Puma Biotechnology, Inc. PBYI reported fourth-quarter 2023 adjusted earnings of 31 cents per share, which missed the Zacks Consensus Estimate of 37 cents. In the year-ago quarter, the company had reported an adjusted loss of 7 cents.
The above-adjusted earnings exclude the impact of stock-based compensation expense. Including the same, reported earnings per share were 26 cents in the fourth quarter of 2023 against a loss of 12 cents reported in the year-ago quarter.
In the fourth quarter, total revenues were $72.2 million, which slightly missed the Zacks Consensus Estimate of $72.8 million.
Revenues, however, increased around 9.9% year over year. Total revenues comprised net product sales of Nerlynx (neratinib), Puma Biotechnology's only marketed drug in the United States, and royalty revenues. Nerlynx is indicated for treating early-stage HER2-positive breast cancer.
Shares of Puma Biotechnology were down 12.4% in after-hours trading on Feb 29 following the announcement of the earnings. The stock has rallied 38.2% in the past year against the industry’s 4.6% decline.
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Quarter in Detail
Product revenues from Nerlynx were $53.2 million in the reported quarter, down 0.9% year over year, as sales were negatively impacted by lower enrollments. Nerlynx’s product sales were lower than the guidance range of $56-$59 million.
Product revenues, however, missed the Zacks Consensus Estimate of $56 million as well as our model estimate of $56.1 million. Product revenues increased 3.1% sequentially.
On the fourth-quarter conference call, management stated that overall demand for Nerlynx declined 12.8% year over year and 3.1% sequentially. Nerlynx total prescriptions decreased year over year and sequentially in the fourth quarter. New prescriptions also declined year over year and sequentially.
Royalty revenues were $19 million, up almost 58.3% from the year-ago quarter. Royalty revenues increased significantly on a sequential basis due to the inventory increase at specialty pharmacies and specialty distributors. Royalty revenues beat our model estimate of $16.4 million.
Puma Biotechnology did not record any license revenues in the fourth quarter.
Total operating costs (including stock-based compensation expense) in the quarter were $57.4 million, up 3.1% year over year.
Selling, general and administrative expenses (including stock-based compensation expense) were down 19.5% year over year to $20.2 million.
Research and development expenses (including stock-based compensation expense) were $12.9 million in the quarter, down 6.5% year over year.
Cash, cash equivalents and marketable securities were $96 million as of Dec 31, 2023, compared with $85 million as of Sep 30, 2023.
Full-Year Results
In 2023, Puma Biotechnology generated total revenues of $235.6 million, which increased 3.3% year over year.
In the same period, the company recorded adjusted earnings of 67 cents per share compared with adjusted earnings of 26 cents in 2022.
2024 Guidance
Puma Biotechnology expects Nerlynx’s product sales in the range of $183-$190 million in 2024. In the first quarter of 2024, Nerlynx product sales are expected in the band of $38-$40 million.
The company’s shares were down, probably because investors were not too impressed with the sales outlook for Nerlynx.
Royalty revenues are expected to be in the $30-$33 million range in 2024. In the first quarter of 2024, royal revenues are expected in the band of $2.5-$3.0 million.
The company expects license revenues to be in the range of $1-$2 million in 2024.
Net income is expected to be in the range of $12-$15 million in 2024.
Pipeline Update
Puma Biotechnology in-licensed the global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda in 2022.
In February 2024, PBYI initiated ALISertib in CAncer (ALISCA-Lung1), a phase II study evaluating its pipeline candidate, alisertib, as a monotherapy for the treatment of patients with extensive stage small cell lung cancer. Interim data from the study is expected in the second half of 2024.
PBYI also plans to study alisertib in HR-positive, HER2-negative breast cancer. The company plans to begin a phase II study on alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer in the fourth quarter of 2024.
The FDA has granted Orphan Drug designation to alisertib for treating patients with small cell lung cancer, an aggressive form of lung cancer.
Puma Biotechnology, Inc. Price, Consensus and EPS Surprise
Puma Biotechnology, Inc. Price, Consensus and EPS Surprise
Puma Biotechnology, Inc. price-consensus-eps-surprise-chart | Puma Biotechnology, Inc. Quote
Zacks Rank & Other Stocks to Consider
Puma Biotechnology currently carries a Zacks Rank #1 (Strong Buy).
Some other top-ranked stocks in the healthcare sector are Indivior PLC INDV Vanda Pharmaceuticals Inc. VNDA and Kiniksa Pharmaceuticals, Ltd. KNSA, each sporting a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Indivior’s 2024 earnings per share have improved from $1.83 to $1.95. In the past year, shares of INDV have risen 17.9%.
Indivior’s earnings beat estimates in each of the trailing three quarters. INDV delivered an average earnings surprise of 48.06%.
In the past 60 days, the Zacks Consensus Estimate for Vanda Pharmaceuticals’ 2024 bottom line has improved from a loss of 46 cents per share to earnings of 1 cent. In the past year, shares of VNDA have plunged 30.5%.
Vanda Pharmaceuticals’ earnings beat estimates in each of the trailing three quarters. VNDA delivered an average earnings surprise of 92.88%.
In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2024 loss per share have narrowed from 53 cents to 11 cents. In the past year, shares of KNSA have risen 68.2%.
Earnings of Kiniksa Pharmaceuticals beat estimates in two of the last four quarters, met the same once while missing the same on the remaining occasion. KNSA delivered a four-quarter average earnings surprise of 53.19%.
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