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Kamada Reports Financial Results for Second Quarter and First Six Months of 2017

KMDA

Reaffirms Total Revenue Guidance of $100 Million for 2017

Conference Call Today at 8:30 AM ET

REHOVOT, Israel, Aug. 01, 2017 (GLOBE NEWSWIRE) -- Kamada Ltd. (Nasdaq:KMDA) (TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications, today announced financial results for the three and six months ended June 30, 2017. 

“Our second quarter financial performance was strong, and the momentum in our business is solid,” said Amir London, Kamada’s Chief Executive Officer.  “Total quarterly revenues of $33 million represented a year-over-year increase of 71%.  These revenues included approximately $11.5 million in sales that were delayed from the first quarter.  Our revenues for the first six months of 2017 were $44 million, which was an increase of 31% over the first six months of 2016.  In addition, gross margins for the second quarter 2017 increased to 36% from 30% in the second quarter last year.  GLASSIA®, our intravenous Alpha-1 Antitrypsin (AAT) for the treatment of Alpha-1 Antitrypsin Deficiency (AATD), continues to be the major growth driver in our Proprietary Products segment and overall business.  Based on our continued solid financial performance, we remain confident in our ability to reach $100 million in total revenue this year.  We also expect to be cash flow positive this year and, with the additional funds raised in our recent follow-on offering, we will have sufficient capital resources to support our strategic plans.”

“We are also pleased to have an upcoming PDUFA date of August 29, 2017, for the completion of the review of the BLA for Kamada’s Anti-Rabies IgG, and we are looking forward to launching this product in the US in collaboration with Kedrion, our strategic partner, if approved by the FDA, before the end of this year,” continued Mr. London.  “We have multiple additional expected upcoming clinical milestones, including a U.S. Phase 3 pivotal clinical trial for our proprietary inhaled AAT for the treatment of AATD, and a combined U.S. and European Phase 2/3 clinical trial for our G1-AAT IV for the treatment of acute Graft-Versus-Host Disease (GvHD), both of which we intend to initiate in 2018.  We also expect top-line results from our Phase 2 trial for D1-AAT IV for the treatment of newly diagnosed Type-1 Diabetes in the second half of 2017.” 

Financial Highlights for the Three Months Ended June 30, 2017:

  • Total revenues were $32.5 million, a 71% increase from the $19.1 million reported in the second quarter of 2016.
  • Revenues from the Proprietary Products segment were $26.9 million, a 122% increase from the $12.1 million reported in the second quarter of 2016.  This included approximately $11.5 million in revenues that were delayed from the first quarter of 2017.
  • Revenues from the Distributed Products segment were $5.7 million, an 18% decrease from the $7.0 million reported in the second quarter of 2016.
  • Gross profit was $11.7 million, a 108% increase from the $5.6 million reported in the second quarter of 2016.
  • Gross margin increased to 36% from 30% in the second quarter of 2016.
  • Net income was $4.9 million, or $0.13 per share, compared to a net loss of $1.6 million, or a loss of $0.04 per share, in the second quarter of 2016.
  • Adjusted net income was $5.1 million compared to adjusted net loss of $1.3 million in the second quarter of 2016.

Financial Highlights for the Six Months Ended June 30, 2017:

  • Total revenues were $44.2 million, a 31% increase from $33.9 million in the first six months of 2016.
  • Revenues from the Proprietary Products segment were $33.5 million, a 44% increase from $23.2 million in the first six months of 2016.
  • Gross profit was $14.0 million, a 35% increase from the $10.4 million reported in the first six months of 2016.
  • Gross margin increased to 32% from 31% in the first six months of 2016.
  • Net income was $0.9 million, or $0.02 per share, compared to a net loss of $3.9 million, or a loss of $0.11 per share, in the same period of 2016.
  • Adjusted net income was $1.3 million compared to an adjusted net loss of $3.2 million in the same period of 2016.

