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Agios' (AGIO) Q3 Loss Wider Than Expected, Revenues Miss
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Agios Pharmaceuticals, Inc. (AGIO - Free Report) reported third-quarter 2020 loss of $1.43 per share, wider than the Zacks Consensus Estimate of a loss of $1.40 but narrower than the year-ago loss of $1.81.
Total revenues of $34.7 million in the reported quarter missed the Zacks Consensus Estimate of $36 million. However, the top line grew 33.4% year over year owing to increased sales of the company’s leukemia drug Tibsovo (ivosidenib).
Tibsovo generated sales of $31.7 million in the third quarter, reflecting a sequential increase of 15% on higher demand for the drug. On the third-quarter conference call, management stated that it continues to see a steady rise in physician preference for Tibsovo, both with respect to the newly-diagnosed as well as the relapsed and refractory acute myeloid leukemia (AML) setting.
Agios raised the lower end of 2020 guidance for Tibsovo sales to the $113-115 million range from the earlier projection of $105-115 million.
Tibsovo was approved for treating adult patients suffering relapsed or refractory AML with IDH-1 mutation in July 2018. The FDA approved Tibsovo for the frontline setting in May 2019.
Shares of Agios were up 1.4% following the earnings announcement on Thursday. However, the stock has declined 11.9% so far this year compared with the industry’s decrease of 1.8%.
Quarter in Detail
Royalty revenues earned from Celgene, now part of Bristol-Myers (BMY - Free Report) , were $0.7 million on Idhifa (enasidenib) net sales in the reported quarter.
Collaboration revenues were $2.3 million in the quarter compared with $5.9 million in the year-ago quarter. Per the company, this downside was due to completion of the research and development service obligation with Celgene in the second quarter of 2020 and adjustment in sales reserves taken by Bristol Myers during the third quarter.
Notably, in March 2020, Agios announced that Celgene refused to extend the metabolic immuno-oncology research collaboration with it.
Research & development expenses declined 11.9% year over year to $89.6 million due to ramped-down activity of clinical studies for Tibsovo.
Selling general and administrative expenses increased 5.4% year over year to $34.8 million on account of higher personnel costs.
Agios ended the third quarter with cash, cash equivalents and marketable securities of $722.4 million, higher than the sequential quarter’s $613.1 million. The company expects this cash balance and revenues recognized from Tibsovo and royalties to effectively fund its current operational plans for at least through the end of 2022.
Tibsovo and Other Pipeline Updates
Last month, Agios withdrew the marketing authorization application (MAA) for Tibsovo to address IDH1-mutant relapsed/refractory AML in Europe owing to an unfavorable feedback from the Committee for Medicinal Products for Human Use (CHMP).
Tibsovo is currently being evaluated in the phase III ClarIDHy study in previously-treated patients with IDH1 mutant cholangiocarcinoma, also called bile-duct cancer. The final overall survival data from the above-mentioned study was reported in September 2020. A consistent trend in improved overall survival (OS) was noticed in patients treated with Tibsovo versus placebo but was not statistically significant. Agios expects to file a supplemental new drug application (sNDA) for the above indication in the first quarter of 2021.
Tibsovo is also being investigated in combination with Celgene’s Vidaza for treating newly diagnosed AML patients, who are ineligible for intensive chemotherapy. Agios plans to conclude enrollment in the study by 2021.
This apart, Agios’ rare genetic diseases candidate mitapivat is being evaluated in the single-arm ACTIVATE-T study for addressing PK in patients who are on regular blood transfusions with top-line results from the same expected in the first quarter of 2021. Also, the ACTIVATE study is evaluating mitapivat for treating PK deficiency in patients with no regular blood transfusions. Top-line data from the same is expected by 2020-end. Agios is also looking to develop mitapivat as a treatment of sickle cell disease.
During the third quarter, Agios initiated a phase I study on its next-generation pyruvate kinase-R (PKR) activator AG-946 for the treatment of hemolytic anemias.
Agios Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Fulcrum Therapeutics’ loss per share estimates have narrowed 1.1% for 2020 and 0.9% for 2021 over the past 60 days.
Halozyme’s earnings estimates have been revised 19.7% and 13.7% upward for 2020 and 2021 each over the past 60 days. The stock has rallied 85.7% year to date.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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Agios' (AGIO) Q3 Loss Wider Than Expected, Revenues Miss
Agios Pharmaceuticals, Inc. (AGIO - Free Report) reported third-quarter 2020 loss of $1.43 per share, wider than the Zacks Consensus Estimate of a loss of $1.40 but narrower than the year-ago loss of $1.81.
