Kiniksa Pharmaceuticals, Ltd. KNSA has been performing well in the last six months, thanks to positive regulatory and pipeline updates.
Shares of the company have gained 14.7% year-to-date against the industry’s decline of 14.8%.
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The company reported a loss of 20 cents per share in the third quarter, which was wider than the Zacks Consensus Estimate of a loss of 18 cents.
However, revenues of $67 million surpassed the Zacks Consensus Estimate of $63 million on the strong revenue growth of Arcalyst.
The company generated net product revenues of $64.8 million from Arcalyst, up 94% year over year.
Arcalyst, a weekly, subcutaneously injected recombinant dimeric fusion protein, blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. The FDA approved it for recurrent pericarditis, cryopyrin-associated periodic syndromes, including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome and deficiency of IL-1 receptor antagonist.
The FDA granted Breakthrough Therapy designation to Arcalyst for the treatment of recurrent pericarditis in 2019. Arcalyst has also enjoys orphan drug exclusivity in the United States since 2021 for the treatment of recurrent pericarditis and the reduction in the risk of recurrence in adults and pediatric patients 12 years and older. Arcalyst also obtained Orphan Drug status in the European Union for the treatment of idiopathic pericarditis.
Management stated that it is currently tracking to the higher end of its previously issued guidance of $220-$230 million in product revenues.
Shares soared in July after the company raised its revenue guidance concurrently with second-quarter results.
The pipeline has been impressive. Kiniksa completed enrollment of the third cohort of the phase II study of KPL-404 in rheumatoid arthritis. Data from the first three cohorts are expected in the first quarter of 2024. Enrollment is ongoing in the fourth cohort.
Kiniksa is pursuing collaborative study agreements to evaluate the potential of mavrilimumab in rare cardiovascular diseases where the granulocyte-macrophage colony-stimulating factor mechanism has been implicated.
We note that Arcalyst was discovered by Regeneron Pharmaceuticals, Inc. REGN. Kiniksa was granted an exclusive license under certain intellectual property rights controlled by Regeneron to develop and commercialize Arcalyst worldwide, excluding the Middle East and North Africa, for all indications other than those in oncology and local administration to the eye or ear.
Regeneron transferred the biologics license application for Arcalyst to the company upon receiving positive phase III data from RHAPSODY study.
Zacks Rank and Other Stocks to Consider
Kiniksa currently has a Zacks Rank #2 (Buy).
A couple of other top-ranked stocks in the overall healthcare sector are Ligand Pharmaceuticals LGND and Dynavax Technologies DVAX. While LGND sports a Zacks Rank #1 (Strong Buy), DVAX carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Earnings estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $4.98 to $5.10 in the past 60 days. During the same period, earnings estimates for 2024 rose from $4.26 to $4.59.
Ligand beat earnings estimates in each of the last four quarters. The company has delivered an earnings surprise of 67.19%, on average.
Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 12 cents for 2023 in the past 30 days. During the same period, earnings estimates for 2024 rose from 3 cents to 18 cents. Shares of DVAX have gained 26.7% year to date.
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