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Agios Pharmaceuticals, Inc. AGIO 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, 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.
Full-Year Results
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.