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Kamada Reports Financial Results for the Second Quarter and First Six Months of 2016

20:00 EDT 1 Aug 2016 | Globe Newswire

Total Revenues for First Half of 2016 Grew 20% to $33.9 Million vs. First Half of 2015

Proprietary Products Revenue Grew 46% to $23.2 Million in First Half of 2016 vs. First Half of 2015

Company Reiterates 2016 Revenue Guidance and 2017 Sales Target of $100 Million

Conference Call Today at 8:30am Eastern Time

NESS ZIONA, Israel, Aug. 02, 2016 (GLOBE NEWSWIRE) -- Kamada Ltd. (Nasdaq:KMDA) (TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announced financial results for the three and six months ended June 30, 2016. 

“We are very pleased with our financial performance and achievements to date in 2016,” said Amir London, Chief Executive Officer of Kamada, Ltd.  “The 20 percent growth in total revenues in the first half of 2016 as compared to the first half of 2015 was driven by a 46 percent increase in sales from our Proprietary Products Segment.  Importantly, the number of patients treated with GLASSIA® in the U.S. through our collaboration with Shire continues to increase strongly and provides us with confidence in our ability to achieve our 2016 revenue guidance of $75 to $80 million, and our $100 million sales target in 2017.  This revenue growth and our improved profitability as reflected in our improved gross profit and positive Adjusted EBITDA reinforces our plan to breakeven 2017.”

Financial Highlights for the Three-Months Ended June 30, 2016:

  • Total revenues were $19.1 million, compared to $19.2 million in the same period of 2015
  • Gross profit was $5.6 million, compared to $3.6 million in the same period of 2015
  • Gross margin increased to 30% from 19% in the same period of 2015
  • Net loss was $1.6 million, or $0.04 per share, compared to $2.3 million, or $0.06 per share, in the same period of 2015

Financial Highlights for the Six-Months Ended June 30, 2016:

  • Total revenues were $33.9 million, compared to $28.2 million in the same period of 2015, an increase of 20 percent
  • Revenues from the Proprietary Product Segment were $23.2 million, as compared to $15.9 million in the same period of 2015, an increase of 46 percent
  • Gross profit was $10.4 million, compared to $4.0 million in the same period of 2015
  • Gross margin increased to 31% from 14% in the same period of 2015
  • Adjusted net loss was $3.2 million, or $0.11 per share, compared to adjusted net loss of $6.6 million, or $0.21 per share, in the same period of 2015

Recent Corporate Highlights:

  • Received a milestone payment from Chiesi upon the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for inhaled alpha-1 antitrypsin (AAT) for the treatment of AAT deficiency (AATD).  Chiesi Farmaceutici is Kamada’s exclusive marketing and distribution partner for its inhaled AAT for the treatment of AATD in Europe. 
  • Received a milestone payment from Baxalta (now part of Shire) as a result of Baxalta achieving an undisclosed sales milestone for Glassia®, Kamada's intravenous (IV) AAT treatment.   
  • FDA approved an expanded label for GLASSIA™ [Alpha-1 Proteinase Inhibitor (Human)], marking the first treatment for adult patients with emphysema due to severe AAT Deficiency that can be self-infused at home after appropriate training.
  • Announced a collaboration with myTomorrows to provide early access throughout Europe to Kamada’s proprietary Alpha-1 Antitrypsin (AAT) to treat bone marrow transplant patients who develop steroid refractory Graft-Versus-Host Disease (GvHD).
  • Appointed Naveh Tov, M.D., Ph.D., to the position of Vice President, Clinical Development and Medical Director for Pulmonary Diseases, where he will lead Kamada’s clinical development activities.

“The expanded label for GLASSIA allowing self-infusion at home was a significant milestone for Kamada that we believe will contribute significantly to further future growth,” continued Mr. London.  “We recently received from the European Medicines Agency their 120-Day List of Questions regarding the Company’s Marketing Authorization Application for our inhaled AAT to treat AAT deficiency, and expect to submit our full response in early 2017, and anticipate a regulatory decision on our regulatory submission in mid-2017.  We recently initiated discussions with the FDA and received preliminary feedback on the regulatory path forward in the U.S. for our inhaled AAT.   We will report the results of those discussions once they have concluded.” 

Second Quarter 2016 Financial Results Compared to Second Quarter 2015 Financial Results

Total revenues for the second quarter of 2016 were $19.1 million, compared to $19.2 million in the same period of 2015. Revenues from the Proprietary Products segment were $12.1 million, as compared to $12.7 million in 2015.  As the second quarter of 2015 included revenues delayed from the first quarter of 2015, we believe the six-month comparison between 2016 and 2015 is more representative of the growth in this segment.  Distributed Products revenue was $7.0 million, compared with $6.5 million in 2015.

