Kamada Reports Second Quarter and First Half 2021 Financial Results, Recent Achievements and Corporate Development Activities

  • Second Quarter 2021 Revenues were $24.2 Million
  • In Connection with the Transition of GLASSIA® Manufacturing, Kamada Largely Completed a Workforce Downsizing in the Second Quarter that will Result in an Approximately 10% Annual Labor Cost Reduction  
  • Pivotal Phase 3 InnovAATe Trial for Inhaled AAT for Treatment of Alpha-1 Antitrypsin Deficiency Continues to Advance as Kamada Evaluates Strategic Partnering Opportunities
  • Ongoing Expansion of Plasma Collection Capacity at Recently Acquired U.S. Plasma Collection Center; Company Intends to Open Additional Centers
  • Kamada Continues to Explore Additional Business Development Opportunities that Utilize and Expand the Company’s Core Plasma-Derived Development, Manufacturing and Commercialization Expertise, and Further its Strategic Objective of Evolving into a Fully Integrated Specialty Plasma Company

REHOVOT, Israel, Aug. 11, 2021 (GLOBE NEWSWIRE) — Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced financial results for the three and six months ended June 30, 2021.

“Our business continued to perform as anticipated throughout the first half of 2021,” said Amir London, Kamada’s Chief Executive Officer. “Despite the expected decrease in revenue as compared to the first half of last year due to the planned transition of GLASSIA manufacturing to Takeda later this year, we achieved gross margins of 37 percent in the first half of 2021, as compared to 34 percent during the first six months of 2020. As an outlook for the second half of 2021, we anticipate a reduction in overall gross margins mainly due to anticipated change in products sales mix.”

“We continue to progress the pivotal Phase 3 InnovAATe clinical trial of our proprietary Inhaled AAT for the treatment of Alpha-1 Antitrypsin Deficiency (AATD) and are exploring a potential commercial partnership with respect to this product. We are pleased with the level of external interest generated in this therapy to date,” continued Mr. London.

“Moreover, we initiated the planning for the opening of additional U.S. plasma collection centers by leveraging our existing U.S. Food and Drug Administration license. In addition, we continue to achieve important progress around the advancement of our business development priorities and are exploring potential strategic transactions that would utilize and expand our core plasma-derived development, manufacturing, and commercialization expertise. We believe we have multiple prospects that would represent significant steps toward accomplishing our strategic goal of becoming a fully-integrated specialty plasma company,” concluded Mr. London.

Financial Highlights for the Three Months Ended June 30, 2021

  • Total revenues were $24.2 million in the second quarter of 2021, compared to $33.1 million recorded in the second quarter of 2020.
  • Gross profit was $9.1 million in the second quarter of 2021, compared to $11.1 million reported in the second quarter of 2020.
  • In connection with the transition of GLASSIA manufacturing to Takeda, during the second quarter of 2021, the Company largely completed the planned workforce downsizing and incurred a one-time expense of $0.6 million related to excess severance remuneration for the employees who were laid-off as part of this downsizing. The downsizing process is expected to result in an annualized reduction of approximately 10% in overall labor costs.
  • Net income was $0.9 million, or $0.02 per share, in the second quarter of 2021, as compared to net income of $3.5 million, or $0.10 per share, in the second quarter of 2020.
  • Adjusted EBITDA, as detailed in the tables below, was $2.4 million in the second quarter of 2021, as compared to $5.5 million in the second quarter of 2020. Adjusted EBITDA in the second quarter of 2021, excluding one-time severance expenses, was $3.0 million.
  • Cash used in operating activities was $3.3 million in the second quarter of 2021, as compared to cash provided by operating activities of $10.7 million in the second quarter of 2020.

Financial Highlights for the Six Months Ended June 30, 2021

  • Total revenues were $49.1 million in the first six months of 2021, compared to $66.4 million recorded in the first six months of 2020.
  • Gross profit was $18.0 million in the first six months of 2021, compared to $22.6 million reported in the first six months of 2020.
  • Net income was $3.6 million, or $0.08 per share, in the first six months of 2021, as compared to net income of $8.7 million, or $0.20 per share, in the first six months 2020.
  • Adjusted EBITDA, as detailed in the tables below, was $6.2 million in the first six months of 2021, as compared to $11.8 million in the first six months of 2020. Adjusted EBITDA in the first six months of 2021, excluding one-time severance expenses, was $6.7 million.
  • Cash used in operating activities was $1.2 million in the first six months of 2021, as compared to cash provided by operating activities of $8.7 million in the first six months of 2020.

Balance Sheet Highlights
As of June 30, 2021, the Company had cash, cash equivalents, and short-term investments of $104.6 million, as compared to $109.3 million on December 31, 2020.

