Kamada Reports Fiscal Year and Fourth Quarter 2021 Financial Results; Provides Revenue and Profitability Guidance with Significant Growth Expected in 2022

Kamada Ltd., a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, announced financial results for the 12 and three months ended December 31, 2021.

  • Total Revenuesfor Fiscal Year 2021 were $103.6Million and Fourth Quarter 2021 Revenues were $31.5 Million.
  • Fiscal Year 2022 Revenues are Expected to Range Between $125 Million to $135Million, Representing a 20% to 30% Increase over 2021; 2022 EBITDA MarginsAnticipated Between12%-15%, Representing More Than 2.5X over2021 EBITDA.
  • Integration of Newly Acquired Portfolio of Four FDA-Approved Commercial Products is Progressing as Planned with Expanded Sales in International Markets.
  • Advancing the Plan forthe Opening of New U.S. Plasma Collection Centers.
  • Company Expands U.S. Leadership Team with Multiple Key Hires to Drive Sales of Proprietary Products and Expansion of Plasma Collection Operations.
  • Added Two New Biosimilar Product Candidates in Israel;Increasing the Expected Potential Collective Annual Peak Sales of the Entire Biosimilar Portfolio of 11 Product Candidates to over$40Million.
  • Pivotal Phase 3 InnovAATe Trial for Inhaled AAT for theTreatment of Alpha-1 Antitrypsin Deficiency Progressing with the Opening of New Sites to Expand Recruitment.
  • GLASSIA® Royalty Payments from Takeda to Commence During Q22022.

REHOVOT, Israel, March 15, 2022 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, today announced financial results for the 12 and three months ended December 31, 2021.

“2021 was a transformational year for Kamada in our path toward becoming a global leader in the plasma-derived specialty hyperimmune market. With the recent acquisition of the portfolio of four FDA-approved commercial products, that generated annual global revenue in 2021 of approximately $41.9 million with over 50% gross margins of which approximately $5.4 million of revenue was recognized by the Company, and the establishment of Kamada Plasma, our U.S. based plasma collection company, we are embarking on a new and exciting chapter in the company’s evolution. We are building on the strong foundation established over the years and entering 2022 as a “New Kamada” – a fully integrated specialty plasma company, with six FDA-approved products and strong commercial capabilities in the U.S. market, as well as a global commercial footprint in over 30 countries,” said Amir London, Kamada’s Chief Executive Officer.

“Our business performed as expected during 2021, and we look ahead to 2022 for which our revenue guidance is between $125 million to $135 million, representing a 20% to 30% growth compared to 2021, with expected EBITDA margins of 12% to 15%, which would represent more than 2.5x of the 2021 EBITDA. This strong guidance reflects the benefits stemmed from our new undertaken strategic direction and our expectation of rapid return to revenue and profitability growth in 2022. We further expect continued growth at a double-digit rate in the foreseeable years ahead.”

“I am happy to report that over the past few months we have made significant progress with all our key growth catalysts, and we are implementing the needed steps to realize our significant growth potential. The integration of the newly acquired immunoglobulins portfolio is well underway in the U.S., as well as in the international markets. We are progressing with our plans for the opening of new plasma collection centers in the U.S. We have expanded our portfolio of Biosimilar product candidates to be distributed in the Israeli market, increasing our expected peak potential annual biosimilar sales, within several years of launch, to over $40 million. In addition, we are expanding our inhaled AAT pivotal Phase 3 trial with up to six additional clinical sites to be opened by mid-2022. Further, commencing in the second quarter of 2022, we are expecting to begin receiving GLASSIA royalty payments from Takeda, improving our profitability and cash position,” concluded Mr. London.

Fiscal Year 2022 Guidance
Kamada currently expects to generate fiscal year 2022 total revenues in a range of $125 million to $135 million which would represent a 20% to 30% growth compared to fiscal year 2021. The Company also anticipates generating EBITDA, during 2022, at a rate of 12% to 15% of total revenues, representing more than 2.5x of the EBITDA for the year ended December 31, 2021.

