EX-99 2 exhibit_99-1.htm EXHIBIT 99.1 exhibit_99-1.htm


Exhibit 99.1
 
News Release  
 
AUGUST 14, 2014
 
Kamada Reports Second Quarter Financial Results

Introduces 2014 Revenue Guidance

Conference Call Begins Today at 8:30 a.m. Eastern Time

NESS ZIONA, Israel (August 14, 2014) – Kamada Ltd. (NASDAQ and TASE: KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announces financial results for the three and six months ended June 30, 2014.

Financial highlights of the second quarter of 2014 and recent weeks include:
 
 
·
Revenues for the quarter were $15.8 million compared with $16.1 million for the second quarter of 2013; the second quarter of 2013 included a one-time payment of $4.5 million received from Baxter International Inc. (Baxter) related to a technology transfer milestone
 
·
Gross loss for the quarter of $0.10 million compared with gross profit of $7.4 million in the year-ago second quarter; excluding a one-time $3.0 million write-off of inventory in the current quarter and the one-time payment from Baxter in the prior-year quarter, gross profit for the second quarter of 2014 was $3.0 million, compared with $2.9 million in the second quarter of 2013
 
·
Introducing 2014 revenue guidance, with total revenue for the year ending December 31, 2014 expected to be between $70 million and $72 million

Clinical highlights of the second quarter of 2014 and recent weeks include:
 
 
·
Received approval from the U.S. Food and Drug Administration (FDA) for enhancements to the Company’s manufacturing process that significantly improve capacity for the production of its Alpha-1 Antitrypsin (AAT) therapeutics
 
·
Announced preliminary top-line results from the Phase 2/3 pivotal clinical trial in Europe and Canada of the Company’s proprietary inhaled AAT therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD or inherited emphysema), with final results expected in September 2014
 
·
Received FDA approval for a significantly improved infusion rate for Glassia® (Alpha-1-Proteinase Inhibitor - Human), the first and only ready-to-use liquid alpha-1-proteinase inhibitor indicated as a chronic augmentation and maintenance therapy in adults with AATD, marketed in the U.S. by Baxter
 
·
Announced a proof-of-concept study with Glassia to treat graft-versus-host disease (GVHD) in cooperation with Baxter; the study is being conducted at the Fred Hutchinson Cancer Research Center in Seattle

Management Commentary
“Building upon the launch in the first quarter of a Phase 2/3 trial with Glassia to treat newly diagnosed pediatric patients with type 1 diabetes and a U.S. Phase 2 trial with inhaled AAT for treating AATD, during the second quarter we further expanded and advanced our clinical development programs with the initiation of a study with Glassia in GVHD, an orphan indication.  In addition, we were particularly pleased to receive FDA approval for our significantly enhanced infusion rate for Glassia, as it represents another competitive distinction for our intravenous AAT therapy. These unique features are key to Glassia’s continually increasing market share in a greater than $750 million global market that is growing at about 10% per year.  The recent FDA approval of our enhanced manufacturing process provides improved efficiencies and capacity that will serve us well as we increase sales of our proprietary protein plasma therapeutics,” stated David Tsur, Co-founder and Chief Executive Officer of Kamada.
 
 
 

 
 
“We reported preliminary, top-line results from the European Phase 2/3 clinical trial of our proprietary inhaled AAT therapy for the treatment of AATD. We are continuing to review the full data set and expect to complete the final analysis and to report those data in September.  We are looking forward to presenting the clinical findings that may support our efforts to bring the first inhaled therapy to patients suffering from this debilitating, life-threatening, orphan lung disease. Subject to the final results, we are preparing to submit for review for regulatory approval with the European Medicines Agency during the fourth quarter of this year.
 
“Revenues for the second quarter of 2014 increased from the first quarter of this year, and the full-year revenue guidance we are introducing today reflects our expectations for significant growth in the second half of the year compared with the first half.

“We are pleased with our recent progress and look forward to a productive second half of the year as we prepare to report final data from our inhaled AAT program and advance other clinical programs.  We have a number of milestones in the coming months and expect that these, along with growing revenues, will support our commitment to enhance shareholder value,” added Mr. Tsur.

