0001178913-15-001582.txt : 20150512 0001178913-15-001582.hdr.sgml : 20150512 20150512075819 ACCESSION NUMBER: 0001178913-15-001582 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20150512 FILED AS OF DATE: 20150512 DATE AS OF CHANGE: 20150512 FILER: COMPANY DATA: COMPANY CONFORMED NAME: KAMADA LTD CENTRAL INDEX KEY: 0001567529 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: L3 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35948 FILM NUMBER: 15852820 BUSINESS ADDRESS: STREET 1: 7 SAPIR ST. WEIZMANN SCIENCE PARK CITY: NESS ZIONA STATE: L3 ZIP: 74140 BUSINESS PHONE: 97289406472 MAIL ADDRESS: STREET 1: 7 SAPIR ST. WEIZMANN SCIENCE PARK CITY: NESS ZIONA STATE: L3 ZIP: 74140 6-K 1 zk1516753.htm 6-K zk1516753.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934

For the Month of May, 2015

Commission File Number 001-35948

Kamada Ltd.
(Translation of registrant’s name into English)
 
7 Sapir St.
Kiryat Weizmann Science Park
P.O Box 4081
Ness Ziona 74140
Israel
 (Address of principal executive offices)
 
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F T   Form 40-F ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes ¨   No T

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-____
 
This Form 6-K is being incorporated by reference into the Registrant’s Form S-8 Registration Statement File No. 333-192720.
 
 

 
The following exhibits are attached:

99.1
Press Release: Kamada Reports First Quarter 2015 Financial Results

99.2
Kamada Ltd.’s Consolidated Financial Statements as of March 31, 2015 (Unaudited)

99.3
Disclosure for Debenture Holders as of March 31, 2015

 
 

 
SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date: May 12, 2015
KAMADA LTD.
 
       
 
By:
/s/ Gil Efron  
   
Gil Efron
 
   
Chief Financial Officer
 
 
 
 

 
 
EXHIBIT INDEX

EXHIBIT NO.
 
DESCRIPTION
     
99.1
 
Press Release: Kamada Reports First Quarter 2015 Financial Results
     
  99.2     Kamada Ltd.’s Consolidated Financial Statements as of March 31, 2015 (Unaudited)
     
99.3   Disclosure for Debenture Holders as of March 31, 2015
 










EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1 exhibit_99-1.htm


EXHIBIT 99.1
 
News Release
   
 
Kamada Reports First Quarter 2015 Financial Results

Introduces 2015 Revenue Guidance

Conference call begins today at 8:30 a.m. Eastern time

NESS ZIONA, Israel (May 12, 2015) – Kamada Ltd. (NASDAQ and TASE: KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announces financial results for the three months ended March 31, 2015.

Financial highlights of the 2015 first quarter included:
 
 
·
Total revenues of $9.0 million compared with $13.2 million for the first quarter of 2014;
 
·
Gross profit of $0.4 million compared with $3.3 million in the year-ago first quarter; and
 
·
Adjusted net loss of $4.8 million compared with an adjusted net loss of $2.0 in the year-ago first quarter.

Other highlights of the 2015 first quarter and recent weeks included:
 
 
·
Announced additional results from the European Phase 2/3 clinical trial of the Company’s inhaled AAT to treat AAT deficiency (AATD), which showed clinically and statistically significant improvement in lung function and improvements in quality-of-life parameters;
 
·
Awarded European Orphan Drug Designation for AAT to treat Graft-versus-Host disease (GvHD);
 
·
Announced that effective July 1st, 2015 David Tsur, co-founder and Chief Executive Officer, will become Deputy Executive Chairman of the Board, and Amir London, currently Senior Vice President of Business Development, will become Chief Executive Officer and Gil Efron, currently Chief Financial Officer, will take on the added role of Deputy Chief Executive Officer; and
 
·
Strengthened the senior leadership team with the appointment of Eran Schenker, M.D. as Vice President-Medical Director.

Management Commentary
“We made progress during the first quarter across a number of key areas, specifically with regard to advancing our program for inhaled AAT. We continued to build our core protein plasma business despite Proprietary Product revenue being impacted by a delay in the release of product batches as we awaited final validation of a filling process. This process was validated in April and  the delayed revenue from the first quarter will be realized in the second quarter of 2015 and gross profit is expected to return to levels gained in prior quarters.  As a result, we remain confident in our ability to achieve our revenue targets for 2015 as well our 2017 revenue goal of $100 million, which includes approximately 75% growth in the Proprietary Products Segment. Increases in the number of patients treated by Glassia are on track through the quarter to meet our target to double the number of patients treated by our intravenous AAT world wide by 2018,” stated David Tsur, co-founder and Chief Executive Officer of Kamada.”

“Our relationship with Baxter, our U.S. strategic partner for Glassia®, remains strong as we collaborate to grow sales and expand use to other indications of unmet medical need.  We are pleased with the consistently increasing number of patients treated by Glassia.  We expect this growth to accelerate in the coming years and to remain a strong contributor to our revenue growth.”

