Alvotech Reports Positive Financial Results and Pipeline Progress in Q3 2024
Key Insights
Alvotech reported positive adjusted EBITDA and operating profit for the second consecutive quarter, driven by increased product revenue and improved gross margins.
The EMA accepted Marketing Authorization Applications (MAAs) for AVT03 (denosumab biosimilar) and AVT05 (golimumab biosimilar), expanding Alvotech's biosimilar portfolio.
A confirmatory patient study was initiated for AVT16, a proposed biosimilar to Entyvio (vedolizumab), targeting ulcerative colitis (search) and Crohn's disease.
Alvotech (NASDAQ: ALVO) announced its financial results for the first nine months of 2024, highlighting significant progress in both financial performance and pipeline development. The company reported its second consecutive quarter with positive adjusted EBITDA and operating profit, driven by increased product revenue and improved gross margins.
Financial Highlights
For the first nine months of 2024, Alvotech reported product revenue of $128.0 million, a substantial increase from $29.8 million in the same period of 2023. This growth was attributed to sales of AVT02 (adalimumab) in Europe and Canada, the launch of AVT02 in the U.S. as SIMLANDI, and the launch of AVT04 (ustekinumab) in Canada, Japan, and select European markets. License and other revenue reached $210.5 million, compared to $8.2 million in the previous year, boosted by milestone achievements in the development of AVT03, AVT05, AVT06 and AVT16.
Operating profit for the period was $56.2 million, a significant turnaround from the $277.7 million loss in the first nine months of 2023. This improvement was driven by increased revenues and the company's efforts to scale and rationalize operations. As of September 30, 2024, Alvotech held $118.3 million in cash and cash equivalents.
Pipeline Advancements
Alvotech continues to advance its biosimilar pipeline. The European Medicines Agency (EMA) accepted Marketing Authorization Applications (MAAs) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab), and AVT05, a proposed biosimilar to Simponi® (golimumab). Alvotech has commercialization agreements in place with STADA and Dr. Reddy’s Laboratories for AVT03, and with Advanz Pharma for AVT05 in European markets.
A confirmatory patient study has been initiated for AVT16, a proposed biosimilar to Entyvio® (vedolizumab). Entyvio, used to treat ulcerative colitis (search) and Crohn’s disease (search), generated approximately $5.4 billion in global sales in the twelve months until June 30, 2024.
Regulatory Approvals and Expansions
Alvotech and Teva Pharmaceuticals announced that the U.S. FDA has approved a new presentation of SELARSDI (search)™ (ustekinumab-aekn), a biosimilar to Stelara® (ustekinumab), in a 130 mg/26 mL single-dose vial for intravenous infusion. This approval also expands SELARSDI's label to include treatment for adults with Crohn’s disease (search) and ulcerative colitis (search), aligning it with the reference product's indications. The U.S. launch of SELARSDI is expected in February 2025.
Management Commentary
Robert Wessman, Chairman and CEO of Alvotech, expressed satisfaction with the company's performance. "We are delighted by the results in the quarter and the first nine months of 2024. The third quarter marked our second consecutive quarter with positive adjusted EBITDA and operating profit. Not only did we see growth in product revenue compared to the previous quarter, but we also experienced a more than doubling of product gross margins, primarily due to improved utilization and scale at our manufacturing site," said Wessman. He also highlighted the steady progress of Alvotech's pipeline, noting that continued research and development activities contribute to the company's topline and provide opportunities for future growth and diversification.