Kamada Reports Strong Fiscal Year and Fourth Quarter 2022 Financial Results, and Provides 2023 Guidance Representing Significant Profitability Growth
03/15/2023 - 07:00 AM
Total Revenues for Fiscal Year 2022 of $129.3 Million Represent ed Growth of 25% Compared to Fiscal Year 2021 ; Fourth Quarter 2022 Revenues of $45. 4 Million Represent ed a 44% Increase Year - over - Year Fiscal Year 2022 EBITDA of $1 7.8 million, Represent ed Margins of 14% , and a 3x Increase Over Fiscal Year 2021 Recorded Highest Annual Operating Cash Flow in Kamada's History of $28. 6 Million in Fiscal Year 2022 ; $34. 3 Million Cash Position as of December 31, 2022, Nearly Double Cash Position at Year- End 2021 Fiscal Year 2023 Revenues Expected to be in Range of $138 Million to $146 Million ; 2023 EBITDA Anticipated to be in Range of $22 M illion to $26 M illion ; Mid-Point Expected EBITDA Represents Approximately 35 % Growth Year - over - Year Strong 2022 Results and 2023 Positive Outlook Driven by Multiple Growth Drivers, including CYTOGAM® and KEDRAB ® Sales, GLASSIA ® Royalties , Other Proprietary Product Sales in International Markets, and Thriving Israeli Distribution Business Continued Progress in Ongoing InnovAATe, Pivotal Phase 3 Clinical Trial of Inhaled AAT , Including Recruitment Acceleration , Successful DSMB Meeting and Intention to Meet Regulatory Agencies During H1/2023 Conference Call and Live Webcast with Slides Today at 8:30 AM ET REHOVOT, Israel and Hoboken, N.J., March 15, 2023 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced financial results for the 12 and three months ended December 31, 2022.
“The success of our rapid strategic transformation to a diversified, fully integrated specialty plasma company is evidenced by our impressive full-year 2022 financial results,” said Amir London, Kamada’s Chief Executive Officer. “We met our 2022 revenue and profitability guidance, with total revenues of $129.3 million , which represented 25% growth compared to 2021, and EBITDA of $17.8 million , a 3x increase over 2021. Moreover, we generated operating cash flow of $28.6 million during 2022, supporting the increase in our cash position to $34.3 million as of December 31, 2022. These impressive results were driven by our ability to leverage multiple growth drivers, including the portfolio of four FDA approved IgGs acquired in late 2021, the sales of which increased 24% year over year in 2022, KEDRAB sales in the U.S., GLASSIA royalties from Takeda, the sales of our other Proprietary products in the international markets, and our thriving Israeli distribution business,” continued Mr. London.
“Importantly, we expect the momentum from 2022 to extend throughout 2023, with profitability to be further enhanced. As such, we are introducing full-year 2023 revenue guidance of $138 million to $146 million and EBITDA guidance of $22 million to $26 million . Mid-point expected EBITDA represents approximately 35% growth year over year. Moreover, our multiple catalysts are anticipated to drive annual double-digit growth in the foreseeable years ahead, with significant upside potential and limited downside risk," concluded Mr. London.
