Full Press Release Details
Reports Second Quarter and First Six Months of 2020 Financial Results, Recent Corporate
Achievements and Strong Cash Position
Israel - August 12, 2020 -- 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, 2020.
"Kamada presented solid financial and
operational performance during the first six months of 2020," said Amir London, Kamada's Chief Executive Officer. "While
the global COVID-19 pandemic persists, we generated total revenues of $66.4 million during the first half of the year, representing
an increase of 7% year-over-year. Importantly, our manufacturing plant continues to be operational and we do not anticipate any
meaningful changes in the foreseeable future due to COVID-19 pandemic. Based on our results in the first six months of 2020 and
our current outlook for the remainder of the year, we are reiterating our guidance of total revenues of between $132 million and
$137 million for full-year 2020."
"We continue to expeditiously advance
the development of our plasma-derived immunoglobulin (IgG) product as a potential treatment
for coronavirus disease (COVID-19)," continued Mr. London. "We have completed manufacturing of the initial batches
of our product and earlier this week we announced first-patient-in our Phase 1/2 open label clinical trial in Israel. We are also
working with the support of our partner, Kedrion Biopharma, toward obtaining FDA's acceptance of the proposed clinical development
program and we expect to hold a pre-IND meeting with the FDA during this quarter."
"We are intensively exploring business
development opportunities to mitigate the effects of the planned transition of GLASSIA manufacturing to Takeda
during 2021. I am optimistic that these opportunities, funded by our strong cash position, along with our organic commercial growth,
our investigational COVID- 19 IgG product, the expected future royalty payments from Takeda together with the contract manufacturing
of an FDA approved and commercialized specialty IgG product will contribute to our future growth" concluded Mr. London.
Highlights for the Three Months Ended June 30, 2020
Highlights for the Six Months Ended June 30, 2020
of June 30, 2020, the Company had cash, cash equivalents, and short-term investments of $104.7 million, as compared to $73.9 million
at December 31, 2019.
management will host an investment community conference call on Wednesday, August 12, 2020, 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
855-327-6837 (from within the U.S.), 1-809-458-327 (from Israel), or 631-891-4304 (International) and entering the conference
identification number: 10010379. The call will also be webcast live on the Internet on the Company's website at www.kamada.com.
Kamada Ltd. ("the Company")
is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product
portfolio and a 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 immune globulins. The Company's flagship product is GLASSIA , the first liquid, ready-to-use,
intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership
with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. The Company's second leading
product is KamRab , a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KamRab is FDA
approved and is being marketed in the U.S. under the brand name KEDRAB through a strategic partnership with Kedrion S.p.A.
In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered
by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India
and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation
of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications,
