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

Loading...
Loading...
  • Total Revenues for Fiscal Year 2021 were $103.6 Million and Fourth Quarter 2021 Revenues were $31.5 Million.
  • Fiscal Year 2022 Revenues are Expected to Range Between $125 Million to $135 Million, Representing a 20% to 30% Increase over 2021; 2022 EBITDA Margins Anticipated Between 12%-15%, Representing More Than 2.5X over 2021 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 for the 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 $40 Million.
  • Pivotal Phase 3 InnovAATe Trial for Inhaled AAT for the Treatment of Alpha-1 Antitrypsin Deficiency Progressing with the Opening of New Sites to Expand Recruitment.
  • GLASSIA® Royalty Payments from Takeda to Commence During Q2 2022.

REHOVOT, Israel, March 15, 2022 (GLOBE NEWSWIRE) -- Kamada Ltd. KMDAKMDA)), 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

Loading...
Loading...
  • 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 
                 

Loading...
Loading...
Market News and Data brought to you by Benzinga APIs
Date
ticker
name
Actual EPS
EPS Surprise
Actual Rev
Rev Surprise
Posted In: EarningsPress Releases
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...