Kiniksa Pharmaceuticals Reports Second Quarter 2024 Financial Results and Recent Portfolio Execution
23 July 2024 - 9:30PM
Kiniksa Pharmaceuticals International, plc (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 second
quarter 2024 financial results and recent portfolio execution.
“Kiniksa’s work to establish ARCALYST as the standard of care in
recurrent pericarditis continues to drive the company’s commercial
performance. As of the end of the second quarter, ~11% of the
14,000 multiple-recurrence target population were actively on
ARCALYST treatment, and total average duration of therapy increased
to approximately 26 months. We now expect 2024 ARCALYST net sales
to increase to between $405 and $415 million from our previous
guidance of between $370 and $390 million,” said Sanj K. Patel,
Chairman and Chief Executive Officer of Kiniksa. “Within our
pipeline, commencing enrollment in the abiprubart Phase 2b trial in
Sjögren’s Disease, a debilitating, chronic autoimmune disease,
which currently has no FDA-approved therapies, represents an
exciting growth opportunity for the company. Clinical development
of abiprubart in Sjögren’s Disease is fully funded in our current
operating plan, and we expect to remain cash flow positive on an
annual basis.”
Portfolio ExecutionARCALYST (IL-1α and
IL-1β cytokine trap)
- ARCALYST net product revenue was $103.4 million for the second
quarter of 2024.
- Since launch in April 2021, more than 2,300 prescribers have
written ARCALYST prescriptions for recurrent pericarditis.
- As of the end of the second quarter of 2024, the average total
duration of ARCALYST therapy in recurrent pericarditis increased to
approximately 26 months, compared to ~23 months as of the end of
the first quarter of 2024.
- As of the end of the second quarter of 2024, approximately 11%
of the target 14,000 multiple-recurrence patients were actively on
ARCALYST treatment, compared to ~9% as of the end of 2023.
- In June 2024, Kiniksa announced its sponsorship of the American
Heart Association’s Addressing Recurrent Pericarditis initiative, a
multi-faceted effort aimed at improving access to expert care and
quality of care for patients with recurrent pericarditis.
- In June 2024, Kiniksa announced a partnership with National
Hockey League Hall-of-Famer, Henrik Lundqvist, to raise awareness
in support of patients suffering from recurrent pericarditis.
Abiprubart (anti-CD40 monoclonal antibody inhibitor of
CD40-CD154 interaction)
- Kiniksa is enrolling patients in a Phase 2b clinical trial
designed to evaluate the efficacy and safety of biweekly and
monthly abiprubart administered subcutaneously in patients with
Sjögren’s Disease.
Financial Results
- Total revenue for the second quarter of 2024 was $108.6
million, compared to $71.5 million for the second quarter of 2023.
- Total revenue for the second quarter of 2024 included $5.2
million in license and collaboration revenue, compared to $17.0
million for the second quarter of 2023.
- Total operating expenses for the second quarter of 2024 were
$108.7 million, compared to $74.6 million for the second quarter of
2023.
- Total operating expenses for the second quarter of 2024
included $30.0 million in collaboration expenses, which are driven
by ARCALYST collaboration profitability, compared to $14.0 million
for the second quarter of 2023.
- Total operating expenses for the second quarter of 2024
included $7.4 million in non-cash, share-based compensation
expense, compared to $6.5 million for the second quarter of
2023.
- Net loss for the second quarter of 2024 was $3.9 million,
compared to a net income of $15.0 million for the second quarter of
2023.
- As of June 30, 2024, Kiniksa had $218.8 million of cash, cash
equivalents, and short-term investments and no debt.
Financial Guidance
- Kiniksa expects 2024 ARCALYST net product revenue of between
$405 million and $415 million, compared to prior guidance of
between $370 million and $390 million.
- Kiniksa expects to remain cash flow positive on an annual
basis.
Conference Call Information
- Kiniksa will host a conference call and webcast at 8:30 a.m.
Eastern Time on Tuesday, July 23, 2024, to discuss second quarter
2024 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.
