across multiple indications.
Vixarelimab (monoclonal antibody inhibitor of signaling
through OSMRβ)
- In the fourth quarter of 2023, Kiniksa recognized a $10.0
million development milestone related to a second new indication
under its global license agreement with Genentech, a member of the
Roche Group.
Financial Results
- Total revenue for the fourth quarter of 2023 was $83.4 million,
compared to $61.9 million for the fourth quarter of 2022. Total
revenue for the full-year 2023 was $270.3 million, compared to
$220.2 million for the full-year 2022.
- Total revenue for the fourth quarter of 2023 included $12.2
million in license and collaboration revenue, compared to $21.9
million for the fourth quarter of 2022.
- Total revenue for the full-year 2023 included $37.1 million in
license and collaboration revenue, compared to $97.7 million for
the full-year 2022.
- Total operating expenses for the fourth quarter of 2023 were
$83.3 million, compared to $55.8 million for the fourth quarter of
2022. Total operating expenses for the full-year 2023 were $295.5
million, compared to $210.4 million for the full-year 2022.
- Total operating expenses for the fourth quarter of 2023
included $16.9 million in collaboration expenses, which are driven
by ARCALYST collaboration profitability, compared to $7.5 million
for the fourth quarter of 2022. Total operating expenses for the
full-year 2023 included $56.5 million in collaboration expenses,
compared to $24.1 million for the full-year 2022.
- Total operating expenses for the fourth quarter of 2023
included $7.8 million in non-cash, share-based compensation
expense, compared to $6.4 million for the fourth quarter of 2022.
Total operating expense for the full-year 2023 included $27.1
million in non-cash, share-based compensation expense, compared to
$25.1 million for the full-year 2022.
- Net income for the fourth quarter of 2023 was $25.2 million,
compared to net income of $4.5 million for the fourth quarter of
2022. Net income for the full-year 2023 was $14.1 million, compared
to net income of $183.4 million for the full-year 2022.
- Net income for the fourth quarter of 2023 included a tax
benefit of $22.8 million, primarily due to the treatment of
non-cash deferred tax assets, compared to a tax expense of $2.4
million for the fourth quarter of 2022.
- Net income for the full-year 2023 included a tax benefit of
$30.7 million, compared to a tax benefit of $172.3 million for the
full-year 2022, both primarily due to the treatment of non-cash
deferred tax assets.
- As of December 31, 2023, Kiniksa had $206.4 million of cash,
cash equivalents, and short-term investments and no debt.
Financial Guidance
- Kiniksa expects 2024 ARCALYST net product revenue of between
$360 million and $380 million.
- Kiniksa expects that its cash, cash equivalents, and short-term
investments will fund its current operating plan into at least
2027.
Conference Call Information
- Kiniksa will host a conference call and webcast at 8:30 a.m.
Eastern Time on Wednesday, February 28, 2024, to discuss fourth
quarter and full-year 2023 financial results and recent portfolio
execution.
- Individuals interested in participating in the call via
telephone may register here. Upon registration, all telephone
participants will receive a confirmation email detailing how to
join the conference call, including the dial-in number along with a
unique passcode and registrant ID that can be used to access the
call. To access the webcast, please visit the Investors and Media
section of Kiniksa’s website. A replay of the event will also be
available on Kiniksa’s website within approximately 48 hours after
the event.
About KiniksaKiniksa is a commercial-stage
biopharmaceutical company focused on discovering, acquiring,
developing, and commercializing therapeutic medicines for patients
suffering from debilitating diseases with significant unmet medical
need. Kiniksa’s immune-modulating assets, ARCALYST, abiprubart, and
mavrilimumab, are based on strong biologic rationale or validated
mechanisms, target a spectrum of underserved cardiovascular and
autoimmune conditions, and offer the potential for differentiation.
For more information, please visit www.kiniksa.com.
About ARCALYSTARCALYST is a weekly,
subcutaneously injected recombinant dimeric fusion protein that
blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β)
signaling. ARCALYST was discovered by Regeneron Pharmaceuticals,
Inc. (Regeneron) and is approved by the U.S. Food and Drug
Administration (FDA) for recurrent pericarditis,
cryopyrin-associated periodic syndromes (CAPS), including Familial
Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and
deficiency of IL-1 receptor antagonist (DIRA). The FDA granted
Breakthrough Therapy designation to ARCALYST for the treatment of
recurrent pericarditis in 2019 and Orphan Drug exclusivity to
ARCALYST in 2021 for the treatment of recurrent pericarditis and
reduction in risk of recurrence in adults and pediatric patients 12
years and older. The European Commission granted Orphan Drug
Designation to ARCALYST for the treatment of idiopathic
pericarditis in 2021.
