Breaking: Alvotech Shares Dips 5% On Earnings Report Shares of Alvotech (NASDAQ: NASDAQ:ALVO ) saw a noteworthy downtick of 5% amidst earnings report yesterday after market close. Alvotech, through its subsidiaries, develops and manufactures biosimilar medicines for patients worldwide. It offers biosimilar products in the therapeutic areas of autoimmune, eye, and bone disorders, as well as cancer.
Financial Performance
In 2024, Alvotech's revenue was $491.98 million, an increase of 426.84% compared to the previous year's $93.38 million. Losses were -$231.86 million, -57.98% less than in 2023.
Highlights of the Financial Results for 2024 Full Year
Cash position and sources of liquidity: As of December 31, 2024, the Company had cash and cash equivalents of $51.4 million.
Product Revenue: Product revenue was $273.5 million for the year ended December 31, 2024, compared to $48.7 million for the same period in the prior year.
License and Other Revenue: License and other revenue was $216.2 million for the year ended December 31, 2024, compared to $42.7 million for the same period in the prior year. The license and other revenue of $216.2 million was primarily attributable to the achievement of key research and development milestones during 2024:
Cost of product revenue: Cost of product revenue was $185.3 million for the year ended December 31, 2024, compared to $160.9 million for the same period in the prior year.
Research and development (R&D) expenses: R&D expenses were $171.3 million for the year ended December 31, 2024, compared to $210.8 million for the same period in the prior year.
General and administrative (G&A) expenses: G&A expenses were $65.7 million for the year ended December 31, 2024, compared to $76.6 million for the same period in the prior year.
Operating profit: Operating profit was $69.6 million for the year ended December 31, 2024, compared to ($354.9) million for the same period in the prior year.
Share of net loss of joint venture and loss on sale of interest in joint venture: In June 2024, the Company sold its share in the joint venture for gross proceeds of $18.0 million (less $1.3 million in transaction costs). The sale resulted in a net loss of $3.0 million during the year ended December 31, 2024.
Finance income: Finance income was $80.1 million for the year ended December 31, 2024, compared to $4.8 million for the same period in the prior year.
Finance costs: Finance costs were $303.2 million for the year ended December 31, 2024, compared to $267.2 million for the same period in the prior year.
Loss on extinguishment of financial liabilities: On June 7, 2024, the Company entered into a $965.0 million Senior Loan Facility, maturing in July 2029 that was funded in July 2024. Upon the closing of the Senior Loan Facility, the Company was required to settle its existing debt obligations.
Income tax (expense) / benefit: Income tax expense was $14.3 million for the year ended December 31, 2024, compared to a benefit of $99.3 million for the same period in the prior year.
Loss for the Year: Reported net loss was $231.9 million, or ($0.87) per share on a basic and diluted basis, for the year ended December 31, 2024, compared to a reported net loss of $551.8 million, or ($2.42) per share on a basic and diluted basis, for the same period in the prior year.
Alvotech
Alvotech breaking out towards 16-18 levelAfter price broke out of the bearish line before and after making a hammer, it started a retracement.
My assumption is it will eventually retest the Weekly EMA 10 levels, which will serve as support.
Going long there (with the SL below the EMA 10) is a conservative way to enter the bullish trend.
We have measure the long wick/shadow of hammer to calculate the target price (12.57-9.15=3.42).
TP1 = 16 (3.42+12.6) handle and TP2 = 18 (old supply zone).
In terms of trade management, when TP1 is hit I would take profit on half of my position and roll my stop loss to breakeven, enjoying a risk free trade towards TP2.
There are 5.5 pips to be made (if this pair follows the script) and the trade has a reward – risk ratio of 9!
Alvotech Nears U.S. Approval for Biosimilar MedicinesIn a significant development for Alvotech (NASDAQ: NASDAQ:ALVO ), a global biotech company specializing in biosimilar medicines, the conclusion of the U.S. Food and Drug Administration (FDA) reinspection of its facility in Iceland has brought the company one step closer to achieving regulatory approval for its biosimilar candidates, AVT02 and AVT04. The inspection, initiated on January 10, 2024, has yielded a single observation in the form of a form 483, prompting Alvotech to swiftly respond and work towards addressing the FDA's concerns.
Addressing the Observations:
Alvotech's Chairman and CEO, Robert Wessman, expressed confidence in promptly addressing the observation, stating, "We believe that the observation is readily addressable, and we intend to respond as quickly as possible." The company expects to provide the FDA with a comprehensive response in the coming days, showcasing its commitment to resolving any regulatory issues and ensuring compliance with FDA standards.
Anticipated Approval Timeline:
Building on the positive outcome of the reinspection, Alvotech has set ambitious goals for the approval of its biosimilar medicines in the U.S. If all goes as planned, the company foresees approval for AVT02 and AVT04 by February 24, 2024, and April 16, 2024, respectively. This timeline reflects the company's confidence in the overall quality and compliance of its manufacturing processes.
Technical Outlook:
From a technical standpoint, Alvotech's stock has recently broken through the ceiling of the rising trend channel. This breakthrough signals a robust upward trajectory, although short-term corrections may occur. The stock's marginal break above the resistance at $14.00 is seen as a positive indicator, with the potential for further gains. The positive volume balance, indicating strong volume on days with rising prices and low volume on days with falling prices, adds to the bullish sentiment.
Price Momentum:
Alvotech's stock is currently trading near the top of its 52-week range and above its 200-day simple moving average. This positioning, coupled with the positive momentum observed, suggests that investors have been actively pushing the share price higher, indicating a continued upward trajectory. This positive momentum serves as a promising sign for the stock's value.
Conclusion:
Alvotech's ( NASDAQ:ALVO ) recent developments, including the conclusion of the FDA reinspection and the positive technical indicators, position the company on the brink of securing regulatory approval for its biosimilar medicines in the lucrative U.S. market. Investors are eagerly awaiting the company's response to the FDA's observation and the subsequent progress towards the anticipated approval dates. As Alvotech navigates the regulatory landscape, the positive market sentiment and technical outlook provide a compelling narrative for the company's future success in the biotech sector.