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Deciphera Pharmaceuticals, Inc. (DCPH - Free Report) reported third-quarter 2023 loss of 58 cents per share, narrower than the Zacks Consensus Estimate of a loss of 60 cents. In the year-ago quarter, DCPH had incurred a loss of 55 cents per share.
Net revenues were $43.3 million, which beat the Zacks Consensus Estimate of $40 million. The figure rose almost 20.4% year over year.
Deciphera’s stock gained 17.5% on Oct 30 and 3.7% in the after-hours, as the company reported better-than-expected results. Year to date, shares of the company have lost 27.2% compared with the industry’s 25.4% fall.
Image Source: Zacks Investment Research
Quarter in Detail
Total revenues comprise net product revenues and collaboration revenues for Qinlock (ripretinib).
Deciphera’s sole marketed drug, Qinlock, was approved by the FDA in 2020 to treat adult patients with advanced gastrointestinal stromal tumors (GIST), who received prior treatment with three or more kinase inhibitors, including Novartis’ Gleevec (imatinib). Qinlock was approved in Europe in late 2021. Apart from Qinlock, there is no marketed drug in the company’s portfolio.
Net product revenues from Qinlock sales were $41.8 million, up 29% year over year. The drug generated sales of $32.7 million and $9.1 million in the United States and ex-U.S. markets, respectively.
Qinlock’s net product revenues beat the Zacks Consensus Estimate of $38.5 million and our model estimate of $37.8 million.
Collaboration revenues totaled $1.5 million, down 59% year-over-year which beat the Zacks Consensus Estimate of $1.33 million but missed our model estimate of $1.6 million.
Research and development expenses (including stock-based compensation) amounted to $62.5 million, up 31.6% year over year, owing to costs related to clinical studies on DCC-3116 and Qinlock.
Selling, general and administrative expenses (including stock-based compensation) totaled $33.3 million, up 11% year over year, owing to increased professional fees, personnel-related costs and consultant fees.
Deciphera had cash, cash equivalents and investments worth $376.9 million as of Sep 30, 2023, compared with $389.4 million as of Jun 30, 2023. The company expects its current cash balance, together with the anticipated product, royalty and supply revenues, excluding any potential future milestone payments under its collaboration or license agreements, to fund its operating and capital expenditures into 2026.
Other Updates
Deciphera is working to expand the label of Qinlock for the larger commercial opportunity in GIST.
During the third quarter, the company reported initiating its phase III INSIGHT study evaluating Qinlock versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18.
Along with the third-quarter earnings release, Deciphera reported positive top-line results from its pivotal phase III MOTION study of vimseltinib for the potential treatment of tenosynovial giant cell tumor (TGCT). Vimseltinib is the company’s investigational, orally-administered CSF1R inhibitor.
Per the data readout, the MOTION study met its primary endpoint of statistically significant and clinically meaningful improvements in objective response rate (ORR) at week 25 compared with placebo in the intent-to-treat (ITT) population. In the ITT population, it was observed that the ORR at week 25 was 40% for patients treated with vimseltinib as compared with 0% in the placebo arm.
Deciphera also reported achieving all key secondary endpoints in the MOTION study with statistical significance and clinically meaningful improvement compared with placebo. The drug was overall well-tolerated in patients with TGCT, with a safety profile consistent with previously disclosed data. Furthermore, treatment with vimseltinib showed no evidence of cholestatic hepatotoxicity.
The company expects to submit regulatory applications for vimseltinib in the TGCT indication in the United States and EU in the second quarter of 2024 and the third quarter of 2024, respectively.
DCPH, in collaboration with Pfizer, Inc. (PFE - Free Report) , is evaluating DCC-3116 in combination with Qinlock in patients with GIST and in combination with encorafenib and cetuximab in patients with colorectal cancer. Per the terms of the agreement with Pfizer, Deciphera will bear the cost of the study while Pfizer will supply encorafenib free of cost. Additionally, the company is also currently evaluating DCC-3116, in an early-mid-stage study, in combination with trametinib, binimetinib and sotorasib in patients with advanced solid tumors.
Enrollment is currently ongoing in all these combination escalation cohorts evaluating DCC-3116 in combination with binimetinib, trametinib, sotorasib, encorafenib/cetuximab and Qinlock to recommend phase II combination dose for potential expansion cohorts.
Deciphera Pharmaceuticals, Inc. Price and Consensus
Deciphera currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the same industry are Anixa Biosciences (ANIX - Free Report) and Adicet Bio, Inc. (ACET - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
In the past 30 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has remained constant at 32 cents. The estimate for Anixa Biosciences’ 2024 loss per share has remained constant at 37 cents. Year to date, shares of ANIX have lost 24.9%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 26.29%.
In the past 30 days, the estimate for Adicet Bio’s 2023 loss per share has remained constant at $2.93. The estimate for Adicet’s 2024 loss per share has remained constant at $2.40. Year to date, shares of ACET have fallen 85.3%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 7.70%.