IMPORTANT SAFETY INFORMATION ABOUT ARCALYST
- ARCALYST may affect your immune system and can lower the
ability of your immune system to fight infections. Serious
infections, including life-threatening infections and death, have
happened in patients taking ARCALYST. If you have any signs of an
infection, call your doctor right away. Treatment with ARCALYST
should be stopped if you get a serious infection. You should not
begin treatment with ARCALYST if you have an infection or have
infections that keep coming back (chronic infection).
- While taking ARCALYST, do not take other medicines that block
interleukin-1, such as Kineret® (anakinra), or medicines that block
tumor necrosis factor, such as Enbrel® (etanercept), Humira®
(adalimumab), or Remicade® (infliximab), as this may increase your
risk of getting a serious infection.
- Talk with your doctor about your vaccine history. Ask your
doctor whether you should receive any vaccines before you begin
treatment with ARCALYST.
- Medicines that affect the immune system may increase the risk
of getting cancer.
- Stop taking ARCALYST and call your doctor or get emergency care
right away if you have any symptoms of an allergic reaction.
- Your doctor will do blood tests to check for changes in your
blood cholesterol and triglycerides.
- Common side effects include injection-site reactions (which may
include pain, redness, swelling, itching, bruising, lumps,
inflammation, skin rash, blisters, warmth, and bleeding at the
injection site), upper respiratory tract infections, joint and
muscle aches, rash, ear infection, sore throat, and runny
nose.
For more information about ARCALYST, talk to your doctor
and see the Product
Information.
About Abiprubart Abiprubart is an
investigational humanized monoclonal antibody that binds to CD40
and is designed to inhibit the CD40-CD154 (CD40 ligand)
interaction, a key T-cell co-stimulatory signal critical for B-cell
maturation and immunoglobulin class switching and Type 1 immune
responses. Kiniksa believes disrupting the CD40-CD154
co-stimulatory interaction is an attractive approach to addressing
multiple autoimmune disease pathologies.
About MavrilimumabMavrilimumab is an
investigational fully human monoclonal antibody that blocks
activity of GM-CSF by specifically binding to the alpha subunit of
the GM-CSF receptor (GM-CSFRα). Phase 2 clinical trials of
mavrilimumab in rheumatoid arthritis and giant cell arteritis
achieved their primary and secondary endpoints with statistical
significance. Kiniksa is evaluating potential partnership
opportunities for mavrilimumab.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. In some cases,
you can identify forward looking statements by terms such as “may,”
“will,” “should,” “expect,” “plan,” “anticipate,” “could,”
“intend,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “potential” or “continue” or the negative of
these terms or other similar expressions, although not all
forward-looking statements contain these identifying words. All
statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements, including without limitation, statements regarding: our
expectation that ARCALYST 2024 net product revenue will be between
$360 million and $380 million; our plan to report data from Cohort
4 of our Phase 2 clinical trial of abiprubart in rheumatoid
arthritis and a new development indication for abiprubart in April
2024; our expectation about our cash reserves funding our current
operating plan into at least 2027; our expectation that we will
help an increasing number of patients in the future; our plan to
develop abiprubart in an additional indication; our plan to present
a poster at the upcoming American College of Cardiology Scientific
Session in April 2024; our beliefs about the mechanisms of our
product candidates and potential impact of their approach,
including that using abiprubart to disrupt the CD40-CD154
co-stimulatory interaction is an attractive approach to address
multiple autoimmune disease pathologies; and our belief that all of
our product candidates offer the potential for differentiation.
These forward-looking statements are based on management’s
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including without limitation, the
following: delays or difficulty in enrollment of patients in, and
activation or continuation of sites for, our clinical trials;
delays or difficulty in completing our clinical trials as
originally designed; potential for changes between final data and
any preliminary, interim, top-line or other data from clinical
trials; our inability to replicate results from our earlier
clinical trials or studies; impact of additional data from us or
other companies, including the potential for our data to produce
negative, inconclusive or commercially uncompetitive results;
potential undesirable side effects caused by our products and
product candidates; our inability to demonstrate safety and
efficacy to the satisfaction of applicable regulatory authorities;
potential for applicable regulatory authorities to not accept our
filings, delay or deny approval of any of our product candidates or
require additional data or trials to support approval; inability to
successfully execute on our commercial strategy for ARCALYST; our
reliance on third parties as the sole source of supply of the drug
substance and drug product used in our products and product
candidates; our reliance on Regeneron as the current sole
manufacturer of ARCALYST; risks arising from our ongoing technology
transfer of ARCALYST drug substance manufacturing; raw material,
important ancillary product and drug substance and/or drug product
shortages; our reliance on third parties to conduct research,
clinical trials, and/or certain regulatory activities for our
product candidates; complications in coordinating requirements,
regulations and guidelines of regulatory authorities across
jurisdictions for our clinical trials; changes in our operating
plan, business development strategy or funding requirements; and
existing or new competition.
