Full Press Release Details
Kamada Reports First Quarter 2020 Financial Results and Highlights
Recent Corporate Progress
REHOVOT, Israel - May 18, 2020
- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced financial results
for the three months ended March 31, 2020.
"As the ongoing COVID-19 global
pandemic continues to create substantial complications in daily life and business operations, we are focused on the safety and
well-being of our employees, who continue to find innovative solutions to support our patients and partners," said Amir
London, Kamada's Chief Executive Officer. "These efforts contributed to our strong performance in the first quarter
of the year. Total revenues were $33.3 million, an increase of 24 percent year-over-year. These results were driven by similar
year-over year increase in sales of both our Proprietary and Distributed products. Based on our strong performance in the first
quarter 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."
"To date, our manufacturing plant
remains operational with no effect on business continuity, even amidst the emergency regulations enforced in Israel in recent
months due to the COVID-19 pandemic. Moreover, based on the most recent interactions with our U.S. distribution partners regarding
finished product inventory levels available for distribution in the U.S and our planned supply for the remainder of the year,
we do not anticipate meaningful supply shortages in the foreseeable future in the U.S. market for GLASSIA or KEDRAB .
In addition, based on currently available inventory levels and planned supply of our Distributed products in Israel, we do not
anticipate significant supply shortages in the foreseeable future. Going forward, although certain COVID-19 pandemic-related dynamics
may affect market demand and production conditions, we intend to maintain our current manufacturing and supply plans, and increased
inventory levels of raw materials through our suppliers and service providers in order to appropriately manage any potential supply
disruptions and secure continued manufacturing," continued Mr. London.
"As previously reported, during the first quarter, we
were able to quickly focus our efforts on the development and manufacturing of a plasma-derived hyperimmune IgG product for COVID-19,
which leverages our proprietary IgG platform technology, as a potential treatment for COVID-19 patients. We are pleased
to report today that we have secured adequate quantities of COVID-19 convalescent plasma in Israel. This has enabled us to initiate
manufacturing of the product, which is expected to be available by the end of the second
quarter for compassionate use treatment in Israel, based on Israeli Ministry of Health (IMOH) regulations. Concurrently, we have
ongoing discussions with the IMOH with regard to the potential initiation of related clinical trials. In addition, we were excited
to recently announce our global collaboration with Kedrion Biopharma, which will allow us to more rapidly develop our plasma-derived
hyperimmune IgG product for COVID-19 and broaden our international reach," concluded
Financial Highlights for the Three Months
Ended March 31, 2020
Balance Sheet Highlights
As of March 31, 2020, the Company had cash,
cash equivalents, and short-term investments of $96.4 million, as compared to $73.9 million at December 31, 2019. This includes
the net proceeds generated from the $25 million private placement transaction with the FIMI Opportunity Fund closed in February
Recent Corporate Highlights
Kamada management will host an investment
community conference call on Monday, May 18, 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.), 1809 406 247
(from Israel), or 201-689-8263 (International) and entering the conference identification number: 13699990. 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. 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
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) the total revenues to be in the range of $132 million to $137 million
for fiscal 2020; 2) not anticipating meaningful supply shortages in the foreseeable future in the U.S. market for
GLASSIA or KEDRAB ; 3) not anticipating significant supply shortages in the foreseeable future for Kamada's
Distributed products in Israel; 4) anticipating maintaining current manufacturing and supply plans; 5) increasing inventory
levels of raw materials through suppliers and service providers in order to appropriately manage any potential supply
disruptions and secure continued manufacturing; 6) anticipating availability for clinical and compassionate-use treatment in
Israel of a plasma-derived hyperimmune IgG product for COVID-19, from COVID-19 convalescent plasma, by the end of the second
quarter of 2020; 7) anticipating that the global collaboration with Kedrion Biopharma will allow Kamada to speed up the
development of the plasma-derived hyperimmune IgG product for COVID-19 and broaden the product's international reach;
and 8) anticipating that Phase 3 InnovAATe clinical trial will resume enrollment in the third quarter of 2020.
