Kamada Reports Second Quarter and First Six Months of 2020 Financial Results, Recent Corporate Achievements and Strong Cash Position

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, 2020.

REHOVOT, Israel, Aug. 12, 2020 (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, 2020.

“Kamada presented solid financial and operational performance during the first six months of 2020,” said Amir London, Kamada’s Chief Executive Officer. “While the global COVID-19 pandemic persists, we generated total revenues of $66.4 million during the first half of the year, representing an increase of 7% year-over-year. Importantly, our manufacturing plant continues to be operational and we do not anticipate any meaningful changes in the foreseeable future due to COVID-19 pandemic. Based on our results in the first six months of 2020 and our current outlook for the remainder of the year, we are reiterating our guidance of total revenues of between $132 million and $137 million for full-year 2020.”

“We continue to expeditiously advance the development of our plasma-derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19),” continued Mr. London. “We have completed manufacturing of the initial batches of our product and earlier this week we announced first-patient-in our Phase 1/2 open label clinical trial in Israel. We are also working with the support of our partner, Kedrion Biopharma, toward obtaining FDA’s acceptance of the proposed clinical development program and we expect to hold a pre-IND meeting with the FDA during this quarter.”

“We are intensively exploring business development opportunities to mitigate the effects of the planned transition of GLASSIA® manufacturing to Takeda during 2021. I am optimistic that these opportunities, funded by our strong cash position, along with our organic commercial growth, our investigational COVID-19 IgG product, the expected future royalty payments from Takeda together with the contract manufacturing of an FDA approved and commercialized specialty IgG product will contribute to our future growth,” concluded Mr. London.

Financial Highlights for the Three Months Ended June 30, 2020

  • Total revenues were $33.1 million in the second quarter of 2020, a 6% decrease from the $35.3 million recorded in the second quarter of 2019
    -  Proprietary Products segment revenues in the second quarter of 2020 were $22.6 million, a 17% decrease from the second quarter of 2019. The decrease this quarter is due to expediting shipments in the first quarter in anticipation of global transportation instability in the wake of COVID-19. Overall six months revenues from the Proprietary Products segment are up 1%.
    -  Distribution segment revenues were $10.5 million in the second quarter of 2020, a 31% increase from the second quarter of 2019
  • Gross profit was $11.1 million in the second quarter of 2020, compared to $13.6 million reported in the second quarter of 2019
    -  Proprietary Product segment gross margins in the second quarter were 43%, down three percentage points from the second quarter of 2019, in line with previous guidance expecting three to five percentage points’ annual decrease which is attributable to a change in sales product mix and reduced plant utilization.
  • Operating expenses, including Research and Development, Sales and Marketing, General and Administrative, and Other expenses, totaled $7.1 million in the second quarter of 2020, as compared to $7.2 million in the second quarter of 2019
    -  2020 Research and Development expenses guidance was for an expected 20-25% annual increase. Given COVID-19-related delays, we currently expect a 15-17% increase for full year 2020 as compared to 2019.
  • Net income was $3.5 million, or $0.08 per share, in the second quarter of 2020, as compared to net income of $6.1 million, or $0.15 per share, in the second quarter of 2019
  • Adjusted EBITDA, as detailed in the tables below, was $5.5 million in the second quarter of 2020, as compared to $7.8 million in the second quarter of 2019
  • Cash provided by operating activities was $10.7 million in the second quarter of 2020, as compared to cash provided by operating activities of $6.8 million in the second quarter of 2019 

Financial Highlights for the Six Months Ended June 30, 2020

  • Total revenues were $66.4 million in the first six months of 2020, a 7% increase from the $62.1 million recorded in the first six months of 2019
    -  Revenues from the Proprietary Products segment for the first six months of 2020 were $47.9 million, a 1% increase from the $47.7 million reported in the first six months of 2019
    -  Revenues from the Distribution segment were $18.4 million in the first six months 2020, a 28% increase from the $14.4 million recorded in the first six months of 2019
  • Gross profit was $22.6 million in the first six months 2020, a 9% decrease from the $24.8 million reported in the first six months 2019, primarily due to changes in the product mix
  • Operating expenses, including Research and Development, Sales & Marketing, General and Administrative, and Other expenses, totaled $13.7 million in the first six months 2020, as compared to $13.2 million in the first six months 2019
  • Net income was $8.7 million, or $0.20 per share, in the first six months of 2020, as compared to net income of $11.1 million, or $0.27 per share, in the first six months of 2019
  • Adjusted EBITDA, as detailed in the tables below, was $11.8 million in the first six months of 2020, as compared to $14.5 million in the first six months of 2019
  • Cash provided by operating activities was $8.7 million in the first six months of 2020, as compared to cash provided by operating activities of $12.8 million in the first six months of 2019 

Balance Sheet Highlights
As of June 30, 2020, the Company had cash, cash equivalents, and short-term investments of $104.7 million, as compared to $73.9 million at December 31, 2019. 

