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


  • Second Quarter Revenues were $33.1 million, Compared to $35.3 million in 2019, First Half 2020 Revenues were $66.4 million, up 7% from 2019 
  • Net Income for the Second Quarter and for the First Half of 2020 was $3.5 million and $8.7 million, Respectively, Compared to $6.1 million and $11.1 million in 2019 Respectively
  • Significant Progress Achieved in Development of a Plasma-Derived Immunoglobulin (IgG) Product as a Potential Treatment for Coronavirus Disease (COVID-19)
  • Approximately $100 million of Available Net Cash as of June 30, 2020
  • Exploring Business Development Initiatives Targeted to Mitigate the Effect of the Planned Transition of GLASSIA® Manufacturing to Takeda During 2021
  • Company Reiterates Full-Year 2020 Total Revenue Guidance of $132 Million to $137 Million

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