EX-99.1 2 ea124902ex99-1_kamada.htm PRESS RELEASE: KAMADA REPORTS SECOND QUARTER AND FIRST SIX MONTHS OF 2020 FINANCIAL RESULTS, RECENT CORPORATE ACHIEVEMENTS AND STRONG CASH POSITION

Exhibit 99.1

 

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 – August 12, 2020 -- 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
  o 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 the COVID-19.  Overall six months revenues from the Proprietary Products segment are up 1%.

oDistribution segment revenues were $10.5 million in the second quarter of 2020, a 31% increase from the second quarter of 2019

 

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Gross profit was $11.1 million in the second quarter of 2020, compared to $13.6 million reported in the second quarter of 2019

  o 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

  o 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
oRevenues 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
oRevenues 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.

 

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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

 

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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 

 

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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 

 

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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 

 

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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 

 

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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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