 
 

 
“We were especially pleased to report final results from our European Phase 2/3 clinical study, which showed clinically and statistically significant improvements in spirometric measures of lung function, particularly in bronchial airflow measurements FEV1 (L), FEV1% predicted and FEV1/SVC.  These favorable results were even more pronounced when analyzing the overall treatment effect throughout the full year.”

“Lung functions are the gold standard measurement for pulmonary disease, and along with symptom improvements and the safety profile of the product, these data support our decision to submit a Marketing Authorization Application with the European Medicines Agency for our inhaled AAT therapy to treat AATD patients.  We expect to make this filing by year-end 2015.”

“We remain pleased with the ongoing favorable data generated from clinical development programs with our intravenous AAT to treat newly diagnosed type 1 diabetes and GvHD, both orphan indications with significant unmet medical need. These results are encouraging us to pursue this opportunity.  In addition to these ongoing studies, we plan to initiate a Phase 2 proof-of-concept study with intravenous AAT to treat patients undergoing lung transplantation.”

“We look forward to achieving a number of important milestones throughout the balance of 2015.  We expect strong second quarter revenue along with continued clinical progress in various programs to strengthen our Company and enhance shareholder value,” concluded Mr. Tsur.

First Quarter Financial Results
Total revenues for the first quarter of 2015 were $9.0 million compare with $13.2 million for the first quarter of 2014.  Revenue from the Proprietary Products Segment was $3.2 million compared with $7.4 million in the year-ago quarter, due to a delay in the release of product batches as the Company awaited final validation of a filling process.  This process was validated in April and the Company expects delayed revenue from the first quarter 2015 to be realized in the second quarter of 2015.  Revenue from the Distributed Product Segment remained steady at $5.8 million for the first quarters of 2015 and 2014.

Gross profit for the first quarter of 2015 was $0.4million compared with $3.3 million for the first quarter of 2014.  Gross margin declined to 4% from 25% in the first quarter of 2014. The decline was a result of lower Proprietary Product revenue for reasons stated earlier and to changes during the quarter in foreign exchange rates in the Distributed Product Segment.

Research and development expenses in the first quarter of 2015 were $3.6 million, up from $3.4 million in the first quarter of 2014 as the company continued to support various clinical studies including three key clinical trials and the closing and analysis of the European Phase 2/3 study of inhaled AAT.

Selling, general and administrative expenses in the first quarter of 2015 of $2.5 million decreased modestly from $2.6 million in the first quarter of 2014.

For the first quarter of 2015, the Company reported an operating loss of $5.8 million compared with an operating loss of $2.7 million for the first quarter of 2014.  The Company recorded a net loss for the first quarter of 2015 of $5.3 million or $0.15 per share, compared with a net loss of $3.1 million or $0.09 per share for the same period in 2014.  The adjusted net loss for the first quarter of 2015 was $4.8 million compared with an adjusted net loss of $2.0 million for the same period in 2014.

Adjusted EBITDA for the first quarter of 2015 was a loss of $4.5 million compared with a loss of $1.0 million for the first quarter of 2014.

 
 

 
Balance Sheet Highlights
As of March 31, 2015, Kamada had cash, cash equivalents and short-term investments of $49.7 million, compared with $51.9 million as of December 31, 2014. During the first quarter of 2015, the Company used $2.0 million in cash to fund operations and $0.5 million for capital expenditures.

2015 Revenue Guidance
For the year ending December 31, 2015, Kamada expects total revenue to be between $70 million and $73 million, with revenue from its Distributed Product Segment projected to be between $26 million and $28 million and revenue from its Proprietary Products Segment projected to be between $45 million and $47 million.  The Company notes that revenue projections for 2015 take into account an expected negative foreign exchange impact of approximately $2.0 million in relation to product sales in Israel and Russia, and presume that U.S. revenue from the agreement with Baxter remains on track.

Conference Call
Kamada management will host an investment community conference call today at 8:30 a.m. Eastern time to discuss these results and answer questions.  Shareholders and other interested parties may participate in the conference call by dialing 888-803-5993 (from within the U.S.), 706-634-5454 (from outside the U.S.) or 1-809-315-362 (toll-free from Israel) and entering the conference identification number: 44127836.

A replay of the call will be accessible beginning two hours after its completion through May 18, 2015 by dialing 855-859-2056 (from within the U.S.) or 404-537-3406 (from outside the U.S.) and entering the conference identification number: 44127836. The call will also be archived for 90 days at www.streetevents.com and www.kamada.com.

About Kamada
Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan indications, and has a commercial product portfolio and a robust 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 proteins.   AAT is a protein derived from human plasma with known and newly-discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties. The Company’s flagship product is Glassia®, the first and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration. Kamada markets Glassia in the U.S. through a strategic partnership with Baxter International.  In addition to Glassia, Kamada has a product line of nine other injectable pharmaceutical products that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America, Eastern Europe and Asia.  Kamada has five late-stage plasma-derived protein products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency that completed pivotal Phase 2/3 clinical trials in Europe and entered Phase 2 clinical trials in the U.S.   Kamada also leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing 10 complementary products in Israel that are manufactured by third parties.

Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, 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, such as statements regarding assumptions and results related to financial results forecast, commercial results, timing and results of clinical trials and EMA and U.S. FDA authorizations.  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, unexpected results of clinical trials, delays or denial in the U.S. FDA or the EMA approval process, additional competition in the AATD market or further regulatory delays.  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:
  Anne Marie Fields  
Gil Efron   LHA  
CFO      212-838-3777  
ir@kamada.com     
afields@lhai.com
 
 
-Tables to Follow-
 
 
 

 
CONSOLIDATED BALANCE SHEETS

 
   
As of March 31,
   
As of December 31,
 
   
2015
   
2014
   
2014
 
   
Unaudited
   
Audited
 
   
In thousands
 
Current Assets
                 
Cash and cash equivalents
  $ 13,011     $ 33,314     $ 14,546  
Short-term investments
    36,693       38,811       37,350  
Trade receivables
    8,863       12,592       17,514  
Other accounts  receivables
    2,954       3,284       2,359  
Inventories
    27,435       28,614       25,423  
                         
      88,956       116,615       97,192  
                         
Property, plant and equipment, net
    21,523       21,384       21,769  
Other long-term assets
    110       262       179  
                         
      21,633       21,646       21,948  
                         
      110,589       138,261       119,140  
Current Liabilities
                       
Short term credit and Current maturities of convertible debentures
    7,411       8,678       7,492  
Trade payables
    13,376       16,321       16,530  
Other accounts payables
    3,493       3,750       4,045  
Deferred revenues
    2,799       5,431       2,919  
                         
      27,079       34,180       30,986  
Non-Current Liabilities
                       
Convertible debentures
    -       7,686       -  
Employee benefit liabilities, net
    739       801       722  
Deferred revenues
    6,958       7,683       7,015  
                         
      7,697       16,170       7,737  
Equity
                       
Share capital
    9,227       9,201       9,208  
Share premium
    158,893       157,117       158,417  
Conversion option in convertible debentures
    1,147       2,217       1,147  
Capital reserve due to translation to presentation currency
    (3,490 )     (3,490 )     (3,490 )
Capital reserve from hedges
    (265 )     87       (116 )
Capital reserve from available for sale  financial assets
    128       12       10  
Capital reserve from share-based payments
    9,009       6,266       8,783  
Capital reserve from employee benefits
    (81 )     (129 )     (81 )
Accumulated deficit
    (98,755 )     (83,370 )     (93,461 )
      75,813       87,911       80,417  
                         
    $ 110,589     $ 138,261     $ 119,140  

 
 

 
 
Consolidated Statements of Comprehensive Income

 
   
Three months period Ended
March, 31
   
Year ended
December 31
 
   
2015
   
2014
    2014  
   
Unaudited
   
Audited
 
   
In thousands
 
                   
Revenues from proprietary products
  $ 3,173     $ 7,421     $ 44,389  
Revenues from distribution
    5,757       5,766       26,676  
                         
Total revenues
    8,930       13,187       71,065  
                         
Cost of revenues from proprietary products
    3,295       5,003       32,617  
Cost of revenues from distribution
    5,243       4,922       23,406  
                         
Total cost of revenues
    8,538       9,925       56,023  
                         
Gross profit
    392       3,262       15,042  
                         
Research and development expenses
    3,643       3,365       16,030  
Selling and marketing expenses
    799       647       2,898  
General and administrative expenses
    1,700       1,957       7,593  
Operating loss
    (5,750 )     (2,707 )     (11,479 )
                         
Financial income
    182       243       1,611  
Income in respect of currency exchange and translation
  differences and derivatives instruments, net
    513       39       -  
Financial expense
    (239 )     (674 )     (3,293 )
Loss before  taxes on income
    (5,294 )     (3,099 )     (13,161 )
Taxes on income
    -       23       52  
                         
Net loss
    (5,294 )     (3,122 )     (13,213 )
                         
Other Comprehensive loss:
                       
Items that may be reclassified to profit or loss in subsequent periods:
                       
Gain on available for sale financial assets
    118       39       37  
Profit (loss) on cash flow hedges
    (221 )     29       (162 )
Net amounts transferred to the statement of profit or loss for cash flow hedges
    72       (98 )     (110 )
Items that will not be reclassified to profit or loss in subsequent periods:
                       
Actuarial gain from defined benefit plans
    -       -       48  
Total comprehensive loss
  $ (5,325 )   $ (3,152 )   $ (13,400 )
                         
Loss per share attributable to equity holders of the Company:
                       
                         
Basic loss per share
  $ (0.15 )   $ (0.09 )     (0.37
                         
Diluted loss per share
  $ (0.15 )   $ (0.09 )      (0.37
Weighted-average number of ordinary shares used to compute
   income (loss) per share attributable to equity holders:
    35,993,130       35,960,487       35,971,335  
 
