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Puma Biotech (PBYI) Q3 Earnings Top, Nerlynx Sales View Up
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Puma Biotechnology (PBYI - Free Report) reported third-quarter 2022 loss of 1 cent per share, beating the Zacks Consensus Estimate of a loss of 11 cents per share. In the year-ago quarter, the company had reported a loss of $1.09 per share.
In the third quarter, total revenues were $57.1 million, beating the Zacks Consensus Estimate of $51 million.
Revenues were up 23.5% year over year, driven by commercial revenues and royalties from Nerlynx
Total revenues comprised net product sales of Nerlynx (neratinib), Puma Biotech's only marketed drug in the United States, and license fees and royalty revenues from PBYI’s sub-licensees. Nerlynx is indicated for treating early-stage HER2-positive breast cancer.
Quarter in Detail
Product revenues from Nerlynx were $54.3 million in the third quarter, up 25.1% year over year, driven by improved demand trends. Nerlynx’s product revenues were much better than management’s guidance of $44 million-$47 million.
Royalty revenues were $2.8 million in the quarter, same as the year-ago quarter. Puma Biotech did not record any license revenues in the third quarter.
Total operating costs in the quarter were $54.7 million, up 0.9% year over year. Research and development expenses were $11.2 million in the quarter, down 40% year over year, primarily due to a decline in clinical trial expenses. Selling, general and administrative expenses fell 8% year over year to $24.0 million due to lower professional fees and expenses.
2022 Guidance
Puma Biotech raised Nerlynx’s product sales guidance range to $194-$196 million from $180-$190 million to reflect improving demand trends for the drug in the United States.
Puma Biotechnology’s shares were up 10.8% after-market on Nov 3 due to the better-than-expected Nerlynx sales in the quarter and the guidance increase. Puma Biotech’s shares have declined 31% this year compared with the industry’s 22.3% decrease.
Image Source: Zacks Investment Research
However, the company lowered its royalty revenue expectations and now expects the same to be in the $25-$27 million range, down from the previous guidance of $27-$30 million. Net income is expected to be in the range of $7-$9 million in 2022 compared with $6-$10 million.
Pipeline Update
Several additional studies on Nerlynx targeting different types of breast cancer patient populations and other types of cancers are currently underway.
A key analysis of Nerlynx is the phase II SUMMIT basket study for treating solid tumors in patients with activating EGFR, HER2 or HER4 mutated cancers. Data from a cohort of the SUMMIT study, which evaluated a combination of neratinib, fulvestrant and trastuzumab in patients with HR-positive, HER-negative, HER2-mutant metastatic breast cancer, showed that the combination achieved an objective response rate of 35.3% at a median progression-free survival of 8.2 months. Puma plans to hold a pre-NDA meeting with the FDA in the first half of 2023 to discuss these results and intends to seek approval in this indication under the accelerated pathway.
The company plans to report data from another cohort of the SUMMIT study evaluating Nerlynx in non-small cell lung cancer patients with EGFR exon 18 mutations and hold a pre-NDA meeting with the FDA to discuss the potential for an accelerated approval pathway for this indication in the first half of 2023.
Later this year, Puma Biotech plans to release results from two cohorts of the phase II TBCRC-022 study on Nerlynx in combination with Roche’s Kadcyla in patients with HER2-positive breast cancer with brain metastases, previously treated with Kadcyla.
In September, Puma Biotech in-licensed global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda. Puma Biotech plans to develop alisertib for the treatment of hormone receptor-positive breast cancer as well as small-cell lung cancer.
Zacks Rank & Other Stocks to Consider
Puma Biotech currently has a Zacks Rank #1 (Strong Buy).
Estimates for Dr. Reddy's earnings per share have risen from $2.65 to $3.09 for fiscal 2023 and from $3.03 to $3.47 for fiscal 2024 in the past 60 days. Shares of Dr. Reddy's have plunged 14.6% in the year-to-date period.
In the last reported quarter, Dr. Reddy's delivered an earnings surprise of 38.98%.
Vertex’s stock has risen 34.4% this year so far. While estimates for Vertex’s 2022 earnings have risen from $14.21 to $14.61 per share in the past 60 days, estimates for 2023 have increased from $15.12 to $15.60 per share during the same period.
Vertex beat earnings estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 3.16%. In the last reported quarter, VRTX delivered an earnings surprise of 8.67%.
Gilead’s stock has risen 9.5% this year so far. While estimates for Gilead’s 2022 earnings have risen from $6.61 to $7.02 per share in the past 60 days, estimates for 2023 have increased from $6.32 to $6.79 per share during the same period.
Gilead beat earnings estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 0.36%. In the last reported quarter, GILD delivered an earnings surprise of 31.94%.
