Market Overview

Kamada Reports Financial Results for Third Quarter and First Nine Months of 2018

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  • Total Revenues for First Nine Months of 2018 were $66.3 Million, a 1% Decrease Year-Over-Year
  • Gross Profit for First Nine Months of 2018 was $20.2 million, a  1% Decrease Year-Over-Year
  • Adjusted EBITDA was $7.4 Million in First Nine Months of 2018, an Increase of 71% Compared to $4.3 Million in Same Period of 2017
  • Reaffirms Revised Revenue Guidance of $102 to $108 Million in Total Revenues for 2018
  • Provides Total Revenue Guidance of $125 to $130 Million for 2019, which represents more than 20% increase over 2018 Guidance

REHOVOT, Israel, Nov. 12, 2018 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA) (KMDA.TA), a plasma-derived protein therapeutics company, today announced financial results for the three and nine months ended September 30, 2018.

"While our revenue and profitability metrics were, as expected, meaningfully impacted in the third quarter by the labor strike at our Beit Kama production facility,  for the first nine months of 2018, our operating and net profits were significantly improved from the same period last year," said Amir London, Kamada's Chief Executive Officer. "Based on our outlook for a strong fourth quarter, we are reiterating our revised full-year 2018 revenue guidance of $102 million to $108 million.  For 2019, based on our projected production capacity and product availability, we expect total revenues in the range of $125 million to $130 million, which would represent an increase of more than 20 percent over anticipated full-year 2018 total revenue.  The projected revenues for 2019 are comprised of approximately 80% of Kamada's proprietary products segment and the balance is revenues of our Israeli distribution segment. The expected growth will primarily be driven by our increased sales of GLASSIA® and KedRAB® in the U.S. market."

"During the first nine months of 2018, we generated operating income of $3.9 million, as compared to operating income of $1.0 million for the same period last year.  In addition, we recorded $4.6 million in net income during the first nine months of 2018, a substantial increase over the $0.6 million of net income recorded in the first nine months of 2017.  Our adjusted EBITDA of $7.4 million for the first nine months increased 71% compared to the same period of 2017.  Moreover, we continue to maintain a strong cash position, including $44.9 million of cash and short-term investments at the end of the third quarter, which provides us with the financial resources needed to continue executing on our business plan," continued Mr. London. 

"Our development pipeline continues to progress.  Following receipt of positive scientific advice from the Committee for Medicinal Products for Human Use of the European Medicines Agency on the overall design of our proposed pivotal Phase 3 study for our proprietary inhaled AAT for the treatment of alpha-1 antitrypsin deficiency, we are finalizing a detailed plan for the clinical program, and preparing a Clinical Trial Application submission.  In the U.S., we continue to advance our discussions with the Food and Drug Administration in order to reach agreement on the regulatory path forward for inhaled AAT as expeditiously as possible," concluded Mr. London.

Financial Highlights for the Three Months Ended September 30, 2018

  • Total revenues were $15.0 million in the third quarter of 2018, a 35% decrease from the $22.9 million recorded in the third quarter of 2017, due to the delay in product supply as a result of the now concluded labor strike.
  • Revenues from the Proprietary Products segment in the third quarter of 2018 were $9.5 million, a 45% decrease from the $17.0 million reported in the third quarter of 2017.
  • Revenues from the Distributed Products segment were $5.5 million in the third quarter of 2018, a 6% decrease from the $5.9 million recorded in the third quarter of 2017.
  • Gross profit was $2.5 million in the third quarter of 2018, a $3.9 million decrease from the $6.4 million reported in the third quarter of 2017.  Gross margin decreased to 17% from 33% in the third quarter of 2017, due primarily to a one-time loss of $0.8 million due to a loss of in-process materials and $1.8 million of overhead cost charges due to lower than standard production level in the third quarter, both of which are directly related to the labor strike.
  • Operating expenses, including R&D and SG&A expenses, totaled $5.0 million in the third quarter of 2018, as compared to $6.8 million in the third quarter of 2017.
  • Net loss was $2.4 million, or ($0.06) per share, in the third quarter of 2018, compared to a net loss of $0.2 million, or ($0.01) per share, in the third quarter of 2017.
  • Adjusted EBITDA was ($1.4) million in the third quarter of 2018, compared to $0.8 million in the third quarter of 2017.
  • Cash provided by operating activities was $1.0 million in the third quarter of 2018, compared to cash used in operating activities of $1.5 million in the third quarter of 2017.