Gross profit for the second quarter of 2016 grew to $5.6 million, compared with $3.6 million in the second quarter of 2015.  Gross margin increased to 30% from 19% in the same period of 2015.

R&D expenses in the second quarter of 2016 were $3.5 million, compared to $3.4 in 2015.  Selling, general and administrative expenses were $2.7 million, flat from the same period in 2015.  Operating loss in the second quarter of 2016 was $0.6 million, compared to an operating loss of $2.5 million in 2015.  The net loss for the second quarter of 2016 was $1.6 million, or $0.04 per diluted share, compared to a net loss of $2.3 million, or $0.06 per diluted share, in 2015.

Adjusted EBITDA for the second quarter of 2016 was $0.6 million, compared with a loss for the second quarter of 2015 of $1.1 million.  Adjusted net loss for the second quarter of 2016 was $1.3 million, compared with an adjusted net loss of $1.8 million in the second quarter of 2015.

Six Months Ended June 30, 2016 vs. June 30, 2015
Total revenues for the six months of 2016 were $33.9 million, compared to $28.2 million in the same period of 2015.  Revenues from the Proprietary Product segment for the six months of 2016 were $23.2 million, as compared to $15.9 million in the same period of 2015.  Distributed Products revenue was $10.6 million for the six months of 2016, compared with $12.3 million in the same period of 2015.

Gross profit for the six-month period of 2016 grew to $10.4 million, compared to $4.0 million during the six-month period of 2015.  Gross margin increased to 31% from 14% in the same period of 2015.

R&D expenses in the six-month period of 2016 were $7.6 million, compared to $7.1 million in the same period of 2015.  Selling, general and administrative expenses in the six-month period of 2016 were $5.4 million, compared to $5.2 million in the same period of 2015.  For the six-month period of 2016, we reported an operating loss of $2.6 million, compared with an operating loss of $8.2 million in the same period of 2015.  The net loss for the six months of 2016 was $3.9 million, or $0.11 per diluted share, compared with a net loss of $7.6 million, or $0.21 per diluted share, in the same period of 2015.

Adjusted EBITDA for the six months ended June 30, 2016, was a loss of $0.2 million, compared with a loss for the six months ended June 30, 2015, of $5.6 million.  Adjusted net loss for the six months ended June 30, 2016, was $3.2 million, compared with an adjusted net loss of $6.6 million in the six months ended June 30, 2015.

Balance Sheet Highlights
As of June 30, 2016, the Company had cash, cash equivalents and short-term investments of $29.5 million, compared with $28.3 million as of December 31, 2015.   During the first half of 2016, the Company generated $1.0 million in cash from operations, used $1.5 million for capital expenditures and generated $1.6 million from financing activities, primarily loans to fund capital expenditures. During the second quarter of 2016, the Company used $6.5 million to fund operations. This change is a result of timing related to payments to suppliers and collections from customers.

2016 Revenue Guidance
For the year ending December 31, 2016, Kamada continues to expect total revenues to be between $75 million and $80 million.

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 888-427-9415 (from within the U.S.) or 719-325-2468 (from outside the U.S.) and entering the conference identification number: 7415234.

A replay of the call will be accessible beginning two hours after its completion through August 16, 2016 by dialing 877-870-5176 (from within the U.S.) or 858-384-5517 (from outside the U.S.) and entering the conference identification number: 7415234. The call will also be archived for 90 days at 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 Immune globulins.  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 Baxalta (formerly Baxter International Inc.’s BioScience business and now part of Shire plc) and in other counties through local distributors.  In addition to Glassia®, Kamada has a product line of seven other pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. Kamada has five late-stage plasma-derived protein products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency that its MAA was submitted to the EMA after completing a pivotal Phase 2/3 clinical trials in Europe and is in Phase 2 clinical trials in the U.S. In addition, Kamada's intravenous AAT is in development for other indications such as type-1 diabetes, GvHD and prevention of lung transplant rejection. Kamada also leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 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.

