REHOVOT, Israel, Aug. 11, 2021 (GLOBE NEWSWIRE) — Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced financial results for the three and six months ended June 30, 2021.
“Our business continued to perform as anticipated throughout the first half of 2021,” said Amir London, Kamada’s Chief Executive Officer. “Despite the expected decrease in revenue as compared to the first half of last year due to the planned transition of GLASSIA manufacturing to Takeda later this year, we achieved gross margins of 37 percent in the first half of 2021, as compared to 34 percent during the first six months of 2020. As an outlook for the second half of 2021, we anticipate a reduction in overall gross margins mainly due to anticipated change in products sales mix.”
“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) and are exploring a potential commercial partnership with respect to this product. We are pleased with the level of external interest generated in this therapy to date,” continued Mr. London.
“Moreover, we initiated the planning for the opening of additional U.S. plasma collection centers by leveraging our existing U.S. Food and Drug Administration license. In addition, we continue to achieve important progress around the advancement of our business development priorities and are exploring potential strategic transactions that would utilize and expand our core plasma-derived development, manufacturing, and commercialization expertise. We believe we have multiple prospects that would represent significant steps toward accomplishing our strategic goal of becoming a fully-integrated specialty plasma company,” concluded Mr. London.
Financial Highlights for the Three Months Ended June 30, 2021
Financial Highlights for the Six Months Ended June 30, 2021
Balance Sheet Highlights
As of June 30, 2021, the Company had cash, cash equivalents, and short-term investments of $104.6 million, as compared to $109.3 million on December 31, 2020.
Recent Corporate Highlights
Conference Call
Kamada management will host an investment community conference call on Wednesday, August 11, 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: 13721962. The call will also be webcast live on the Internet at http://public.viavid.com/index.php?id=145993.
About Kamada
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 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; 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) workforce downsizing resulting in an approximate 10% annual labor cost reduction, 2) anticipation of a reduction in overall gross margins during the second half of 2021 mainly due to anticipated change in products sales mix, 3) optimism about commercial partnership prospects associated with our Inhaled AAT product, 4) plans for the opening of additional plasma collection centers in the U.S. by leveraging our FDA license, 5) optimism about strategic business development opportunities that will utilize and expand our core plasma-derived development, manufacturing, and commercialization expertise, and 6) the belief that those opportunities are may be significant steps toward accomplishing our strategic goal of becoming a fully integrated specialty plasma company. 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 and ability to find a suitable commercial partnership for this product, 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.
CONTACTS:
Chaime Orlev
Chief Financial Officer
IR@kamada.com
Bob Yedid
LifeSci Advisors, LLC
646-597-6989
Bob@LifeSciAdvisors.com
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
| As of June 30, |
As of December 31, |
|||||||||||
| 2021 | 2020 | 2020 | ||||||||||
| Unaudited | Audited | |||||||||||
| Assets | U.S Dollars in thousands | |||||||||||
| Current Assets | ||||||||||||
| Cash and cash equivalents | $ | 68,416 | $ | 57,399 | $ | 70,197 | ||||||
| Short-term investments | 36,137 | 47,272 | 39,069 | |||||||||
| Trade receivables, net | 27,743 | 19,823 | 22,108 | |||||||||