 
 

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

 
   
Three months period Ended
March, 31
   
Year Ended
December 31,
 
   
2015
    2014    
2014
 
   
Unaudited
   
Audited
 
    In thousands  
Cash Flows from Operating Activities
                 
                   
  Net loss
  $ (5,294 )   $ (3,122 )   $ (13,213 )
                         
Adjustments to reconcile loss to net cash used in operating activities:
                       
                         
Adjustments to the profit or loss items:
                       
                         
Depreciation and amortization
    771       663       2,788  
Finance expenses, net
    (447 )     392       1,682  
Cost of share-based payment
    505       1,086       3,751  
Taxes on income
    -       23       52  
Loss from sale of property and equipment
    -       -       (2 )
Change in employee benefit liabilities, net
    17       (26 )     (57 )
                         
      846       2,138       8,214  
Changes in asset and liability items:
                       
                         
Decrease (increase) in trade receivables
    8,418       5,236       (869 )
Increase in other accounts receivables
    (829 )     (240 )     (50 )
Increase in inventories
    (2,012 )     (6,681 )     (3,490 )
Decrease  in deferred expenses
    71       559       1,209  
Decrease (increase)   in trade payables
    (2,572 )     2,241       3,261  
Decrease in other accounts payables
    (659 )     (563 )     (344 )
Decrease  in deferred revenues
    (177 )     (846 )     (4,026 )
                         
      2,240       (294 )     (4,309 )
                         
Cash paid and received during the period for:
                       
Interest paid
    (121 )     (301 )     (1,210 )
Interest received
    350       94       758  
Taxes paid
    (29 )     (60 )     (158 )
                         
      200       (267 )     (610 )
                         
  Net cash used in operating activities
  $ (2,008 )   $ (1,545 )   $ (9,918 )

 
 

 
 
CONSOLIDATED STATEMENTS OF CASH FLOWS

 
   
Three months period Ended
March 31
   
Year Ended
December 31
 
   
2015
    2014    
2014
 
   
Unaudited
   
Audited
 
                   
Cash Flows from Investing Activities
  $  425     $ (23,432 )   $ (23,746 )
Short-term investments
    (509 )     (616 )     (3,076 )
Purchase of property and equipment
    -       -       3  
Proceeds from sale of property and equipment
                       
      (84 )     (24,048 )     (26,819 )
Net cash used in investing activities
                       
                         
Cash Flows from Financing Activities
    -       -       -  
Exercise of warrants and options into shares
    -       -       88  
Short term credit from bank and others, net
    -       -       (7,728 )
Repayment of convertible debentures
                       
Net cash provided by (used in) financing activities
    -       -       (7,640 )
      557       (203 )     (187 )
Exchange differences on balances of cash and cash equivalent
                       
      (1,535 )     (25,796 )     (44,564 )
Decrease in cash and cash equivalents
                       
      14,546       59,110       59,110  
Cash and cash equivalents at the beginning of the year
                       
    $  13,011     $ 33,314     $ 14,546  
Cash and cash equivalents at the end of the period
                       
                         
    Significant non-cash transactions                        
                         
Exercise of convertible debentures into shares
  $  -     $ 7     $ 7  
Exercise of options into shares
  $  216     $ -     $ -  

 
 

 
 
Adjusted EBITDA
 
   
Three months period
Ended March 31
   
For the year
Ended December 31
 
   
2015
   
2014
   
2014
 
   
Thousands of US dollar
 
                   
Net income (loss)
  $ (5,294 )   $ (3,122 )   $ (13,213 )
                         
Income tax expense
    -       23       52  
                         
Financial expense, net
    57       431       1,682  
                         
Depreciation and amortization expense
    771       663       2,788  
                         
Share-based compensation charges
    505       1,086       3,751  
                         
Income in respect of translation differences and derivatives instruments, net
    (513 )     (39 )     -  
                         
Adjusted EBITDA
  $ (4,474 )   $ (958 )   $ (4,940 )

Adjusted net income
 
   
Three months period
Ended March 31
   
For the year
Ended December 31
 
   
2015
   
2014
   
2014
 
   
Thousands of US dollar
 
                   
Net income (loss)
  $ (5,294 )   $ (3,122 )   $ (13,213 )
                         
Share-based compensation charges
    505       1,086       3,751  
                         
Adjusted EBITDA
  $ (4,789 )   $ (2,036 )   $ (9,462 )
 
 


 
EX-99.2 3 exhibit_99-2.htm EXHIBIT 99.2 exhibit_99-2.htm


EXHIBIT 99.2
 
KAMADA LTD.

CONSOLIDATED FINANCIAL STATEMENTS
 
AS OF MARCH 31, 2015
 
TABLE OF CONTENTS
 

 
 

 
KAMADA LTD.
 