Second Quarter Financial Results
Total revenue for the second quarter of 2014 of $15.8 million compared with $16.1 million for the second quarter of 2013.  Revenue from the Proprietary Products Segment was $8.7 million compared with $11.9 million in the year-ago quarter, which included a one-time payment of $4.5 million received from Baxter related to a technology transfer milestone.  Excluding this one-time payment, our revenues this quarter increased 18% compared with the second quarter of 2013 and increased 18% compared with the first quarter of 2014. Revenue from the Distribution Segment of $7.1 million increased from $4.2 million in the second quarter of 2013, primarily due to higher IVIG sales in the Israeli market.

Research and development (R&D) expenses in the second quarter of 2014 of $5.1 million increased from $2.6 million in the second quarter of 2013 and from $3.4 million in the first quarter of 2014, due to increased activity in support of various clinical studies including the launch of three important clinical trials, the closing and analysis of the European Phase 2/3 study of inhaled AAT, as well as by facility costs allocated to research and development use.

Selling, general and administrative (SG&A) expenses in the second quarter of 2014 of $2.8 million decreased from $3.2 million in the second quarter of 2013, largely due to one-time costs in the prior-year quarter associated with our U.S. IPO.

Gross loss for the second quarter of 2014 was $0.10 million compared with gross profit of $7.4 million in the second quarter of 2013.  Gross loss in the second quarter of 2014 included a one-time write-off of inventory of $3.0 million, and gross profit in the second quarter of 2013 was favorably impacted by the $4.5 million milestone payment.  Excluding these one-time events, gross profit for the second quarter of 2014 increased to $3.0 million from $2.9 million in the second quarter of 2013, reflecting the level of revenue and product mix within the Proprietary Segment as well as the increase in revenue in the Distributed Products segment.
 
 
 

 
 
Gross margin decreased to 0% from 46% in the second quarter of 2013 due to product mix as the Distribution Segment revenues increased during the quarter and to the product write-off described above.   Gross margin in the second quarter of 2013 benefitted from milestone revenue received under the technology transfer agreement with Baxter.

For the second quarter of 2014, the Company reported an operating loss of $7.9 million compared with operating income of $1.7 million for the second quarter of 2013.  Net loss for the second quarter of 2014 was $8.4 million or $0.23 per share, compared with net income of $0.89 million or $0.03 per diluted share for the same period in 2013.  Adjusted net loss for the second quarter of 2014 was $7.4 million compared with adjusted net income of $2.7 million for the same period in 2013.
 
Adjusted EBITDA for the second quarter of 2014 was negative $6.2 million compared with positive $4.2 million for the second quarter of 2013.
 
Six Month Financial Results
Total revenue for the first half of 2014 of $29.0 million compared with $28.7 million for the first half of 2013.  Revenue in the Proprietary Products Segment was $16.1 million, compared with $20.0 million for the same period in 2013, which included a $4.5 milestone payment.  Excluding this payment, Proprietary Products revenues in the first half of 2014 increased by 4% to $16.1 million compared with $15.5 million in the first half of 2013.  Revenue in the Distribution Segment increased 45% to $12.8 million from $8.8 million in the first half of 2013. 
 
Gross profit for the first half of 2014 decreased to $3.2 million from $11.6 million in the first half of 2013, with gross margin declining to 11% from 40% in the comparable prior-year period.  Excluding the inventory write-off in the 2014 period and the milestone payment in the 2013 period, gross profit for the first half of 2014 decreased to $6.2 million from $7.1 million in the first half of 2013.

Operating loss for the first six months of 2014 of $10.6 million compared with operating income of $0.35 million for the first six months of 2013.  Net loss for the first half of 2014 was $11.5 million or $0.32 per share, compared with a net loss of $1.1million or $0.04 per share for the same period in 2013. 
 
Adjusted EBITDA for the first six months of 2014 was negative $7.2 million, compared with positive $3.9 million for the same period last year.