Forward-Looking StatementsThis press release
contains forward-looking statements. 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 $405 million
and $415 million; our expectation that clinical development of
abiprubart in Sjögren’s Disease is fully funded in our current
operating plan; our expectation to remain cash flow positive on an
annual basis; 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; 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; 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.
Every Second Counts! ®
Kiniksa Investor and Media ContactRachel
Frank(339) 970-9437rfrank@kiniksa.com
|
KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC |
(FORMERLY KNOWN AS KINIKSA PHARMACEUTICALS,
LTD.) |
SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (LOSS) |
(In thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
103,394 |
|
|
$ |
54,495 |
|
|
$ |
182,279 |
|
|
$ |
97,154 |
|
License and collaboration revenue |
|
|
5,237 |
|
|
|
16,978 |
|
|
|
6,210 |
|
|
|
22,664 |
|
Total revenue |
|
|
108,631 |
|
|
|
71,473 |
|
|
|
188,489 |
|
|
|
119,818 |
|
Costs and operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
12,322 |
|
|
|
7,699 |
|
|
|
22,905 |
|
|
|
14,735 |
|
Collaboration expenses |
|
|
30,014 |
|
|
|
13,986 |
|
|
|
50,815 |
|
|
|
22,274 |
|
Research and development |
|
|
24,017 |
|
|
|
23,767 |
|
|
|
50,351 |
|
|
|
38,939 |
|
Selling, general and administrative |
|
|
42,395 |
|
|
|
29,175 |
|
|
|
81,077 |
|
|
|
58,220 |
|
Total operating expenses |
|
|
108,748 |
|
|
|
74,627 |
|
|
|
205,148 |
|
|
|
134,168 |
|
Loss from operations |
|
|
(117 |
) |
|
|
(3,154 |
) |
|
|
(16,659 |
) |
|
|
(14,350 |
) |
Other income |
|
|
2,421 |
|
|
|
1,915 |
|
|
|
4,687 |
|
|
|
3,747 |
|
Income (loss) before income taxes |
|
|
2,304 |
|
|
|
(1,239 |
) |
|
|
(11,972 |
) |
|
|
(10,603 |
) |
Benefit (provision) for income taxes |
|
|
(6,212 |
) |
|
|
16,211 |
|
|
|
(9,640 |
) |
|
|
13,305 |
|
Net income (loss) |
|
$ |
(3,908 |
) |
|
$ |
14,972 |
|
|
$ |
(21,612 |
) |
|
$ |
2,702 |
|
Net income (loss) per share attributable to ordinary
shareholders—basic |
|
$ |
(0.06 |
) |
|
$ |
0.21 |
|
|
$ |
(0.31 |
) |
|
$ |
0.04 |
|
Net income (loss) per share attributable to ordinary
shareholders—diluted |
|
$ |
(0.06 |
) |
|
$ |
0.21 |
|
|
$ |
(0.31 |
) |
|
$ |
0.04 |
|
Weighted average ordinary shares outstanding—basic |
|
|
71,004,640 |
|
|
|
69,918,287 |
|
|
|
70,818,831 |
|
|
|
69,835,452 |
|
Weighted average ordinary shares outstanding—diluted |
|
|
71,004,640 |
|
|
|
71,634,729 |
|
|
|
70,818,831 |
|
|
|
71,420,026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC |
(FORMERLY KNOWN AS KINIKSA PHARMACEUTICALS,
LTD.) |
SELECTED CONSOLIDATED BALANCE SHEET DATA |
(In thousands) |
(Unaudited) |
|
|
|
|
|
|
|
As of |
|
|
June 30, |
|
December 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
Cash, cash equivalents, and short-term investments |
|
$ |
218,758 |
|
|
$ |
206,371 |
|
Working capital |
|
|
216,730 |
|
|
|
212,631 |
|
Total assets |
|
|
542,428 |
|
|
|
526,322 |
|
Accumulated deficit |
|
|
(499,562 |
) |
|
|
(477,950 |
) |
Total shareholders' equity |
|
|
435,095 |
|
|
|
438,839 |
|
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