Financial Highlights for the Nine months Ended September 30, 2018

  • Total revenues were $66.3 million in the first nine months of 2018, a 1% decrease from the $67.1 million recorded in the same period of 2017. 
  • Revenues from the Proprietary Products segment in the first nine months of 2018 were $47.6 million, a 6% decrease from the $50.6 million reported in the same period of 2017.
  • Revenues from the Distributed Products segment were $18.6 million in the first nine months of 2018, a 12% increase from the $16.5 million recorded in the same period of 2017.
  • Gross profit was $20.2 million in the first nine months of 2018, a $0.3 million decrease from the $20.5 million reported in the first nine months of 2017. Gross margin increased to 31% from 30% in the first nine months of 2017.
  • Operating expenses, including R&D and SG&A expenses, totaled $16.3 million in the first nine months of 2018, as compared to $19.5 million in the same period of 2017. This decrease was attributable to a decrease in R&D spending.
  • Net income was $4.6 million, or $0.11 per share, in the first nine months of 2018, compared to net income of $0.6 million, or $0.02 per share, in the same period of 2017.
  • Adjusted EBITDA was $7.4 million in the first nine months of 2018, an increase of approximately 71% compared to $4.3 million in the same period of 2017.
  • Cash flow provided by operating activities was $4.2 million, compared to cash used in operating activities of $0.1 million in the same period of 2017.

       
Balance Sheet Highlights
As of September 30, 2018, the Company had cash, cash equivalents and short-term investments of $44.9 million, compared with $43.0 million at December 31, 2017.

Recent Corporate Highlights

  • Concluded labor strike at Beit Kama production facility in Israel.
  • Announced the extension of an ongoing investigator initiated, proof-of-concept study evaluating the potential benefit of the Company's liquid AAT on liver preservation and transplant rejection prevention. Kamada is collaborating with Massachusetts General Hospital, which is conducting and funding a study to assess the effect of AAT on liver graft quality and viability, and to evaluate the liver graft for markers of Ischemia-Reperfusion Injury and tissue damage. 
  • Appointed Eitan Kyiet as Vice President of Business Development.  Mr. Kyiet has over 20 years of experience in business development, strategic operations and corporate law, with a significant portion of his career spent in the life sciences industry.  He will lead Kamada's business development and strategic commercial activities, with a focus on advancing market opportunities for the Company's products.

Conference Call
Kamada management will host an investment community conference call on Monday, November 12 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 888-394-8218 (from within the U.S.), 1809-212-883 (from Israel), or 323-701-0225 (International) and entering the conference identification number: 7992586. 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 November 27 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: 7992586. 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 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 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 six other plasma-derived 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 late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency, and in addition, it's intravenous AAT is in development for other indications, such as type-1 diabetes, GvHD and prevention of lung transplant rejection. Kamada's rabies immune globulin (Human) product received FDA approval for Post-Exposure Prophylaxis against rabies infection in August 2017 and was launched in the US during Q1-2018. 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 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 (without limitation) statements regarding the company's full-year 2018 and 2019 total revenue guidance, the optimism associated with the development plan for Kamada's proposed pivotal Phase 3 study for its proprietary inhaled Alpha-1 Antitrypsin (AAT) and related regulatory path, as well as the progress of the collaboration with Massachusetts General Hospital for evaluating the potential benefit liquid AAT on liver preservation and transplant rejection prevention.. 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 ongoing clinical studies, delays in clinical and pre-clinical studies, additional competition in relevant markets, regulatory delays, prevailing market conditions, and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise. 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:
Chaime Orlev
Chief Financial Officer
IR@kamada.com

Bob Yedid
LifeSci Advisors, LLC
646-597-6989
Bob@LifeSciAdvisors.com

             
             
CONSOLIDATED BALANCE SHEETS            
    As of September 30,   As of December 31,
     2018     2017     2017 
             
    Unaudited   Audited
         
    In thousands
Current Assets            
Cash and cash equivalents   $   12,871     $   12,156     $     12,681  
Short-term investments     32,051       27,986       30,338  
Trade receivables, net     14,826       21,980       30,662  
Other accounts  receivables     1,857       2,683       2,132  
Inventories     28,934       23,144       21,070  
      90,539       87,949       96,883  
             
Property, plant and equipment, net     24,406       23,597       25,178  
Other long term assets     176       443       49  
      24,582       24,040       25,227  
    $     115,121     $     111,989     $     122,110  
Current Liabilities            
Current maturities of loans and capital leases     585       602       614  
Trade payables     11,512       12,004       18,036  
Other accounts payables     4,662       6,299       5,820  
Deferred revenues     1,854       4,816       4,927  
      18,613       23,721       29,397  
Non-Current Liabilities            
             