such as GvHD and prevention of lung transplant rejection, and during 2020, the Company initiated the development of a plasma derived
immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company leverages its expertise and
presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel that are
manufactured by third parties. 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
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) Total revenues to be in the range
of $132 million to $137 million for fiscal 2020; 2) not anticipating meaningful changes in operations in the
foreseeable future due to COVID-19 pandemic; 3) actions taken to mitigate the effect of the planned transition of GLASSIA
manufacturing to Takeda during 2021; 4) optimism that business development opportunities, funded by our strong cash
position, along with our organic commercial growth, our investigational COVID- 19 IgG product, the expected future royalty
payments from Takeda together with the contract manufacturing of an FDA approved and commercialized specialty IgG product
will contribute to our future growth; 5) developments relating FDA's acceptance of
the proposed clinical development program and clearance of Kamada's IND relating to its plasma-derived immunoglobulin
(IgG) product as a potential treatment for coronavirus disease (COVID-19) following the pre-Investigational New Drug
(IND) meeting with the FDA expected to take place in the third quarter of 2020; 6) guidance of an expected annual three to
five percentage points decrease in the Proprietary Product segment gross margin which is attributable to a change in sales
product mix and reduced plant utilization; and 7) previously expected increase of 20-25% in Research and Development expenses
for 2020 in comparison to 2019 will not materialize mainly related to COVID-19 related delays in research projects and
current expectation of an approximately 15-17% increase in Research and Development expenses in full year 2020 as compared to
2019. 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,
ability to offset significant revenue loss associated with GLASSIA manufacturing transitioning to Takeda, 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 obtain
regulatory approval for clinical trials of the plasma-derived hyperimmune IgG product
for COVID-19, ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of
clinical studies and on-going compassionate-use treatments, 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
CONSOLIDATED CONDENSED
| As of June 30, | As of December 31, | |||||||||||
| 2020 | 2019 | 2019 | ||||||||||
| Unaudited | Audited | |||||||||||
| U.S Dollars in thousands | ||||||||||||
| Assets | ||||||||||||
| Current Assets | ||||||||||||
| Cash and cash equivalents | $ | 57,399 | $ | 23,835 | $ | 42,662 | ||||||
| Short-term investments | 47,272 | 38,122 | 31,245 | |||||||||
| Trade receivables, net | 19,823 | 25,497 | 23,210 | |||||||||
| Other accounts receivables | 2,980 | 3,292 | 3,272 | |||||||||
| Inventories | 47,646 | 35,501 | 43,173 | |||||||||
| Total Current Assets | 175,120 | 126,247 | 143,562 | |||||||||
| Non-Current Assets | ||||||||||||
| Property, plant and equipment, net | 24,574 | 24,478 | 24,550 | |||||||||
| Right-of-use-assets | 3,796 | 3,946 | 4,022 | |||||||||
| Other long term assets | 1,058 | 174 | 352 | |||||||||
| Contract asset | 911 | - | - | |||||||||
| Deferred taxes | 632 | 1,644 | 1,311 | |||||||||
| Total Non-Current Assets | 30,971 | 30,242 | 30,235 | |||||||||
| Total Assets | $ | 206,091 | $ | 156,489 | $ | 173,797 | ||||||
| Liabilities | ||||||||||||
