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Biogen (BIIB) Beats on Q1 Earnings, Ends Some Research Programs
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Biogen (BIIB - Free Report) reported first-quarter 2023 adjusted earnings per share (EPS) of $3.40, beating the Zacks Consensus Estimate of $3.25 and our model estimate of $3.33. Earnings however declined 6% year over year due to lower revenues. On a constant currency basis, earnings were flat year over year.
Sales came in at $2.46 billion, down 3% on a reported basis (flat on a constant-currency basis) from the year-ago quarter, hurt by lower sales of multiple sclerosis (MS) drugs like Tecfidera and Vumerity. Sales beat the Zacks Consensus Estimate as well as our estimate of $2.34 billion.
Product sales in the quarter were $1.76 billion, down 14.3% year over year. Revenues from anti-CD20 therapeutic programs were flat at $399.5 million. The revenues include royalties on sales of Roche’s (RHHBY - Free Report) Ocrevus and Biogen’s share of Roche’s drugs, Rituxan and Gazyva. Contract manufacturing and royalty revenues rose 383% in the quarter to $319.0 million.
Multiple Sclerosis Revenues
Biogen’s MS revenues were $1.13 billion in the reporter quarter, down 19% on a reported basis and 17% on a constant currency basis year over year.
Tecfidera sales declined 33% to $274.5 million as multiple generic versions of the drug have been launched in the United States and new generic launches are ongoing in several EU countries. Tecfidera sales were better than our model estimate of $234.0 million as well as the Zacks Consensus Estimate of $271 million.
Vumerity recorded $108.2 million in sales, down 15.5%. Vumerity sales were lower than the Zacks Consensus Estimate of $152 million.
Tysabri sales declined 9.2% year over year to $472.8 million, which missed the Zacks Consensus Estimate of $494 million.
Combined interferon revenues (Avonex and Plegridy) in the quarter were $245.6 million, down 20.7%, hurt by a continued shift from the injectable platform to oral or high-efficacy therapies.
Other Products
Sales of Spinraza declined 6% on a reported basis and 2% on a constant currency basis to $443.0 million. Spinraza sales were better than the Zacks Consensus Estimate of $428 million but in line with our model estimate.
In the quarter, biosimilars revenues decreased 1% year over year to $192 million. However, on a constant currency basis, biosimilars revenues rose 4%.
Biogen recorded ($18.0) million of Alzheimer’s disease revenues, which included product revenues from Alzheimer’s drug, Aduhelm and revenues from the Leqembi collaboration. Biogen and partner Eisai’s new Alzheimer’s drug, Leqembi, an anti-amyloid beta protofibril antibody drug, was granted accelerated approval by the FDA in January. The drug is not expected to contribute much to revenues until the CMS grants reimbursement for it under Medicare plans. This is expected to happen once Leqembi gets traditional approval. Eisai had submitted a supplemental biologics license application (sBLA) to the FDA for traditional approval of Leqembi the same day it received the accelerated approval. In March, the FDA accepted the sBLA and granted priority review designation to the sBLA, with a decision expected on Jul 6, 2023.
From the first quarter of 2023, Biogen started recording its 50% share of net commercial profits and losses for Leqembi in the United States as a component of total revenues.
Research and development expenses were $571.0 million, up 3% year over year. Adjusted selling, general and administrative expenses declined 5% year over year to $603.0 million, driven by the company’s cost-savings initiatives.
2023 Guidance Maintained
The company maintained its previously issued earnings and sales guidance for 2023.
Total revenues are expected to decline at a mid-single-digit percentage in 2023 from the 2022 level.
Adjusted earnings are expected in the range of $15.00 to $16.00 per share.
Pipeline Setbacks
Biogen announced that it is terminating its involvement in the development of BIIB093 due to operational challenges to help save costs. BIIB093 was being developed in a phase III study for large hemispheric infarction and a phase II study for brain contusion. Biogen has sent a letter of termination to Remedy Pharmaceuticals, which had originally developed the candidate. Remedy Pharmaceuticals now has the option to resume development of both programs.
