Alteogen

Alteogen is a biotechnology platform company whose core asset is Hybrozyme, a recombinant human hyaluronidase platform (development code ALT-B4, generic name berahyaluronidase alfa) that converts intravenously administered antibody and protein drugs into subcutaneous formulations.

ALT-B4 works by temporarily degrading hyaluronic acid, a main component of the extracellular matrix, thereby promoting the diffusion and absorption of the co-administered drug, and it is cited as cutting a dosing session from about 30 minutes intravenously to roughly one to two minutes.

Revenue rests on two pillars: upfronts, option-exercise fees, development and sales milestones plus material supply from ALT-B4 licenses to global pharmaceutical companies, and domestic sales of Tergase, a standalone hyaluronidase injection (segment revenue mix is not verifiable, so no figures are given).

With the Novartis agreement, Hybrozyme licensing partners increased to ten in total, expanding from the first deal with Sanofi in 2019 to Merck (MSD), Intas, Daiichi Sankyo and AstraZeneca.

Commercial-stage products the company has disclosed include Merck's Keytruda, Daiichi Sankyo's Enhertu and GSK's Jemperli, while remaining pipelines are covered by confidentiality, with only modalities such as monoclonal antibodies, bispecifics and antibody-drug conjugates known.

Tergase, approved by Korea's MFDS in July 2024 and launched that November, is the first human recombinant hyaluronidase in Korea, and in August 2026 the company said it supplies more than 30 of Korea's 47 tertiary general hospitals, that prescribing accounts had roughly doubled year on year, and that it had cleared drug committee reviews at more than 100 hospitals.

Domestic marketing and sales are handled by subsidiary Alteogen Biologics, and the clinic-channel co-promotion partner was switched from Pharma Research to GC Biopharma Wellbeing in April 2026.

The competitive picture is twofold: only two companies worldwide, Halozyme and Alteogen, have commercialized recombinant human hyaluronidase for intravenous-to-subcutaneous conversion, while Korea's standalone market is led by Huons' animal-derived Hyalase injection, with Huons pushing for leadership via its recombinant Hydizyme injection.

The profit and loss structure has been transformed within three years.

Revenue rose from KRW 28.8 billion in 2022 to KRW 96.5 billion in 2023, KRW 102.9 billion in 2024 and KRW 215.8 billion in 2025, while operating results moved from losses of KRW 29.4 billion in 2022 and KRW 9.7 billion in 2023 to profits of KRW 25.4 billion in 2024 and KRW 106.9 billion in 2025.

The operating margin jumped from 24.7 percent in 2024 to 49.5 percent in 2025, reflecting a structural shift in which low-cost licensing and milestone recognition accounts for a larger share of revenue.

Net profit attributable to owners was KRW 141.7 billion in 2025 with operating cash flow of KRW 124.1 billion, confirming that earnings translated into cash, in contrast with negative operating cash flow of KRW 7.8 billion in 2023.

On the balance sheet, end-2025 total equity stood at KRW 454.4 billion against total liabilities of KRW 244.3 billion, with a debt-to-equity ratio of 53.8 percent, down from 73.2 percent in 2023.

Quarterly figures swing sharply with the timing of contract recognition: the second quarter of 2025 showed revenue of KRW 18.6 billion and an operating loss of KRW 0.4 billion, followed by revenue of KRW 49.0 billion and operating profit of KRW 26.7 billion in the third quarter, KRW 64.5 billion and KRW 19.6 billion in the fourth, KRW 71.6 billion and KRW 39.3 billion in the first quarter of 2026, and KRW 68.9 billion and KRW 34.2 billion in the second.

First-quarter 2026 net profit attributable to owners of KRW 71.7 billion far exceeded that quarter's operating profit, suggesting a sizeable non-operating contribution, while second-quarter net profit of KRW 28.4 billion came in below operating profit, showing how volatile this line is quarter to quarter.

In a preliminary disclosure on August 7, 2026 the company said first-half cumulative revenue was KRW 140.5 billion with operating profit of KRW 73.5 billion and net profit of KRW 101.3 billion, and set additional licensing results as a second-half goal, broadly consistent with the sum of the confirmed quarterly figures.

Subcutaneous conversion has become a core formulation strategy for blockbuster drugs, improving patient convenience and hospital throughput at the same time.

Competition has intensified between Merck, defending against the patent cliff ahead of Keytruda's 2028 US substance patent expiry, and Halozyme, seeking to preserve its subcutaneous franchise, placing Alteogen at the center of that contest. Downstream demand indicators point to an early diffusion phase.

In Merck's second-quarter 2026 results, Qlex accounted for USD 463 million, or 5.5 percent, of USD 8.366 billion in combined Keytruda-family sales, after USD 40 million in the fourth quarter of 2025 and USD 128 million in the first quarter of 2026.

Merck attributed rising adoption to the granting of a permanent reimbursement code in the United States and set a target of lifting Qlex to 30 to 40 percent of US Keytruda volumes by the end of 2027.

In a report cited in August 2026, Samsung Securities projected Keytruda Qlex sales of USD 1.9 billion in 2026, USD 10.1 billion in 2027 and USD 16.9 billion in 2028.

Geographic expansion is also under way: on August 24, 2026 a Japanese Ministry of Health, Labour and Welfare subcommittee recommended manufacturing and marketing approval for Keytruda Qlex, covering the 22 indications Keytruda already holds in Japan. Relative positioning hinges on contract terms.

The Merck agreement is understood to carry a 2 percent royalty on net sales after all sales-based milestones are achieved, which some viewed as below market expectations, while the Biogen agreement signed in March 2026 was shown in Biogen's quarterly filing to carry a mid-single-digit royalty.

Halozyme, meanwhile, continued expanding its own book of deals, announcing in January 2026 an exclusive license with Takeda applying ENHANZE to vedolizumab.

The most recent verified development is deal expansion.

On September 2, 2026 the company signed an option and license agreement with Novartis to develop and commercialize subcutaneous formulations of multiple products, its fourth deal this year and the tenth for the Hybrozyme platform, stating that receipts could reach up to USD 3.223 billion if all options are exercised and milestones achieved, with net-sales royalties payable separately after commercialization.

The filing, however, deferred disclosure of the target products, milestones and royalties until 2053 on confidentiality grounds, and noted the total contract value could shrink on clinical failure or weak sales and that the agreement could be terminated in cases such as approval failure.

Cash inflow from the sales stage is only beginning. The company issued an invoice on August 31, 2026 for its first sales-linked fee of USD 25 million from Merck, with payment due within 30 days of issuance under the contract.

At BIO USA in June 2026, Chief Executive Jeon Tae-yeon said KRW 1.5 trillion in milestones remained to be received from Merck and that meaningful royalties were expected to begin about three years later.

Domestically, the company said multiple investigator-initiated trials are under way to broaden Tergase's applications and that it has begun preparing the trials and procedures needed for overseas entry including Europe.

On the capital markets side, the company disclosed on July 16, 2026 that after reviewing market conditions, KOSDAQ revitalization policy and flow effects it would postpone the KOSPI transfer, would revisit the timing later, and would carry out a bonus issue of 0.3 new shares per share.

Shinhan Investment Securities analyst Um Min-yong said on September 3, 2026 that he was raising his target price from KRW 480,000 to KRW 540,000 and maintaining a Buy rating, reflecting the possibility that antibody-oligonucleotide conjugate therapeutics were included in the Novartis deal.