Recent Corporate Highlights

  • The FDA approved a label update for KEDRAB® (Rabies Immune Globulin [Human]), establishing the product’s safety and effectiveness in children.  KEDRAB is now indicated for passive, transient post-exposure prophylaxis of rabies infection in persons of all ages when given promptly following contact with a rabid or possibly rabid animal.
  • Completed the supply of our plasma-derived COVID-19 Immunoglobulin (IgG) investigational product to the Israeli Ministry of Health (IMOH) for the treatment of hospitalized COVID-19 patients.

Conference Call
Kamada management will host an investment community conference call on Wednesday, August 11, 2021, at 8:30am Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-407-0792 (from within the U.S.), 1-809-406-247 (from Israel), or 201-689-8263 (International) and entering the conference identification number: 13721962. The call will also be webcast live on the Internet at http://public.viavid.com/index.php?id=145993

About Kamada
Kamada Ltd. (the “Company”) is a global specialty plasma-derived biopharmaceutical company 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 its current commercial products, its plasma-derived development pipeline and its manufacturing expertise, while evolving into a vertically integrated plasma-derived company. The Company’s two leading commercial products are GLASSIA® and KEDRRAB®. GLASSIA was the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited (“Takeda”) 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 until 2040. KEDRAB is an FDA approved anti-rabies immune globulin (Human) for post-exposure prophylaxis treatment. KEDRAB is being marketed in the U.S. through a strategic partnership with Kedrion S.p.A. The Company has additional four plasma-derived products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has two leading development programs; 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, and 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 Israeli pharmaceutical market to distribute in Israel more than 20 products that are manufactured by third parties and have recently added nine 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 2025. 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) workforce downsizing resulting in an approximate 10% annual labor cost reduction, 2) anticipation of a reduction in overall gross margins during the second half of 2021 mainly due to anticipated change in products sales mix, 3) optimism about commercial partnership prospects associated with our Inhaled AAT product, 4) plans for the opening of additional plasma collection centers in the U.S. by leveraging our FDA license, 5) optimism about strategic business development opportunities that will utilize and expand our core plasma-derived development, manufacturing, and commercialization expertise, and 6) 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, the effects of the COVID-19 pandemic and related government mandates on the availability of adequate levels of work-force required to maintain manufacturing plans, disruption to the supply chain due to COVID-19 pandemic, continuation of inbound and outbound international delivery routes, impact of the workforce downsizing plan, continued demand for Kamada’s products, including GLASSIA and KEDRAB, in the U.S. market and its Distribution segment related products in Israel, financial conditions of the Company’s customer, suppliers and services providers, ability to reap the benefits of the recent acquisition of the plasma collection center, including the ability to open additional U.S. plasma centers, the ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial and ability to find a suitable commercial partnership for this product, unexpected results of clinical studies, including plasma-derived IgG treatment for COVID-19 and the level of demand for such product, Kamada’s ability to manage operating expenses, additional competition in the markets that Kamada competes, regulatory delays, prevailing market conditions and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

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
June 30,
    As of
December 31,
 
    2021     2020     2020  
                   
    Unaudited     Audited  
             
Assets   U.S Dollars in thousands  
Current Assets                  
Cash and cash equivalents   $ 68,416     $ 57,399     $ 70,197  
Short-term investments     36,137       47,272       39,069  
Trade receivables, net     27,743       19,823       22,108  
Other accounts  receivables     2,450       2,980       4,524  
Inventories     44,601       47,646       42,016  
Total Current Assets     179,347       175,120       177,914  
                         
Non-Current Assets                        
Property, plant and equipment, net     25,665       24,574       25,679  
Right-of-use-assets     3,453       3,796       3,440  
Other long term assets     3,413       1,058       1,573  
Contract assets     4,472       911       2,059  
Deferred taxes           632        
Total Non-Current Assets     37,003       30,971       32,751  
Total Assets   $ 216,350     $ 206,091     $ 210,665  
Liabilities                        
Current Liabilities                        
Current maturities of bank loans   $ 61     $ 431     $ 238  
Current maturities of lease liabilities     1,149       990       1,072  
Trade payables     17,948       22,760       16,110  
Other accounts payables     6,989       5,497       7,547  
Deferred revenues           589        
Total Current Liabilities     26,147       30,267       24,967  
                         
Non-Current Liabilities                        
Bank loans     5       63       36  
Lease liabilities     3,401       3,704       3,593  
Deferred revenues     3,025       1,025       2,025  
Employee benefit liabilities, net     1,429       1,267       1,406  
Total Non-Current Liabilities     7,860       6,059       7,060  
                         