Total revenues of $34.7 million in the reported quarter missed the Zacks Consensus Estimate of $36 million. However, the top line grew 33.4% year over year owing to increased sales of the company’s leukemia drug Tibsovo (ivosidenib).
Tibsovo generated sales of $31.7 million in the third quarter, reflecting a sequential increase of 15% on higher demand for the drug. On the third-quarter conference call, management stated that it continues to see a steady rise in physician preference for Tibsovo, both with respect to the newly-diagnosed as well as the relapsed and refractory acute myeloid leukemia (AML) setting.
Agios raised the lower end of 2020 guidance for Tibsovo sales to the $113-115 million range from the earlier projection of $105-115 million.
Tibsovo was approved for treating adult patients suffering relapsed or refractory AML with IDH-1 mutation in July 2018. The FDA approved Tibsovo for the frontline setting in May 2019.
Shares of Agios were up 1.4% following the earnings announcement on Thursday. However, the stock has declined 11.9% so far this year compared with the industry’s decrease of 1.8%.
Quarter in Detail
Royalty revenues earned from Celgene, now part of Bristol-Myers (BMY - Free Report) , were $0.7 million on Idhifa (enasidenib) net sales in the reported quarter.
Collaboration revenues were $2.3 million in the quarter compared with $5.9 million in the year-ago quarter. Per the company, this downside was due to completion of the research and development service obligation with Celgene in the second quarter of 2020 and adjustment in sales reserves taken by Bristol Myers during the third quarter.
Notably, in March 2020, Agios announced that Celgene refused to extend the metabolic immuno-oncology research collaboration with it.
Research & development expenses declined 11.9% year over year to $89.6 million due to ramped-down activity of clinical studies for Tibsovo.
Selling general and administrative expenses increased 5.4% year over year to $34.8 million on account of higher personnel costs.
Agios ended the third quarter with cash, cash equivalents and marketable securities of $722.4 million, higher than the sequential quarter’s $613.1 million. The company expects this cash balance and revenues recognized from Tibsovo and royalties to effectively fund its current operational plans for at least through the end of 2022.
Tibsovo and Other Pipeline Updates
Last month, Agios withdrew the marketing authorization application (MAA) for Tibsovo to address IDH1-mutant relapsed/refractory AML in Europe owing to an unfavorable feedback from the Committee for Medicinal Products for Human Use (CHMP).
Tibsovo is currently being evaluated in the phase III ClarIDHy study in previously-treated patients with IDH1 mutant cholangiocarcinoma, also called bile-duct cancer. The final overall survival data from the above-mentioned study was reported in September 2020. A consistent trend in improved overall survival (OS) was noticed in patients treated with Tibsovo versus placebo but was not statistically significant. Agios expects to file a supplemental new drug application (sNDA) for the above indication in the first quarter of 2021.
Tibsovo is also being investigated in combination with Celgene’s Vidaza for treating newly diagnosed AML patients, who are ineligible for intensive chemotherapy. Agios plans to conclude enrollment in the study by 2021.
This apart, Agios’ rare genetic diseases candidate mitapivat is being evaluated in the single-arm ACTIVATE-T study for addressing PK in patients who are on regular blood transfusions with top-line results from the same expected in the first quarter of 2021. Also, the ACTIVATE study is evaluating mitapivat for treating PK deficiency in patients with no regular blood transfusions. Top-line data from the same is expected by 2020-end. Agios is also looking to develop mitapivat as a treatment of sickle cell disease.
During the third quarter, Agios initiated a phase I study on its next-generation pyruvate kinase-R (PKR) activator AG-946 for the treatment of hemolytic anemias.
Agios Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Agios Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Agios Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Agios currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the drug/biotech sector include Fulcrum Therapeutics, Inc. (FULC - Free Report) and Halozyme Therapeutics, Inc. (HALO - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Fulcrum Therapeutics’ loss per share estimates have narrowed 1.1% for 2020 and 0.9% for 2021 over the past 60 days.
Halozyme’s earnings estimates have been revised 19.7% and 13.7% upward for 2020 and 2021 each over the past 60 days. The stock has rallied 85.7% year to date.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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