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 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, continued demand for
Kamada's products, including GLASSIA and KEDRAB, in the U.S. market and its distributed products in Israel, ability to
obtain regulatory approval for clinical trials of the plasma-derived hyperimmune IgG product for COVID-19, unexpected
results of clinical studies and on-going compassionate-use treatments, ability to find doctors and medical facilities to
collaborate on 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 Balance Sheets
| As of March 31, | As of December 31, | |||||||||||
| 2020 | 2019 | 2019 | ||||||||||
| Unaudited | Audited | |||||||||||
| U.S Dollars in thousands | ||||||||||||
| Assets | ||||||||||||
| Current Assets | ||||||||||||
| Cash and cash equivalents | $ | 49,288 | $ | 22,037 | $ | 42,662 | ||||||
| Short-term investments | 47,124 | 33,800 | 31,245 | |||||||||
| Trade receivables, net | 26,266 | 23,210 | 23,210 | |||||||||
| Other accounts receivables | 1,736 | 3,442 | 3,272 | |||||||||
| Inventories | 41,787 | 31,708 | 43,173 | |||||||||
| Total Current Assets | 166,201 | 114,197 | 143,562 | |||||||||
| Non-Current Assets | ||||||||||||
| Property, plant and equipment, net | 24,379 | 24,642 | 24,550 | |||||||||
| Right-of-use assets | 3,800 | 4,187 | 4,022 | |||||||||
| Other long term assets | 1,053 | 174 | 352 | |||||||||
| Deferred expenses | 421 | - | - | |||||||||
| Deferred taxes | 939 | 1,895 | 1,311 | |||||||||
| Total Non-Current Assets | 30,592 | 30,898 | 30,235 | |||||||||
| Total Assets | $ | 196,793 | $ | 145,095 | $ | 173,797 | ||||||
| Liabilities | ||||||||||||
| Current Liabilities | ||||||||||||
| Current maturities of bank loans | $ | 465 | $ | 470 | $ | 489 | ||||||
| Current maturities of lease liabilities | 928 | 961 | 1,020 | |||||||||
| Trade payables | 18,440 | 15,255 | 24,830 | |||||||||
| Other accounts payables | 4,875 | 4,424 | 5,811 | |||||||||
| Deferred revenues | 649 | 461 | 589 | |||||||||
| Total Current Liabilities | 25,357 | 21,571 | 32,739 | |||||||||
| Non-Current Liabilities | ||||||||||||
| Bank loans | 138 | 591 | 257 | |||||||||
| Lease liabilities | 3,663 | 4,036 | 3,981 | |||||||||
| Deferred revenues | 569 | 605 | 232 | |||||||||
| Employee benefit liabilities, net | 1,251 | 823 | 1,269 | |||||||||
| Total Non-Current Liabilities | 5,621 | 6,055 | 5,739 | |||||||||
| Shareholder's Equity | ||||||||||||
| Ordinary shares | 11,647 | 10,412 | 10,425 | |||||||||
| Additional paid in capital net | 204,702 | 179,352 | 180,819 | |||||||||
| Capital reserve due to translation to presentation currency | (3,490 | ) | (3,490 | ) | (3,490 | ) | ||||||
| Capital reserve from hedges | 264 | 11 | 8 | |||||||||
| Capital reserve from financial assets measured at fair value through other comprehensive income | - | 118 | 145 | |||||||||
| Capital reserve from share-based payments | 8,903 | 9,463 | 8,844 | |||||||||
| Capital reserve from employee benefits | (356 | ) | 4 | (359 | ) | |||||||
| Accumulated deficit | (55,855 | ) | (78,401 | ) | (61,073 | ) | ||||||
| Total Shareholder's Equity | 165,815 | 117,469 | 135,319 | |||||||||
| Total Liabilities And Shareholder's Equity | $ | 196,793 | $ | 145,095 | $ | 173,797 |
Consolidated Statements
of Comprehensive Income
| Three months period ended | Year ended | |||||||||||
| March 31, | December 31, | |||||||||||
| 2020 | 2019 | 2019 | ||||||||||
| Unaudited | Audited | |||||||||||
| U.S Dollars in thousands | ||||||||||||
| Revenues from proprietary products | $ | 25,317 | $ | 20,381 | $ | 97,696 | ||||||
| Revenues from distribution | 7,973 | 6,416 | 29,491 | |||||||||
| Total revenues | 33,290 | 26,797 | 127,187 | |||||||||