Financial Highlights for the Year Ended December 31, 202 2
Total revenues were $129.3 million in the year ended December 31, 2022, as compared to $103.6 million recorded in the year ended December 31, 2021.The increase in revenues was primarily attributable to sales of the acquired four IgG products. Gross profit and gross margins were $46.7 million and 36% , respectively, in the year ended December 31, 2022, compared to $30.3 million and 29% , respectively, reported in the year ended December 31, 2021. Gross profit and gross margins in 2022, excluding intangible assets depreciation in the amount of $5.3 million would have been $52.0 million and 40% , respectively, representing a significant increase year-over-year. Operating expenses, including R&D, Sales & Marketing (S&M), G&A and other expenses, totaled $42.2 million in the year ended December 31, 2022, as compared to $31.0 million in the prior year. This increase was attributable to an increase in S&M costs associated with the recently acquired portfolio, as well as increased R&D costs, primarily due to advancing the pivotal Phase 3 InnovAATe trial for Inhaled AAT through the opening of new clinical sites and the manufacturing of clinical supply for the study. S&M costs for the year ended December 31, 2022, included $1.7 million of depreciation expenses of intangible assets generated through the IgG products acquisition. Finance expense, net for the year ended December 31, 2022, included $6.3 million of expenses associated with the revaluation of the contingent consideration and other long-term liabilities, assumed as part of the IgG products acquisition. For more information with respect to such contingent consideration and other long-term liabilities please refer to Note 5 of the Company’s 2022 financial statements included in the 2022 Annual Report on Form 20-F filed on March 15, 2023, with the Securities and Exchange Commission. Net loss was $2.3 million , or $(0.05) per share in the year ended December 31, 2022. Excluding depreciation expenses of intangible assets generated through the recent acquisition, and finance expense associated with the revaluation of the contingent consideration and other assumed long-term liabilities, the Company would have recorded net income of $11.0 million , or $0.25 per share, in the year ended December 31, 2022, as compared to net loss of $2.2 million , or $(0.05) per share, in the prior year. Adjusted EBITDA, as detailed in the tables below, was $17.8 million in the year ended December 31, 2022, as compared to $5.4 million in the year ended December 31, 2021, representing an over 3x increase year-over-year, and 14% margins, which was in line with Kamada’s annual guidance. Cash provided by operating activities was $28.6 million in the year ended December 31, 2022, as compared to cash used in operating activities of ($8.8) million in the prior year. Financial Highlights for the Three Months Ended December 31, 202 2
Total revenues were $45.4 million in the fourth quarter of 2022, a 44% increase from the prior year period. Total revenues during the fourth quarter of 2022 included strong sales from the portfolio of four acquired FDA-approved IgG products. Gross profit and gross margins were $15.3 million and 34% , respectively, in the fourth quarter of 2022, compared to $6.6 million and 21% , respectively, reported in the prior year period. The increase in profitability was driven by a positive product sales mix, including sales of the four new IgG products, KEDRAB U.S sales and GLASSIA royalties. Cost of goods sold in the Company’s Proprietary segment in the fourth quarter of 2022 included $1.3 million of depreciation expenses associated with intangible assets generated through the IgG products acquisition. Gross profit and gross margins, excluding such intangible assets depreciation, would have been $16.6 million and 37% , respectively. Operating expenses, including R&D, S&M, G&A and other expenses, totaled $11.3 million in the fourth quarter of 2022, as compared to $9.9 million in the fourth quarter of 2021. This increase was attributable to increased S&M costs associated with expanded U.S. commercial operations. S&M costs for the fourth quarter of 2022 included $0.4 million of depreciation expenses of intangible assets generated through the IgG products acquisition. Finance expense, net for the fourth quarter of 2022 included $0.3 million of expenses associated with the revaluation of the contingent consideration and other long-term liabilities assumed as part of the IgG products acquisition. Net income was $2.9 million , or $0.07 per share, in the fourth quarter of 2022. Excluding depreciation expenses of intangible assets mentioned above and finance expense associated with the revaluation of the contingent consideration and other assumed long-term liabilities, the Company would have recorded net income of $5.0 million , or $0.11 per share, in the fourth quarter of 2022, as compared to a net loss of ($5.0) million , or $(0.11) per share, in the fourth quarter of 2021. Adjusted EBITDA, as detailed in the tables below, was $7.2 million in the fourth quarter of 2022, as compared to ($1.3) million in the fourth quarter of 2021. Cash provided by operating activities was $6.7 million in the fourth quarter of 2022, as compared to cash used in operating activities of ($5.0) million in the fourth quarter of 2021. Balance Sheet Highlights $34.3 million , as compared to $18.6 million on December 31, 2021. The increase in Kamada’s cash position was driven by continued positive operational cash flows, which is indicative of the significant momentum in the Company’s commercial operations.
Recent Corporate Highlights
Submitted applications to the U.S. Food and Drug Administration (FDA) and to Health Canada to manufacture CYTOGAM® (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV) at Kamada’s facility in Beit Kama, Israel. Reported on progress achieved in the ongoing pivotal Phase 3 clinical trial of inhaled AAT, InnovAATe, including acceleration in trial recruitment, a successful DSMB meeting, encouraging safety data observed to date, and the intention to meet with the FDA and European Medicines Agency during first half of 2023 to discuss study progress and potential opportunities to shorten the regulatory pathway. Fiscal Year 2023 Guidance $138 million to $146 million and EBITDA in the range of $22 million to $26 million ; mid-point expected EBITDA represents approximately 35% growth year-over-year.
Conference Call https://viavid.webcasts.com/starthere.jsp?ei=1601498&tp_key=dfb5545156
Non-IFRS financial measures
About Kamada 21% of the outstanding ordinary shares.
