Full Press Release Details
Reports First Quarter 2021 Financial Results, Recent Achievements and Corporate Development Activities
Israel - May 12, 2021 -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced
financial results for the three months ended March 31, 2021.
financial results for the first quarter of 2021 were in-line with our expectations and we continue to advance our business activities
in multiple strategic directions," said Amir London, Kamada's Chief Executive Officer.
pivotal Phase 3 InnovAATe clinical trial of Inhaled AAT for the treatment of Alpha-1 Antitrypsin Deficiency (AATD) is progressing, as
we concurrently evaluate strategic opportunities to engage a commercialization partner for this key product candidate, in a market which
is currently estimated at over one billion dollar and growing six to eight percent annually. In addition, we continue to supply our plasma-derived
COVID-19 Immunoglobulin (IgG) investigational product to the Israeli Ministry of Health (IMOH) for the treatment of hospitalized patients,
and during the first quarter of the year, we finalized the planned production ramp up of the product in anticipation of potential demand
from additional international markets," continued Mr. London.
are actively engaged in expanding the hyperimmune plasma collection capacity of our recently acquired Texas-based plasma collection center
and initiated planning for the opening of additional U.S. centers by leveraging our U.S. Food and Drug Administration license. We are
committed to growing our hyperimmune IgG portfolio and believe that expanding our plasma collection capabilities
is a significant strategic step toward accomplishing this goal. In addition, we remain focused on evaluating new strategic business development
opportunities that will utilize and expand our core expertise in the development, manufacturing and commercialization of plasma-derived
therapeutics and will further advance our strategic objective of evolving into a fully integrated specialty plasma company. In order
to leverage these opportunities, we intend to utilize our strong cash position of nearly $110 million," concluded Mr. London.
Highlights for the Three Months Ended March 31, 2021
of March 31, 2021, the Company had cash, cash equivalents, and short-term investments of $109.5 million, as compared to $109.3 million
on December 31, 2020. The slight increase was due to positive operational cash flow.
Corporate Highlights
management will host an investment community conference call on Wednesday, May 12, 2021, at 8:30am Eastern Time to discuss 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: 13719388.
The call will also be webcast live on the Internet at http://public.viavid.com/index.php?id=144748.
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
KEDRRAB . 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. 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; a plasma-derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19) and 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. 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.
Note Regarding Forward-Looking Statements
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 to receive a $2 million payment from Takeda by the end
of 2021 upon completion of the transition of GLASSIA manufacturing to Takeda, and the transfer to Takeda of the GLASSIA BLA, 2) plans
to affect a workforce downsizing during early third quarter of 2021, which may result in potential annual labor costs savings of approximately
10%, 3) continue advancement of the pivotal Phase 3 InnovAATe clinical trial of Inhaled AAT for the treatment of Alpha-1 Antitrypsin
Deficiency (AATD) and evaluation of strategic opportunities to engage commercialization partner for this key product candidate, 4) statement
regarding the size and annual growth rate of the AATD market, 5) continuation of supply of the plasma-derived COVID-19 IgG investigational
product to the IMOH for the treatment of hospitalized patients, and anticipation of potential demand for the product from additional
international markets, 6) expansion of the hyperimmune plasma collection capacity of the recently acquired Taxes based plasma collection
center and initiation of planning for the opening of additional centers in the U.S. by leveraging our FDA license, 7) commitment to growing
the hyperimmune IgG portfolio, 8) focus on exploring new strategic business development opportunities
that will utilize and expand our core expertise in the development, manufacturing and commercialization of plasma-derived therapeutics
and advance will further our strategic objective to evolve into a fully integrated specialty plasma company, 9) leveraging these
business development opportunities by the intention to utilize the strong cash position of nearly $110 million, and 10) anticipated reduction
in revenues and profitability during 2021 driven by the transition of GLASSIA manufacturing to Takeda and the continued effect on
the Company's operating environment created by the ongoing global COVID-19 pandemic. 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, 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.