| Cost of revenues from proprietary products | 14,947 | 10,490 | 52,425 | |||||||||
| Cost of revenues from distribution | 6,892 | 5,123 | 25,025 | |||||||||
| Total cost of revenues | 21,839 | 15,613 | 77,450 | |||||||||
| Gross profit | 11,451 | 11,184 | 49,737 | |||||||||
| Research and development expenses | 3,347 | 2,766 | 13,059 | |||||||||
| Selling and marketing expenses | 940 | 1,092 | 4,370 | |||||||||
| General and administrative expenses | 2,312 | 2,094 | 9,194 | |||||||||
| Other expense | 2 | 23 | 330 | |||||||||
| Operating income | 4,850 | 5,209 | 22,784 | |||||||||
| Financial income | 317 | 280 | 1,146 | |||||||||
| Income (expense) in respect of securities measured at fair value, net | 102 | (52 | ) | (5 | ) | |||||||
| Income (expense) in respect of currency exchange differences and derivatives instruments, net | 432 | (313 | ) | (651 | ) | |||||||
| Financial expense | (77 | ) | (71 | ) | (293 | ) | ||||||
| Income before tax on income | 5,624 | 5,053 | 22,981 | |||||||||
| Taxes on income | 406 | 130 | 730 | |||||||||
| Net Income | $ | 5,218 | $ | 4,923 | $ | 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 | ) | 108 | 143 | ||||||||
| Gain on cash flow hedges | 241 | 74 | 92 | |||||||||
| Net amounts transferred to the statement of profit or loss for cash flow hedges | 34 | (2 | ) | (23 | ) | |||||||
| Items that will not be reclassified to profit or loss in subsequent periods: | ||||||||||||
| Remeasurement gain (loss) from defined benefit plan | - | - | (388 | ) | ||||||||
| Tax effect | 27 | (28 | ) | (11 | ) | |||||||
| Total comprehensive income | $ | 5,332 | $ | 5,075 | $ | 22,064 | ||||||
| Earnings per share attributable to equity holders of the Company: | ||||||||||||
| Basic income per share | $ | 0.12 | $ | 0.12 | $ | 0.55 | ||||||
| Diluted income per share | $ | 0.12 | $ | 0.12 | $ | 0.55 |
Consolidated Statements of Cash Flows
| Three months period Ended | Year Ended | |||||||||||
| March 31, | December 31, | |||||||||||
| 2020 | 2019 | 2019 | ||||||||||
| Unaudited | Audited | |||||||||||
| U.S Dollars in thousands | ||||||||||||
| Net income | $ | 5,218 | $ | 4,923 | $ | 22,251 | ||||||
| Adjustments to reconcile net income to net cash provided by operating activities: | ||||||||||||
| Adjustments to the profit or loss items: | ||||||||||||
| Depreciation and impairment | 1,192 | 1,127 | 4,519 | |||||||||
| Financial expenses (income), net | (774 | ) | 156 | (197 | ) | |||||||
| Cost of share-based payment | 258 | 315 | 1,163 | |||||||||
| Taxes on income | 406 | 130 | 730 | |||||||||
| Loss (gain) from sale of property and equipment | - | (6 | ) | (2 | ) | |||||||
| Change in employee benefit liabilities, net | (18 | ) | 36 | 94 | ||||||||
| 1,064 | 1,758 | 6,307 | ||||||||||
| Changes in asset and liability items: | ||||||||||||
| Decrease (increase) in trade receivables, net | (3,016 | ) | 4,727 | 5,117 | ||||||||
| Decrease (increase) in other accounts receivables | 1,513 | 131 | (214 | ) | ||||||||
| Decrease (increase) in inventories | 1,386 | (2,392 | ) | (13,857 | ) | |||||||
| Decrease (increase) in deferred expenses | (421 | ) | (246 | ) | 399 | |||||||
| Increase (decrease) in trade payables | (7,216 | ) | (2,368 | ) | 6,259 | |||||||
| Increase (decrease) in other accounts payables | (1,180 | ) | (510 | ) | 863 | |||||||
| Increase (decrease) in deferred revenues | 397 | (63 | ) | (283 | ) | |||||||
| (8,537 | ) | (721 | ) | (1,716 | ) | |||||||
| Cash received (paid) during the year for: | ||||||||||||
| Interest paid | (55 | ) | (63 | ) | (243 | ) | ||||||
| Interest received | 451 | 172 | 1,106 | |||||||||
| Taxes paid | (61 | ) | (8 | ) | (134 | ) | ||||||
| 335 | 101 | 729 | ||||||||||
| Net cash provided by (used in) operating activities | $ | (1,920 | ) | $ | 6,061 | $ | 27,571 |