Shareholder’s Equity                        
Ordinary shares     11,716       11,662       11,706  
Additional paid in capital     209,942       207,731       209,760  
Capital reserve due to translation to presentation currency     (3,490 )     (3,490 )     (3,490 )
Capital reserve from hedges     58       411       357  
Capital reserve from share-based payments     4,746       6,204       4,558  
Capital reserve from employee benefits     (320 )     (356 )     (320 )
Accumulated deficit     (40,309 )     (52,397 )     (43,933 )
Total Shareholder’s Equity     182,343       169,765       178,638  
Total Liabilities and Shareholder’s Equity   $ 216,350     $ 206,091     $ 210,665  

CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME

                   
    Six months period ended     Three months period ended     Year ended  
    June 30,     June 30,     December 31,  
    2021     2020     2021     2020     2020  
                               
                   
    Unaudited     Unaudited     Audited  
                               
                   
    U.S Dollars In thousands  
                               
Revenues from proprietary products   $ 40,193     $ 47,942     $ 19,323     $ 22,625     $ 100,916  
Revenues from distribution     8,946       18,437       4,916       10,464       32,330  
                                         
Total revenues     49,139       66,379       24,239       33,089       133,246  
                                         
Cost of revenues from proprietary products     23,527       27,881       11,059       12,934       57,750  
Cost of revenues from distribution     7,609       15,932       4,108       9,040       27,944  
                                         
Total cost of revenues     31,136       43,813       15,167       21,974       85,694  
                                         
Gross profit     18,003       22,566       9,072       11,115       47,552  
                                         
Research and development expenses     5,364       6,970       2,736       3,623       13,609  
Selling and marketing expenses     2,547       2,118       1,424       1,178       4,518  
General and administrative expenses     6,112       4,619       3,303       2,307       10,139  
Other expenses     570       34       563       32       49  
Operating income     3,410       8,825       1,046       3,975       19,237  
                                         
Financial income     209       615       99       298       1,027  
Income (expense) in respect of securities measured at fair value, net *           102                   102  
Income (expenses) in respect of currency exchange differences and derivatives instruments, net     121       65       (145 )     (367 )     (1,535 )
Financial expenses     (116 )     (135 )     (63 )     (58 )     (266 )
Income before tax on income     3,624       9,472       937       3,848       18,565  
Taxes on income           796             390       1,425  
                                         
Net Income   $ 3,624     $ 8,676     $ 937     $ 3,458     $ 17,140  
                                         
Other Comprehensive Income (loss) :                                        
Amounts that will be or that have been reclassified to profit or loss when specific conditions are met                                        
Gain (loss) from securities measured at fair value through other comprehensive income           (188 )                 (188 )
Gain (loss) on cash flow hedges     (43 )     441       30       200       876  
Net amounts transferred to the statement of profit or loss for cash flow hedges     (256 )     (7 )     (2 )     (41 )     (528 )
Items that will not be reclassified to profit or loss in subsequent periods:                                        
Remeasurement gain (loss) from defined benefit plan                             64  
Tax effect           15             (12 )     19  
Total comprehensive income   $ 3,325     $ 8,937     $ 965     $ 3,605     $ 17,383  
                                         
Earnings per share attributable to equity holders of the Company:                                        
Basic net earnings per share   $ 0.08     $ 0.20     $ 0.02     $ 0.10     $ 0.39  
Diluted net earnings per share   $ 0.08     $ 0.20     $ 0.02     $ 0.10     $ 0.38  

CONSOLIDATED STATEMENTS OF CASH FLOWS

                   
    Six months period Ended     Three months period Ended     Year Ended  
    June, 30     June, 30     December 31,  
    2021     2020     2021     2020     2020  
                               
    Unaudited     Audited  
             
    U.S Dollars In thousands  
Cash Flows from Operating Activities                              
Net income   $ 3,624     $ 8,676     $ 937     $ 3,458     $ 17,140  
                                         
Adjustments to reconcile net income to net cash provided by (used in) operating activities:                                        
                                         
Adjustments to the profit or loss items:                                        
                                         
Depreciation and impairment     2,372       2,380       1,225       1,188       4,897  
Financial expenses (income), net     (214 )     (647 )     109       127       672  
Cost of share-based payment     370       588       155       330       977  
Taxes on income           796             390       1,425  
Loss (gain) from sale of property and equipment           (6 )           (6 )     (7 )
Change in employee benefit liabilities, net     23       (2 )     60       16       201  
      2,551       3,109       1,549       2,045       8,165  
Changes in asset and liability items:                                        
                                         
