Kamada Reports Fourth Quarter and Fiscal Year 2020 Financial Results, Recent Achievements and Corporate Development Activities
Kamada Ltd. (NASDAQ: KMDA) reported full-year 2020 revenues of $133.2 million, aligning with guidance and marking a 5% increase from 2019. The company overcame operational challenges from the COVID-19 pandemic, achieving adjusted EBITDA of $25.1 million. Kamada has entered the U.S. plasma collection market through the acquisition of an FDA-approved facility, aiming to expand its hyperimmune IgG portfolio. Additionally, it is supplying a plasma-derived COVID-19 product to the Israeli Ministry of Health, expecting about $3.4 million in related revenue.
- Full-year 2020 revenues of $133.2 million, a 5% increase from 2019.
- Adjusted EBITDA for 2020 was $25.1 million.
- Acquired FDA-approved plasma collection facility, entering the U.S. market.
- Expected revenue of approximately $3.4 million from COVID-19 product supply to IMOH.
- Plans to launch nine biosimilar products between 2022 and 2025 with estimated sales of $25 million to $35 million.
- Net income decreased to $17.1 million in 2020 from $22.3 million in 2019.
- Gross profit fell to $47.6 million in 2020, down from $49.7 million in 2019.
- Operating expenses increased to $28.3 million in 2020 from $27 million in 2019.
- Transition of Glassia manufacturing to Takeda and ongoing pandemic uncertainties expected to reduce 2021 revenues and profitability.
- Full-Year 2020 Revenues were
$133. 2 Million, In-Line with the Company’s Guidance; Adjusted EBITDA for 2020 was$25. 1 Million - Kamada Enters U.S. Plasma Collection Market Through Acquisition of an FDA-Approved Facility, Furthering its Strategic Goal of Becoming a Fully Integrated Specialty Plasma Company Focused on Growing its Hyperimmune IgG Portfolio
- Israeli Ministry of Health (IMOH) Initiated Treatment of Hospitalized COVID-19 Patients with Kamada’s Plasma-Derived COVID-19 Immunoglobulin (IgG) Investigational Product Primarily as Part of a Multi-Center Clinical Study Led by the IMOH; Current Planned Supply to IMOH is Sufficient to Treat an Estimated 500 Patients
- Kamada Continues to Expand Existing Business Lines as Evidenced by the Recent Additions to its Israeli Distribution Biosimilar Products Portfolio; Also Exploring Business Development Opportunities and Intends to Leverage IgG Platform Technology as Response to Future Pandemic Situations
REHOVOT, Israel, Feb. 10, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced financial results for the three and 12 months ended December 31, 2020.
“We are pleased to have overcome meaningful operational challenges caused by the global COVID-19 pandemic and met our key financial targets for 2020,” said Amir London, Kamada’s Chief Executive Officer. “For full-year 2020, we recorded total revenues of
"The acquisition of the Blood and Plasma Research (B&PR) collection center and establishment of our wholly-owned subsidiary, Kamada Plasma LLC, represents our entry into the U.S. plasma collection market, furthers our strategic goal of becoming a fully integrated specialty plasma company, and is expected to improve our IgG competitive profile in multiple markets. We intend to significantly expand our hyperimmune plasma collection capacity by investing in this center and leveraging its FDA license to open additional centers in the U.S.," continued Mr. London.
"We continue to advance the rapid development and manufacturing of our plasma-derived COVID-19 IgG investigational product, which is being supplied to the Israeli Ministry of Health (IMOH) for the treatment of an estimated 500 hospitalized patients, through an agreement that is expected to generate approximately
“In addition, we continue to develop our pipeline, primarily focusing on the pivotal Phase 3 InnovAATe clinical trial of Inhaled AAT for the treatment of Alpha-1 Antitrypsin Deficiency and on exploring new strategic business development opportunities that will utilize and expand our core plasma-derived development, manufacturing, and commercialization expertise. Moreover, we intend to leverage our IgG platform technology as a strategic business line, with the ability to respond to future potential pandemic situations,” concluded Mr. London.
