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


EXHIBIT 99.1
 
   
 
Kamada Reports Third Quarter 2013 Financial Results

European Phase 2/3 trial of inhaled AAT for AATD to complete by year-end
Adjusting 2013 revenue guidance; product sales from Baxter remain on track
Conference call begins today at 8:30 a.m. Eastern time
 
NESS ZIONA, Israel (October 29, 2013) – Kamada Ltd. (NASDAQ and TASE: KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announces financial results for the three and nine months ended September 30, 2013.

“Overall we are very pleased with our third quarter financial performance.  We made continued steady progress growing proprietary product revenue, advancing clinical development programs and enhancing manufacturing processes to meet expected product demand,” stated David Tsur, Founder and Chief Executive Officer of Kamada.  “Importantly, we are nearing the completion of two Phase 2/3 trials with expected data readouts from our Phase 2/3 trial in Europe of our inhaled Alpha-1 Antitrypsin (AAT) for the treatment of AAT deficiency (AATD) in early 2014, and are about to embark upon two late-stage clinical programs in the coming months.

“Our European pivotal, multi-center Phase 2/3 trial of inhaled AAT for the treatment of AATD will complete by year-end and we expect to report top-line results in early 2014.  We are very excited about the potential for this first inhaled treatment for AATD and are working on launch plans with our European marketing partner, Chiesi.  The open-label extension portion of this trial has enrolled a high percentage of eligible patients, which we believe supports patient and physician preference for an inhaled treatment for AATD.  In addition, we are preparing for a U.S. clinical study of our inhaled AAT for treatment of AATD that will test pharmacokinetic parameters of different analytes in epithelial lining fluid and serum, as well as safety and tolerability.  We have an Investigational New Drug protocol approved by the U.S. Food and Drug Administration and expect to initiate the trial by the end of this year.

“By the end of the year we plan to initiate a Phase 2/3 trial with Glassia in pediatric patients newly diagnosed with type 1 diabetes with the goal of establishing efficacy in halting the progression of the disease and maintaining the ability of the pancreas to produce insulin.  This is a very exciting opportunity for Kamada as data from the Phase 1/2 trial showed positive signals of disease modification, which may potentially represent a breakthrough in the treatment of this disease.

“2013 continues to be a significant year of growth and expansion for Kamada, with achievements to date providing the foundation for continued success through the balance of the year and into 2014,” concluded Mr. Tsur.

Third Quarter Financial Results
Total revenue for the third quarter of 2013 decreased 1.1% to $17.5 million from $17.7 million for the third quarter of 2012, reflecting higher revenue in the Proprietary Products Segment offset by expected declines in revenue in the Distribution Segment and increased 8.5% compared to the second quarter in 2013.

Revenue from the Proprietary Products Segment increased 9.4% to $12.1 million from $11.0 million in the year-ago quarter and product sales increased 63.1% compared to the second quarter of 2013, after excluding the one-time milestone payment of $4.5 million recorded in that quarter.  Revenue from the Distribution Segment declined 18.6% to $5.4 million from $6.6 million in the third quarter of 2012 and increased 28.4% compared to second quarter of 2013.
 
 
 

 
 
Research and development (R&D) expenses in the third quarter of 2013 of $2.8 million increased from $2.7 million in the third quarter of 2012 and $2.6 million in the second quarter of 2013.

Selling, general and administrative (SG&A) expenses in the third quarter of 2013 of $2.1 million increased from $1.6 million in the third quarter of 2012 and $1.8 million in the second quarter of 2013, after eliminating a one-time IPO related expense, due in part to the costs associated with being a U.S. public company.

Gross profit for the third quarter of 2013 increased to $5.9 million from $5.6 million in the third quarter of 2012, while gross margin increased to 34% from 32% in the third quarter of 2012.

For the third quarter of 2013 the Company reported operating income of $1.0 million compared with $1.3 million for the third quarter of 2012.  Net income for the third quarter of 2013 was $0.0 million or $0.00 per diluted share, compared with net income of $0.0 million or $0.00 per diluted share for the same period in 2012.

Adjusted EBITDA for the third quarter of 2013 was $2.0 million compared with $2.3 million for the same quarter last year.

Nine Month Financial Results
Total revenue for the first nine months of 2013 decreased 9.5% to $46.2 million from $51.0 million for the first nine months of 2012, due to expected declines in revenue in the Distribution Segment.