Biogen also announced that it is pausing the initiation of a phase IIb study for BIIB131 for acute ischemic stroke while it works out whether to begin the study. Biogen also said it is discontinuing the development of BIIB132 in spinocerebellar ataxia type 3.
Our Take
Biogen’s first-quarter results were better than expected as it beat estimates on both counts. It also maintained its previously-issued financial outlook for 2023. However, the company said it is pausing or discontinuing some pipeline candidates including two candidates in stroke as part of the ongoing R&D pipeline optimization. In response, Biogen’s shares were down 1% in pre-market trading.
Biogen’s stock has risen 36.6% in the past year against a decline of 9.2% for the industry.
Image Source: Zacks Investment Research
While most of its key drugs are facing declining sales due to intense competitive pressure, Biogen’s potential new product launches, such as Leqembi for Alzheimer’s disease (already launched) and zuranolone for depression, could help revive growth. A new drug application seeking approval of zuranolone for major depressive disorder and postpartum depression is under priority review in the United States, with a decision expected on Aug 5, 2023.
In the past 60 days, loss estimates per share for 2023 for Celularity have narrowed from 78 cents to 67 cents while that for 2024 have narrowed from 81 cents to 71 cents. Shares of Celularity have lost 94.7% in the past year.
Annovis Bio’s loss per share estimates for 2023 have narrowed from $2.93 to $2.33 in the past 60 days. ANVS stock has risen 25.6% in the past year.
ANVS witnessed a trailing two-quarter earnings surprise of 43.74%, on average. In the last reported quarter, Annovis Bio’s earnings beat estimates by 66.96%.
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Biogen (BIIB) Beats on Q1 Earnings, Ends Some Research Programs
Biogen (BIIB - Free Report) reported first-quarter 2023 adjusted earnings per share (EPS) of $3.40, beating the Zacks Consensus Estimate of $3.25 and our model estimate of $3.33. Earnings however declined 6% year over year due to lower revenues. On a constant currency basis, earnings were flat year over year.
Sales came in at $2.46 billion, down 3% on a reported basis (flat on a constant-currency basis) from the year-ago quarter, hurt by lower sales of multiple sclerosis (MS) drugs like Tecfidera and Vumerity. Sales beat the Zacks Consensus Estimate as well as our estimate of $2.34 billion.
Product sales in the quarter were $1.76 billion, down 14.3% year over year. Revenues from anti-CD20 therapeutic programs were flat at $399.5 million. The revenues include royalties on sales of Roche’s (RHHBY - Free Report) Ocrevus and Biogen’s share of Roche’s drugs, Rituxan and Gazyva. Contract manufacturing and royalty revenues rose 383% in the quarter to $319.0 million.
Multiple Sclerosis Revenues
Biogen’s MS revenues were $1.13 billion in the reporter quarter, down 19% on a reported basis and 17% on a constant currency basis year over year.
Tecfidera sales declined 33% to $274.5 million as multiple generic versions of the drug have been launched in the United States and new generic launches are ongoing in several EU countries. Tecfidera sales were better than our model estimate of $234.0 million as well as the Zacks Consensus Estimate of $271 million.
Vumerity recorded $108.2 million in sales, down 15.5%. Vumerity sales were lower than the Zacks Consensus Estimate of $152 million.
Tysabri sales declined 9.2% year over year to $472.8 million, which missed the Zacks Consensus Estimate of $494 million.
Combined interferon revenues (Avonex and Plegridy) in the quarter were $245.6 million, down 20.7%, hurt by a continued shift from the injectable platform to oral or high-efficacy therapies.
Other Products
Sales of Spinraza declined 6% on a reported basis and 2% on a constant currency basis to $443.0 million. Spinraza sales were better than the Zacks Consensus Estimate of $428 million but in line with our model estimate.
