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Biogen (BIIB) to Report Q3 Earnings: Will It Beat Estimates?
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We expect Biogen (BIIB - Free Report) to beat expectations when it reports third-quarter 2023 results on Nov 8, before market open. In the last reported quarter, the company delivered an earnings surprise of 6.63%.
Factors to Consider
Biogen’s sales in the third quarter are likely to have been hurt by lower sales of its multiple sclerosis (“MS”) drugs like Tecfidera and Tysabri and rising competitive pressure in the MS market. Tecfidera sales are declining as multiple generic versions of the drug have been launched in the United States.
The Zacks Consensus Estimate and our model estimate for third-quarter sales of Tecfidera are pegged at $245.0 million and $226.9 million, respectively.
The Zacks Consensus Estimate and our estimate for Tysabri are pegged at $474 million and $475.1 million, respectively.
Sales of another MS drug Vumerity rose in the second quarter backed by higher volumes in international markets. It remains to be seen if the positive trend continued in the third quarter.
The Zacks Consensus Estimate and our estimate for Vumerity are pegged at $157.0 million and $160.6 million, respectively.
Biogen receives royalties on U.S. sales of Roche’s (RHHBY - Free Report) MS drug, Ocrevus, which is also expected to have contributed to the top line.
Revenues from Biogen’s profit share of Roche’s drugs, Rituxan and Gazyva, are also likely to have declined in the quarter due to biosimilar competition for Rituxan.
Sales of Biogen’s spinal muscular atrophy drug, Spinraza, are expected to have risen in the United States, driven by patient growth, which is likely to have been backed by favorable data from studies and expected overall market improvement. Outside the United States, currency headwinds and unfavorable pricing hurt sales in the second quarter. It remains to be seen if things improved in the third quarter. The Zacks Consensus Estimate and our estimate for Spinraza are pegged at $432.0 and $452.4 million, respectively.
Biosimilars revenues are expected to have been modest as the continued launch of Byooviz is likely to have made up for pricing pressure in certain markets.
In the third quarter, Biogen expects to recognize a reduction of Alzheimer’s disease revenues, with commercial expense exceeding initial revenues. Alzheimer’s disease revenues include product revenues from Alzheimer’s drug, Aduhelm and revenues from the Leqembi collaboration with Eisai.
Investors will be keen to know the initial sales numbers of Biogen’s new drugs, all in areas of high unmet need, including Alzheimer's disease, major depressive disorder, postpartum depression and SOD1-ALS.
Leqembi/lecanemab gained full approval from the FDA for early Alzheimer’s disease in the United States and broad reimbursement from CMS in July. Qalsody/tofersen was approved to treat ALS with SOD1 mutations in the United States in April 2023, while it is under review in the EU. Zuranolone, to be marketed as Zurzuvae, was approved by the FDA to treat women with postpartum depression in August.
However, the FDA issued a complete response letter (CRL) for the new drug application (NDA) seeking approval of zuranolone for the major depressive disorder (MDD) indication. The FDA has asked for an additional study to be conducted as it believes the NDA did not provide enough evidence to prove the candidate’s effectiveness in the treatment of MDD.
Regarding Leqembi, Biogen had said on the second-quarter conference call that sales are expected to be slightly slow in 2023 and then pick up 2024 onward. An update is expected on the third -quarter conference call.
Key Event in the Quarter
In September, Biogen acquired Reata Pharmaceuticals for approximately $7.3 billion. The acquisition added Reata’s newly approved rare disease drug, Skyclarys or the treatment of Friedreich’s ataxia to Biogen’s portfolio. The drug’s commercial launch in the United States is underway, Biogen said. A regulatory filing for the drug in a similar indication is currently under review in Europe.
Biogen’s stock has declined 9.9% so far this year compared with a decrease of 21% for the industry.
Image Source: Zacks Investment Research
Earnings Whispers
Our proven model predicts an earnings beat for Biogen in the to-be-reported quarter. A stock needs to have both a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) for a likely positive surprise. This is the case here, as elaborated below.
Earnings ESP: Biogen’s Earnings ESP is +2.90% as the Most Accurate Estimate of $4.08 is higher than the Zacks Consensus Estimate of $3.97. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Zacks Rank: Biogen has a Zacks Rank #3.
Other Stocks to Consider
Here are some large drug/biotech stocks that also have the right combination of elements to beat on earnings this time around:
bluebird bio’s stock has declined 49.7% so far this year. bluebird bio beat earnings estimates in all the last four quarters. BLUE delivered a four-quarter earnings surprise of 89.60%, on average. bluebird bio is scheduled to release its third-quarter results on Nov 7.
Mirati Therapeutics has an Earnings ESP of +0.76% and a Zacks Rank #3.
Mirati’s stock has risen 23.7% so far this year. The company beat earnings estimates in all the last four quarters. MRTX delivered a four-quarter earnings surprise of 7.77%, on average.
