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Samsung Epis Holdings rebounds toward opening price
Samsung Epis Holdings jumped 24.21% (up 107,000 won) from the previous session to close at 549,000 won.
The rally followed news that the company had submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 1 clinical trial of an antibody drug conjugate (ADC) candidate targeting bladder cancer patients.
This is Samsung Epis Holdings’ first new drug pipeline, and the company is aiming to start a global phase 1 trial next year.
Beyond the biosimilar (generic biologics) business of its wholly owned subsidiary Samsung Bioepis Samsung Epis Holdings has set up a new drug development subsidiary, Epis Nexlab, signaling an aggressive push into innovative drug R&D. The group is throwing its weight behind enhancing corporate value through novel drug projects.
Samsung Epis Holdings which was spun off from Samsung Biologics, through a physical division and re listed began trading at 611,000 won per share on Nov. 24. It ended that first day at 438,500 won wiping out roughly 20 trillion won in market capitalization.
While the stock has since recovered sharply it still has not returned to its opening price a point drawing investor attention.
Wenesday's hike was also propelled by Hana Securities analyst Kim Sun-ah's report titled "Undervalued from Every Angle" that set a target price of 610,000 won for Samsung Epis Holdings.
"Competition in the biosimilar market is indeed intensifying, but the company is expanding the overall market while steadily growing its revenues.” Kim wrote.
“To date, it has launched eight biosimilar products, two additional biosimilars have completed development and reached the commercialization stage and the company plans to develop more than 10 new products by 2030.” she said explaining her positive view on Samsung Epis Holdings.
She also pointed out that its Keytruda biosimilar is advancing through clinical development faster than rival candidates.
Kim added that “a decline in profit margins driven by full-scale new drug development is inevitable but the top line growth trend is expected to continue.”
She noted that when Samsung Biologics acquired the remaining stake in Samsung Bioepis from U.S.-based Biogen in 2022 there was already purchase price allocation (PPA) amortization and that the remaining amortization costs were fully transferred to Samsung Epis Holdings through the recent spin-off.
As a result she factored in annual amortization of intangible assets of around 200 billion to 300 billion won.
Based on EBITDA (earnings before interest, taxes, depreciation and amortization) for 2027 that reflects these intangible amortization costs, she estimated Samsung Epis Holdings’ operating value at 14.7632 trillion won.
Adding 251.5 billion won in cash and cash equivalents yields an enterprise value of about 15 trillion won. Dividing this by approximately 2.48 million shares outstanding she calculated a fair value of 610,000 won per share, implying 36.9% upside from the current share price of 442,000 won.
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Y2Solution surges on U.S. subsidiary potential
Y2Solution Co surged 14.89% (up 525 won) to close at 4,050 won. The move is seen as being driven by the public release that day on major portals of a PharmEdaily premium content article published on Nov. 26 titled “Why M&A hungry biopharma is eyeing Y2Solution’s U.S. subsidiary”
According to that PharmEdaily article, Luxa Biotechnology a U.S. joint venture of Y2Solution, is drawing industry attention as its dry age related macular degeneration (dry AMD) therapy in development is seen as superior to competitors in both productivity and clinical performance.
Y2Solution invested 15 billion won in 2019 to acquire a 50% stake in Luxa. Luxa’s dry AMD candidate “RPESC RPE 4W” is viewed as having differentiated competitiveness. The therapy is manufactured by differentiating RPESCs (retinal pigment epithelial stem cells) derived from adult retina tissue over four weeks.
According to the company, cells from a single donor can yield enough product to treat thousands to tens of thousands of patients. Despite being a cell therapy it has built a near off the shelf like mass production system which is seen as a key factor attracting interest from global pharmaceutical companies in terms of productivity and supply stability.
Luxa’s therapy is already reported to have caught the attention of global pharma players thanks to its technological strengths. The company has said that various forms of talks covering license out deals equity investments and M&A are actively under way.
At a recent conference it reportedly held multiple technology transfer meetings with big pharma companies and some overseas investment institutions are said to have valued Luxa at around US$300 million (roughly 400 billion won).
A Y2Solution official said “It’s true that with some parties we have been exploring a wide range of possibilities including technology and business partnerships investments licensing and M&A.”
adding “We have also received multiple merger proposals from Nasdaq listed companies.”
However the official cautioned “If we disclose company names or terms before contracts are signed, it could raise concerns about violating fair disclosure rules so we cannot comment in detail.”
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Genome&Company poised to receive milestones?
Genome&Company climbed 17.29% (up 650 won) to close at 4,410 won. The sharp rally came despite the absence of any disclosures or press releases drawing market interest.
Genome&Company has evolved from a microbiome therapeutics developer into an ADC-focused innovative drug company and is concentrating on early license out of its in-house discovery pipelines to monetize them.
In May 2024, the company licensed out its novel-target ADC antibody “Debio 0633” to Switzerland-based Debiopharm. In February this year, it licensed out its novel target immunooncology antibody drug “GENA-104 (EP0089)” to U.K.-based Ellipses Pharma.
Debiopharm is currently preparing to launch a phase 1 trial, while Ellipses Pharma has registered a phase 1/2a trial on ClinicalTrials and is conducting a study in about 190 patients.
A Genome&Company official said “We have two pipelines that have been licensed out one already in clinical trials and the other preparing to start and we see this as being the time when those developments start to be reflected.”
adding “We are still only at the beginning.”
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