     
Consolidated Balance Sheets
  As of June 30, As of December 31,
   2016   2015   2015 
  Unaudited Audited
  In thousands
Current Assets      
Cash and cash equivalents $7,136  $6,807  $5,047 
Short-term investments  22,391   37,511   23,259 
Trade receivables, net  15,936   15,584   23,071 
Other accounts  receivables  3,475   4,408   2,881 
Inventories  28,423   24,785   26,336 
       
   77,361   89,095   80,594 
       
Non-Current Assets      
Property, plant and equipment, net  21,138   21,562   21,309 
Other long-term assets  73   103   89 
       
   21,211   21,665   21,398 
       
   98,572   110,760   101,992 
Current Liabilities
Current maturities of loans and convertible debentures
      
  392   7,924   37 
Trade payables  10,247   14,808   16,917 
Other accounts payables  6,068   3,385   4,064 
Deferred revenues  5,114   1,792   1,921 
       
   21,821   27,909   22,939 
       
Non-Current Liabilities      
Loans  1,537   -   151 
Employee benefit liabilities, net  402   693   787 
Deferred revenues  5,424   6,895   5,608 
       
   7,363   7,588   6,546 
Shareholder's Equity      
Ordinary shares of NIS 1 par value:            
Authorized - 60,000,000 ordinary shares; Issued and outstanding – 36,418,741 and 36,387,929 shares at June 30, 2016 and 2015, respectively.  9,320   9,312   9,320 
Share premium  162,649   160,927   162,238 
Conversion option in convertible debentures  -   1,147   - 
Capital reserve due to translation to presentation currency  (3,490)  (3,490)  (3,490)
Capital reserve from hedges  9   134   (1)
Capital reserve from available for sale  financial assets  119   49   73 
Capital reserve from share-based payments  9,455   8,362   9,157 
Capital reserve from employee benefits  (59)  (81)  (59)
Accumulated deficit  (108,615)  (101,097)  (104,731)
   69,388   75,263   72,507 
  $98,572  $110,760  $101,992 
             


Consolidated Statements of Comprehensive Income
  Six months period
ended
June 30,
 Three months period
ended
 June 30,
 Year ended
December 31,
   2016   2015   2016   2015   2015 
  Unaudited Audited
  In thousands (except for per-share data)
           
Revenues from proprietary products $23,226  $15,881  $12,106  $12,708  $42,952 
Revenues from distribution  10,637   12,295   6,960   6,538   26,954 
           
Total revenues  33,863   28,176   19,066   19,246   69,906 
           
Cost of revenues from proprietary products  14,410   12,930   7,479   9,635   30,468 
Cost of revenues from distribution  9,047   11,214   5,958   5,971   23,640 
           
Total cost of revenues  23,457   24,144   13,437   15,606   54,108 
           
Gross profit  10,406   4,032   5,629   3,640   15,798 
           
Research and development expenses  7,609   7,058   3,502   3,415   16,530 
Selling and marketing expenses  1,691   1,743   856   944   3,652 
General and administrative expenses  3,674   3,437   1,861   1,737   7,040 
           
Operating loss  (2,568)  (8,206)  (590)  (2,456)  (11,424)
           
           
Financial income  298   300   133   114   463 
Income (expense) in respect of currency exchange and derivatives instruments, net  (59)  761   90   248   625 
Financial expense  (67)  (491)  (30)  (248)  (934)
Loss before  taxes on income  (2,396)  (7,636)  (397)  (2,342)  (11,270)
Taxes on income  1,488   -   1,188   -   - 
           
Loss  (3,884)  (7,636)  (1,585)  (2,342)  (11,270)
           
Other Comprehensive Income (loss):          
Items that may be reclassified to profit or loss in subsequent periods:          
Gain (loss) on available for sale financial assets  46   39   (25)  (79)  63 
Profit (loss) on cash flow hedges  80   194   (165)  415   71 
Net amounts transferred to the statement of profit or loss for cash flow hedges  (70)  56   (36)  (16)  44 
Items that will not be reclassified to profit or loss in subsequent periods:          
Actuarial net gain of defined benefit plans  -   -   -   -   22 
Total comprehensive loss $(3,828) $(7,347) $(1,811) $(2,022) $(11,070)
           
Loss per share attributable to equity holders of the Company:          
Basic loss per share $(0.11) $(0.21) $(0.04) $(0.06) $(0.31)
           
Diluted loss per share $(0.11) $(0.21) $(0.04) $(0.06) $(0.31)
                     


Consolidated Statements of Cash Flows
  Six months period Ended  Three months period Ended  Year Ended 
 June 30,June 30, December 31, 
  2016   2015   2016   2015   2015 
 Unaudited
Audited
 In thousands
 
Cash Flows from Operating Activities 
  
Net loss$(3,884) $(7,636) $(1,585) $(2,342) $(11,270)
      
Adjustments to reconcile loss to net cash provided by (used in) operating activities:     
      
Adjustments to the profit or loss items:     
      
