Pure-Play Biosimilar Company Reports 10-Fold Revenue Increase for First Half of 2024

Alvotech, a pure-play biosimilar company based in Iceland, announced a 10-fold increase in revenues during the first half of 2024 compared with the same period last year.¹

According to the report, Alvotech achieved record total revenues of $236 million for the first six months of 2024. Product revenues for the first half of 2024 reached $66 million, reflecting a 190% increase from the same period last year, with $53 million of that total generated in the second quarter alone.

The news comes after the company secured its first 2 FDA approvals for biosimilars. Simlandi (adalimumab-ryvk) , a biosimilar to Humira (reference adalimumab), was approved in February 2024 and launched on the US market in May 2024.^2,3 Selarsdi (ustekinumab-aekn), a biosimilar to Stelara (reference ustekinumab) was approved in April 2024 and will launch in 2025, as a result of a settlement agreement with Janssen, the maker of Stelara.^4,5 Selarsdi is also approved in Europe, Japan, and Canada.^6,7

Alvotech reported $236 million in revenue for the first 6 months of 2024, a 10-fold increase from the same period the year prior. The new figures come after the company received its first 2 FDA approvals in 2024. | Image credit: Napat - stock.adobe.com

“Our order book for biosimilar Humira in the U.S. for 2024 has already grown from the initial 1 million units previously announced, to approximately 1.3 million units today. Revenues generated from these U.S. orders will be predominantly recognized in the second half of the year. Our recent launch of Stelara in Canada, Japan, and Europe highlights our global, multiproduct strategy. As we enter the second half of the year, we are already receiving replenishment orders in certain markets,” commented Robert Wessman, chairman and CEO of Alvotech, in a statement.

Financial Findings

As of June 30, 2024, Alvotech reported a cash and cash equivalents position of $10.9 million, excluding $25 million in restricted cash. Following a refinancing in July, the company's proforma cash balance increased to $153 million, with proforma gross borrowings of $1.035 billion, a slight reduction from the $1.056 billion recorded as of June 30. This refinancing improved Alvotech’s liquidity and debt profile, positioning the company for future growth.

For the 6 months ended June 30, 2024, Alvotech saw a significant increase in product revenue, reaching $65.9 million compared to $22.7 million in the same period of 2023. This growth was driven by the sales of AVT02 (adalimumab biosimilar; Simlandi) in Europe and Canada, the launch of AVT02 in the US, and AVT04 (ustekinumab biosimilar; Selarsdi) in Canada and Japan.

License and other revenue also experienced a substantial increase, totaling $169.7 million, up from a loss of $2.5 million in the first half of 2023. This rise was primarily due to milestone achievements, including the approval of AVT04 in Europe, the commencement of clinical phases for AVT16 (vendolizumab biosimilar), and the completion of confirmatory efficacy and safety studies for AVT03 (denosumab biosimilar) and AVT05 (golimumab biosimilar).

Despite the strong revenue performance, Alvotech reported a net loss of $153.5 million for the first half of 2024, compared to a loss of $86.9 million in the same period of 2023. The increased loss was largely attributable to finance costs, including a $120.5 million charge related to the fair value adjustment of predecessors earn out shares and a $63.1 million loss on the early redemption of existing debt. These costs, coupled with other financial adjustments, offset the gains in operating profit, which improved to $43.5 million from a loss of $189.1 million in the first half of 2023.

Other Corporate Milestones

Alvotech has made significant strides in both commercial and corporate development. They reported positive results from clinical studies for AVT03, a proposed biosimilar to Prolia and Xgeva (reference denosumab) and have expanded their strategic alliance with STADA Arzneimittel to include AVT03, granting STADA semi-exclusive and exclusive commercial rights in various regions. Alvotech also extended its partnership with Advanz Pharma for the commercialization of biosimilars to Eylea (reference aflibercept) in Europe, with a marketing application for AVT06 (aflibercept biosimilar) accepted by the European Medicines Agency. Additionally, Alvotech and STADA launched Uzpruvo, a biosimilar to Stelara (ustekinumab), in Europe following the expiry of exclusivity.

On July 1, 2024, the company converted a majority of its subordinated convertible bonds into ordinary shares, increasing its total issued shares to over 324 million. This conversion reflects strong investor confidence and enhances Alvotech's equity base.

Additionally, Alvotech secured a $965 million senior first lien term loan facility, led by GoldenTree Asset Management, which closed on July 11, 2024. The facility allowed the company to refinance its existing debt, reducing capital costs and improving its debt profile. With this strategic refinancing, Alvotech has positioned itself for sustained financial stability and growth, with all outstanding debt maturing in June 2029 or later.

References

1. Alvotech reports record revenues and adjusted EBITDA for the second quarter and first six months of 2024. News release. Alvotech; August 15, 2024. Accessed August 21, 2024. https://investors.alvotech.com/news-releases/news-release-details/alvotech-reports-record-revenues-and-adjusted-ebitda-second

2. Jeremias S. FDA approves 10th adalimumab biosimilar, Simlandi. The Center for Biosimilars®. February 24, 2024. Accessed August 21, 2024. https://www.centerforbiosimilars.com/view/fda-approves-tenth-adalimumab-biosimilar-simlandi

3. Jeremias S. Eye on Pharma: Simlandi US launch; ranibizumab partnership; expanded access for adalimumab biosimilars. The Center for Biosimilars. May 27, 2024. Accessed August 21, 2024. https://www.centerforbiosimilars.com/view/eye-on-pharma-simlandi-us-launch-ranibizumab-partnership-expanded-access-for-adalimumab-biosimilars

4. Jeremias S. Alvotech’s Stelara biosimilar, Selarsdi, receives FDA approval. The Center for Biosimilars. April 16, 2024. Accessed August 21, 2024. https://www.centerforbiosimilars.com/view/alvotech-s-stelara-biosimilar-selarsdi-receives-fda-approval

5. Jeremias S. Eye on pharma: first PBM to cover Yusimry; Celltrion to test Ocrevus biosimilar; another Stelara settlement. The Center for Biosimilars. June 15, 2023. Accessed August 21, 2024. https://www.centerforbiosimilars.com/view/eye-on-pharma-first-pbm-to-cover-yusimry-celltrion-to-test-ocrevus-biosimilar-another-stelara-settlement

6. Jeremias S. EMA approved first ustekinumab biosimilar, Uzpruvo. The Center for Biosimilars. January 10, 2024. Accessed August 21, 2024. https://www.centerforbiosimilars.com/view/ema-approves-first-ustekinumab-biosimilar-uzpruvo

7. Jeremias S. Eye on pharma: VA picks Hadlima; Biocon, Sandoz partnership; a Stelara settlement abroad. The Center for Biosimilars. February 21, 2024. August 21, 2024. https://www.centerforbiosimilars.com/view/eye-on-pharma-va-picks-hadlima-biocon-sandoz-partnership-a-stelara-settlement-abroad