Year-to-date revenue from the Proprietary Products Segment increased 4.9% to $32.0 million from $30.5 million for the same period in 2012.  Revenue from the Distribution Segment declined 30.9% to $14.2 million from $20.5 million in the same period of 2012.

Gross profit for the first nine months of 2013 increased to $17.5 million from $14.7 million, while gross margin increased to 38% from 28% in the comparable prior-year period.

Operating income for the first nine months of 2013 of $1.3 million compared with operating income of $0.7 million for the first nine months of 2012.  The net loss for the nine-month period ended September 30, 2013 narrowed to $1.1 million or $0.04 per share, from a net loss of $2.6 million or $0.10 per share for the same period in 2012.

Adjusted EBITDA for the first nine months of 2013 increased 50% to $5.9 million compared with $3.9 million for the same period last year.

Balance Sheet Highlights
As of September 30, 2013, the Company had cash, cash equivalents and short-term investments of $75.9 million, compared with $33.8 million as of December 31, 2012.

Financial Guidance
The Company is revising 2013 revenue guidance and now expects total revenue for the year to be between $70 million and $72 million, compared with previous guidance for total revenue to be $74 million.  This revision is mainly due to a countrywide pricing change enacted by the national drug pricing regulator in India, National Pharmaceutical Pricing Authority, which affects the Company’s distributor sales in India.  The Company notes that U.S. revenues from the agreement with Baxter International remain on track.  Kamada now expects 2013 revenue from its Distribution Segment to be $20 million as expected compared to $26 million in 2012 and revenue from its Proprietary Products Segment to be between $50 million and $52 million for the year ending December 31, 2013 compared to $47 million in 2012 representing growth in Kamada more profitable and strategic segment.
 
 
 

 
 
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 (toll-free from within the U.S.) or 706-634-5454 (from outside the U.S.) or 809-315-362 (toll-free from Israel) and entering passcode 87555865. The call also will be broadcast live on the Internet at www.streetevents.com, www.earnings.com and www.kamada.com.

A replay of the conference call will be accessible two hours after its completion through November 4, 2013 by dialing 855-859-2056 (toll-free from within the U.S.) or 404-537-3406 (from outside the U.S.) and entering passcode 87555865. The call will also be archived for 90 days at www.streetevents.com, www.earnings.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 is in pivotal Phase 2/3 clinical trials in Europe and will be entering 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 US 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, clinical trials, the EMA and U.S. FDA authorizations and timing of clinical trials.  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
Anne Marie Fields
CFO
LHA
ir@kamada.com
212-838-3777
 
afields@lhai.com
 
-Tables to Follow-
 
 
 

 
CONSOLIDATED BALANCE SHEETS

 
   
As of September 30,
   
As of
December 31,
 
   
2013
   
2012
   
2012
 
   
Unaudited
   
Audited
 
   
In thousands
 
Current Assets
                 
Cash and cash equivalents
  $ 71,232     $ 15,470     $ 16,866  
Short-term investments
    4,707       18,040       16,929  
Trade receivables
    17,285       12,979       13,861  
Other accounts  receivables
    2,532       1,849       1,661  
Inventories
    22,279       19,040       20,513  
                         
      118,035       67,378       69,830  
Non-Current Assets
                       
Long-term inventories
    165       394       238  
Property, plant and equipment, net
    20,951       18,245       18,827  
Other long-term assets
    177       153       219  
      21,293       18,792       19,284  
                         
      139,328       86,170       89,114  
                         
Current Liabilities
                       
Short term credit and Current maturities of convertible debentures
    5,658       12       5,370  
Trade payables
    9,124       12,618       12,220  
Other accounts payables
    4,312       3,067       3,413  
Deferred revenues
    7,603       8,314       8,176  
                         
      26,697       24,011       29,179  
Non-Current Liabilities
                       
Loans from banks and others
            3       -  
Warrants
            19       23  
Convertible debentures
    20,653       22,714       18,747  
Employee benefit liabilities, net
    866       578       718  
Deferred revenues
    9,489       14,415       12,054  
                         
      31,008       37,729       31,542  
Equity
                       
Share capital
    9,010       7,165       7,204  
Share premium
    149,219       95,943       96,874  
Conversion option in convertible debentures
    3,789       3,794       3,794  
Capital reserve due to translation to presentation currency
    (3,490 )     (3,490 )     (3,490 )
Capital reserve from hedges
    185       (99 )     229  
Other capital reserves
    4,709       4,666       4,473  
Accumulated deficit
    (81,799 )     83,549       (80,691 )
                         