Balance Sheet Highlights
As of June 30, 2014, Kamada had cash, cash equivalents and short-term investments of $67.7 million, compared with $74.2 million as of December 31, 2013. During the first half of 2014, the Company used $5.3 million in cash to fund operations and $1.5 million for capital expenditures.

Financial Guidance
For the year ending December 31, 2014, Kamada expects total revenue to be between $70 million and $72 million, with revenue from its Distribution Segment projected to be between $25 million to $26 million and revenue from its Proprietary Products Segment to be between $45 million and $47 million.  The Company notes that U.S. revenues from the agreement with Baxter remain on track.

Conference Call
Kamada management will host an investment community conference call today beginning 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 1-809-457-877 (toll-free from Israel) and entering the conference identification number: 76337212.

A replay of the call will be accessible two hours after its completion through August 20, 2014 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: 76337212. 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:
Gil Efron  
CFO
ir@kamada.com
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
 
-Tables to Follow-
 
 
 

 

CONSOLIDATED BALANCE SHEETS 

 
   
As of June 30,
   
As of December 31,
 
   
2014
   
2013
   
2013
 
   
Unaudited
   
Audited
 
   
In thousands
 
   Current Assets
                 
Cash and cash equivalents
  $ 25,083     $ 73,403     $ 59,110  
Short-term investments
    42,603       9,152       15,067  
Trade receivables, net
    15,215       12,340       17,882  
Other accounts  receivables
    2,299       1,400       3,694  
Inventories
    23,871       23,901       21,933  
                         
      109,071       120,196       117,686  
                         
    Non-Current Assets                        
Long-term inventories
    -       165       -  
Property, plant and equipment, net
    21,668       19,993       21,443  
Other long-term assets
    160       193       250  
                         
      21,828       20,351       21,693  
                         
      130,899       140,547       139,379  
    Current Liabilities                        
Short term credit and Current maturities of convertible debentures
     8,798        5,534        8,718  
Trade payables
    15,942       9,098       14,093  
Other accounts payables
    4,510       5,481       4,313  
Deferred revenues
    5,264       8,596       5,454  
                         
      34,514       28,709       32,578  
                         
Non-Current Liabilities
                       
Convertible debentures
    8,039       19,930       7,498  
Employee benefit liabilities, net
    834       770       827  
Deferred revenues
    6,867       10,149       8,506  
                         
      15,740       30,849       16,831  
Equity
                       
Share capital
    9,203       8,983       9,201  
Share premium
    157,212       148,655       157,100  
Conversion option in convertible debentures
    2,217       3,794       2,218  
Capital reserve due to translation to presentation currency
    (3,490 )     (3,490 )     (3,490 )
Capital reserve from hedges
    54       121       156  
Capital reserve from available for sale  financial assets
    93       -       (27 )
Capital reserve from share-based payments
    7,217       4,903       5,189  
Capital reserve from employee benefits
    (129 )     (141 )     (129 )
Accumulated deficit
    (91,732 )     (81,836 )     (80,248 )
                         
      80,645       80,989       89,970  
                         
    $ 130,899     $ 140,547     $ 139,379  

 
 
 

 
 
Consolidated Statements of Comprehensive Income (loss)

 
   
Six months period
ended
June 30,
   
Three months period
ended
 June 30,
   
Year ended
December 31
 
   
2014
   
2013
   
2014
   
2013
   
2013
 
   
Unaudited
   
Audited
 
   
Thousands of US dollar (Except for per-share income (loss) data)
 
                               
Revenues from proprietary products
  $ 16,142     $ 19,957     $ 8,721     $ 11,897     $ 50,658  
Revenues from distribution
    12,842       8,754       7,076       4,218       19,965  
                                         
Total revenues
    28,984       28,711       15,797       16,115       70,623  
                                         
Cost of revenues from proprietary products
    14,706       9,682       9,703       5,121       27,104  
Cost of revenues from distribution
    11,082       7,412       6,160       3,573       17,112  
                                         