STATEMENTS OF FINANCIAL POSITION
| As of March 31, | As of December 31, | |||||||||||
| 2021 | 2020 | 2020 | ||||||||||
| Unaudited | Audited | |||||||||||
| U.S Dollars in thousands | ||||||||||||
| Assets | ||||||||||||
| Current Assets | ||||||||||||
| Cash and cash equivalents | $ | 61,436 | $ | 49,288 | $ | 70,197 | ||||||
| Short-term investments | 48,038 | 47,124 | 39,069 | |||||||||
| Trade receivables, net | 20,367 | 26,266 | 22,108 | |||||||||
| Other accounts receivables | 4,091 | 1,736 | 4,524 | |||||||||
| Inventories | 41,155 | 41,787 | 42,016 | |||||||||
| Total Current Assets | 175,087 | 166,201 | 177,914 | |||||||||
| Non-Current Assets | ||||||||||||
| Property, plant and equipment, net | 25,492 | 24,379 | 25,679 | |||||||||
| Right-of-use assets | 3,479 | 3,800 | 3,440 | |||||||||
| Other long term assets | 3,175 | 1,053 | 1,573 | |||||||||
| Contract assets | 3,295 | 421 | 2,059 | |||||||||
| Deferred taxes | - | 939 | - | |||||||||
| Total Non-Current Assets | 35,441 | 30,592 | 32,751 | |||||||||
| Total Assets | $ | 210,528 | $ | 196,793 | $ | 210,665 | ||||||
| Liabilities | ||||||||||||
| Current Liabilities | ||||||||||||
| Current maturities of bank loans | $ | 127 | $ | 465 | $ | 238 | ||||||
| Current maturities of lease liabilities | 1,092 | 928 | 1,072 | |||||||||
| Trade payables | 15,076 | 18,440 | 16,110 | |||||||||
| Other accounts payables | 5,682 | 4,875 | 7,547 | |||||||||
| Deferred revenues | - | 649 | - | |||||||||
| Total Current Liabilities | 21,977 | 25,357 | 24,967 | |||||||||
| Non-Current Liabilities | ||||||||||||
| Bank loans | 20 | 138 | 36 | |||||||||
| Lease liabilities | 3,417 | 3,663 | 3,593 | |||||||||
| Deferred revenues | 2,525 | 569 | 2,025 | |||||||||
| Employee benefit liabilities, net | 1,369 | 1,251 | 1,406 | |||||||||
| Total Non-Current Liabilities | 7,331 | 5,621 | 7,060 | |||||||||
| Shareholder's Equity | ||||||||||||
| Ordinary shares | 11,713 | 11,647 | 11,706 | |||||||||
| Additional paid in capital net | 209,859 | 204,702 | 209,760 | |||||||||
| Capital reserve due to translation to presentation currency | (3,490 | ) | (3,490 | ) | (3,490 | ) | ||||||
| Capital reserve from hedges | 30 | 264 | 357 | |||||||||
| Capital reserve from share-based payments | 4,674 | 8,903 | 4,558 | |||||||||
| Capital reserve from employee benefits | (320 | ) | (356 | ) | (320 | ) | ||||||
| Accumulated deficit | (41,246 | ) | (55,855 | ) | (43,933 | ) | ||||||
| Total Shareholder's Equity | 181,220 | 165,815 | 178,638 | |||||||||
| Total Liabilities And Shareholder's Equity | $ | 210,528 | $ | 196,793 | $ | 210,665 |
STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
| Three months period ended | Year ended | |||||||||||
| March 31, | December 31, | |||||||||||
| 2021 | 2020 | 2020 | ||||||||||
| Unaudited | Audited | |||||||||||
| U.S Dollars in thousands | ||||||||||||
| Revenues from proprietary products | $ | 20,870 | $ | 25,317 | $ | 100,916 | ||||||
| Revenues from distribution | 4,030 | 7,973 | 32,330 | |||||||||
| Total revenues | 24,900 | 33,290 | 133,246 | |||||||||
| Cost of revenues from proprietary products | 12,468 | 14,947 | 57,750 | |||||||||
| Cost of revenues from distribution | 3,501 | 6,892 | 27,944 | |||||||||
| Total cost of revenues | 15,969 | 21,839 | 85,694 | |||||||||
| Gross profit | 8,931 | 11,451 | 47,552 | |||||||||
