Full Press Release Details
Kamada Reports Third Quarter and First Nine
Months of 2021 Financial Results,
and Strategic Transformational Acquisition of
a Portfolio of Four FDA-Approved Plasma-Derived Hyperimmune Commercial Products
REHOVOT, Israel - November 22, 2021
-- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced financial results for the three
and nine months ended September 30, 2021.
"As our business continues to perform as
expected in 2021, we look ahead to several exciting potential growth catalysts for the Company," said Amir London, Kamada's
Chief Executive Officer. "We are thrilled to separately announce a new important growth driver
for our business with the strategic acquisition of a portfolio of four U.S. Food and Drug Administration (FDA)-approved plasma-derived
hyperimmune commercial products from Saol Therapeutics. As a result of this transaction, Kamada is strengthening its global leadership
position in the plasma-derived specialty hyperimmune market. The annual global revenue of the acquired portfolio in 2021 is expected to
be between $40 million to $45 million, with approximately 75% and 20% of sales generated in the U.S. and Canada, respectively. This is
a strategic and synergistic acquisition for Kamada and furthers our core objective of entering 2022 as a fully-integrated specialty plasma
company, with strong commercial capabilities in the U.S. market. We expect to leverage our existing strong international distribution
network to grow the acquired portfolio revenues in new geographic markets."
"We have now transferred our GLASSIA
manufacturing responsibilities to Takeda and will begin receiving royalty payments in 2022 at a
rate of 12% on net sales through August 2025 and at a rate of 6% thereafter until 2040. We project receiving royalties from Takeda
in the range of $10 million to $20 million per year from 2022 to 2040. In addition, we continue to advance the process aimed at both expanding
our current U.S. plasma collection center in Texas and opening additional U.S. centers by leveraging our existing FDA license. We view
the opening of new U.S. plasma collection centers as a significant growth opportunity for Kamada, and an important step in becoming a
vertically integrated specialty plasma products company. Lastly, we continue to progress the pivotal Phase 3 InnovAATe clinical trial
of our proprietary Inhaled AAT for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). We are encouraged by a recent Data and Safety
Monitoring Board (DSMB) review that concluded that the data generated to date support the continuation of the trial without the need for
modifications," concluded Mr. London.
Financial Highlights for the Three Months Ended
Financial Highlights for the Nine Months Ended
Balance Sheet Highlights
As of September 30, 2021, the Company had cash,
cash equivalents, and short-term investments of $99.8 million, as compared to $109.3 million on December 31, 2020. The Company's
working capital as of September 30, 2021, comprising of current assets (excluding cash and cash equivalents, and short-term investments)
net of current liabilities, increased by $8.8 million, to $52.5 million.
Kamada management will host an investment community
conference call on Monday, November 22, at 8:30am Eastern Time to discuss the strategic acquisition and these results and answer questions.
Shareholders and other interested parties may participate in the conference call by dialing 877-407-0792 (from within the U.S.), 1-809-406-247
(from Israel), or 201-689-8263 (International) and entering the conference identification number: 13724183. The call will also be webcast
live on the Internet at:
Kamada Ltd. (the "Company") is a global
specialty plasma-derived biopharmaceutical company with a diverse portfolio of marketed products, a robust development pipeline and industry-leading
manufacturing capabilities. The Company's strategy is focused on driving profitable growth from its current commercial products,
its plasma-derived development pipeline and its manufacturing expertise, while evolving into a vertically integrated plasma-derived company.
The Company's two leading commercial products are GLASSIA and KEDRAB . GLASSIA was the first liquid, ready-to-use, intravenous
plasma-derived AAT product approved by the FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals
Company Limited ("Takeda") and in other countries through local distributors. Pursuant to an agreement with Takeda, the Company
will continue to produce GLASSIA for Takeda through 2021 and Takeda will initiate its own production of GLASSIA for the U.S. market in
2021, at which point Takeda will commence payment of royalties to the Company until 2040. KEDRAB is an FDA approved anti-rabies immune
globulin (Human) for post-exposure prophylaxis treatment. KEDRAB is being marketed in the U.S. through a strategic partnership with Kedrion
S.p.A. During November 2021, the Company acquired a portfolio of four FDA-approved plasma derived hyperimmune products comprising of CYTOGAM ,
WINRHO , HEPAGAM and VARIZIG , these products are distributed in the U.S., Canada, and additional markets worldwide. The
Company has additional four plasma-derived products administered by injection or infusion, that are marketed through distributors in more
than 15 countries, including Israel, Russia, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has two
leading development programs; an inhaled AAT for the treatment of AAT deficiency for which the Company is currently conducting the InnovAATe
clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, and a plasma-derived hyperimmune immunoglobulin
(IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company leverages its expertise and presence in the Israeli
pharmaceutical market to distribute in Israel more than 20 products that are manufactured by third parties and have recently added nine
biosimilar products to its Israeli distribution portfolio, which, subject to EMA and the Israeli MOH approvals, are expected to be launched
in Israel between the years 2022 and 2025. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company's
lead shareholder, beneficially owning approximately 21% of the outstanding ordinary shares.