As previously reported, the transition of Glassia manufacturing to Takeda and the continued uncertainty in the operating environment created by the ongoing global COVID-19 pandemic are expected to result in reduced revenues and profitability in 2021. At the same time, Kamada continues to focus on expanding its existing growth drivers, which include:
- Continued market share growth for KedRAB in the U.S.;
- Expanding the sales of Glassia and the Company’s IgG portfolio in ex-U.S. markets, including registration and launch of the products in new territories;
- Generating royalties from Glassia, projected to be in the range of
$10 million to$20 million per year commencing in 2022; - Launching nine biosimilar products in the Israeli-based Distribution segment between 2022 and 2025, pending regulatory approval, with estimated maximum sales in the range of
$25 million to$35 million ; and - Leveraging the Company’s plasma-derived products manufacturing facility and expertise to offer contract manufacturing services of specialty IgG products, including an FDA-approved and commercialized IgG product that is expected to add between
$8 million to$10 million in annual revenues, beginning in 2023.
Financial Highlights for the Three Months Ended December 31, 2020
- Total revenues were
$31.5 million in the fourth quarter of 2020, a 2% decrease from the$32.1 million recorded in the fourth quarter of 2019. - Gross profit was
$10.2 million in the fourth quarter of 2020, compared to$12.1 million reported in the fourth quarter of 2019. - Net income was
$1.6 million , or$0.04 per share, in the fourth quarter of 2020, as compared to net income of$5.4 million , or$0.13 per share, in the fourth quarter of 2019. - Adjusted EBITDA, as detailed in the tables below, was
$4.0 million in the fourth quarter of 2020, as compared to$6.8 million in the fourth quarter of 2019. - Cash provided by operating activities was
$12.7 million in the fourth quarter of 2020, as compared to cash provided by operating activities of$8.6 million in the fourth quarter of 2019.
Financial Highlights for the Year Ended December 31, 2020
- Total revenues were
$133.2 million in the year ended December 31, 2020, a5% increase from the$127.2 million recorded in the year ended December 31, 2019. - Gross profit was
$47.6 million in the year ended December 31, 2020, compared to$49.7 million in the same period of 2019. - Proprietary Product segment gross margins in the year ended December 31, 2020 were
43% , down three percentage points from the year ended December 31, 2019, and in-line with the Company’s expectations of an annual decrease of three to five percentage points, primarily attributable to a change in product sales mix and reduced plant utilization. - Operating expenses, including Research and Development, Sales & Marketing, General and Administrative, and Other Expenses, totaled
$28.3 million in the year ended December 31, 2020, as compared to$27.0 million in the year ended December 31, 2019. - The
4% increase in Research and Development expenses for full-year 2020 as compared to 2019 was below Kamada’s guidance of a13% -15% year-over-year increase. This is primarily due to the delay in patient enrollment in the Company’s InnovAATe clinical trial due to the impact of the COVID-19 pandemic. - Net income was
$17.1 million , or$0.38 (fully diluted) per share, in the year ended December 31, 2020, as compared to net income of$22.3 million , or$0.55 per share, in the year ended December 31, 2019. - Adjusted EBITDA, as detailed in the tables below, was
$25.1 million in the year ended December 31, 2020, as compared to$28.5 million in the year ended December 31, 2019. - Cash provided by operating activities was
$19.1 million in the year ended December 31, 2020, as compared to cash provided by operating activities of$27.6 million in the year ended December 31,2019.
Balance Sheet Highlights
As of December 31, 2020, the Company had cash, cash equivalents, and short-term investments of
Recent Corporate Highlights
- Acquired privately held B&PR’s plasma collection center in Beaumont, TX, which specializes in the collection of hyper-immune plasma used by Kamada in the manufacture of its anti-D products.
- Began supplying its COVID-19 plasma-derived IgG product to the IMOH for the treatment of COVID-19 patients in Israel; agreement expected to generate approximately
$3.4 million in revenue to Kamada. - Entered into agreements with two undisclosed international pharmaceutical companies to commercialize three biosimilar product candidates in Israel. Subject to approval by the European Medicines Agency and subsequently by the IMOH, the three products are expected to be launched in Israel between 2022 and 2024 and Kamada estimates the potential collective maximum sales generated by the sale of these three products, achievable following regulatory approval and within several years of launch, to be in the range of
$5 million to$7 million annually. - Added to the NASDAQ Biotechnology Index® (Nasdaq: NBI) designed to track the performance of a set of either biotechnology or pharmaceutical companies listed on The NASDAQ Stock Market®.
Conference Call
Kamada management will host an investment community conference call on Wednesday, February 10, 2020, at 8:00am 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.), 1-809-409-247 (from Israel), or 201-689-8263 (International) and entering the conference identification number: 13715277. The call will also be webcast live on the Internet on the Company’s website at http://public.viavid.com/index.php?id=143096.