Decrease (increase) in trade receivables, net     (5,646 )     3,416       (7,231 )     6,432       1,332  
Decrease (increase) in other accounts receivables     1,629       741       1,643       (772 )     115  
Increase in inventories     (2,401 )     (4,473 )     (3,446 )     (5,859 )     1,157  
Decrease (increase) in deferred expenses     (2,362 )     (911 )     (1,209 )     (490 )     (3,085 )
Increase (decrease) in trade payables     1,139       (2,719 )     2,623       4,497       (9,560 )
Increase (decrease) in other accounts payables     (799 )     (314 )     1,346       866       1,736  
Decrease in deferred revenues     1,000       793       500       396       1,204  
      (7,440 )     (3,467 )     (5,774 )     5,070       (7,101 )
Cash received (paid) during the period for:                                        
                                         
Interest paid     (107 )     (107 )     (59 )     (52 )     (209 )
Interest received     217       601       76       150       1,211  
Taxes paid     (23 )     (74 )     (9 )     (13 )     (101 )
      87       420       8       85       901  
                                         
Net cash provided by operating activities   $ (1,178 )   $ 8,738     $ (3,280 )   $ 10,658     $ 19,105  

CONSOLIDATED STATEMENTS OF CASH FLOWS

                   
    Six months period Ended     Three months period Ended     Year Ended  
    June, 30     June, 30     December 31,  
    2021     2020     2021     2020     2020  
                               
    Unaudited     Audited  
             
    U.S Dollars In thousands  
Cash Flows from Investing Activities                              
                               
Proceeds of investment in short term investments, net   $ 2,967     $ (15,646 )   $ 11,967     $     $ (7,646 )
Purchase of property and equipment and intangible assets     (1,463 )     (1,901 )     (1,332 )     (1,005 )     (5,488 )
Proceeds from sale of property and equipment           6             6       7  
Acquisition of  subsidiary (LLC), net (1)     (1,404 )                          
Net cash used in investing activities     100       (17,541 )     10,635       (999 )     (13,127 )
                                         
Cash Flows from Financing Activities                                        
                                         
Proceeds from exercise of share base payments     10       20       3       15       64  
Repayment of lease liabilities     (595 )     (540 )     (306 )     (262 )     (1,103 )
Repayment of long-term loans     (206 )     (247 )     (85 )     (124 )     (492 )
Proceeds from issuance of ordinary shares, net           24,895                   24,895  
                                         
Net cash provided by (used in) financing activities     (791 )     24,128       (388 )     (371 )     23,364  
                                         
Exchange differences on balances of cash and cash equivalent     88       (588 )     13       (1,177 )     (1,807 )
                                         
Increase in cash and cash equivalents     (1,781 )     14,737       6,980       8,111       27,535  
                                         
Cash and cash equivalents at the beginning of the period     70,197       42,662       61,436       49,288       42,662  
                                         
Cash and cash equivalents at the end of the period   $ 68,416     $ 57,399     $ 68,416     $ 57,399     $ 70,197  
                                         
Significant non-cash transactions                                        
Right-of-use asset recognized with corresponding lease liability   $ 588     $ 345     $ 286     $ 287     $ 539  
Purchase of property and equipment   $ 748     $ 722     $ 748     $ 722     $ 722  

Appendix A (1)   Six months
period
Ended
June, 30
2021
 
Acquisition of a subsidiary that was first consolidated      
       
Current Assets (exclusive of cash and cash equivalents)     (184 )
Non Current Assets     (1,460 )
Current Liabilities     240  
      (1,404 )

Adjusted EBITDA                              
    Six months period ended     Three months period ended     Year ended  
    June 30,     June 30,     December 31,  
    2021     2020     2021     2020     2020  
                               
    In thousands  
Net income   $ 3,624     $ 8,676     $ 937     $ 3,458     $ 17,140  
Taxes on income     –         796       –         390       1,425  
Financial expense (income), net     (214 )     (647 )     109       127       692  
Depreciation and amortization expense     2,372       2,380       1,225       1,188       4,897  
Non-cash share-based compensation expenses     370       588       155       330       977  
Adjusted EBITDA   $ 6,152     $ 11,793     $ 2,426     $ 5,493     $ 25,131  

Adjusted net income                              
    Six months period ended     Three months period ended     Year ended  
    June 30,     June 30,     December 31,  
    2021     2020     2021     2020     2020  
                               
    In thousands  
Net income   $ 3,624     $ 8,676     $ 937     $ 3,458     $ 17,140  
Share-based compensation charges     370       588       155       330       977  
Adjusted net income   $ 3,994     $ 9,264     $ 1,092     $ 3,788     $ 18,117  

 

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