      81,623       24,430       28,393  
                         
    $ 139,328     $ 86,170     $ 89,114  

 
 

 
 
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

 
   
For the 9 months period
ended September 30,
   
For the 3 months period
ended September 30,
   
For the year ended December 31
 
   
2013
   
2012
   
2013
   
2012
    2012  
   
Unaudited
   
Audited
 
   
In thousands (except per share data)
 
                                 
Revenues from Proprietary Products
  $ 32,023     $ 30,532     $ 12,066     $ 11,030     $ 46,445  
Revenues from Distribution
    14,168       20,500       5,414       6,648       26,230  
                                         
Total revenues
    46,191       51,032       17,480       17,678       72,675  
                                         
Cost of revenues from Proprietary Products
    16,516       18,323       6,834       6,184       26,911  
Cost of revenues from Distribution
    12,133       18,100       4,721       5,788       23,071  
                                         
Total cost of revenues
    28,649       36,423       11,555       11,972       49,982  
                                         
Gross profit
    17,542       14,609       5,925       5,706       22,693  
                                         
Research and development expenses
    9,167       8,979       2,833       2,769       11,821  
Selling and marketing expenses
    1,554       1,404       591       438       1,853  
General and administrative expenses
    5,514       3,565       1,543       1,132       4,781  
                                         
Operating  income
    1,307       661       958       1,367       4,238  
                                         
Financial income
    245       455       80       119       578  
Income (expense) in respect of currency exchange and translation differences and derivatives
    (166 )     (15 )     (96 )     34       (100 )
Income(expense) in respect of revaluation of warrants to fair value
    -       (554 )     -       19       (576 )
Financial expense
    (2,479 )     (2,545 )     (926 )     (836 )     (3,357 )
                                         
Income (loss) before taxes on income
    (1,093 )     (1,998 )     16       703       783  
                                         
Taxes on income (tax benefit)
    15       600       (21 )     600       523  
Net income (loss)
    (1,108 )     (2,598 )     37       103       260  
Other Comprehensive Income (Loss)
                                       
Items that may be reclassified to profit or loss in subsequent periods:
                                       
Net gain (loss) on cash flow hedge
    (44 )     (99 )     64       (99 )     229  
Items that will not be reclassified to profit or loss in subsequent periods:
                                       
Actuarial net gain of defined benefit plans
    -       -       -       -       46  
                                         
Total comprehensive Income (loss)
  $ (1,152 )   $ (2,697 )   $ 101     $ 4     $ 535  
                                         
Income (loss) per share attributable to equity holders of the Company:
                                       
Basic income (loss) per share
  $ (0.04 )   $ (0.10 )   $ 0.00     $ 0.00     $ 0.01  
                                         
Diluted income (loss) per share
  $ (0.04 )   $ (0.10 )   $ 0.00     $ 0.00     $ 0.01  
 
 
 

 
 
CONSOLIDATED STATEMENTS OF CASH FLOWS

 
   
For the 9 months period
ended September 30,
   
For the 3 months period
ended September 30,
 
For the year ended December 31
 
   
2013
   
2012
   
2013
   
2012
 
2012
 
   
Unaudited
 
Audited
 
   
In thousands
 
                               
Cash Flows from Operating Activities
                             
                               
Net income (loss)
  $ (1,108 )   $ (2,598 )   $ 37     $ 103     $ 260  
                                         
Adjustments to reconcile Net income (loss) to net cash provided by (used in) operating activities:
                                       
                                         
Adjustments to profit or loss items:
                                       
                                         
Depreciation and amortization
    2,267       2,283       752       777       3,044  
Financial expenses, net
    2,400       2,659       946       664       3,455  
Taxes on income
    15       600       (21 )     600       523  
Cost of share-based payment
    915       974       266       296       1,267  
Loss from sale of property and equipment
    73       3       6       (11 )     -  
Change in employee benefit liabilities, net
    148       (148 )     96       (137 )     38  
                                         
      5,818       6,371       2,045       2,189       8,327  
Changes in asset and liability items:
                                       