Loans and capital leases     880       1,501       1,370  
Deferred revenues     677       1,000       707  
Employee benefit liabilities, net     1,035       2,057       1,144  
      2,592       4,558       3,221  
Shareholder's Equity            
Ordinary shares     10,406       10,399       10,400  
Additional paid in capital     178,873       177,193       177,874  
Capital reserve due to translation to presentation currency     (3,490 )     (3,490 )     (3,490 )
Capital reserve from hedges     (8 )     57       46  
Capital reserve from fair value financial assets through other comprehensive income     (5 )     34       (4 )
Capital reserve from share-based payments     9,246       10,413       9,566  
Capital reserve from employee benefits     (337 )     (81 )     (337 )
Accumulated deficit     (100,769 )     (110,815 )     (104,563 )
      93,916       83,710       89,492  
    $   115,121     $   111,989     $     122,110  
 


 
Consolidated Statements of Profit or Loss and Other Comprehensive Income (Loss)
 
  Nine months period ended    Three months period ended   Year ended
  September 30,   September 30,   December 31,
  2018   2017   2018   2017   2017
                   
  Unaudited   Audited
       
  In thousands
Revenues from proprietary products $ 47,646     $ 50,568     $ 9,454     $ 17,058     $ 79,559  
Revenues from distribution   18,612       16,547       5,521       5,860       23,266  
                   
Total revenues   66,258       67,115       14,975       22,918       102,825  
                   
Cost of revenues from proprietary products   30,506       32,727       7,869       11,509       51,335  
Cost of revenues from distribution   15,536       13,930       4,587       4,961       19,402  
                   
Total cost of revenues   46,042       46,657       12,456       16,470       70,737  
                   
Gross profit   20,216       20,458       2,519       6,448       32,088  
                   
Research and development expenses   7,174       10,056       2,323       3,418       11,973  
Selling and marketing expenses   2,724       3,133       818       1,021       4,398  
General and administrative expenses   6,132       6,270       1,902       2,323       8,273  
Other expenses   311       -       -       -       -  
Operating income ( loss)   3,875       999       (2,524 )     (314 )     7,444  
                   
Financial income   628       266       214       92       500  
Financial expenses   (297 )     (50 )     (84 )     (14 )     (162 )
Income (expense) in respect of currency exchange differences and derivatives instruments, net   334       (479 )     3       -       (612 )
Income ( loss) before taxes   4,540       736       (2,391 )     (236 )     7,170  
Taxes on income   (11 )     87       -       -       269  
                   
Net Income ( loss)   4,551       649       (2,391 )     (236 )     6,901  
                   
Other Comprehensive Income (loss)                  
Items that may be reclassified to profit or loss in subsequent periods:                  
Gain (loss) from securities measured at fair value through other comprehensive income   (1 )     15       28       3       (23 )
Gain (loss) on cash flow hedges   (88 )     303       56       (69 )     329  
Net amounts transferred to the statement of profit or loss for cash flow hedges   34       (219 )     27       (103 )     (256 )
Items that will not be reclassified to profit or loss in subsequent periods:                  
Actuarial gain (loss) from defined benefit plans   -       -       -       -       (256 )
Total comprehensive income (loss) $ 4,496     $ 748     $ (2,280 )   $ (405 )   $ 6 ,695  
                   
Income (loss) per share attributable to equity holders of the Company:                  
Basic income (loss) per share $ 0.11     $ 0.02     $ (0.06 )   $ (0.01 )   $ 0.18  
Diluted income (loss) per share $ 0.11     $ 0.02     $ (0.06 )   $ (0.01 )   $ 0.18  
 


 
Consolidated statement of cash flow
 
  Nine months period Ended   Three months period Ended   Year Ended
  September, 30   September, 30   December 31,
  2018   2017   2018   2017   2017
                   
  Unaudited   Audited
       
  In thousands
Cash Flows from Operating Activities                  
                                       
Net income (loss) $ 4,551     $ 649     $ (2,391 )   $ (236 )   $ 6,901  
                   
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:                  
                   
Adjustments to the profit or loss items:                  
                   
Depreciation and impairment   2,814       2,648       874       903       3,523  
Financial expenses (income), net   (665 )     263       (133 )     (78 )     274  
Cost of share-based payment   679       659       294       218       483  
Income tax expense (income)   (11 )     87       -       -       269  
Gain from sale of property and equipment   70       (49 )     -       (4 )     (52 )
Change in employee benefit liabilities, net   (109 )     278       (18 )     137       166  
    2,778       3,886       1,017       1,176       4,663  
Changes in asset and liability items:                  
                   