About Kamada
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. 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. 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 hyperimmune 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
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) 2020 financial results being indicative of the fundamental strengths of Kamada’s business, 2) benefits of the B&PR acquisition, including furthering Kamada’s strategic goal of becoming a fully integrated specialty plasma company, the acquisition’s ability to improve Kamada’s IgG competitiveness in different markets and ability to expand Kamada’s hyperimmune plasma collection capacity by investing in the acquired center and leveraging its FDA license to open additional centers in the U.S., 3) plasma derived COVID-19 IgG investigational product supplied to the IMOH is estimated to be used to treat 500 hospitalized patient, through an agreement expected to generate approximately
CONTACTS:
Chaime Orlev
Chief Financial Officer
IR@kamada.com
Bob Yedid
LifeSci Advisors, LLC
646-597-6989
Bob@LifeSciAdvisors.com
CONSOLIDATED BALANCE SHEETS
As of December 31, | ||||||||||
2020 |
| 2019 | ||||||||
Assets | U.S. Dollars in thousands | |||||||||
Current Assets | ||||||||||
Cash and cash equivalents | $ | 70,197 | $ | 42,662 | ||||||
Short-term investments | 39,069 | 31,245 | ||||||||
Trade receivables, net | 22,108 | 23,210 | ||||||||
Other accounts receivables | 4,524 | 3,272 | ||||||||
Inventories | 42,016 | 43,173 | ||||||||
Total Current Assets | 177,914 | 143,562 | ||||||||
Non-Current Assets | ||||||||||
Property, plant and equipment, net | 25,679 | 24,550 | ||||||||
Right-of-use-assets | 3,440 | 4,022 | ||||||||
Other long term assets | 1,573 | 352 | ||||||||
Contract asset | 2,059 | - | ||||||||
Deferred taxes | - | 1,311 | ||||||||
Total Non-Current Assets | 32,751 | 30,235 | ||||||||
Total Assets | $ | 210,665 | $ | 173,797 | ||||||
Liabilities | ||||||||||
Current Liabilities | ||||||||||
Current maturities of bank loans | $ | 238 | $ | 489 | ||||||
Current maturities of lease liabilities | 1,072 | 1,020 | ||||||||
Trade payables | 16,110 | 24,830 | ||||||||
Other accounts payables | 7,547 | 5,811 | ||||||||
Deferred revenues | - | 589 | ||||||||
Total Current Liabilities | 24,967 | 32,739 | ||||||||
Non-Current Liabilities | ||||||||||
Bank loans | 36 | 257 | ||||||||
Lease liabilities | 3,593 | 3,981 | ||||||||
Deferred revenues | 2,025 | 232 | ||||||||
Employee benefit liabilities, net | 1,406 | 1,269 | ||||||||
Total Non-Current Liabilities | 7,060 | 5,739 | ||||||||
Shareholder's Equity | ||||||||||
Ordinary shares | 11,706 | 10,425 | ||||||||
Additional paid in capital net | 209,760 | 180,819 | ||||||||
Capital reserve due to translation to presentation currency | (3,490 | ) | (3,490 | ) | ||||||
Capital reserve from hedges | 357 | 8 | ||||||||
Capital reserve from financial assets measured at fair value through other comprehensive Income | - | 145 | ||||||||
Capital reserve from share-based payments | 4,558 | 8,844 | ||||||||
Capital reserve from employee benefits | (320 | ) | (359 | ) | ||||||
Accumulated deficit | (43,933 | ) | (61,073 | ) | ||||||
Total Shareholder’s Equity | 178,638 | 135,319 | ||||||||
Total Liabilities and Shareholder’s Equity | $ | 210,665 | $ | 173,797 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
For the year ended | Three months period ended | ||||||||||||||||
December 31, | December 31, | ||||||||||||||||
2020 |
| 2019 | 2020 |
| 2019 | ||||||||||||
U.S. Dollars in thousands, other than per share information | |||||||||||||||||
Revenues from proprietary products | $ | 100,916 | $ | 97,696 | $ | 23,283 | $ | 25,175 | |||||||||
Revenues from distribution | 32,330 | 29,491 | 8,259 | 6,896 | |||||||||||||