Image: Shutterstock
Biogen (BIIB) to Report Q3 Earnings: Will It Beat Estimates?
We expect Biogen (BIIB - Free Report) to beat expectations when it reports third-quarter 2023 results on Nov 8, before market open. In the last reported quarter, the company delivered an earnings surprise of 6.63%.
Factors to Consider
Biogen’s sales in the third quarter are likely to have been hurt by lower sales of its multiple sclerosis (“MS”) drugs like Tecfidera and Tysabri and rising competitive pressure in the MS market. Tecfidera sales are declining as multiple generic versions of the drug have been launched in the United States.
The Zacks Consensus Estimate and our model estimate for third-quarter sales of Tecfidera are pegged at $245.0 million and $226.9 million, respectively.
The Zacks Consensus Estimate and our estimate for Tysabri are pegged at $474 million and $475.1 million, respectively.
Sales of another MS drug Vumerity rose in the second quarter backed by higher volumes in international markets. It remains to be seen if the positive trend continued in the third quarter.
The Zacks Consensus Estimate and our estimate for Vumerity are pegged at $157.0 million and $160.6 million, respectively.
Biogen receives royalties on U.S. sales of Roche’s (RHHBY - Free Report) MS drug, Ocrevus, which is also expected to have contributed to the top line.
Revenues from Biogen’s profit share of Roche’s drugs, Rituxan and Gazyva, are also likely to have declined in the quarter due to biosimilar competition for Rituxan.
Sales of Biogen’s spinal muscular atrophy drug, Spinraza, are expected to have risen in the United States, driven by patient growth, which is likely to have been backed by favorable data from studies and expected overall market improvement. Outside the United States, currency headwinds and unfavorable pricing hurt sales in the second quarter. It remains to be seen if things improved in the third quarter. The Zacks Consensus Estimate and our estimate for Spinraza are pegged at $432.0 and $452.4 million, respectively.
Biosimilars revenues are expected to have been modest as the continued launch of Byooviz is likely to have made up for pricing pressure in certain markets.
In the third quarter, Biogen expects to recognize a reduction of Alzheimer’s disease revenues, with commercial expense exceeding initial revenues. Alzheimer’s disease revenues include product revenues from Alzheimer’s drug, Aduhelm and revenues from the Leqembi collaboration with Eisai.
Investors will be keen to know the initial sales numbers of Biogen’s new drugs, all in areas of high unmet need, including Alzheimer's disease, major depressive disorder, postpartum depression and SOD1-ALS.
Leqembi/lecanemab gained full approval from the FDA for early Alzheimer’s disease in the United States and broad reimbursement from CMS in July. Qalsody/tofersen was approved to treat ALS with SOD1 mutations in the United States in April 2023, while it is under review in the EU. Zuranolone, to be marketed as Zurzuvae, was approved by the FDA to treat women with postpartum depression in August.
However, the FDA issued a complete response letter (CRL) for the new drug application (NDA) seeking approval of zuranolone for the major depressive disorder (MDD) indication. The FDA has asked for an additional study to be conducted as it believes the NDA did not provide enough evidence to prove the candidate’s effectiveness in the treatment of MDD.
Regarding Leqembi, Biogen had said on the second-quarter conference call that sales are expected to be slightly slow in 2023 and then pick up 2024 onward. An update is expected on the third -quarter conference call.
Key Event in the Quarter
In September, Biogen acquired Reata Pharmaceuticals for approximately $7.3 billion. The acquisition added Reata’s newly approved rare disease drug, Skyclarys or the treatment of Friedreich’s ataxia to Biogen’s portfolio. The drug’s commercial launch in the United States is underway, Biogen said. A regulatory filing for the drug in a similar indication is currently under review in Europe.
Image Source: Zacks Investment Research
Earnings Whispers
Our proven model predicts an earnings beat for Biogen in the to-be-reported quarter. A stock needs to have both a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) for a likely positive surprise. This is the case here, as elaborated below.
Earnings ESP: Biogen’s Earnings ESP is +2.90% as the Most Accurate Estimate of $4.08 is higher than the Zacks Consensus Estimate of $3.97. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Zacks Rank: Biogen has a Zacks Rank #3.
Other Stocks to Consider
Here are some large drug/biotech stocks that also have the right combination of elements to beat on earnings this time around:
bluebird bio (BLUE - Free Report) has an Earnings ESP of +12.73% and a Zacks Rank #3. You can see the complete list of today’s Zacks #1 Rank stocks here.
bluebird bio’s stock has declined 49.7% so far this year. bluebird bio beat earnings estimates in all the last four quarters. BLUE delivered a four-quarter earnings surprise of 89.60%, on average. bluebird bio is scheduled to release its third-quarter results on Nov 7.
Mirati Therapeutics has an Earnings ESP of +0.76% and a Zacks Rank #3.
Mirati’s stock has risen 23.7% so far this year. The company beat earnings estimates in all the last four quarters. MRTX delivered a four-quarter earnings surprise of 7.77%, on average.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.