CONSOLIDATED BALANCE SHEETS

 
   
As of March 31,
   
As of December 31,
 
   
2015
   
2014
   
2014
 
   
Unaudited
   
Audited
 
   
In thousands
 
Current Assets
                 
Cash and cash equivalents
  $ 13,011     $ 33,314     $ 14,546  
Short-term investments
    36,693       38,811       37,350  
Trade receivables
    8,863       12,592       17,514  
Other accounts  receivables
    2,954       3,284       2,359  
Inventories
    27,435       28,614       25,423  
                         
      88,956       116,615       97,192  
                         
Property, plant and equipment, net
    21,523       21,384       21,769  
Other long-term assets
    110       262       179  
                         
      21,633       21,646       21,948  
                         
      110,589       138,261       119,140  
Current Liabilities
                       
Short term credit and Current maturities of convertible debentures
    7,411       8,678       7,492  
Trade payables
    13,376       16,321       16,530  
Other accounts payables
    3,493       3,750       4,045  
Deferred revenues
    2,799       5,431       2,919  
                         
      27,079       34,180       30,986  
Non-Current Liabilities
                       
Convertible debentures
    -       7,686       -  
Employee benefit liabilities, net
    739       801       722  
Deferred revenues
    6,958       7,683       7,015  
                         
      7,697       16,170       7,737  
Equity
                       
Share capital
    9,227       9,201       9,208  
Share premium
    158,893       157,117       158,417  
Conversion option in convertible debentures
    1,147       2,217       1,147  
Capital reserve due to translation to presentation currency
    (3,490 )     (3,490 )     (3,490 )
Capital reserve from hedges
    (265 )     87       (116 )
Capital reserve from available for sale  financial assets
    128       12       10  
Capital reserve from share-based payments
    9,009       6,266       8,783  
Capital reserve from employee benefits
    (81 )     (129 )     (81 )
Accumulated deficit
    (98,755 )     (83,370 )     (93,461 )
      75,813       87,911       80,417  
                         
    $ 110,589     $ 138,261     $ 119,140  

The accompanying Notes are an integral part of the Consolidated Financial Statements.

 
2

 
KAMADA LTD.

Consolidated Statements of Comprehensive Income

 
   
As of March 31,
   
Year ended
December 31
 
   
2015
   
2014
   
2014
 
   
Unaudited
   
Audited
 
   
In thousands
 
                   
Revenues from proprietary products
  $ 3,173     $ 7,421     $ 44,389  
Revenues from distribution
    5,757       5,766       26,676  
                         
Total revenues
    8,930       13,187       71,065  
                         
Cost of revenues from proprietary products
    3,295       5,003       32,617  
Cost of revenues from distribution
    5,243       4,922       23,406  
                         
Total cost of revenues
    8,538       9,925       56,023  
                         
Gross profit
    392       3,262       15,042  
                         
Research and development expenses
    3,643       3,365       16,030  
Selling and marketing expenses
    799       647       2,898  
General and administrative expenses
    1,700       1,957       7,593  
Operating loss
    (5,750 )     (2,707 )     (11,479 )
                         
Financial income
    182       243       1,611  
Income in respect of currency exchange and translation differences and derivatives instruments, net
    513       39       -  
Financial expense
    (239 )     (674 )     (3,293 )
Loss before  taxes on income
    (5,294 )     (3,099 )     (13,161 )
Taxes on income
    -       23       52  
                         
Net loss
    (5,294 )     (3,122 )     (13,213 )
                         
Other Comprehensive loss:
                       
Items that may be reclassified to profit or loss in subsequent periods:
                       
Gain on available for sale financial assets
    118       39       37  
Profit (loss) on cash flow hedges
    (221 )     29       (162 )
Net amounts transferred to the statement of profit or loss for cash flow hedges
    72       (98 )     (110 )
Items that will not be reclassified to profit or loss in subsequent periods:
                       
Actuarial gain from defined benefit plans
    -       -       48  
Total comprehensive loss
  $ (5,325 )   $ (3,152 )   $ (13,400 )
                         
Loss per share attributable to equity holders of the Company:
                       
                         
Basic loss per share
  $ (0.15 )   $ (0.09 )     (0.37
                         
Diluted loss per share
  $ (0.15 )   $ (0.09 )     (0.37

The accompanying Notes are an integral part of the Consolidated Financial Statements
 
 
3

 
KAMADA LTD.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

 
   
Share Capital
   
Share premium
   
Conversion option in convertible debentures
   
Capital reserve from available for sale financial assets
   
Capital reserve due to translation to presentation currency
   
Capital reserve from hedges
   
Capital reserve from share-based payments
   
Capital reserve from employee benefits
   
Accumulated deficit
   
Total equity
 
    Unaudited  
    In thousands  
Balance as of January 1, 2015
  $ 9,208     $ 158,417     $ 1,147     $ 10     $ (3,490 )   $ (116 )   $ 8,783     $ (81 )   $ (93,461 )   $ 80,417  
Net loss
    -       -       -       -       -       -       -       -       (5,294 )     (5,294 )
                                                                                 
