Agreements

Date: 2016-10-06

Type of information: Milestone

Compound: ORMD-0801

Company: Oramed Pharmaceuticals (Israel) Hefei Tianhui Incubation of Technologies HTIT (China)

Therapeutic area: Metabolic diseases

Type agreement: licensing - investment

Action mechanism: protein. ORMD-0801is an orally administered insulin.

Disease:

Details:

• On December 29, 2015, Oramed Pharmaceuticals announced the closing of its previously-announced license and investment deal with Hefei Tianhui Incubation of Technologies Co. Ltd. Oramed has sold 1,155,367 restricted shares of Common Stock at a price of $10.39 per Share, for an aggregate amount of $12 million. Oramed has additionally received approval from the Office of the Chief Scientist of the Israeli Ministry of Economy (“OCS”) for the out-licensing agreement with HTIT. Following receipt of the OCS’s approval, the out-licensing deal for ORMD-0801, a novel oral insulin capsule, has now closed. Under the terms of the agreement, Oramed has granted HTIT exclusive rights for commercialization of ORMD-0801 in Greater China. The license includes multiple milestone payments aggregating $38 million and up to a 10% royalty, based on net sales of the product in China.
• On November 30, 2015, Oramed Pharmaceuticals announced it has signed definitive licensing and investment agreements valued at up to $50,000,000 with Hefei Tianhui Incubator of Technologies Co. for exclusive rights to market Oramed’s oral insulin capsule, ORMD-0801, in China, Hong Kong and Macau. The agreements were signed at the Israel Knesset (Parliament).

Financial terms:

The license agreement payments include a $3 million payment due upon execution of the agreement, $8 million in near-term payments subject to Oramed entering into certain agreements and the balance payable upon achievement of certain milestones. In addition, if all conditions are met, HTIT will pay a 10% royalty on net sales of the related commercialized products. In addition to the contemplated payments under the license agreement, pursuant to the investment agreement, Oramed will issue to HTIT 1,155,469 restricted shares of Oramed’s common stock at a price per share of approximately $10.39 and $12 million in total, subject to customary closing conditions.

Latest news:

• On October 6, 2016, Oramed Pharmaceuticals announced it has received an additional milestone payment of $4 million from Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT). This milestone is part of a previously-announced license and investment agreement between Oramed and HTIT, and follows recent milestone payments of $4 million and $6.5 million.
• On August 2, 2016, Oramed Pharmaceuticals announced it has received a milestone payment of $4 million from Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT). This milestone follows Oramed’s report of additional positive efficacy and safety data from its recently completed Phase IIb trial of its oral insulin product, ORMD-0801.
• On June 21, 2016, Oramed Pharmaceuticals announced that HTIT is transferring a $6.5 million milestone payment from the previously-announced license and investment agreement between Oramed and HTIT. The payment follows Oramed’s positive top-line results from its Phase IIb trial designed to evaluate the safety and efficacy of Oramed’s oral insulin capsule ORMD-0801 in patients with type 2 diabetes.