| Current Liabilities | ||||||||||||
| Current maturities of bank loans | $ | 431 | $ | 480 | $ | 489 | ||||||
| Current maturities of lease liabilities | 990 | 960 | 1,020 | |||||||||
| Trade payables | 22,760 | 19,879 | 24,830 | |||||||||
| Other accounts payables | 5,497 | 4,876 | 5,811 | |||||||||
| Deferred revenues | 589 | 461 | 589 | |||||||||
| Total Current Liabilities | 30,267 | 26,656 | 32,739 | |||||||||
| Non-Current Liabilities | ||||||||||||
| Bank loans | 63 | 482 | 257 | |||||||||
| Lease liabilities | 3,704 | 3,988 | 3,981 | |||||||||
| Deferred revenues | 1,025 | 542 | 232 | |||||||||
| Employee benefit liabilities, net | 1,267 | 818 | 1,269 | |||||||||
| Total Non-Current Liabilities | 6,059 | 5,830 | 5,739 | |||||||||
| Shareholder's Equity | ||||||||||||
| Ordinary shares | 11,662 | 10,418 | 10,425 | |||||||||
| Additional paid in capital | 207,731 | 179,471 | 180,819 | |||||||||
| Capital reserve due to translation to presentation currency | (3,490 | ) | (3,490 | ) | (3,490 | ) | ||||||
| Capital reserve from hedges | 411 | 8 | 8 | |||||||||
| Capital reserve from financial assets measured at fair value through other comprehensive income | - | 187 | 145 | |||||||||
| Capital reserve from share-based payments | 6,204 | 9,663 | 8,844 | |||||||||
| Capital reserve from employee benefits | (356 | ) | 4 | (359 | ) | |||||||
| Accumulated deficit | (52,397 | ) | (72,258 | ) | (61,073 | ) | ||||||
| Total Shareholder's Equity | 169,765 | 124,003 | 135,319 | |||||||||
| Total Liabilities and Shareholder's Equity | $ | 206,091 | $ | 156,489 | $ | 173,797 |
condensed statements of comprehensive income
| Six months period ended | Three months period ended | Year ended | ||||||||||||||||||
| June 30, | June 30, | December 31, | ||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | 2019 | ||||||||||||||||
| Unaudited | Unaudited | Audited | ||||||||||||||||||
| U.S Dollars In thousands | ||||||||||||||||||||
| Revenues from proprietary products | $ | 47,942 | $ | 47,662 | $ | 22,625 | $ | 27,281 | $ | 97,696 | ||||||||||
| Revenues from distribution | 18,437 | 14,388 | 10,464 | 7,972 | 29,491 | |||||||||||||||
| Total revenues | 66,379 | 62,050 | 33,089 | 35,253 | 127,187 | |||||||||||||||
| Cost of revenues from proprietary products | 27,881 | 25,178 | 12,934 | 14,688 | 52,425 | |||||||||||||||
| Cost of revenues from distribution | 15,932 | 12,088 | 9,040 | 6,965 | 25,025 | |||||||||||||||
| Total cost of revenues | 43,813 | 37,266 | 21,974 | 21,653 | 77,450 | |||||||||||||||
| Gross profit | 22,566 | 24,784 | 11,115 | 13,600 | 49,737 | |||||||||||||||
| Research and development expenses | 6,970 | 6,253 | 3,623 | 3,487 | 13,059 | |||||||||||||||
| Selling and marketing expenses | 2,118 | 2,280 | 1,178 | 1,188 | 4,370 | |||||||||||||||
| General and administrative expenses | 4,619 | 4,621 | 2,307 | 2,527 | 9,194 | |||||||||||||||
| Other expenses | 34 | 28 | 32 | 5 | 330 | |||||||||||||||
| Operating income | 8,825 | 11,602 | 3,975 | 6,393 | 22,784 | |||||||||||||||
| Financial income | 615 | 559 | 298 | 274 | 1,146 | |||||||||||||||
| Income (expense) in respect of securities measured at fair value, net * | 102 | (58 | ) | - | (7 | ) | (5 | ) | ||||||||||||
| Income (expenses) in respect of currency exchange differences and derivatives instruments, net | 65 | (528 | ) | (367 | ) | (215 | ) | (651 | ) | |||||||||||
| Financial expenses | (135 | ) | (149 | ) | (58 | ) | (72 | ) | (293 | ) | ||||||||||
| Income before tax on income | 9,472 | 11,426 | 3,848 | 6,373 | 22,981 | |||||||||||||||
| Taxes on income | 796 | 360 | 390 | 230 | 730 | |||||||||||||||
