On this page of StockholderLetter.com we present the latest annual shareholder letter from Kiniksa Pharmaceuticals, Ltd. — ticker symbol KNSA. Reading current and past KNSA letters to shareholders can bring important insights into the investment thesis.
2024 Annual Report
Vanessa
Living with Recurrent Pericarditis
Dear Fellow Shareholders,
In 2024, Kiniksa continued its positive track record of commercial
and clinical execution, working to improve the lives of patients
suffering from debilitating diseases with unmet need by developing
and commercializing novel therapies.
Recurrent Pericarditis initiative. This multi-year initiative facilitates
knowledge-sharing across a collaborative network of healthcare
providers around the United States and streamlines referral
pathways to a growing number of regional centers of excellence.
Through robust revenue growth and disciplined capital allocation,
Kiniksa has established a strong balance sheet that supports
additional value creation and portfolio development. This financial
strength provides the capacity to continue investing in our specialty
cardiology franchise and to pursue business development
opportunities. The company   s specialty cardiology portfolio is
currently comprised of ARCALYST   (rilonacept), KPL-387, and KPL-1161.
To support additional innovation with ARCALYST, we are also
engaged in an ongoing Phase 2 collaborative study of ARCALYST
in cardiac sarcoidosis being conducted by Mayo Clinic and The
Johns Hopkins University.
ARCALYST
ARCALYST, an interleukin-1 alpha (IL-1  ) and interleukin-1 beta (IL-1  )
cytokine trap, is the only U.S. Food and Drug Administration (FDA)approved therapy for the treatment of recurrent pericarditis and
reduction in risk of recurrence.
Since launching ARCALYST for the treatment of recurrent
pericarditis in April 2021, Kiniksa   s efforts have established ARCALYST
as the standard of care for the disease. In August 2024, data from
our ongoing RESONANCE patient registry were presented at the
European Society of Cardiology Annual Congress. These data
illustrated a shift in prescribing practices among physicians at
leading treatment centers, favoring ARCALYST as the second-line
treatment of choice ahead of corticosteroids.
Importantly, patients and prescribers nationwide continue to
demonstrate a high degree of satisfaction with ARCALYST. Since
launch, more than 2,850 healthcare providers have written
prescriptions for ARCALYST, with approximately 26% having written
multiple prescriptions. Additionally, average total duration of
therapy has grown to approximately 27 months as real-world
prescribing practices move closer to the 3-year median natural
history of recurrent pericarditis.
For the full year 2024, this continued execution drove ARCALYST
revenue to $417.0 million, representing a 79% year-over-year
increase from 2023.
Our commercial organization has succeeded in bringing ARCALYST
to thousands of patients suffering from recurrent pericarditis.
However, we believe there is significant opportunity for continued
growth ahead. As of the end of 2024, only 13% of the approximately
14,000 target patients with multiple recurrences were actively on
ARCALYST treatment. The broad ARCALYST label enables treatment
across every stage of the disease, including the additional 26,000
patients who have experienced one recurrence. Throughout
2024, approximately 15% of ARCALYST prescriptions were written
for patients on their first recurrence, with the remaining 85%
of prescriptions written for patients experiencing two or more
recurrences. Encouragingly, market research continues to show
that providers are utilizing the full breadth of the label to prescribe
early in the course of disease and prevent patients from suffering
