Agios Pharmaceuticals, Inc. (AGIO - Free Report) reported fourth-quarter 2019 loss of $1.60 per share, narrower than the Zacks Consensus Estimate of a loss of $1.78 but slightly wider than the year-ago loss of $1.58.
Total revenues in the reported quarter were $35.4 million, higher than the Zacks Consensus Estimate of $31 million. Moreover, revenues grew 18% on a year-over-year basis.
Agios’ first wholly owned drug Tibsovo (ivosidenib) generated sales of $19.6 million in the fourth quarter of 2019, reflecting a sequential increase of 12.6%. The company expects Tibsovo U.S. revenues to be in the range of $105-$115 million in 2020.
Tibsovo was approved for treating adult patients suffering relapsed or refractory AML with IDH-1 mutation in July 2018. Last May, the FDA approved Tibsovo for the frontline setting. The drug is also under review in the EU for treating relapsed or refractory AML with a potential approval expected by this year-end.
Shares of Agios were up 5.4% following the better-than-expected results on Thursday. However, the stock has lost 12.3% in the past year versus the industry’s rally of 9.9%.
Meanwhile, royalty revenues earned from Celgene, which is now part of Bristol-Myers (BMY - Free Report) , were $3 million on Idhifa (enasidenib) net sales in the reported quarter. Collaboration revenues were $12.9 million. Idhifa is owned by Agios’ partner Celgene and the company is entitled to receive royalties on the drug’s net sales.
Quarter in Detail
Research & development expenses rose 13.2% year over year to $106.2 million, largely due to higher cost of late-stage clinical studies for pipeline development.
General and administrative expenses increased 9.1% year over year to $34.8 million on account of higher investments and personnel costs.
Agios ended the fourth quarter with cash, cash equivalents and marketable securities of $717.8 million, lower than the sequential quarter’s level of $540.5 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 2021.
For 2019, Agios’ revenues of $117.9 million were up 24.9% year over year.
Adjusted loss per share was $6.86 compared with a loss of $6.03 a year ago.
For 2019, Tibsovo recorded sales of 59.9 million, reflecting a significant increase year over year.
Tibsovo and Other Pipeline Updates
Tibsovo is being evaluated in the phase III ClarIDHy study in previously-treated patients with IDH1 mutant cholangiocarcinoma also called bile-duct cancer. The company expects to file a supplemental new drug application (sNDA) for the above indication by 2020 end. Currently, there are no treatment options available to treat this cancer.
In December 2019, the FDA granted Breakthrough Therapy designation to Tibsovo for the treatment of relapsed/refractory myelodysplastic syndrome (MDS) in adult patients with a susceptible IDH1 mutation.
Tibsovo is also being evaluated 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 2020.
The company’ key pipeline candidate mitapivat is being developed to treat patients with PK deficiency. It is conducting the single-arm ACTIVATE-T study for addressing PK in patients, who are on regular blood transfusions and also the ACTIVATE study for treating PK deficiency in patients with no regular blood transfusions. Top-line data from both studies are expected by the end of 2020.
Last month, Agios announced that the phase II study on mitapivat for treating patients with non-transfusion-dependent thalassemia achieved the clinical proof-of-concept.
Agios Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Zacks Rank & Stocks to Consider
Agios currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Kala Pharmaceuticals, Inc. (KALA - Free Report) and Vericel Corp. (VCEL - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Kala Pharmaceuticals’ loss per share estimates have narrowed 0.9% for 2020 over the past 60 days.
Vericel’s earnings estimates have been revised 12.5% upward for 2020 over the past 60 days.
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