Full Press Release Details
Kiniksa Pharmaceuticals
Reports Second Quarter 2024 Financial Results and Recent Portfolio Execution
(rilonacept) Q2 2024 net product revenue of $103.4 million, representing 90% year-over-year growth -
2024 expected net product revenue increased to $405 - $415 million -
clinical development fully funded; Phase 2b clinical trial in Sj gren's Disease enrolling patients -
expects to remain cash flow positive on an annual basis -
call and webcast scheduled for 8:30 am ET today -
- July 23, 2024 - 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 Sj gren'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 Sj gren's Disease is fully funded in our current operating plan, and we expect to remain
cash flow positive on an annual basis."
ARCALYST (IL-1 and IL-1
| 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)
| - | 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. |
| 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. |
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, 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.
is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1 ) and interleukin-1
beta (IL-1 ) 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.
SAFETY INFORMATION ABOUT ARCALYST
more information about ARCALYST, talk to your doctor and see the Product Information.
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 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 2024 net product revenue
will be between $405 million and $415 million; our expectation that clinical development of abiprubart in Sj gren'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 Contact
KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC
(FORMERLY KNOWN AS KINIKSA PHARMACEUTICALS, LTD.)
SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
| 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 |
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Cost of goods sold | $ | 353 | $ | 311 | $ | 712 | $ | 597 | ||||||||
| Research and development expenses | 1,501 | 1,395 | 2,954 | 2,839 | ||||||||||||
| Selling, general and administrative expenses | 5,509 | 4,767 | 10,903 | 9,152 | ||||||||||||
| $ | 7,363 | $ | 6,473 | $ | 14,569 | $ | 12,588 |
KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC
(FORMERLY KNOWN AS KINIKSA PHARMACEUTICALS, LTD.)
SELECTED CONSOLIDATED BALANCE SHEET DATA
| 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 |