| Other accounts receivables | 2,450 | 2,980 | 4,524 | |||||||||
| Inventories | 44,601 | 47,646 | 42,016 | |||||||||
| Total Current Assets | 179,347 | 175,120 | 177,914 | |||||||||
| Non-Current Assets | ||||||||||||
| Property, plant and equipment, net | 25,665 | 24,574 | 25,679 | |||||||||
| Right-of-use-assets | 3,453 | 3,796 | 3,440 | |||||||||
| Other long term assets | 3,413 | 1,058 | 1,573 | |||||||||
| Contract assets | 4,472 | 911 | 2,059 | |||||||||
| Deferred taxes | – | 632 | – | |||||||||
| Total Non-Current Assets | 37,003 | 30,971 | 32,751 | |||||||||
| Total Assets | $ | 216,350 | $ | 206,091 | $ | 210,665 | ||||||
| Liabilities | ||||||||||||
| Current Liabilities | ||||||||||||
| Current maturities of bank loans | $ | 61 | $ | 431 | $ | 238 | ||||||
| Current maturities of lease liabilities | 1,149 | 990 | 1,072 | |||||||||
| Trade payables | 17,948 | 22,760 | 16,110 | |||||||||
| Other accounts payables | 6,989 | 5,497 | 7,547 | |||||||||
| Deferred revenues | – | 589 | – | |||||||||
| Total Current Liabilities | 26,147 | 30,267 | 24,967 | |||||||||
| Non-Current Liabilities | ||||||||||||
| Bank loans | 5 | 63 | 36 | |||||||||
| Lease liabilities | 3,401 | 3,704 | 3,593 | |||||||||
| Deferred revenues | 3,025 | 1,025 | 2,025 | |||||||||
| Employee benefit liabilities, net | 1,429 | 1,267 | 1,406 | |||||||||
| Total Non-Current Liabilities | 7,860 | 6,059 | 7,060 | |||||||||
| Shareholder’s Equity | ||||||||||||
| Ordinary shares | 11,716 | 11,662 | 11,706 | |||||||||
| Additional paid in capital | 209,942 | 207,731 | 209,760 | |||||||||
| Capital reserve due to translation to presentation currency | (3,490 | ) | (3,490 | ) | (3,490 | ) | ||||||
| Capital reserve from hedges | 58 | 411 | 357 | |||||||||
| Capital reserve from share-based payments | 4,746 | 6,204 | 4,558 | |||||||||
| Capital reserve from employee benefits | (320 | ) | (356 | ) | (320 | ) | ||||||
| Accumulated deficit | (40,309 | ) | (52,397 | ) | (43,933 | ) | ||||||
| Total Shareholder’s Equity | 182,343 | 169,765 | 178,638 | |||||||||
| Total Liabilities and Shareholder’s Equity | $ | 216,350 | $ | 206,091 | $ | 210,665 | ||||||
CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
| Six months period ended | Three months period ended | Year ended | ||||||||||||||||||
| June 30, | June 30, | December 31, | ||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | 2020 | ||||||||||||||||
| Unaudited | Unaudited | Audited | ||||||||||||||||||
| U.S Dollars In thousands | ||||||||||||||||||||
| Revenues from proprietary products | $ | 40,193 | $ | 47,942 | $ | 19,323 | $ | 22,625 | $ | 100,916 | ||||||||||
| Revenues from distribution | 8,946 | 18,437 | 4,916 | 10,464 | 32,330 | |||||||||||||||
| Total revenues | 49,139 | 66,379 | 24,239 | 33,089 | 133,246 | |||||||||||||||
| Cost of revenues from proprietary products | 23,527 | 27,881 | 11,059 | 12,934 | 57,750 | |||||||||||||||
| Cost of revenues from distribution | 7,609 | 15,932 | 4,108 | 9,040 | 27,944 | |||||||||||||||
| Total cost of revenues | 31,136 | 43,813 | 15,167 | 21,974 | 85,694 | |||||||||||||||
| Gross profit | 18,003 | 22,566 | 9,072 | 11,115 | 47,552 | |||||||||||||||
| Research and development expenses | 5,364 | 6,970 | 2,736 | 3,623 | 13,609 | |||||||||||||||
| Selling and marketing expenses | 2,547 | 2,118 | 1,424 | 1,178 | 4,518 | |||||||||||||||
| General and administrative expenses | 6,112 | 4,619 | 3,303 | 2,307 | 10,139 | |||||||||||||||
| Other expenses | 570 | 34 | 563 | 32 | 49 | |||||||||||||||
| Operating income | 3,410 | 8,825 | 1,046 | 3,975 | 19,237 | |||||||||||||||
| Financial income | 209 | 615 | 99 | 298 | 1,027 | |||||||||||||||
| Income (expense) in respect of securities measured at fair value, net * | – | 102 | – | – | 102 | |||||||||||||||
| Income (expenses) in respect of currency exchange differences and derivatives instruments, net | 121 | 65 | (145 | ) | (367 | ) | (1,535 | ) | ||||||||||||
| Financial expenses | (116 | ) | (135 | ) | (63 | ) | (58 | ) | (266 | ) | ||||||||||