Total cost of revenues
    25,788       17,094       15,863       8,694       44,216  
                                         
Gross profit (loss)
    3,196       11,617       (66 )     7,421       26,407  
                                         
Research and development expenses
    8,433       6,334       5,068       2,604       12,745  
Selling and marketing expenses
    1,366       963       719       450       2,100  
General and administrative expenses
    3,994       3,975       2,037       2,719       7,862  
                                         
Operating income (loss)
    (10,597 )     345       (7,890 )     1,648       3,700  
                                         
Financial income
    421       165       179       79       289  
Income (expense) in respect of currency exchange and translation differences and derivatives instruments, net
    136       (70 )     97       (132 )     (369 )
Financial expense
    (1,410 )     (1,549 )     (737 )     (693 )     (3,153 )
Income (loss) before  taxes on income
    (11,450 )     (1,109 )     (8,351 )     902       467  
Taxes on income
    34       36       11       12       24  
Net Income (loss)
    (11,484 )     (1,145 )     (8,362 )     890       443  
Other Comprehensive Income (loss):
                                       
Items that may be reclassified to profit or loss in subsequent periods:
                                       
Net gain (loss) on available for sale financial assets
    120       -       81       -       (27 )
Net loss on cash flow hedge
    (102 )     (108 )     (33 )     (67 )     (73 )
Items that will not be reclassified to profit or loss in subsequent periods:
                                       
Actuarial net gain of defined benefit plans
    -       -       -       -       12  
Total comprehensive income (loss)
  $ (11,466 )   $ (1,253 )   $ (8,314 )   $ 823     $ 355  
                                         
Income (loss) per share attributable to equity holders of the Company:
                                       
Basic income (loss) per share
  $ (0.32 )   $ (0.04 )   $ (0.23 )   $ (0.03 )   $ 0.01  
                                         
Diluted income (loss) per share
  $ (0.32 )   $ (0.04 )   $ (0.23 )   $ (0.03 )   $ 0.01  

 
 

 
 
CONSOLIDATED STATEMENTS OF CASH FLOWS

 
    Six months period Ended
June 30,
    Three months period Ended
June 30,
    Year Ended
December 31,
 
    2014     2013     2014     2013     2013  
     Unaudited     Audited  
    Thousands of US dollar  
                               
Cash Flows from Operating Activities
                             
                               
Net income (loss)
  $ (11,484 )   $ (1,145 )   $ (8,362 )   $ 890     $ 443  
                                         
Adjustments to reconcile loss to net cash provided by (used in) operating activities:
                                       
                                         
Adjustments to the profit or loss items:
                                       
                                         
Depreciation and amortization
    1,315       1,515       652       692       3,001  
Finance expenses, net
    853       1,454       461       747       3,233  
Cost of share-based payment
    2,095       649       1,009       436       1,327  
Loss from sale of fixed assets
    -       67       -       67       24  
Taxes on income
    34       36       11       12       73  
Change in employee benefit liabilities, net
    7       52       33       32       121  
                                         
      4,304       3,773       2,166       1,986       7,779  
Changes in asset and liability items:
                                       
                                         
Decrease (increase) in trade receivables
    2,764       1,743       (2,472 )     (3,097 )     (3,445 )
Decrease  (increase) in other accounts receivables
    530       207       770       649       (444 )
Decrease (increase) in inventories and long-term inventories
    (1,938 )     (3,315 )     4,743       (85 )     (1,182 )
Decrease (increase) in deferred expenses
    814       28       255       139       (1,231 )
Increase (decrease)  in trade payables
    1,898       (3,178 )     (342 )     (3,716 )     1,579  
Increase (decrease) in other accounts payables
    196       960       759       1,190       264  
Decrease  in deferred revenues
    (1,829 )     (1,485 )     (983 )     (1,351 )     (6,270 )
                                         
      2,435       (5,040 )     2,730       (6,271 )     (10,729 )
    Cash paid and received during the period for:
                                       
Interest paid
    (602 )     (1,062 )     (301 )     (527 )     (1,968 )
Interest received
    132       195       38       112       663  
Taxes paid
    (64 )     (54 )     (4 )     (23 )     (42 )
                                         
