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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13
or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): January 13, 2025
Kiniksa
Pharmaceuticals International, plc
(Exact name of Registrant as Specified in Its
Charter)
England and Wales |
|
001-730430 |
|
98-1795578 |
(State
or other jurisdiction of
incorporation or organization) |
|
(Commission
File Number) |
|
(I.R.S. Employer
Identification No.) |
Kiniksa Pharmaceuticals International, plc
23 Old Bond Street, Floor 3
London, W1S 4PZ
England,
United Kingdom
(781)
431-9100
(Address, zip code and telephone number, including
area code of principal executive offices)
Kiniksa Pharmaceuticals Corp.
100 Hayden Avenue
Lexington, MA, 02421
(781) 431-9100
(Address, zip code and telephone number, including
area code of agent for service)
N/A
(Former Name or Former Address, if Changed Since
Last Report)
Check the appropriate box below
if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following
provisions
¨ | Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which
registered |
Class A
Ordinary Shares $0.000273235 nominal value |
|
KNSA |
|
The
Nasdaq Stock Market LLC |
|
|
|
|
(Nasdaq Global Select Market) |
Indicate by check mark whether the registrant is
an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02. Results of Operations and Financial Condition
On January 13, 2025,
Kiniksa Pharmaceuticals International, plc issued a press release announcing, among other things, that (i) ARCALYST net product revenue was $121.9 million and $416.4 million for the fourth quarter and full year 2024, respectively (unaudited)
and (ii) as of December 31, 2024 it had $243.6 million of cash, cash equivalents and short-term investments (unaudited). A copy of the press
release is furnished with this Current Report on Form 8-K as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC |
|
|
Date: January 13, 2025 |
By: |
/s/ Madelyn Zeylikman |
|
|
Madelyn Zeylikman |
|
|
Senior Vice President, General Counsel and Secretary |
Exhibit 99.1
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Kiniksa
Pharmaceuticals Reports Preliminary 2024 Net Product Revenue and Provides 2025 Net Product Revenue Guidance
–
ARCALYST® (rilonacept) 2024 net product revenue of $416.4 million (unaudited), representing ~79% year-over-year growth
–
–
ARCALYST 2025 net product revenue expected to be $560 - $580 million –
–
Kiniksa expects to remain cash flow positive on an annual basis –
LONDON
– January 13, 2025 –
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 preliminary unaudited
fourth quarter and full year 2024 ARCALYST net product revenue and provided 2025 ARCALYST net product revenue guidance.
“ARCALYST
uptake in recurrent pericarditis continues to grow. As of the end of 2024, approximately 13% of the multiple-recurrence target
population was actively on ARCALYST therapy, driving net product revenue to $416.4 million, representing 79% year-over-year growth.
Importantly, there is still substantial opportunity ahead for Kiniksa to drive further ARCALYST revenue as we continue executing on
our commercial strategy,” said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. “We are also advancing
our clinical portfolio as we work to bring new life-changing therapies to patients with unmet medical needs. Lastly, our robust
financial profile provides the ability to pursue additional value-creating opportunities.”
Commercial
Execution
ARCALYST
(IL-1α and IL-1β cytokine trap)
| · | ARCALYST
net product revenue was $121.9 million and $416.4 million for the fourth quarter and full
year 2024, respectively (unaudited). |
| · | As
of the end of the fourth quarter of 2024, approximately 13% of the target 14,000 multiple-recurrence
patients were actively on ARCALYST treatment. |
| · | Since
launch, more than 2,850 prescribers have written ARCALYST prescriptions for recurrent pericarditis. |
| · | As
of the end of the fourth quarter of 2024, average total duration of ARCALYST therapy in recurrent
pericarditis was approximately 27 months. |
| · | Kiniksa
expects 2025 ARCALYST net product revenue of between $560 million and $580 million. |
Corporate
Update
| · | As
of December 31, 2024, Kiniksa had $243.6 million of cash, cash equivalents, and short-term
investments (unaudited). |
| · | Kiniksa
expects to remain cash flow positive on an annual basis. |
43rd
Annual J.P. Morgan Healthcare Conference
| · | Sanj
K. Patel, Chairman and Chief Executive Officer of Kiniksa, and Ross Moat, Chief Commercial
Officer, will provide a corporate presentation at the 43rd Annual J.P. Morgan
Healthcare Conference on January 13, 2025, at 1:30 p.m. Pacific Time (4:30 p.m. Eastern
Time). A live webcast of Kiniksa’s presentation will be accessible through the Investors &
Media section of the company’s website at www.kiniksa.com. A replay of
the webcast will also be available on Kiniksa’s website within approximately 48 hours
after the event. |
About
Kiniksa
Kiniksa
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 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
ARCALYST
ARCALYST
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 the treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and
children 12 years and older. ARCALYST is also approved by the FDA for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS),
including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older, and
the maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg
or more. The FDA granted Orphan Drug Exclusivity to ARCALYST upon its approval for recurrent pericarditis in 2021. 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.
Forward-Looking
Statements
This
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 2025 net product revenue will be
between $560 million and $580 million; our expectation to remain cash flow positive on an annual basis; our belief that there is
still substantial opportunity ahead for Kiniksa to drive further ARCALYST revenue; our belief that our financial profile provides
the ability to pursue additional value-creating opportunities; our beliefs about the mechanisms of our assets and potential impact
of their approach; 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.
ARCALYST® is
a registered trademark of Regeneron Pharmaceuticals, Inc.
Every
Second Counts! ®
Kiniksa
Investor Contact
Jonathan
Kirshenbaum
(781)
829-3949
jkirshenbaum@kiniksa.com
Kiniksa
Media Contact
Tyler
Gagnon
(781)
431-9100
tgagnon@kiniksa.com
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