| Income before tax on income | 3,624 | 9,472 | 937 | 3,848 | 18,565 | |||||||||||||||
| Taxes on income | – | 796 | – | 390 | 1,425 | |||||||||||||||
| Net Income | $ | 3,624 | $ | 8,676 | $ | 937 | $ | 3,458 | $ | 17,140 | ||||||||||
| Other Comprehensive Income (loss) : | ||||||||||||||||||||
| Amounts that will be or that have been reclassified to profit or loss when specific conditions are met | ||||||||||||||||||||
| Gain (loss) from securities measured at fair value through other comprehensive income | – | (188 | ) | – | – | (188 | ) | |||||||||||||
| Gain (loss) on cash flow hedges | (43 | ) | 441 | 30 | 200 | 876 | ||||||||||||||
| Net amounts transferred to the statement of profit or loss for cash flow hedges | (256 | ) | (7 | ) | (2 | ) | (41 | ) | (528 | ) | ||||||||||
| Items that will not be reclassified to profit or loss in subsequent periods: | ||||||||||||||||||||
| Remeasurement gain (loss) from defined benefit plan | – | – | – | – | 64 | |||||||||||||||
| Tax effect | – | 15 | – | (12 | ) | 19 | ||||||||||||||
| Total comprehensive income | $ | 3,325 | $ | 8,937 | $ | 965 | $ | 3,605 | $ | 17,383 | ||||||||||
| Earnings per share attributable to equity holders of the Company: | ||||||||||||||||||||
| Basic net earnings per share | $ | 0.08 | $ | 0.20 | $ | 0.02 | $ | 0.10 | $ | 0.39 | ||||||||||
| Diluted net earnings per share | $ | 0.08 | $ | 0.20 | $ | 0.02 | $ | 0.10 | $ | 0.38 | ||||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Six months period Ended | Three months period Ended | Year Ended | ||||||||||||||||||
| June, 30 | June, 30 | December 31, | ||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | 2020 | ||||||||||||||||
| Unaudited | Audited | |||||||||||||||||||
| U.S Dollars In thousands | ||||||||||||||||||||
| Cash Flows from Operating Activities | ||||||||||||||||||||
| Net income | $ | 3,624 | $ | 8,676 | $ | 937 | $ | 3,458 | $ | 17,140 | ||||||||||
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: | ||||||||||||||||||||
| Adjustments to the profit or loss items: | ||||||||||||||||||||
| Depreciation and impairment | 2,372 | 2,380 | 1,225 | 1,188 | 4,897 | |||||||||||||||
| Financial expenses (income), net | (214 | ) | (647 | ) | 109 | 127 | 672 | |||||||||||||
| Cost of share-based payment | 370 | 588 | 155 | 330 | 977 | |||||||||||||||
| Taxes on income | – | 796 | – | 390 | 1,425 | |||||||||||||||
| Loss (gain) from sale of property and equipment | – | (6 | ) | – | (6 | ) | (7 | ) | ||||||||||||
| Change in employee benefit liabilities, net | 23 | (2 | ) | 60 | 16 | 201 | ||||||||||||||
| 2,551 | 3,109 | 1,549 | 2,045 | 8,165 | ||||||||||||||||
| Changes in asset and liability items: | ||||||||||||||||||||
| Decrease (increase) in trade receivables, net | (5,646 | ) | 3,416 | (7,231 | ) | 6,432 | 1,332 | |||||||||||||
| Decrease (increase) in other accounts receivables | 1,629 | 741 | 1,643 | (772 | ) | 115 | ||||||||||||||
| Increase in inventories | (2,401 | ) | (4,473 | ) | (3,446 | ) | (5,859 | ) | 1,157 | |||||||||||
| Decrease (increase) in deferred expenses | (2,362 | ) | (911 | ) | (1,209 | ) | (490 | ) | (3,085 | ) | ||||||||||
| Increase (decrease) in trade payables | 1,139 | (2,719 | ) | 2,623 | 4,497 | (9,560 | ) | |||||||||||||
| Increase (decrease) in other accounts payables | (799 | ) | (314 | ) | 1,346 | 866 | 1,736 | |||||||||||||
| Decrease in deferred revenues | 1,000 | 793 | 500 | 396 | 1,204 | |||||||||||||||
| (7,440 | ) | (3,467 | ) | (5,774 | ) | 5,070 | (7,101 | ) | ||||||||||||
| Cash received (paid) during the period for: | ||||||||||||||||||||
| Interest paid | (107 | ) | (107 | ) | (59 | ) | (52 | ) | (209 | ) | ||||||||||
| Interest received | 217 | 601 | 76 | 150 | 1,211 | |||||||||||||||
| Taxes paid | (23 | ) | (74 | ) | (9 | ) | (13 | ) | (101 | ) | ||||||||||
| 87 | 420 | 8 | 85 | 901 | ||||||||||||||||
| Net cash provided by operating activities | $ | (1,178 | ) | $ | 8,738 | $ | (3,280 | ) | $ | 10,658 | $ | 19,105 | ||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Six months period Ended | Three months period Ended | Year Ended | ||||||||||||||||||
