Agios Pharmaceuticals, Inc.


AGIO

reported fourth-quarter 2020 loss of $1.41 per share, which was in line with the Zacks Consensus Estimate. The reported loss was narrower than the year-ago loss of $1.60.

Total revenues of $44 million in the reported quarter surpassed the Zacks Consensus Estimate of $36 million. Moreover, the top line grew 24.3% year over year owing to increased sales of the company’s leukemia drug, Tibsovo (ivosidenib), which has been approved by the FDA for treating adult patients suffering from relapsed or refractory acute myeloid leukemia with IDH-1 mutation. The drug is also approved in the frontline setting.

Tibsovo generated sales of $39.1 million in the fourth quarter, reflecting a sequential increase of 23.3% on higher demand for the drug. On the fourth-quarter conference call, management stated that sales performance of Tibsovo in the reported quarter was driven by growth in new scripts and refills, and favorable gross to net proceeds.

Shares of Agios were down 4.9% following the earnings announcement on Thursday. However, the stock has rallied 16.1% so far this year compared with the

industry’s

increase of 7%.

Quarter in Detail

Royalty revenues earned from Celgene, now part of

Bristol-Myers


BMY

, were $2.9 million on Idhifa (enasidenib) net sales in the reported quarter.

Collaboration revenues were $2 million in the quarter compared with $12.9 million in the year-ago quarter.

Research & development expenses declined 9.9% year over year to $95.7 million due to ramped-down activity of clinical studies for Tibsovo.

Selling general and administrative expenses increased 14.4% year over year to $39.8 million on account of higher personnel costs and professional fees related to the Servier transaction.

Agios ended the fourth quarter with cash, cash equivalents and marketable securities of $670.5 million, lower than $722.4 million at the end of the third quarter. The company expects this cash balance and revenues recognized from Tibsovo and royalties to effectively fund its current operational plans at least through the end of 2022.

Full-Year Results

For 2020, Agios generated revenues of $203.2 million, reflecting an increase of 72.3% year over year. Tibsovo net product sales were $121.1 million in 2020, reflecting a significant increase year over year.

For the same period, the company reported loss of $4.74 per share compared with the year-ago loss of $6.86 per share.

Recent Updates and Tibsovo

In December 2020, Agios

entered

into a definitive agreement to sell its commercial, clinical and research-stage oncology portfolio to France-based pharmaceutical company, Servier, for up to $2 billion.

The transaction is expected to close by March 2021, subject to approval by Agios’ shareholders and customary closing conditions. With the proceeds from the deal, the company is looking to advance its genetically defined disease portfolio and strengthen its capital structure.

Importantly, mitapivat is one of the key pipeline candidates of Agios, which is being developed for treating patients with pyruvate kinase (“PK”) deficiency. The candidate is being evaluated in two phase III studies namely, ACTIVATE and ACTIVATE-T, for treating PK deficiency in adults who are not regularly transfused and those who are regularly transfused, respectively.

Agios plans to submit a new drug application for mitapivat in the United States in the second quarter of 2021. The company also plans to file a marketing authorization application in the EU by the middle of this year.

Agios is also developing mitapivat for treating sickle cell disease (“SCD”), a blood disorder, and thalassemia. A phase II/III study on mitapivat for SCD is expected to begin by year-end. The company also plans to initiate two phase III studies on mitapivat in thalassemia (regularly transfused as well as not regularly transfused) in the second half of 2021.

Agios is also evaluating AG-946, its next-generation pyruvate kinase-R activator, in a phase I study for the treatment of hemolytic anemias.

Meanwhile, Agios’ wholly owned product, Tibsovo, is currently being evaluated in the phase III ClarIDHy study in previously treated patients with IDH1 mutant cholangiocarcinoma, also called bile-duct cancer. Agios expects to file a supplemental new drug application (sNDA) for the above indication in the first quarter of 2021.

Apart from Tibsovo, Agios’ oncology portfolio includes pipeline candidates vorasidenib and AG-270.

Zacks Rank & Stocks to Consider

Agios currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include

Lexicon Pharmaceuticals, Inc.


LXRX

and

Nabriva


Therapeutics AG


NBRV

, 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


.

Lexicon’s loss per share estimates have narrowed 74.2% for 2021 over the past 60 days. The stock has skyrocketed 118.7% year to date.

Nabriva’s loss per share estimates have narrowed 8.9% for 2021 over the past 60 days.

Just Released: Zacks’ 7 Best Stocks for Today

Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.9% per year.

These 7 were selected because of their superior potential for immediate breakout.

See these time-sensitive tickers now >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.

Click to get this free report

To read this article on Zacks.com click here.

Zacks Investment Research