In the quarter, biosimilars revenues decreased 1% year over year to $192 million. However, on a constant currency basis, biosimilars revenues rose 4%.
Biogen recorded ($18.0) million of Alzheimer’s disease revenues, which included product revenues from Alzheimer’s drug, Aduhelm and revenues from the Leqembi collaboration. Biogen and partner Eisai’s new Alzheimer’s drug, Leqembi, an anti-amyloid beta protofibril antibody drug, was granted accelerated approval by the FDA in January. The drug is not expected to contribute much to revenues until the CMS grants reimbursement for it under Medicare plans. This is expected to happen once Leqembi gets traditional approval. Eisai had submitted a supplemental biologics license application (sBLA) to the FDA for traditional approval of Leqembi the same day it received the accelerated approval. In March, the FDA accepted the sBLA and granted priority review designation to the sBLA, with a decision expected on Jul 6, 2023.
From the first quarter of 2023, Biogen started recording its 50% share of net commercial profits and losses for Leqembi in the United States as a component of total revenues.
Research and development expenses were $571.0 million, up 3% year over year. Adjusted selling, general and administrative expenses declined 5% year over year to $603.0 million, driven by the company’s cost-savings initiatives.
2023 Guidance Maintained
The company maintained its previously issued earnings and sales guidance for 2023.
Total revenues are expected to decline at a mid-single-digit percentage in 2023 from the 2022 level.
Adjusted earnings are expected in the range of $15.00 to $16.00 per share.
Pipeline Setbacks
Biogen announced that it is terminating its involvement in the development of BIIB093 due to operational challenges to help save costs. BIIB093 was being developed in a phase III study for large hemispheric infarction and a phase II study for brain contusion. Biogen has sent a letter of termination to Remedy Pharmaceuticals, which had originally developed the candidate. Remedy Pharmaceuticals now has the option to resume development of both programs.
Biogen also announced that it is pausing the initiation of a phase IIb study for BIIB131 for acute ischemic stroke while it works out whether to begin the study. Biogen also said it is discontinuing the development of BIIB132 in spinocerebellar ataxia type 3.
Our Take
Biogen’s first-quarter results were better than expected as it beat estimates on both counts. It also maintained its previously-issued financial outlook for 2023. However, the company said it is pausing or discontinuing some pipeline candidates including two candidates in stroke as part of the ongoing R&D pipeline optimization. In response, Biogen’s shares were down 1% in pre-market trading.
Biogen’s stock has risen 36.6% in the past year against a decline of 9.2% for the industry.
Image Source: Zacks Investment Research
While most of its key drugs are facing declining sales due to intense competitive pressure, Biogen’s potential new product launches, such as Leqembi for Alzheimer’s disease (already launched) and zuranolone for depression, could help revive growth. A new drug application seeking approval of zuranolone for major depressive disorder and postpartum depression is under priority review in the United States, with a decision expected on Aug 5, 2023.
Zacks Rank & Stocks to Consider
Biogen currently has a Zacks Rank #3 (Hold).
Biogen Inc. Price, Consensus and EPS Surprise
Biogen Inc. price-consensus-eps-surprise-chart | Biogen Inc. Quote
A couple of better-ranked stocks in the biotech include Celularity (CELU - Free Report) and Annovis Bio (ANVS - Free Report) , each of which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, loss estimates per share for 2023 for Celularity have narrowed from 78 cents to 67 cents while that for 2024 have narrowed from 81 cents to 71 cents. Shares of Celularity have lost 94.7% in the past year.
Annovis Bio’s loss per share estimates for 2023 have narrowed from $2.93 to $2.33 in the past 60 days. ANVS stock has risen 25.6% in the past year.
ANVS witnessed a trailing two-quarter earnings surprise of 43.74%, on average. In the last reported quarter, Annovis Bio’s earnings beat estimates by 66.96%.