| Research and development expenses | 2,628 | 3,347 | 13,609 | |||||||||
| Selling and marketing expenses | 1,123 | 940 | 4,518 | |||||||||
| General and administrative expenses | 2,809 | 2,312 | 10,139 | |||||||||
| Other expense | 7 | 2 | 49 | |||||||||
| Operating income | 2,364 | 4,850 | 19,237 | |||||||||
| Financial income | 110 | 317 | 1,027 | |||||||||
| Income in respect of securities measured at fair value, net | - | 102 | 102 | |||||||||
| Income (expense) in respect of currency exchange differences and derivatives instruments, net | 266 | 432 | (1,535 | ) | ||||||||
| Financial expense | (53 | ) | (77 | ) | (266 | ) | ||||||
| Income before tax on income | 2,687 | 5,624 | 18,565 | |||||||||
| Taxes on income | - | 406 | 1,425 | |||||||||
| Net Income | $ | 2,687 | $ | 5,218 | $ | 17,140 | ||||||
| Other Comprehensive Income (loss) : | ||||||||||||
| Amounts that will be or that have been reclassified to profit or loss when specific conditions are me | ||||||||||||
| Gain (loss) from securities measured at fair value through other comprehensive income | - | (188 | ) | (188 | ) | |||||||
| Gain on cash flow hedges | (73 | ) | 241 | 876 | ||||||||
| Net amounts transferred to the statement of profit or loss for cash flow hedges | (254 | ) | 34 | (528 | ) | |||||||
| Items that will not be reclassified to profit or loss in subsequent periods: | ||||||||||||
| Remeasurement gain (loss) from defined benefit plan | - | - | 64 | |||||||||
| Tax effect | - | 27 | 19 | |||||||||
| Total comprehensive income | $ | 2,360 | $ | 5,332 | $ | 17,383 | ||||||
| Earnings per share attributable to equity holders of the Company: | ||||||||||||
| Basic income per share | $ | 0.06 | $ | 0.12 | $ | 0.39 | ||||||
| Diluted income per share | $ | 0.06 | $ | 0.12 | $ | 0.38 |
STATEMENTS OF CASH FLOWS
| Three months period Ended | Year Ended | |||||||||||
| March 31, | December 31, | |||||||||||
| 2021 | 2020 | 2020 | ||||||||||
| Unaudited | Audited | |||||||||||
| U.S Dollars in thousands | U.S Dollars in thousands | |||||||||||
| Net income | $ | 2,687 | $ | 5,218 | $ | 17,140 | ||||||
| Adjustments to reconcile net income to net cash provided by operating activities: | ||||||||||||
| Adjustments to the profit or loss items: | ||||||||||||
| Depreciation and impairment | 1,147 | 1,192 | 4,897 | |||||||||
| Financial expenses (income), net | (323 | ) | (774 | ) | 672 | |||||||
| Cost of share-based payment | 215 | 257 | 977 | |||||||||
| Taxes on income | - | 406 | 1,425 | |||||||||
| Loss (gain) from sale of property and equipment | - | - | (7 | ) | ||||||||
| Change in employee benefit liabilities, net | (37 | ) | (18 | ) | 201 | |||||||
| 1,002 | 1,063 | 8,165 | ||||||||||
| Changes in asset and liability items: | ||||||||||||
| Decrease (increase) in trade receivables, net | 1,585 | (3,016 | ) | 1,332 | ||||||||
| Decrease (increase) in other accounts receivables | (14 | ) | 1,513 | 115 | ||||||||
| Decrease (increase) in inventories | 1,045 | 1,386 | 1,157 | |||||||||
| (Increase) decrease in deferred expenses | (1,153 | ) | (421 | ) | (3,085 | ) | ||||||
| (Decrease) Increase in trade payables | (1,484 | ) | (7,216 | ) | (9,560 | ) | ||||||
| Increase (decrease) in other accounts payables | (2,145 | ) | (1,180 | ) | 1,736 | |||||||
| Increase in deferred revenues | 500 | 397 | 1,204 | |||||||||
| (1,666 | ) | (8,537 | ) | (7,101 | ) | |||||||