Cautionary Note Regarding Forward-Looking Statements $138 million to $146 million , 2) 2023 EBITDA guidance in the range of $22 million to $26 million , 3) expected mid-point EBITDA representing approximately 35% growth year over year, 4) expectations that significant multiple catalysts are driving Kamada’s annual double-digit growth in the foreseeable years ahead, with significant upside potential and limited downside risks, 5) intention to meet with the FDA and European Medicines Agency during the first half of 2023 to discuss study progress and potential opportunities to shorten the regulatory pathway, and 6) expectation of launching eleven biosimilar products in the Israel market through 2028. 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, 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, the impacts of the failure of Silicon Valley Bank and recent turmoil in the banking industry, 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 OrlevIR@kamada.com
Brian Ritchiebritchie@LifeSciAdvisors.com
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION As of December 31, 2022 2021 U.S. Dollars in thousands Assets Current Assets Cash and cash equivalents $ 34,258 $ 18,587 Trade receivables, net 27,252 35,162 Other accounts receivables 8,710 8,872 Inventories 68,785 67,423 Total Current Assets 139,005 130,044 Non-Current Assets Property, plant and equipment, net 26,157 26,307 Right-of-use assets 2,568 3,092 Intangible assets, Goodwill and other long-term assets 147,072 153,663 Contract asset 7,577 5,561 Total Non-Current Assets 183,374 188,623 Total Assets $ 322,379 $ 318,667 Liabilities Current Liabilities Current maturities of bank loans $ 4,444 $ 2,631 Current maturities of lease liabilities 1,016 1,154 Current maturities of other long term liabilities 29,708 17,986 Trade payables 32,917 25,104 Other accounts payables 7,585 7,142 Deferred revenues 35 40 Total Current Liabilities 75,705 54,057 Non-Current Liabilities Bank loans 12,963 17,407 Lease liabilities 2,177 3,160 Contingent consideration 17,534 21,995 Other long-term liabilities 37,308 43,929 Deferred revenues - 15 Employee benefit liabilities, net 672 1,280 Total Non-Current Liabilities 70,654 87,786 Shareholder’s Equity Ordinary shares 11,734 11,725 Additional paid in capital net 210,495 210,204 Capital reserve due to translation to presentation currency (3,490 ) (3,490 ) Capital reserve from hedges (88 ) 54 Capital reserve from share-based payments 5,505 4,643 Capital reserve from employee benefits 348 (149 ) Accumulated deficit (48,484 ) (46,163 ) Total Shareholder’s Equity 176,020 176,824 Total Liabilities and Shareholder’s Equity $ 322,379 $ 318,667
CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME For the year ended Three months period ended December 31, December 31, 2022 2021 2022 2021 U.S. Dollars in thousands, other than per share information Revenues from proprietary products $ 102,598 $ 75,521 $ 35,400 $ 18,205 Revenues from distribution 26,741 28,121 10,039 13,264 Total revenues 129,339 103,642 45,439 31,469 Cost of revenues from proprietary products 58,229 48,194 20,373 12,589 Cost of revenues from distribution 24,407 25,120 9,775 12,285 Total cost of revenues 82,636 73,314 30,148 24,874 Gross profit 46,703 30,328 15,291 6,595 Research and development expenses 13,172 11,357 2,991 3,448 Selling and marketing expenses 15,284 6,278 4,849 2,475 General and administrative expenses 12,803 12,636 3,322 3,833 Other expenses 912 753 111 141 Operating income (loss) 4,532 (696 ) 4,018 (3,302 ) Financial income 91 295 59 18 Income (expenses) in respect of currency exchange differences and derivatives instruments, net 298 (207 ) (458 ) (281 ) Financial Income (expense) in respect of contingent consideration and other long- term liabilities. (6,266 ) - (342 ) - Financial expenses (914 ) (1,277 ) (331 ) (1,099 ) Income before tax on income (2,259 ) (1,885 ) 2,946 (4,664 ) Taxes on income 62 345 2 345 Net Income (loss) $ (2,321 ) $ (2,230 ) $ 2,944 $ (5,009 ) Other