Kamada Ltd. (NASDAQ:KMDA) (TASE:KMDA), a plasma-derived
protein therapeutics company focused on orphan indications, today
reports that revenue during the first half of 2015 is in line with its
plans at $28 million. As a result, the Company affirms its previously
reported full year 2015 revenue guidance in the range of $70 million to
$73 million.
“During the first quarter of 2015, our Proprietary Product revenue was
impacted by a delay in the release of product batches as we awaited
final validation of a filling process. This process was validated in
April and the delayed revenue from the first quarter was realized in the
second quarter of 2015. Consequently, we are pleased to report that our
revenue for the first half of 2015 from Proprietary Products was
approximately $16 million and we are on track to achieve our full year
2015 revenue projections and to achieve our annual Glassia sales target
worldwide, a significant part of which is secured with orders already
received from Baxalta,” stated Gil Efron, Deputy Chief Executive and
Chief Financial Officer of Kamada.
The Company expects to report complete financial results for the three
and six months ended June 30, 2015 on July 30th. Information
regarding the conference call with investors will be provided in a
separate notification in the coming weeks.
About Kamada
Kamada Ltd. is focused on plasma-derived protein therapeutics for
immunomodulation orphan indications, and has a commercial product
portfolio and a robust late-stage product pipeline. The Company uses its
proprietary platform technology and know-how for the extraction and
purification of proteins from human plasma to produce Alpha-1
Antitrypsin (AAT) in a highly-purified, liquid form, as well as other
plasma-derived proteins. AAT is a protein derived from human plasma with
known and newly-discovered therapeutic roles given its immunomodulatory,
anti-inflammatory, tissue-protective and antimicrobial properties. The
Company’s flagship product is Glassia®, the first and only liquid,
ready-to-use, intravenous plasma-derived AAT product approved by the
U.S. Food and Drug Administration. Kamada markets Glassia in the U.S.
through a strategic partnership with Baxalta. In addition to Glassia,
Kamada has a product line of nine other injectable pharmaceutical
products that are marketed through distributors in more than 15
countries, including Israel, Russia, Brazil, India and other countries
in Latin America, Eastern Europe and Asia. Kamada has five late-stage
plasma-derived protein products in development, including an inhaled
formulation of AAT for the treatment of AAT deficiency that completed
pivotal Phase 2/3 clinical trials in Europe and entered Phase 2 clinical
trials in the U.S. Kamada also leverages its expertise and presence in
the plasma-derived protein therapeutics market by distributing 10
complementary products in Israel that are manufactured by third parties.
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of
Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E
of the U.S. Securities Exchange Act of 1934, as amended, and the safe
harbor provisions of the U.S. Private Securities Litigation Reform Act
of 1995. Forward-looking statements are statements that are not
historical facts, such as statements regarding assumptions and results
related to financial results forecast, commercial results, timing and
results of clinical trials and EMA and U.S. FDA authorizations.
Forward-looking statements are based on Kamada’s current knowledge and
its present beliefs and expectations regarding possible future events
and are subject to risks, uncertainties and assumptions. Actual results
and the timing of events could differ materially from those anticipated
in these forward-looking statements as a result of several factors
including, but not limited to, unexpected results of clinical trials,
delays or denial in the U.S. FDA or the EMA approval process, additional
competition in the AATD market or further regulatory delays. The
forward-looking statements made herein speak only as of the date of this
announcement and Kamada undertakes no obligation to update publicly such
forward-looking statements to reflect subsequent events or
circumstances, except as otherwise required by law.
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