Recent Corporate Highlights:

  • Submitted to the U.S. Food and Drug Administration (FDA) for review a proposed pivotal Phase 3 protocol for Kamada’s proprietary inhaled AAT therapy for the treatment of AATD.  The Company expects a response from the FDA shortly in regards to the proposed protocol.  If approved to move forward by the FDA, Kamada intends to proceed with a U.S. Phase 3 pivotal clinical trial as quickly as possible.
  • Following discussions with the European Medicines Agency in regards to the study results of Kamada’s Phase 2/3 study in the EU with Inhaled AAT to treat AATD, the Company recently withdrew the Marketing Authorization Application in Europe. Kamada intends to resubmit the application, should the results of the Company’s planned Phase 3 U.S. pivotal study of inhaled AAT for AATD support this plan.
  • Reached an agreement with Shire whereby the Investigational New Drug application approved by the FDA for the Phase 2/3 study evaluating Alpha-1 Antitrypsin (G1-AAT IV) for the treatment of acute Graft-Versus-Host Disease (GvHD) will be transferred from Shire to Kamada.  Kamada will take full ownership and responsibility for the clinical development of the product in this indication.   The Company expects to initiate a combined U.S. and European Phase 2/3 trial in 2018, following the completion of standardizing the study design across both territories.
  • Received an undisclosed milestone payment from Shire under the supply and distribution agreement for GLASSIA®, Kamada’s intravenous (IV) Alpha-1 Antitrypsin (AAT).  The milestone payment was triggered by Shire achieving a sales milestone for GLASSIA® in the U.S.
  • Presented updated Phase 2 clinical trial data of the Company’s proprietary inhaled AAT therapy for the treatment of AATD at the 2017 American Thoracic Society International Conference.
  • Appointed Michal Stein, M.D., as Vice President and Medical Director for Immunology.  Dr. Stein will lead Kamada’s medical affairs in all of the Company’s Immunology and specific IgG products and indications, such as Type-1 Diabetes, GvHD, transplantations, and Anti-Rabies IgG.

Upcoming Milestones:

  • PDUFA date of August 29, 2017 for the completion of the review of the BLA for Anti-Rabies IgG therapy.
  • Expect to receive FDA approval to conduct a pivotal Phase 3 trial for inhaled AAT.
  • Last patient enrolled in February 2017 in the Company’s Type-1 Diabetes Phase 2 trial; top-line results anticipated in the second half of 2017.
  • Completed patient recruitment in the Company’s lung transplantation Phase 2 trial; expect to have an interim report from this trial in the second half of 2017.
  • Anticipate submitting Clinical Trial Application for IV AAT in GvHD in Europe in the second half of 2017, and initiating the combined U.S. and European trial in 2018.

Second Quarter 2017 Financial Results Compared to Second Quarter 2016 Financial Results

Total revenues were $32.5 million, a 71% increase from the $19.1 million reported in the second quarter of 2016.  Revenues from the Proprietary Products segment included approximately $11.5 million in revenues that were delayed from the first quarter, and were $26.9 million, a 122% increase from the $12.1 million reported in the second quarter of 2016.  Revenues from the Distributed Products segment were $5.7 million, an 18% decrease from the $7.0 million reported in the second quarter of 2016.

Gross profit was $11.7 million, a 108% increase from the $5.6 million reported in the second quarter of 2016.  Gross margin increased to 36% from 30% in the second quarter of 2016, primarily as a result of an increase in revenues from the Proprietary Products segment.

R&D expenses in the second quarter of 2017 were $3.5 million, essentially flat as compared to the second quarter of 2016. Selling, general and administrative expenses were $3.2 million, up 18% from the $2.7 million reported in the same period in 2016.  Operating income in the second quarter of 2017 was $5.0 million, compared to the $0.6 million operating loss recorded in the same period of 2016.  Net income for the second quarter of 2017 was $4.9 million, or $0.13 per diluted share, compared to a net loss of $1.6 million, or loss of $0.04 per diluted share, in the same period of 2016.

Adjusted EBITDA for the second quarter of 2017 was $6.1 million, compared with Adjusted EBITDA for the second quarter of 2016 of $0.6 million. Adjusted net income for the second quarter of 2017 was $5.1 million, compared with an adjusted net loss of $1.3 million in the second quarter of 2016.

Six Months Ended June 30, 2017 vs. June 30, 2016

Total revenues were $44.2 million, a 31% increase from the $33.9 million reported in the first six months of 2016.  Revenues from the Proprietary Products segment were $33.5 million, a 44% increase from the $23.2 million reported in the six month period of 2016.  Revenues from the Distributed Products segment were $10.7 million, essentially flat with the $10.6 million reported in the six month period of 2016.

