REYKJAVIK - Alvotech, a biotech company specializing in biosimilars, has announced positive topline results from a patient study of AVT03, a biosimilar candidate to Prolia® (denosumab) and Xgeva® (denosumab).
The study met its primary endpoints, demonstrating clinical similarity in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK) in postmenopausal women with osteoporosis. This could potentially lead to additional indications for AVT03 as a biosimilar to Xgeva, based on extrapolation.
The confirmatory patient study, AVT03-GL-C01, involved approximately 532 postmenopausal women diagnosed with osteoporosis. Participants were randomly assigned to receive three doses of either AVT03 or Prolia at six-month intervals. The primary outcomes measured were changes in bone mass density (BMD) and a biomarker for bone resorption at 6 and 12 months.
In addition to the patient study, Alvotech conducted two pharmacokinetic studies comparing AVT03 to Prolia and Xgeva, both of which met their primary endpoints. These studies assessed the PK, safety, and tolerability of AVT03.
Joseph McClellan, Chief Scientific Officer of Alvotech, expressed satisfaction with the results, highlighting the capabilities of their biosimilar platform and the diversification of their portfolio. The company expects to file marketing applications for AVT03 in major global markets later this year.
Denosumab, the reference biologic for AVT03, is used for the treatment of osteoporosis in postmenopausal women and bone loss in adults at increased risk of fracture. It also serves to prevent skeletal-related events in adults with advanced malignancies involving bone and is used in the treatment of giant cell tumor in bone.
Alvotech focuses on the development and manufacture of biosimilar medicines for patients worldwide. The company has already launched two biosimilars and has nine disclosed biosimilar candidates in its pipeline aimed at treating various conditions, including autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer.
The information in this article is based on a press release statement from Alvotech. AVT03 is currently an investigational product and has not received regulatory approval. Biosimilarity has not been established by regulatory authorities and is not claimed.
In other recent news, Alvotech, a biopharmaceutical firm, has made significant strides in its operations and financial performance. The company experienced a robust first quarter in 2024, with total revenues surging 132% year-over-year to $36.9 million and subsequently raised their full-year revenue guidance to between $400 million and $500 million. Alvotech's CEO, Robert Wessman, announced the company's anticipated transition towards profitability, expecting to achieve positive adjusted EBITDA in Q2.
In addition to financial developments, Alvotech issued stock options and restricted share units (RSUs) to its Board of Directors, aligning the interests of its directors with those of the shareholders.
The company also entered a strategic partnership with RDY and inked a deal with CIGNA, which have significantly contributed to its growth. The upcoming launch of Alvotech's biosimilar Selardsi in February 2025 is expected to impact a $7 billion U.S. market due to limited competition.
Despite these positive developments, analysts forecast a loss with an estimated earnings per share for the first fiscal year at around -$0.27, improving in the second fiscal year to -$0.07. Barclays (LON:BARC) Capital Inc. maintains an overweight stock rating for Alvotech with a price target increase to $22.00. These recent developments highlight Alvotech's strategic focus on biosimilars and its potential for growth in the market.
InvestingPro Insights
Alvotech has been making significant strides in the biotech industry with its biosimilar candidates, and the recent positive results from its AVT03 patient study have garnered attention. As investors consider the potential impact of these developments on the company's financial outlook, certain metrics and InvestingPro Tips offer additional context to Alvotech's market position.
InvestingPro Data reveals that Alvotech currently holds a market capitalization of $3.46 billion USD. Despite the company's growth prospects, it trades with a negative P/E ratio of -6.43, indicating that it is not currently profitable. This aligns with the InvestingPro Tips, which suggest that analysts do not anticipate the company will be profitable this year. Additionally, Alvotech's revenue for the last twelve months as of Q1 2024 stands at $114.39 million USD, with an impressive quarterly revenue growth rate of 132.29% in Q1 2024.
However, there are challenges ahead. Alvotech's gross profit margin was negative at -23.89% for the same period, underscoring the InvestingPro Tip that the company suffers from weak gross profit margins. Moreover, the stock price often moves in the opposite direction of the market, which could indicate higher investment risk or potential for countercyclical investment opportunities.
For investors looking for growth, Alvotech may be of interest due to its high return over the last year, with a 59.69% price total return. Yet, the company does not pay dividends, which may be a consideration for those seeking income-generating investments.
For a deeper dive into Alvotech's financials and to access additional InvestingPro Tips that could aid in making informed investment decisions, visit https://www.investing.com/pro/ALVO. There are 8 more tips available on InvestingPro, and readers can use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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