| Cash received (paid) during the year for: | ||||||||||||
| Interest paid | (48 | ) | (55 | ) | (209 | ) | ||||||
| Interest received | 141 | 451 | 1,211 | |||||||||
| Taxes paid | (14 | ) | (61 | ) | (101 | ) | ||||||
| 79 | 335 | 901 | ||||||||||
| Net cash provided by (used in) operating activities | $ | 2,102 | $ | (1,921 | ) | $ | 19,105 |
STATEMENTS OF CASH FLOWS
| Three months period Ended | Year Ended | |||||||||||
| March 31, | December 31, | |||||||||||
| 2021 | 2020 | 2020 | ||||||||||
| Unaudited | Audited | |||||||||||
| U.S Dollars in thousands | U.S Dollars in thousands | |||||||||||
| Cash Flows from Investing Activities | ||||||||||||
| Investment in short term investments, net | $ | (9,000 | ) | $ | (15,646 | ) | $ | (7,646 | ) | |||
| Purchase of property and equipment and intangible assets | (131 | ) | (896 | ) | (5,488 | ) | ||||||
| Proceeds from sale of property and equipment | - | - | 7 | |||||||||
| Acquisition of subsidiary, net of cash (Appendix A below) | (1,404 | ) | - | - | ||||||||
| Net cash used in investing activities | (10,535 | ) | (16,542 | ) | (13,127 | ) | ||||||
| Cash Flows from Financing Activities | ||||||||||||
| Proceeds from exercise of share base payments | 7 | 5 | 64 | |||||||||
| Repayment of lease liabilities | (289 | ) | (278 | ) | (1,103 | ) | ||||||
| Repayment of long-term loans | (121 | ) | (123 | ) | (492 | ) | ||||||
| Proceeds from issuance of ordinary shares, net | - | 24,895 | 24,895 | |||||||||
| Net cash provided by (used in) financing activities | (403 | ) | 24,499 | 23,364 | ||||||||
| Exchange differences on balances of cash and cash equivalent | 75 | 590 | (1,807 | ) | ||||||||
| Increase (decrease) in cash and cash equivalents | (8,761 | ) | 6,626 | 27,535 | ||||||||
| Cash and cash equivalents at the beginning of the year | 70,197 | 42,662 | 42,662 | |||||||||
| Cash and cash equivalents at the end of the year | $ | 61,436 | $ | 49,288 | $ | 70,197 | ||||||
| Significant non-cash transactions | ||||||||||||
| Purchase of property and equipment through capital lease | $ | 302 | $ | 58 | $ | 539 | ||||||
| Purchase of property and equipment | $ | 670 | $ | 579 | $ | 722 |
| Appendix A | ||||
| Acquisition of a subsidiary that was first consolidated | ||||
| Current Assets (exclusive of cash and cash equivalents) | (184 | ) | ||
| Non Current Assets | (1,500 | ) | ||
| Current Liabilities | 280 | |||
| (1,404 | ) |
| Adjusted EBITDA | ||||||||||||
| Three months period Ended | Year ended | |||||||||||
| March 31, | December 31, | |||||||||||
| 2021 | 2020 | 2020 | ||||||||||
| U.S. Dollars in thousands | ||||||||||||
| Net income (loss) | $ | 2,687 | $ | 5,218 | $ | 17,140 | ||||||
| Taxes on income | - | 406 | 1,425 | |||||||||
| Financial expense (income), net | (323 | ) | (774 | ) | 672 | |||||||
| Depreciation and amortization expense | 1,147 | 1,192 | 4,897 | |||||||||
| Cost of share - based payments | 215 | 257 | 977 | |||||||||
| Adjusted EBITDA | $ | 3,726 | $ | 6,299 | $ | 25,111 |
| Adjusted Net Income | ||||||||||||
| Three months period Ended | Year ended | |||||||||||
| March 31, | December 31, | |||||||||||
| 2021 | 2020 | 2020 | ||||||||||
| U.S. Dollars in thousands | ||||||||||||
| Net income (loss) | $ | 2,687 | $ | 5,218 | $ | 17,140 | ||||||
| Cost of share - based payments | 215 | 257 | 977 | |||||||||
| Adjusted net income | $ | 2,902 | $ | 5,475 | $ | 18,117 |