Gross profit was $14.0 million, a 35% increase from the $10.4 million reported in the six month period of 2016.  Gross margin increased to 32% from 31% in the six month period of 2016. 

R&D expenses were $6.6 million, a decrease of 13% as compared to $7.6 million in the same period of 2016.  Selling, general and administrative expenses were $6.1 million, an increase of 13% compared to $5.4 million in the same period of 2016.  The Company reported operating income of $1.3 million, compared with an operating loss of $2.6 million in the same period of 2016.  Net income was $0.9 million, or $0.02 per diluted share, compared with a net loss of $3.9 million, or $0.11 per diluted share, in the same period of 2016.

Adjusted EBITDA was $3.5 million, compared with negative Adjusted EBITDA of $0.2 million for the same period of 2016.  Adjusted net income was $1.3 million compared to an adjusted net loss of $3.2 million in the six month period of 2016.

Balance Sheet Highlights

As of June 30, 2017, the Company had cash, cash equivalents and short term investments of $26.9 million, compared with $28.6 million as of December 31, 2016. Kamada generated $0.4 million of cash from operations and used $1.9 million for capital expenditures in the second quarter of 2017.

2017 Revenue Guidance

For the year ending December 31, 2017, Kamada continues to expect total revenues to be $100 million, with Proprietary Products revenues between $76 and $78 million and Distributed Products revenues between $22 and $24 million.

Conference Call

Kamada management will host an investment community conference call at 8:30am Eastern Time to discuss these results and answer questions.  Shareholders and other interested parties may participate in the conference call by dialing 888-221-9591 (from within the U.S.), 1 80 924 6042 (from Israel), or 719-325-4893 (International) and entering the conference identification number: 2753969. The call will also be webcast live on the Internet on the Company’s website at www.kamada.com.

A replay of the call will be accessible two hours after its completion through August 15 by dialing 844-512-2921 (from within the U.S.) or 412-317-6671 (from outside the U.S.) and entering the conference identification number: 2753969. The call will also be archived for 90 days on the Company’s website 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 (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 for which a MAA was submitted to the EMA after completing a pivotal Phase 2/3 clinical trials in Europe.  Kamada has also completed its Phase 2 clinical trials in the U.S for the treatment of AAT deficiency with inhaled AAT. 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 submissions and 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,
      2017       2016       2016  
    Unaudited     Audited
    In thousands
Current Assets            
Cash and cash equivalents   $ 11,024     $ 7,136     $ 9,968  
Short-term investments     15,906       22,391       18,664  
Trade receivables, net     22,778       15,936       19,788  
Other accounts  receivables     2,087       3,475       3,063  
Inventories     24,072       28,423       25,594  
             
      75,867       77,361       77,077  
             
Non-Current Assets            
Property, plant and equipment, net     23,925       21,138       22,249  
Other long-term assets     404       73       370  
             
      24,329       21,211       22,619  
             
      100,196       98,572       99,696  
Current Liabilities            
Current maturities of loans and convertible debentures     545       392       412  
Trade payables     14,134       10,247       16,277  
Other accounts payables     6,772       6,068       5,614  
Deferred revenues     5,177       5,114       4,903  
             
      26,628       21,821       27,206  
             
Non-Current Liabilities            
Loans     1,433       1,537       1,364  
Employee benefit liabilities, net     863       402       722  
Deferred revenues     2,934       5,424       3,661  
             
      5,230       7,363       5,747  
Shareholder's Equity            
Ordinary shares     9,321       9,320       9,320  
Share premium     162,686       162,649       162,671  
Capital reserve due to translation to presentation currency     (3,490 )     (3,490 )     (3,490 )
Capital reserve from hedges     229       9       (27 )
Capital reserve from available for sale financial assets     31       119       19  
Capital reserve from share-based payments     10,221       9,455       9,795  
Capital reserve from employee benefits     (81 )     (59 )     (81 )
Accumulated deficit     (110,579 )     (108,615 )     (111,464 )
      68,338       69,388       66,743  
    $ 100,196     $ 98,572     $ 99,696  


CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
    Six months period
ended
June 30,
  Three months period
ended
 June 30,
  Year ended
December 31
      2017       2016       2017       2016       2016  
    Unaudited   Audited
    In thousands (except for per-share data)
                     
Revenues from proprietary products   $ 33,510     $ 23,226     $ 26,874     $ 12,106     $ 55,958  
Revenues from distribution     10,687       10,637       5,675       6,960       21,536  
                     
Total revenues     44,197       33,863       32,549       19,066       77,494  
                     
Cost of revenues from proprietary products     21,218       14,410       16,053       7,479       37,433  
Cost of revenues from distribution     8,969       9,047       4,784       5,958       18,411  
                     
Total cost of revenues     30,187       23,457       20,837       13,437       55,844  
                     
Gross profit     14,010       10,406       11,712       5,629       21,650  
                     
Research and development expenses     6,638       7,609       3,487       3,502       16,245  
Selling and marketing expenses     2,112       1,691       1,084       856       3,243  
General and administrative expenses     3,947       3,674       2,117       1,861       7,643  
                     
Operating income (loss)     1,313       (2,568 )     5,024       (590 )     (5,481 )
                     
                     
Financial income     174       298       96       133       469  
Income (expense) in respect of currency exchange and derivatives instruments, net     (479 )     (59 )     (245 )     90       127  
Financial expense     (36 )     (67 )     (13 )     (30 )     (126 )
Gain (loss) before taxes on income     972       (2,396 )     4,862       (397 )     (5,011 )
Taxes on income     87       1,488       -       1,188       1,722  
                     
Net income (loss)     885       (3,884 )     4,862       (1,585 )     (6,733 )
                     
Other Comprehensive Income (loss):                    
Items that may be reclassified to profit or loss in subsequent periods:                    
Gain (loss) on available for sale financial assets     12       46       (6 )     (25 )     (54 )
Profit (loss) on cash flow hedges     372       80       165       (165 )     47  
Net amounts transferred to the statement of profit or loss for cash flow hedges     (116 )     (70 )     (94 )     (36 )     (73 )
Items that will not be reclassified to profit or loss in subsequent periods:                    
Actuarial net gain of defined benefit plans     -       -       -       -       (22 )
Total comprehensive income (loss)   $ 1,153     $ (3,828 )   $ 4,927     $ (1,811 )   $ (6,835 )
                     
Earnings (loss) per share attributable to equity holders of the Company:                    
Basic earnings (loss) per share   $ 0.02     $ (0.11 )   $ 0.13     $ (0.04 )   $ (0.18 )
                     
Diluted earnings (loss) per share   $ 0.02     $ (0.11 )   $ 0.13     $ (0.04 )   $ (0.18 )


CONSOLIDATED STATEMENTS OF CASH FLOWS              
                                       
                                       
  Six months period
Ended
June 30,
  Three months period 
Ended
June 30,
  Year Ended
December 31,
    2017       2016       2017       2016       2016  
  Unaudited   Audited
  In thousands
                   
Cash Flows from Operating Activities                  
                   
   Net loss $ 885     $ (3,884 )   $ 4862     $ (1,585 )   $ (6,733 )
                   
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   1,745       1,709       861       878       3,501  
Finance expense ( income), net   341       (172 )     162       (193 )     (470 )
Cost of share-based payment   441       709       196       328       1,071  
Income tax expense   87       1,488       -       1,188       1,722  
Loss (gain) from sale of property and equipment   (45 )     10       (45 )     -       (18 )
Change in employee benefit liabilities, net   141       (385 )     43       (250 )     (87 )
                   
    2,710       3,359       1,217       1,951       5,719  
Changes in asset and liability items:                  
                   
Decrease (increase) in trade receivables, net   (3,787 )     7,304       (12,277 )     (6,955 )     3,489  
Decrease  in other accounts receivables   154       147       409       905       211  
Decrease (increase) in inventories   1,522       (2,087 )     3,605       3,182       742  
Decrease (increase) in deferred expenses   1,004       (774 )     434       (304 )     (433 )
Decrease in trade payables   (1,979 )     (6,869 )     (115 )     (7,939 )     (2,650 )
Increase in other accounts payables   1,189       726       1,928       439       1,520  
Increase (decrease)  in deferred revenues   (453 )     3,009       278       3,975       1,035  
                   