These and other important factors discussed in our filings with
the U.S. Securities and Exchange Commission, including under the
caption “Risk Factors” contained therein, could cause actual
results to differ materially from those indicated by the
forward-looking statements made in this press release. Any such
forward-looking statements represent management’s estimates as of
the date of this press release. Except as required by law, we
disclaim any intention or obligation to update or revise any
forward-looking statements. These forward-looking statements should
not be relied upon as representing our views as of any date
subsequent to the date of this press release.
ARCALYST® is a registered trademark of Regeneron. All other
trademarks are the property of their respective owners.
Every Second Counts! ®
Kiniksa Investor and Media ContactRachel
Frank(339) 970-9437rfrank@kiniksa.com
KINIKSA
PHARMACEUTICALS, LTD. |
|
CONSOLIDATED
STATEMENTS OF OPERATIONS |
|
(In
thousands, except share and per share amounts) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Years
Ended |
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
|
|
|
|
|
2023 |
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
71,220 |
|
$ |
39,939 |
|
|
$ |
233,176 |
|
|
$ |
122,524 |
|
|
|
License and collaboration revenue |
|
|
12,175 |
|
|
21,945 |
|
|
|
37,083 |
|
|
|
97,656 |
|
|
|
|
|
Total revenue |
|
|
83,395 |
|
|
61,884 |
|
|
|
270,259 |
|
|
|
220,180 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
9,584 |
|
|
6,710 |
|
|
|
33,407 |
|
|
|
22,895 |
|
|
|
Collaboration expenses |
|
|
16,939 |
|
|
7,522 |
|
|
|
56,524 |
|
|
|
24,071 |
|
|
|
Research and development |
|
|
20,052 |
|
|
14,390 |
|
|
|
76,097 |
|
|
|
65,490 |
|
|
|
Selling, general and administrative |
|
|
36,739 |
|
|
27,215 |
|
|
|
129,427 |
|
|
|
97,951 |
|
|
|
|
|
Total operating expenses |
|
|
83,314 |
|
|
55,837 |
|
|
|
295,455 |
|
|
|
210,407 |
|
Income (loss) from operations |
|
|
81 |
|
|
6,047 |
|
|
|
(25,196 |
) |
|
|
9,773 |
|
Other income |
|
|
2,369 |
|
|
794 |
|
|
|
8,544 |
|
|
|
1,253 |
|
Income (loss) before income taxes |
|
|
2,450 |
|
|
6,841 |
|
|
|
(16,652 |
) |
|
|
11,026 |
|
Benefit (provision) for income taxes |
|
|
22,787 |
|
|
(2,380 |
) |
|
|
30,736 |
|
|
|
172,337 |
|
Net income |
|
|
$ |
25,237 |
|
$ |
4,461 |
|
|
$ |
14,084 |
|
|
$ |
183,363 |
|
Net income per share attributable to common shareholders—basic |
|
$ |
0.36 |
|
$ |
0.06 |
|
|
$ |
0.20 |
|
|
$ |
2.64 |
|
Net income per share attributable to common
shareholders—diluted |
|
|
0.35 |
|
|
0.06 |
|
|
|
0.20 |
|
|
|
2.60 |
|
Weighted average common shares outstanding—basic |
|
|
70,371,601 |
|
|
69,609,342 |
|
|
|
70,058,952 |
|
|
|
69,382,275 |
|
Weighted average common shares outstanding—diluted |
|
|
72,660,171 |
|
|
71,369,394 |
|
|
|
71,922,915 |
|
|
|
70,421,322 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KINIKSA
PHARMACEUTICALS, LTD. |
|
SELECTED
CONSOLIDATED BALANCE SHEET DATA |
|
(In
thousands) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
|
|
|
|
|
|
|
December
31, |
December
31, |
|
|
|
|
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term investments |
|
$ |
206,371 |
|
|
$ |
190,608 |
|
|
|
Working capital |
|
|
212,631 |
|
|
|
195,994 |
|
|
|
Total assets |
|
|
|
526,322 |
|
|
|
459,672 |
|
|
|
Accumulated deficit |
|
|
(477,950 |
) |
|
|
(492,034 |
) |
|
|
Total shareholders' equity |
|
|
438,839 |
|
|
|
396,149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
- |
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- |
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Kiniksa Pharmaceuticals (NASDAQ:KNSA)
過去 株価チャート
から 5 2024 まで 6 2024
Kiniksa Pharmaceuticals (NASDAQ:KNSA)
過去 株価チャート
から 6 2023 まで 6 2024