Other comprehensive income (loss)
    -       -       -       118       -       (149 )     -       -       -       (31 )
Total comprehensive income (loss)
    -       -       -       118               (149 )                     (5,294 )     (5,325 )
Exercise of options into shares
    19       476                                       (279 )                     216  
Cost of share-based payment
    -       -       -       -       -       -       505       -       -       505  
Balance as of March  31, 2015
  $ 9,227     $ 158,893     $ 1,147     $ 128     $ (3,490 )   $ (265 )   $ 9,009     $ (81 )   $ (98,755 )     75,813  

   
Share Capital
   
Share premium
   
Conversion option in convertible debentures
   
Capital reserve from available for sale financial assets
   
Capital reserve due to translation to presentation currency
   
Capital reserve from hedges
   
Capital reserve from share-based payments
   
Capital reserve from employee benefits
   
Accumulated deficit
   
Total equity
 
    Unaudited  
    In thousands  
Balance as of January 1, 2014
  $ 9,201     $ 157,100     $ 2,218     $ (27 )   $ (3,490 )   $ 156     $ 5,189     $ (129 )   $ (80,248 )   $ 89,970  
Net loss
    -       -       -       -       -       -       -       -       (3,122 )     (3,122 )
                                                                                 
Other comprehensive income (loss)
    -       -       -       39       -       (69 )     -       -       -       (30 )
Total comprehensive income (loss)
    -       -       -       39               (69 )                     (3,122 )     (3,152 )
Conversion of convertible debentures into shares
    (* )     8       (1 )     -       -       -       -       -       -       7  
Forfeiture of options
    -       9       -       -       -       -       (9 )     -       -       -  
Cost of share-based payment
    -       -       -       -       -       -       1,086       -       -       1,086  
Balance as of March  31, 2014
  $ 9,201     $ 157,117     $ 2,217     $ 12     $ (3,490 )   $ 87     $ 6,266     $ (129 )   $ (83,370 )   $ 87,911  

 (*) Represents an amount lower than $1

The accompanying Notes are an integral part of the Consolidated Financial Statements.

 
4

 
KAMADA LTD.
 
CONSOLIDATED STATEMENTS OF CASH FLOWS

 
   
Share capital
   
Share premium
   
Warrants
   
Conversion option in convertible debentures
   
Available for sale reserve
   
Capital reserve due to translation to presentation currency
   
Capital reserve from hedges
   
Capital reserve from share-based payments
   
Capital reserve from employee benefits
   
Accumulated deficit
   
Total equity
 
    In thousands  
Balance as of December 31, 2013
  $ 9,201     $ 157,100     $ -     $ 2,218     $ (27 )   $ (3,490 )     156     $ 5,189     $ (129 )   $ (80,248 )   $ 89,970  
Net loss
    -       -       -       -       -       -       -       -       -       (13,213 )     (13,213 )
Other comprehensive income (loss)
    -       -       -       -       37       -       (272 )     -       48       -       (187 )
Total comprehensive income (loss)
    -       -       -       -       37       -       (272 )     -       48       (13,213 )     (13,400 )
Exercise of options into shares
    7       238       -       -       -       -       -       (157 )     -       -       88  
Conversion of convertible debentures into shares
    (* )     9       -       (1 )     -       -       -       -       -       -       8  
Expiration of conversion option on convertible debentures
    -       1,070       -       (1,070 )     -       -       -       -       -       -       -  
Cost of share-based payment
    -       -       -       -       -       -       -       3,751       -       -       3,751  
Balance as of December 31, 2014
  $ 9,208     $ 158,417     $ -     $ 1,147     $ 10     $ (3,490 )   $ (116 )   $ 8,783     $ (81 )   $ (93,461 )   $ 80,417  
 
(*) Represents an amount lower than $1

The accompanying Notes are an integral part of the Consolidated Financial Statements.
 
 
5

 
KAMADA LTD.
 
CONSOLIDATED STATEMENTS OF CASH FLOWS


   
Three months period Ended
March, 31
   
Year Ended
December 31,
 
   
2014
   
2015
   
2014
 
   
Unaudited
   
Audited
 
    In Thousands  
Cash Flows from Operating Activities
                 
                   
  Net loss
  $ (5,294 )   $ (3,122 )   $ (13,213 )
                         
Adjustments to reconcile loss to net cash used in operating activities:
                       
                         
Adjustments to the profit or loss items:
                       
                         
Depreciation and amortization
    771       663       2,788  
Finance expenses, net
    (447 )     392       1,682  
Cost of share-based payment
    505       1,086       3,751  
Taxes on income
    -       23       52  
Loss from sale of property and equipment
    -       -       (2 )
Change in employee benefit liabilities, net
    17       (26 )     (57 )
                         
      846       2,138       8,214  
Changes in asset and liability items:
                       
                         
Decrease (increase) in trade receivables
    8,418       5,236       (869 )
Increase in other accounts receivables
    (829 )     (240 )     (50 )
Increase in inventories
    (2,012 )     (6,681 )     (3,490 )
Decrease  in deferred expenses
    71       559       1,209  
Decrease (increase) in trade payables
    (2,572 )     2,241       3,261  
Decrease in other accounts payables
    (659 )     (563 )     (344 )
Decrease  in deferred revenues
    (177 )     (846 )     (4,026 )
                         
      2,240       (294 )     (4,309 )
Cash paid and received during the period for:
                       
Interest paid
    (121 )     (301 )     (1,210 )
Interest received
    350       94       758  
Taxes paid
    (29 )     (60 )     (158 )
                         
      200       (267 )     (610 )
                         
  Net cash used in operating activities
  $ (2,008 )   $ (1,545 )   $ (9,918 )
 
The accompanying Notes are an integral part of the Consolidated Financial Statements.

