Kiniksa Pharmaceuticals Reports Third Quarter 2023 Financial Results and Recent Portfolio Execution
October 31 2023 - 7:30AM
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 third quarter 2023 financial
results and recent portfolio execution.
“We continue to advance all aspects of our business, including
strong revenue growth with ARCALYST and clinical trial execution
with KPL-404, and we have cash runway into at least 2027,” said
Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. “On
the commercial side, we are building the recurrent pericarditis
market and are focused on helping as many patients as possible. We
are currently tracking to the high end of our previously issued
guidance of $220 million to $230 million in product revenue. Within
our clinical development portfolio, we have completed enrollment in
the third cohort of the Phase 2 trial of KPL-404 in rheumatoid
arthritis. We now expect data from Cohorts 1-3 in the first quarter
of 2024.”
Portfolio ExecutionARCALYST (IL-1α and
IL-1β cytokine trap)
- ARCALYST net product revenue was $64.8 million for the third
quarter of 2023.
- Since launch, more than 1,450 prescribers have written ARCALYST
prescriptions for recurrent pericarditis.
- As of the end of the third quarter of 2023, average total
duration of ARCALYST therapy in recurrent pericarditis was
approximately 20 months.
- Average total duration of therapy includes the approximately
45% of patients who restarted ARCALYST, within an average of 8
weeks, after having discontinued therapy.
KPL-404 (monoclonal antibody inhibitor of CD40-CD154
interaction)
- Kiniksa completed enrollment of the third cohort of the Phase 2
clinical trial of KPL-404 in rheumatoid arthritis. The company now
expects data from Cohorts 1-3 in the first quarter of 2024.
- Kiniksa is currently enrolling a fourth cohort (Cohort 4) of
the Phase 2 clinical trial of KPL-404 in rheumatoid arthritis. The
additional cohort will evaluate a fixed dose level administered as
a single subcutaneous injection once monthly. The company expects
data from Cohort 4 in the second quarter 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
- ARCALYST net product revenue for the third quarter of 2023 was
$64.8 million, compared to $33.4 million for the third quarter of
2022.
- Total revenue for the third quarter of 2023 was $67.0 million,
including $2.2 million in license and collaboration revenue,
compared to total revenue for the third quarter of 2022 of $99.1
million, including $65.7 million in license and collaboration
revenue.
- Total operating expenses for the third quarter of 2023 were
$78.0 million, compared to $52.7 million for the third quarter of
2022.
- Total operating expenses for the third quarter of 2023 included
$17.3 million in collaboration expenses, due to increasing ARCALYST
profitability, compared to $4.6 million for the third quarter of
2022.
- Total operating expenses for the third quarter of 2023 included
$6.8 million in non-cash, share-based compensation expense,
compared to $6.0 million for the third quarter of 2022.
- Net loss for the third quarter of 2023 was $13.9 million,
compared to net income of $224.1 million for the third quarter of
2022.
- As of September 30, 2023, Kiniksa had $201.1 million of cash,
cash equivalents, and short-term investments and no debt.
Financial Guidance
- Kiniksa expects 2023 ARCALYST net product revenue of between
$220 million and $230 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 Tuesday, October 31, 2023, to discuss third quarter
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 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, 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 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 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 that we will report data from cohorts 1-3 of our Phase
2 clinical trial of KPL-404 in rheumatoid arthritis in the first
quarter of 2024 and data from cohort 4 of such trial in the second
quarter of 2024; our expectation that our full-year net product
revenue will be at the high end of our $220 million to $230 million
guidance range; our expectation about our cash reserves funding our
current operating plan into at least 2027; our beliefs about the
mechanisms of action of our product candidates and potential impact
of their approach, including 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 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. |
SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (LOSS) |
(In thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2023 |
|
|
2022 |
|
2023 |
|
|
2022 |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
64,802 |
|
|
$ |
33,424 |
|
$ |
161,956 |
|
|
$ |
82,585 |
License and collaboration revenue |
|
2,244 |
|
|
|
65,711 |
|
|
24,908 |
|
|
|
75,711 |
Total revenue |
|
67,046 |
|
|
|
99,135 |
|
|
186,864 |
|
|
|
158,296 |
Costs and operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
9,088 |
|
|
|
6,937 |
|
|
23,823 |
|
|
|
16,185 |
Collaboration expenses |
|
17,311 |
|
|
|
4,623 |
|
|
39,585 |
|
|
|
16,549 |
Research and development |
|
17,106 |
|
|
|
16,485 |
|
|
56,045 |
|
|
|
51,100 |
Selling, general and administrative |
|
34,468 |
|
|
|
24,677 |
|
|
92,688 |
|
|
|
70,736 |
Total operating expenses |
|
77,973 |
|
|
|
52,722 |
|
|
212,141 |
|
|
|
154,570 |
Income (loss) from operations |
|
(10,927 |
) |
|
|
46,413 |
|
|
(25,277 |
) |
|
|
3,726 |
Other income |
|
2,428 |
|
|
|
322 |
|
|
6,175 |
|
|
|
459 |
Income (loss) before income taxes |
|
(8,499 |
) |
|
|
46,735 |
|
|
(19,102 |
) |
|
|
4,185 |
Benefit (provision) for income taxes |
|
(5,626 |
) |
|
|
177,358 |
|
|
7,679 |
|
|
|
174,717 |
Net income (loss) |
$ |
(14,125 |
) |
|
$ |
224,093 |
|
$ |
(11,423 |
) |
|
$ |
178,902 |
Net income (loss) per share attributable to common
shareholders—basic |
$ |
(0.20 |
) |
|
$ |
3.23 |
|
$ |
(0.16 |
) |
|
$ |
2.58 |
Net income (loss) per share attributable to common
shareholders—diluted |
$ |
(0.20 |
) |
|
$ |
3.18 |
|
$ |
(0.16 |
) |
|
$ |
2.55 |
Weighted average common shares outstanding—basic |
|
70,186,016 |
|
|
|
69,445,071 |
|
|
69,953,591 |
|
|
|
69,305,755 |
Weighted average common shares outstanding—diluted |
|
70,186,016 |
|
|
|
70,552,018 |
|
|
69,953,591 |
|
|
|
70,286,444 |
|
|
|
|
|
|
|
|
|
|
|
|
KINIKSA PHARMACEUTICALS, LTD. |
SELECTED CONSOLIDATED BALANCE SHEET DATA |
(In thousands) |
(Unaudited) |
|
|
|
|
|
As of |
|
September 30, |
December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
Cash, cash equivalents, and short-term investments |
$ |
201,084 |
|
|
$ |
190,608 |
|
Working capital |
|
202,371 |
|
|
|
195,994 |
|
Total assets |
|
482,794 |
|
|
|
459,672 |
|
Accumulated deficit |
|
(503,457 |
) |
|
|
(492,034 |
) |
Total shareholders' equity |
|
404,857 |
|
|
|
396,149 |
|
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