Conference Call
Kamada management will host an investment community conference call on Wednesday, August 12, 2020, 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 855-327-6837 (from within the U.S.), 1-809-458-327 (from Israel), or 631-891-4304 (International) and entering the conference identification number: 10010379. The call will also be webcast live on the Internet on the Company’s website at www.kamada.com.

About Kamada
Kamada Ltd. (“the Company”) is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived immune globulins. The Company’s flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. The Company’s second leading product is KamRab®, a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KamRab is FDA approved and is being marketed in the U.S. under the brand name KEDRAB® through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company’s intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection, and during 2020, the Company initiated the development of a plasma derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel that are manufactured by third parties. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company’s lead shareholder, beneficially owning approximately 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) Total revenues to be in the range of $132 million to $137 million for fiscal 2020; 2) not anticipating meaningful changes in operations in the foreseeable future due to COVID-19 pandemic; 3) actions taken to mitigate the effect of the planned transition of GLASSIA manufacturing to Takeda during 2021; 4) optimism that business development opportunities, funded by our strong cash position, along with our organic commercial growth, our investigational COVID-19 IgG product, the expected future royalty payments from Takeda together with the contract manufacturing of an FDA approved and commercialized specialty IgG product will contribute to our future growth; 5) developments relating FDA’s acceptance of the proposed clinical development program and clearance of Kamada’s IND relating to its plasma-derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19) following the pre-Investigational New Drug (IND) meeting with the FDA expected to take place in the third quarter of 2020; 6) guidance of an expected annual three to five percentage points decrease in the Proprietary Product segment gross margin which is attributable to a change in sales product mix and reduced plant utilization; and 7) previously expected increase of 20-25% in Research and Development expenses for 2020 in comparison to 2019 will not materialize mainly related to COVID-19 related delays in research projects and current expectation of an approximately 15-17% increase in Research and Development expenses in full year 2020 as compared to 2019. 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, ability to offset significant revenue loss associated with GLASSIA manufacturing transitioning to Takeda, 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 obtain regulatory approval for clinical trials of the plasma-derived hyperimmune IgG product for COVID-19, ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of clinical studies and on-going compassionate-use treatments, 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 CONDENSED BALANCE SHEETS

    As of June 30,     As of December 31,  
    2020     2019     2019  
    Unaudited     Audited  
             
    U.S Dollars in thousands  
Assets                  
Current Assets                        
Cash and cash equivalents   $ 57,399     $ 23,835     $ 42,662  
Short-term investments     47,272       38,122       31,245  
Trade receivables, net     19,823       25,497       23,210  
Other accounts receivables     2,980       3,292       3,272  
Inventories     47,646       35,501       43,173  
Total Current Assets     175,120       126,247       143,562  
                         
Non-Current Assets                        
Property, plant and equipment, net     24,574       24,478       24,550  
Right-of-use-assets     3,796       3,946       4,022  
Other long term assets     1,058       174       352  
Contract asset     911       -       -  
Deferred taxes     632       1,644       1,311  
Total Non-Current Assets     30,971       30,242       30,235  
Total Assets   $ 206,091     $ 156,489     $ 173,797  
Liabilities                        
Current Liabilities                        
Current maturities of bank loans   $ 431     $ 480     $ 489  
Current maturities of lease liabilities     990       960       1,020  
Trade payables     22,760       19,879       24,830  
Other accounts payables     5,497       4,876       5,811  
Deferred revenues     589       461       589  
Total Current Liabilities     30,267       26,656       32,739  
                         
Non-Current Liabilities                        
Bank loans     63       482       257  
Lease liabilities     3,704       3,988       3,981  
Deferred revenues     1,025       542       232  
Employee benefit liabilities, net     1,267       818       1,269  
Total Non-Current Liabilities     6,059       5,830       5,739  
                         