Comprehensive Income (loss): Amounts that will be or that have been reclassified to profit or loss when specific conditions are met Gain (loss) on cash flow hedges (776 ) - 54 (25 ) Net amounts transferred to the statement of profit or loss for cash flow hedges 634 (303 ) 115 44 Items that will not be reclassified to profit or loss in subsequent periods: Remeasurement gain (loss) from defined benefit plan 497 171 136 171 Total comprehensive income (loss) $ (1,966 ) $ (2,362 ) $ 3,249 $ (4,819 ) - Earnings per share attributable to equity holders of the Company: Basic net earnings per share $ (0.05 ) $ (0.05 ) $ 0.07 $ (0.11 ) Diluted net earnings per share $ (0.05 ) $ (0.05 ) $ 0.07 $ (0.11 )
CONSOLIDATED STATEMENTS OF CASH FLOWS For the year ended Three months period ended December 31, December 31, 2022 2021 2022 2021 Cash Flows from Operating Activities Net income (loss) $ (2,321 ) $ (2,230 ) $ 2,944 $ (5,009 ) Adjustments to reconcile net income to net cash provided by (used in) operating activities: Adjustments to the profit or loss items: Depreciation and impairment 12,155 5,609 3,012 1,997 Financial expenses (income), net 6,791 1,189 1,072 1,362 Cost of share-based payment 1,153 529 218 25 Taxes on income 62 345 2 345 Change in employee benefit liabilities, net (111 ) 45 (5 ) (16 ) 20,050 7,717 4,299 3,713 Changes in asset and liability items: Decrease (increase) in trade receivables, net 7,603 (12,861 ) (3,141 ) (8,415 ) Decrease (increase) in other accounts receivables (578 ) (1,634 ) (3,495 ) (3,191 ) Decrease (increase) in inventories (1,361 ) (2,373 ) 4,245 3,590 Decrease (increase) in deferred expenses (1,340 ) (6,883 ) 1,256 (2,124 ) Increase (decrease) in trade payables 7,055 7,917 1,160 5,192 Increase (decrease) in other accounts payables 290 (392 ) (276 ) 1,091 Decrease in deferred revenues (20 ) 1,815 (20 ) 265 11,649 (14,411 ) (271 ) (3,592 ) Cash received (paid) during the period for: Interest paid (853 ) (228 ) (303 ) (89 ) Interest received 97 375 82 18 Taxes paid (36 ) (42 ) (9 ) (10 ) (792 ) 105 (230 ) 81 Net cash provided by (used in) operating activities $ 28,586 $ (8,819 ) $ 6,742 $ (4,969 )
CONSOLIDATED STATEMENTS OF CASH FLOWS For the year ended Three months period ended December 31, December 31, 2022 2021 2022 2021 U.S Dollars In thousands Cash Flows from Investing Activities Investment in short term investments, net $ - $ 39,083 $ - $ - Purchase of property and equipment and intangible assets (3,784 ) (3,730 ) (977 ) (744 ) Business combination - (96,403 ) - (94,999 ) Net cash provided by (used in) investing activities (3,784 ) (61,050 ) (977 ) (95,743 ) Cash Flows from Financing Activities Proceeds from exercise of share base payments 9 19 2 5 Receipt of long-term loans - 20,000 20,000 Repayment of lease liabilities (1,098 ) (1,221 ) (256 ) (318 ) Repayment of long-term loans (2,628 ) (205 ) (1,111 ) 16 Repayment of other long-term liabilities (5,626 ) - (1,507 ) - Net cash provided by (used in) financing activities (9,343 ) 18,593 (2,872 ) 19,703 Exchange differences on balances of cash and cash equivalent 212 (334 ) 113 (244 ) Increase (decrease) in cash and cash equivalents 15,671 (51,610 ) 3006 (81,253 ) Cash and cash equivalents at the beginning of the period 18,587 70,197 31,252 99,840 Cash and cash equivalents at the end of the period $ 34,258 $ 18,857 $ 34,258 $ 18,587 Significant non-cash transactions Right-of-use asset recognized with corresponding lease liability $ 551 $ 845 $ 526 $ 76 Purchase of property and equipment and Intangible assets $ 618 $ 1,001 $ 134 $ 649
NON-IFRS MEASURES - EBITDA For the year ended Three months period ended December 31, December 31, 2022 2021 2022 2021 In thousands Net income $ (2,321 ) $ (2,230 ) $ 2,944 $ (5,009 ) Taxes on income 62 345 2 345 Financial expense (income), net 6,791 1,189 1,072 1,362 Depreciation and amortization expense 12,155 5,609 3,012 1,997 Non-cash share-based compensation expenses 1,153 529 218 25 Adjusted EBITDA $ 17,840 $ 5,442 $ 7,248 $ (1,280 )
