Biogen Beats on Q3 Earnings & Sales, Raises '24 EPS View

Biogen BIIB reported third-quarter 2024 adjusted earnings per share (EPS) of $4.08, which beat the Zacks Consensus Estimate of $3.77. While earnings declined 6% year over year on a reported basis, it remained flat on a constant-currency basis.Total revenues came in at $2.47 billion, down 3% year over year on both reported and constant-currency basis. This decline was due to lower sales of key multiple sclerosis (MS) drugs like Tecfidera and Tysabri as well as spinal muscular atrophy (SMA) drug Spinraza, partially offset by higher revenues from new drugs. Sales also beat the Zacks Consensus Estimate of $2.44 billion.See the Zacks Earnings Calendar to stay ahead of market-making news.More on BIIB’s EarningsProduct sales in the quarter were $1.77 billion, down 2% year over year. Revenues from anti-CD20 therapeutic programs rose 6% to $446.2 million, which include royalties on sales of Roche’s RHHBY Ocrevus and Biogen’s share of RHHBY’s drugs, namely Rituxan, Gazyva and Lunsumio.Contract manufacturing and royalty revenues declined 19% year over year to $250.2 million. The figure also includes Biogen’s 50% share of net product revenues and cost of sales (including royalties) from Alzheimer’s drug Leqembi (lecanemab), which has been developed in collaboration with Eisai. Eisai recorded nearly $67 million in global revenues from Leqembi sales in the third quarter, showing a strong improvement from $40 million in the second quarter.Leqembi has already been launched in the United States, Japan and China. It was recently approved in some other countries like Israel, Hong Kong, South Korea, the UAE and Great Britain.Biogen expects the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) to complete the re-examination of a negative opinion on Eisai’s Leqembi filing before this year’s end. In July, CHMP had given a negative opinion regarding marketing approval for Leqembi in early Alzheimer’s disease in the EU. This negative opinion was reportedly due to a brain swelling side effect called amyloid-related imaging abnormalities associated with the use of anti-amyloid therapies like Leqembi.BIIB’s Multiple Sclerosis RevenuesBiogen’s MS revenues totaled $1.05 billion, down 9% on a reported as well as constant-currency basis due to generic competition for Tecfidera and rising competitive pressure in the MS market.Tecfidera sales declined 2.8% to $232.8 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. The drug’s sales beat the Zacks Consensus Estimate of $232 million and our estimate of $223 million.Vumerity recorded $158.1 million in sales, down 4.5% year over year. The drug’s sales missed the Zacks Consensus Estimate of $171 million and our model estimate of $177 million.Tysabri sales declined 11% year over year to $406.1 million due to increased competition. The figure missed the Zacks Consensus Estimate of $413 million and our estimate of $411 million.Combined interferon revenues (Avonex and Plegridy) in the quarter were $237.5 million, down 14.5% due to a continued shift from the injectable platform to oral or high-efficacy therapies.BIIB’s Rare Disease DrugsSales of Spinraza declined 15% to $381.4 million due to increased competition. The figure missed the Zacks Consensus Estimate of $435 million and our estimate of $460 million.Rare disease drug Skyclarys, which was added with the September 2023 acquisition of Reata Pharmaceuticals, generated sales of $102.3 million compared with $100.0 million in the previous quarter. Skyclarys is the only drug approved for the treatment of Friedreich’s ataxia.Qalsody, which was launched in the United States for amyotrophic lateral sclerosis (ALS) last year, recorded sales of $11.1 million compared with $5.0 million in the previous quarter. The drug was approved in the EU in May.Other Products Marketed by BIIBZurzuvae (zuranolone), which was launched for postpartum depression in December 2023, recorded $22 million in sales compared with $15 million in the previous quarter. Per management, the launch uptake of the drug is showing encouraging early trends.Biogen has developed Zurzuvae in partnership with Sage Therapeutics SAGE. BIIB and SAGE share equal profits and losses for the commercialization of Zurzuvae in the United States. At the same time, outside U.S. markets, Biogen records product sales (excluding Japan, Taiwan, and South Korea) and pays royalties to Sage Therapeutics.Alongside its earnings update, management announced that it would not pursue further development of Zurzuvae in major depressive disorder (MDD) indication. Last year, the FDA refused to approve the company’s filing seeking marketing approval for the drug in MDD indication. Per the agency, the data supporting the filing did not provide substantial evidence of effectiveness to support a potential approval and had recommended conducting additional clinical studies.Biosimilar revenues were flat year over year at $196.6 million.BIIB’s Costs DeclineAdjusted research and development (R&D) expenses declined 9% year over year to $491 million, driven by the company’s cost-saving initiatives under its “Fit for Growth” program. Adjusted selling, general and administrative expenses rose 1% to $556 million due to costs to support the new product launches.In the quarter, the collaboration profit-sharing was a net expense of around $69 million, which included nearly $60 million of net profit-sharing expenses related to Biogen’s biosimilar collaboration with Samsung Bioepis and around $9 million of net profit-sharing expenses linked to Biogen’s collaboration with Sage for marketing Zurzuvae in the United States.2024 GuidanceThe company maintained its previously issued guidance for total revenues in 2024, which is expected to decline by a low single-digit percentage from the 2023 level.Core pharmaceutical revenues (comprising product sales plus Leqembi revenues) are expected to be roughly flat year over year in 2024. This is because the decline in MS revenues is expected to be offset by higher revenues from new products.Adjusted earnings guidance was raised from $15.75-$16.25 to $16.10-$16.60, implying growth of approximately 11% (previously 9%) at the midpoint. Shares were trading higher in pre-market trading today likely due to this raised guidance.Year to date, the stock fell 29.1% compared with the industry’s 3.3% decline.Image Source: Zacks Investment ResearchOperating income in 2024 is expected to grow at a high-teen percentage versus the prior expectation of a mid-to-high-teen percentage. This increase can be attributed to lower cost of sales and lower operating costs due to the cost-saving initiatives.The operating margin is expected to increase by a mid-single-digit percentage point in 2024.Biogen Inc. Price Biogen Inc. price | Biogen Inc. QuoteBIIB’s Zacks Rank & A Key PickBiogen currently has a Zacks Rank #3 (Hold).A better-ranked stock in the biotech sector is ANI Pharmaceuticals ANIP, which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.In the past 90 days, estimates for ANI Pharmaceuticals’ 2024 EPS have moved up from $4.68 to $4.73. EPS estimates for 2025 have increased from $5.25 to $5.67. Year to date, shares of ANIP have risen 6.2%.ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 31.32%.Zacks Names #1 Semiconductor StockIt's only 1/9,000th the size of NVIDIA which skyrocketed more than +800% since we recommended it. NVIDIA is still strong, but our new top chip stock has much more room to boom.With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $803 billion by 2028.See This Stock Now for Free >>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 Biogen Inc. (BIIB): Free Stock Analysis Report Roche Holding AG (RHHBY): Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP): Free Stock Analysis Report Sage Therapeutics, Inc. (SAGE): Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks