Kamada Reports Third Quarter and First Nine Months of 2020 Financial Results, Recent Achievements and Corporate Development


  • Third Quarter and First Nine Months of 2020 Revenues were $35.3 million and $101.7 million Respectively, a 7% Increase Compared to Both 2019 Periods; Company Reiterates Full-Year 2020 Total Revenue Guidance of $132 Million to $137 Million
  • Net Income for Third Quarter and First Nine Months of 2020 was $6.8 million and $15.5 million, Respectively, Compared to $5.8 Million and $16.9 Million in 2019, Respectively
  • Continued to Advance Development of a Plasma-Derived Immunoglobulin (IgG) Product as a Potential Treatment for Coronavirus Disease (COVID-19) Through a $3.4 million Supply Agreement with the Israeli Ministry of Health and Positive Interim Results from an Ongoing Phase 1/2 Clinical Study
  • Exploring Strategic Business Development Initiatives Focused on Utilizing Kamada's Core Plasma-Derived Pharmaceuticals Development, Manufacturing and Commercialization Expertise by Leveraging Its Strong Financial Position

REHOVOT, Israel, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced financial results for the three and nine months ended September 30, 2020.

“We are pleased with our solid financial and operational results during the recently completed quarter and first nine months of 2020, achieved in the midst of the COVID-19 global pandemic,” said Amir London, Kamada’s Chief Executive Officer. “Total revenues increased seven percent for both the three and nine months ended September 30, 2020 as compared to the same periods in 2019. Based on our solid performance in the first nine months of the year, and our positive outlook for the fourth quarter, we are reiterating our full-year 2020 total revenue guidance of $132 million to $137 million.”

“We continue to achieve important progress in the development of our plasma derived immunoglobulin (IgG) product as a potential therapy for COVID-19 disease,” continued Mr. London. “We executed an agreement with the Israeli Ministry of Health (“IMOH”) to supply our product for the treatment of COVID-19 patients in Israel, under which the initial supply is expected to generate approximately $3.4 million in revenues during the first quarter of 2021. Importantly, per recent discussions with the IMOH, the treatment utilizing our product will be provided as part of a multi-center clinical study led by the IMOH. From a supply perspective, we are ramping up our COVID-19 IgG manufacturing capacity, and we intend to increase our supply capabilities during 2021 to support potential increased demand from the IMOH as well as from other potential international markets. In addition, we completed enrollment and announced positive initial interim results from our ongoing Phase 1/2 open-label COVID-19 clinical trial in Israel. Lastly, following recent response from the U.S. Food and Drug Administration (“FDA”) to our previously submitted pre-Investigational New Drug (IND) information package, we, together with our partner, Kedrion Biopharma, are currently evaluating the suitable targeted patient population for our US clinical program and will submit an IND application upon conclusion of such evaluation and successful completion of additional required activities.”

“As we move into 2021 and in anticipation of the reduction in revenues due to the planned transition of GLASSIA manufacturing to Takeda, we are exploring strategic business development opportunities that will utilize and expend our core plasma-derived therapeutics development, manufacturing, and commercialization expertise. These opportunities will be funded by our strong cash position. We believe that our COVID-19 IgG program demonstrates Kamada’s ability to quickly respond to emerging pandemic situations, and we plan to leverage these capabilities and our IgG platform technology as a strategic business line, with the ability to respond to other potentially similar future pandemic situations. These strategic opportunities are anticipated to be added to the expected organic commercial growth of our existing products portfolio, including KEDRAB, our distributed products in Israel, the anticipated future royalty payments from Takeda, and the contract manufacturing of an FDA approved and commercialized specialty IgG product.” concluded Mr. London.