    (2,350 )     1,456       (5,738 )     (6,697 )     3,914  
                   
Cash received (paid) during the period for:                  
Interest paid   (9 )     (9 )     (5 )     (7 )     (60 )
Interest received   149       424       41       138       842  
Taxes paid   (10 )     (306 )     (6 )     (303 )     (1,785 )
                   
    130       109       30       (172 )     (1,003 )
                   
Net cash provided by (used in) operating activities $ 1,375     $ 1,040     $ 371     $ (6,503 )   $ 1,897  

 

CONSOLIDATED STATEMENTS OF CASH FLOWS              
                   
  Six months period   Three months period     
  Ended   Ended   Year Ended
  June 30,   June 30,   December 31,
    2017       2016       2017       2016       2016  
  Unaudited   Audited
  Thousands of US dollar
                   
Cash Flows from Investing Activities                  
Proceeds from sale of (investment in) short term investments, net $ 2,973     $ 776     $ 2,061     $ 1,392     $ 4,236  
Purchase of property and equipment   (2,615 )     (1,469 )     (1,879 )     (543 )     (2,641 )
Proceeds from sale of property and equipment   53       21       53       -       42  
                   
Net cash provided by (used in) investing activities   411       (672 )     235       849       1,637  
                   
Cash Flows from Financing Activities                  
Proceeds from exercise of warrants and options   1       -       -       -     *  
Receipt of long-term loans   -       1,701       -       1,071       1,701  
Repayment of long-term loans   (238 )     (61 )     (133 )     (50 )     (211 )
                   
Net cash provided by (used in) financing activities   (237 )     1,640       (133 )     1,021       1,490  
                   
Exchange differences on balances of cash and cash equivalent   (493 )     81       (227 )     164       (103 )
                   
Increase (decrease) in cash and cash equivalents   1,056       2,089       246       (4,469 )     4,921  
                   
Cash and cash equivalents at the beginning of the period   9,968       5,047       10,778       11,605       5,047  
                   
Cash and cash equivalents at the end of the period $ 11,024     $ 7,136     $ 11,024     $ 7,136     $ 9,968  
                   
Significant non-cash transactions                  
                   
Purchase of property and equipment through capital lease $ 282     $ 84     $ 282     $ -     $ 132  
Purchase of property and equipment $ 575     $ -     $ 575     $ -     $ 1,968  
                   
* Represent an amount of less than 1 thousand                  


ADJUSTED EBITDA
    Six months period
Ended 
June 30,
  Three months period
Ended June 30,
  For the year
Ended December 31,
 
      2017       2016       2017     2016     2016
 
     
    Thousands of US dollar
                     
Net income (loss)   $ 885     $ (3,884 )   $ 4,862   $ (1,585 )   $ (6,733 )
                                       
Income tax expense     87       1,488       -     1,188       1,722  
                     
Financial expense (income), net     (138 )   (231 )       (83 )     (103 )       (343 )
                     
Depreciation and amortization expense     1,745       1,709       861     878       3,501  
                     
Share-based compensation charges     441       709       196     328       1,071  
                     
Expense (Income) in respect of translation differences and derivatives instruments, net     479       59       245     (90 )     (127 )
                     
Adjusted EBITDA   $ 3,499     $ (150 )   $ 6,081   $ 616     $ (6,290 )


ADJUSTED NET INCOME
    Six months period Ended
June 30,
  Three months period
Ended June 30,
  For the Year
Ended December
31,
 
      2017       2016     2017   2016   2016
 
    Thousands of US dollar  
                       
Net income (loss)   $ 885     $ (3,884 )   $ 4,862   $ (1,585 )   $ (6,733 )  
                       
Share-based compensation charges     441       709       196     328       1,071    
                       
Adjusted Net income (loss)     1,326 $   (3,175)   $   $ 5,058   $ (1,257 )   $ (5,662 )  


CONTACTS: Gil Efron Deputy CEO & Chief Financial Officer IR@kamada.com Bob Yedid LifeSci Advisors, LLC 646-597-6989 Bob@LifeSciAdvisors.com

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