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking
statements within the meaning of 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, including statements regarding: 1) anticipation of receiving royalties from Takeda in the range of $10 million to $20 million
per year from 2022 to 2040, 2) optimism about strategic
business development opportunities that will utilize and expand our core plasma-derived development, manufacturing, and
commercialization expertise, 3) the belief that those opportunities are may be significant steps toward accomplishing our
strategic goal of becoming a fully integrated specialty plasma company, 4) plans for the opening of additional plasma collection
centers in the U.S. by leveraging our FDA license, 5) workforce downsizing resulting in an approximate 10% annual labor cost
reduction, 6) being encouraged by a recent DSMB review relating to Phase 3 InnovAATe
clinical trial that concluded that the data collected to date supports the continuation of the trial without a need for
modifications, 7) anticipated global revenue of the acquired product portfolio between $40
million to $45 million in 2021, and 8) the acquisition advancing Kamada's objective of entering 2022 as fully integrated
specialty plasma company, with strong commercial capabilities in the U.S. market, strengthening
its global leadership position in the plasma-derived specialty hyperimmune market. 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, the continued evolvement of the COVID-19
pandemic, its scope, effect and duration, availability of sufficient raw materials required to maintain manufacturing plans, the
effects of the COVID-19 pandemic and related government mandates on the availability of adequate levels of work-force required to
maintain manufacturing plans, disruption to the supply chain due to COVID-19 pandemic, continuation of inbound and outbound
international delivery routes, impact of the workforce downsizing plan, continued demand for Kamada's products, including
GLASSIA and KEDRAB, in the U.S. market and its Distribution segment related products in Israel, financial conditions of the
Company's customer, suppliers and services providers, Kamada's ability to integrate the new product portfolio into its
current product portfolio, Kamada's ability to grow the revenues of this new product portfolio, and leverage and expand its
international distribution network, ability to reap the benefits of the recent acquisition of the plasma collection center,
including the ability to open additional U.S. plasma centers, the ability to continue enrollment of the pivotal Phase 3 InnovAATe
clinical trial, unexpected results of clinical studies, including plasma-derived IgG treatment for COVID-19 and the level of demand
for such product, Kamada's ability to manage operating expenses, additional competition in the markets that Kamada competes,
regulatory delays, prevailing market conditions and the impact of general economic, industry or political conditions in the U.S.,
Israel or otherwise.. 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.
Chief Financial Officer
LifeSci Advisors, LLC
STATEMENTS OF FINANCIAL POSITTION
| As of September 30, | As of December 31, | |||||||||||
| 2021 | 2020 | 2020 | ||||||||||
| Unaudited | Audited | |||||||||||
| U.S Dollars in thousands | ||||||||||||
| Current Assets | ||||||||||||
| Cash and cash equivalents | $ | 99,840 | $ | 52,487 | $ | 70,197 | ||||||
| Short-term investments | - | 47,230 | 39,069 | |||||||||
| Trade receivables, net | 26,548 | 28,643 | 22,108 | |||||||||
| Other accounts receivables | 4,392 | 3,533 | 4,524 | |||||||||
| Inventories | 48,163 | 42,618 | 42,016 | |||||||||
| Total Current Assets | 178,943 | 174,511 | 177,914 | |||||||||
| Non-Current Assets | ||||||||||||
| Property, plant and equipment, net | 25,856 | 25,323 | 25,679 | |||||||||
| Right-of-use-assets | 3,361 | 3,694 | 3,440 | |||||||||
| Other long term assets | 3,380 | 1,081 | 1,573 | |||||||||
| Contract assets | 4,987 | 1,438 | 2,059 | |||||||||
| Deferred taxes | - | 298 | - | |||||||||
| Total Non-Current Assets | 37,584 | 31,834 | 32,751 | |||||||||
| Total Assets | $ | 216,527 | $ | 206,345 | $ | 210,665 | ||||||
| Current Liabilities | ||||||||||||
| Current maturities of bank loans | $ | 52 | $ | 322 | $ | 238 | ||||||
| Current maturities of lease liabilities | 1,181 | 1,038 | 1,072 | |||||||||
| Trade payables | 19,010 | 15,110 | 16,110 | |||||||||
| Other accounts payables | 6,346 | 6,236 | 7,547 | |||||||||
| Deferred revenues | - | 486 | - | |||||||||
| Total Current Liabilities | 26,589 | 23,192 | 24,967 | |||||||||
| Non-Current Liabilities | ||||||||||||
| Bank loans | - | 48 | 36 | |||||||||
| Lease liabilities | 3,283 | 3,589 | 3,593 | |||||||||
| Deferred revenues | 3,575 | 1,525 | 2,025 | |||||||||
| Employee benefit liabilities, net | 1,467 | 1,262 | 1,406 | |||||||||
| Total Non-Current Liabilities | 8,325 | 6,424 | 7,060 | |||||||||
| Shareholder's Equity | ||||||||||||
| Ordinary shares | 11,720 | 11,703 | 11,706 | |||||||||
| Additional paid in capital | 210,005 | 209,650 | 209,760 | |||||||||
| Capital reserve due to translation to presentation currency | (3,490 | ) | (3,490 | ) | (3,490 | ) | ||||||
| Capital reserve from hedges | 35 | 234 | 357 | |||||||||
| Capital reserve from share-based payments | 4,817 | 4,550 | 4,558 | |||||||||
| Capital reserve from employee benefits | (320 | ) | (356 | ) | (320 | ) | ||||||
| Accumulated deficit | (41,154 | ) | (45,562 | ) | (43,933 | ) | ||||||
| Total Shareholder's Equity | 181,613 | 176,729 | 178,638 | |||||||||
| Total Liabilities and Shareholder's Equity | $ | 216,527 | $ | 206,345 | $ | 210,665 |