 
6

 
KAMADA LTD.
 
CONSOLIDATED STATEMENTS OF CASH FLOWS

 
   
Three months period Ended
March 31
   
Year Ended
December 31
 
   
2015
    2014    
2014
 
   
Unaudited
   
Audited
 
    In Thousands  
Cash Flows from Investing Activities
  $  425     $ (23,432 )   $ (23,746 )
Short-term investments
    (509 )     (616 )     (3,076 )
Purchase of property and equipment
    -       -       3  
Proceeds from sale of property and equipment
                       
      (84 )     (24,048 )     (26,819 )
Net cash used in investing activities
                       
                         
Cash Flows from Financing Activities
    -       -       -  
Exercise of warrants and options into shares
    -       -       88  
Short term credit from bank and others, net
    -       -       (7,728 )
Repayment of convertible debentures
                       
Net cash provided by (used in) financing activities
    -       -       (7,640 )
      557       (203 )     (187 )
Exchange differences on balances of cash and cash equivalent
                       
      (1,535 )     (25,796 )     (44,564 )
Decrease in cash and cash equivalents
                       
      14,546       59,110       59,110  
Cash and cash equivalents at the beginning of the year
                       
    $  13,011     $ 33,314     $ 14,546  
Cash and cash equivalents at the end of the period
                       
                         
    Significant non-cash transactions                        
                         
Exercise of convertible debentures into shares
  $  -     $ 7     $ 7  
Exercise of options into shares
  $  216     $ -     $ -  

The accompanying Notes are an integral part of the Consolidated Financial Statements.
 
 
7

 
KAMADA LTD.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 
Note 1:-
General

These Financial Statements have been prepared in a condensed format as of March 31, 2015 and for the three months then ended ("interim consolidated financial statements").

These financial statements should be read in conjunction with the Company's annual financial statements as of December 31, 2014 and for the year then ended and the accompanying notes ("annual consolidated financial statements").
 
Note 2:-
Significant Accounting Policies

 
a.
Basis of preparation of the interim consolidated financial statements:

The interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles for the preparation of financial statements for interim periods, as prescribed in IAS 34, "Interim Financial Reporting".
 
Note 3:-
Operating Segments

 
a.
General:

The company has two operating segments, as follows:

Proprietary Products
-
Medicine development, manufacture and sale of plasma-derived therapeutics products.
     
Distribution
-
Distribution of drugs in Israel manufacture by other companies for clinical uses, most of which are produced from plasma or its derivatives products.

 
b.
Reporting on operating segments:
 
   
Proprietary Products
   
Distribution
   
Total
 
   
In thousands
 
   
Unaudited
 
Three months period ended March 31,2015
                 
                   
Revenues
  $ 3,173     $ 5,757     $ 8,930  
                         
Gross profit (loss)
  $ (122 )   $ 514       392  
                         
Unallocated corporate expenses
                    (6,142 )
Finance expenses, net
                    456  
                         
Loss before taxes on income
                  $ (5,294 )

 
8

 
KAMADA LTD.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 
Note 3:-
Operating Segments (Cont.)
 
   
Proprietary Products
   
Distribution
   
Total
 
   
In thousands
 
   
Unaudited
 
Three months period Ended March 31,2014
                 
                   
Revenues
  $ 7,421     $ 5,766     $ 13,187  
                         
Gross profit
  $ 2,418     $ 844       3,262  
                         
Unallocated corporate expenses
                    (5,969 )
Finance expenses, net
                    (392 )
                         
Loss before taxes on income
                  $ (3,099 )
 
   
Proprietary Products
   
Distribution
   
Total
 
   
In thousands
 
                   
Year Ended December 31, 2014
                 
                   
Revenues
  $ 44,389     $ 26,676     $ 71,065  
                         
Gross profit
  $ 11,772     $ 3,270     $ 15,042  
                         
Unallocated corporate expenses
                    (26,521 )
Finance expenses, net
                    (1,682 )
                         
 Loss before taxes on income
                  $ (13,161 )

 
9

 
KAMADA LTD.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 
Note 4:-
Financial Instruments

 
a.
Classification of financial instruments by fair value hierarchy

Financial assets measured at fair value

   
Level 1
   
Level 2
 
   
In thousands
 
March 31, 2015
           
Marketable securities at fair value through profit or loss:
           
Equity shares
  $ 583     $ -  
Mutual funds
    1,314       -  
Exchange traded notes
    35       -  
Debt securities (corporate and government)
    6,685       -  
      8,617          
                 