unnecessary future flares. We remain committed to further
expanding ARCALYST utilization, and in January 2025, we guided to
a 2025 net product revenue range of $560 to $580 million.
In addition to direct engagement with existing and potential toptier prescribers, we are also advancing several activities aimed at
reaching more patients with recurrent pericarditis. We continue to
emphasize disease education and proactive treatment through
initiatives like our Life DisRPted    campaign with GRAMMY   awardwinning singer-songwriter Carly Pearce and National Hockey
League Hall-of-Famer Henrik Lundqvist. We are also focused
on shortening the patient journey to diagnosis and expanding
access to pericardial disease expertise. Earlier this year, we joined
the American Heart Association in sponsoring the Addressing
As the market leader in recurrent pericarditis, Kiniksa   s commitment
to patients is unwavering. We are leveraging our existing clinical
expertise to explore additional treatment options in cardiovascular
indications, including recurrent pericarditis, that have the potential
to bring transformative benefit to patients.
KPL-387
KPL-387 is a fully human immunoglobulin G2 monoclonal antibody
developed independently by Kiniksa that binds interleukin-1
receptor 1 (IL-1R1), inhibiting the signaling of IL-1   and IL-1  . KPL-387
could provide a meaningful additional therapeutic option to
recurrent pericarditis patients by enabling dosing with a single
monthly subcutaneous injection in a liquid formulation. We plan
to initiate a Phase 2/3 clinical trial in the middle of this year, with
Phase 2 data expected in the second half of 2026.
KPL-1161
KPL-1161 is an Fc-modified monoclonal antibody IL-1 antagonist
developed independently by Kiniksa that binds IL-1R1, with a target
profile of quarterly subcutaneous dosing. We are conducting
Investigational New Drug-enabling activities with the molecule,
focusing on creating additional opportunities within cardiovascular
indications that may be served by a less frequent dosing regimen.
In February 2025, we announced the strategic decision to discontinue
the development of abiprubart in Sj  gren   s Disease. This was
an important capital allocation decision, enabling us to focus
development on debilitating specialty cardiovascular diseases,
where we see greater opportunity to build sustainable value for both
patients and shareholders. We continue to believe in the profile and
differentiation of abiprubart, which has been well-tolerated through
Phase 2 studies, as we look to partner the asset.
Alongside our existing assets, business development remains a
core component of Kiniksa   s strategy. We continue to evaluate
opportunities to expand our portfolio with programs that have strong
biologic rationale and validated mechanisms, particularly those in
specialty cardiology.
Kiniksa continues to maintain a robust balance sheet supported by
our strong commercial performance, prudent capital allocation,
and financial discipline. As a result, we expect our current operating
plan to remain cash flow positive on an annual basis while enabling
continued growth across our business.
Our progress is a direct result of the commitment of Kiniksa   s
employees, and we are well-positioned for 2025 and beyond.
Thank you for your ongoing support.
Every Second Counts!
Sincerely,
Sanj K. Patel
CEO and Chairman of the Board
 • shareholder letter icon 4/21/2025 Letter Continued (Full PDF)
 • stockholder letter icon 4/27/2023 KNSA Stockholder Letter
 • stockholder letter icon 4/23/2024 KNSA Stockholder Letter
 • stockholder letter icon More "Drugs & Pharmaceuticals" Category Stockholder Letters
 • Benford's Law Stocks icon KNSA Benford's Law Stock Score = 68