| June, 30 | June, 30 | December 31, | ||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | 2020 | ||||||||||||||||
| Unaudited | Audited | |||||||||||||||||||
| U.S Dollars In thousands | ||||||||||||||||||||
| Cash Flows from Investing Activities | ||||||||||||||||||||
| Proceeds of investment in short term investments, net | $ | 2,967 | $ | (15,646 | ) | $ | 11,967 | $ | – | $ | (7,646 | ) | ||||||||
| Purchase of property and equipment and intangible assets | (1,463 | ) | (1,901 | ) | (1,332 | ) | (1,005 | ) | (5,488 | ) | ||||||||||
| Proceeds from sale of property and equipment | – | 6 | – | 6 | 7 | |||||||||||||||
| Acquisition of subsidiary (LLC), net (1) | (1,404 | ) | – | – | – | |||||||||||||||
| Net cash used in investing activities | 100 | (17,541 | ) | 10,635 | (999 | ) | (13,127 | ) | ||||||||||||
| Cash Flows from Financing Activities | ||||||||||||||||||||
| Proceeds from exercise of share base payments | 10 | 20 | 3 | 15 | 64 | |||||||||||||||
| Repayment of lease liabilities | (595 | ) | (540 | ) | (306 | ) | (262 | ) | (1,103 | ) | ||||||||||
| Repayment of long-term loans | (206 | ) | (247 | ) | (85 | ) | (124 | ) | (492 | ) | ||||||||||
| Proceeds from issuance of ordinary shares, net | – | 24,895 | – | – | 24,895 | |||||||||||||||
| Net cash provided by (used in) financing activities | (791 | ) | 24,128 | (388 | ) | (371 | ) | 23,364 | ||||||||||||
| Exchange differences on balances of cash and cash equivalent | 88 | (588 | ) | 13 | (1,177 | ) | (1,807 | ) | ||||||||||||
| Increase in cash and cash equivalents | (1,781 | ) | 14,737 | 6,980 | 8,111 | 27,535 | ||||||||||||||
| Cash and cash equivalents at the beginning of the period | 70,197 | 42,662 | 61,436 | 49,288 | 42,662 | |||||||||||||||
| Cash and cash equivalents at the end of the period | $ | 68,416 | $ | 57,399 | $ | 68,416 | $ | 57,399 | $ | 70,197 | ||||||||||
| Significant non-cash transactions | ||||||||||||||||||||
| Right-of-use asset recognized with corresponding lease liability | $ | 588 | $ | 345 | $ | 286 | $ | 287 | $ | 539 | ||||||||||
| Purchase of property and equipment | $ | 748 | $ | 722 | $ | 748 | $ | 722 | $ | 722 | ||||||||||
| Appendix A (1) | Six months period Ended June, 30 2021 |
|||
| Acquisition of a subsidiary that was first consolidated | ||||
| Current Assets (exclusive of cash and cash equivalents) | (184 | ) | ||
| Non Current Assets | (1,460 | ) | ||
| Current Liabilities | 240 | |||
| (1,404 | ) | |||
| Adjusted EBITDA | ||||||||||||||||||||
| Six months period ended | Three months period ended | Year ended | ||||||||||||||||||
| June 30, | June 30, | December 31, | ||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | 2020 | ||||||||||||||||
| In thousands | ||||||||||||||||||||
| Net income | $ | 3,624 | $ | 8,676 | $ | 937 | $ | 3,458 | $ | 17,140 | ||||||||||
| Taxes on income | – | 796 | – | 390 | 1,425 | |||||||||||||||
| Financial expense (income), net | (214 | ) | (647 | ) | 109 | 127 | 692 | |||||||||||||
| Depreciation and amortization expense | 2,372 | 2,380 | 1,225 | 1,188 | 4,897 | |||||||||||||||
| Non-cash share-based compensation expenses | 370 | 588 | 155 | 330 | 977 | |||||||||||||||
| Adjusted EBITDA | $ | 6,152 | $ | 11,793 | $ | 2,426 | $ | 5,493 | $ | 25,131 | ||||||||||
| Adjusted net income | ||||||||||||||||||||
| Six months period ended | Three months period ended | Year ended | ||||||||||||||||||
| June 30, | June 30, | December 31, | ||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | 2020 | ||||||||||||||||
| In thousands | ||||||||||||||||||||
| Net income | $ | 3,624 | $ | 8,676 | $ | 937 | $ | 3,458 | $ | 17,140 | ||||||||||
| Share-based compensation charges | 370 | 588 | 155 | 330 | 977 | |||||||||||||||
| Adjusted net income | $ | 3,994 | $ | 9,264 | $ | 1,092 | $ | 3,788 | $ | 18,117 | ||||||||||
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