Total revenues | 133,246 | 127,187 | 31,542 | 32,071 | |||||||||||||
Cost of revenues from proprietary products | 57,750 | 52,425 | 13,933 | 14,013 | |||||||||||||
Cost of revenues from distribution | 27,944 | 25,025 | 7,444 | 5,969 | |||||||||||||
Total cost of revenues | 85,694 | 77,450 | 21,377 | 19,982 | |||||||||||||
Gross profit | 47,552 | 49,737 | 10,165 | 12,089 | |||||||||||||
Research and development expenses | 13,609 | 13,059 | 3,274 | 3,329 | |||||||||||||
Selling and marketing expenses | 4,518 | 4,370 | 1,221 | 929 | |||||||||||||
General and administrative expenses | 10,139 | 9,194 | 3,006 | 2,343 | |||||||||||||
Other expenses and (incomes) | 49 | 330 | 15 | 3 | |||||||||||||
Operating income | 19,237 | 22,784 | 2,649 | 5,485 | |||||||||||||
Financial income | 1,027 | 1,146 | 162 | 259 | |||||||||||||
Income (expense) in respect of securities measured at fair value, net | 102 | (5 | ) | - | (2 | ) | |||||||||||
Income (expense) in respect of currency exchange differences and derivatives instruments, net | (1,535 | ) | (651 | ) | (839 | ) | (148 | ) | |||||||||
Financial expenses | (266 | ) | (293 | ) | (62 | ) | (76 | ) | |||||||||
Income before taxes | 18,565 | 22,981 | 1,910 | 5,518 | |||||||||||||
Taxes on income | 1,425 | 730 | 281 | 156 | |||||||||||||
Net Income | $ | 17,140 | $ | 22,251 | 1,629 | $ | 5,362 | ||||||||||
Other Comprehensive Income (loss) : | |||||||||||||||||
Amounts that will be or that have been reclassified to profit | |||||||||||||||||
Gain from securities measured at fair value through other comprehensive income | (188
| )
| 143 | - | 11 | ||||||||||||
Gain (loss) on cash flow hedges | 876 | 92 | 360 | (7 | ) | ||||||||||||
Net amounts transferred to the statement of profit or loss for cash flow hedges | (528 | ) | (23 | ) | (255 | ) | (3 | ) | |||||||||
Items that will not be reclassified to profit or loss in subsequent periods: | |||||||||||||||||
Remeasurement gain (loss) from defined benefit plan | 64 | (388 | ) | 64 | (388 | ) | |||||||||||
Tax effect | 19 | (11 | ) | (10 | ) | 22 | |||||||||||
Total comprehensive income | $ | 17,383 | $ | 22,064 | $ | 1,788 | $ | 4,997 | |||||||||
Earnings per share attributable to equity holders of the | |||||||||||||||||
Basic income per share | $ | 0.39 | $ | 0.55 | $ | 0.04 | $ | 0.13 | |||||||||
Diluted income per share | $ | 0.38 | $ | 0.55 | $ | 0.04 | $ | 0.13 | |||||||||
| | | | | | | | |
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the year ended | Three months period ended | ||||||||||||||||
December 31, |
| December 31, |
| ||||||||||||||
2020 | 2019 | 2020 | 2019 |
| |||||||||||||
U.S. Dollars in thousands | |||||||||||||||||
Cash Flows from Operating Activities | |||||||||||||||||
Net income | $ | 17,140 | $ | 22,251 | $ | 1,629 | $ | 5,362 | |||||||||
Adjustments to reconcile net income to net cash provided by (used in) operating activities: | |||||||||||||||||
Adjustments to the profit or loss items: | |||||||||||||||||
Depreciation and impairment | 4,897 | 4,519 | 1,265 | 1,140 | |||||||||||||
Financial income, net | 672 | (197 | ) | 739 | (33 | ) | |||||||||||
Cost of share-based payment | 977 | 1,163 | 124 | 176 | |||||||||||||
Taxes on income | 1,425 | 730 | 281 | 156 | |||||||||||||
Gain from sale of property and equipment | (7 | ) | (2 | ) | - | - | |||||||||||
Change in employee benefit liabilities, net | 201 | 94 | 208 | (3 | ) | ||||||||||||
8,165 | 6,307 | 2,617 | 1,436 | ||||||||||||||
Changes in asset and liability items: | |||||||||||||||||
Decrease (increase) in trade receivables, net | 1,332 | 5,117 | 6,872 | 709 | |||||||||||||
Increase in other accounts receivables | 115 | (214 | ) | (857 | ) | (1,418 | ) | ||||||||||
Increase in inventories | 1,157 | (13,857 | ) | 602 | (9,142 | ) | |||||||||||