Financial Highlights for the Year Ended December 31, 2021

  • Total revenues were $103.6 million in the year ended December 31, 2021, as compared to $133.2 million recorded in the year ended December 31, 2020. This decrease was primarily due to the transition of GLASSIA manufacturing to Takeda resulting in an overall $38.7 million year over year decrease, and a year over year decrease of $6.4 million in KEDRAB sales to Kedrion as a result of a high level of product inventory at Kedrion as of December 31, 2020, due to the COVID-19 pandemic effect on KEDRAB sales by Kedrion during 2020. These decreases were partially offset by $5.4 million of revenues generated from the newly acquired portfolio between November 22, 2021, through December 31, 2021, as well as an increase in revenues of our other Proprietary products.
  • Gross profit was $30.3 million in the year ended December 31, 2021, compared to $47.6 million reported in the year ended December 31, 2020. The decrease compared to 2020 is primarily attributed to the overall change in product sales mix, specifically the decrease in sales of GLASSIA to Takeda and KEDRAB to Kedrion (as detailed above).
  • Net loss was $2.2 million, or $(0.05) per share, in the year ended December 31, 2021, as compared to net income of $17.1 million, or $0.38 per share, in the year ended December 31, 2020.
  • EBITDA, as detailed in the tables below, was $5.4 million in the year ended December 31, 2021, as compared to $25.1 million in the year ended December 31, 2020. Adjusted EBITDA, excluding certain costs, as detailed in the tables below, was $7.2 million for the year ended December 31, 2021.
  • Non-IFRS adjusted EBITDA for the year ended December 31, 2021, as detailed in the reconciliation table below, is presented excluding the following: (i) approximately $1.2 million in legal and other related fees associated with completing the acquisition transactions; and (ii) an expense of approximately $0.6 million related to excess severance remuneration for the employees who were laid-off as part of downsizing, following the transition of GLASSIA manufacturing to Takeda.
  • Cash used in operating activities was $8.8 million in the year ended December 31, of 2021, as compared to cash provided by operating activities of $19.1 million in the year ended December 31, 2020.

Financial Highlights for the Three Months Ended December 31, 2021

  • Total revenues were $31.5 million in the fourth quarter of 2021, equivalent to the revenues recorded in the fourth quarter of 2020.
  • Gross profit was $6.6 million in the fourth quarter of 2021, compared to $10.2 million reported in the fourth quarter of 2020.
  • Net loss was $5.0 million, or $(0.11) per share, in the fourth quarter of 2021, as compared to net income of $1.6 million, or $0.04 per share, in the fourth quarter of 2020.
  • EBITDA, as detailed in the tables below, was $(1.3) million in the fourth quarter of 2021, as compared to $4.0 million in the fourth quarter of 2020. Adjusted EBITDA, excluding certain costs, as detailed in the table below, was $(0.5) million in the fourth quarter of 2021.
  • Non-IFRS adjusted EBITDA for the fourth quarter of 2021, as detailed in the reconciliation table below, is presented excluding approximately $0.7 million in legal and other related fees associated with completing the acquisitions transaction.
  • Cash used in operating activities was $5.0 million in the fourth quarter of 2021, as compared to cash provided by operating activities of $12.7 million in the fourth quarter of 2020.

Balance Sheet Highlights
As of December 31, 2021, the Company had cash, cash equivalents, and short-term investments of $18.6 million, as compared to $109.3 million on December 31, 2020. The primary use of cash during 2021 was the acquisition of four FDA-approved plasma-derived hyperimmune commercial products. Kamada’s working capital as of December 31, 2021, comprising of current assets (excluding cash and cash equivalents, and short-term investments) net of current liabilities, totaled $57.4 million, representing an increase of $13.7 million compared to December 31, 2020.

The Company secured a $40 million credit facility from Bank Hapoalim, Israel’s leading commercial bank. The credit facility is comprised of a $20 million 5-year term loan and a $20 million short-term revolving credit facility. As of December 31, 2021, the Company drew-down the entire long-term loan and did not utilize the short-term revolving credit facility.