Financial Highlights for the Three Months Ended September 30, 2020

  • Total revenues were $35.3 million in the third quarter of 2020, a 7% increase from the $33.1 million recorded in the third quarter of 2019.
  • Proprietary Products segment revenues in the third quarter of 2020 were $29.7 million, a 19% increase from the third quarter of 2019.
  • Distribution segment revenues were $5.6 million in the third quarter of 2020, a 31% decrease from the third quarter of 2019.
  • Gross profit was $14.8 million in the third quarter of 2020, compared to $12.9 million reported in the third quarter of 2019.
  • Proprietary Product segment gross margins in the third quarter were 46%, down one percentage point from the third quarter of 2019. For full-year 2020, Kamada continues to expect an annual decrease of three to five percentage points in Proprietary Product segment gross margins, primarily 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 third quarter of 2020, as compared to $7.2 million in the third quarter of 2019.
  • The Company continues to expect a 13%-15% increase in Research and Development expenses for full-year 2020 as compared to 2019.
  • Net income was $6.8 million, or $0.15 per share, in the third quarter of 2020, as compared to net income of $5.8 million, or $0.14 per share, in the third quarter of 2019.
  • Adjusted EBITDA, as detailed in the tables below, was $9.3 million in the third quarter of 2020, as compared to $7.2 million in the third quarter of 2019.
  • Cash used in operating activities was $2.4 million in the third quarter of 2020, as compared to cash provided by operating activities of $6.1 million in the third quarter of 2019.

Financial Highlights for the Nine months Ended September 30, 2020

  • Total revenues were $101.7 million in the first nine months of 2020, a 7% increase from the $95.1 million recorded in the first nine months of 2019.
  • Revenues from the Proprietary Products segment for the first nine months of 2020 were $77.6 million, a 7% increase from the $72.5 million reported in the first nine months of 2019.
  • Revenues from the Distribution segment were $24.1 million in the first nine months 2020, a 7% increase from the $22.6 million recorded in the first nine months of 2019.
  • Gross profit was $37.4 million in the first nine months 2020, compared to $37.6 million in the first nine months of 2019.
  • Operating expenses, including Research and Development, Sales & Marketing, General and Administrative, and Other Expenses, totaled $20.8 million in the first nine months 2020, as compared to $20.3 million in the first nine months of 2019.
  • Net income was $15.5 million, or $0.35 per share, in the first nine months of 2020, as compared to net income of $16.9 million, or $0.42 per share, in the first nine months of 2019.
  • Adjusted EBITDA, as detailed in the tables below, was $21.1 million in the first nine months of 2020, as compared to $21.7 million in the first nine months of 2019.
  • Cash provided by operating activities was $6.4 million in the first nine months of 2020, as compared to cash provided by operating activities of $18.9 million in the first nine months of 2019.

Balance Sheet Highlights
As of September 30, 2020, the Company had cash, cash equivalents, and short-term investments of $99.7 million, as compared to $73.9 million at December 31, 2019. This increase is mainly related to the sale of $25 million of equity to FIMI Opportunity Fund, the leading private equity investor in Israel.

Recent Corporate Highlights

  • Appointed Yifat Philip, Esq. as Vice President Legal, General Counsel and Corporate Secretary.

Conference Call
Kamada management will host an investment community conference call on Wednesday, November 11, 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 877-407-0792 (from within the U.S.), 1-809-409-247 (from Israel), or 201-689-8263 (International) and entering the conference identification number: 13710863. 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. Pursuant to an agreement with Takeda, the Company will continue to produce Glassia for Takeda through 2021 and Takeda is planning to 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. 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 hyperimmune 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) ability to ramp up Kamada’s COVID-19 IgG manufacturing capacity and its plan to increase its supply capabilities during 2021 to support potential increased demand from the IMOH as well as from other potential international markets; 3) ability to advance the U.S. clinical development of a plasma derived hyperimmune immunoglobulin (IgG) product as a potential treatment for COVID-19; 4) ability to explore strategic business development opportunities that utilize and expend Kamada’s core plasma-derived therapeutics development, manufacturing, and commercialization expertise; and 5) Kamada’s belief that its COVID-19 IgG program demonstrates its ability to quickly respond to emerging pandemic situations, and its plan to leverage these capabilities and its IgG platform technology as a strategic line of business. 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 September 30,  As of
December 31,
 
 2020  2019  2019 
 Unaudited  Audited 
   
 U.S Dollars in thousands 
Assets  
Current Assets           
Cash and cash equivalents$52,487  $27,449  $42,662 
Short-term investments 47,230   39,380   31,245 
Trade receivables, net 28,643   23,999   23,210 
Other accounts receivables 3,533   1,722   3,272 
Inventories 42,618   34,031   43,173 
Total Current Assets 174,511   126,581   143,562 
            