KNSA Shareholder/Stockholder Letter Transcript:

2024 Annual Report
Vanessa
Living with Recurrent Pericarditis

Dear Fellow Shareholders,
In 2024, Kiniksa continued its positive track record of commercial
and clinical execution, working to improve the lives of patients
suffering from debilitating diseases with unmet need by developing
and commercializing novel therapies.
Recurrent Pericarditis initiative. This multi-year initiative facilitates
knowledge-sharing across a collaborative network of healthcare
providers around the United States and streamlines referral
pathways to a growing number of regional centers of excellence.
Through robust revenue growth and disciplined capital allocation,
Kiniksa has established a strong balance sheet that supports
additional value creation and portfolio development. This financial
strength provides the capacity to continue investing in our specialty
cardiology franchise and to pursue business development
opportunities. The company   s specialty cardiology portfolio is
currently comprised of ARCALYST   (rilonacept), KPL-387, and KPL-1161.
To support additional innovation with ARCALYST, we are also
engaged in an ongoing Phase 2 collaborative study of ARCALYST
in cardiac sarcoidosis being conducted by Mayo Clinic and The
Johns Hopkins University.
ARCALYST
ARCALYST, an interleukin-1 alpha (IL-1  ) and interleukin-1 beta (IL-1  )
cytokine trap, is the only U.S. Food and Drug Administration (FDA)approved therapy for the treatment of recurrent pericarditis and
reduction in risk of recurrence.
Since launching ARCALYST for the treatment of recurrent
pericarditis in April 2021, Kiniksa   s efforts have established ARCALYST
as the standard of care for the disease. In August 2024, data from
our ongoing RESONANCE patient registry were presented at the
European Society of Cardiology Annual Congress. These data
illustrated a shift in prescribing practices among physicians at
leading treatment centers, favoring ARCALYST as the second-line
treatment of choice ahead of corticosteroids.
Importantly, patients and prescribers nationwide continue to
demonstrate a high degree of satisfaction with ARCALYST. Since
launch, more than 2,850 healthcare providers have written
prescriptions for ARCALYST, with approximately 26% having written
multiple prescriptions. Additionally, average total duration of
therapy has grown to approximately 27 months as real-world
prescribing practices move closer to the 3-year median natural
history of recurrent pericarditis.
For the full year 2024, this continued execution drove ARCALYST
revenue to $417.0 million, representing a 79% year-over-year
increase from 2023.
Our commercial organization has succeeded in bringing ARCALYST
to thousands of patients suffering from recurrent pericarditis.
However, we believe there is significant opportunity for continued
growth ahead. As of the end of 2024, only 13% of the approximately
14,000 target patients with multiple recurrences were actively on
ARCALYST treatment. The broad ARCALYST label enables treatment
across every stage of the disease, including the additional 26,000
patients who have experienced one recurrence. Throughout
2024, approximately 15% of ARCALYST prescriptions were written
for patients on their first recurrence, with the remaining 85%
of prescriptions written for patients experiencing two or more
recurrences. Encouragingly, market research continues to show
that providers are utilizing the full breadth of the label to prescribe
early in the course of disease and prevent patients from suffering
unnecessary future flares. We remain committed to further
expanding ARCALYST utilization, and in January 2025, we guided to
a 2025 net product revenue range of $560 to $580 million.
In addition to direct engagement with existing and potential toptier prescribers, we are also advancing several activities aimed at
reaching more patients with recurrent pericarditis. We continue to
emphasize disease education and proactive treatment through
initiatives like our Life DisRPted    campaign with GRAMMY   awardwinning singer-songwriter Carly Pearce and National Hockey
League Hall-of-Famer Henrik Lundqvist. We are also focused
on shortening the patient journey to diagnosis and expanding
access to pericardial disease expertise. Earlier this year, we joined
the American Heart Association in sponsoring the Addressing
As the market leader in recurrent pericarditis, Kiniksa   s commitment
to patients is unwavering. We are leveraging our existing clinical
expertise to explore additional treatment options in cardiovascular
indications, including recurrent pericarditis, that have the potential
to bring transformative benefit to patients.
KPL-387
KPL-387 is a fully human immunoglobulin G2 monoclonal antibody
developed independently by Kiniksa that binds interleukin-1
receptor 1 (IL-1R1), inhibiting the signaling of IL-1   and IL-1  . KPL-387
could provide a meaningful additional therapeutic option to
recurrent pericarditis patients by enabling dosing with a single
monthly subcutaneous injection in a liquid formulation. We plan
to initiate a Phase 2/3 clinical trial in the middle of this year, with
Phase 2 data expected in the second half of 2026.
KPL-1161
KPL-1161 is an Fc-modified monoclonal antibody IL-1 antagonist
developed independently by Kiniksa that binds IL-1R1, with a target
profile of quarterly subcutaneous dosing. We are conducting
Investigational New Drug-enabling activities with the molecule,
focusing on creating additional opportunities within cardiovascular
indications that may be served by a less frequent dosing regimen.
In February 2025, we announced the strategic decision to discontinue
the development of abiprubart in Sj  gren   s Disease. This was
an important capital allocation decision, enabling us to focus
development on debilitating specialty cardiovascular diseases,
where we see greater opportunity to build sustainable value for both
patients and shareholders. We continue to believe in the profile and
differentiation of abiprubart, which has been well-tolerated through
Phase 2 studies, as we look to partner the asset.
Alongside our existing assets, business development remains a
core component of Kiniksa   s strategy. We continue to evaluate
opportunities to expand our portfolio with programs that have strong
biologic rationale and validated mechanisms, particularly those in
specialty cardiology.
Kiniksa continues to maintain a robust balance sheet supported by
our strong commercial performance, prudent capital allocation,
and financial discipline. As a result, we expect our current operating
plan to remain cash flow positive on an annual basis while enabling
continued growth across our business.
Our progress is a direct result of the commitment of Kiniksa   s
employees, and we are well-positioned for 2025 and beyond.
Thank you for your ongoing support.
Every Second Counts!
Sincerely,
Sanj K. Patel
CEO and Chairman of the Board



shareholder letter icon 4/21/2025 Letter Continued (Full PDF)
 

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