Conference Call
Kamada management will host an investment community conference call on Tuesday, March 15, 2022, at 8:30am Eastern Time to present the Company’s 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: 13727620. The call will also be webcast live on the Internet at:
https://viavid.webcasts.com/starthere.jsp?ei=1533883&tp_key=876a5d54ec

Non-IFRS financial measures
We present EBITDA and adjusted EBITDA because we use this non-IFRS financial measure to assess our operational performance, for financial and operational decision-making, and as a means to evaluate period-to-period comparisons on a consistent basis. Management believes this non-IFRS financial measure are useful to investors because: (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and provide investors with a meaningful perspective on the current underlying performance of the Company’s core ongoing operations; and (2) they exclude the impact of certain items that are not directly attributable to our core operating performance and that may obscure trends in the core operating performance of the business. Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation from, or as a substitute for, our IFRS results. We expect to continue reporting non-IFRS financial measures, adjusting for the items described below, and we expect to continue to incur expenses similar to certain of the non-cash, non-IFRS adjustments described below. Accordingly, unless otherwise stated, the exclusion of these and other similar items in the presentation of non-IFRS financial measures should not be construed as an inference that these items are unusual, infrequent or non-recurring. EBITDA and adjusted EBITDA are not recognized terms under IFRS and do not purport to be an alternative to IFRS terms as an indicator of operating performance or any other IFRS measure. Moreover, because not all companies use identical measures and calculations, the presentation of EBITDA and adjusted EBITDA may not be comparable to other similarly titled measures of other companies. EBITDA and adjusted EBITDA are defined as net income (loss), plus income tax expense, plus or minus financial income or expenses, net, plus or minus income or expense in respect of securities measured at fair value, net, plus or minus income or expenses in respect of currency exchange differences and derivatives instruments, net, plus depreciation and amortization expense, plus non-cash share-based compensation expenses and certain other costs.

About Kamada
Kamada Ltd. (the “Company”) is a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, 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 our current commercial activities as well as our manufacturing and development expertise in the plasma-derived biopharmaceutical market. The Company’s commercial products portfolio includes its developed and FDA approved products GLASSIA® and KEDRAB® as well as its recently acquired FDA approved plasma-derived hyperimmune products CYTOGAM®, HEPAGAM B®, VARIZIG® and WINRHO®SDF. The Company has additional four plasma-derived products which are registered in markets outside the U.S. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has a diverse portfolio of development pipeline products including 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 eleven 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 2028. 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) 2022 revenue guidance in the range of $125 million to $135 million, a 20% to 30% growth compared to 2021, 2) 2022 EBITDA, as a rate of total revenues, of 12% to 15%, 3) expected continued growth at a double-digit rate in the foreseeable years ahead, 4) expectation of rapid return to revenue and profitability growth in 2022, 5) plans for the opening of new plasma collection centers in the U.S., 6) expectation of peak potential annual biosimilar sales to over $40 million for the 11 Biosimilar product candidates to be distributed in the Israel market, 7) expansion of inhaled AAT pivotal Phase 3 trial with up to six additional clinical sites to be opened by mid-2022, 8) receipt of GLASSIA royalty payments from Takeda during the second quarter of 2022, 9) optimism about strategic business development opportunities that will utilize and expand our core plasma-derived development, manufacturing, and commercialization expertise, and 10) 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, 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 and its Distribution segment related products in Israel, financial conditions of the Company’s customer, suppliers and services providers, Kamada’s ability to integrate the new product portfolio into its current product portfolio, Kamada’s ability to grow the revenues of this new product portfolio, and leverage and expand its international distribution network, ability to reap the benefits of the recent acquisition of the plasma collection center, including the ability to open additional U.S. plasma centers, and acquisition of the FDA-approved plasma-derived hyperimmune commercial products, the ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of clinical studies, 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, and other risks detailed in Kamada’s filings with the U.S. Securities and Exchange Commission (the “SEC”) including those discussed in its most recent Annual Report on Form 20-F and in any subsequent reports on Form 6-K, each of which is on file or furnished with the SEC and available at the SEC’s website at www.sec.gov. 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 December 31,
2021 2020
U.S. Dollars in thousands
Assets
Current Assets
Cash and cash equivalents $ 18,587 $ 70,197
Short-term investments - 39,069
Trade receivables, net 35,162 22,108
Other accounts receivables 8,872 4,524
Inventories 67,423 42,016
Total Current Assets 130,044 177,914
Non-Current Assets
Property, plant and equipment, net 26,307 25,679
Right-of-use assets 3,092 3,440
Intangible assets, Goodwill and other long-term assets 153,663 1,573
Contract asset 5,561 2,059
Total Non-Current Assets 188,623 32,751
Total Assets $ 318,667 $ 210,665
Liabilities
Current Liabilities
Current maturities of bank loans $ 2,631 $ 238
Current maturities of lease liabilities 1,154 1,072
Current maturities of other long term liabilities 17,986 -
Trade payables 25,104 16,110
Other accounts payables 7,142 7,547
Deferred revenues 40 -
Total Current Liabilities 54,057 24,967
Non-Current Liabilities
Bank loans 17,407 36
Lease liabilities 3,160 3,593
Contingent consideration 21,995 -
Other long-term liabilities 43,929 -
Deferred revenues 15 2,025
Employee benefit liabilities, net 1,280 1,406
Total Non-Current Liabilities 87,786 7,060
Shareholder’s Equity
Ordinary shares 11,725 11,706
Additional paid in capital net 210,204 209,760
Capital reserve due to translation to presentation currency (3,490 ) (3,490 )
Capital reserve from hedges 54 357
Capital reserve from share-based payments 4,643 4,558
Capital reserve from employee benefits (149 ) (320 )
Accumulated deficit (46,163 ) (43,933 )
Total Shareholder’s Equity 176,824 178,638
Total Liabilities and Shareholder’s Equity $ 318,667 $ 210,665

CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME

For the year ended Three months period ended
December 31, December 31,
2021 2020 2021 2020
U.S. Dollars in thousands, other than per share information
Revenues from proprietary products 75,521 $ 100,916 18,205 $ 23,283
Revenues from distribution 28,121 32,330 13,264 8,259
Total revenues 103,642 133,246 31,469 31,542
Cost of revenues from proprietary products 48,194 57,750 12,589 13,933
Cost of revenues from distribution 25,120 27,944 12,285 7,444
Total cost of revenues 73,314 85,694 24,874 21,377
Gross profit 30,328 47,552 6,595 10,165
Research and development expenses 11,357 13,609 3,448 3,274
Selling and marketing expenses 6,278 4,518 2,475 1,221
General and administrative expenses 12,636 10,139 3,833 3,006
Other expenses and (incomes) 753 49 141 15
Operating income (696 ) 19,237 (3,302 ) 2,649
Financial income 295 1,027 18 162
Income (expense) in respect of securities measured at fair value, net - 102 - -
Income (expense) in respect of currency exchange differences and derivatives instruments, net (207 ) (1,535 ) (281 ) (839 )
Financial expenses (1,277 ) (266 ) (1,099 ) (62 )
Income before taxes (1,885 ) 18,565 (4,664 ) 1,910
Taxes on income 345 1,425 345 281
Net (loss) Income (2,230 ) $ 17,140 (5,009 ) 1,629
Other Comprehensive Income (loss) :
Amounts that will be or that have been reclassified to profit
or loss when specific conditions are met:
Gain from securities measured at fair value through other comprehensive income - (188 ) -
Gain (loss) on cash flow hedges - 876 (25 ) 360
Net amounts transferred to the statement of profit or loss for cash flow hedges (303 ) (528 ) 44 (255 )
Items that will not be reclassified to profit or loss in subsequent periods:
Remeasurement gain (loss) from defined benefit plan 171 64 171 64
Tax effect - 19 - (10 )
Total comprehensive (loss) income $ (2,362 ) $ 17,383 $ (4,819 ) $ 1,788
Earnings per share attributable to equity holders of the Company:
Basic (loss) income per share $ (0.05 ) $ 0.39 $ (0.11 ) $ 0.04
Diluted (loss) income per share $ (0.05 ) $ 0.38 $ (0.11 ) $ 0.04