Shareholder’s Equity                        
Ordinary shares     11,662       10,418       10,425  
Additional paid in capital     207,731       179,471       180,819  
Capital reserve due to translation to presentation currency     (3,490 )     (3,490 )     (3,490 )
Capital reserve from hedges     411       8       8  
Capital reserve from financial assets measured at fair value through other comprehensive income     -       187       145  
Capital reserve from share-based payments     6,204       9,663       8,844  
Capital reserve from employee benefits     (356 )     4       (359 )
Accumulated deficit     (52,397 )     (72,258 )     (61,073 )
Total Shareholder’s Equity     169,765       124,003       135,319  
Total Liabilities and Shareholder’s Equity   $ 206,091     $ 156,489     $ 173,797  

 

 

CONSOLIDATED CONDENSED STATEMENTS OF COMPREHENSIVE INCOME

    Six months period ended     Three months period ended     Year ended  
    June 30,     June 30,     December 31,  
    2020     2019     2020     2019     2019  
                               
    Unaudited     Unaudited     Audited  
                   
    U.S Dollars In thousands  
                                         
Revenues from proprietary products   $ 47,942     $ 47,662     $ 22,625     $ 27,281     $ 97,696  
Revenues from distribution     18,437       14,388       10,464       7,972       29,491  
                                         
Total revenues     66,379       62,050       33,089       35,253       127,187  
                                         
Cost of revenues from proprietary products     27,881       25,178       12,934       14,688       52,425  
Cost of revenues from distribution     15,932       12,088       9,040       6,965       25,025  
                                         
Total cost of revenues     43,813       37,266       21,974       21,653       77,450  
                                         
Gross profit     22,566       24,784       11,115       13,600       49,737  
                                         
Research and development expenses     6,970       6,253       3,623       3,487       13,059  
Selling and marketing expenses     2,118       2,280       1,178       1,188       4,370  
General and administrative expenses     4,619       4,621       2,307       2,527       9,194  
Other expenses     34       28       32       5       330  
Operating income     8,825       11,602       3,975       6,393       22,784  
                                         
Financial income     615       559       298       274       1,146  
Income (expense) in respect of securities measured at fair value, net *     102       (58 )     -       (7 )     (5 )
Income (expenses) in respect of currency exchange differences and derivatives instruments, net     65       (528 )     (367 )     (215 )     (651 )
Financial expenses     (135 )     (149 )     (58 )     (72 )     (293 )
Income before tax on income     9,472       11,426       3,848       6,373       22,981  
Taxes on income     796       360       390       230       730  
                                         
Net Income   $ 8,676     $ 11,066     $ 3,458     $ 6,143     $ 22,251  
                                         
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 )     198       -       90       143  
Gain (loss) on cash flow hedges     441       71       200       (3 )     92  
Net amounts transferred to the statement of profit or loss for cash flow hedges     (7 )     (2 )     (41 )     -       (23 )
Items that will not be reclassified to profit or loss in subsequent periods:                                        
Remeasurement gain (loss) from defined benefit plan     -       -       -       -       (388 )
Tax effect     15       (49 )     (12 )     (21 )     (11 )
Total comprehensive income   $ 8,937     $ 11,284     $ 3,605     $ 6,209     $ 22,064  
                                         
Earnings per share attributable to equity holders of the Company:                                        
Basic net earnings per share   $ 0.20     $ 0.27     $ 0.08     $ 0.15     $ 0.55  
Diluted net earnings per share   $ 0.20     $ 0.27     $ 0.08     $ 0.15     $ 0.55  

 

 

CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

    Six months period Ended     Three months period Ended     Year Ended  
    June, 30     June, 30     December 31,  
    2020     2019     2020     2019     2019  
                               
    Unaudited     Audited  
             
    U.S Dollars In thousands  
Cash Flows from Operating Activities                                        
Net income   $ 8,676     $ 11,066     $ 3,458     $ 6,143     $ 22,251  
                                         
Adjustments to reconcile net income to net cash provided by (used in) operating activities:                                        
                                         
Adjustments to the profit or loss items:                                        
                                         
Depreciation and impairment     2,380       2,251       1,188       1,124       4,519  
Financial expenses (income), net     (647 )     176       127       20       (197 )
Cost of share-based payment     588       634       330       319       1,163  
Taxes on income     796       360       390       230       730  
Loss (gain) from sale of property and equipment     (6 )     (2 )     (6 )     4       (2 )
Change in employee benefit liabilities, net     (2 )     31       16       (5 )     94  
      3,109       3,450       2,045       1,692       6,307  
Changes in asset and liability items:                                        
                                         
Decrease (increase) in trade receivables, net     3,416       2,602       6,432       (2,125 )     5,117  
Decrease (increase) in other accounts receivables     741       249       (772 )     118       (214 )
Increase in inventories     (4,473 )     (6,185 )     (5,859 )     (3,793 )     (13,857 )
Decrease (increase) in Contract asset and deferred expenses     (911 )     (272 )     (490 )     (26 )     399  
Increase (decrease) in trade payables     (2,719 )     1,927       4,497       4,295       6,259  
Increase (decrease) in other accounts payables     (314 )     (53 )     866       457       863  
Decrease in deferred revenues     793       (126 )     396       (63 )     (283 )
      (3,467 )     (1,858 )     5,070       (1,137 )     (1,716 )
Cash received (paid) during the period for:                                        
                                         
Interest paid     (107 )     (124 )     (52 )     (61 )     (243 )
Interest received     601       300       150       128       1,106  
Taxes paid     (74 )     (16 )     (13 )     (8 )     (134 )
      420       160       85       59       729  
                                         
Net cash provided by operating activities   $ 8,738     $ 12,818     $ 10,658     $ 6,757     $ 27,571  

 

 

CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

    Six months period Ended     Three months period Ended     Year Ended  
    June, 30     June, 30     December 31,  
    2020     2019     2020     2019     2019  
                               
    Unaudited     Audited  
             
    U.S Dollars In thousands  
Cash Flows from Investing Activities                              
                                         
Proceeds of investment in short term investments, net   $ (15,646 )   $ (5,128 )   $ -     $ (4,070 )   $ 1,727  
Purchase of property and equipment and intangible assets     (1,901 )     (757 )     (1,005 )     (453 )     (2,300 )
Proceeds from sale of property and equipment     6       9       6       3       9  
Net cash used in investing activities     (17,541 )     (5,876 )     (999 )     (4,520 )     (564 )
                                         
Cash Flows from Financing Activities                                        
                                         
Proceeds from exercise of share base payments     20       9       15       6       16  
Repayment of lease liabilities     (540 )     (529 )     (262 )     (266 )     (1,070 )
Repayment of long-term loans     (246 )     (232 )     (123 )     (117 )     (476 )
Proceeds from issuance of ordinary shares, net     24,894       -       -       -       -  
                                         
Net cash provided by (used in) financing activities     24,128       (752 )     (370 )     (377 )     (1,530 )
                                         
Exchange differences on balances of cash and cash equivalent     (588 )     (448 )     (1,178 )     (62 )     (908 )
                                         
Increase in cash and cash equivalents     14,737       5,742       8,111       1,798       24,569  
                                         
Cash and cash equivalents at the beginning of the period     42,662       18,093       49,288       22,037       18,093  
                                         
Cash and cash equivalents at the end of the period   $ 57,399     $ 23,835     $ 57,399     $ 23,835     $ 42,662  
                                         
Significant non-cash transactions                                        
Right-of-use asset recognized with corresponding lease liability   $ 345     $ 4,548     $ 287     $ 117     $ 5,035  
Purchase of property and equipment   $ 722     $ 385     $ 722     $ 385     $ 992  

 

 

 

Adjusted EBITDA                              
    Six months period ended     Three months period ended     Year ended  
    June 30,     June 30,     December 31,  
    2020     2019     2020     2019     2019  
                               
      In thousands  
Net income   $ 8,676     $ 11,066     $ 3,458     $ 6,143     $ 22,251  
Taxes on income     796       360       390       230       730  
Financial expense (income), net     (647 )     176       127       20       (197 )
Depreciation and amortization expense     2,380       2,251       1,188       1,124       4,519  
Non-cash share-based compensation expenses     588       634       330       319       1,163  
Adjusted EBITDA   $ 11,793     $ 14,487     $ 5,493     $ 7,836     $ 28,466  

 

 

 

Adjusted net income                              
    Six months period ended     Three months period ended     Year ended  
    June 30,     June 30,     December 31,  
    2020     2019     2020     2019     2019  
                               
      In thousands  
Net income   $ 8,676     $ 11,066     $ 3,458     $ 6,143     $ 22,251  
Share-based compensation charges     588       634       330       319       1,163  
Adjusted net income   $ 9,264     $ 11,700     $ 3,788     $ 6,462     $ 23,414  

 

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