Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a
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
2022 financial results and recent portfolio execution.
“Kiniksa executed across its cardiovascular and emerging
autoimmune franchises in 2022,” said Sanj K. Patel, Chairman and
Chief Executive Officer of Kiniksa. “Within the cardiovascular
franchise, we are focused on increasing brand awareness of
ARCALYST, the only FDA-approved treatment for recurrent
pericarditis, and pursuing collaborative study agreements for
mavrilimumab in rare cardiovascular diseases. In our emerging
autoimmune franchise, we believe KPL-404, our CD40 antagonist, has
significant potential for differentiation in targeting chronic
autoimmune diseases. We are advancing the Phase 2 trial of KPL-404
in rheumatoid arthritis into the efficacy portion and expect data
in the first half of 2024. Additionally, our profitable ARCALYST
collaboration, non-dilutive capital from strategic out-licensing
transactions, and continued financial discipline support these
efforts while providing cash runway into at least 2025.”
Portfolio ExecutionARCALYST (IL-1α and
IL-1β cytokine trap)
- ARCALYST net product revenue was $39.9 million and $122.5
million for the fourth quarter and full-year 2022,
respectively.
- Since launch, greater than 800 prescribers have written
ARCALYST prescriptions for recurrent pericarditis, with 22% having
written prescriptions for 2 or more patients.
- As of the end of the fourth quarter of 2022, there was a
greater than 90% payer approval rate of completed patient cases for
recurrent pericarditis.
- As of the end of the fourth quarter of 2022, ARCALYST average
total duration of therapy was approximately 18 months after
accounting for the approximately 45% of recurrent pericarditis
patients who had discontinued therapy and restarted treatment.
- ARCALYST average initial duration of therapy remained
approximately 12 months as of the end of the fourth quarter of
2022.
- As of the end of the fourth quarter of 2022, approximately 5%
of the target 14,000 multiple-recurrence pericarditis patients were
actively on ARCALYST treatment.
KPL-404 (monoclonal antibody inhibitor of CD40-CD154
interaction)
- Kiniksa has completed enrollment of the second and final cohort
of the multiple ascending dose portion of the Phase 2 clinical
trial of KPL-404 in rheumatoid arthritis. Following completion of
this portion of the trial, the proof-of-concept portion will begin.
The company expects data from the trial in the first half of
2024.
Mavrilimumab (monoclonal antibody inhibitor targeting
GM-CSFRα)
- Kiniksa is pursuing collaborative study agreements to evaluate
the potential of mavrilimumab in rare cardiovascular diseases where
the granulocyte macrophage colony stimulating factor (GM-CSF)
mechanism has been implicated.
Financial Results
- Total revenue for the fourth quarter of 2022 was $61.9 million,
compared to $18.7 million for the fourth quarter of 2021. Total
revenue for the full-year 2022 was $220.2 million, compared to
$38.5 million for the full-year 2021.
- Total revenue for the fourth quarter of 2022 included $39.9
million in ARCALYST net product revenue and $21.9 million in
license and collaboration revenue from Roche and Genentech, a
member of the Roche Group (Genentech). Kiniksa did not report
license and collaboration revenue in the fourth quarter of
2021.
- Total revenue for the full-year 2022 included $122.5 million in
ARCALYST net product revenue and $97.7 million in license and
collaboration revenue from Hangzhou Zhongmei Huadong Pharmaceutical
Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd
and Genentech. Kiniksa did not report license and collaboration
revenue in 2021.
- Total operating expenses for the fourth quarter of 2022 were
$55.8 million, compared to $54.9 million for the fourth quarter of
2021. Total operating expenses for the full-year 2022 were $210.4
million, compared to $195.2 million for the full-year 2021.
- Total operating expenses for the fourth quarter of 2022
included $6.4 million in non-cash, share-based compensation
expense, compared to $6.1 million for the fourth quarter of
2021.
- Total operating expenses for the full-year 2022 included $25.1
million in non-cash, share-based compensation expense, compared to
$25.2 million for the full-year 2021.
- Net income for the fourth quarter of 2022 was $4.5 million,
compared to a net loss of $36.3 million for the fourth quarter of
2021. Net income for the full-year 2022 was $183.4 million,
compared to a net loss of $157.9 million for the full-year 2021.
- Net income for the full-year 2022 included a $172.3 million tax
benefit primarily due to the release of a valuation allowance on
non-cash deferred tax assets.
- As of December 31, 2022, Kiniksa had $190.6 million of cash,
cash equivalents, and short-term investments and no debt.
Financial Guidance
- Kiniksa expects ARCALYST net product revenue for the full-year
2023 of between $190 million and $205 million.
- Kiniksa expects that its cash and cash equivalents will fund
its current operating plan into at least 2025.
Conference Call Information
- Kiniksa will host a conference call and webcast at 8:30 a.m.
Eastern Time on Tuesday, February 28, 2023, to discuss fourth
quarter and full-year 2022 financial results and to provide a
corporate update.
- 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 biopharmaceutical
company focused on discovering, acquiring, developing, and
commercializing therapeutic medicines for patients suffering from
debilitating diseases with significant unmet medical need.