Depreciation, amortization and impairment of equipment 1,709   1,572   878   801   3,227 
Finance income, net (172)  (570)  (193)  *(114)  (154)
Cost of share-based payment 709   1,029   328   524   1,907 
Income tax expense 1,488   -   1,188   -   - 
Loss from sale of property and equipment 10   -   -   -   - 
Change in employee benefit liabilities, net (385)  (29)  (250)  (46)  87 
                    
  3,359   2,002   1,951   1,165   5,067 
Changes in asset and liability items:                   
      
Decrease (increase) in trade receivables, net 7,304   2,211   (6,955)  (6,207)  (5,604)
Decrease  (increase) in other accounts receivables 147   (502)  905   *102   118 
Decrease (increase) in inventories (2,087)  638   3,182   2,650   (913)
Increase in deferred expenses (774)  (1,400)  (304)  (1,471)  (565)
Increase (decrease) in trade payables (6,869)  (1,461)  (7,939)  1,111   887 
Increase (decrease) in other accounts payables 726   (584)  439   75   94 
Increase (decrease)  in deferred revenues 3,009   (1,247)  3,975   (1,070)  (2,405)
      
  1,456   (2,345)  (6,697)  (4,801)  (8,388)
Cash received (paid) during the period for:     
Interest paid (9)  (243)  (7)  (122)  (484)
Interest received 424   594   138   244   1,143 
Taxes paid (306)  (47)  (303)  (18)  (47)
      
  109   304   (172)  104   612 
      
Net cash provided by (used in) operating activities$1,040  $(7,675) $(6,503) $(5,883) $(13,979)
                    
*Reclassification                   
                    

 

Consolidated Statements of Cash Flows
  Six months period Ended  Three months period Ended Year Ended
 June 30,June 30, December 31, 
  2016   2015   2016   2015   2015 
 UnauditedAudited
 In thousands
 
Cash Flows from Investing Activities 
Proceeds from sale of (investment in) short term investments, net$776  $25  $1,392  $(400) $13,971 
Purchase of property and equipment (1,469)  (1,332)  (543)  (823)  (2,718)
Proceeds from sale of property and equipment 21   -   -   -   - 
                    
Net cash provided by (used in) investing activities (672)  (1,307)  849   (1,223)  11,253 
                    
Cash Flows from Financing Activities                   
Proceeds from exercise of warrants and options -   1,165   -   * 949   1,254 
Receipt of long-term loans 1,701   -   1,071   -   197 
Repayment of long-term loans (61)  -   (50)  -   (9)
Repayment of convertible debentures -   -   -   -   (7,797)
                  - 
Net cash provided by (used in) financing activities 1,640   1,165   1,021   949   (6,355)
                    
Exchange differences on balances of cash and cash equivalent 81   78   164   *(47)  (418)
                    
Increase (decrease) in cash and cash equivalents 2,089   (7,739)  (4,469)  (6,204)  (9,499)
                    
Cash and cash equivalents at the beginning of the period 5,047   14,546   11,605   13,011   14,546 
                    
Cash and cash equivalents at the end of the period$7,136  $6,807  $7,136  $6,807  $5,047 
                    
Significant non-cash transactions                   
Purchase of property and equipment through capital lease$84  $-  $-  $-  $- 
                    
                    
*Reclassification                   
                    


Adjusted EBITDA
  Six months period Ended
June 30,
 Three months period
Ended June 30,
 For the year
Ended
December 31,
 
   2016   2015   2016   2015   2015 
                      
  In thousands
           
Net loss $(3,884) $(7,636) $(1,585) $(2,342) $(11,270)


Income tax expense
  1,488   -   1,188   -   - 
           
Financial expense (income), net  (172)  (570)  (193)  (114)  (154)
           
Depreciation and amortization expense  1,709   1,572   878   801   3,227 
           
Share-based compensation charges  709   1,029   328   524   1,907 
           
Adjusted EBITDA $(150) $(5,605) $616   (1,131) $(6,290)
                     


Adjusted net income
  Six months period Ended
June 30,
 Three months period
Ended June 30,
 For the Year
Ended
December 31,
   2016   2015   2016   2015   2015 
  In thousands
           
Net loss $(3,884) $(7,636) $(1,585) $(2,342) $(11,270)
           
Share-based compensation charges  709   1,029   328   524   1,907 
           
Adjusted Net loss $(3,175) $(6,607) $(1,257) $(1,818) $(9,363)
                 


CONTACT:

Gil Efron
Chief Financial Officer
ir@kamada.com

Bob Yedid
LifeSci Advisors
646-597-6989
bob@lifesciadvisors.com

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