Decrease (increase) in trade receivables, net   15,346       (2,924 )     9,929       863       (9,967 )
Decrease (increase) in other accounts receivables   (179 )     (393 )     (16 )     (547 )     328  
Decrease (increase) in inventories   (7,864 )     2,450       (1,561 )     928       4,524  
Decrease (increase) in deferred expenses   522       872       91       (132 )     594  
Decrease (decrease) in trade payables   (6,394 )     (3,885 )     (4,786 )     (1,906 )     (838 )
Increase (decrease) in other accounts payables   (1,117 )     716       (141 )     (473 )     71  
Decrease  in deferred revenues   (3,860 )     (1,691 )     (1,286 )     (1,238 )     (2,930 )
    (3,546 )     (4,855 )     2,230       (2,505 )     (8,218 )
Cash received (paid) during the year for:                  
                   
Interest paid   (42 )     (16 )     (12 )     (7 )     (21 )
Interest received   451       266       204       117       399  
Taxes paid   (17 )     (14 )     (8 )     (4 )     (116 )
    392       236       184       106       262  
                   
Net cash provided by (used in) operating activities $ 4,175     $ (84 )   $ 1,040     $ (1,459 )   $ 3,608  
 


 
  Nine months period Ended   Three months period Ended     Year Ended
  September, 30   September, 30     December 31,
  2018   2017   2018   2017     2017
                     
  Unaudited     Audited
    In thousands
Cash Flows from Investing Activities                    
                     
Proceeds from sale of (investment in) short term investments, net $ (1,747 )   $ (9,068 )   $ 207     $ (12,041 )     $ (11,501 )
Purchase of property and equipment and intangible assets   (2,033 )     (3,407 )     (534 )     (792 )       (4,167 )
Proceeds from sale of property and equipment   15       57       -       4         60  
Net cash used in investing activities   (3,765 )     (12,418 )     (327 )     (12,829 )       (15,608 )
                     
Cash Flows from Financing Activities                    
                     
Proceeds from exercise of share base payments   6       2       3       1         3  
Receipt of long-term loans   -       279       -       279         279  
Repayment of long-term loans   (450 )     (380 )     (149 )     (142 )       (530 )
Proceeds from issuance of ordinary shares, net   -       15,558       -       15,558         15,568  
                     
Net cash provided by (used in) financing activities   (444 )     15,459       (146 )     15,696         15,320  
                     
Exchange differences on balances of cash and cash equivalent   224       (769 )     (52 )     (276 )       (607 )
                     
Increase in cash and cash equivalents   190       2,188       515       1,132         2,713  
                     
Cash and cash equivalents at the beginning of the period   12,681       9,968       12,356       11,024         9,968  
                     
Cash and cash equivalents at the end of the period $ 12,871     $ 12,156     $ 12,871     $ 12,156       $ 12,681  
                     
Significant non-cash transactions                    
Purchase of property and equipment through capital lease   -       282       -       -         282  
                                         
Purchase of property and equipment $ 215     $ 398     $ 215     $ 398       $ 1,681  
 


 
Adjusted EBITDA                  
                   
  Nine months period ended   Three months period ended   Year ended
  September 30,   September 30,   December 31,
  2018   2017   2018   2017   2017
                   
  Thousands of US dollars
Net income (loss) $ 4,551     $ 649     $ (2,391 )   $ (236 )   $ 6,901  
                                       
Income tax expense   (11 )     87       -       -       269  
Financial expense, net   (331 )     (216 )     (130 )     (78 )     (338 )
                                       
Depreciation and amortization expense   2,814       2,648       874       903       3,523  
                                       
Share-based compensation charges   675       659       291       218       483  
Expense (Income) in respect of translation differences and derivatives instruments, net   (334 )     479       (3 )     -       612  
  $ 7,364     $ 4,306     $ (1,360 )   $ 807     $ 11,450  
                   
                   
Adjusted net income                  
  Nine months period ended   Three months period ended   Year ended
  September 30,   September 30,   December 31,
  2018   2017   2018   2017   2017
                   
  Thousands of US dollars
Net income (loss) $ 4,551     $ 649     $ (2,391 )   $ (236 )   $ 6,901  
                                       
Share-based compensation charges   679       659       294       218       483  
Adjusted net income (loss) $ 5,230     $ 1,308     $ (2,097 )   $ (18 )   $ 7,384  

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