Puma Biotechnology, Inc. PBYI reported first-quarter 2024 adjusted lack of 5 cents per share, which was narrower than the Zacks Consensus Estimate of a lack of 16 cents. Within the year-ago quarter, the corporate had reported adjusted earnings of 9 cents.
The above-adjusted loss excludes the influence of stock-based compensation expense. Together with the identical, reported loss per share was 10 cents within the first quarter of 2024 in opposition to earnings of three cents reported within the year-ago quarter.
Within the first quarter, whole revenues had been $43.8 million, which beat the Zacks Consensus Estimate of $42 million.
Revenues, nonetheless, decreased round 17% yr over yr. Whole revenues comprised web product gross sales of Nerlynx (neratinib), Puma Biotechnology’s solely marketed drug in america, and royalty revenues. Nerlynx is indicated for treating early-stage HER2-positive breast most cancers.
Shares of Puma Biotechnology have rallied 14.6% up to now this yr in opposition to the trade’s 8.8% decline.
Quarter in Element
Product revenues from Nerlynx had been $40.3 million within the reported quarter, down 13.9% yr over yr, as gross sales had been negatively impacted by stock drawdown at specialty pharmacies and specialty distributors. Nonetheless, Nerlynx’s product gross sales had been larger than the steerage vary of $38-$40 million.
Product revenues additionally beat the Zacks Consensus Estimate of $38.6 million, in addition to our mannequin estimate of $38.5 million. Nerlynx revenues decreased 24.2% sequentially.
On the first-quarter convention name, administration acknowledged that total demand for Nerlynx declined round 18% yr over yr and eight% sequentially. Nerlynx whole prescriptions decreased 16% yr over yr and three% sequentially within the first quarter. New prescriptions elevated 27% sequentially however declined 15% yr over yr.
Royalty revenues had been $3.5 million, down nearly 41.7% from the year-ago quarter. Royalty revenues decreased 81.5% on a sequential foundation as a result of timing of shipments to PBYI’s companion in China. Royalty revenues beat our mannequin estimate of $2.9 million.
Puma Biotechnology didn’t report any license revenues within the first quarter.
Whole working prices (together with stock-based compensation expense) within the quarter had been $46.1 million, down 4.8% yr over yr.
Promoting, normal and administrative bills (together with stock-based compensation expense) had been down 3.1% yr over yr to $21.8 million.
Analysis and growth bills (together with stock-based compensation expense) had been $13.6 million within the quarter, up 7.1% yr over yr.
Money, money equivalents and marketable securities had been $107.2 million as of Mar 31, 2024, in contrast with $96 million as of Dec 31, 2023.
2024 Steering
Puma Biotechnology expects Nerlynx’s product gross sales to be within the vary of $183-$190 million in 2024, unchanged from the earlier steerage vary. Within the second quarter of 2024, Nerlynx product gross sales are anticipated within the band of $43-$45 million.
Royalty revenues are anticipated to be within the $30-$33 million vary in 2024, additionally unchanged from the earlier steerage vary. Within the second quarter of 2024, royal revenues are anticipated within the band of $2.5-$3.0 million.
The corporate expects license revenues to be within the vary of $1-$2 million in 2024.
Web earnings is anticipated to be within the vary of $12-$15 million in 2024. PBYI expects to report web loss within the vary of $6-$9 million within the second quarter of 2024.
Pipeline Replace
Puma Biotechnology in-licensed the worldwide growth and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda in 2022.
In March 2024, the FDA notified the corporate that its investigational new drug utility has been reviewed and that it will possibly proceed with the scientific growth of alisertib for the therapy of sufferers with human epidermal development issue receptor 2-negative, hormone receptor-positive metastatic breast most cancers within the section II ALISCA-Breast1 trial examine. The examine is more likely to be initiated within the fourth quarter of 2024.
PBYI is already conducting ALISCA-Lung1, a section II examine (PUMA-ALI-4201) evaluating alisertib as monotherapy for the therapy of sufferers with in depth stage small cell lung most cancers. Interim information from the examine is anticipated within the fourth quarter of 2024.
In the meantime, alisertib can also be being studied together with Tagrisso (osimertinib) in sufferers with metastatic EGFR-mutant non-small cell lung most cancers who’ve developed Tagrisso resistance. Up to date information from this examine is anticipated later within the second quarter of 2024.
Zacks Rank & Shares to Contemplate
Puma Biotechnology at the moment has a Zacks Rank #3 (Maintain).
Some top-ranked shares within the healthcare sector are Voyager Therapeutics, Inc. VYGR, Ligand Prescription drugs Included LGND and ANI Prescription drugs, Inc. ANIP, every sporting a Zacks Rank #1 (Robust Purchase) at current.
Prior to now 60 days, estimates for Voyager Therapeutics’ 2024 loss per share have narrowed from $1.89 to $1.64. 12 months up to now, shares of VYGR have elevated 1.1%.
VYGR’s earnings beat estimates in three of the trailing 4 quarters and missed the identical as soon as, the common shock being 545.93%.
Prior to now 60 days, estimates for Ligand’s 2024 earnings per share have improved from $4.42 to $4.56. 12 months up to now, shares of LGND have risen 1.3%.
Earnings of LGND beat estimates in every of the trailing 4 quarters, the common shock being 84.81%.
Prior to now 60 days, estimates for ANI Prescription drugs’ 2024 earnings per share have improved from $4.25 to $4.44. 12 months up to now, shares of ANIP have jumped 21.7%.
Earnings of ANIP beat estimates in every of the trailing 4 quarters, the common shock being 109.06%.