Kiniksa’s portfolio of immune-modulating assets, ARCALYST, KPL-404,
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 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
designation to ARCALYST for the treatment of pericarditis in 2020.
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 KPL-404KPL-404 is an investigational
humanized monoclonal antibody that is designed to inhibit
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 interaction is an attractive approach to address
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 the development of mavrilimumab
in rare cardiovascular diseases where the GM-CSF mechanism has been
implicated.
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 (i) that the proof-of-concept portion of the Phase 2
clinical trial of KPL-404 in rheumatoid arthritis will begin after
completion of the multiple ascending dose portion of such trial,
and (ii) that we will report data from such trial in the first half
of 2024; our pursuit of collaborative study agreements to evaluate
the potential of mavrilimumab in rare cardiovascular diseases where
the GM-CSF mechanism has been implicated; our expectation that
ARCALYST full-year 2023 net product revenue will be between $190
million and $205 million; our expectation about our cash reserves
funding our current operating plan into at least 2025; our beliefs
about the mechanisms of action of our product candidates and
potential impact of their approach, including (i) that KPL-404 has
significant potential for differentiation in targeting chronic
autoimmune diseases and (ii) that using KPL-404 to disrupt the
CD40-CD154 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 sole manufacturer of
ARCALYST; 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; the
impact of the COVID-19 pandemic and any subsequent pandemic and
measures taken in response to such pandemics on our business and
operations as well as the business and operations of our
manufacturers, CROs upon whom we rely to conduct our clinical
trials, and other third parties with whom we conduct business or
otherwise engage, including the FDA and other regulatory
authorities; changes in our operating plan and 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. 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 |
|
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|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
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|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
39,939 |
|
|
$ |
18,745 |
|
|
$ |
122,524 |
|
$ |
38,544 |
|
|
|
|
License and collaboration revenue |
|
|
21,945 |
|
|
|
— |
|
|
|
97,656 |
|
|
— |
|
|
|
|
|
|
Total revenue |
|
|
61,884 |
|
|
|
18,745 |
|
|
|
220,180 |
|
|
38,544 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
6,710 |
|
|
|
3,867 |
|
|
|
22,895 |
|
|
9,100 |
|
|
|
|
Collaboration expenses |
|
|
7,522 |
|
|
|
835 |
|
|
|
24,071 |
|
|
835 |
|
|
|
|
Research and development |
|
|
14,390 |
|
|
|
27,433 |
|
|
|
65,490 |
|
|
99,297 |
|
|
|
|
Selling, general and administrative |
|
|
27,215 |
|
|
|
22,741 |
|
|
|
97,951 |
|
|
85,948 |
|
|
|
|
|
|
Total operating expenses |
|
|
55,837 |
|
|
|
54,876 |
|
|
|
210,407 |
|
|
195,180 |
|
|
Income (loss) from operations |
|
|
6,047 |
|
|
|
(36,131 |
) |
|
|
9,773 |
|
|
(156,636 |
) |
|
Other income |
|
|
794 |
|
|
|
77 |
|
|
|
1,253 |
|
|
97 |
|
|
Income (loss) before income taxes |
|
|
6,841 |
|
|
|
(36,054 |
) |
|
|
11,026 |
|
|
(156,539 |
) |
|
Benefit (provision) for income taxes |
|
|
(2,380 |
) |
|
|
(279 |
) |
|
|
172,337 |
|
|
(1,385 |
) |
|
Net income (loss) |
|
$ |
4,461 |
|
|
$ |
(36,333 |
) |
|
$ |
183,363 |
|
$ |
(157,924 |
) |
|
Net income (loss) per share attributable to common
shareholders—basic |
$ |
0.06 |
|
|
$ |
(0.53 |
) |
|
$ |
2.64 |
|
$ |
(2.30 |
) |
|
Net income (loss) per share attributable to common
shareholders—diluted |
$ |
0.06 |
|
|
$ |
(0.53 |
) |
|
$ |
2.60 |
|
$ |
(2.30 |
) |
|
Weighted average common shares outstanding—basic |
|
|
69,609,342 |
|
|
|
68,970,730 |
|
|
|
69,382,275 |
|
|
68,576,810 |
|
|
Weighted average common shares outstanding—diluted |
|
|
71,369,394 |
|
|
|
68,970,730 |
|
|
|
70,421,322 |
|
|
68,576,810 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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KINIKSA PHARMACEUTICALS, LTD. |
|
SELECTED CONSOLIDATED BALANCE SHEET DATA |
|
(In thousands) |
|
(Unaudited) |
|
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As of |
|
|
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|
|
|
|
|
|
December 31, |
December 31, |
|
|
|
|
|
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term investments |
|
$ |
190,608 |
|
|
$ |
182,201 |
|
|
|
Working capital |
|
|
195,994 |
|
|
|
151,622 |
|
|
|
Total assets |
|
|
|
459,672 |
|
|
|
232,800 |
|
|
|
Accumulated deficit |
|
|
(492,034 |
) |
|
|
(675,397 |
) |
|
|
Total shareholders' equity |
|
|
396,149 |
|
|
|
185,037 |
|
|
|
|
|
|
|
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