NON-IFRS MEASURES

EBITDA
For the year ended Three months period ended
December 31, December 31,
2021 2020 2021 2020
U.S. Dollars in thousands
Net (loss) income $ (2,230 ) $ 17,140 $ (5,009 ) $ 1,629
Taxes on income 345 1,425 345 281
Financial expense, net 1,189 672 1,362 739
Depreciation and amortization expense 5,609 4,897 1,997 1,265
Non-cash share-based compensation expenses 529 977 25 124
EBITDA $ 5,442 $ 25,111 $ (1,280 ) $ 4,038
Adjusted EBITDA excluding referenced costs
For the year ended Three months period ended
December 31, December 31,
2021 2020 2021 2020
U.S. Dollars in thousands
Adjusted EBITDA (as in table above) $ 5,442 $ 25,111 $ (1,280 ) $ 4,038
Legal and other related costs associated with completing the acquisition transactions 1,212 - 742 -
Excess severance remuneration 560 - - -
Adjusted EBITDA excluding above referenced costs $ 7,214 $ 25,111 $ (538 ) $ 4,038

CONSOLIDATED STATEMENTS OF CASH FLOWS

For the year ended Three months period ended
December 31, December 31,
2021 2020 2021 2020
U.S. Dollars in thousands
Cash Flows from Operating Activities
Net (loss) Income $ (2,230 ) $ 17,140 $ (5,009 ) $ 1,629
Adjustments to reconcile net income to net cash provided by (used in) operating activities:
Adjustments to the profit or loss items:
Depreciation and impairment 5,609 4,897 1,997 1,265
Financial income, net 1,189 672 1,362 739
Cost of share-based payment 529 977 25 124
Taxes on income 345 1,425 345 281
Gain from sale of property and equipment - (7 ) - -
Change in employee benefit liabilities, net 45 201 (16 ) 208
Total adjustments 7,717 8,165 3,713 2,617
Changes in asset and liability items:
Decrease (increase) in trade receivables, net (12,861 ) 1,332 (8,415 ) 6,872
Increase in other accounts receivables (1,634 ) 115 (3,191 ) (857 )
Increase in inventories (2,373 ) 1,157 3,590 602
Decrease (increase) in Contract asset and deferred expenses (6,883 ) (3,085 ) (2,124 ) (621 )
Increase (decrease) in trade payables 7,917 (9,560 ) 5,192 928
Increase (decrease) in other accounts payables (392 ) 1,736 1,091 1,310
Decrease in deferred revenues 1,815 1,204 265 14
Total changes in assets and liabilities (14,411 ) (7,101 ) (3,592 ) 8,248
Cash received (paid) during the period for:
Interest paid (228 ) (209 ) (89 ) (51 )
Interest received 375 1,211 18 320
Taxes paid (42 ) (101 ) (10 ) (14 )
105 901 (81 ) 255
Net cash (used in)provided by operating activities $ (8,819 ) $ 19,105 $ (4,969 ) $ 12,749

CONSOLIDATED STATEMENTS OF CASH FLOWS (continued)

For the year ended Three months period ended
December 31, December 31,
2021 2020 2021 2020
U.S. Dollars in thousands
Cash Flows from Investing Activities
Proceeds of investment in short term investments, net $ 39,083 $ (7,646 ) - $ 8,000
Purchase of property and equipment and intangible assets (3,730 ) (5,488 ) (744 ) (2,116 )
Business combination (96,403 ) - (94,999 )
Proceeds from sale of property and equipment - 7 - -
Net cash provided by (used in) investing activities (61,050 ) (13,127 ) (95,743 ) 5,884
Cash Flows from Financing Activities
Proceeds from exercise of share base payments 19 65 5 4
Receipt of long-term loan 20,000 - 20,000 -
Repayment of lease liabilities (1,221 ) (1,103 ) (318 ) (288 )
Repayment of long-term loans (205 ) (492 ) 16 (119 )
Proceeds from issuance of ordinary shares, net - 24,894 - -
Net cash used in financing activities 18,593 23,364 19,703 (403 )
Exchange differences on balances of cash and cash equivalent (334 ) (1,807 ) (244 ) (520 )
Increase in cash and cash equivalents (51,610 ) 27,535 (81,253 ) 17,710
Cash and cash equivalents at the beginning of the period 70,197 42,662 99,840 52,487
Cash and cash equivalents at the end of the period 18,857 $ 70,197 18,587 $ 70,197
Significant non-cash transactions
Purchase of property and equipment through leases $ 845 $ 539 $ 76 $ -
Purchase of property and equipment $ 1,001 $ 722 $ 649 $ 722


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