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Deciphera (DCPH) Stock Gains 17% on Q3 Earnings & Sales Beat
Deciphera Pharmaceuticals, Inc. (DCPH - Free Report) reported third-quarter 2023 loss of 58 cents per share, narrower than the Zacks Consensus Estimate of a loss of 60 cents. In the year-ago quarter, DCPH had incurred a loss of 55 cents per share.
Net revenues were $43.3 million, which beat the Zacks Consensus Estimate of $40 million. The figure rose almost 20.4% year over year.
Deciphera’s stock gained 17.5% on Oct 30 and 3.7% in the after-hours, as the company reported better-than-expected results. Year to date, shares of the company have lost 27.2% compared with the industry’s 25.4% fall.
Image Source: Zacks Investment Research
Quarter in Detail
Total revenues comprise net product revenues and collaboration revenues for Qinlock (ripretinib).
Deciphera’s sole marketed drug, Qinlock, was approved by the FDA in 2020 to treat adult patients with advanced gastrointestinal stromal tumors (GIST), who received prior treatment with three or more kinase inhibitors, including Novartis’ Gleevec (imatinib). Qinlock was approved in Europe in late 2021. Apart from Qinlock, there is no marketed drug in the company’s portfolio.
Net product revenues from Qinlock sales were $41.8 million, up 29% year over year. The drug generated sales of $32.7 million and $9.1 million in the United States and ex-U.S. markets, respectively.
Qinlock’s net product revenues beat the Zacks Consensus Estimate of $38.5 million and our model estimate of $37.8 million.
Collaboration revenues totaled $1.5 million, down 59% year-over-year which beat the Zacks Consensus Estimate of $1.33 million but missed our model estimate of $1.6 million.
Research and development expenses (including stock-based compensation) amounted to $62.5 million, up 31.6% year over year, owing to costs related to clinical studies on DCC-3116 and Qinlock.
Selling, general and administrative expenses (including stock-based compensation) totaled $33.3 million, up 11% year over year, owing to increased professional fees, personnel-related costs and consultant fees.
Deciphera had cash, cash equivalents and investments worth $376.9 million as of Sep 30, 2023, compared with $389.4 million as of Jun 30, 2023. The company expects its current cash balance, together with the anticipated product, royalty and supply revenues, excluding any potential future milestone payments under its collaboration or license agreements, to fund its operating and capital expenditures into 2026.
Other Updates
Deciphera is working to expand the label of Qinlock for the larger commercial opportunity in GIST.
During the third quarter, the company reported initiating its phase III INSIGHT study evaluating Qinlock versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18.
Along with the third-quarter earnings release, Deciphera reported positive top-line results from its pivotal phase III MOTION study of vimseltinib for the potential treatment of tenosynovial giant cell tumor (TGCT). Vimseltinib is the company’s investigational, orally-administered CSF1R inhibitor.
Per the data readout, the MOTION study met its primary endpoint of statistically significant and clinically meaningful improvements in objective response rate (ORR) at week 25 compared with placebo in the intent-to-treat (ITT) population. In the ITT population, it was observed that the ORR at week 25 was 40% for patients treated with vimseltinib as compared with 0% in the placebo arm.
Deciphera also reported achieving all key secondary endpoints in the MOTION study with statistical significance and clinically meaningful improvement compared with placebo. The drug was overall well-tolerated in patients with TGCT, with a safety profile consistent with previously disclosed data. Furthermore, treatment with vimseltinib showed no evidence of cholestatic hepatotoxicity.
The company expects to submit regulatory applications for vimseltinib in the TGCT indication in the United States and EU in the second quarter of 2024 and the third quarter of 2024, respectively.
DCPH, in collaboration with Pfizer, Inc. (PFE - Free Report) , is evaluating DCC-3116 in combination with Qinlock in patients with GIST and in combination with encorafenib and cetuximab in patients with colorectal cancer. Per the terms of the agreement with Pfizer, Deciphera will bear the cost of the study while Pfizer will supply encorafenib free of cost. Additionally, the company is also currently evaluating DCC-3116, in an early-mid-stage study, in combination with trametinib, binimetinib and sotorasib in patients with advanced solid tumors.
Enrollment is currently ongoing in all these combination escalation cohorts evaluating DCC-3116 in combination with binimetinib, trametinib, sotorasib, encorafenib/cetuximab and Qinlock to recommend phase II combination dose for potential expansion cohorts.
Deciphera Pharmaceuticals, Inc. Price and Consensus
Deciphera Pharmaceuticals, Inc. price-consensus-chart | Deciphera Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Deciphera currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the same industry are Anixa Biosciences (ANIX - Free Report) and Adicet Bio, Inc. (ACET - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has remained constant at 32 cents. The estimate for Anixa Biosciences’ 2024 loss per share has remained constant at 37 cents. Year to date, shares of ANIX have lost 24.9%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 26.29%.
In the past 30 days, the estimate for Adicet Bio’s 2023 loss per share has remained constant at $2.93. The estimate for Adicet’s 2024 loss per share has remained constant at $2.40. Year to date, shares of ACET have fallen 85.3%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 7.70%.