| Net Income | $ | 8,676 | $ | 11,066 | $ | 3,458 | $ | 6,143 | $ | 22,251 | ||||||||||
| 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 | ) | 198 | - | 90 | 143 | ||||||||||||||
| Gain (loss) on cash flow hedges | 441 | 71 | 200 | (3 | ) | 92 | ||||||||||||||
| Net amounts transferred to the statement of profit or loss for cash flow hedges | (7 | ) | (2 | ) | (41 | ) | - | (23 | ) | |||||||||||
| Items that will not be reclassified to profit or loss in subsequent periods: | ||||||||||||||||||||
| Remeasurement gain (loss) from defined benefit plan | - | - | - | - | (388 | ) | ||||||||||||||
| Tax effect | 15 | (49 | ) | (12 | ) | (21 | ) | (11 | ) | |||||||||||
| Total comprehensive income | $ | 8,937 | $ | 11,284 | $ | 3,605 | $ | 6,209 | $ | 22,064 | ||||||||||
| Earnings per share attributable to equity holders of the Company: | ||||||||||||||||||||
| Basic net earnings per share | $ | 0.20 | $ | 0.27 | $ | 0.08 | $ | 0.15 | $ | 0.55 | ||||||||||
| Diluted net earnings per share | $ | 0.20 | $ | 0.27 | $ | 0.08 | $ | 0.15 | $ | 0.55 |
CONSOLIDATED CONDENSED STATEMENTS OF
| Six months period Ended | Three months period Ended | Year Ended | ||||||||||||||||||
| June, 30 | June, 30 | December 31, | ||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | 2019 | ||||||||||||||||
| Unaudited | Audited | |||||||||||||||||||
| U.S Dollars In thousands | ||||||||||||||||||||
| Cash Flows from Operating Activities | ||||||||||||||||||||
| Net income | $ | 8,676 | $ | 11,066 | $ | 3,458 | $ | 6,143 | $ | 22,251 | ||||||||||
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: | ||||||||||||||||||||
| Adjustments to the profit or loss items: | ||||||||||||||||||||
| Depreciation and impairment | 2,380 | 2,251 | 1,188 | 1,124 | 4,519 | |||||||||||||||
| Financial expenses (income), net | (647 | ) | 176 | 127 | 20 | (197 | ) | |||||||||||||
| Cost of share-based payment | 588 | 634 | 330 | 319 | 1,163 | |||||||||||||||
| Taxes on income | 796 | 360 | 390 | 230 | 730 | |||||||||||||||
| Loss (gain) from sale of property and equipment | (6 | ) | (2 | ) | (6 | ) | 4 | (2 | ) | |||||||||||
| Change in employee benefit liabilities, net | (2 | ) | 31 | 16 | (5 | ) | 94 | |||||||||||||
| 3,109 | 3,450 | 2,045 | 1,692 | 6,307 | ||||||||||||||||
| Changes in asset and liability items: | ||||||||||||||||||||
| Decrease (increase) in trade receivables, net | 3,416 | 2,602 | 6,432 | (2,125 | ) | 5,117 | ||||||||||||||
| Decrease (increase) in other accounts receivables | 741 | 249 | (772 | ) | 118 | (214 | ) | |||||||||||||
| Increase in inventories | (4,473 | ) | (6,185 | ) | (5,859 | ) | (3,793 | ) | (13,857 | ) | ||||||||||
| Decrease (increase) in Contract asset and deferred expenses | (911 | ) | (272 | ) | (490 | ) | (26 | ) | 399 | |||||||||||
| Increase (decrease) in trade payables | (2,719 | ) | 1,927 | 4,497 | 4,295 | 6,259 | ||||||||||||||
| Increase (decrease) in other accounts payables | (314 | ) | (53 | ) | 866 | 457 | 863 | |||||||||||||
| Decrease in deferred revenues | 793 | (126 | ) | 396 | (63 | ) | (283 | ) | ||||||||||||
| (3,467 | ) | (1,858 | ) | 5,070 | (1,137 | ) | (1,716 | ) | ||||||||||||
| Cash received (paid) during the period for: | ||||||||||||||||||||
| Interest paid | (107 | ) | (124 | ) | (52 | ) | (61 | ) | (243 | ) | ||||||||||
| Interest received | 601 | 300 | 150 | 128 | 1,106 | |||||||||||||||
| Taxes paid | (74 | ) | (16 | ) | (13 | ) | (8 | ) | (134 | ) | ||||||||||
| 420 | 160 | 85 | 59 | 729 | ||||||||||||||||
| Net cash provided by operating activities | $ | 8,738 | $ | 12,818 | $ | 10,658 | $ | 6,757 | $ | 27,571 |