                                         
Increase in trade receivables
    (2,983 )     (6,199 )     (4,726 )     (1,856 )     (6,662 )
Decrease (increase) in other accounts receivables
    (1,075 )     (20 )     (1,282 )     (850 )     451  
Increase (decrease) in inventories and long-term inventories
    (1,693 )     (3,545 )     1,622       (1,974 )     (4,861 )
Decrease  in deferred expenses
    156       102       128       63       89  
Increase (decrease) in trade payables
    (3,289 )     299       (111 )     (48 )     (157 )
Increase (decrease) in other accounts payables
    646       (61 )     (314 )     (47 )     322  
Decrease  in deferred revenues
    (3,138 )     (607 )     (1,653 )     3,428       (3,438 )
                                         
      (11,376 )     (10,031 )     (6,336 )     (1,284 )     (14,256 )
Cash paid and received during the period for:
                                       
                                         
Interest paid
    (1,573 )     (1,665 )     (511 )     (525 )     (2,200 )
Interest received
    411       574       216       144       249  
Taxes paid
    (97 )     (639 )     (43 )     (603 )     (642 )
                                         
      (1,259 )     (1,730 )     (338 )     (984 )     (2,593 )
                                         
Net cash provided by (used in) operating activities
    (7,925 )     (7,988 )     (4,592 )     24       (8,262 )

 
 

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

 
   
For the 9 months period
ended September 30,
   
For the 3 months period
ended September 30,
   
For the year ended December 31
 
   
2013
   
2012
   
2013
   
2012
   
2012
 
   
Unaudited
   
Audited
 
   
In thousands
 
                               
Cash Flows from Investing Activities
                             
                               
Short-term investments
    12,159       (1,619 )     4,311       (3,531 )     665  
Purchase of property and equipment
    (4,425 )     (3,118 )     (1,678 )     (1,136 )     (4,609 )
Proceeds from sale of equipment
    3       -       -       -       -  
Restricted cash, net
    -       1,512       -       -       1,512  
                                         
Net cash provided by (used in) investing activities
    7,737       (3,225 )     2,633       (4,667 )     (2,432 )
                                         
Cash Flows from Financing Activities
                                       
                                         
Exercise of warrants and options into shares
    545       2,525       277       1,944       2,978  
Proceeds from issuance of ordinary shares, net
    53,099       -       (859 )     -       -  
Short term credit from bank and others, net
    (6 )     (9 )     -       (3 )     (12 )
Net cash provided by (used in) financing activities
    53,638       2,516       (582     1,941       2,966  
                                         
Exchange differences on balances of cash and cash equivalent
    916       (207 )     370       (106 )     220  
                                         
Increase (decrease) in cash and cash equivalents
    54,366       (8,904 )     (2,171 )     (2,808 )     (7,508 )
                                         
Cash and cash equivalents at the beginning of the year
    16,866       24,374       73,403       18,278       24,374  
                                         
Cash and cash equivalents at the end of the year
  $ 71,232     $ 15,470     $ 71,232     $ 15,470     $ 16,866  
                                         
Significant non-cash transactions
                                       
Purchase of Property  and equipment and intangible assets on credit
  $ -     $ 488     $ -     $ -     $ -  
                                         
Exercise of options presented as liability
  $ 23     $ 1,209     $ -     $ -     $ 1,215  
                                         
Issuance expenses accrued in other accounts payable
  $ 235     $ -     $ -     $ -     $ -  
                                         
Exercise of convertible debentures into shares
  $ 35     $ -     $ 35     $ -     $ -  
 
 
 

 
 
ADJUSTED EBITDA


   
Nine months period
Ended September 30
   
Three months period
Ended September 30
   
Year ended
December 31
 
   
2013
   
2012
   
2013
   
2012
   
2012
 
   
Thousands of US dollar (Except for per-share loss data)
 
                               
Net income (loss)
    (1,108 )     (2,598 )     37       103       260  
                                         
Income tax expense
    15       600       (21 )     600       523  
                                         
Financial expense, net
    2,234       2,090       850       717       2,779  
                                         
Depreciation and amortization expense
    2,267       2,283       752       777       3,044  
                                         
                                         
Share-based compensation charges
    915       974       266       296       1,267  
                                         
Expense (Income) in respect of translation differences and derivatives instruments, net
    166       15       96       (34 )     100  
                                         
Expense (income) in respect of revaluation of warrants fair value
            554       -       (19 )     576  
                                         
One time management compensation
    1,386                                  
Adjusted EBITDA
    5,875       3,918       1,980       2,440       8,549