Apogee Therapeutics signs manufacturing deal with Samsung Biologics

Published 11/03/2025, 11:36
Apogee Therapeutics signs manufacturing deal with Samsung Biologics

Apogee (NASDAQ:APOG) Therapeutics, Inc. (APGE), a biotechnology company specializing in biological products with a market capitalization of $2.2 billion, has entered into a significant agreement with Samsung (KS:005930) Biologics Co., Ltd. for the manufacture of a drug substance known as APG777. According to InvestingPro data, the company’s stock has shown significant momentum, gaining over 23% in the past week, though trading below its 52-week high of $72.29. The Master Services Agreement (MSA), effective as of February 28, 2025, outlines the production and supply of APG777 for clinical development and potential commercial sale if approved.

Under the agreement, confirmed on Monday, Apogee will pay Samsung service fees for each batch produced, in addition to costs for materials, testing, and storage. These financial details will be further specified in Project Specific Agreements (PSAs). The company maintains a strong financial position, with InvestingPro analysis showing more cash than debt on its balance sheet and a healthy current ratio of 18.55, indicating robust liquidity to meet its obligations.

Concurrently, Apogee has signed an Initial PSA with Samsung, also effective February 28, 2025. This PSA tasks Samsung with producing clinical batches of APG777 at its Incheon, South Korea facility, conducting process characterization and validation, and manufacturing process performance qualification lots.

Apogee is committed to purchasing minimum quantities of the product under the Initial PSA and has agreed to a separate PSA for commercial supply, which includes minimum purchase commitments from 2029 to 2034. Should Apogee decide against entering the commercial supply PSA, the company will be subject to an exit fee in the high single-digit millions.

The MSA is set to terminate in February 2035, or upon termination of an active PSA, and may be extended by mutual agreement. The Initial PSA will end in December 2034. Both parties have the right to terminate the agreements in the case of an uncured material breach, insolvency, or a force majeure event that prevents performance. If Apogee terminates the MSA or Initial PSA without cause, they will generally be responsible for the remaining product commitment purchase price, adjusted for any prior payments.

Details of the MSA and Initial PSA are expected to be included in Apogee’s Quarterly Report on Form 10-Q for the quarter ending March 31, 2025. This strategic partnership marks a significant step for Apogee Therapeutics in advancing its clinical development pipeline and potentially bringing new therapeutic options to market. Analysts maintain a strong buy consensus with price targets ranging from $80 to $116, suggesting significant upside potential. For more detailed financial analysis and exclusive insights, including additional ProTips and comprehensive valuation metrics, visit InvestingPro. The information in this article is based on a press release statement.

In other recent news, Apogee Therapeutics has been the focus of several analyst assessments and clinical trial updates. TD Cowen reiterated a Buy rating on Apogee Therapeutics, highlighting the company’s consistent performance in clinical developments, particularly with its Phase I APG990 trials. The analyst expressed confidence in the upcoming Phase II AD study results for APG777, which are expected by mid-year. Jefferies also maintained a Buy rating on Apogee, raising the stock’s price target to $86 from $82, following promising data from early-stage trials. The analyst noted positive outcomes from the Single Ascending Dose study of APG990, emphasizing its potential for quarterly to semiannual dosing.

Guggenheim, on the other hand, reaffirmed its Buy rating amid trial failures by competitors in the atopic dermatitis market. The firm’s confidence is based on Apogee’s focus on monoclonal antibodies targeting clinically validated epitopes and a trial design that mitigates placebo effects. These recent developments suggest a strategic advantage for Apogee, particularly as the atopic dermatitis market is projected to grow significantly by 2035. Apogee’s approach and the reduced competition in the market could position the company favorably in the coming years.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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