Non-Current Assets           
Property, plant and equipment, net 25,323   24,197   24,550 
Right-of-use-assets 3,694   4,100   4,022 
Other long term assets 1,081   178   352 
Contract asset 1,438   -   - 
Deferred taxes 298   1,445   1,311 
Total Non-Current Assets 31,834   29,920   30,235 
Total Assets$206,345  $156,501  $173,797 
Liabilities           
Current Liabilities           
Current maturities of bank loans$322  $573  $489 
Current maturities of lease liabilities 1,038   964   1,020 
Trade payables 15,110   13,079   24,830 
Other accounts payables 6,236   5,439   5,811 
Deferred revenues 486   561   589 
Total Current Liabilities 23,192   20,616   32,739 
            
Non-Current Liabilities           
Bank loans 48   461   257 
Lease liabilities 3,589   4,052   3,981 
Deferred revenues 1,525   347   232 
Employee benefit liabilities, net 1,262   884   1,269 
Total Non-Current Liabilities 6,424   5,744   5,739 
            
Shareholder’s Equity           
Ordinary shares 11,703   10,420   10,425 
Additional paid in capital 209,650   179,589   180,819 
Capital reserve due to translation to presentation currency (3,490)  (3,490)  (3,490)
Capital reserve from hedges 234   18   8 
Capital reserve from financial assets measured at fair value through other comprehensive income -   137   145 
Capital reserve from share-based payments 4,550   9,898   8,844 
Capital reserve from employee benefits (356)  4   (359)
Accumulated deficit (45,562)  (66,435)  (61,073)
Total Shareholder’s Equity 176,729   130,141   135,319 
Total Liabilities and Shareholder’s Equity$206,345  $156,501  $173,797 




CONSOLIDATED CONDENSED STATEMENTS OF COMPREHENSIVE INCOME

 Nine months period ended  Three months period ended  Year ended 
 September 30,  September 30,  December 31, 
 2020  2019  2020  2019  2019 
         
 Unaudited  Unaudited  Audited 
   
 U.S Dollars In thousands 
               
Revenues from proprietary products$77,633  $72,521  $29,691  $24,859  $97,696 
Revenues from distribution 24,071   22,595   5,634   8,207   29,491 
                    
Total revenues 101,704   95,116   35,325   33,066   127,187 
                    
Cost of revenues from proprietary products 43,817   38,412   15,936   13,234   52,425 
Cost of revenues from distribution 20,500   19,056   4,568   6,968   25,025 
                    
Total cost of revenues 64,317   57,468   20,504   20,202   77,450 
                    
Gross profit 37,387   37,648   14,821   12,864   49,737 
                    
Research and development expenses 10,335   9,730   3,365   3,477   13,059 
Selling and marketing expenses 3,297   3,441   1,179   1,161   4,370 
General and administrative expenses 7,133   6,851   2,514   2,230   9,194 
Other expenses 34   327   -   299   330 
Operating income 16,588   17,299   7,763   5,697   22,784 
                    
Financial income 865   887   250   328   1,146 
Income (expense) in respect of securities measured at fair value, net 102   (3)  -   55   (5)
Income (expenses) in respect of currency exchange differences and derivatives instruments, net (696)  (503)  (761)  25   (651)
Financial expenses (204)  (217)  (69)  (68)  (293)
Income before tax on income 16,655   17,463   7,183   6,037   22,981 
Taxes on income 1,144   574   348   214   730 
                    
Net Income$15,511  $16,889  $6,835  $5,823  $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)  132   -   (66)  143 
Gain (loss) on cash flow hedges 516   99   75   28   92 
Net amounts transferred to the statement of profit or loss for cash flow hedges (273)  (20)  (266)  (18)  (23)
Items that will not be reclassified to profit or loss in subsequent periods:                   
Remeasurement gain (loss) from defined benefit plan -       -   -   (388)
Tax effect 29   (33)  14   16   (11)
Total comprehensive income$15,595  $17,067  $6,658  $5,783  $22,064 
                    
Earnings per share attributable to equity holders of the Company:                   
Basic net earnings per share$0.35  $0.42  $0.15  $0.14  $0.55 
Diluted net earnings per share$0.35  $0.42  $0.15  $0.14  $0.55 




CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

 Nine months period Ended  Three months period Ended  Year Ended 
 September 30,  September 30,  December 31, 
 2020  2019  2020  2019  2019 
      