Decrease (increase) in Contract asset and deferred expenses | (3,085 | ) | 399 | (621 | ) | 66 | |||||||||||
Increase (decrease) in trade payables | (9,560 | ) | 6,259 | 928 | 10,844 | ||||||||||||
Increase (decrease) in other accounts payables | 1,736 | 863 | 1,310 | 484 | |||||||||||||
Decrease in deferred revenues | 1,204 | (283 | ) | 14 | (62 | ) | |||||||||||
(7,101 | ) | (1,716 | ) | 8,248 | 1,481 | ||||||||||||
Cash received (paid) during the period for: | |||||||||||||||||
Interest paid | (209 | ) | (243 | ) | (51 | ) | (61 | ) | |||||||||
Interest received | 1,211 | 1,106 | 320 | 552 | |||||||||||||
Taxes paid | (101 | ) | (134 | ) | (14 | ) | (109 | ) | |||||||||
901 | 729 | 255 | 382 | ||||||||||||||
Net cash provided by operating activities | $ | 19,105 | $ | 27,571 | $ | 12,749 | $ | 8,661 |
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the year ended | Three months period ended | ||||||||||||||||
December 31, |
| December 31, |
| ||||||||||||||
2020 |
| 2019 |
| 2020 | 2019 |
| |||||||||||
U.S. Dollars in thousands | |||||||||||||||||
Cash Flows from Investing Activities | |||||||||||||||||
Proceeds of investment in short term investments, net | $ | (7,646 | ) | $ | 1,727 | $ | 8,000 | $ | 7,887 | ||||||||
Purchase of property and equipment and intangible assets | (5,488 | ) | (2,300 | ) | (2,116 | ) | (812 | ) | |||||||||
Proceeds from sale of property and equipment | 7 | 9 | - | - | |||||||||||||
Net cash provided by (used in) investing activities | (13,127 | ) | (564 | ) | 5,884 | 7,075 | |||||||||||
Cash Flows from Financing Activities | |||||||||||||||||
Proceeds from exercise of share base payments | 65 | 16 | 4 | 4 | |||||||||||||
Repayment of lease liabilities | (1,103 | ) | (1,070 | ) | (288 | ) | (276 | ) | |||||||||
Repayment of long-term loans | (492 | ) | (476 | ) | (119 | ) | (123 | ) | |||||||||
Proceeds from issuance of ordinary shares, net | 24,894 | - | - | - | |||||||||||||
Net cash used in financing activities | 23,364 | (1,530 | ) | (403 | ) | (395 | ) | ||||||||||
Exchange differences on balances of cash and cash equivalent | (1,807 | ) | (908 | ) | (520 | ) | (128 | ) | |||||||||
Increase in cash and cash equivalents | 27,535 | 24,569 | 17,710 | 15,213 | |||||||||||||
Cash and cash equivalents at the beginning of the period | 42,662 | 18,093 | 52,487 | 27,449 | |||||||||||||
Cash and cash equivalents at the end of the period | $ | 70,197 | $ | 42,662 | $ | 70,197 | $ | 42,662 | |||||||||
Significant non-cash transactions | |||||||||||||||||
Purchase of property and equipment through leases | $ | 539 | $ | 5,035 | $ | - | $ | 51 | |||||||||
Purchase of property and equipment | $ | 722 | $ | 992 | $ | 722 | $ | 992 |
ADJUSTED EBITDA
For the year ended | Three months period ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
U.S. Dollars in thousands | ||||||||||||||||
Net income (loss) | $ | 17,140 | $ | 22,251 | $ | 1,629 | $ | 5,362 | ||||||||
Taxes on income | 1,425 | 730 | 281 | 156 | ||||||||||||
Financial expense (income), net | 672 | (197 | ) | 739 | (33 | ) | ||||||||||
Depreciation and amortization expense | 4,897 | 4,519 | 1,265 | 1,140 | ||||||||||||
Non-cash share-based compensation expenses | 977 | 1,163 | 124 | 176 | ||||||||||||
Adjusted EBITDA | $ | 25,111 | $ | 28,466 | $ | 4,038 | $ | 6,801 | ||||||||
ADJUSTED NET INCOME
For the year ended | Three months period ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
U.S. Dollars in thousands | ||||||||||||||||
Net income (loss) | $ | 17,140 | $ | 22,251 | $ | 1,629 | $ | 5,362 | ||||||||
Share-based compensation charges | 977 | 1,163 | 124 | 176 | ||||||||||||
Adjusted net income | $ | 18,117 | $ | 23,414 | $ | 1,753 | $ | 5,538 | ||||||||
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