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Puma Biotech (PBYI) Q3 Earnings Top, Nerlynx Sales View Up
Puma Biotechnology (PBYI - Free Report) reported third-quarter 2022 loss of 1 cent per share, beating the Zacks Consensus Estimate of a loss of 11 cents per share. In the year-ago quarter, the company had reported a loss of $1.09 per share.
In the third quarter, total revenues were $57.1 million, beating the Zacks Consensus Estimate of $51 million.
Revenues were up 23.5% year over year, driven by commercial revenues and royalties from Nerlynx
Total revenues comprised net product sales of Nerlynx (neratinib), Puma Biotech's only marketed drug in the United States, and license fees and royalty revenues from PBYI’s sub-licensees. Nerlynx is indicated for treating early-stage HER2-positive breast cancer.
Quarter in Detail
Product revenues from Nerlynx were $54.3 million in the third quarter, up 25.1% year over year, driven by improved demand trends. Nerlynx’s product revenues were much better than management’s guidance of $44 million-$47 million.
Royalty revenues were $2.8 million in the quarter, same as the year-ago quarter. Puma Biotech did not record any license revenues in the third quarter.
Total operating costs in the quarter were $54.7 million, up 0.9% year over year. Research and development expenses were $11.2 million in the quarter, down 40% year over year, primarily due to a decline in clinical trial expenses. Selling, general and administrative expenses fell 8% year over year to $24.0 million due to lower professional fees and expenses.
2022 Guidance
Puma Biotech raised Nerlynx’s product sales guidance range to $194-$196 million from $180-$190 million to reflect improving demand trends for the drug in the United States.
Puma Biotechnology’s shares were up 10.8% after-market on Nov 3 due to the better-than-expected Nerlynx sales in the quarter and the guidance increase. Puma Biotech’s shares have declined 31% this year compared with the industry’s 22.3% decrease.
Image Source: Zacks Investment Research
However, the company lowered its royalty revenue expectations and now expects the same to be in the $25-$27 million range, down from the previous guidance of $27-$30 million. Net income is expected to be in the range of $7-$9 million in 2022 compared with $6-$10 million.
Pipeline Update
Several additional studies on Nerlynx targeting different types of breast cancer patient populations and other types of cancers are currently underway.
A key analysis of Nerlynx is the phase II SUMMIT basket study for treating solid tumors in patients with activating EGFR, HER2 or HER4 mutated cancers. Data from a cohort of the SUMMIT study, which evaluated a combination of neratinib, fulvestrant and trastuzumab in patients with HR-positive, HER-negative, HER2-mutant metastatic breast cancer, showed that the combination achieved an objective response rate of 35.3% at a median progression-free survival of 8.2 months. Puma plans to hold a pre-NDA meeting with the FDA in the first half of 2023 to discuss these results and intends to seek approval in this indication under the accelerated pathway.
The company plans to report data from another cohort of the SUMMIT study evaluating Nerlynx in non-small cell lung cancer patients with EGFR exon 18 mutations and hold a pre-NDA meeting with the FDA to discuss the potential for an accelerated approval pathway for this indication in the first half of 2023.
Later this year, Puma Biotech plans to release results from two cohorts of the phase II TBCRC-022 study on Nerlynx in combination with Roche’s Kadcyla in patients with HER2-positive breast cancer with brain metastases, previously treated with Kadcyla.
In September, Puma Biotech in-licensed global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda. Puma Biotech plans to develop alisertib for the treatment of hormone receptor-positive breast cancer as well as small-cell lung cancer.
Zacks Rank & Other Stocks to Consider
Puma Biotech currently has a Zacks Rank #1 (Strong Buy).
Some other top-ranked generic/biotech stocks are Dr. Reddy's Laboratories Limited (RDY - Free Report) , Vertex Pharmaceuticals Incorporated (VRTX - Free Report) and Gilead Sciences (GILD - Free Report) , each of which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Dr. Reddy's earnings per share have risen from $2.65 to $3.09 for fiscal 2023 and from $3.03 to $3.47 for fiscal 2024 in the past 60 days. Shares of Dr. Reddy's have plunged 14.6% in the year-to-date period.
In the last reported quarter, Dr. Reddy's delivered an earnings surprise of 38.98%.
Vertex’s stock has risen 34.4% this year so far. While estimates for Vertex’s 2022 earnings have risen from $14.21 to $14.61 per share in the past 60 days, estimates for 2023 have increased from $15.12 to $15.60 per share during the same period.
Vertex beat earnings estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 3.16%. In the last reported quarter, VRTX delivered an earnings surprise of 8.67%.
Gilead’s stock has risen 9.5% this year so far. While estimates for Gilead’s 2022 earnings have risen from $6.61 to $7.02 per share in the past 60 days, estimates for 2023 have increased from $6.32 to $6.79 per share during the same period.
Gilead beat earnings estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 0.36%. In the last reported quarter, GILD delivered an earnings surprise of 31.94%.