Key Highlights – expected completion in YR 2025:
- OraTech Pharmaceuticals Inc. - A new joint venture
focused on oral insulin development, with planned U.S. Phase 3
trials.
- Distribution of majority of Oramed's holding in OraTech to
Oramed shareholders via dividend planned to coincide with OraTech's
public listing.
- Cash dividend planned (~$0.25 per
share).
- Marketing Authorization Application has been submitted by HTIT,
and commercialization preparations are underway for oral insulin
capsule. OraTech expected to receive royalties from sales in
China.
- Oramed to receive royalty streams over the next decade from
multiple Scilex products including $400,000 due for Q4 2024 sales.
NEW
YORK, March 4, 2025 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) ("Oramed"), a
clinical-stage pharmaceutical company focused on the development of
oral drug delivery platforms, today issued a letter to its
shareholders from its President and Chief Executive Officer
Nadav Kidron.
Dear Shareholders,
I am happy to take this opportunity to provide our shareholders
with an overview of our key accomplishments and outline our future
direction.
Oramed-HTIT Joint Venture: OraTech - A Transformational
Partnership
We are excited about our joint venture, OraTech Pharmaceuticals,
Inc. ("OraTech"), which we believe represents a significant step
forward in advancing our proprietary oral drug delivery technology.
This company will serve as the foundation for developing,
marketing, and commercializing innovative treatments leveraging
Oramed's oral insulin and POD™ platform.
The collaboration combines Oramed's innovative drug delivery
technology with Hefei Tianhui Biotech Co., Ltd's ("HTIT")
state-of-the-art manufacturing capabilities, creating a powerful
synergy that we believe positions OraTech as a true game-changer in
the pharmaceutical industry. This integration of cutting-edge
technology and advanced manufacturing expertise will enable us to
ensure consistent, high-quality production at scale, setting new
standards for oral protein delivery.
OraTech is backed by a substantial capital and operational
commitment. These resources are earmarked to support the initiation
of a Phase 3 clinical trial in the U.S., a key milestone in
bringing oral insulin to market. By leveraging insights from prior
clinical studies, we have strategically designed this refined Phase
3 trial to focus on key patient subpopulations that we believe have
the highest potential to demonstrate efficacy.
In parallel, HTIT has already submitted a Marketing
Authorization Application to China's regulators for the oral insulin
capsule in China.
Commercialization preparations are underway, and OraTech is
expected to receive royalties from sales in China.
The establishment of OraTech represents a unique opportunity to
build a company focused on advancing next-generation therapies,
unlocking new market potential.
Stock Dividend and Strategic Opportunities
OraTech has initiated work on the Securities and Exchange
Commission registration process with the goal of achieving Nasdaq
trading status later this year. As part of this strategic
initiative, Oramed plans to distribute OraTech stock to its
shareholders via a dividend, granting them the majority of Oramed's
ownership in OraTech. This distribution is expected to coincide
with OraTech's public trading debut on Nasdaq.
Cash Dividend
Oramed is evaluating an opportunity to issue cash dividends of
approximately $0.25 per share
intended to help offset any potential tax liabilities associated
with the OraTech stock distribution. Beyond mitigating potential
tax concerns, this initiative underscores our commitment to
maximizing shareholder value.
Strategic Scilex Financing : Delivering Tangible
Value
Our investment in Scilex Holding Company ("Scilex") underscores
our commitment to generating meaningful value through
well-structured financial transactions. To date, we have received
$70 million from our $99.5 million secured loan agreement, with
additional payments of approximately $53
million expected over the next two years.
Beyond these direct financial returns, the transaction has
provided us with 12.25 million shares of Scilex common stock, which
will increase to 18.75 million shares this month as a result of
warrant vesting. Additionally, we structured this deal to include
meaningful upside through ongoing royalty streams from the
following Scilex products:
- ZTlido – A 4% royalty on sales worldwide for the next
decade and a 25% profit share on the majority of sales outside the
U.S., leveraging its U.S. Food and Drug Administration approval as
a lidocaine topical system targeting the global pain patch market
valued at $4.8 billion in 2021, and
is projected to reach $7.3 billion by
2031. Oramed will receive $400,000 in
royalties for Q4 2024 and expects this amount to increase on a
quarterly basis. More details at www.ztlido.com.
- ELYXYB – The first ready-to-use oral solution for acute
migraines, addressing a condition that affects approximately 39
million Americans. We hold a 2% royalty on worldwide sales. More
details at www.elyxyb.com.
- GLOPERBA – An innovative oral liquid formulation for
gout treatment, tapping into a market with strong growth potential.
We hold a 2% royalty on worldwide sales and a 25% profit share on
the majority of sales outside the U.S. More details at
www.gloperba.com.
Strong Balance Sheet: Positioned for Growth and Value
Creation
Oramed maintains a robust financial position, strengthened by
our strategic Scilex transaction and the OraTech joint venture. Our
disciplined approach to cash management includes CDs, bonds, real
estate and equities. We believe that our disciplined capital
allocation strategy enables us to maintain sufficient liquidity for
both our core operations and strategic initiatives, positioning
Oramed for sustainable long-term growth.
Looking Ahead: A Commitment to Strategic Growth
Looking forward, we are actively pursuing acquisitions and
partnerships that leverage our expertise in technology development
and strategic dealmaking. We have identified several promising
opportunities across multiple innovation ecosystems and expect to
announce additional strategic initiatives in the coming
quarters.
Sincerely,
Nadav
Kidron
Chief Executive Officer
Forward-looking statements: This press release
contains forward-looking statements, which may generally be
identified by the use of the words "anticipates," "expects,"
"intends," "plans," "should," "could," "would," "may," "will,"
"believes," "estimates," "potential," "target," or "continue" and
variations or similar expressions and include statements that
OraTech will serve as the foundation for developing, marketing, and
commercializing innovative treatments leveraging Oramed's oral
insulin and POD™ platform, that the initiation of a Phase 3
clinical trial in the U.S. will be a key milestone in bringing oral
insulin to market, that OraTech is a true game-changer in the
pharmaceutical industry, that integration of cutting-edge
technology and advanced manufacturing expertise enables Oramed to
ensure consistent, high-quality production at scale, setting new
standards for oral protein delivery, expected royalties from sales
in Greater China, unlocking new
market potential, the process and timing for OraTech becoming a
publicly traded company listed on Nasdaq, Oramed plans to
distribute OraTech stock to its shareholders via a dividend,
Oramed's ability to create shareholder value, including through
well-structured financial transactions, expected royalty
contributions from Scilex and expectations to announce additional
strategic initiatives in the coming quarters. These statements are
based upon the current expectations and beliefs of management and
are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include,
but are not limited to, uncertainties in satisfaction of closing
conditions for the contemplated transactions, risks and
uncertainties discussed in the Company's most recent annual and
quarterly reports and detailed from time to time in the Company's
other filings with the Securities and Exchange Commission, all of
which could cause the actual results or performance of Oramed to
differ materially from those contemplated in such forward-looking
statements. These forward-looking statements speak only as of the
date hereof. Oramed undertakes no obligation to update any of these
forward-looking statements to reflect events or circumstances after
the date hereof or to reflect actual outcomes, unless required by
law.
Company Contact:
+1-844-9-ORAMED
ir@oramed.com
www.oramed.com
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SOURCE Oramed Pharmaceuticals Inc.