 Unaudited  Audited 
   
 U.S Dollars In thousands 
Cash Flows from Operating Activities              
Net income$15,511  $16,889  $6,835  $5,823  $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 3,632   3,379   1,252   1,128   4,519 
Financial expenses (income), net (67)  (164)  580   (340)  (197)
Cost of share-based payment 853   987   265   353   1,163 
Taxes on income 1,144   574   348   214   730 
Gain from sale of property and equipment (7)  (2)  (1)  -   (2)
Change in employee benefit liabilities, net (7)  97   (5)  66   94 
  5,548   4,871   2,439   1,421   6,307 
Changes in asset and liability items:                   
                    
Decrease (increase) in trade receivables, net (5,540)  4,408   (8,956)  1,806   5,117 
Decrease (increase) in other accounts receivables 972   1,204   231   955   (214)
Decrease (increase) in inventories 555   (4,715)  5,028   1,470   (13,857)
Decrease (increase) in Contract asset and deferred expenses (2,464)  333   (1,553)  605   399 
Increase (decrease) in trade payables (10,488)  (4,585)  (7,769)  (6,512)  6,259 
Increase in other accounts payables 426   379   740   432   863 
Increase (decrease) in deferred revenues 1,190   (221)  397   (95)  (283)
  (15,349)  (3,197)  (11,882)  (1,339)  (1,716)
Cash received (paid) during the period for:                   
                    
Interest paid (158)  (182)  (51)  (58)  (243)
Interest received 891   554   290   254   1,106 
Taxes paid (87)  (25)  (13)  (9)  (134)
  646   347   226   187   729 
                    
Net cash provided by (used in) operating activities$6,356  $18,910  $(2,382) $6,092  $27,571 




CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

 Nine months period Ended  Three months period Ended  Year Ended 
 September 30,  September 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) $(6,160) $-  $(1,032) $1,727 
Purchase of property and equipment and intangible assets (3,372)  (1,488)  (1,471)  (731)  (2,300)
Proceeds from sale of property and equipment 7   9   1   -   9 
Net cash used in investing activities (19,011)  (7,639)  (1,470)  (1,763)  (564)
                    
Cash Flows from Financing Activities                   
                    
Proceeds from exercise of share base payments 61   12   41   3   16 
Repayment of lease liabilities (815)  (794)  (275)  (265)  (1,070)
Repayment of long-term loans (373)  (353)  (127)  (121)  (476)
Proceeds from issuance of ordinary shares, net 24,894   -   -   -   - 
                    
Net cash provided by (used in) financing activities 23,767   (1,135)  (361)  (383)  (1,530)
                    
Exchange differences on balances of cash and cash equivalent (1,287)  (780)  (699)  (332)  (908)
                    
Increase (decrease) in cash and cash equivalents 9,825   9,356   (4,912)  3,614   24,569 
                    
Cash and cash equivalents at the beginning of the period 42,662   18,093   57,399   23,835   18,093 
                    
Cash and cash equivalents at the end of the period$52,487  $27,449  $52,487  $27,449  $42,662 
                    
Significant non-cash transactions                   
Right-of-use asset recognized with corresponding lease liability$539  $4,984  $194  $436  $5,035 
Purchase of property and equipment$973  $264  $973  $264  $992 




Adjusted EBITDA

 Nine months period ended  Three months period ended  Year ended 
 September 30,  September 30,  December 31, 
 2020  2019  2020  2019  2019 
   
 In thousands 
Net income$15,511  $16,889  $6,835  $5,823  $22,251 
Taxes on income 1,144   574   348   214   730 
Financial expense (income), net (67)  (164)  580   (340)  (197)
Depreciation and amortization expense 3,632   3,379   1,252   1,128   4,519 
Non-cash share-based compensation expenses 853   987   265   353   1,163 
Adjusted EBITDA$21,073  $21,665  $9,280  $7,178  $28,466 




Adjusted net income

 Nine months period ended  Three months period ended  Year ended 
 September 30,  September 30,  December 31, 
 2020  2019  2020  2019  2019 
   
 In thousands 
Net income$15,511  $16,889  $6,835  $5,823  $22,251 
Share-based compensation charges 853   987   265   353   1,163 
Adjusted net income$16,364  $17,876  $7,100  $6,176  $23,414