      (534 )     (921 )     (267 )     (438 )     (1,347 )
                                         
Net cash used in operating activities
  $ (5,279 )   $ (3,333 )   $ (3,733 )   $ (3,833 )   $ (3,854 )

 
 
 

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

 
    Six months period Ended
June 30,
    Three months period Ended
June 30,
    Year Ended
December 31,
 
    2014     2013     2014     2013     2013  
    Unaudited     Audited  
    Thousands of US dollar  
                               
Cash Flows from Investing Activities
                             
Short-term investments
  $ (26,784 )   $ 7,848     $ (3,352 )   $ 1,279     $ 1,732  
Purchase of property and equipment
    (1,535 )     (2,747 )     (919 )     (1,473 )     (5,643 )
Proceeds from sale of equipment
    -       3       -       3       8  
                                         
Net cash provided by (used in) investing activities
    (28,319 )     5,104       (4,271 )     (191 )     (3,903 )
                                         
Cash Flows from Financing Activities
                                       
Exercise of options into shares
    39       309       39       136       562  
Proceeds from issuance of ordinary shares, net
    -       53,958       -       54,479       52,953  
Short term credit from bank and others, net
    -       (6 )     -       (6 )     (12 )
Repayment of convertible debentures
    -       -       -       -       (4,295 )
                                         
Net cash provided by financing activities
    39       54,261       39       54,609       49,208  
                                         
Exchange differences on balances of cash and cash equivalent
    (468 )     505       (266 )     177       793  
                                         
Increase (decrease) in cash and cash equivalents
    (34,024 )     56,537       (8,231 )     50,762       42,244  
                                         
Cash and cash equivalents at the beginning of the period
    59,110       16,866       33,314       22,641       16,866  
                                         
Cash and cash equivalents at the end of the period
  $ 25,083     $ 73,403     $ 25,083     $ 73,403     $ 59,110  
                                         
Significant non-cash transactions
                                       
Purchase of property, equipment  and intangible assets on credit
  $ -     $ -     $ -     $ -     $ 151  
Exercise of options presented as liability
  $ -     $ 23     $ -     $ -     $ 23  
Exercise of convertible debentures into shares
  $ 7     $ -     $ -     $ -     $ 6,508  
Issuance expenses accrued in other accounts payables
  $ -     $ 1,094     $ -     $ 994     $ -  
 
 
 
 

 

Adjusted EBITDA
 
   
Six months period
Ended June 30
   
Three months period
Ended June 30
   
Year ended
December 31
 
   
2014
   
2013
   
2014
   
2013
    2013  
   
Thousands of US dollar
 
                               
Net Income (loss)
  $ (11,484 )   $ (1,145 )   $ (8,362 )   $ 890     $ 443  
Income tax expense
    34       36       11       12       24  
Financial expense, net
    853       1,384       461       614       2,864  
                                         
Depreciation and amortization expense
    1,315       1,515       652       692       3,001  
                                         
Share-based compensation charges
    2,095       649       1,009       436       1,327  
                                         
Expense (income) in respect of translation differences and derivatives instruments, net
    -       70       -       132       369  
                                         
one-time management compensation
            1,386               1,386       1,386  
                                         
Adjusted EBITDA
  $ (7,187 )   $ 3,895     $ (6,229 )   $ 4,162     $ 9,414  

Adjusted net income

   
Six months period
Ended June 30
   
Three months period
Ended June 30
   
Year ended
December 31
 
   
2014
   
2013
   
2014
   
2013
   
2013
 
   
Thousands of US dollar
 
                               
Net income (loss)
  $ (11,484 )   $ (1,145 )   $ (8,362 )   $ 890     $ 443  
                                         
Share-based compensation charges
    2,095       649       1,009       436       1,327  
                                         
One time management compensation
            1,386               1,386       1,386  
                                         
Adjusted net income
  $ (9,389 )   $ 890     $ (7,353 )   $ 2,712     $ 3,156