Available for sale debt securities (corporate and government)
  $ -     $ 28,076  
                 
    $ 8,617     $ 28,076  
March 31, 2014
               
Derivatives instruments qualified for hedging
  $ -     $ 117  
Marketable securities at fair value through profit or loss:
               
Equity shares
    1,051       -  
Mutual funds
    2,290       -  
Exchange traded notes
    79       -  
Debt securities (corporate and government)
    8,786       -  
      12,206       117  
                 
Available for sale debt securities (corporate and government)
  $ -     $ 26,605  
                 
    $ 12,206     $ 26,722  
       December 31, 2014
               
       Marketable securities at fair value through profit or loss:
               
Equity shares
  $ 587     $ -  
Mutual funds
    577       -  
Exchange traded notes
    46       -  
Debt securities (corporate and government)
    7,610       -  
                 
Available for sale debt securities (corporate and government)
    -       28,530  
                 
    $ 8,820     $ 28,530  
 
Financial liabilities measured at fair value:

   
Level 1
   
Level 2
 
   
In thousands
 
March 31, 2015
           
Derivatives instruments qualified for hedging
  $ -     $ 183  
December 31, 2014
               
Derivatives instruments qualified for hedging
  $ -     $ 76  
 
10

 
KAMADA LTD.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS


Note 4:-
Financial Instruments (Cont.)
 
Liabilities for which fair values are disclosed

   
Level 1
 
   
In thousands
 
March 31, 2015
     
Convertible debentures
  $ 7,411  
         
March 31, 2014
       
Convertible debentures
  $ 25,763  
         
December 31, 2014
       
Convertible debentures
  $ 8,275  
 
During the three months ended on March 31, 2015 there was no transfer due to the fair value measurement of any financial instrument from Level 1 to Level 2, and furthermore, there were no transfers to or from Level 3 due to the fair value measurement of any financial instrument.

Note 5:-
Subsequent Events
 
 
1.
On April 26, 2015 the Company's Compensation Committee approved an increase of the pool of shares allocated for grant under the 2011 option plan by 500,000 shares.

 
2.
On April 27, 2015 the Company's Board of Directors approved the grant, for no consideration, of 519,400 options to employees, management and directors of the Company exercisable into ordinary shares at an exercise price of NIS 17.84 for employees and 18.73 for management and directors. The fair value of the options was estimated at $1.2 million.

11


EX-99.3 4 exhibit_99-3.htm EXHIBIT 99.3 exhibit_99-3.htm


EXHIBIT 99.3

Disclosure for debenture holders as of March 31, 2015

 
1.
Summary of Financial Undertakings (according to repayment dates) as of March 31, 2015

Israeli Securities Law Regulations (Periodic and Immediate Reports) 38e
 
a.
Convertible debentures issued to the public by the Company and held by the public.

   
Principal payments
   
Gross interest payments (without deduction of tax)
   
Total
 
   
ILS
 
       
one year
    30,246,082       1,432,430       31,678,512  
Total
    30,246,082       1,432,430       31,678,512  
 
b.
Bank guarantees as of March 31, 2015, totaling US $169 thousand

 
 

 

 
2.
Details with Regard to Company Debentures

Israeli Securities Law Regulations (Periodic and Immediate Reports) 10(b)13 and 48c(12)
 
Issue Date
Par value at issuance (US Dollar)
Accumulated interest (US Dollar)
Book value (US Dollar) as of  March 31, 2015
Market Value (US Dollar) as of    March  31, 2015
Interest payment
 dates
Principal
 payment
schedule
Type of
interest
Converted
to another
 security
10/18/2009
25,125,628
 
39,599
 
 
7,411,309
 
7,850,251
Quarterly payments on   the outstanding debt, on March 1st, June 1st, September 1st and December 1st of 2015.
one installment on December 1, 2015.
Bears annual interest at a variable rate, plus annual margin of 6.1% above the annual interest rate for Israeli Government Debentures (Series 817) for each interest period.
Yes
 
 
3.
Details with Regard to the Trustee

MISHMERET TRUST COMPANY LTD, No. Corporate 51-377133-7, Address: 46-48 Menachem Begin, Tel Aviv, Israel
Contact information: Rami Sebty, Vice President, Telephone No.: 972-3-6374355, Fax No.: 972-3-6374344, e-mail: ramis@bdo.co.il

 
 

 

 
4.
Conversion of convertible debentures
 
Security Details
Conversion ratio
Major Conversion Details
Ordinary shares of NIS 1 par value
From December 2nd, 2012 to November 15th, 2015, each NIS 37.12 par value debentures (Series C) may be convertible into one ordinary share of NIS 1 par value of the Company.
Debentures may be converted each trading day from registration of the Debentures until November 15th, 2015 except during November 16th to December 1st of each of the years 2013 and 2014.
 
 
5.
At the end of the reporting period and during such reporting period the Company has complied with all the conditions and obligations under the trust deed.






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