CONSOLIDATED CONDENSED
STATEMENTS OF CASH FLOWS
| Six months period Ended | Three months period Ended | Year Ended | ||||||||||||||||||
| June, 30 | June, 30 | December 31, | ||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | 2019 | ||||||||||||||||
| Unaudited | Audited | |||||||||||||||||||
| U.S Dollars In thousands | ||||||||||||||||||||
| Cash Flows from Investing Activities | ||||||||||||||||||||
| Proceeds of investment in short term investments, net | $ | (15,646 | ) | $ | (5,128 | ) | $ | - | $ | (4,070 | ) | $ | 1,727 | |||||||
| Purchase of property and equipment and intangible assets | (1,901 | ) | (757 | ) | (1,005 | ) | (453 | ) | (2,300 | ) | ||||||||||
| Proceeds from sale of property and equipment | 6 | 9 | 6 | 3 | 9 | |||||||||||||||
| Net cash used in investing activities | (17,541 | ) | (5,876 | ) | (999 | ) | (4,520 | ) | (564 | ) | ||||||||||
| Cash Flows from Financing Activities | ||||||||||||||||||||
| Proceeds from exercise of share base payments | 20 | 9 | 15 | 6 | 16 | |||||||||||||||
| Repayment of lease liabilities | (540 | ) | (529 | ) | (262 | ) | (266 | ) | (1,070 | ) | ||||||||||
| Repayment of long-term loans | (246 | ) | (232 | ) | (123 | ) | (117 | ) | (476 | ) | ||||||||||
| Proceeds from issuance of ordinary shares, net | 24,894 | - | - | - | - | |||||||||||||||
| Net cash provided by (used in) financing activities | 24,128 | (752 | ) | (370 | ) | (377 | ) | (1,530 | ) | |||||||||||
| Exchange differences on balances of cash and cash equivalent | (588 | ) | (448 | ) | (1,178 | ) | (62 | ) | (908 | ) | ||||||||||
| Increase in cash and cash equivalents | 14,737 | 5,742 | 8,111 | 1,798 | 24,569 | |||||||||||||||
| Cash and cash equivalents at the beginning of the period | 42,662 | 18,093 | 49,288 | 22,037 | 18,093 | |||||||||||||||
| Cash and cash equivalents at the end of the period | $ | 57,399 | $ | 23,835 | $ | 57,399 | $ | 23,835 | $ | 42,662 | ||||||||||
| Significant non-cash transactions | ||||||||||||||||||||
| Right-of-use asset recognized with corresponding lease liability | $ | 345 | $ | 4,548 | $ | 287 | $ | 117 | $ | 5,035 | ||||||||||
| Purchase of property and equipment | $ | 722 | $ | 385 | $ | 722 | $ | 385 | $ | 992 |
| Adjusted EBITDA | ||||||||||||||||||||
| Six months period ended | Three months period ended | Year ended | ||||||||||||||||||
| June 30, | June 30, | December 31, | ||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | 2019 | ||||||||||||||||
| In thousands | ||||||||||||||||||||
| Net income | $ | 8,676 | $ | 11,066 | $ | 3,458 | $ | 6,143 | $ | 22,251 | ||||||||||
| Taxes on income | 796 | 360 | 390 | 230 | 730 | |||||||||||||||
| Financial expense (income), net | (647 | ) | 176 | 127 | 20 | (197 | ) | |||||||||||||
| Depreciation and amortization expense | 2,380 | 2,251 | 1,188 | 1,124 | 4,519 | |||||||||||||||
| Non-cash share-based compensation expenses | 588 | 634 | 330 | 319 | 1,163 | |||||||||||||||
| Adjusted EBITDA | $ | 11,793 | $ | 14,487 | $ | 5,493 | $ | 7,836 | $ | 28,466 |
| Adjusted net income | ||||||||||||||||||||
| Six months period ended | Three months period ended | Year ended | ||||||||||||||||||
| June 30, | June 30, | December 31, | ||||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | 2019 | ||||||||||||||||
| In thousands | ||||||||||||||||||||
| Net income | $ | 8,676 | $ | 11,066 | $ | 3,458 | $ | 6,143 | $ | 22,251 | ||||||||||
| Share-based compensation charges | 588 | 634 | 330 | 319 | 1,163 | |||||||||||||||
| Adjusted net income | $ | 9,264 | $ | 11,700 | $ | 3,788 | $ | 6,462 | $ | 23,414 |